NASH Analysis Lab. Report of the audit. Prepared by: NASH Analysis Lab. CEO: Ni Ni Win. Quality manager: AgnieszkaPaszkowska

Transcription

1 Report of the audit Prepared by: NASH Analysis Lab CEO: Ni Ni Win Quality manager: AgnieszkaPaszkowska Lab manager: Héloïse Besson Lab technician: Sylvestre Pagkeu Organization to be assessed: The National Veterinary Research Institute Adress: AlejaPartyzantów Puławy tel: ; fax: adress Scope of audit: EN ISO / IEC Review of requests, tenders and contracts EN ISO / IEC Subcontracting of tests and calibration Date of audit: 22/07/2015 1

2 1. General description of the laboratory The National Veterinary Research Institute was established in 1945 as a research and development unit of the Ministry of Agriculture and Rural Development. In 2003 it gained the status of a state research institute. The major mission of the Institute is to conduct research in veterinary medicine, particularly concentrating on the diagnosis and prophylactics of infectious diseases of animals, hygiene and toxicology of food of animal origin, protection of the environment, and development of the production technology of veterinary biologicals and diagnostic kits. The Institute also conducts training postgraduate and specialization for veterinarians in the Veterinary Postgraduate Education Centre. It is the national reference center for the evaluation of the epidemiological situation in Poland and the monitoring of residues of xenobiotics in food of animal origin. It also conducts an official inspection and testing preregistration of veterinary biologicals, participates in the licensing process for drugs and vaccines and is responsible of the expertise for the Veterinary Administration. The organizational structure of the Institute are departments and laboratories representing specific disciplines such as microbiology, biochemistry, pathology, toxicology, physiopathology of reproduction, hygiene of food of animal origin and feed hygiene and plant diseases of animal species (cattle, sheep, horses, pigs, poultry, dogs, cats, fur animals, fish, bees), as well as facilities for research on important livestock diseases (eg. FMD). Staff members are continuously trained for validation of analytical measurement procedures and use of analytical equipments. The National Veterinary Institute - National Research Institute already has eight of accreditation certificates numbered AB 485, AB 544, AB 563, AB 633, AB 957, AB 958, AB 1016 and AB 1090 issued by the Polish Centre for Accreditation. National Veterinary Institute - National Research Institute - has established and implemented a management system appropriate to the scope of its activities, in accordance with the requirements of PN-EN ISO / IEC 17025: (in 2005) "General requirements for the competence of testing and calibration laboratories"; Developed quality policy, quality programs, procedures and instructions needed for quality management and quality assurance test results. A wide range of research, the high specificity of tasks and complex organizational structure resulted in the need to create several levels of quality management system documentation for the National Veterinary Institute. 2

3 Its Quality management system documentation PIWet-NRI is composed of the following levels: Quality Manual PIWet-PIB (KJ PIWet-PIB) - a document describing the management system in the whole area of activity PIWet-PIB; Plant Quality Manual (QLC) - documents describing the management system in the organizational units of the extent to which it is characteristic of these cells; General procedures (PO) - documents describing procedures in individual areas of quality management system; Test procedures (PB) and standard methodology (N) - documents describing research methods; Instructions (I) - documents describing in detail how to implement particular actions, their place, necessary equipment, etc., In relation to the essential activities described in the documents of a higher order, ie., The books of quality, general procedures and research; System standards, regulations, manuals, software. Staff: Director General: Krzysztof Niemczuk Deputy Director for research: Jacek Kuźmak Deputy Director for Economic Affairs, Chief Accountant: Barbara Kotelba Scientific secretary: Mirosław Paweł Polak Quality Manager: Anna Kuba Used equipment: Spectrometer MS Spectrophotometer UV-VIS GC-MS LC-MS GC-MS-MS LC-MS-MS ICP-MS 3

4 2. List of questions for assessment NASH Analysis Lab 1) How do you deal with customers requirements, reviews and contracts? Referring to the paragraph of EN ISO/IEC ) How do you deal with records regarding contracts? Referring to paragraph of EN ISO/IEC ) Do you inform to customers about any changes in the contract? Referring to paragraph of EN ISO/IEC ) What happens in case you don t have the capability and resources necessary to carry out specific tasks? Are you using a subcontractor? Referring to paragraph of EN ISO/IEC Answer and information obtained from the staff members 1) There is a special form in the institute that must be filled in with the information about the sample by clients before sample arrives to the institute. This form needs to be signed by the client and sent it to the institute. The corresponding staffs verify it and very often call the client or send him an and review before preparing another form as contract. After signing the contract, the sample is sent to the sample entry office together with the sample sub registration form. 2) The institute has a special room to store past test documents, contracts etc. The information on the client s requirements or the results of the work during the period of execution of the contracts are maintained together with the initial order. 3) The staffs inform the customers about significant changes in the contract and most often send , in case of emergency contact them by phone. A few significant changes which do not affect the quality of services are not informed to the clients. 4) When such case happens, the institute will call the client and inform him that the specific task cannot be carried out. The institute doesn t have any special procedure for this case because the contract has not been endorsed yet. But on the other hand, the institute has a flexible accreditation so if the client wants to do research related tasks of the sample for instance, the analysis of some new compound it has possibility to develop a new validated method for the clients. Even if the client has agreed to pay, it would be very expensive. The institute doesn t do subcontracting because the institute is very high level and scope of the analysis is very wide. In Poland some analysis can be done only in this institute. So the institute cannot find any subcontracting and also on the practical point of view it is really hard to verify the quality of subcontractors for quality inspection. 4

5 4. Sum up of the evaluation Audited company Summary of Audit Findings The National Veterinary Research Institute Auditors Scope of audit NASH Analysis Lab 4.4 Review of requests, tenders and contracts 4.5 Subcontracting of tests and calibration Date of audit 22/07/2015 Proceed to/continue Certification YES In conclusion, it was found that each contract is needed to be signed by both the laboratory and the customer. Before the appropriate test method is selected it should be verified and meet the customer s requirements. If any change appears in the contract, the clients have to be informed by or by phone, unless it is not significant and does not affect the quality of the results. Records of reviews, including significant changes should be maintained together with the initial order. The contracts and reviews are kept in a specific room. They do not do subcontracting. After checking with clause 4.4 to 4.5 of EN ISO/IEC 17025, the laboratory complies with these clauses and therefore it is fit to receive accreditation when the remaining clauses are assessed positively. Signed by, Ni Ni Win AgnieszkaPaszkowska Heloise Besson PAGKEU Sylvestre Leader member member member 5