INDEX S. No.
Particular
Page No.
1.
Preface
1-2
2.
Executive Summary
3-8
3.
Report
9 - 30
4.
Annex
31 -156
1. Terms of Reference
31 - 33
2. Agenda for 1st Meeting of WG
34 - 43
3. Supplementary Agenda for WG
44 - 52
4. Minutes of WG 1st Meeting
53 - 57
5. MoH’s Letter to Chairman QCI
58 - 59
6. Terms of References of Task Forces
60 - 62
7. Minutes of WG 2nd Meeting
63 - 67
8. Final Report – TF1
68 - 105
9. Final Report – TF2
106 - 115
10. Final Report - TF3
116 - 123
11. Final Report – TF4
124 – 129
12. Final Report – TF5
130 – 133
13. Final Report – TF6
134 – 154
14. WG report Annex 14 Funds Rqmnt
155 - 156
PREFACE The Planning Commission, recognizing the importance of quality, standardization and conformity assessment to India’s economic growth, constituted a Working Group on Quality, Certification and Conformity Assessment for the 11th Plan for the first time in history this year. This was a path breaking initiative. The Working Group on Quality held two meetings and each of the six Task Forces set up to address individual issues held 2-3 meetings all of which, led to some very lively discussions. The final recommendations of the Working Group on Quality have been based on this background work. With the dismantling of tariff barriers and quota regime, quality has taken the centre stage in the global market. This has led to a manifold increase in the importance of standards and conformity assessment. The impact of WTO regime, and the TBT and SPS Agreements, will progressively widen. It will not only be in terms of Indian industry meeting stringent standards of health and safety for access to international market but also in driving domestic standards to international levels as competition from foreign goods sets in. The Indian consumer is bound to become more enlightened and demanding with growing purchasing power and advocacy by NGOs. The Working Group recognized that Indian industry has to intensify its pursuit of quality. It has already done this in no small measure. It has succeeded in making India a hub of world class manufacturing for international markets in many sectors like in automotive sector. It is the Government institutions, which need to gear up to meet the challenge of WTO regime and be equal partners in fuelling India’s growth in world market as provider of world class goods and services. Accordingly, the major recommendations of the Working Group relate to the policies that India should pursue in relation to the standardization, conformity assessment and regulatory framework. The key remarks are : a. National standards system with the Bureau of Indian Standards as repository of all voluntary national standards. b. National conformity assessment policy requiring all conformity assessment bodies like inspection/certification bodies and laboratories to operate as per applicable international standards whether in government or in private sector. c. Good Regulatory Practice whereby there are single regulatory bodies for each area. These bodies to rely on the available national standards and conformity assessment infrastructure rather than duplicating the same. This would mean that the government machinery has to be leaner and can focus on enforcement of regulations, while the technical work of standardization and conformity assessment can be left to duly accredited professional organizations in respective fields. d. Policy on negotiating Mutual Recognition Agreements/MoUs relating to standards and conformity assessment for regulations in trade to be developed.
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The Working Group has recommended setting up of a national regulatory authority to control the conformity assessment bodies in the country. This would ensure that the quality infrastructure in the country, especially in the government sector, is upgraded to international levels. The Working Group also recognized that quality related issues have become so complex that government institutions working in this area, be it a regulatory body like Food Authority or EIC or standardization body like BIS or conformity assessment body like QCI or a supporting technical institution, should be professionally managed. and given autonomy to perform. The Working Group also took note of the fact that standardization, conformity assessment and regulatory bodies are manpower intensive. There is an anomaly in that while huge funds have been given to government institutions to upgrade laboratories with state of the art equipment, manpower squeeze applied in general has led to underutilization of such costly equipment. The Working Group has recommended that such institutions should be given autonomy to perform and to begin with those which are self sustaining should be given freedom to decide their manpower and compensation structures with the approval of their governing bodies without reference to the government. The Working Group foresees that licensing of professionals is set to grow in international market and therefore has identified strengthening of personnel certification infrastructure as one of the important programme to be undertaken in the 11th Plan. As for empowerment of the industry, the Working Group recognized the need for government support to the SSI sector to attain international levels. It has identified steps to encourage manufacturers to set up in-house labs as a good manufacturing practice, replacement of certification linked subsidy by financial incentive for tangible quality improvement like stage wise implementation of international standards like ISO 9000 and ISO 14000, which has been successfully tried in many countries, and funding for infrastructure upgradation in sectors with critical implications for health and safety like food and pharma. In order to give a major push to promotion of quality in all sectors, it has recommended allocation of funds to all Ministries for the purpose of awareness, training and counseling. On a request received from the Ministry of Health & Family Welfare, a specific Task Force deliberated on the issue of food safety practices like Good Hygienic/Manufacturing Practices (GHP/GMP) and has recommended that these be implemented on a mandatory basis accompanied by mandatory standards for drinking water and good agricultural/animal husbandry practices to be notified within a defined time frame. I would like to place on record my sincere thanks to all members of the Working Group on Quality as well as the Task Forces for their valuable contribution in preparing the report and Secretary General, QCI for the excellent support given to the Working Group by QCI. On behalf of the Working Group members, I would also like to compliment the Planning Commission for setting up this Working Group and giving quality professionals in the country an opportunity to provide their perspective to the government. (R.A. Mashelkar) Secretary, DSIR & DG, CSIR & Chairman, Working Group on Quality 2
EXECUTIVE SUMMARY 0.
Introduction
0.1 The quality movement has traveled a long way from the days when craftsmanship reigned to the Industrial Revolution of the early 1800s to total quality and beyond in the current era. Quality today has moved beyond manufacturing into service, healthcare, education and government sectors. 0.2 Quality today means best practices, continuous improvement, and tapping the full power of knowledge. Quality means making ourselves and our world better. Quality defines and drives successful individuals, organizations and communities and nations. 0.3 Globalization, like no other force in the past, is challenging the old order, making organizations, and countries, look inwards and make paradigm changes in approach in order to survive and prosper. In meeting the challenge of globalization, two related weaknesses specific to developing countries need to be addressed. The first is the lack of a competitive supply capability of industrial goods to be traded. The second is related to the serious technical problems faced by developing countries in actually accessing international markets as products have to comply with a myriad of technical standards and health, safety and environmental requirements set by importing countries. 0.4 To help India overcome the above weaknesses and achieve and sustain total quality and reliability in all areas of life, work, environment, product and services at individual, organizational, community and societal levels, there is a need to relook at our structures, policies and programmes in relation to quality to make them relevant to the challenging times we are in. 0.5 Accordingly, India has to concentrate on: •
Capacity development at the level of Governments, institutions and enterprises for implementing continuous improvement, quality management and productivity improvement methodologies.
•
Promoting the establishment of quality and productivity centres for quality improvement and benchmarking.
•
Capacity building in the area of regulation, standards, conformity assessment and accreditation to overcome TBT/SPS constraints; and
•
Enhancing the competitiveness of our enterprises especially SMEs through quality and productivity improvements, and supporting the development of mechanisms to assist them in accessing global subcontracting and supply chains and networks.
3
•
1.
Promoting quality in the service sector with emphasis on health, education and public services to build Quality India
Issues
The WG on Quality considered a number of issues as follows: •
•
•
• • • • • • • •
Lack of regulation – While the WTO regime allows member countries the freedom to impose mandatory standards on account of health, safety, environment, deceptive trade practices and national security, there are several sectors in India which remain unregulated like toys, electrical/electronics/IT/telecom equipment, industrial and fire safety equipment which have health and safety implications. Further, there has been proliferation of certification and inspection bodies and laboratories but there is no system of imposing any rules or disciplines on them except accreditation, which is voluntary, leading to malpractices. Multiplicity of Regulatory /Standardization/Conformity assessment bodies with government setting up specific institutions for defined purposes and yet allowing a number of other organizations to perform the same functions resulting in avoidable duplication and waste of resources. With TBT/SPS Agreements encouraging adoption of international standards in trade, participation in international standardization has become vital to protect India’s interests. There is a lack of appreciation of impact of standards on business which contributes to the apathy towards standardization in general and international standardization in particular among all stakeholders especially the industry. Laboratory infrastructure is weak in terms of international norms – be it accreditation or vital support activities such as availability of certified reference materials or proficiency testing. Lack of information on standards, regulations and conformity assessment procedures of India’s trading partners despite designated TBT and SPS enquiry points. Lack of awareness in the industry about the performance gaps with reference to global benchmarks and reluctance to share their own performance levels Lack of awareness about impact of standards, international standards in particular, on competitiveness Inadequate skills among quality professionals guiding quality improvement efforts in the industry about quality tools and techniques for assessing economic impact of quality Inadequate understanding of the contribution of quality to profitability due to which the top managements do not devote attention to quality Absence of consumer demand for quality goods and services primarily due to lack of awareness amongst consumers on quality issues. Absence of regulatory pressure and deterrent product liability with industry knowing it can get away with poor quality without any check.
4
•
2.
Need for organizations to change their way of thinking and the way they are managed and realize that quality cannot be viewed ‘in isolation’- it must be built in to the management system. Recommendations:
Keeping the above in view, the WG on Quality has made wide ranging recommendations on a variety of subjects which are critical to India’s pursuit for total quality. They relate both to policy changes to create an enabling environment for quality to flourish and programmes to be undertaken to which are summarized below: 2.1 Standardization • • •
• •
Create a National Standards System to move towards a single national standard with BIS as the national standards body being repository of all national standards whether developed by it or by other Standards Developing Organizations (SDOs) Fund participation of identified technical experts in international standardization fora like ISO/IEC/ITU/Codex on a continuing basis Fund creation of standards cells in industry bodies and professional/technical organizations to support national/international standardization by eliciting comments from industry/professional bodies/organizations to formulate India’s position Designate identified scientific institutions to conduct research/studies to support standardization and fund them through the standards/regulation forming bodies like BIS/MoH (later Food Authority)/EIC etc. Establish Centre for study of impact of standards on competitiveness of Indian industry in QCI
2.2 Regulation • • • •
• • •
Good Regulatory Practice to be followed by India Create a national regulatory authority for standardization and conformity assessment The RBs, ABs and CABs should be strictly dedicated to regulation, accreditation and conformity assessment respectively with clear separations without combining any other conflicting roles. Therefore any activity of regulation/accreditation/conformity assessment existing in any organization not dedicated to regulation/accreditation/conformity assessment should be transferred to bodies established/designated for these purposes and Plan funding approved accordingly. All conformity assessment bodies used for regulation and other purposes by the government and its bodies to be accredited within 3 years failing which they should not be used Identified products to be brought under regulation to protect health and safety Policy for negotiating agreements related to standards and conformity assessment for trade
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2.3 Conformity Assessment •
National Conformity Assessment Policy requiring all CABs to adopt applicable international standards within a reasonable period from commencing operations
2.4 Laboratory upgradation • •
•
Creation of new labs in government sector to be undertaken only when there is well justified need Encourage public private partnership in labs – models such as leasing out management of labs with building and equipment owned by govt or funding a part of capital equipment cost or joint establishment with private sector/non-profit organizations Initiate national programmes for development of Proficiency testing (PT) services and Certified Reference Materials (CRMs)
2.5 Empowerment of industry •
•
• • •
Fund each ministry for promotion of quality within their domain like awareness, training and counseling to the industry through industry bodies, professional bodies, technical organizations – Planning Commission to invite all Ministries to seek funds for programmes for promotion of quality in the country within their domain Discontinue certification linked subsidy programmes and replace by financial incentives to be given based on defined quality improvement parameters – encourage staegwise implementation of ISO 9000/ISO 140000etc. like in many countries like South Africa, Japan, UK, France In sectors critical to health and safety like food or drugs, fund infrastructure upgradation costs for the SSI and below to attain national/international standards/regulations like GMP/GHP/HACCP Encourage manufacturers to set up in-house labs as a good manufacturing practice – policy directive to financial institutions to fund entrepreneurs when lab is part of the proposal National Benchmarking Centre to be set up in QCI to act as repository of best international/national practices and their dissemination among the industry in India
2.6 Promotion of quality • • •
Initiate work for regulation on product liability to create pressure on industry to produce quality Promote comparative testing and wide dissemination of its results to enlighten consumers and generate consumer pressure on industry Fund proposals for awareness of consumers like portals/magazines/websites/ books
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2.7 Human Resources • •
•
• • • •
Professional leadership and management for all institutions in the government sector related to quality, be it regulatory bodies or standardization or conformity assessment bodies. Any technical institution, which is self supporting and not dependent on govt for non-plan budgetary support, be given freedom to create posts, recruit manpower and decide salary/compensation structure with the approval of its governing body without reference to the govt. Exemption from normal instructions on freezing recruitment or curtailing manpower to such technical institutions as the regulatory and conformity assessment bodies, standardization bodies, laboratories, and supporting bodies including research & training bodies especially where infrastructure has been upgraded at substantial costs in the govt sector and there is an imperative need to ensure proper utilization of technical infrastructure. Development of Quality related curriculum by NCERT and other educational institutions like IITs /IIMs/NITs/MCI for professional study and training of teachers to act as faculty with support from QCI. Improvement of quality of schools by adopting with suitable modifications, where needed , of the KOALATY KID model designed by the American Society of Quality in USA. Accreditation of ITIs to improve their quality and ensure that they meet the industry’s expectations. Creation and strengthening of personnel certification bodies
2.8 Promoting Quality Culture in Organizations • •
Create dedicated cell in QCI to develop models of quality based management approach in Indian organizations and promote their adoption – initial funding and to be self sustaining later Fund implementation of national standard, IS 15700, on quality of public service delivery developed at the instance of DARPG in central/state govt ministries and govt organizations – Planning Commission may write to all Ministries/States to initiate implementation and project funding
2.9 Food sector • • •
Implement GHP/GMP/HACCP in all food industry/establishments by regulation in a phased manner Initiate a comprehensive awareness/training/counseling programme especially for SSI and below including street food sector Notify national standard for drinking water for mandatory compliance by water supply agencies
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• • •
Initiate a national programme for promoting Good Agricultural/Animal Husbandry Practices with the ultimate aim of notifying them as mandatory under a suitable legislation Initiate a national programme for monitoring residues/contaminants in the entire food chain under MoA and MoH (later Food Authority) for domestic regime and EIC for exports Implement same good practices in transportation and storage of food products
Many of the recommendations of the WG on Quality require policy decisions at the highest level of the government especially to rationalize the standardization, regulatory and conformity assessment infrastructure in the country and create an enabling environment for the growth of the industry as envisaged in the Approach Paper for the 11th Plan. At the same time, the WG on Quality has recommended funding by the government for identified programmes in the 11th Plan, some of which are expected to need only initial funding and then become self-sustaining like National Benchmarking Centre or market driven like PT services and CRMs for laboratory upgradation.
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REPORT 0.
INTRODUCTION
0.1 The quality movement can trace its roots back to medieval times when craftsmen reigned and until the early 19th century, manufacturing in the industrialized world tended to follow the craftsmanship model. The factory system, with its emphasis on product inspection, started in Great Britain in the mid-1750s and grew into the Industrial Revolution in the early 1800s. 0.2 In the early 20th century, manufacturers began to include quality processes in production practices. 0.3 After the World War II, quality became a critical component of the war effort: Bullets manufactured in one state, for example, had to work consistently in rifles made in another. The armed forces initially inspected virtually every unit of product; then to simplify and speed up this process without compromising safety, the military began to use sampling techniques for inspection, aided by the publication of military-specification standards and training courses. 0.4 The birth of total quality in the United States came as a direct response to the quality revolution in Japan following World War II. Rather than concentrating on inspection, the Japanese focussed on improving all organizational processes through the people who used them. 0.5 By the 1970s, U.S. industrial sectors such as automobiles and electronics had been broadsided by Japan’s high-quality competition. The U.S. response, emphasizing not only statistics but approaches that embraced the entire organization, became known as total quality management (TQM). 0.6 In the few years since the turn of the century, the quality movement seems to have matured beyond total quality. New quality systems have evolved from the foundations of Deming, Juran and the early Japanese practitioners of quality, and quality has moved beyond manufacturing into service, healthcare, education and government sectors. 0.7 Quality today means best practices, continuous improvement, and tapping the power of knowledge. Quality means making ourselves and our world better. Quality defines and drives successful individuals, organizations and communities and Nations. 0.8 Globalization, like no other force in the past, is challenging the old order, making organizations, and countries, look inwards and make paradigm changes in approach in order to survive and prosper. 0.9 To help India achieve and sustain total quality and reliability in all areas of life, work, environment, product and services at individual, organizational, community and societal
9
levels, we need to relook at our structures, policies and programmes to make them relevant to the challenging times we are in. 0.10 In the context of globalization, enterprises in almost all sectors of industry and related services are looking for worldwide outsourcing and supply opportunities in a continuous quest for increased competitiveness. In this environment, only the most efficient and productive businesses can survive. The enhancement of competitiveness though restructuring, upgrading, and continuous improvements thus constitute the foundations for success. In the present global trade setting, competitiveness is the key to market entry and quality, cost and delivery capability are the determinants of success. 0.11 Competitiveness is a measure of the operators’ ability to cope in the marketplace and to deal with the perpetual change of their operative environment. High quality, low costs and promptitude are essential for the competitiveness of enterprises, communities and organizations, as well as entire nations. 0.12 Competitiveness is intimately linked to quality. Research shows that it pays off to invest in quality – by reducing rework/rejection costs, optimum utilization of resources and adopting a systems approach. High quality generates customer satisfaction which, in turn, makes the customer inclined to spend more on the product or service, thus increasing the company's profit margin. 0.13 The need for improving business results by improving the quality of products, services and processes is driven by macro-economic events and customer demands for better products and services at the lowest possible costs. The tools and techniques to achieve a greater level of quality in the past may not be enough for today. The changing needs of society, customers, shareholders and regulators are some of the reasons organizations must continually improve and breakthrough to new levels. 0.14 One of the major concerns today is the marginalization of developing countries from global trade. The problem arises from two related weaknesses specific to developing countries. The first is the lack of a competitive supply capability of industrial goods to be traded. The second is related to the serious technical problems faced by developing countries in actually accessing international markets. Products have to comply with a myriad of technical standards and health, safety and environmental requirements set by importing countries. These problems are addressed in the two key WTO agreements on technical barriers to trade (TBT) and sanitary and phyto-sanitary measures (SPS) which seek to lay down rules for international trade in the areas of standards and conformity assessment. 0.15 If India aims to become a developed country and secure a significant share in the world market, it needs to pay attention to both these aspects. Although the fears that Indian industry would perish in the face of competition when economic reforms were initiated in early 1990s have proved to be unfounded, and India is on its way to becoming a hub of manufacturing, the opening up of Indian market means goods made to international standards are now freely available in the domestic market and Indian
10
industry has to upgrade quality to meet the challenge posed by them. Since both TBT and SPS agreements encourage adoption of international standards for trade and such standards are not deemed to be barriers, international standards have acquired centre stage in the global market. 0.16 A principal precondition for compliance with the TBT/SPS requirements is to have the necessary regulatory framework in place. This regulatory regime might encompass a number of measures, including import/export inspections, market surveillance, the promotion of consumer safety and protection of health, and the protection of the environment through voluntary and mandatory means, as may be deemed appropriate. The full implementation of the TBT/SPS agreements demands a functional standards setting organization, supported by conformity assessment capabilities be it certification bodies or inspection bodies or testing and calibration laboratories. A key issue today is the growing marginalization of the developing countries from the global standard setting process. At present there are more than 100,000 standards in the world, with more than 1000 new standards being added every year. In addition, voluntary standards such as the ISO 9000 for quality management systems, the ISO 14000 for environmental management system, and the hazard analysis and critical control point (HACCP) food safety system are increasingly becoming mandatory requirements for trade. Further, there are voluntary initiatives like SA 8000 for social accountability or WRAP i.e. Worldwide Responsible Apparel Production certification or Forest Stewardship Council certification for good forestry practices or EurepGap for good agricultural practices which are becoming barriers for Indian industry in world market. Needless to say, this requires a strong standards and conformity assessment infrastructure in the country with active participation of industry and other stakeholders. It has therefore become of paramount importance to India to intensify its voice in international standards setting process and ensure that such standards take into account Indian interests. 0.17 Accordingly, India has to concentrate on: •
Capacity development at the level of Governments, institutions and enterprises for implementing continuous improvement, quality management and productivity improvement methodologies.
•
Promoting the establishment of quality and productivity centres for quality improvement and benchmarking.
•
Capacity building in the area of regulation, standards, conformity assessment and accreditation to overcome TBT/SPS constraints; and
•
Enhancing the competitiveness of our enterprises especially SMEs through quality and productivity improvements, and supporting the development of mechanisms to assist them in accessing global subcontracting and supply chains and networks.
11
•
1.
Promoting quality in the service sector with emphasis on health, education and public services to build Quality India CONSTITUTION OF WG
1.1 The Planning Commission set up a high level Working Group for 11th Plan on Quality, Certification and Conformity Assessment vide its Order no I&M-3(33)/2006 dated 25 May 2006. A copy of the order is given at Annex 1 which also gives the constitution and terms of reference (ToRs) of the Working Group. 1.2 The WG on Quality held its first meeting on 11 July 2006 to deliberate on the issues which should be addressed by it within the ambit of its ToRs. The copies of agenda and minutes of the 1st meeting of the WG are placed at Annex 2-4. 1.3 The WG constituted the following Task Forces to address the individual issues: Task Force 1 on Regulatory, Standardization, Conformity assessment and supporting infrastructure issues Task Force 2 on Empowerment of industry for global competitiveness Task Force 3 on Promotion of Quality Task Force 4 on Human Resources for Quality Task Force 5 on Promotion of Culture of Quality in Organizations Subsequently, the Ministry of Health & Family Welfare approached the Chairman, QCI, who was also Chairman of the WG, for constituting a core group of stakeholders for deciding the mechanism of checking compliance to GHP/GMP being introduced under PFA Rules in the food sector. A copy of MoH’s letter dated 12 July 2006 is placed at Annex 5. Therefore, in consultation with MoH, and with the approval of the Chairman, it was decided to constitute another Task Force under the WG as under to address the issue: Task Force 6 on Introduction of GMP/GHP/HACCP in the Food sector on mandatory basis The composition and the terms of reference of the Task Forces are given at Annex 6. 1.4 The Task Forces held extensive discussions on the issues assigned to them and the reports of Task Forces were presented to the WG and discussed in its 2nd meeting held on 29 Aug 2006. The minutes of the 2nd meeting of the WG are placed at Annex 7. 1.5 The final reports of the Task Forces are placed at Annex 8 – 13. 1.6 Issues •
Lack of regulation – While it is accepted worldwide that governments are responsible for health and safety of their populace and accordingly take whatever
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measures they deem fit which finds place in the WTO regime under which TBT and SPS agreements allow member countries the freedom to impose mandatory standards on account of health, safety, environment, deceptive trade practices and national security, there are several sectors in India which remain unregulated like toys, electrical/electronics/IT/telecom equipment, industrial and fire safety equipment which have health and safety implications. Further, there has been proliferation of certification and inspection bodies and laboratories but there is no system of imposing any rules or disciplines on them except accreditation, which is voluntary, leading to malpractices. •
Multiplicity of Regulatory Bodies/Standardization/Conformity assessment bodies - Even as the Integrated Food Law aims to tackle this problem, it remains in many areas like regulation of exports where despite Export (Quality Control & Inspection) Act, which empowers government to regulate exports, and Export Inspection Council is the regulatory body, a number of organizations like APEDA, Spices Board, Tea Board etc. are also into regulation which is also inconsistent with their promotional role and funding the industry for competitiveness for exports. Similarly, despite national accreditation being available, several bodies have recognition schemes for CABs duplicating the work and imposing multiple audits on CABs. A number of voluntary standardizing bodies are operating in India while BIS is the national standards body whereas the aim should be to have a single national standard.
•
There are several voluntary initiatives like Forest certification, Worldwide Responsible Apparel Production (WRAP) certification, and Social Accountability (SA 8000) which are limiting India’s access to world markets but we are unable to respond timely to such developments nor have a strategy in place to deal with them.
•
With TBT/SPS Agreements encouraging adoption of international standards in trade, participation in international standardization has become vital to protect India’s interests. However our participation is weak and involvement of industry and scientific institutions who should be providing data is poor. Part of the reason is that participation costs money and industry or scientific institutions either do not regard this as their responsibility or are not having sufficient funds for the same. There is also a lack of appreciation of impact of standards on business which also contributes to the apathy towards standardization in general and international standardization in particular.
•
Laboratory infrastructure is weak in terms of international norms – laboratories in govt sector, especially those involved in regulation which is on grounds of health, safety and environment, are slow to go for accreditation, the worldwide accepted means of evaluating competence of CABs. Support activities which are vital for labs like Certified reference materials and Proficiency testing services need to be considerably strengthened to meet the growing needs of labs in the country.
13
•
Lack of information on standards, regulations and conformity assessment procedures of India’s trading partners despite designated TBT and SPS enquiry points.
•
Lack of awareness about the performance gaps with reference to global benchmarks and reluctance to share their own performance levels
•
Lack of awareness about impact of standards, international standards in particular, on competitiveness.
•
Inadequate skills among quality professionals guiding quality improvement efforts in the industry about quality tools and techniques for assessing economic impact of quality
•
Inadequate understanding of the contribution of quality to profitability due to which the top managements do not devote attention to quality. The industry has unfortunately not been able to realize that quality means profitability and if given top priority then it will not only grow but also provide better return on investment. If the Industry is convinced that if they invest more on improving quality then they would definitely grow and build the desired confidence in the consumers about the benefits from purchasing quality products and services.
•
Absence of consumer demand for quality goods & services are primarily due to lack of awareness amongst consumers on benefits from quality products and services. Due to such low level of awareness with consumers on quality the markets also sell poor quality products and services and there is practically no pressure on the industry to manufacture or sell quality products and services. While such a scenario is existing for our domestic market, on the other hand all products and services for the export market are of quality because of stringent standards and inspection procedure prior to shipment or delivery of the service and the same industry has shown considerable enterprise in upgrading quality levels. The purchasing power of the consumers is also a factor which determines the quality levels.
•
Absence of regulatory pressure which, in any case, can be only in those areas where health, safety and environment issues are involved. Further, there is absence of deterrent product liability and industry knows it can get away with poor quality without any check.
•
Regulation, standardization, conformity assessment and capacity building on quality are manpower intensive tasks and therefore it is necessary to ensure sufficiency and adequacy of manpower in government institutions vested with the responsibility of discharging the above tasks.
•
Creating a culture for quality in organizations – the task of improving quality of goods and services is the responsibility of the top management, whether in the
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government or the private sector. To improve the quality of goods and services on a sustainable basis, it must balance the interests of all stakeholders i.e customers, employees, investors and society. There are teachings of many quality gurus like Deming, Juran, Crosby and several models which are being practiced worldwide like Malcolm Baldridge Award, EFQM, TQM, Kaizen etc. In addition, in India, we have awards like Rajiv Gandhi National Quality Award and now IS 15700 specifically for quality management in public service organizations. All these profess to promote culture of quality in organizations although there may be differences in approaches. The organizations need to change their way of thinking and the way they are managed to achieve this objective. The quality cannot be viewed ‘in isolation’, it must be built in to the management system. 2.
RECOMMENDATIONS The final recommendations of the WG can be divided into two broad groups:
a. b.
Recommendations relating to policy decisions to be taken by the Government Recommendations relating to the programmes to be taken up for funding by the Government. These have been given below; the detailed justifications for each recommendation are available in the reports of the Task Forces placed at Annex 8-13.
2.1
POLICY DECISIONS
2.1.1 NATIONAL STANDARDS SYSTEM – The following policy is recommended: • •
• • • •
BIS shall be the national standards body and repository of all voluntary national standards. Wherever standards are being formulated by other standards development organizations (SDOs) which are recognized as national (like IRC or Agmark), these shall be published as national standards by BIS while these bodies would continue to make these standards and published standards shall duly acknowledge this fact. BIS shall work out formal mutual understanding with all SDOs including revenue sharing model for income from sale of standards made by other SDOs in consultation with all stakeholders, if need be. All SDOs shall follow the code of good practice prescribed in the WTO TBT Agreement. There shall be a defined system of accreditation of the SDOs to be developed and operated by QCI and all SDOs shall take accreditation to be part of the national standards system. BIS shall endeavour to build formal linkages with Regulatory bodies to encourage them to rely on national standards thus developed for the regulations developed by them.
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•
The national standards shall be open for certification by any CB duly accredited by QCI.
2.1.1.1 Grades in national standards – Recognizing that there is a large gap between the number of product standards available and the products certified, it is felt that industry needs to be incentivized to adopt national standards voluntarily. In order to
enable consumers to make informed choices based on transparent information take care of the highly varying purchasing power of the consumers in India protect the interests of the consumers many of who are uneducated and not conscious of their rights, and to take care of the Indian reality of a wide spectrum of industry from cottage to tiny to small, medium and large scale sectors with varying capability to achieve quality standards in which, while some may be capable of meeting international standards, many may meet lower standards which meet the functional needs of the consumer without compromising on health and safety parameters,
It is recommended that grades be given in national standards so that all certified products are not seen to be on par and those which meet higher quality standards get some kind of premium certification mark. Of course, there should be no compromise with health and safety parameters even in the lowest grade. 2.1.1.2 Designated scientific institutions for supporting standardization - Scientific and technical institutions, whether in govt or private or non-profit sectors, should be designated to conduct studies and generate data for supporting standardization and take up India’s position in international standardizing fora like ISO or Codex. 2.1.2 NATIONAL CONFORMITY ASSESSMENT POLICY - The following policy is recommended: a. b. c. d.
e.
Accreditation being the highest conformity assessment activity in a country, shall be supported by the government without in any way compromising its independence and impartiality. The principle of one accreditation body shall be followed with non-competition as key element. The accreditation bodies (ABs) shall operate as per applicable international standards and seek admission to multilateral arrangements to gain international acceptability for accreditation. All conformity assessment bodies (CABs) shall operate as per applicable international standards and obtain accreditation, preferably national accreditation, within a reasonable period of starting operations not exceeding two years. CABs shall be free from any activity that has potential for compromising their independence and impartiality.
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f.
