Hello Friends,

Just curious as to what the rest of you are doing.

I currently have one procedure for both, and I am considering making two seperate procedures.

What are you doing?:bigwave:

Thanks,
CarolX

We did just the opposite here. We had 2 seperate procedures under the old standard and then combined them when we upgraded. Now we have one procedure and one form to cover both.

Same here Richard,

One procedure here as well.

/Claes

I have 2 but then again, we are still under the old QS standard. Might be different later.

Dave

We had one under ISO 9001:1994.
Our last surveillance audit in Sept '02 (my first as "Quality Guy") pointed out that our Preventitive was very weak and no proof of using that part.

I recently updated Procedure (still just one) and form. Although the Procedure and form are more corrective oriented, it is designed to do both.

Hopefully our last 1994 assessment (03-11-03) and upcoming pre-assessment (9k2k) will not force/encourage me to seperate them.

For the size of our little company and limited resources and SPC style anaylsis, I think we'd get even less Preventitive Actions if they were seperated.

*shrug*

:bigwave: Hi, I'm new here. We are working on transitioning to 9001:2000. At our last audit, the auditor told me I had to make corrective and preventive two separte procedures. Is this correct? I'm having trouble creating preventive action form
Thanks Kim

Hi Kim and wlecome :bigwave:

There is nothing in the standard that requires them to be seperate procedures. This sounds like a personal preference of the auditor. We have made the transition to 9001:2000 and have one procedure for both (we also have one procedure to combine document and record control). The auditor had no problem with this and actually liked the idea of simplifying it into one procedure and one form.

:cool: Thanks Guys,
I have really been struggling with this one!!!

Oh well, as some of you know, I don't mind telling the registrar no if I think they are wrong. One is enough if that is what you want. It's what we have. As for the form, I use one and choose corrective action or preventive action as the type. When I set up my actions to be taken i.e. corrective or preventive action, the field is just named Action To Be Taken. That way, nobody can come back on me and say, "you said this is a preventive action request, but your actions state they are corrective." I developed my CA/PA system in a database, so I could just develope one (internal corrective action) system and then just copy tables, and add additional fields for things like audit corrective actions and customer complaints/claims/feedback.

Make your system work for you, the chances that you are in the same business as your registrar are mighty slim, why let them tell you what you need to run your business past the obvious you met or did not meet the intent of the standard?:bonk:

Have a good one

Carol,

I have elected to keep these together because from my perspective, both are continuous improvement activities. Making the distinction helps to satisfy a curious auditor perhaps, but in the long run, it is what it is. Opportunity for improvement.

I do make the distinction as to which is which, just for the reason noted above. I track and trend both activities within the same database. Amazingly, what I find the most interesting is in the difficulty of others to understand the difference between the two. By treating them as one under the label of "Continuous Improvement", the confusion is mitigated.

But to each their own I suppose. If splitting them helps, do it!!

Kind regards,

Kevin:bigwave:

I normally keep them together. I find there is confusion for those not familiar with the concepts and hate to see too much energy spent trying to decide if something is corrective or preventive. I do have a checkbox at the top of the form to catagorize things, but don't worry if somebody checks the wrong one. The important thing is they fix the issue.

I use an additional procedure for continuous improvement projects. Things that require major planning (new equipment, reorganizations, etc.) go through this system. I like to have some additional planning data for these preventive actions over the "create a work instruction" variety that do not take as much time.

Tom

tomvehoski said:

I normally keep them together. I find there is confusion for those not familiar with the concepts and hate to see too much energy spent trying to decide if something is corrective or preventive.
---X---
Tom

Very good point, Tom... as usual, I might add. That is completely in line with the KISS principle.

/Claes

We, also, have one procedure. It makes sense for us because of all the reasons mentioned above. I like Kevin's perspective that both are "opportunities for improvement" and to separate them out only seems to "muddy the waters".

Bill

Thanks for the vote of confidence, Bill. I will go to say that while making the distinction internally might not be all that important, it is important to know the difference. Auditors these days are pressing harder than ever to determine how and where Preventive Actions are taken. In the past, the mindset has always been to wait until something breaks before fixing it. This says a lot about an organization's culture. The transition into the PA world is regarded as being very slow. I have to agree.

Being able to make the distinction between different classes/levels of PA is an important contribution made by Tom. Auditors often hear about the usual suspects like planning and holding FMEAs for various aspects of Design Control. What they aren’t hearing are the other broader magnitude PA opportunities. Organizations going through the motions of a passive PA program will not fair as well as one with an active approach.

Good discussion folks!!

Regards,

Kevin

Hi everyone-

Originally I had both the CA's & PA's separate from each other. It just made more sense to combine them. We now have one simple procedure for both. It works well for us. Keep it simple as you can as long as it is effective for your system.

Dave N

My personal preference is to combine them into one procedure. I always discuss this with my clients though, and have them weigh the pros and cons. Some of them decide to do separate procedures just to place emphasis on the fact that both need to be done. Too many times I've seen companies do one or two preventive actions just to meet the ISO 9001 requirements, then sit back and forget that they need to continue to be proactive. As Kevin said, CA and PA fall under the continuous improvement umbrella. Many companies are really just doing "intermittent improvement."

Just a thought. Can corrective action be considered a continuous improvement? All the CA does is get the process back to where it was supposed to be in the first place. This is not improvement. Preventive action would be considered a continuous improvement, because you are preventing the non-conformance from reoccuring. We combine our CA/PA to make sure it is continuous improvement

That's a good point. And if you live with ISO/TS 16949, then most corrective actions are NOT considered to be continual improvement.

Continual improvement is implemented once manufacturing processes are capable and stable, or product characteristics are predictable and meet customer requirements.

HMMMMMMMMMMMMMMM,

Doesn't corrective action come into being when a nonconformance is discovered?

Continuous improvement comes about when you want to improve a process that is in control? But still affording nonconformances?

Preventive action comes from knowing the basics of a process from experience and enacting measures to prevent it happening again?

Yes a murky area, but if something is already made incorrectly, it is a corrective action.

Please do a search and you will see many differing description that all come down to the same results.

IMHO
Al..

Hi All,

I thought I may add my humble thoughts. During our CA process we must develop a PA plan to ensure that the problem does not recur. Now I am sure people are going to start on symantics again and say no this is CA not really PA....but who cares.

My auditor asks me to prove our committment to CA and I show him our procedures and training. I show him our files of 'closed out' CAs and the subsequent audits of some of those areas. He is satisfied. We are very good at CA. We have always been good at fixing things after they happened and this is the meaning of CA. The problem has already occured....past tense.
PA means it has not yet happened as in 'Our Preventative Action Plan for CA has not yet happened'. Future tense.
I taught some new inductees yesterday and explained PA as the way we identifi Potential Problems (Risks). If they identify a risk to our product etc they can submit a CAR and have the potential problem dealt with in the same manner as a CA.
We point out that our Audits, Management meetings, Training, Maintenance, Knowledge and Quality Awarness programs are part of our PA program.
I have included a single chapter on PAs in our CA procedure and indicate the procedure is the same as CA - Identify, Investigate, Evaluate, Implement (Preventative Action Plan) and Monitor etc.

I'll get off my soapbox.

Greg B

Originally posted by Al Dyer
Doesn't corrective action come into being when a nonconformance is discovered?

OK, lets get nit picky then. The actual ISO definition is "action to eliminate the cause of a detected nonconformity or other undesirable situation." Undesirable situations may not be nonconformities, and can occur in stable processes that are under control.

The point I was trying to bring out above was that continual improvement involves continual actions. Many companies do a flurry of activity before an audit just to meet a requirement that hasn't really been integrated into their system. I consider this to be intermittent improvement, not continual. ;)

howste,

Don't get "continual" confused with "continuous".

From the American Heritage Dictionary: Continual is chiefly restricted to what is intermittent or repeated at intervals: The continual banging of the shutter in the wind gave me a headache. Continuous implies lack of interruption: The horizon is a continuous line.

So even if personnel run around at the last minute making those "improvements", it still qualifies as "continual improvement".:bigwave:

Maybe ISO should call it continual improvement. I dont think anyone could claim improvement without interuption. Anyway, its just a matter of interpretation. Just like the horizon, its according to the way you look at it, through the trees or above the trees.

Maybe ISO should call it continual improvement.

Uh Mike, They do!:biglaugh:

OK. I`m still stuck in the 94 mode. But anyway, to break the dictionary out, in mine continuous and continual mean the same thing.

Either way, I don`t believe running around trying to fix something or complete a requirement before the auditor arrives could be concidered CI. It is CA. Liike Al Dyer says, If you make an improvement to a stable process before the auditor arrives this would be CI.

Wow. I just got into the whole CA vs PA thing with someone in my dept today. She was explaining our HSE audit process to me and was saying that CA was the thing that someone did to fix the one instance and PA was the actions they took to make sure it didn't happen again.

When I explained to her that, actually, a correction was what brought the one instance back to normalcy and CA was the actions taken to make sure it didn't happen again, she looked lost. She was like "no, it's preventive". She didn't see the difference between preventing something from happening the first time, and preventing it from happening a second or third time. She was focusing on the word "prevent" and figured since that word was used in both instances, they were the same thing.

Not the same thing. PA is to make sure you never experience the loss. Ever. Not even the first time.

Some may call it a semantics game, but actually there is good reason to separate the thought processes on the two activities. CA is handed to you on a platter. PA is a Search and Destroy.

But I agree that there are aspects that can be combined within a single written procedure and that information on both can be kept in a single database but with designations to identify them. We use a database reporting system for reporting observations and near misses as well as incidents and can easily run reports from it.

Lucinda,

Nice to see you back! Where you been hidin'? Drop in more often -- we can always use more common sense around here! :bigwave:

Hey Mike, I've been hiding under that HSE rock. You know, the one that no one ever looks under for fear of someone screaming at them for handling such a heavy rock without proper PPE in place.;)

Just spent the whole day today in a meeting to spec out an upgrade to our incident reporting software and will spend the next two days doing the same with our driver safety program's hardware and software. Then after a full week next week of running safety reports and statistics, will head back into meetings to continue with more of the same. Fun, fun.

And as Randy can tell you, I spend most of what little time I have in the evenings still doing the real estate gig. (ask him how he got such groovy digs in Arkansas...:) )

But I still pop in here from time to time and will open my big mouth when subjects close to my heart get discussed..!

This isn't a new problem by any means. What we found that worked the best was using the verbiage from the 8D format for the correction part - Interim and Permanent. That helps in the confusion with the preventive action that corrects a problem. If the Permanent Corrective Action from 1 process can be implemented in another, now it can be viewed as a Preventive Action. Our Continuous Improvment goes along the line of innovations (even if they don't work well) and new technologies.
For summation we look at Interim and Permanent Corrective Actions as "REACTIVE" actions. As stated before "the problem already occured".
Continuous Improvement is "PROACTIVE" actions, even if the action is copied from similar processes. The failure has not been experienced in the process before.

We have separate CA and PA procedure / process.


Reasoning: a Corrective Action is an “INPUT” into our Preventive Action “PROCESS”.

I have only one procedure for CAPA. and here it is.

pl. comment.

We do have in our ISO system a Sub process “Nonconformity, Corrective/Preventive Actions” containing following documents:

Sub Process document, (flow chart, steps, KPIs,)
WI – Problem solving by team approach
WI – Decision making for problem solving
WI – Using database for Nonconformities/Problems, Corrective/ Preventive/ Improvements Actions, Causes, Action Plans
WI – Specific preventive actions for visual defects
WI – Using Fish bond diagram
Forms

Vio

Randy Stewart said:

"If the Permanent Corrective Action from 1 process can be implemented in another, now it can be viewed as a Preventive Action. Our Continuous Improvment goes along the line of innovations (even if they don't work well) and new technologies.
For summation we look at Interim and Permanent Corrective Actions as "REACTIVE" actions. As stated before "the problem already occured".
Continuous Improvement is "PROACTIVE" actions, even if the action is copied from similar processes. The failure has not been experienced in the process before."

Randy, I have to agree here. Lucid, indeed.

For those of us "in the trenches", grabbing onto ANYTHING, from anywhere, to improve the system performance is proactive, unless it was dropped on us as a system failure. Then it is the miserable process of CA. On this, I will not yield.

Indeed, we need to be looking for the areas that need improvement (FMEA) but when we trip over an area to improve one part of the system, it should count, too, as preventive for the rest of the system, if we apply it system wide.

Anyone who trips, and does not realize that there is a systemic problem, needs to find another line of work.

Just my 2 pence.

Craig

I have only one procedure for CAPA. and here it is.

pl. comment.Since you asked for comments, I thought I'd throw a few ideas. I think that the procedure does a great job of covering problem solving methods for corrective and preventive actions. There are a couple of items that struck me as areas you may want to look at to improve the procedure.

1) The scope of the procedure doesn't seem to meet the intent of preventive action:SCOPE

Applicable to all repeat non-conformances observed at any stage of manufacturing (i.e. In-coming, In-process & final stages) including the customer complaints / warranty / customer returns & integrated management system related non-conformities.
This implies that only recurring problems would be addressed, and no preventive actions (by definition) would take place. Also, if a major problem occurred, it might not be addressed unless it happened more than once. This is probably not really the case.

2) In the preventive action section (6.2) it seems like the sources of identifying potential problems are somewhat limited. That is, unless the "monthly MIS" you referred to addresses more. Internal audits, management reviews, FMEAs (if you use them), etc. are also excellent sources to identify potential problem areas.

Anyway, there's my $.02

Hi :bigwave:
Basically, in our case what we have one procedure for both corrective and preventive action. It has addressed on the preventive action, if the current problem was a recurrence of a close corrective action. IMO, one should track and document the corrective action taken on the previous problem, so that in the future, you could easily tell whether that if its a recurrence of the past problem.

Best regards,
Raffy

I have only one procedure for CAPA. and here it is.

pl. comment.
Manoj,
After reading your CA/PA procedure I found it manufacturing heavy. You might consider involving the entire business system, not just what happens out on the floor. We just recently revised our PA program with a target of 6 suggestions/year from each Manager/Supervisor inorder to start getting some much needed ideas and to "involve" everyone. Time will tell if this improves our PA program.

1) The scope of the procedure doesn't seem to meet the intent of preventive action:
This implies that only recurring problems would be addressed, and no preventive actions (by definition) would take place. Also, if a major problem occurred, it might not be addressed unless it happened more than once. This is probably not really the case.

2) In the preventive action section (6.2) it seems like the sources of identifying potential problems are somewhat limited. That is, unless the "monthly MIS" you referred to addresses more. Internal audits, management reviews, FMEAs (if you use them), etc. are also excellent sources to identify potential problem areas.

Anyway, there's my $.02

During an interview with a prospective Registrar, I asked that very same question. Because of heavy discussion on this topic in another thread, I wanted to hear what the Auditor thought. I asked him if I find something wrong with part X and apply what we learned to part Y, is that considered Preventive Action. He said, "Absolutely. Why not?" I mentioned how there was an ongoing discussion where that type of action was considered by some to be an extension of Corrective Actions.
He said, "That's silly". Why did he say that? IMHO, it shows how hard it is for some of us to tell the difference. Him, too? :vfunny: :ko:

I like the idea of a combined CA/PA procedure.

We're contemplating tying in the nonconforming procedure as well. It will still be separate but any CA actions taken when finding late stage nonconformities will still be handled by the CA procedure. This leaves discovery, hold shipment, and isolation as the main pieces of the nonconforming procedure. Agree?

Wally

During an interview with a prospective Registrar, I asked that very same question. Because of heavy discussion on this topic in another thread, I wanted to hear what the Auditor thought. I asked him if I find something wrong with part X and apply what we learned to part Y, is that considered Preventive Action. He said, "Absolutely. Why not?" I mentioned how there was an ongoing discussion where that type of action was considered by some to be an extension of Corrective Actions.
He said, "That's silly". Why did he say that? IMHO, it shows how hard it is for some of us to tell the difference. Him, too? :vfunny: :ko:

Sheriff-

Earlier this year, when I showed our external auditor how one of our design teams designed out existing failure modes found on current products on the new product they were developing, they debated just the opposite - that because the defect was "known" that it wasn't PA! I debated this issue for 15 minutes with them. Finally, I asked "So IYO what is considered PA?" They answered "FMEA, because it is the only point where defects can be identified before they are manifested." "FMEA!" I responded, "That's it? Are you kidding me?" Bottom line: He relunctantly accepted all examples of PA found on any product and applied to all others; existing or in development.

