Corrective Action vs. Preventive (Predictive) Action (CAPA) - A Definitive Discussion

Sidney Vianna said:

Are we going round in circles? Hershal, are you suggesting that the solution for this problem is for the PA procedure to identify clauses of the standard such as, for example, 7.3 - Design and Development, as preventive actions?

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Actually, if properly used and implemented, they are PA.....why not bite the bullet and say so? After all, PA is simply trying to find and prevent problems before they become problems.....much of the topics elsewhere in most standards help do that.

That does not mean they are the only PA possible, I am just being prudent here.....calibration, internal audit and management review, training, are all good examples of PA.....maintenance plans, disaster recovery plans, firewalls and anti-virus are examples of PA not usually covered in the various standards.

Hope this explains better.

Hershal

Hershal said:

Actually, if properly used and implemented, they are PA.....why not bite the bullet and say so?

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Thanks. But I don't buy it. Most of the requirements of any quality management system standard are designed to PREVENT problems. What sense would it make it for a standard to require a number of actions/processes to be in place to prevent problems and then, another element of the standard (8.5.3) to list all of these actions already required as preventive actions. It would be totally redundant to say the least...

Just because is preventive (in nature) it does not mean that is preventive (action).

Sidney Vianna said:

Thanks. But I don't buy it. Most of the requirements of any quality management system standard are designed to PREVENT problems. What sense would it make it for a standard to require a number of actions/processes to be in place to prevent problems and then, another element of the standard (8.5.3) to list all of these actions already required as preventive actions. It would be totally redundant to say the least...

Just because is preventive (in nature) it does not mean that is preventive (action).

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So, for example, FMEA wouldn't be considered preventive action? I don't understand the distinction you're making. I think that part of the problem that prevents a definitive (per the thread title) answer is that any action take to prevent something bad from happening is preventive action, and the standard writers beat the language beyond recognition by insisting that some preventive actions aren't preventive actions, all this while no such dichotomy is even necessary. Here's the fix: Change the standard to say,

• Do your best to keep things from going wrong. When you do something in this regard, document it and share it with others who might be facing similar problems.
• When something does go wrong, fix the immediate problem so that the customer is protected from receiving bad stuff, then find out why the bad thing happened, and fix the process so that the likelihood of it happening again is minimized. Document what you did, and share it with others.

There. I covered the intent without ever using the words "corrective," "preventive," or "action." Just write the !@*#& standard in plain English!!!

Jim Wynne said:

Here's the fix: Change the standard to say,

• Do your best to keep things from going wrong. When you do something in this regard, document it and share it with others who might be facing similar problems.
• When something does go wrong, fix the immediate problem so that the customer is protected from receiving bad stuff, then find out why the bad thing happened, and fix the process so that the likelihood of it happening again is minimized. Document what you did, and share it with others.

There. I covered the intent without ever using the words "corrective," "preventive," or "action." Just write the !@*#& standard in plain English!!!

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I like it
What about: Fix before it breaks. If it is broken, fix it and make sure it doesn't break again. Or else.

Sidney Vianna said:

It would be totally redundant to say the least...

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Well, not too many folks claim these Standards are perfect.....

Hershal

Re: Corrective Action vs. Preventive (Predictive) Action - A Definitive Discussion

Rob Nix said:

Hi guys. I've been swamped for months with major projects, effectively keeping me away from this forum. However, just a little while ago (1 hour or so) I received an E-Mail thru Elsmar from Dan Nelson, the author of the article I referenced in this thread, entitled "Correct Me If I'm Wrong".

He took offense at my comments and I'd like to publically apologize to him as I meant no harm. I simply used his article as a springboard regarding popular confusion over the definitions of correction and prevention.

I, in a 'tongue in cheek' manner (as I've been guilty of doing from time to time), answered his article title request, "Correct me if I'm Wrong", with the answer, 'I will because you are'. He said I was mistaken and suggested that others had already pointed that out to me. None had, so I appreciate his belated reproof.

He also found it difficult to believe that I consider myself a Quality Professional, let alone a Quality Director! I find it hard to believe myself sometimes.

Dan has not posted anything to this forum (other than the PM to me), so I hope this reaches him. Otherwise I'll have to go the simple route and reply to his E-Mail.

Actually, the main reason I wanted to post a reply was to get my number of total posts, on this June 6th of '06, off of the number 666. Phew!

