Some thoughts from the ISO ListServe:
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From: Nancy Jennejohn
Date: Tue, 31 Jul 2001 10:06:42 -0500
Subject: Re:
FMEA /../VanDorp/Salinger
From: Salinger
Darryl VanDorp asked about Preventive Action:
>
> How does a smallish firm deal with Preventive
> Action in a documented manner? Say I have 10 people.
>
> Does preventive action have to be recorded on
> a PA form. Can evidence of PA be shown through
> meeting minutes and other documentation? Let's
> face it PA is something (as is Corrective Action)
> that we all do alot and often. The problem is the
> documentation. As Charley's dog anecdote,
> if I know there's a big bad dog that hangs out
> on a street corner in order to prevent getting
> bit my preventive action is to use a different
> route when I'm walking to work. Problem is
> I'll be darned if I write that down on a "form"
ISO 9001:2000 does NOT require a preventive action form. It does require a documented system, but you define the system, so long as the system includes determination of potential nonconformities, evaluating the need for action, determining and implementing the needed action, keeping records, and reviewing the actions. You can figure out the easiest way to document this that will work for you.
I've seen a log book kept by lab people in which they wrote such things as: "we don't have spare heating elements for the oven, so our testing would be delayed if one burnt out." The log books are reviewed periodically and determination made as to which entries need follow-up, and what this follow-up would be. Review of the results of the actions also happens. This could be simpler that having an individual form for each instance of preventive action.
Regards,
Rudy Salinger
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Date: Tue, 31 Jul 2001 10:10:25 -0500
Subject: Re: FMEA /../VanDorp/Scott
From: PFSCOTT
> Can evidence of PA be shown through meeting minutes
> and other documentation?
I believe that depends on what information is written down in those minutes and "other documentation." I've seen minutes that were nothing more than "he said, she said." If the minutes of the meeting or the other documentation clearly document the PA plan specifics, and the outcome of the PA in terms that allow its effectiveness to be determined, then I would be hard pressed to say you have to have form.
> Problem is I'll be darned if I write that down on a "form" Do
> you write it down anywhere?
It would be nice if all potential problems were as simple as the biting dog example you cited. While the essence of the example is true, many times preventive actions are based on a best understanding or things not fully known. One reason forms are developed for activities such as PA is that, to the extent they're actually used, they help introduce consistency and, to the extent they're well-designed, they drive the recording of the information needed by the users...information that assists in making reasoned decisions.
Phil