TS 16949 8.1.1 Identification of Statistical Tools - Requirement Scope?

[morteza]

Hi all
In clause 8.1.1 ISO/TS 16949 states:
Appropriate statistical tools for each process shall be determined during advance quality planning and included in the control plan.
The words each process and control plan lead to interpret the above requirement in this way that the organization shall determine the appropriate statistical tools for each stage of production (from incoming material to final product, including packaging) because control plan is provided only for manufacturing processes (stages).
But the problem arises from IATF guidance (for TS:2002) on this clause. The guidance states that statistical tools can be used in product development or field analysis. This means that this requirement applies to early stages of product design up to post delivery activities.
So my question is that: what is the scope of clause 8.1.1?
Product realization processes (from marketing to delivery or post delivery) or only manufacturing processes?
It should be mentioned that my organization uses several tools in product development stages, such as reliability analysis, DOE, etc. Also, my organization uses some tools in field analysis such as Pareto or Trend chart. We did not included these tools in or CP because there is no CP for these stages.
Thanks all

 

[Jim Wynne]

Re: 8.1.1 Identification of statistical tools-Requirement scope?

Hi all
In clause 8.1.1 ISO/TS 16949 states:
Appropriate statistical tools for each process shall be determined during advance quality planning and included in the control plan.
The words each process and control plan lead to interpret the above requirement in this way that the organization shall determine the appropriate statistical tools for each stage of production (from incoming material to final product, including packaging) because control plan is provided only for manufacturing processes (stages).
But the problem arises from IATF guidance (for TS:2002) on this clause. The guidance states that statistical tools can be used in product development or field analysis. This means that this requirement applies to early stages of product design up to post delivery activities.
So my question is that: what is the scope of clause 8.1.1?
Product realization processes (from marketing to delivery or post delivery) or only manufacturing processes?
It should be mentioned that my organization uses several tools in product development stages, such as reliability analysis, DOE, etc. Also, my organization uses some tools in field analysis such as Pareto or Trend chart. We did not included these tools in or CP because there is no CP for these stages.
Thanks all

There are three phases or types control plan: prototype, pre-launch, and production. Each is described in the APQP manual.

 

[qusys]

Hi all
In clause 8.1.1 ISO/TS 16949 states:
Appropriate statistical tools for each process shall be determined during advance quality planning and included in the control plan.
The words each process and control plan lead to interpret the above requirement in this way that the organization shall determine the appropriate statistical tools for each stage of production (from incoming material to final product, including packaging) because control plan is provided only for manufacturing processes (stages).
But the problem arises from IATF guidance (for TS:2002) on this clause. The guidance states that statistical tools can be used in product development or field analysis. This means that this requirement applies to early stages of product design up to post delivery activities.
So my question is that: what is the scope of clause 8.1.1?
Product realization processes (from marketing to delivery or post delivery) or only manufacturing processes?
It should be mentioned that my organization uses several tools in product development stages, such as reliability analysis, DOE, etc. Also, my organization uses some tools in field analysis such as Pareto or Trend chart. We did not included these tools in or CP because there is no CP for these stages.
Thanks all

My interpretation is that statistical tools are inserted in production control plan ( from incoming to shipping) and this shall be planned in advance during product realization planning.

 

[v9991]

Re: 8.1.1 Identification of statistical tools-Requirement scope?

There are three phases or types control plan: prototype, pre-launch, and production. Each is described in the APQP manual.

could you also indicate either tools or the parameters usually part of control plan at each of those three phases.

{note :- the reason i ask is that, we have been of opinion that at earlier two phases (prototype & pre-launch), there are not many statistical tools which are relevant...}

thank you in advance for your thoughts and guidance

 

[morteza]

Re: 8.1.1 Identification of statistical tools-Requirement scope?

There are three phases or types control plan: prototype, pre-launch, and production. Each is described in the APQP manual.

Hi Jim,
thanks for your reply
As you told, we have three types of CP. But our production CP is up to packaging stage. So, how can we include tools which are use in our CRM process such as field analysis, in our control plan?
I think it would be better that ISO/TS would use quality plan instead of control plan.

 

[Jim Wynne]

Re: 8.1.1 Identification of statistical tools-Requirement scope?

Hi Jim,
thanks for your reply
As you told, we have three types of CP. But our production CP is up to packaging stage. So, how can we include tools which are use in our CRM process such as field analysis, in our control plan?
I think it would be better that ISO/TS would use quality plan instead of control plan.

You can include things in a prototype control plan that don't appear in subsequent control plans. The control plan should generally change as the development process goes on. You should keep copies of each version as evidence of having met the requirements for each stage.

 

[Jim Wynne]

Re: 8.1.1 Identification of statistical tools-Requirement scope?

could you also indicate either tools or the parameters usually part of control plan at each of those three phases.

{note :- the reason i ask is that, we have been of opinion that at earlier two phases (prototype & pre-launch), there are not many statistical tools which are relevant...}

thank you in advance for your thoughts and guidance

If there are no "appropriate" statistical tools for a given stage of product development, you just need to have the rationale for not including any. As the OP suggests, things such as DOE and reliability studies might be used in product development. The prototype stage might also be the time when MSA is done, especially if dedicated gaging is involved. Production of prototype parts might involve some form of SPC, and the same is true of the pre-launch phase.

 

[qusys]

Re: 8.1.1 Identification of statistical tools-Requirement scope?

If there are no "appropriate" statistical tools for a given stage of product development, you just need to have the rationale for not including any. As the OP suggests, things such as DOE and reliability studies might be used in product development. The prototype stage might also be the time when MSA is done, especially if dedicated gaging is involved. Production of prototype parts might involve some form of SPC, and the same is true of the pre-launch phase.

Agree with you, Jim.
I was waiting for your response first given that the question was direct to you.
If possible , I would only like to add this: in prodcution control plan there is also a column where it is possible to link, just in case there are any, the stats tools we are talking about, for instance check sheets, x bar-R charts, x-MR chart, Anova and stuff like that.
Hope this helps

 

[Jim Wynne]

Re: 8.1.1 Identification of statistical tools-Requirement scope?

Agree with you, Jim.
I was waiting for your response first given that the question was direct to you.
If possible , I would only like to add this: in prodcution control plan there is also a column where it is possible to link, just in case there are any, the stats tools we are talking about, for instance check sheets, x bar-R charts, x-MR chart, Anova and stuff like that.
Hope this helps

Yes--that's the "Control Method" column.

 

[v9991]

Re: 8.1.1 Identification of statistical tools-Requirement scope?

Yes--that's the "Control Method" column.

just another query...
given the scale differences (not only the lot size but also the equipment s used...(scale dependent and scale-independent variables...)) between development and pre-launch and commercial batches. ; how 'good' is any data generated during development phases, so as to be taken as baseline (or correlate with that of commercial/pre-launch batches)

thank you once again for your thoughts and guidance.

note:- incidentally I am quoting from previous posts; my intent is to just provide context for my queries/responses; solutions/guidance from each one is solicited & appreciated.