Manufacturing Process Design and Development Review - TS 16949 Clause 7.3.4

mjoakin

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#1
Hi. Here's my question. I'm not responsible for product design, I receive drawings and specifications and just proceed to produce parts.

TS 16949 7.3.4 says that includes "manufacturing process design", so, to meet this requirement I need to perform reviews to ensure the process is working AS expected? reviews as process capabilities and efficiency?

Then, I need to meet 7.3.5 and 7.3.6: I have to verify my process (process is capable to meet customer requirements) and validate the process (validate its intended use? produce as planned?)

Is it like efficiency and effectiveness: my process can meet the requirements but I spent the double of the time to meet them?

Am I right? or am I missing something?

Thanks in advance.

Jaime.
 
Last edited:
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U

Umang Vidyarthi

#2
Hi. Here's my question. I'm not responsible for product design, I receive drawings and specifications and just proceed to produce parts.

TS 16949 7.3.4 says that includes "manufacturing process design", so, to meet this requirement I need to perform reviews to ensure the process is working AS expected? reviews as process capabilities and efficiency?

Am I right? or am I missing something?

Thanks in advance.

Jaime.
The design and development reviews are for the organisation that is responsible for design of the component. Since you recieve the drawings and specs, you are not in the ambit of 7.3.4.

Umang :D
 

mjoakin

Involved In Discussions
#3
The design and development reviews are for the organisation that is responsible for design of the component. Since you recieve the drawings and specs, you are not in the ambit of 7.3.4.

Umang :D
That's why I thought at first ... BUT ... TS 16949 says: "7.3.4 ... reviews [...] include manufacturing process design" ... and "requirements of 7.3.5 and 7.3.6 apply to both product and manufacturing process"

I edited my question, please have a look, I'm understanding that TS also asks me to pay attention to the way I design my process (not the product) so I can ensure I'll have the result expected.
 

jerry_Malaysia

Quite Involved in Discussions
#4
That's why I thought at first ... BUT ... TS 16949 says: "7.3.4 ... reviews [...] include manufacturing process design" ... and "requirements of 7.3.5 and 7.3.6 apply to both product and manufacturing process"

I edited my question, please have a look, I'm understanding that TS also asks me to pay attention to the way I design my process (not the product) so I can ensure I'll have the result expected.
I think you are right mjoakin. If you receive drawing and spec from customer, probably you are not responsible for "product design"
But no matter how, you must be responsible for "process design"
:2cents:
 

mjoakin

Involved In Discussions
#8
Typically APQP, Feasability anaylsis, PPAP, FMEA, and Control Plans are what covers these requirements.
That's also my own thinking, but what I wanted to make sure is that 7.3.4, 7.3.5 and 7.3.6 definitely applies for "process design" and that I'm interpreting correctly:

7.3.4 Review: engineering calculated correctly how many machines, operators, inspector etc to meet customer requirements? (production schedule)

7.3.5 Verification: the process designed by engineering ensure all specs will be met? seam width, stitches per inch, correct assemblies, components in right place, etc. ... am I using the correct machinery?

7.3.6 Validation: now, my process meet the specs, but, am I using the resources stated in the review? I'm getting the parts intended within the time scheduled? i.e. is not right if I said I'll use 1 machine to get 200 parts per hour, but instead I'm using 2 machines to get the same 200 parts, so, validation failed!
 
R

ralphsulser

#9
That's also my own thinking, but what I wanted to make sure is that 7.3.4, 7.3.5 and 7.3.6 definitely applies for "process design" and that I'm interpreting correctly:

7.3.4 Review: engineering calculated correctly how many machines, operators, inspector etc to meet customer requirements? (production schedule)

7.3.5 Verification: the process designed by engineering ensure all specs will be met? seam width, stitches per inch, correct assemblies, components in right place, etc. ... am I using the correct machinery?

7.3.6 Validation: now, my process meet the specs, but, am I using the resources stated in the review? I'm getting the parts intended within the time scheduled? i.e. is not right if I said I'll use 1 machine to get 200 parts per hour, but instead I'm using 2 machines to get the same 200 parts, so, validation failed!
You should change your Control Plan to reflect what you are actually doing to achieve acceptable product process design. The FMEAs also will need to be reviewed to see if RPNs are affected. You may have to revalidate your Cpks and re-PPAP if your customer requires it because you changed the process from one to two machines. Check your latest PPAP book and your customer specific requirements.
You can change anything within the customer specifications, but you need to follow the requirements of all the TS16949 standards including the "Core tools" blue books.
 

mjoakin

Involved In Discussions
#10
You should change your Control Plan to reflect what you are actually doing to achieve acceptable product process design. The FMEAs also will need to be reviewed to see if RPNs are affected. You may have to revalidate your Cpks and re-PPAP if your customer requires it because you changed the process from one to two machines. Check your latest PPAP book and your customer specific requirements.
You can change anything within the customer specifications, but you need to follow the requirements of all the TS16949 standards including the "Core tools" blue books.
Well, I put a example of using two machines instead of 1, what I needed to hear was: "yes, that's how you review, verify and validate; that's how you met 7.3.4, 7.3.5 and 7.3.6"

so, i guess I'm on the right path, I'll review the plans, I'll verify if the process gives the expected results and validate if the process is being doing it the way we planned.

:thanks:

Thanks everyone.

:thanx:
 
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