SBS - The best value in QMS software

Preventive Action (PA) and Corrective Action (CA) - One or Two Procedures?

One procedure or two

  • One procedure

    Votes: 64 54.7%
  • Got one, changing to two

    Votes: 8 6.8%
  • Two procedures

    Votes: 44 37.6%
  • I need more than two for my system (OUCH!!)

    Votes: 1 0.9%

  • Total voters
    117
Status
Not open for further replies.
B

betterlife

asutherland said:
Does CA occur, If the process was followed correctly?
If PA is taking place, why does CA need to happen?
Nice questions. I believe that no system can guarantee zero nonconformities.

It is no doubt expected that the process will be followed correctly, but there are many variables - the process itself, its interaction with other processes, understanding of the concerned personnel, application and monitoring of process controls, determining of process trends etc. Any one of them can vary and might affet the process.

Taking PA ceertainly helps in preventing occurrence of NC, but here again there may be situations which have not been identified. Regarding those identified, the important factor is whether all aspects of the potential problem have been considered and effective actions taken for prevention.
 
Elsmar Forum Sponsor

Manix

Get Involved!!!
Trusted Information Resource
One, for sure. Corrective action is reactive and therfore is to correct a prior mistake or issue. Preventative is proactive, concetrates on ensuring the issue does not occur again.

Would you not find that if you keep the two separate, you loose the inherent link which is so important. You may perform corrective action but not then prevent the issue occuring again. Visa versa, you may prevent an occrurence without considering what is required in the short term!?

I think Automotive has this one down to a T with the 8D procedure (not sure if it is correct to call it an automotive procedure!), which never fails us and is flexible enough to be used internally and externally.

Any thoughts?
 

Helmut Jilling

Auditor / Consultant
Manix said:
One, for sure. Corrective action is reactive and therfore is to correct a prior mistake or issue. Preventative is proactive, concetrates on ensuring the issue does not occur again.

Would you not find that if you keep the two separate, you loose the inherent link which is so important. You may perform corrective action but not then prevent the issue occuring again. Visa versa, you may prevent an occrurence without considering what is required in the short term!?

I think Automotive has this one down to a T with the 8D procedure (not sure if it is correct to call it an automotive procedure!), which never fails us and is flexible enough to be used internally and externally.

Any thoughts?

I agree that it can be one procedure, which I commonally see. And I agree that the Automotive (Ford) 8D is a very good tool. However, step 7, referred to as the "Prevent" step is intended as a "Permanent step" - such as a change to the system documentation or training. It is not intended to serve as a "Preventive Action" as described by ISO/TS cl 8.5.3.

(Actually, in this regard, I think the GM PRR 5 step process is more clear.)

If you review the ISO definitions for Corrective and Preventive Actions, Preventive are to prevent the cause from occuring in the first place. Preventing it from "occuring again" is actually the definition for Corrective Action.

It is not a big deal, as APG points out, but there is a lot of confusion about this, including on this forum. I hesitate to even bring it up again, however, more and more auditors are beginning to understand the distinction, and the RAB and IAOB witness auditors are beating it up.

The more important thing is that the "root cause" of a problem, or potential problem, has been eliminated and thus the situation will not occur.

I'm just trying to help clarify this continuing confusion between the two tools. Similar, but different. Reactive vs. proactive.

I would disagree with the comment about the "inherent link." They are not linked, one does not feed into the other, they are actually opposite sides of the problem solving coin.
 

Manix

Get Involved!!!
Trusted Information Resource
hjilling said:
I would disagree with the comment about the "inherent link." They are not linked, one does not feed into the other, they are actually opposite sides of the problem solving coin.
OK i take on board the ISO definition, but is it not true, that a non-conformance may require "Corrective Action" to imediately correct yet this corrective action may not prevent further occurances?

I think it maybe because I use the 8D procedure so much, but I have just had a non conformance on an audit, that required one action to correct yet a different action to prevent future occurances!
 

Peter Fraser

Trusted Information Resource
Manix said:
OK i take on board the ISO definition, but is it not true, that a non-conformance may require "Corrective Action" to imediately correct yet this corrective action may not prevent further occurances?
Absolutely not! But the problem is in the (ISO) terminology. "Correction" is what is required at once (ie to fix what is wrong) followed by "corrective action" to avoid the risk of it happening again. So many people get confused by the wording that it makes you think that ISO9000 should have put it another way.

