The meaning of the term CAPA
- Thread starter David_
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chris1price
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I cant give you a template, but if you look at ISO9001 part 10.2 it will explain the actions you need to perform for a corrective action.
10.2.1 When a nonconformity occurs, including any arising from complaints, the organization shall:
a) react to the nonconformity and, as applicable:
1) take action to control and correct it;
2) deal with the consequences;
b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not
recur or occur elsewhere, by:
1) reviewing and analysing the nonconformity;
2) determining the causes of the nonconformity;
3) determining if similar nonconformities exist, or could potentially occur;
c) implement any action needed;
d) review the effectiveness of any corrective action taken;
e) update risks and opportunities determined during planning, if necessary;
f) make changes to the quality management system, if necessary.
Corrective actions shall be appropriate to the effects of the nonconformities encountered.
10.2.2 The organization shall retain documented information as evidence of:
a) the nature of the nonconformities and any subsequent actions taken;
b) the results of any corrective action.
This is a good list of actions, if you meet each of these steps, you wont go far wrong.
10.2.1 When a nonconformity occurs, including any arising from complaints, the organization shall:
a) react to the nonconformity and, as applicable:
1) take action to control and correct it;
2) deal with the consequences;
b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not
recur or occur elsewhere, by:
1) reviewing and analysing the nonconformity;
2) determining the causes of the nonconformity;
3) determining if similar nonconformities exist, or could potentially occur;
c) implement any action needed;
d) review the effectiveness of any corrective action taken;
e) update risks and opportunities determined during planning, if necessary;
f) make changes to the quality management system, if necessary.
Corrective actions shall be appropriate to the effects of the nonconformities encountered.
10.2.2 The organization shall retain documented information as evidence of:
a) the nature of the nonconformities and any subsequent actions taken;
b) the results of any corrective action.
This is a good list of actions, if you meet each of these steps, you wont go far wrong.
CAPA is a misleading acronym that should be banned. Correction, corrective action and preventive action are SEPARATE and different actions that cannot be mashed together.
Correction - a nonconformance has occurred. A correction fixes the nonconforming thing in front of you. Correction returns the nonconforming thing to a conforming state; Rework/repair etc. A correction will not prevent the future occurrence of the same nonconformance occuring from the same cause.
Corrective Action - a nonconformance has occurred. An action taken to prevent the future occurrence of the same nonconformance occuring from the same cause. Almost always requires knowledge of the root cause. A good framework for corrective action is 8D. While the 8D can be used to document corrective action it should not be used as a ‘form’ only. It should provide direction and guidance for corrective action…
Prevention - has a different meaning for nonconformances that have occurred (see corrective action above) and for nonconformances that have never occurred (see preventive action below)
Preventive Action - the nonconformance has not yet occurred. There are many actions that are preventative: FMEA, 5S, Lean, most controls like SPC and mistake proofing (which can also be a corrective action if the nonconformance has occurred), preventive maintenance etc.. As such there is no real form required for these types of actions. They are so different from each other that a single form won’t work and collecting all of those actions separately is wasteful.
Correction - a nonconformance has occurred. A correction fixes the nonconforming thing in front of you. Correction returns the nonconforming thing to a conforming state; Rework/repair etc. A correction will not prevent the future occurrence of the same nonconformance occuring from the same cause.
Corrective Action - a nonconformance has occurred. An action taken to prevent the future occurrence of the same nonconformance occuring from the same cause. Almost always requires knowledge of the root cause. A good framework for corrective action is 8D. While the 8D can be used to document corrective action it should not be used as a ‘form’ only. It should provide direction and guidance for corrective action…
Prevention - has a different meaning for nonconformances that have occurred (see corrective action above) and for nonconformances that have never occurred (see preventive action below)
Preventive Action - the nonconformance has not yet occurred. There are many actions that are preventative: FMEA, 5S, Lean, most controls like SPC and mistake proofing (which can also be a corrective action if the nonconformance has occurred), preventive maintenance etc.. As such there is no real form required for these types of actions. They are so different from each other that a single form won’t work and collecting all of those actions separately is wasteful.
CAPA is a hold over term from versions of ISO 9001 prior to the 2015 version. It means corrective action preventive action. The very term CAPA lead to merging them together which was NEVER the intent of the writers of the standard.
