Document Control where a document is part of a software package

Hello
I could do with some pointers here
If a document is part of a software package and is used in mail merge letters would it need to be controlled as per the requirements of 4.2.3 c i.e
would it need to have its revision number and who authorized it for use marked on it ?

That would be dependant on the document generated, I guess. If, for example, it was letters to customers or employees, then I do not see the need, but if it was documents for the QMS-handbook, then it would need to be. You evaluate the importance and the need for which documents are controlled.

well it is both of those things really !
It is a letter sent out to a customer which is referred to in a Procedure

How do I stand on that ?

thank you

debbie135 said:

well it is both of those things really !
It is a letter sent out to a customer which is referred to in a Procedure

How do I stand on that ?

thank you

Click to expand...

One of three choices:
1. You print a copy of the master document and approve and control it.
2. You specify the content in your QMS, and state that that is all you need in this case.
3. You choose not to control, because it does not need to be controlled

Eg. a letter to customer acknowledging receipt of a complaint. This could be chosen to be either of the three, it is your choice. (I would probably go with no. 2)

Hello Debbie,

What procedure? What is the document for? Does it need to be part of a mail merge?

Al...

thank you for your quick response and apologies for my lack of understanding but if I choose option 2 as the preferred option how would I describe this in the procedure which refers to the letter -a caveat such as "this document not considered to require control"

I am just not quite sure what you mean by this but thank you for your help

debbie135 said:

thank you for your quick response and apologies for my lack of understanding but if I choose option 2 as the preferred option how would I describe this in the procedure which refers to the letter -a caveat such as "this document not considered to require control"

I am just not quite sure what you mean by this but thank you for your help

Click to expand...

What I would state in my QMS - using the same example as above - would be something like:
The customer shall receive in writing within xx days a letter acknowledging receipt of the complaint. The letter shall contain the following information:
What has been complained about
Who is handling the complaint
Complaint no.
etc.
etc.

That would - in this case be sufficient. Other cases may require another approach.

if you are mail merging your customer/address list into letters, isn't your customer list a database? that would make it an electronic record of your customers, and you should have backups etc. of electronic data. Or am I way off base here?

I handle a lot of software controlled documents with the following, which our auditor was fine with

1. Name of document when printed
2. Screen(s) where document can be viewed and/or printed from
3. Statement - "cannot be changed or modified due to software - no further control required"

#3 was tricky as I had to prove to him that it could not be changed. Once I proved it he was fine with it.

Jumping in here again. Debbie had sent an e-mail to me asking to further clarify my earlier post...first, I am notoriously bad at checking my personal e-mail (sorry) second, this could be a question others have, so I will answer in the thread.

I stated that the information being merged (customer info) could probably be considered a record and not need "document" control, but to be controlled as a record. i.e. we have a customer database. It is a record, which is a specialized type of document. Control is done through the computer system (changes id'd by time, person, unique record number, and backed up per our procedure) We routinely merge the information into things like invoices, shipping notices, mass mailings of upcoming price changes etc. All of those documents are/can be records by themselves. We do not have/keep the same type of revision history on computer records that we keep for, say, a work instruction. We have an actual revision history with a paragraph stating what revisions are made in a written document, but the computer program logs the (rev) information by time stamp and person making the change. Plus we have backups.

I hope this helps.