1. QUALITY REQUIREMENTS FOR OFFICIAL FOOD LABORATORIES WITHIN EURL AND NRL (LABORATORY NETWORKS IN EUROPE) dr. Tina Pirš, dr. vet. med. Quality Manager, Veterinary Faculty, Slovenia

2. About EURLs – legal background

3. principles of standards to official controls Requirements for performing official control so as to ensure impartiality and effectiveness: sufficient number of suitably qualified and experienced staff adequate facilities and equipment recognised and documented procedures the legal power to carry out official controls

4. EURL NRL Country 1 NRL Country 2 NRL Country.. NRL Country 28 Official labs. country 1 Official labs. country 2 Official labs. country … Official labs. country 28

5. EU Reference Laboratories (EURLs) Aim: high-quality, uniform testing in the EU and support Commission activities on risk management and risk assessment in the area of laboratory analysis. Article 32 882/2004 defines tasks, duties and requirements; Annex VII lists the EURLs Provide NRLs with analytical methods and diagnostic technics, and coordinate their application; Train NRL staff and experts from developing countries; Assist the Commission scientifically and technically e.g. when EU countries contest results of analysis; Collaborate with the competent laboratories in non-EU countries; Assist actively in the diagnosis of animal disease outbreaks in EU countries.

6. National Reference Laboratories (NRLs) Article 33 of Regulation EC 882/2004 defines tasks, duties and requirements MS shall arrange for the designation of 1/more NRL for each EURL. collaboration with the EURL; coordination of the activities of official laboratories responsible for the analysis of samples; organise comparative tests between the official national laboratories and ensure an appropriate follow-up of such comparative testing; dissemination of information supplied by EURL to the competent authority and official national laboratories; provide scientific and technical assistance to the competent authority for the implementation of coordinated control plans

11. Article 12 of Regulation (EC) No. 882/2004 (updated by Comission Regulation (EC) No 1029/2008) 1. The competent authority shall designate laboratories that may carry out the analysis of samples taken during official controls. 2. However, competent authorities may only designate laboratories that operate and are assessed and accredited in accordance with the following European Standards: (a) EN ISO/IEC 17025 on "General requirements for the competence of testing and calibration laboratories"; (b) EN ISO/IEC 17011 on „ General requirements for accreditation bodies accrediting conformity assesment bodies; taking into account criteria for different testing methods laid down in Community feed and food law. Official laboratories

12. Analytical result must come from a laboratory accredited to ISO/IEC 17025 to have a legal validity. Accreditation can be for single test or for a group of tests. Accreditation body must be accredited according to ISO 17011. BUT: Compliance with ISO 17025 is necessary but not necessarily sufficient The standard ISO/IEC 17025 specifies the general requirements to carry out tests (and/or calibrations) Covers management and technical issues.

13. ISO 17025 short overview Basic structure: Introduction, 1 Scope, 2 Normative References, 3 Terms and definitions 4 Management requirements 5 Technical requirements

14. Sampling Handling of samples Testing Records Test report Test results; conditions; MU Sampling plan; documentation Unique identification; Protection of integrity Quality of test results Ensure record integrity; Security Control of documentation Corrective and preventive actions Handling of complaints; service to the customer Suppliers and Subcontractors Organisational structure Internal audits Management review

15. Organisation should be the entity that can be held legally responsible Organisation and management structure and the relationships should be defined. Organisational structure should be such that there are no conflicting interests that could impact quality. Personnel should be free from commercial/financial pressures which might influence their technical judgment. Quality manager should be appointed. Management Requirements Organisation (4.1)

16. Commitment of management to comply with standard and continually improve the effectiveness of management system. There should be a quality manual with a policy statement of the top management. All documents should be properly controlled (approved by a competent person, record of issuing, unique identification, reviewing and updated). Management Requirements Management system (4.2) Document control (4.3)

17. Management Requirements Review of requests, tenders and contracts (4.4) Subcontracting (4.5) Purchasing services and supplies (4.6) The requirements should be adequately defined, reviewed, understood, and documented. Tests subcontracted should be done by competent subcontractor (e.g. according to the ISO 17025). Service and supplies delivered should not adversely impact the quality and effectiveness of laboratory operations (the list of approved suppliers, evaluation should be maintained). The quality of purchased material should be verified before use.

