What does "process audit" really mean and how different is it from product audit ?

What are the steps to conduct one?

Andrews,
For a process audit think in terms of the "5 M's";

Manpower, adequate, traineded,
Methods, work instructions,
Machine, maintenance, settings,
Materials, correct
Measures, efficiency, Cpk, on-going SPC, in-process inspection.

These are INPUTS, which is what makes the process work.

The product is the OUTPUT.

The product audit is verification & validation that the product meets the requirements of the design record.

My definition would be:

Process audit - making sure the product was made per the defined procedure/plan/arrangement. Example questions:

1. Was raw material purchased from an approved supplier?
2. Was material inspected per the inspection requirements?
3. Were gages used calibrated?
4. Is material in storage properly labeled, protected, etc?
5. Were proper instructions followed for removing from inventory (rotation, handling, etc.)?
6. Was part made on correct machine per the control plan?
7. Was SPC done as defined on the control plan?
8. Was process rate per requiremenets?
9. Do quality levels meet requireemtents (scrap, etc.)?
10. Are all steps on the control plan followed in the proper order?
11. Were inspection requirements followed?
12. Is the nonconforming product procedure followed when necessary?



Product Audit - making sure product meets all specifications.

1. Are all dimensions/specifications correct.?
2. Is it in the proper box/container?
3. Is the container properly labeled?
4. Is all paperwork completed properly?



I am sure there are more.

Tom

now that with process and product audit being stressed on in ISO/TS, the process audit to me is to ensure that whatever happen in the value-chain to produce the product is effective and efficient.

input --->process ---> output

it is no longer saying that with a trained personnels, and methodologies in place ensure the product is produce according to spec, with minimum wastage, low defect, etc...but the question is how effective and efficient ?

product audit on the other hand is done periodically to ensure customer receive the product they wants. Product audit is done on different stages. A lot of companies overlook the delivery process, where IMO is one of the important area.

Originally posted by YKT
A lot of companies overlook the delivery process, where IMO is one of the important area.

YKT

Interesting you should say this. We have a lot more problems with "trucking complaints" than we do with complaints about our product. We sell FOB, our plant, and our customers usually arrange trucking, including choosing the trucker.

Well, some of the ones they choose have got to be doing "loop the loops", or some similar manuver, before they deliver to the customer. Broken and shifted bags are our fault, though (though legally, it should be between the customer and Evil Kenevil trucker).

Does anyone have experience effectively handling a similar situation?

Craig

Should adherence to cycle time be a checkpoint in the process audit?

Andrews

It's me again.

Shouldn't the process auditor be an expert in the process he audits?

Andrews

Andrews,

Also see:

Product / Process Audit (http://Elsmar.com/Forums/showthread.php?s=&threadid=4258)

Process Audit (http://Elsmar.com/Forums/showthread.php?s=&threadid=3709)

Process audit check list (http://Elsmar.com/Forums/showthread.php?s=&threadid=5329)

QMS audit, process audit, product audit (http://Elsmar.com/Forums/showthread.php?s=&threadid=6123)

There are many more related threads if you Search the forums.

Originally posted by Craig H.
YKT

Interesting you should say this. We have a lot more problems with "trucking complaints" than we do with complaints about our product. We sell FOB, our plant, and our customers usually arrange trucking, including choosing the trucker.

Well, some of the ones they choose have got to be doing "loop the loops", or some similar manuver, before they deliver to the customer. Broken and shifted bags are our fault, though (though legally, it should be between the customer and Evil Kenevil trucker).

Does anyone have experience effectively handling a similar situation?

Craig
I agree with you - if they arrange the trucking they should be responsible. But, it seems that according to 7.5.5, you are responsible to package the product so that it arrives conforming:

7.5.5 Preservation of product
The organization shall preserve the conformity of product during internal processing and delivery to the intended
destination. This preservation shall include identification, handling, packaging, storage and protection.

Hi,
Process audits are done to determine if the process is in control and that all requirements are met to assure that the output meets its intended purpose.
Example of Process audit checklist for the semiconductor industry is attached.

What does "process audit" really mean and how different is it from product audit ?

What are the steps to conduct one?
Hi Andrew,
Let me give you an example.
My organization manufactures Semiconductors. For a Product audit, i would take the marketing drawing and some industry test requirements and i would pull same samples from the warehouse, prior shipment of the product and will do some measurement according to the marketing drawing and or some test either destructive or non destructive to determine if the product that is to be shipped out meet the requirements of the marketing drawing in terms of dimensions and the industry standard in terms of certain test. Example of some test are drop test, test to determine if the markings on the semiconductor are still intack after subjecting them to waver soldering process. So product audits are basically an audit on the product itself be it be dimension, characteristics or others. Hope this helps.