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.
L

Laurie Anderson

jaimezepeda said:
We have 2 procedures where I get paid.

I understand that a preventive action does exactly that, it prevents something from happening. Also, I understand that a corrective action does just that, it corrects what caused something to go wrong so it does not happen again.

But then again, many have already pointed this out.

Jaime

Jaimie,

Come again !

Seems you have preventive action and a preventive action that you have called corrective.

Please Correct me if I am wrong .

Laurie
 
Elsmar Forum Sponsor
Q

qualitytrec

Continual Improvement includes corrective action, prventive action, increases in efficiencies and decrease in inefficiencies. Being that the standard requires us to establish measurables (quality objectives) the efficiencies/inefficiencies could be considered part of the CA/PA if you want to concider the parties involved as internal customers.
Corrective action is reactive to a "problem" that has occured and does involve preventing it from happening again, but this prevention is not the same prevention of the PA requirement. It is corrective because it should not have happened and did so you have to fix it.
Preventive action means proactive when there is the potential for a "problem" and you "fix" or put something in place before their is a problem. For example a preventive maintenance program for tooling, benchmarking industry practice, poka yoke might be used. Prevention is based on knowledge and lessons learned in similar areas.
The line between the two seems to be if it has gone wrong yet or not. On an audit it would be the difference between a Nonconformance(major or minor) and a concern.
At least this is how I understand it and I think I am right ;p
:lol:
Mark
 

Wes Bucey

Prophet of Profit
How about this for an analogy between corrective and preventive:
  1. You drive a car until the tires wear out and go flat, so your car won't function.
  2. You replace the tires AFTER they are flat - CORRECTIVE ACTION
  3. You examine the tires on a regular basis and replace the tires AT YOUR SCHEDULE so you are never inconvenienced by the car being unable to function at an inconvenient or inappropriate time - PREVENTIVE ACTION
The failure or "nonconformance" in this example is not the tire, but the function of the automobile.

In a manufacturing scenario, think of replacing tool bits BEFORE they break (PREVENTIVE), versus AFTER they break (CORRECTIVE). The nonconformance we prevent is the nonconformance of a spoiled production piece, which in some cases is worth much more than the tool bit.
 

RoxaneB

Super Moderator
Super Moderator
Laurie Anderson said:
Seems you have preventive action and a preventive action that you have called corrective.

Please Correct me if I am wrong .
It's not a question of right or wrong - although the debate on the difference between the two terms might indicate otherwise - but rather interpretation. I believe that many of us go by the definitions located in ISO 9000:2000

Let's use Wes's example of the car...

Wes Bucey said:
You drive a car until the tires wear out and go flat, so your car won't function.
You replace the tires AFTER they are flat - CORRECTIVE ACTION
You examine the tires on a regular basis and replace the tires AT YOUR SCHEDULE so you are never inconvenienced by the car being unable to function at an inconvenient or inappropriate time - PREVENTIVE ACTION
When your car's tires go flat, obviously you will fix or replace them. However, is that all you do? Do you simply purchase new tires, install them and drive away satisfied that you have done all that you needed to do? No. You want to know WHY the tires went flat. This is called root cause analysis. Why determine the root cause???? To ensure that the problem will not happen AGAIN.

By identifying the root cause of the tires going flat, you can take suitable actions beyond simply replacing the tires. You can avoid driving through that construction zone on your way to work, ladened with sharp stones and metal scraps that punctured your tire in the first place. You are eliminating (by finding an alternate route) the cause (metal scraps and sharp stones) of a detetected nonconformity or undesirable situation (flat tire).

Preventive action means taking action to eliminate (by taking a different route to work) the cause (metal scraps and sharp stones) of a potential nonconformity or other undersirable potential situation (flat tire). In other words, we hear on the radio in the morning that our normal route is under heavy construction and we decide to take an alternate route so the possibility of a flat tire is negated.

Perhaps part of the problem lies in how many of have been defining Corrective Action - we include the phrase "...prevent the problem from happening again." The use of the work "prevent" automatically makes some people think that a detected nonconformity can be both a Corrective and Preventive situation. Using the word "elimate" may help to lessen the confusion or better explain our interpretation of the difference between the two terms.
 
J

jaimezepeda

Laurie Anderson said:
Seems you have preventive action and a preventive action that you have called corrective.

Please Correct me if I am wrong .

Laurie
Laurie

I understand a preventive action keeps something from happening AT ALL in the first place.

I understand that anything you do to avoid something, that has already happened, from happening again is a corrective action.

It's like trying to step inside a room you are already in. It's impossible.

I understand that preventive actions are measures taken to prevent a potential nonconformance from happening at all.

Once the nonconformance takes place you can no longer prevent it. You can only correct it.

Jaime
 
L

Laurie Anderson

My Last Words

Hi guys & gals

I agree with some of the definitions that some of you are stating and some are strictly to the standard, ISO 9000 etc.

Corrective Action is taken as a result of a Non conformance to correct what HAS happened.

Root Cause Analysis is obvious, and yes this is part of “Control of Non Conforming Material or Product”. This action is noted on the Non Conformance Report.

When this is established (the cause) there is then, as we operate, a Preventive Action taken so it does not recur. This is in line with Wes’s “flat tire analogy”. The Preventive action here was as a result of the flat tire regardless that the non conformance was the car function. But then there’s the piece with the tool bit. Same thing. All very well to replace tool bits before they break. How do you determine when it is time to replace the tool bits. I guess it is from experience of having them break after a certain number of operations and thus resulting in non conformances. I guess there are still those of you who would argue otherwise. So be it !