18. Management Requirements Service to the costumer (4.7) Maintenance of good communication (informing about delays, major deviations, advise in technical matters…) Seek and analyse positive and negative feedback Complaints (4.8) Records of complaints and corrective actions

19. Management Requirements Control of nonconforming testing work (4.9) Improvement (4.10) Corrective actions (4.11) Laboratory should establish policy and procedures and designate authorities for implementing corrective actions Investigation to determine root cause Monitor the effectiveness of implementation ACTING and LEARNING Preventive action (4.12)

20. Management Requirements Records(4.13) Maintained to ensure data integrity and availability. Internal audit (4.14) Key monitoring system of quality system Done annually by trained and qualified personnel (independent of the audited activity). Management review (4.15) Review of complete quality system by top management Annually, results should be included in plan for coming year

21. Technical Requirements Correct and reliable result Measurement traceability (5.6) Sampling (5.7) Handling test items (samples) (5.8) Equipment (5.5) Test methods (5.4) Environmental conditions (5.3) Human factor (5.2)

22. Technical Requirements Personnel (5.2) Personnel should be qualified for the assigned tasks. Environmental conditions (e.g. temperature, humidity) should be monitored and controlled. Incompatible activities should be separated. Environmental conditions (5.2)

23. Technical Requirements Methods (5.4) Selection of the method that meet the specific need (it is prescribed/meet the needs of the costumer). Fit for purpose. preferably standard methods that have been published in international standards, regional or national standards. or have been published by widely recognised organisations or as specified by the manufacturer of the equipment

24. Methods of analysis 882/2004 Article 11 Sampling and analysis (Paragraphs 1, 2, 3, 7) 1. Sampling and analysis methods used in the context of official controls shall comply with relevant Community rules or, (a) if no such rules exist, with internationally recognised rules or protocols, for example those that the European Committee for Standardisation (CEN) has accepted or those agreed in national legislation; or, (b) in the absence of the above, with other methods fit for the intended purpose or developed in accordance with scientific protocols.

25. Official laboratories 2. Where paragraph 1 does not apply, validation of methods of analysis may take place within a single laboratory according to an internationally accepted protocol. 3. Wherever possible, methods of analysis shall be characterised by the appropriate criteria set out in Annex III. Annex III Methods of analysis should be characterised by the following criteria: accuracy; applicability (matrix and concentration range); limit of detection; limit of quanitification; precision; repeatability; reproducibility; recovery; selectivity; sensitivity; linearity; measurement uncertainty; other criteria that may be selected as required.

27. Technical Requirements Methods (5.4) Validation and verification of test method When using in-house methods (developed in the laboratory), standard methods outside the intended scope, modification of standard method VALIDATION (following e.g. ISO/TR 13843: guidance on the validation of methods for water microbiology, ISO 16140 : Microbiology of food and animal feeding stuffs -- Protocol for the validation of alternative methods…) For standard and already validated method: VERIFICATION (the laboratory should verify its competence to successfully carry out the standard method (e.g. by repeating critical validation experiments, through running method specific quality control, proficiency test samples).

28. Technical Requirements Measurement uncertainty (5.4.6) Uncertainty estimation should be done with identifying all the components of uncertainty. Sources contributing to the uncertainty can include the reference materials used, the methods and equipment used for sampling and testing, environmental conditions and personnel. Equipment (5.5) Measurement Traceability (5.6) Calibration before use and according to the established program Traceability to SI units Appropriate (complying with requirements for test) Calibrated/checked before use

29. Technical Requirements Sampling (5.7) Handling of test items (5.8) Samples should be uniquely identified. The sample integrity should be protected during transport and storage. Article 11 of R (EC) 882/2004: 7. Samples must be handled and labelled in such a way as to guarantee both their legal and analytical validity. Sampling should be performed according to a sampling plan, and all sample details should be documented.

30. Technical Requirements Assuring the quality and test and calibration results(5.9) Monitoring the validity of tests: regular use of certified reference materials and/or internal quality control using secondary reference material (NRL - EURL network) participation in interlaboratory comparisons or proficiency-testing programs (NRL - EURL network) - satisfactory performance, trend analysis replicate tests using the same or different methods. retesting of retained items. correlation of results for different characteristics of an item. Reporting the results (5.10) The results should be reported clearly, accurately; test report should include information necessary for interpretation of test and about the method used. Minimum information included is prescribed (such as name and address of laboratory, signatories..).

31. From Regulation (EC) No 178/2002: „Networking of laboratories of excellence, at regional and/or interegional level, with the aim of ensuring continuous monitoring of food safety, could play an important role in the prevention of potential health risks for citizens.“ The overall objective of the laboratory network is to ensure and improve the quality, uniform testing, accuracy and comparability of the results at official control laboratories. The goal of meeting quality requirements is a reliable result, an essential component of a food safety system. Conclusions