This document provides an overview of failure mode and effects analysis (FMEA). FMEA is a systematic process for identifying potential failures in a design, manufacturing or production process. It involves reviewing all possible failures, their causes and effects. Potential failures are ranked according to severity, occurrence, and the ability to detect the failure. This ranking is used to identify areas that need improvement and prevent potential problems. The document discusses the different types of FMEAs (e.g. design, process), how to conduct one including using a worksheet to document the analysis, and how FMEAs can benefit processes by reducing risks and costs.

1. FAILURE MODES EFFECT ANALYSIS
(FMEA)

2. WHAT IS FMEA?
A systemized group of activities designed to:
▪ recognize and evaluate the potential failure of
a product/process and its effects
▪ identify actions which could eliminate or
reduce the chance of potential failure
▪ document the process
Failure Mode and Effect Analysis

3. FAILURE MODE AND EFFECT ANALYSIS
Simply put FMEA is:
a process that identifies all the possible types of
failures that could happen to a product and potential
consequences of those failures.

4. FMEA TERMS
Failure mode - the way in which something
might fail
Effects analysis – studying the consequences of
the various failure modes to determine their
severity to the customer.

5. 5
WHAT IS FMEA?
FMEA--a tool to identify risks in your
process
Can be used in multiple places in process
improvement
Determine where problems are
Help identify cause/effect relationships
Highlight risks in solutions and actions to take
Starts with input from processes
Identifies three risk categories
Severity of impact
Probability of occurrence
Ability to detect the occurrence

6. 6
WHEN TO USE
Early stages (Define) to understand process and
identify problem areas
Analyze data (Analyze) to help identify root
causes
Determine best solutions (Improve) with lowest
risk
Close out stage (Control) to document
improvement and identify actions needed to
continue to reduce risk

7. THE REASONS FOR FMEA
Get it right the first time
Identifies 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

8. FMEA PROVIDES THE POTENTIAL TO:
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

9. BENEFITS
Identify potential and known failures
Reduce the number of engineering changes
Reduce product development time
Lower start-up costs
Greater customer satisfaction
Increased cooperation and teamwork between
various functions
Continuous improvement

10. TYPES OF FMEA
System - focuses on global system functions
Design - focuses on components and subsystems
Process - focuses on manufacturing and assembly
processes
Service - focuses on service functions
Software - focuses on software functions

11. TYPES OF FMEA

12. CONCEPT FMEA
Used to analyze concepts in the early stages
before hardware is defined (most often at
system and subsystem)
Focuses on potential failure modes associated
with the proposed functions of a concept
proposal
Includes the interaction of multiple systems
and interaction between the elements of a
system at the concept stages.

13. DESIGN FMEA
Aid in the objective evaluation of design requirements
and design alternatives
Aid in the initial design for manufacturing and
assembly
Increase the probability that potential failure modes
have been considered
Provide additional information to aid in the planning of
efficient design testing

14. PROCESS FMEA
Indentify potential product related process
failure modes
Assess the potential customer effects of the
failures
Indentify the potential manufacturing causes
on which to focus on
Develop a ranked list of potential failure modes
Document the results of the manufacturing

15. APPLICATION EXAMPLES
Manufacturing: A manager is responsible for
moving a manufacturing operation to a new
facility. He/she wants to be sure the move goes as
smoothly as possible and that there are no
surprises.
Design: A design engineer wants to think of all
the possible ways a product being designed could
fail so that robustness can be built into the
product.
Software: A software engineer wants to think of
possible problems a software product could fail
when scaled up to large databases. This is a core
issue for the Internet.

16. RISK PRIORITY NUMBER

17. FMEA WORKSHEET
Process or
Product Name
Prepared by: Page _____ of ______
Person
Responsible
Date (Orig) ___________ Revised __________
Process
Step
Key
Process
Input
Potential
Failure
Mode
Potential
Failure
Effect
S
e
v
Potential
Causes
O
c
c
Current
Controls
D
e
t
R
P
N
Actions
Recommended
S
e
v
O
c
c
D
e
t
R
P
N
Sev - Severity of the failure (what impact will it have on our process?)
Occ – How likely is the event to occur (probability of occurrence)
Det – How likely can the event be detected in time to do something about it
RPN – Risk Priority Number (multiply Sev, Occ, and Det)

18. 18
HOW TO COMPLETE THE FMEA
General Suggestions
Use large white board or flip chart with a
FMEA form drawn on it during the
generation phase
Focus the team on the specific area of study
(product or process).
Have process map available
Have all subassemblies and component part
of a product.

19. FMEA PROCEDURE
1. For each process input (start with high value
inputs), determine the ways in which the input
can go wrong (failure mode)
2. For each failure mode, determine effects
Select a severity level for each effect
3. Identify potential causes of each failure mode
Select an occurrence level for each cause
4. List current controls for each cause
Select a detection level for each cause
Process Steps

20. FMEA PROCEDURE (CONT.)
5. Calculate the Risk Priority Number (RPN)
6. Develop recommended actions, assign
responsible persons, and take actions
Give priority to high RPNs
MUST look at severities rated a 10
7. Assign the predicted severity, occurrence, and
detection levels and compare RPNs
Process Steps

21. SEVERITY, OCCURRENCE,
AND DETECTION
Severity
Importance of the effect on customer requirements
Occurrence
Frequency with which a given cause occurs and
creates failure modes (obtain from past data if
possible)
Detection
The ability of the current control scheme to detect
(then prevent) a given cause (may be difficult to
estimate early in process operations).
Analyzing
Failure &
Effects

22. RATING SCALES
2
2
There are a wide variety of scoring
“anchors”, both quantitative or qualitative
Two types of scales are 1-5 or 1-10
The 1-5 scale makes it easier for the
teams to decide on scores
The 1-10 scale may allow for better
precision in estimates and a wide
variation in scores (most common)
Assigning
Rating
Weights

23. RATING SCALES
2
3
Severity
1 = Not Severe, 10 = Very Severe
Occurrence
1 = Not Likely, 10 = Very Likely
Detection
1 = Easy to Detect, 10 = Not easy to Detect
Assigning
Rating
Weights

24. RISK PRIORITY NUMBER (RPN)
RPN is the product of the severity, occurrence, and
detection scores.
Severity Occurrence Detection RPNX X =
Calculating a
Composite
Score

