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TRANSCRIPT
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
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.
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.
.
Evaluation
Evaluation
Evaluation
LAB SOP 0085
Minnesota Department
of Agriculture
For Copies of SOP, Forms contact,
Gary Horvath
651-201-6563