So even external auditors can have misinterpretations of what CA and PA is.

Tom

I have a question.

I work in transportation. Our drivers conduct a pre trip and post trip inspection on every piece of equipment they use daily. These inspections are to discover defects prior to departure to prevent a problem from happening enroute. Can this process itself be considered a preventive action? Would a registrar accept that preventive actions are built into a process?

C Emmons:

I would have to say that looking for a problem (we don't expect one, and have no reason to think there is one) is definately PA. So, yes, I would buy that argument.

FWIW

Craig

2 procedures here simply from a standard numbering standpoint. They are handled the same however they are opened for different reasons. A CA is opened when you are below the goal and the need is there to address the situation. PA is opened when a trend over time is negative but not necessarily below the goal.

In reading Tom’s post (with Energy’s quote), it reminded me that from a QS9000 perspective, the view on what an extended CA is and PA is weren’t always different. If someone has access to the original requirements, before section 2 and 3 were merged, I believe that you will find that the definition of a PA included the extended application of a CA. This changed after 2 and 3 were combined, whereby PA dealt more specifically with prevention of potential problems. I believe the sanctioned interpretations were also along these lines.

The question on whether or not FMEAs are preventive action or not has been an ongoing debate amongst some groups for sometime now. Me: I always thought they were PA by definition of why they were performed and in general, when they were performed which is as part of the Design/Design Transfer process. It certainly can be run as part of an investigation process for a CA, thus changing the light a bit. Nonetheless, from the perspective of Edward Link, who cares so long as a CI effort is being made? For the most part, it is just semantics. But not completely.

What kind of organization do you work for? One that reacts to problems when they pop up (detect/correct)? Or, do you work for an organization that tries to avoid problems (predict/prevent)? This is perhaps where the distinction between CI activities has the most merit. An organization reacting to trends within control limits makes me feel better than an organization who only reacts when a point is outside of the limits. It also shows me that the organization has made an effort to draw a useful distinction between what a CA and PA might be (perhaps this is another ongoing debate). I sense a forward thinking organization, here. Yes, I think I might do business with them.

Good discussion folks!!

Kevin

While I'm a bit late to the party, we use a single procedure for CA and PA. It too is entirely manufacturing centric.

What I see as problematic is that our system is very much a reactive process. Our higher lever CAPA SOPs state that we respond with a CA or PA in the event of a non-conformance.

FMEA and Hazard Analysis fall under Risk Management in our organization. While Hazard Analysis could be considered part of a wider PA progeam, it is used during Design Review by Development only. FMEA is our only current, formalized tool to evaluate failure modes as a PA.:( :eek:

We are ISO certified, have many CE marked products and are number 1 in our Medical Device category, worldwide.
Despite our "successes" in the marketplace I have never liked the reactive PA view here. I was repeatedly told that PA is in response to a defect only, separate from continuous improvement (which we are only now beginning to touch upon from a practical standpoint).
Additionally we do not formally consider the role of Quality beyond manufacturing, another view that I find "incorrect" and short-sighted.

It's nice to hear another set of perspectives.

cheers

I am in the process of developing our procedure now. I am using one procedure for both CA & PA. I am not sure if this will meet all of the requirements as it is short and to the point. I have also referenced CA/PA in all other procedures for any nonconformances that occur. In your opinion, is this enough to meet the requirements?

I am in the process of developing our procedure now. I am using one procedure for both CA & PA. I am not sure if this will meet all of the requirements as it is short and to the point. I have also referenced CA/PA in all other procedures for any nonconformances that occur. In your opinion, is this enough to meet the requirements?

CA/PA may be the "result" of the Management Review process as well. Furthermore I do have a few questions related specifically to the following section of your procedure.

"6.2. CAR/PAR Analysis and Closure
The responsible department head will determine the root cause, identify potential solutions, records all possible solutions on the CAR/PAR, implement the most effective solution, complete the supplier sections of the CAR/PAR and return it to the originator for further processing prior to the response due date. If it is not possible to implement the solution within the thirty (30) day period, the supplier will indicate expected implementation date on the CAR/PAR. The originator will review the proposed action and notify the ISO Coordinator as to the need for a review date. The ISO Coordinator will assign a review date to the CAR/PAR taking into consideration the expected implementation date, assemble a cross-functional team and assess the effectiveness of the action taken on the review date. If the action is deemed effective by the team, the CAR/PAR will be closed. Otherwise, the CAR/PAR will be returned to the responsible department head for further action. This process will continue until the action is deemed effective"

Q1: What value do you gain from having "all possible solutions" listed on the CAR/PAR? Along with that: Who determines if in-fact these are ALL the possible solutions?

Q2: If you are allowing 30 days to "respond" to the CAR/PAR (per 6.1), are you allowing an additional 30 days for implementation? (It appears that you are in-fact assuming that your going to receive the response prior to the end of the 30 days allowed, and are then allowing the remaining time for implementation - but what happens if it takes the full 30 days for response?)

Q3: If the "response" is "unacceptable" what steps occur? And how long is the supplier given to provide an "acceptable" response?

Q4: If the action is NOT effective, how long is allowed for implementing "effective" action?

Scenario to be concerned about: Response on day 30, response unacceptable, second response received on day 60, implementation on day 90, action ineffective, revised response on day 120, implementation on day 150. Conclusion and closure 5 months after action requested. For complex issues 5 months may be acceptable, but are you willing to allow that for issues that should be easy to fix? :bigwave:

ddhartma,

Thanks for the critique. It has opened my eyes to some gaps in the procedure and I will begin working on those.

As for listing all possible solutions, I had an auditor tell me that we should list the potential solutions, select the best one and try the others if that one did not work however, he did not say all solutions. I will be removing the "all".

As for the 30 days, I will be rewording that section of the procedure to include extension requests and update intervals.

Thanks again,

Mshell

While I'm a bit late to the party, we use a single procedure for CA and PA. It too is entirely manufacturing centric.

What I see as problematic is that our system is very much a reactive process. Our higher lever CAPA SOPs state that we respond with a CA or PA in the event of a non-conformance.

FMEA and Hazard Analysis fall under Risk Management in our organization. While Hazard Analysis could be considered part of a wider PA progeam, it is used during Design Review by Development only. FMEA is our only current, formalized tool to evaluate failure modes as a PA.:( :eek:

Despite our "successes" in the marketplace I have never liked the reactive PA view here. I was repeatedly told that PA is in response to a defect only, separate from continuous improvement (which we are only now beginning to touch upon from a practical standpoint).


I'm late too! And I share your concern about the interpretations you mention. My view is that CA is triggered by something happening (or not happening) - ie an event or an incident - and PA is triggered by you realising that something might happen (or not happen) - ie a thought. It sounds to me that your PAs are CAs?

The fact that the standard says that you must have a “documented procedure” to explain how you address PA means that you need to describe how you identify what might go wrong and how you avoid it. But it does not even need to be in a single document. It could (should?) be addressed in your processes for planning, allocation of responsibilities, product design, process design, management review ... It is neither a single process nor a single action. The identification and reduction of risk should be part of an organisation's operating strategy. Not just in manufacturing, not reactive, not for just for "quality", but for the sake of staff, safety, profits, and ongoing improvement ... In fact, it is an intrinsic part of good "process management".

Under the 1994 standard, we had one document covering both. About a year - year and a half ago, we decided to split these out into two documents... We think this helps our employees better understand the differences between the two. We felt this change would also help us get away from the old habit of reacting to problems only after they occur. After splitting into two documents, we then realized that there were already so many places that preventive action was already occurring... we were just doing a poor job of acknowledging / recognizing it... it helped open a lot of eyes all around.

We have a 2 procedures. A CA procedure and a PA procedure. But the form for the PA is called a "Process Modification Request" and feeds into the improvement facet of the system.

I got a headache trying to figure out what was corrective and what was preventive and what was improvement.

James

We had 1 procedure for both under 9001-1994, and it worked fine. At least there was nothing wrong with the procedure itself, but sometimes our dedication to CAPA could use a little shot in the arm. Anyway, now the consultant hired by corporate has decided there should be 2 different procedures because that's how his canned software does it. :rolleyes:

The software is whiz-bang, gee-whiz stuff, but it takes 5 times as long to do something as it used to when we didn't have all these (IMO unnecessary) bells and whistles. It is amazing how they have money for consultants and whiz-bang stuff while some other critical areas suffer due to "no money for that" syndrome. But I'm just a lowly QM, what do I know vs. owners and consultants? :(

Hey Mike, you're playing my tune. Sounds like we are both marching in the same parade.

We used to have only one procedure but I split them up about 2 years ago. I felt the Prevention needed to be addressed diferently and wasn't getting the right treatment when looked at with the C/As. My feeling was that Prevention should be an ongoing thought process with different identifiers than C/A. We were tending to "allocate" projects in retrospect. The driving force being a nonconformance. Our new two procedure system allows Prevention to be identified in a number of ways not "covered" under the old procedure. I find we are identifying and initiating a lot more with the 2 procedures. JMHO

Dave

Dave,

I can't agrue with the logic, and certainly not with the success.

I guess my biggest beef is with the software we are forced to use. Where a wheelbarrow would do nicely we're forced to use a Mack dump-truck and it is costing us in inefficiency and complexity. But, like the old Rush song says, "conform or be cast out".

we have one , and poeple seems don't care whether it's c or p as they're both opportunity to make improvment.

I do make the distinction as to which is which, just for the reason noted above. I track and trend both activities within the same database. Amazingly, what I find the most interesting is in the difficulty of others to understand the difference between the two. By treating them as one under the label of "Continuous Improvement", the confusion is mitigated.


Kevin,

This is a great post - hits the nail on the head for my company. (Thanks to whoever started this thread - I can't remember who did...)

This is going to be an issue for our upcoming switch to 9K:2K (from QS 9000). I'm in an environment where folks are *convinced* that:

Corrective action: an action taken to fix the immediate problem
Preventive action: an action taken to make sure the problem *never* happens again...

They've been following these definitions as long as we've had a QS registration, from what I can see. We currently don't really *have* a preventive action system. The closest thing we have to a PA system are the OFIs identified during each internal audit...and even *they* are not always followed up on. We're working toward this - we created a database for OFIs (previously tracked on paper and filed away to forget!) and this will be rolled out during our next IA.

Is this enough? Or are we going to get nailed in our registration assessment?

"Anyone?Anyone?"

Cheers,
-R. :bigwave:

Even in QS there is this distinction but every one ignored it.

If you are QS then you do have preventative actions.
In your FMEA you deal with non conformities that could and have not happened yet.
In my procedure I refer to FMEA's and say that the tracking and actions are done there so you do not have duplicate records.

Good advice Howard!:applause:

Corrective Action ----- Identified during APQP or not, "OOPS" do an 8D. Could lead to a continuous improvement but not a preventive action

Preventive Action ----- Document on FMEA "living document", could lead to continuous improvement activities but not corrective action

Continuous Improvement ----- Driven by reviewing Company Measurables, could lead to updating FMEA data but no relation to corrective action.

These are not written in stone and most companies will have some deviations and grey areas they argue about. The important thing is to have documented definitions and a tracking method.

Al...

Kevin,

This is a great post - hits the nail on the head for my company. (Thanks to whoever started this thread - I can't remember who did...)

This is going to be an issue for our upcoming switch to 9K:2K (from QS 9000). I'm in an environment where folks are *convinced* that:

Corrective action: an action taken to fix the immediate problem
Preventive action: an action taken to make sure the problem *never* happens again...

They've been following these definitions as long as we've had a QS registration, from what I can see. We currently don't really *have* a preventive action system. The closest thing we have to a PA system are the OFIs identified during each internal audit...and even *they* are not always followed up on. We're working toward this - we created a database for OFIs (previously tracked on paper and filed away to forget!) and this will be rolled out during our next IA.

Is this enough? Or are we going to get nailed in our registration assessment?

"Anyone?Anyone?"

Cheers,
-R. :bigwave:

Our employees thought the same way as yours, Rachel, about 3 years ago. Then I came aboard, revamped the system, and suddenly, the proverbial lightbulb went on. In fact, the one person who was the worst for saying something was a CAR and PAR, is now my best champion at getting others to understand when there is confusion! :D

Our current system, in our efforts to continually improve, has become even more definitive for discrepancies...or it will, shortly...

Opportunities for Improvement will remain, with their own log and own form to be filled in.

The Nonconformance Report and Log will be modified into....dum deedee dum...the Failure Treatment Report and Log (FTR and FTL...we're acronym lovers over on this side of T.O.).

Classifications will be:


Abnormality - An operational-related discrepancy, such as unscheduled downtime < xx minutes, that can be addressed immediately by floor personnel (kinda like making an immediate correction).
Nonconformance - A minor discrepancy as outlined on the Failure Treatment Guidelines Matrix that basically results in a wham!bam!fix-it-and-let's-get-back-to-making-steel approach.
Corrective Action - A discrepancy as outlined on the Failure Treatment Guidelines Matrix that results in root cause, fish-bone diagram, action plan and verification plan
Preventive Action - Adverse trend and action plan, etc.

Kevin,

I'm in an environment where folks are *convinced* that:

Corrective action: an action taken to fix the immediate problem
Preventive action: an action taken to make sure the problem *never* happens again...

They've been following these definitions as long as we've had a QS registration, from what I can see. ,
-R. :bigwave:

It seems you are not alone but what puzzles me is that these terms were defined in ISO 8402 way back in 1986 when Correction was action to fix the nonconformity, Corrective Action was action to prevent recurrence and Preventive Action was action to prevent occurrence so why didn't the third party auditors pick this up. Its not a QS thing because QS contained ISO 9001:1994. Its taken 17 yrs and we still seem to have confusion. ISO 9001:2000 has not really changed anything. OK the clauses are now separate but there's no difference in intent from 1986.

FMEA as someone has already pointed out is PA and so too is planning and training. Risk Assessment is PA when the risks are acted upon but its not otherwise. When you take this view of CA and PA, you can't have one or even two procedures - you probably will have several and are not aware of it.

ISO 9001:2000 places CA under Improvement which is not strictly correct. Both Deming and Juran would argue that CA is not improvement because what it does is bring the process back to where it should have been in the first place. CA would therefore appear to serve process control rather than inprovement.

ISO 9001:2000 places CA under Improvement which is not strictly correct. Both Deming and Juran would argue that CA is not improvement because what it does is bring the process back to where it should have been in the first place. CA would therefore appear to serve process control rather than inprovement.

Sweet. Stick it to 'em... :agree1:

It's true - I've wondered that myself. Arguable, I suppose - but if you've got something that's non-conforming, you've already acknowledged that you're below the average. The resolution brings you back to average. There's no *improvement* there...

...although, I say *arguably* because in some cases, "fixing the problem so that it never happens again" may be more of an improvement than a simple resolution. Example from here - one NC may impact only one product line. Applying the fix to all similar product lines puts us beyond where we were before the NC was issued. But, I still agree that it's a chintzy way of being proactive...

I'm trying to reinforce the definitions as follows:

Immediate fix: what you do to fix the immediate problem.

Corrective action: what you do to make sure that the same problem, or a similar problem, never happens again.

Preventive action: what you do to pinpoint problems *before* they start...the key here is that preventive actions are not triggered by a non-conformance.

But, then, is that 100% true??? (Specifically, that NCs can't generate PAs?)

Sweet. Stick it to 'em... :agree1:

Example from here - one NC may impact only one product line. Applying the fix to all similar product lines puts us beyond where we were before the NC was issued. But, I still agree that it's a chintzy way of being proactive...[/B]

But, then, is that 100% true??? (Specifically, that NCs can't generate PAs?)

Rachel - It is quite a common view that fixing a problem in a product or process that has not yet ocurred is classed as preventive action but if you think about it, the problem is there for you to fix - it just has not manifested itself yet. The conditions or circumstances have not yet occurred in which the nonconformity will be revealed. There is an undetected nonconfomity not a potential nonconformity. Therefore removing it is corrective action. Hence an NC cannot generate preventive action in the context of ISO 9000 definitions. In the real world we can call CA and PA anything we like and often do!!

I have no problem with what people want to call these things as long as the deeds they perform match the intent of the requirement. It is perhaps unfortunate that so many people claimed to have preventive action procedures but all they did was to elminate the root cause on existing nonconformities either in the product/process in which it was detected or similar products/processes.