25. PROCESS FOR FMEA
Process to Change Oil in a Car
3000 miles
driven
Drive car
on lift
Fill with
new oil
Drain Oil Replace
Filter
Take Car
off lift
Process
Complete

26. HOW TO COMPLETE THE FMEA
Step 1. Complete header information
Step 2. Identify steps in the process
Step 3. Brainstorm potential ways the area of
study could theoretically fail (failure
modes)
Suggestion: Use Affinity Diagram
as a brainstorming tool

27. FMEA WORKSHEET
Process or
Product Name
Change Oil in Car Prepared by: Leon Page _1____ of __1____
Person
Responsible
Leon Mechanic Date (Orig) __27 Sep 2007___ Revised __________
Process
Step
Key
Process
Input
Potential
Failure
Mode
Potential
Failure
Effect
S
e
v
Potential
Causes
O
c
c
Current
Controls
D
e
t
R
P
N
Actions
Recommended
S
e
v
O
c
c
D
e
t
R
P
N
Fill
with
new
oil
New
Oil—
Mech
anic
Wrong
type of
oil
Engine
wear
No oil
added
Engine
Failure
Sev - Severity of the failure (what impact will it have on our process?)
Occ – How likely is the event to occur (probability of occurrence)
Det – How likely can the event be detected in time to do something about it
RPN – Risk Priority Number (multiply Sev, Occ, and Det)

28. 28
HOW TO COMPLETE A FMEA
Step 4
For each failure mode, determine impact
or effect on the product or operation using
criteria table (next slide)
Rate this impact in the column labeled SEV
(severity)

29. 29
SEVERITY (SEV) RATING
SEV Severity Product/Process Criteria
1 None No effect
2 Very Minor Defect would be noticed by most discriminating customers. A portion of the product may have to be
reworked on line but out of station
3 Minor Defect would be noticed by average customers. A portion of the product (<100%) may have to be
reworked on line but out of station
4 Very Low Defect would be noticed by most customers. 100% of the product may have to be sorted and a
portion (<100%) reworked
5 Low Comfort/convenience item(s) would be operable at a reduced level of performance. 100% of the
product may have to be reworked
6 Moderate Comfort/convenience item(s) would be inoperable. A portion (<100%) of the product may have to
be scrapped
7 High Product would be operable with reduced primary function. Product may have to be sorted and a
portion (<100%) scrapped.
8 Very High Product would experience complete loss of primary function. 100% of the product may have to be
scrapped
9 Hazardous
Warning
Failure would endanger machine or operator with a warning
10 Hazardous
w/out
Warning
Failure would endanger machine or operator without a warning

30. 30
FMEA WORKSHEET
Process or
Product Name
Change Oil in Car Prepared by: Leon Page _____ of ______
Person
Responsible
Leon Mechanic Date (Orig) __27 Sep 2007___ Revised __________
Process
Step
Key
Process
Input
Potential
Failure
Mode
Potential
Failure
Effect
S
e
v
Potential
Causes
O
c
c
Current
Controls
D
e
t
R
P
N
Actions
Recommended
S
e
v
O
c
c
D
e
t
R
P
N
Fill
with
new
oil
New
Oil—
Mech
anic
Wrong
type of
oil
Engine
wear
2
No oil
added
Engine
Failure
1
0
Sev - Severity of the failure (what impact will it have on our process?)
Occ – How likely is the event to occur (probability of occurrence)
Det – How likely can the event be detected in time to do something about it
RPN – Risk Priority Number (multiply Sev, Occ, and Det)

31. 31
HOW TO COMPLETE A FMEA
Step 5
For each potential failure mode identify one
or more potential causes (Could use Affinity
Diagram again to brainstorm ideas)
Rate the probability of each potential cause
occurring based on criteria table (next slide)
Place the rating in the column labeled OCC
(occurrence).

32. 32
FMEA OCCURRENCE (OCC RATING)
OCC Occurrence Criteria
1 Remote 1 in 1,500,000 Very unlikely to occur
2 Low 1 in 150,000
3 Low 1 in 15,000 Unlikely to occur
4 Moderate 1 in 2,000
5 Moderate 1 in 400 Moderate chance to occur
6 Moderate 1 in 80
7 High 1 in 20 High probability that the event will occur
8 High 1 in 8
9 Very High 1 in 3 Almost certain to occur
10 Very High > 1 in 2

33. FMEA WORKSHEET
Process or
Product Name
Change Oil in Car Prepared by: Leon Page _____ of ______
Person
Responsible
Leon Mechanic Date (Orig) __27 Sep 2007___ Revised __________
Process
Step
Key
Process
Input
Potential
Failure
Mode
Potential
Failure
Effect
S
e
v
Potential
Causes
O
c
c
Current
Controls
D
e
t
R
P
N
Actions
Recommended
S
e
v
O
c
c
D
e
t
R
P
N
Fill
with
new
oil
New
Oil—
Mech
anic
Wrong
type of
oil
Engine
wear
2 Mis-
labeled
3
No oil
added
Engine
Failure
1
0
Hurrying 3
Sev - Severity of the failure (what impact will it have on our process?)
Occ – How likely is the event to occur (probability of occurrence)
Det – How likely can the event be detected in time to do something about it
RPN – Risk Priority Number (multiply Sev, Occ, and Det)

34. 34
HOW TO COMPLETE THE FMEA
Step 6
Identify current controls or detection
Rate ability of each current control to prevent
or detect the failure mode once it occurs
using criteria table (next slide)
Place rating in Det column

35. 35
FMEA DETECTION (DET) RATING
DET Detection Criteria
1 Almost
Certain
Current Controls are almost certain to detect/prevent the failure mode
2 Very High Very high likelihood that current controls will detect/prevent the failure
mode
3 High High Likelihood that current controls will detect/prevent the failure mode
4 Mod. High Moderately High likelihood that current controls will detect/prevent the
failure mode
5 Moderate High Likelihood that current controls will detect/prevent the failure mode
6 Low Low likelihood that current controls will detect/prevent failure mode
7 Very Low Very Low likelihood that current controls will detect /prevent the failure
mode
8 Remote Remote likelihood that current controls will detect/prevent the failure
mode
9 Very
Remote
Very remote likelihood that current controls will detect/prevent the failure
mode

