Quality System vs. Process vs. Product Audit - TS16949

[richroland - 2009]

I'm really at wits end. I have been debating the issue of why we are performing forty four (44) product audits a week. There are so many repeats between machines and operators, it isn't funny. Manufacturing is also doing the same audits every day. Help. Amount is too much for a company of 100 people. three shifts. Any suggestions?

 

[AndyN]

I'm really at wits end. I have been debating the issue of why we are performing forty four (44) product audits a week. There are so many repeats between machines and operators, it isn't funny. Manufacturing is also doing the same audits every day. Help. Amount is too much for a company of 100 people. three shifts. Any suggestions?

Yup, Rich, that is waaaaay too much for a small company. What do you mean when you say 'repeats'? It would help to know what you're talking about here, before we can answer exactly.

When setting up a product audit schedule, I chose those items which had been a problem with customers, (first) followed by those which had been found during 'safe launch' or were new products. We did them weekly and, depending on what was the reason for the associated issues, like mislabeling, we did the audits close to the area that 'caused' the problem.

 

[Helmut Jilling]

I'm really at wits end. I have been debating the issue of why we are performing forty four (44) product audits a week. There are so many repeats between machines and operators, it isn't funny. Manufacturing is also doing the same audits every day. Help. Amount is too much for a company of 100 people. three shifts. Any suggestions?

That sounds like a lot! Why are you doing so many? How is your quality performance running? PPM?

 

[Helmut Jilling]

Some firms perform system audits and process audits (in production area) in the same way, using of course process approach which include the inputs, outputs, criteria, metrics, objectives & targets, sequence of the process, effectiveness and linkages to other processes, and of course control plan, fmea analysis, flow-charts, work instructions. And then they say "Why do we need separate system audit and process audit in production? Let's integrate them". In the end - they have one audit in production (for system and process). My question - Do they implement/fulfil TS requirements (8.2.2.1and 8.2.2.2)?

If they are just sampling some items in production, it might not meet the requirement. If they are thoroughly walking a control plan or flowchart, might be ok...

Well. A lot of CB auditors say that all internal auditors shall be qualified so company shall establish minimum qualification requirements for system/process/product auditors. It usually includes training. I remember the events CB auditors notified nonconformities in cases - process/product auditors weren't trained.

There was an official answer that product auditors would not necessarily have to be fully trained, competent internal auditors.

 

[Peters]

There was an official answer that product auditors would not necessarily have to be fully trained, competent internal auditors.

Thank you. What source of this official answer?

 

[Helmut Jilling]

Thank you. What source of this official answer?

Unfortunately, I do not recall...sorry.

 

[Bayca1]

hello Guys

I'm new to this site, I enjoy reading all the wonderful great information.

Do any body know or have a product-audit checklist that could see or review for ideas on how to do one at our facility. I work for the aerospace industry.

Thanks

 

[Stijloor]

hello Guys

I'm new to this site, I enjoy reading all the wonderful great information.

Do any body know or have a product-audit checklist that could see or review for ideas on how to do one at our facility. I work for the aerospace industry.

Thanks

Welcome to The Cove Forums!

What Standard applies to your organization?

Stijloor.

 

[ajikkn08]

Hi every body...

System Audit is the audit of quality system to check whether the system fulfills the requirements of ISO Standards.The audit could be from top management to all depts.

Process audit will be carried out to ascertain the effectiveness of various process .

Product audit will be carried out on the product,this is normally carried out after the product is ready,and any non conformance thus noticed will ensure even the product being recalled.whereas process audit will improve the product .

 

[Bayca1]

Thank you for your response.
The Standards that apply to my company is AS9100.
If you know any procedure or checklist to start my development of a product audit, will be great.