CAPA (Corrective Preventive Action) Form for critique

[Darren1974]

Hi all

A usual problem in my company is raising CAPA's (NCR's) but more so the completion of them

After a recent meeting I was asked to potentially modify the content of our CAPA forms to make them 'less time consuming'. The purpose of how they are laid out is to capture all elements, also to show root cause analysis has taken place, the corrective or preventive action and then to show that the action taken has been verified for it effectivness

If anyone would like to have a look and then offer any opinion I would be very grateful

A much larger organisation who are a bif client of our's gave us an NCR last week and the Op's director commented it was simple and on only two pages. Personally I think its was a bad example, but can only agree it would have been far quicker to complete, however speed should never come before quality with regards to corrective/preventive actions in my opinion


many thanks

Darren

 

[jkuil]

Re: CAPA Form for critique

There should always be a good balance between the detail of your form and the risk of incomplete or inadequate data. 2 pages may seem short, but on the other hand might provide the required flexibility in data collection required by knowledgable employees. E.g. I like to determine my root cause through a Kepner Trego assessment, or an Ishikawa Fishbone. Bummer, your form requires 5-why, I ask myself why?

Finaly I found my root cause, however "Form - inflexible" is not in the drop down list. Is someone going to make a pareto out of all these options? What on earth is management going to do with all these details?

Luckily the CAPA (7) section does not force me to identify an action owner, nor completion due date. So nobody can hunt me down, when I do not complete the action on time, or not at all. Will they not have a action tracking system?

Bottom line: first identify your objectives (user requirements) and then design the form.

 

[piney]

Corrective and Preventive Actions are completely separate entities and should IMO never be inlcuded in the same form.

Corrective Action - Action to eliminate the cause of nonconformities in order to prevent recurrence.

Preventive Action - Action to eliminate the causes of potential nonconformances in order to prevent their occurence.

It is understandable that you have defined preventive action as what is done as part of the corrective action to prevent the nonconformance in the future. However, the ISO 9001 standard requires a separate documented procedure for Preventive Action where nonconforances are identified before they occur. To include Corrective and Preventive Action as part of the same form will tend to confuse users of the form regarding the true definition of these terms.

 

[RickRay]

Some good points brought up by jkuil.

My suggestion would be to take a look at some of the examples and discussions found here at the Cove.

 

[QCAce]

Hi all

A usual problem in my company is raising CAPA's (NCR's) but more so the completion of them

After a recent meeting I was asked to potentially modify the content of our CAPA forms to make them 'less time consuming'. The purpose of how they are laid out is to capture all elements, also to show root cause analysis has taken place, the corrective or preventive action and then to show that the action taken has been verified for it effectivness

If anyone would like to have a look and then offer any opinion I would be very grateful

A much larger organisation who are a bif client of our's gave us an NCR last week and the Op's director commented it was simple and on only two pages. Personally I think its was a bad example, but can only agree it would have been far quicker to complete, however speed should never come before quality with regards to corrective/preventive actions in my opinion


many thanks

Darren

In general, I do not find any problems with the form you've supplied. Based on your statment I would say your issue may be that you need to separate your NCR and CAPA systems.

Make your NCR system the simple, front-end data collection system. Have the processes in place to segregate and repair/replace the NCR material.

Then let the data from that system determine what CAPA's get generated.

 

[Jim Wynne]

A much larger organisation who are a bif client of our's gave us an NCR last week and the Op's director commented it was simple and on only two pages. Personally I think its was a bad example, but can only agree it would have been far quicker to complete, however speed should never come before quality with regards to corrective/preventive actions in my opinion

You might be confusing the time it takes to perform the actions themselves and the time it takes to complete the paperwork explaining what was done. I've never seen a CA situation (and I've seen plenty) that couldn't be adequately explained on one page. For an example of what I see as excess, why do you require people to do the "5 Whys" thing and write it all down in the report? I really think your form is too long, and if I were in the middle of a very busy day with the alligators lustily nipping at my behind and had a six-page CA form (or any other six-page form) thrust before me I might do or say something I would regret later.