36. FMEA WORKSHEET
Process or
Product Name
Change Oil in Car Prepared by: Leon Page _____ of ______
Person
Responsible
Leon Mechanic Date (Orig) __27 Sep 2007___ Revised __________
Process
Step
Key
Process
Input
Potential
Failure
Mode
Potential
Failure
Effect
S
e
v
Potential
Causes
O
c
c
Current
Controls
D
e
t
RPN Actions
Recommended
S
e
v
O
c
c
D
e
t
R
P
N
Fill
with
new oil
New
Oil
from
supplier
Wrong
type of
oil
Engine
wear
2 Misread oil
chart for
vehicle
3 None 9
No oil
added
Engine
Failure
1
0
Hurrying 3 Engine light 3
Sev - Severity of the failure (what impact will it have on our process?)
Occ – How likely is the event to occur (probability of occurrence)
Det – How likely can the event be detected in time to do something about it
RPN – Risk Priority Number (multiply Sev, Occ, and Det)

37. 37
HOW TO COMPLETE THE FMEA
Step 7
Multiply SEV, OCC and DET ratings and place the value in the
RPN (risk priority number) column. The largest RPN numbers
should get the greatest focus. For those RPN numbers which
warrant corrective action, recommended actions and the person
responsible for implementation should be listed.
SEV * OCC * DET = RPN ( 2 * 3 * 9 = 54 )
Process
Step
Key
Process
Input
Potential
Failure
Mode
Potential
Failure
Effect
S
e
v
Potential
Causes
O
c
c
Current
Controls
D
e
t
RPN Actions
Recommended
S
e
v
O
c
c
D
e
t
R
P
N
Fill with
new oil
New Oil
from
supplier
Wrong
type of
oil
Engine
wear
2 Misread
oil chart
for
vehicle
3 None 9 54
No oil
added
Engine
Failure
1
0
Hurrying 3 Engine light 3 90

38. 38
FMEA RANKINGS
Severity Occurrence Detection
Hazardous without
warning
Very high and almost
inevitable
Cannot detect or
detection with very
low probability
Loss of primary
function
High repeated
failures
Remote or low
chance of detection
Loss of secondary
function
Moderate failures Low detection
probability
Minor defect Occasional failures Moderate detection
probability
No effect Failure Unlikely Almost certain
detection
Rating
10
1
High
Low
Source: The Black Belt Memory Jogger, Six Sigma Academy

39. ACTION RESULTS
Step 8
After corrective action has been taken, place
summary of the results in the ‘Actions
Recommended’ block
Assign new value for:
Severity
Occurrence
Detection
Calculate new RPN number

40. FMEA WORKSHEET
Process or
Product Name
Change Oil in Car Prepared by: Leon Page _____ of ______
Person
Responsible
Leon Mechanic Date (Orig) __27 Sep 2007___ Revised __________
Process
Step
Key
Process
Input
Potential
Failure
Mode
Potential
Failure
Effect
S
e
v
Potential
Causes
O
c
c
Current
Controls
D
e
t
RPN Actions
Recommended
S
e
v
O
c
c
D
e
t
R
P
N
Fill
with
new oil
New
Oil
from
supplier
Wrong
type of
oil
Engine
wear
2 Misread oil
chart for
vehicle
3 None 9 54
No oil
added
Engine
Failure
1
0
Hurrying 3 Engine light 3 90 Oil level
checked by
partner
1
0
3 1 3
0
Sev - Severity of the failure (what impact will it have on our process?)
Occ – How likely is the event to occur (probability of occurrence)
Det – How likely can the event be detected in time to do something about it
RPN – Risk Priority Number (multiply Sev, Occ, and Det)

41. FMEA EXAMPLE
Source: Quality Digest/ August 2006 Quality Service at the Special Olympics World Games, Tang Xiaofen
Process or Product
Name:
Hotel Service at Special Olympics Prepared by: Page _____ of ______
Person Responsible: Joe Quality Date (Orig) ___________ Revised __________
Process
Step
Key
Process
Input
Potential
Failure
Mode
Potential
Failure
Effect
S
e
v
Potential
Causes
O
c
c
Current
Controls
D
e
t
R
P
N
Actions
Recommended
S
e
v
O
c
c
D
e
t
R
P
N
Register
guest
Service
Desk
Cannot
Register
in time
Complaints 5 Lack of
language
and
communicat
ion skills,
support of
volunteers
not
sufficient
4 No plan on
training
content;
training and
volunteer
support
sufficient
3 72
Provide
Guest
Services
Guest
Support
Lack of
barrier-
free
facility
Inconvenien
ce and
injury
10 Cannot
provide
barrier-free
facility
3 Providing
barrier-free
facility
7 210
Provide
Meals
Food
Service
Food
goes bad
Disease or
injury
10 Past shelf
life
6 No control of
raw material
8 240
Provide
Medical
Service
Medical
Service
Service
not in
time
Illness
changes for
worse
10 No 24 Hour
service
6 12 hour
service
3 180

42. FAULT TREE ANALYSIS

43. INTRODUCTION
Fault Tree Analysis was originally developed in
1962 at Bell Laboratories by H.A. Watson.
FTA is a deductive analysis approach for
resolving an undesired event into its causes.
Logic diagrams and Boolean Algebra are used to
identify the cause of the top event.
2

44. CONTD…
A logic diagram called Fault tree is constructed
to show the event relationship.
Probability of occurrence values are assigned to
the lowest events in the tree in order to obtain
the probability of occurrence of the top event.
3

45. WHY FTA IS CARRIED OUT?
Identify the cause of a failure.
Monitor and control safety performance of a
complex system.
To identify the effects of human errors .
Minimize and optimize resources.
4

46. THE FAULT TREE
Fault tree is the logical model of the relationship of
the undesired event to more basic events.
The top event of the Fault tree is the undesired
event.
The middle events are intermediate events and the
basic events are at the bottom.
The logic relationship of events are shown by logic
symbols or gates.
5

47. BASIC FAULT TREE STRUCTURE
6

48. EVENTS OF A FAULT TREE
7
Basic Event: A lower most event that can not be further developed.
Intermediate Event: This can be a intermediate event (or)
a top event. They are a result logical combination of lower
level events.
Undeveloped Event:An event which has scope for
further development but not done usually because of
insufficient data.
External Event:An event external to the system
which can cause failure.

