2. DEFINITION
“Reliability engineering method for risk elimination.”
“FMEA is a specific methodology to evaluate a system,
design and process for possible ways in which failures
can occur.”
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3. INTRODUCTION
We need to eliminate risk if we are to eliminate
Waste !
The concept of getting things right first time!!!
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4. INTRODUCTION
U.K and USA Industry needs to change both
PacePace and TuneTune
if it is to survive
Change brings risk !Change brings risk !
A forward thinking company will have considered
risk management
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5. INTRODUCTION
In industry today we can not tolerate wasteful
activities if we are to compete in an ever increasing
competitive market
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7. INTRODUCTION
The elimination of risk should be a total commitment of
the entire organisation.
Before After
SOLUTION OF A PROBLEM
MONITORING OF WASTE
QUANTIFICATION OF RELIABILITY
PREVENTION OF A PROBLEM
ELIMINATION OF WASTE
REDUCTION OF UNRELIABILITY
“If you do what you’ve always done, you will get
what you’ve always got”
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8. GENERAL OVERVIEW
The three types of FMEA
SYSTEM FMEA DESIGN FMEA PROCESS FMEA
MANPOWER
MACHINE
METHOD
MATERIAL
MEASUREMENT
ENVIRONMENT
MAIN SYSTEMS
SUB SYSTEMS
COMPONENTS
MAIN SYSTEMS
SUB SYSTEMS
COMPONENTS
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9. GENERAL OVERVIEW
When new systems, products, processes or
services are designed
When existing systems, designs, products,
processes or services are about to change
Continuously improving
When is the FMEA started?
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10. GENERAL OVERVIEW
System & Design FMEA - These are complete
when the product is obsolete.
Process FMEA - Complete when the product or
process becomes obsolete.
When is the FMEA complete?
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11. GENERAL OVERVIEW
The process of conducting an FMEA, 4 Step Approach
•Select team
•Brainstorm process
•Model process
•Brain storm elements to define failure modes
•Define occurrence, severity and detection ratings for failure modes.
•Calculate risk priority number (RPN)
•Define action to reduce rpn
•Define person responsible for carrying out action
•Next meeting record the result of the actions
•Deduce the occurrence, severity and detection calculate the new RPN
•Once the process has been analysed start again.
Spend 50% of time
}Step 1
PLAN
Step 2
DO
Step 3
CHECK
Step 4
ACT
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12. GENERAL OVERVIEW
A good FMEA:-
Very well planned
Identifies known and potential failures
Identifies the cause and effects of each failure
Prioritises the identified failure modes
Provides a problem follow up and corrective action
FMEA is one of the most effective early
warning and preventative techniques
available.
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13. FMEA VOCABULARY
Failure Mode: A physical description of the manner
in which a failure occurs.
Cause of Failure: The root cause of the failure mode.
Search for the complete elimination of the problem.
Effect of Failure: The outcome of the failure mode.
View both local and global effects (domino effect).
Current Controls: Exists to prevent the cause of the
failure from occurring.
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14. GUIDE TO RATINGS
OCCURRENCE
CRITERIA RATING
REMOTE
Remote probability of occurrence.
1
VERY HIGH
Very high probability of occurrence. Process out of control failure is
almost certain. 5
HIGH
High probability of occurrence. Process in control with failures often
occurring. 4
MODERATE
Moderate probability of occurrence. Process in control with occasional
failures. 3
LOW
Low probability of occurrence. Process under control.
2
1:10000
1:1
1:10
1:100
1:1000
STATISTICAL
WEIGHTING
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15. GUIDE TO RATINGS
SEVERITY
MINOR
Negligible effect on performance of functional equipment under
consideration. No noticeable effect on programme. 1
VERY HIGH
Equipment failure or high degree of rework. Programme
irrecoverable. 5
HIGH
High degree of impact due to nature of failure. Rework required,
significant programme setback. 4
MODERATE
Significant degradation of functional equipment under
consideration with some rework, small impact on programme. 3
LOW
Minor degradation of functional equipment under consideration.
