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Sequence of performing risk assessment: User_FMEA (User Errors) vs Design Inputs

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#1
1. what is the sequence of performing risk assessment.
user_fmea vs design inputs .
premise being that selected design would lead to user-errors
VS
user-errors should be considered to lead to design-inputs

2. are there any specific criteria and qualifications for performing design-fmea
( apart from the experience, and functional_role(s) involving in the activities)
 
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indubioush

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#2
Looks like nobody responded, so I guess I will. Maybe some others can help too. I'm going to assume you are referring to medical device design.

Medical device design, risk management, and usability are cyclical processes. I can't really represent the cyclical process in just words, but this example sequence may help you.

User needs, Reg requirements, Initial risk assessment --> Initial design inputs --> Device design 1 --> DFMEA --> Design inputs from design risk assessment --> Device design 2 --> UFMEA and Formative usability evaluations --> Design inputs from usability risk assessment --> Device design 3 --> Design verification including summative usability evaluation --> PFMEA and process validation --> Device Design 4 and repeat all necessary testing --> Design validation

This is just a general example and many devices will have these items in a slightly different order.

As for specific criteria and qualifications for performing the design FMEA, you need to have a cross-functional team. You need people who understand the device, people who understand clinical implications of hazards, and people (Quality or Regulatory) who understand risk management requirements. Please also know that the traditional FMEA does not meet all requirements of ISO 14971. Hope that helps.
 
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