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Author Topic:   Documentation Out of Control
Andy Bassett
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Posts: 274
From:Donegal Ireland
Registered: Jun 1999

posted 11 October 2000 10:25 AM     Click Here to See the Profile for Andy Bassett   Click Here to Email Andy Bassett     Edit/Delete Message   Reply w/Quote
I have just started on the Documentation clear-up for a company preparing for ISO. This subject is new to them, and after a three hour meeting we did not reach a consensus. They really taxed my patience and to be honest knoweledge with some of their questions.

Im not sure if they genuinely have a complex company, or if they are making it more complex than necessary. A couple of phone calls during the meeting to our planned Certification Body did not help the situation, they managed to persuade my client that a Customer Order is a Quality Record instead of a Document. Who's going mad here, me or them?

Here are a sample of some of the issues.

1. What classifies as a document? If you take the definition 'anything that has the potential to impinge on the quality of the product' this CAN be absolutely anything from Delivery Notes to Personnel Holiday Requests.

2. Why differentiate between a Document and a Quality Record?, basically they have to be handled in the same way.

3. Does it make sense to vary the retention age from document to document? Is it not simply easier to set one age, say 12 years for all documents.

4. Nowadays most documents seem to start life as a Mask before becoming a Document and then maybe eventually a Quality Record. A confusion exists about displaying the revision status for the Mask itself and for the content. Currently the mask status is stated in the middle at the bottom of the sheet, and the content status is diplayed at the top. Employees do not understand the difference.

6. The whole issues seems unmanageable, alone the task of trying to maintain a Master List for external supplied documents appears to be a job for a full-time person. External documents of varying importance are scattered all over the company.

7. E Mails are merrily going back and forwards to all and sundry without any form of control. I cannot honestly say that this is a problem.

8. This company is essentially a prototype company operating between 6 and 11 projects simultaneously. They have over 400 templates/masks, i dread the thought of trying to create and maintain a Master List. In this instance i see no way round it. How else could you show who for example is responsible to approve certain types of documents?

Any insights would be gratefully accepted, possibly most helpful would be suggestions as to the general approach to documentation clean-ups.

I started by laying out a matrix that lists across the top the issues that have to be covered ie Creation, Checking, Release, Rework, Distribution, Availability and Archiving. Along the left-hand side i tried to list the GENERAL type of documents. The feeling is that there are so many different types and uses of documents, it is impossible to set up any general rules.

At the moment its looking like a 10 page Matrix is the only solution.

Regards

------------------
Andy B

[This message has been edited by Andy Bassett (edited 11 October 2000).]

[This message has been edited by Andy Bassett (edited 11 October 2000).]

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Curtis
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Posts: 11
From:Clayton, NC USA
Registered: Sep 2000

posted 11 October 2000 11:39 AM     Click Here to See the Profile for Curtis   Click Here to Email Curtis     Edit/Delete Message   Reply w/Quote
Here's the official line on documents:

From ISO 9001:2000 FDIS

"4.2.3 Control of documents

Documents required by the quality management system shall be controlled. Quality records are a special type of document and shall be controlled according to the requirements given in 4.2.4."

ISO 9000:2000 FDIS

"2.7.2 Types of document used in quality management systems

The following types of document are used in quality management systems:

a) documents that provide consistent information, both internally and externally, about the organization's quality management system; such documents are referred to as quality manuals;
b) documents that describe how the quality management system is applied to a specific product, project or contract; such documents are referred to as quality plans;
c) documents stating requirements; such documents are referred to as specifications;
d) documents stating recommendations or suggestions; such documents are referred to as guidelines;
e) documents that provide information about how to perform activities and processes consistently; such documents can include documented procedures, work instructions and drawings;
f) documents that provide objective evidence of activities performed or results achieved; such documents are referred to as records."

I have used a basic differentiation as follows:

A document is anything (procedure, specification, form) you need to fulfill a work order.
A quality record is anything that provides evidence of how a work order was fulfilled.
Example: a blank form is required for use. It is controlled under document control requirements. A completed form is a quality record and is controlled under those requirements.

