Quality Management System Control of Nonconforming Work (QP-4)
Prepared by: CPHST Quality Management Unit August 2006
Purpose
Describes the steps used to ensure that work which does not conform to requirements is identified and controlled to prevent its unintended use or delivery
Scope
This procedure applies to all of the work conducted by CPHST which is covered under the ISO scope of registration.
What is Nonconforming Work?
Nonconforming Work – Laboratory work that does not meet the requirements of the quality management system.
Who is Responsible?
Nonconforming Work is identified by:
Laboratory Director Technical Manager Quality Manager CPHST Management CPHST Quality Management Unit
REPORT OF NONCONFORMING WORK (RNC)
RNC# RNC Written BY: Nonconforming Product Department/Section where detected: Unique Identification of Nonconforming Product: Quantity of Product Rejected: Reason for Rejection: CPHST Laboratory: | Date:
Corrective Action Comments:
Applicable to other products/services
□
Yes
□
No
Form 4-1
CAR Required □ yes □ no If yes CAR #_________
Impact
Disposition of Nonconforming Material: Disposition Authorized By: □ Use As is (see below) □ Rework Rework inspected by: Use As is Disposition: Customer Waiver/Director release
□ Other: ____________________________________
Date:
Date:
Has nonconforming product been delivered to customer? □ No | □ Yes | If Yes, note Action that must be appropriate to the effect or potential effect of the nonconformance. Action: Verified By: Comments: Date:
Close Out Signature and Date
Has the Nonconforming Work Been Released to the Customer?
Yes?
Management must notify the customer and discuss available options.
A record of this discussion must be maintained.
No?
Next Question
Does the detected nonconformity adversely affect the quality of the laboratory work?
No?
The nonconforming work may be released upon obtaining customer agreement.
Yes?
Management must determine the disposition of the nonconforming work.
Use As Is Rework – All rework must be re-inspected prior to being released to the customer
Is Corrective Action Necessary?
Yes? – Follow procedures outlined in QP-5
No? – No further action is required
Nonconforming Work Log
All Reports of Nonconforming work are tracked with a Nonconforming Work Log
Questions or Comments
Please Contact CPHST Quality Management Unit
John Gallagher, CPHST Director of Quality Management
(228) 323-4678 john.b.gallagher@aphis.usda.gov
Or
Kathy Burch, CPHST Senior Quality Auditor
(228) 323-4686 or (228) 822-3221 katherine.j.burch@aphis.usda.gov