LABORATORY CERTIFICATION & LABORATORY CERTIFICATION & ACCREDITATION IN INDIA WITH SPECIAL ACCREDITATION IN INDIA WITH SPECIAL

REFERENCE TO QUALITY CONTROL REFERENCE TO QUALITY CONTROL LABORATORY FOR SEA FOOD INDUSTRYLABORATORY FOR SEA FOOD INDUSTRY

MANORANJAN MANTHANMANORANJAN MANTHANDEPUTY DIRECTORDEPUTY DIRECTOR

EXPORT INSPECTION AGENCY EXPORT INSPECTION AGENCY –– KOLKATAKOLKATA(Ministry of Commerce & Industry, Govt. of India)(Ministry of Commerce & Industry, Govt. of India)

KolkataKolkata -- 700001700001

ROLE OF EIC / EIASROLE 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 pre- shipment 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 FunctionsExport 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 PerformedQuality Assurance of

commoditiesProduct CertificationTesting of samplesCertification of preferential origin

Major Laboratories

Chennai

Kochi

Kolkata

Mumbai

ISO 17025 compliantNABL Accredited

Major Products Tested

Fish & Fishery Products

Egg Products

Poultry Meat

Milk Products

Honey

Water

Imported Foods

Orders of Fresh, Frozen and Processed Fish & Fishery Products Order

S.O. 729 (E) dated 21st August 1995Sub-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 / EIASROLE 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 / EIASROLE 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.”

ROLE OF EIC / EIASROLE OF EIC / EIAS

CERTIFICATIONCERTIFICATION

1st

party certification

2nd

party Certification

3rd

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

International 

Organization 

for 

Standardization 

(ISO)  defines accreditation as:

“Third‐party  attestation 

related 

to 

a 

conformity 

assessment 

body 

conveying 

formal  demonstration 

of 

its 

competence 

to 

carry 

out 

specific conformity assessment tasks.”

WHAT IS ACCREDITATION ?WHAT IS ACCREDITATION ?

ILAC

ILAC International Laboratory Accreditation CooperationEA European Cooperation for AccreditationAPLAC Asia Pacific Laboratory Accreditation CooperationIAAC Inter-American Accreditation CooperationSADCA Southern African Development Community Accreditation

The Role of the International Laboratory The Role of the International Laboratory Accreditation Cooperation (ILAC)Accreditation Cooperation (ILAC)

To develop the principles and the practice of To develop the principles and the practice of laboratory accreditation.laboratory accreditation.

To harmonize procedures and criteria for To harmonize procedures and criteria for accreditationaccreditation

To assist in the development of new To assist in the development of new programmesprogrammes

To facilitate mutual recognition of membersTo facilitate mutual recognition of members’’

programmeprogramme

To reduce technical barriers in tradeTo reduce technical barriers in trade

To improve International acceptability of test results.To improve International acceptability of test results.

Present Conformity StructureInternational Laboratory

Accreditation Cooperation (ILAC)

International Accreditation Forum(IAF)

Asia Pacific Laboratory Accreditation Cooperation

(APLAC)

Testing Laboratories

International Mutual Recognition

Pacific Accreditation Cooperation

(PAC)

National Accreditation Board for Testing and Calibration Laboratories

(NABL)

Quality Council of India(QCI)

NABCB

NABET

NABH

ISO/IEC 17011

ISO/IEC 17025

ISO 15189

ISO/IEC 17021 Certification Bodies

Training & Eductaion

Inspection BodiesCalibration Laboratories

Medical Laboratories

ISO/IEC 17020

Hospital & Healthcare providers

ISO/IEC 17011

NBQP

ISO/IEC 17024

Quality Promotion

IN INDIA -

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

About NABLNABL is an autonomous body under the Department of NABL is an autonomous body under the Department of Science & Technology, Government of India, and is Science & Technology, Government of India, and is registered under the Societies Act.registered under the Societies Act.

