LABORATORY CERTIFICATION & ACCREDITATION IN INDIA WITH SPECIAL REFERENCE TO QUALITY CONTROL LABORATORY FOR SEA FOOD INDUSTRY

MANORANJAN MANTHAN
DEPUTY DIRECTOR

EXPORT INSPECTION AGENCY KOLKATA

(Ministry of Commerce & Industry, Govt. of India)

Kolkata - 700001

ROLE OF EIC / EIAS

Export (Quality Control & Inspection) Act, 1963

OBJECTIVE
SOUND DEVELOPMENT OF EXPORT TRADE THROUGH QUALITY CONTROL & INSPECTION

Powers of Central Govt Under the Act

o To subject commodities to compulsory preshipment inspection o To specify the type of quality control or inspection and specifications for such commodities o To establish or recognise agencies for quality control and / or inspection

Export Inspection Council

Established in the year 1964 under section 3 of the Export (Quality Control and Inspection) Act, 1963

Export Inspection Agencies

Established in the year 1965 for implementing policies of the Central Govt. 5 in numbers (Chennai, Delhi, Kochi, Kolkata & Mumbai) Operate under technical and administrative control of Export Inspection Council

EIC / EIA Network

Main Functions
Export Inspection Council:

To advise the Central Government on measures for sound development of export trade through quality control & inspection To draw up programmes for quality control & inspection of commodities To undertake such responsibilities as are assigned by the GoI from time to time

Main Functions (2)

Export Inspection Agencies:

Implementation of policies of the Central Government / EIC

Field organisation of EIC

Products Notified Under the Act

958 commodities MAJOR FOOD PRODUCTS

Fish & Fishery / Marine Products Egg Products Poultry Meat Products Milk Products Meat & Meat Products Honey

Liberalization

Procedural reforms initiated in early nineties Section 16 A of the Export Act used to exempt from compulsory PSI, status exporters / exporters with letter from foreign buyer not requiring official inspection Impact - All certification became voluntary with the exception of FOOD PRODUCTS

Tasks Performed
Quality

Assurance of commodities Product Certification Testing of samples Certification of preferential origin

Major Laboratories
Chennai Kochi Kolkata Mumbai ISO 17025 compliant NABL Accredited

Major Products Tested

Fish & Fishery Products Egg Products Poultry Meat Milk Products Honey Water Imported Foods

ROLE OF EIC / EIAS

Orders of Fresh, Frozen and Processed Fish & Fishery Products Order S.O. 729 (E) dated 21st August 1995 Sub-sequently amended vide No. Orders S.O. 792 (E) dated 17th August 2001, S.O. 722 (E) dated 10th July 2002, S.O. 464 (E) dated 24th April 2003, S.O. 1227 (E) dated 23rd October 2003 & S.O. 1227 (E) dated 31st July 2006.

Notifies that Fresh, Frozen and Processed Fish and Fishery Products shall be subject to quality control inspection and monitoring prior to export --------. prohibits the export of Fresh, Frozen and Processes Fish & Fishery Products by a unit in the Course of international trade unless it conforms to the standard specifications applicable to it, and is accompanied by a certificate stating that such unit is approved and monitored by the Export Inspection Agencies

ROLE OF EIC / EIAS

Notifications of Fresh, Frozen and Processed Fish & Fishery S.O. 730 (E) dated 21st August 1995 Sub-sequently amended vide No. Notifications S.O. 415 (E) dated 11th April 2002, S.O. 1029 (E) dated 24th September 2002, S.O. 1034 (E) dated 9th September 2003, S.O. 717 dated 25th February 2005, S.O. 612 dated 15th February 2007, S.O. 1519 dated 16th June 2008, S.O. 2714 (E) dated 28th October 2009 & S.O. 143 (E) dated 21.1.2011 S.O. 497(E) dated 10.3.2011

ROLE OF EIC / EIAS

The inspection and monitoring of establishments / landing centers / factory vessels / freezer vessels / fishing vessels / aquaculture farms / hatcheries / feed mills (text substituted as per Notification S.O. 497 (E) dated 10th March 2011) shall be carried out regularly under the responsibility of the recognised competent authority which shall at all times have free access to all parts of the establishments/factory vessel and records pertaining to application of this notification. (Inserted as per Notification S.O. 1034(E) dated 9th Sept. 2003) 12.3. The Director may take the assistance of Marine Products Export Development Authority (MPEDA) or any other suitable organisation for residue monitoring.