49. BASIC GATES OF A FAULT TREE
8
OR Gate: Either one of the bottom event results in
the occurrence of the top event.
AND Gate: For the top event to occur all the bottom events
should occur.
Inhibit Gate: The top event occurs only if
the bottom event occurs and the inhibit
condition is true.

50. PROCEDURE
9
Procedure for Fault Tree Analysis
Define TOP
event
Define overall
structure.
Explore each
branch in
successive level
of detail.
Solve the fault
tree
Perform
corrections if
required and
make decisions

51. PROCEDURE
Define Top Event:
Use Process hazard assessment (PHA), Piping & Instrumentation
Diagram (P&ID), Process description etc., to define the top event.
If its too broad, overly large FTA will result. E.g. Fire in process.
If its too narrow, the exercise will be costly. E.g. Leak in the valve.
The boundaries for top event definition can be a System, Sub-system,
Unit, Equipment (or) a Function.
Some good examples are: Overpressure in vessel V1, Motor fails to
start, Reactor high temperature safety function fails etc.,
10

52. PROCEDURE
Define overall structure:
Determine the intermediate events &
combination of failure that will lead to the
top event.
Arrange them accordingly using logical
relationship
11

53. PROCEDURE
Explore each branch in successive level of detail:
Continue the top down process until the root cause for each
branch is identified and/or until further decomposition is
considered unnecessary.
So each branch will end with a basic event or an
undeveloped event.
Consider Common cause failure & Systematic failures in
the process of decomposition.
A good guide to stop decomposing is to go no further than
physical (or) functional bounds set by the top event.
12

54. PROCEDURE
13
Solve the Fault Tree:
Assign probabilities of failure to the lowest level
event in each branch of the tree.
From this data the intermediate event frequency
and the top level event frequency can be
determined using Boolean Algebra and Minimal
Cut Set methods.

55. PROCEDURE
14
Minimal Cut Set theory:
The fault tree consists of many levels of basic and intermediate
events linked together by AND and OR gates. Some basic events
may appear in different places of the fault tree.
The minimal cut set analysis provides a new fault tree, logically
equivalent to the original, with an OR gate beneath the top event,
whose inputs (bottom)are minimal cut sets.
Each minimal cut set is an AND gate with a set of basic event
inputs necessary and sufficient to cause the top event.

56. PROCEDURE
15
Perform corrections and make decisions:
Application of Boolean Algebra and Minimal Cut
Set theory will result in identifying the basic
events(A) and combination of basic events(B.C.D)
that have major influence on the TOP event.
• This will give clear insight on what needs to be
attended and where resources has to be put for
problem solving.

57. EXAMPLE
16

58. SPECIFICATIONS FOR THE BPC FT
Undesired top event : Motor does not start when
switch is closed.
Boundary of the FT : The circuit containing the
motor, battery, and switch.
Resolution of the FT: The basic components in the
circuit excluding the wiring.
Initial State of System: Switch open, normal
operating conditions.
17

59. START OF BPC FT (1)
18

60. START OF BPC FT (2)
19

61. START OF BPC FT (3)
20

62. ADVANTAGES OF FTA
21
•Deals well with parallel, redundant or alternative fault
paths.
•Searches for possible causes of an end effect which may
not have been foreseen.
•The cut sets derived in FTA can give enormous insight
into various ways top event occurs.
•Very useful tool for focused analysis where analysis is
required for one or two major outcomes.

63. DISADVANTAGES OF FTA
Requires a separate fault tree for each top
event and makes it difficult to analyze complex
systems.
Fault trees developed by different individuals
are usually different in structure, producing
different cut set elements and results.
The same event may appear in different parts
of the tree, leading to some initial confusion.
22

64. APPLICATIONS
Used in the field of safety engineering and Reliability
engineering to determine the probability of a safety
accident or a particular system level failure.
Aerospace Engineering.
23

65. POKA-YOKE
24

66. INTRODUCTION
What is a Poka- yoke?
Shigeo shingo defined poka-yoke as POKA- ‘Inadvertent
mistake that anyone can make’ and YOKE- ‘To prevent or
proof’
Poka-yoke is a tool to have “zero defects” and even reduce or
eliminate quality control.
Poka-yoke is a Japanese name for “fool-proofing”.
Poke-yoke represents the intelligence of the operator by
excluding repetitive actions that require a thinking process.
25

67. MISTAKE PROOFING
Mistake-Proofing a product's design and its manufacturing
process is a key element of design for manufacturability /
assembly (DFM/A)
Mistake proofing is also a key element of improving product
quality and reliability
FACTORS CONTRIBUTING TO MISTAKE PROOFING:
Attention
Perception
Memory
Logical reasoning
26

68. PRINCIPLES OF MISTAKE-PROOFING
There are six mistake-proofing principles or methods.
Elimination seeks to eliminate the possibility of error by
redesigning the product or process so that the task or part is no
longer necessary.
Replacement substitutes a more reliable process to improve
consistency.
Prevention engineers the product or process so that it is
impossible to make a mistake at all.
Facilitation employs techniques and combining steps to make
work easier to perform.
Detection involves identifying an error before further
processing occurs so that the user can quickly correct the
problem.
Mitigation seeks to minimize the effects of errors. 27

69. 2-STATUS & 3-FUNCTIONS OF POKA-YOKE
POKA-YOKE HAS 2 STATUS AND 3 FUNCTIONS:
Status:
1.The fault will happen or
2.The fault has happened
Functions:
1.Stop
2.Check or
3.Alarm
28

70. THREE STRATEGIES FOR ZERO DEFECT
Only make the product when required!
Make the product so it can not be used for anything else.
If the product is ready use it immediately.
29

71. POKA-YOKE CLASSIFICATION
Poka-yoke is classified into the following types:
Server Poka-Yokes
Task
Treatment Tangibles
Customer Poka-Yokes
Preparation
Encounter
Resolution
30

72. PROVIDER(SERVER) ERRORS
Task Errors
• Doing the work incorrectly
• Doing work not requested
• Doing work in the wrong order
• Doing work too slowly
Treatment Errors
• Not acknowledging the customer
• Not listening to the customer
• Not reacting appropriately to the customer
Tangible Errors
• Failure to clean facilities
• Failure to control noise
31

73. CUSTOMER ERRORS
Preparation Errors
• Failure to bring necessary materials to the encounter
• Failure to engage the correct service
Encounter Errors
• Failure to remember steps in the service process
• Failure to follow system flow
• Failure to follow instructions
Resolution Errors
• Failure to learn from experience
• Failure to adjust expectations appropriately
32

