Do nonconformances always result in corrective action

Greetings

I am having a debate with management, the question being do nonconformities ALWAYS result in corrective action or are there cases where a nonconformity DOES NOT result in a corrective action. Any examples you might have would be greatly appreciated.

Thank You

maxwell said:

Greetings

I am having a debate with management, the question being do nonconformities ALWAYS result in corrective action or are there cases where a nonconformity DOES NOT result in a corrective action. Any examples you might have would be greatly appreciated.

Thank You

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I would say not always. For example, there are times when a simple correction is sufficient to address the nonconformance. It could be a simple, silly mistake that someone made - not due to a lack of training or competence, just a mistake, as in human nature.

There are probably other more specific examples, I'm sure, but I can't think of any at the moment...

In our QMS, a nonconformance always triggers the Corrective Action process flow.

That said, there is room within that flow for an "informal" corrective action. The correction gets documented to close out the NC tag, but the whole process of direct and root causes, actions, follow-ups, etc normally required is simplified significantly. If the same informal action comes up multiple times though, a formal action must be taken.

Categorically - NO

Let's say a finding was "The form XYZ isn't filled in completely" - IMHO isn't worthy of a corrective action. Actually, there are a number of threads being discussed here where auditors have written findings that don't warrant a CAR

From the requirements, a nonconformity ALWAYS needs a corrective action

corrective action
action to eliminate the cause of a detected nonconformity (3.6.2) or other undesirable situation

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8.5.2 Corrective action
The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence.
Corrective actions shall be appropriate to the effects of the nonconformities encountered.

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But my opinion is that a lot of what people call nonconformities in fact are not because they can´t have their root causes eliminated.

Just for clarification - do you mean a documented corrective action?

Becasue any the minor correction due to human error as indicated by GStough is a corrective action.
This type probably fails inot the "informal" corrective action of domingue's process.

I imagine that you would want to look at it as does this make good business sense. What value does it add to document an "informal" corrective action?

There may be a people managment component that your question does not reveal. Taking AndyN's example of an incomplete form, is the same person not correctly completing the form? Would it warranty an examination of the training process or at least a look at why the form is not correctly filled out? Sometimes a form is essential from a traceablity stand point to help with a recall or proof that something was done correctly.

So, can you flesh out you and the management's concern with the non-conformity process? It would help with an answer to know whether or not you are applying it to pencils or implantable devices, as I believe the approach would be on a sliding scale.

maxwell said:

Greetings

I am having a debate with management, the question being do nonconformities ALWAYS result in corrective action or are there cases where a nonconformity DOES NOT result in a corrective action. Any examples you might have would be greatly appreciated.

Thank You

Click to expand...

It depends on the specific circumstances. (I am not a Subject Matter Expert on ISO 13485.)

You must document the nonconformance, and what the next actions, to be taken, will be defined.

The organization must determine when a Corrective Action is required. It could be a blanket statement as Domingue mentioned, in his organization, it requires that a Corrective Action is required on any and all non-conformances.

What I feel deserves a Corrective Action may not be how/when someone else would issue a Corrective Action. That is why it needs to documented on how the Organization will meet the intent of the standard.

corrective action
action to eliminate the cause of a detected nonconformity (3.6.2) or other undesirable situation

8.5.2 Corrective action
The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence.
Corrective actions shall be appropriate to the effects of the nonconformities encountered.

Click to expand...

One of the operative statements is that corrective actions shall be appropriate. A minor or incidental (to the customer) cosmetic defect that is easily detected and corrected, but requires significant capital investment to eliminate the cause, may have corrective action that amounts to "we will eliminate this cause the next time the process is re-engineered, and take steps to assure that any reoccurance is detected and corrected in the interim." You are allowed to take economics into account! Which may be your management's point.

Geoff Withnell

Along the lines of mmantunes....if we think of the number of times a non-conforming product is encountered, would you take corrective action for each occasion? Let's say a drill breaks and the part is now scrap. Is anyone saying that a corrective action is required for that? I hope not, sincerely.

The item would be recorded, reviewed and dispositioned. However, if parts were found to be scrapped time and again for broken off drills, it then becomes a $$ issue, which is likely to result in a corrective action. Hence are corrective actions required for ALL non-conformities - NO!

Why can't the same apply to audit non-conformities?

NO. Definitely not.

If you held to that point of view, you could end up with a blindly rigid or authoritarian system that drove people bananas.

I recently cleaned up a system where the previous consultant would do the internal audits, find a tiny little 'NC' and then as far as I could see spend at least 30 minutes handwriting out a CAR that reported gobsmacking issues such as 'form XYZ was missing its issue date'. I figure he spent more time writing them out than fixing!

Andy's examples are good ones, highlighting the difference between when one might write up an NC and when one might not.

Ah hah, will say the rigid authoritarian, if you don't write up everything, then how will you know if there is a trend or not? It's an OK question on the one hand, but on the other, you have to keep in mind risk management, status and importance, as well as commercial considerations. And it is a question you need to have a reasonable answer to.