CERTIFICATION 1st party certification

Laboratory belongs to user, who is satisfied and uses for his own jobs Laboratory does not belong to user but user using his own means certifies the laboratory, and uses for his own requirements. Certifying/Accreditation body for laboratories, is neither the owner of the laboratory nor is the user

2nd party Certification

3rd

Party Certification

WHAT IS ACCREDITATION ? International Organization for Standardization (ISO) definesaccreditationas:

Thirdparty attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specificconformityassessmenttasks.

ILAC

ILAC International Laboratory Accreditation Cooperation EA European Cooperation for Accreditation APLAC Asia Pacific Laboratory Accreditation Cooperation IAAC Inter-American Accreditation Cooperation SADCA Southern African Development Community Accreditation

The Role of the International Laboratory Accreditation Cooperation (ILAC)

To develop the principles and the practice of laboratory accreditation. To harmonize procedures and criteria for accreditation To assist in the development of new programmes To facilitate mutual recognition of members programme To reduce technical barriers in trade To improve International acceptability of test results.

Present Conformity Structure

International Laboratory Accreditation Cooperation (ILAC)
Asia Pacific Laboratory Accreditation Cooperation (APLAC)
National Accreditation Board for Testing and Calibration Laboratories (NABL)

International Mutual Recognition

International Accreditation Forum (IAF)

Pacific Accreditation Cooperation (PAC)
Quality Council of India (QCI)

ISO/IEC 17011

ISO/IEC 17011

NABCB

Testing Laboratories Calibration Laboratories

ISO/IEC 17025

ISO/IEC 17021 ISO/IEC 17020

Certification Bodies Inspection Bodies

Medical Laboratories

ISO 15189

NABET
ISO/IEC 17024 Training & Eductaion

NBQP
Quality Promotion

NABH
Hospital & Healthcare providers

IN INDIA NABL: (NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES IS THE ACCREDITATION BODY

About NABL
NABL is an autonomous body under the Department of Science & Technology, Government of India, and is registered under the Societies Act. NABL has been established with the objective to provide Government and Industry with a scheme for third-party assessment of testing, calibration and medical laboratories Program started in 1981 First Accreditation granted in 1992 Autonomous Body registered under societies Act in 1998

REQUIREMENTS(CLAUSES)OFISO/IEC17025
Management o Organization o Managementsystem o Documentcontrol o Reviewofrequests o Subcontracting o Purchasing o Servicetothecustomer o Complaints o Nonconformingtests o Improvement o Correctiveaction o Preventiveaction o Recordscontrol o Internalaudits o Managementreview Technical o General o Personnel o Accommodation&environmentalconditions o Testmethods&validation o Equipment o Measurementtraceability o Sampling o Handlingtestitems o Assuringqualityoftestresults o Reportingtheresults

NABL Accreditation
Procedure by which an authoritative body (NABL) gives formal recognition that a body (laboratory) or person (signatory) is competent to carryout specific tasks (scope) o Criteria-ISO/IEC 17025 (includes all ISO 9001 elements) o Assures the client that the procedures are technically valid. o Recognizes the technical competence of laboratory staff o Assures the client that the results are technically valid o Endorses the quality management system

