1. Evaluation of Suppliers of Critical Consumables, Supplies and Services Section 4.6.4
February 2016

2. ISO 17025:2005 Section 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 these evaluations and list those approved.

3. ISO 17025:2005 Section 4.6.4 ALLAC also states:
“Once a supplier has been evaluated and approved there shall be a program to ensure continued suitability of the supplier”.

4. Procurement at MDA prior to Accreditation
State procurement was a Global system designed by accountants for accountants.
Laboratory has a homegrown front end to this system that provides a catalog feature and captures data of interest to Laboratory Managers.

5. Filemaker Catalog
Written in Filemaker
Drop down menus

6. Section 4.6.4 Major Objectives of standard was to: Evaluate Suppliers
Maintain Record of Evaluation
Program of continued monitoring

7. Section 4.6.4 Some Questions and Concerns: State uses contract vendors
One contract vendor provides many various critical consumables and supplies
Where best to build system?

8. Contract Vendors

9. Contract Vendors
Large Contract Vendors are only suppliers if they provide their own line of critical material.
As problems arise you evaluate that individual supply or consumable.
Disqualify the contract vendor for that commodity.

10. Contract Vendors

11. Contract Vendors
Use the Vendor performance report stressing the requirements of the Standard.
This has been and should be sufficient to go “off contract”

12. Where Best to Build System?
Decided to build approved supplier list into our QMS
Driven off a FORM which can be downloaded from our QMS document module.
Completed form is attached to the vendor file in the approved supplier list.
Supplier status is verified when entering orders.
Process described in SOP.

13. When Ordering
Requestor orders based on method/Work Instruction requirements.
Determines if item can affect quality of result.
Verifies if supplier is on the approved list.

14. When Ordering
Items from suppliers not on the list must be evaluated after receipt.
Certain suppliers of services that hold accreditation to ISO17043, ISO17025 or ISO Guide 34 are generally considered acceptable.

15. Upon Receipt of Supplies
Item is inspected for package integrity.
Contents are verified against purchase order and shipping paperwork is initialed and dated by lab staff.
Added to unit inventory following established procedures.

16. Evaluations
Checks are performed per the method or specific work instructions.
Findings are documented in lab technical records.
Unsatisfactory materials are reported to superviser who has supplier removed from the approved supplier list and Filemaker system.

17. All vendors in Front End Purchasing System were evaluated.
Evaluation Form 5 Pages
All vendors in Front End Purchasing System were evaluated.
New Vendors are recorded after commodity is received and evaluated.
Detailed list of consumable, supply or services covered.
Section on PT providers.
Applicable Pages are completed as necessary.

22. .

23. Evaluation

24. Evaluation

25. Evaluation

26. LAB SOP 0085

27. Minnesota Department of Agriculture
For Copies of SOP, Forms contact,
Gary Horvath