Preventive Action is taken to prevent a Non conformance from happening, whether it is a result of a Root Cause Analysis (prevent recurrence) or where there is a perceived potential for a non conformance.

Corrective Action as a result of a Non Conformance being raised and cleared as to disposition.

Preventive Action as a result of a Change Request being raised and a procedure / work instruction or other document (i.e. drawing) being changed.

There is also those who come up with totally localised terminologies with their own definitions to try and clear the muddy waters. This only serves to colour the mud and does nothing to make things any clearer.

If you guys out there are just looking to complicate things, go right ahead. You are certainly doing a good job. The way in which we handle it here, works. Our auditor is happy, we are happy and the end result is achieved. I now understand why a certain very cool person actually lost it in this very forum or was it another of the same subject, some time back.

You can argue the point till you are blue in the face, the bottom line is the actions are taken, they are recorded and they make the Auditor a happy chappy and that is what it is all about.

That is the way we operate and this is the last word from me on the subject !


Laurie
 

Wes Bucey

Prophet of Profit
I interspersed some comments in blue.
Laurie Anderson said:
When this is established (the cause) there is then, as we operate, a Preventive Action taken so it does not recur. This is in line with Wes’s “flat tire analogy”. The Preventive action here was as a result of the flat tire regardless that the non conformance was the car function. But then there’s the piece with the tool bit. Same thing. All very well to replace tool bits before they break. How do you determine when it is time to replace the tool bits. I guess it is from experience of having them break after a certain number of operations and thus resulting in non conformances. I guess there are still those of you who would argue otherwise. So be it !

In fact, there are techniques and technologies to gauge tool bit wear and sensors which attach to tooling to check status of tool bit prior to beginning work on a piece part or to stop a process if a tool bit breaks. Most modern shops doing large volume work or work on large, expensive pieces employ one or more of these technologies. By periodically examining tool bits during a run, amount and cause of wear can be tracked and predicted and bits changed out BEFORE any failure occurs. In addition, causes of wear can be addressed (chatter, feed or rotational speed, lubrication, chip breakage and removal characteristics of bit profile, etc.)

Preventive Action is taken to prevent a Non conformance from happening, whether it is a result of a Root Cause Analysis (prevent recurrence) or where there is a perceived potential for a non conformance. (FMEA?)

Corrective Action as a result of a Non Conformance being raised and cleared as to disposition.

Preventive Action as a result of a Change Request being raised and a procedure / work instruction or other document (i.e. drawing) being changed.
Isn't this covered under "perceived potential for a non conformance"?

There is also those who come up with totally localised terminologies with their own definitions to try and clear the muddy waters. This only serves to colour the mud and does nothing to make things any clearer.
Yep. Sadly, there are lots of folks out there who think Standard is only a word in a title and not a concept of creating a system to compare apples and apples.

If you guys out there are just looking to complicate things, go right ahead. You are certainly doing a good job. The way in which we handle it here, works. Our auditor is happy, we are happy and the end result is achieved. I now understand why a certain very cool person actually lost it in this very forum or was it another of the same subject, some time back.

You can argue the point till you are blue in the face, the bottom line is the actions are taken, they are recorded and they make the Auditor a happy chappy and that is what it is all about.
Is it always the same auditor or do you have to "retrain" new auditors into your way of thinking?

That is the way we operate and this is the last word from me on the subject !

Laurie
It's always nice to have folks willing to express an opinion.
 
Last edited:

E Wall

Just Me!
Super Moderator
Well said Kevin and others. :applause:

We also use one documented procedure to outline both processes with identification and linkage to other initiatives set up by management which also result in corrective or preventive actions (a rose by any other name).

Regarless of any guidance from registrar or consultants each company/organization must evaluate what works best for them. If what someone else would 'Like to see' doesn't work for you - DO NOT DO IT! Just be able to justify sound business reasons for your decision and most will back down.

From my experiences I think there are many unnoticed 'preventive' actions done regularly. As is often the case the paperwork trail and linkage to show improvement is the toughest to provide.

By nature of the focus regarding nonconformances (in either product or processes, they quite obviously get more attention and include supporting documentation).

Actions taken when changing equipment, products, personnel, etc...usually involve multiple run throughs to ensure process runs safely and smoothly producing good product and many efforts will quite naturally go undocumented and often unrealized as preventive actions.

If you have a good company culture and good employees (regarless of position from shop floor to executive office) they will want to work smarter not harder and will add value to the process as they can. Many if you stop and take an interest will tell you "Hey, I changed the way this flows because I saw that _______ might happen and it would _______ (impacting) the product/process".

That's preventive action but quite often isn't enough of a 'WOW' to catch attention and as I said earlier often goes unnoticed.

IMHO this is fine as long as:
1) you identified in personnel training what is critical and cannot be changed without approval (usually well defined between control plan and process and product specs),
2) the person actually has the skills and information to be sure the change won't impact a subsequent process or the product, and
3) communications, at least between all personnel in the process, take place to use best practices across all shifts.

Okay, I'm getting carried away :) which is so easy to do! My appologies all.

My best to all,
Eileen
 
A

amanbhai

we had two seperate procedures under old standard but now under ISO 9001: 2000 we have a single procedure to keep things simple. Main theme is to improvement in the organization. when it is simple it will be easier for floor people & will be encouraged to use it.
 
B

betterlife

In new standard, unlike the old one, corrective and preventive actions are two different clauses. Their intent is also different. In my opinion the sequence should be - corrections, corrective actions, impact of corrective actions, preventive actions. First three are part of corrective action, and the last one is no doubt preventive action.

I will recommend two separate procedures for corrective and preventive actions. Having one procedure for both may confuse the people. Preventive action is not an extension of corrective action. It is an independent process.
 
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