posted 29 September 1999 12:30 AM               

From: [email protected]
Subject: Re: Q: Doc & Data Control - What about Forms? /Conley/Naish

Patti,

I have seen a number of different methods used and most have been successful as long as you had a clear procedure (or Procedure by department) and the procedure was followed.

The following are some examples and in some cases the pro's and con's where I
have seen them:

1) Large company central form control-- all forms go through one department
Pro's:
A) No duplication of numbers
B) Positive notification to all who are listed as users of the form
C) one stop shopping to find current rev and get a clean copy of a form
Con's:
A) Manpower required
B) Whose department pays for space, storage units, manpower,
C) Who is accountable for the individual departments that use the wrong one
(This can end up in finger pointing --- I told them, I didn't get it issues
D) Too long to approve due to signature loops

2) Each department has sole control:
Pro's
A) Clear accountability
B) Clear assignment of costs
C) System matches the department needs for approval and release
Con's
A) Duplication of efforts --- Same data but different forms so repeat data
collection numerous times
B) Data does not meet Quality system requirements since no one looks at the
whole system to see how the data meshes and meets the standards requirements

3) Single procedure for all departments, with each department approval and
release, and a review of an appointed person (Like Management Rep) for
compliance to the standard and the rest of the quality system.
Pro's
A) All departments follow the same process
B) Review reduces non compliancy or conflicts
C) Speeds approval and release cycle
D) Allows local control for quick verififcation and duplication
Con's
A) Can over load the Assigned review person
B) May still allow some although greatly reduces redundant efforts.