Differences - Nonconformances vs CAPA, Corrections vs Corrective Actions

[gporter]

I'd appreciate people's thoughts on the following regarding how/what system our medical device company uses for NMRs, CAPAs, corrections, corrective/preventive actions...

As the head of Quality for my company, I hold regular meetings with influential members of my organization to discuss Quality System philosophies. A belief of mine is that all areas of our Quality System should drive disparate activity and shouldn't have overlapping goals. For example, if a product complaint investigation identifies a non-conformance with the complaint product, then a separate nonconforming report (NMR) should be opened to address it in addition to the complaint to address the field feedback. We shouldn't address the non-conformance through the complaint process - that's what the NMR process is for. These well-defined systems help eliminate confusion.

One conversation that has been a hot topic recently is the differences between requirements for nonconforming material/event reports and CAPAs. My team and I get caught up in the discussion if it is allowable to perform corrective actions in an NMR. My stance is that all corrective actions belong in our CAPA system, as opposed to our NMR system. A proper corrective action requires root cause determination and verification of effectiveness (VoE) of the corrective action. Our NMR process does not include VoE. It does have a provision for assignable cause, but not root cause. For the same reason, I do not require root cause in our NMR system because corrective actions are not required. Corrections are used in the NMR system, corrective (and preventive) actions are in our CAPA system.

NMRs require:

1. Non-conformance identification
2. risk assessment (which is requires escalation to CAPA if risk is high enough)
3. investigation and assignable cause
4. interim actions (if necessary)
5. disposition
6. closure

CAPAs require:

1. Non-conformance identification
2. investigation
3. root cause
4. corrective/preventive action
5. VoE

My goal is to not have the ability to chose between using a NMR or CAPA for corrective actions by eliminating grey areas so people are clear on what system would be required. It is possible for "corrective action"-type actions to be taken in an NMR's Interim Actions (update a specification, for example), but without a formal root cause investigation or VoE activity, I hesitate to allow formal corrective actions in the NMR process. If we performed corrective actions in an NMR, couldn't an auditor say "I see you took corrective actions here, don't you have a CAPA process?" or "What was the identified root cause in this case?" or "How did you verify the effectiveness of this corrective action?" I feel in some ways it boils down to semantics, but the words can matter...

What are people's thoughts on this topic? Can "corrective actions" live in both NMRs and CAPAs? Thanks for the input.

 

[Sidney Vianna]

Sorry for being a "purist", but it is critical to keep terminology in check. Corrections, such as "update a specification" is not the same as corrective actions.

Actually, in the Medical Device sector, the term CAPA seems to be misaligned with most of the rest of the world. The PA in CAPA seems to refer to prevention of recurrence of a problem and that, in the ISO 9000 definition is deemed to be corrective action (not preventive action).

It seems to me that you are really asking if we need (full blown) corrective actions with root cause analysis for each and every nonconformity and the answer is a resounding NO. We have discussed this many times and maybe someone can point to similar threads. There are many cases where system changes (the essence of corrective actions) are not justified based on severity, criticality and/or frequency of the problem.

 

[Jim Wynne]

This all seems fraught with overcomplication and too much thinking. In your list of the things that NMRs require, #2 says that CAPA is necessary in some high-risk cases. Is there any reason that high-risk NMR findings shouldn't just be handed off to the CAPA process? Is there any good reason for tightly circumscribing the processes? Is the tail wagging the dog?

 

[Marcelo]

Yes, CAPA is a term which stems from an incorrect use of the terms from the FDA, in fact CAPA (corrective action then preventive action) does not exist in practice.

 

[Pancho]

Yes, CAPA is a term which stems from an incorrect use of the terms from the FDA, in fact CAPA (corrective action then preventive action) does not exist in practice.

Such a common misconception. I bet it even played a part in getting rid of preventive action in ISO 9001:2015.

 

[Ronen E]

I'd appreciate people's thoughts on the following regarding how/what system our medical device company uses for NMRs, CAPAs, corrections, corrective/preventive actions...

As the head of Quality for my company, I hold regular meetings with influential members of my organization to discuss Quality System philosophies. A belief of mine is that all areas of our Quality System should drive disparate activity and shouldn't have overlapping goals. For example, if a product complaint investigation identifies a non-conformance with the complaint product, then a separate nonconforming report (NMR) should be opened to address it in addition to the complaint to address the field feedback. We shouldn't address the non-conformance through the complaint process - that's what the NMR process is for. These well-defined systems help eliminate confusion.

One conversation that has been a hot topic recently is the differences between requirements for nonconforming material/event reports and CAPAs. My team and I get caught up in the discussion if it is allowable to perform corrective actions in an NMR. My stance is that all corrective actions belong in our CAPA system, as opposed to our NMR system. A proper corrective action requires root cause determination and verification of effectiveness (VoE) of the corrective action. Our NMR process does not include VoE. It does have a provision for assignable cause, but not root cause. For the same reason, I do not require root cause in our NMR system because corrective actions are not required. Corrections are used in the NMR system, corrective (and preventive) actions are in our CAPA system.

