Corrective Action Plan Submission Timeframe

Jim Wynne

Staff member
Admin
#11
Although there is no clear cut specification for how soon you need to close a corrective action in ISO 9001:2008, I believe that element 4.1 c at least in spirit can be applied.

"The organization shall . . . determine criteria and methods that ensure both the operation and control of these processes are effective . . ."

My point of emphasis is the word "effective".

If you don't close them out in a timely manner, your control of the process that they impact would not be "effective".
I think this is a misinterpretation of the clause in question. If the organization has indeed determined the criteria and methods that ensure the operation and control of processes are effective, and those criteria do not include timely closure of CAs, there is no violation of the requirement. The clause leaves the determination of criteria and methods up to the organization.

Furthermore, the fact that a nonconformity has been identified doesn't necessarily mean that the process in question isn't effective, because the definition of "effective" in that sense is also a matter of discretion on the part of the organization.
 
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Big Jim

Super Moderator
#12
I think this is a misinterpretation of the clause in question. If the organization has indeed determined the criteria and methods that ensure the operation and control of processes are effective, and those criteria do not include timely closure of CAs, there is no violation of the requirement. The clause leaves the determination of criteria and methods up to the organization.

Furthermore, the fact that a nonconformity has been identified doesn't necessarily mean that the process in question isn't effective, because the definition of "effective" in that sense is also a matter of discretion on the part of the organization.
That's why I said "in spirit".

As to if I would attempt to write an NCR citing that element, I would say that it isn't likely unless the violation is egiegious.

If it were based on an internal audit nonconformance, it would probably be written agains 8.2.2 "The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without any undue delay to eliminate detected nonconformities and their causes".

If written against 8.5.2 it would depend on their procedure. If their procedure puts time restraints on curing nonconformances then it would be cited against 8.5.2 AND their own procedure.

If I find a bunch of very aged open NCRs, I'm going to be giving them special scrutney.
 

bobdoering

Stop X-bar/R Madness!!
Trusted Information Resource
#13
Having a particular time to close a corrective action is absurd (although some customers still think it is a clever idea.) If you specify 30 days, and the action required is a redesigned mold with 8 week lead time, you blew your foot off. NEVER specify a time - it encourages a quick patch and not an effective long-term fix. Show a plan and progress towards it.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#14
Thread moved to the Nonconformance and Corrective Action forum

:topic: I have moved this thread to the Nonconformance and Corrective Action forum and left a Permanent Redirect in the Registrars forum since quite a few replies are not specific to registrars.
 

Big Jim

Super Moderator
#15
Having a particular time to close a corrective action is absurd (although some customers still think it is a clever idea.) If you specify 30 days, and the action required is a redesigned mold with 8 week lead time, you blew your foot off. NEVER specify a time - it encourages a quick patch and not an effective long-term fix. Show a plan and progress towards it.
Most of the time when I see a time frame specified in a corrective action procedure, it provides for extensions when there are unusual circumstances. The one you cited would certainly fit.
 
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bobdoering

Stop X-bar/R Madness!!
Trusted Information Resource
#16
Re: Corrective Action Plan Submission Time frame

Most of the time when I see a time frame specified in a corrective action procedure, it provides for extensions when there are unusual circumstances. The one you cited would certainly fit.
Still - by what logic is there a specific time limit for discovering and implementing the optimum corrective action? It could be an hour...it could be 6 months. There is no natural law that would specify an optimum endpoint time. It is sheer dartboard logic...or wishful thinking. I try to avoid that...when I have a choice.
 

Jim Wynne

Staff member
Admin
#17
Re: Corrective Action Plan Submission Time frame

Still - by what logic is there a specific time limit for discovering and implementing the optimum corrective action? It could be an hour...it could be 6 months. There is no natural law that would specify an optimum endpoint time. It is sheer dartboard logic...or wishful thinking. I try to avoid that...when I have a choice.
I agree. Too many people paint themselves into corners with due dates that don't take anything reasonable into account. If you have to do something, set a time for followup to make sure the thing hasn't fallen through the cracks.
 

Big Jim

Super Moderator
#18
Re: Corrective Action Plan Submission Time frame

Still - by what logic is there a specific time limit for discovering and implementing the optimum corrective action? It could be an hour...it could be 6 months. There is no natural law that would specify an optimum endpoint time. It is sheer dartboard logic...or wishful thinking. I try to avoid that...when I have a choice.
First of all, I didn't say I consider that optimal, just that I often see it.

With that said, I would like to explain my reasoning for having a general concept of what timely means on resolving corrective actions.

The analogy I like to make is with account receivable. Most accounts receivable are settled in 30 days. Mainly because that is the most common commercial terms. Accounts receivable have a value associated with them, hopefully the face value of each one.

When an accountant runs an accounts receivable ledger, he knows that as one ages much past 30 days, its value drops. At some point, depending on circumstances, the accountant knows that the likelihood of collecting is greatly diminished. In other words, the value drops dramatically. When does it get written off? Again, depending on circumstances, when it is determined that it is highly unlikely that it can be collected.

Your corrective actions have a value too. Perhaps not something you can put a dollar price on, but a value in that the resolution helps to improve your quality management system.

If there are a bunch of unresolved corrective actions that are beyond six months or even a year, (the worst example I can remember there three years old and there were a batch of them), I would submit to you that the resolution of actions that cannot be clearly remembered has little or no value for your quality management system.

On the accounts receivable example, there may be exceptions. For example a loan made to the president's brother in-law, or the customer that stuck by you when times were tough and now you are extending the same courtesy when they are going through tough times.

And of course, there will be exceptions on aging corrective actions. As you have pointed out, they have special needs for any of several reasons. But the reason for them still being open should be clearly understood (not just forgotten).
 

bobdoering

Stop X-bar/R Madness!!
Trusted Information Resource
#19
Re: Corrective Action Plan Submission Time frame

First of all, I didn't say I consider that optimal, just that I often see it.
I agree - I often see it, too...usually to appease an auditor or a customer's rote rubber stamping of a dartboard rule.

There are situations where a problem occurs, and there is no economically feasible method to resolve it. No one can agree on a print change because of other cumbersome '''rules". It may have been a misunderstanding of a requirement (e.g. misuse of the concentricity callout). It lies fallow for a long time. To an outsider, it appears to be lack of corrective action effort. Very simplistic. In fact, the effort applied may have already been excessive, but external roadblocks prevent resolution.

But, more often ambitious, fast goals cause people to band aid to meet their unreasonably self-inflicted time limits. Sure, you can put in some extension methodology, but then you will end up with the wasteful overhead of trying to define under what specific conditions they can be employed, and how these conditions are to be documented as justification, to appease an auditor.
 

andreww

Involved In Discussions
#20
Yes I fully agree. You can not set a uniform closing dates for all NCRs. Some NCRs would be easy to close and it would take one or two weeks to close it off, some would be very difficcult to close off in short period due to locating right root cause and find right CA and PA. If we rush to it you will get time right, however real outcome of CA & PA including RC will be incorrect, which is meaningless. In stead of approaching this way, I would suggest to request supplier a RCA plan, and then monitor this plan to get right outcome in the end.
 
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