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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 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
Autoclavable Biohazard Bag, 14" X 19" 14220-028 VWR ●Autoclavable Infectious Waste Bag, 12" X 24" 14220-090 VWR ●Autoclave Biohazard Bag, 8" X 12" O1-828A Fisher ●Autoclave Circular Chart 13-939-280 Fisher ●Autoclave Indicator Tape 11-889-14 Fisher ●Autoclave Printer Paper Rolls 129362-819 Steris ● ● ● ●Bench-Top Keeper 14-375-266 Fisher ● ● ● ● ●Cartridge Ribbon 150828-440 Steris ● ● ● ●Cell Strainers, 40 µm Mesh Size, Sterile 64751-10 Fisher ●Coliform Sample Container w/o tablet 1705100 Fisher ●Cotton Balls, absorbent 07-886 Fisher ●Cotton-Tipped Applicators 23-400-125 Fisher ● ● ●CryoBank Bead System 14-906-51 Fisher W-434 ● ● ●Filter Paper, qualitative grade plain circles 09-805F Fisher ● ●Filtra-Bag, 12 L 10048-888 VWR ●Glass-Disposal Boxes 12-009-7A Fisher ●Gloves, Large Extended Cuff Nitrile Exam 19-041-170C Fisher ●Gloves, Large, Comfort Nitrile Exam 19-041-171D Fisher ●Gloves, Medium Comfort Nitrile Exam 19-041-171C Fisher ●Gloves, Medium Extended Cuff Nitrile Exam 19-041-170B Fisher ●Gloves, Small Comfort Nitrile Exam 19-041-171B Fisher ●Hazardous Waste Label, 6 X 6" S-369 Uline ●Infectious/Diagnostic Shippers, 2000 and 2050 19-075-384B Fisher ●Kimtex™ Wipers 15-235-85 Fisher ●Kimwipes™ Delicate Task Wipers 06-666 Fisher ●Lab Blender Bags: Square 14-258-205 Fisher ● ● ● ●Lab Blender Bags: Square (filtered) 14-258-206 Fisher ● ● ● ●
Methods on Scope
Consumable Material
• 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.
Date Received Item Number Product Name Vendor Lot Number Date Expires Approved Initial12/16/15 7675A Buffered Listeria Enrichment Broth Neogen 107485B 03/19/19 N/A TS09/10/15 89405-030 Columbia Blood Agar, 5% VMR H15243 11/29/15 Certificate JD09/18/15 951358 Liquid Bleach Staples 5813GA1 A415232 0123 01/20/16 N/A AM12/17/15 3563694 Rapid L.mono plates Bio-Rad 5K0639 01/22/16 Certificate TS11/16/15 951358 Clorox germicidal bleach Staples N/A 04/03/16 N/A TS12/18/15 30704 Vidas LMO2 60 Test Biomerieux 1003886620 04/12/16 Certificate TS09/11/15 30122 VIDAS UP, E.coli O157:H7 Rapid AssaybioMerieux 1003751480 04/20/16 Certificate JD09/29/15 8335 DON Veratox Kit Neogen 219231 04/27/16 Certificate ML11/17/15 8335 DON Veratox Kit Neogen 220693 05/11/16 Certificate AM09/16/15 30122 E.coli Vidas Kit Biomerieux 1003896920 06/06/16 Certificate AM10/16/15 30702 VIDAS Salmonella bioMerieux 1004141530 06/22/16 Certificate AM10/28/15 30702 VIDAS Salmonella Assay bioMerieux 1004152820 06/25/16 Certificate ML11/10/15 30706 VIDAS QCV Kit bioMerieux 1004140760 06/25/16 Certificate ML12/22/15 42121 SX2 Broth bioMerieux 527806 07/01/16 Certificate ML12/22/15 9505 Histamine Veratox Kit Neogen 221803 07/18/16 Certificate ML09/11/15 21345 VITEK 2 GN ID Card bioMerieux 241351140 07/25/16 Certificate JD09/15/15 8030 Aflatoxin Veratox Kit Neogen 219451 07/29/16 Certificate AM10/09/15 OXSR0194E Samonella Selective Supplement Fisher 1527298 07/31/16 Certificate JD09/29/15 30111 VIDAS Campylobacter bioMerieux 1004069470 08/24/16 Certificate ML09/08/15 50607726 MAG Beads Anti E.coli O103 1mL Fisher 130335 09/08/16 Certificate JD09/08/15 506077245 MAG Beads Anti E.coli O111 1mL Fisher 130325 09/08/16 Certificate JD09/08/15 50607728 MAG Beads Anti E.coli O121 1mL Fisher 130346 09/08/16 Certificate JD09/08/15 50607727 MAG Beads Anti E.coli O145 1mL Fisher 130336 09/08/16 Certificate JD09/08/15 50607723 MAG Beads Anti E.coli O157 1mL Fisher 103295 09/08/16 Certificate JD09/08/15 50607725 MAG Beads Anti E.coli O26 1mL Fisher 130326 09/08/16 Certificate JD09/08/15 50607729 MAG Beads Anti E.coli O45 1mL Fisher 130347 09/08/16 Certificate JD11/17/15 8030 Aflatoxin Veratox Kit Neogen 220683 09/15/16 Certificate AM10/16/15 30122 VIDAS UP E.coli 0157 bioMerieux 1004149230 09/22/16 Certificate AM11/10/15 30122 VIDAS E.coli O157:H7 Assay bioMerieux 1004149230 09/22/16 Certificate ML
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
2 work instructions (Media Prep and Media Performance)
• 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)
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.
The culture media’s batch number is track on the sample worksheets to maintain traceability.
Thanks For Your Time – Questions?