The document discusses Failure Mode and Effects Analysis (FMEA), a risk management process used across various industries to identify potential failures and their consequences on products or processes. Developed originally by the US military in the 1940s, FMEA aims to improve product/design quality and reliability by systematically addressing potential failure modes. The document outlines the procedures for conducting an FMEA, including team formation, identifying failure modes, assessing severity and occurrence, and determining critical actions to mitigate risks.

1. OCCUPATIONAL SAFETY AND HEALTH (KAS 3501)
Course name : Bachelor of Technology (Environmental)
Semester : Year 3 6th Sem
Group number : 9
Group members :
Presentation Date : 7th April 2015
No. Name Matric number
1. Nurul Izzaty binti Mohd Walid UK29520
2. Mohd Syukri bin Abdullah UK29529
3. Nur Ain Zuriati binti Daud UK29525
4. Cheng Jing Jing UK29523
5. Amira Aqilah binti Safian UK29527

2. Simply put an FMEA is:
a process that identifies all the possible types of failures or risk
that could happen to a product or process and potential
consequences of those failures.
The Failure Mode : what could go wrong
The Effect Analysis : how it would happen;
how likely is it to go wrong;
how bad would it be

3. BackgroundoftheFMEA
 1940s - First developed by the US military in 1949 to
determine the effect of system and equipment
failures
 1960s - Adopted and refined by NASA (used in the
Apollo Space program)
 1970s – Ford Motor Co. introduces FMEA after the
Pinto affair. Soon adopted across automotive
industry
 Today – FMEA used in both manufacturing and
service industries

4. FMEA:
• Commonly used in a variety of industries for Risk
Management
• One of the most useful and effective tools for developing
designs, processes and services
• Goals of FMEA:
 To align risk as closely as possible with its source
• This enables:
 the determination of the root causes of the risk
 allow the selection of ways to detect the
occurrence/probability of a particular failure
 find options to prevent/mitigate the effects of a particular
failure

5.  It is important to know why we would do an FMEA.
 It is for procedures or inventions that would be very risky
or very expensive.
 We want to prevent problems before they happen and
that is exactly what an FMEA does.
 Doing an FMEA is imperative to making sure things run
smoothly.
HINTS:
 Preventing problems is cheaper and easier than cleaning them up.
 Some things are too risky or costly to incur mistakes.

6. TheReasonsforFMEA
 Get it right the first time
 Indentifies any inadequacies in the development of the
product
 Tests and trials may be limited to a few products
 Regulatory reasons
 Continuous improvement
 Preventive approach
 Team building
 Required procedures

7. FMEAprovidesthepotentialto:
 Reduce the likelihood of customer complaints
 Reduce the likelihood of campaign changes
 Reduce maintenance and warranty costs
 Reduce the possibility of safety failures
 Reduce the possibility of extended life or reliability
failures
 Reduce the likelihood of product liability claims

8. FMEAisaTeamProcess
Team Formation
 Product Development
 Design
 Manufacturing
 Quality
 Sales/Marketing
 Suppliers
 Reliability and testing
Team Roles
 Facilitator
 Champion
 Recorder/librarian
6-10 members is optimal

9. WhentouseFMEA
 IMPROVE
-When a process, product or service is being designed or
redesigned, after quality function development
-When existing product is applied in a new way
- Before developing control plans for a new or modified
process.
-When improvement goals are planned for an existing
process, product or service.

10. WhentouseFMEA
 ANALYSE
-When analyzing failures of an existing process, product
or service.
- Periodically throughout the life cycle of the process,
product or service.

11. TypesofFMEA
FMEA
Design FMEA
System
Sub-System
Component
Process FMEA
Assembly
System
Sub-System
Component
Manufacturing
System
Sub-System
Component

12. ProcessFMEA
 Analyze manufacturing and assembly processes at the
system, sub-system or component levels
 Focuses on potential failure modes of the process that
are caused by manufacturing or assembly process
deficiencies
 Commonly used in regard to patient care, especially
associated with certain types of surgery
 Commonly used in many industries to access certain
process involved in providing customer care.

