Quality System vs. Process vs. Product Audit - TS16949

[ranvir.jaryal]

Can anyone help me differentiate among the System/proces/product audit ?

Rocky

[D.Scott]

In Reply to Parent Post by ranvir.jaryal

Can anyone help me differentiate among the System/proces/product audit ?

Rocky

The System audit is an audit of the entire Quality Management System (QMS). This determines Conformance to the 16949 (or other) Standard. These audits are typically the ones your registrar does for certification. You or a customer might do these audits as well when evaluating the entire QMS.

A process audit is an in-depth look at a single process. For example, you may want to audit the purchasing process. You would review that process and the interaction it has with other processes. The scope of these process audits will define the areas of your company that will be audited. These are typically done by your internal audit group.

Product audits are looking at a specific part or product. They are sometimes called "trace" audits. The audit starts at receiving and follows that particular part through the entire process to delivery to the customer. This audit is called a "Forward Trace" audit. You could start from the other end and go in reverse to track all the steps the part actually went through to the point of receipt. This would be a "Backward/Reverse Trace" audit. These audits are generally done to evaluate the flow of a single part. Customers often want to do a product audit on one of their parts.

Hope this helps.

Dave

[pondo]

My understanding of process audit is auditing the manufacturing process. Control Plan, operator instructions, kan bans, data collection, etc.

Quality system audit is by auditing the all the different processes (turtles) through the course of the year/schedule.

During Mgmt Review you are looking at the "whole" system and its effectiveness.

[Helmut Jilling]

In Reply to Parent Post by ranvir.jaryal

Can anyone help me differentiate among the System/proces/product audit ?

Rocky

If you do a search on the Cove, we have discussed this a lot in the past. Remember, internal and external audits in TS require a process approach. This applies to system audits as well.

[raspin]

Hi, I have always considered the following to satisfy the 8.2.2 Internal Audit requirements. These have been acceptable to our external auditors.

8.2.2.1 Quality Management System Audit
These are the internal audits of the entire quality system which are similar to which your registrar auditors do.

8.2.2.2 Manufacturing Process Audits
These are the audits on your individual manufacturing processes. If you look at Section 3.0, Terms and Definitions, Manufacturing is described as the process of making or fabrication. So a detailed audit of a particular manufacturing process (e.g assembly stage) taking into account the control plan.

8.2.2.3 Product Audits
These are looking at auditing the 'Product' at particular points of the production. Does it meet the specifications required. So this might be similar to an 'Out of Box' audit at the end of production.

Remember to satisfy the requirements of 8.2.2.4 these must be covered across all shifts. And yes, they must follow the 'Process Approach'

Hope this helps

[pondo]

I want to note that our 3rd party auditor stated that daily dock audits and quality checks called out on control plan do not suffice for product audits.

Last year we performed product audits on each of our finished products once every 2 months. Due to the good results last year, we have changed it to every 4 months.

[Helmut Jilling]

In Reply to Parent Post by pondo

I want to note that our 3rd party auditor stated that daily dock audits and quality checks called out on control plan do not suffice for product audits.

Last year we performed product audits on each of our finished products once every 2 months. Due to the good results last year, we have changed it to every 4 months.

Not sure why he/she would state that. I know of no guidance that mandates that interpretation. I think the approach you stated could clearly meet the requirement, if done correctly and the results support it.

[AndyN]

In Reply to Parent Post by pondo

I want to note that our 3rd party auditor stated that daily dock audits and quality checks called out on control plan do not suffice for product audits.

Last year we performed product audits on each of our finished products once every 2 months. Due to the good results last year, we have changed it to every 4 months.

I have heard similar. If you are simply checking product features etc., then I could see a case for such a comment. Product audits are not just 'product' - typically you should look at packaging, dunnage, labelling, delivery requirements, etc. The challenge is to avoid stepping over the (fine) line and turning it into an audit of the manufacturing process......Oh, and of course the product audit should also include functionality (if that's not covered by the inspections/tests)

Andy