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

Baldrick

Noooooo!!!!

Hi Rajeeva, :)

Sorry to keep restating this, but No.3 in your example is NOT preventive action - it is CORRECTIVE ACTION IMPACT.

Preventive action can ONLY be taken to prevent something which has NOT YET HAPPENED! All 3 of the steps you define are done in relation to an ACTUAL NONCONFORMITY. This means they are all part of CORRECTIVE ACTION.

Here are the relevant clauses (from TS16949):

8.5.2 Corrective action

The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformities encountered. A documented procedure shall be established to define requirements for

a) reviewing nonconformities (including customer complaints),
b) determining the causes of nonconformities,
c) evaluating the need for action to ensure that nonconformities do not recur,
d) determining and implementing action needed,
e) records of the results of action taken (see 4.2.4), and
f) reviewing corrective action taken.

8.5.2.3 Corrective action impact

The organization shall apply to other similar processes and products the corrective action, and controls implemented, to eliminate the cause of a nonconformity.

8.5.3 Preventive action

The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems.

A documented procedure shall be established to define requirements for

a) determining potential nonconformities and their causes,
b) evaluating the need for action to prevent occurrence of nonconformities,
c) determining and implementing action needed,
d) records of results of action taken (see 4.2.4), and
e) reviewing preventive action taken.


Here are some definitions - note the final statement, which I cannot stress enough. "Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence.":

Correction (ISO9000:2000 3.6.6)

Action to eliminate a detected nonconformity. A correction can be made in conjunction with a corrective action. A correction can be, for example, rework or regrade.

Corrective Action (ISO9000:2000 3.6.5)

Action to eliminate the cause of a detected nonconformity or other undesirable situation. There can be more than one cause for a nonconformity. Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence. There is a distinction between correction and corrective action.

Corrective Action Impact (ISO TS 16949:2002 8.5.2.3)

Application of corrective action to other similar processes and products to eliminate the cause of a nonconformity.

Preventive Action (ISO9000:2000 3.6.4)

Action to eliminate the cause of a potential nonconformity or other undesirable potential situation. There can be more than one cause for a potential nonconformity. Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence.
 
Elsmar Forum Sponsor

Rajeeva

Quality Manager, CMQ/OE, CQA
Re: Noooooo!!!!

Baldrick said:
Hi Rajeeva, :)

Sorry to keep restating this, but No.3 in your example is NOT preventive action - it is CORRECTIVE ACTION IMPACT.

Preventive action can ONLY be taken to prevent something which has NOT YET HAPPENED! All 3 of the steps you define are done in relation to an ACTUAL NONCONFORMITY. This means they are all part of CORRECTIVE ACTION.

Here are the relevant clauses (from TS16949):

8.5.2 Corrective action

The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformities encountered. A documented procedure shall be established to define requirements for

a) reviewing nonconformities (including customer complaints),
b) determining the causes of nonconformities,
c) evaluating the need for action to ensure that nonconformities do not recur,
d) determining and implementing action needed,
e) records of the results of action taken (see 4.2.4), and
f) reviewing corrective action taken.

8.5.2.3 Corrective action impact

The organization shall apply to other similar processes and products the corrective action, and controls implemented, to eliminate the cause of a nonconformity.

8.5.3 Preventive action

The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems.

A documented procedure shall be established to define requirements for

a) determining potential nonconformities and their causes,
b) evaluating the need for action to prevent occurrence of nonconformities,
c) determining and implementing action needed,
d) records of results of action taken (see 4.2.4), and
e) reviewing preventive action taken.


Here are some definitions - note the final statement, which I cannot stress enough. "Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence.":

Correction (ISO9000:2000 3.6.6)

Action to eliminate a detected nonconformity. A correction can be made in conjunction with a corrective action. A correction can be, for example, rework or regrade.

Corrective Action (ISO9000:2000 3.6.5)

Action to eliminate the cause of a detected nonconformity or other undesirable situation. There can be more than one cause for a nonconformity. Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence. There is a distinction between correction and corrective action.

Corrective Action Impact (ISO TS 16949:2002 8.5.2.3)

Application of corrective action to other similar processes and products to eliminate the cause of a nonconformity.

Preventive Action (ISO9000:2000 3.6.4)

Action to eliminate the cause of a potential nonconformity or other undesirable potential situation. There can be more than one cause for a potential nonconformity. Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence.

No, Sir,

I think you have not interpreted my statement properly. What I am saying is when the lessons learnt/ effective corrective action implemented at one location/ site/ section will become preventive action at another location/ site/ section if this incident has not occured at that location/ site section so far.

Let me put this way!

Say, Mr. X has a three year old son. One day the kid fell ill and the father took him to a doctor. Doctor gave some tablets and cured him(1). When the kid fell ill again, doctor has suggested him to go for vaccination. After providing vaccination, kid did not fell ill(2).

