If the master print is stamped controlled, do we need to control the others?

[Dawn]

If the master print is stamped controlled, do we need to control the prints in Engineering and Quality also? If they are not stamped controlled, do they need to be signed and dated?

[Howard Atkins]

If the prints in the other departments are not controlled then how can you guarantee that they will be changed if the master print is changed?
IMHO the document control system must apply to prints to ensure this factor.

[Dawn]

Walk me through this: If the prints in the Safe are stamped controlled, then the copies go to Engineering, and Quality. When they are stamped controlled, they cannot have markups on them whether signed and dated or not. The prints in Engineering and Quality can have markups without being signed and dated. They know they have the proper revision because they can compare the print to the print in the safe at any time. There is a procedure stating the Office Assistant controls the prints in the safe and copies the master to Engineering and Quality. Are we in compliance? Why or why not? Thanks, after you look at this stuff so many times you forgot what you did know.

[Marc]

Your control system has to address the prints quality and engineering have. They are able to be marked up. So what? Are these to be changes to be submitted via an Eng Chng Notice (or whatever you call them in your system) or what? How does one know which markups are submitted for change on an ECN? How does one know how many 'copies' are out there? They 'CAN compare their 'copy' to the one in the safe but what triggers an engineer or quality person with a copy to 'check the safe'? Are the 'copies' marked 'COPY' or anything? Is there more than 1 copy of the same print floating around engineering or quality?

I would say off hand you are not in compliance if your system does not define these copies, how they are used, etc. My problem is that they are obviously making decisions based upon them and secondarily I would want to know more about the markups - how made, how used, etc.

[Don Winton]

Dawn,

My take on this. Original prints need not be stamped, only identified as controlled. What I have done is that originals are not stamped. The FDA requires a Device Master Record (in another incarnation, I called this the Design Master Document), which is the control point for all documents. My procedure states that “issued documents” are controlled, engineering and document control are exempt (after all, there should be working drafts). Maybe, Maybe not.

Best Regards,

Dawn,
Sounds like you've got a small mess on your hands. My advice is similar to Marc's. Make sure you document when a change is allowed, who is authorized to make the change, which copies must be changed, and what must occur as a result of a mark up.

The simplest way to manage this is to say, no markup will be made by unauthorized personnel only under certian conditions that are followed up by proper distribution/markup or all other prints identically and a formal change taking place like a ECN, ECO etc.... This you can prove to an auditor. It is controlled although a bit of a pain.

Mark ups must be communicated effectively and followed up with a formal change process to get the master up to date appropriately. Keeping the master in a safe is one way of handling revision control but how do you know that the copy in engr. or QA is the current revision. Is there a master list? or do you have a very controlled distribution process that you can prove that the other copies are always at current revision?

A rule I try to follow with my clients is no markups (permante/formal changes only) without formal change resulting documentation (ECO etc) and all copies existing being marked up identically, signed & dated. This means that a temporary change is not indicated on a print, but on an accompanying document that expires.