ACCREDITATION PROCEDURE
Application for Accreditation (by Laboratory) Acknowledgement & Scrutiny of Application (by NABL Secretariat) Adequacy of Quality Manual (by Lead Assessor) Pre-Assessment of Laboratory (by Lead Assessor) Final Assessment of Laboratory (by Assessment Team) Scrutiny of Assessment Report (by NABL Secretariat) Recommendations for Accreditation (by Accreditation Committee) Approval of Accreditation (by Chairman, NABL) Issue of Accreditation Certificate (by NABL Secretariat)

Feed back To laboratory and Necessary Corrective Action by Laboratory

EVALUATING THE COMPETENCE

o On site assessment of the laboratory by the experts for its technical competence and its adherencetomanagementsystempractices o By analyzing the test data of a particular test/measurement generated by the laboratory during participation in a proficiency testing program

SCOPE OF NABL ACCREDITATION

TestingLaboratories
Biological Chemical Electrical Electronics FluidFlow Mechanical NonDestructiveTesting OpticalandPhotometry Radiological Thermal Forensic

TRAINING PROGRAMS FOR ASSESSORS AND LABORATORIES o NABL organizes Assessors training courses as per ISO/IEC 17025 and ISO 15189. o NABL also organizes technical training & quality system courses for laboratories. o NABL imparts in-house training as per ISO/IEC 17011.

New Areas of Accreditation

o AccreditationofPTProviders o Accreditation of Reference Material Producers o AccreditationinSoftwareTesting o AccreditationinMedicaldevices o AccreditationinWildLifeforForensic

EIC LABORATORY APPROVAL SCHEME (EICLAS)

o o o o

Initiated in year 2002. 2000 / 2001 expansion following EU residue audit National Residue Monitoring Programme (NRMP) / National Residue Control Programme (NRCP). Vet drug residues, pesticides, heavy metals, Hormones etc in food products (Milk, Honey, Poultry meat, Egg products, Meat, Fish & Fishery Products) wherever possible EIC imparts training to Lab personnel towards harmonization.

REQUIREMENTS FOR EICLAS

o o

LAB must have implemented and maintained QMS as per ISO 17025. Adequate capability and competency for testing of food safety and quality parameters as per EIC / EIA / IMPORTING COUNTRIES. Validation as per Commission Decision 2002/657/EC, so far RMP is concerned.

(e ----- has been substituted with below text- as per Order S.O.722 (E) dated 10th July, 2002) (e) Maximum Residual Limits (MRLs) for pesticides, heavy metals and antibiotics and other pharmacologically active substances in fish and fishery products shall meet the requirements as given below. However, if the MRLs fixed by the importing countries are more stringent than these prescribed limits, the standards specified by those countries will be complied with : Pesticides* Serial number 1. 2. 3. 4. 5.

Pesticides BHC Aldrin Dieldrin Endrin DDT

Maximum permissible residual level in ppm 0.3 0.3 0.3 0.3 5.0

Antiboitics* Serial number 1. 2 3 4. Antiboitics* Maximum permissible residual level in ppm (mg/kg) Tetracycline 0.1 Oxytetracycline 0.1 Trimethoprim 0.05 Oxolinic acid 0.3

Heavy Metals* Serial number 1. 2 3 4 5 6 7 Heavy Metals Mercury Cadmium Arsenic Lead Tin Nickel Chromium Maximum permissible residual level in ppm (mg/kg) 1.0 3.0 75 1.5 250 80 12

(f) the use of any of the following antibiotics and other pharmacologically active substances shall be prohibited in the culture of; or in any hatchery for producing the juveniles or nauplii of; or in any unit manufacturing feed for; or in any unit preprocessing or processing shrimps, prawns or any other variety of fish and fishery products: (i) All Nitrofurans including Furaltadone Furazolidone Furylfuramide Nifuratel Nifurozxime Nifurprazine Nitrofurantoin Nitrofurazone contd--

