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.

[Shawn Mosby]

In Reply to Parent Post by 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.

I would have to disagree with this. Focus on production processes in process audits is insufficient. A process can be defined as a systematic series of actions. Your turtles are most definitely processes.

[Helmut Jilling]

In Reply to Parent Post by Shawn Mosby

I would have to disagree with this. Focus on production processes in process audits is insufficient. A process can be defined as a systematic series of actions. Your turtles are most definitely processes.

I think you are partly correct. Auditing in a process approach clearly is not limited to production processes. A process approach should be applied to all processes - Purchasing, Engineering, Maintenance, etc., not just Manufacturing.

Turtle diagrams, or flowcharts, procedures, etc. are not processes themselves, they are documents that can be used to describe processes. They are useful to usewhen auditing each process.

Auditing each manufacturing process by walking through the control plan is a very effective and widely accepted method of doing the production process audits.

[Athies]

We too perform product audits on our products as per the ISO/TS requirement ie packaging, labelling, dimension functionality...
We sample products at particular points along the process flow and yearly our Internal Auditors perform an audit to ensure the product audit is performed per the respective process procedures.
Then here comes a customer ( Not an automotive customer) and their intrpretation is that if a company is certified ISO/TS, then product audit SHALL be performed for all products irrespective whether the product is automotive or not.
Another intrepretation of the Product Audit, especially for semiconductor suppliers is that even the wire size, die dimension, leadframe dimension is required to be audited, when the ISO/TS is very clear on packaging, labelling, dimension and functionality.

[ranvir.jaryal]

Athies,

What i can understand from your statement is that , if we audit product at all production stages (including FG shipping etc) (Here by QC) and during internal quality audit we check whether we are following the checkpoints at each stage is good enough to qualify for compliance with TS requirement.



Rocky

[pondo]

In Reply to Parent Post by ranvir.jaryal

Athies,

What i can understand from your statement is that , if we audit product at all production stages (including FG shipping etc) (Here by QC) and during internal quality audit we check whether we are following the checkpoints at each stage is good enough to qualify for compliance with TS requirement.



Rocky

No. Not the requirement for TS. Product audit is of the finished product...above and beyond all other conformance checks called out in your process documentation. And not a dock audit either. And not annual layout either. The frequency can be very low if you can provide evidence to support it.