TS/ISO 16949 Process Audit Checklist required

[S.Chaichana]

Dear All,

Our team has conficted internally since recently we received NC from registar auditor that our organization had not conducted process audit.

The auditor explained us TS system required 3 type audit
1) System audit
2) Process audit
3) Product audit
1) and 3) were done, but no evidence for 2)

Our team has nobody understand well for this matter!
Can someone teach me what is process audit?
and Can you give me some checklist for process audit?

Await for your support.
Thank you in advance for your kind assistance.

Thailand
S.Chaichana

[Alex Kobzar]

Here is how I've done it for purpose of our TS:
We have no special "Quality management system audit" under TS because the QMS is comprised by the COPs (Customer-Oriented Processes); so once you have audited all the processes - you have audited the whole QMS (this idea has been eventually OK'ed by our registrar).

To conduct a "process audit":
1. I have the process defined in the "QMS COPs' map" (see Figure 1 of the standard; I've also posted it somewhere here);
2. in our Quality Manual I have a short "process sheet" describing ownership for the process, inputs, outputs and core actions within the process;
3. I have the attached table determining the TS requirements applicable to the process (the table is an old revision; and may be used for reference only);
4. I refer to the "process sheet" and see whether the inputs, the operations and the outputs are managed effectively and appropriately to the purpose of the Company; record observations and findings;
5. I refer to the table, take the applicable QP's and ask for objective evidence that the requirements are implemented effectively and appropriately to the purpose of the Company; record observations and findings;
6. Review the records and address the identified nonconformance findings and opportunities for improvement with responsible managers,
7. follow-up on implementation of the CAPA,
8. make a summary of the CAPA for the management review.
...and no any checklists!

[Howard Atkins]

The requirement is for

8.2.2.2 Manufacturing process audit
The organization shall audit 8.2.2.2 Manufacturing process audit
The organization shall audit each manufacturing process to determine its effectiveness. to determine its effectiveness.

This means that you must audit all manufacturing processes.
The system audit must also be in a process manner.
You determine the inputs and outputs and then check the monitoring and measurement for effectiveness and efficiency.
You then audit the how( methods, support etc) the who (people, qualifications etc) and the with what (machinery, materials etc.)

This is for all processes.
You must ensure that each manufacturing process is audited in every shift.

[Marc]

Originally Posted by S.Chaichana

Can someone teach me what is process audit?
and Can you give me some checklist for process audit?

You should read these existing discussion threads: Process Audit discussions and example forms. You will want to look closely at discussion threads where layered process audits are discussed.