Trinity Operating Procedures - TOPs
TOP-RCALL: Recall of Product
Rev: 09/30/2024
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:
* Upper Management as defined in
this TOP
refers to anyone on the vice-presidential level or above.
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 RMA; initiate CAR
if
necessary per TOP-CARRR
3
Upper Management*
Upon
being notified of potential problem with
product
RMA; 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 RMA and
return to QA Manager
4
QA Manager
Upon
return of RMA
RMA
File RMA
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 |
09/30/2024 |
Removed "Potential Recall Memo" for "RMA" |
Carina Alvarez |
Dustin Jump |
|
|
|
|
|
|
|
|
|
|
|
|