posted 21 March 2001 08:31 PM               

Numbering systems...this will open a can of worms, I'm sure

My approach...

I try to number the policy manual consistent (in some way!) with the standard. For ISO 9000:2000, I use ISO section 4 = My section 1, ISO section 5 = My section 2, etc.

I tend to number the procedures consistent with the policy. For example, a procedure for document control might be numbered 1.01, a procedure for management review might be numbered 2.01.

By the time I get to instructions, I move to a system that makes sense internally. I might group generasl quality system instructions in a section 1, process instructions in a section 2, inspection instructions in a section 3, etc. I tend to make the section breaks at the instruction level with the way the company views it's processes.

The form numbering pretty much follows the instrutions. For example, forms related to inspection would be numbered in the "300" sequence.

The bottom line: I tend to keep the policy and procedures numbered somewhat consistent in a unified manner with the standard; I tend to number the instructions and forms using a system that's consistent with the internal process flow.

My philosophy has been: I want my policy and procedures tied to a quality system that's universal; once I move to instructions and forms, I want a system that matches the way the people think internally. The people making the translation between policy/procedures to instructions/forms generally have to think both ways...but then that's what the managers are paid to do...interpret.

posted 21 March 2001 08:39 PM               

If you have a numbering system that everyone is comfortable with already, maybe the thing to do is slide the new requirements into your current numbering system in a place that makes sense to you. Then create a cross reference matrix (not much different than the matrix included in the standard) that tells the external auditor where to look for the new requirements.

The auditor (one person) may have a tough time figuring out the relationship, but your users (many persons) should have an easier time. Who should suffer...one or many?

Added PS...I realize your management balking at the matrix, but maybe because they see it as something the company is going to have to use internally on a routine basis. I guess I see matrix as something that is designed more for those outside your system, a directory in a way, telling the external user where you've addressed the elements. Internal users of the system, I sdon't believe, would have to use the matrix at all. I use a tool like this to lead the ISO 17025 requirements into an ISO 9000 based quality manual.

posted 22 March 2001 01:54 PM               

QS-000 Level I Policy Manual

QS-011 Level II Procedure (4.1 Management Review)
QS-021 Level II Procedure (4.2 Quality System)
QS-031 Level II Procedure (4.3 Contract Review)
QS-041 Level II Procedure (4.4 Design)
etc...
etc...
etc...

QS-171 Level II Procedure (4.17 Internal Audit)

qs-171A Level III Form (Audit Initiation)
qs-171B Level III Form (Audit Checksheet)
qs-171C Level III Form (Audit C/A Sheet)

wi-171-01 Level III Instruction (Audit Initiation)
wi-171-02 Level III Instruction (Audit Reporting)
wi-171-03 Level III Instruction (Audit Closure)

Hard to get the point across in this format but the intent is to have all documents under the element trace back to the controlling procedure.

Capital "QS" prefix always designates the Policy or a Procedure.

Small "qs" prefix always designates a form related to the procedure.

Small "wi" prefix always designates a work instruction called out in a Procedure or Form.

ASD...

posted 22 March 2001 03:55 PM               

I feel the pain, let alone setting up a numbering system, it is equally as hard to keep it up and explain its relevence in interfacing with other documents.

As said before, the most important aspect is to keep it simple so all employees understand and comply.

Depending on the size of the company there may even be a person who is soley the Document Control Coordinator.

This is one area where I think there are some good canned packages that can reduce the pain.

posted 30 March 2001 02:36 PM               

Needless to say half of the people couldn't find them and the other half didn't know what to do when they did find them.

End results; 10 operators, 10 work instructions and 10 MINORS. The auditor stopped short of citing a major, stating that we would do the same thing at our next surveillance audit.

posted 30 March 2001 04:24 PM               

Your Quote

"...And as good MR's we have taught eveyone to reply with " I don't need work instructions, I have been trained to do the job".

With all due respect, Bullcrap!

Why would you as a "good MR" teach people to give a canned response that they might not be able to explain when questioned further?

Do you have to follow an auditor around and explain what different responses from different personnel really mean?

Do you have that little faith in the workforce?

