Howdy everyone. I am currenty rewriting our corrective action and preventive action procedures and am thinking of combining them into one written procedure. As long as all the components of both are there and there is everything to support it, does anyone see any problems with combining them and having just one procedure instead of two?

You could, and we all had a similar discussion before, so long as the differences are clearly identified and you dont confuse the two issues.

Why would you want to combine the procedures ?

The general idea going around is to try and simplify everything (we have way too many procedures here). So several people (including management) have mentioned combining the two. And everyone knows how things go once management gets an idea. :p

The reason I ask is because, as you know, both actions stem from different sources, and require different methods - so the actual procedures are not that similar (in my opinion).

That's one thing I've been working on, but the progress is slow. I'm trying to explain the difference between corrective and preventive action to management. They feel that corrective actions can be used as preventive actions as well since they prevent the problem from happening again. It's a vicious cycle. :frust:

I think if I keep the two actions seperate in the procedure, I should be able to keep them seperated and clearly defined. If not, I'll have to convince people to change their mind. :bonk:

I did this in a previous job and didn't have any problem. I had them exist as totally different sections, and included a clear definition for each, including the triggers for each.

While there have been tons of discussion between CA and PA, I have not seen anything that can help with writing a PA procedure. There are a lot of opinons as to what it is, some very argumentative, but nothing as concrete as a sample download for study. Even the Premium Files here at the Cove touch very lightly on the subject. I want to combine the two because I do not believe an auditor has the absolute proof that what I call Preventive is actually Corrective, or vice versa. My interviews with potential Registrars deliberately asked for what would be the difference. I came away with the feeling that only here in these discussions do we see such insistance that they are totally different. It's a gray area. There are those that say if I have a corrective action for one thing and I look at all different product for the potential of that thing, it is merely an extension of my original corrective action. Then there are those that say Management Review can be classified as preventive action because we look at trends and define actions. Quite honestly, I do not know conclusively what is a Preventive Action. Here's my thought: I go out into the manufacturing areas and look around and invent a preventive action to satisfy that clause. Like, I recommend that all the toolboxes have new wheels put on them because a worn wheel may cause a tool box to tip over and damage personnel or product. I look at the ceiling and have someone inspect it to make sure all the corners and joints are sound. I could do that all day long. All good manufacturing practices are Preventive in nature and I find it difficult to take this clause as something new. If one were to list all the things a company does, a case can be made that they are mostly Preventive. Now, let's mention effectiveness. Well, the roof stayed on, toolboxes remained upright, etc.. Things never happened so we must be effective. When they do, we have Corrective action. Egads.:bonk: :ko: :smokin:

Yes energy.

We talked on this very subject a while back, and I suggested just bullet pointing everything you do in your QMS as preventive action, as the old 1994 standard stated that was what ISO9001 was all about.

I still have not heard a good argument for not doing that (other than it is a bit of a waste of paper). If PA is analysing trends and taking action then we already do that under the Measure, Monitor, Analyse and Improve section of the standard. If its considering all things before we do anything then it is part of quality planning, where tools like FMEA might be used. It is just not a stand alone clause that needs a procedure - in my very humble opinion.

M Greenaway said:

Yes energy.

We talked on this very subject a while back, and I suggested just bullet pointing everything you do in your QMS as preventive action, as the old 1994 standard stated that was what ISO9001 was all about.



M. There's a few threads where this thing has been produced some strange interpretations. See

http://Elsmar.com/Forums/showthread.php?s=&threadid=2654&perpage=15&pagenumber=2

This topic is worth doing a search on. We have bantered this one around for the past several years. I am amazed at how many variations we get on preventive actions!!

5.2 Preventive Action

5.2.1 Preventive Action shall be initiated when opportunities are identified to
determine potential causes of nonconformities relating to the product, process or
Quality Management system. Sources of information include:

— Quality trends including concessions (deviations) and scrap/rework.
— Internal and external audit findings.
— Customer complaint trends.
— Concerns about suitability or effectiveness of the Quality Management
System.
— Supplier or Subcontractor quality, delivery or service trends.
— Other product quality measures.

5.2.2 Preventive Action plans are primarily proposed through the system of
inspection/verification points and addressed through the Corrective Action System; however, the primary means of identifying preventive action opportunities are the management review meetings and analysis of company data.

:ko: :smokin:

Energy -- Where did that come from???

Jim and Mike,

The 5.1 and 5.2 are merely numbers in our procedures. All the procedures start with 5.0. Like 1.0 is Purpose...2.0 is Scope..3.0 Applicable Forms and references...4.0 Responsibilities...5.0 Procedure...6.0 Records and Objective Evidence ... 7.0 Attachments or flowcharts....8.0 Revision Control.

I was floating the trial balloon for Content. I expected a thrashing on that. As for where it comes from, I'm sworn to plagarist's secrecy, unless it's a hit. (which I doubt). But, it's what I have.

So?

:ko: :smokin:

Back to the original question......

Richard there is nothing that says you have to have a separate ( i.e. uniquely numbered and documented) procedure. In fact you could conceivably write all 6 required procedures into one document if you could figure out a coherent way of doing it.