It always puzzled me why the authors of QS-9000 and TS 16949 did not put the FMEA requirement under Preventive Action.

Preventive action takes place during the design of products, services and processes but unfortunately ISO placed the requirements under improvement.
There are two types of improvement, improvement by better control and improvement by raising standards. What PA and CA are is improvement by better control. After all if we know something could go wrong and we don't do something about it either in the design or afterwards its hardly an improvement when we eventually fix it - is it?

Rachel - It is quite a common view that fixing a problem in a product or process that has not yet ocurred is classed as preventive action but if you think about it, the problem is there for you to fix - it just has not manifested itself yet. The conditions or circumstances have not yet occurred in which the nonconformity will be revealed. There is an undetected nonconfomity not a potential nonconformity. Therefore removing it is corrective action. Hence an NC cannot generate preventive action in the context of ISO 9000 definitions. In the real world we can call CA and PA anything we like and often do!!

So if I'm running a control chart at my machine and I have noted that the last several measurements are moving towards the upper control limit, according to your position noted above any adjustment is a "corrective action" and not "preventive" even though no nonconformity has occurred and in-fact my actions have "prevented" one from occurring. Or did I misunderstand?
:confused:

So if I'm running a control chart at my machine and I have noted that the last several measurements are moving towards the upper control limit, according to your position noted above any adjustment is a "corrective action" and not "preventive" even though no nonconformity has occurred and in-fact my actions have "prevented" one from occurring. Or did I misunderstand?
:confused:

Yeah, I have to agree with David here. I'm not 100% clear on what a PA is, then...because I always thought it was nipping an issue in the proverbial bud. I always thought that it was irrelevant whether the issue was waiting to happen in a few days, a few weeks, a few months...

Also, what do you folks think of the notion that a PA *could* accompany a CA? Our CAR form has both (and our system won't *close* a CAR without *something* being written in the PA field - scary!!). At my ISO LA training, the instructor said that "a sure sign that a company doesn't understand the intent of the CA system is when all CARs have a PA filled out". Unless the company has redefined the terms, I agree. But...is it possible to ever have a CA with a PA? When, and how?

So if I'm running a control chart at my machine and I have noted that the last several measurements are moving towards the upper control limit, according to your position noted above any adjustment is a "corrective action" and not "preventive" even though no nonconformity has occurred and in-fact my actions have "prevented" one from occurring. Or did I misunderstand?
:confused:
The key question would seem to be, is the process in design mode or is it capable? If its in design mode the action is preventive but if this happens to a process previously deemed capable it sounds like the process is going out of control - a special cause of variation is present. Something has happened that should not have happened. A process nonconformity exists so its removal is a corrective action.

In the final analysis it does not matter what we call these actions, only that we take the appropriate action. The trap many might have fallen into is in not doing the risk assessment of products and processes whilst in design mode. In the automotive and aerospace industry, they addressed this by FMEA but in other industries, they have still to learn how useful FMEA is at removing potential problems. In ISO 9004 it is addressed under clause 7.1.3.3 rather than 8.5.3

Yeah, I have to agree with David here. I'm not 100% clear on what a PA is, then...because I always thought it was nipping an issue in the proverbial bud. I always thought that it was irrelevant whether the issue was waiting to happen in a few days, a few weeks, a few months...

Also, what do you folks think of the notion that a PA *could* accompany a CA? Our CAR form has both (and our system won't *close* a CAR without *something* being written in the PA field - scary!!). At my ISO LA training, the instructor said that "a sure sign that a company doesn't understand the intent of the CA system is when all CARs have a PA filled out". Unless the company has redefined the terms, I agree. But...is it possible to ever have a CA with a PA? When, and how?

Oh dear - I seem to have opened a can of worms. Sorry! If we assume products and processes should be right first time, the action taken to remove any nonconformities following design, whether or not they have materialized is a corrective action - at least that is how I interpret ISO 9000:2000 clause 3.6.5. So if this is correct you can't have a form that has both CA and PA on it. When I have seen these forms in the past, the CA is not CA according to ISO but what ISO call Correction (ISO 9000:2000 clause 3.6.6) - ie it fixes the problem and PA is not PA according to ISO, it prevent recurrence not prevents occurrence. If the PA had been effective there would be no CA. If the form was RA and CA (Remedial Action and Corrective action, I would imagine that some forms would have both RA and CA filled out, and there would be many with only RA filled out, because taking CA implies the process is not achieving its objectives and must be brought back under control.

So in conclusion, I don't think it is possible to have both a CA and PA on the same form but it depends on how you define the terms. In all of this debate, I have tried to interpret the terms as ISO intended but perhaps someone from TC 176 could clarify the situation and put it to bed?

...you can't have a form that has both CA and PA on it. When I have seen these forms in the past, the CA is not CA according to ISO but what ISO call Correction (ISO 9000:2000 clause 3.6.6) - ie it fixes the problem and PA is not PA according to ISO, it prevent recurrence not prevents occurrence. If the PA had been effective there would be no CA.

I like that. Maybe that was the goal of the ISO gods in splitting up the CA and PA into two separate clauses. There's no doubt in my mind now that a CA is not the band-aid fix. It's the stitches. That clears up half of the mystery...

...the other half, IMO, is the wording of 8.5.3. "The org shall determine action to eliminate the causes of potential nonconformities..." Okay, so define "potential".

The key question would seem to be, is the process in design mode or is it capable? If its in design mode the action is preventive but if this happens to a process previously deemed capable it sounds like the process is going out of control...

See, I don't agree with this...that implies that the only time you could implement a PA is during the design phase. If we take PAs as part of the push toward CI, then how do you ever improve upon a process that already exists?

Picking brains because it's more interesting than the NCP procedure I'm supposed to be writing...
-R.

PS:
If the form was RA and CA (Remedial Action and Corrective action, I would imagine that some forms would have both RA and CA filled out...

I like that RA term a *lot*...mind if I steal it? :) I think it would solve a lot of headaches around here.

I...the other half, IMO, is the wording of 8.5.3. "The org shall determine action to eliminate the causes of potential nonconformities..." Okay, so define "potential".



See, I don't agree with this...that implies that the only time you could implement a PA is during the design phase. If we take PAs as part of the push toward CI, then how do you ever improve upon a process that already exists?

PS:

I like that RA term a *lot*...mind if I steal it? :) I think it would solve a lot of headaches around here.
Rachel you won't be stelling it - it appeared in BS 4778 (A British Standard of the 1970s) and in fact appears in ISO 9000:2000 clause 3.6.9 - have a look.

I think 'potential' means 'capable of coming into being' I hope this is not too contraversial but we keep hearing about WMD existing but no one has found it yet. The problem is we knew it did exist so I guess the politicians are saying it isn't a potential problem its a real problem - it just hasn't been used again- thank God!

Regarding your other point, when you change the process objectives you go back into design mode. You might recall Deming saying something like - that a process will deliver only what it's capable of delivering. So if its not delivering what it was designed to deliver, it needs redesigning.

Oh, crap.
Anyone else want to take this one??? Now I'm just confused. :confused:

So using SPC to trend data and attack negative trends before they go out of control - that's considered corrective?

See, I get what you're saying here, Pennington, but to me that doesn't seem right. It just seems that our definition for "potential non-conformity" is too complicated...because in the above case, there *is* only a potential.

Lost in a sea of acronyms and bad procedures...
-R.

Oh, crap.
Anyone else want to take this one??? Now I'm just confused. :confused:

So using SPC to trend data and attack negative trends before they go out of control - that's considered corrective?

See, I get what you're saying here, Pennington, but to me that doesn't seem right. It just seems that our definition for "potential non-conformity" is too complicated...because in the above case, there *is* only a potential.

Lost in a sea of acronyms and bad procedures...
-R.
Rachel - I will try to send you a lifeboat but take no notice of what it is called - if it works for you its OK. I think the terms have evolved. Outside the concept of process capability, it does seem logical that stopping something occurring before it happens must be a preventive action and I think that is how most ordinary folk see it. Nothing wrong with that. Unfortunately we are trying to use common English words for complex concepts. If there is an inherent defect in a product or process that we only discover when we are monitoring trends and we call the action to remove the problem 'preventive action', what do we call the action we take when we avoid building in inherent weaknesses into the product or process in the first place - such as when we perform an FMEA? That too is preventive, isn't it?

In principle, I see nothing wrong with using the term preventive action for both cases, BUT my point was that if our imagination becomes limited to the first case we are not managing the processes effectively. To meet the intent of the standard we should do both. The act of using forms that are intended to address CA and PA, puts a limit on our imagination, when if we separated them we might take account of the wider implications and design reliable products and capable processes.

I think the problem might be resolved if we redefine the terms we use
Remedial Action for eliminating actual nonconformities (it has happened because I did this)
Corrective Action for eliminating inherent nonconformities (it could happen because I have done this)
Preventive Action for avoiding potential nonconformities (it might happen if I do this)

I don't know if this is sound but it might be!!

There is an article in the March Quality Digest regarding this very topic. It is written by Dan Nelson and depicts it from an "ISO" auditor point of view which seems to support Pennington's remarks. Don't know if you need to have subscribed to read it but here's the link to the article.

http://www.qualitydigest.com/currentmag/departments/lastword.shtml

Bill

There is an article in the March Quality Digest regarding this very topic. It is written by Dan Nelson and depicts it from an "ISO" auditor point of view which seems to support Pennington's remarks. Don't know if you need to have subscribed to read it but here's the link to the article.

http://www.qualitydigest.com/currentmag/departments/lastword.shtml

Bill

:thanks: for locating this article Bill, Dan Nelson and I are on the same wavelength. I think one cause of confusion between the two terms was the wording of the Preventive Action requirement in ISO 9001:1994 clause 4.14.3a) "the use of appropriate sources of information such as processes and work operations which affect product quality,..... to detect and eliminate potential causes of nonconformities." The implication is that one should analyse SPC data for instance to detect variation that if left alone will eventually result in product nonconformity. The fault here was that the requirement did not faithfully reflect the definition of PA in ISO 8402. Clearly a process with such variation is unstable and restoring stability is a corrective action. We should not forget that standards do not reflect latest thinking as they sometimes take decades to materialize and by the time they do the world has moved on.

Okay, forgive me for being cheeky at this point...because I realize this is a very cheeky question. But, well, this is what it comes down to, isn't it?...

Will the majority of auditors accept SPC and such as PA?

Okay, forgive me for being cheeky at this point...because I realize this is a very cheeky question. But, well, this is what it comes down to, isn't it?...

Will the majority of auditors accept SPC and such as PA?

Rachel, auditors might accept SPC as Preventive Action but they would be wrong in my opinion if auditing against ISO 9001:2000. They could have been right to do so under ISO 9001:1994.

I guess its not a problem if they accept SPC as PA providing they also seek evidence of PA in product and process design

Okay, forgive me for being cheeky at this point...because I realize this is a very cheeky question. But, well, this is what it comes down to, isn't it?...

Will the majority of auditors accept SPC and such as PA?

In our case, our Registrar accepts SPC as one form of Preventive Action. Our Opportunities for Improvement can sometimes be deemed to be PA...or CI, depending on what initiated it. Ongoing training is a form of PA...to ensure that our personnel have the most current knowledge to perform their jobs. Quality Planning is a form of PA...ensuring that we have considered all variables when changing a process/infrastructure. Your system probably already has many tools and aspects within it that could fall under Preventive Action.

In our case, our Registrar accepts SPC as one form of Preventive Action. Our Opportunities for Improvement can sometimes be deemed to be PA...or CI, depending on what initiated it. Ongoing training is a form of PA...to ensure that our personnel have the most current knowledge to perform their jobs. Quality Planning is a form of PA...ensuring that we have considered all variables when changing a process/infrastructure. Your system probably already has many tools and aspects within it that could fall under Preventive Action.

*Nice.* That makes me feel better.
Sorry for being so dependent - so how exactly do you structure your documentation for this one without double-documenting things? Just a list of references to other SOPs?

*Nice.* That makes me feel better.
Sorry for being so dependent - so how exactly do you structure your documentation for this one without double-documenting things? Just a list of references to other SOPs?

Ah...that's the wonderful thing about the Quality Manual! In the field for 'Related Documentation', the reader will find links to how we formally address the paperwork related with Preventive Actions, but within the text of this section, our tools are listed.

Something to the extent of "Preventive Action can be conducted via one of the following, but not limited to, methodologies:


Nonconformance Reports;
Abnormality Reports;
Opportunities for Improvement Reports;
5S Programme and Audit Results;
Internal Audits;
Key Indicators; and
Recognition of adverse trends."

Something to the extent of "Preventive Action can be conducted via one of the following, but not limited to, methodologies:


Nonconformance Reports;
Abnormality Reports;

But isn't that corrective?

:confused: :(

But isn't that corrective?

:confused: :(

Our Nonconformance and Abnormality Reports have check boxes on them to indicate what action is being taken. Don't get too hung up on the name of the form. :)

Please understand that this is coming from an "on the floor" Quality Engineer who spends a heck of a lot of time each day fighting fires and asking lots of questions to be sure we cover all bases.

On :soap:
I think all this rhetoric trying to define Corrective from Preventive is great and I know the standard calls for separate documented procedures, but when the rubber meets the road, does it really matter whether the action is one or the other? Both terms are sub-clauses of the overall clause of IMPROVEMENT (8.5). At the end of the day, if I 've helped correct or improve or prevent anything, I could care less which one it should be applied to.
Off :soap:

How does this work regarding SPC - The implementation of SPC tools is Preventive but the "retargetting" of the process is Corrective (which, of course, Prevents nonconformances (as I believe Dave Scott alluded to months ago in this thread)). :frust: My head hurts

BTW - Wonderful discussions. Something just came over me today that I had to join in (even though I don't have to take care of making sure actions taken get put under the "proper" column heading).

Bill

On :soap:
I think all this rhetoric trying to define Corrective from Preventive is great and I know the standard calls for separate documented procedures, but when the rubber meets the road, does it really matter whether the action is one or the other? Both terms are sub-clauses of the overall clause of IMPROVEMENT (8.5). At the end of the day, if I 've helped correct or improve or prevent anything, I could care less which one it should be applied to.

I agree with you, Bill - it's making my head hurt too!

It does matter to me, only because I'm trying to determine if we even *have* any system(s) that constitute as PA (which I now know we do). The problem at my end is that folks have no clue what the difference btwn CA and PA is...and we're documenting things wrong.

Cheers,
-R.

I'm trying to determine if we even *have* any system(s) that constitute as PA (which I now know we do).
Just a quickie response (one of our "embers" is about to explode into a full-fledged fire :blowup: )


Do you have a Preventive Maintenance Program? I, at least, don't see any quarrels with this being a Preventive Action.

Bill

... and I know the standard calls for separate documented procedures...

It does? Where does it state that they need to be separate? As long as the process is documented, that's all that matters, right?

, but when the rubber meets the road, does it really matter whether the action is one or the other? Both terms are sub-clauses of the overall clause of IMPROVEMENT (8.5). At the end of the day, if I 've helped correct or improve or prevent anything, I could care less which one it should be applied to.

Do I care about the application? Yes. Why? Because my organization has a Business Management System and there are reasons why we use the tools that we do.

If you do not have the proper application, how do you propose to get buy in from the users of the BMS? If you do not have buy in, how do you propose to have an effective system? If you do not have an effective system, how do you propose to truly move from a reactive to a proactive approach?

A process for the application of corrective/preventive/improvement based activities needs to be established and formalized. There can be no improvement, however, without standardization.

I stand corrected. There is no shall that they be separated (but why did they separate them as sub-clauses?).

If you do not have the proper application, how do you propose to get buy in from the users of the BMS? If you do not have buy in, how do you propose to have an effective system? If you do not have an effective system, how do you propose to truly move from a reactive to a proactive approach?
I don't go to my boss and ask him whether I should approach an issue from the corrective or preventive point of view. I go take care of the issue with the "Quality Tool(s)" I have been trained in, and send the report on to him. He is the administrator of our QMS. I don't care which column he places the action, with its documentation, under. It's not worth the discussion if I don't happen to agree with where he puts it.

