Deviation guidance

[MedtechQuality]

Hello all,

I am currently handling an NCMR where a part failed during one of the testing procedures. However, the NC originator did not clearly describe the findings in the NC description. The information provided was subjective and open-ended.
After discussing the issue with the NC originator, we were still unable to arrive at a clear understanding of the findings. We eventually agreed that the testing would be demonstrated to help explain the issue. Based on that agreement, I removed the parts from the cage and took them for re-testing, which led to the identification of the actual findings. I made the operator to correct the findings per GDP. Further, I attached this updated document and updated the NC description.
However, I now realize that removing the component from the cage and performing re-testing should have been done following proper documented instructions or authorization, which I did not obtain beforehand.
I would like to understand how this situation should be addressed systematically and documented appropriately. Could you please advise on the proper course of action in this case?

Thank you for your support.

 

[Bev D]

In my past experience we would simply add the re-testing to the original “NCMR” or what ever you call the documentation. This goes under the category of clarifying ro confirming or verifying the nonconformance. It is VERY typical of any non-conforming material disposition process. i think it’s even a standard process flow in most reputable ERP systems with a quality module. I know that in the old days we would just write it down on whatever paper work accompanied the suspect NC Material in aerospace, defense and automotive industries. In my last organization (veterinary diagnostic) th einstrument might fail and then a suspect part would be removed durign reqork. It was imperative to confirm that the removed part was responsible for the instrument failure.

 

[v9991]

Hello all,

I am currently handling an NCMR where a part failed during one of the testing procedures. However, the NC originator did not clearly describe the findings in the NC description. The information provided was subjective and open-ended.
After discussing the issue with the NC originator, we were still unable to arrive at a clear understanding of the findings. We eventually agreed that the testing would be demonstrated to help explain the issue. Based on that agreement, I removed the parts from the cage and took them for re-testing, which led to the identification of the actual findings. I made the operator to correct the findings per GDP. Further, I attached this updated document and updated the NC description.
However, I now realize that removing the component from the cage and performing re-testing should have been done following proper documented instructions or authorization, which I did not obtain beforehand.
I would like to understand how this situation should be addressed systematically and documented appropriately. Could you please advise on the proper course of action in this case?

Thank you for your support.

a. Very fact that complete details are enclosed with the NC, gives an sorted scenario; this needs to be explained logically ; and this could be justified when the initial "unclear description " is addressed in the CAPA either at an operator level and preferably in the NC-form so that recurrence is arrested.
b. another dimension is that, this is apparently non-destructive testing; hence lesser impact or concern; however what are the differences in the initial reading reported and the repeated readings.; need to add rationale for same.
c. Further, you mentioned that you lead the activity; if that is done in the capacity of Quality, then simply document the decision; or is there a procedure / process defined involving a subject matter expert or cross functional team, then need to add a CAPA. in case your role is not quality, then it warrants another CAPA!

 

[Bev D]

Further, you mentioned that you lead the activity; if that is done in the capacity of Quality, then simply document the decision; or is there a procedure / process defined involving a subject matter expert or cross functional team, then need to add a CAPA. in case your role is not quality, then it warrants another CAPA!

I disagree and here is why:
1) not every NC requires a “Corrective Action”. Simple correction through disposition is often all that is required.
2) “Quality” personnel are not magically imbued with disposition skills and/or responsibility. Anyone who is competent and skilled can properly disposition NC material - there is NO indication that this person is not capable, skilled or responsible. Indeed the fact that they recognized that a proper confirmation of the actual problem was needed is evidence enough of their capability.
3) there is no such thing as a “CAPA”. That is a misnomer abbreviation.
4) Confirmation of failure is a routine act and as long as it is documented that is sufficient as it properly identified the correct disposition and correction.

 

[yodon]

I can't 'like' the above response from @Bev D enough! Spot on, every point. Don't blow this up more than needed.

However, I now realize that removing the component from the cage and performing re-testing should have been done following proper documented instructions or authorization, which I did not obtain beforehand.

I do want to touch on this point. For this, you weren't "testing for score," you were just trying to figure out what was going on so I'm not clear why you think you should have documented instructions or authorization. As part of the investigation, it's good to capture details on "here's how we were able to identify or replicate the issue."

Frankly, from what you posted, I think y'all did a good job! You flagged the issue, realized you needed more information, & took the actions to isolate and understand the issue.

 

[Bev D]

Does an internal procedure require some ‘authorization’? If so what does it actually say?

There really is nothing wrong with you did. Unless you have a Customer that specifically requires an authorized trained experienced list of ‘dispositioners’. Aerospace often requires this.

 

[v9991]

I disagree and here is why:
1) not every NC requires a “Corrective Action”. Simple correction through disposition is often all that is required.

I do acknowledge that not every NC requires CAPA; and acknowledge that CA and PA are distinct and different from correction.
however, CA in the context could be relevant or an opportunity ; to updated the problem definition/reporting to reflect guiding terms 4W+1H or personnel could be trained up to ensure avoidance of such recurrence.

