Quality Digest

After reviewing a customer purchase order and entering it into the system, we either e-mail, fax, or mail a copy of our Sales Order Acknowledgement to the customer to confirm their order. This Acknowledgement is discuss in the Sales procedure and is listed as a record.

This form is electronically generated (no hard copies are ever available) and does not have a form # or revision level on it, or go through any approval process if changes need to be made to it. Changes are simply made by the Issuing dept., based on a request from any one of the three depts. that use the form.

There is a debate as to whether this form needs to be controlled with a form #, revision level and approvals.

The Issuing dept. feels that it is controlled because it is “electronically generated”, therefore, it is always at the latest revision.

I have 2 questions:
Do electronically generated forms need revision and approval control?

When a form is referenced in a procedure and supports the quality system as part of that process, does it need a form number?