A process for the application of corrective/preventive/improvement based activities needs to be established and formalized. There can be no improvement, however, without standardization.
You lost me there (but I'm normally pretty set against "absolutes"). Are you saying that if I tackle an issue using a tool that is not "standardized" within our QMS, I have no chance of improving/correcting/preventing something?

Bill

I stand corrected. There is no shall that they be separated (but why did they separate them as sub-clauses?).

Perhaps to distinguish between their functions and applications; to show that they have different reasons for occurring?

I don't go to my boss and ask him whether I should approach an issue from the corrective or preventive point of view. I go take care of the issue with the "Quality Tool(s)" I have been trained in, and send the report on to him. He is the administrator of our QMS. I don't care which column he places the action, with its documentation, under. It's not worth the discussion if I don't happen to agree with where he puts it.

If that is the system that you have, great! But note that in the end, the issue is classified as either Preventive or Corrective or whatever terminology your organization uses.

So how does your approach differ when you take either the corrective or preventive point of view?

You lost me there (but I'm normally pretty set against "absolutes"). Are you saying that if I tackle an issue using a tool that is not "standardized" within our QMS, I have no chance of improving/correcting/preventing something?

How can you improve upon something that is not standardized? One could argue that the first attempt to standardize is, in itself, a form of improvement. Chicken and egg argument.

Try this...

You have an accepted way of doing things with an accepted set of requirements for the output. That is a process. This is your standard. This is how you do it and this is what you get when you follow the process.

Suddenly, you start doing things differently from the norm or, for whatever reason, your output is not meeting the requirements it is supposed to. This calls for Corrective Action.

Or, Option 2, things are still okay, but the numbers are showing a distinctive trend to the outer limits. Preventive Action.

The results of either scenario could result in:


The abnormality addressed and the standard returned to; or,
The abnormality addressed and a new, better way standard discovered (also called improvement).


In the end, Bill, what we seem to have here is a difference within our systems. What works for you is great! What works for me is great, too! Again showing that even though ISO 9001:2000 provides us with the requirements to meet, we still find ways to make our systems unique.

I contend that there is no such thing as a preventive action. All preventive action is based on what we know has happened before. We eat right and get plenty of exercise because experience shows that the opposite is bad for your health. Sure, it might prevent a heart attack, and I've never had a heart attack, but it is based on others having a heart attack. What it does is to prevent another heart from failing. The same thing is true with preventive maintenance. We perform it because we know that without it things fail. We are still reacting to something failing, it is still corrective in nature.

Okay, with that said, what do we do? How can we meet 8.5.3, if there is no preventive actions out there? Well, we cheat a bit. If a failure has not happened to a particular process, product, activity, or equipment, then anything we do things to prevent failure. We can call that preventive action, should we choose to. Remember, the standard allows you a lot of flexibility. Use it! SPC can be preventive, or corrective. It all depends on how you define it.

It is your QMS/EMS, and you make the rules.

I contend that there is no such thing as a preventive action. All preventive action is based on what we know has happened before. We eat right and get plenty of exercise because experience shows that the opposite is bad for your health. Sure, it might prevent a heart attack, and I've never had a heart attack, but it is based on others having a heart attack. What it does is to prevent another heart from failing. The same thing is true with preventive maintenance. We perform it because we know that without it things fail. We are still reacting to something failing, it is still corrective in nature.

Okay, with that said, what do we do? How can we meet 8.5.3, if there is no preventive actions out there? Well, we cheat a bit. If a failure has not happened to a particular process, product, activity, or equipment, then anything we do things to prevent failure. We can call that preventive action, should we choose to. Remember, the standard allows you a lot of flexibility. Use it! SPC can be preventive, or corrective. It all depends on how you define it.

It is your QMS/EMS, and you make the rules.

Dave,

Would it be "preventive" if I have a stable controlled process, but I implement a change that will make the process more robust (i.e. reducing variation around the norm)? Or, have I "corrected" the process by eliminating variation (even though the previously established limits were still conforming to spec)?
:confused:

Dave,

Would it be "preventive" if I have a stable controlled process, but I implement a change that will make the process more robust (i.e. reducing variation around the norm)? Or, have I "corrected" the process by eliminating variation (even though the previously established limits were still conforming to spec)?

Why would you want to make the process more robust? Because data suggests that a more robust process will reduce variation. Variation is the cause of nonconforming product. Your action would be corrective in nature. Now, I sure you realize that I am engaging in purely philosophical banter. In the real world, But if you really analyzed it, you would probably agree that most of the preventive things we do are nothing more than corrective.

BTW, I vote for two separate procedures because I think the scope would be different. And this coming from a guy that doesn’t believe in preventive action.

BTW, I vote for two separate procedures because I think the scope would be different. And this coming from a guy that doesn’t believe in preventive action.

:lol: :biglaugh: It's a good thing then that I voted for one, just to "prevent" yours from counting.

BTW: I do understand where you're coming from and can see that virtually any action could be interpreted as corrective. So in effect my vote has actually "corrected" your voting error.
:lmao:

:lol: :biglaugh: It's a good thing then that I voted for one, just to "prevent" yours from counting.

BTW: I do understand where you're coming from and can see that virtually any action could be interpreted as corrective. So in effect my vote has actually "corrected" your voting error.
:lmao:

Or did I correct yours! :bonk:

Dave,

Would it be "preventive" if I have a stable controlled process, but I implement a change that will make the process more robust (i.e. reducing variation around the norm)? Or, have I "corrected" the process by eliminating variation (even though the previously established limits were still conforming to spec)?
:confused:

Now that the Dave's are done correcting or preventing themselves...????...., within my organization's system, well, we'd disagree with db's comment that this is corrective. Why? Because you are still conforming to spec, even though you have variation around the norm. You are conforming, that means you are meeting requirements.

The activity of making the system more robust would be Improvement at my organization because we a standard process that is apparently stable and now we wish to reduce the amount of variation.

A preventive action would be when the difference from the norm was taking a downward trend to one of the limits. Not yet out of spec, but apparently heading in that direction. PA would entail maybe changing some equipment that has worn out, or getting a cup of coffee for the guy taking measurements for the samples...you get the idea.

A preventive action would be when the difference from the norm was taking a downward trend to one of the limits. Not yet out of spec, but apparently heading in that direction. PA would entail maybe changing some equipment that has worn out, or getting a cup of coffee for the guy taking measurements for the samples...you get the idea.

Ah ha!

Why are you taking action? "the difference from the norm was taking a downward trend to one of the limits". So, you are reacting to a situation. Your experience tells you that continual downward trend would lead to a nonconformance. You are correcting the trend. That's corrective.

Okay, let's change the scenario. Let's say you are making an adjustment because it means that it will save you money, or time or something. The process is okay, the way it is, but you want to make it better. Now that's prventive, right? No, you are reacting to a less than desirable state, but you are still reacting. Still corrective.

Ah ha!

Why are you taking action? "the difference from the norm was taking a downward trend to one of the limits". So, you are reacting to a situation. Your experience tells you that continual downward trend would lead to a nonconformance. You are correcting the trend. That's corrective.

Okay, let's change the scenario. Let's say you are making an adjustment because it means that it will save you money, or time or something. The process is okay, the way it is, but you want to make it better. Now that's prventive, right? No, you are reacting to a less than desirable state, but you are still reacting. Still corrective.

Could we discussing semantics here? Yes, I agree that action is being taken, to what degree?

In the first scenario, we are reacting to an adverse trend the could lead to nonconforming product. However, the nonconformance has not yet happened...and we are taking steps to prevent it from happening.

In the second scenario, we have stable process, but obviously wish to save money or time or something. To save money or time or something on a routine process is an improvement. To modify a routine is to hopefully improve the process. Once the goal is reached (i.e, once you have successfully saved the money or time or something), that new process becomes the routine.

As you aluded to earlier, we may never encounter a true "Preventive Action" in the real world (if we were to follow your reasons like the exercising and eating properly).

The reasoning that I've explained for our PA and Improvements is simply my organization's way (one organization out of many) of doing things. Not saying that it's better...but it works for us...and has since the 1980's. :D

Could we discussing semantics here?

We are way beyond semantics. I am existing in the twilight zone.

...is simply my organization's way of doing things.

And that is all that matters. If it works, call it what you like. Just make sure you can back up your words.

Do you know how disconcerting it is to wake up and find that the Northern Hemispere has been at War over corrective and preventative? because of my geographic location I rarely get to banter 'real time' with the cove and after reading some of this I wonder if that is a good or bad thing.

This string of posts is recounted and fought over in Many, Many threads and it is always the same. A 'Cover' asks for help to implement their system or they want US to offer some of our expertise (what we do in our workplace) and the conversation inevitably degenerates into a Chicken or the Egg discussion and NOONE wins. We should offer our advice (that is why we have - IMHO) and see if it helps the thread starter or the person that has asked the question. JMHO

I for example have ONE procedure as I personnaly think that these two subjects are intertwined and it cuts down on an extra procedure. I don't care if a person thinks that thier Issue is a preventative or a Corrective action as long as it stops a recurrence or an event from happening. :)

Greg B

Hi everyone-

Originally I had both the CA's & PA's separate from each other. It just made more sense to combine them. We now have one simple procedure for both. It works well for us. Keep it simple as you can as long as it is effective for your system.

Dave N

We're using consolidated it into one.

I'll offer a reply from the ISO/IEC 17025 world.....

One procedure or two makes no difference, so long as both are specifically addressed. In other words, CA can not imply PA, PA can not imply CA....both must be specific.

Hershal

IMHO, it doesn't matter how this would be interpreted, one or two procedures or consolidate into one, as long as in your process your at ease is using it.

Raffy :cool:

We have one procedure. It is posted in the thread titled: "Preventive Action (PA) - Employee Suggestion Box, Engineering Change Order?"

Section 3.1.2 and 3.10 will be revised soon as we will be required in the very near future to provide formal process FMEA's to a number of newer customers that we are going to prepare FAI's for. I'll also add our APQP procedure to the list of reference documents in section 4.0.

one procedure for the simple that:

- the less procedures, the better
- ISOand TS are process based so it makes sense to have have one-process orientated procedure describing your complete complaint/issue management system.

We have one procedure for the reasons others have posted. Fewer procedures is better and most people here would have a hard time understanding the differences.

Bob has said It is very hard to differentiate between CA and PA. I would say If CA is being taken on one issue , It is imposible to have PA on this. As per my understanding, PA is on the events which has never occured and once event/events happened only Corrections or / and Corrective Actrions (CA) would be taken place.

Hello Friends,

Just curious as to what the rest of you are doing.

I currently have one procedure for both, and I am considering making two seperate procedures.

What are you doing?:bigwave:

Thanks,
CarolX
I realize this post is fairly old but I started with two separate procedures. I realized that I could combine them and did so as a Continual Improvement Procedure. After evaluating them for a while I decided to separate them again. It just seems easier to me to keep them separate. For CA we do the 8-D, as such CA is also CI because you are supposed to correct the system to prevent reoccurance. I do not concider this part of the 8-D process to be Preventative in the sence of the standard because it is not pro active but re active.
JMO
Mark

I realize this post is fairly old but I started with two separate procedures. I realized that I could combine them and did so as a Continual Improvement Procedure. After evaluating them for a while I decided to separate them again. It just seems easier to me to keep them separate. For CA we do the 8-D, as such CA is also CI because you are supposed to correct the system to prevent reoccurance. I do not concider this part of the 8-D process to be Preventative in the sence of the standard because it is not pro active but re active.
JMO
Mark
Mark,

Don't sweat this being an old thread. People are voting in this all the time, and it is reviewed fairly often. We have a wealth of info in this one.

I find it interesting that you had 2 procedures, then combined into one, then found that was not effective and went back to 2. Sounds like you have a dynamic system that works well.

In my opinion it's corrective/preventive action. Separating the two is like separating eating into chewing and swallowing.

You have a discrepancy.
Corrective: (Immediate) What are you going to do to correct it now, i.e. rework, remake, return to vendor etc.
Preventive: (Future) What are you going to do to prevent it from happening again, i.e., Revise work instruction, Retrain, Improve Process etc.

In my opinion it's corrective/preventive action. Separating the two is like separating eating into chewing and swallowing.

You have a discrepancy.
Corrective: (Immediate) What are you going to do to correct it now, i.e. rework, remake, return to vendor etc.
Preventive: (Future) What are you going to do to prevent it from happening again, i.e., Revise work instruction, Retrain, Improve Process etc.


And see, Underdog, that's not what I've been told - there are so many schools of thought on this. I have been taught that a corrective action is what you execute to eliminate the root cause of a nonconformance (i.e., what are you going to do to ensure that it never happens again?), and a preventive action is an application of a fix to a situation where there is potential for a nonconformance (i.e., that's a good idea for a correction to production line A, and I think it would work for B and C as well). The 9K:2K standard at 8.5.2(c) states that we are to "evaluat[e] the need for action to ensure that nonconformities do not recur".

I have been told that there are immediate corrective actions (the 'let's fix this quick' ones) and there are proper corrective actions (the 'eliminate the root cause' ones). The latter of the two, at least, must exist in every nonconformance record (provided that a legitimate problem is actually identified), and likely both will exist. However, a preventive action is optional and does not always exist as part of a CAR. There may be cases where your fix is applied to other areas to prevent nonconformances, but this may not always apply.

Just my take on things.
Cheers,
-R.

In my opinion it's corrective/preventive action. Separating the two is like separating eating into chewing and swallowing.

You have a discrepancy.
Corrective: (Immediate) What are you going to do to correct it now, i.e. rework, remake, return to vendor etc.
Preventive: (Future) What are you going to do to prevent it from happening again, i.e., Revise work instruction, Retrain, Improve Process etc.

Underdog, like Rachel, I have been trained to view Corrective and Preventive in a manner different from yours. And I think most of us in the Cove would not necessarily agree with how you have defined them.

Using your example of incorporating a "time" factor into explaining the difference, my training has taught:


Correction = Immediate
Corrective = Timely
Preventive = Never


Allow me to use an example...

Ouch! I cut my finger!

Correction means I clean the wound and apply a bandaid and then continue on with whatever I was doing.

Corrective action means:


Apply Root Cause Analysis (5 Why's, Ishikawa, etc.) - Why did I cut my finger? What causes led to this effect?
Action Plan development - What must I do to stop the bleeding/pain? What must I do ensure this does not happen again? Assign responsibilities and deadlines. Record results.
Verification Plan development - How to verify that the Action Plan truly addressed the root cause and assign responsibilty(s) and deadline(s). Record results


Preventive action means - okay, we're seeing a trend of finger cutting or we have idenfied an opportunity to avoid the possibility of someone cutting their finger. Develop an Action Plan and Verification Plan (where appropriate) to ensure that no more fingers, or no fingers at all, are cut.

When I started at my organization, Underdog, many people had the same line of thought as you - that corrective and preventive were part of the same methodology. Unfortunately, I believe you find that the accepted interpretation by the majority is that they are separate items.

that's not what I've been told - there are so many schools of thought on this.
I've been told a lot of things too, and I analyze what I've been told and employ what works.

PS My School is HKU (Hard Knock University), What is yours?

Underdog, like Rachel, I have been trained to view Corrective and Preventive in a manner different from yours. And I think most of us in the Cove would not necessarily agree with how you have defined them.

Using your example of incorporating a "time" factor into explaining the difference, my training has taught:


Correction = Immediate
Corrective = Timely
Preventive = Never




Where do you get Correction action from?

And I'm curious to find out if most of you at the cove do not agree (disagree).

Where do you get Correction action from?

As I said, I was attempting use the "time" approach that you used in your definitions. It was my intent to speak using terms you were familiar with.

Correction is also a term that is used to imply immediate action before one has the time to sit down and conduct a root cause analysis. Obviously, if you cut your finger badly, you will want to stop the bleeding (correction) before realizing that the equiment you were using has a sharp edge with no protective guard in place (part of corrective action).

And I'm curious to find out if most of you at the cove do not agree (disagree).

One thing is for certain, Underdog...Covers very rarely withhold their opinions on topics. :) That's why we often have such wonderful discussions! :agree1:

that's not what I've been told - there are so many schools of thought on this.

I've been told a lot of things too, and I analyze what I've been told and employ what works.

PS My School is HKU (Hard Knock University), What is yours?

Underdog - School has nothing to do with it ("school of thought" is an expression). I learned that at my lead auditor training, actually. My whole point was that this is a topic that is often interpreted differently from organization to organization.