The CABs shall ensure that the activities of their related bodies do not compromise the confidentiality, objectivity and impartiality of their conformity assessment activities. There shall be clear separation between regulators, CABs and promotional/counselling bodies. In particular, organizations involved in extending any financial incentives to the industry shall not conduct certification. CABs shall maintain transparent procedures and information about the conditions under which they offer services shall be publicly available. CABs shall conduct their activities in a manner so as to facilitate international or national trade. CABs shall have a publicly available procedure for attending to and resolving complaints from any of their stakeholders. The costs of conformity assessment shall be available to any applicant and should not be applied so as to restrict market competition or impede trade. The CABs shall cooperate among themselves in exchange of experience and on common issues and shall evolve and implement a code of conduct.
g.
h. i. j. k. l.
2.1.3 GOOD REGULATORY PRACTICE - The following principles shall guide in the development of a regulatory framework system: • maintain high standards for the protection of health and safety of workers, the general public and the environment; • maintain image of India as a producer of high quality goods and services in the global market and facilitate exports • use existing legislation and regulatory institutions to clarify roles, responsibilities and authorities to ensure that regulators are free from activities which lead to conflict of interest and avoid duplication; • continue to develop clear guidelines for evaluating products which are in harmony with national priorities and lead to adoption of international standards, where required; • provide for a sound scientific database on which to assess risk and evaluate products; • ensure that both development and enforcement of regulations are open and include consultation; and • contribute to the prosperity and well being of Indians by fostering a favourable climate for investment, development, innovation and adoption of sustainable products and processes. 2.1.3.1 The following recommendations are made: •
A National Regulatory Authority for Standards & Conformity Assessment may be created to ensure regulation of conformity assessment activity in the country. The regulation may also empower the govt to notify compliance to any recognized standard for regulation and should be futuristic in that it allows government the flexibility to regulate on quality related issues in respect of any new areas and
17
•
•
•
•
•
•
respond to new developments wherever sector-specific Regulatory Bodies (RBs) do not exist. It is also necessary that the concept of single RB is followed - for example many countries have regulatory standards in telecommunication sector while India does not have and it is recommended that TRAI undertakes regulation of quality and safety aspects in telecom sector. Similarly, when there is a specific Act devoted to regulation for exports, Export (Quality Control & Inspection) Act, all regulation in case of exports should be done by EIC under it using available resources and infrastructure for conformity assessment. Since in a federal structure like India’s, regulation invariably is the responsibility of the state governments, it is necessary that they operate to some common norms for uniformity of operation across the country. It is recommended that QCI may evolve norms for RBs and a system of their evaluation to ensure that RBs are impartial, consistent and uniform. The Regulatory Bodies (RBs) should not duplicate the standardization infrastructure and should be encouraged to rely on national standards evolved by BIS in the regulations; however, there should be institutional linkages between RBs and BIS in the form of MoUs clearly defining responsibilities and obligations of each party. RBs may also need to fund the activity undertaken to meet their needs. Compliance to regulations should be not only by certification but using the Europe’s CE mark model as reference, should be by various means depending on whether the product is high or medium or low risk category. At the lowest level, Suppliers’ declaration of conformity (SDOC) should be encouraged based on prescribed conformity assessment (inspection/testing) while third party intervention/certification may be prescribed for high risk products. In the case of third party compliance checking, the units may be required to go to designated CABs by rotation to prevent nexus between units and individual CABs. We should also encourage self-regulation by encouraging industry associations to set up compliance checking cells for their members and assist them in self regulation besides awareness, training and counselling. A system of reward and punishment should also be built in whereby consistently complying units can move from third party intervention to lower level of intervention or SDOC and vice versa. This would encourage responsible behaviour on the part of the industry. In order that RBs can use designated CABs for checking compliance, BIS should change its policy to allow other CBs to certify against national standards. The CABs used for regulatory purposes should necessarily be accredited under the national accreditation system by QCI/NABL. All regulation for export should be done under EIC’s umbrella even as competencies in other organizations for certification/inspection/testing are utilized by it. It may not be desirable to regulate quality of every export item and therefore, EIC should, encourage voluntary certification through its notifications in areas other than those in which mandatory quality control for exports is operational. EIC should also seek recognition from overseas RBs so that Indian products have an easier entry to foreign markets.
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•
•
•
• a. b. c. d. e. f. g. h. i. j. k.
The RBs, ABs and CABs should be strictly dedicated to regulation, accreditation and conformity assessment respectively with clear separations without combining any other conflicting roles. The roles of funding industry, assistance to industry in marketing their products, counseling etc. are inconsistent with the roles of regulation and conformity assessment and promotional bodies should not undertake regulation related to quality, certification or accreditation. Therefore any activity of regulation/accreditation/conformity assessment existing in any organization not dedicated to regulation/accreditation/conformity assessment should be transferred to bodies established/designated for these purposes and Plan funding approved accordingly. While it is a laudable aim to expect govt institutions to become self-sustaining, the pressure of earning revenues can also compromise the independence of these bodies because they have to realize revenue in the form of fee for their services from the same clients who they are expected to regulate or evaluate. Therefore, there is a need to balance the two aspects and commit a certain level of funding to such bodies to ensure their independence. It is recommended that govt institutions like the RBs should rely on accredited CABs only and a time frame of 3 years be set beyond which if their own labs or inspections or certifications are not accredited, they would not be used for regulatory or other purposes. At the same time, funds should be made available for meeting the accreditation costs and for maintaining accreditation until they become self-sustaining. The following product groups have been identified for regulation: Telecom Electrical appliances and goods Electronics and IT goods Fire safety equipment Industrial safety equipment Helmets Medical devices Toys Plastic pipes and materials used for potable water supplies Plastic and other materials used for food packaging Products for export regulation – Based on past record of rejections and quality related problems in exports, products especially agrifood products like chillies, nuts and oilseeds (groundnuts, sesame seeds etc.), fresh and processed fruits and vegetables, ready meals, coffee, tea, etc may be brought under export regulation.
2.1.3.2 Regulation in Food sector – It is recommended that: a. •
GHP/GMP/HACCP may be mandated under PFA Rules under a three-tier system based on size and risk category of food items: GHP/GMP/HACCP to be mandated for Large Scale Units and Hotels with 4 star and higher ratings
19
• • •
b.
GMP/GHP to be mandated for Small Scale Units and Hotels with 1 star to 3 star ratings. GHP to be mandated in Tiny Sector/Street Food vendors/unstarred hotels/Restaurants Industry to be encouraged to adopt HACCP with the option of voluntary certification to ISO 22000 and exemption/relaxation from regulatory compliance checks. The following timeframes may be adopted:
Large Scale units & Hotels 4 star and above HACCP
GMP/GHP
1 Year*
(Specific high risk sectors) GMP/GHP 3 Years*
SSIs including Hotels 1-3 star Tiny Scale/Street vendors/unstarred Hotels/ Restaurants
GHP
4 Years*
*from date of final notification c. A national standard may be notified for mandatory compliance by all water supply agencies – rural or urban - in a time frame of 2 years. The Department of Drinking Water Supply (DDWS) may fund development of infrastructure for potable water supply in terms of provision of sources, treatment and testing/training of technical manpower by the state govts/agencies for water supply. d. All water testing labs may be asked to go for national accreditation beginning with national and state labs within next 2 years and District labs within 3 years after which no unaccredited lab should be used for water quality testing. e. It is recognized that there has to be application of good practices through the entire food chain and since there is currently no Act suitable for notifying mandatory compliance to GAP/GAHP, an expert committee may be set up to identify how these can be mandated or a new legislation be drafted after review of existing legislation. f. A formal residue monitoring system should be put in place for monitoring of all residues, the controls as well as management of the test labs and results – this would require collaborative effort between MoA and MoH (later Food Authority) wherein MoA should manage GAP and GAHP while MoH should manage food industry/establishments. A similar system for exports is already being operated by EIC which may need to be strengthened and all agencies should share data. It would be necessary to involve accredited agencies/labs to draw samples, test and provide reports to state govt agencies responsible for management of programme in their respective areas for analysis and corrective actions; g. Residue limits should be laid down for the raw materials as well as the food products;
20
h. An approach of categorizing of labs based on their capability and designating identified labs, as National Referral Lab (s) should be adopted. The designated Referral laboratories at the apex, shall have responsibility for actions such as • • • •
Training of personnel engaged in testing Making available validated test methods Making available Proficiency Testing Programs Making available necessary Certified Reference Materials (CRM) and Certified Reference Samples (CRS) -
The Referral laboratories may carry out routine commercial testing to maintain their competence but should maintain their role as a guiding organizations for developmental purposes. 2.1.3.3 Liability Provisions - There is a need to create deterrent liability provisions including punitive damages for sub-standard goods to create pressure on manufacturers to adopt quality. This requires a suitable legislative framework and adequately equipped regulatory authority on the lines of the US Consumer Product Safety Commission. It is recommended that govt. should initiate work in this direction. Pending the creation of suitable liability provisions as recommended above, the product certification systems like ISI mark of BIS and Agmark of DMI should be modified to provide that information relating to suspensions/cancellations of use of mark on account of quality is publicized and CBs may specify product recall or that no certified product be placed in market, if necessary, which will be in line with the norms in ISO Guide 65, the international standard for product certification bodies which provides for cessation of use of mark when suspended. 2.1.3.4 Spurious drugs – The WG considered the request of Ministry of Chemicals and Fertilizers for proposing measures to fight menace of spurious drugs. It was felt that the instances of spurious drugs are normally detected by the medical practitioners who seldom report such cases. Therefore, it is necessary that their licensing code should make it obligatory for them to report such cases to an independent body. This would require creation of a body which would be repository of such information and responsible for investigations and if evidence is found substantiating that the drug is spurious, it should report to the regulator to take necessary punitive action under the law. Such a centralized repository will ensure prompt action and recall of spurious drugs. 2.1.3.5 Institutions for Competent Advice on Quality Issues to Courts/Consumers – It is felt that there is lack of independent institutions to advise on technical matters relating to quality in the absence of which even Consumer courts under the Consumer Protection Act are handicapped in deciding whether the products complained against suffer from quality defects. Therefore, there is a need for independent institutions which can render competent advice on quality issues.
21
2.1.4 POLICY ON NEGOTIATING MUTUAL RECOGNITION AGREEMENTS (MRAs) WITH INDIA’S TRADING PARTNERS – The following policy is recommended: • •
•
All MRAs on standards and conformity assessment relating to regulations should be negotiated by the Commerce Ministry. There should be a high level standing steering committee to establish the need for MRAs and guide negotiations with all stakeholders like concerned Ministries (MoH, MoA, MEA etc.), Regulatory Bodies which are involved in regulation, accreditation bodies, national standards body, and major industry associations in regulated sectors as members. The secretariat of the committee could be in EIC as the body operating the export control system. The preferred option should be to seek recognition of India’s export control system operated under the aegis of EIC by India’s trading partners through an MoU and only if the trading partner specifically seeks reciprocal recognition, dialogue for MRA should be initiated.
2.1.5 AUTONOMY OF SCIENTIFIC INSTITUTIONS – It is recommended that autonomy of scientific institutions in general and those involved in work related to quality in particular should be ensured. In this regard, the cases of BIS and EIC are specifically cited which are financially independent and yet not truly autonomous. 2.1.6 MANPOWER POLICY – It is recommended that: a) b)
c)
It is necessary that all institutions in the government sector related to quality, be it regulatory bodies or standardization or conformity assessment bodies, are provided with professional leadership and management. It is equally necessary that Technical Institutions involved in activities relating to regulation, conformity assessment, standardization, training/counselling and research in the area of quality are empowered to augment technical manpower strength as per their requirements. In this regard, the decision of the Department of Expenditure, Ministry of Finance to empower Governing Body of NABL to create posts and (salary) structure in NABL provided the Governing Body monitors the work requirement and NABL generates twice the amount required for salary, was noted. It is recommended that any technical institution, which is self supporting and not dependent on govt for non-plan budgetary support, is given freedom to create posts, recruit manpower and decide salary/compensation structure with the approval of its governing body without reference to the govt. It is also recommended that normal instructions on freezing recruitment or curtailing manpower should not apply to such technical institutions as the regulatory and conformity assessment bodies, standardization bodies, laboratories, and supporting bodies including research & training bodies especially where infrastructure has been upgraded at substantial costs in the govt sector and there is an imperative need to ensure proper utilization of technical infrastructure. In order
22
to utilize the infrastructure properly, such technical institutions should be allowed to engage personnel by fast track methods like engagement on contract. 2.1.7 INFORMATION CENTRE – The notification of regulatory standards for domestic industry, except where there is a sector specific RB, should be given to a single nodal authority which in turn should also notify the conformity assessment bodies who would certify compliance to such regulatory standards. The same authority should also develop and implement the national notification system required under the TBT Agreement. Country specific requirements should be maintained by the national authority with appropriate linkages to QCI, EIC, BIS and other interested organizations in information dissemination. This work may be assigned to the National Regulatory Authority recommended above. 2.1.8 DISCONTINUANCE OF CERTIFICATION LINKED SUBSIDY - It is recognized that subsidy for ISO 9000/ISO 14000/HACCP certifications has led to dilution of quality of certification, nexus between CBs, consultants and manufacturers and malpractices by CBs which have hurt India’s image and the benefits of ISO 9000 and other international standards have not been fully realized. Therefore, subsidy for certification for SSI units in its present form should be stopped forthwith. 2.1.9 PROMOTING INHOUSE LABS IN MANUFACTURING UNITS Recognizing that any good manufacturer must have an inhouse lab, at least for routine testing to assure quality of outgoing products by in process and end product testing, it is recommended that financial support be given to manufacturers to set up inhouse labs for which govt should advise all financial institutions/commercial banks/state financial corporations/state industrial development corporations etc. to necessarily include provision for testing facilities and labs as an integral component of the cost of setting up/expansion/upgradation/modernization of any manufacturing unit. 2.1.10 PERSONNEL CERTIFICATION –The creation and strengthening of personnel certification bodies and setting up of level 2 and 3 bodies as per the following 3 tier structure in the country for registration of personnel is recommended: • • •
Level 1 Level 2 Level 3
National Registration Board for Personnel and Training (NRBPT) State Level Registration Bodies accredited/approved by NRBPT District/City Level Registration Centres under the State Body
2.1.11 EDUCATION – The following are recommended: • •
Development of Quality related curriculum by NCERT and other educational institutions like IITs /IIMs/NITs/MCI for professional study and training of teachers to act as faculty with support from QCI. Improvement of quality of schools by adopting with suitable modifications, where needed , of the KOALATY KID model designed by the American Society of Quality in USA. Koalaty Kid encourages the use of training to implement a rigorous continuous improvement effort in schools.
23
•
Accreditation of ITIs to improve their quality and ensure that they meet the industry’s expectations.
2.1.12 PROMOTION OF QUALITY CULTURE IN ORGANIZATIONS – The following are recommended • • • •
• • • • •
• • • •
Develop Leaders who can think and practice Quality based management approach in public and private organizations Criteria for Selection and Performance appraisal of Senior Management persons/Bureaucrats should include competence (achievement, knowledge, demonstrated ability) in line with Quality management principles Recognition of individuals such as Practitioners (from CEO to cutting edge level), Quality Professionals, Publications, Institutions who are role models for practicing or propagating Quality Propagate Quality Models/Fundamental Principles for an integrated Quality based management Approach (Deming Principles, The Excellence Models like RGNQA/MBNQA/EFQM; and IS15700-Sevottam model and Charter Mark scheme for public services) for self-assessment, improvement and external evaluation and recognition. All PSUs/Government agencies should have a score as per the chosen model for improving Quality Culture (some select PSUs are already doing it through their MoUs with the Government) Review existing national quality awards and introduce a single set of prestigious national quality award to be given by the President of the country to recognize organizations based on evaluation against the chosen model Develop a Modular Approach to meet the requirements and aspirations of organizations of different size and maturity level (reference South African approach as an example of modularity) Facilitate dissemination of the knowledge required for implementing the models/standards mentioned in the above approaches Quality based management approach should be a part of the curriculum of all management, engineering and other professional courses at under graduate and post- graduate levels. The Quality Fundamentals should also be a part of the school curriculum. Quality based management approach induction programmes for technocrats and bureaucrats(e.g. LBSNAA Mussourie) at different levels. It should also be a part of the on-going training and re-training. Development, promotion and delivery of certified training programmes on Quality through out the country for building competences at different levels of people in the organization Identify, capture, and disseminate good practices/ performance (Create a Benchmarking Data Bank) Conduct national surveys of organizations (public and private) on Customer satisfaction for the products and services delivered by them and publicize results nationwide
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•
Conduct national surveys/study of organizations (public and private) and publicize results nationwide on linkages amongst Employee satisfaction, Quality Culture and Performance Excellence.
2.1.13 MEASUREMENT OF BENEFITS – In all the schemes which are funded by the Government to the manufacturers or service providers whose products or services have direct interface with common consumer, there should be a system of measuring the benefit from such funding in the form of customer satisfaction surveys periodically by an independent agency preferably by specialized organizations working on such activities and are not funded by industry. 2.1.14 SUBSIDIZED SERVICE FROM PUBLIC FUNDED QUALITY INFRASTRUCTURE – The Government is funding many quality related institutions like laboratories, hospitals and manufacturing units who should be obliged to provide services at subsidized rates to consumers as a sign of their responsibility to consumers. This may be ensured by placing a nominee of the govt on the governing bodies of such institutions. 2.2 PROGRAMMES TO BE FUNDED BY GOVERNMENT – The WG identified the following programmes for funding by the Government in the 11th Plan: 2.2.1 PARTICIPATION IN INTERNATIONAL STANDARDIZATION – Recognizing the importance of international standards in trade and therefore considering India’s participation in international standardization fora vital, it is recommended that: •
•
•
separate fund be created for participation in international standardization which could be placed at the disposal of the concerned organizations like BIS for participation in ISO/IEC work, MoH for Codex work and DoT for ITU or it could be centrally placed at the disposal of one Ministry/organization who would also oversee that right experts are funded from this. All stakeholders like manufacturers, regulators, scientific institutions, consumer organizations and conformity assessment bodies should be encouraged to participate. Industry associations/professional bodies and organizations should be encouraged to set up standardization cells dedicated to study of draft standards, dissemination among interested members, eliciting industry viewpoint and transmitting it to nodal organization for formulating India’s views, and sensitizing industry to the importance of standards in the global market. Since these cells would be cost centres, initially they may be funded by the govt but ultimately, say after the 11th Plan, industry should support this activity. A Centre under QCI should be set up to study the impact of standards in general and International Standards in particular on competitiveness of Indian industries. Further, designated scientific institutions should be supported to enable them to support standardization.
2.2.2 CERTIFIED REFERENCE MATERIALS – A national programme for development, production, certification and accreditation of CRMs and CRM producers
25
needs to be initiated, which would be initially funded by the govt through 11th Plan but should aim to become self-sustaining in 5 years with participation of private and nonprofit organizations besides government institutions. The programme may be coordinated by NPL as the nodal organization under the guidance of a steering committee comprising all stakeholders and interested organizations in line with the approach paper recommended by TF1. 2.2.3 PROFICIENCY TESTING SERVICES - A national programme for development of PT services needs to be initiated, which would be initially funded by the govt through 11th Plan but should aim to become self-sustaining in 5 years with participation of private and non-profit organizations besides government institutions. The programme may be coordinated by NABL as the nodal organization under the guidance of a steering committee comprising all stakeholders and interested organizations in line with the approach paper recommended by TF1. 2.2.4 ESTABLISHMENT OF A NATIONAL BENCHMARKING CENTRE – A National Benchmarking Centre may be established in QCI to get information on benchmarks in different industrial sectors so that Indian industries are made aware of gaps in their performance as compared to world benchmarks. 2.2.5 FINANCIAL ASSISTANCE/INCENTIVES TO INDUSTRY – Industry may be given financial assistance/incentives for: a. quality improvement based on performance indicators in lieu of certification linked subsidy which is in vogue now and which is recommended for discontinuance vide item 2.1.8 of the report. In this connection, the South African model of phased progress towards ISO 9000 for SMEs given in TF2 report is recommended for use as input for verifiable performance indicators for quality improvement by units. b. Corporate quality scholarships to professionals in the industry for acquiring advanced knowledge on quality management for those organizations who demonstrate good quality performance measured against defined criteria may be given. c. Assistance in capacity building through awareness/training/consultancy in identified priority sectors may be given with potential for growth and employment and following sectors have been identified based on NMCC priority list: Textiles and garments Leather and leather goods Food processing including GM products Gems and jewellery Handlooms and handicrafts Chemicals including plastics Pharmaceuticals including herbal products IT hardware/ electronics Auto components Human resource development relating to manufacturing
26
Capital goods industry Paper industry, and packaging material Packaging materials especially for food products
Training needs identification in the industry should be done on a continuous basis through special cells to be created within professional bodies like QCI, Institution of Engineers, NSC, and industry associations like CII, NASSCOM, etc. d. Assistance for labs - Since testing is an important part of assuring quality of products but individual manufacturers especially in small and micro sectors may not be able to afford all testing facilities, it is recommended that industry associations, be supported to set up labs for common use by members and part of the total project cost, say 50%, may be provided by the govt. e. Food sector - A national programme on awareness, training and counselling through interactive programmes, class room teaching, and mass media like TV/print media etc may be initiated with MFPI/MoH/DCSSI as the nodal points for funding SSI and below in view of mandatory GHP/GMP implementation. The funding should cover training, counseling, compliance checking and accreditation costs. Govt. institutions like AIIPHH, industry associations, promotional bodies like DCSSI/SISI, commodity boards, export promotion councils, NGOs and vendor associations should be involved in the national programme. The above funding should however be limited to training/counselling from accredited training courses providers/consultants for which QCI may develop a simpler scheme, if need be, for registration of Consultants/training course providers for Ministry of Health based on international norms for accreditation of personnel. The scheme should, however, not be restricted to individuals and should include Industry Associations as well as Govt. organizations (central or state) and NGOs. f. Infrastructure upgradation – Adopting a principle that in areas of health and safety, govt needs to support the industry, especially the SSI and below, in infrastructure upgradation , the following is recommended: Implementation of GHP/GMP in food sector would entail infrastructure upgradation for which support may be provided to the small/tiny sectors for modifications in the infrastructure for effective implementation of GMP/GHP by funding say 25% of the project cost. It would have to be one-time funding for cottage/street vendors. Implementation of GMP in Pharma sector by SSI needs to be supported through soft loans or subsidizing interest rates upto 5% etc. In this connection, the schemes of TUFS of Ministry of Textiles and CLCSS of DC (SSI) could be followed. 2.2.6 PROMOTION OF QUALITY CULTURE – It is recommended that a programme on promoting quality culture in organizations on an institutional basis is undertaken as follows:
To create an Apex Body in the form of a steering committee, comprising all stakeholders to provide guidance in the implementation of recommendations
27
• • •
and ensure their effective implementation. It will be supported by a dedicated division in QCI with a clear mandate to manage the implementation of the recommendations. Apex body constitutes a competent group to develop the Quality Principles and the Quality model appropriate to the needs of the country, which shall form the basis for the development of all education, training and consulting material; and evaluation criteria for recognition. Involve Academia, Industry, BIS, EIC and other Expert organisations to develop a Body of Knowledge, Training programs, Consulting modules for creating awareness, training and consulting methodologies for promotion of quality culture in line with the chosen model and principles. The Training programmes, Consulting modules, Training/Consulting Professionals should be duly accredited by QCI (NRBPT), and delivered by accredited consultants/professionals/organisations. The list of accredited consultants, programmes and organisations may be widely publicized. Co-ordinate with HRD Ministry and academia to include quality in the course curriculum of schools and colleges. Launch a nation wide Quality Campaign through programmes for creating awareness amongst all sections of society. Awareness programmes should be initially supported by the Government in the form of programme subsidies. Participants should pay a part of the cost as registration fee. Organize annual convention at national level Recognize the role model Organizations, Individuals, and Publications Share successful Strategies and Practices Deliberate on new trends, concerns, and challenges Steering Committee of QCI and BIS should work out the modalities for administering the Rajiv Gandhi National Quality Award in line with the chosen model, to identify and recognize organizations as role models of Quality culture in the country. Publish a Quality Journal periodically to publish articles, case studies, and study reports Separately, funding should be provided to govt organizations to implement ‘Sevottam’ for improvement in public service delivery initiated by DARPG.
2.2.7 CENTRAL PORTAL ON QUALITY RELATED SCHEMES – While the government has floated several schemes for funding upgradation of industry, the information is not readily available at a single location. It is recommended that a portal with links to Ministries/Organizations having funding schemes for upgradation of quality in industry be created. 2.2.8 SUPPORT FOR QUALITY RELATED INFORMATION, CASE STUDIES AND EXPERIENCE SHARING IN INDIAN CONTEXT – It is recommended that voluntary initiative by any segment, govt institutions, private sector, or non-profit organizations, towards promoting quality in industry in the form of hosting
28
portals/websites, publishing case studies, sharing experiences etc should be encouraged by providing funding support. 2.2.8.1 Sponsored studies on contribution of quality to profitability may be carried out by QCI under the National Quality Campaign to demonstrate to top managers the economic benefits of quality which in turn should encourage them to integrate quality in the overall management approach. 2.2.8.2 Awards for case studies on cost benefits from quality which were instituted by QCI in the year 2005-06 and given away during the 1st National Quality Conclave in Mar, 2006 should become an annual feature. 2.2.9 COMPARATIVE TESTING – In order to increase consumer awareness and create consumer pressure on manufacturers of goods and service providers, a programme of comparative testing by consumer organizations/non profit organizations using accredited labs should be instituted. 2.2.10 SUPPORT FOR LABS - All labs in the government sector should be supported not only for upgradation but also for acquiring NABL accreditation for which necessary funds may have to be made available, since in the government sector, labs would generally not be self-sustaining. This may cover academic and scientific institutions, NGOs and non-profit organizations. The creation of new labs as well as upgradation of existing labs should be supported considering that in some sectors, testing techniques are changing rapidly and labs have to keep pace with them. However, such support should be extended after analyzing the capacity of existing labs in specific areas (productwise and regionwise) and establishing need for new/upgradation of labs. The concept of networking of labs for utilization by all users should also be addressed. 2.2.11 GOOD AGRICULTURAL/ANIMAL HUSBANDRY PRACTICES - It is recognized that there has to be application of good practices through the entire food chain and therefore, it is recommended that material on GAP and GAHP be got prepared by the Ministry of Agriculture through relevant bodies such as ICAR, NDRI, CIFT etc. which may be funded by the govt. The documentation so prepared should be used by MoA for promoting the same for each sector through the existing infrastructure. The model being operated by the Spices Board in propagating good agricultural practices is also recommended for implementation by all promotional bodies. 2.2.12 RESIDUE MONITORING – A national programme for monitoring of pesticides/antibiotic/heavy metal residues with government funding should be undertaken which would require a collaborative effort between MoA and MoH (later Food Authority) wherein MoA should manage GAP and GAHP, MoH should manage food industry/establishments and EIC may conduct monitoring for exports, wherever needed. It would be necessary to:
29
3.
involve accredited agencies/labs to draw samples, test and provide reports to state govt agencies responsible for management of programme in their respective areas for analysis and corrective actions. lay down the residue limits for the raw materials as well as the food products; develop a system of cooperation and networking between different organizations for sharing of the data so that the results from the same can be used for monitoring different aspects of the quality control, for example, Export Inspection Council of India for exports, Ministry of Health & Family Welfare (Food Authority) for domestic, etc. AREAS FOR PPP/ALTERNATIVE FUNDING
The following areas have been identified for PPP/alternative funding: Laboratories - Govt. should explore mechanisms such as partnership with or • leasing out labs to private sector or non-profit organizations to ensure their efficient and professional operation and optimum capacity utilization. • CRMs • PT Services • Infrastructure upgradation – While the industry/establishments in food/pharma sectors may raise funds from FIs, govt should only fund part of the project cost for upgradation or subsidize interest..
Some of the programmes may be initiated with government support but should become self sustaining in due course, say after the 11th Plan like:
National Benchmarking Centre Project for Promoting Quality Culture in Organizations Standardization cells in industry/professional bodies/organizations
4.
PROJECTED FUND REQUIREMENT
Based on the programmes recommended by the WG in item 2 above, the requirements of funds are given below and a detailed statement is given in Annex 14.