74. SEVEN STEPS TO POKA-YOKE
ATTAINMENT
Quality Processes
Utilize a team environment
Elimination of Errors
Eliminate the “Root Cause” of The Errors
Do It Right The First Time
Eliminate Non-Value Added Decisions
Implement a Continual Improvement Approach
33

75. POKA-YOKE APPROACH
Proactive Approach :
A fully implemented ZERO DEFECT QUALITY system requires
Poka-Yoke usage at or before the inspection points during the process.
Poka-yoke will catch the errors before a defective part is
manufactured 100% of the time.
Reactive Approach :
Check occurs immediately after the process.
Can be an operator check at the process or successive check at the
next process.
Not 100% effective, will not eliminate all defects.
Effective in preventing defects from being passed to next process.
34

76. Two Poka-Yoke System approaches are utilized in
manufacturing which lead to successful ZERO
DEFECT QUALITY:
1.Control Approach:
Shuts down the process when an error occurs.
Keeps the “suspect” part in place when an operation
is incomplete.
2.Warning Approach
Signals the operator to stop the process and correct
the problem.
35

77. CONTROL SYSTEM
Takes human element out of the equation ; does not depend on
an operator or assembler.
Has a high capability of achieving zero defects.
Machine stops when an irregularity is detected.
36

78. WARNING SYSTEMS
Sometimes an automatic shut off system is not an option.
A warning or alarm system can be used to get an operators
attention.
Color coding is also an effective non-automatic option
37

79. TEN TYPES OF HUMAN MISTAKES
Forgetfulness
Mis-understanding
Wrong identification
Lack of experience
Willful (ignoring rules or procedure)
Inadvertent or sloppiness
Slowliness
Lack of standardization
Surprise (unexpected machine operation, etc.)
Intentional (sabotage)
38

80. POKA-YOKE DEVICES
Poka yoke is implemented by using simple objects like fixtures,
jigs, warning devices and the like to prevent people from
committing mistakes, even if they try to!.
The main feature of poka-yoke devices is their exceptional
suitability for reducing or eliminating defects through effective
feedback and instantaneous corrective action.
These devices are capable of being used all the time by all
workers; simple and usually installed with low implementation
cost.
Poka-yoke devices help eliminate errors and defects by giving
machines the “intelligence” to stop and signal when a error
occurs.
Poka-yoke devices stop machines and alert workers when a
problem exists. 39

81. THE THREE LEVELS OF POKA-YOKE:
There are three levels at which your company can effect poka-
yoke:
Eliminating errors defects and losses at the source or
prevention of a mistake from being committed..
Detection of a loss or mistakes it occurs,allowing correction
before it becomes a problem.
Detection of a loss or mistakes after it has occurred,just in time
before it blows up into a major issue(least effective).
40

82. EXAMPLES OF POKA-YOKE PRODUCTS
41

83. 42

84. IMPLEMENTATION IN MANUFACTURING
Poka-yoke can be implemented at any step of a
manufacturing process where something can go wrong or an
error can be made.
Shigeo Shingo recognized three types of poka-yoke for
detecting and preventing errors in a mass production system:
The contact method identifies product defects by testing the
product's shape, size, color, or other physical attributes.
The fixed-value (or constant number) method alerts the operator
if a certain number of movements are not made.
The motion-step (or sequence) method determines whether the
prescribed steps of the process have been followed.
43

85. ADVANTAGES
They are simple and cheap.
They are part of the process, implementing what Shingo calls
"100%" inspection.
They are placed close to where the mistakes occur, providing
quick feedback to the workers so that the mistakes can be
corrected.
Once put in place, they require minimal supervision.
44

86. CONCLUSION
Poka-yokes deals with understanding why
people make errors and how to analyze the process to know
where errors are likely to occur and what root causes
contribute to them.
Since the poka-yoke devices detect errors at their roots
& prevent them from blowing up to become bigger
problems, there is consistency in the quality of the
products, saving the cost and time spent in subsequent
quality inspection processes.
45

87. New management Tools

90. Affinity diagrams:

94. Advantages of Affinity Diagram
A team can generate a large number of ideas in a relatively short
period of time.
Encourages participation because every person’s ideas find their
way into the process.
Encourages ‘new’ thinking when only ‘old’ solutions are emerging
from a group.
Facilitates the exploration of new and logical thought patterns by
encouraging people to react from a creative response level rather
than the intellectual and logical levels.
An effective way to deal with large and complex issues which may
be ‘paralyzing’ the brainstorming of a team.
Consensus and support are reached on a solution because all
participants have ‘ownership’ in the process.

95. Limitations of Affinity Diagram
The use of technical language skills may require
detailed clarification of ideas which is not
allowed because ideas are generated in silence
and without discussion.
Group members must have the necessary
expertise on the issue.
Getting a non-traditional group together that is
willing to engage in ‘new thinking’ may be hard
to do.

115. QUALITY FUNCTION
DEPLOYMENT

116. Brief History of QFD
Origin - Mitsubishi Kobe Shipyard 1972
Foundation - Belief That Products Should Be Designed
To Reflect Customer Desires and Tastes
Developed By Toyota and Its Suppliers
Expanded To Other Japanese Manufacturers
Consumer Electronics, Home Appliances, Clothing, Integrated
Circuits, Apartment Layout Planning
Adopted By Ford and GM in 1980s

117. = QFD
HIN SHITSU
Quality
Features
Attributes
Qualities
KI NO TEN KAI
Deployment
Diffusion
Development
Evolution
Function
Mechanization
Quality Function Deployment - “Customer
Driven Product / Process Development”
QFD FROM THE JAPANESE -

118. There is no single, right definition for QFD; this one
captures its essential meaning:
A system for translating customer requirements into
appropriate company requirements at each stage
from research and product development to
engineering and manufacturing to marketing/sales
and distribution
DEFINITION OF QUALITY FUNCTION
DEPLOYMENT :
Prerequisites to QFD are ‘Market Research’ and ‘VOC
gathering’.

119. Quality Function Deployment
Is a structured method that is intended to transmit and
translate customer requirements, that is, the
Voice of the Customer
through each stage of the product development and
production process, that is, through the product
realization cycle.
These requirements are the collection of customer needs,
including all satisfiers, exciters/delighters, and
dissatisfiers.

