We are aiming for CE mark through compliance with MDD and the assessor has provided some feedback pertaining to our risk management activities. The verbatim we've been given is:
The assessor determines that the provided documentation does not provide evidence on conformity to essential requirements of Annex I of 93/42/EEC in respect to:
- Missing Identification of risks in supply chain and during development activities (e.g. HW, SW development)
I am debating internally whether or not this is a real finding as I do not see how risks in supply chain and during development activities has an impact on product safety. We have started developing a SupplyChainFMEA to address this finding and the risks identified thus far relate to operational and economic risks such as the severity and likelihood of supplier shortages. I do not think this is the correct solution as Annex I of MDD talks mainly about the safe design and construction... no where does it talk about risks in supply chain.
The only way I can make sense of this is if the assessor has just worded the finding poorly and is actually referring to downstream supply chain risks such as product reliability during transport/storage.
Is the assessor's finding legitimate?
If so, what clause or section in the MDD is it referring to?
Do you have any suggestions as to how we can address this finding?
The assessor determines that the provided documentation does not provide evidence on conformity to essential requirements of Annex I of 93/42/EEC in respect to:
- Missing Identification of risks in supply chain and during development activities (e.g. HW, SW development)
I am debating internally whether or not this is a real finding as I do not see how risks in supply chain and during development activities has an impact on product safety. We have started developing a SupplyChainFMEA to address this finding and the risks identified thus far relate to operational and economic risks such as the severity and likelihood of supplier shortages. I do not think this is the correct solution as Annex I of MDD talks mainly about the safe design and construction... no where does it talk about risks in supply chain.
The only way I can make sense of this is if the assessor has just worded the finding poorly and is actually referring to downstream supply chain risks such as product reliability during transport/storage.
Is the assessor's finding legitimate?
If so, what clause or section in the MDD is it referring to?
Do you have any suggestions as to how we can address this finding?