Standardization (S. No. 1 of Annex 14) Rs. 380 cr Capacity Building (S. No. 2 of Annex 14) Rs. 4560 cr Laboratory upgradation (S. No. 3 of Annex 14) Rs. 776.75 cr Promotion of Quality (S. No. 4 of Annex 14) Rs. 1193 cr Promotion of Quality Culture QCI (S. No. 5 of Annex 14) Rs. 330 cr
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Annex 1 No.I&M-3(33)1/2006 Government of India Planning Commission (Industry Division) Yojana Bhavan, Sansad Marg New Delhi the 25th May, 2006 ORDER Subject: Constitution of a Working Group for 11th Plan on Quality, Certification and Conformity Assessment. In the context of formulation of the Eleventh Five Year Plan (2007-2012), it has been decided to set up a Working Group on Quality, Certification and Conformity Assessment. The terms of reference and composition of the Working Group will be as follows: I. Terms of Reference 1. To recommend a comprehensive set of policies/ programmes and action plan to create culture for quality within the country and to raise the quality of Indian products and services on par with their global counterparts. 2. To evolve innovative instruments such as public private partnership (PPP), which can incentivise value addition through quality up-gradation. 3. To workout corresponding financial resource requirements on aggregate and yearwise basis for the 11th Five Year Plan and sources of financing with minimum burden on budgetary resources. 4. To suggest a unified institutional arrangement for comprehensively addressing all the constituent elements of the quality cycle viz. standard setting, conformity assessment and compliance. 5. Any other relevant issue. II. Composition of Working Group 1. Dr. R.A. Mashelkar, Secretary, D/o Scientific & Ind. Research (DSIR) - Chairman Director General, CSIR 2. Secretary, Department of Industrial Policy & Promotion Member 3. Secretary, Department of Small Scale Industry & ARI
Member
4. Secretary, Department of Chemicals & Petrochemicals
Member
5. Secretary, Department of Commerce
Member
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Contd…2/6. Secretary, Ministry of Health & Family Welfare
Member
7. Secretary, Ministry of Food Processing Industries
Member
8. Secretary, Ministry of Textiles
Member
9. Secretary (Agriculture), Deptt. of Agriculture & Cooperation
Member
10. Secretary, Department of Consumer Affairs
Member
11. Secretary General, Quality Council of India
Member - Secretary
12. Dr. Jaiprakash Narain, Loksatta, Hyderabad
Member
13. Representative of Drug Controller General (India)
Member
14. Chairman, Central Pollution Control Board
Member
15. Director, Export Inspection Council
Member
16. Director General, Bureau of Indian Standards
Member
17. President, Confederation of Indian Industries
Member
18. President, Federation of Indian Chambers of Commerce & Industries
Member
19. President, Associated Chamber of Commerce
Member
20. Director, National Physical Laboratory
Member
21. Director, National Accreditation Board for Test & Calibration Laboratories Member 22. Director General, National Safety Council
Member
23. Dr. Sunita Narain, Centre for Science & Technology
Member
24. Representative of Institution of Engineers
Member
25. Chief Executive Officer, Shriram Test House
Member
26. Adviser (Industry & VSE), Planning Commission
Member
2. The Chairman of the Working Group may include additional term (s) of reference in consultation with Member (Industry), Planning Commission, who is Chairman of the concerned Steering Committee. 3. The Chairman of the Working Group may co-opt any other Expert as Member of the Working Group, if considered necessary. 4. The Working Group will submit its report within three months to the Chairman of the Steering Committee. The Quality Council of India will provide the Secretarial assistance for the Working Group. 5. The expenditure on TA/DA of official members in connection with the meetings of the Working Group will be borne by the parent Department/Ministry to which the official belongs as per the rules of entitlement applicable to them. The non-official members of
32
Contd…..3/the Group will be entitled to TA/DA as permissible to Grade I officers of the Government of India under SR190 (a) and this expenditure will be borne by the Planning Commission. 6. Shri D. Banerjee, Dy Adviser (CI), Room No.319A Yojana Bhavan (Ph. 2309 6710) will act as the Nodal Officer and any further communication in this regard may be made with the Nodal Officer. (K.K.Chhabra) Under Secretary to the Govt. of India To Chairman and all the Members (including Convenor) of the Working Group Copy to 1. PS to DCH/MOS(Planning)/Members/Member-Secretary, Planning Commission 2. All Principal Advisers/Advisers/HODs in Planning Commission 3. Prime Minister’s Office, South Block, New Delhi 4. Cabinet Secretariat, Rashtrapati Bhavan, New Delhi 5. Information Officer, Planning Commission 6. Joint Secretary (Administration), Planning Commission 7. Controller of Accounts, Planning Commission. (K.K.Chhabra) Under Secretary to the Govt. of India
33
Annex 2 AGENDA
WORKING GROUP FOR 11th PLAN ON QUALITY, CERTIFICATION AND CONFORMITY ASSESSMENT - 1st MEETING Date
11 July 2006
Venue
Office of DG, CSIR, Anusandhan Bhawan, 2, Rafi Marg, New Delhi – 110001.
CHAIRMAN : MEMBER SECRETARY : Item 1
Time
14 00h
Dr. R.A. Mashelkar, DG, CSIR Shri G.J.Gyani, Secretary General, QCI
OPENING OF THE MEETING
1.1 Welcome by Member Secretary 1.2 Opening Address by Chairman Item 2
TERMS OF REFERENCE OF THE WG
2.1 The Terms of Reference of the WG have been given in Planning Commission’s Order no. I&M-3(33)/2006 dated 25 May 2006, a copy of which is enclosed as Annex 1. The Chairman of the Working Group is authorized vide item II.2 of the Order to include additional term(s) of reference in consultation with Member (Industry), Planning Commission, who is Chairman of the concerned Steering Committee. WG may kindly note and suggest any additional ToRs. Item 3
COMPOSITION OF THE WG
3.1 The composition of the WG has been given in the Order mentioned in item 2.1 above and enclosed as Annex 1. The Chairman of the Working Group is authorized vide item II.3 of the Order to co-opt any other Expert as Member of the Working Group, if considered necessary.
34
WG may kindly note. Item 4
PROPOSALS FOR CONSIDERATION
4.1 A brief on the proposed areas of focus for the WG is attached as Annex 2. 4.2 Proposals had been invited from Members of WG vide MS’ letter dated 10 June 2006 for consideration of the WG; proposals have been received from some members as follows: a) National Accreditation Board for Testing and Calibration Laboratories (NABL) (Annex 3) b) National Safety Council (Annex 4) c) Institution of Engineers (India) (Annex 5) WG may kindly consider. Item 5
ANY OTHER BUSINESS
Item 6
DATE & TIME FOR NEXT MEETING
Item 7
VOTE OF THANKS
35
Annexure - 3
36
37
38
Annexure - 4
39
40
41
Annexure - 5
42
43
Annex 3 SUPPLEMENTARY AGENDA
WORKING GROUP FOR 11th PLAN ON QUALITY, CERTIFICATION AND CONFORMITY ASSESSMENT - 1st MEETING Since issue of Agenda on 3 July 2006, we have received some more proposals and the following may be added under item 4.2 of the Agenda: d) Export Inspection Council of India (Annex 6) e) Sports Goods Export Promotion Council (Annex 7) f) Shriram Institute For Industrial Research (Annex 8)
44
Annexure - 6
45
46
47
48
Annexure - 7
49
Annexure - 8
50
51
52
ANNEX - 4 MINUTES
WORKING
GROUP FOR 11th PLAN ON QUALITY, CERTIFICATION CONFORMITY ASSESSMENT - 1st MEETING
Date
11 July 2006
Venue
Office of DG, CSIR, Anusandhan Bhawan, 2, Rafi Marg, New Delhi - 110001.
Time
CHAIRMAN:
Dr. R.A. Mashelkar,
MEMBER
SECRETARY:
Shri G.J. Gyani, Secretary
MEMBERS
PRESENT:
As per list at Annexure 1
Item 1
OPENING
AND
1400h
DG, CSIR General,
QCI
OF THE MEETING
1.1 Welcome by Member Secretary - Shri G. J. Gyani extended a warm welcome to the members to the 151 meeting of the WG and highlighted that quality had been recognized as national issue by the Planning Commission and a separate WG had ,been set up. 1.2 Opening Address by Chairman - Dr. R.A. Mashelkar, in his opening remarks, complimented the Planning Commission for the unique initiative of setting up a WG on Quality. This sentiment was shared by a number of members. He stated that the recommendations of the WG would impinge on all sectors and there would be a need for the Planning Commission to integrate the report of this WG with other WGs which may be looking at individual sectors. He apprised the members of the ToRs of the WG and suggested that it should offer practical solutions incorporating short, medium and long term measures to achieve quality. He also suggested that the WG may create small Task Forces to look at individual issues and their recommendations could be placed before the WG. He advised that as far as possible, the WG should stick to the timel ine of 3 months for its report. He also advised the secretariat to draft a letter from him inviting comments from important stakeholders. Item 2
TERMS
OF REFERENCE
OF THE WG
2.1 The representative of the Department of Consumer Affairs (DCA), Shri Desh Bandhu. US. informed that the Planning Commission had set up another WG on
53
Consumer Protection under the chairmanship of Secretary (Consumer Affairs) which has quality infrastructure and standardization as part of its ToRs and therefore DCA had written to Planning Commission that ToR 4 of WG on Quality may be deleted. [t was decided that while the Planning Commission considers the matter, this WG would continue to deliberate on ToRs assigned to it. 2.2
The members noted the ToRs of the WG as given in Annex I of the Agenda.
Item 3 3.1
COMPOSITION
The WG noted the composition
Item 4
PROPOSALS
OF THE WG of the WG as given in Annex I of the Agenda.
FOR CONSIDERATION
A presentation on the proposed areas of focus for the WG based on the brief given in Annex 2 of the Agenda was made by S/Sh Gyani and Anil Jauhri from the secretariat. A copy of the presentation was given to participants along with meeting papers.
4.1
4.2 The Chairman invited the members to give their comments and propose any other issues that the WG should address. 4.2.1
4.2.2
4.2.3
4.2.4
on the presentation
Dr. Sunita Narain, Director, CSE, suggested that it may be desirable to compile a list of existing institutions related to conformity assessment and funding they may have been given. She suggested that we should not be too overly focussed on requirements of international trade and rather be driven by internal demands especially in food/drugs/consumer goods/environment sectors. In this context she specifically mentioned the problem of free inflow of imports. It was felt that the report for setting up National Drug Authority may serve as a good reference point. Shri K.C. Gupta, DG, NSC, proposed that attention should be given to the occupational health and safety at the workplace and the need for OHS professionals like auditors and consultants as well as certification. He also emphasized the need for independence of regulatory, accreditation and cel1ification bodies and their separation from promotional roles. Quality of public services rendered by the govt organizations was another area suggested. Dr. R.K.Khandal, Director, SIIR, emphasized the importance of participation in international standardization but brought out that it involved considerable costs which many organizations may not be able to afford. Ms. Shashi Sareen, Director, EIC, emphasized the need for role clarity among organizations to ensure their independence and avoid duplication. She also suggested pooling of resources by networking of organizations, especially labs, so that same infrastructure or competency was not created at a number of places in the government. She also proposed that manpower resources required for regulation/conformity assessment should also be looked at because after creating physical infrastructure at great cost, we may end up not utilizing it to the fullest in the absence of sufficient manpower.
54
4.2.5
4.2.6
4.2.7
4.2.8
4.2.9
Mr. Arvind Mathur emphasized the need for identifying ways to manage organizations based on philosophy of improvement to bring in quality culture. He said that even if top managements were sincere, they would be constrained by such factors as tough competition, lack of customer focus, low calibre of working level manpower, sacrificing quality in pursuit of targets and fear of failure and punishment among individuals. Dr. Sulbha Gupta, Director, NABL, suggested inclusion of competency issue of manpower for metrology and measures to preserve independence of voluntary, third party bodies like NABL as issues for consideration. Dr. P.S. Chandurkar, Plant Protection Adviser, MoA, also stressed on the need for participation in international standardization and manpower needs for inspection and testing. During discussions, it was felt that manpower intensive activities need to be identified and the government policies on the same relooked. The Chairman remarked that manpower for scientific and development work should not be governed by same policies which govern non-technical manpower. Shri S.K. Kakkar, CII, mentioned that a group comprising representatives from industry associations i.e. CII, FICCI and ASSOCHAM had deliberated on the ToRs from the industry perspective. He invited members to consider the issues as given in Annex 2 of the Agenda covering the entire chain of stakeholders to create quality culture in the country. Shri R. Verma, ADG, BIS, stated that BIS had formulated nearly 18000 national standards and granted nearly 19000 licenses for the use of ISI mark on almost 1200 products. He stated that much of it was due to pressure from govt since it was one of the biggest buyers. There was a need to generate commitment to quality among the common man, farmers etc. He also suggested that the needs of small and micro industries should be looked into. He said that a number of
organizations were setting standards and there was a need to ensure they follow uniform procedures in line with the code of good practice of WTO. He agreed that India needs to send strong delegations in international fora and apprised of BIS' efforts in this regard. 4.2.10 Shri P. Chaturvedi, Institution of Engineers, highlighted the need for improvement in quality of public services. He mentioned the development of national standard IS 15700 and informed that Govt of Uttaranchal was going for its implementation. 4.2.11 Shri Surendra Singh, AD, MFPI, spoke of the need for HACCP impleme~tation and certification/accreditation in the food sector. He mentioned that M FPI had signed an MoU with QCI to provide accreditation
services in this sector.
4.3 Based on the above, it was decided to create Task Forces on i) Regulatory/conformity assessment issues, ii) Empowerment of Industry, iii) Promotion of Quality, iv) HR for Quality and v) Quality Culture in organizations with SG, QCI, Lt Gen H. Lal, Mr. Bejon Misra, DG, NSC, and Dr. Sunita Narain as Convenors respectively. While suggestions for composition of TFs were made, it was decided that the Secretariat would draft ToRs and composition of each TF, circulate among members by email for 2 days for comments and then take approval of Chairman which would be attached to the Minutes. The approved ToRs and composition ofTFs is enclosed as Annex 2.
55
Item 5
DATE & TIME FOR NEXT MEETING
It was decided that TFs may be requested to submit their reports within one month and the WG may meet again in the 3rd week of Aug, 2006 with the aim of finishing its work by 31 Aug 2006
Item 7
VOTE OF THANKS
The meeting ended with a vote of thanks to the Chair.
56
Annexure - 1
List of Participants attended the 1st meeting (11 July 2006)
1.
Ms. Arvind Jamini Ani! RC. Desh Rakesh B. Madhulika Venkatram Chaturvedi Jauhri Khandal Jha Bandhu Mathur K. Verma Sharma Prakash Add!. Advisor Invitee lEI Secy. DG--Min. NABCB BIS DG AD SG-Adviser OCI MFPI NABL NRBPT Mr. Dr. Mr. RK. RA. Avik P. S.K. S.C. Shirish Arun Chandurkar Mashelkar Kakkar Arora Mitra Baroka Asthana Sr. Consultant - H. FICCI ACCOCHAM Director Shashi Sareen Head CII -SIIR 10 of &&Chern. FW Director, -NSC FAD, NABCB BIS CPCB EIC Jt. Under Secy. Min. of of Consumer Affairs Ms. S.D. Vipin K.C. D. G.J. Surinder Sulbha Banerjee Gyani Makhijani Gupta Sahni Gupta Singh Dte. Dy. Director Of Agriculture -Min. DC-SSI PP Secretary,Dt. & Petroleum (CI) -Textiles Planning Commission Secretary, DSIR
57
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ANNEX-5
- 110011
GOVERNMENT OF INDIA MINISTRY OF HEALTH & FAMILY WELFARE NIRMAN BHAVAN, NEW DELHI-110011
RIT A TEAOTIA Joint Secretary Tel. : 23061195 (0) Telefax: 23061842 E-mail:
[email protected]
D.O.No.P.15023/86/04-PH(F) Dated the 12th July, 2006
Dear Dr.Mashelkar, We have recently received a letter from the Secretary General, Quality Council of India informing us that they have introduced accreditation of product certification bodies as per ISO 65 with effect from 15t June, 2006. They have also informed us that consequent on the publication of ISO 22000 for Food Safety Management Systems incorporating HACCP, they have launched accreditation for FSMS certification bodies from 15t May, 2006. They have, therefore, requested the Ministry of Health & F.W. to refer all matters relating to accreditation of certification bodies to the Quality Council of India. As you are aware, the Ministry of Health & F.W. specifies the mandatory food standards nationally under the provisions of the Prevention of Food Adulteration Act, 1954. Currently, Hazard Analysis Critical Control Point Systems are not mandatory in the country. However, the Ministry of Health & F.W. has taken a decision to introduce mandatory GHP and GMP systems for food manufacturing
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The compulsory GMP/GHP requirements now proposed to be introduced would also need to be certified and we would be interested in working with the Quality Council of India for developing appropriate systems for accreditation of
'-
departments, we request that you may consider constituting a Core Group under your guidance in the capacity of Chairman of Quality India The to work the accreditation scheme for mandatory GMP/GHP for Council the food of sector. Core on Group agencies for this purpose. Since this scheme would have ramifications across several should include apart from the Ministry of Health & Family Welfare, the Ministry of
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Food Processing Industries, the Department of Consumer Affairs and Council for & Industrial Research. Scientific
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58
We request your kind consent for constitution as well as chairing of the Core Group for the purpose. With regards, Yours sincerely,
(RIT A TEAOTIA)
Dr.R.A. Mashelkar, Director General, CSIR, New Delhi.
59
ANNEX-6 Task Force 1 on Regulatory, Standardization, Conformity assessment and supporting infrastructure Composition : SG,QCI (Convener), EIC, NABL, BIS, SIIR, MoH, MoC, MFPI, MoCh, NPL, MoA, NABCB ToRs a. To recommend an integrated regulatory system within the framework of WTO Agreements on Standards and Conformity Assessment like TBT/SPS Agreements and identify sectors where quality needs to be regulated b. To identify voluntary sectors where India is facing non-tariff barriers and strategy to deal with them c. To suggest the standardization and conformity assessment infrastructure necessary to meet the international challenges including WTO regime and propose a national policy on conformity assessment d. To recommend steps to prevent multiplicity of regulatory/standardizing/ conformity assessment bodies and propose clear demarcation of roles of such bodies in the country to avoid conflicts of interest and in line with international norms e. To identify important support activities for the above like scientific data for standardization, dissemination of information on regulations of trading partners notified at the TBT/SPS enquiry points, production of standard reference materials, creation of proficiency testing service providers etc.
Task Force 2 on Empowerment of industry for global competitiveness Composition: Lt Gen H. Lal - FICCI (Convener), CII, ASSOCHAM, DCSSI, DIPP, one EPC/Commodity Board each from Textiles, Food (APEDA) and Engineering (EEPC) sectors, representative of SSI sector (FISME), FIEO, BIS, QCI ToRs a. To identify areas related to quality where industry needs empowerment b. To suggest mechanism for creating awareness of gaps vis-à-vis developed economies and benchmarking c. To suggest programmes for promotion of quality in industry d. To suggest financial or other incentives along with criteria and modalities e. To suggest measures for addressing special needs of SMEs f. To suggest areas for research studies on major quality issues which affect Indian industry towards development of national startegy
60
Task Force 3 on Promotion of Quality Composition: Mr. Bejon Mishra (Convener), Consumer Coordination Council, Dr. Jaiprakash Narain, NABL, MFPI, MoT, BIS, Spices Board, QCI (NBQP) ToRs a. To propose strategies and programmes for promotion of quality in all sectors of industries in manufacturing as well as service sector with special reference to public services, healthcare and education b. To suggest programmes to identify and address the needs of all stakeholders in the chain to build quality into the final product c. To suggest mechanism to promote application of relevant standards and quality tools to enable different sectors of industries to be globally competitive d. To propose measures for partnership with civil society to empower consumers to be able to demand quality e. To suggest strategies and action plan to disseminate message of quality through mass campaign f. To suggest national benchmarks on quality i.e. national quality awards, competitive case studies etc. aimed at sharing and promoting quality Task Force 4 on Human Resources for Quality Composition : Shri K.C. Gupta, DG, NSC (Convener), Institution of Engineers, BIS (NITS), EIC, SIIR, CII, QCI/ NRBPT ToRs a. To suggest measures for empowerment of human resources for quality across all sectors to ensure adequacy and effectiveness b. To suggest mechanism for evaluation of needs of industry and gap in skills available vs need c. To propose measures for inclusion of subject of quality management in management/technical curriculum d. To identify training needs - technical as well as systems, appropriate institutions – creation – continous upgradation – development of industry relevant courses – accreditation mechanism e. To propose Personnel certification programmes - identification of priority sectors and institutions - credibility through adoption of international standards – accreditation
61
Task Force 5 on Promotion of Culture of Quality in Organizations Composition: Mr. S.K. Kakkar, CII (Convener), FICCI, ASSOCHAM, DARPG, Mr. Arvind Mathur, TCS, SIIR, QCI ToRs a. To recommend strategies, policies and programmes for promoting culture of quality in organizations by facilitating integration of quality into overall management approach b. To suggest institutional framework for supporting such programmes on a continuing basis and capacity building in organizations to promote culture of quality c. To identify institutions to be created or strengthened to operate the national programme d. To suggest mechanism for evaluation of effectiveness of such programmes and the agency to be responsible for the same Task Force 6 on Introduction of GMP/GHP/HACCP on mandatory basis Composition : Dr. Shiv Lal, Additional DG, PFA (Convener), Ms. Rita Teaotia, MoH, MFPI, Min of Consumer Affairs, BIS, EIC, APEDA, industry associations (CII/FICCI/ASSOCHAM/AIFPA/FHRAI). Director (Food) from DCSSI’s office, NABL, DDWS, MoA, QCI ToRs: a. to consider introduction of GMP/GHP/HACCP on a mandatory basis under regulation b. to prepare a roadmap for introduction of mandatory GMP/GHP in the first instance with the ultimate objective of introducing HACCP including identification and/or phasing of specific sectors for such regulation, if need be, and mechanism for checking compliance using accreditation c. to recommend strategies and programmes for strengthening the industry to meet the mandatory requirements and roles of various Ministries/organizations in such programmes d. any other relevant issue
62
ANNEX-7
MINUTES
WORKING GROUP FOR 11th PLAN ON QUALITY, CERTIFICATION AND CONFORMITY ASSESSMENT – 2nd MEETING Date
29 Aug 2006
Time
Venue
Office of DG, CSIR, Anusandhan Bhawan, 2, Rafi Marg, New Delhi – 110001.
1500h
CHAIRMAN :
Dr. R.A. Mashelkar, Secretary, DSIR
MEMBER SECRETARY :
Shri G.J. Gyani, Secretary General, QCI
MEMBERS PRESENT :
As per list at Annexure 1
Item 1 Welcome by Member Secretary – Shri G. J. Gyani extended a warm welcome to the members to the 2nd meeting of the WG. Item 2 Opening Remarks by Chairman – Dr. R.A. Mashelkar, in his opening remarks, complimented the various Task Forces on the work done in such a short time frame and invited the respective Conveners to present their reports. Item 3 Confirmation of Minutes of the 1st Meeting – The minutes were deemed to be confirmed in the absence of any comments. Item 4 Presentations on reports of Task Forces 4.1 The following presentations were made: TF1 Mr. Anil Jauhri, Adviser, QCI TF2 Lt. Gen. H. Lal, DG, FICCI Quality Forum
63
TF3 TF4 TF5 TF6
Mr. Bejon Misra, CEO, Consumer Voice Mr. Vipin Sahni, Director, NRBPT (QCI) Mr. S.K. Kakkar, Head, Institute of Quality, CII Ms. Rita Teaotia, JS, MoH
(Note: Copies of presentations have since been circulated to all members by email) 4.2 Discussions – The following points were made by the members during discussions on the reports: Mr. R.C. Jhamtani stated that while making recommendations, it may be kept in view that Quality includes sustainability. He informed that the Draft Approach paper on 11th Plan is on the Commission’s website which may be kept in view while finalizing WG’s report. The WG needs to recommend programmes with phases, if any, resource requirements and outcomes expected. He also emphasized the need for inclusive growth and enabling investments for SMEs. Mr. Jhamtani also mentioned that we needed to identify top priority areas/products for focus in next 5 year plan and to set achievable targets in these areas. Ms. Sunita Narain also emphasized inclusiveness considering the multilayered nature of the industry which would merit differential treatment. Further, the regulatory institutions need to be enabling tools for SMEs while regulating the Large ones. She also argued for strengthening of existing institutions with respect in internal expertise rather than creating new institutions. She also advocated for autonomy for scientific institutions. Ms. M. Prakash spoke of a need for institutional frame work, consideration to the unorganized sector, personnel certification in service sector and strengthening of comparative testing. She informed that BIS was making a standard on comparative testing which would make a uniform procedure for such testing and help in identifying institutions with capability for conducting such testing. Dr. Sulbha Gupta, while referring to insufficiency of PT services as mentioned in the report of TF1, pointed out that NABL had organized 96
64
PT programmes. She however agreed on need for strengthening PT programmes and development of CRMs. She also spoke of the need for clarity of roles of different institutions as mentioned in item 6.2.4.7 of report of TF1. Mr. Bejon Misra shared his organization’s good experience of conducting Comparative testing using NABL accredited labs and of studies in service sector like banks. Dr. R.K. Khandal raised the issue of lack of CRMs and the exorbitant costs when sourced from abroad and advocated public-private partnership in development of CRMs in India. He also called for prescribing MRLs and support to industry when faced with rejections abroad. He shared SIIR’s experience of defending honey test results against the report given by an overseas regulatory body. He also emphasized the need for ensuring that only quality products leave India’s shores. Ms. Shashi Sareen pointed out that once graded GHP/GMP/HACCP is implemented, it would apply to imports also which may be kept in mind. She also spoke of the need for strengthening of existing institutions and streamlining of their activities, time bound action plan for new initiatives and ensuring that cost implications of any measure are not disproportionately high. Mr. K.C.Gupta stated that safety, health and environment issues should be considered as integral to quality. Cdr A.K. Poothia called for integrating quality in education and institutionalizing a mechanism for the same in the long term. Ms. Rita Teaotia stated that MoH recognizes the diversity in Indian industry and is proposing differential treatment for each sector like LS, SS and tiny/street vendors. It is also looking to utilize different institutions in their respective areas. Regarding numbers, she said that there are no authentic figures but estimates are about 40 lakh establishments where GHP/GMP would need to be implemented.
65
Lt. Gen. H. Lal also supported more autonomy for scientific institutions in discharging their functions. The Chairman, intervening at various points during the discussion, said that we should follow the principles of expansion, inclusion and excellence. He said that we should go the extra mile to bring quality into nation’s consciousness and should make some bold statements in the WG report. He also endorsed the thought of autonomy for scientific institutions and those related to quality. 4.3 After the above discussions, it was decided that: 1. members may study the reports of TFs and send additional comments, if any, to Member Secretary within one week. These would be suitably incorporated before finally submitting to the Planning Commission. 2. estimates of funds required for various programmes recommended to be added. 3. the requirements of key institutions related to quality may be indicated for which Planning Commission may provide statement of allocation and expenditure in 10th Plan. Item 5 Vote of thanks - The meeting ended with a hearty vote of thanks to the Chair.
66
Annexure - I List of Member Present 1.
Lt. Gen. H.Lal
Director General - FICCI Quality Forum
2.
Mr. K.C. Gupta
Director General - NSC
3.
Dr. Sulbha Gupta
Director - NABL
4.
Dr. Sunita Narain
Director - CSE
5.
Mr. R.C. Jhamtani
Adviser (Industry) - Planning Commission
6.
Dr. R.K. Khandal
Director –Shriram Institute of Industrial Research
7.
Mr. S. K. Kakkar
Head Institute of Quality – CII
8.
Mr. M.S. Dhakad
Director - DIPP
9.
Mr. Avik Mitra
Principal Consultant - Assocham
10.
Dr. A.K. Hanjura
Scientist & Quality Manager - NPL
11.
Ms. Madhulika Prakash
Head (FAD) – BIS
12.
Cdr. A.K. Poothia
Director General - Institution of Engineers India
13.
Mr. R.C. Saini
Deputy. Secretary - Min. of Textiles
14.
Mr. Bejon Misra
CEO – Consumer Voice, Convener TF 3
15.
Ms. Rita Teaotia
JS – MoH, representing/convener TF 6
16.
Mr. Arvind Mathur
Invitee
17.
Dr. Sneh Bhatla
Head (SP & CAD) - BIS
18.
Mr. O.N. Srivastava
Head (CMD2) - BIS
19.
Mr. D.S. Chadha
Consultant - CII
20.
Mr. B.K. Malhotra
Under Secy. – DIPP
21.
Dr. K.M. Chacko
Dy. Director - Shriram Institute of Industrial Research
22.
Mr. B. Venkataram
Director - QCI
23.
Mr. Anil Jauhri
Adviser - QCI
24.
Mr. Vipin Sahni
Director - QCI
25.
Dr. B.K. Rana
Dy. Director - QCI
26.
Ms. S. Sareen
Director - EIC
67
Annex 8 REPORT OF TASK FORCE 1 ON REGULATORY, STANDARDIZATION, CONFORMITY ASSESSMENT AND SUPPORTING INFRASTRUCTURE ISSUES 1.
The Task Force 1 on Regulatory, Standardization, Conformity assessment and supporting infrastructure issues had the following terms of reference: a. To recommend an integrated regulatory system within the framework of WTO Agreements on Standards and Conformity Assessment like TBT/SPS Agreements and identify sectors where quality needs to be regulated b. To identify voluntary sectors where India is facing non-tariff barriers and strategy to deal with them c. To propose a national policy on conformity assessment and suggest the standardization and conformity assessment infrastructure necessary to meet the international challenges including WTO regime d. To recommend steps to prevent multiplicity of regulatory/standardizing/ conformity assessment bodies and propose clear demarcation of roles of such bodies in the country to avoid conflicts of interest and in line with international norms with specific reference to areas where governmental funds are being utilized (both plan and non-plan) while ensuring synergy between various government bodies. e. To identify important support activities for the above like participation in standards development, scientific data for standardization, dissemination of information on regulations of trading partners notified at the TBT/SPS enquiry points, production of standard reference materials, creation of proficiency testing service providers etc.
2.
The TF1 had the following composition: a. b. c. d. e. f. g. h. i. j. k. l. m. n.
Mr. G.J. Gyani, SG, QCI (Convener) Dr. Sulbha Gupta, Director, NABL Ms. Shashi Sareen, Director, EIC Ms. Parminder Bajaj, Head (IR&TISD), BIS Mr. O.N. Srivastava, Head (CMD-2), BIS Dr. R.K. Khandal, Director, SIIR, Dr. D. Chattopadyay, ADG (PFA), Ministry of Health & Family Welfare Ministry of Commerce Ministry of Food Processing Industries Ministry of Chemicals Dr. Ashok Hanjura, Quality Manager, NPL, Dr. P.S.Chandurkar, PPA, MoA, Dr. R.N. Chowdhury, Sr. Counsellor, CII FICCI
68
o. Dr. S.N. Nandi, ASSOCHAM p. Mr. B. Venkataram, Director, NABCB q. Mr. Anil Jauhri, Adviser, QCI
3. The TF met on 1 Aug 2006, 9 Aug 2006 and 17 Aug 2006 and held extensive discussions on the issues assigned to it. 4.
The TF identified the following weaknesses in our system: • Lack of regulation – While it is accepted worldwide that governments are responsible for health and safety of their populace and accordingly take whatever measures they deem fit which finds place in the WTO regime under which TBT and SPS agreements allow member countries the freedom to impose mandatory standards on account of health, safety, environment, deceptive trade practices and national security, there are several sectors in India which remain unregulated like toys, electrical/electronics/IT/telecom equipment, industrial and fire safety equipment which have health and safety implications. Further, there has been proliferation of certification and inspection bodies and laboratories but there is no system of imposing any rules or disciplines on them except accreditation, which is voluntary, leading to malpractices. • Multiplicity of Regulatory Bodies (RBs)/Standardization/Conformity assessment bodies (CABs) - Even as the Integrated Food Law aims to tackle this problem, it remains in many areas like regulation of exports where despite Export (Quality Control & Inspection) Act, which empowers government to regulate exports, and Export Inspection Council is the regulatory body, a number of organizations like APEDA, Spices Board, Tea Board etc. are also into regulation which is also inconsistent with their promotional role and funding the industry for competitiveness for exports. Similarly, despite national accreditation being available, several bodies have recognition schemes for CABs duplicating the work and imposing multiple audits on CABs. A number of voluntary standardizing bodies are operating in India while BIS is the national standards body whereas the aim should be to have a single national standard. • There are several voluntary initiatives like Forest certification, Worldwide Responsible Apparel Production (WRAP) certification, and Social Accountability (SA 8000) which are limiting India’s access to world markets but we are unable to respond timely to such developments nor have a strategy in place to deal with them. • With TBT/SPS Agreements encouraging adoption of international standards in trade, participation in international standardization has become vital to protect India’s interests. However our participation is weak and involvement of industry and scientific institutions who should be providing data is poor. Part of the reason is that participation costs money and industry or scientific institutions either do not regard this as their responsibility or are not having sufficient funds for the same. There is also a lack of appreciation of impact of standards on business which also contributes to the apathy towards standardization in general and international standardization in particular.