Essentially, "something having gone wrong" is what triggers CA, and "you realising that something might go wrong (but it hasn't happened yet)" triggers PA. The process is the same, it is just the trigger that is different. So why does ISO make it confusing???

1 A problem has arisen, so fix it ("correction")
2 A problem might arise, so avoid it (whether it has happened before or not) ("CA" or "PA")

For both CA and PA, the key is to identify and assess the risk, and take steps to mitigate it.
 

Helmut Jilling

Auditor / Consultant
Manix said:
OK i take on board the ISO definition, but is it not true, that a non-conformance may require "Corrective Action" to imediately correct yet this corrective action may not prevent further occurances?

I think it maybe because I use the 8D procedure so much, but I have just had a non conformance on an audit, that required one action to correct yet a different action to prevent future occurances!

The immediate (corrective) action is very important, and is generally referred to as containment. The semantics don't really matter, of course, but this immediate action is more oriented to stopping the bleeding, but generally doesn't prevent the root cause from reoccurring.

I strongly support the idea that the terms and titles are not near as important as actually doing the investigations and actions. But it doesn't hurt to know what the various component parts are of corrective actions and preventive actions.
 
T

tristan

hjilling said:
I strongly support the idea that the terms and titles are not near as important as actually doing the investigations and actions. But it doesn't hurt to know what the various component parts are of corrective actions and preventive actions.
hello guys, would this be the right place to discuss 8D versus DMAIC (6-sigma)? which is better, in the context of SMEs new to ISO?
 

Manix

Get Involved!!!
Trusted Information Resource
Thanks guys,

I have more insight now into these terms, and it is clear that the 8D has clouded things a little by following PA after CA.

So PA is a before the event and CA is a reaction after the event. You could almost say that CA comes in two forms:

Immediate CA (Stopping the bleeding as it was put)

Long Term CA (Ensuring the bleeding does not occur again)

Whereas PA should be seen as something that anticipates the event of bleeding, identifies the potential causes of this event and takes action.

Although I agree that the actual terms are not as important as the actions taken, I do feel that is these terms are going to be used in ISO standards, then they should have very clear and meaningful definitions, clearly, these terms have differing meanings to different people, as this thread suggests!
 

CarolX

Super Moderator
Super Moderator
Intent of this thread

tristan said:
hello guys, would this be the right place to discuss 8D versus DMAIC (6-sigma)? which is better, in the context of SMEs new to ISO?
Hi tristan,

The best thing would be to start a new thread. The original intent of this thread (started by yours truly) was to poll users as to how CA and PA were addressed procedurally.

Some great discussions have been had through the years (this thread goes back to 2003) and has lots of great information. But if you want a discussion of your particular subject, just start a new thread.
 

Helmut Jilling

Auditor / Consultant
Manix said:
Thanks guys,

...you could almost say that CA comes in two forms:

Immediate CA (Stopping the bleeding as it was put)

Long Term CA (Ensuring the bleeding does not occur again)

Although I agree that the actual terms are not as important as the actions taken, I do feel that if these terms are going to be used in ISO standards, then they should have very clear and meaningful definitions, clearly, these terms have differing meanings to different people, as this thread suggests!


The Immediate CA is often called Containment or Short Term CA. It is a very important part of the 8D format, but for some reason, ISO does not specifically require it.

The official ISO definitions are pretty clear between CA and PA, but some old dogs don't want to accept the definitions as written. That is what leads to differing opinions, IMO.

You've got it, however!
 
