Correction actions implemented vs 'intent'.

As a Foreword please move this to the correct forum if I've posted in the wrong place.

Morning all,

I'd appreciate your guidance on something.

Today I was asked to review our organisations response to an NCR we received during a third party audit.

During the review, I noticed that the actions for the correction were written in 'Intent', non-of these actions had actually been implemented by my organisation. More of a 'plan' if you will.

I've never encountered this before, usually the correction actions have already been implemented which led me to ponder & put it to you all here?


I'm looking forward to your thoughts (if any)

Have a nice day.

 

Apologies for the delayed reply Andy.

Thank you for your answer, yes given the context of the finding a more long term correction would be more appropriate.


I'll share the details of what actually occurred:

There's a critical components list (BoM essentially), for an approved product that has to be documented & maintained.

During the Audit, several work orders were found in production to be denoted as the aforementioned approved product, though their part numbers did not cross reference to the critical components list. These items are outside the scope of approval.

It transpires that the design department had done a poor job of maintaining which items would be within the scope of approval (They initially added a bunch of items, before deciding what would actually be submitted for approval). They never actually updated their product lists to remove items that were not to be part of the approval.

I requested the above information, documented it as a 'controlled' critical components list, with this being the final version to which the auditor reviewed.


I have my own thoughts as to what the root cause may be, but if anyone would like to add their input. Feel free.

 

Typically, CB's have their own form for issuing a nonconformity. There are at least two types of actions that an organization need to propose:

• Correction - action to eliminate a detected nonconformity (this type of action is usually immediate and focuses on addressing the issue that the auditor observed). In your case, the outdated component list. This can be addressed by updating the list;
• Corrective action - action to eliminate the cause of a nonconformity and to prevent recurrence (this type of action is usually long-term and focuses on the factors the led to the nonconformity). This will require analysis of the cause/s of the outdated component list. Actions are then determined on each identified cause.

Since verification of the actual implementation of both types of actions will happen on the CB's next visit, your company can set target dates on when the actions are to be completed. The description of the actions and their target dates are expected to be indicated in the NCR form. You don't need to complete them before responding back to the CB. Just make sure that the actions are completed before the next visit.

 

Thank you for your replies.

@Miner the imposed target dates are very logical & are something I'll be putting forward to my team when dealing when long Audit NCRs.

@tony s True, Maybe I was hasty in my approach/thinking, but you're correct & I agree, as long as these agreed upon actions are implemented before the next audit then I don't see a problem!.

Have a nice day.