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• Laboratory infrastructure is weak in terms of international norms – laboratories in govt sector, especially those involved in regulation which is on grounds of health, safety and environment, are slow to go for accreditation, the worldwide accepted means of evaluating competence of CABs. Support activities which are vital for labs like Certified reference materials and Proficiency testing services need to be considerably strengthened to meet the growing needs of labs in the country. • Lack of information on standards, regulations and conformity assessment procedures of India’s trading partners despite designated TBT and SPS enquiry points.
5.
Accordingly, the TF decided that it should propose: • • • •
National standards system Good regulatory practice National conformity assessment policy Policy on MRAs/MoUs with trading partners on standards and conformity assessment
and also focus on the following supporting activities: • • • • • • •
6.
CRMs PT service providers Participation in international standardization Mechanism for industry viewpoint Repository for data to support standardization or formulating India’s position in international fora Studies to support standardization Information on standards
The recommendations of the TF are given below:
6.1 NATIONAL STANDARDS SYSTEM The Bureau of Indian Standards is the national standards body of India and represents India on ISO and IEC. It formulates national standards in a variety of sectors called ‘Indian Standards’ and has formulated over 18,000 standards to date. However, there are several sectors where there are other standardizing bodies formulating voluntary standards like Indian Roads Congress, Agmark, Telecommunication Engineering Centre, Central Public Health and Environmental Engineering Organization etc. There may be new and emerging sectors where need for standardization may be felt and it may be desirable to identify a suitable, specialized organization to undertake the work.
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It is desirable to pool the expertise of various organizations to create a national standards system which leads to a single national standard. With a number of Standards Development Organizations (SDOs) in the country, it would also be necessary to have a system for ensuring that all of them operate to a set of rules which is periodically verified. A system of accreditation of SDOs has begun to develop in countries like USA, Canada and Australia taking care that the system operates independent of any SDO. It is likely that this would develop into a worldwide system as increasingly NSBs would realize that they may not have the expertise to make standards in all sectors especially the emerging sectors. Therefore, India needs to reorganize its standardization activity. Accordingly, the following policy is recommended: • BIS shall be the national standards body and repository of all voluntary national standards. • Wherever standards are being formulated by other standards development organizations (SDOs) which are recognized as national (like IRC or Agmark), these shall be published as national standards by BIS while these bodies would continue to make these standards and published standards shall duly acknowledge this fact. • BIS shall work out formal mutual understanding with all SDOs including revenue sharing model for income from sale of standards made by other SDOs in consultation with all stakeholders, if need be. • All SDOs shall follow the code of good practice prescribed in the WTO TBT Agreement. • There shall be a defined system of accreditation of the SDOs to be developed and operated by QCI and all SDOs shall take accreditation to be part of the national standards system. • BIS shall endeavour to build formal linkages with Regulatory bodies to encourage them to rely on national standards thus developed in regulations. • The national standards shall be open for certification by any CB duly accredited by QCI. 6.2 GOOD REGULATORY PRACTICE 6.2.1 Introduction - It is accepted worldwide that governments are responsible for health and safety of their populace and accordingly take whatever measures they deem fit. This finds place in the WTO regime under which TBT and SPS agreements allow member countries the freedom to impose mandatory standards on account of health, safety, environment, deceptive trade practices and national security. However, in order that such measures do not become barriers to trade, these agreements prescribe set of rules to govern international trade and encourage members to align such standards with international standards. Under the national treatment principle, such mandatory standards apply to imports also and therefore have become means of protecting one’s domestic industry/market also. Many countries, including India, have imposed mandatory standards in sectors such as food, drugs, electrical appliances and accessories, gas cylinders etc.
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6.2.2 International trend - Internationally, the trend is that governments prescribe such regulatory standards under some legislation and leave it to a designated regulatory body, who owns the certification mark as well if there is need for one, to enforce such standards using one or more conformity assessment bodies - certification/inspection bodies and labs. The regulatory bodies are technical bodies and can be created sector-wise giving regard to specializations. These bodies also get involved in G-to-G MRAs on Standards and Conformity Assessment with their counterpart regulatory bodies in other countries. It is also accepted worldwide that RBs may set standards and check compliance themselves. However, increasingly the trend is towards utilizing existing competencies and infrastructure by using designated CA bodies who in turn would have to have accreditation as per relevant international standards from the accreditation bodies. EU is also moving towards the principle of one AB per country recognizing that it is a national activity and by introducing noncompetition as a key requirement. Similarly, RBs are increasingly using national standards developed by the NSBs in the regulations except in food and drug sector. 6.2.3 Indian Scene - In India, while there are dedicated RBs for some sectors, although not independent as the worldwide trend is, (For example, food is regulated by PFA/health authorities, drugs & cosmetics are regulated by the Drugs Controller, LPG cylinders and related items are regulated by the Chief Controller of Explosives, X-ray machines are regulated by AERB), consumer products are being regulated generally through the BIS Act which has a provision vide Section 14 for prescribing mandatory BIS certification through a notification by the Central government and products like cement, electrical appliances and accessories and thermometers have been brought under mandatory BIS certification invoking Section 14; in the current thinking, such notifications are issued by Ministries supposedly related to the product group and state govt departments like Industries or Weights & Measures have been prescribed as Appropriate authorities to enforce the regulations. The enforcement of such regulations by state govts is generally unsatisfactory. Similarly, there is the Export (Quality Control & Inspection) Act for regulation of exports by EIC; however, some promotional bodies/commodity boards are also engaged in sector-specific regulation. There is another important factor – given the current govt policy, all government institutions are under pressure to reduce manpower and therefore, reliance on private enterprise in conformity assessment is going to be the order of the day. 6.2.4 Policy 6.2.4.1 The following principles shall guide in the development of a regulatory framework system: • •
maintain high standards for the protection of the health and safety of workers, the general public and the environment; maintain image of India as a producer of high quality goods and services in the global market and facilitate exports
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• • • • •
use existing legislation and regulatory institutions to clarify roles, responsibilities and authorities to ensure that regulators are free from activities which lead to conflict of interest and avoid duplication; continue to develop clear guidelines for evaluating products which are in harmony with national priorities and leading to adoption of , international standards, where required; provide for a sound scientific database on which to assess risk and evaluate products; ensure both the development and enforcement of regulations are open and include consultation; and contribute to the prosperity and well being of Indians by fostering a favourable climate for investment, development, innovation and adoption of sustainable products and processes.
6.2.4.2 With conformity assessment business growing leading to proliferation of certification/inspection bodies and labs, there is a need for a regulation (as in China) which would require CABs to register and give govt the power to enforce some rules and discipline as well as take punitive action including imposing fines and asking a CAB to shut down. The regulation may also require that any CAB registered and operating in India must take accreditation, from NABCB/NABL (as Indonesia has done it) or equivalent (subject to scrutiny by QCI to ensure CABs are audited regularly) within a reasonable time, say 18 months or 2 years from starting operations. The regulation may also empower the govt to notify compliance to any recognized standard for regulation and should be futuristic in that it allows government the flexibility to regulate on quality related issues in respect of any new areas and respond to new developments. This requires creation of a National Regulatory Authority for Standards & Conformity Assessment wherever sector-specific Regulatory Bodies (RBs) do not exist. 6.2.4.3 The RBs do not have to duplicate the standardization infrastructure and should be encouraged to rely on national standards evolved by BIS in the regulations; however, there is a definite need for building institutional linkages between RBs and BIS in the form of MoUs clearly defining responsibilities and obligations of each party. RBs may also need to fund the activity undertaken to meet their needs. 6.2.4.4 In order that RBs can use designated CABs for checking compliance, it would need a change in BIS policy to allow other CBs to certify against national standards. The CABs used for regulatory purposes should necessarily be accredited under the national accreditation system by QCI/NABL. 6.2.4.5 In this model, RBs would make reference to BIS standards in the regulations, designate CA bodies to who the individual units would go to seek evidence of conformity to the regulatory standard based on which the RBs would register/approve such units. RBs would enforce the regulations, maybe along with state govts, carry out market surveillance by drawing random samples of regulated products from the market to keep a check on quality of such products in the market, attend to complaints, and periodically audit the CA bodies, preferably jointly with QCI/NABL.
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6.2.4.6 It is also necessary that concept of single RB is followed - for example many countries have regulatory standards in telecommunication sector while India does not have and it is recommended that TRAI undertakes regulation of quality and safety aspects in telecom sector. Similarly, when there is a specific Act devoted to regulation for exports, all regulation in case of exports should be done by EIC under it using available resources and infrastructure for conformity assessment. 6.2.4.7 There must be ground rules for RBs, ABs and CABs like independence, freedom from conflict of interest. Ideally, these bodies should be strictly dedicated to regulation, accreditation and conformity assessment respectively with clear separations without combining any other conflicting roles. The roles of funding industry, assistance to industry in marketing their products counseling etc. are inconsistent with the roles of regulation and conformity assessment. Therefore, Promotional bodies should not undertake regulation related to quality, certification or accreditation. Therefore any activity of regulation/accreditation/conformity assessment existing in any organization not dedicated to regulation/accreditation/conformity assessment should be transferred to bodies established/designated for these purposes and Plan funding approved accordingly. 6.2.4.8 Compliance to regulations should be not only by certification but using the CE mark model as reference, should be by various means depending on whether the product is high or medium or low risk category. At the lowest level, Suppliers’ declaration of conformity (SDOC) should be encouraged based on prescribed conformity assessment (inspection/testing) while third party intervention/certification may be prescribed for high risk products. In case of third party compliance checking, the units may be required to go to designated CABs by rotation to prevent nexus between units and individual CABs. We should also encourage self-regulation by encouraging industry associations to set up compliance checking cells for their members and assist them in self regulation besides awareness, training and counselling. A system of reward and punishment should also be built in whereby consistently complying units can move from third party intervention to lower level of intervention or SDOC and vice versa. This would encourage responsible behaviour on part of the industry. 6.2.4.9 India must also recognize that it has a range of industry in any sector from cottage to small scale to large scale and it may not always be possible to apply international standards by regulation in domestic market. HACCP is an excellent example – while MoH has not been able to specify it in any sector for domestic industry under PFA, EIC has prescribed it for sectors like fisheries and dairy for export purposes. The Export (Quality Control & Inspection) Act, 1963 gives us an ideal vehicle to regulate exports by specifying standards which may not be achievable or suitable for domestic market. Therefore, all regulation for export should be done under EIC’s umbrella even as competencies in other organizations for certification/inspection/testing are utilized by it. It may not be desirable to regulate quality of every export item and therefore, EIC should encourage voluntary certification through its notifications in areas other than those in which mandatory quality control for exports is operational and seek recognition from overseas RBs so that Indian products have an easier entry to foreign markets.
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6.2.4.10 Norms for RBs – Since in a federal structure like India’s, regulation invariably is the responsibility of the state governments, it is necessary that they operate to some common norms for uniformity of operation across the country. It is recommended that QCI may evolve norms for RBs and a system of their evaluation to ensure that RBs are impartial, consistent and uniform. 6.2.4.11 Funding of RBs/CABs – One of the reasons why CABs in India, and indeed worldwide are losing credibility, is the commercial angle – while on one hand they are supposed to examine clients and deliver judgement of compliance or non-compliance, on the other they are service providers looking for business. While voluntary sector may pursue the current model, in case of regulatory sectors, where health and safety issues are involved, there is a need to minimize if not totally eliminate the commercial angle – say by fixing charges. While it is a laudable aim to expect govt institutions to become self-sustaining, the pressure of earning revenues can also compromise the independence of these bodies because they have to realize revenue in the form of fee for their services from the same clients who they are expected to regulate or evaluate. Therefore, there is a need to balance the two aspects and commit a certain level of funding to such bodies to ensure their independence. 6.2.4.12 It is recommended that govt institutions like RBs should rely on accredited CABs only and a time frame of 3 years be set beyond which if their own labs or inspections or certifications are not accredited, they would not be used for regulatory or other purposes. At the same time, plan funds should be made available for meeting the accreditation costs and for maintaining accreditation until they become self-sustaining. 6.2.4.13 a. b. c. d. e. f. g. h. i. j. k.
The following product groups were identified for regulation: Telecom Electrical appliances and goods Electronics and IT goods Fire safety equipment Industrial safety equipment Helmets Medical devices Toys Plastic pipes and materials used for potable water supplies Plastic and other materials used for food packaging Products for export regulation – Based on past record of rejections and quality related problems in exports, products especially agrifood products like chillies, nuts and oilseeds (groundnuts, sesame seeds etc.), fresh and processed fruits and vegetables, ready meals, coffee, tea, etc may be brought under export regulation.
6.3 NATIONAL POLICY ON CONFORMITY ASSESSMENT 6.3.1 Conformity assessment – any activity concerned with directly or indirectly that relevant requirements are fulfilled – is increasingly being utilized by governments, regulators, industry
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and consumers to provide assurance that product and services conform to the specified requirements and meet the needs and expectations of the user. Such assessments are also being utilized in international trade and free trade agreements whether bilateral or multilateral. 6.3.2 WTO-TBT Agreement requires that conformity assessment procedures be "prepared, adopted and applied so as to grant access for suppliers of like products originating in the territories of other Members [signatories to the agreement] under conditions no less favorable than those accorded to suppliers of like product of national origin or originating in any other country...." 6.3.3 On the domestic front, regulators are also relying increasingly on conformity assessment procedures as a means of ensuring health and safety of their populations. 6.3.4 Hence there is a need to have a policy on conformity assessment so that rules for operating a conformity assessment body are clearly spelt out. 6.3.5
The following policy is proposed:
a. Accreditation being the highest conformity assessment activity in a country, shall be supported by the government without in any way compromising its independence and impartiality. b. The principle of one accreditation body shall be followed with non-competition as key element. c. The accreditation bodies shall operate as per applicable international standards and seek admission to multilateral arrangements to gain international acceptability for accreditation. d. All conformity assessment bodies (CABs) shall operate as per applicable international standards and obtain accreditation, preferably national accreditation, within a reasonable period of starting operations not exceeding two years. e. CABs shall be free from any activity that has potential for compromising their independence and impartiality. f. The CABs shall ensure that the activities of their related bodies do not compromise the confidentiality, objectivity and impartiality of their conformity assessment activities. g. There shall be clear separation between regulators, CABs and promotional/counselling bodies. In particular, organizations involved in extending any financial incentives to the industry shall not conduct certification. h. CABs shall maintain transparent procedures and information about the conditions under which they offer services shall be publicly available. i. CABs shall conduct their activities in a manner so as to facilitate international or national trade. j. CABs shall have a publicly available procedure for attending to and resolving complaints from any of their stakeholders k. The costs of conformity assessment shall be available to any applicant and should not be applied so as to restrict market competition or impede trade. l. The CABs shall cooperate among themselves in exchange of experience and on common issues and shall evolve and implement a code of conduct.
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6.4 POLICY ON MRAs/MoUs ON STANDARDS & CONFORMITY ASSESSSMENT 6.4.1 In the WTO regime, which permits member nations to impose mandatory standards or technical regulations on grounds of health, safety, environment, deceptive trade practices and national security, there is a growing trend of mutual recognition agreements between members whereby each (importing) country recognizes the conformity assessment by the other (exporting country) to its (importing country’s) standards for acceptance of goods into it (importing country) and vice versa. 6.4.2 Such agreements are provided for in TBT/SPS Agreements and are driven by the need for gaining access into each other’s market. These are Government-to-Government agreements in which the regulatory bodies are involved. 6.4.3 Ideally, these agreements should be driven by the motive of enhancing India’s exports keeping the balance of trade in view to ensure that India gains in terms of enhanced trade. Sometimes, these may be driven by tactical considerations like gaining access into an important trade block like ASEAN or political considerations like helping a neighbour or an ally like Nepal or Bhutan in its economic growth. 6.4.4 • •
•
The following policy on negotiating MRAs is recommended: All MRAs on standards and conformity assessment relating to regulations should be negotiated by the Commerce Ministry. There should be a high level standing steering committee to establish the need for MRAs and guide negotiations with all stakeholders like concerned Ministries (MoH, MoA, MEA etc.), RBs which are involved in regulation, accreditation bodies, national standards body, and major industry associations in regulated sectors as members. The secretariat of the committee could be in EIC as the body operating the export control system. The preferred option should be to seek recognition of India’s export control system operated under the aegis of EIC by India’s trading partners through an MoU and only if the trading partner specifically seeks reciprocal recognition, dialogue for MRA should be initiated.
6.5 CERTIFIED REFERENCE MATERIALS – A national programme for development, production, certification and accreditation of CRMs and CRM producers needs to be initiated, which would be initially funded by the govt through 11th Plan but should aim to become selfsustaining in 5 years with participation of private and non-profit organizations besides government institutions. The final approach paper is enclosed as Annexure 1. The programme may be coordinated by NPL as the nodal organization under the guidance of a steering committee comprising all stakeholders and interested organizations. 6.6 PROFICIENCY TESTING SERVICES - A national programme for development of PT services needs to be initiated, which would be initially funded by Planning Commission through 11th Plan but should aim to become self-sustaining in 5 years with participation of private and non-profit organizations besides government institutions. The final approach paper is enclosed as Annexure 2. The programme may be coordinated by NABL as the nodal
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organization under the guidance of a steering committee comprising all stakeholders and interested organizations. 6.7 PARTICIPATION IN INTERNATIONAL STANDARDIZATION It is recommended that; • Separate fund be created for participation in international standardization which could be placed at the disposal of the concerned organizations like BIS for participation in ISO/IEC work, MoH for Codex work and DoT for ITU or it could be centrally placed at the disposal of one Ministry/organization who would also oversee that right experts are funded from this. All stakeholders like manufacturers, regulators, scientific institutions, consumer organizations and conformity assessment bodies should be encouraged to participate. • Industry associations should be encouraged to set up standardization cells dedicated to study of draft standards, dissemination among interested members, eliciting industry viewpoint and transmitting it to nodal organization for formulating India’s views, and sensitizing industry to the importance of standards in global market. Since these cells would be cost centres, initially they may be funded by the govt but ultimately, say after the 11th Plan, industry should support this activity. • A Centre under QCI should be set up to study the impact of standards in general and International Standards in particular on competitiveness of Indian industries. • Scientific institutions, whether in govt or private or non-profit sectors, should be designated to conduct studies and generate data for supporting standardization and argue India’s position in international standardizing fora like ISO or Codex. 6.8 INFORMATION CENTRE – The notification of regulatory standards for domestic industry, except where there is a sector specific RB, should be given to a single nodal authority which in turn should also notify the conformity assessment bodies who would certify compliance to such regulatory standards. The same authority should also develop and implement the national notification system required under the TBT Agreement. Country specific requirements should be maintained by the national authority with appropriate linkages to QCI, EIC, BIS and other interested organizations in information dissemination. This work may be assigned to the National Regulatory Authority recommended above.
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ANNEXURE-1 DEVELOPMENT OF CERTIFIED REFERENCE MATERIALS – RECOMMENDED APPROACH 0. INTRODUCTION 0.1 Virtually every aspect of society is supported some way or the other by analytical measurements – be it commerce and trade, conformity to various regulations, health and safety aspects or reciprocal comparisons. The reliability of analytical/measurement data play a very important role in the decision making process involved therein. Reference Materials (RM’s) are very important for realising a number of aspects of measurement quality and reliability which help in correct decision making. 0.2 Reference Materials are required for use in any one or more of the following activities which are essential components of a measurement process : a) b) c) d) e) f) g)
Calibration of Instrument; Standardisation of analytical measurement; Method validation studies; Estimation of uncertainty of measurement; Training of analysts / testing personnel; Internal Quality Control; External quality assurance (QA) (proficiency testing).
0.3 Availability of authentic and credible Reference Materials (Reference Material with certified value - CRM) is one of the very important factors affecting laboratory’s capability to produce reliable test results. 0.4 In an International Comparison/competitiveness scenario brought about by Accreditation, it is of utmost importance that test results produced by different accredited labs are comparable and use of reliable reference materials plays one of the most important roles in achieving this. 0.5 In fact in most of modern methods of chemical analysis using techniques like Chromatography, spectroscopy/spectrometry, instrumentation involving mass detectors, etc, the results are directly related to reference materials which are used for calibration/ standardization of instruments. Hence the need for reference material is the highest in chemical analysis involving such types of techniques. 1. REFERENCE MATERIALS 1.1 As per ISO definition (as given in ISO-Guides 30:1992 ) Reference Material (RM) is a Material or substance one or more of whose property values are sufficiently homogeneous and well established to be used for the calibration of an apparatus, the assessment of a measurement method, or for assigning values to materials.
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1.2 Another term which is used in relation to Reference materials is Certified Reference Materials (CRM) which is defined in ISO-Guides 30:1992 as: Reference material, accompanied by a certificate, one or more of whose property values are certified by a procedure which establishes its traceability to an accurate realization of the unit in which the property values are expressed, and for which each certified value is accompanied by an uncertainty at a stated level of confidence. 1.3 Most results of analytical measurements are directly related to reference materials which are used for the calibration of the measurement process. For fulfilling the requirements of the laboratory accreditation criteria ISO 17025:2005, two decisive preconditions are required to be met in order to obtain a result which is traceable to the SI. First, the used reference material itself must carry an SI-traceable value and an attached uncertainty. Secondly, the whole measurement procedure - from sampling to calculation of the result - must be fully validated and the uncertainty must be evaluated according to ISO GUM document or any other International guidance document. While the analyst is required to validate his procedure and to evaluate his measurement uncertainty by himself, he has to depend on reference material supplier to ensure that the value declared on the label of the reference material is traceable to the SI. Thus, the reference material plays a very important role as it serves as a transfer standard in the traceability chain. And in a laboratory accreditation scenario, Certified Reference Material (Reference Material with a valid certificate) is an essential component. 1.4 Types of Reference Materials - RMs may be used to support measurements concerned with chemical composition, biological, clinical, physical, engineering properties, etc. They may be characterised for ‘identity’ (e.g. chemical structure, fibre type, microbiological species/cultures etc.) or for ‘property values’ (e.g. amount of specified chemical entity, hardness etc.). Some commonly encountered categories of reference materials are as follows: a) Chemical composition - Reference materials, being either pure chemical compounds or representative sample matrices, either natural (e.g. metals) or with added analytes (e.g. animal fats spiked with pesticides for residues analysis), characterised for one or more chemical or physicochemical property values; b) Biological and clinical properties - Materials similar to above Category , but characterised for one or more biochemical or clinical property values; c) Physical properties - Materials characterised for one or more physical property values, e.g. melting point, viscosity, density; pH, conductivity, turbidity etc. d) Engineering properties - Materials characterised for one or more engineering property values (e.g. hardness, tensile strength, surface characteristics, electrical resistance, etc; e) Miscellaneous Materials
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1.5 Desirable characteristics of Reference Material/Certified Reference Material a) It must be uniform and homogenous in composition and pure in cases where relevant; b) The exact property value must be known; c) Traceabilty to SI units should be established; d) Its shelf life (if relevant) must be known; e) The Measurement Uncertainty of the property value must be known; and f) It should be available in fairly large quantities for effective distribution. 1.5.1 In addition to the above for Certified Reference Material, it is desirable that: a) The reference value for relevant property/characteristics is known and is certified by a procedure which establishes its traceability to an accurate realization of the unit in which the property values are expressed. b) The validity of the ‘certification’ and uncertainty data, including conformance of key procedures should be established in line with the requirements of ISO Guide 35 and other relevant ISO requirements. c) Both the producer and the material should have a track record of good performance, for example when - a RM in use has been subjected to an interlaboratory comparison, cross-checked by use of different methods, or there is experience of use in a number of laboratories over a period of years. d) Each CRM should be accompanied by a certificate stating the property value and an uncertainty value at a stated level of confidence in line with the requirements of ISO Guide 31 and a report covering the characterisation, certification and statistical analysis procedures, complying with ISO Guide 35. e) There should be a demonstrated compliance of the production of the reference materials with quality standards such as ISO Guides 34 or ILAC requirements, or compliance of the measurement of property values with ISO/IEC 17025 requirements. 2. RELEVANT ISO GUIDES AND OTHER INTERNATIONAL PUBLICATIONS ISO Guides dealing with Reference Materials are listed below : a) ISO Guide 30 :1992 Terms and definitions used in connection with reference materials. b) ISO Guide 31 :2000 Contents of certificates of reference materials. c) ISO Guide 32 :1997 Calibration of chemical analysis and use of certified reference materials. d) ISO Guide 33 :2000 Use of certified reference materials. e) ISO Guide 34 :2000 Quality system guidelines for the production of reference materials. f) ISO Guide 35 :2006 Certification of reference materials - General and statistical principles.
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Other relevant International publications are : a) EEE/RM/062rev3 The selection and use of reference materials - A basic guide for laboratories and accreditation bodies. A EA-EURACHEM publication. b) ILAC-G12:2000 Guidelines for the Requirements for the Competence of Reference Material Producers. NOTE : Reference has been made to above guides in preparation of this discussion paper. Requirements for the Competence Of Reference Material Producers are covered in Appendix 1. 3. AVAILABILTY OF RM’s/CRM’s 3.1 Increasing Requirements of Reference Materials/Certified Reference Materials 3.1.1 Due to a number of reasons like increase in industrial activities and agricultural production, increase in international trade and commerce due to globalization, greater emphasis on health and safety issues, there is marked increase in testing requirements. Further due to greater emphasis on compliance to technical competence criteria – ISO 17025 and subsequent accreditation, importance of reliability of test data generated too has increased. Thus there is an increase in requirements of Reference Materials by Laboratories both in terms of quantity and type/range. 3.1.2 In the present scenario of globalization of economic activities, in order to maintain international consistency of results, importance of Certified reference Materials – Reference Materials produced and certified in conformity to the international standards (provisions of ISO Guides 30 to 35) has become more relevant. 3.1.3 It is generally observed world over that the demand for reference materials exceeds supply in terms of the range of materials and availability and is even more difficult for CRM’s. It is rare to have a choice of alternative RMs and the user is many times required to choose the most suitable material available. 3.2 Suppliers of RMs/CRMs in International Market 3.2.1 There are a number of organisations producing large quantities of reference materials to meet the demands worldwide. Producers include internationally renowned institutions such as NIST; collaborative government/semi-government sponsored programs such as the EU-BCR program, FLUKA-EMPA-BAM; Metrology institutes; semicommercial; sectoral or trade associations such as the American Oil Chemicals Association and an increasing number of commercial organisations. It is understood that Internationally the distinction between government institutes and commercial businesses is disappearing with the privatisation of a number of national laboratories.
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Not all materials that are used as reference materials are described as such. Commercially available chemicals from sources like Emerck, Acu standards, Chem services, etc, of varying purity, commercial matrix materials and products from research programs are often used as standards or reference materials. In the absence of ‘certification’ data provided by the supplier it is the responsibility of the user to assess the information available and undertake further characterisation as appropriate. 4. REQUIREMENTS OF INDIAN LABORATORIES 4.1 The demand for RM’s especially CRM’s both in terms of range and quantity, has increased phenomenally in India in the last few years due to following reasons : a)
More and more laboratories are opting for accreditation to ISO 17025 under the laboratory accreditation program run by NABL.
b)
Stringent traceability demands brought about by NABL’s mutual recognition arrangement (MRA) with APLAC and ILAC, leading to mutual acceptance of test results and measurement data between different International partners.
c)
Increase in India’s trade with other countries.
d)
Setting up of more stringent standards in areas involving environment, health and safety both nationally and internationally.
e)
Greater awareness with respect to quality of testing, among the laboratories and their users.
4.2 Type and range of RMs/CRMs commonly required The maximum requirement of RM’s/CRM’s toady is in chemical test areas. In fact in most of modern methods of chemical analysis using techniques like Chromatography, spectroscopy/spectrometry, instrumentation involving mass detectors, etc, the results are directly related to reference materials which are used for calibration / standardization of the instruments. Hence the need for reference material today is the highest in chemical analysis involving such types of techniques. Further stringent regulatory requirements in the field of food products from importing countries, in recent years, has led to increased testing requirements for residue analysis (Elemental, pesticide and drug residues) and hence increase in RM/CRM requirements both in terms of range and quantity. An illustrative list of CRMs required is given in Appendix 2. 4.3 Present status of supply - Some of the known sources of RM’s and CRM’s in India are :
NPL, New Delhi 1. Mono-element Solutions (covering 13 elements at 1 ppm level) – useful for AAS/ICP analysis. 2. Multi-element solution (covering 3 elements at 100 ppm level). 3. Silicon Powder for X-ray diffraction.
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4. Pesticides (covering two pesticides, nominal purity 99.9%) 5. gas mixture (methane in nitrogen, nominal concentration 10 ppm) 6. geochemical (high grade gold ore, nominal concentration of gold 12 ppm
NML, Jamshedpur 1. Metal – Steel, Stainless steel, Brass (In drilling form and do not cover full range of elements) 2. Ores – Iron, Nickel, Manganese ore, Fluorspar 3. Ferro alloys, Si-Al Alloys (In drilling form).
Central Manufacturing Technology Institute, Bangalore and FIE Hardness test blocks.
NCCBM, Bahadurgarh Cement for both chemical and physical requirements.