Status
Not open for further replies.
Thread starter Similar threads Forum Replies Date
L Separate Corrective Action and Preventive Action Procedures ISO 13485:2016 - Medical Device Quality Management Systems 13
R Non conformance (NC) or Corrective & Preventive action (CAPA) CE Marking (Conformité Européene) / CB Scheme 7
B Stakeholder Initiated Corrective and Preventive Action Misc. Quality Assurance and Business Systems Related Topics 5
B Corrective and Preventive Action (CAPA) A Key Process of the Quality Management System Dec 17... Training - Internal, External, Online and Distance Learning 0
J If Corrective and Preventive Action were truly Effective IATF 16949 - Automotive Quality Systems Standard 3
K CAPA (Corrective and Preventive Action) - ISO 13485 Nonconformance and Corrective Action 1
J Software and Methods for Tracking CAPA (Corrective and Preventive Action) items US Food and Drug Administration (FDA) 3
A Preventive Action or Corrective Action - Paper cuts Nonconformance and Corrective Action 14
M Corrective and Preventive Action - Prevent Recurrence is not Preventive Action? Nonconformance and Corrective Action 24
K Definition Correction, Corrective Action and Preventive Action - Definition of terms Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 28
F Software recommendations for corrective and preventive action Quality Assurance and Compliance Software Tools and Solutions 2
K Corrective and preventive action for Non Conformance on PFMEA FMEA and Control Plans 30
W Compliance to 8.5.2 Corrective action 8.5.3 Preventive action ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
T Corrective Action and Preventive Action in a Holding Company Nonconformance and Corrective Action 6
M What is Preventive Action taken as part of a Corrective Action? Nonconformance and Corrective Action 5
C The prudence of combining non-conformance reports with corrective/preventive action Nonconformance and Corrective Action 10
N Corrective and Preventive Action in 8D Problem Solving Nonconformance and Corrective Action 21
D CAPA (Corrective and Preventive Action) Flow Chart example wanted Preventive Action and Continuous Improvement 3
J Can Corrective Action be the same as Preventive Action? Nonconformance and Corrective Action 33
sagai Preventive Action vs. Corrective Action as defined by 21CFR820 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
C Nonconformance, Corrective and Preventive Action Procedure(s)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
Q Recommendations for criteria on creating a CAPA (Corrective and Preventive Action) ISO 13485:2016 - Medical Device Quality Management Systems 8
L How to deal with too many CARs (Corrective Action Requests), PARs (Preventive Action) Nonconformance and Corrective Action 25
N Combining both Corrective Action and Preventive action procedures into one SOP Nonconformance and Corrective Action 4
sagai Should Corrective Action be segregated from Preventive Action? ISO 13485:2016 - Medical Device Quality Management Systems 10
B Electronic Corrective/Preventive Action Report for our Customer Service Department Nonconformance and Corrective Action 9
B Corrective and Preventive Action Procedure for Customer Service Nonconformance and Corrective Action 5
Q Recover a Damaged CAPA (Corrective and Preventive Action) Project Preventive Action and Continuous Improvement 6
P FDA Part 820 Clause 820.100 Corrective and Preventive Action 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
C Corrective Action and Preventive Action for Operator Error (Cosmetic - Handling) Preventive Action and Continuous Improvement 15
B Questions regarding Non-Conformance, Corrective Action and Preventive Action ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
E CAPA (Corrective and Preventive Action) Plan Templates Nonconformance and Corrective Action 5
M CAPA (Corrective and Preventive Action) Standards & Templates for Tier 1 Supplier IATF 16949 - Automotive Quality Systems Standard 4
kedarg6500 Horizontal Deployment of Corrective Action - is it Preventive Action? Nonconformance and Corrective Action 21
W Are CAPAs (Corrective Action Preventive Action) Input or Outputs ISO 13485:2016 - Medical Device Quality Management Systems 6
Q CAPA (Corrective Action and Preventive Action) after Correction always? Nonconformance and Corrective Action 10
Q CAPA (Corrective Action Preventive Action) NC recommended for IT, HR, ACC.? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Icy Mountain Continual Improvement, Preventive Action and Corrective Action Database Quality Tools, Improvement and Analysis 23
Q Calibration Failure - CAPA (Corrective and Preventive Action) General Measurement Device and Calibration Topics 3
P When is an issue a CAPA (Corrective and Preventive Action) request? Nonconformance and Corrective Action 6
C FDA - CAPA (Corrective Action and Preventive Action) & Complaint Database 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Suggestions for a CAPA (Corrective and Preventive Action) Software Program Quality Assurance and Compliance Software Tools and Solutions 17
Q CAPA (Corrective and Preventive Action) Guidance Needed 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Issue Tracking and CAPA (Corrective and Preventive Action) Management Nonconformance and Corrective Action 6
N Nonconformance and Corrective Actions vs. Preventive Action - Problem Supplier Nonconformance and Corrective Action 24
A When to take Corrective / Preventive Action and Continuous Improvements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Q Corrective and Preventive Action (CAPA), 820.100 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
W Corrective Action, not Preventive Action? Nonconformance and Corrective Action 10
V CAR (Corrective Action Request) vs. PAR (Preventive Action Request) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
D CAPA (Corrective Preventive Action) Form for critique ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8

Similar threads

Top Bottom