NABL has been established with the objective to provide NABL has been established with the objective to provide Government and Industry with a scheme for thirdGovernment and Industry with a scheme for third--party party assessment of testing, calibration and medical laboratoriesassessment of testing, calibration and medical laboratories

Program started in 1981Program started in 1981

First Accreditation granted in 1992First Accreditation granted in 1992

Autonomous Body registered under societies Act in 1998Autonomous Body registered under societies Act in 1998

REQUIREMENTS (CLAUSES) OF ISO/IEC 17025

Managemento Organizationo Management systemo Document controlo Review of requestso Subcontractingo Purchasingo Service to the customero Complaintso Non‐conforming testso Improvemento Corrective actiono Preventive actiono Records controlo Internal auditso Management review

Technicalo Generalo Personnelo Accommodation & environmental conditions o Test methods & validationo Equipmento Measurement traceabilityo Samplingo Handling test itemso Assuring quality of test resultso Reporting the results

NABL AccreditationNABL Accreditation

Procedure by which an authoritative body (NABL) gives Procedure by which an authoritative body (NABL) gives formal recognition that a body (laboratory) or person formal recognition that a body (laboratory) or person (signatory) is competent to carryout specific tasks (signatory) is competent to carryout specific tasks (scope)(scope)

oo CriteriaCriteria--ISO/IEC 17025 (includes all ISO 9001 elements)ISO/IEC 17025 (includes all ISO 9001 elements)oo Assures the client that the procedures are technically Assures the client that the procedures are technically

valid.valid.oo Recognizes the technical competence of laboratory staffRecognizes the technical competence of laboratory staffoo Assures the client that the results are technically validAssures the client that the results are technically validoo Endorses the quality management systemEndorses the quality management system

Acknowledgement & Scrutiny of Application (by NABL Secretariat)

Adequacy of Quality Manual(by Lead Assessor)

Application for Accreditation (by Laboratory)

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 backTo laboratory

and

Necessary CorrectiveAction

byLaboratory

ACCREDITATION PROCEDURE

EVALUATING THE COMPETENCEEVALUATING THE COMPETENCE

o

On 

site 

assessment 

of 

the 

laboratory 

by 

the  experts 

for 

its 

technical 

competence 

and 

its 

adherence  to  management system practices

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

Testing Laboratories

‐

Biological

‐

Non‐Destructive Testing‐

Chemical  ‐ Optical and Photometry

‐

Electrical

‐

Radiological‐

Electronics  ‐ Thermal 

‐

Fluid‐Flow

‐

Forensic‐

Mechanical

TRAINING PROGRAMS FOR ASSESSORS TRAINING PROGRAMS FOR ASSESSORS AND LABORATORIESAND 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 Accreditation of PT Providers

o Accreditation 

of 

Reference 

Material 

Producers

o Accreditation in Software Testing

o Accreditation in Medical devices

o Accreditation in Wild Life for Forensic

EIC LABORATORY APPROVAL SCHEME (EICLAS)EIC LABORATORY APPROVAL SCHEME (EICLAS)

o Initiated in year 2002.

o 2000 / 2001 expansion following EU residue audit

o National Residue Monitoring Programme (NRMP) / National Residue Control Programme (NRCP).

o Vet drug residues, pesticides, heavy metals, Hormones etc in food products (Milk, Honey, Poultry meat, Egg products, Meat, Fish & Fishery Products)

o wherever possible EIC imparts training to Lab personnel towards harmonization.

REQUIREMENTS FOR EICLASREQUIREMENTS FOR EICLAS

oo LAB must have implemented and maintained QMS as LAB must have implemented and maintained QMS as per ISO 17025.per ISO 17025.

oo Adequate capability and competency for testing of Adequate capability and competency for testing of food safetyfood safety and quality parameters as per EIC / EIA / and quality parameters as per EIC / EIA / IMPORTING COUNTRIES.IMPORTING COUNTRIES.

oo Validation as per 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 Pesticides Maximum permissible

residual level in ppm1. BHC 0.3 2. Aldrin 0.3 3. Dieldrin 0.3 4. Endrin 0.3 5. DDT 5.0

Antiboitics*

Serial number Antiboitics* Maximum permissible residual level in ppm (mg/kg)

1. Tetracycline 0.1 2 Oxytetracycline 0.1 3 Trimethoprim 0.05 4. Oxolinic acid 0.3

Heavy Metals*

Serial number Heavy Metals Maximum permissible residual level in ppm (mg/kg)

1. Mercury 1.0 2 Cadmium 3.0 3 Arsenic 75 4 Lead 1.5 5 Tin 250 6 Nickel 80 7 Chromium 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 pre- processing or processing shrimps, prawns or any other variety of fish and fishery products:

(i) All Nitrofurans including FuraltadoneFurazolidoneFurylfuramideNifuratelNifurozximeNifurprazineNitrofurantoinNitrofurazone

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