Institute of Microbial Technology, Chandigarh/ NCL Pune Reference Cultures for biological testing.
Besides the above there are some private sector organizations like M/S C. C. Shroff Research Institute, Mumbai, Jai Research Foundation, Vapi who are making CRM’s in the field of Pesticide, for their own or limited outside consumption. 4.4 Demand vs Supply However, considering the present need the demand outstrips the supply from Indian sources, by a very, very wide margin both in terms of quantity and range. Generally the Indian labs depend on import from known International suppliers, although all of them are not CRM’s (with traceabilty). For example today say a laboratory carrying out pesticide residue testing in food commodities meant for exports to EU countries, Japan, etc may require to procure and stock around 150 to 200 pesticide CRMs. This demand outstrips the availability by a huge margin - two pesticide CRMs have been so far developed by NPL and about 10 - 15 RMs sold by M/S CC Shroff Research Institute, Mumbai. 5. NATIONAL PROGRAMME FOR CRM DEVELOPMENT 5.1 The Need The need for having indigenous suppliers of RM’s/CRM’s need not be over emphasized especially in view of growing importance of Reference Materials in today’s testing scenario and growing needs with introduction of new tests and requirements on a regular basis. Some of the relevant reasons for the same are: c) The High cost of imports; d) The Repetitive nature of the requirements since most of these reference materials have a defined shelf life; e) The time delay in receipt on account of imports.
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f) Many of the Reference Materials in use today are not Certified Reference Materials and declared values by the supplier are simply taken as the certificate value. In view of the reasons as listed above, a need is felt for evolving a National program for Development, certification and distribution of Certified Reference Material. A suggested model for evolving a National System for Development of Certified Reference Materials in different testing fields is enclosed at Appendix 3.
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APPENDIX 1 REQUIREMENTS FOR THE COMPETENCE OF REFERENCE MATERIALS PRODUCERS Producer of Reference Material In accordance with the ISO definition as given in ISO Guide 30, a Producer of Reference Materials would be one who has the capability to produce material or substance one or more of whose property values are sufficiently homogeneous and well established to be used for the calibration of an apparatus, the assessment of a measurement method, or for assigning values to materials. Producer of Certified Reference Material The producer of Certified Reference Materials is required to have, in addition to the above, the technical competence to assign and certify one or more of property values to the Reference material, by a procedure which establishes its traceability to an accurate realization of the unit in which the property values are expressed, and for which each certified value is accompanied by an uncertainty at a stated level of confidence. Different activities/functions that would be involved in production of Certified Reference Materials would include : a) b) c) d) e) f)
Planning; Material Preparation; Homogeneity and stability assessment; Testing; Assignment of property values and their uncertainties: Packaging, labeling, and distribution of the CRM.
In actual practice there may be different arrangements in place for supply and characterization of and assignment of property values to reference materials. These range from all functions being performed by a single organisation, through to various combinations of organisations conducting separate tasks leading to supply of a Certified Reference Material. In many cases the skill and technical competence requirements for production of reference material on a large scale and its distribution may be different from those required for assignment of traceable value, an activity which would require putting lot of effort in developing technical competence in a primary measurement process. In such cases a division of tasks may be the most suitable way, where different institutes and companies focus on their different skills and core activities. While a private company may
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be able to produce a reference material most efficient on a large scale and the assignment of a traceable value may not be its special skill. Normally national metrological institutes in a country or any other referral laboratory specially designed for the purpose are predestinated to assign a traceable value, because normally it is one of their core tasks to provide the ultimate link to the SI by performing a primary measurement. ISO Guide 30:1992 defines a RM certifying body as a: “Technically competent body organisation or firm, public or private) that issues a reference material certificate which provides the information detailed in ISO Guide 31”. Guide 30 also notes that: “the certifying body may be the same as, or different from, the issuing body (i.e. the body from which the certified reference material is available) and the testing body (i.e. the organisation that carried out the measurements leading to certification)”. The organisation which is responsible for supplying a reference material is expected to ensure that all sub-tasks leading to such supply have been performed competently, whether such tasks are carried out directly by the producer itself or in combination with various subcontractors.
Need for Accreditation System for CRM Producers The demand for Reference Materials of demonstrated and reliable quality is increasing as a consequence of both the increased precision of measuring equipment and the requirement for more accurate and reliable data in technological and scientific disciplines. It is therefore not only necessary for Reference Material producer to supply certificate along with the RM but also to demonstrate their competence in certifying reference materials of appropriate quality. ISO Guides 30 -35 provide guidance on various activities involved in production and certification of Reference Materials. Among these ISO Guide 34:2000 Quality system guidelines for the production of reference materials and ISO Guide 35 :2006 Certification of reference materials - General and statistical principle are directly relevant for the purpose of accreditation. Infact ILAC has issued a guidance document, ILAC-G12:2000 Guidelines for the Requirements for the Competence of Reference Material Producers, These Guidelines in ILAC G 12 are based on existing ISO Guides relevant to the production, characterisation and use of reference materials (ISO Guides 30-35) and on the relevant elements of ISO/IEC 17025 applicable to tests and measurements involved in the assignment of property values to reference materials. Additionally, relevant elements of ISO 9000 are included in the Guidelines to eliminate the need for separate recognition of a producer of reference materials for compliance with ISO 9000. In the last few years, some of the ILAC/APLAC MRA partner laboratory accreditation bodies like NATA of Australia, UKAS of United Kingdom, and A2LA of United States of America have introduced accreditation of CRM producers against ISO Guide 34, which in turn requires compliance with ISO Guide 30, ISO Guide 31 and ISO Guide 35.
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An appropriate Accreditation scheme could also be developed and introduced in India by NABL, as and when need is established. CRM producers should participate in key comparison program organized by BIPM/ CIPM or RMO and get their key comparison data included in Appendix B of BIPM website.
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APPENDIX 2 LIST OF CRMs
S. Broad Category No. Chemical 1
Inorganic Reference Material
Types Of Tests/activities
Preparation of Standard Solutions for titrations, etc.
1. Calibration/standardization of equipments like AAS, ICP, Spectrophotometer, Flame photometer,, etc, for elemental analysis 2. Residue analysis in food products . 2.
Metallic Composition Reference Materials
3.
Organic Reference Material
Composition of Metals Ferrous and Nonferrous using wet analysis techniques (Classical & instrumental) and techniques like OES, X-Ray etc. Testing of technical/formulation grade pesticides, dyes, organic solvents and other compounds.
Types of reference Materials Salts like Potassium Dichromate, Sodium Chloride, Potassium Hydrogen Phthalate, EDTA, Sodium Oxalate, etc Single or multi-element solutions
1. Metal drillings and solid metal CRM’s. 2. Pure metal CRM’s like Copper, Platinum, Silver, Gold, etc. Pure Organic Compounds
Residue level analysis for Pesticide residues, Drug residues, Naturally occurring toxins, Organic residues like PCB’s, PAH’s, Dioxins, Banned dyes, etc 4.
Nonmetal Ion Standard solution
Testing of water for ions like Fluoride, Cyanide, nitrite, Nitrate, Bromide, Bromate, Sulphide, etc
Single ion solution CRM
5.
Minerals and Ore
Various chemical parameters
Individual ores
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6.
Petroleum Products
Miscellaneous materials 8. Environmental Reference Material Biological/Clinical
Testing of various physical parameters
Standards for various physical parameters like viscosity density, etc.
Testing of various physical and chemical parameters
Standards for chemical parameters like Sulphur in petrol, wear metals in lubricants, metallic impurities in naptha, calorific values of fuels, etc pH standard solution
Emission Gas analysis
Reference Gas – Co2, CO, Oxides of Nitrogen, Hydrocarbons, etc.
Microbiological Testing for presence of various pathogens and other microorganisms Biochemical testing of various biological substances like serum
Cultures for Salmonella & shigella, ecoli, pseudomonas, Staphylococcus, etc.
Test blocks for Brinell, Vickers and Rockwell hardness.
7.
1.
Pure Cultures
2.
Biological substances
Physical/Engineering 1.
Mechanical properties
Hardness testing
2.
Electrical Properties
Electrical resistance
NOTE : The list given above is not exhaustive and is made only for illustrative purposes.
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APPENDIX 3 SUGGESTED MODEL FOR EVOLVING A NATIONAL SYSTEM FOR DEVELOPMENT OF CRMs IN DIFFERENT FIELDS Three different groups would be involved in this exercise as given below : a) Task Force / Working Group / Nodal Agency, however suitably designated. b) CRM producers for different identified fields. These could be single or group of organizations with designated areas of operation and one of them being identified as nodal organization. c) NABL for establishing and introducing a system for accreditation of CRM producers. The various functions/activities required to be performed by the three groups as defined above would be : 1. Task Force / Working group / Nodal Agency will have following main functions/ activities : a) Identification/listing of different Reference Materials used in Indian laboratories. b) Prioritising the development need based on different criteria like most commonly used, more expansive to import, availability of ready development capability within the country, etc. c) Identification of area and product/tests for which CRMs are needed to be prepared, certified and distributed, priority wise. d) Identification of organisations competent for the above activities in different areas identified. NOTE 1 - As already discussed all the functions relevant to CRM development, namely, production of RM, its certification (characterization and assignment of property values) and distribution and supply may be done by the same organisation or by two or more organisation depending on skill and expertise required for performing these individual functions. NOTE 2 - In actual practice it may be observed that a private/public manufacturing company may be able to produce a reference material in most efficient manner on a large scale, however may not at the same time be proficient in assigning a traceable value which would invariably require putting lot of effort in a primary measurement capability, which at least for a private producer will often not be economically a viable proposition. Hence a division of tasks may be the most suitable way, where different institutes/organisations and companies focus on their different skills and core activities.
Example of one such public private partnership exists in a German model – Between FLUKA GmbH, a (private specialty chemical manufacturing company and EMPA a research institute under Swiss federal organisation RTH Domain and BAM (Federal Institute for Materials Research and Testing, Germany), which was
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involved from the beginning as a partner for CRM development activities of EMPA/FLUKA. BAM and EMPA are an ISO 17025 accredited organisation. EMPA and FLUKA are also ISO 9001:2000 certified. As per the agreement FLUKA is required to produce the reference materials according to ISO guide 34 and other requirements defined by EMPA. EMPA controls the batch for its homogeneity and approximate content before the material is released for bottling and packaging. The certification analysis is performed by EMPA and BAM using randomly chosen bottles. Two different methods of measurement are applied. The results are combined to the certified value. Long term stability tests are carried out by EMPA in parallel. A certificate is provided only when all criteria including stability are met. NOTE 3 In India also similar model could be employed – say a public private partnership between a private RM producer having adequate competency and capacity for production and a CSIR Lab having necessary testing and property value assigning skills, leading to a more effective to combination of different skills in a complementary way. NOTE 4 This entire activity may be supported by the government till such time that it becomes self sustainable. e) Assigning responsibility to the identified organization (s) for developmental work. f) During the initial stages the working group may be involved in planning,
and give technical support in any of the areas like production, certification and distribution, as needed, at least till such time that this activity becomes self sustainable and the organisations involved are accredited for the activity by the relevant accreditation board (NABL). NOTE – Planning would be one of the key activities which would involve decision on Properties to be measured and certified; The limits of accuracies to be laid down; Methods required for ensuring homogeneity, shelf life studies and for subsequent certification to be identified/selected, procedure for certification to be evolved and Procedure for packaging, labeling and distribution to be evolved. g) Subsequently the working group may have the task of monitoring the activity and in case any new requirements are identified the steps a) to f) may be required to be repeated 2. Functions and activities of the designated CRM producer As explained earlier all the relevant functions like production of RM, its certification and distribution may be performed by single organisation or through combination of organisations conducting separate tasks leading to supply of a Certified Reference. However, for the purpose of exercising control and assigning responsibility the organization which is responsible for supply of both the reference material and authorization of the data accompanying the reference material, whether in the form of a
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certificate (for a CRM) or in any other form of assignment of property values (for a reference material), is generally known as the producer. It is expected that the organisation which is responsible for supplying a reference material should ensure that all sub-tasks leading to such supply are performed competently, whether such tasks are carried out directly by the producer itself or in combination with various subcontractors/collaborators. The activities involved in production are: a) Planning; b) Material Preparation; c) Homogeneity and stability assessment; d) Testing; e) Assignment of property values and their uncertainties; f) Packaging, labeling, and distribution of the CRM. Some of the key requirements expected to be established and implemented fulfilled by the producer for ensuring quality are : a) Procedures for ensuring the suitable choice (e.g. sample matrix, particle size, concentration range) of reference materials; b) Preparation procedures; c) Procedure for assessment and quantification of the required degree of homogeneity of the reference material; d) Procedure for assessment of the stability of the reference material, including ongoing assessment of stability where necessary; e) Procedures for undertaking characterization and practical realization of traceability to national or international standards of measurement; f) Procedure for assignment of property values, including preparation of certificates or statements in accordance with ISO Guide 31 when appropriate; g) Provision of suitable production facilities; h) Procedures for suitable identification, labelling and packaging facilities, packing and delivery procedures and customer service. 3. National Accreditation Board for Test and Calibration Laboratories (NABL) Simultaneously NABL would be required to develop and introduce accreditation scheme for RM producers and also for Proficiency test providers since these two may be undertaken as complementary activities.
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Annexure 2 DEVELOPMENT OF PROFICIENCY TESTING SERVICES – RECOMMENDED APPROACH
0. INTRODUCTION 0.1 Measurements are an essential input for decision making in a wide variety of activities and areas – be it commerce and trade, verifying conformity to various regulations, health and safety aspects, reciprocal comparisons or even acceptance/rejection of test equipments based on calibration. The reliability of analytical/measurement data play a very important influencing role in the decision making process involved therein. 0.2 A variety of means are adopted by the laboratories for monitoring the validity/reliability of test data generated and the performance of tests undertaken, which include – Replicate tests using same or different test methods, Retesting/recalibration of retained items, correlation of results, comparison of test results with other laboratories through participation in Interlaboratory test comparison or Proficiency testing programmes, etc. These are also prescribed in ISO 17025:2005 as a means of ensuring quality of testing by laboratories. Among those listed above, participation in Proficiency testing programmes are generally independent assessments, hence most preferred. 0.3 Even the laboratory accreditation systems as per ISO/IEC 17025, recommend a regular independent assessment of the technical performance of a laboratory, as an important means of assuring the validity of analytical measurements and also as a part of the overall quality strategy. 1. INTERLABORATORY TEST COMPARISONS 1.1 Interlaboratory Test Comparisons are conducted for a number of purposes and may be used by participating laboratories and other parties for the following purposes :. a) To determine the performance of individual laboratories for specific tests or measurements and to monitor laboratories' continuing performance. b) To identify problems in laboratories and initiate remedial actions, which may be related, for example, to individual staff performance or calibration of instrumentation, etc. c) To establish the effectiveness and comparability of new test or measurement methods and similarly to monitor established methods. d) To provide additional confidence to laboratory customers. e) To identify inter-laboratory differences. f) To determine the performance characteristics of a test method - often known as collaborative trials, inter-laboratory trials, round-robins to determine its fitness for use. g) For assigning values to reference materials (RMs) and assess their suitability for use in specific test or measurement procedures as part of CRM production. 94
1.2 Interlaboratory test comparisons may be initiated by an individual laboratory or an independent organization for a variety of reasons as listed above. Few existing examples are covered in Appendix 1. 2. PROFICIENCY TESTING It is the use of inter-laboratory comparisons to determine the performance of individual laboratories for specific tests or measurements. 2.1 How Is It Done ? Inter-comparisons of test results can be organized by the laboratory itself and involve only a few other laboratories (Interlaboratory test comparison), or the laboratory can participate in an independent inter-comparison services provided by a designated lab or professional provider (PT provider), where usually a number of other laboratories participate. A Proficiency Testing (PT) scheme/programme is a system for objectively evaluating laboratory results by external means, and includes regular comparison of a laboratory’s results at intervals with those of other laboratories. This is achieved by the scheme/programme coordinator regularly or through one-time distribution of homogeneous test samples to participating laboratories for analysis and reporting of the data. Each distribution of test samples is referred to as a round. The main objective of a PT scheme is to help the participating laboratory to assess the accuracy of its test results. 2.2 OFFICIAL DEFINITIONS Interlaboratory comparison (ILC) is the organization, performance and evaluation of calibrations/tests on the same or similar calibration/test items by two or more laboratories in accordance with predetermined conditions. Proficiency testing (PT) is the determination of the calibration or testing performance of a laboratory or the testing performance of an inspection body by means of interlaboratory comparison. 2.3 WHY PROFICIENCY TESTING IS ESSENTIAL 2.3.1 While individual laboratories use Intelaboratory comparisons/PT Programme data for internal verifications, Accreditation bodies like the NABL use proficiency testing as part of the overall assessment of a laboratory’s ability to perform tests competently. It is increasingly considered as an essential part of the accreditation programme, complementing the on-site laboratory assessment by technical experts, and providing information to support the accreditation decision process. In many countries, in certain specialized areas, which are generally in the regulated sector, like food testing, drinking water and environmental testing, participation in certain specified PT programmes by the laboratories is considered essential as per the requirements stipulated in the regulation. 2.3.2 The International Standard for laboratory accreditation bodies, ISO 17011:2004 “Conformity assessment — General requirements for accreditation bodies accrediting conformity assessment bodies” specifies the following : 95
7.15 Proficiency testing and other comparisons for laboratories 7.15.1 The accreditation body shall establish procedures to take into account, during the assessment and the decision-making process, the laboratory's participation and performance in proficiency testing. 7.15.2 The accreditation body may organize proficiency testing or other comparisons itself, or may involve another body judged to be competent. The accreditation body shall maintain a list of appropriate proficiency testing and other comparison programmes. NOTE Guidelines on operation and selection of proficiency testing and related definitions exist in ISO/IEC Guide 43-1 and ISO/IEC Guide 43-2. 7.15.3 The accreditation body shall ensure that its accredited laboratories participate in proficiency testing or other comparison programmes, where available and appropriate, and that corrective actions are carried out when necessary. The minimum amount of proficiency testing and the frequency of participation shall be specified in cooperation with interested parties and shall be appropriate in relation to other surveillance activities. NOTE 1 It is recognized that there are particular areas where proficiency testing is impractical. NOTE 2 Proficiency testing may also be used in many types of inspection. Clause 7.15 should be read in this sense. 2.3.3 Further requirements with respect to Proficiency testing are specified in ILAC P1:2003 “ILAC Mutual Recognition Arrangement Requirements for Evaluation of Accreditation Bodies by ILAC Recognized Regional Co-operations” which is required to be fulfilled by Laboratory accreditation bodies like NABL for entering in to Mutual Recognition Arrangement (MRA) with the International Laboratory Accreditation Cooperation (ILAC) or a regional accreditation cooperation such as the Asia Pacific Laboratory Co-operation (APLAC). APLAC MR0001 “Procedures for Establishing and Maintaining Mutual Recognition Agreements Between Accreditation Bodies” Section 3.3 requires accreditation bodies to specify that accredited laboratories participate in a minimum of one proficiency test prior to accreditation and one proficiency test for each major sub-area of major disciplines of a laboratory’s scope of accreditation at least every four years. 2.3.4 In view of the above all laboratory accreditation bodies in their accreditation criteria/system specify the minimum amount of proficiency testing (Self initiated Interlaboratory comparison studies in absence of availability of PT programmes) and the frequency of participation, appropriate in relation to other surveillance activities. 2.3.5 Notwithstanding what is stated in ISO 17025 and the accreditation procedure of the laboratory accreditation body, Proficiency testing is an excellent way to validate one’s own measurement/analysis processes. Proficiency tests can validate the participating laboratory’s measurement/analytical method, technical training of personnel, traceability of standards and uncertainty budgets. Even though the laboratory may had been most 96
rigorous in developing the above mentioned laboratory processes, it is important to use proficiency testing as an additional way to verify that all aspects of the laboratory measurement system are sound and hence are considered very essential. 2.4 DIFFERENT TYPES OF PROFICIENCY TEST SCHEMES/PROGRAMME 2.4.1 Proficiency testing techniques vary depending on the nature of the test item, the method in use and the number of laboratories participating. Most possess the common feature of comparison of results obtained by one laboratory with those obtained by one or more other laboratories. In some schemes, one of the participating laboratories may have a controlling, coordinating, or reference function. 2.4.2 The most common types of proficiency testing schemes/programmes are Measurement comparison schemes, Interlaboratory testing schemes, Split-sample testing scheme, Qualitative schemes, Known-value schemes, Partial-process schemes 2.5 ESSENTIAL COMPONENTS OF PROFICIENCY TESTING PROGRAMMES 2.5.1 There are two distinct processes involved in designing and organizing a Proficiency testing programme, which are concerning the following: a) Sample or the artifact (as in case of testing of discrete articles or calibration), and b) The statistical processing and evaluation of data for drawing accurate conclusions on performance of participating laboratories. Both the steps need to be designed and carried out appropriately in order to ensure useful and accurate conclusions arising out of the Proficiency testing programme. 2.5.2 The following factors related to sample or the artefact have direct influence on quality and reliability of Proficiency testing performed. i) Sample/artefact Quality, Homogeneity, Reliability – Samples/artefacts are needed to be carefully selected keeping in mind all essential components. The selection process should consider the uncertainty attainable, transportation and packaging conditions required. ii) Homogeneity of the sample/artifact – This needs to be to be ensured through appropriate homogeneity studies. iii) Availability of all relevant information in respect of stability of the sample/ artefact at least from the point of characterization (including during transportation) to the point of testing/calibration; attainable uncertainty, etc. iv) Choice of appropriate reference laboratory, where required, for accurate characterization (Reference Value and uncertainty determination, relevant specially for calibration) of artefact/sample. 2.5.3 Other important factors which have direct influence on the conclusions drawn on the basis of participation of proficiency testing are:
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i) Statistical design of the proficiency testing programme, with appropriate choice of test statistics used. This is required to be decided at the planning stage itself. ii) Appropriate statistical treatment of the data generated by the participating laboratories for drawing accurate and meaningful conclusions. iii) Design and quality of final report – Important from users point of view. iv) Completion of the entire programme within reasonable time frame as planned for during the design stage and prompt delivery of report to participating laboratories. 2.6 REQUIREMENTS FOR PROFICIENCY TEST PROVIDERS 2.6.1 The requirements for competent Proficiency Test Providers are : i) Capability to design and plan Proficiency test programmes, appropriate to the purpose, which should take in to account all the requirements as listed above. One of the most significant one being that the PT provider should provide evidence that the test samples/items are sufficiently stable and homogeneous, to ensure that they will not undergo any significant change throughout the conduct of the proficiency test. It is critical to the design of a successful proficiency test that the PT providers understand the metrological characteristics of the sample/artefacts, the measurements, such as pivot laboratory measurements, if used in the proficiency test, in order to ensure that the stability and suitability of the artefact is well understood. ii) The Proficiency test programmes should be designed and structured and carried out to ensure fitness for purpose. This can be achieved by the proficiency test providers by carrying out their activities in accordance to the International standards/guides available on the subject, namely – ISO/IEC Guide 43 Pt1 & 2, ILAC G13 in combination with International conformity assessment standard like ISO/IEC 17025 for generation of test/calibration data. iii) The proficiency test provider should preferably be accredited to the provisions of above standards, wherever such accreditation exists. 2.7 RELEVANT ISO GUIDES AND OTHER INTERNATIONAL PUBLICATIONS 2.7.1 ISO Guides dealing with Reference Materials are listed below : a) ISO Guide 43 Part 1:1997 Proficiency testing by Interlaboratory comparisons -Part 1: Development and operation of proficiency testing schemes. b) ISO Guide 43 Part 2:1997 Proficiency testing by Interlaboratory comparisons -Part 2: Selection and use of proficiency testing schemes by laboratory accreditation bodies. 2.7.2 Other relevant International publications are : a) ISO 17025:2005 General requirements for the competence of testing and calibration laboratories.
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b) ISO 17020:1998 General criteria for the operation of various types of bodies performing inspection. c) ILAC-G13:2000 Guidelines for the Requirements for the Competence of Providers of Proficiency. d) ILAC-G22:2004 Use of Proficiency Testing as a Tool for Accreditation in Testing. NOTE : Reference has been made to above standards and guides in preparation of this discussion paper. 2.8 AVAILABILITY OF PROFICIENCY TEST SCHEMES/PROGRAMMES With growth of laboratories and corresponding realization of importance of the test results in decision making processes in many economic, health and safety areas, the requirements of reliable and accurate results has grown tremendously. In recent years both laboratories and accreditation bodies have increasingly realised the importance of proficiency tests as tool not only for helping the laboratories to assess their own performance and helping them in improving reliability of test/calibration data but also as an excellent tool to demonstrate and assess the performance of laboratories with regard to specific measurement, testing, and analytical tasks. Today it is also well appreciated that Proficiency tests can support accreditation processes and indirectly, give a feedback on the quality and impact of accreditation. Despite these benefits the participation in proficiency tests is generally hampered not only by the restricted offer of suitable proficiency testing schemes in many testing areas but also by the lack of information on their availability. However internationally this scene has changed in recent years. 2.8.1 INTERNATIONAL SCENE Today a large number of Proficiency Test Providers are available especially spread over in USA, Europe and Australia – some laboratories in Government sector, some association level laboratories, some are National Measurement Institutes of different countries and many others are totally independent private professional PT providers. Some of these have been in existence as early as in 1970’s. A very comprehensive list of PT providers world over in different test and calibration areas is available on the website (www.nata.asn.au) of Australian accreditation body NATA (National Association of Testing Authorities, Australia). In fact, in Europe, in an effort to collate information about PT providers world over and create a network of PT providers, in 1998, 16 organisations in 16 European countries joined forces. A network was accordingly established under the auspices of the European Co-operation for Accreditation (EA) and the European laboratory organisations, Eurachem and Eurolab, in subsequent years supported by organizations like ILAC, EA, IRMM, IAAC and many others from USA Latin America. The partners of this network extensively surveyed the availability of PT schemes and their characteristics within their respective countries. All this was entered into a database which was made public on the internet in the year 2000. A website was created to give access to the database, and to provide additional information concerning PT. The network, website and database were 99
called EPTIS for European PT Information System. The European Union supported the foundation of EPTIS with financial contribution convinced about its contribution to strengthening PT as a valuable proof of technical competence and its role to help removing technical barriers to trade. After the EU funding of the project ended, the 16 partners agreed to continue their co-operation on a voluntary basis. They formalised their cooperation in a joint Protocol in 2001. Besides constant updating of the data base a new section for PT providers who wish to announce their forthcoming PT rounds has been installed. They also include information regarding accredited PT programmes. It is apparent from the information contained in database that today large number of PT providers internationally in various testing and calibration fields and their number is growing by the day. With a number of PT providers now available world over, in recent years the need for performance evaluation of Proficiency test providers to assess their fitness for purpose, by an independent body has also been felt. Many of the laboratory accreditation bodies in USA, Europe and that in Australia have introduced Accreditation of PT providers, Details of accreditation are given in Appendix 2. 2.8.2 NATIONAL SCENE The national laboratory accreditation system has been in existence in India since 1991/92. The need for participation in PT programme was primarily driven by the requirements given in the laboratory accreditation criteria. Subsequently the need for participation in PT programmes increased with stricter norms being prescribed as a result of revision of Accreditation criteria for laboratories (ISO/IEC 17025:2005 and also the earlier version of 1999) and recently with revision in Criteria for accreditation bodies (ISO/IEC 17011:2004). Further to meet the requirements of APLAC MR001 it is mandatory for all accrediting bodies, who are APLAC MRA partners, to undertake proficiency testing programmes for its accredited laboratories. All applicant laboratories are required to successfully participate in at least one Inter - Laboratory Proficiency Testing in accordance with ISO/IEC Guide-43 (I)-1996. However there are hardly any independent, professional PT providers in the country. The gap is partly met through organization of PT programmes by NABL for its accredited as well as applicant laboratories. Non-accredited laboratories are also invited to participate in these programmes. The programmes are run through nodal laboratories identified by NABL. NABL has also prepared and published NABL - 162 Guidelines for Proficiency Testing programmes for Testing and Calibration Laboratories for conducting PT programmes. Further, as advised by NABL, accredited laboratories regularly participate in the PT programmes organized by APLAC and other international bodies. NABL also encourages participation of applicant / accredited laboratories in Proficiency Testing programmes conducted by other national and international bodies. Accredited laboratories are encouraged to participate in as many of these external programmes as possible to enhance their quality assurance.
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3. NATIONAL REQUIREMENT However, in view of the large number of laboratories, in a wide variety of fields, accredited today in India, and this number growing by the day, the gap between availability of Proficiency test programmes and the requirements/demand is getting wider. Further, there is a growing perception in the international accreditation scene, that laboratory accreditation bodies should not organize Proficiency testing programmes themselves, because this could be termed as conflict of interest. There are today a large number of International Professional Proficiency Test Providers, accessible to Indian laboratories. Some of them are also accredited to ISO/IEC Guide 43, by accreditation bodies like UKAS, NATA, A2LA, etc. However the disadvantages of solely depending on these International PT providers are many. Some of these are listed below : a) They are very expensive ranging between Rs 15 000.00 to Rs 30 000.00 per programme per testing field be and depending upon the logistic elements, may also involve extra packing and forwarding charges. For a multi-product testing laboratory this would involve considerable expenditure to cover all the product/test categories in the scope. Further this need is repetitive in nature since satisfactory performance in proficiency testing will have to demonstrated by the laboratories at a regular predefined frequency. b) They are available as per fixed schedules and not as and when the actual need is felt by the laboratory. c) They may not always be as per Indian laboratory’s specific testing needs or product categories. Thus in the interest of Indian laboratories and the laboratory accreditation system there exists a need for : 1. Developing indigenous professional/independent PT Providers. 2. Developing and introduce system for Accreditation of Proficiency test providers. It is understood that this need has already been felt by NABL and actions have already been initiated in this direction. Keeping in mind the general and specific test/calibration related expertise required for organizing and conducting on a professional basis the proficiency test programmes, following options are suggested both in terms of taking care of immediate needs and as long term strategy. 3.1 SHORT TERM STRATEGY A suggested short term strategy for meeting the immediate requirements in respect of proficiency testing needs of Indian Labs is given below : i. For test and calibration fields which are routine in nature we may continue with the present system of organizing PT programmes – Identification of nodal laboratory by NABL and organisation and conduct of PT testing under the supervision and control of NABL. This arrangement would be a stop gap arrangement till such time that independent sources of professional PT Providers are developed and accredited by NABL.