13.  Potential failures: operator assembling part incorrectly,
excess variation in process resulting in out spec products
 Example: Air Bag Assembly Process (operator may not
install air bag properly on assembly line such that it may
not engage during impact)

14. DesignFMEA
 Used to analyze products before produce
 Examine the function of a system, sub-system or
component
 Focuses on potential modes of products caused by
design deficiencies
 Done at three levels-system, sub-system and component
levels
 Analyze hardware, functions or a combination

15.  Potential failures: incorrect material choice,
inappropriate specification
 Example: Air Bag (excessive air bag inflator force)

16. BENEFITSOFFMEA
 Improve product/process quality, reliability and safety
 Reduce development time
 Early identification and elimination of potential
product/process failure modes
 Prevent failure before they happen.
 Identifies critical aspect of design and process

17. LIMITATIONSOFFMEA
 Examinations of human error is limited
 Examinations of external influences is limited
 Results are depended on the mode of operations.

18. FMEAProcedure
1. Assemble a cross-functional team of people
with diverse knowledge about the process,
product or service and customer needs.
Functions often included are:
design, manufacturing, quality, testing, reliability,
maintenance, purchasing (and suppliers), sales,
marketing (and customers) and customer service.

19. FMEAProcedure
2. Identify the scope of the FMEA :
- Is it for concept, system, design, process or service?
-What are the boundaries?
- How detailed should we be?
Use flowcharts to identify the scope and to make sure
every team member understands it in detail.

20. FMEAProcedure
3. Fill in the identifying information at the top
of your FMEA form.
Figure 1 shows a typical format.
The remaining steps ask for information that will go
into the columns of the form.

21. FMEA FORM
Figure 1:Typical format of FMEA

22. FMEAProcedure
4. Identify the functions of your scope :
-What is the purpose of this system, design, process or
service?
In the form, name it with a verb followed by a noun.
Usually you will break the scope into separate
subsystems, items, parts, assemblies or process steps
and identify the function of each.

23. Item/ Process function
• Briefly outline function, step or item being analysed
• Be specific
• For example, part of a machine such as pump or oil filter

24. FMEAProcedure
5. For each function, identify all the ways failure
could happen.
These are potential failure modes.
How does the item or process fail to meet specifications
or purpose of design?
If necessary, go back and rewrite the function with
more detail to be sure the failure modes show a loss of
that function.

25. Potential Failure Mode
• Identify failure modes. (Hazard analysis)
• A failure mode is defined as the manner in which a component,
subsystem, system or process could potentially fail to meet the
design intent

26. FMEAProcedure
6. For each failure mode, identify all the
consequences on the system, related
systems, process, related processes, product,
service, customer or regulations.
These are potential effects of failure.

27. Potential Effect(s) of Failure
• List out all the possible effects of the failure.
• For example, reduced performance, potential risk and injury

28. FMEAProcedure
7. Determine how serious each effect is.
• This is the severity rating, or S.
• Severity is usually rated on a scale from 1 to 10,
where 1 is insignificant and 10 is catastrophic.
• All effects should be rated although rating of
severity is based on the most severe effect.

29. Severity
•Determine the severity of the failure effects on a scale of 1- 10
• All effects should be rated
• If severity is based upon criteria or standard, rating tables
should be included with the analysis.

30. Table1:Examplesofseverityratingtable

31. FMEAProcedure
8. Is this failure mode associated with a critical
characteristic?
• Usually, critical characteristics have a severity of 9 or
10 and occurrence and detection ratings above 3.
• Examples of critical characteristics include
dimensions, specifications, tests, assembly sequences,
tooling, joints, torques, welds, attachments, and
component usages.
• Special actions or controls necessary to meet these
requirements may involve manufacturing, assembly, a
supplier, shipping, monitoring, or inspection.

32. Classification
• Classification is used to define the critical characteristics (product or process
requirements that affect safety or compliance with government regulations
and require special controls)
• ‘Y’ or ‘N’ will be filled in the Classification column to show whether special
controls are needed.

33. FMEAProcedure
9. For each failure mode, determine all the
potential root causes.
• Use tools classified as cause analysis tool, as well as
the best knowledge and experience of the team.
• List all possible causes for each failure mode on the
FMEA form.

