IATF16949 item c) and f)

Lewis Liu

Does any one can help explain why it need a "special approvals" for xFMEA and control plan? Who will do the special approvals?


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Tose points for product safety.
IATF defines Product Safety as ” standards relating to the design and manufacturing of products to ensure they do not represent harm or hazards to customers“.
So if Your FMEA contains Product Safety Characteristics, approval needs to be done by Product Safety Representative of the location (e.g. PSCR, PSO,…) and/or according to applicable customer specific requirement. Usually it is dedicated assighment or role inside organization( need to be certified).
As VDA statement: A Product Safety & Conformity Representative (PSCR) is the one who has the necessary information and qualification to have a targeted approach to ensure that product integrity meets local and international legal statutes, and also justifies the safety expectations of the public.


Quite Involved in Discussions
Please see FAQ as attached :
c) The special approvals for design FMEAs would be identified in customer specifics, see item b) above. d) and e) The identification of product safety related characteristics and their controls would be defined by the customer in its definition of special characteristics and required controls. The personnel developing PFMEAs and Control Plans would need to be knowledgeable in those areas of their customer(s) documents.
Each line item f) through m) can also be similarly analyzed to determine the level of training and source of that training for each requirement within the safety requirements. Since many of the requirements depend upon customer specific requirements, there is no single complete industry training on this topic. The organization needs to review the customer and regulatory requirements associated with each of its parts appropriate for the intended country of use and safety-related part characteristics. Some customers may have specific requirements regarding product safety, training, knowledge, and personnel. It is the organization’s responsibility to understand their customer’s specific requirements related to product safety


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