But if you want to be snarky - congratulations on your graduation from HKU.

Corrective: (Immediate) What are you going to do to correct it now, i.e. rework, remake, return to vendor etc.Um... I would label that Control of nonconforming product - Clause 8.3....Preventive: (Future) What are you going to do to prevent it from happening again, i.e., Revise work instruction, Retrain, Improve Process etc.As indicated by the others we have turned that subject inside out on numerous occasions. Some examples:

Correction - Corrective Action - Preventive Action (http://elsmar.com/Forums/showthread.php?t=8617&highlight=preventive+definition)
Corrective Action vs. Preventive (Predictive) Action - A Definitive Discussion (http://elsmar.com/Forums/showthread.php?t=687&highlight=preventive+definition)
I need help creating a practical preventive action process (http://elsmar.com/Forums/showthread.php?t=5951&highlight=preventive+definition)
Continual Improvement & Preventive action (http://elsmar.com/Forums/showthread.php?t=6103&highlight=preventive+definition)
Preventive Action Documentation (http://elsmar.com/Forums/showthread.php?t=5750&highlight=true+preventive+action)

The bottom line is that it is rather difficult to prevent something that has already happened. A further indication to that effect is that the requirement to prevent recurrence is found under clause 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
----
c) evaluating the need for action to ensure that nonconformities do not recur, /Claes

Underdog,
You are right on.
Why does this have to be so complicated?
It can be either one procedure or it can be two procedures.
That's purely a choice you make. Makes no difference to the definition of Corrective and Preventive.
In our case we have the one procedure covering both Corrective and Preventive Actions and very closely linked to the Non Conformance, Deficiency and Field Failure Procedure.

By the way these terminoloigies as we use them are:

Non conformance - usually refers to product

Deficiency - were procedure / work instruction has not been followed

Field Failure - Basically anything post delivery.

Um... I would label that Control of nonconforming product - Clause 8.3....As indicated by the others we have turned that subject inside out on numerous occasions... Corrective action/Claes

I'm not viewing ISO-9000 or AS9100 (which is what I am working to) as a linear document. There is of course a flow, but all of it needs to be taking place concurrently.

8.3 Control of Nonconforming Product
8.5.2 Corrective Action: "appropriate to the effects of the nonconformity’s"

Nonconformance is the driver.

Help me out here on something. The title of this string is Corrective action, Preventive action - One or Two procedures. I don’t find the term "Preventive Action" in the spec; maybe I'm not looking in the right place. What’s the history on the use of Preventive, Corrective Action terminology? Is that something the trade came up with as a way to deal with the different aspects of Nonconformance?

PS You confused me with...

The bottom line is that it is rather difficult to prevent something that has already happened. A further indication to that effect is that the requirement to prevent recurrence is found under clause 8.5.2: Corrective action/Claes

Specifically the "prevent something that has already happened" part

I'm not viewing ISO-9000 or AS9100 (which is what I am working to) as a linear document. There is of course a flow, but all of it needs to be taking place concurrently.Absolutley. Help me out here on something. ...I don’t find the term "Preventive Action" in the spec; maybe I'm not looking in the right place.In the standard, you mean? I don't know about AS9100, but in ISO9001:2000 you'll find it under clause 8.5.3: What’s the history on the use of Preventive, Corrective Action terminology? Is that something the trade came up with as a way to deal with the different aspects of Nonconformance? It's the terminology used in ISO9001:2000 (and explained in ISO9000:2000 Quality Management Systems - Fundamentals and vocabulary.): 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. We have to go looking for trouble and stop it before it happens...
PS You confused me with... Specifically the "prevent something that has already happened" partSee above. I wonder if maybe we didn't confuse each other a wee bit? http://elsmar.com/Forums/images/smilies/lol.gif Not to worry, it's bound to happen every now and then...

/Claes

ISO 9001:2000 - section 8.5.3 Preventive Action "The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurence. Preventive actions shall be appropriate to the effects of the potential problems." Also mentioned in section 8.5.1.

Training I've had suggests that preventive is most easily applied during the design phase of a project - Looking at the questions what can go wrong, & what can we do to make sure that it doesn't happen.

All training I've had say once you've had a problem/nonconformance the actions you're taking are corrective, even if it occured on line 1 and you're also applying it to line 2, where you haven't had the problem crop up yet.

For me, the blurry area is more continual improvement/preventive action. For example, we have a program to improve the cleanliness of iron powder being produced. We have not had a problem with the current level, but are trying to apply our product to more demanding end use applications. Long term we may get a competitive advantage for a time if we improve cleanliness, even though it meets current specifications, also will reduce the possibility of parts produced from the powder failing in the field. We're calling it a continual improvement project - could probably also be called a preventive action. It depends in part I think on corporate culture.

Just another 2 cents worth thrown into the pot.

Where do you get Correction action from?

And I'm curious to find out if most of you at the cove do not agree (disagree).

I do agree with Roxane. The immediate correction (as Claes mentioned) has to do with nonconforming product - what did you do with the product? Rework it? This is the correction - often referred to as "interim action" as well. However, fixing the product does not keep the defect from "recurring". This is where you need the corrective action.

Preventive action means you prevented the problem before it happened. Preventing occurance.

For me, the blurry area is more continual improvement/preventive action.

:agree1: :agree1: :agree1:
I agree three times over.
That's one that I'm still struggling with. As I see it - not every continual improvement is a preventive action (i.e., buying an automatic stapler will improve efficiency in clerical work, but it's not going to prevent nonconformances) - but every preventive action is a continual improvement. (Then again, you could argue the same thing for corrective action.)

We have one procedure because in our case we review all input activity for correttive action or prevenction action (Non conformity in internal Audits, statistical analysis of :Custumer's complaint, non conformity of product, defects of product etc) in a montly meeteng :bigwave:

Welcome to the cove, Cavanna. :bigwave:

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

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

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

How about this for an analogy between corrective and preventive:

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
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.

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...

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.

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

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

I interspersed some comments in blue.

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 !

LaurieIt's always nice to have folks willing to express an opinion.

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

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.

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.

I have occassion to read this thread because an auditor just cracked one of my clients open on the preventive action clause AS9100 8.5.3 I argued for one form for both CA and PA, to no avail. A minor non conformity was written up. This is the first time one of my clients have been caught up on this . . . all to this point have used one form. However, I will say I think the auditor makes sense on this.

So in Wes' scenario I will be writing a procedure to prevent the tire from going flat before it occurs. Makes sense. I would like to develop a preventive action process and form.

Any good ones out there?

I have occassion to read this thread because an auditor just cracked one of my clients open on the preventive action clause AS9100 8.5.3 I argued for one form for both CA and PA, to no avail. A minor non conformity was written up.

Noooooo. Who is the registrar? (come on give it up.) What was the reasoning that the form could not be for both CA and PA?? I have one form but have not been audited yet - still in the implementation process.

It is BSI.

...However, I will say I think the auditor makes sense on this.
How so? We use one form for both - but that doesn't mean it would make sense for someone else. Can you give us the exact wording of the minor nc, please?

Also - I note in our Quality Issue Procedure that not all preventive actions are documented on this form. I reference our APQP procedure for a description of job specific preventive actions (PFMEA), for example.

Preventive action process is designed to prevent an occurance, CA addresses issues that have already occurred.

The following is from the 9101B checklist:

8.5.3 Preventive Action
53 Does the organization determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence (2)?

54 Are preventive actions appropriate to the effects of the potential problems?


55 Is a documented procedure 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) recording of the results of the action taken (see 4.2.4)?
e) reviewing preventive action taken?


I don't really want to release the exact wording of the report, however, the CA process did not satisfy "potential problems" for them. It really is okay anyway, because I will write a process that helps them to evaluate this potentials like the examples already set forth in this thread.

I have occassion to read this thread because an auditor just cracked one of my clients open on the preventive action clause AS9100 8.5.3 I argued for one form for both CA and PA, to no avail. A minor non conformity was written up. This is the first time one of my clients have been caught up on this . . . all to this point have used one form. However, I will say I think the auditor makes sense on this.
So in Wes' scenario I will be writing a procedure to prevent the tire from going flat before it occurs. Makes sense. I would like to develop a preventive action process and form.
Any good ones out there?

I would suggest adoption of Proess Approach for Corective and Prevenive Action Processes. One can adopt SIPOC model - (Supplier input processes - Input - Process - Output - Customer output processes).
First - define the Output of the process.
Second - specify Inputs to achive the defined Output.
Third - specify input-processes from which these Inputs will come.
fourth - specify out-processes to which the Output will go.

Then one can also specify Performance Indicators, Qualiy Objectives, Team details and any other Resources required.

I've gone with two separate procedures. Even though they are almost identical in wording, I wanted to make sure that others using the system would have no issue with understanding one or both procedures as individual pieces of the quality puzzle.

Two separate procedures are OK to meet he requirements of ISO 9001 for six mandatory procedures. However one should clearly understand the difference between corrective and preventive actions. I have tried to explain this difference in one of my previous posts.

I have a Question. I am merging my companies QMS with our EMS. TS16949 and ISO 14001. In 14001 corrective and preventative actions are one clause, 4.5.3
It is because of this that I have combined our ca and pa processes into one process. Am I to believe that this should not be?

Thank you
Sean

1 procedure

MK

I have a Question. I am merging my companies QMS with our EMS. TS16949 and ISO 14001. In 14001 corrective and preventative actions are one clause, 4.5.3
It is because of this that I have combined our ca and pa processes into one process. Am I to believe that this should not be?
Thank you
Sean

There is nothing wrong in it. You have only to ensure that people are not confused and clearly undestand the differnce between corrective and preventive actions.

There is nothing wrong in it. You have only to ensure that people are not confused and clearly undestand the differnce between corrective and preventive actions.

Betterlife and Reset,

Good luck in trying to tell EVERYONE the difference between CA and PA because if Professionals like us need this much discussion over it then how is the layman ever supposed to understand it???? There are over 15 pages of comment in just this thread and there are others.
IMHO and I have said this MANY times it does NOT matter. They are both trying to prevent further/future occurance of something we don't want to happen again or ever. Concentrate on the measure to ensure this does not happen such as Quality Awareness training, Audits, Reviews, Process Development. In process inspections, Risk Management, Operator AND Management involvement etc
For the record, I agree with the Environmental standard and it should be ONE clause. I will now step down off my box and please do not get me started on the whole 'Shall' thing. I have had a very bad day auditing suppliers. :frust:

Let's try to be simple. For sure it doesn't matter if you have one or two procedures.
Only "must" is you have to have a way to treat both occurrences(CA or PA) according your needs, availability of resources, etc, etc.

We have one procedure now, but we are switching to two. The reason for this is that Quality owns the Corrective Action process, but it seems that Quality is not the best owner of Preventive Action. It would make more sense for the Engineering/Planning function to do this.

We have one procedure now, but we are switching to two. The reason for this is that Quality owns the Corrective Action process, but it seems that Quality is not the best owner of Preventive Action. It would make more sense for the Engineering/Planning function to do this.

G'Day waterdog and welcome to the Cove,

I am sorry, but I have been dragged back to this particular thread (see my post 2 above your last and you will understand that I am not a fan of CAPA). You are going to have to explain this one to me. WHY is the engineering/planning department better at Preventative Action? Do they have the only crystal ball? I think not. Can't engineering also perform CA? Correct it after it has broken and Preventative Maintenance to ensure it or something else does not break? You would seem to be coming from a purely 'ACTION' versus 'REACTION' standpoint and IMHO when this occurs you get division in work areas, responsibilities etc. When do you start CA and stop PA? How is this detailed? What committee decides if a CA is not also a PA? Do you then have to file the responses in two separate files because they are one in the same action I could go on......

I would really like someone to explain in the greatest detail (especially the standards guys that developed this twaddle WHY do we have CA and PA? It should have stayed (IMHO) as ONE dish - CA with a side serving of PA as you can't have one without the other but it throws up all sorts of conundrums and conflicts of interest when you have them separate (just look at this thread)

Sorry Waterdog this is DEFINITELY not against you but the system!!!!

WHY is the engineering/planning department better at Preventative Action? Do they have the only crystal ball? I think not. Can't engineering also perform CA? Correct it after it has broken and Preventative Maintenance to ensure it or something else does not break? You would seem to be coming from a purely 'ACTION' versus 'REACTION' standpoint and IMHO when this occurs you get division in work areas, responsibilities etc.

Greg brings up an excellent point. The procedures for our Corrective and Preventive Action processes are owned by my department (Management Systems), however, the methodologies are applied by everyone through the company at all levels and in different manners.

Preventive/Preventative/Predictive Maintenance is just one aspect to taking steps with the intent to reduce the liklihood of something adverse occurring. What about Opportunties for Improvement, generated from Internal/External Audits?...I doubt Engineering is responsible for those. What about Key Performance Indicators?...if everyone has them, surely every department is looking at them and when adverse trends are identified, taking Preventive Action?

CAPA are "department-specific" processes...they are meant to be applied on a company-wide scale. If you need a department, though, to take ownership of the documentation, might I suggest "Corporate" or "QA" or "Administration"...an area that has global impact.

Greg,
Perhaps I should explain this a little further. There are several reasons we decided to give PA to engineering and manufactiring. First of all, it makes sense to our organization. This may not work for every company, but it seems like a natural fit to us. Quality, at least in my organization, rarely prevents nonconformance. Second, we are trying to spread the responsiblity of meeting the standard (AS9100 in our case) among all management, and not just the quality department. Third, there is nothing in the standard that says we can't. It is important to note also that just because engineering owns PA doesnt mean quality can't write them, or sales, or the president. This goes for CA as well. I am much newer at quality than most Covers, and perhaps I am a little naive, but it seems to me that the best thing about the standard(s) is that they are not rigid and you can be creative and find what actually works for you.

There are several reasons we decided to give PA to engineering and manufactiring. First of all, it makes sense to our organization. This may not work for every company, but it seems like a natural fit to us.

As long as it fits, that's great...but what I think Greg was saying was that concepts such as PA do not necessarily "belong" to one department. That's why, in an effort to demonstrate not only management committment but to also get global 'buy-in', owners of documents for such processes may experience better success (i.e., adherence to the process) if at a corporate level. But if it works for you...great! :agree1:

Quality, at least in my organization, rarely prevents nonconformance.

You are right that departments with the word "Quality" in their title are more likely to correct than prevent, but which department is responsible for implementing the PA processes? The CA processes? Internal audits? Nonconforming products? Customer complaints?

Preventive actions can be sourced out of many fields.

Review the CAs...is there an adverse trend?...there's a PA!
An Opportunity for Improvement...there's a PA!
Review Nonconforming products...there's a PA!
Review Customer complaints...is there an adverse trend?...there's a PA!
Customer feedback with areas for improvement...there's a PA!


Perhaps you can understand why Greg and I disagree with Engineering taking 'ownership' of this process, based on that list. :)

Second, we are trying to spread the responsiblity of meeting the standard (AS9100 in our case) among all management, and not just the quality department.

So, how does giving the ownership of PA to Engineering help out in this? Is it going to the Engineering Manager, instead? Maybe you could create an ownership area of Management instead of using Engineering?

Third, there is nothing in the standard that says we can't.

We didn't mean that you couldn't. :) But based on your post when you said Engineering was a better and left it at that, well, we had some concerns. I apologize if you thought we were saying that what you were doing was a no-no.

It is important to note also that just because engineering owns PA doesnt mean quality can't write them, or sales, or the president. This goes for CA as well.

That alleviates much of our concerns, but I still think that creating an ownership area of Management would be more effective than making Engineering the owner of the document. I don't know much about your company, waterdog, but with mine, I know that our Engineering Manager would never write this document and it would fall to their department document author who understands only the Engineering facet of PA. It has been more effective for us to put the ownership of the process at the 30,000' level where all possible means of demonstrating PA can be identified (i.e., seeing all the trees within the forest).

I am much newer at quality than most Covers, and perhaps I am a little naive, but it seems to me that the best thing about the standard(s) is that they are not rigid and you can be creative and find what actually works for you.

Naturally. The "shall's" are merely the what to do, not the how to do it. If giving this to Engineering is the best possible solution for your organization, great job! :agree1: From my 10+ of ISO and management systems (started when I was in university), I would offer up that there perhaps more suitable owners of the process. :)

Excellent points. :thanx:

Roxane,

You are my Hero (I am not worthy) :applause: . That is exactly what I meant it is just that you explained it whole lot better and without my subtle sense of sarcasm. Sorry Waterdogs if I cam across a bit strong.

