Corrective Action Implementation

Aeroquality

Registered
Looking for opinions regarding corrective action implementation for registrar audit findings. Our CAPA process requires us to hold the CAR at "awaiting external approval" when customer/outside approval is required. We do not implement the action(s) until that approval is received in writing. Our registrar is telling us they expect everything to be implemented for their follow-up visit, even though they have not approved our responses in OASIS or via email.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Welcome to The Cove Aeroquality!

Are these NCs from this same registrar? If yes, I am thinking they sound very old.

How long have you been waiting for response? If it has been more than two weeks I would contact Customer Service. Maybe that auditor has moved on.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Sometimes its easier to beg forgiveness than ask permission. I would use their response as motion to proceed with implementing it. If you dont how can this move forward?
 

Michael_M

Trusted Information Resource
Looking for opinions regarding corrective action implementation for registrar audit findings. Our CAPA process requires us to hold the CAR at "awaiting external approval" when customer/outside approval is required. We do not implement the action(s) until that approval is received in writing. Our registrar is telling us they expect everything to be implemented for their follow-up visit, even though they have not approved our responses in OASIS or via email.

I kind of sounds like you painted yourself into a corner with the way your corrective actions are written/required. Is this something you can look at and/or possibly change? Change the working to something like "customer and internal corrective actions require external approval" or "when required, ...external approval". This gives you some room to maneuver the odd corrective actions that come along.
 

Mike S.

Happy to be Alive
Trusted Information Resource
I'd change your process to remove that requirement to hold for approval.

I've had registrar auditors suggest that I send them my proposed RC/CA response before formally submitting it, which I will do, but my procedure does not require me to wait to do anything until after the external approval. Why box yourself in like that? Hold it if you want to for some good reason, but don't require the hold. JMO.
 

Golfman25

Trusted Information Resource
Agree with everyone else. Only require approval where necessary, such as change to customer process.
 

Aeroquality

Registered
Welcome to The Cove Aeroquality!

Are these NCs from this same registrar? If yes, I am thinking they sound very old.

How long have you been waiting for response? If it has been more than two weeks I would contact Customer Service. Maybe that auditor has moved on.
NCs are from June audit. Oasis has been down the entire time. The auditor refused to look at any of the responses during this time.
 

Aeroquality

Registered
I kind of sounds like you painted yourself into a corner with the way your corrective actions are written/required. Is this something you can look at and/or possibly change? Change the working to something like "customer and internal corrective actions require external approval" or "when required, ...external approval". This gives you some room to maneuver the odd corrective actions that come along.
I would not want to implement until registrar accepts the plan. If it gets rejected, we will need to readdress the implementation and training. Since we have many contracts imposing customer approval of CARs from them, we decided on one system. Our registrar is considered a customer.
 

Aeroquality

Registered
I'd change your process to remove that requirement to hold for approval.

I've had registrar auditors suggest that I send them my proposed RC/CA response before formally submitting it, which I will do, but my procedure does not require me to wait to do anything until after the external approval. Why box yourself in like that? Hold it if you want to for some good reason, but don't require the hold. JMO.
Registrar auditor refused to review anything while OASIS was down. It came back online this week, audit was in June. We have one system for external CARs since most customer require approval prior to implementation.
 
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