ISO 9001: Avoiding Over Documentation

[Claes Gefvenberg]

Overdocumentation.

Rachel wrote a good post about overdocumentation in the New to Internal Process Auditing - Seeking Sample Process Audits thread. We have discussed the topic before, but I still felt that it deserved a thread of it's own. Over to Rachel:

My only worry with that approach is that it will *undoubtedly* result in SOP revisions - a good thing in many cases, but the tendency for us (from what I've seen so far) is to *overdocument everything*. I've seen very little evidence of the "competence" factor in our SOPs - goes back to the theory that you don't write a "How to Insert an IV" SOP for a nurse, because she's assumed to be competent. That train of thought doesn't always apply here - and I really hesitate to dumb down the SOPs to that level. In some work areas it would make sense, b/c of the high turnover and so on - but in others it's already more of a hindrance.

Note: here's one for you guys - I'm in the process of converting our SOPs to flowcharts - I'm working on a section of the process right now that I'm finding is not only double-documented, but *triple-* and sometimes **quadruple-**documented. ridiculous!

Cheers,
-R.

Over to the group for comments...

/Claes

 

[David Hartman]

I have run into this many times. One approach that I have taken in the past is to document the subject process one time, then where necessary make reference to that process (e.g. Create a process for handling nonconforming material, then in processes that may result in nonconforming material such as assembling, welding, testing, etc. make reference to the nonconforming material process).

 

[Claes Gefvenberg]

Rachel,

Many of us used to overdocument things in the past. The fact that you are a newbie may just make it even easier for you to spot it. Now, since you're in the process of converting SOPs to flowcharts: Here's your chance..

Have a look at this old thread thread (there are several of them) on the subject: Keeping Procedures Simple .

/Claes

 

[Al Dyer]

As just a comment to help the thread move along, I recently worked with a compnay that had over 2,400 controlled documents!!!:mg:

2 million in sales, 30 employees, and 3 products. Would anybody else consider this overkill?
(TS-16949 and not even close to registration)
Al...

 

[mshell]

Al,

I would consider that overkill and a document control nightmare I work for a company with 35 employees, we have 115 controlled documents and this works well for us.

 

[Wes Bucey]

As just a comment to help the thread move along, I recently worked with a compnay that had over 2,400 controlled documents!!!:mg:

2 million in sales, 30 employees, and 3 products. Would anybody else consider this overkill?
(TS-16949 and not even close to registration)
Al...

Well . . . . . . . . . . . . . (that's a deep topic!)

Are most of these documents "records" or are they "designs" or "procedures" or "work instructions" or something else?

I'd also be pretty interested in the definition and method of "control" as it relates to documents at that organization.

We're in aerospace and we generate a ton of "controlled documents" every year. (sometimes as much as 100 pounds for each aircraft type our product is installed on - the paperwork easily outweighs the product) due to the preponderance of regulatory requirements from government agencies throughout the world. We have a lot more than 3 products, though. Some of them are very simple, some are very complex, like a cockpit mounted Traffic Collision Avoidance System.

The interesting part of Standards based on ISO is they allow for variation according to the needs of the organization and the various entities with which it interreacts.

 

[howste]

Wes, having spent a fair amount of time in the aerospace industry myself, that sounds about right. My guess is that most of those 100 pounds of documents are in the form of records rather than instructions though. My impression is that most people in this thread are talking about documents used to control processes, not documents to record results.

 

[Wes Bucey]

Wes, having spent a fair amount of time in the aerospace industry myself, that sounds about right. My guess is that most of those 100 pounds of documents are in the form of records rather than instructions though. My impression is that most people in this thread are talking about documents used to control processes, not documents to record results.

Each aircraft on which the product is installed gets a big book [manual] (as much as ten pounds) with instructions, wiring diagrams, engineering drawings of product and its place in the aircraft (airframe, skin, bulkheads, cabin configuration, etc.), maintenance schedules, etc.

Every one of these manuals is a "Controlled Document" in its entirety. We have a Controlled Copy duplicate of each manual in our file. FAA gets a Controlled Copy. Aircraft owner may have another Controlled Copy besides the one travelling with the aircraft. Because of the slight configuration differences between aircraft of the same make and model, almost every installation gets its own unique book (even though the only difference may be in the length or route of a wiring run.)

Each of these Controlled Copies is subject to recall or update as we gain information from the field on each installation, depending on whether the info pertains to aircraft model, assembled product, or individual component within an assembly.

There are many times I think it would be cheaper (and lighter) to provide every aircraft with a DVD player and disks for every manual for all the aftermarket installations. Alas, nobody ever listens to my Jeremiad.

 

[Mike S.]

Alas, nobody ever listens to my Jeremiad.

Your what?

Maybe if you wouldn't use so many "overeducated" words they'd listen more .

 

[db]

Your what?

Maybe if you wouldn't use so many "overeducated" words they'd listen more .

I thought it was a typo, until I looked it up!

I worked with a company that had 3 employees and over 10,000 controlled documents. Of course, they were a design house, and they considered the designs as product, not documents.

The important thing is that there is no magic number of documents. That is why note 2 is in 4.2.1. If the sheer number of documents creates control issues, then you either have to change your number of documents, or change you level and type of control.