I'm not sure I understand the structure of your client organization. Your comments about the multiple projects leads me to offer a potential approach. If the documents can be segregated against the projects, you might consider several mini document control mechanisms linked to a company wide document control mechanism. One simple way to accomplish is thru an intranet. Each project maintains its own control process and master list electronically (the control process can be identical across projects - you just have multiple document handlers). At the company level, you hyper-link your document control to the individual projects and monitor the mini control areas. In this way you have decentralized control and centralized monitoring.
This approach was used by the North Carolina Department of Labor in managing document control of 19 divisions offering services under 17 industrial classification codes. Hope this helps - or at least sparks some ideas.

Regards,

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Andy Bassett
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Posts: 274
From:Donegal Ireland
Registered: Jun 1999

posted 11 October 2000 12:10 PM     Click Here to See the Profile for Andy Bassett   Click Here to Email Andy Bassett     Edit/Delete Message   Reply w/Quote
Thanks for your comments Curtis, they have indeed sparked some thoughts. Your differentiation between a Document and a Record would echo my onw thoughts, (where do you place a Customer Order in this case).

Your listing of the different types of documents seems to indicate that a Record is one of only 5/6 types of documents, i must admit that this thinking is new to me, and i wander why so much emphasis is placed on just the records side of documents.

I will think about the Intranet Solution, my inital thoughts are that they are not developed far enough to implement and maintain such a solution, the last attempt at Hyperlinking, from a parts list to digital photos ended in disaster.

Regards

------------------
Andy B

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Curtis
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From:Clayton, NC USA
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posted 11 October 2000 12:40 PM     Click Here to See the Profile for Curtis   Click Here to Email Curtis     Edit/Delete Message   Reply w/Quote
Andy,

Imho, a customer order becomes a record immediately upon receipt.

It is also an instruction and should be protected as such for as long as it is used in fulfilling the order. If the organization transfers the requirements to its own internal document and uses this new document for the production process, then the customer order is no longer an instruction.

Please note that the list I sent you was a direct quote from the final draft of ISO 9000.

Good luck with the structural design work!

Regards,

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Alf Gulford
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Posts: 60
From:Portland, OR
Registered: Aug 2000

posted 11 October 2000 02:08 PM     Click Here to See the Profile for Alf Gulford   Click Here to Email Alf Gulford     Edit/Delete Message   Reply w/Quote
Andy-
I'd like to reply to just one of your questions.

#3 asks about retention times. Presumably, you aren't faced with the medical device considerations that I am, but even so a company might want to define different periods just because of space requirements. We are required to keep our (4.16) Quality Records for several years. Even if we weren't, it makes good business sense; this is how we can prove we final-tested the product before it went out the door (e.g.; prove in court).

On the other hand, most in-process records are only kept for three months. This allows us to look back and see what happened if there's a problem with recent parts/sub-assemblies that needs to be corrected or quantified and allows us to see who may need some additional training. If we were to keep these records for the same amount of time as the 'Quality Records,' we'd need several more buildings just for storage.

I'd say to categorize the documents and set retention times that make sense for legal and business reasons.

Good luck on this project.

Alf

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AJPaton
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Posts: 73
From:Fayetteville, NC USA
Registered: Apr 2000

posted 11 October 2000 03:48 PM     Click Here to See the Profile for AJPaton   Click Here to Email AJPaton     Edit/Delete Message   Reply w/Quote
One question, I've always understood that employee training records remain as long as the employee does. Does anyone regularly turn out old training records for current employees?

Training records are quality records, but I've always seen them as having flexible retention times based on employee retention.

AJP

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Alf Gulford
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From:Portland, OR
Registered: Aug 2000

posted 11 October 2000 05:54 PM     Click Here to See the Profile for Alf Gulford   Click Here to Email Alf Gulford     Edit/Delete Message   Reply w/Quote
Agreed. Training records are a very important exception to my very general statements. Others might be Equipment Maintenance records, Design Project Folders and probably more that I didn't think of.

Thanks for the reminder.

Alf

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Marc Smith
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From:West Chester, OH, USA
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posted 12 October 2000 04:29 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
In regard to the original post, the following may help simplify things: https://elsmar.com/pdf_files/Doc_Matrix.pdf

If you look under 4.1 you will see Management Review Form (Original) - a 'controlled document' (a form, but none the less a controlled document). Next you will see (in RED) Management Review Form (post meeting) as a quality record. Same document - just one is used (evidence is entered).

