TS16949 - section 7.3.3.2 - Design Output - Data for reliability

9

97miata - 2005

#1
I am looking for any guidance on this section relative to "manufacturing process design output shall include...data for reliability..."

As an injection molder we design a process that encompasses the tool, molding machine and a molding process, but how do I get reliability data at the process design output without looking at previous tools and mean time between failures or using some sort of regression analysis? Any suggestions would be apprciated.

We have the remainder of this subject well covered, but this one piece on reliability is stumping me! :confused:
 
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B

Bob Ablondi

#2
97miata said:
I am looking for any guidance on this section relative to "manufacturing process design output shall include...data for reliability..."

As an injection molder we design a process that encompasses the tool, molding machine and a molding process, but how do I get reliability data at the process design output without looking at previous tools and mean time between failures or using some sort of regression analysis? Any suggestions would be apprciated.

We have the remainder of this subject well covered, but this one piece on reliability is stumping me! :confused:
If you comply with the customer's PPAP level 3 reqiuirements, you probably have met the manufacturing process design requirements. Ask your Registrar's Lead Auditor.
 
9

97miata - 2005

#3
Bob,

Thanks for the reply. This was an issue that came up as a finding during our TS upgrade audit and we showed the registrar our customer approved level 3 PPAP's. He indicated we still did not meet the requirement for "design output reliability data".

Unfortuanately, they keep steering me back to MTBF for this and I cannot see how we can comply with this. Predicting tool failure when each tool is different (unique) combined with differences in material (resins) processed makes this very difficult. I am looking for options to show compliance.

We have a mature QMS registered to ISO9001:2000 and QS9000 for some time. The upgrade to the TS took us several months of preparation, but I have not found any guidance on this issue. Any other suggestions would be welcome.
Thanks!
 

Howard Atkins

Forum Administrator
Staff member
Admin
#4
If you look first at 7.3.2.2, Manufacturing design input, you are required to set targets for reliability.
In 7.3.3.2 you need data to enable you to measure that you have reached your targets.

This obviously takes time and in fact is an on going situation and is part of the validation of the processnow and in the future

The targets for reliability can be seen as say 1000K shots,
the inputs are your mold building specifications, which are based on your knowledge and data from the past,(MTBF) in general mold design, and the data the maintenance records. Incoming inspection of the mold is also part of the data for reliability.
This can be seen in the same light as validation that can not aways be done before delivery.
I think that you have everything it is just a matter of putting a different name on it.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#5
From Bob Ablondi:

Here is how I wrote in the QA manual how we implement the process measurables of 8.2.3: The company performs process studies on all new manufacturing (including assembly or sequencing) processes to verify process capability and to provide additional input for process control. The results of process studies are documented with specifications, where applicable, for production, measurement and test, and maintenance instructions. These studies include objectives for manufacturing process capability, maintainability and availability, as well as acceptance criteria. The organization maintains manufacturing process capability or performance as specified by the customer part approval process requirements or the procedures identified in the AIAG, Production Part Approval Process (PPAP) Reference Manual. The organization ensures that the control plan and process flow diagram are implemented according to the applicable sections of the AIAG Advanced Quality Planning and Control Plan (APQP) Reference Manual, including adherence to the specified:
a) measurement techniques;
b) sampling plans;
c) acceptance criteria;
d) reaction plans when acceptance criteria are
not met.

Significant process events such as tool change, machine repair are noted on the SPC charts in accordance with the guidelines of AIAG Statistical Process Control (SPC) Reference Manual. Production Management initiates a reaction plan for characteristics that are „out of control i.e., CpK is less than 1.33‰ or exceeds the upper or lower specification limits. These reaction plans include containment of product and 100% inspection as appropriate. The Production Management, indicating specific timing and assigned responsibilities to assure that the process becomes stable and capable, and if necessary, will complete a corrective action plan. The plans shall be reviewed with and approved by the customer when so required. The organization shall maintain records of effective dates of process change resulting from the corrective taken.
 
P

psavijay

#6
Is the above mentioned solutions in 2005 are still OK now? During my last audit I specifically asked auditor about it but he just checked people knowledge level about Reliability, Maintainability, And he gone through our system of Target setting for Tool life, tool regrinding and preventive maintenance frequency along with tool performance analysis reports.

(neither objected nor given acceptance, kind of stalemate!!!)

Regards

A.Vijayakumar
 
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