120. Return on Investment from
Using QFD
Companies using QFD to reflect "The Voice of the
Customer" in defining quality have a competitive
advantage because there is/are:
1. Fewer and Earlier Design Changes
2. Fewer Start-up Problems
3. Shorter Development Time
4. Lower Start-up Costs
5. Warranty Cost Reductions
6. Knowledge Transfer to the Next Product
7. Customer Satisfaction

121. QUALITY FUNCTION DEPLOYMENT
Identify customer wants
Identify how the good/service will satisfy
customer wants
Relate customer wants to product hows
Identify relationships between the firm’s
hows
Develop importance ratings
Evaluate competing products

122. BUILDING A HOUSE OF QUALITY
List Customer Requirements (What’s)
List Technical Descriptors (How’s)
Develop Relationship (What’s & How’s)
Develop Interrelationship (How’s)
Competitive Assessments
Prioritize Customer Requirements
Prioritize Technical Descriptors

123. QFD HOUSE OF QUALITY

124. Technical Descriptors
(Voice of the organization)
Prioritized Technical
Descriptors
Interrelationship
between
Technical Descriptors
Customer
Requirements
(Voiceofthe
Customer)
Prioritized
Customer
Requirements
Relationship between
Requirements and
Descriptors

125. Absolute Weight and Percent
Prioritized Technical
Descriptors
Degree of Technical Difficulty
Relative Weight and Percent
Target Value
Customer
Requirements
Prioritized
Customer
Requirements
Technical
Descriptors
Primary
Primary
Secondary
Secondary
Technical
Competitive
Assessment
Customer
Competitive
Assessment
Our
A’s
B’s
CustomerImportance
TargetValue
Scale-upFactor
SalesPoint
AbsoluteWeight
Our
A’s
B’s
Relationship between
Customer Requirements
and
Technical Descriptors
WHATs vs. HOWs
Strong
Medium
Weak
+9
+3
+1
Strong Positive
Positive
Negative
Strong Negative
+9
+3
-3
-9
Interrelationship between
Technical Descriptors
(correlation matrix)
HOWs vs. HOWs

126. CustomerRequirements
(WHATs)
Primary
Secondary
Tertiary

127. TechnicalDescriptors
(HOWs)
Primary
Secondary
Tertiary

128. Customer
Requirements
Technical
Descriptors
Primary
Primary
Secondary
Secondary

129. Customer
Requirements
Technical
Descriptors
Primary
Primary
Secondary Secondary
Relationship between
Customer
Requirements and
Technical Descriptors
WHATs vs. HOWs
Strong
Medium
Weak
+9
+3
+1

130. Customer
Requirements
Technical
Descriptors
Primary
Primary
Secondary
Secondary
Relationship between
Customer Requirements
and
Technical Descriptors
WHATs vs. HOWs
Strong Positive
Positive
Negative
Strong Negative
+9
+3
-3
-9
Interrelationship between Technical
Descriptors (correlation matrix)
HOWs vs. HOWs
Strong
Medium
Weak
+9
+3
+1

131. Customer
Requirements
Customer
Competitive
Assessment
Ours
A’s
B’s
5
3
1
2
5
1
4
4
Relationship between
Customer Requirements
and
Technical Descriptors
WHATs vs. HOWs
Strong
Medium
Weak
+9
+3
+1

132. 1 3 4 2 1 2 1 4
Customer
Requirements
Customer
Competitive
Assessment
Our
A’s
B’s
5
3
1
2
5
1
4
4
Relationship between
Customer Requirements
and
Technical Descriptors
WHATs vs. HOWs
Strong
Medium
Weak
+9
+3
+1Technical
Competitive
Assessment
Our
A’s
B’s

133. Importance Rating
Target Value
Scale‐Up Factor
Sales Point
Absolute Weight & Percent
(Importance Rating)
(Scale‐Up Factor)
(Sales Point)

134. 7
3
9
10
2
4
8
1
Customer
Requirements
Prioritized
Customer
Requirements
Technical
Descriptors
Primary
Primary
Secondary
Secondary
Technical
Competitive
Assessment
Customer
Competitive
Assessment
Our
A’s
B’s
CustomerImportance
TargetValue
Scale-upFactor
SalesPoint
AbsoluteWeight
1 3 4 2 1 2 1 4
5
3
1
2
5
1
4
4
5
3
2
3
5
2
4
4
1.5
1
1.2
1.5
1
1
1.5
1
1.5
1
15
3
Our
A’s
B’s
Relationship between
Customer Requirements
and
Technical Descriptors
WHATs vs. HOWs
Strong
Medium
Weak
+9
+3
+1

135. Absolute Weight and Percent
Prioritized Technical
Descriptors
Degree of Technical Difficulty
Relative Weight and Percent
Target Value
1 8 4 2 9 8 2 5
90
133
2 3 4 3 1 3 1 5
7
3
9
10
2
4
8
1
Customer
Requirements
Prioritized
Customer
Requirements
Technical
Descriptors
Primary
Primary
Secondary
Secondary
Technical
Competitive
Assessment
Customer
Competitive
Assessment
Our
A’s
B’s
CustomerImportance
TargetValue
Scale-upFactor
SalesPoint
AbsoluteWeight
1 3 4 2 1 2 1 4
5
3
1
2
5
1
4
4
5
3
2
3
5
2
4
4
1.5
1
1.2
1.5
1
1
1.5
1
1.5
1
15
3
Our
A’s
B’s
Relationship between
Customer Requirements
and
Technical Descriptors
WHATs vs. HOWs
Strong
Medium
Weak
+9
+3
+1
Strong Positive
Positive
Negative
Strong Negative
+9
+3
-3
-9
Interrelationship between
Technical Descriptors
(correlation matrix)
HOWs vs. HOWs

137. Design
Requirements
Customer
Requirements

138. Part Quality
Characteristics
Design
Requirements

139. Phase III
Process Planning
Key Process
Operations
PartQuality
Characteristics

140. Phase IV
Production Planning
Production
Requirements
KeyProcess
Operations
Production Launch

141. HOUSE OF QUALITY EXAMPLE
You’ve been assigned
temporarily to a QFD
team. The goal of the
team is to develop a new
camera design. Build a
House of Quality.

