Red Tape (1 of 4) ISO Requirement – 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”
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Georgia Dept. of Ag Laboratories Culture Media and Supplies Management A low tech approach to meet ISO Requirements • 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
Transcript
Georgia Dept. of Ag Laboratories Culture Media and Supplies Management
A low tech approach to meet ISO Requirements
• 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 ShellFood Laboratory Program Director Georgia Dept. of AgricultureAtlanta, Ga. 30334
Georgia Dept. of Ag Laboratories Media and Supplies
Management (Low Tech) • First – ISO 17025 requirements and general
ordering process to ordering.
• Second - receiving and critical supply verification process.
• Third – media control will be
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”
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)
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.
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.
Procedures and Work instruction available in the receiving room.
Georgia Dept. of Ag Laboratories Media and Supplies
Management (Low Tech) • First – ISO 17025 requirements and general
ordering process to ordering.
• Second - receiving and critical supply verification process.
• Third – media control will be
Evaluation of Supplier’s F-079
SUPPLIER PHONE NO. ACCOUNT NO. VENDOR ID DATE EVALUATED APPROVED PROBATION INITIALS3M 1-800-328-6553 GAM 6640 0000008693Airgas South 404-524-0242 WHR 31 0000009257American Proficiency Institute 1-855-FOODPT1 Ga. Dept. of Ag. 0000559458AOAC International 1-301-924-7077 ext. 124 or 153 Ga. Dept. of Ag. 0000035981BioGX 205-250-8055 Ga. Dept. of Ag. 0000499258BioMérieux 1-800-634-7656 1042307 0000008944Bio-Rad 1-800-424-6723 ext. 2635 33005000 0000015991Certified Measurements 1-478-953-5171 GA 1869 0000038644Decagon 1-800-755-2751 3574 0000203807Dixie Cert. & Testing 678-648-9959 Ga. Dept. of Ag. 0000396472Evoqua Water Tech. 1-800-466-7873 602043386 000004211Fisher Scientific 1-800-766-7000 033123-001 0000005119IDEXX 1-800-321-0207 20215 0000026132Lab Tech/Alpha Liberty 770-794-4450 Ga. Dept. of Ag. 0000356801Neogen 1-800-234-5333 GAD 002-0003 0000026392Phenova 1-866-942-2978 Ga. Dept. of Ag. 0000540285Qualicon, DuPont 1-800-863-6842 55286742 0000133659Sigma-Aldrich 1-800-325-3010 49447836 0000034251Steris 1-800-333-8828 Ga. Dept. of Ag. 0000008144VWR 1-800-932-5000 State of Georgia 0000003536aSuppliers of critical consumables, supplies, and services that affect the quality of testing.
Supplier Lista
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.
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.
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.
W-436 Supply ListConsumable Material Item No. Vendor NA Certificate Box Label Instruction Afla E. coli L. mono Salm
• 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.
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)
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
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.