Corrective action and Preventive action were next to each other, written in a parallel manner, and corrective action used the term prevent in it. Many felt that preventive action was the end of corrective action when you determined how to prevent the problem from returning. It was not. It was still part of the corrective action.
To clarify the difference, corrective actions are incident control. It was what you do after a negative event to resolve it. Preventive action is what you do to a POTENTIAL problem to keep it from happening.
Corrective action is reactive while preventive action is proactive.
When the 2015 version was introduced, Nigel Croft, the chairman of TC-176 (the committee that writes the ISO 9001 standard), explained that preventive action had not lived up to its mission.
So the writers quit using the term preventive action. Risk replaced it. They also separated the two, moving risk up toward the front of the standard it its own section (well OK, it is shared with opportunity and quality objectives).
Unfortunately, the term CAPA is so entrenched that it may never completely go away.
Corrective action and Preventive action were next to each other, written in a parallel manner, and corrective action used the term prevent in it. Many felt that preventive action was the end of corrective action when you determined how to prevent the problem from returning. It was not. It was still part of the corrective action.
To clarify the difference, corrective actions are incident control. It was what you do after a negative event to resolve it. Preventive action is what you do to a POTENTIAL problem to keep it from happening.
Corrective action is reactive while preventive action is proactive.
When the 2015 version was introduced, Nigel Croft, the chairman of TC-176 (the committee that writes the ISO 9001 standard), explained that preventive action had not lived up to its mission.
So the writers quit using the term preventive action. Risk replaced it. They also separated the two, moving risk up toward the front of the standard it its own section (well OK, it is shared with opportunity and quality objectives).
Unfortunately, the term CAPA is so entrenched that it may never completely go away.
This is my nomination in the category of "Understatement of the Decade, Quality division".
I struggle (daily) with trying to drive peers/reports/organization towards a more mature (in the organizational sense) set of behaviors; one of the foundational (inertial?) artifacts that I feel works against me is when there is no recognizable difference between corrective action and preventive action. Once there is no daylight between CA and PA (in understanding or implementation) it is only a matter of time before an organization slips into VERY dangerous modes of thinking; in particular I have observed that once a (nominally) "defined" quality system begins to treat CA and PA the same, there develops a strong desire to treat every non-conformance (no matter if it falls within well-predicted failure rates, or is attributable to a single, specific cause) as worthy of inclusion in a CA process. I see this as backsliding towards a reactionary approach, which I abhor. YMMV.
The final bit of @Bev D post is what I see as the reason why so many organizations struggle with the difference between CA and PA. Both CA and PA require critical thinking, but any individual PA is only rarely going to look like any other PA... in implementation. Too many folks with "quality" in their title are uncomfortable when one thing doesn't look like something else. It is a (poorly motivated, IMO) desire to avoid discomfort that leads to rigidity of thought (stifling critical thinking) and eventually "cut-and-paste" approaches to problems (e.g. cargo cult-like "solutions").
Preventive action is meant to happen before the work thereby making corrective action unnecessary as in “fail to plan and you’re planning to fail”.
So, most preventive action is a consequence of planning. Planning includes risk assessment and the removal of root causes of undesired risks. Your process-based management system may specify enough preventive action to make it a normal everyday part of work.
Your system may also require the collection, analysis and use of data to further improve action to prevent the occurrence of nonconformity.
Preventive action is meant to be the norm but occasionally root causes of nonconformity persist thereby making corrective action necessary, such as doing a better job of service design to keep your promises.
So, most preventive action is a consequence of planning. Planning includes risk assessment and the removal of root causes of undesired risks. Your process-based management system may specify enough preventive action to make it a normal everyday part of work.
Your system may also require the collection, analysis and use of data to further improve action to prevent the occurrence of nonconformity.
Preventive action is meant to be the norm but occasionally root causes of nonconformity persist thereby making corrective action necessary, such as doing a better job of service design to keep your promises.
In many cases what we see as preventive action is actually a correction of poor process design.
And planning is part of process design.
My point was that the line between preventive and corrective is often blurred. Planning is a part of everything. Sometimes overlooking something that's not immediately obvious is not evidence of failure to plan, although it might be a failure of the planning.
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