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Hi Rob. I don't stop by often, so I didn't notice until just today that you had posted something for my benefit (two years ago!). Sorry for the delay. I accept your apology and offer a (partial) explanation: not only did you baldly assert I was wrong, you "rolled your eyes" at the idea that there was actually a difference between corrective and preventive action. Having no other information about you (beyond your undue criticism), I honesty wondered if you were a quality professional. This issue has caused too much trouble in the ISO 9000 arena, it seems, to be treated so crassly.
Frankly, I wish TC 176 would remove the distinction. As long as organizations are fixing stuff (at their root) and improving as the result of planned actions, who cares if it is corrective or preventive? But the requirements are what they are and if they were properly understood and applied, many related audit findings would go away.
I'm a consultant who has taken scores of organizations through certification to ISO 9001 and associated sector schemes since 1994. Part of the problem with auditors' findings regarding CA/PA is that they themselves did not understand CA/PA properly--to the demise of my clients. It is better now then it was.
But back then--when the article came out--it was common for auditors to explain (errantly), that "a corrective action fixes the problem and preventive action keeps if from happening again." Of course, this errant wisdom requires organizations to engage in preventive actions in the wake of corrective actions. But an effective corrective action already prevents recurrence. Furthermore, preventive action is too late if there has already been a problem. Any actions taken to eliminate the cause of existing problems are corrective actions, while preventive action is plainly not applicable.
Nevertheless, auditors often insisted that corrective actions taken in response to their audit findings needed to be accompanied by preventive actions. Else, their registrars would reject them. This caused my clients to expend resources entertaining nonsensical "requirements." (It also succeeded in assuring us that these auditors did not understand CA/PA, and neither did the registrars for whom they worked.)
Notice too, at the time, that the puffed-up CA process required of the heralded 8D process actually required preventive actions to be taken as a matter of processing corrective action. 8D was wrong, kind of. If corrective action is applicable and effectively implemented, the preventive action section of the form should properly read, "N/A."
The reason the eye rolling brought doubt into my mind as to your knowledge of ISO was because this misunderstanding of the requirement has caused plenty of unnecessary headaches. These types of headaches are alleviated by clarifying the terms and their application. And educating auditors.
I see your apology and raise you one. Sorry, Rob. I was in a bad way. Better now, I regret having replied to you as I did. I hope no hard feelings.

Re: Corrective Action vs. Preventive (Predictive) Action (CAPA) - A Definitive Discus

Hi

Rams definition was the best. All too often people forget that the whole purpose of corrective action is to prevent re-occurance. This terminology often confuses people as they then think "aha, I'm preventing re-occurance...that must be preventive action, right?" Wrong!!

Try never to use the term CAPA (although we always do). It automatically gets you on the wrong foot. In the perfect system, preventive action ought to come first, if it doesn't work you then do corrective action:

So, using Rams example we should have:
PA= Ban smoking and install fire detection & suppression system in house to prevent fire;
The house catches fire
Remedial action = extinguish fire
Corrective action= root cause identified system was not working properly - implement weekly tests and regular servicing of fire system.

The very best strategic PA system you can have is business continuity plans, which should be reviewed six monthly. These should include:
- Supply chain integrity (what happens if your main suppliers go bust)
- Infrastructure integrity ( what happens if your building and stock goes up in smoke)
- Staffing integrity (what if they win the lottery or your RA manager goes under a bus)

The plans should include prevention of the occurence in the first instance and then the corrective action in case disaster hits.
Your management review should include a review of the plans, to make sure they are upto date, in line with business needs and have been effective.

Re: Corrective Action vs. Preventive (Predictive) Action (CAPA) - A Definitive Discus

Hi,

I have been into this rummaging for quite some time. Can u please help me in this regard?

The explanation for Preventive Action somebody says that if an organization has a few branches and the incident happened in one place correction and corrective action is taken, the action taken in another branch is a Preventive action. Somebody denies this.

Can u please help this specific question?

Geetha Radhakrishnan
elsmar--- pargeetha

Re: Corrective Action vs. Preventive (Predictive) Action (CAPA) - A Definitive Discus

Hi,

I have come across varying responses to this situation. Strictly speaking, a group quality registration, covering multiple branches, is one quality system. Thus applying lessons learnt in one branch to another, is still corrective action as you are just preventing it happening again, in another part of the quality system.

However, if you used this method, in addition to other, more strategic examples of preventive action, most registrars wouldn't really raise it as an issue. If this method was your only demonstration of preventive action, then I could see that this would be considered weak.

Hope that helps

Re: Corrective Action vs. Preventive (Predictive) Action (CAPA) - A Definitive Discus

Corrective action: after occurance of the failure.

Preventive action: before occurance of potential failure.