One point I would like to expand on is

(Originally Posted by waterdog) Quality, at least in my organization, rarely prevents non-conformance.
I agree with Rox's points but I also TEACH - Preventative Action, Vigilance, Product Identification, Non Conformance and Contamination etc.

I am JUST like the plant Safety Officer. He teaches Behaviour Based Safety (among other tools) to PREVENT accidents to Plant and People.

Here are my slide shows on Quality that may show how their are synergies with Safety, Environment and Quality (they are all Preventative Measures) PPP Slide (http://elsmar.com/Forums/attachment.php?attachmentid=708) and the thread that it comes from is Quality Culture - Teaching Quality is as Important as Safety (http://elsmar.com/Forums/attachment.php?attachmentid=708) and another What is a Quality Management System (http://elsmar.com/Forums/attachment.php?attachmentid=2176).

I hope these slides convey that a Quality system IS a Preventative Action Tool probably more so than the Engineering Department.

Usually companies do a very good job of handling Corrective Actions. However they quite often include Preventive Action in the same procedure and don't do a very good job of identifying and monitoring and measuring PA's. I believe by separating them into two procedures the Preventive Actions have a better chance of being recognized and acted on. Preventive Actions can be things like setting action limits on processes such as Bioburden or other processes. The actions taken when excurations begin to occur that are recognized prior to a process failure can then be counted as a PA and appropriate measures can be taken. These are in essence what some companies would count as a CA, but it is more obvious a PA when it is treated this way.

One Procedure
One Form

The only difference is : Are we correcting a problem or preventing one. Once that is determined then just fill out the necessary section on the form.

The number of procedures is not an issue either way. I have spent a significant amount of time investigating the lack of preventive actions. The failure in preventive is not the procedures. In my experience, there are two root causes. We go months or weeks without any, and no one is pounding the table in meetings saying this is a big deal. No demand, no par's.

The other main cause is we are not looking for root causes, we are looking for solutions to problems. Consequently, we are limited in what kind of preventives we can initiate.

my two cents...

Following is the copy of the APG Guidance document on PA:

1) Introduction
ISO 9000:2000 clause 3.6.4 defines preventive action as “action to eliminate the cause of a potential nonconformity or other undesirable potential situation”.
This can be considered as an action taken to prevent a nonconformity from happening. However, if there is no nonconformity to start with, and if the preventive action is effective, the status quo will be maintained. This raises the difficulty of auditing a process for which the desired output is to maintain the status quo.
There is often confusion about the differences between the terms i.e. correction, corrective action and preventive action (please refer to ISO 9000:2000 for their formal definitions), and also in relation to an organization's activities in respect of each of them.
Auditing an organization’s correction and corrective action processes is relatively straightforward, because the results and effectiveness of these processes are usually well defined (i.e. if the organization has already identified a nonconformity, it is relatively simple for an auditor to evaluate the process the organization used, or is planning to use, to correct it, and whether or not this will be effective in avoiding re-occurrence of the nonconformity); however, auditing preventive action processes is usually more complex.

2) Auditing Guidance
2.1) ISO 9001:2000 requires the organization to have a documented procedure for preventive action.
Note: The combination of corrective action and preventive action documented procedures into a single QMS document is acceptable, but is not recommended. If these are combined, then it is important for the auditor to verify that the organization understands clearly the difference between the intent of corrective and preventive actions.
2.2) The Standard requires this documented procedure to include:
a) How the organization determines potential nonconformities and their causes.

Typical examples include:
 Trend analysis for process and product characteristics (output from the data analysis process). A worsening trend might indicate that if no action is taken, a nonconformity could occur.
 Alarms to provide early warning of approaching "out-of-control" operating conditions.
 Monitoring of customer perception, by both formal or informal feedback systems.
 Analysis of trends in process capability, using statistical techniques.
 Ongoing failure mode and effect analysis for processes and products (this is a requirement of TS 16949, for the automotive industry, for example).
 Evaluation of nonconformities that have occurred in similar circumstances, but for other products, processes, or other parts of the organization, or even in other organizations.
 Through planning activities for both predictable situations (e.g. due to expansion, maintenance, or personnel changes – see also ISO 9001, Clause 5.4.2b)) and for unpredictable situations (e.g. naturally occurring problems such as hurricanes, earthquakes, floods etc.)
 ISO 9004:2000 clause 8.5.3 Loss prevention provides other examples (Note: this ISO 9004 guidance is not mandatory).

b) An evaluation of the need for preventive action.
Methods used in the evaluation could include:
 Risk analysis approaches
 Failure mode and effect analysis, as mentioned in (a) above.
(Note: neither of these specific approaches or methodologies are requirements of ISO 9001:2000.)

c) How the organization determines what action is required, and how it is implemented.
An auditor should look for evidence that:
 the organization has analyzed the causes of potential nonconformities (use of cause and effect diagrams and other quality tools may be appropriate for this).
 the required actions are deployed in all relevant parts of the organization, and in a timely manner
 there are clear definitions of the responsibilities for the identification, evaluation, implementation and review of preventive actions

d) Records of the results of the actions taken
 What records are kept?
 Are they appropriate, and are they a true reflection of the results?
 Are they being controlled in accordance with ISO 9001:2000 clause 4.2.4?

e) A review of the preventive actions taken
 Were the actions effective (i.e. was a nonconformity prevented from occurring and were there any additional benefits)?
 Is there a need to continue with the preventive actions the way they are?
 Should they be changed, or is it necessary to plan new actions?

2.3) There is often significant “philosophical” discussion between the auditor and the organization about where corrective action ends, and where preventive action begins. For example, if a nonconformity is detected in process “A”, are actions taken to avoid future nonconformities in processes “B”, “C” and “D” preventive actions, or simply within the scope of the corrective actions taken for process ”A”? The auditor should avoid being “side-tracked” by these discussions, and concentrate on whether or not the actions were effective. The “labeling” of the actions taken is of secondary importance!

I have blended them both into one procedured for simplicity, ease of use and minimum confusion.

I have blended them both into one procedured for simplicity, ease of use and minimum confusion.

It is OK as long as there is no confusion.

Does CA occur, If the process was followed correctly?

If PA is taking place, why does CA need to happen?

Does CA occur, If the process was followed correctly?
Do you mean, does sh*t happen to the best of us? Yes.

If PA is taking place, why does CA need to happen?

Because the best PA doesn't always account for everything, and if you expect that it will, you're more likely to have problems.

A person who thinks he has all the answers is more likely to be wrong than someone who understands his own ignorance.

Experience has taught me that over 95% of the reasons for CA was that we were not following the method designed to prevent the occurance in the first place. The only reason I see CA to be effective is in those situations where the process did not cover the whole process.
An example might be..."Bent contact". If the stamping machine is cleaned, the stamp is not worn, etc... This machine will make a good contact. If I take the contact and correctly install it into a switch, it should work.
The problem here is, what about the action between making and building. If I do not consider how the material is handled between processes. This contact could get bent enought to not visually see, but still miss-function.
(Which many may say, oh, look, training problem...making the assumption that the contact was bent by the assembly process). If this root cause was determined, then the CA becomes the PA to cause it not to happen again.
I have seen too many excess CA's implemented causing extra work and non-value-added inspection when simply following the process will work.

Experience has taught me that over 95% of the reasons for CA was that we were not following the method designed to prevent the occurance in the first place. The only reason I see CA to be effective is in those situations where the process did not cover the whole process.

I think "over 95%" might be a bit of an exaggeration, and I'm not sure how a process can't cover a whole process, but I think I see your point. I agree that a lot of trouble could be saved if people would just follow the process, but when they don't, it's a good idea to look and see if there was a reason for them not to.

An example might be..."Bent contact". If the stamping machine is cleaned, the stamp is not worn, etc... This machine will make a good contact. If I take the contact and correctly install it into a switch, it should work. The problem here is, what about the action between making and building. If I do not consider how the material is handled between processes. This contact could get bent enought to not visually see, but still miss-function.(Which many may say, oh, look, training problem...making the assumption that the contact was bent by the assembly process). If this root cause was determined, then the CA becomes the PA to cause it not to happen again.
Here you seem to be arguing against yourself and seeing value in the type of CA you didn't like in the first paragraph.

I have seen too many excess CA's implemented causing extra work and non-value-added inspection when simply following the process will work. Now you're back on the original track. I agree that formal CA isn't always necessary or prudent, and shouldn't necessarily happen every time something goes wrong, if that's what you're saying.

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.

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?

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.

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!

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.

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.

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?

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!

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.

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!

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.


ISO 9000-2000 (3.6.4 Note 2):
Preventive action is action taken to prevent occurrence whereas corrective action is taken to prevent recurrence.

The problem with the foregoing definition is that "recurrence" is a form of "occurrence." That is, a "recurrence" is an "occurence," although an "occurrence" is not necessarily a "recurrence."

In point of fact, it doesn't make a diddly-d*mn bit of difference what I call the respective types of actions, except to hopeless pedants who have their heads inextricably stuck in the standard, rather than in the process. Stop confusing the container for the thing contained and look at the work, and the results of the work if you want to find out about the efficacy of the system.Some "old dogs" are smart enough to follow the right scent and not be fooled by inconsequential distractions.

Some "old dogs" are smart enough to follow the right scent and not be fooled by inconsequential distractions.



Aw, c'mon, Jimmie...you may be an ol' dog on some posts...but this time around, your kind wasn't the kind I was talkin' bout.

The post I replied to was commenting on the confusion between what is correction (reactive) and what is preventive action (proactive).

The old dogs I was talking about were those who cling to the twenty year old paradigm of corrective actions become preventive and lump it all together into a mush.

I agree the container and titles are not the issue. However the ISO paradigm that proactive is better than reactive, that is extremely important. Most failures could be prevented if we were proactive.

arff...

PS: by the way, what's a pedant? Isn't that those dirty ol' men that have to register with the cops when they move?

PS: by the way, what's a pedant? Isn't that those dirty ol' men that have to register with the cops when they move?

See sense #1 here: http://www.bartleby.com/61/42/P0144200.html

I'm going to have one procedure, one tracking database, but two forms.

does that make sense?

I'm going to have one procedure, one tracking database, but two forms.

does that make sense?

Sure, why not...if it works. I actually have a multitude of PA forms, since we clasify calibration, preventive maintinance and engineering change orders as PA. They each have a seperate form.

One procedure is sufficient, but remember they are two different processes. Corrective Action fixes the problem. Usually you put in place a preventative action to reduce or eliminate the problem, but preventative action processes should also include actions taken BEFORE a problem arises. Make sense?

:frust:

I too have been struggling with this PA -vs- CA issue.

Question: The both 8.5.2 and 8.5.3 state; "A documented procedure SHALL be established to define requirements for...." wouldn't you interpret this as 2 documents rather than combining the two?

I'm looking for direction prior to my upcoming August audit; your feedback is very much appreciated.

Question: The both 8.5.2 and 8.5.3 state; "A documented procedure SHALL be established to define requirements for...." wouldn't you interpret this as 2 documents rather than combining the two? You can do it either way.

From http://isotc.iso.org/livelink/livelink/3816351/APG-PreventiveAction.doc?func=doc.Fetch&nodeid=3816351 (http://isotc.iso.org/livelink/livelink/3816351/APG-PreventiveAction.doc?func=doc.Fetch&nodeid=3816351)


Note: The combination of corrective action and preventive action documented procedures into a single QMS document is acceptable, but is not recommended. If these are combined, then it is important for the auditor to verify that the organization understands clearly the difference between the intent of corrective and preventive actions.

:frust:

I too have been struggling with this PA -vs- CA issue.

Question: The both 8.5.2 and 8.5.3 state; "A documented procedure SHALL be established to define requirements for...." wouldn't you interpret this as 2 documents rather than combining the two?

I'm looking for direction prior to my upcoming August audit; your feedback is very much appreciated.

Try not to squeeze more out of the standard than you need to. In addition to Sidney's direct advice, look at the phrase "documented procedure." It's not a redundancy, it's referring to two different things: the procedure (the process) and the documentation of it. In other words, the standard is saying that it's not enough to have a process; the process also has to be documented. In other cases there is no requirment for processes to be documented. So when the two clauses both say that a "documented procedure" is necessary, just substitute "process" for "procedure" and you'll see why it's permissible to have a single document.

:frust:

I too have been struggling with this PA -vs- CA issue.

Question: The both 8.5.2 and 8.5.3 state; "A documented procedure SHALL be established to define requirements for...." wouldn't you interpret this as 2 documents rather than combining the two?

I'm looking for direction prior to my upcoming August audit; your feedback is very much appreciated.

I have one top level procedure and a variety of lower level work instructions decribing how to accomplish all the points in my procedure.

For example - we clasify calibration and preventive maintainence as part of our PA system. I have seperate work instruction for those processes.

I am not a quality guru. I devote most of my time with lean.

I seem to sense that we're missing the point when addressing CA and PA.

Systematically, we have leak cause, system cause, process cause. Depending on the cause, shouldn't we be looking at this first before deciding if we need to implement a CA or a PA.

Of course if a defect has been discovered . . . its too late, the defect already leaked out. From my perspective, this must first address CA.
Then depending on whether it is a system cause or process cause, we must then address a PA.

All other actions on defects that have not happened would be classified as PA.

Getting back to the origional question, 1 or 2 procedures . . . Since the process is simular, ie. . . (problem solving). . are we not using one procedure to address defects in two different forms? Leak cause (CA), System / process cause (PA)?

Well . . . thats my two cents for what ever its worth.

First, it shall be pointed out clearly: both actions are preventive in nature, but CA prevents REcurrence of the problem, PA prevents OCcurrence.
Second: correction is essential part of CA, but it shall not be limited to it.
Third: if you try to invent relevant "processes", you go to nothing. The problem is that both CA and PA shall be carried out on various levels. On top management level it is a part of management review , which is part of the strategic planning process. On operation level, it is essential part of each business process - when we monitor and /or measure process output, we can arrive to necessity for PA or CA, if the output don't conform to the established requirements and/or other process criteria. So in fact the procedures for CA and PA may be described in QM as an approach, and in details - in some particular cases, connected with some specific process. Separate paper procedures and CAR sheets never works - at least in CIS countries practice. What is working - when each process manager has a special log for recording some operational information, and each person (operator, technologist, foreman, quality inspector, etc - may write his/her observations, which are then discussed at regular meetings - and if required - necessary CA or PA are recorded in the same log in special column, together with terms of implementation and person(s) responcible. Follow up and effectiveness verification may be recorded at the same log by relevant personnel. If you use SPC - it's obvious that CA and PA are essential part of each operational process. If some actions are required on the level of top management and enterprize as whole, that it is appropriate to review these issues at the management review meeting or by another suitable procedure (e-mail conference, etc) and take necessary decisions.
General guidance may be formulated as such:
Look attentively at your business flow and all necessary to support and control it, and the last thing to look at - ISO 9001 clauses and sequence of them. Don't treat each clause as separate "process" - it's just a requirement you have to follow, in the way, suitable for your business and activity.

CA prevents REcurrence of the problem, PA prevents OCcurrence.

Urm? Correct me if I am wrong but isn't prevention of reoccurrence the same as preventing occurrence?

How can you prevent something you do not know could exist!?

I see it as this:

Corrective action is stopping the bleed. Correcting something that is wrong. What oyu do with something you have found to be wrong.

Preventative Action is stopping the cause of the bleed from occuring again. How will you prevent it from happening. This PA can then be carried over for future Cont Imp activities to ensure the occurence cannot OCCUR!!!! :bonk:

Urm? Correct me if I am wrong but isn't prevention of reoccurrence the same as preventing occurrence?

Your problem here is that you are applying logic and common sense, and that's not always allowed by the standard (although it is most of the time).

How can you prevent something you do not know could exist!?

You can't, at least not intentionally, but that's not the question. Although no one in my office has ever, to my knowledge, slipped and fallen because of oil being spread all over the floor, I know that if oil is spread all over the floor, someone is likely to slip and fall. I can prevent an accident from happening by refraining from spreading oil, even though the accident in question has never happened. We know that some conditions A and B in combination have been known to result in phenomenon C, or that there are properties of the combination that might allow C occur.

