Traceability after changing the machine

hopech

Starting to get Involved
#1
Hello,
I need to know what is the traceability required after changing the machine (a new one) of a process for an automotive part and changing the batch of raw material
in other words when i have to redo SPC , MSA , the PFMEA the control plan etc.
thank you for your clarifiations
 
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John C. Abnet

Teacher, sensei, kennari
Staff member
Super Moderator
#2
Hello,
I need to know what is the traceability required after changing the machine (a new one) of a process for an automotive part and changing the batch of raw material
in other words when i have to redo SPC , MSA , the PFMEA the control plan etc.
thank you for your clarifiations
Good day @hopech ;
Allow me to ask you some questions...
- What's the risk?

* If it's a new machine, then why wouldn't you want to verify the statistical capabilities of that new machine in regards to product conformance? Wouldn't you want to know if the new machine produces "better", or same, or "worse" product?

* If it's a new machine, and the process steps, controls (and, therefore, risks), are the same, then why would you redo the PFMEA and control plans?

* Assuming it is a production machine we are speaking of, does the new machine verify (i.e. "measure" product?) . If not, then why would your perform an additional MSA ?

* Does your customer have requirements in their contract/supplier handbook, etc..., specific to machine change?

Determine what can be impacted. That will help you determine what is at risk. Then act accordingly.

Hope this helps.

Be well.
 

hopech

Starting to get Involved
#3
Hello
Thank you So Much for replying
Your analysis is logic but im asking about exhaustive requirements according to iatf 16949 in other words im afraid of forgetting one of these parameters
SPC must be done when changing one of the 5 M ??
MSA must be done when changing measure method operators or part specifications
 

John C. Abnet

Teacher, sensei, kennari
Staff member
Super Moderator
#4
Nope. No such specifics dictated by IATF 16949. IATF promotes risked based thinking (RBT) and fortunately is not "too" prescriptive. I defer back to my original response.

Hope this helps.
Be well.
 

hopech

Starting to get Involved
#5
Okay
Thank you
But iatf 16949 does mention when to do a reaction plan in the Control plan
So based on your thinking i must do a cm cmk analysis due to machine change and spc analysis due to machine change and raw material batch change
If i Will change the process Flow chart i must change the pfmea and the Control plan to manage additionnal risks
MSA is the same analysis because the same Control devices are used same product and same Control staff
Thank you for your help
 

John C. Abnet

Teacher, sensei, kennari
Staff member
Super Moderator
#6
Okay
Thank you
But iatf 16949 does mention when to do a reaction plan in the Control plan
So based on your thinking i must do a cm cmk analysis and spc analysis due to machine changing
If i Will change thé process Flow chart i must change thé pfmea and the Control plan to manage risks
MSA is the same analysis because the same Control devices are used same product and same Control staff
Thank you for your help
* If the process flow changes (apparently the "new" machine is more than simply replacing a previous machine?), then I must assume the PFMEA and Control Plan will need addressed.
* Based on what you stated, then no MSA would be needed.
* I/we are unable to tell you/your organization exactly what statistical process performance analysis is needed. But yes, I would certainly imagine you/your organization would indeed wish to know that statistical performance.

You are most welcome. Hope this all helps.

Be well.
 

Johnnymo62

Haste Makes Waste
#7
Are you submitting a new PPAP to the customer for the machine (process) and material (design) changes? This is usually a requirement for automotive. The PPAP should cover all of your requirements.
 
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