Infrastructure and Infrastructure and Capacity Building for Capacity Building for
Food Safety and Quality – Food Safety and Quality – Indian ScenarioIndian Scenario
Anil JauhriAnil JauhriAdviserAdviser
Quality Council of IndiaQuality Council of India
INTRODUCTIONINTRODUCTION• WTO regime - Quality & safety have acquired centre
stage - Represent the biggest non-tariff barriers – estimated 60%
• TBT Agreement/SPS Agreement – importance of Codex standards - recognized as international stds for trade - being not deemed to be barriers – both for products as well as systems – time to build capacity for developing countries - pressure on India to adopt in domestic regime – from foreign goods coming in, NGOs, for export, international funding agencies
• Food – highly regulated sector worldwide• Emergence of Voluntary or private standards –
certification/accreditation
EMERGING STRUCTUREEMERGING STRUCTUREGovernment
(to enact legislation)Regulatory Bodies – may be sector specific like Food, Drugs
(to enforce the law)National Standards Body – Accreditation Body
(vol. standards-linkage to RBs) - (tech.competence of CABs)Conformity Assessment Bodies (CABs)
(support regulation – voluntary certification/quality assurance)Manufacturers and Service providers
Common man – recipient of goods and services
WG on QUALITYWG on QUALITY• Initiative of Planning Commission – Working
Group on Quality, Certification and Conformity Assessment for 11th Plan in May, 2006 – Dr. R.A. Mashelkar, former Secretary, DSIR (also Chmn, QCI) as Chairman – Mr. G.J.Gyani, Secretary General, QCI as Secy
• 6 Task Forces :– Task Force 1 on Regulatory, Standardization,
Conformity assessment and supporting infrastructure issues
– Task Force 2 on Empowerment of industry for global competitiveness
WG on QUALITY WG on QUALITY (contd)(contd)
– 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
• 2 meetings of WG – 11 July 2006 and 29 Aug 2006
• Each TF had 2-3 meetings• WG report submitted in Nov, 2006 to Planning
Commission – decisions expected by June, 2007
TERMS OF REFERENCETERMS OF REFERENCE• 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.
• To evolve innovative instruments such as public private partnership (PPP), which can incentives value addition through quality up-gradation.
• To workout corresponding financial resource requirements on aggregate and year-wise basis for the 11th Five Year Plan and sources of financing with minimum burden on budgetary resources.
• To suggest a unified institutional arrangement for comprehensively addressing all the constituent elements of the quality cycle viz. standard setting, conformity assessment and compliance.
• Any other relevant issue.
Background - Food sectorBackground - Food sector• MoH debating introduction of HACCP under PFA
Rules in line with worldwide trend• Initially GHP/GMP considered appropriate as
building blocks towards HACCP• Draft notification issued for comments• Request to Chairman, QCI in July, 2006 for
stakeholder consultation to prepare roadmap for implementation and accreditation of agencies to check compliance by QCI
Task Force 6 on Introduction of GMP/GHP/HACCP in the Food sector on mandatory basis
INFRASTRUCTURAL INFRASTRUCTURAL REQUIREMENTSREQUIREMENTS
• Nodal point for participation in international stdzn (Codex/ISO/IEC/ITU)-Min of Health/BIS/DoT
• Domestic Regulatory Mechanism (BIS Act/Drugs/PFA/Food Law)
• Export regulation and certification system (EIC) for recognition
• Information access (TBT/SPS enquiry points – BIS/Min of Agriculture/Health)
• Conformity assessment bodies (BIS/EIAs/Govt & Pvt certification/inspection bodies/labs)
• Accreditation Mechanism (QCI/NABL)WHETHER EFFECTIVE IS DEBATABLE
ISSUESISSUES• Poor participation in int stdzn – conformity
assessment stds being written in CASCO (ISO) and CCFICS (Codex) – govern not only trade but domestic market - Lack of scientific data – no designated scientific institutions - testing technology driving safety limits – no challenge
• Industry indifferent to standards – no tangible/ immediate financial benefits – misconception int stds only for exports esp among SMEs
ISSUES ISSUES (contd)(contd)
• Multiplicity – being hopefully addressed in food – no of govt organizations in regulation/stds setting/ certification/ accreditation despite specific bodies for the purposes –when handholding (training/ counselling) is dire need – promotional bodies getting into certification/accreditation
• Lack of coordination/synergy within govt bodies
RecommendationsRecommendations• Participation in int stdzn – separate fund for identified
experts – standards cells in industry bodies – centre for study of impact of stds– designate scientific institutions for studies to support standards setting
• Good Regulatory Practice – to follow international trend of clear separation between govt, RBs, ABs, CABs – single, dedicated RBs (EIC,TRAI) - RBs to rely on national standards – MoU with BIS – national CA system – accredited CABs – BIS to open stds for certification Compliance model – promote self regulation – flexibility in 3rd party intervention – Norms for RBs – Funding – RBs to rely on accredited CABs in 3 yrs – failing which not to be used
RecommendationsRecommendations (contd)(contd)
• National Regulatory Authority – control over CABs – Hoda committee on EHS and SA
• National Standards System – Need for single national standard - BIS to be repository of all national standards – networking with SDOs – accreditation of SDOs by QCI
• Policy on MRAs/MoUs on Regulations – Commerce Min to be nodal point – standing committee of stakeholders – RBs, ABs, NSB, industry bodies, CABs – all proposals to be cleared
RecommendationsRecommendations (contd)(contd)
• Labs in govt sector – caution – only if absolutely necessary - PPP – bldg/equipment by govt – lease management- joint ownership
• CRMs – national programme for development and production – identified labs to be designated initially – ultimately market driven - NPL
• PT services – national programme as above - NABL
RecommendationsRecommendations (contd)(contd)
• All institutions in the government sector related to quality, be it regulatory bodies or standardization or conformity assessment bodies, to be provided with professional leadership/management
• Autonomy – self sufficient to be given more freedom• To augment technical manpower strength as per their
requirements – self supporting ones to decide manpower/ compensation with approval of governing body – no ref to govt
• Normal instructions on freezing recruitment or curtailing manpower not to apply to ensure proper utilization of technical infrastructure - fast track methods like engagement on contract.
