Documentation Out of Control - What classifies as a Controlled Document?

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#11
> 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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A

Andy Bassett

#12
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



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Andy B
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#14
> 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
 
J

John C

#15
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).]
 
#16
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.
 
A

AJPaton

#17
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
 
A

Andy Bassett

#18
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
 
D

Derek Barrett

#19
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
 
D

David Mullins

#20
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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