142. HOUSE OF QUALITY EXAMPLE
☺High relationship Medium relationship Low Relationship
Customer
Requirements
Customer
Importance
Target Values

143. HOUSE OF QUALITY EXAMPLE
☺High relationship Medium relationship Low Relationship
Target Values
Light weight
Easy to use
Reliable
What the customer desires
(‘wall’)
Aluminum
Parts
Auto
Focus
Auto
Exposure
Customer
Requirements
Customer
Importance

144. HOUSE OF QUALITY EXAMPLE
☺High relationship Medium relationship Low Relationship
Customer
Requirements
Customer
Importance
Target Values
Light weight
Easy to use
Reliable
Aluminum
Parts
Auto
Focus
Auto
Exposure
3
1
2
Average customer
importance rating

145. HOUSE OF QUALITY EXAMPLE
☺High relationship Medium relationship Low Relationship
Customer
Requirements
Customer
Importance
Light weight
Easy to use
Reliable
Aluminum
Parts
Auto
Focus
Auto
Exposure
3
2
1
Relationship between customer
attributes & engineering
characteristics (‘rooms’)

146. HOUSE OF QUALITY EXAMPLE
☺High relationship Medium relationship Low Relationship
Customer
Requirements
Customer
Importance
Target Values
Light weight
Easy to use
Reliable
Aluminum
Parts
Auto
Focus
Auto
Exposure
3
2
1
5 1 1
Target values for engineering
characteristics (‘basement’);
key output ☺

147. HOUSE OF QUALITY EXAMPLE
☺High relationship Medium relationship Low Relationship
Customer
Requirements
Customer
Importance
Target Values
Light weight
Easy to use
Reliable
Aluminum
Parts
Auto
Focus
Auto
Exposure
3
2
1
5 1 1
☺

148. SAME EXAMPLE – COMPLETE YOUR
SELF WITH THE FOLLOWING “WHAT”
Lightweight
Easy to use
Reliable
Easy to hold steady
Color correction

149. SOLUTION

150. HOUSE OF QUALITY EXAMPLE
Customer
importance
rating
(5 = highest)
Lightweight 3
Easy to use 4
Reliable 5
Easy to hold steady 2
Color correction 1
What the
customer
wants
What the
Custome
r
Wants
Relationship
Matrix
Technical
Attributes and
Evaluation
How to Satisfy
Customer
Wants
Interrelationships
Analysisof
Competitor
s

151. HOUSE OF QUALITY EXAMPLE
What the
Custome
r
Wants
Relationship
Matrix
Technical
Attributes and
Evaluation
How to Satisfy
Customer
Wants
Interrelationships
Analysisof
Competitor
s
Lowelectricity
requirements
Aluminumcomponents
Autofocus
Autoexposure
Paintpallet
Ergonomicdesign
How to Satisfy
Customer Wants

152. Lightweight 3
Easy to use 4
Reliable 5
Easy to hold steady 2
Color corrections 1
HOUSE OF QUALITY EXAMPLE
What the
Custome
r
Wants
Relationship
Matrix
Technical
Attributes and
Evaluation
How to Satisfy
Customer
Wants
Interrelationships
Analysisof
Competitor
s
High relationship
Medium relationship
Low relationship
Relationship matrix

153. HOUSE OF QUALITY EXAMPLE
What the
Custome
r
Wants
Relationship
Matrix
Technical
Attributes and
Evaluation
How to Satisfy
Customer
Wants
Interrelationships
Analysisof
Competitor
s
Lowelectricity
requirements
Aluminumcomponents
Autofocus
Autoexposure
Paintpallet
Ergonomicdesign
Relationships
between the
things we can
do

154. HOUSE OF QUALITY EXAMPLE
Weighted
rating
What the
Custome
r
Wants
Relationship
Matrix
Technical
Attributes and
Evaluation
How to Satisfy
Customer
Wants
Interrelationships
Analysisof
Competitor
s
Lightweight 3
Easy to use 4
Reliable 5
Easy to hold steady 2
Color corrections 1
Our importance ratings 22 9 27 27 32 25

155. HOUSE OF QUALITY EXAMPLE
CompanyA
CompanyB
G P
G P
F G
G P
P P
Lightweight 3
Easy to use 4
Reliable 5
Easy to hold steady 2
Color corrections 1
Our importance ratings 22 5
How well do
competing products
meet customer
wants
What the
Custome
r
Wants
Relationship
Matrix
Technical
Attributes and
Evaluation
How to Satisfy
Customer
Wants
Interrelationships
Analysisof
Competitor
s

156. HOUSE OF QUALITY EXAMPLEWhat the
Custome
r
Wants
Relationship
Matrix
Technical
Attributes and
Evaluation
How to Satisfy
Customer
Wants
Interrelationships
Analysisof
Competitor
s
Target
values
(Technical
attributes)
Technical
evaluation
Company A 0.7 60% yes 1 ok G
Company B 0.6 50% yes 2 ok F
Us 0.5 75% yes 2 ok G
0.5A
75%
2’to∞
2circuits
Failure1per10,000
Panelranking

157. HOUSE OF QUALITY EXAMPLE
Completed
House of
Quality
Lightweight 3
Easy to use 4
Reliable 5
Easy to hold steady 2
Color correction 1
Our importance
ratings
Lowelectricityrequirements
Aluminumcomponents
Autofocus
Autoexposure
Paintpallet
Ergonomicdesign
CompanyA
CompanyB
G P
G P
F G
G P
P P
Target
values
(Technical
attributes)
Technical
evaluatio
n
Company A 0.7 60% yes 1 ok G
Company B 0.6 50% yes 2 ok F
Us 0.5 75% yes 2 ok G
0.5A
75%
2’to∞
2circuits
Failure1per10,000
Panelranking
22 9 27 27 32 25

158. TAGUCHI LOSS FUNCTION

159. WHAT IS QUALITY?
Quality means different things to different people
Following Taguchi, the quality of a product is
measured in terms of the total loss to society due to
functional variation and harmful effects. The loss
would be zero for the ideal quality.

160. TAGUCHI LOSS FUNCTION
It’s a graphical depiction of loss developed by the
Japanese business statistician Genichi Taguchi to
describe a phenomenon affecting the value of
products produced by a company.
'loss' is depicted by a quality loss function and it
follows a parabolic curve mathematically given by
L = k(y–m)2,
where m is the theoretical 'target value' or 'mean
value' and y is the actual size of the product, k is a
constant and L is the loss. This means that if the
difference between 'actual size' and 'target value' i.e.
(y–m) is large, loss would be more, irrespective of
tolerance specifications.

