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A recovery plan for audit failures

October 08, 2009

You are in the middle of your ISO9001 certification audit. The auditor asks to see a particular document, let's say the Process Map. It's the document that shows the overview of the whole system. It's pretty important. Let's listen in...

manager: (flipping through pages in the quality manual): Oh it's here somewhere... well it should be here. I can't find it. Hang on, I'll go and ask John.

John: Oh, I asked Fred to make a few changes to it last week. He hasn't put it back in the folder. I'll go ask Fred.

John: (returns) Fred is away today. I've looked on his desk and we can't find it. Jane is calling him now to see if he can tell us the password to get on his computer.

(John sees Jane shaking her head) No, sorry. Fred is not answering the telephone.

manager (feeling embarrassed): John, do you have the old version?

John: mmmm.... I don't think so. I gave it to Fred with the suggested edits written on it. Jane says she has a copy but she's not sure what version it is. I'll ask around the office to see if anyone else has a copy.

auditor: (who has seen this before) hmmm... how about your Document Control process, can I see that?

There's a couple of issues here that the auditor is clearly going to investigate. If they can't be resolved, it's going to be a non-conformance and a failed audit.

First, what is the document control process? Do they even have one? Is it being followed? What documents do they have to control? (The Process Map is one of them!) Where are they supposed to be stored? Who should be editing them? How is that controlled? Are they keeping track of changes? How do they know which is the current version?

It could actually be worse! Imagine this scenario. Sales adjusts an important production document in response to customer feedback. However, the changes never get to Production. Production goes ahead on an out-dated version of the document and the product is shipped. It gets returned by an unhappy customer who's needs were not met.

Wasted hours, wasted resources, unhappy customer. All for the sake of Document Control.

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