TS 16949 - Feasibility Review, including Risk Anaylsis vs. FMEA



Our feasibility review does not show risk anaylsis, we do have risk anyalsis on the FMEA. Does this comply with the intention of the TS 16949 standard?


Feasibility Review

I assume you are referring to

Here is the $64,000 question. Is the FMEA part of the review? The feasibility review must occur prior to acceptance. In many cases, the FMEA is not performed prior to acceptance.

In order to claif the FMEA meets the requirements, you must show two things.

1) The FMEA meets all of the risk analysis requirements.
2) The FMEA is reviewed prior to commitment to supply product (as outlined in 7.2.2)

Hope that helps.


The FMEA is more concerned with product and process. Other subjects included in up-front risk analysis is; capacity, equipment, delivery and trained personnel. Actually, an in-depth capacity verification wiil answer these questions.
A good tool to use in conjunction with your feasibility study is the "turtle" diagram. This document is used for defining processes and the associated risks. Although not a requirement; if you do not presently have a documented method of risk analysis your auditor will suggest the "turtle" or a variant.


If a corporate location has multiple plants do all plants sign off on the feasibility if it is going to run at the other locations?


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it is up to you how to proceed. The important is that the mfg feasibility is documented, also including the risk analysys. I think that the fact of having multiple mfg site could be a risk to be addresses under an unique document.
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