NMRs require:

1. Non-conformance identification
2. risk assessment (which is requires escalation to CAPA if risk is high enough)
3. investigation and assignable cause
4. interim actions (if necessary)
5. disposition
6. closure

CAPAs require:

1. Non-conformance identification
2. investigation
3. root cause
4. corrective/preventive action
5. VoE

My goal is to not have the ability to chose between using a NMR or CAPA for corrective actions by eliminating grey areas so people are clear on what system would be required. It is possible for "corrective action"-type actions to be taken in an NMR's Interim Actions (update a specification, for example), but without a formal root cause investigation or VoE activity, I hesitate to allow formal corrective actions in the NMR process. If we performed corrective actions in an NMR, couldn't an auditor say "I see you took corrective actions here, don't you have a CAPA process?" or "What was the identified root cause in this case?" or "How did you verify the effectiveness of this corrective action?" I feel in some ways it boils down to semantics, but the words can matter...

What are people's thoughts on this topic? Can "corrective actions" live in both NMRs and CAPAs? Thanks for the input.

I think that your thinking makes sense.
NC SOPs should be about responding and dispositioning the instance at hand, not about preventing recurrence. NC SOP should be a "down to earth", everyday practical tool.
Wherever your system flags recurrence as an issue (it's not always so), CA is in order with all of its heavy cannons (read: resource hungry process).
PA is not directly related to all that - it should be a proactive, continuous improvement tool not directly driven by day-to-day issues.

 

[somashekar]

NMR .. Nonconforming Material report
is for the identification and control of the nonconforming material to prevent its unintended use or delivery. as in 8.3.2
CAR .. Corrective Action Report
is for the action to eliminate the cause of nonconformity in order to prevent recurrence. as in 8.5.2

If you force the requirement of CAR into NMR then you will begin to see a mountain of open corrective action.
Your study and analysis of the NMR must lead you to decide if you have to make a CAR.
Perhaps several NMR may need one CAR

 

[gporter]

Sorry for being a "purist", but it is critical to keep terminology in check. Corrections, such as "update a specification" is not the same as corrective actions.

Actually, in the Medical Device sector, the term CAPA seems to be misaligned with most of the rest of the world. The PA in CAPA seems to refer to prevention of recurrence of a problem and that, in the ISO 9000 definition is deemed to be corrective action (not preventive action).

It seems to me that you are really asking if we need (full blown) corrective actions with root cause analysis for each and every nonconformity and the answer is a resounding NO. We have discussed this many times and maybe someone can point to similar threads. There are many cases where system changes (the essence of corrective actions) are not justified based on severity, criticality and/or frequency of the problem.

Thanks for your thoughts. Two responses:

1. In our CAPA system, we have an opportunity for CA and/or PA in a single CAPA file. CA would address the root cause of the nonconformance that occurred (the depth of the nonconformance), and PA would address similar systems that could have a similar issue (the breadth of the issue).
2. I think you've misunderstood my question slightly by the way you restated it. I'll take your words and modify it: "Is it appropriate to have (full blown) corrective actions with root cause analysis for any basic nonconformity (read as "NMR") in lieu of a CAPA?" I'd like to understand your response to that

 

[gporter]

This all seems fraught with overcomplication and too much thinking. In your list of the things that NMRs require, #2 says that CAPA is necessary in some high-risk cases. Is there any reason that high-risk NMR findings shouldn't just be handed off to the CAPA process? Is there any good reason for tightly circumscribing the processes? Is the tail wagging the dog?

Thanks, Jim. We would hand off high risk cases to the CAPA process as a matter of process requirements. However, if the risk does not reach that high level, is it appropriate to perform corrective actions in your NMR system? Again, I could even be sold on the argument that if we chose our words properly, "corrective action"-type activities could happen in an NMR, but called something different as to not step on the toes of formal Corrective Action.

 

[Jim Wynne]

Thanks, Jim. We would hand off high risk cases to the CAPA process as a matter of process requirements. However, if the risk does not reach that high level, is it appropriate to perform corrective actions in your NMR system? Again, I could even be sold on the argument that if we chose our words properly, "corrective action"-type activities could happen in an NMR, but called something different as to not step on the toes of formal Corrective Action.

Disclaimer: My experience with medical devices is practically nil. Having said that, I've never worked in a system where CA isn't a normal part of the process in dealing with NC material. I'm still not clear on the motivation for creating borders and territories. We get too hung up on what things are called and lose sight of what actually needs to be done. I'm often reminded of the two guys being eaten by a carnivorous reptile while arguing about whether it's an alligator or a crocodile. If something is broken, fix it.