Hierarchy of TS 16949 Requirements within an Organization

Team,

We are having some problems where I beleive some of the TS requirements are more wholistic toward the entire organisation, and others believe each peice of the standard are to be applied to each and every process. Is there any guidance on what clause applies to every process vs. what should be applied once to the entire organization?
Ex. Management review - I believe pertains to the entire organization (company) while others believe MR occurs where any process can be measured...

There will be some cases where one could arguably expect to find a certain clause being applied in every process. I can think of Element 8.5, Corrective and preventive action; 6.2, human resources, and 7.5 (I think it is) work instructions.

There could be more, but some people may be able to find a process that is completely automated--and claim that process has no need for 6.2.

If there is a piece of guidance as you are asking for, I would be suspicious it did not suit all aspects of my organization's unique properties. I would not feel sure I could trust it to be accurate in all cases.

So when it comes to things like Management Review, I would start with what the standard expressly calls for, then add to that what we do to make out own system run smoothly and makes our customers happy.

Thanks Jennifer. So in our case the company is extremely siloed between manufacturing areas and sites, so the managers I am working with to interpret and apply TS 16949 standards would not necessarily be wrong in applying all of the standards at a department level if the company culture is to have organizations nested within organizations.

Back in my early days of auditing about 10 yrs ago, I remember getting written up for processes not being systemic, kind of a general 4.1 write up. Now I don't see those types of audit findings anymore from our external registrar. They go from one site to another and see two totally different infractructure processes such as one site using FMEA and Control plans and the other not, and different systems for corrective actions and say nothing.

qualityboi said:

Team,

We are having some problems where I believe some of the TS requirements are more wholistic toward the entire organisation, and others believe each piece of the standard are to be applied to each and every process. Is there any guidance on what clause applies to every process vs. what should be applied once to the entire organization?
Ex. Management review - I believe pertains to the entire organization (company) while others believe MR occurs where any process can be measured...

Click to expand...

Qualityboi,

I think that you make this unnecessarily complex. When I start working with a Client, one of the first things the Client and I do is identify the processes that make up their Quality Management System. My son would say: "What's up?"

There is a tendency to get wrapped up (bogged down) in standards too soon. The danger is that the standard and its requirements becomes the focus of the implementation process, not the Quality Management System.

Some organizations like to categorize their processes (key, support, management) but that is not required. It can be helpful though.

Once we have a clear idea of the processes that the Client has, then we develop a simple (draft) matrix that lists all the processes, the "owner" for each process, inputs, outputs, objectives, measurements.

Now, in addition to the above, we look at each process and list the ISO or ISO/TS or other standard requirements that apply to each of these processes. If regulatory, statutory, and customer-specific requirements apply, we'll list them as well. There is a basic example of this matrix that I provided in the "Post Attachments List"

We may not be able to finalize this matrix all at once. It takes some time.

This process matrix is what I call the "Bill of Material" for the Quality Management System. The Process Map is the "Assembly Drawing."

These two documents describe the processes and their interaction (per 4.1.)

So, the standard requirements are not the drivers of the QMS, the processes are. In other words, the needs of the organization and its customers always come first. Then we look at what the Standards require and match those with the processes.

I hope this helps.

Stijloor.

qualityboi said:

... So in our case the company is extremely siloed between manufacturing areas and sites, so the managers I am working with to interpret and apply TS 16949 standards would not necessarily be wrong in applying all of the standards at a department level if the company culture is to have organizations nested within organizations.

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The TS standard should be applied to each organization being certified. Applying every clause to every department is probably going too far.

Back in my early days of auditing about 10 yrs ago, I remember getting written up for processes not being systemic, kind of a general 4.1 write up. Now I don't see those types of audit findings anymore from our external registrar. They go from one site to another and see two totally different infractructure processes such as one site using FMEA and Control plans and the other not, and different systems for corrective actions and say nothing.

Click to expand...

If you are saying that some organizations were certified to TS without using FMEAs and Control Plans, that would be very irregular. If you are saying they use different customer formats, in different countries, that would not be all that unusual.

qualityboi said:

Team,

We are having some problems where I beleive some of the TS requirements are more wholistic toward the entire organisation, and others believe each peice of the standard are to be applied to each and every process. Is there any guidance on what clause applies to every process vs. what should be applied once to the entire organization?
Ex. Management review - I believe pertains to the entire organization (company) while others believe MR occurs where any process can be measured...

Click to expand...

Mgt. review is clearly a review process, by the management team, and usually focuses around a meeting. Not to be confused with the reviewing and managing that department managers perform on a daily basis.

Some clauses are more global, 4, 5, 6, 8, and some are very specific, cl 7.