I guess all people in your organization are trained to perform all aspects of your "Quality" system since they have been trained and one year from now they can go back and perform the same function without the use of a guide (work instruction).

I guess the statement made that got under my dander (with whatever hair I have remaining) was "As good MR's"

I have never had "MR" training and am not sure if it is even available, and would not work for a company that considered an "MR" as the means to cover up process inconsistencies.

I do believe that the MR is a resource that is available to train the workforce in how the quality standards are structured and how they apply to their individual situations.

As an aside, as MR's we are responsible to ensure that coffee and pastries are available to the "real" auditors!

Sam, I've read many and agreed with a high majority of your posts but this one just hit me wrong! Keep the faith!

ASD...

posted 02 April 2001 10:43 AM               

I cringed when I read the "nobody uses/needs procedures" quotes above. Nothing wrong with the auditors questioning at all. probably saw the pile of dust on the files..LOL

posted 02 April 2001 08:00 PM               

I've set up a number of multiple site registrations and have used the following for differentiating between levels of documents:

EG1:
Quality System Procedures (QSP)
Work Instruction (WI, which had two numbering systems, one for WIs relating to QPs, and another for workplace stuff - obviously not ideal)

EG2:
Quality Procedures (QP)
Regional Procedures (RP)
This dispensed with any confusion about what level a document should become a WI, we just call everything procedures.

EG3: (I didn't set this one up)
XP, where X represented the Department that had the most at stake, and P for procedure.
XI, where X=department and I=instruction.
This process approach (of sorts) really sucked. It made it very difficult to control repetition and conflict between procedures. Copnsequently nobody paid much attention to what the documents said, and I couldn't be buggered fixing it all and left

EG4:
VP, where V was the start of the company name.
LI, Local Instruction.
Forms are aligned to procedures and instructions as VF's and LF's.

THE MATRIX.
My thoughts:
Forget about aligning procedures with the standard, they'll only change the structure again, and nobody outside the quality manager cares about the standard,s numbering, they only relate to what the procedures, instructions, etc. say.
If a matrix works - good, if your company doesn't want one, don't give them one. After all, Corrective action relates back to EVERY procedure and instruction (in reality).
So new rules are developed in peoples heads about what constitutes a strong and a weak link, and therefore what gets cross referenced and what doesn't - more rules that aren't written down that users don't care about.

The infamous flow chart, using referencing of system level procedures (LII) is more than enough information for them (I may change my mind down the track).

At the end of the day, if you need all this cross referencing, matrices, etc., what chance in hell does the poor old punter (user) have of understanding such a system. They just want to do their job, and have any changes to it make life easier and simpler.

posted 02 April 2001 08:45 PM               

I agree, back to the basics,

I have read and re-read your message. At first I thought you were off-base, but upon reflection I almost agree with your total thought process.

1: I still believe that with the level of personnel currently available there needs to be a common system that relates document levels back to their preceding documents levels and ultimately company policy. This is a learning curve that we have to deal with within our own situations. We have to do the job.

2: I believe that all personnel can be trained to understand the documentation level and to where they fit into that structure and which documents they need to perform their functions.

3: I am not convinced that the document structure as proposed by ISO/QS/TS is the best option, I've not seen better yet. (I am still open)

4: If the document numbering system is set up correctly there is no need for matices and master lists that are only good for the Management Rep. to use a reference.

(yes I know I keep spelling refference wrong)

5: For all the reasons above and from the many posts to this forum (not just document control) I am in firm belief that document control systems need to be mostly paperless and controlled through a network type (view only) system.

Will this happen soon? No, there are too many companies that either don't have the internal resources (programmers) or the $$$$ required to initiate such a system.

I see a networked system as a type of "keep it simple stupid" idea.

Good Post Dave!

posted 21 June 2001 06:35 PM              

This thread reminds me of so many "document control" converstations I have had with so many people so many times...

My background is in publications development and production rather than quality. My experience is that the pursuit of "meaningful" control numbers for documentation tends to be a quest for the Holy Grail.

