FMEA

Failure Mode Effect Analysis

What is FMEA

A Failure Mode Effect Analysis

(FMEA) is an extremely powerful
tool that can be applied in all
industries and utilised by all
professions
Different Types of FMEA’S

• There are 3 main types of FMEA’s used today

– System FMEA:
• Used to analyse complete systems and or Sub systems
during the design stage
– Design FMEA:
• Used to analyse a product design before it is released into
manufacturing (Toyota / General motors etc)
– Process FMEA:
• Used to analyse manufacturing or assembly processes

Of the 3 types of FMEA, the most common used and the

least complex is the Process FMEA (PFMEA)
History of FMEA
• FMEA has been round for many years
• FMEA was used during the Apollo missions in the 1960’s to
establish potential failures and fixes for the Apollo space rockets
• In 1974, the US navy used FMEA’S and developed MIL-STD-
1629 which was the first real documentation of the proper
application of the tool
• Around this time the Automotive industry also started using
FMEA’s and have never let go
• Today the FMEA is used universally
 The FMEA Process
There are 3 steps to the FMEA process
1. Understanding the process
2. Developing the FMEA.
3. The review process

The steps are carefully designed to allow the designers to follow a

prescriptive process which when applied allows a logical process to
problem solving

FMEA’s should not be designed in isolation and are very much a team activity
The FMEA process

• Step 1 – Understanding the process

– There are potentially 2 processes which should be
considered prior to FMEA development
• Flow Charts
• Cause and Effect diagrams (C&E)
– Either method can be used as step 1 in the FMEA
development.
3 Steps to designing a PFMEA
• Step 1 - Understanding the process
– Flow Charts
• A stepwise flow chart is developed with each step being referenced
• The flow chart is built up by asking “What happens next in the
process” – Descriptions are kept short and simple and should
represent the process the problem follows
• The Flow chart is uniquely identified with the process name, date
and issue number
• A flow chart may represent a “Family of products” having a similar
process
 3 Steps to designing a PFMEA
• Step 1 - Understanding the process
• Cause and Effect matrix
– List the CTQs across the top of a matrix.
– Rank and assign scores to each CTQ according to its importance to the customer.
– List the causes on the left side of the matrix
– Determine correlation scores between each cause and CTQ based on the strength
of their relationship (E.g. 1 – weak, 3 – some, 9 – strong)
– Cross multiply correlation scores with priority scores and add across for each
cause
– Create a Pareto chart and focus on the causes with the higher overall scores.
Cause & Effect

KPOV = Key process output variable

KPIV = Key process input variable
3 Steps to designing a PFMEA

• Step 2
– Once a flow chart or C&E matrix has been produced,
a FMEA is produced using the FMEA form.
– There are 13 steps to developing the FMEA form
3 Steps to designing a PFMEA
• Step 2
– The 13 steps to designing a PFMEA form
1. List the key process steps in the first column
– These should have the same reference number as your flow chart or your
C&E diagram
2.List the potential failure mode for each process step
– Brainstorming is used in order to ensure that every “Failure Cause” is
considered for each potential failure mode. (Cause and effect diagrams can
be used at this stage)
3.List the Effects of this Failure mode for each process step
– If the failure mode occurs, what impact would it have on our internal / external
customers – In short, what is the effect
 3 Steps to designing a PFMEA
• Step 2
– The 13 steps to designing a PFMEA
4. Rate how severe the effect is (Severity – S)
– 1 being not to severe and 10 being extremely severe
– Us the team to develop your own scoring system – Never copy it from a book.
5.Identify the potential causes of the Failure mode / effect
– This time we are looking for the potential reasons why the failure mode may occur
6.Rate how severe the potential causes an be (Occurrence - O)
– This time we are scoring how likely this cause may occur
– Typically, 1 means it is very un-likely with 10 meaning a high probability
3 Steps to designing a PFMEA
• Step 2
– The 13 steps to designing a PFMEA form
7. Identify the controls in place to detect the Potential cause
– Here we are looking for the current controls that we have in place
that should detect and prevent the potential cause becoming a
customer issue. If a SOP is place for this, then enter the SOP
number
8. Rate the effectiveness of the detection against the current
controls (Detection – D)
– Here typically we would rank 1 as having excellent controls and 10
as having weak or no controls.
3 Steps to designing a PFMEA
• Step 2
– The 13 steps to designing a PFMEA
9. Establishing the Risk priority
– Multiply the Severity (S) Occurrence (O) and Detection (D)
numbers to establish a Risk Priority number (RPN)
– This is the key number that will be used to identify where the
team should focus first for the biggest impact on the initial
problem ie: S = 10 (Very severe), O = 10 (Occurs all the time),
D = 10 (Cannot detect it) our RPN = 1000 and we have a
serious issue.
3 Steps to designing a PFMEA

• Step 2
– The 13 steps to designing a PFMEA
10. Sort by RPN Number
– Pareto analysis may be used at this time to rank in order the
concerns
– The team must decide where to focus
– In general special attention is given if severity is high
regardless of RPN Number
3 Steps to designing a PFMEA

• Step 2
– The 13 steps to designing a PFMEA
11. Assign specific action
– Decide as a team what actions need to take place to reduce the
RPN number
12. Action ownership
– As a team Determine the “Who & When” that will ensure ownership
of the actions
– Actions should not be allocated to people outside the initial team
unless with they have kept up to date during the FMEA development
and have agreed on the action and its impact
3 Steps to designing a PFMEA

• Step 2
– The 13 steps to designing a PFMEA
13. Once actions have been completed, re-score the
occurrence and the detection and re-establish the RPN
– In most cases, the severity score will not change unless the
customer decides that this is no longer an important issue
The FMEA
3 Steps to designing a PFMEA

• Step 3 – The review process

– FMEA’S Should be reviewed monthly as part of the 6th
meeting
• Actions to be reviewed and their impact on the RPN
• Top 5 issues according to the PRN should be added onto the CI
plan
• RPN number to be updated based on improvements
• Pareto to be re-visited to direct further actions
• Target dates for actions not completed to be determined ad
amended.
The FMEA Circle
FMEA – A dynamic document

• The FMEA is a dynamic document

– It lives as long as the process it relates to lives
– It should not be put away in a cabinet and forgotten
(keep it live by including it on the CI plan)
– It should be available, reviewed constantly and
updated
FMEA for Maintenance
• Meridium is the maintenance arm of SAP
– Uses the same thought process as standard FMEA
– Looks at risk in 4 ways:
• Safety
• Environmental
• Operations
• Financial (maintenance and loss of production) – highest risk of the
above 3
– Unmitigated risk
– Mitigated risk, leading to inspection routines, pms etc
FMEA for Maintenance
FMEA for Maintenance

• Spreadsheet set up to logically go

through the risk assessments for
each asset
• FMEA at equipment level
• RCM (reliability centred
maintenance at parts level)
• Looks at system the asset is
used in
FMEA Exercise

• Foreign body FMEA - Plastic

• Equipment FMEA – Forming machine
(Koppens / De Jong)