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).