Difficulty in determining who should be addressing NCRs

[Dazzur]

Good Morning everyone,

Currently having a discussion within my Quality Department along with the director about who is involved in the NCR process and where?

The Directors view is that the Quality assurance Department should be leading and completing the RCA, Corrective action & Risk analysis of the NCR for manufacturing problems where as I, believe that our Quality Assurance Department should be 'managing' the NCR case, I.e requesting action to be taken as it's out standing etc. but I don't think the QA Department should be actively be taking examining, controlling & implementation actions etc for manufacturing NCRs. the QA Department should only be completing and closing NCRs that concern Quality Processes.

Maybe I'm completely wrong in my thinking here but I just want other's opinions on this, (I tried to search but I couldn't find exactly what i'm looking for)

Thank you for any replies.

 

[Bev D]

By NCR do you mean a corrective action (requiring determination of root cause and action to prevent recurrence) or do you mean simple non-conformance’s that can be cleared up through ’correction‘ of the affected parts only (scrap, rework, use-as-is…)

In general I have found that the most effective approach is a (small, 3-5 people) team effort with QA, engineering and operations personnel. It depends of course on where the problem solving experts and subject matter experts are in your organization…

 

[Dazzur]

In general I have found that the most effective approach is a (small, 3-5 people) team effort with QA, engineering and operations personnel. It depends of course on where the problem solving experts and subject matter experts are in your organization…

Hi Bev, by NCR I mean corrective action! I also very much agree with your above statement but it seems that Top Management are pushing QA to be the sole responsible parties for corrective action.

 

[Zero_yield]

Hello Dazzur,

I've worked in both scenarios, and I agree with Bev D. The best situation is a collaborative one.

When QA owns all nonconformance investigations and CAPAs, you tend to get good investigations but potentially ineffective CAPAs. Why? Because almost all CAPAs require effort by the part of the organization where the nonconformance occurred to implement and maintain the correction.

When the people who own the process do the investigation and own the CAPAs, maybe the nonconformance reports need a little punching up on the wording, but the people who make the correction understand and are invested in the process they're fixing.

 

[hogheavenfarm]

"When QA owns all nonconformance investigations and CAPAs, you tend to get good investigations but potentially ineffective CAPAs. Why? Because almost all CAPAs require effort by the part of the organization where the nonconformance occurred to implement and maintain the correction."

In many cases, this is intentional. Some management does not like to take responsibility for "problems", it is easier to just assign that responsibility to QA, certainly many low level managers and departments see this as "extra work" so they avoid it also.

 

[gpainter]

Years back when I was involved in QMS our department managers were for the most part issued the CAR. If Quality Assurance is sent them all, then we have really moved several steps back. Which it seems a lot of companies are. Quality has really changed over the past 10 years

 

[Zero_yield]

"When QA owns all nonconformance investigations and CAPAs, you tend to get good investigations but potentially ineffective CAPAs. Why? Because almost all CAPAs require effort by the part of the organization where the nonconformance occurred to implement and maintain the correction."

In many cases, this is intentional. Some management does not like to take responsibility for "problems", it is easier to just assign that responsibility to QA, certainly many low level managers and departments see this as "extra work" so they avoid it also.

Absolutely agreed. At the place I work, we're at the point right now where most groups own their own investigations and CAPAs, but there are some obstinate holdouts that want QA to "do the quality", so they can do the "real work" (in their minds). I think some people see QA as gremlin tricksters that skulk around throwing extra work on hapless victims who break their arcane rules. There's definitely a need to push back and educate that quality is everyone's job, all the time.

 

[Dazzur]

Thanks for the replies everyone, the comments made in this thread confirmed my feelings about this process as a whole, I had a meeting with the director who oversees Quality along with my own Manager and reiterated many of the points that were made in this thread and the Director agreed!

However, I've now got to stipulate who interacts with the CAPA Process and where and then put this forward, it's fairly obvious in my opinion but it's a step in the right direction for my Department & Organisation.

Thank you all greatly again for giving me the courage to speak up about this!