Seeking Internal Audit Plan - Design Responsible Manufacturing company



We are a manufacturing company having design (4 department headed by different sec head) also production and quality, purchase, store, maintenance department is common for all these - i am in need of audit plan. We do have audit plan by department wise and have department procedure separately. One external auditor object this planning method. Please help me to make a good plan. Department :thanx: wise audit covering the ISO element is not acceptable? Your views please.
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Audit Plan

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ISO has requested that people use the "process method" to audit internally as well as externally.Departmental audits are a thing of the past although it is much easier to apply the elements by department, by process isn't that bad. You just need to refocus to thinking in terms of processes within your organization. It takes time but it is possible and more effective. Try purchasing a book on how to audit using the process technique. See the ASQ website's bookstore.
Since the latest revision of ISO 9000 came out the certification auditors prefer that ll companies regardless of industry use the process method for auditing.
I hope this helps



IEGeek - 2006

This is more of a Process Flow but I think it is something you are looking for.

Try it and see if you can apply it to your situation.




Hi sridharafep,

One way to do a process audit plan is to define the scope of the audit by using your procedures and use your procedures to develop audit questions.

For example, if the audit is of Engineering, then define the scope of the audit as all of the procedures that relate to Engineering. Then read each procedure and develop questions related to the key points in the procedure.

If the procedure states that you create a design file for each new design, then choose a new design and ask to see the design file. Does it contain everything that the procedures says it should? Does it have evidence of review and approval? Does it have inputs and outputs? Are there results of verification and validation.

This method helps you to avoid having audits that ask the same questions each time, and keeps the audits fresh.

This method may not work well if you are new to ISO 9000 and have not yet established that your quality system has addressed all the elements of the standard.
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