The fact that controlled documents and quality records are 'handled the same way' doesn't say anything. You can say every quality record is a controlled document but you cannot say every controlled document is a quality record. Quality records are typically nothing more than completed (used) forms. Forms must be controlled so - the forms are conmtrolled documents.

Controlled FORM -----data added----> Quality Record

There is no retention time requirement for controlled documents. You just have to be able to show history of at least 1 revision. Quality records must have defined retention times. You vary times if you see a need to in your specific situation. Or you can blanket with 12 years. I have seen small companies 40 years old which have all records - they throw nothing away.

My quality records retention requirements comments are based on ISO 9001, not FDA which has specific requirements for certain quality records as was pointed out in an earlier post.

If you're contemplating a single master list -- think again. There is no requirement for a master listing. It is an option. You can choose alturnatives. A directory listing (or listings of multiple directories) can also serve as 'master lists' either for the company or by department. Don't over complicate the issue in your mind.

E-mail may be more of a 'problem' than you realize. Many do in fact have significant content. I would look closely at e-mail control.

> 4. Nowadays most documents seem to start life as a Mask before
> becoming a Document...

By mask do you mean template?

> ...6. The whole issues seems unmanageable,...

As does life at times.

> ...alone the task of trying to maintain a Master List for external
> supplied documents appears to be a job for a full-time person.

This may in fact prove to be a resource issue for you.

[This message has been edited by Marc Smith (edited 12 October 2000).]

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Marc Smith
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From:West Chester, OH, USA
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posted 12 October 2000 04:35 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
quote:
Originally posted by Andy Bassett:

...i wonder why so much emphasis is placed on just the records side of documents.


Because they are E-V-I-D-E-N-C-E.

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Andy Bassett
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Posts: 274
From:Donegal Ireland
Registered: Jun 1999

posted 12 October 2000 10:02 AM     Click Here to See the Profile for Andy Bassett   Click Here to Email Andy Bassett     Edit/Delete Message   Reply w/Quote
And the story roles on after another one and a half hour meeting. Just a few of the giblets.

My client has understood that when creating EDP Documentation it should be done in such a way that prevents the content from being changed and saved with the same name.

Fair comment, but the QC person jumped out of the seat to protest that this is over the top, it would mean renaming her QC Statistic Database 10 times per day.

I told her that this is not the case, that a database can retain its saved name, so long as it can be seen inside the Database when info was added. Not so, says the client, it should be PHYSICALLY IMPOSSIBLE for anyone to change the contents of the database, without being forced to change the file name.

I guess that this will also apply to a lot of other databases ie None-Conformance Databases, Parts Lists etc.

Any comments.

Regards

------------------
Andy B

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Marc Smith
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posted 12 October 2000 11:16 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
> Not so, says the client, it should be PHYSICALLY IMPOSSIBLE for anyone
> to change the contents of the database, without being forced to change
> the file name.

This is bunk. A database is a 'quality record' which is ongoing. Requiring a name change for each revision is simply stupid. Stupid, stupid, stupid.

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Andy Bassett
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Posts: 274
From:Donegal Ireland
Registered: Jun 1999

posted 12 October 2000 11:53 AM     Click Here to See the Profile for Andy Bassett   Click Here to Email Andy Bassett     Edit/Delete Message   Reply w/Quote
Thanks for your comment Marc, it was duly passed on.

I suppose i may have caused some of the problems myself. As we are getting close to certification i asked the Certification Body to visit us to give us a quote, and at the same time make a short presentation on two areas where i know i will face an uphill battle, and suspected that i needed support; development and documentation.

On reflection neither of these presentations seemed to do much except create a lot of fog. In fairness to the certifier they simply stated that documents should be renamed if they are changed, at this time nobody thought to ask about ongoing Quality Records (or databases as i will class them in future).