 

[howste]

If anyone would like to have a look and then offer any opinion I would be very grateful

On top of what has already been said, I have a few other issues with the form posted.

1) "People" should be the absolute last item on the list of preliminary causes. My experience is that way too often people jump to the conclusion that it's somebody's fault, and as soon as they find someone to blame it on, they stop thinking. This is compounded by the fact that the 5-why example ends with a root cause of lack of training. Then, to make it (much, much) worse it has a field that says: "If the cause of the problem involves an employee or contractor please identify the person(s):" :mg: Why? So we can counsel, retrain, and/or punish them? The form is setting the stage for corrective actions that aren't focused on the system.

2) By definition, you can't take both corrective action and preventive action on the same problem. It's an either/or proposition - it's either already happened (do a corrective action) or it hasn't (do a preventive action).

3) The form is asking for a review of the action, not the effectiveness of the action. This is asking for someone to just confirm that the plan was implemented, not to confirm that it eliminated the cause and prevented recurrence.

If you're looking for another example of a corrective action form, I posted one in another thread a while back. Here's a link: Generic Corrective and Preventive Action Report.doc

...if I were in the middle of a very busy day with the alligators lustily nipping at my behind...

 

[jkuil]

1) "People" should be the absolute last item on the list of preliminary causes. My experience is that way too often people jump to the conclusion that it's somebody's fault, and as soon as they find someone to blame it on, they stop thinking. This is compounded by the fact that the 5-why example ends with a root cause of lack of training. Then, to make it (much, much) worse it has a field that says: "If the cause of the problem involves an employee or contractor please identify the person(s):" :mg: Why? So we can counsel, retrain, and/or punish them? The form is setting the stage for corrective actions that aren't focused on the system.

People are hardly ever the root cause. People do make mistakes, but then do use the 5-why method of the form: because the procedure was unclear, because the training was ineffective, because the workload was too high, etc. There is no use to put people for ever on the scaffold. If you need to interview the people you can find them through your records. Commonly the mistake could have been easily made by their collegues as well, they were only the unfortunate ones that had to do the task.

2) By definition, you can't take both corrective action and preventive action on the same problem. It's an either/or proposition - it's either already happened (do a corrective action) or it hasn't (do a preventive action).

What I occasionally find is that companies identify a corrective action for the area where the issue was found and a preventive action for areas where the issue potentially also could have occured. E.g. where 2 departments have a separate but similar procedure that is non-conforming, then a CA is identified for the departmental procedure where it was observed and a PA for the other department. As this stimulated people to look beyond the scope of the original observation, I am quit happy with this.
Piney stated there should be separate procedures for CA and PA. That is incorrect. There should be a procedure for CA and for PA, but they do not necessarily need to be separate. At the company I currently work for I have written a procedure that on top of the CA and PA procedures, also incorporates the non-conforming product procedure. Thus one procedure for half of the ISO 9001 required procedures and that is fully acceptable.

I would say your issue may be that you need to separate your NCR and CAPA systems.

Make your NCR system the simple, front-end data collection system. Have the processes in place to segregate and repair/replace the NCR material.

Then let the data from that system determine what CAPA's get generated.

The company indeed has separated the forms for handling non-conformities (NCR) and CAPAs as suggested by Andy

Untill now we have only eleminated elements. Also some advise to add an element. In medical device it is common to perform a risk assessment upon a non-conformity. If risk is assessed as being low, it is acceptable not to define any CAPA, but to limit the actions to the correction of the NC.

 

[JoCam]

Hi Darren,

Your form seems quite long winded to me, and incorporates a number of activities that could be recorded elsewhere. My approach is to keep forms to a single page where possible, as in my experience they are then more inclined to be used.

For corrective actions I have a Non-conformance process that results in the proposal, implemenetation and verification of appropriate corrective actions. This system includes two NCR forms, one for general non-conformances and a second for non-conforming components and product.

I have attached these forms, together with the procedure for their completion, and hopes this helps you get your process on track.

I've also added a copy of our preventive action form, as I agree with piney in that these two processes should be kept separate. I have made reference to the requirement for a preventive action on each of the NCR forms, as this is a good place to start with being proactive for similar potential non-conformances.

Jo