Auditing Forms

TacitBlue

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Should forms be included as part of a process procedure audit? or should forms be considered the objective evidence associated with a procedure?
 

Randall Beck

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Could be both. Not sure I understand exactly what a "process procedure audit" is but if you are auditing a whole process or just a procedure (part of a process), verify that the appropriate referenced forms are being used and have correct revisions, location (if applicable) and approval. After those forms become records, verify that they are stored and maintained per your procedures! Sorry if I misunderstood the intent of your question.
 

TacitBlue

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Randall, thank you for your response. Please accept my apologies for the hasty nature of my post. We are thinking about including forms in our internal audit schedule that list the process to be audited as well as any applicable procedures. The question was whether, because forms are considered records for objective evidence, we should include listing our internal form numbers as reference on our internal audit schedule alongside procedures. Forms, in addition to being records and objective evidence, should, in my opinion, be included as part of the audit schedule and reviewed during an audit alongside procedures to ensure that information is recorded correctly and in accordance with the procedure.
 
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Randall Beck

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When I first started, I used to think of forms (Documentation requirements) as an entire process, as they had their own section in ISO9001. This really doesn't lend itself too well to the process-based auditing approach we should be using. Every auditor has their own style and organization their own methods. If I am auditing the calibration process for example, I will follow the process from purchasing to quality approval of certificate per the procedures. As I pick up forms to review as part of that entire process, I will look at my current list of document revisions and locations I just printed off (Sorry I kill trees when I audit) to ensure they are current, legible, approved, that properly trained personnel completed them, they are located where the storage matrix says they should be, etc. I would never review documents or forms related to quoting or shipping while auditing Calibration. Also, not all forms become records.....

If you add a form for making lists on what to audit, you'll just be auditing that just to audit something. Keep it as simple as possible.
 
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