Page 109 - Safety Risk Management for Medical Devices

88 Safety Risk Management for Medical Devices

taking responsibility for the creation and maintenance of the work products. Some of
the reasons for this preference are:
1. Mitigations are the domain of design and manufacturing engineering. They
can best determine the possibility, practicality, and impact of mitigations on
design and manufacturing.
2. Risk management is only one of the beneficiaries of the FMEAs and uses the
FMEAs as a tool for detection of the System Hazards. Since risk management
is focused on safety, if risk management owns the FMEAs, the attention would
be primarily on the safety-related Failure Modes and some of the nonsafety-
related Failure Modes may not get the attention that they deserve. Therefore
the knowledge that could be gained and the value that could be delivered to
product development may not become realized.

Tip Involve the FMEA reviewers and stakeholders in the production of the FMEAs. Not only the
collective participation enriches the analysis, but also the familiarity which is gained as a result of
the participation, will make the review of the FMEAs easier.

12.4.9 Making your way through the FMEA
Performing FMEAs on any product of moderate to high complexity takes a large
amount of time and resources. Often participants get tired and the quality of their
input declines. You could even witness lengthy arguments that don’t come to any
conclusions. This is one of the reasons people tend to shy away from doing FMEAs.
Or, if they do it, they try to get through it as quickly as they can, and check the box
as “done.”
Here are some of the causes for unsuccessful FMEA sessions:

• The team is sequestered for long sessions for several days.
• The team loses focus on what is the subject of the analysis, or what is the con-
text of operation for the subject of the analysis.
• Only a small part of the FMEA spreadsheet is projected on a screen; people
can’t see all the columns, or column headings; they get lost.
• One person dominates the conversation; others quiet down and just nod in
agreement.
• Participants check their emails, smart phones, or do other work and lose focus.
• People get confused and have trouble distinguishing Causes from Failure
Modes, and effects.
• The team is scoring severity and occurrences as they go; this promotes incon-
sistencies in ratings as people’s frames of minds drift over time.