Minor rework, insignificant impact on programme. 2
< 5 MINUTE
< 1 WEEK
< 24 HOURS
< 4 HOURS
< 30 MINUTE
CRITERIA RATING
STATISTICAL
WEIGHTING
for rework
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16. GUIDE TO RATINGS
DETECTION
VERY HIGH
Current control will almost certainly detect the failure mode. Defect will
be detected during own process or operation 1
VERY LOW
Current control will not detect the failure mode. Defect will reach
customer 5
LOW
Current controls have a poor chance of detecting the existence of a failure
mode. Defect may reach customer. 4
MODERATE
Current controls may detect the failure mode. Defect should be detected
during at a stage of build or test. 3
HIGH
Current controls have a good chance of detecting the failure mode. Defect
will be detected during own process or operation 2
1:1
1:10 000
1:1000
1:100
1:10
CRITERIA RATING
STATISTICAL
WEIGHTING
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17. COMPLETING THE FMEA
FORM STEP BY STEP
Process
Description/
Process
Purpose
Potential
Failure
Mode
Potential
Effect(s) of
Failure
Potential
Cause(s)
of Failure
O
C
C
S
E
V
D
E
L
T
A
Current
Controls
D
E
T
R
P
N
Recommended
Action(s)
Area/
Individual
Responsible.
Completion
date
Action Results
Actions
Taken
S
E
V
O
C
C
D
E
T
R.
P.
N.
1 2 3 4 5 6 7 8 9 10 11 12 13
Team Effort
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18. FMEA FORM EXAMPLE
Process
Description/
Process
Purpose
Potential
Failure
Mode
Potential
Effect(s) of
Failure
Potential
Cause(s)
of Failure
O
C
C
S
E
V
D
E
L
T
A
Current
Controls
D
E
T
R
P
N
Recommended
Action(s)
Area/
Individual
Responsible.
Completion
date
Action Results
Actions
Taken
S
E
V
O
C
C
D
E
T
R.
P.
N.
Fixing unit
to jig plate
Screws too
short
Thread
breakout from
jig, possible
unit damaged
or scraped
Wrong
torque
applied to
screws
Unit may
become loose.
Damage to feet
on device
under test
5
5
Thread
breakout from
jig, possible
unit damaged
or scraped
Operator
picks wrong
screw
Wrong
wrench used
2
2
Operator
skill at
recognising
screws
Operator
checks torque
wrench if not
recognised as
one used
before
3
4
30
40
Revive storage bins
for screws
Label torque wrench
John Jones
Steve Smith
Labeled storage bin for
each type of screw, nut
and washer. Screw
thrown away after use
Dated calibration labels
stuck to torque
wrenches.
15315
40425
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19. TEAM AND TEAM
MECHANICS
To do a complete job with the best results the:
FMEA must be written by a team
Team must be multi-disciplined and cross functional
Team must be committed to achieving common
objectives
Whole team must participate
Team members must maintain a positive attitude
Team must reach a consensus
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20. TEAM AND TEAM
MECHANICS
The Team
Responsible Engineer
Planner
Manufacturing Engineer
Quality
Operator
The team should be no more than 5 - 8 people
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21. TEAM AND TEAM MECHANICS
Handling difficult people
The Individuals Who Talk Too Much
Members Who Talk Too Little
Members Who Say The Wrong Things
The facilitator must manage the situation
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22. TEAM AND TEAM MECHANICS
Common Meeting Pitfalls:
Competing for power, often by challenging the leader
Joking and clowning excessively, which is a distraction
Failing to agree on a problem or issue
Arguing about others’ opinions and suggestions
Wondering off the topic at hand
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25. WithAdrian™
Things I would like to do again
Lead initiatives, spark creativity, explore insights,
cultivate brands, strengthen companies, build teams,
encourage others, challenge myself
This presentation will take approximately 1 hour After this you will be be able to : Understand the principles of FMEA. Completing an FMEA Select a team for an FMEA F.M.E.A. is as its name suggests a method for analyising potential failures. FMEA provides a forum to discuss and record new ideas to improve the products and processes, in so doing reducing risk. When looking back many failures are in hindsight obvious. Introduce presentation as part of FMEA course
3 TYPES OF FMEA’s A product development cycle covers three stages. System design, Design and manufacturing. The system FMEA is the highest level FMEA and analysis the system at the concept stage. The design FMEA analyses the subsystems down to component level. The process FMEA analyses the manufacturing processes, failure here will fall under :- Manpower Machine Method Material Measurement Environment
By definition the FMEA is a methodology to maximise the satisfaction of the customer by eliminating potential problems. To do this the FMEA must start as soon as possible. An FMEA can be started at any point between design conception and manufacturing. Do not wait for all the info because it will never start, make do with what you have
A very common question is “when is the FMEA Complete” It is important to keep re-addressing the FMEA all through the life cycle of the product, this is the only way the FMEA maintains its usefulness.
