Process FMEA responsible For "Make to Design Parts" (Inhouse or Suppliers ?)


Dear All,

Need a suggestion, we're a startup aviation industry implementing APQP/PPAP tools.

Question is regarding PFMEA,

We're designing our own Product (levels: System, Sub-System and Components), the initial manufacturing Process (not physical part) will be established inhouse but the individual components (few Sub-systems also) will be manufactured by various identified Suppliers. Typically "Make to Design" approach for potential suppliers.

Suppliers will manufacture as per inhouse Method of Manufacturing /Manufacturing Process Flow --> during the physical product manufacturing phase, method of Manufacturing (Manufacturing Process Flow) may be optimized in collaboration with the supplier.

In this case, for such parts should we create the PFMEAs inhouse? Or Rely on Suppliers PFMEA only?

PS: System Level DFMEA and PFMEA will be created inhouse.
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Involved In Discussions
you need to develop FMEA for processes that YOU will use for creation your product. Your product may contain parts that are built in differenr suppliers- they have to have their FMEA analysis for their proccesses of creation those subcomponents for Your product.


Quite Involved in Discussions
*The information & controls received from FMEA & control plan relevant suppliers /materials could be part of input , it's parts of Suppliers development requirement as IATF 16949 also ;
*The operation flowcharts, control plan in prototype stages & DFMEA output should be considered for initial PFMEA
*AIAG manuals regarding APQP , control plans , FMEA /VDA manual & examples of severity ;occurrences score, RPN weighting for components , sub system , --etc --- all of these are basics & fundamentals for initiations


Quite Involved in Discussions
* we should consider also the manufacture activities ; if it's relevant automotive parts ; the score in referenced tables should be followed; otherwise if the products are not relevant for automotive , there's no need for complex criteria of selecting the tighten score ; the score estimation / determination regarding severity / occurrences could be more simple
IMHO, it depends on contractual roles and responsibilities between you and your supplier. For critical, high risk parts - as demonstrated in DFMEA (among other considerations) you should be doing as the designer, I would assure that suppliers are chosen that have good ability to perform PFMEAs (among other things like good QMS and competent personnel in Mgmnt, Engineering, and operators) and expect them to own the PFMEA task as they are experts in their process, tooling, measurement system capability, operator skill/training. I would expect that any control you identified in your DFMEA that relies on process control, test, inspection that must be done by the supplier is communicated as input to their PFMEA and Control Plan. Don't expect a good PFMEA from a supplier that was chosen on price alone without assurance that they have the ability to do a good PFMEA on a critical part. You will have to hold their hand a LOT, if not do it for them and then constantly assure that they stay on track and maintain the Process and PFMEA as additional risks (failure modes) are identified and weighed for RPN and needed mitigation.
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