1. Thanks for giving me an opportunity to share with you our process for controlling media and other supplies. Disclaimer: We are not yet accredited to ISO 17025 although are seeking. I hope this talk will be informative yet receptive to advice from the audience. J. Dana Shell Food Laboratory Program Director Georgia Dept. of Agriculture Atlanta, Ga. 30334

2. Georgia Dept. of Ag Laboratories Media and Supplies Management (Low Tech)

3. Red Tape (1 of 4) ISO Requirement 4.6.1 – The laboratory shall have a policy and Procedure(s) for the selection and purchasing of services and supplies it uses that affect the quality of the tests and /or calibrations. Procedures shall exist for the purchase, reception and storage of reagents and laboratory consumables material relevant for the tests and calibrations. QA manual – The lab authorizes requestors and approvers to purchase supplies and services (refer to procedure P-614 “Purchasing of Supplies, Services and Equipment) QA manual – For information on receiving and storing reagents and consumables (refer to procedure P-615 “Labeling and Storing Standards, Media, and Equipment”

4. Red Tape (2 of 4) ISO Requirement 4.6.2 – The laboratory shall ensure that purchased supplies and reagents and consumable material that affect the quality of tests and /or calibrations are not used until they have been inspected or otherwise verified as complying with standard specification or requirements defined in the methods for the test and /or calibrations concerned. These services and supplies used shall comply with specified requirements. Records of actions taken to check compliance shall be maintained. GDA QA manual – Before the lab uses Supplies they are verified (refer to procedure P-621 “Verifying Supplies and Reagents)

5. Red Tape (3 of 4) ISO Requirement 4.6.3 – Purchasing documents for items affecting the quality of laboratory output shall contain data describing the service and supplies ordered. These purchasing documents shall be reviewed and approved for technical content prior to release. Note: The description may include type, class, grade, precise identification, specification, drawings, inspections instructions, other technical data including approval of test results, the quality required and the management system standard under which they were made. QA manual – Authorized requestors create requisitions which describe what is being ordered. An authorized approver reviews all requisitions before approving the order.

6. Red Tape (4 of 4) ISO Requirement 4.6.4 – The laboratory shall evaluate suppliers of critical consumables, supplies and services which affect the quality of testing and calibration, and shall maintain records of theses evaluations and list those approved. GDA – The lab keeps lists of suppliers and evaluations. – refer to P-614 “Purchasing Supplies, Services and Equipment” – Refer to form F-079 Supplier List.

7. Procedures and Work instruction available in the receiving room.

8. Georgia Dept. of Ag Laboratories Media and Supplies Management (Low Tech)

9. Evaluation of Supplier’s F-079 Initially this was used for Analyst to put together order needs, by calling vendor and getting quotes. This saves our Requestor (program manager) time as they can quickly review and initiate order. We just added couple columns for perform the vendor evaluation.

10. P-614 “Purchasing Supplies, Services and Equipment” All items, including samples, are delivered to central receiving area and analysts rotate this position weekly. This ensures sufficient depth and training at this position since these actions are now requirements. This position is now just as critical as any one performing analysis. The Receiver’s Job – – checks items against the original requisition and packing slips, initialing and dating when received. – checks items against work instructions (W-436 Supply List). – will collect necessary documentation (certificates of analysis, box labels, sterilization certificates, etc., and ensure items received are appropriate for the intended usage. – ensures quality critical supplies are maintained in compliance with (P-621 Verifying Supplies and Reagents). – will mark each individual container with initials and date received. – will document ALL received items on form (F-073 Supplies Received List) to record the actions and approval of items before usage. – will keep unapproved items in the receiving room and will distribute approved items to appropriate lab section. Once the items have been approved and distributed they are ready for usage.

11. P-621 “Verifying Supplies and Reagents” The Program Manager – orders everything and was going out on maternity leave. After I had a panic attack I asked her make me a list of what to order while she was out. – The list includes, but not limited to, critical consumables, supplies, kits, and services in their workgroup. (Refer to work instructions W-436 Supply List). I was not think about ISO at this point. Afterwards we realized it not only meet a component but was really useful. It is used not only to know what to order but what to do with it when it is received.

12. W-436 Supply List This list contains every item the lab could order. It’s name, Order ID, Vendor, usage, and steps to take to document it was verified before use. This list is multiple pages and tabs (consumables, media, reagents, kits, etc,.) Initially in needs updated regularly. This list is used to inform the Receiver what criteria to check the supplies against and what action to perform next. This list is ALL SUPPLIES beyond only quality critical supplies. We wanted to avoid exceptions and ensure the receiver is not deciding what is critical and what is not.

13. Records are kept for every item that is critical to the test method. Pre-labeled files for consumables, Kits, Media, Reagents, references and standards. All items unless listed as N/A (not applicable)

14. P-621 “Verifying Supplies and Reagents” The Receiver – – verifies raw material name, vendor name, item quantity and receiving document match container label. – provides documentation to Buyer that order is complete, correct, and can be paid. – manages all QC standards or certificates on consumables as directed. – initiates nonconformance and inform supervisor or finance of any discrepancies found. – obtains and maintains that each lot of reagents, media, and standards are evaluated and deemed suitable for intended use by Performance evaluations. – Records received items and evaluations on form F-073

15. F-073 Supplies Received List All supplies are received onto this list. The Receiver references the work instruction (list) for necessary criteria then manages it’s records and perform verification as needed. Once it is done, approved and initialed, the supplies are ready for use and can be placed in the lab.

17. Georgia Dept. of Ag Laboratories Media and Supplies Management (Low Tech)

18. 2 work instructions (Media Prep and Media Performance)

19. Media is made in batches. After prep the batch is tag with RED (Stop - QC pending) After QC is completed the tag is replaced with Green (Go – QC ok)

20. Culture Media Performance I’ve heard - ISO considers media similar to equipment and each batch needs to be verified before usage. Each batch is assigned a unique code. Each batch is tested for performance criteria and sterility to ensure suitable. After the QC checks out it’s available for usage.

21. The culture media’s batch number is track on the sample worksheets to maintain traceability.

22. Thanks For Your Time – Questions?