To conduct an FMEA effectively one must follow a systematic approach The 4 step method follows the PLAN, DO, CHECK, ACT cycle PLAN Select a cross functional team. Model the process, this should be a step by step flow chart. Points to remember when modelling a process are: 1. Make sure the objectives for the model are clearly defined 2. Model boundary , disregard information which is outside the model purpose or redefine the model and start again. 3. Model view point, is the model considered from the view point of the customer, employee, environment etc. If the model definition is to loose arguments can arise as to the consequence of failures on the system. Use affinity diagrams to identify and arrange the process. Brain storm process to gather elements of process. Organise elements into groups, address ill defined areas, look for and hidden relationships. DO Brain storm each process element for failure modes. In each case consider Material, Man Power, Method, Machine Measurement & Environment, these identify the key areas where failures are found. Quantify these effects using occurrence, severity and detection ratings(these are defined later). Multiply these ratings together to deduce the Risk Priority Number (RPN). Use the RPN to decide the importance of the failure mode relative to the other failure modes. Define the corrective actions to reduce the RPN, the lower the RPN the lower the risk associated with the failure mode. Assign members of the team to be responsible for executing the actions. CHECK At subsequent meetings record the result of the action. Deduce the new Occurrence, severity and detection ratings, calculate the new RPN and compare it to the original. Ask the following questions: Is the situation better than before ?, worse than before ?, the same as before ?. ACT Continually repeat the FMEA. Each member must maintain enthusiasm to improve the process.
FMEA helps map out the road to continuous improvement
Low occurrence, low severity high detection will give a low RPN. This indicates a low priority failure mode. Inversely high occurrence, high severity and low detection will give a high RPN. This indicates a very high priority failure mode. It is important to remember that the statistical weighting is arbitrary. It has to be decided by the FMEA team. It is very important that once a statistical weighting has been decided the team should try to use it where possible. The ratings for all FMEAs are graded between 1 and 5.
1.Process description - Identify the process element under consideration from the process map. 2.Failure mode - The problem, the concern, the opportunity. There can be more than one. 3.Effect of failure - The potential effects of the failure is the consequence of a process failure. 4.Severity of effect - Severity is a rating indicating the seriousness of the effect. 5.Critical characteristic- Is the process element critical to the whole process, enter “ “ for yes. 6.Cause of failure - The cause of a process failure mode is the process deficiency that results in the failure mode. There could be more than one cause. 7.Occurrence - It is the rating value corresponding to the estimated frequency of failures. 8.Current controls - Identify current controls that help detect or prevent failure modes and help the estimation of the detection rating. 9.Detection - It is a rating corresponding to the likelihood that the current process controls will detect the cause of failure. 10.RPN - This number is the product of severity, occurrence and detection. 11.Recommend action - Reduces RPN, may be specific action or further study. 12.Area/Individual responsible - The owner of the risk who will carry out action. 13.Action results - After the actions are incorporated, the FMEA team should re-evaluate the severity, occurrence and detection.
Sum of the group is greater than the sum of the individuals The team is the foundation for improvement When conducting FMEA the following types of people slow down the process 1. The individuals who talk too much. 2. Members who talk too little. 3. Members who say the wrong thing - do not stick to agenda. These are not necessarily negative people. The group must draw as much useful information as possible. Try to be constructive not punitive.
Team should meet on regular basis, for example once a week to review the effectiveness of the corrective actions and to look at new failure modes.
Adrian Beale USA Address: Date of Birth: 24/09/61 1106 Marital Status: Married Fern Hill Road Health: Excellent Mooresville Driving License: Full/Clean North Carolina Work: +44776337534 USA Mobile: 7049051291