AUDIT REPORT. Auditor(s) UFPAL

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1 National Veterinary Research Institute AUDIT REPORT Area being audited 4.6. Purchasing services and supplies Auditor(s) UFPAL Date/Time 22/07/2015 Contact: UFPAL Aleja Królewska Puławy Phone Number: (916) Fax: (916) Auditee(s): The National Veterinary Research Institute Address: Aleja Partyzantów Puławy Phone number: ; fax: address Audit Summary Short narrative summary of audit activities including judgment on the level of compliance with the standard: Audit was carried out according to the rules which apply to such an audit. First we reviewed the document EN ISO/IEC 17025, section 4.6 Purchasing services and supplies. We reviewed the document and prepared questions for the contact person of the company to present during the audit. We found some non-critical non-conformities, which should be corrected according to EN ISO/IEC Opportunities for improvement and system strenghts: The institute shall have a mechanism to evaluate the supplies according to the previous experiences on the timeline and quality of goods and services and to create a list of approved suppliers. In this way chemicals, glassware and small equipment (under certain price limit for public tender) can be purchased easier and quicker at the cost stated by the approved supplier. The institute has a comprehensible and well thought-out Quality Management System in accordance with the good professional practice.

2 DESCRIPTION OF THE LABORATORY National Veterinary Research Institute The National Veterinary Research Institute (NVRI) 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 and the permission to use the name of the National Veterinary Institute - National Research Institute in Puławy. The primary task of the Institute is to conduct research in the field of veterinary medicine with particular emphasis on the diagnosis and prevention of infectious diseases of animals, including zoonoses, hygiene and toxicology of food of animal origin. The Institute also runs postgraduate and specialization training program for veterinarians in the Veterinary Postgraduate Education Centre. The Institure is the national reference center for the evaluation of the epidemiological situation in the country and the monitoring of residues of xenobiotics in food of animal origin. It conducts an official inspection and pre-registration testing of veterinary biologics and also takes care of veterinary hygiene institutions and it serves as a scientific adviser to the veterinary administration. The organizational structure of the Institute included the departments and laboratories with 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 laboratories for research on livestock diseases (eg. FMD). Basic research interests of the Institute involves: etiology, diagnosis and prevention of infectious and parasitic diseases, the hygiene of food of animal origin, toxicology and veterinary pharmacology, pathology of reproduction and diseases of the mammary gland, pathophysiology of animals. The high level of services of the Institute is provided by: qualified staffs, who are continuously trained for applying research methods appropriate for the intended use and fit for the purpose of test result and by laboratories with modern measuring equipment (e.g. Spectrometer MS, Spectrophotometer UV-VIS, ICP-MS, GC-MS) and analytical procedures to ensure the reliability of the obtained results. Scientific achievements of Institute are disseminated by publications, manuals and monographs. The Scientific Council of the Institute has the right to confer degrees: Doctor of Science (ScD) and Doctor of Philosophy (PhD) in veterinary sciences. National Veterinary Research Institute already has got eight certificates of Accreditation, 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. Staff: Director General: Krzysztof Niemczuk, DVM, PhD, ScD. Deputy Director for Research: Professor Jacek Kuźmak, DVM, PhD, ScD

3 Deputy Director for Economic Affairs and Chief Accountant: Barbara Kotelba, MSc National Veterinary Research Institute Scientific Secretary: Mirosław Paweł Polak, DVM, PhD, ScD Quality Manager: Anna Kuba, MSc Research staff: The Institute employs 350 people: - 33 researchers with Sc.D. and Ph.D researchers with Ph.D researchers with D.V.M. or M.Sc technicians.

