with FMEA Presenter: Sigurdur Sigurdsson Introduction
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
THE RISK MANAGEMENT (RM) PROCESS Risk Management Process Where does FMEA help with RM? THE FMEA PROCESS Origin of FMEA
FMEA was developed as a military
procedure MIL-P-1629 and published in 1949 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 Analysis 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) THE RISK ASSESSMENT SESSION Preparation - Preparation - Preparation
The importance of a good workshop
preparation is sometimes overlooked Clearly define the system boundaries beforehand Provide good background information Determine the evaluation criteria beforehand 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 discussion 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
team Overly optimistic/pessimistic people Too much reliance on similar/recent system evaluation Wrong/incorrect information about the system/problem at hand Summary
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 FMEA (Failure Mode and Effect Analysis) Any Questions or Comments? Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.