ISO 9001: Avoiding Over Documentation

Cari Spears

Super Moderator
Staff member
Super Moderator
#11
Al Dyer said:
...I recently worked with a compnay that had over 2,400 controlled documents!!!

...2 million in sales, 30 employees, and 3 products...

(TS-16949 and not even close to registration)
His post is about an automotive company that produces 3 products.
Sounds like overkill to me.
 
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D

David Hartman

#12
Wes Bucey said:
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.
Wes,

As I understand your elucidation the controlled documents to which you refer are in-fact deliverables (probably called out as such within your contract). In the world of regulated industries DoD, FDA, et cetera, the creation and delivery of these reams of processed precious wood pulp are a fact of life. And although a subject probably worthy of our time, are really not the sort of "documentation" that Rachel was "worried" about.

It appears that Rachel has concern regarding the amount of documentation it takes to properly define and control her internal quality management system. I believe the question really boils down to:

How do we determine the amount of detail required to ensure consistency in our processes?

To this my response would be a paraphrase of the old Mil-Q-9858a and early ISO 9000 documents: Documentation detail should be dependent upon such factors as experience, training, education, etc. For those with little training, experience, et cetera - a greater amount of detail may be required; for those with a greater amount of training, experience, et cetera - a lesser amount of detail.
:2cents:
 
A

Al Dyer

#14
To all, these are not just some type of controlled, they are controlled with registration numbers that are tied back to every policy, procedure, and instruction possible. The policies were getting to be more of a document reference list that the procedures they were supposed to be.

By the way, this small company uses a 10,000 dollar document control program based out of Tampa florida.
Al...
 
R

Rachel

#15
Wow, guys - thanks for the feedback.

In our upcoming ISO upgrade, I'm really trying to weed out the redundancies in our documents. There are just a lot of documents that are poor all around - poorly phrased (sometimes to the point of illegibility), repetitive, and badly organized. It's a result of having a 4-tiered system in which the 3rd tier ("Level II" or supporting SOPs, and WIs) allowed for document generation on an "as-needed" basis. The result? If someone thinks we need one, boom! there it is. Numbered, approved, and ready for circulation. Got an NCR? Issue a new SOP...that'll fix it.

In some cases, justified...you need to leave room for your system to grow - especially in our case, where we're on the brink of rapid growth and the communication and documentation trails are becoming more and more critical. It wasn't that long ago that this company was a *lot* smaller...to the point of having completely undocumented departments. Why bother, when there are only 2 people in a department? (Keep in mind, this is the old department-based mentality talking...) All of a sudden, things are growing - the senior employees long for the days when they didn't have to fill out a stupid form just to bring in a wee supplier sample, and the newer people want an SOP for *everything* to make sure that all their bases (and, not coincidentally, their :ca: ) are covered.

But, in some cases, not justified. If I hire someone as a technician in a medical laboratory, and they have a bachelor's in biology or biochemistry, I would seriously consider letting them go if they asked me for a procedure on preparing microscope slides for throat swabs. I would assume that their 4 years' worth of biology labs would have provided them with those skills. And, sadly, that's the case at times here - an employee who wants an SOP spelled out for everything, even though he/she has a degree, a diploma or a background in this, that or the other, and was hired on the basis of those very credentials.

I have a degree in chemical engineering. I would think they'd expect me to know how to calculate a flowrate or do a simple mass balance...I would expect to get canned if I didn't.

There's my rant for the day.

I might be new to the forum, but it sounds like the construction of my soapbox is coming along mighty well. :biglaugh:
 
R

Rob Nix

#16
Al,

All I can say is if that is the way they want to spend their money, I wish I was their consultant! :yes:
 

Wes Bucey

Quite Involved in Discussions
#20
commission?

Rob Nix said:
Al,

All I can say is if that is the way they want to spend their money, I wish I was their consultant! :yes:
I want the commission on selling them paper and ink and file cabinets! Maybe a little vigorish on the computers and word processing software to generate the documents, too.
 
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