Corrective Action Implementation

Bev D

Heretical Statistician
Leader
Super Moderator
Sorry I really don't get this. Technically you can do whatever you want. Sure the Customer or registrar (who is NOT a Customer they are a supplier in this relationship) need to approve the ultimate corrective action. BUT once you accept that the finding is real why would you want to stay in a state of nonconformance???? IF you have assessed the Corrective for the potential to be effective and not cause other problems why wouldn’t you want to implement it? Why in Deming’s name couldn’t you implement it??? This just sounds like silly red tape to me.
 

Golfman25

Trusted Information Resource
Riddle me this -- how do you "accept" a corrective action that hasn't been implemented and proven effective? Your CA may or may not work -- you need to show effectiveness as part of the CA process, no?
 

AEOS_QA

Involved In Discussions
May not be relevant to AS9100 but it could be a software related issue on the auditor side.
EASA has been using Intelex Inspection and Findings Platform for the last 2 audits. The auditor has to approve or reject individually each of the three components of the Corrective Action plan submitted for each Action related to each piece of evidence. It has certainly made it much harder to close findings off. If you have 3 findings some with multiple pieces of evidence you have to get a minimum of 9 ticks before you can proceed to the next stage.

-------- Extract from the EASA Dashboard ------------------------
For findings raised during onsite audits, inside each finding create one action for each evidence associated with the finding and provide EASA with a Corrective Action plan (CAP) that includes:

1. The root cause analysis, which should also consider possible implications of the finding in other areas of your organisation;
2. The corrective action(s) to the specific finding identified by EASA and associated timescale for closure;
3. The preventive action(s) to avoid reoccurrence (based on the outcome of the root cause analysis) along with the associated timescales for closure.

Once EASA has accepted the CAP you should provide evidence of the implementation of the action proposed according to the timescale proposed in the CAP.
--------
 

Steve Prevette

Deming Disciple
Leader
Super Moderator
Our CAPA process requires us to hold the CAR at "awaiting external approval" when customer/outside approval is required.
How do you determine if "customer/outside approval is required?" That may be the key to solving this. And is it approval of the plan, or approval of yes, the action is completed and is effective? We did have a customer that on certain CAP's required their approval of some actions (as specified by them) and their effectiveness review. But they attended our corrective action meetings, so that was easy to stay in synch with them.
 

Mike S.

Happy to be Alive
Trusted Information Resource
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.
Never heard of a customer requiring CA approval before implementation. Does the customer own you? Approval of your report, yes. How can you let a customer stop you from fixing a leak in your boat until they approve the method? :oops:
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
What I am getting from this is that the NCs are from the June 3rd party audit. CA plans would have to be approved by the registrar but the official software for doing so was not working and the auditor would not review outside of that software interface. This really does look like an issue with the CB.

Aeroquality, when is your next audit?
 

Jim Wynne

Leader
Admin
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.
Your CA response to a CB should not be considered as your company making a suggestion. Your registrar isn't a customer, they're a supplier. A special type of supplier but a supplier nonetheless. I would get rid of the "Awaiting external approval" thing, implement the change(s) and react accordingly when the CB dispositions your response.
 

Sidney Vianna

Post Responsibly
Leader
Admin
Your CA response to a CB should not be considered as your company making a suggestion. Your registrar isn't a customer, they're a supplier. A special type of supplier but a supplier nonetheless. I would get rid of the "Awaiting external approval" thing, implement the change(s) and react accordingly when the CB dispositions your response.
https://iaqg.org/wp-content/uploads/2022/12/9101-Form-4-14-Feb-2022.doc

In the case of IAQG AS91X0 audits, the established process requires the CB to review, not only the corrective action plan, but also containment and correction as required. The form I linked has fields and the back of the form you see the instructions for each field.
 

Golfman25

Trusted Information Resource
Never heard of a customer requiring CA approval before implementation. Does the customer own you? Approval of your report, yes. How can you let a customer stop you from fixing a leak in your boat until they approve the method? :oops:
The only area I can think of is when CA falls under process changes which may need approval. So I have a process, defect occurs and part of my CA is to make a new tool and add a step to the production process. Customer may need to approve that extra step -- Although, we usually implement that extra step and submit samples to prove effectiveness.
 

Golfman25

Trusted Information Resource
https://iaqg.org/wp-content/uploads/2022/12/9101-Form-4-14-Feb-2022.doc

In the case of IAQG AS91X0 audits, the established process requires the CB to review, not only the corrective action plan, but also containment and correction as required. The form I linked has fields and the back of the form you see the instructions for each field.
I guess where I am confused is with the timing. Do they have to approve the containment first? Then when that is done, then the Root cause? Then when that is done, then the Corrective Action? Or can I do the whole CA process, including implementation and effectiveness evaluation (which seems to be missing from the form) and submit the whole thing for approval?
 
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