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ii. For test and calibration fields which are highly specialized in nature and where enough technical expertise in terms of testing skills, basic nature and understanding of stability/homogeneity parameters as required for being a nodal lab for PT programmes, has not yet been developed indigenously, the labs shall be asked for participating in international PT programmes. Since these programmes are expensive the cost of participation shall be subsidized. The exact system of implementation needs to be worked out. A nodal agency will be needed to be identified for this purpose, which could be NABL. The various steps involved would be: a) Identification of Tests/Calibrations of specialized nature as defined above and where need exists in terms of number of labs already accredited or in the process of being accredited or even those which are in the process of implementing ISO 17025; b) Identification of competent International PT provider (preferably accredited) for individual areas and advise to labs for participating the programme. c) Either the labs could be asked to directly contact the identified labs or the designated nodal agency could have a dialogue with the identified organisation for including Indian labs in any of the suitable ongoing programmes or for designing or conducting a suitable programme for Indian labs. d) The results would be received directly by the lab in the first case as stated above and disbursement of subsidy could be made based on lab’s claim. In case where the nodal agency would have dialogue with PT provider a similar suitable model could be developed. Some of the specialized areas where an immediate need is felt for Proficiency testing and where the indigenous expertise for carrying out PT programmes does not exist are – Residue (pesticide and other chemicals like PCB’s, PAH’s; veterinary drugs, mycotoxins, Heavy metal and other toxic elements) in food products, testing of electrical products and in many calibration related areas. 3.2 LONG TERM STRATEGY 3.2.1 A suggested model for evolving a National System for Development of Professional Proficiency Test Providers is described in the following paragraphs. 3.2.1.1Three different groups would be involved in this exercise as given below : a) Steering committee/Task Force /Working Group/Nodal Agency, however suitably designated. b) Proficiency Test Providers for different identified fields. c) NABL for establishing and introducing a system for accreditation of Proficiency Test Providers. NOTE : Steering committee/Task Force / Working Group/Nodal Agency for development of PT providers could be the same as that set up for development of CRM providers since some of the actions are complementary and infact it is expected that many of the CRM producers especially in chemical and biological fields would also be able to provide PT Programs.
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The various functions/activities required to be performed by the three groups as defined above would be : i. The Steering Committee/Task Force/Working group/Nodal Agency will have following main functions/ activities : a) Identification/listing of different types of Test and Calibration activities in India where need for PT Programmes Reference Materials used in Indian laboratories. b) Prioritising the development of PT programmes based on different criteria like number of labs accredited in the field, non-availability of suitable programmes Internationally, Expenses involved in existing International programmes, expertise available and availability of ready development capability within the country, etc. c) Identification of areas of testing and calibration for which PT programmes are needed to be developed, priority wise. d) Identification of organisations competent for the above activities in different areas identified. e) Identifying training needs, develop suitable programme modules, identify training organisations. The organisations identified for this work will need to undergo extensive training before the job of developing PT programmes can be undertaken by them. f) Assigning responsibility to the identified organization (s) for developmental work. g) During the initial stages the steering committee/nodal agency working group may be involved in planning, and give technical support in any relevant areas as needed, at least till such time that this activity becomes self sustainable and the organisations involved are accredited for the activity by the relevant accreditation board (NABL). The administrative expenses involved during the initial stages, till such time that this activity becomes self-sustainable, will also have to be met through independent (plan fund) sources. h) Subsequently the Steering Committee/working group/nodal agency may have the task of monitoring the activity and in case any new requirements are identified the steps a) to g) may be required to be repeated ii. Functions and activities of the designated PT Provider It is expected that the organisation which is assigned the task for developing and conducting PT programmes shall ensure that all sub-tasks leading to conduct and reporting of the programme are performed competently in line with the requirements with respect to PT programmes and PT test providers as listed earlier and in line with existing International guidelines as listed earlier and accreditation criteria as and when laid down by NABL. iii. National Accreditation Board for Test and Calibration Laboratories (NABL) Simultaneously NABL would be required to develop and introduce accreditation scheme for PT Providers.
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Appendix 1 Different uses of Inter-lab comparison studies (other than for Proficiency testing) Examples 1. Characterisation of Certified Reference Materials through Interlab comparison : a) Bureau of Analysed Standards, UK use data from Inter-lab comparison values from 5 to 8 laboratories for characterizing and certifying British Chemical Standard Certified Reference Materials (BCS-CRMs) and ECRMs (EURONORM Certified Reference Materials). b) BAM – Federal Institute for Material Research and Testing, Germany; IRRM and use Inter-lab collaboration studies for characterisation of CRM’s developed by them in a variety of areas. 2. Use of Interlab Comparisons for Development of Validated Test Methods : a) AOAC International – providers of Validated Test methods in the field of Chemical analysis and Microbiology, develop and harmonize their published methods using the process of collaborative interlab comparison programmes. b) ASTM International, which is one of the largest voluntary standards development organizations in the world, uses confirmations through Interlab collaborative studies for performance characterization and validation of the test methods it specifies.
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Appendix 2 ACCREDITATION OF PROFICIENCY TEST PROVIDERS The two main documents that drive the quality requirements of Proficiency Test Providers are ISO Guide 43-1 and ILAC G13:2000. International Scene It is observed in the International scenario that few of the accreditation bodies in USA, Europe and Australia, like UKAS, A2LA, NATA are now providing accreditation of Proficiency Test Providers. However there is still no harmonization in approaches adopted by these accreditation bodies. The accreditation as PT provider is based on a variety of combinations of several normative documents. It is seen that by and large there are two distinct approaches: either the use of normative documents only, which are exclusively focused on PT (ISO Guide 43 [1], ILAC G13), or of those using these documents in combination with international conformity assessment standards (ISO/IEC 17025 or 17020). The provisions/requirements of the above referred guides and standards are: ISO Guide 43 “Proficiency testing by interlaboratory comparisons – Part 1: Development and operation of proficiency testing describes different types of proficiency testing schemes, their organisation and design, the operation and reporting. Important aspects are test item management (homogeneity and stability), packing and transportation, data analysis and evaluation and confidentiality. Examples of statistical methods for data treatment are given in its annex. ISO Guide 43 refers only to specific aspects for PT organisation and does not contain any detailed information on the general quality management or the general requirements for technical competence of an organisation. However, in most cases, PT organisation include laboratory testing, e.g. sample characterisation, homogeneity &stability testing, which is be carried out according to the general requirements for the competence of a laboratory as described in ISO/IEC 17025. The guidance document published by ILAC (International Laboratory Accreditation Cooperation) has incorporated all the relevant aspects of ISO Guide 43 and ISO/IEC 17025 into one document ILAC G13. It also provides a cross reference list between ISO Guide 43, ISO/IEC 17025 and ISO 9001. In some cases it may be more practical to treat the general work of the PT provider, as an inspection activity, for which the requirements are laid down in ISO/IEC 17020, especially if the characterisation of sample/artefact is not being done by PT provider and is subcontracted instead. As the data collected from the accreditation bodies show, currently different options of the normative documents described above are applied/used for accrediting PT providers. Indian Scene System accreditation of PT providers is currently not being offered by NABL. However it is understood that the preliminary work in this direction has already begun.
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Annex 9 REPORT OF TASK FORCE 2 ON EMPOWERMENT OF INDUSTRY FOR GLOBAL COMPETITIVENESS 1. The Task Force 2 on Empowerment of industry for global competitiveness had the following terms of reference: a. To identify areas related to quality where industry needs empowerment b. To suggest mechanism for creating awareness of gaps vis-à-vis developed economies and benchmarking c. To suggest programmes for promotion of quality in industry including export sector d. To suggest financial or other incentives along with criteria and modalities e. To suggest strategies, measures and means for addressing special needs of SMEs f. To suggest areas for research studies on major quality issues which affect Indian industry towards development of national strategy g. To suggest mechanism to promote application of relevant standards and quality tools to enable different sectors of industry to be globally competitive 2. The TF2 had the following composition: a. b. c. d. e. f. g. h. i. j. k. l. m. n.
Lt Gen H. Lal – DG, FICCI Quality Forum (Convener), Mr. N.N.Prasad, JS, DIPP Mr. C.V.Subrahmanyan, Sr. Counsellor, CII Mr. A. Mitra, Principal Counsellor, ASSOCHAM Mr. Shirish Asthana, Dy. Director, DCSSI Mr. K.K. Jalan, Secretary, AEPC Mr. A.K. Gupta, Adviser, APEDA Mr. Rajat Srivastava, EEPC Mr. P. Sadana, FISME Ms. Priya Safaya, Director, FIEO Mr. P. Chaturvedi, Institution of Engineers Dr. D. K. Chaudhuri, Head (PCD), BIS Mr. B. Venkataram, Director, NABCB Mr. Anil Jauhri, Adviser, QCI
3. The TF met on 26 July 2006, 4 Aug 2006 and 19 Aug 2006 and held extensive discussions on the issues assigned to it. 4. The TF identified the following weaknesses in Indian industry which are causing lack of competitiveness: a. Lack of awareness about the performance gaps with reference to global benchmarks and reluctance to share their own performance levels
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b. Lack of awareness about impact of standards, international standards in particular, on competitiveness c. Inadequate skills among quality professionals guiding quality improvement efforts in the industry about quality tools and techniques for assessing economic impact of quality d. Inadequate understanding of the contribution of quality to profitability due to which the top managements do not devote attention to quality 5.
Accordingly, the TF recommends the following:
a) Establishment of a National Benchmarking Centre to get information on benchmarks in different industrial sectors so that Indian industries are made aware of gaps in their performance as compared to world benchmarks. Once the deficiencies in specific areas are identified, it will be easy for them to take necessary actions to bridge the gap and come up to global standards. The benchmarking centre will not only provide information on performance standards of foreign companies but also facilitate data sharing of Indian companies and even organize exchange visits in non-propriety areas. The estimate of budget for 5 years is Rs. 100 million after which NBC should sustain itself by a combination of its own income from services and finding sponsors to support studies or the Centre itself. b) Sponsored studies on contribution of quality to profitability to be carried out by QCI under the National Quality Campaign to demonstrate to top managers the economic benefits of quality which in turn should encourage them to integrate quality in the overall management approach. c) Corporate quality scholarships to professionals in the industry for acquiring advanced knowledge on quality management for those organizations who demonstrate good quality performance measured against defined criteria. d) Awards for case studies on cost benefits from quality which were instituted by QCI in the year 2005-06 and given away during the 1st National Quality Conclave in Mar, 2006 should become an annual feature. e) It was recognized that subsidy for ISO 9000/ISO 14000 certifications has led to dilution of quality of certification, nexus between CBs, consultants and manufacturers and malpractices by CBs which have hurt India’s image and the benefits of ISO 9000 have not been fully realized. Therefore, subsidy for certification for SSI units in its present form should be stopped forthwith and replaced by financial incentives for quality improvement based on performance indicators. In this connection, the SA model of phased progress towards ISO 9000 for SMEs was considered (Annexure 1) and the TF recommends that it may be used as input for verifiable performance indicators for quality improvement by units for financial incentives without linking subsidy to certification. f) Strengthening of industry associations especially the product specific ones for participation in standardization, quality promotion and providing common laboratory facilities - With TBT/SPS Agreements encouraging adoption of international standards in trade, participation in international standardization has become vital to protect India’s interests. However, our participation is weak and involvement of industry who should be providing data and comments is poor. Part of the reason is that participation costs money and industry either does not regard this as its responsibility or does not having sufficient
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funds for the same. There is also a lack of appreciation of impact of standards on business which also contributes to the apathy towards standardization in general and international standardization in particular. Therefore, industry associations should be encouraged to set up standardization cells dedicated to study of draft standards, dissemination among interested members, eliciting industry viewpoint and transmitting it to nodal organization for formulating India’s views, and sensitizing industry to the importance of standards in global market. Since these cells would be cost centres, initially they may be funded by the govt but ultimately, say after the 11th Plan, industry should support this activity. g) Assistance in training/consultancy to identified sectors – The TF recommended that priority sectors may be identified with potential for growth and employment and assistance given in upgrading quality levels through awareness, training and consultancy. The following sectors, based on identification done by NMCC, have been identified:
Textiles and garments Leather and leather goods Food processing including GM products Gems and jewellery Handlooms and handicrafts Chemicals including plastics Pharmaceuticals including herbal products IT hardware/electronics Auto components Human resource development relating to manufacturing Capital goods industry Paper industry, and packaging material Packaging materials especially for food products
h) Recognizing that any good manufacturer must have an inhouse lab, at least for routine testing to assure quality of outgoing products by in process and end product testing, it is recommended that financial support be given to manufacturers to set up inhouse labs for which govt should advise all financial institutions/commercial banks/state financial corporations/state industrial development corporations etc. to necessarily include provision for testing facilities and labs as an integral component of the cost of setting up/expansion/upgradation/modernization of any manufacturing unit. Similarly, industry associations should be supported to set up labs for common use by members for testing facilities which may not be affordable for individual units and part of the total project cost, say 50%, may be provided by the govt. It was also recommended that creation of new labs as well as upgradation of existing labs should be supported considering that in some sectors, testing techniques are changing rapidly and labs have to keep pace with them. (Note – Separately, TF1 has recommended a model of regulatory compliance which provides for self regulation by self declaration and monitoring by industry associations and inhouse labs, duly accredited, shall be recognized for self regulation purposes.) j) Central portal on quality related schemes – While the government has floated several schemes for funding upgradation of industry, the information is not readily available at a
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single location. The TF recommends creation of a portal with links to Ministries/Organizations having funding schemes for upgradation of quality in industry. h) Support for quality related information, case studies and experience sharing in Indian context – It was felt that voluntary initiative by any segment, govt institutions, private sector, or non-profit organizations, towards promoting quality in industry in the form of hosting portals/websites, publishing case studies, sharing experiences etc should be encouraged by providing funding support.
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Annexure-1
FOCUS
IPC Plenary Building Competitiveness in Small and Medium Enterprises Through QMS. D. Iain Muir Accreditation Manager SABS South Africa IPC Vice Chair
30 October 2006
30 October 2006
BACKGROUND
Small, Medium and Micro Enterprises
Based on Experiences in South Africa
In Europe or the USA a small business is one usually defined as one with < 200 employees.
Political and Economic transformation
In South Africa, a small business is one with < 50 employees.
Unemployment on the rise New player emerges in the name of the SMME
In Europe or the USA a medium business is one usually defined as one with < 500 employees.
Small, Medium and Micro Enterprises
In South Africa, a medium business is one with < 200 employees.
30 October 2006
30 October 2006
Criteria for SMME Government Support
Small, Medium and Micro Enterprises •
In South Africa there are many emerging (very) small businesses which are defined as Micro Enterprises.
• • -
This business could be a sole proprietor, a partnership, a small family business or a community project.
-
Existence >1year Annual turnover of min. R 100,000 or max. R3m 50% should qualify as follows: Be owned by people with disabilities Black Economic Empowerment (BEE) enterprises Majority ownership by Historically disadvantaged individuals (HDI’S) Joint Ventures between HDIs and non HDIs encouraged
Typically < 20 staff 30 October 2006
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Business is Business
Constraints facing the SMME
Whilst South Africa is sympathetic to the SMME –business is still business and the natural laws of supply and demand apply.
• • •
The customer still buys on quality, service and price (not necessarily in that order!)
• •
Lack of resources Time constraints Access to Finance Access to contracts Perception that SMME’s lack quality in their business
Many purchasers demand that their suppliers are ISO 9001 registered
30 October 2006
30 October 2006
A Solution?
INVISIBLE TRADE BARRIERS
It is recognized internationally that one of the best ways to survive in business is by applying the requirements of ISO 9001.
The demands for ISO 9000 certification during the tender / procurement process place unfair pressures on SMME’s often excluding them from the process. This is a direct contravention of WTO protocols on Invisible Trade Barriers.
The SABS also recognized the needs of SMME’s to survive in business and to gain access to contracts and developed the
The challenge:
SIYAKHULA CERTIFICATE.
How to assist SMME’s to survive in business!
30 October 2006
30 October 2006
SIYAKHULA CERTIFICATE
SIYAKHULA CERTIFICATE Siyakhula means
Is inspired by: • • •
The National Small Business Act 1996 Broad- Base Black Economic Empowerment Act 2003 Presidential Imperatives Projects on SMME Development and the stimulation of the South African economy
“We
are growing” Xhosa
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SIYAKHULA CERTIFICATE • -
SIYAKHULA CERTIFICATE
Encourages Learning organization Customer orientation Involvement of people Leadership Continuous improvement Development of a quality culture
•
PDCA cycle Level of Business Development
Phase 3 Phase 2
System is developed based on the 8 quality management principles of ISO 9001
Phase 1
Time
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3 PHASE CERTIFICATION PROCESS
PHASE ONE:PRINCIPLES
Continual improvement
Phase 3 Phase 2 Phase 1 6 MONTHS
6 MONTHS
6 MONTHS
90 days
• • •
ISO 9001:2000 Certified
COF
Customer Focus Leadership Involvement of People
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PHASE ONE SIYAKHULA CERTIFICATE
Phase one - milestones • • • • • • • • • • •
Vision Mission Business plan Quality policy Scope Measurable Quality objectives Appoint management representative Responsibilities & authorities defined Evidence of internal communication Establish customer requirements/ expectations Establish relevant statutory/ regulator requirements
• • • • • • • • • • •
5.1 5.1 5.4.2 5.3 4.1 5.4.1 5.5.2 5.5.1 5.5.3 5.2 5.1
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•
LOGO
•
VALID 6 MONTHS
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Phase two Process & systems approach
PHASE TWO : PRINCIPLES • • • • •
Customer Focus Leadership Involvement of People Process Approach System Approach
• • • • • • • •
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• • •
• • • • • • •
4.1/4.2 4.2.2 4.2.3 8.2.2 8.5.2 8.5.3 8.3 4.1
Phase Two- Milestones •
•
ID Resources Human Resources Infrastructure Work environment
•
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PHASE 2 Leadership & People Involvement •
ID. processes & interrelation Proc doc control Proc control of records Proc internal audits Doc – corrective action Doc – preventive Doc – NC prod ID outsourced processes
• • •
6.1 6.2 6.3 6.4
• • • • • • • •
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Quality manual Process maps / procedures / work Instructions Training plans HR processes Employee records Infrastructure – process equipment etc Suitable work environment Scope exclusions Management review 30 October 2006
PHASE TWO SIYAKHULA CERTIFICATE
PHASE 3- PRINCIPLES
LOGO
• • • • • • • •
Leadership Involvement of People Process Approach System Approach Continual Improvement Customer Focus Factual Approach to Decision Making Supplier Relationships
Valid for 6 Months 30 October 2006
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PHASE THREE REQUIREMENTS • • • • • • •
Planning Interaction of processes Scope exclusions – justification Communication – internal & external Responsibilities & authorities General provision of resources Monitoring & Measurement
PHASE 3 REQUIREMENTS CLAUSE 7.1 • • • • • • •
•
7.1- 7.6 7.1/ 4.1 4.2 5.5.3/ 7.2 5.5.1 6.1 8.1/8.5
• • • • • •
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PHASE 3 REQUIREMENTS CLAUSE 7.2 • •
PHASE 3 REQUIREMENTS CLAUSE7.3 •
Customer requirements – orders / customer communications Product info – marketing info
• • • • •
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• • •
Planning – D&D teams Design inputs Design outputs Review Verification & Validation Changes
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PHASE 3 REQUIREMENTS CLAUSE 7.4 •
Product specs Validation & test methods & records Ops instructions Responsibilities & authorities Evidence of process & product conformance Customer info Product info
PHASE 3 REQUIREMENTS CLAUSE 7.5
Criteria for selecting approved suppliers Evidence of evaluation & re-evaluation (records) Purchasing info – adequacy Verification – of purchased product – receiving inspection
•
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production & service provision
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PHASE 3 REQUIREMENTS CLAUSE 8
ASSESSMENT •
• • • • • • • •
Customer feedback Internal audits – ff-up Non conforming prod Corrective actions Preventive action Analysis of data Improvements Management review
• •
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CLEARANCE OF FINDINGS • • • •
CONDUCTED BY REGISTERED AUDITOR WITH RELEVANT SIC CODE (ISO 19011 REQUIREMENT) CONDUCTED 12 MONTHS AFTER PHASE 1 ASSESSMENT MANDAY REQUIREMENT AS PER IAF GUIDELINES
ISO 9001:2000 CERTIFICATION
90 DAYS AFTER ASSESSMENT RECOMMENDATION FOR CERTIFICATION SUBMITTED TO APPROVAL BOARD SIGN CONTRACT SIGN NEW QUOTE FOR SURVEILLANCE AUDIT Certificate valid for three years 30 October 2006
30 October 2006
IPC Plenary Building Competitiveness in Small and Medium Enterprises Through QMS.
Thank you for listening Any questions? D. Iain Muir Accreditation Manager SABS South Africa IPC Vice Chair
[email protected]
30 October 2006
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Annex 10 REPORT OF TASK FORCE 3 ON PROMOTION OF QUALITY 1. The Task Force 3 on Promotion of Quality had the following terms of reference: a. To review existing quality promotion schemes and propose strategies and programmes for promotion of quality in all sectors of industries in manufacturing as well as service sector with special reference to public services, healthcare and education b. To suggest programmes to identify and address the needs of all stakeholders like primary producers in the chain to build quality into the final products and services c. To propose measures for partnership with civil society to empower consumers to be able to demand quality d. To suggest strategies and action plan to disseminate message of quality through mass campaign 2.
TF3 had the following composition: a. b. c. d. e. f. g. h.
Mr. Bejon Misra, CEO, Consumer Voice (Convener) Dr. Sulbha Gupta, Director, NABL Dr. S. Bhatla, Head (SP&CAD)BIS, Mr. S. Kannan, Director, Spices Board, Consumer Coordination Council MFPI Cotton Export Promotion Council, Ministry of Textiles Mr. Anil Jauhri, Adviser, QCI
3.
The TF met on 1 Aug 2006, 9 Aug 2006 and 17 Aug 2006 and held extensive discussions on the issues assigned to it.
4.
The TF identified the following reasons for lack of quality consciousness in the country:
Absence of consumer demand for quality goods and services are primarily due to lack of awareness amongst consumers on benefits from quality products and services. Due to such low level of awareness with consumers on quality the markets also sell poor quality products and services and there is practically no pressure on the industry to manufacture or sell quality products and services. While such a scenario is existing for our domestic market, on the other hand all products and services for the export market are of quality because of stringent standards and inspection procedure prior to shipment or delivery of the service and the same
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industry has shown considerable enterprise in upgrading quality levels. However, with increasing competition – both local and from imports – it is expected that industry would realize the importance of quality. The purchasing power of the consumers is also a factor which determines the quality levels. The industry has unfortunately not been able to realize that quality means profitability and if quality is given top priority, then it will not only grow but also provide better return on investment. The industry is to be convinced that if it invests more on improving quality, it would build the desired confidence in the consumers about the benefits of purchasing quality products and services. Absence of regulatory pressure which, in any case, can be only in those areas where health, safety and environment issues are involved. Further, there is absence of deterrent product liability and industry knows it can get away with poor quality without any check.
5.
In view of the above, it is necessary to adopt measures which would build consumer demand for quality, encourage the industry to regard quality as contributor to profitability and create an effective regulatory regime in the country. The TF noted that TF2 on Empowerment of Industry was specifically devoted to industry and therefore, it would focus on measures for sections other than industry.
6.
The TF noted that there are a number of schemes funded by the government to promote quality some of which are: i. ii. iii. iv. v.
7.
Reimbursement scheme for ISO 9000/ISO 14000 certification for SSI sector through DC SSI Implementation of HACCP in food sector through Commodity Boards like APEDA, Spices Board, Tea Board for exports and MOFPI for domestic market Upgradation of labs by MOFPI and Commodity Boards like APEDA National Quality Campaign through QCI Funding for individual institutions like EIC (labs/training/ computerization) and BIS Training Institute
The TF considered recommendations:
the
above
scenario
and
made
the
following
i. Measurement of benefits – In all the schemes which are funded by the Government to the manufacturers or service providers whose products or services have direct interface with common consumer, there should be a system of measuring the benefit from such funding in the form of customer satisfaction surveys periodically by an independent agency preferably by specialized organisations working on such activities and are not funded by industry. The results of such surveys should be made public and accessible to
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every citizen in a transparent and friendly manner. This will ensure accountability on public expenditures and enable a common consumer to be informed about the benefits from such public money and to the extent it was effectively utilized for upgradation of quality for which it was intended. ii. Grades in national standards - Recognizing that there was a large gap between number of product standards available and products certified, it was felt that industry needs to be incentivized to adopt national standards voluntarily. One of the ways it could be achieved was by giving grades in standards so that all certified products are not seen to be on par and those who meet higher quality standards get some kind of premium certification mark. Of course, there should be no compromise with health and safety parameters even in the lowest grade. The grading under Agmark was cited as precedent for grading in standards (see Annexure 1). This would protect the interests of the consumers many of who are uneducated and not conscious of their rights, enable them to make informed choices based on transparent information and would take care of the highly varying purchasing power of the consumers in India. It would also take care of the Indian reality of a wide spectrum of industry from cottage to tiny to small, medium and large scale sectors with varying capability to achieve quality standards in which while some may be capable of meeting international standards, many may meet lower standards which meet the functional needs of the consumer without compromising on health and safety parameters.
iii. Comparative testing - In order to create consumer pressure for quality, it was felt that Comparative Testing on a wide range of consumer products and services by consumer and non-profit organizations needs to be promoted. This would require not only funding but also equipping such organizations technically. In order to ensure proper and uniform methodology adopted by all institutions in comparative testing, it would be necessary that institutions qualifying for doing comparative testing would need to be identified at the national level. BIS is developing a standard for the procedures to be adopted and this may be used as the benchmark for comparative testing. All comparative testing, to qualify for support, should be done in accredited labs and NABL should take such steps necessary to equip itself for assessments of such labs. While the results of comparative testing should be made public, the detailed reports could be made available to individual manufacturers for a charge and in the long run, such reports could be source of revenue to minimize funding requirements.
iv. Liability provisions - There is a need to create deterrent liability provisions including punitive damages for sub-standard goods to create pressure on manufacturers to adopt quality. This requires a suitable legislative framework and adequately equipped regulatory authority on the lines of the US Consumer Product Safety Commission. The TF recommended that government should
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initiate work towards this direction by institutionalizing such Commission in India at the earliest. v. Product Certification system – Pending the creation of suitable liability provisions as recommended above, the product certification systems like ISI mark of BIS and Agmark of DMI should be modified to provide that information relating to suspensions/cancellations of use of mark on account of quality is publicized which will be in line with the norms in ISO Guide 65, the international standard for product certification bodies which provides for cessation of use of mark when suspended and that CB may specify product recall or that no certified product be placed in market, if necessary. vi. Subsidized service from public funded quality infrastructure – The Government is funding many quality related institutions like laboratories, hospitals and manufacturing units who should be obligated to provide services at subsidized rates to consumers as a sign of their responsibility to consumers and in return for the govt support. In this connection, the example of hospitals being given land at low price and being asked to provide free treatment to poor was cited so that in the 11th plan we make sure quality health care is provided to the poor at the most affordable price. vii. Spurious drugs – The TF considered the request of Ministry of Chemicals and Petrochemicals for proposing measures to fight menace of spurious drugs. It was felt that the instances of spurious drugs are normally detected by the medical practitioners who seldom report such cases. Therefore, it is necessary that their licensing code should make it obligatory for them to report such cases to an independent body. This would require creation of a body who would be repository of such information and responsible for investigations and if evidence is found substantiating that the drug is spurious, it reports to the regulator to take necessary punitive action under the law. Such a centralized repository will ensure prompt action and recall. viii. Capacity building - There is need for capacity building of Civil Society/RWAs/NGOs in technical/quality matters so that they can effectively reflect consumer viewpoint in technical fora like standards development and tariff fixation consultations before the regulators of products and services. The criteria for funding of NGOs should be based on previous performance and tangibles outcomes and an independent monitoring mechanism in the form of third party audits by competent organizations should be put in place to ensure accountability of public money by NGOs also as much as they want Government to be made accountable towards public expenditure.
ix. Awareness/training/counseling – While empowerment of industry was dealt with by TF2, it was recognized that the quality of products, especially in food sector, was dependent on the entire chain covering the suppliers on one side and services like transportation on the other. The TF considered the model
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being operated by the Spices Board in propagating good agricultural practices (see Annexure 2)) and recommended it for adoption. x. Institutions for competent advice on quality issues to courts/consumers – It was felt that there is lack of independent institutions to advise on technical matters relating to quality in the absence of which even Consumer courts under the Consumer Protection Act are handicapped in deciding whether the products complained against suffer from quality defects. Therefore, there is a need for independent institutions that can render competent advice on quality issues. xi. Information dissemination – In order to spread awareness among consumers, consumer education websites like www.MouthShut.com, www.consumer-voice.org and www.core.nic.in which compares prices, read consumer written product reviews on movies, music, books, cars, digital cameras and millions of other products and services, by consumer or nonprofit organizations or professional bodies should be promoted and funded. Similarly, quality related books/magazines should be made available to consumers at affordable price for which funding may be set aside to subsidize the cost/subscription to enable consumers to realize the benefits from purchasing quality products and services. It is also important for the Government to facilitate a process of working professionally within the Government structure to build a large promotion campaign to share honest and truthful information amongst the consumers on quality related matters so that all misleading advertisements and information carried by the media can be rebutted and challenged by the Government in the interest of the consumers and the industry who are doing a good job on quality related aspects. All such communications should be in a language understandable by all especially our large population of illiterate citizens or consumers not knowing English and Hindi.
