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  ISO 9001/4:2000
  Detail Required in Documented Procedures

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Author Topic:   Detail Required in Documented Procedures
Steve
unregistered
posted 17 May 2001 01:52 PM           Edit/Delete Message   Reply w/Quote
What is the level of detail generally required in a documented procedure? My approach was to make the procedures fairly "vague" (or open ednded) and expect the person performing the procedure to use their best judgement. Other people at my commpany seem to want to include every little detail they can think if. So I am unsure of what level of detail is necessary in the procedure.

For example, I said that, for our ESD prcedure, that ground connections should be inspected to ensure that they are in good repair. Is it enough to leave it at that? Or do I need to "define" what the requirements for "good repair" are. This would seem to me to be overkill. Is it unreasonable to asume that the person making the inspection has the judgement to determine what "good repair" is?

Any thoughts you have would be appreciated.

Thanks,

Steve.

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energy
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Posts: 228
From:New Britain, CT
Registered: Nov 2000

posted 17 May 2001 02:24 PM     Click Here to See the Profile for energy   Click Here to Email energy     Edit/Delete Message   Reply w/Quote
How about using an Ohmeter to verify continuity and visually inspect connectors and cable (wire) for wear or damage?
That's not too many more words and kind of narrows it down a bit.
energy

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MrPhish
unregistered
posted 17 May 2001 04:12 PM           Edit/Delete Message   Reply w/Quote
I see that a good part of your QMS relies on qualified personnel to perform the work, not just written procedures and work instructions. Look at ISO 9001:2000 section 4.2.1 NOTE 2 " The extent of the QMS documentation can differ from one organization to another due to c) the competence of personnel."
This tells me that as I increase the use of more qualified (and now competent) personnel my amount and detail level of documentation can (doesn't have to) go down (inverse proportion).
Now a danger in this scenario is that if these "qualified and competent" personnel don't perform well ... then the absence of "detailed guidance" may be brought up by the external auditor as a flaw in the QMS. Its a tough call. I think a company has to make sure all of its employees understand the goals of the company and what is expected from them. Then when they are forced to make a decision (maybe based on a lack of "written detail") they can rely on their understanding (and skills)of what is expected of them as employees to make the right call and make the quality decision.
Another down side of less detail is if you have a bunch of "Sea-lawyers" working with you. They question everything that is not laid out in front of them I guess so they don't have to think for themselves. Less detail works well with self motivated employees who understand that the whole game is about customer satisfaction.
Its hard to know how much or how little is correct. Good luck on the high wire.

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tim banic
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Posts: 28
From:St George, Ontario, canada
Registered: Apr 2000

posted 17 May 2001 04:48 PM     Click Here to See the Profile for tim banic   Click Here to Email tim banic     Edit/Delete Message   Reply w/Quote
Another thing you will have to watch out for, is training records of your staff. You will have to show that they are compitant to make the decision whether the product is good or bad.

one reason for detailed work instructions is when you need to train new staff in that position...what documentation do you use to train them. Eventually yes they will become compitant enough to do the job with out looking at the work instruction but until then, they need something to reference.

Hope this helps

tim banic
"if it moves, train it...if it doesn't move, calibrate it...if it isn't written down, it never happened!"

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David Mullins
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Posts: 248
From:Adelaide, South Australia, Australia
Registered: Nov 1999

posted 17 May 2001 08:17 PM     Click Here to See the Profile for David Mullins   Click Here to Email David Mullins     Edit/Delete Message   Reply w/Quote
STEVE,
From the methodology that I employ, the short answer is that it depends on the standardisation already inherent within the organisation at the time you write these procedures. You are a change agent - don't make the change so big that you lose everone on the way.

ESD EXAMPLE:
Unfortunately this is not a good example for my point. Let's say that different areas within the org were using different inspection methods, and some didn't perform inspection at all. This is a prime candidate for establishing a standardised work practice where you want everyone to perform an inspection, but don't take it to the Nth degree of stipulating the actual inspection instructions - hance a major change for some, and no change for others.
In reality we clearly need to stipulate what the inspections consists of, which can be stated in the procedure, an annex to the procedure, or a separate work instruction. This represents major change for some, minor change for some, and no change for the others.
Why do we have to stipulate the inspection methodolgy? Because (and this utilises the basic principles of quality - every process has variation, if you don't control it you can't improve it, &, If you donât measure it you can only change it you donât know if you improved it) you will get greater variation in measurement outcomes without it, thus increasing process capability spread to the point that you can't actually calculate it because you don't control the process.

Also to take into consideration, is this degree of standardisation going to adversely impact user impressions, to the extent that it turns them off the quality system all together. In this case I don't think the impact is going to be Earth shattering - indeed this kind of things reduces or eliminates barriers that previously existed between work groups.

I could say more but I've got work to do.
Let me know if you want more dribble
David.

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Dan Larsen
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Posts: 137
From:Sussex, WI
Registered: Feb 2001

posted 18 May 2001 12:36 AM     Click Here to See the Profile for Dan Larsen   Click Here to Email Dan Larsen     Edit/Delete Message   Reply w/Quote
My approach...

The policy defines why.

Procedures define who does what and when.

Instructions (or another document vehicle) defines how.

In you example for the ground connectors, I'd say the procedure would be OK (except for possibly defining the frequency). An instruction would be used to define acceptance critertia.

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rock
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Posts: 11
From:Racine, WI USA
Registered: Apr 2001

posted 18 May 2001 08:54 AM     Click Here to See the Profile for rock   Click Here to Email rock     Edit/Delete Message   Reply w/Quote
Hi Steve,
I agree with Dan. In your system, too many corrective actions may point to a need for specific work instructions.
Mike

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Fire Girl
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Posts: 41
From:Orillia, Ontario, Canada
Registered: Apr 2001

posted 18 May 2001 11:01 AM     Click Here to See the Profile for Fire Girl   Click Here to Email Fire Girl     Edit/Delete Message   Reply w/Quote
Our system, is a very cumbersome one. At least that's my opinion.

However, I will tell you how we do it. We have a general procedure manual which basically laid out on the same format as the Standard. Then I have operations manuals for Production, Toolroom and QA. In the Operations Manual are the specfics on how to do the job. I feel these are still fairly vague, and taking into account the Operators are skilled setter/operators. They also have 'Set-Up Instructions'. There is a Set-Up Instruction sheet for EVERY job that we run. This gives sort of 'tricks' for setting up that particular job.

For the ISO 9k:2K I am hoping to go to shaved down procedures and flow charts....

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