ISO/TS 16949 - 7.3.3.2 Manufacturing Process Design Output

A

Andrews

#1
The subject clause says
manufacturing process deisgn out put shall include
- process appproval acceptance criteria
- methods of rapid detection and feedback of product / manufacturing process non conformities.

Can some one explain with example what this means?
 
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qusys

Trusted Information Resource
#2
Re: 7.3.3.2 manufacturing process design output

The subject clause says
manufacturing process deisgn out put shall include
- process appproval acceptance criteria
- methods of rapid detection and feedback of product / manufacturing process non conformities.

Can some one explain with example what this means?
You are referring to ISO TS.
for item 1: Process approval can be referred to materials, services, specs used in process flow, including risks as well as cost analysis. The results shall be assessed versus the expectations to provide the acceptance.

for item 2: Some examples could be related to lean manufacturing such poka yoke, inventory control, production control systems, visual checks , production layout and staff like that, with the intent to reduce/eliminate dead times and waste.
Waiting for other Covers feedbacks.
Hope this helps in meantime:bigwave:
 
#3
Re: 7.3.3.2 manufacturing process design output

Based on response from qusys above, this thread is now moved to ISO/TS 16949 - International Automotive Quality Systems Standard sub-forum.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
#4
Re: 7.3.3.2 manufacturing process design output

To expand on qusys response, "methods of rapid detection and feedback" are intended to focus on timely recognition and resolution of issues that can result in product defects and even missed goals like on-time shipments. Process monitoring such as SPC is not only in place, but is being actively used to find issues as quickly as possible. Response mechanisms are expected to be effective to help ensure no defective product is shipped, but also to help eliminate causes in the process so defective product is not repeatedly being produced.
 

morteza

Trusted Information Resource
#5
Hi
Acceptance criteria for process approval are those indices, if would be met, show that the manufacturing process is capable to deliver the expected outputs. Some of these criteria can be Cpk, defect rate, RPN, production rate and so on.
These criteria are used for process validation according to clause 7.3.6.

Methods of rapid detection and feedback of product / manufacturing process non-conformities, are methods which are used for detection and alarming of nonconformities in product/process. We use some sensors in our manufacturing processes which automatically check the product characteristics and process parameters (especially for heat treatment process). When characteristics/parameters are out of range, the machine will stop and start to alarm by a big red light and in some cases by sound.
This requirement has a relationship with clause 8.2.1.1.
For more information you can search about ANDON.
Hope this helps:)
 
A

Andrews

#6
Re: 7.3.3.2 manufacturing process design output

You are referring to ISO TS.
for item 1: Process approval can be referred to materials, services, specs used in process flow, including risks as well as cost analysis. The results shall be assessed versus the expectations to provide the acceptance.

for item 2: Some examples could be related to lean manufacturing such poka yoke, inventory control, production control systems, visual checks , production layout and staff like that, with the intent to reduce/eliminate dead times and waste.
Waiting for other Covers feedbacks.
Hope this helps in meantime:bigwave:

Thanks for your input.

Item 1: Can actual production output and defect ppm be considered as process approval acceptance criteria

Item 2 : Error proofing are separately given as an manufacturing process design output in clause 7.3.3.2. Can hourly inspection be considered as "methods of rapid detection and feedback"
 

qusys

Trusted Information Resource
#7
Re: 7.3.3.2 manufacturing process design output

Thanks for your input.

Item 1: Can actual production output and defect ppm be considered as process approval acceptance criteria

Item 2 : Error proofing are separately given as an manufacturing process design output in clause 7.3.3.2. Can hourly inspection be considered as "methods of rapid detection and feedback"
Yes, I think so
 
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