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Annexure-1
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Annexure 2 SPICES BOARD training scheme of farm resource persons The SPICES BOARD has been training unemployed youth as agricultural resource persons; so far eighty youths from Kerala, Tamilnadu, Karnataka, Andhra Pradesh and Northeastern States were trained on Good Agricultural Practices for quality spice production. Due to overwhelming response and interest for the training, the Spices Board has decided to extend this training programme in 2006 also covering Kerala, Tamilnadu, Andra Pradesh, Karnataka and Northeastern states with three programmes as follows : 1. March 2006 to May 2006 - For Kerala 2. August 2006 to October 2006 - For Tamilnadu, Karnataka & Andra Pradesh 3. November 2006 to January 2007 - for Northeastern states This scheme is designed to act as an alternative extension mechanism, fully conversant with good agricultural practices rooted in rural communities with self-reliance. This programme will help in bridging the gap in current yield levels and potential yield of crops. Training will be imparted on Good Agricultural Practices (GAP) for all major export oriented spices such as vanilla, cardamom, (small & large), chilli, pepper, ginger, turmeric, herbal spices, seed spices and tree spices. The objective is to train a large number of resource personnel from the rural communities where the developments targeted by the Board is expected to come up. They would provide an interface between the Board and spice producers of the area by providing necessary advisory services to the spice growers in the area. Curriculum : Practical training on production of quality planting materials, organic inputs such as vermi-compost, conventional composting, biodynamic preparations, traditional knowledge based inputs such as panchakavya, bio-fertilizers, bio-agents, (trichoderma, pseudomonas, Mycorrhizae etc), identification and management of major pests and diseases of spices, soil testing and advisory services, post harvest handling and processing including on-farm value addition will be imparted during the programme. Medium of instruction will be English Location : Training will be provided at the Indian Cardamom Research Institute, SPICES BOARD, Myladumpara, Idukki District, Kerala State or at other suitable locations in partnership with State Agricultural Universities and Indian Institute of Spices Research, Calicut. Duration : The duration of the programme is three months. It is compulsory residential programme. Eligibility : Unemployed youths from agricultural families including agricultural labourers with 10+2 (Science) or VHSC (Agriculture) or 10th Pass/Arts Graduate from special zones
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in remote areas like Northeast are eligible. Candidates who are members of Kudumbasree or similar farmer’s group will be given preference. Candidates whose age is between 18-30 years as on 1.1.2006 only need apply (33 years for SC/ST). Stipend for trainees : Rs.1000/- per month for the period of training to cover expenses for travel, food and stay. Trainees from Northeastern states will be provided with Second Class Rail fare from the place of domicile to training station and back. Post-training activities : After successful completion of the training programme, it is expected that the trainees will continue to engage themselves in agriculture-based activity including production of quality spice in their own village and provide side by side extension services to the spice growers interested in sourcing their expertise on payment basis. The Board will give periodic refresher training besides giving linkage with existing development schemes of the Board, wherever feasible and guidance in seeking financial support from Governmental/Financial agencies such as NHB/NABARD etc for establishment of production units such as certified nurseries, bio-agent production units such as certified nurseries, vermi-compost/organic input production units. Last date of receipt of application : 31st January 2006. Submission of the application : Application in the prescribed format (attached or may be downloaded from website www.indianspices.com neatly hand written or typed on plain paper shall be addressed to “The Director (Research), Indian Cardamom Research Institute, Spices Board, Kailasanadu P.O., Idukki District 685 553 or the Deputy Director (Development), Spices Board, U.N. Bezbarua Road, Silpukhuri, Guwahati, Assam 781 003. Tel : 03612664228 (for north eastern applicants) ******
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Annex 11 REPORT OF TASK FORCE 4 ON HUMAN RESOURCES FOR QUALITY 1. The Task Force 4 on Human Resources for Quality had the following terms of reference: a. To suggest measures for empowerment of human resources for quality covering all stakeholders (including standardization, regulatory and conformity assessment bodies) to ensure adequacy and effectiveness of quality control. b. To suggest mechanism for evaluation of needs of industry in the country ( for present and future, as well as upto 2020) for skilled manpower, identify gaps in availability and needs of skills and suggest measures for development of the necessary skills at all levels to bridge the gap between the availability and the need to achieve global competitiveness c. To propose measures for inclusion of subject of quality management in UG/vocational/management/technical curriculum d. To identify training needs - technical as well as systems and appropriate institutions for creation and continuous upgradation of industry relevant courses along with accreditation mechanism e. To propose Personnel certification programmes - identification of priority sectors and institutions - credibility through adoption of international standards – accreditation 2. The TF5 had the following composition: a. b. c. d. e. f. g. h. i.
Mr. K.C. Gupta, DG, NSC Cdr. A.K Poothia, SDG, Institution of Engineers Mr. Anupam Kaul, Head (NITS), BIS Ms. Shashi Sareen, Director, EIC Dr R.K Khandal, Director, SIIR Col. I.S. Gahlaut, Consultant, CII Mr. S.C Arora, Principal Consultant, FICCI Mr Anil Jauhri, Adviser, QCI Mr Vipin Sahni, Director, (NRBPT), QCI
Convener Member Member Member Member Member Member Member Member
3. INTRODUCTION The human capital of a nation is a primary determinant of its strength. A productive and educated workforce is a necessity for long-term economic growth. This is especially true for technical institutions such as the regulatory bodies, standardization bodies, conformity assessment bodies, training and counseling bodies and research bodies etc involved in activities related to Quality which are
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manpower intensive and therefore ensuring availability of the right number and right type of personnel suited for the job is imperative. Without adequate human capital, the infrastructure set up for promoting/ enforcing Quality cannot be utilized. To be able to make use of the new technologies, equipment, machines the availability of human capital is absolutely necessary without which the equipment, machines etc cannot be utilized. The TF recognized that institutions relating to quality are generally manpower intensive and therefore this needs to be kept in mind while formulating policies regarding recruitment/deployment of human resources in technical institutions. The TF held three meetings on 1 Aug 2006, 9 Aug 2006 and 17 Aug 2006 and held extensive discussions on the issues assigned to it. While formulating the recommendations the following methodology was adopted by the Task Force. 4.
METHODOLOGY
The TF adopted the following methodology: a) Identification of Priority Sectors b) Identification of levels of human resources/professionals, types of competencies required c) Identification of gaps, training needs d) Infrastructure requirements for training- capacity building e) Mechanism for skills and knowledge of professionals f) International acceptance of the verification/assessment mechanism g) Financial Outlay for the Five Year Plans It was also realized that to support the above activities it would be necessary to • • 5.
Strengthen the regulatory mechanism Formulate national standards to support training and personnel registration IDENTIFICATIOIN OF PRIORITY SECTORS
The following priority sectors based on their contribution to GDP and requiring empowerment of human resources for quality were identified. It was felt that these sectors require support in a structured manner at different levels in various areas. a. Manufacturing sector ( with main focus on SMEs/Tiny keeping in view that large scale sector has adequate resources to take care of its HR needs,) • Food products (including GM foods, meat & marine foods, spices) • Pharma GMP Compliance (Schedule M)
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Promotional bodies and need for training and consultancy Creation of a separate consultancy/training agency to support SMEs Strengthening of regulatory mechanism Creating mechanism for certification to overseas standards of GMP possibly through EIC GLP Compliance • • • • • • • • b.
Electrical/Electronics/IT Toys Gems and Jewellery Leather goods Handicrafts Hospital, Healthcare equipment & Medical Devices Apparels, Garments and Dyeing Automotive component Industry covering small ancillary manufacturers
Service Sector • •
• • •
Health Care sector (Primary Health care) and Emergency Medical Response (Andhra Model) Public Services (IS 15700) – Central Govt. has identified 10 departments/organizations for initial implementation of this national standard and all Ministries have to implement in a timeframe of 2 years which requires competence building in the implementing ministries/ departments/ organizations Strengthening competence in the training institutions to support the above competence building of accreditation/certification infrastructure IT sector – training of regulatory manpower for effective enforcement of IT and related Acts (covering national security and e-crimes). Education Sector (quality of primary education) - Training of teaching, administrative and inspecting staff; Formulating a system of performance based incentives
6. RECOMMENDATIONS Having identified the sectors which required human empowerment, the following recommendations were made: 6.1
Manpower Policy
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a) It is necessary that all institutions in the government sector related to quality, be it regulatory bodies or standardization or conformity assessment bodies, are provided with professional leadership and management. b) It is equally necessary that Technical Institutions involved in activities relating to regulation, conformity assessment, standardization, training/counselling and research in the area of quality are empowered to augment technical manpower strength as per their requirements. In this regard, the decision of the Department of Expenditure, Ministry of Finance to empower Governing Body of NABL to create posts and (salary) structure in NABL provided the Governing Body monitors the work requirement and NABL generates twice the amount required for salary, was noted. It is recommended that any technical institution, which is self supporting and not dependent on govt for non-plan budgetary support, is given freedom to create posts, recruit manpower and decide salary/compensation structure with the approval of its governing body without reference to the govt. c) It was also recommended that normal instructions on freezing recruitment or curtailing manpower should not apply to such technical institutions as the regulatory and conformity assessment bodies, standardization bodies, laboratories, and supporting bodies including research & training bodies especially where infrastructure has been upgraded at substantial costs in the govt sector and there is imperative need to ensure proper utilization of technical infrastructure. In order to utilize the infrastructure properly, such technical institutions should be allowed to engage personnel by fast track methods like engagement on contract. d) To deploy qualified research and development personnel for the identified priority sectors (Food, Pharma, Electrical, Toys, Gem and Jewellery, Hospitals and healthcare, Apparels, Garments and Dyeing), for safety, health and environment issues. e) Simultaneously, there is a need for optimization of manpower through use of available conformity assessment infrastructure outside the govt for regulatory purposes by utilizing services of existing accredited conformity assessment bodies. 6.2
Competency Building
a) There should be regular identification of training needs of technical manpower in regulatory bodies, conformity assessment bodies and laboratories in the government sector in order to equip the to effectively discharge their statutory responsibilities. b) Competency of Regulatory and accrediting/certification bodies to be improved through regular training through recognized (registered) training institutes Competence building in new and emerging acceptance requirements by importing countries (inspection & technical manpower specially in the food, marine, meat and poultry products) c) Strengthening and development of auditing (including inspecting), training and consulting personnel in different areas like quality, safety, environment, food, etc.
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d) Training gaps to be fulfilled through special training cum facilitation centres to be set up in industry clusters/SEZs etc under PPP approach who will impart continuous training in trade related disciplines. e) Higher level training to be imparted on WCM and modern quality management techniques for middle management through recognized training institutes and industry associations. f) Awareness and Training in unorganized sectors on Safety g) Project support/funding for the identified training institutes (like NSC, CII, BIS, NPC, Institution of Engineers) and setting up new institutes h) Training needs identification on continuous basis through special cells to be created within professional bodies like QCI, Institution of Engineers, NSC, and industry associations like CII, NASSCOM, etc. i) Subsidy for training to government sector bodies j) Recognition /registration of training institutes and training courses for providing training to personnel for continual professional development. k) Competence development in Skilled Tradesmen/craftsmen – Vocational training/multi skilling 6.3
Personnel certification
In line with international trends and as per ISO 17024, it is necessary to certify and continuously maintain competence of professionals in such technical institutions through the system of approval/registration of the above personnel and training organizations as follows: 6.3.1 Creation and strengthening of personnel certification bodies and setting up of level 2 and 3 bodies as per the following 3 tier structure in the country for registration of Personnel: • • •
Level 1 National Registration Board for Personnel and Training (NRBPT) Level 2 State Level Registration Bodies accredited/approved by NRBPT Level 3 District/City Level Registration Centres under the State Body
6.3.2 Introduction of Registration schemes in the identified professional areas for priority sectors (model of Registration of Engineers developed by Institution of Engineers) for Continuing Professional Development and Evaluation: • • • • • •
OHS Professionals including Fire Safety Professionals Food safety Professionals Paramedical Staff and Nurses BPO staff Tour Professionals (tour operators, guides, travel agents, transporters) Trainers
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•
Teachers
6.4 Education • Development of Quality related curriculum by NCERT and other educational institutions like IITs /IIMs/NITs /MCI for professional study and training of teachers to act as faculty. • Improvement of quality of schools by adopting a suitable modification, if need be, of the KOALATY KID model designed by the American Society of Quality in USA. Koalaty Kid encourages the use of training to implement a rigorous continuous improvement effort in schools. When schools apply these principles and techniques to the critical issues in their schools, the opportunity for Koalaty Kid to create positive, lasting change in schools and students is dramatic. • Accreditation of ITIs to improve their quality and ensure that they meet the industry’s expectations 6.5
Some other recommendations made by TF4 were:
• To set up a regulatory mechanism for BPO and ITEs for safety, health and environment issues – this can be considered under PPP approach through strengthening of existing bodies like NASSCOM and promoting self regulation. • Build a deterrent liability mechanism for poor quality of products and services (Note: recommended by TF3 also)
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Annex 12 REPORT OF TASK FORCE 5 ON PROMOTION OF CULTURE OF QUALITY IN ORGANIZATIONS 1.
The Task Force 5 on Promotion of Culture of Quality in Organizations had the following terms of reference: a. To recommend strategies, policies and programmes for creating and promoting culture of quality in organizations by facilitating integration of quality into overall management approach b. To suggest institutional framework for supporting such programmes on a continuing basis c. To identify institutions to be created or strengthened to operate the national programme(s) d. To suggest mechanism for periodic evaluation of effectiveness of such programme(s) and the agency(ies) to be responsible for the same e. To suggest national benchmarks on quality i.e. national quality awards, competitive case studies etc. aimed at sharing and promoting culture of quality
2.
TF5 had the following composition: a. b. c. d. e. f. g. h. i. j.
Mr. S. K. Kakkar, Head, Institute of Quality, CII (Convener) Mr. P. K. Gambhir, Head (MSCD), BIS Mr. A.N.Singh, Principal Counsellor, FICCI, Mr. Avik Mitra, Principal Counsellor, ASSOCHAM, Dr. (Ms) S.Bajaj, TCS Mr. Y.K.Gupta, Under Secretary, DARPG, Dr. R.K.Khandal, Director, SIIR, Prof Ravi Shankar, Asstt Prof, IIT-Delhi Mr. Arvind Mathur (in personal capacity) Mr. Anil Jauhri, Adviser QCI
3.
The TF met on 1 Aug 2006, 9 Aug 2006 and 17 Aug 2006 and held extensive discussions on the issues assigned to it.
4.
The TF recognized that the task of creating a culture for quality and improving quality of goods and services is the responsibility of the top management, whether in the government or the private sector. To improve the quality of goods and services on a sustainable basis, it must balance the interests of all stakeholders i.e customers, employees, investors and society. The organisations need to change their way of thinking and the way it is managed to achieve this objective. The quality cannot be viewed ‘in isolation’, it must be built in to the management
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system. This can be achieved though an environment of cooperation, teamwork, harmony, joy in work, intrinsic motivation, learning and improvement. The TF also noted that there are teachings of many quality gurus like Deming, Juran, Crosby and several models which are being practiced worldwide like Malcolm Baldridge Award, EFQM , TQM, Kaizen etc. In addition, in India, we have awards like Rajiv Gandhi National Quality Award and now IS 15700 specifically for quality management in public service organizations. All these profess to promote culture of quality in organizations although there may be differences in approaches. The TF recognized the need to learn from the above philosophies/models and develop a suitable approach to promote quality culture in Indian organizations.
5.
Recommendations The TF made the following recommendations: • • • •
• • • • •
Develop Leaders who can think and practise Quality based management approach in public and private organizations Criteria for Selection and Performance appraisal of Senior Management persons/ Bureaucrats should include competence (achievement, knowledge, demonstrated ability) in line with Quality management principles Recognition of individuals such as Practitioners (from CEO to cutting edge level), Quality Professionals, Publications, Institutions who are role models for practicing or propagating Quality Propagate Quality Models/Fundamental Principles for an integrated Quality based management Approach (Deming Principles, The Excellence Models like RGNQA/MBNQA/EFQM; and IS15700-Sevottam model and Charter Mark scheme for public services) for self-assessment, improvement and external evaluation and recognition. All PSUs/Government agencies should have a score as per the chosen model for improving Quality Culture (some select PSUs are already doing it through their MoUs with the Government) Review existing national quality awards and introduce a single, prestigious national quality award to be given by the President of the country to recognize organizations based on the evaluation against the chosen model Develop a Modular Approach to meet the requirements and aspirations of organizations of different size and maturity level (reference RSA approach as an example of modularity) Facilitate dissemination of the knowledge required for implementing the models/standards mentioned in the above approaches through Quality based management approach should be a part of curriculum of all management, engineering and other professional courses at under graduate and post- graduate levels. The Quality Fundamentals should also be a part of school curriculum.
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• • • • •
Quality based management approach induction programmes for technocrats and bureaucrats(e.g. LBSNAA Mussourie) at different levels. It should also be a part of the on-going training and re-training Development, promotion and delivery of certified training programmes on Quality through out the country for building competences at different levels of people in the organization Identify, capture, and disseminate good practices/ performance (Create a Benchmarking Data Bank) – also recommended by TF2 Conduct national surveys of organizations (public and private) on Customer satisfaction for the products and services delivered by them and publicize results nationwide Conduct national surveys/study of organizations (public and private) and publicize results nationwide on linkages amongst Employee satisfaction, Quality Culture and Performance Excellence.
6. Mechanism
To create an Apex Body in the form of a steering committee, comprising all stakeholders to provide guidance in the implementation of recommendations and review the effective implementation. It will be supported by a dedicated division with in QCI with a clear mandate to manage the implementation of the recommendations. Apex body constitutes a competent group to develop the Quality Principles and the Quality model appropriate to the needs of the country, which shall form the basis for the development of all education, training and consulting material; and evaluation criteria for recognition. Involve Academia, Industry, BIS, and other Expert organisations to develop a Body of Knowledge, Training programs, Consulting modules for creating awareness, training and consulting methodologies for promotion of quality culture in line with the chosen model and principles. The Training programmes, Consulting modules, Training/Consulting Professionals should be duly accredited by QCI (NRBPT), and delivered by accredited consultants/professionals/organisations. The list of accredited consultants, programmes and organisations to be widely publicized. Co-ordinate with HRD Ministry and academia to include quality in the course curriculum of schools and colleges. Launch a nation wide Quality Campaign through programmes for creating awareness amongst all sections of society. Awareness programmes should be initially supported by the Government in the form of programme subsidies. Participants should pay a part of the cost as registration fee. Organise annual convention at national level • Recognize the role model Organizations, Individuals, and Publications • Share successful Strategies and Practices • Deliberate on new trends, concerns, and challenges
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6.1 Steering Committtee of QCI and BIS should work out the modalities for administering the Rajiv Gandhi National Quality Award in line with the chosen model, to identify and recognise organisations as role models of Quality culture in the country. 6.2 Set up a separate Benchmarking Centre, managed by QCI, to identify, capture and disseminate best practices and performance. Conduct various studies and publish results. 6.3 Publish a Quality Journal periodically to publish articles, case studies, and study reports
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Annex 13 REPORT OF TASK FORCE 6 ON INTRODUCTION OF GMP/GHP/HACCP ON MANDATORY BASIS 1. The Task Force 6 on Introduction of GMP/GHP/HACCP on mandatory basis had the following terms of reference: i) To consider introduction of GMP/GHP/HACCP on a mandatory basis under regulation ii) To prepare a roadmap for introduction of mandatory GMP/GHP in the first instance with the ultimate objective of introducing HACCP including identification and/or phasing of specific sectors for such regulation, if need be, and mechanism for checking compliance using accreditation iii) To recommend strategies and programmes for strengthening the industry to meet the mandatory requirements and roles of various Ministries/organizations in such programmes iv) Any other relevant issue 2. The TF6 had the following composition: a. b. c. d. e. f. g. h. i. j. k. l. m. n. o. p.
Dr. Shiv Lal, Additional DG, PFA Ms. Rita Teaotia, JS, Ministry of Health Ms. Shashi Sareen, Director, EIC Ministry of Food Processing Industry Ministry of Consumer Affairs Ms. M. Prakash, Head (FAD), BIS Mr. S. Dave, Director, APEDA Dr. Indrani Ghose, Sr. Counsellor, CII Mr. Deepak Mathur, Consultant, CII Mr. D.S.Chadha, Consultant, CII Mr. Arun Kapoor, ASSOCHAM Ms. Malini Rajendran, FHRAI Dr. Subodh Jindal, AIFPA Mr R.P Vaishya, Director (Food), DCSSI Mr. Sameer Barde, Director, FICCI Mr. Anil Jauhri, Adviser, QCI
Convener Member Member Member Member Member Member Member Member Member Member Member Member Member Member Member
3. Introduction Food Safety has been the concern to mankind since the dawn of history, and many of the problems encountered in our food supply go back to the earliest recorded years. Despite progress in food science and technologies, food borne diseases remain one of the most widespread public health problems in the contemporary
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As per WHO, upto one third of populations of developed countries are affected by the food borne illness each year and the problem is likely to be even more widespread in developing counties. Epidemiological investigations have indicated that a large proportion of food borne diseases result from unhygienic handling of food especially in small businesses. The integration and consolidation of agricultural and food industries and the globalization of the food trade are also fast changing the patterns of food production and distribution. The fast changing lifestyle, eating habits, demand for a wide variety of foods and increasing dependence on food cooked outside home are now posing much serious health risks than ever before. Street food vendors and food service premises are an essential and increasing part of the food supply system. but, are without strict control of food preparation, storage and display practices, which may become a major source of food borne disease. Until recently, most systems for regulating food safety were based on end product testing and inspection. These systems do not respond to existing and emerging challenges to food safety because they do not provide or stimulate a preventive approach. To achieve maximum prevention it is essential that safety be built into food products from production through consumption. In fact most of the hazards in the food chain come from a) Agricultural sources & improper harvesting practices. b) Primary food sources e.g. poultry, cattle, fish. c) Unsanitary storage conditions by bulk commodity storage agencies d) Neglect by civic authorities of primary food arrival-&-collectioncentres e) Unhygienic water supply systems f) Use of Pesticides, Veterinary Drugs, Infected Animal Feed. This calls for a comprehensive and integrated farm-to-table approach. A holistic, risk based “prevention is better than cure” approach in managing food safety throughout the food chain needs to be adopted whereby the role of the supervisory/regulatory authorities is to prescribe standards and to ensure that producers, processors and traders who are identified as having primary responsibility for food safety have adequate control systems based on GMP/GHP/HACCP principles. 4. International Scene Changing consumption patterns for food, as well as changing global trade practices, can make huge impacts on food safety and risk assessment. The emphasis for ensuring food safety is shifting from mere end product testing to application of a proactive systems approach such as GMP/GHP/HACCP. Several countries have either mandated or are considering mandating HACCP requirements into their national legislation and they are specific in their HACCP
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requirements for particular sectors of their food industries. The expectation is that exporting countries will meet the same requirements for internationally traded foods. In particular, the introduction of HACCP based regulations for fish and fish products, particularly in the EU and the US, has triggered the need for production under the HACCP system in fish exporting countries. It is reported that approximately 60% of the international fish markets require that fish and fish products are processed under HACCP systems, of which the EU and US account for 50%, while Japan at 34% has not yet required HACCP compliance. Food Safety for prevention of hazards is now mandated for some or all of the food sectors in the EU, the US, Canada, New Zealand and Australia. While HACCP is mandated for fish and fish products in most fish exporting countries for other food sectors and for domestic market it still is being implemented on a voluntary basis. Realizing that Food safety is the very basic right of people almost all countries including Republic of China, Iran, Malaysia, Nepal, Philippines, Sri Lanka, Thailand and Vietnam are promoting implementation of HACCP through either HACCP certification on a voluntary basis or merely application of HACCP principles, GMP and GHP in Food manufacturing units. In fact, Republic of China is operating a Food Good Manufacturing Practice (FGMP) high Quality Food Mark system apart from HACCP certification. Philippines is also operating a GMP certification scheme in addition to HACCP certification scheme on a voluntary basis. However, in Thailand, Good Manufacturing Practice has been provided in the National law and has been enforced in 57 products. 5. INDIAN SCENARIO Indian food industry is highly decentralized having mostly street vendors/cottage/small units and some Large Scale units with a total estimate of approx 40 lakh establishments. The product quality also varies considerably to meet the requirements of consumers of different income groups of society. While large-scale units are increasingly adopting HACCP/GMP/GHP to become competitive in the global market, food quality in the domestic market is regulated through end product specifications and in some cases, mandatory certification. In addition, voluntary standards and certifications are also prevalent in some sectors. Realizing the need not only to remain competitive in the global market but primarily to cater to the need for safe food for the Indian consumer for purchase of quality products/ services, it has become necessary to follow the global trend and prescribe systems approach in the form of GHP/GMP/HACCP through domestic legislation, currently PFA Act and shortly Integrated Food Law. 6. RECOMMENDATIONS: The TF6 held three meetings on 8 Aug 2006, 17 Aug 2006 and 15 Sept 2006 and based on the deliberations in the meetings, the following recommendations have been proposed:
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6.1 GHP/GMP/HACCP may be mandated under PFA under a three-tier system based on size and risk category of food items • • • •
GHP/GMP/HACCP to be mandated for Large Scale Units and Hotels with 4 star and higher ratings GMP/GHP to be mandated for Small Scale Units and Hotels with 1 star to 3 star ratings. GHP to be mandated in Tiny Sector, Street Food units, unstarred hotels and restaurants Industry to be encouraged to adopt HACCP with the option of voluntary certification to ISO 22000 and exemption/relaxation from regulatory compliance checks.
Regarding draft notifications, it is felt that they need to clearly spell out the requirements of tiny/street food, SS and LS sectors. It is noted that MoH is in the process of issuing only the preliminary notification for public comments and that industry would be free to comment when the draft notification is issued; any comments received in the TF would also be forwarded to MoH for consideration. 6.2
Time targets
6.2.1
It is recommended that deadlines for compliance may be:
Large Scale units including 4 & 5 star Hotels SSIs including Hotels 1-3 star Tiny Scale/ Unstarred hotels/Street vendors/ Restaurants
-
GMP/GHP/ 1 Year* HACCP (Specific high risk sectors) GMP/GHP 3 Years* GHP 4 Years*
*from the date of final notification The Compliance checking shall begin on expiry of the above deadlines before which all establishments have to be ready. 6.2.2 To accomplish the above, apart from the draft GHP/GMP notification already under finalization, a separate notification prescribing HACCP requirements shall be drafted and issued by Ministry of Health for checking compliance to HACCP. 6.3
Awareness campaign
6.3.1 The implementation of GHP/GMP especially in SS sector and below would require enormous hand holding, and it is recommended that:
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a) A national programme on awareness, training and counselling through interactive programmes, class room teaching, and mass media like TV/print media etc may be initiated with MFPI/MoH/DCSSI as the nodal points for funding SSI and below. b) The training material is to be developed in regional languages. c) The funding should cover training, counselling, compliance checking and accreditation costs. Govt. institutions like AIIPHH, industry associations, promotional bodies like DCSSI/SISI, commodity boards, export promotion councils, NGOs and vendor associations should be involved in the national programme. d) The above funding should however be limited to training/counselling from accredited training courses providers/consultants for which QCI may develop a simpler scheme, if need be, for registration of Consultants/training course providers for Ministry of Health based on international norms for accreditation of personnel. The scheme should, however, not be restricted to individuals and should include Industry Associations as well as Govt. organizations (central or state) and NGOs. 6.4
Infrastructure upgradation
6.4.1 Implementation of GHP/GMP would entail infrastructure upgradation including setting up facilities for treatment of water for which support may be provided to the small/tiny sectors for modifications in the infrastructure for effective implementation of GMP/GHP. In this connection, the schemes of TUFS of Ministry of Textiles and CLCSS of DC (SSI) which is also the model proposed by Ministry of Chemicals for SSI drug manufacturers for implementing GMP were noted and it is recommended that funding of say 25% cost of upgradation may be given. 6.5
Food testing labs
6.5.1 To cater to the large number of samples arising as a result of the mandatory implementation of GMP/GHP/HACCP, Food testing labs need to be developed and existing labs strengthened. 6.5.2 An approach of categorizing of labs based on their capability and designating identified labs as National Referral Lab (s) should be adopted. The designated Referral laboratories at the apex, shall have responsibility for actions such as • • • •
Training of personnel engaged in testing Making available validated test methods Making available Proficiency Testing Programs Making available necessary Certified Reference Materials (CRM) and Certified Reference Samples (CRS)
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The Referral laboratories may carry out routine commercial testing to maintain their competence but should maintain their role as a guiding organizations for developmental purposes. For upgradation of laboratories, it is recommended that the approach given in Annexure 1 may be adopted. 6.5.3 All labs should be supported for acquiring NABL accreditation for which necessary funds have to be made available. Since in the government sector generally labs would not be self-sustaining, accreditation and upgradation costs should be funded. 6.5.4 As a good manufacturing practice, all food establishments should be encouraged to set up inhouse labs at least for routine testing for which funding should be given and testing in such labs, if accredited, should be recognized for the purpose of self-regulation. 6.6
Water Quality
6.6.1 The provision of potable water was considered important for implementation of GMP/GHP/HACCP and while medium and large scale sector may be expected to take responsibility for treating water to make it potable, the SSI sector and below would necessarily depend on water supply by state agencies and hence it is important that such water is potable. It was noted that BIS has formulated IS 10500 for Drinking water and DDWS proposes to use that as the national standard. 6.6.2 •
•
•
•
Therefore the Task Force recommends that: A national standard may be notified for mandatory compliance by all water supply agencies – rural or urban - in a reasonable time frame of 2 years. DDWS may fund development of infrastructure for potable water supply in terms of provision of sources, treatment and testing/training of technical manpower by the state govts/ agencies for water supply. All water testing labs would be asked to go for national accreditation beginning with national and state labs within next 2 years and District labs within 3 years after which no unaccredited lab should be used for water quality testing. The Govt. should review its policy on technical manpower especially in labs where massive funds are being injected for modernization and upgradation but their optimum utilization is undermined by lack of adequate manpower to allow sanctioned strength and manpower on contract. It is imperative to provide requisite qualified trained manpower. (Note – this aspect is covered in detail in TF4) Simultaneously, Govt. should explore mechanisms such as partnership with or leasing out labs to private sector or non-profit organizations to ensure their optimum capacity is utilized.
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•
BIS should develop standards for Rapid Water testing methods/kits to enable screening of water quality.
