Prepared By: NASH Analysis Lab

NASH Analysis Lab

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 57
24-100 Puławy
tel: 81 889 30 00; fax: 81 886 25 95

adress e-mail:

Scope of audit:

EN ISO / IEC 170254.4 Review of requests, tenders and contracts

EN ISO / IEC 17025 4.5 Subcontracting of tests and calibration

Date of audit:

22/07/2015

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 Instituteis to conduct research in veterinarymedicine, particularly concentrating on the diagnosis and prophylactics of infectiousdiseases of animals, hygiene and toxicology of food of animalorigin, protection of the environment, and development of the productiontechnology of veterinarybiologicals and diagnostickits.

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 pre-registration 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 membersare 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.

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: MirosławPawełPolak
Quality Manager: Anna Kuba

Used equipment:

Spectrometer MS
Spectrophotometer UV-VIS
GC-MS
LC-MS
GC-MS-MS
LC-MS-MS
ICP-MS

List of questionsfor assessment

1)How do youdeal with customers requirements, reviews and contracts?Referring to the paragraph 4.4.1 of EN ISO/IEC 17025

2)How do you deal with records regarding contracts?Referring to paragraph 4.4.2 of EN ISO/IEC 17025

3)Doyouinform tocustomers about anychanges in the contract?Referring to paragraph 4.4.4 of EN ISO/IEC 17025

4)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 4.5.1 of EN ISO/IEC 17025

Answer and informationobtained from the staffmembers

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 email and review before preparing another form as contract. After signing the contract, the sample is sent to the sample entry officetogether 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’srequirements or the results of the work during the period of execution of the contracts are maintained together with the initial order.

3)The staffs informthe customersaboutsignificantchanges in the contract andmost often send e-mail, in case of emergencycontactthem by phone. A fewsignificantchanges which do not affect the quality of services are not informed tothe 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.

Sum up of the evaluation

Summary of AuditFindings
Audited company / The NationalVeterinaryResearchInstitute
Auditors / NASH Analysis Lab
Scope of audit / 4.4 Review of requests, tenders and contracts
4.5 Subcontracting of tests and calibration
Date of audit / 22/07/2015
Proceed to/ContinueCertification / 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 e-mail 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 thereforeit is fit to receive accreditation when the remaining clauses are assessed positively.

Signed by,

Ni Ni WinAgnieszkaPaszkowskaHeloise BessonPAGKEU Sylvestre

Leadermember membermember