Trinity Operating Procedures - TOPs

TOP-RCALL: Recall of Product

Rev: 12/06/2017

Scope: This procedure covers the recall of product known or suspected of not meeting the customer's specifications or of violating a statute or regulation.

Procedure:

STEP WHO WHEN INFO TO USE WHAT TO DO
1 Any team member Upon becoming aware of any information that leads him/her to believe that bad product may have shipped Any information that surfaces which could cast doubt on the quality of product Immediately notify QA Manager of all facts
2 QA Manager Upon being made aware of potential problem with product Facts provided by original source plus any other information QA Manager deems pertinent Discontinue if suspicions prove unwarranted; present to upper Management* a Potential Recall Memo; initiate CAR if not already done per TOP-CARRR
3 Upper Management* Upon being notified of potential problem with product Potential Recall Memo; any information  deemed necessary Determine course of immediate action and execute it promptly; course of action to include immediate notification to the customer and any other interested party, such as suppliers or regulatory agencies; record disposition on Potential Recall Memo and return to QA Manager
4 QA Manager Upon return of Potential Recall Memo Potential Recall Memo File Potential Recall Memo

* Upper Management as defined in this TOP refers to anyone on the vice-presidential level or above.

Revision history:

Release Date

Description of Change

Owner

Approver

12/06/2017

Updated to comply with revised Quality Manual and new TOPs format.

Tim Ellis

Todd Sheppard


















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