Essential Components of a credible and transparent accreditation system

Transcription

1 Essential Components of a credible and transparent accreditation system to issue trusted certificates that facilitate the seed trade Dr. Rasha El Khadem ISTA Accreditation and Technical Department

2 Over the last years, the international Seed Trade has become more and more international. Seed needs to cross borders more then ever before in history.

3 Example: breeding, production, marketing of tomato Breeding of parental lines : EUROPE State 1 2 Production of basic seeds : EUROPE State 2 3 Treatment and manufacturing of basic seeds : EUROPE State 1 4 Production of hybrid seeds : CHINA 5 Treatment and manufacturing of commercial hybrid seeds: EUROPE - State 1 6 Commercial packaging: USA 7 Final sale and use: MEXICO Source: Gerard Meijerink, ISF

4 Seed Quality Parameters are frequently tested when seed is crossing borders. A smooth passage across borders should require reproducibility in testing results for seed quality parameters. Uniformity of results and trusted certificates are the key element for the trade of seed lots

5 To achieve uniformity and reliability of testing resultsfor seedqualityparameters parameters, accreditation systems for seed testing laboratories need to be in place. This accreditation system needs to fullfill requirements covering all steps from sampling of the seed lot, analyses in laboratory and issuance of the certificate of analysis.

6 Conditions, that mustbe fullfilled: 1. Accreditation standard needs to be internationally accepted and available for the public. 2. The used sampling and testing methods that are validated and available for public and international scrutiny. The process of sampling and testing ti must be transparent. t 3. The certificates of analysis as final document for trade need to be clear, trusted and must guarantee the traceabilty from the lot to the analysis. 4. Laboratory performance (sampling, testing and reporting results) needs to be monitored continuously. 5. Audit teams need to be competent independent and impartial.

7 1. Accreditation Standard The Accreditation Standard needs to address: the seed sampling and seed testing process the procedure for seed sample submission to the laboratory.

8 2. Sampling and Testing Methods Only validated methods should be used, with public scrutiny of the detailed methods available. It must be clear which method is used if there is more than one. Transparent validation process must be defined Validation reports must be available for public scrutiny.

9 2. Sampling and Testing Methods continued If the use of in house methods is approved within the accreditation programme, the validation study comparing the in house method against the reference method must be available for public scrutiny. The reference method needs to be published. Thein housemethod must bereported on the Certificate.

10 3. Certificates of analysis Traceability, transparency and uniformity of information provided on : Seed lot, customers, Laboratoryandrelevant and relevant accreditations Methods used when accredited or when derivations, in house methods information need to be clearly stated. Dates of analyses, size of analysed sample

11 4. Monitoring of Laboratory Performance Quality control procedures for monitoring of the laboratory s performance is in place Regular monitoring following a defined process Includes monitoring of samplers Includes monitoring of analysts

12 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Final evaluation results of the latest PT rounds: Purity 11 3 T.pra Other Seeds by numbers 11 3 T.pra 100% 90% 80% 70% BMP 60% C 50% 40% B 30% A 20% 10% 0% Accredited Non accredited Accredited Non accredited BMP C B A Germination 11 3 T.pra Moisture 11 2 T.aes 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Accredited Non accredited BMP C B A 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Accredited Non accredited BMP C B A

13 5. Team of Auditors Qualified and competent auditors following a defined process Impartial regarding the accredited laboratory Impartial regarding the business of the particular laboratory/country Independent as not involved in consultancy related to the laboratory

14 Five Conditions, that must be fullfilled. How does ISTA fullfil them?

15 ISTA Laboratory Accreditation Standard version 5.0 availableon the ISTA website ISTA Rules published, available for sale to the public (definesampling and testing procedures) Clear definition whether it is allowed to deviate from a method and how to report deviations Clear definition how to report test results and p when it is prohibited to report using Certificates

16 Process for the Validation Programme available and followed Validation studies available on ISTA website including the required statistics Monitoring of laboratory s performance using the ISTA Proficiency Test Programme, Mini PT, audits Requirements of competency of ISTA auditors q p y defined for all types of auditors

17 Specific contracts with auditors and monitoring of auditor s performance Laboratories can reject auditors if there are good reasons The ISTA Accreditation System leads to Uniformity of results and trusted Certificates

18 Conclusions: Use the 5 conditions of the checklist before recognising an accreditation body and the certificates issued under their accreditation system.

19 Conclusions continued: If you can not tick the 5 conditions confirming the requirements related to the: 1. Accreditation Standard used 2. Sampling and testing methods used 3. Certificates of analysis 4. Monitoring oflaboratory performance 5. Impartial, independent and competent auditors The value of the provided certificates should be questioned.

20 Documentation and transparency is required to provide proof of a credible system Leading to reliability and certainty. Thank you for your attention