We were bowling along quite merrily on a Process Optimising Project, i did not mention ISO for many long months, now i am starting to hear all the things i was afraid of 'We need an Archive Software because of ISO' (40,000D), we cannot accept uncertified suppliers when we are registered to ISO', This will be a rocket up Marketings chuff' and so on.

The ability of ISO raise fear and panic in equal measures never seems to amaze me. What have we unleashed on the world?

Regards

------------------
Andy B

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Marc Smith
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From:West Chester, OH, USA
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posted 12 October 2000 12:41 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
"How does this apply to us?" The implementation battle cry...

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Marc Smith
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posted 12 October 2000 12:52 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
> In fairness to the certifier they simply stated that documents should
> be renamed if they are changed,...

This is only 1 way of many to do it. I admit I prefer it -- suffix each document file name with the date -- e.g. DocumentControl_2000-10-11.doc or (if you're into weird documentation numbering schemes) something like B123-alfalfa_2000-10-11.doc

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John C
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Posts: 134
From:Cork City, Ireland
Registered: Nov 98

posted 30 October 2000 08:16 AM     Click Here to See the Profile for John C   Click Here to Email John C     Edit/Delete Message   Reply w/Quote
Andy,
Why do I keep going on about 'read the standard and follow the words, not people's interpretations, guidelines, etc'?
Between your client, the ISO 9000:2000 guidelines and some of the well meaning opinions given, you are in danger of being pulled into a maelstrom of paperwork. Where did all these rules, regulations and requirements come from? Are they really from the standard? Remember we are talking about certification to ISO 9001.
In my copy of ISO 9002:1994, 4.5, (the currently applicable standard) there is a simple requirement to control documents and data by means of a master list or equivalent and ensure the current rev is what is in use. Nowhere does it say that documents have to have numbers. Nowhere does it say anything about templates or templates also having numbers.
Nowhere does it say that quality records are documents or that documents are (or are not) quality records.
In 4.16, it says that quality records will be established, etc......right through to disposed of. Their purpose is described as 'to demonstrate conformance' and it tells us that we should look after them. Again, nowhere does it say anything about numbers, revs, templates, etc.
It's all in the head. You believe the great myth that's going around and still haven't tried to see what ISO 9002 really requires. No wonder you don't like ISO 9002.
In my recent employment I wrote up a management review procedure and have recently done the same for a client. It says; The minutes of the management review meeting are filed as a quality record of the implementation of management review. The agreed actions are then added to the same document to form a corrective action report and this, in turn, is updated with the implementation and closing date to record same. It is then filed as a quality record of corrective action.
By filing the email format record, I cover the requirements of 4.5 and 4.16 and fullfill a number of functions including the corrective action process and even recording who was at the meeting and providing evidence that they received the reports at each stage. Not a form, template, document number or rev in sight. No possible need for them. And, if the company stands up for the process as a team, and if the process is followed and can be seen to work, few auditors will complain and none can prevail against us.
As we say here in Cork; "Up here for thinking, down there for dancing".
Keep it simple. Don't live in fear of non conformance but of failing to provide an efficient and effective management system.
rgds, John C

[This message has been edited by John C (edited 30 October 2000).]

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Sam
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posted 30 October 2000 09:57 AM     Click Here to See the Profile for Sam   Click Here to Email Sam     Edit/Delete Message   Reply w/Quote
Wow, John C, I think you may have hit on a revolutuionary new process.
Documents without numbers or revision identification; can you share this process on how you provide evidence of document control and/or removal of obsolete documents.
I have tried for years to come with a method based on what you have described; to no avail.

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AJPaton
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From:Fayetteville, NC USA
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posted 30 October 2000 11:08 AM     Click Here to See the Profile for AJPaton   Click Here to Email AJPaton     Edit/Delete Message   Reply w/Quote
Sam,

I think John's got "records" without numbers or revision identification, not simply "documents".

And hoping for a kinder simpler documentation system, I'll pose this one.

Can you use "records" as evidence of customer requests for variances from their "documents" for product specifications.

We're talking about a customer who is ISO in theory more than spirit, (don't even bring reality into the discussion), and we can't get them to document variances via their system.

Since a telephone call saying "do it" is currently the mode of change, can we totally ignore our customer's procedures and say that an engineering entry/fax or e-mail is sufficient? (I do know that our procedures would have to be updated.)

