Preventive Action Documentation - How to formalize the capture and documentation of

[chermann]

The company I work for recently passed our ISO registration audit, but we did have one weak area - Preventive Action. We do preventive action in several different areas such as FMEA's, employee ideas, first article reviews, etc. The problem is that each of these are pretty much stand alone systems with preventive action built into their function. Each of these areas may only generate one or two true Preventive Actions in a year. The current system requires that someone says to themselves, "Hey, this sounds like a preventive action, I should tell someone so we can document it and get credit for it at the next audit." In those cases, we document the PA in our PA/CA software.

I have considered creating a Preventive Action Task Force, but that would seem to be very inefficient. Somehow, we need to come up with a way to formalize the capture and documentation of preventive actions.

My plea is for some suggestions on ways you have seen this done successfully.

Thanks,

[gaboring]

This may be helpful. We had the same problem in 1999. We incoporated PA as a part of CA. What I mean is that when you perform a Corrective Action and there are other areas that can be identified with the possibility of the same thing happening that is like or similar to the CA problem, you identify the action you take as PA for the like or similar issues.

Confused? I was until we tried it. And it worked. Our auditor told us that this was GOOD Preventive Action.

I hope it works for you.
This is my first post. Good Luck!

Danno

[Jimmy Olson]

I agree that including in the CA program is a good option. We do the same thing here. But there is a word of caution with this. It would be a good idea to check with your auditor before implementing this to make sure they don't have a problem. Some do and some don't.

There have been a couple of pretty good debates about corrective and preventive action and how to classify them. There are some people that would say the system described here would still be corrective action since it is in response to something. So just make sure that your auditor won't give you problems first. Otherwise, this is a good way to go.

[M Greenaway]

Isnt performing FMEA a preventive action, even if the review itself does not generate further actions to reduce risks, the very identification of low or no risk through FMEA is a preventive action - well it is to me.

[db]

I would agree Martin, but we can get into all sorts of tangles if we look at terminology. For example, if you do react to the RPN to lower them, is that preventive, or corrective? We've been down that road before.

chermann, I think it is important that you have a system that works for you, not your auditor. If your current system is based on:

"Hey, this sounds like a preventive action, I should tell someone so we can document it and get credit for it at the next audit."

Then at best your actions are an exercise in futility.

[M Greenaway]

db

By virtue of the fact that FMEA should be done at the product and process design stage I would say that any action to reduce RPN is preventive as you have not made anything yet. FMEA's conducted further down the line, where incidences of occurence are based on true data is, as you say, corrective by nature.

[chermann]

Just to clarify, we are a job shop and only a handful of our customers require FMEAs (we are not a direct supplier to automotive).

Being a job shop, we develop processes specific to each part number our customers send to us. We have 50-100 new part numbers show up every day. We have 2 technicians who review the part and the process for each of these orders and create a process program (anodize, electroless nickel, etc.) This review process is not typically a formal FMEA, but these guys do incorporate preventive actions in this process. For example, if a part has alot of blind holes, extra rinsing and a note to rinse thoroughly might be added to the process program to "prevent" possible problems with solution bleed out. It would be nearly impossible to track each part number specifically to see if your preventive action was effective, especially considering a large percentage of these orders (part numbers) may never show up again.

[M Greenaway]

chermann

To my mind what you describe are perfect examples of preventive actions, and they are often called contract review, or design control/review, or process planning. In fact every part of our system is a preventive action isnt it. ISO9001:1994 used to say in its opening paragraphs somewhere that the whole standard was based on prevention, and many of the clauses contained comments such as 'in order to prevent.......' etc, etc, etc.

Donkeys posts ago I suggested that a PA procedure only had to bullet point all the things that you do in your QMS, as it is all preventive.