Preventive Action Process question - ISO 9001 Clause 8.5.3

[Marc]

You are quite welcome, Randy!

 

[Big Jim]

Some (myself included) would question that. Corrective action, by definition, is preventing the recurrence of a nonconformity. Rebuilding the house will not prevent the fire from happening again.

Rebuilding the house was the Correction or Containment part of the Corrective Action. Root Cause Analysis and Corrective Action still need to be applied.

From ISO 9000 we learn that Correction is the action (awkward here, but that's how ISO used it) taken to correct a nonconformance.

Also from ISO 9000 we learn that Corrective Action is the action taken to correct the CAUSE of a nonconformance. It can't be done until the cause is determined.

 

[Big Jim]

ISO 9001: 8.5.3 states "... determine requirements for
a) Determining potential nonconfromities and their causes,..."

Maybe I am reading into this to much or I am having a difficult time define the requirements for determining potential nonconformities and their causes. Currently I am thinking along these lines.

Preventive Actions may be identified during: management reviews, trend analysis, etc.

But I do not believe it is that simple and these do not seem like requirements to me. Any help would be greatly appreciated.

Let me toss out a few thoughts on the page.

Besides the difference of an actual nonconformance and a potential nonconformance, these two things have other differences as well.

Corrective actions tend to be reactive in nature. That is, it is in reaction to something that went wrong.

Preventive actions are proactive in nature. You act before the problem develops.

The cause of corrective actions tend to be hidden or occluded. The cause of a preventive action is usually known as soon as the preventive action is identified (not hidden). On this point, it is interesting to note that the standard treats them differently here in that for corrective action the reviewing of them and determining the cause are two separate lines (8.5.2 a & b) and for preventive actions, they are on the same line (8.5.3 a).

Corrective actions are practiced to prevent recurrence. Preventive actions are practiced to prevent occurrence.

Besides looking at KPI trends, as you recognized, other possible sources include audit observations, audit opportunities for improvement, and management decisions.

About management decisions, managers, by nature, solve problems, potential or otherwise. It is innate to the position. Management decisions that are part of continual improvement can be recorded as preventive actions. It may help to remind managers to do so. It could be a standing agenda item for a weekly management meeting to say something like "have any of you made any management decisions this past week that should be recorded as a preventive action? If you have, please stick around for a moment so we can start the paperwork".

It has been my experience that most companies actually are pretty good about practicing preventive actions, just lousy at recording them.

 

[Pancho]

... It could be a standing agenda item for a weekly management meeting to say something like "have any of you made any management decisions this past week that should be recorded as a preventive action? If you have, please stick around for a moment so we can start the paperwork".

Management decisions that impact the QMS naturally cause changes in documentation. So if the processes and their docs are already affected, why is it desirable to further record these actions as preventive actions?

 

[mguilbert]

It has been my experience that most companies actually are pretty good about practicing preventive actions, just lousy at recording them.

That is where we were, we were not documenting well.

 

[Big Jim]

Management decisions that impact the QMS naturally cause changes in documentation. So if the processes and their docs are already affected, why is it desirable to further record these actions as preventive actions?

I'm sure that most of what you describe do not involve changes to your documentation, but besides that, the standard requires that you practice preventive actions and attached to it is the need to maintain records. As you know from 4.2.4, records need to be retrievable. How easily can you show that you are practicing preventive actions from your filing system?

 

[Sidney Vianna]

It has been my experience that most companies actually are pretty good about practicing preventive actions, just lousy at recording them.

At the risk of derailing yet another thread, most of what a QMS standard requires is preventive in nature. To that effect, organizations prevent a lot of problems just by implementing, following and improving their QMS processes. But that is not the 8.5.3-preventive action type of actions.

 

[Helmut Jilling]

Management decisions that impact the QMS naturally cause changes in documentation. So if the processes and their docs are already affected, why is it desirable to further record these actions as preventive actions?

It would not serve any purpose to record a preventive action after it is complete. That is just filling out a form to get credit. You would not fill out a corrective action after the fact, you use the form to guide the project.

I like Sidney's comment that many things are preventive in nature, but that is not the 8.5.3 type of preventive action. So, the routine management tasks and QMS changes can be recorded only the way you have been doing them. Then, seek specific projects that will prevent potential problems and work through them using your preventive action form. That will meet the intent of cl 8.5.3 much better.

 

[Pancho]

I'm sure that most of what you describe do not involve changes to your documentation, but besides that, the standard requires that you practice preventive actions and attached to it is the need to maintain records. As you know from 4.2.4, records need to be retrievable. How easily can you show that you are practicing preventive actions from your filing system?

I can't think of a process change that does not require corresponding changes in documentation. Can you give me an example?

We have a shortcut in our Continuous Improvement procedure. If root cause and proper CA or PA are obvious to the person that detects a non-conformity or potential NC, then she can go straight to modifying the process and its docs. No CAPA request form need be filled out. Such modification is obviously CAPA, and is recorded as a change in the affected documents, but no unnecessary paperwork is created.

As Helmut points out, Requests for CA or PA are useful to guide the project. They are indispensable for actions requiring collaboration.

 

[Big Jim]

I can't think of a process change that does not require corresponding changes in documentation. Can you give me an example?

We have a shortcut in our Continuous Improvement procedure. If root cause and proper CA or PA are obvious to the person that detects a non-conformity or potential NC, then she can go straight to modifying the process and its docs. No CAPA request form need be filled out. Such modification is obviously CAPA, and is recorded as a change in the affected documents, but no unnecessary paperwork is created.

As Helmut points out, Requests for CA or PA are useful to guide the project. They are indispensable for actions requiring collaboration.

Not all companies have procedures for all aspects of their operations. The standard only requires that six topics be covered by documented procedures. Most companies have more than that, but many companies have many procedures that are not documented.

So, as an example, a company does not have a written procedure for purchasing (none required, not one of the required six topics). They see a better way to check in received goods and implement the improvement. No records needed. No documentation of the change needed.

Don't fall into the trap of assuming all companies have to function the same as your does.