(ii) Chloramphenicol (iii) Neomycin (iv) Nalidixic acid (v) Sulphamethoxazole (vi) Aristolochia spp and preparations thereof (vii) Chloroform (viii) Chlorpromazine (ix) Colchicine (x) Dapsone (xi) Dimetridazole (xii) Metronidazole (xiii) Ronidazole (xiv) Ipronidazole (xv) Other nitroimidazoles (xvi) Clenbuterol (xvii) Diethylstibestrol (DES) (xviii) Sulfonamide drugs** (xix) Fluoroquinolones (xx) Glycopeptides ** (Except approved Sulfadimethoxine, Sulfabromomethazine and (Sulfaethoxypyridazine)

(g) The levels of dioxin in fish and fishery products shall not exceed 4 pg. per gm., Fresh Weight (i.e. 4 picogram per gram, fresh weight). (h inserted as per order S.O 1227(E) dated 23rd October, 2003) use of any of the following substances having anabolic effect and unauthorised substances, veterinary drugs and contaminants and other substances and other environmental contaminants shall be prohibited in the culture of, or in any hatchery for producing the juveniles or larvae or nauplii of, or any unit manufacturing feed for, or in any unit pre-processing or processing, shrimps, prawns or any other variety of fish and fishery products, namely:(i) substances having anabolic effect and unauthorised substancezs, namely :(a) stilbenes, stibene derivatives and their salts and esters; (b) steroids. (ii) Veterinary drugs and contaminants namely:(a) antibacterial substances, including quinolones; (b) anthelmintics (iii) Other substances and environmental contaminants namely :(a) organochlorone compounds including PcBs; (b) mycotoxins; (c) Dyes.

(I inserted as per order No.1227 (E) dated 31st July, 2006) 1. The level of benzo (a) pyrene in muscle meant of smoked fish and Smoked fishery products shall not exceed 5 ppb (wet weight); 2. The level of benzo (a) pyrene in muscle meat of fish other than smoked fish shall not exceed 2 ppb (wet weight) and ; 3. The level of benzo (a) pyrene in bivalve molluscs, crustacean and cephalopods other than smoked shall not exceed 5 ppb (wet weight).

VALIDATION OF METHODS AS PER Commission Decision 2002/657/EC

Introduction of performance criteria for new technologies scientific update Introduction of the concept of identification points Introduction of the MRPL for banned substances Introduction of alternative analytical definitions

Detection capability Decision limit

Inclusion of detailed instructions for method validation

Identification by identification points earned

Suitable analytical data give identification points Group A compounds:
Confirmation of the identity on the basis of 4 identification points

Group B compounds:
Confirmation of the identity on the basis of 3 identification points

Relationship between a range of classes of mass fragment and Identification Points earned

Detection capability
Smallest content at which a method is able, with reasonable error probability of , to detect, identify and quantify the analyte. Visualisation:
Suppose the critical value (CC ) is 1 ppb Suppose is 5%

Samples of a pool of different samples, all with a content of the analyte of 1 ppb, should give a positive results in 95% of all cases.

Decision Limit
Limit at which it can be decided that a sample is truly violative with an error probability of The decision limit should be determined in such a way that all criteria for confirmatory methods are fulfilled Visualisation:

Suppose the critical value (CC) is 1 ppb

When the content of the analyte is 1 ppb, the method is capable to identify the sample as non-compliant

Quantitative limits
Maximum Residue Level (MRL): The concentration of a substance in a commodity (food) that may not be exceeded. Values based on an evaluation of health risks. Minimum Required Performance Limit (MRPL): Limit established by the European Commission and/or Community Reference Laboratories. It is the minimum content of an analyte in a sample, which at least has to be detected and confirmed. It is intended to harmonise the analytical performance of methods for unauthorised substances across Member States

Interpretation of results
Non compliant result:
the concentration of the analyte exceeds the value of CC (or the MRL) and the appropriate identification criteria are fulfilled.

Compliant results:
The concentration of the analyte does not exceed the value of CC (or the MRL) or the appropriate identification criteria are not fulfilled.

THANKS