Difficulty in determining who should be addressing NCRs

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.

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…

Bev D said:

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…

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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.

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.

"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.

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

hogheavenfarm said:

"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.

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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.

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!

Dazzur said:

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.

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In the context of Nonconformance Reports (NCRs) related to manufacturing problems, the Quality Assurance (QA) Department should not be solely responsible for conducting the Root Cause Analysis (RCA), corrective action, and risk analysis. Instead, the QA Department should manage the NCR process, ensuring that appropriate actions are taken and that outstanding issues are addressed. The responsibility for addressing manufacturing-related NCRs should involve relevant departments, such as engineering, risk management, and production teams, who have direct knowledge and expertise in the specific manufacturing processes.

According to the FDA Quality System Regulation (21 CFR 820.100), manufacturers must establish and maintain procedures for implementing corrective and preventive actions. These procedures should include analyzing processes, work operations, quality records, and other sources of quality data to identify existing and potential causes of nonconforming products or other quality problems. The procedures should also involve investigating the cause of nonconformities, identifying necessary actions to correct and prevent recurrence, and ensuring that information related to quality problems is disseminated to those directly responsible for assuring the quality of the product or the prevention of such problems.

In summary, the QA Department should manage the NCR process, but the responsibility for addressing manufacturing-related NCRs should be shared among relevant departments with direct knowledge and expertise in the specific manufacturing processes. This collaborative approach ensures that the most appropriate and effective corrective and preventive actions are taken to address nonconformities and prevent their recurrence.

hogheavenfarm said:

"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.

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Completely agree! It's easy. No involvement in the corrective action. No backing to make it happen and no responsibility or accountability. Sounds like the perfect position to be in. Unfortunately it happens. We're really fortunate to have not only involvement and ownership but also support from upper management to help remove roadblocks as necessary.