2) “Quality” personnel are not magically imbued with disposition skills and/or responsibility. Anyone who is competent and skilled can properly disposition NC material - there is NO indication that this person is not capable, skilled or responsible. Indeed the fact that they recognized that a proper confirmation of the actual problem was needed is evidence enough of their capability.

Indeed, acknowledge each point within the perspective defined procedure in SOP ;
I might have been overboard, a little of pharma background overhanging; will watch out to keep it neutral.

3) there is no such thing as a “CAPA”. That is a misnomer abbreviation.

would like to understand more a) in the context of possible CA above b) ISO does mention the CAPA

4) Confirmation of failure is a routine act and as long as it is documented that is sufficient as it properly identified the correct disposition and correction.

indeed, however, what could make it tricky is the scenario of different results, and invalidating the one of the measurement. Hence its usually done with diligence and oversight .

 

[Bev D]

In the OLD versions of ISO9001 there were separate and distinct sections on Corrective Action and Preventiv Action. Their intent and use were different from each other. In the early days many companies, consultants, etc. didn’t take the tiem to understand the difference and they mashsed them together and treated them the same. A single procedure and a single form. Hence the sloppy/lazy Misnomer CAPA. Horribly wrong, inefficient and ineffective. ISO then realized that they couldn’t break this misinterpretation and misapplication, so they eliminated the section on Preventive action and replaced it with “risk based thinking”. ISO never refers or referred to CAPA. ISO only mentions correction and corrective action to prevent recurrence. This preventing of recurrence is NOT preventive action. Preventive action occurs BEFORE a defect or NC is observed.

The OP didn’t ‘invalidate’ the original NC description or measurement. They were very clear that the NC was only vaguely described and unclear as to wha twas wrong - if anything. (An example common in medical devices and other assemblies is that the test failure occurs at the assembly level yet the rework operators may remove a SUSPECT component with vague language that doesn’t affirm the the component is in fact responsible for the assembly failure…). So a ‘retest’ is only a validation that the component is in fact non-complaint and provides specifica actionable information. Re-read what the OP said…this confirmation is very common and routine in any NC material disposition process. If the OP’s organization has a procedrue that contradicts or precludes thsi it should be changed. A simple correction not a corrective action.

Without further specifics from the OP that is about all we can say.

 

[Tidge]

From my PoV, "PA" (i.e. "Preventive Action") is the biggest bête noire in 13485. The concept is absolutely well-motivated, but the idea that companies should be formally proactive about medical device non-conformities is duplicating what 14971, and the other part of PA in 13486 is about preventing potential non-conformities to regulatory (and internal QMS) compliance (in a 100% formalized and prescriptive manner) is a fool's errand. This is *not* me saying companies cannot and should not be proactive about trying to prevent NCs in the QMS space, my attitude is more along the lines of "actions to avoid QMS non-conformities should be well-motivated, but not by some hypothesis study comparing implementation and non-implementation of the PA".

In practice, medical device companies (and auditor expectations) are that CA and PA follow the same process, which rarely makes sense. Simple points that people have tie themselves into logical knots is trying to "is/is-not" or "5-Why" a PA, dealing with "containment", and as noted above trying to have a meaningful effectiveness check for a PA. The formalities of approvals and reviews of a CAPA process has the end effect that very few PA get started and completed, because nobody wants to have the CAPA review board participating in the decision to do something like change the oil in a machine on the floor, or move a station to accommodate left-handed associates, lock up red pens, or whatever.

The medical device manufacturing community has another complication: the consensus standard for risk management (14971) is applicable only to products, not to quality systems... so for CA the practical approach is to direct risk assessment to 14971 files for product, and terms in that standard can further confuse things. For example, we all know IBD/PM/IFS from 14971... but the PM stands for "protective measure" not "preventive measure" or "preventive maintenance" (the latter two are subsets of the first), so formally trying to inject 8.5.3 of 13485 into 14971 is not adding value, only complication.

For the QMS NC in a CAPA process there is typically some arbitrary scale (usually cold/warm/hot) about "how much QMS risk does the NC introduce?"... which at least can be assessed for when a NC has actually occurred... but there is no calibrated way to objectively determined the QMS risk for a NC that has never occurred. Humans will make the calls and they'll be totally arbitrary when it comes to "OMG, that could be bad!" I have personal experience where Executive Management made it the highest priority to do things like seize every red pen in the building (because people might generate quality records with red ink that might not be legible/scannable/copyable/whatever) but rejected ideas like "maybe engineering should review and approve this design change?"

 

[Bev D]

Agree. I’ve always found the focus on “QMS” NCs over PRODUCT NCs (I prefer the phrase defect or failure to be less confusing) to be completely missing the point of any quality system.

I do agree that processes and procedures that are ineffective in directly assuring product conformance to be essential and any failure to conform to effective processes is also serious and needs to be corrected. But too many people are unable to make this assessment and so they focus only on strict conformance to whatever procedure is in place.

A miss on initiating an Out of Tolerance investigation for OOT calibration is serious. This has a direct line to nonconforming product. Is it a major? Who cares. Its serious and needs to be fixed.