Is a Form Number Required?

I am the ISO Coordinator/Lead Auditor for a small EMS (~ 42 FTE). We are ISO certified, but over the course of the last year, we have been working on reorganization of the entire company in preparation for expansion. As a result, I am working with one of our Vice Presidents to reorganize our QMS, specifically to make sure our QMS and Quality Procedures are accurate to our company's restructuring and to clean up and modernize the appearance of many of our documents. Currently, we are trying to rein in our Document Control procedure, which has never been satisfactory to my mind, and I have a couple of questions.

My main question is this, regarding forms and documentation control:

What qualifies a document as needing an ISO identification # and a rev #/date? I maintain a database of all items that were identified as "Forms" before I got here. This list includes actual forms, but also includes all quality documents, templates for manufacturing instructions, checklists for various activities, logs for recording/tracking all kinds of actions and changes, tracking cards, Non-QMS procedures (i.e. Lockout/Tagout procedures, Flux change procedures), Lists (i.e. A list of trained auditors, a list of owned equipment) - so basically everything they determined to need an ISO identification #. There are also plenty of logs and lists and signs and schedules that I know are used in various departments that are un-identified by ISO. I don't know how many of these un-identified items need ISO identifications, and I am at a loss as to a response when I get the question, "Why does it need to be an ISO document if only So-and-so and I use it or even look at it?" or "I've always used this log to track stuff within my department, and no one has said anything before."


I have only been in this position for the last three and a half years - sometimes that feels like a long time and others it feels completely and inadequately short. Formerly, I taught high school English and moved on to management for private supplemental education and taught high-end math and science while there, so it was a very new world for me to move into manufacturing. I took the QMS Auditor/Lead Auditor course almost 3 years ago, but really even after three years of being, for all intents and purposes, the company's ISO expert, I feel like there is so much I don't know. I really appreciate all the guidance anyone can give. If there is another thread about this, please refer me, I couldn't find anything before posting.

Thanks!

Re: ISO Form # required?

MichelleMcR said:

What qualifies a document as needing an ISO identification # and a rev #/date? I maintain a database of all items that were identified as "Forms" before I got here. This list includes actual forms, but also includes all quality documents, templates for manufacturing instructions, checklists for various activities, logs for recording/tracking all kinds of actions and changes, tracking cards, Non-QMS procedures (i.e. Lockout/Tagout procedures, Flux change procedures), Lists (i.e. A list of trained auditors, a list of owned equipment) - so basically everything they determined to need an ISO identification #.

Click to expand...

It really depends on how your company works (and I always dislike this answer).

Where I work, we use the Identification # and revision level to control forms and document changes. For example, we have a machine maintenance record that was recently upgraded to revision 'B', the original revision 'A' did not have a requirement to check coolant concentration level. This requirement was added to the form (document) and the form moved from 'A' to 'B'. All previous revision 'A' documents were collected and disposed of (to prevent the accidental use). Everyone that matters now knows that the document is 'level B'.

This is how we do it, but your company may or may not want to do it a different way. So long as you have control of the documents and records, you can choose to do it your way.

We have some documents that have not been updated on 2-3 years because they are good as they stand.

As for your specific question: I would answer: "What does your company think is important enough to control?"

Re: ISO Form # required?

Michelle,

Blank forms are data collection devices.

All other documents that are called forms may simply be the result of an inadequate document coding scheme or someone's attempt to control what did not need controlling.

You could archive all documents not used in the past three months (5S has some useful rules to follow here). Best to encourage your process owners to do this with their process teams (potential users of the docs).

You could extend the design of your document coding scheme to include templates and other doc types but please drop the ISO designation in favor of your company's management system. Name it for your company not after ISO and definitely not after any clause number in ISO 9001!

And drop the date in favor of a revision status.

Encourage your process owners to be brutal. After all you can easily retrieve a useful doc from your archive. Users will be glad to not see the clutter.

BTW, most companies code and control the documents they originate that are subject to revision. These include their manual, procedures, instructions (if they have them) and forms. Add templates if users find them useful and they are subject to revision.

John

Re: ISO Form # required?

John - The clutter is definitely part of my problem with the whole thing. Currently our server is numerous layers deep, but we are working on a plan to eliminate all the clutter and streamline access to controlled documents. We currently do not identify our documents using any section of the standard (even if they are ISO documents); all documents contain a number (currently 1-160) and each item on the list has the form number, rev date, and rev number in the header or footer. But you are saying all I need for identification is the identification and the revision "status" - in fear of sounding ignorant, I don't know what that means. Does that mean I only need to record the revision # and no date?

