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IATF 9.1.1.1 Monitoring and Measurement of Manufacturing Processes

Golfman25

Trusted Information Resource
#1
Anyone want to breakdown IATF 16949 9.1.1.1 for me. I have no clue what they are talking about. We make stamped components.

Para 1 requires process studies on all new manufacturing processes to verify capability and provide additional input for process control.

Sounds to me like APQP and PPAP duplication, no? It doesn't lay out any specific CPK requirements.

Para 2 talks about verification that the PFD, PFMEA and control plan are implemented.

Sounds like manufacturing process audit stuff, no?

Para 4 talks about a reaction plan for characteristics that are not statistically capable or unstable.

Based on what? What if it is not statistically capable, but stable?

I am at a complete loss on this section. It seems like either duplication or overkill.
 
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JerryJ

#2
For Para 1
When we start a new job (stamping's also) we will take the characteristics that we are going to check in-process (fixture checks, trim lines, hole locations etc) and do a random 30 pc. cap study just to make sure that the process is stable. And if there is anything that the customer calls out then we will do those requests also. We use the 1.67 ppk / 1.33cpk and if the study's do not pass then adjustments will be made before we do the PPAP run. But we do not submit all the studies with the PPAP unless they are requested.
 
R

Rodrigo Avles

#3
Greetings Golfman25!

Were you able to find the answers to your questions? I have the same doubts as you and I can not find help to clear my doubts.
 

Sebastian

Trusted Information Resource
#5
It is useless, but ...

Paragraph 1.
I see there reference to pre-launch activity. Final opportunity to answer a question: "Does a process we have designed and developed is mature enough to move it to serial conditions?". Based on satisfactory capability results we will be allowed to transform pre-launch control plan to serial one and instead of 100% inspection put there sampling.

Paragraph 2.
First sentence want us to perform post-SOP process study to know how much our process get deteriorated comparing to PPAP timing. Second one presents "content" of manufacturing process audit.

Paragraph 3.
It is making us aware of "classic" cases having impact on process/product capability, which unrecorded can lead us to false conclusions related to process condition.

Paragraph 4.
It points out SPC/capability study as a trigger of activities aiming correcting process, e.g. through change of setup. There are two scenarios - consecutive measurement results show stable growing/decreasing value trend while capability value is worsening. Second one is when consecutive measurement values do not create any trend (as expected) because it is set of unjustifiable "ups and downs", but capability value is still satisfactory. Both request initiation of reaction plan.

For stamping process we expect stable trend starting from poor capability, then improving and finally worsening before tool recovery. If there are no significant process events and trend is not developing as expected, it has to trigger a reaction plan.
 
#6
Hello All. I too need some clarification on this clause just for sanity purposes, lol.

In recent audit my org was dinged clause 9.1.1.1d due to the fact we have variable spec ranges listed on control plan for critical characteristics being 100% tested during Assembly process, but its actually a pass or fail with no recorded data other than than the scrap qty for the particular test being performed.

On the other hand, Management team wants to dispute saying the scrap results for the test is the data along with the masters checks performed at beginning of shift and the R&R of the tester is the Capability study. However, the QE, Auditor, along with myself do not classify that as appropriate capability study or variable data records.

I am needing expert advise to better understand the needs of this requirement.
 
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