Is preventive action required for each CAPA initiated?

[YellowQCPro]

Hello!

I need all your help! I have always opperated under the assumption that a corrective action required a preventive action. Not necessarily a 1-for-1 ratio, but if you open a CAPA, you have all your corrections and/or corrective actions along with a preventive action.
Now I have searched BS EN ISO 13485:2019+A11:2021, 21 CFR 820.100. Elsmar, GHTF/S3/N18:2010: Quality Management System Medical Devices –Guidance on corrective action and preventive action and related QMS processes and the good 'ole internet and cannot confirm my line of thinking!

It there a regulatory requirement to have at least one preventive action with a CAPA? If so, can you point me to the specific requirement?

Thanks Forum!
YellowQCPro

 

[GStough]

I disagree. If you have to implement a corrective action for something, then it's too late for a preventive action. Preventive action is something you can do to prevent a negative outcome (nonconformance, defect, reject, etc.), which is usually why you have a corrective action in the first place. Preventive action takes into consideration the risk(s) associated with taking no corrective action vs. implementing action to mitigate or eliminate that risk. Preventive action is taken to *prevent* the need for a corrective action.

Others may share their perspective on this for a spirited discussion, however.

 

[Mike S.]

I am NOT 13485 fluent, but generally speaking, I would only have a PA associated with a CA if there were other areas or products that could benefit from the lessons learned in doing the CA. For example I implement a CA as a result of a NC in the Lawnmower Production Line and realize that the same kinda problem might someday happen to the guys in the other building in the Chipper Shredder Production Line, so a PA is implemented there.

 

[John Broomfield]

Hello!

I need all your help! I have always opperated under the assumption that a corrective action required a preventive action. Not necessarily a 1-for-1 ratio, but if you open a CAPA, you have all your corrections and/or corrective actions along with a preventive action.
Now I have searched BS EN ISO 13485:2019+A11:2021, 21 CFR 820.100. Elsmar, GHTF/S3/N18:2010: Quality Management System Medical Devices –Guidance on corrective action and preventive action and related QMS processes and the good 'ole internet and cannot confirm my line of thinking!

It there a regulatory requirement to have at least one preventive action with a CAPA? If so, can you point me to the specific requirement?

Thanks Forum!
YellowQCPro

Stopping recurrence is not preventive action. Removal of the root causes from the system is part of corrective action.

Correction alone is incomplete as corrective action.

Would you like to rephrase your question?

 

[YellowQCPro]

Thank you! I think I may not have been clear.

I totally agree with what you are saying. I meant to ask, if we open a CAPA and there are Corrections and Corrective Actions, are we required to have a Preventive Action within that same CAPA?

For example:

NC - No defined process for XYZ
Root Cause - Individuals lack of understanding the need for a documented process

Correction - Create process (action to eliminate a detected nonconformity)
Corrective action - Train individual (action to eliminate the cause of a detected nonconformity or other undesirable situation)
Preventive action - Update QM to require a procedure/record when the regulatory requirements call out for one (preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence)

I disagree. If you have to implement a corrective action for something, then it's too late for a preventive action. Preventive action is something you can do to prevent a negative outcome (nonconformance, defect, reject, etc.), which is usually why you have a corrective action in the first place. Preventive action takes into consideration the risk(s) associated with taking no corrective action vs. implementing action to mitigate or eliminate that risk. Preventive action is taken to *prevent* the need for a corrective action.

Others may share their perspective on this for a spirited discussion, however.

 

[Jim Wynne]

...if you open a CAPA, you have all your corrections and/or corrective actions along with a preventive action.

I'm not a medical devices expert but there seems to be some confusion here. I'm using an old copy (2005) of ISO Q9000, but I don't think the definitions have changed:

3.6.4
preventive action
action to eliminate the cause of a potential nonconformity (3.6.2) or other undesirable potential situation
NOTE 1 There can be more than one cause for a potential nonconformity.
NOTE 2 Preventive action is taken to prevent occurrence whereas corrective action (3.6.5) is taken to prevent recurrence.
3.6.5
corrective action
action to eliminate the cause of a detected nonconformity (3.6.2) or other undesirable situation
NOTE 1 There can be more than one cause for a nonconformity.
NOTE 2 Corrective action is taken to prevent recurrence whereas preventive action (3.6.4) is taken to prevent
occurrence.
NOTE 3 There is a distinction between correction (3.6.6) and corrective action.
3.6.6
correction
action to eliminate a detected nonconformity (3.6.2)
NOTE 1 A correction can be made in conjunction with a corrective action (3.6.5).
NOTE 2 A correction can be, for example, rework (3.6.7) or regrade (3.6.8).

(My emphasis)
Elimination of the cause of a nonconformity is not "preventive action." Preventive action is preemptive, always. "Correction" is directly fixing the present nonconformity itself. For example, if a part is missing a required hole, "correction" would be adding the hole.

To answer your question, a "preventive" action isn't normally part of a corrective action.

 

[Jim Wynne]

Thank you! I think I may not have been clear.

I totally agree with what you are saying. I meant to ask, if we open a CAPA and there are Corrections and Corrective Actions, are we required to have a Preventive Action within that same CAPA?

For example:

NC - No defined process for XYZ
Root Cause - Individuals lack of understanding the need for a documented process

Correction - Create process (action to eliminate a detected nonconformity)
Corrective action - Train individual (action to eliminate the cause of a detected nonconformity or other undesirable situation)
Preventive action - Update QM to require a procedure/record when the regulatory requirements call out for one (preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence)

What you're calling a preventive action in your example isn't. It's part of the corrective action--what you do to ensure that the same NC doesn't happen again.

 

[Sidney Vianna]

The term CAPA does not reconcile with ISO 13485, as this standard mandates the definitions of ISO 9000:2015.

Check

The meaning of the term CAPA &
Separate Corrective Action and Preventive Action Procedures

 

[John Broomfield]

Thank you! I think I may not have been clear.
For example:

NC - No defined process for XYZ
Root Cause - Individuals lack of understanding the need for a documented process

Correction 1 - Create process (action to eliminate a detected nonconformity)
Corrective actionCorrection 2- Train individual (action to eliminate the cause of a detected nonconformity or other undesirable situation)
Preventive Corrective action - Update QM and institute training so users can determine when a procedure must be documented.

I’ve made a few corrections to your example to accord with ISO 9000:2015.

 

[Bev D]

CAPA is one of the most egregiously misleading terms/acronyms that was ever coined in the quality profession.

Correction and Corrective Action take place after a defect or nonconformance have occurred.
Correction applies only to the actual defective condition itself.
Corrective Action includes Correction and involves actions to prevent the recurrence of the defect/nonconformance in the future.

Preventive Action occurs before a defect or nonconformance occurs.
Preventive Action can take many forms: FMEA, SPC, Lean organization of process steps and materials, etc.

Corrective Action and Preventive Action are independent of each other.
It is possible to claim that a Preventive Action is taken on a different process or product that could be effected by the same causal mechanism as that found in a Corrective Action. However, this is rare, a stretch and is a very isolated application of Preventive Action.