4 Audit Report National Veterinary Research Institute Prepared questions: 1. Do you have a policy and procedure for the selection and purchasing of services and supplies that affect the quality of tests and calibration (especially for purchasing, reception and storage of the supplies)? 2. How do you evaluate your suppliers and how are those procedures recorded? 3. What kind of specified requirements do you need to verify when you are inspecting suppliers? 4. When do you review and approve the purchasing documents? 5. What are the special requirements for critical consumables suppliers? Information obtained from the staff members: 1. Do you have a policy and procedure for the selection and purchasing of services and supplies that affect the quality of tests and calibration (especially for purchasing, reception and storage of the supplies)? First, when receiving supplies, supplies (reagents) are labeled with the code which is also registered on the computer (database). This includes the date of entry to the lab, shelf life and signature of the person who received the supplies. Laboratory staff has a general procedure for the storage chemicals. There exists a special storage for dangerous goods. Receiving procedure is suitable and according to this standard. The overall responsibility for the inspection of equipments and reagents in the laboratory is taken by Technical Manager. There are specific requirements, for example some equipment need to be serviced once or twice a year. As far as purchasing of supplies is concerned, it is not organized entirely according to the standard. There is not a documented procedure for the purchasing of critical goods. The purchasing of supplies is based mostly on cost and less on quality. Each year a plan is made regarding the purchase of supplies within their budget, which has some tolerance. It is possible to use other budgets if it is necessary. The Quality Manager has a supplier's logbook, however most of documents are on the website/lims. 2. How do you evaluate your suppliers and how are those procedures recorded? There are no special procedures for evaluating suppliers. Supplies are verified after purchase and during use. All supplies are verified by the person who needs them. The way of verifying depends on kind of reagents and method. There are no real options to

5 National Veterinary Research Institute choose between suppliers due to specific supplies. No records are kept for why a certain supplier was chosen over another. As far as price of supplies is concerned, if a purchase costs under 3500 zlotys there is no special procedure used but if the cost is higher, the purchase has to be put out for public bids. 3. What kind of specified requirements do you need to verify when you are inspecting suppliers? Although supplier invoices are reviewed to check for the correctness by comparing the articles to purchase orders, sometimes there is little chance to choose between only one or two suppliers for some difficult supplies such as some reference standards for HPLC measurements. 4. When do you review and approve the purchasing documents? No procedure for reviewing and approving purchases through documentation before purchases. 5. What special requirements are there for critical consumables suppliers? No documented special requirements for suppliers. Evaluation of answers to the prepared questions Questions 1 and 2 were answered well and in necessary detail. Information regarding questions 3 5 was gathered from other discussion due to time constraints. Potential non-compliances with the EN ISO/IEC 17025:2005 The laboratory shall have a documented procedure for the purchasing of critical supplies and services. The laboratory shall evaluate supplies of critical consumables, supplies and services which affect the quality of testing and calibration, and shall maintain record of this evaluation and list those approved.

6 National Veterinary Research Institute We would like to conclude as follows: Purchasing systems are a key component of effective inventory management in that they monitor existing stock and help companies determine what to buy, how much to buy and when to buy it. Although they have a good procedure for receiving and storage of the supplies, they sometimes have to follow the constraint of economy of scale in some supplies for which they cannot put much focus on the best quality. It is a common practice that the decisions for the purchase materials are done for the lowest cost. Moreover, they do not have special procedures for evaluating suppliers. According to teh standard the laboratory shall evaluate supplies of critical consumables supplies and survices which affect the quality of testing and calibration, and shall maintain record of this evaluation and list those approved. This is a non-conformity with the standard and an area the laboratory should improve. Summary of Audit Findings Standard audit conducted against: EN ISO/IEC 17025, section 4.6 Team leader (1): Khin Myo Htwe Team Members (2, 3, 4, 5): 1. Jukka Pasanen 2. Gizachew Betru Tegegn 3. Karolina Szymanek 4. Kristina Preskar Audit Date(s) from to Is a follow up visit required: NO Team Leader Recommendation: Proceed to/continue Certification: YES Scope of Supply: PURCHASING SERVICES AND SUPPLIES

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