When Mr. X became father of a second child, with his experience on his first kid illness, he went to the doctor and provided vaccination to the second child(3).

If you analyze this, 1 - is the remidial action, 2 is the corrective action and 3 is the preventive action.

Still you don't agree!!!

Regards,

Rajeev
 
B

Baldrick

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

Hi Rajeeva,

No - I don't agree, and the definitions in ISO9000 don't agree!!! :)

Applying the learning from a nonconformity - even at different sites - is NOT preventive action.

What you describe is CORRECTIVE ACTION IMPACT!!!

Honestly, it really is!!!

Here is the clause again:

8.5.2.3 Corrective action impact
The organization shall apply to other similar processes and products the corrective action, and controls implemented, to eliminate the cause of a nonconformity.

PLEASE read the standard and explain why this clause doesn't cover what you are talking about!!!

Best regards,

Alex

P.S. You are not alone in not quite grasping this - earlier in this thread LOTS of people defined PA in the same way as you have.
 

Rajeeva

Quality Manager, CMQ/OE, CQA
Re: Corrective Action (CA) and Preventive Action (PA) - One or Two Procedures?

Baldrick said:
Hi Rajeeva,

No - I don't agree, and the definitions in ISO9000 don't agree!!! :)

Applying the learning from a nonconformity - even at different sites - is NOT preventive action.

What you describe is CORRECTIVE ACTION IMPACT!!!

Honestly, it really is!!!

Here is the clause again:

8.5.2.3 Corrective action impact
The organization shall apply to other similar processes and products the corrective action, and controls implemented, to eliminate the cause of a nonconformity.

PLEASE read the standard and explain why this clause doesn't cover what you are talking about!!!

Best regards,

Alex

P.S. You are not alone in not quite grasping this - earlier in this thread LOTS of people defined PA in the same way as you have.
Hi,

Thanks for the clarification. You have used the reference from the standard I am not familier with. Corrective Action Impact (ISO TS 16949:2002 8.5.2.3)

Rajeev
 

Peter Fraser

Trusted Information Resource
Re: Corrective Action (CA) and Preventive Action (PA) - One or Two Procedures?

Rajeeva said:
Hi,

Thanks for the clarification. You have used the reference from the standard I am not familier with. Corrective Action Impact (ISO TS 16949:2002 8.5.2.3)

Rajeev
What (avoidable) confusion! I haven't read TS 16949:2002, and seeing this definition from it I will leave it that way. How does this help anyone who is already struggling to work out why ISO9000 defines CA and PA separately?

"The organization shall apply to other similar processes and products the corrective action, and controls implemented, to eliminate the cause of a nonconformity." How do they define "similar"? If the NC didn't occur in the "similar process" - which by the definition it didn't - why is it not PA for this other process? Why introduce another term? Adding more words to a definition or procedure can often introduce more contradiction and confusion rather than it solves.

What if something went wrong in one process because it was not planned and defined in enough detail, or staff training had been neglected, or lessons hadn't been learned from previous instances of the process? Does it mean that improving any another process by addressing any of these factors ceases to be PA?

Once you have either (i) found a problem or (ii) realised that there is a risk of a problem, you need to respond by changing a process / giving training / allocating resources....

The trigger is different, but the action you take is the same. Identify a risk, and take action to mitigate it.
 
R

Rezzi

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

Hi all,
we have only one procedure. In the forms we do not point out whether the action is corrective or preventive. Our registrar (BSI) didn't like the idea at the beginning but when I pointed out that our people (and myself) gets confused from time to time regarding the nature of the action, he accepted our procedure.

So I believe the way that works for you and your company is properly the best way
 

Ajit Basrur

Staff member
Admin
Re: Corrective Action (CA) and Preventive Action (PA) - One or Two Procedures?

Seeing the confusion prevailing amongst us between CA and PA, I would keep my procedures seperate to avoid confusions amongst our employees. :cool:

Both of my procedures are seperate with illustrations provided as examples.
 
J

jhoniegudel

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

I think it must be in separate procedure, because the difference between Corrective Action and Preventive Action.
Corrective Action : action taken to eliminate the cause of nonconformities in order to prevent reocurrence
Preventive Action : action taken to eliminate the cause of potential nonconformities in order to prevent their occurence.

jhoniegudel/GKD
 

Helmut Jilling

Auditor / Consultant
Re: Corrective Action (CA) and Preventive Action (PA) - One or Two Procedures?

I think it must be in separate procedure, because the difference between Corrective Action and Preventive Action.
Corrective Action : action taken to eliminate the cause of nonconformities in order to prevent reocurrence
Preventive Action : action taken to eliminate the cause of potential nonconformities in order to prevent their occurence.

jhoniegudel/GKD

Your post just described the difference in two short sentences. The difference is only a few words. But you feel that makes it be two different procedures.

Either one or two is OK, but I am curious.
 
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