• 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.
Recommendations Recommendations (contd)(contd)
• Strengthening of industry associations especially the product specific ones for participation in standardization, quality promotion and providing common laboratory facilities
• Financial support be given to manufacturers to set up inhouse labs through FIs and industry associations to set up labs for common use by members for testing facilities which may not be affordable for individual units
• Infrastructure upgradation – critical sectors like drugs/food – support to SSI
Recommendations Recommendations (contd)(contd)
• Regular identification of training needs regulatory bodies, conformity assessment bodies and laboratories in the government sector - Competence building in new and emerging areas (inspection & technical manpower especially in the food, drugs) - Strengthening and development of auditing (including inspecting),
• Training and consulting personnel in different areas like quality, safety, environment, food, etc. – industry bodies, professional institutions
RecommendationsRecommendations (contd)(contd)
• Large Scale units/4 & 5 star Hotels GMP/GHP 1 Year
HACCP (specific sectors) 2 Years• SSI/Hotels 1-3 star
GMP/GHP 3 Years• Tiny Scale/Restaurants/Street vendors
GHP 4 Years
Recommendations Recommendations (contd)(contd)
• Awareness campaign - training material in regional languages - training/counseling from accredited training courses providers/consultants – QCI to evolve scheme
• Infrastructure upgradation - infrastructure for effective implementation of GMP/GHP – funding to SSI
• Water Quality - Notify national standard – 2 years - Accreditation of labs (2/3 yrs)
• Good Agricultural Practices (GAP) and Good Animal Husbandry Practices (GAHP) – promotion campaign by MoA – expert committee to examine regulation
RecommendationsRecommendations (contd)(contd)
• Food testing labs - categorizing labs based on their capability and designating identified labs as National Referral Lab(s) Training of personnel engaged in testing Making available validated test methodsMaking available Proficiency Testing Programs Making available necessary Certified Reference Materials (CRMs)
(excellent example set by APEDA in grapes with NRC – accredited?)
•Food units to be encouraged to set up inhouse labs – to be recognized for self regulation
RecommendationsRecommendations (contd)(contd)
• Management of Residue Monitoring Plans – prescribe residue limits – system of sampling/ testing/analysis of data/corrective actions
• Compliance Self regulation in the form of self declaration and
monitoring by industry associations Regulatory checking through accredited agencies –
varying frequency based on risk category - swab samples and product samples
Voluntary certification for ISO 22000 – promotion of ISO 22000 in SMEs - phased implementation - South African model for ISO 9000 – phased implementation of ISO 14000 in Japan, UK, France etc.
ABOUT QCIABOUT QCI• Established in 1997 by a Cabinet decision – in
partnership with CII, FICCI, ASSOCHAM• Autonomous body – regd as society - Chairman
appointed by PM (Ratan Tata, Venu Srinivasan, Dr. R.A. Mashelkar) – nodal Ministry - DIPP
• Provide accreditation structure in the country -reference to accreditation in Art 6 of TBT Agreement and Official accreditation in Codex stds
• Provide right and unbiased information on quality & related standards
• Spread quality movement in India – National Quality Campaign
• Represent India’s interest in intnl forums• Help establish brand equity of Indian products and
services
STRUCTURE OF QCISTRUCTURE OF QCI
QUALITY COUNCIL OF INDIA
NATIONAL ACCREDITATION
BOARD FOR CERTIFICATION
BODIES
(NABCB)
NATIONAL BOARD FOR QUALITY
PROMOTION (NBQP)
NATIONAL ACCREDITATION
BOARD FOR TESTING AND CALIBRATION
LABORATORIES (NABL)*
NATIONAL REGISTRATION
BOARD FOR PERSONNEL AND
TRAINING (NRBPT)
NATIONAL ACCREDITATION BOARD FOR HOSPITALS
AND HEALTHCARE PROVIDERS (NABH)
*CURRENTLY INDEPENDENT BODY
INFORMATION ON ACCREDITATIONINFORMATION ON ACCREDITATION
QUALITY COUNCIL OF INDIA 2ND FLOOR, INSTITUTION OF ENGINEERS BUILDING
2, BAHADUR SHAH ZAFAR MARGNEW DELHI - 110002
INDIA
Telefax : +91-11-23379321/9260/0567/8057email : [email protected], [email protected]
Websites : www.qcin.org, www.nabl-india.org