As a practical matter there are only three requirements in a document numbering system:

1. Each document must have a unique ID code. (This includes revisions.)

2. The filename of a document's electronic original must be identical to, or substantially based on, the unique ID code.

3. The ID code must physically appear on the printed or electronically viewable document.

The most robust document numbering system I have ever used had the format: YYMMSSSR, where:

YY = the year the document was created.
MM = the month the document was created.
SSS = sequence number of the document produced that month (000, 001, 002, etc.)
R = revision (A, B, C, etc.)

With this system a company can produce up to 999 new documents every month FOREVER, and easily track the life cycle (or revision history) of each one, both in hard copy and electronically.

The numbering system may be "arbitrary," but it is easy for anyone to understand, especially low-paid file clerks and temporary word processors.

It works for every type of document, from multi-volume manuals to procedures to work instructions to standard forms to illustrations. (Be sure to assign unique document numbers to individual graphics, and include them as part of the illustration. That way, you can retrieve the original illustration separately and apart from the document in which it appears.)

As long as the document itself has the control number on it, you can look it up in whatever filing system you are using, paper-based or electronic.

These advantages far, Far, FAR outweigh the disadvantage of having to maintain a "matrix" that links specific document ID codes to elements of the ISO 9001 standard. Such a matrix requires only occassional maintenance.

Besides, most end-users will look for documents by their titles, not by their control numbers. Structured and "meaninful" numbers won't help them at all.

Sorry for the rant, but if this helps just one budding documentation coordinator, my life will be fulfilled. The system I have described was a real eye-openner to me when an Old Navy Chief "turned me on" to it.

posted 22 June 2001 10:38 AM               

Our numbering system goes like this:
(example given is document control)

Policy: 4.5
Procedure: 4.5.1
Forms: 4.5.1.xxx
Sub-Procedures: 4.5.2 --> 4.5.9

In this simple system, one can always identify the top-level policy. (and yes I agree with the selfish reasoning that us captain-QA's have for keeping it this way!)

And, Yes I agree that people go for names, not just numbers. So the policy & procedure will have the same name - with the top heading being "QA Manual" or "QA Procedure" (spelled out of course)
e.g. (Policy)
QUALITY ASSURANCE MANUAL
DOCUMENT CONTROL
e.g. (procedure)
QUALITY ASSURANCE PROCEDURE
DOCUMENT CONTROL

Keep being inventive.
Trakman.

I guess the wagon ride is over?

posted 22 June 2001 11:44 AM               

Your way is good, too. I just have to commit the new standard sections to memory. Working with the "elements" way of numbering for a few years, someone chose the topic and "Blam", I had the procedure if not the procedures. Made me look smart. At my age, the memory is the second thing to go.

posted 22 June 2001 12:58 PM               

Yes I can understand that someone changed our favourite recipe and suddenly we are lost. Our magnificient brilliance goes away. We are getting registered to the 9001:94 standard, so my time is also limited to cling to the 94 version elements.

As a suggestion, take the new standard and put it into a flowchart, taking advantage of the fact that there is a pattern to each top level section.
Example; 7.0 Product Realization: starts at planning and ends with production/service, and with the old familiar IMTE at the end.
Do the flowchart (in Visio or your pet program) and stick it onto the wall above your monitor.
Look at it and Think about it for a few months, before you change anything.

I read an article in a business owners magazine once upon a time, and they suggested that to solve a problem;
keep thinking about it,
keep it in front of you,
ask other people for their ideas,
and it will hit you.

posted 22 June 2001 03:34 PM               

Our Format:

Level 1 - Quality Manual/Quality Policy
Level 2 - QC Procedures
#ing examples: Take the 4 off the ISO Element number and use: QCP-0100, QCP-0500, QCP-0502, QCP-1400, etc...[I just chose randomly for examples]

Level 3 - Work instructions, SOPs, Drawings, etc....
CWI-05-QAD-0001 (Columbus Work Instruction-ISO element 4.5-Mgmt responsibility to what department-sequential # start with 0001)
SOP-000 - The authorization block identifies department, key process, parent document, how many copies posted, approval signatures, title, etc..
Drawings - Heck the Engineers don't even know how they're numbering them anymore - from my 3 years here...it seems they just go from 111### & up
Level 4 - Forms
CF-Q-05 (Columbus Form - Department - numerically sequential number) Revisions go up numerically as well