Should documents that support the operation of its processes be excluded from control?

Bev D

Heretical Statistician
Super Moderator
Of course anyone can decide to control any form - or record; a filled-out form - in any way that they find valuable. We should control certain kinds of records and the form/work instruction that describes the needed contents. In some cases these are also ‘required’ by certain standards
(Military, FAA, FDA, USDA, NADCAP, etc.) This would be records of actions that have a direct effect on product quality, legal liability, etc. Some fo these things are controlled automatically in an ERP or other software system.

However, remember that the OP had a ‘form’ for daily production schedules. This is not the aforementioned critical direct effect on product quality. As for its usefulness to the organization, I am sure they have other documentation that records what was built and when if that is deemed necessary by the organization.


The general reason I believe that documents that support the operation of processes should not be excluded from control is that documents and processes that have been shown to work should be controlled so that they are not lost when inevitably a new incumbent of the position comes on the scene.

A good flexible system for document development is to allow the 'document owner' or 'subject matter expert', to develop a document that they need as they know what they want in the document. There is by trial and error until everyone is happy with the document. At that stage the QMS requests that the document owner send a copy to the Quality Manager for inclusion in the Document Control Register.

I know this is all very old school and there is software that does it better, but in the absence of the software, that's what we try to do.
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