I know that if oil is spread all over the floor, someone is likely to slip and fall. I can prevent an accident from happening by refraining from spreading oil, even though the accident in question has never happened

But just to be a bit anal, if you had never known oil spread all over the floor was a hazard (I.e. no one on earth has ever had this unlikely accident) then you would not know that spreading the oil would indeed be a hazard! Going back to my original thoughts, that you can carry over common sense and TGW from not only your's or your companies experience but those of others!

Going back to the original reason this thread was started. We have 1 document that deals with implementing CA and then looking at PA.

I see it as this:

Corrective action is stopping the bleed. Correcting something that is wrong. What oyu do with something you have found to be wrong.

Preventative Action is stopping the cause of the bleed from occuring again. How will you prevent it from happening. This PA can then be carried over for future Cont Imp activities to ensure the occurence cannot OCCUR!!!! The way you see it is not in line with the ISO 9000:2005 definitions of correction, corrective action and preventive action. Since ISO 9000 is a normative reference for ISO 9001, one should follow the definitions of ISO 9000, before claiming compliance with ISO 9001.

Yea, a lot of folks get stuck on the actions to eliminate "potential" nonconformities....that could be anything right? Wrong! Do a PFMEA, P = "potential" not "process" in this case. Implement detection for the highest RPN, hope that it doesn't happen and if it doesn't, bingo bango, you have proved its effectiveness, life is good! :notme:

I changed ours to one procedure, but having two separate processes.
It made more sense, since in my opinion they are related but different processes.
It worked for us. Hope this helps.
Dave N

Thanks for pointing me to that thread, Al.

I figured that it is just a preference of the ISO consultant that we are using but always good to get other opinions.

I am working for a very small medical device contract manufacturer trying to get ISO 13485 certification. Our company name does not appear on any finished product - does the advisory notice process apply to us? Is it permissible to just state that advisory notices are the responsibility of the company whose name appears on the label? I am really struggling with this advisory notice procedure.

Does anyone have an advisory notice procedure that they'd be willing to share? I'm looking for one that does not address product recalls.

Does anyone have any ISO guidance docs that explain the intent of the advisory notice system a bit better?

I am having a tough time with this and would appreciate advice.

Thanks again,
Jeff

Dear Sir,

Per my idea, as ISO 9001:2000 requirements, it is no mention about 1 or 2 separate procedures, so 1 or 2 is belong to the user. With the meaning of corretive and preventive action, I did combined into one procedure and one form, with this I can write down what preventive actions for each problem if we have.

Vu Nguyen

Dear Manix,

CA & PA is easy to be misunderstand, but could you view the FMEA form that can show you the preventive actions, most of preventive actions are applied for big issues. Let take an example: A problem had occurred on product A, then we take CA to remove the reasons, beside we also apply PA for product B. In this case, the problem already happened on product A, but not yet happened on product B. So the PA is correct for product B only.

That is my idea, please discuss.

Thanks, Vu Nguyen

Urm? Correct me if I am wrong but isn't prevention of reoccurrence the same as preventing occurrence?

How can you prevent something you do not know could exist!?

I see it as this:

Corrective action is stopping the bleed. Correcting something that is wrong. What oyu do with something you have found to be wrong.

Preventative Action is stopping the cause of the bleed from occuring again. How will you prevent it from happening. This PA can then be carried over for future Cont Imp activities to ensure the occurence cannot OCCUR!!!! :bonk:


My take (opinion) on the differences between PA and CA are as follows:

CA=To correct the initial escape/nonconformity (otherwise bandage)
PA=To eliminate the potential escape/nonconformity (process failure)

Coury Ferguson

PS: I voted for two procedures

My take (opinion) on the differences between PA and CA are as follows:

CA=To correct the initial escape/nonconformity (otherwise bandage)
PA=To eliminate the potential escape/nonconformity (process failure)

Coury Ferguson

PS: I voted for two proceduresI see what you describe as CA as "correction" and my definition of CA is to change the process to eliminate (as much as possible) future nonconformance.

Imagine a loose fitting causing a machine to turn out non-conforming product. A "correction" would be to tighten the fitting. A "corrective action" might be to add Loctite or other sealant to reduce the probability of future loosening.

Preventive action is an outgrowth of FMEA (Failure Mode & Effects Analysis) - essentially a "what if" exercise which allows us to build in controls into the process to reduce or eliminate the possibility of a nonconformance BEFORE any nonconformance occurs (meaning there is nothing to correct.)

In FMEA, we sit down and imagine, "What if this fitting works loose from vibration during operation? How will that affect the product? Let's put Loctite on it to reduce the chance of it working loose." Thus reducing the probability of ANY nonconformance.

I see what you describe as CA as "correction" and my definition of CA is to change the process to eliminate (as much as possible) future nonconformance.

Imagine a loose fitting causing a machine to turn out non-conforming product. A "correction" would be to tighten the fitting. A "corrective action" might be to add Loctite or other sealant to reduce the probability of future loosening.

Preventive action is an outgrowth of FMEA (Failure Mode & Effects Analysis) - essentially a "what if" exercise which allows us to build in controls into the process to reduce or eliminate the possibility of a nonconformance BEFORE any nonconformance occurs (meaning there is nothing to correct.)

In FMEA, we sit down and imagine, "What if this fitting works loose from vibration during operation? How will that affect the product? Let's put Loctite on it to reduce the chance of it working loose." Thus reducing the probability of ANY nonconformance.


Wes, that is a good definition of PA vs CA. Yes the PA would require the "what if" questions to ensure that the potential failure/escape/nonconformity would not occur.

Coury Ferguson

Also see:

Preventive and corrective procedures - Separate Procedures? Special Procedures? (http://elsmar.com/Forums/showthread.php?t=4836)
Corrective vs. Preventive Systems and Procedures - Separate Procedures? (http://elsmar.com/Forums/showthread.php?t=2694)

Hi,

In my view, for all Corrective Action Requests, three below actions are to be implemented.

1. Remidial Action - (Immediate) - Immediate action to be implemented to make it acceptable.

2. Corrective Action - Action required to prevent the recurrance of the same in the same location/ project/ section

3. Preventive Action - Action implemented at some other location/ project/ section from the occurance of similar type of problem.

I believe that the ultimate aim of implementing all corrective actions/ preventive actions is to ensure the elimination of non-conformances. So the preventive action is effective only if the implemented corrective action is able to prevent the recurrance of the similar nonconformances.

Rajeev

Boy, this thread does seem to go round and round in circles!

Rajeeva, your number 1 and 2 are correct :agree1: but the activity you describe in number 3 is the part of the standard defined as Corrective Action Impact.

You CANNOT do preventive action in response to something that has already gone wrong.

If the problem has already happened, everything you do in response is CORRECTIVE. Stopping something happening again is CORRECTIVE ACTION. Applying this learning to other similar products and processes is CORRECTIVE ACTION IMPACT.

If you have foreseen a problem BEFORE IT HAS HAPPENED then everything you do to prevent it happening is PREVENTIVE.

Hope this helps. :)

Another way of putting it:

If your action is REACTIVE then it is CORRECTIVE
If your action is PROACTIVE then it is PREVENTIVE

You CANNOT do preventive action in response to something that has already gone wrong.

You'll probably find that many people will disagree with you on this to a certain degree...but I think I know what you're trying to say. Unfortuantely, not everything in Management Systems is so black-and-white.

I look at like this...the Corrective Action methodology can (and should) include Preventive Action, however, not all Preventive Actions are generated from a Corrective Action.

Situation
I'm going out for a long bike ride. Suddenly, my rear tires goes flat, my chain slips off and my brakes fail to work. Thankfully, I manage to roll my bike (and myself) into a soft field of grass. Phew!

Correction
Apply patch to tire and reinflate. Slip chain back on. Bike slowly home.

Corrective Action (developed after root cause analysis)
1. Purchase and install new tire.
2. Bring bike in to shop for service.
3. Bring all bikes of family members in for service, as well (don't want this to happen to them!)...sounds rather preventive.
4. Bring bikes in for tune-up prior to spring cycling season...rather preventive, too, don't you think?

Of course, the solely Preventive situation would involve a scenario where I am out for a bike ride and I find that my bike is becoming increasing more difficult to stop and my butt is beginning to hurt from the low pressure in the tire.

Preventive Action would have me bring in my bike before something horrible happens...better yet, Preventive Action would have me doing regular tune-ups and inspections of my bike so that I don't even have to worry about the brakes or tire pressure.

If your action is REACTIVE then it is CORRECTIVE
If your action is PROACTIVE then it is PREVENTIVE

I'm all for simplicity...but just keep in mind that a proper corrective action, will include proactive steps...actions that go behind merely fixing the description of the corrective action, but may apply to other areas.

We had a recent external audit finding where a micrometer was found to past due for calibration.

We calibrated it...correction.
We ensured that it had a history set-up in the software to ensure it wouldn't be missed again...corective action.
We checked every other piece of equipment in the software to ensure that it had a history which would guarantee a reminder of every calibration due date...preventive action within a corrective action.

You'll probably find that many people will disagree with you on this to a certain degree...but I think I know what you're trying to say. Unfortuantely, not everything in Management Systems is so black-and-white.

I look at like this...the Corrective Action methodology can (and should) include Preventive Action, however, not all Preventive Actions are generated from a Corrective Action.

Situation
I'm going out for a long bike ride. Suddenly, my rear tires goes flat, my chain slips off and my brakes fail to work. Thankfully, I manage to roll my bike (and myself) into a soft field of grass. Phew!

Correction
Apply patch to tire and reinflate. Slip chain back on. Bike slowly home.

Corrective Action (developed after root cause analysis)
1. Purchase and install new tire.
2. Bring bike in to shop for service.
3. Bring all bikes of family members in for service, as well (don't want this to happen to them!)...sounds rather preventive.
4. Bring bikes in for tune-up prior to spring cycling season...rather preventive, too, don't you think?

Of course, the solely Preventive situation would involve a scenario where I am out for a bike ride and I find that my bike is becoming increasing more difficult to stop and my butt is beginning to hurt from the low pressure in the tire.

Preventive Action would have me bring in my bike before something horrible happens...better yet, Preventive Action would have me doing regular tune-ups and inspections of my bike so that I don't even have to worry about the brakes or tire pressure.

I'm all for simplicity...but just keep in mind that a proper corrective action, will include proactive steps...actions that go behind merely fixing the description of the corrective action, but may apply to other areas.

We had a recent external audit finding where a micrometer was found to past due for calibration.

We calibrated it...correction.
We ensured that it had a history set-up in the software to ensure it wouldn't be missed again...corective action.
We checked every other piece of equipment in the software to ensure that it had a history which would guarantee a reminder of every calibration due date...preventive action within a corrective action.

People are entitled to disagree, but I stand by everything I wrote.

The steps you talk about taking in your examples which you cite as "Preventive" are not Preventive Action - they have only come about as a result of something which went wrong - this puts them under the category of CORRECTIVE ACTION. In the case of some of your steps, CORRECTIVE ACTION IMPACT.

Had you thought to do these things BEFORE your mishap, they would have been PREVENTIVE ACTION.

Remember, we are not debating the meanings of English words - we're debating what the standard requires, and how the standard defines these terms.

In your examples, which steps would you define as the Corrective Action Impact? This is a required clause of the standard which no-one seems to remember. :nope: But it defines the type of action you describe as "preventive action within a corrective action".

All of the terms we're using are clearly defined in the standard - I understand there is still a lot of confusion, but people will grasp things a lot easier if they start by accepting the basic premise I mentioned previously:

BY DEFINITION - You CANNOT do preventive action in response to something that has already gone wrong.

Preventing something happening AGAIN is called CORRECTIVE ACTION IMPACT.

Regards,

Alex

Boy, this thread does seem to go round and round in circles!

Rajeeva, your number 1 and 2 are correct :agree1: but the activity you describe in number 3 is the part of the standard defined as Corrective Action Impact.

You CANNOT do preventive action in response to something that has already gone wrong.

If the problem has already happened, everything you do in response is CORRECTIVE. Stopping something happening again is CORRECTIVE ACTION. Applying this learning to other similar products and processes is CORRECTIVE ACTION IMPACT.

If you have foreseen a problem BEFORE IT HAS HAPPENED then everything you do to prevent it happening is PREVENTIVE.

Hope this helps. :)

Another way of putting it:

If your action is REACTIVE then it is CORRECTIVE
If your action is PROACTIVE then it is PREVENTIVE


It is good to start with common ground i.e., you agree for number 1 & 2. The lesson learnt or the action implemented is effective and if you implement at another location/ project/ section (where this kind of problem may occur but not occured so far), then # 3 is the preventive action.

Rajeev

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.

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

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 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

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.

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

You are totally right.

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.

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

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.

This thread has really pointed out how difficult is it to understand its meaning. :cool:

This thread has really pointed out how difficult is it to understand its meaning. :cool:

I like to think that this thread has highlighted that even when there is debate and ambiguity within terminology, we all acknowledge the importance of developing a system that will work for the organization.

Does is really matter if one company has one procedure and another has two? Does it really matter if one company has CAPA combined in one process where another has a clear distinction between them?

At the end of the day, what is important, is having a system that works for you (i.e., effective), that is user-friendly and blocks the root causes in an efficient manner.

And if the system does that...it's not important how it's documented or how it's defined.

Very correctly said, RCBeyette

:applause:

Hi,

Generally we have been advising for two seperate procedures for Corrective Action and Preventive Action; and our clients have been maintaining them. I have seen and also have been working to combine the two procedures. In fact, depending on the organisation's characterstics, I think, 8.3 Control of Non Conforming Product can also be combined with these two to give a single documented procedure and one format for all three clauses, 8.3, 8.5.2, and 8.5.3 wherein the nature of nonconformity, wether actual or potential, its effect or possible effect, cause/s, immediate action, corrective action and / or preventive action as required may be described and records maintained.

What do the others think?

Best Regards

In fact, depending on the organisation's characterstics, I think, 8.3 Control of Non Conforming Product can also be combined with these two to give a single documented procedure and one format for all three clauses, 8.3, 8.5.2, and 8.5.3 wherein the nature of nonconformity, wether actual or potential, its effect or possible effect, cause/s, immediate action, corrective action and / or preventive action as required may be described and records maintained.


Hello, atitheya...I see that you are relatively new to the Cove so if I have not already said this "Welcome!" :bigwave:

An organization's documentation can - and should - be written in such a way that represents their organization's culture, system and users. If combining the three-into-one works for them, go for it! :)

For my own organization, however, this does not work. Why? Because we have a business management system...not a quality management system.

Nonconforming product, to us, is just that...product that does not meet specifications. However, a nonconformance is any abnormal occurence be it product, process, operations, etc. Our process for corrective/preventive action addresses all nonconformances above and beyond product.

But that is us. Again...develop a system that works for you and document it accordingly.

Thanks Beyette, I completely agree with you on the subject. The same is also reflected in my earlier post when I say that 'Generally we have been advising for two seperate procedures for Corrective Action and Preventive Action' and it is a thought for some companies where combining the three would be an effective approach, the basic idea being to lay down an effective business system that takes care of the quality and hence improvement in quality and business.

Best Regards

Huge thread but glad it's still going. Currently going ISO from QS and started reviewing the procedures today. Current corrective action procedure includes minimal preventive action language.At first I planned to make them 2 written procedures but after reading this thread I have second thoughts.What do you all think about expanding some of my preventive language currently there and leave it as one procedure? I was also thinking for the current CA form we use I could change the heading of it to have Corrective on top left and Preventive on top right.When filling one out the author circles which action it is where by I save having 2 different forms.

Huge thread but glad it's still going. Currently going ISO from QS and started reviewing the procedures today. Current corrective action procedure includes minimal preventive action language.At first I planned to make them 2 written procedures but after reading this thread I have second thoughts.What do you all think about expanding some of my preventive language currently there and leave it as one procedure? I was also thinking for the current CA form we use I could change the heading of it to have Corrective on top left and Preventive on top right.When filling one out the author circles which action it is where by I save having 2 different forms.


One procedure and one form can certainly get the job done. Many folks do it that way. They are very similar. Just make sure the procedure is clear that preventive actions are undertaken to prevent to occurance of a failure or root cause, whereas corrective actions are to prevent the reoccurance of a failure or root cause.

Hello,

I think one procedure or as we do it- process description, can do it, but from my experience as internal auditor, it is difficult for the stuff to explain the differences and to show examples for preventive actions. One procedure should need a clear definition what is corrective and what preventive actions.

