Difference between QMS Audit, Manufacturing Audit and Product Audit?

Hi!

I'm very confused with the QMS audit, Manufacturing Process audit and Product audit. What is the interval of each audit is most appropriate and can we use back the same auditor for all the audit? Can all the audit be perform together or need to be separate?

Thanks.

A QMS Audit is an audit of a Quality Management SYSTEM that is conducted to ensure all of the SYSTEM requirements are functioning as designed and achieving the results that are desired.

A Manufacturing Process Audit would be an audit of something like auditing an electroplating activity to ensure whatever is supposed to happen and however it is supposed to happen actually is.

As for a Product Audit (which I have nevre performed myself) I guess it would be similar to the QA/QC process and final testing or what we call validation. I may be way off base on this one.

QMS auditing scope include all processes that contribute to the QMS designing which include manufacture processes and any others

Randy said:

A QMS Audit is an audit of a Quality Management SYSTEM that is conducted to ensure all of the SYSTEM requirements are functioning as designed and achieving the results that are desired.

A Manufacturing Process Audit would be an audit of something like auditing an electroplating activity to ensure whatever is supposed to happen and however it is supposed to happen actually is.

As for a Product Audit (which I have nevre performed myself) I guess it would be similar to the QA/QC process and final testing or what we call validation. I may be way off base on this one.

Click to expand...

Not offbase at all. Product Audit is sometimes called a "Dock Audit." It audits the product characterisitics itself, as well as the packaging and labelling requirements were met.

Thanks, I'll add it to my lessons learned file.

Product audit

According to ISO TS Product audits should be performed " at appropriate stages of production and delivery ". (8.2.2.3)

A " dock audit " is only a part of the product audits (when the parts are ready to be shipped - the delivery stage).
If you only perform dock audits you are missing the " appropriate stages of production " part IMO.
We have always tried to perform the dock audit on the shipment when it has arrived at the customer's premises. You will learn at lot by doing this.

Check in your production area what appropriate stages are and perform audits in these areas as well. A product audit is an independent check if everything has been produced, checked, tested, labeled, identified, protected, etc....... at that appropriate stage.

Best regards,

Antoine

On an annual basis, we walk the control plan for "product audits". Any issues with customer requirements, the audit frequency is increased. Included in the product audit is a review of the flow chart, FMEA and any special characteristics. It's enlightening to see what pops up during these audits. IMHO, our product audits are much more value added than any other performed.

Product Audits

In most organizations the systems audit is conducted by a corporate team, the process audits can be conducted by the corporate team or a management team put together that does not work in the area. We have always been able to get by with product audits being done by the manufacturing area itself as long as the people doing it are auditing someone else's work and not their own.

That is exactly how we approach the audit process. I (division) perform the process and system audits and the manufacturing facilities perform the layered and product audits. If process audits are performed effectively, all system requirements will be answered.

Randy - I really like your definition of the system audit. In fact, I like it so much I may steal it and add it to our system as the definition we use.

Product audits - we are currently doing these as "dock/final product" audits. I doubt that I can drive it to the appropriate stages of production phase until we are caught by our registrar's auditor We do use control plans as part of our audits of manufacturing, so it is not quite as uncovered as it might otherwise seem to be.