Separate Forms or Procedure Attachments - What's more common?

[cscalise]

What do you find most common for the forms used in a QMS?

My experience (mostly in medical device manufacturing) has been that most forms are found as attachments or referenced to a procedure or work instruction. This makes sense to me as it provides easy access to instructions and guidelines for filling out and completing the forms, and is easy to monitor/record for training purposes. Recently I have encountered a number of facilities (focused on ISO9001 or AS9100) that include forms not associated with a procedure.

I understand that employees can be trained on the use of a form without an associated procedure, but am wondering if this practice is the "norm" or if it is more common to have forms linked or referenced to a procedure. I tend to be very conservative in my approach and want to tie most forms to a supporting document.

Thanks for the feedback.

 

[Pjservan]

It depends.

Certainly there is no requirement and either approach works. It is really up to each organization.

As ISO has moved away from being so procedural dependent you can see many organizations that all they have are forms to demonstrate their processes or an activity is meeting ISO requirements. Having the procedure attached or reference the form(s) used is ideal. However in small and dynamic organizations multiple processes and activities might be deployed where no documentation (procedure or work instruction) might exist but just the form.

 

[John Broomfield]

cscalise,

I used to keep them together in a neat pack but I soon learned.

Control them separately. That way you can keep most your system docs to no more than one page.

Also form design tends to be poor if it depends on a procedure or instruction that describes how to complete it.

Make your forms self explanatory to their users and they may even thank you for it.

Keep any necessary work instructions separate too.

John