Tamara :o

I have written them up as seperate procedures in draft.After thinking about it my corrective action process has steps that I feel prevent should not have.Say I want to add rubber protection pads to a fixture to prevent nicks/scratches on parts.Should I have to (or need to) send the PA to my QA director for review,then he passes it on to the department head,then back to him for review/exceptance or rejection.What do you think?

Say I want to add rubber protection pads to a fixture to prevent nicks/scratches on parts.Should I have to (or need to) send the PA to my QA director for review,then he passes it on to the department head,then back to him for review/exceptance or rejection.What do you think?

In the interest of making sure that 1) your preventive action does not negatively impact downstream operations, 2) preventive actions are assessed for possible implementation (or similar implementation) elsewhere in your facility, why would you NOT send it through your QA Director (or some other "gatekeeper") to help keep the lines of communication open?

Now, in your scenario of protection pads, it might not be a problem, but in my business if someone decides to turn the cooling water down on a new grade to improve something, we might want to look at the downside, or scale build-up, to see the negative impact.

I think that the biggest misunderstanding we perpetuate about preventive actions is that they are somehow less worthy of scrutiny than their cousin corrective actions. The impact of preventive actions to the bottom line can be as great as corrective actions, or greater (because if you fix it before it breaks, you aren't going to pay the customer).

Now, that being said, you most certainly may find that 2 procedures are useful. It makes no difference within the ISO requirements, 1, 2 or 20, as long as you have documented procedures that cover all the requirements. Do what works best for you and your company.

In the interest of making sure that 1) your preventive action does not negatively impact downstream operations, 2) preventive actions are assessed for possible implementation (or similar implementation) elsewhere in your facility, why would you NOT send it through your QA Director (or some other "gatekeeper") to help keep the lines of communication open?

Now, in your scenario of protection pads, it might not be a problem, but in my business if someone decides to turn the cooling water down on a new grade to improve something, we might want to look at the downside, or scale build-up, to see the negative impact.

I think that the biggest misunderstanding we perpetuate about preventive actions is that they are somehow less worthy of scrutiny than their cousin corrective actions. The impact of preventive actions to the bottom line can be as great as corrective actions, or greater (because if you fix it before it breaks, you aren't going to pay the customer).


Yes! :agree1: The #1 rule in problem solving: Make sure that your "solution" doesn't create a different problem.

I agree 100% and assumed a complete review of a PA would be taken for granted in my post (it would be).My point is I do a lot of little things everyday that would fall under preventive action but I guess nothing says I have to write everything up.

I agree 100% and assumed a complete review of a PA would be taken for granted in my post (it would be).My point is I do a lot of little things everyday that would fall under preventive action but I guess nothing says I have to write everything up.

CA or PA should be appropriate to the magnitude of the risk and issues.

The little stuff should just be done. If it takes longer to fill out the form than to do the action, just do it.

I suggest the CA or PA form should be used to help you determine the cause and appropriate actions. So, if you know the cause, and the actions are obvious, and it is not a big issue, just do it. Save the paperwork for when it serves a purpose.

CA or PA should be appropriate to the magnitude of the risk and issues.

The little stuff should just be done. If it takes longer to fill out the form than to do the action, just do it.

Well said :applause:

Now, that being said, you most certainly may find that 2 procedures are useful. It makes no difference within the ISO requirements, 1, 2 or 20, as long as you have documented procedures that cover all the requirements. Do what works best for you and your company.

Our Registration Auditor required 2 procedures so we developed 2. Company Management never understood nor accepted Preventive Action as a seperate entity; "its not how WE do things - not our culture". We maintained our registration less than 18 months. We would have done much better with only one procedure. We still "maintain" a Quality Management System - but now its going "Lean". Guess what managment decided was waste in our "Lean Quality Management System"? :biglaugh:

Our Registration Auditor required 2 procedures so we developed 2. Company Management never understood nor accepted Preventive Action as a seperate entity; "its not how WE do things - not our culture". We maintained our registration less than 18 months. We would have done much better with only one procedure. We still "maintain" a Quality Management System - but now its going "Lean". Guess what managment decided was waste in our "Lean Quality Management System"? :biglaugh:

I think the best you can do as a start is to require that your registrar sends you a new auditor. The auditor may recommend 2 separate procedures and if its true as you mention that the auditor actually required you to have 2 separate procedures, you should then report that to the registrar so that they can do something and to implement corrective actions regarding their issue with incompetent auditors.

Our Registration Auditor required 2 procedures so we developed 2. Company Management never understood nor accepted Preventive Action as a seperate entity; "its not how WE do things - not our culture". We maintained our registration less than 18 months. We would have done much better with only one procedure. We still "maintain" a Quality Management System - but now its going "Lean". Guess what managment decided was waste in our "Lean Quality Management System"? :biglaugh:

Your comment actually has two things going on.

1. I agree that the auditor should not have required 2 procedures. He overstepped. 1 or 2 would meet the requirement either way.

2. However, this statement:

"Company Management never understood nor accepted Preventive Action as a seperate entity; "its not how WE do things..."

is not right. Preventive Action is a separate entity. They are two different kinds of projects. Please reread the definitions in ISO 9000:2000. Preventive actions prevent the occurrance of a root cause.
Corrective actions prevent the REoccurrance of a root cause.

The reason why one procedure can address both is because they are similar. But you still need two sections, or some way to explain the difference between the two.

Although the process developers understood the nuances between these two processes, many in management could not see the benefit of preventive action, especially documenting preventive action. They felt that it was a hindrance to change (no one need explain how it would benefit, I know and have talked myself blue in the face - that's when I hear that "It's not our culture"). Following this thread got me wondering how or if we could have written preventive and corrective action together to get more acceptance and utilization. I will keep it in mind for the future since it is now a moot point - top managment changed and almost the first thing done was to drop our Quality Management System registration and the requirement to follow some of the procedures they didn't see a need for, preventive action was one. At the moment those of us still involved in what is called a quality managment system are doing our best to keep the system as close to the standard as we can and we wait to see what will happen with the next change in managment.

Although the process developers understood the nuances between these two processes, many in management could not see the benefit of preventive action, especially documenting preventive action. They felt that it was a hindrance to change (no one need explain how it would benefit, I know and have talked myself blue in the face - that's when I hear that "It's not our culture"). Following this thread got me wondering how or if we could have written preventive and corrective action together to get more acceptance and utilization. I will keep it in mind for the future since it is now a moot point - top managment changed and almost the first thing done was to drop our Quality Management System registration and the requirement to follow some of the procedures they didn't see a need for, preventive action was one. At the moment those of us still involved in what is called a quality managment system are doing our best to keep the system as close to the standard as we can and we wait to see what will happen with the next change in managment.

Sometimes you can lead 'em to water, but... In a similar situation I once suggested to a clueless manager that since a preventive action process wasn't necessary, we could get rid of all of the maintenance done on machines, just wait for them to break down, and save a lot of money. I also suggested that he could save some money personally by no longer changing the oil in his car. Somehow I wasn't able to convince him that processes break down just like machines do, and often with similar consequences. Fortunately he wasn't in a position of authority on the subject, and I was able to work around him, but there's always at least one.

In my opinion:
One document can cover two processes: corrective and preventive actions.

Who is a customer of your procedure - auditor or your organisation and personel?

Rules:
#1 Auditor is allways right
#2 If auditor is wrong:
a) reread #1 or
b) discus with auditor about written requirements (ISO9001, ISO/TS) - if you
have a good knowledge about requirements; do not discus after audit
process!

In my opinion:
Rules:
#1 Auditor is allways right


No, they are not. And good, professional auditors won't insist on this. They will welcome debate and discussion on the relevant section/s of the Standard and they will want to see reasonable evidence that it is being met. And be open-minded and fair.

We should never just accept blindly the 'Auditor is always right' view. (I've had some very lively encounters & debates with auditors who held that viewpoint.)

Thought I'd throw my :2cents:

We have one procedure that covers both Corrective and Preventive actions. However, we do make a distinction between the two in the following ways.


We hold an MRB meeting every other week. In this meeting, we discuss all Corrective actions. (Many times the Corrective actions stem from NCMR)

We hold a "Continuous Improvement" meeting once a month. In this meeting, we discuss Preventive actions.

During Management Reviews, we are careful to separate out the Corrective and Preventative Actions.

Hope this helps...

I agree with Jane and Renae - I have one procedure for both which is acceptable for ISO9001 - it may not be for Aerospace, Telecommunications, Medical, etc. If you go to www.tc176.org/FAQ.asp and click on SC2 link you will find some excellent information. I'm attaching two items from the link.:agree:

I am currently addressing findings and recommendations from our pre-assessment audit for ISO 9001:2000. The auditor and I had a long discussion about this very subject. He presented a very different approach (management friendly possibly).

He concedes that most managers (especially upper levels) won't be open to documenting strict preventative actions. He suggested separating the corrective and preventative action procedures (they started as 2, went to 1, now going back to 2). He recommended and more "open" prevenative action procedure that doesn't require the use of a strict form when conducting preventative actions. This does not exempt us from requiring documentation as objective evidence..however makes it much easier to have documentation (at least for us.).

Due to the nature of our business, we are conducting preventative action on a daily if not weekly basis. I am in the process of ensuring that these incidences are documented so we can present our actions to the auditor.

During the pre-assessment, I showed him one large example (major project we completed for one of our largest clients) of how we took actions to PREVENT possible failure on our part and ensuring customer satisfaction. He loved it. Furthermore, when I presented this to management, they understood it and embraced it. It basically allows them to not change how they do things (they do need to document more) yet we address one of the major requirements of the standard.

Has anyone else been presented with this type of approach?

I have one procedure. I have a seperate form to document CAR from PAR.
I am a believer the less procedures the better.

IHas anyone else been presented with this type of approach?

Absolutley - one of the biggest reasons that I place PA in a seperate procedure is that many activities are PA in nature - calibration, preventive maintainence, FEMA activities, etc.

My thoughts are that everyone does a lot in this arena - they just don't identify it as PA.

I am very new and can not find your attachments. I am OVERWHELMED with the whole ISO situation.
Kathy

Here's some info from Whittington's Newsletter. I suggest using a process turtle to start the document process. A documented form is not a requirement, but you may have processes that you use to initiate preventive action, e.g. Design Review, FEMA (see attached from Whittington Newsletter). You may refer to existing processes that may have forms (Calibration, ESD Logs, PM audits, Internal Audits and an employee incentive form like a Suggestion Box). There's a lot of good suggestions here - it's what works for them. Do what works for you. Somerqc's approach got him a thumbs up from assessor without using a form - all he has to do now is to describe the method he used in the PA Procedure. If it's CA & PA is up to you - just know the difference. Don't be overwhelmed - 2000 ISO is a piece of cake compared to 1994 version.

....He loved it. ...

Furthermore, when I presented this to management, they understood it and embraced it. It basically allows them to not change how they do things (they do need to document more) yet we address one of the major requirements of the standard.

Has anyone else been presented with this type of approach?


I think that may be the key part of your post. If the approach is compliant, and top management embraces it - that is the intersection of two items that you want. That would seem to be the better approach.

Hijilling,
If I combine both corrective and preventive actions into one procedure, what should I be aware of to cover both?

It seems to me that a preventive action can stand alone without a nonconformance. Is that correct?
Thanks
Kathy

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

Eileen, if I write 2 separate procedures, does that mean paperwork has to be done everytime there is a preventive action such as you suggested earlier?

Hijilling,
If I combine both corrective and preventive actions into one procedure, what should I be aware of to cover both?


I'm not sure I understand your question. I will attempt to answer.

Whether you do one procedure or two, please keep in mind these are two different activities.

One would perform either a CA or a PA. They have the same steps, but they are not the same function. One is a reactive action, one is a proactive action.

The reason they can be one procedure is they follow the same steps, and many people use a common form. However, even if it is one procedure, it can have two sections, one for CA and one for PA.

Hope that helps.

The auditor and I had a long discussion about this very subject. He presented a very different approach (management friendly possibly).

That's wonderful. Sounds like you have a good and fair auditor, who is willing to discuss issues, and sounds keen to see that the company understands the meaning of the Standard, and willing to assist and promote that understanding. The system must be management-friendly - if it isn't, it's going to struggle.

He concedes that most managers (especially upper levels) won't be open to documenting strict preventative actions.

Frequently true if it means they have to start doing something quite different or in addition to from what they are already doing, & even more so if they're doing a good/reasonable job already!

I have implemented these kinds of procedures for many companies, as I found very, very few senior/executive managers who are keen on filling in forms. Usually the more senior, the less they want to. And often it isn't because they aren't doing this stuff, it's because they have a different method that doesn't involve a form.

If there's a better alternative that works, I think that's reasonable. Filling in forms is only one method. Yes, it's a well-known method, and yes, it's often used and yes some auditors like it because it's very familiar and known to them, but none of these reasons mean it's the only way it can be done.

I cannot think of any managers I've encountered who, once they understand, are averse to the need to have some records to demonstrate, or to improve their records if necessary. (If they remain averse, of course, then they will need to reconsider their desire to become or remain certified.)

He recommended a more "open" prevenative action procedure that doesn't require the use of a strict form when conducting preventative actions. This does not exempt us from requiring documentation as objective evidence..however makes it much easier to have documentation (at least for us.).

Yeah, I'm with him. Great. Really, really pleased to hear it, & just the sort of system flexibility that's possible, while still of course conforming to the requirements of the Standard. And that's the sort of intelligent, switched on auditor I like to hear about and wish there were more of. The kind of auditor it's almost a pleasure to watch or be audited by.

Mind you, I'm assuming when you say he 'recommended' this, that he actually probably said something along the lines of not being able to consult, but perhaps suggesting that you might consider the idea, or mentioned perhaps other clients who had used this approach, and for you to think about it & see if it might perhaps work in your company.

Eileen, if I write 2 separate procedures, does that mean paperwork has to be done everytime there is a preventive action such as you suggested earlier?

Not to be glib, but that rest entirely on what you mandate when you write your procedure :)

Jane B,

In short, yes, he did approach it with a "you may want to consider this option that I have seen elsewhere" approach. My auditor has actually been doing this for over 15 years for a major CB in Canada. He is an alum from the same university as me as well! (didn't know this until the pre-assessment audit).

You are right. He is very fair and understands that a business needs to run using the system therefore flexibility and understanding management is critical.

Feb 14-16 are the big days around here! :mg:

I'm not sure I understand your question. I will attempt to answer.

Whether you do one procedure or two, please keep in mind these are two different activities.

One would perform either a CA or a PA. They have the same steps, but they are not the same function. One is a reactive action, one is a proactive action.

The reason they can be one procedure is they follow the same steps, and many people use a common form. However, even if it is one procedure, it can have two sections, one for CA and one for PA.

Hope that helps.

That is what I needed to hear. Thank you.
Kathy

WOW, this has to be on of the longest running threads around here.

I would certainly like to thank all that have taken part, because although it did get mighty confusing with everyone seeming to have a slightly different take, I feel that the message is getting across and I now know how I should approach this.

I have a notice up by my desk that simply states:

If your action is REACTIVE then it is CORRECTIVE

If your action is PROACTIVE then it is PREVENTATIVE

I know that is a quote from someone on this thread, but I am not sure who!

I think the important part of this thread is not the way in which you approach this (one or two procedures) but how you interpret the meaning of both, as I have stated above. However, do keep in mind that combining the two can lead to confusion of the definition. Remember permanent corrective action, is still just that, corrective.

Thanks everyone, this has thrown clarity on the subject for me at least.

If your action is REACTIVE then it is CORRECTIVE

If your action is PROACTIVE then it is PREVENTATIVE

I know that is a quote from someone on this thread, but I am not sure who!

I think the important part of this thread is not the way in which you approach this (one or two procedures) but how you interpret the meaning of both, as I have stated above. However, do keep in mind that combining the two can lead to confusion of the definition. Remember permanent corrective action, is still just that, corrective.

I like the simple way of interpreting Corrective/Preventive action. However, there is one more term "Correction" which also comes under "REACTIVE" mode. There is a little difference between Corrective Action and Correction.

We can divide the two as follows:

Quick Fix Reactive Action (Not fixing the root cause) = CORRECTION
Root Cause Eliminating Action (In Reactive Mode) = CORRECTIVE ACTION