Although we have yet to implement an effective CA and PA procedure here (but we have issued three Improvement Notes and gotten one action closed! Yippee), I set it up as a single procedure for the time being with a single "funnel" (the Improvement Note) which is reviewed and then either relegated to a Preventive Action pile or a CAR is raised and it enters our CA pile.

As we get more sophisticated, I'll still use this single entry point (Improvement Note) but will describe PA in more detail and will, out of neccessity, move it to its own document.

Energy,

Looks pretty darn reasonable to me, but I'm just me. If it works for you and your auditor likes it -- what else matters? So what does your CA "section 5" say to complement this PA section?

Mike,

5.1 is all about Corrective Action. We state the various channels that provide input to the QA Manager for significant N/C's (or potential N/C's), investigation and sebsequent actions, if any. It's too lengthy to post here.

Incidentally, as to our Auditor being happy with it, we are not yet ready to bring in a Registrar, so I don't know how it would fly. As far as I'm concerned, it says what we do, even though I "borrowed" a large part of our procedure from a company that experiences many audits from Airline Companies that really dig into their Corrective Action system. AS-9000, at the time. I look at it as a blueprint for implementing an efficent and effective CA system. We have buy in and everyone agrees that's how we will do it. After all, we had nothing! My only problem is making sure employees report problems and not try to cover them up because it might reflect on their co-workers. That's a tough nut to crack! Everybody wants to look good. I have explained that Auditors would expect a lot of CA's as we work into the ISO scheme, but that they should show a decrease over time. They appear to come in spurts. So, I now check all incoming RGA's weekly and actively pursue reports from key personnel. These people are in positions to report Customer Complaints, concessions such as free freight and parts sent no-charge, parts coming back with no explanations, etc..We then go to the appropriate people and remind them that they have an obligation to report problems. Like-Mandatory. Just have to keep re-enforcing. I hate it, but it's a living.:vfunny: :ko: :smokin:

Energy (and others),

At what point do you do formal (i.e. written) CA's vs. just discussing the issue among the applicable parties and handling it informally? I tend to reserve formal CA's for "larger" problems, "smaller" problems which could have easily been much "larger", recurrent "smaller" problems, and/or customer complaints. It might not be ideal, but I'm always willing to listen to others' ideas.

Alot of us come from the automotive world, where QS-9000 makes a clear distinction between Corrective and Preventitive Actions. To me, it was an unfortunate choice of words, since what we are all doing is trying to prevent problems. In QS speak, CA is solving a problem once it has occured in such a way that it cannot happen again. PA is preventing a problem from happening in the first place. To further confound things, both the Ford and the Chrysler CA form have a PA section on them. The idea is that you're suppossed look at similar products and processes to see if the CA you just developed is applicable anywhere else, thus preventing a problem before it occurs.
Marc Richardson
Sr. Q.A. Eng.

Marc Richardson said:
The idea is that you're suppossed look at similar products and processes to see if the CA you just developed is applicable anywhere else, thus preventing a problem before it occurs.
Marc Richardson
Sr. Q.A. Eng.

There are those members who consider that to be just an extension of an existing Corrective Action. One potential Registrar Lead Auditor said that looking for similar problems regarding the existing CA, is Preventive Action. I would hope so. Who wants the task of going around imagining what would happen and where just to satisfy an interpretation that suggests you do that? Audits, Inspections, Mgt reviews, Checklists, etc.. are all Preventive Actions.
:ko: :smokin:

Corrective/Preventitive Action Pocedure:

1. Make a statement: Preventitive action shall be applied via auditing on an intraval basis. Utilizing a Continuoius improvement method.
2. Make a form template for the Preventitive Action audits.
3. Identify process procedures utilized in the differant production areas, and list them on the forms for audit.
4. Note that any non-conformance to a preventitive action audit will result in a non-conformance (Ref procedure), and Corrective Action (Ref procedure or paragraph in this procedure) to prevent recurrance.

I fail to see the difficulty in this question. Is it me? Preventitive actions are simply audits to reduce risk of a non-conformace by checking if the people are following the procedures in building what ever product your making.
Corrective Action is the process preventing a recurrance of any non-conformance created by taking and documenting the action and following up via audit of that item non-conformance has not recurred over a time period.
What is so confusing? The question can Preventitive action and Corrective action be in the same procedure-Certainly! It is generally that way if you look at the procedures that are already in place almost anywhere. Just label the procedure "Corrective and Preventive Action Procedure 101" The question comes to getting to the part that you need to get to in the procedure without confusion of the other sections that will not apply so you need to be clear about where to go and when to go there. Drive the ready around your procedure :

Energy (and others),

At what point do you do formal (i.e. written) CA's vs. just discussing the issue among the applicable parties and handling it informally? I tend to reserve formal CA's for "larger" problems, "smaller" problems which could have easily been much "larger", recurrent "smaller" problems, and/or customer complaints. It might not be ideal, but I'm always willing to listen to others' ideas.

Mike,
We pretty much handle CA's the way your company does. We do, however, use an internal type of form called a Discrepancy Notice for the "smaller", internal-type problems. If these problems reoccur or show trends they typically will be formally written. Customer Complaints, audit (internal/3rd party) findings, etc. are other formally written CA's.
Viki