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Qualitative Risk Assessment

with FMEA
Sigurdur Sigurdsson

This presentation is based on a MSc

dissertation in Pharmaceutical Engineering
at the University of Manchester.
Tutor: Dr. Rodger Edwards
Mentor: Mr. Robin Coverdale, I. Eng.
The Presentation Structure

The Risk Management Process

The FMEA Process

Risk Assessment Session/Workshop

Questions and Comments

Risk Management Process
Where does FMEA help with RM?
Origin of FMEA

FMEA was developed as a military

procedure MIL-P-1629 and published in
Initially it was used extensively for active
military applications and NASA
Later, its use was extended into the industry
at large
FMEA - 101

The method starts by identifying failure

mode by evaluating what can go wrong.
Then the likelihood of occurrence and
potential consequences are evaluated
Once this is established, risk treatment can
be decided on and applied
Applicability of FMEA

It is used in quite different settings like

manufacturing, project management and
software & product development
Although not required by law it is
extensively used for regulatory compliance
on both sides of the Atlantic
Pros and Cons of FMEA

A simple tool with wide applicability

A universally accepted tool and familiarity
with the process

Highly dependent on contribution by

individual persons or a group of them
Subject to bias
FMEA Standards

MIL-STD-1629a "Procedures for Performing

a Failure Mode, Effects and Criticality
IEC/ISO 31010:2009, Risk management
Risk assessment techniques
IEC 60812:2006, Analysis techniques for
system reliability Procedure for failure
mode and effect analysis (FMEA)
Preparation - Preparation - Preparation

The importance of a good workshop

preparation is sometimes overlooked
Clearly define the system boundaries
Provide good background information
Determine the evaluation criteria
Workshop discussion

Each participant is selected because he/she

is expected to contribute.
Make sure each voice is heard
No single person can dominate the
Freedom of speech during the session
Workshop schedule

Stick to the meeting agenda / schedule

Make sure every item is properly processed
before the next subject is discussed
Stop discussion when no longer productive
Take scheduled breaks, even if behind
Conducting the Workshop

Participate in the discussion when needed,

otherwise listen and record
The mediator must control the discussion,
not the results
By maintaining a small distance the
mediator can intervene when needed
Evaluating and Prioritizing Risk

Evaluate each item of risk

Agree beforehand on the evaluation criteria
Then prioritize the risk items
The risk matrix defines the priority classes
A simple Risk Matrix
Risk matrix
The all important Risk Register

The Risk register is used to:

Document the risk assessment
Coordinate the risk management effort
Control the risk treatment process
Sample Risk Register
Distribution of the Risk Register
The Risk Register is an open document,
which is distributed in whole or in parts to
all concerned
Upper management needs a list of current
most important items of risk
Risk Owners need a detailed update of their
action list
Updating the Risk Register

The risk register must be updated as needed

The update workshop should be conducted
by key personnel from earlier workshop
Alternatively it might be preferred to start
over from scratch
Biased Results ?

The main problem with bias is that we are

often not aware of it
Consequently the results are assumed to be
correct, when the situation is really
significantly worse or better
Some frequent causes of bias

Not a representative group of people on the

Overly optimistic/pessimistic people
Too much reliance on similar/recent system
Wrong/incorrect information about the
system/problem at hand

The Risk Management Process

Process description and how FMEA is used
to its advantage
The FMEA tool
Discussion on the mechanics
Risk Assessment Session/Workshop
Lessons learned applied
Qualitative Risk Assessment with
(Failure Mode and Effect Analysis)
Any Questions or Comments?
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.