Definition Controlled Document Definition - What constitutes a controlled document?

S

shereenk

#1
Hi, I am new to the forum but have read through some very helpful threads.

Right now, I am trying to come up with a good document control process and would like to know the following:
1. How do I determine what documents need controlling? My company has the following types:
a) Process documents - which WILL be controlled
b) Documents sent to customers by Marketing - brochures, flyers, presentation slides, newsletter
c) Invoices, receipts, credit notes - which are generated by software
d) Product documentation - notes on the products generated by Technical Writer

2. One proposed document ID format (by consultant) uses document types like RP - Report, FR - Form, CK- Checklist, PR - Procedure... he even said should have one called TM - Template.. but I'm thinking... isn't everything a template? So it's funny that I have:
FR-001 for Training Form
TM-001 for the same Training Form
Is it right to do away with TM document type?

3. Some of the process documents have been in used for years but there is no release date or version number. How should this be tackled? I just use version 1 and current date?


Hope you guys can help out.

Thanks,
Shereen
 
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harry

Super Moderator
#2
Re: What constitutes a controlled document?

Welcome to the Cove, Shereen.

This had been extensively discussed here before and I will direct you to some previous discussions instead. See: What is the difference between a controlled document and an uncontrolled document? Also, scroll down the page to read other threads in the 'Similar Discussion Threads' box.

Unless you are a very big organization with hundreds of documents, you can control documents by 'name of the document' and revision number. Issued date is useful but not necessary. It is your choice if you do not want the cumbersome 'dinosaur' practice that you had described.

Existing documents can be put under control by starting with Revision 'Zero' or even 'One' if you choose so. After all, these will be described in your document control procedure.

Some related and informative threads found using the search function.
 
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J

Jeff Frost

#3
Re: What constitutes a controlled document?

Shereenk ,

This can get a little complicated for those starting the control of documentation for the first time. There are typically three types of documents that must be controlled.

Management Documents
· Quality Policy
· Quality Manual
· Procedures
· Work Instructions

Technical Documents
· External Specifications (MIL, ASTM, customer specs, etc.)
· CAD Drawings
· Blueprints
· Schematics
· Job travelers/work orders
· Order-specific instructions
· Reference charts

Forms
· Forms

Each type of document can have their own format or template so you really do not have to reinvent the wheel here just standardize of one format for management documents and technical documents. Forms are, well… forms so they should be in a format needed to collect or record data.

Because you are implementing a new system for control of documents the revision for historical documents can start at Revision 1, or NC or A, date of approval and a revision history note such as “original issue”.

Hope this helps.

Jeff
 
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M

Matt Swartwood

#4
Re: What constitutes a controlled document?

Long story short, ask the question "Does or could the application of the document adversely affect the quality of the product" If the answer is yes, then you must control the document. If the answer is no, it is your choice on whether or not to control the document.
 
#5
Re: What constitutes a controlled document?

well, the standard tells you what is required in 4.2.1. The kicker is 4.2.1 d). Matt's suggestion is correct, but I would take it one step farther. Does the document affect the effectiveness or efficiency of the process as well? Bottom line is.... if I need the document to do my job, it must be controlled.
 

SteelMaiden

Super Moderator
Super Moderator
#6
Re: What constitutes a controlled document?

I tried to post yesterday, but had some computer problems. I agree that stopping at "does it affect product quality" is probably not far enough. ISO-9001 is about your quality systems, not about your product quality. If all we had to worry about was product quality we could stop with an ASTM standard and a bunch of inspections. That was not effective, effecient nor economically healthy, that is why we are all following some sort of qualty management system now instead of only quality control.:agree:
 
S

shereenk

#7
Re: What constitutes a controlled document?

Thank you very much for your advice... Makes it much clearer now and I'm on my way to listing out the documents.. :)
 
F

ffemt1

#8
The way I determine if a document needs revision control is to ask 3 questions.

FIRST - "Can the relevant information it provides ever change?"
If the answer is NO, you do not need to control the document. - Example - Wal-Mart has several calendars, some with cats, some with dogs, and some even have spaceships on them, but Jan. 1, 2009 is always on Thursday and will never change so we do not need to control calendars even though they may look different.

If the answer to the first question is YES then ask, "Can the change DIRECTLY affect the quality of the product we produce?"
If the answer is NO, you do not need to control the document. Example - The internal phone list changes all the time, but does not knowing my new phone number DIRECTLY affect the quality of the product we produce?" Probably not. You can call the operator and get the new number so we do not need to control phone lists.

If the answer to question 2 is Yes, the document needs to be controlled. Example - Job tickets can change and if you do not have the current revision, it might affect the quality the customer will get. Is that ticket we printed last week still current?

You then need to ask "Who needs to know about the change?" Some changes just a few people need to know about. Example - Customer Files can change and we may be receiving a new file from a customer. Maybe only Customer Service and Prepress needs to know this. Some changes a lot of people need to know about. Maybe a customer increases counts and changes binding style. Many people need to know about this. When a change is made, we need to know who is affected.

The main reason we need to control documents is to make sure the right information is in the right place at the right time.

"CONTROL" means when there is a change we should be able to find ALL of the old documents and replace them with new ones, and if training is needed, know who needs it. That way there is no chance of of using old information, and everyone understands the change.
 
Y

Yarik

#10
2. One proposed document ID format (by consultant) uses document types like RP - Report, FR - Form, CK- Checklist, PR - Procedure... he even said should have one called TM - Template.. but I'm thinking... isn't everything a template? So it's funny that I have:
FR-001 for Training Form
TM-001 for the same Training Form
Is it right to do away with TM document type?
Hi Shereen,

It's difficult to answer this question without understanding what exactly do you (or your consultant) mean by "template".

If the issue with ID convention is still open, could you please clarify how many templates are you planning to have and documents of what types are going to use each template?

For example, you might have a separate template for each document type (one template for reports, another - for checklist, yet another - for forms, etc.).

Best regards,
Yarik.
 
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