Process FMEA Owner, Designer or Manufacturer ?

[Dhiraj554445]

I have a query related to ownership of Process FMEA ..... my Company name is X which is only assemble the part , we are not responsible for product and process design. a remote source is responsible for process and product design . in this case who will be the responsible to own the process FMEA , either we are responsible or remote source is responsible for process FMEA to comply the IATF16949 Requirements

 

[Nishant Tyagi]

I have a query related to ownership of Process FMEA ..... my Company name is X which is only assemble the part , we are not responsible for product and process design. a remote source is responsible for process and product design . in this case who will be the responsible to own the process FMEA , either we are responsible or remote source is responsible for process FMEA to comply the IATF16949 Requirements

Mr Dhiraj,
Thank you for your Query..!!

As per my understanding if Manufacturing Site is not responsible either for Product and Process then Product output DFMEA and Process Output PFMEA will be done by Remote location only.
We should monitor Process changes and inform to our remote location for approval and recording. Based on the changes in PFMEA or any addon if any document supports manufacturing unit that Manufacturing site is only responsible for that document Only.

Thank you, have a nice day.

 

[Jim Wynne]

Your company is responsible for your company's processes and PFMEA pertaining to what you do.

 

[Enghabashy]

*As IATF regulation ; the remote locations should be recorded in APF "audit plan form "before conducting the certification or before the conducting surveillance audit;
**the control plan should be referenced with FMEA & " the relevant CSR if applicable "; the error proof & the other controls used " i.e. : work instructions, inspection & tests --etc., hence the relevant information should be available also as evidences of compliance the requirements '
*** if the company is planning to IATF certification ' the information & references should be clear in the document review plan; otherwise the process FMEA of assembly could be enough as part of ISO 9001 " risk determination & assessment requirement "

 

[dramman]

Did your company design the manufacturing process? Fi this is a case where it is your factory and another organization (internal or external) designed the manufacturing process that entity would have started the PFMEA. Your factory would then take over maintaining the pFMEA as a living document. Regardless, your company would have ownership of ensuring the PFMEA was done correctly.

 

[Dhiraj554445]

Did your company design the manufacturing process? Fi this is a case where it is your factory and another organization (internal or external) designed the manufacturing process that entity would have started the PFMEA. Your factory would then take over maintaining the pFMEA as a living document. Regardless, your company would have ownership of ensuring the PFMEA was done correctly.

Mr.Dramman,
Thankyou for replying
No my company did not design the manufacturing process.

 

[dramman]

Did your company pay a consulting company to design the production process? Did the buy another company? Did your customer provide the process?

All of these are common ways manufacturing companies end up with a process they did not design. I think from your customer's viewpoint (or IATF certification) your company has ownership of ensuring there is a PFMEA in place. Even if it needs to be done after the process is implemented.

 

[Jim Wynne]

I think from your customer's viewpoint (or IATF certification) has ownership of ensuring there is a PFMEA in place.

Please clarify. The first half of the sentence doesn't match the second.

 

[dramman]

Please clarify. The first half of the sentence doesn't match the second.

I made an edit. Thanks for the QA inspection. I should have done a PFMEA.

 

[Golfman25]

I have a query related to ownership of Process FMEA ..... my Company name is X which is only assemble the part , we are not responsible for product and process design. a remote source is responsible for process and product design . in this case who will be the responsible to own the process FMEA , either we are responsible or remote source is responsible for process FMEA to comply the IATF16949 Requirements

Not sure I would over complicate it. If you do the assembly, you have an assembly process. Thus, you'll need a FMEA for the assembly process that you do. Other vendors would do a FMEA for their processes as well such as -- machining, plating/painting, etc.