And I am not sure I understand the rest of your advice, so let me try to clarify for myself:

What I hear you saying is that I do not need to control the list of approved auditors or our blank fax cover sheet or our internal guidelines for ESD compliance or even our work instruction templates, but I do need to control our forms and logs that are used to collect &/or store data. Is that right?

Also, what about customer-required tracking records? My instinct is that they should be identified in a list/folder related to the customer, but that they do not belong in our ISO form listing. Do you agree with that?

Re: ISO Form # required?

Michelle:

You have a legacy issue to deal with. 1) is that some folks believe that effective document control means giving everything an "ISO #" and 2) old (Windows) file naming conventions dictated numbers rather than descriptors.

Today we (should) know better in that Windows descriptors can be just simple titles and so can the documents we use in our management systems. So, if you have an NCR Form (non conformance) form, you can call it and file it as that. Doesn't need any XXX-YYY-ISO-NNNN format or similar. Call it NCR rev6-14 and that's all you need. Use the footer to reference the file name, so when printed it shows up and "BINGO" you're all set! Same for procedures, too!

Re: ISO Form # required?

All of the above advice is good.

Some random thoughts from my Monday morning brain...

If the document / form / record has an effect on the quality of the product or service you provide, some level of control is advisable. This discourages people from removing information from the process that they'd rather not provide.

The other side of that coin is you don't need a document number / revision on something unless you require it. If you can demonstrate control of the process in some other manner, then you can construct an argument that it is controlled, just not in the manner somebody else may expect.

Flip the coin over again, and you have the argument that not enough levels of control encourages loose practices.

I have worked in environments where people would argue for the lack of control of a given document at every opportunity, leading to processes that should be controlled being played fast and loose by persons who don't play well with others. Enforcing the "we do it this way in this case, and this way in other cases" becomes tedious. Sometimes it's simpler to say "everything gets a document number and a revision. Period."

Referencing ISO element numbers as document numbers only helps somebody who knows what they mean. It's clumsy and serves no real value. In my small organization document number prefixes denote the department who owns the process - 70 - QA, 71 - Sales, 72 - Engineering, 73 - Operations.

This may be too cumbersome for your purposes, but it helps me to identify ownership. You may be content with simply identifying your documents with titles. Do what works for you.

Re: ISO Form # required?

Michelle,

You should have a documented procedure for filing and archiving. Filing was for instant access and archiving was for planned access but these days of scanning and electronic record keeping, with search all you need is filing and a spreadsheet organized by type of record, ID, where filed, by whom filed and for how long kept on file.

You file records so they do not become illegible or lost and are easy to retrieve. Completed forms are examples of records and customer-specified tracking records would be kept in a folder with the client's name, I would think. The spreadsheet used for your filing procedure would specify where etc...

Would your list of "approved" auditors should be part of your table of competent employees? This table (spreadsheet) would be dated each time its content is updated.

Please drop the term ISO Doc Listing. These are docs for your company's continued success not to conform to an ISO standard or keep a certificate.

I believe Andy answered your other questions.

John

Re: ISO Form # required?

In the most basic terms, the standard says: "Documents required by the quality management system shall be controlled".

As an auditor, if I find it in use, and it is not controlled, I'm writing a nonconformance.

Control doesn't mean that a form number is needed unless your written procedure says it does. It can be controlled by title. Revision dates can be used instead of revision numbers or letters. Part of the control can be by maintaining a list. It could also be, especially in this computer age, simply what is in the database where the original of the most current versions are stored.

Don't make it any harder for yourself than you need to.

I recall an Auditor telling me once that if a form is to become a record it needs a unique form number and issue number traceable to the QMS.

hope this helps.

Robgreen5 said:

I recall an Auditor telling me once that if a form is to become a record it needs a unique form number and issue number traceable to the QMS.

hope this helps.

Click to expand...

Rob - welcome! How's life in the city of the "magic round-a-bout"? Auditors often speak from no basis of understanding or practical implementation experience. It most certainly doesn't need a form number and if the control process is robust, not even a rev on it (number can also be letter). It's the responsibility of the organization to understand what's required to control documents, some of which are used to record stuff. Once complete, those "special" documents then need to be controlled as a record. Simples!