34. Potential Cause(s) / Mechanism(s) of Failure
•For each failure mode, determine and list all the potential
root causes

35. FMEAProcedure
10.For each cause, determine the occurrence
rating, or O.
• This rating estimates the probability of failure
occurring for that reason during the lifetime of your
scope.
• Occurrence is usually rated on a scale from 1 to 10,
where 1 is extremely unlikely and 10 is inevitable.
• On the FMEA table, list the occurrence rating for
each cause.

36. Occurrence
• For each cause, determine the occurrence rating.
•This rating estimates the probability of failure occurring
• Occurrence is usually rated on a scale from 1 to 10, where 1 is
extremely unlikely and 10 is inevitable

37. FMEAProcedure
11. For each cause, identify current process
controls.

38. Current process control
• Identify current process controls.
•These are tests, procedures or mechanisms that now keep failures from
reaching people involved such as employee.
•These controls might prevent the cause from happening, reduce the
likelihood that it will happen or detect failure after the cause has already
happened

39. FMEAProcedure
12. For each control, determine the detection
rating, or D.
• Detection is usually rated on a scale from 1 to 10,
where 1 means the control is absolutely certain to
detect the problem and 10 means the control is certain
not to detect the problem (or no control exists).
• On the FMEA table, list the detection rating for each
cause.

40. Detectability
• Determine the detection rating for each control.
•This rating estimates how well the controls can detect either
the cause or its failure mode after they have happened but
before people is affected.
• Detection is usually rated on a scale from 1 to 10

41. FMEAProcedure
13. Calculate the risk priority number, or RPN,
which equals S × O × D.
• Also calculate Criticality by multiplying severity by occurrence
, S × O.
• Lowest detection rating is used to calculate RPN
• These numbers provide guidance for ranking potential failures in
the order they should be addressed.

42. RPN (Risk Priority Number)
• RPN = Severity × Occurrence × Detection
•These numbers provide guidance for identifying items which
required attention and assign a priority to them.

43. FMEAProcedure
14. Identify recommended actions.

44. Recommended Action(s)
• Identify recommended actions.
•These actions may be design or process changes to lower
severity or occurrence.
•They may be additional controls to improve detection.

45. Responsibility andTarget Completion Date
• List out the name of people who is responsible for the
actions
•The date by which the action(s) need to be taken

46. FMEAProcedure
15. As actions are completed, note result and the date on
the FMEA form.
Also, update new S, O or D ratings and new RPNs to
reflect actions taken.
 Unless the failure mode has been eliminated, severity
should not change
 Occurrence may or may not be lowered based upon
the results of actions
 Detection may or may not be lowered based upon the
results of actions
 If severity, occurrence or detection ratings are not
improved, additional recommended actions defined

47. Action(s)Taken
• Remedial actions taken must be listed out in details

48. Severity, Occurrence, Detectability, RPN
As actions are completed, new Severity, Occurrence and
Detectability ratings and new RPNs are determined.

49. ExampleofFMEAform

50. Prevention is better than cure.

51. References
 Benefits of FMEA. (n.d.). Retrieved from: http://a-
anai.com/FMEA_benefits.htm
 Failure Mode Effects Analysis (FMEA). (n.d.) . Retrieved from:
http://asq.org/learn-about-quality/process-analysis-
tools/overview/fmea.html
 FMEA-FMECA,Your Guide for FMEA Information and Resources Retrieved
from: http://www.fmea-fmeca.com/types-of-fmea.html
 Friend, M.A., John, J. P. (2007). Fundamentals of Occupational Safety and
Health. UK: Government Institutes.
 Nancy R.Tague’s, The QualityToolbox, Second Edition,ASQ Quality
Press, 2004, pages 236–240.
 University of Ljubljana. (2009). Failure Mode and Effects (and Criticality)
Analysis FaultTree Analysis. Retrieved from: http://lrss.fri.uni-
lj.si/sl/teaching/rzd/tutorials/slovak2010_FMEA_FTA.pdf

52. Thank You