TS 16949 8.1.1 Identification of Statistical Tools - Requirement Scope?

[Jim Wynne]

In Reply to Parent Post by qusys

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]

In Reply to Parent Post by Jim Wynne

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.

[Jim Wynne]

In Reply to Parent Post by v9991

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 welcome.

As I said in my first response to you, "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." The "goodness" of any sort of data is dependent on individual circumstances.

[v9991]

"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." The "goodness" of any sort of data is dependent on individual circumstances

he 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.

it would be nice to see some examples around to completely understand the interpretation and application.

my sincere thanks for your thoughts and guidance.

[Bev D]

just a few thoughts on 'statistical tools' that can be used in prototype and other pre-launch stages:

Designed Experiments such as fractional screeening, blocking experimetns, full factorials and response surface experimetns to determine the important factors. Modeling (multi-factor regression) set specifications on the inputs to guarantee the outputs. Statistical sample size calculations for the experiments. and of course MSA for the measurement systems.