Corrective actions - The act of having an MRB review and disposition

[Mark Smith]

Last week we had our annual ISO surveillance audit and one of the non-conformances written up was the fact that our SOP for corrective actions states that " Data identifying needs for CA/PA may originate from one of the following sources:
Inspection and Test Records
MRB Reports
Audit Findings
Customer Complaints
Service Reports
Employee Feedback"

but the work instruction for Corrective actions states in the SCOPE section
"2.1. This procedure does not include corrective or preventive action systems covered by other procedures such as complaint handling, MRB, general inspection, internal audits, ECN's, field corrections or medical device reporting".

The auditor saw a conflict but I argued that corrective actions can exist but not be named as such. For instance, the act of having an MRB review and disposition non-conforming materials is in itself a corrective action for dealing with the presence of non-conforming material. In my opinion , there would be no added value in also assigning a corrective action request to this effort. comments?

 

[Dan Larsen]

I also see a conflict. CA involves a lot more steps than is typically applied to a quick response to a customer complaint or a single reject. Most often, these involve a "quick fix" to resolve the immediate issue.

I think your response to the finding should include a change in the wording for your instruction. The action taken on the individual issues in each of the items you're quoting is, to me, "containment" and not full CA (careful root cause analysis and long term action). The trend information from each of the systems you quoted can and should be used for corrective/preventive actions.

For example, you can respond to each individual customer complaint (containment) and your system could stop there. But if you get a lot of complaints of the same type (trend analysis), you may want to initiate a corrective/preventive action to reduce the total number of customer complaints.

I use this approach with most of my clients. I tend to keep the reject/complaint systems separate from CA to avoid the need for a full blown audit system. The info from these systems is then evaluated for trends that can be moved to the CA system.

 

[David Mullins]

I don't know about conflict, I'd say more like contradiction. This looks pretty messy, so I'd say your auditor was quite correct to make mention of the contradictions contained in the documentation of this fundamental area.

The quote from the WI also suggests you are overdoing the number of procedures - can't you roll some together? I wouldn't recommend having disparate CA/PA guidelines.

------------------

 

[Marc]

Contemporary comments?

 

[Jim Wynne]

Contemporary comments?

As to the OP's question, the appearance of conflict probably could have been avoided if the scope had just stated what the document did apply to, and not to what it didn't.

Also, CA wrt an MRB system involves both disposition (a decision as to how to proceed with the NC material) and the act of carrying out the disposition (scrap, use as is, rework, etc.), as well as actions to prevent recurrence (let's not start that CA/PA discussion again, please). So it seems to me that if the OP is saying, "We did our MRB thing, and that's the CA," then important parts of the story aren't getting told, and perhaps the auditor was correct in asking for clarification within the system.

 

[Jim Howe]

Corrective Actions

It has been my experience as QAE assigned to MRB that the customer and/or the government would not accept the MRB disposition without extensive corrective actions that were documented on the non-conformance report that brought the item to MRB. That having been said, I have also experienced corrective actions based on Trends Analysis that came out of QA Records. Many times these trends would include the non-conformance reports that were addressed by MRB especially for the follow up to determine if the C/A actually corrected the problem.
So I must agree with the original poster that Corrective Actions can come from several sources unrelated to each other. However, I do believe my wording would have said "including" instead of "not including".

 

[Bev D]

sounds like the intent was appropriate - but the semantics of what is meant by teh phrase "corrective action" is the trip point. Typically for MRB, customer complaints, etc. there are "remedial actions" taken to repair or rework - or scrap and replace - the existing nonconformance. "Corrective Action" - as typicalloy covered in a CAPA system involves identifying immediate and root causes and taking corrective actions to prevent or reduce re-occurrence. Two very different actions - but we typically use the same 'catch-all' phrase of "corrective action" to apply to both...

I see no conflict - only a better phrasing

But this is the crux of why I am opposed to ISO registration - external auditors who can't be logical and reasonable; if these guys were doign the right things - and it soudnds like they were - who cares if they used the phrase corrective action in a manner that sounded contradictory to the auditor? Isnt' the important thing that they were doing all of appropriate types of corrective action? They are a manufacturing facility - no ta publishing house with editiorial expertise.

 

[Jim Wynne]

there are "remedial actions" taken to repair or rework - or scrap and replace - the existing nonconformance. "Corrective Action" - as typicalloy covered in a CAPA system involves identifying immediate and root causes and taking corrective actions to prevent or reduce re-occurrence. Two very different actions - but we typically use the same 'catch-all' phrase of "corrective action" to apply to both...

I've long advocated the distinction between remedial action (fix the part) and corrective action (fix the process), but as you suggest, CA becomes a big tent covering everything that happens when NC conditions are found. As you also suggest, it doesn't help that the standard fails to make the proper distinctions, and auditors feel duty-bound sometimes to honor the letter of the standard while running roughshod over the intent (and I can't say that I blame them for it).

 

[Jim Howe]

MRB Corrective Actions

sounds like the intent was appropriate - but the semantics of what is meant by teh phrase "corrective action" is the trip point. Typically for MRB, customer complaints, etc. there are "remedial actions" taken to repair or rework - or scrap and replace - the existing nonconformance. "Corrective Action" - as typicalloy covered in a CAPA system involves identifying immediate and root causes and taking corrective actions to prevent or reduce re-occurrence. Two very different actions - but we typically use the same 'catch-all' phrase of "corrective action" to apply to both...
I see no conflict - only a better phrasing

But this is the crux of why I am opposed to ISO registration - external auditors who can't be logical and reasonable; if these guys were doign the right things - and it soudnds like they were - who cares if they used the phrase corrective action in a manner that sounded contradictory to the auditor? Isnt' the important thing that they were doing all of appropriate types of corrective action? They are a manufacturing facility - no ta publishing house with editiorial expertise.

Perhaps I have misunderstood your post but in my world these were not remedial actions. Yes, MRB makes disposition of the non-conforming part (the remedial action you seem to be referring to), but the C/A that I am referring to (in my post) is a full fledged C/A (root cause, etc.) which was demanded by government and/or customer.

In my opinion, such dispositions ("remedial") are not-acceptable as C/A.

As a QAE for MRB I not only acted on behalf of the company but was also the acting representative for two Customers and I can assure everyone that the C/A in our MRB were not "remedial". If I have mis-understood your remarks, my apologies. Perhaps you can explain further.

 

[Jim Wynne]

I can assure everyone that the C/A in our MRB were not "remedial".

"Remedial" means "Of or pertaining to a remedy." Disregarding any specialized use of the term, how is it possible for any CA to be anything other than remedial?