I see potential problems when our customer undergoes their ISO audit, since their system is not flexible.

Suggestions?

AJP

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Andy Bassett
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Posts: 274
From:Donegal Ireland
Registered: Jun 1999

posted 01 November 2000 07:09 AM     Click Here to See the Profile for Andy Bassett   Click Here to Email Andy Bassett     Edit/Delete Message   Reply w/Quote
Hello John

I dont really know how to reply to your post. It certainly isnt impossible that i am missing something on this subject. I should however mention that i have gone back to the standard (ISO 9000:2000) many times and examined it in detail hoping to find some clear guidance or answers to all the questions that appear with documentation.

I have been very happy to get help and ideas from this forum, but the variation in answers seems to suggest that this subject is not so cut and dried as you imply.

Maybe the complexity of the environments i have been working in recently doesnt help, as none of them are true manufacturing and very few of them have had good discipline.

Anyway this afternoon i will write the company guidelines for documentation for the 'problem client', and i will do it based on what i think is necessary for the company and what i think they can implement, which means, horror of horrors, i will do it without referring to the standard. I just simply dont feel that it offers enough guidance to cover all possibilities (as i doubt that any standard could).

Ill E mail you a copy when its finished and would appreciate your comments.

------------------
Andy B

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Derek Barrett
Lurker (<10 Posts)

Posts: 1
From:England
Registered: Nov 2000

posted 17 November 2000 06:58 AM     Click Here to See the Profile for Derek Barrett   Click Here to Email Derek Barrett     Edit/Delete Message   Reply w/Quote
I've only just found your forum and find it all very usefull, but somewhat frightening.
In all this documentation/records banter most of you seem to have got lost in the mire of trying to control everything.

As in everything else, there should be one governing rule, "KISS" Keep it simple Stupid!

Im my several years in implimenting ISO & AQAP systems I have always found that you should only have one way to control anything. If people have to stop and ask "is this a document or is it a template or is it a record?" then you have lost the battle, because the average user couldn't care less and will do his/her own thing at the first opportunity.

In my current setup I have all forms and templates in a central directory. Everyone has read only access to it. All forms have a form number.
Most forms have built in macros to e-mail them round a standard distribution list and are archived in a central store. That way anyone can see where a document has got to and what it's status is.

My system says that the masters of all documents are what is on the computer so all paper copies are considered to be uncontrolled, even the procedures. Superceded issues are kept in another directory (called Superceded documents!)
In most cases the quality records are the outputs from test reports run on the computer and filed internally. The only paper copy is the one sent out with the item to the customer.

Links to all procedures are maintained on the company Intranet so there is no need for complex management of manauls and binders.
Some people are happier reading from paper so I have issued binders of documents to most departments (where most gather dust from diss use) If a document gets revised I simly email the people who need to know to say that the new version is on the Intranet and paper coipes will be released the next time I do an update. The frequency of this depends on how many, or how important, the upadets are. I am trying to slowly get rid of the paper copies.

I have rarely had problems with assessors demanding issue control on computer generated documents. I simply state that the issue control of such output documents is given by the date and time in the document footer and that the document is uncontrolled anyway as the master is the computer. If you realy have to, you could put a footer statement along the lines of "This document is valid only on the day of printing".

I have the feeling that this topic will run for a long time, best of luck out there

------------------
Regards
Derek Barrett

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

posted 19 November 2000 06:32 PM     Click Here to See the Profile for David Mullins   Click Here to Email David Mullins     Edit/Delete Message   Reply w/Quote
Dear Derek,

How do you prove that personnel have been trained in the revisions to procedures when you just give them e-mail advice that a change has occured?

------------------

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awk
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From:Ontario, Canada
Registered: Sep 2000

posted 19 November 2000 10:45 PM     Click Here to See the Profile for awk   Click Here to Email awk     Edit/Delete Message   Reply w/Quote

Andy:

I hope this information will be useful to you.

A Document is any material, electronic, hardcopy, video or pictorial that outlines a process, guides or instructs, and requires revising. This incldes Master Forms or Templates.