6.7 Application of Good Agricultural Practices (GAP) and Good Animal Husbandry Practices (GAHP) 6.7.1 It was recognized that there has to be application of good practices through the entire food chain and therefore, the Task Force recommends that material on GAP and GAHP be got prepared by the Ministry of Agriculture through relevant bodies such as ICAR, NDRI, CIFT etc. which may be funded by the govt. The documentation so prepared should be used by MoA for promoting the same for each sector through the existing infrastructure. 6.7.2 Further, as there is currently no Act suitable for notifying mandatory compliance to GAP/GHP and therefore an expert committee may be set up to identify how these can be mandated or a new legislation be drafted after review of exiting legislation. 6.8
Compliance Checking
6.8.1 The TF recognized that it would be highly desirable and cost effective if the compliance checking work is outsourced to QCI accredited agencies and recommends the following model for Compliance checking: • Self regulation in the form of self declaration and monitoring by industry associations • Regulatory checking through QCI accredited agencies at varying frequencies based on risk levels of foods dealt with by an establishment. There should be a provision to vary it and make it more liberal or strict based on the past performance of the establishment and confidence in the self regulation exercised by it. • Option of voluntary certification for ISO 22000 may be given to encourage adoption of HACCP with exemption/relaxation from regulatory checks. The TF noted that BIS is bringing out a management systems standard on GMP/GHP and once the standard becomes available, voluntary certification could be similarly encouraged. • The list of accredited agencies should be notified and hosted on MoH/QCI website and industry would be free to go to any agency. However, a system of rotation would be used so that one establishment does not go to the same agency again and again. • To reduce the commercial angle, which could undermine compliance checking, it is recommended that the charges for compliance checking by the independent agencies be worked out and notified; a range of charges could be notified as was being done in some other cases in MoH. • During the regulatory checking, apart from swab samples, product samples should also be drawn and tested in designated labs for compliance to prescribed
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standards. There were concerns whether results of such product samples would be basis for prosecution which needs to be examined vis-vis the provisions of Integrated Food Law and it is recommended that such samples should be used as a means for correction/improvement only. A procedure for checking compliance by QCI accredited agencies with clear definitions of critical/major/minor NCs should be notified in which actions consequent to NCs would also be spelled out. • The South African model for promotion of QMS in SMEs should be adopted with suitable modifications for promoting ISO 22000 in SMEs by following a phased approach towards achieving certification. BIS was requested to take the lead in developing a suitable scheme for the Indian context and DCSSI could fund the implementation of ISO 22000 in SSI sector based on milestones rather than final certification. 6.9
Management of Residue Monitoring Plans (RMPs)
Presence of residues of environmental contaminants and veterinary drugs in food products is a major concern of food businesses all over the world. To ensure that foods are safe from environmental contaminants which include antibiotics, pesticides, heavy metals, toxins etc., both for domestic use and exports, it is necessary to develop a system for residue monitoring and control. The objective of ensuring that residues in the end product are within the permissible limits, can be achieved by end product inspection and testing. However, this is generally an expensive method as every batch/consignment would need to be tested. This would also not be very effective as it is well known that quality cannot be inspected and tested into a product and once the residue is found to be present, it is not possible to either reduce or remove it and the only option left is destruction of the product. In developed countries such as EC, a system of testing and monitoring the residues through a National Residue Monitoring Plan is generally being implemented wherein the farms, raw material and other inputs and the final products of the processing units are covered. Samples are drawn at certain prescribed intervals and in case detection of residues above limits, the source is identified and measures taken to rectify the problem. In the present scenario in India, Residue Monitoring Plans (RMPs) are being implemented for exports under the Export (Quality Control & Inspection) Act, 1963 for marine, dairy, egg, poultry and honey sectors. Such a system in isolation for exports cannot be very effective as farms/raw materials and products being monitored are not exclusively producing for exports. Further, it is also essential that products consumed domestically are also safe and do not contain contaminants at levels higher than those prescribed. It therefore becomes essential to implement a residue monitoring system for the entire production to cover domestic use as well as exports.
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The TF noted that ICAR is implementing a project on pesticide residue monitoring since last financial year of the 10th Plan covering 19 commodities and 21 labs and is proposing to considerably enlarge its scope in the 11th Plan. It is in the process of publishing standard protocols of pesticide residue analysis and preparing the labs for accreditation. The envisaged outcome is a national database on pesticide residue levels in commodities of food and feed. The residue monitoring and control system would aim towards: Establishing a system for monitoring residues, antibiotics, pesticides, heavy metals, toxins etc., at farm level, raw material such as seeds, animal feeds, water, ice and other sources through which residues may enter the product; Establishing a system of corrective action in the event of detection of residues higher than the prescribed limits by issuing alert information; Ensuring that the products, for the domestic consumption, meet the regulatory requirements and for exports meet the requirements of the importing countries. It is therefore recommended that a system of testing and monitoring residues through a Residue Monitoring & Control Plan be developed for the country. The steps proposed for development and implementation of Residue Monitoring & Control Plans as follows: The monitoring, the controls as well as management of the test labs and results would require a collaborative effort between MoA and MoH (later Food Authority) wherein MoA should manage GAP and GAHP while MoH should manage food establishments. EIC may continue its programme for RMPs in exports where additional parameters are to be monitored which are not necessary for domestic regime. It would be necessary to involve accredited agencies/labs to draw samples, test and provide reports to state govt agencies responsible for management of programme in their respective areas for analysis and corrective actions; All labs involved in the proramme should go for NABL accreditation within 3 years. The residue limits to be laid down for the raw materials as well as the food products; Develop a system of cooperation and networking between different organizations for sharing of the data so that the results from the same can be used to monitoring different aspects of the quality control, for example, Export Inspection Council of India for exports, Ministry of Health & Family Welfare for domestic, etc Even as the Plan as above is implemented, there is a need for implementation of Good Agricultural Practices (GHP) and Good Animal Husbandry Practices (GHP), Good Manufacturing Practices (GMP) and Good Environmental Practices
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(GEP) through planned and regulated use of Plant protection chemicals (Pesticides) and veterinary drugs. Use of appropriate practices for farming/breeding, storage and transportation would help in preventing build up of residues beyond acceptable limits in the first place. 6.10 Retailing/Transportation – The TF felt that transportation of food products is an important part of the supply chain and it is necessary that good practices are prescribed for transportation of food products to assure safety. Similar step would be necessary for wholesale and retail trade which would be part of the supply chain. The TF noted that BIS is contemplating developing an Indian Standard on Good Retail Practices for voluntary adoption.
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Annexure-1 UPGRADATION OF FOOD LABS – RECOMMENDED APPROACH INTRODUCTION "We are what we eat" is an old proverb. Our nutritional status, health, physical and mental faculties depend on the food we eat and how we eat it. Access to good quality food has been man's main endeavor from the earliest days of human existence. Safety of food is a basic requirement of food quality. "Food safety" implies absence or acceptable and safe levels of contaminants, adulterants, naturally occurring toxins or any other substance that may make food injurious to health on an acute or chronic basis. Food quality can be considered as a complex characteristic of food that determines its value or acceptability to consumers. Besides safety, quality attributes include: nutritional value; organoleptic properties such as appearance, colour, texture, taste; and functional properties. Food safety which is the most important quality parameter contributing to food quality is related to presence of food borne hazards in food at the point of consumption. Food reaches a consumer via supply chains that may link many different types of organizations like primary producer, manufacturer, transport and storage contractors, distributors and retailers and caterers, etc. Food safety hazards can occur in the food chain at any stage, hence adequate control is required to be exercised throughout the supply chain. The confirmation of the adequacy of controls is invariably through laboratory testing. Hence the reliability and accuracy of testing plays a very important role in ensuring Food Quality. FOOD TESTING REQUIREMENTS The quality parameters of different types of food products that are encountered in various stages of food chain have been listed in Appendix 1. The list also distinguishes between the parameters contributing to food safety aspects and others. The testing requirements generally would include for both these types of parameters as applicable to various categories of food products. Testing for most of the quality attributes would be at percentage levels and would not require a specialized laboratory. These group of tests are categorised as Group A. Certain other parameters like micronutrient (vitamins, etc), organoleptic tests would require certain degree of specialization. Then again tests for detection, identification and estimation of adulterants and additives in processed and ready to eat foods would also require greater amount of specialization and investigative capabilities. Further the microbiological parameters for determining food safety aspects would invariably involve testing for pathogens, which would call for additional skill and training requirements. These group of tests are categorised as Group B. There would be a requirement of stand alone microbiological testing laboratory under the regulatory regime of GMP/GHP. They would be required to perform routine or
144
specialized pathogen testing as per the specific need of the industries. These are categorised as Group B1. While chemical hazards, the most important from chemical safety point of view, would invariably involve testing at residue {sub-ppm (µg/g) and ppb (ng/g)} levels and hence would require the most specialized test setup involving sophisticated instrumentation and highly skilled and trained manpower. These group of tests are categorised as Group C. SPECIFIC REQUIREMENTS OF FOOD TESTING LABORATORIES The requirements with respect to food testing laboratory would vary for different categories of tests as stated above. The requirements in terms Testing methods, equipments & infrastructure and personnel engaged in testing of the same are given below : GROUP A 1. Test methods – The test methods used for this category of tests are invariably standard test methods given in national and International standards like - IS, ISO, AOAC, GAFTA, AOCS, etc. These are generally validated methods and do not require any further inhouse validations. 2. Equipment and infrastructure – These tests generally do not require highly sophisticated test equipment or infrastructure facilities. A normal chemical testing laboratory consisting of balances, ovens, furnaces, Nitrogen analysers, etc is sufficient for carrying out the tests. Few tests may require equipments like colorimeter/tintometer/spectrophotometer. 3. Testing personnel - Testing personnel having basic degree in chemistry/food technology or related fields, with basic training regarding food analysis and laboratory quality assurance, provided even inhouse is considered sufficient for the purpose. GROUP B 1. Test methods – The test methods used for this category of tests are most of the times standard test methods given in national and International standards like IS, ISO, AOAC, GAFTA, AOCS, BAM (microbiological requirements), etc. These are generally validated methods and do not require any further inhouse validations. However for tests concerning detection, identification and estimation of adulterants and additives in processed and ready to eat foods there may not be many standard methods and since they would require certain amount of investigation and methods based on deduction and judgments. These tests would require validations and extensive documentation. Use of appropriate kits and rapid testing methods could also be provided for in specified test methods, which would be especially useful in places where immediate results are required for taking decisions as in food production units.
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These could cover areas like testing of water used for processing, microbiological testing for production controls, etc. 2. Equipment and infrastructure – The parameters involving chemical tests would require, in addition to general food testing equipments, equipments like spectrophotometer, Fluorimeter, Atomic absorption spectrophotometer, automated TLC set up, Gas liquid chromatograph, High Performance Liquid chromatograph. The pathogen testing would also require more sophisticated equipments and infrastructure requirements like Bio-safety laminar flow cabinets, air handling units, facilities with appropriate layout, etc. 3. Testing personnel - Although as a minimum a basic degree in chemistry/food technology or related areas is considered adequate for testing personnel engaged in chemical analysis for tests covered in group 2, a postgraduate degree would be more useful. In any case the testing personnel is required to have sufficient experience and developed skills for testing in the areas covered. For microbiology testing of pathogens, although a post graduate degree in microbiology is desirable, a degree in microbiology/food technology or related areas may be considered adequate, if skills required for pathogen testing and interpretations of results, have been developed through appropriate experience and if the competence is demonstratable. In all cases however, experience and training, sufficient to develop skills in the relevant area is considered essential. For Group B1 (Stand alone microbiological testing) as defined above, the equipment, infrastructure and qualification & skill requirements need to be commensurate with the types of microbiological (routine ones like Total plate count/coliform and ecoli or pathogen) testing done. GROUP C These cover chemical hazard parameters which are most undesirable in any food products and the presence of which make them unsafe. Accordingly regulatory requirements laid down by different countries prescribe maximum residue levels for these. The undesirable chemical hazards – residues are generally expressed as MRLs (The maximum concentration of the chemical residue, expressed as milligrams of residue per kilogram of commodity), when the product is applied for protection of the crop/commodity and is generally based on safety studies. However in case the chemical is prohibited from use i.e. not approved for use, then the residue is expressed as the Limit of Determination (LOD), which is the lowest concentration of a chemical residue that can be identified/measured using analytical procedures. 1. Test methods – Even if the test methods are based on AOAC, APHA, EPA methods, their performance needs to be validated in every laboratory where these tests are carried out, to establish that the test procedure is fit for the purpose. The performance of the test procedure would be governed by the optimum combination of techniques/methods, equipments used and the competence of personnel engaged in the analysis. This is especially relevant where the MRLs are set based on LODs. The method performance studies would establish laboratory’s Limit of detection, Limit of quantification, linearity,
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specificity, accuracy/recovery, repeatability, etc for various combinations of residues and the matrix. Another area which needs to be explored for residue analysis is the use of initial screening methods for identification of presence of residue followed by the quantitative estimation using the above techniques in cases where found positive. These screening tests may be kit based or may be developed using GCMS/LCMS techniques and would be much faster. 2. Equipment and infrastructure – The residue analysis at the continuously lowering levels, as are being prescribed Internationally today, require use of highly sophisticated equipments like Gas Liquid Chromatograph (GLC), High Performance Liquid Chromatographs HPLC), Gas Chromatograph-Mass detector (GCMS), Liquid Chromatograph-Mass Detector (LCMS) for organic residue analysis and Atomic Absorption Spectrophotometer (AAS), Inductively Coupled Plasma Spectrometer (ICP), ICP- Mass Detector (ICPMS), etc for Inorganic residue analysis. Further residue analysis would also require specific infrastructure and other requirements like controlled atmosphere rooms for housing these equipments, Uninterrupted power supplies, Separate rooms for residue extractions, high grade water purifiers, etc. 3. Testing personnel - For chemical analysis covering highly specialized residue testing, a post graduate degree in chemistry is desirable. Besides this, experience and training sufficient to develop skills in the relevant area is considered essential. The competence required for testing in this highly specialized area must be demonstratable. In addition to the above there would be other specific requirements like Certified Reference Materials, availability of performance assessing mechanisms like PT programs, which play a very significant role in ensuring reliability of results for these types of analysis. SPECIFIC REQUIREMENTS OF EXISTING LABORATORY NETWORK IN THE COUNTRY IN RESPECT OF TESTING OF FOOD PRODUCTS COVERING GROUPS DESCRIBED ABOVE 1. GROUP A There are a number of laboratories in Government as well as Semi government and private sector who are competent to carry out tests in this category on all types of food products. Many of these have also been accredited to ISO 17025 by NABL. 2. GROUP B Chemical Tests – Many of the laboratories engaged in testing for Group A would also be testing for chemical requirements listed in Group B. However in respect of testing for adulterants and additives in processed and ready to eat foods, as already, stated certain specialization and investigative capabilities are required, which would need to be constantly upgraded, especially if the lab is engaged in testing imported food products, since the regulatory requirements in the exporting country may be different from ours. A specific hands-on type of training needs for all the testing personnel
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engaged in this type of testing are envisaged. Also performance evaluation through proficiency testing is also considered very important in this area. Microbiological Tests – There are a number laboratories engaged in testing of microbiological requirements including pathogen testing. Pathogen testing is very important from food safety point of view. This requires very specific and high level of testing and interpretative skills, especially since microbiology testing is some kind of special process, where repetition of tests to confirm results is invariably not possible. In this area too, specific hands-on type of training needs are envisaged for all the testing personnel. A system for performance evaluation through proficiency testing is also considered very important in this area. 3. GROUP C This category mostly covers residue testing and as described earlier, requirements for these types of testing are highly specialized. Although some requirements with respect to pesticide and other metallic residues are prescribed in Indian regulations on food safety - The Prevention of Food Adulteration Act; residue analysis is largely driven by export requirements of food products. Most of the developed economies today have very strict, and low level requirements in respect of residues (all types as given in Annex 1) in food products, especially the primary produce like agri-products and products of animal origin like marine products, eggs, meat and poultry. Many laboratories in India today are engaged in residue testing especially for exports. Although few laboratories are available in government sector, largely they are private commercial testing laboratories. In view of the highly specialisd nature of testing and considering that residue testing at the levels now required is only about three years old, many challenges are faced by laboratories engaged in this type of testing, or envisaging entry in to residue analysis. It would require certain initiatives at national level. These are: a) Grants in aid for purchase of equipment – The residue testing equipments like GCMS, LCMS, ICP, AAS-GF, etc are imported equipment and costs run in to Crores of rupees and it is difficult for any food testing laboratory to purchase these equipments at least initially. The grant could also include expenditure on specific infrastructure and other requirements. Presently certain provisions are exist under Ministry of Food processing Industry, Ministry of Commerce (APEDA), etc, for such initiatives. However these may not be sufficient in view of constantly changing requirements in respect of residues – Constant downward revision in the residue limits and addition to the list of residues. However a careful assessment of facilities already available and their extent of utilization should be carried out while deciding about these grants. Attempts should be made at first to fully utilize the existing facilities by bridging the gaps like availability of additional trained and experienced manpower, other essential accessories like CRM’s, etc. b) Training of personnel engaged in residue testing - The types of testing techniques used in residue testing are highly specialized and require skill development through actual work experience, which is not considered adequate for most of the testing personnel presently engaged in it, since residue testing at the levels now required is only about three years old in India. Further there are no specialized hands-on training providers in India in
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this field. The equipment suppliers are also not very well versed, especially in the analytical aspects. Hence there is an immediate need to train the residue analysts in various aspects of analysis – Extraction principles, Instrumentation techniques, test methods, etc. Since indigenous expertise for training is not available, assistance would be required from laboratories overseas. There are today a number of laboratories available in Europe (EU) who specialize in these types of testing. Some of them are EU designated referral labs, like CSL, UK; TNO, Netherlands; etc. There is a requirement for organizing In collaboration with these laboratories, a series of training programs in India and abroad for the benefit of residue analysts in India. This needs to be done at government initiative. c) Making available validated test methods – As described earlier, standard methods are not available which can be followed to the tee, for getting the desired results. Based on laboratory’s choice of technique and general data on methods available in literature or published by authorities like EPA, AOAC, it’s competence in terms of detection limits for different residues and different matrices, performance in terms of accuracy of results, etc, need to be validated. Due to inadequacy of experience and non availability of training and ready indigenous data, this becomes a very time consuming and costly exercise, ill affordable by a commercial testing laboratory. As a result of this there is a tendency to short cut this entire exercise, thereby diminishing the reliability of the results obtained. A need is thus felt for an independent referral type of laboratories, preferably government funded, to undertake validation type exercises and provide the input to the testing laboratories. d) Making available Proficiency Testing Programs – Given the specialized nature of residue testing, there is a need for a system of independently organized proficiency testing. The laboratory identified for organizing proficiency needs to be expert in designated testing area having all necessary equipment , infrastructure, etc, in fact one generation ahead of the routine commercial testing setups. e) Making available necessary Certified Reference Materials (CRM) and Certified Reference Samples (CRS) - Laboratory is required to procure CRMs and matrix matched CRSs for every residue, that is required to analysed by the laboratory. At present these are regularly procured from imported sources since no local sources are available and since they have a limited shelf life. Hence there is a need for developing indigenous sources. An estimate of costing of labs is given in Appendix 2. REQUIREMENTS WITH RESPECT TO STRUCTURING AND NETWORKING FOOD LABS IN THE COUNTRY
OF
For dealing with specialized nature of testing, especially those covered in Group 2 and Group 3 and for capacity building in residue testing at national level, there is need for networking and pooling together of available expertise and other similar resources. However the private commercial testing laboratories may not directly interact with other similar laboratories because of competitive/commercial reasons. This will however be
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possible through structuring of laboratory network and providing a system of designated National Referral Laboratories at the apex, having stated responsibility for actions as stated at b), c), d) and e) above. The Referral laboratory will also be required to carry out certain amount of routine testing to maintain its skill and competence levels. However it should maintain its primary role as a guiding organization for developmental purposes. Hence it is best if it is in a government or semi-government setup with adequate financial resources – being funded by government. However given the nature of its activities, its developmental activities will need to be constantly monitored by an independent steering committee consisting of stake holders among others. A similar set up already exists in a specific area of pesticide residue testing in grapes for export purposes. Under the programme coordinated by APEDA, National Research Centre (NRC), Grapes, Pune is the referral lab. However t is observed that the role presently played by NRC does not cover all the requirements as stated above and in the entire gamut of residue testing as referred above is very insufficient. Therefore a need exists for covering the entire food testing under similar structuring of labs – either commodity-wise or test wise. A suggested list of possible referral labs is given in Appendix 3. REQUIREMENTS WITH RESPECT TO COMPETENCE ASSESSMENT OF THE LABORATORIES All the laboratories involved in food testing should fulfill the following criteria as a mark of their competence in the specified fields of testing : 1. Laboratories should be accredited by NABL for the specified scope of testing covering all the tests carried out by the laboratory. 2. The laboratory should be required to undergo proficiency testing for the major testing groups at least once in two or three years. In cases, especially for residue testing, where proficiency testing programmes are not available within the country, they may be required to undertake international PT programmes since participation in PT programmes is considered essential component of demonstration of core competence. 3. In the field of food testing under regulatory framework, independent periodic verification of laboratories, through system of forwarding dummy samples and then comparing the results reported with the actual results may be necessary to keep check over their testing. This could be undertaken by the designated referral labs.
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Appendix 1 DIFFERENT CATEGORIES OF FOOD AND RELATED PRODUCTS AND THEIR QUALITY PARAMETERS 1. Agricultural Products – Raw and Processed (Which would include food grains and seeds, spices as well as processed like floors, oils and fats, ground spices, tea, etc.) a) b) c) d) e) f) g)
Physical/visual Examination, Grading, Organoleptic tests, etc. Proximate/ Nutritional Analysis. Miscellaneous Parameters like pH, moisture, Ash, Acidity, Fat content, etc. Micronutrients including vitamins. Filth analysis. Adulterants. Residue Analysis (as applicable) i) Pesticide residues; ii) Mycotoxins / Naturally occurring toxin; iii) Residual radioactive materials; iv) Heavy or toxic metals; and other adulterants or trace elements; v) Enzymes and hormones, vi) Allergens, vii) Dioxins, acrylamide, PAH, PCB’s, Furans and environmental and other organic chemical contaminants, h) Microbiological Parameters (where applicable). Food safety parameters - e) to h) above 2. Foods of Animal Origin – Raw and Processed a) b) c) d) e)
Physical/visual Examination, Grading, Organoleptic tests, etc. Proximate/ Nutritional Analysis. Micronutrients including vitamins. Adulterants. Residue Analysis (as applicable) i) Pesticide residues, ii) Heavy or toxic metals; and other adulterants or trace elements, iii) Veterinary Drugs / Antibiotic residues, iv) Enzymes and hormones v) Biotoxins and Allergens. f) Quality Indicators – Histamines, etc. g) Microbiological Parameters. Food safety parameters - d) to g) above
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3. Ready to eat Food Products (including those distributed through catering services, restaurants) a) Physical / visual Examination, etc. b) Proximate / Nutritional Analysis. c) Compositional and other miscellaneous parameters like pH, water activity, moisture, etc. d) Sensory evaluation. e) Micronutrients including vitamins. f) Filth analysis. g) Adulterants. h) Residue Analysis (as applicable): i) Pesticide residues, ii) Mycotoxins / Naturally occurring toxins, iii) Residual radioactive matters, iv) Heavy or toxic metals; and other adulterants or trace elements, v) Enzymes and hormones, vi) Allergens, vii) Added Additives viii) Dioxins, acrylamide, PAH, PCB’s, Furans and environmental and other organic chemical contaminants. i) Microbiological Parameters testing. Food safety parameters - f) to i) above 4. Miscellaneous a) Food additives – Food Colours, Anti-oxidants, Stabilizers, Anti-caking agents, Artificial sweeteners, Flavours – Both Quality and safety requirements. b) Water Testing – Mostly Safety requirements. c) Food packaging material testing (Migration tests – Safety requirements) d) Genetically modified foods (Safety Parameters). e) Organic Food testing
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Appendix 2
COSTING FOR VARIOUS TYPES OF FOOD TESTING LABS EQUIPMENT and LABORATORY FURNISHING (Equipment Tables, Fume Hood, ACs, etc) COST : 1. Group A --- 6 - 8 Lakhs 2. Group B --10 – 20 Lakhs 3. Group B1 (Microbiology) --- 6 – 12 Lakhs depending upon if only simple tests like TPC, Coliform and eColi are required to be done or the complete set of pathogens. 4. Group C --- 2 – 2.5 Crores if all the residues including Pesticide Residues and Antibiotic residues as per EU and other international norms are required to be tested. ESTABLISHMENT COST : The establishment cost, which would include cost of building and infrastructure like , partitioning, flooring, lighting, water supply, etc, would be additional and will depend upon location, and the type chosen.
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Appendix 3 SUGGESTED LIST OF REFERRAL LABS S. Name of the No. laboratory 1. Central Food Lab, CFTRI, Mysore 2. 3.
Quality Assurance Laboratory at RRL, Jammu EIC Labs
4.
MPEDA, Cochin
5.
Spices Board Laboratory, Cochin
Testing Areas Group A Group B (Including B1) Group C Group A Group B (Including B1) Group C Group A Group B(Including B1) Group C Group A (Marine Products) Group B (Marine Products) Group C (Marine Products – Veterinary Drug Residues) Group A (Spices) Group B (Spices) Group C (Spices – Pesticide residues, Banned dyes, Mycotoxins, etc)
6.
ITRC, Lucknow
7.
NRC, Grapes/ Pomegranate, Pune Insecticide Residue Testing Laboratory (IRTL), Department of Agriculture, Govt Of Maharastra, Pune FRAC, New Delhi Group A Group B(Including B1) Group C
8.
9.
Remarks
Group C (Pesticide & elemental residues) Group C (Pesticide residues in agriproducts) Group C (Pesticide residues in agriproducts, Mycotoxin residues) It is an association level lab, under FICCI
The above list is an illustrative list of existing labs already engaged/accredited in the fields listed. Other labs in Govt. and Semi Government sector, which could be readily upgraded to the status of referral labs could also be identified for fulfilling specific identified needs.
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ANNEX -14 Year wise funds requirement (Rs. Crores) Sr. No.
Programme
Ministries to whom funds to be Implementing Agency(ies) allocated
1
2
3
4
5
Total
Health, Telecommunication s, Consumer Affairs, Surface Transport and any other who may raise requirement
Organizations representing India on international standardization bodies like BIS for ISO/IEC MoH for Codex, DoT for ITU etc.
25
40
50
60
75
250
All Ministries
Industry associations especially product specific associations/professional bodies/organizations/Scientif ic Institutions
15
20
25
30
30
120
DIPP
QCI
Standardization
1
a)
Participation in International standardization
b)
Standard cells for eliciting industry/professional bodies' comments * Centre for study impact of standards Capacity building Capacity building for quality covering
c) 2 a)
i)
Covered in NQC
All Ministries
300
300
300
300
300
1500
MFPI, DCSSI
300
400
500
600
700
2500
Deptt. of Chemicals & Petrochemicals
218
100
80
65
40
560
Industrybodies/NGOs/Nonprofit organisations/Govt. labs (other than ii below)
100
100
100
100
100
500
Industry associations, NGO, Govt. promotional organisations like EPCS/Commodity Board Organisation like NSC, NPC, Commodity Boards like APEDA, MPEDA etc. Technical institutions/industry bodies/ professional bodies, Export Promition Council
Awareness/Training/ Counselling,
Upgrading, training and ii) counselling bodies for quality related work Identification of training iii) needs through dedicated cells Infrastructure upgradation: Food - for i) MFPI, Min. of SSI GMP/GHP/HACCP Pharma - Includes 27 crore ii) in 2006-07 & 30 crore in Chemicals 2012-13 Laboratory upgradation a) Assistance for Labs b)
3
i) Industry /others
All Ministries
ii) Specific Sectors in Govt.
Food Labs
Water Testing Labs Environmental Labs Accreditation costs ** b) c) 4 a) i) ii) b) i) ii)
c)
Certified reference materials Proficiency testing services Promotion of Quality Food Sector Good agricultural/animal husbandry practices Residue monitoring & Control plans Education Development of quality related curriculum and training of teachers Koality Kid modelDevelopment of model Implementation in selected schools (Kendriya Vidyalaya) Accreditation of ITIs National Quality Campaign
10
10
10
10
10
50
MoRD MoEF All Ministries
Regulatory bodies like DGHS,EIC, Promotional bodies, APEDA, Spice board. Scientific institutions like ICSR, CFTRI etc. DDWS CPCB All labs in Govt. sector
11 30 4
6 30 3
6 30 3
6 30 x
6 30 x
35 150 10
S&T
NPL
6
6
6
6
6
30
S&T
NABL
0.25
0.25 0.25
0.25
0.25
1.75
MoA
Organisation like IARI, NDRI, CIFT etc.
100
100
100
100
100
500
100
100
100
100
100
500
10
10
10
10
10
50
5
25
25
125
All Ministries especially MoH, MoC&I, MoA
MoA, MoH, MoC&I, ICAR, EIC, Food Authority MFPI
Min. of HRD
NCERT/IITs/IIMs/University/ UGC/AICTE with support from QCI
DIPP
QCI
Min. of HRD
KVS
DIPP
QCI
Covered in NQC 5
5
25
25
5
5
Covered in NQC
QCI
155
25
25
d) e) 5 a) b)
Central portal on quality related schemes Personnel Certification National benchmarking centre Building for QCI Comparative Testing Promotion of Quality culture in organizations Dedicated centre Implementation of Sevottam in Govt. organisations ***
DIPP
QCI
Covered in NQC
DIPP
QCI
Covered in NQC
Consumer Affairs
QCI Consumer Affairs
DIPP All Ministries
QCI Individual departments/ attached/subordinates offices, autonomous public service bodies
10 3
8 3
-3
-3
18 15
x
300
Covered in NQC 100
100
100
x Total
* ** ***
-3
7239.75
Covers funding for scientific institution to suport standardization One time cost @ Rs. 2 lakhs/labs. Subsequently labs should absorb recurring costs into their regular bud One time implementation costs. Ministries should absorb recurring costs into their regular budgets
Note: The projected funds are an estimate; it is recommended that exact fund requirement may be ascertained from respective Ministries
156