How to Integrate System Audit, Manufacture Process Audit and Product Audit

[haifeng]

Who has the actural experience to integrate the system audit, manufacture process audit and product audit into the internal audit? can u give me some ideas about it? Thanks

[cyclonez]

get here for the first time
It is a nice place

[Marc]

Any takers on this?

[bpritts]

I'll try an answer here.

Some of my answer is based on the history of the TS16949 requirements, so it cannot be directly determined from the language of TS16949 itself. I believe that it reflects the intent of the developers, but please don't criticize me when you find that some of the thinking isn't specifically written in the standard. I know that it's not!

1) Quality Systems Audit using the Process Approach

-- This is a high-level view of your entire system. It should
look like a repeat of what the registrar auditors do.

Audit Scope: The entire quality system
Audit Criteria: Compliance with all TS16949 requirements
Audit Organization: Design your quality system based on your business processes; then audit following those processes. "Turtle diagrams" are recommended tools for documenting processes.
Auditors: Must be highly trained in Quality Management. Many customers expect lots of training and experience - see especially Ford's Customer Specific Requirements for auditors
Frequency: Probably one full audit per year.

2) Manufacturing Process Audits

-- Very focused audits of your shop floor manufacturing processes

Scope: Manufacturing processes (maybe "departments", work cells, or individual part numbers)
Criteria: Compliance with the established procedures; and effective in the judgement of the auditor (one goal is to identify possible improvements)
Organization: Cover all of your processes, most likely in separate audits for individual processes.
Auditors: Need to be trained in this specific type of auditing, but do not
need to be all knowing.
Frequency: Not specified by the TS requirements; my opinion (based on the
practice with VDA 6.1, a TS predecessor): there should be lots of audits of
processes. When they all pass, then audit for improvement opportunities. One per month per process, perhaps more?

3) Product Audits

-- Product (part) oriented audits. These will verify that all part specifications have been met. At least the easy inspections should be repeated. Possibly expensive or time consuming tests may not be repeated, but records should be checked.

Audit Scope: Parts to the part print/ specifications
Criteria: Parts must meet all part print/ specifications
Organization: To be based on the production flow of the part. My bias: do checks using a part sampled from the shipping dock, ready to ship; BUT if
that isn't possible (perhaps because a part is changed during the process; for example, you can't check the incoming hardness of steel after you have heat treated it.)
Auditors: Need to be trained on the specific inspection/test techniques
Frequency: Not defined; but for some customers, could easily be combined with their annual layout inspections/performance tests.


Does this help?

Also - for other readers - perhaps we can debate this. As noted, some of
these points are my opinion, which I recognize is not supported in the
"letter" of the standard.


With best regards,


Brad

[Helmut Jilling]

Originally Posted by haifeng

Who has the actural experience to integrate the system audit, manufacture process audit and product audit into the internal audit? can u give me some ideas about it? Thanks

BPritts gave an excellent answer. It may be possible to integrate them, but they were clearly not intended to do so.

In the TS literature, it evens discusses different levels of skill for the auditors. Product and Mfg. Process audits can be performed by inspectors and such and do not necessarily need full, formal auditor training. They must be trained adequately to be competent for the task.

[RCBeyette]

I completed my organization's first-ever integrated audit a few weeks ago. It combined ISO 9001 and ISO 14001. All it really required from me was a bit more planning than an audit where only one standard was involved.

I looked for the common clauses, sub-clauses and requirements. From that, I was able to develop an agenda to follow the process of how we make our product.

While there are common requirements, there is enough of a difference between the standards that I ended up not asking questions directly from the standards, but rather "all emcompassing" questions like "What is the process of management review?" The answer suitably addressed both requirements and allowed the opportunity to ensure the process was effective.

To demonstrate operational control, we verified that the tools in use on the floor were utilized properly and that items such as process audits and job observations are being done by the proper levels and the information communicated to the proper authorities.

Product audits are done at a different level. At a system audit level, we ensure that they are done and done correctly.