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

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,

Preventive Action

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

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.

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.

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."

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Then at best your actions are an exercise in futility.

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.

More Information

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.

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.

Re: More Information

chermann said:
. 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.

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Do you keep records of those process plans? Do you keep records of customer returns? No return, no problem. Maybe a result of the PA's built into your process and maybe not. Proving a PA is effective is not easy. But proving that problems aren't reported is easy. Make the assumption that the PA is as effective as can be demonstrated by lack of returns.

Also, is it possible to make something formal? Such as a table showing some possible problems that could occur in one column and then some preventive actions listed that would address that sort of problem listed in another, and then the type of part that this kind of problem is most likely to occur in? I don't mean create one for each part, but something that is used over and over for all parts that are made. Something like that could show that there is some PA planning in effect and is a good reference guide for those who put together those process programs. It may also brainstorm additional PA's that hadn't been thought of previously.
Lastly I would then suggest that you have a program that when a new part with new risks is being made, that there is a review of the chart to ensure that there is nothing additional to add, and that you have a method for updating and modifying the chart.

Employee suggestions for anything and everything that impacts the business should also go through your PA/CA process. If it saves money, improves efficiency, prevents something bad from happening, etc. it is all good. This can be done as simply as informing everyone by email and/or bulletin board that Susie Q in Accounting is accepting employee suggestions by email or note. And then having Susie Q log these into a simple Access database or Excel spreadsheet. Set aside a time for review of the suggestions and log in the actions taken.

Sorry so longwinded. Does any of this sound feasible/reasonable?

Yes, we do keep records of the process, it is stored in the computer and used as the default when that part shows up again. We also formally document customer complaints and returns. I can take a look at the feasibility of looking at no returns as the measure of effectiveness. As I mentioned, the real challenge for us is that we do not "make" the parts. Our customers send us their raw parts for us to add a coating and return it to them. If a customer changes from part # 1234A to 1234B, our system assumes it is a completely different part. With 50 new parts a day, 250 new parts a week, 13,000 new parts a year, it boggles the mind to try to track the effectiveness of a single preventive action implemented on part #1234A.

We do have an employee suggestion process, but that really seems to wane with time. Every once in a while, someone breathes a little life into it, but it is usually short lived. When we do get an idea, it is reviewed by the Continuous Improvement Team and assigned to someone. We do get a few PA's from that process.

I do like your suggestion on creating a table for the process rather than the part. I will use that as a starting point and see where it leads, thanks and longwindednesss is is fine by me. Everyone on this sight seems to offer very helpful and useful advice. I appreciate your feedback.