Clause for use of expired quality alerts

Smchandler

Involved In Discussions
Question, we found several expired quality alerts in a work area, would I write the CAR against AS9100 Clause "7.5.3.2e For the control of documented information the organization shower dress the following activities as applicable. E) prevention of the unintended use of obsolete documented information by removal or buy application of suitable identification or controls if cap for any purpose"
Or is there a more applicable clause for this failure?
 

Mikey324

Quite Involved in Discussions
If I were you, I wouldn't get too hung up on the clauses. If this was found during an internal audit, or otherwise, I would work on figuring out why they were up, what the potential damage could be, and what we can do about it.
 

Jim Wynne

Leader
Admin
  1. What's a quality alert? Why do they have expiration dates?
  2. Why wouldn't you write the CAR against your own internal documentation?
 

Big Jim

Admin
I believe you have found the correct clause. What I'm not so sure of is are you sure they are officially obsolete?
 

Ram Prasad

Registered
Hi,

Quality Alerts are issued at the initially stage of customer complaint receipt, I think the quality Alert does not require a expire date, instead why cannot you update your CAR internal document to update when the Quality alerts will be removed, I believe it should be based on the evaluation of corrective action on the non conformance.
 

ChrisM

Quite Involved in Discussions
How did you know that the alerts had expired? If they are controlled documents. then there is most likely a failure in either your document control procedure or the quality alert procedure. The alerts should be reviewed periodically so that action can be taken to leave them in place, amend them or withdraw them, and it appears that such reviews were/are not taking place.
 

Smchandler

Involved In Discussions
What's a quality alert?
A notification of a quality concern to impacted employees issued for things like customer complaint, internal issue etc.
Why do they have expiration dates?
Our procedure does allow for no expiration date required, however some were issued with an expiration date.
Why wouldn't you write the CAR against your own internal documentation?
Absolutely we could, I don't want to get hung up on schematics but there is nothing in or procedure that says we must remove when expired, so instead of debating it with the owners I wanted to also reference a AS9100 clause that was applicable.
 
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Smchandler

Involved In Discussions
I believe you have found the correct clause. What I'm not so sure of is are you sure they are officially obsolete?

they would be "Expired" as per the expiration date on the document. This is usually because the issue was resolved and no longer needed or they changed a process so that QA instructions may no longer be correct.
 

Smchandler

Involved In Discussions
If I were you, I wouldn't get too hung up on the clauses. If this was found during an internal audit, or otherwise, I would work on figuring out why they were up, what the potential damage could be, and what we can do about it.

Thank you, I agree somewhat, however my role is to perform Internal Audits on the Process, determining RCCA is up to the owner of the process to resolve and address.
 

Mikey324

Quite Involved in Discussions
Thank you, I agree somewhat, however my role is to perform Internal Audits on the Process, determining RCCA is up to the owner of the process to resolve and address.
Of course. I just mean the finding the root cause, whoever's responsibility that is, is far more important than finding a clause to match it to.
Just out of curiosity, why would a quality alert have an expiration date? What would make it no longer valid? If there was a problem that required heightened sensitivity to whatever the issue may be, did that cease to exist at the expiration date? Have the actions from the quality alert been added to the control plan and made permanent? Will there be a failure or flow out is the quality alert is used say as part of the inspection? I've never understood an expiration date on a document. Milk yes, QMS documentation not so much.
 
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