Audit Nonconformity for FMEA - Transit, Warehousing and Shipping

[Leetcc]

I just went through an ISO 13485 certification audit with one minor non-conformity. it relates to defining product realization. If this is from design to delivery then am I required to provide risk management FMEA for not only manufacturing but transit, warehousing and shipping? I've never seen this as part of an FMEA and we are a medical device component supplier only.

 

[Jim Wynne]

Re: Audit Nonconformity for FMEA

Hello

I've moved your post to its own thread in a more appropriate forum for better responses.

 

[isoalchemist]

I think your auditor has stretched things a bit especially as a component supplier. I have seen transportation and warehousing conditions taken into consideration for finished products however. Sealed packages made at sea level do have some problems going over the Rockies staying sealed. Same as items needing refrigeration going unrefrigerated trucks.

Depending on your product it may or may not be a valid concern being raised. I think if it was you would have considered it already FEMA or not.

 

[AndyN]

I think your auditor has stretched things a bit especially as a component supplier. I have seen transportation and warehousing conditions taken into consideration for finished products however. Sealed packages made at sea level do have some problems going over the Rockies staying sealed. Same as items needing refrigeration going unrefrigerated trucks.

Depending on your product it may or may not be a valid concern being raised. I think if it was you would have considered it already FEMA or not.

Isn't the idea to use the FMEA to consider the risks at all stages and then decide, based on RPN, if anything needs to be done? Without those aspects appearing on the FMEA, there's really no justification for determining that nothing needs doing...?

 

[Ronen E]

I just went through an ISO 13485 certification audit with one minor non-conformity. it relates to defining product realization. If this is from design to delivery then am I required to provide risk management FMEA for not only manufacturing but transit, warehousing and shipping? I've never seen this as part of an FMEA and we are a medical device component supplier only.

I would say definitely yes. Have a look in ISO 14971. FMEA is just a tool; the requirement is for risk management.

I do, however, question the relevance of ISO 13485 to component-only suppliers (look in 0.1). In that sense anything and everything in the standard is questionable.

Cheers,
Ronen.