Samples:
Internal Documents requiring control are Work Instructions, Quality Manual, Processes, etc.

External Documents requiring control are MSD Sheets, Ministry of Labour Health and Safety Manuals, Manufacturer Specifications, etc.
These require revising by the body forwarding them to you, however once you receive the update it is your responsibility to ensure the old is replaced with the new.

Once you take a document and add substance and a signature (objective evidence or proof of an action)it then becomes a record.

You probably could get away with a retention period of 12 years right across the board. This would depend on the company. I generally advise my clients to take a hard look at their records and put into place what they actually do. For instance it might be wise to keep an employment record for 1 year past employee termination. A service record for a certain period of years after the warranty is up, etc.

Any document or literature that does not require revising and is therefore used for reference only is not considered a Controlled Document. Possibly some of what you term as 400 masks could be considered as Reference Only.

In ISO 9001/2/3:1994 wherever 4.16 and in ISO 9001:2000 4.2.4 are mentioned are the areas requiring a record to be kept.

Sample:ISO 9001:1994
4.1.3 Management Review
The record is the minutes taken.

4.4.6 Design Review.
The record of the review.

4.4.7 Design Verification.
The record of the verification.

4.9 Process Control
The records are those showing qualified processes, equipment(maintenance sheets, etc.) and personnel(training records).

A Controlled Document List would include:
all documents Internally Controlled, such as Master Forms, Templates, Quality Manual, Procedures (listed individually if each has a separate Authorization),etc.
all documents Externally Controlled
include their revision level.

all Software and their version, such as Auto Cad 16, etc.

Any questions please contact me.

awk

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Andy Bassett
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From:Donegal Ireland
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posted 21 November 2000 01:20 PM     Click Here to See the Profile for Andy Bassett   Click Here to Email Andy Bassett     Edit/Delete Message   Reply w/Quote
Sorry accidental double post.

[This message has been edited by Andy Bassett (edited 21 November 2000).]

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Andy Bassett
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Posts: 274
From:Donegal Ireland
Registered: Jun 1999

posted 21 November 2000 01:21 PM     Click Here to See the Profile for Andy Bassett   Click Here to Email Andy Bassett     Edit/Delete Message   Reply w/Quote
Many thanks for all the comments so far, especially AWK, whose points i will take on board.

Maybe i can just tell you what we have done.

All our EDP generated documents are effectively controlled (This is relatively simple because most of the work is done by the server). Why have we done this? Because it is more trouble to distinguish between a document that needs controlling and one that doesnt for the employees.

A Document Approval Matrix has been created that lists which documents need to be approved and where the original approved hardcopy lives. Why have we done this? Because as the latest copy of a document is always on the EDP Server, we cannot see the need for a Document Matrix as normally used (ie to define the latest revision status of the document). BTW We are not allowing electronic signatures because our EDP experience is not up to it. Also the only hardcopy of documents that we allow in the company is the original signed. No other copies are allowed.

We dont ever talk about Quality Records, only Documents. Why have we done this? Because we cannnot see any difference between the two, for us the handling and storage problems are the same. Ie After a car is built we want to have available for a certain time all the documentation that is relevant for that car going together. It doesnt matter if it is a parts list or a Test Protocoll.

We standardised the retention time for everything at 12 years. (ie all EDP/electronic files documents mentioned in the Approval Matrix). Why did we do this, becuase it is too much trouble to define different retention periods for different documents.

It took us a long time to agree the guideline, but i do feel that it is the easiest to understand and administer.

Please post any questions you may have about this guideline so that i can establish if there are any holes in it.

Regards

------------------
Andy B

[This message has been edited by Andy Bassett (edited 21 November 2000).]

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energy
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From:New Britain, CT
Registered: Nov 2000

posted 21 November 2000 03:34 PM     Click Here to See the Profile for energy   Click Here to Email energy     Edit/Delete Message   Reply w/Quote
harrington-group.com has a great document control system for mutiple users that you can download for free for thirty days. No, I don't work for them, but, I've used it. Have their Corrective Action program right now with plans to get the Document Control A.S.A.P. (I have a new job so it will take some time to sweet talk the boss) The address may not be correct but the search engine will find it. Good Luck

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