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

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.

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”.

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.

Filemaker Catalog Written in Filemaker Drop down menus

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

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?

Contract Vendors

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.

Contract Vendors

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

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.

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.

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.

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.

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.

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.

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Evaluation

Evaluation

Evaluation

LAB SOP 0085

Minnesota Department of Agriculture For Copies of SOP, Forms contact, Gary Horvath Gary.Horvath@state.mn.us 651-201-6563