161. In Taguchi's view tolerance specifications are given by
engineers and not by customers; what the customer
experiences is 'loss'. This equation is true for a single
product; if 'loss' is to be calculated for multiple
products the loss function is given by
L = k[S2 + y – m)2],
where S2 is the 'variance of product size' and y is the
average product size.

163. LSL USL
BAD BADGOOD
GOAL POST MENTALITYGOAL POST MENTALITY
0
m -
0
m +
m
L(y)

164. QUALITY LOSS FUNCTION − THE
FRACTION DEFECTIVE FALLACY
m− Δ 0 m
Distribution of telephone cable resistance.
Initial distribution
After process improvement and shifting the mean.
Resistance ( Ohms / Kilometre)
m+ Δ0

165. LSL USL
0
m -
0
m +
m
L(y)

166. Average quality loss
Q = k [( m - μ )2 + σ 2 ]
It consists of two components:
Shift of process average (μ) from the target
value (m)
Spread of the process (σ2)
S/N ratios are a log-modified form of Average
quality loss function

167. TAGUCHI PHILOSOPHY
1. Quality should be designed into the product and not
inspected into it.
2. Quality is best achieved by minimizing the deviation
from a target. The product should be so designed
that it is immune to uncontrollable environmental
factors.
3. The cost of quality should be measured as a function
of deviation from the standard and the losses should
be measured system-wide.

168. Maximizing S/N ratio is equivalent to reducing variance
due to various noise factors and hence improves quality
during manufacturing, customer usage and aging and
simultaneously reducing cost substantially.
S/N ratio

169. Taguchi specified three situations:
Larger the better (for example, agricultural yield);
Smaller the better (for example, carbon dioxide emissions);
On-target, minimum-variation (for example, a mating part in
an assembly).
The first two cases are represented by simple monotonic loss
functions. In the third case, Taguchi adopted a squared-error loss
function for several reasons:
Taguchi’s Specification

170. USUAL APPROACH TO IMPROVE THE QUALITY OF
A PRODUCT OR PROCESS
Identify various causes, known as noise factors, that
degrade the product (process) performance
variations in raw materials and components, machinery,
workmanship, temperature, humidity, loading, etc.
Eliminate the noise factors one by one

171. RESULT OF USUAL APPROACH TO IMPROVE THE
QUALITY OF A PRODUCT OR PROCESS
Eliminating noise factors always leads to
increased costs
Reduction in profitability or loss of market
share in the face of global competition

172. TAGUCHI/ ROBUST DESIGN METHOD
New method of design optimization for
performance, quality, & cost
For existing processes, emphasis is on
parameter design
Smallest, affordable development cost

173. TAGUCHI/ ROBUST DESIGN METHOD
All engineering designs involve setting values
of a large number of decision variables.
Common approach is to study one variable at
a time or by trial and error
Either long and expensive time span for completing
the design / premature termination of the design
process

174. TAGUCHI/ ROBUST DESIGN METHOD
MATHEMATICAL TOOL
Orthogonal arrays to study large number of
decision variables with a small number of
experiments
NEW MEASURE OF QUALITY
Signal to noise (s/n) ratio to predict the quality from the
customer perspective

175. ANALYSIS OF RESULTS
1. To establish the best or the optimum condition for a
product or a process.
2. To estimate the contribution of individual factors.
3. To estimate the response under the optimum
conditions.

176. RESPONSE
NOISE FACTORS
CONTROL
FACTORS
SIGNAL
FACTORS
M
X
Y
BLOCK DIAGRAM OF A PRODUCT/ PROCESS
Z
A1 A2

177. PROCESS CAPABILITY
Size

178. TAGUCHI/ ROBUST DESIGN METHOD
Many cos. Big or small, high-tech and low-
tech have found the method valuable
High quality at a low competitive price while
maintaining profit margin

179. THE NEW APPROACH –ITS APPEAL AND
LIMITATIONS
Upfront improvement of quality by design
and process development.
Measurement of quality in terms of
deviation from the target (loss function).
Problem solution by team approach and
brainstorming.

180. THE NEW APPROACH –ITS APPEAL AND
LIMITATIONS (CONT.)
Consistency in experimental design and analysis.
Reduction of time and cost of experiments.
Design of robustness into product/process.
Reduction of variation without removing its
causes.
Reduction of product warranty and service costs
by addressing them with the loss function.

181. Overview of ISO 9001
and ISO 14001

182. What Is A Quality Management System?
People
Processes
Materials
Equipment
Resources
Planned
Individually
System
“Best Practice”
Implemented
Collectively
Documented System
Describes how this
happens

183. Why Document?
• Communication Tool
• Manage Change
• Aids consistency
• Record of Best Practice
• Enables Effective Audit
• ISO 9001 Pre-requisite

184. Documented Q.M.S.
POLICY
QUALITY
MANUAL
PROCEDURES
LOCAL/WORK INSTRUCTIONS
RECORDS / FORMS
INTENT
WHAT?
PROOF
HOW?
WHY?

185. ISO 9001 AND ISO 14001 IN BRIEF
ISO 9001 and ISO 14001 are among ISO's most well
known standards ever.
They are implemented by more than a million
organizations in some 175 countries.
ISO 9001 helps organizations to implement quality
management.
ISO 14001 helps organizations to implement
environmental management.

186. QUALITY MANAGEMENT
ISO 9001 is for quality management.
Quality refers to all those features of a product (or
service) which are required by the customer.
Quality management means what the organization
does to
ensure that its products or services satisfy the
customer's quality requirements and
comply with any regulations applicable to those
products or services.

187. QUALITY MANAGEMENT (CONT.)
Quality management also means what the
organization does to
enhance customer satisfaction, and
achieve continual improvement of its performance.

188. ENVIRONMENTAL MANAGEMENT
ISO 14001 is for environmental management. This
means what the organization does to:
minimize harmful effects on the environment
caused by its activities,
to conform to applicable regulatory requirements,
and to
achieve continual improvement of its environmental
performance.

189. ISO14001 - Environmental management system model for
the international standard
Environmental Policy
Planning
•Environmental aspects
•Legal and other requirements
•Objectives and targets
•Environmental management
programmes
Implementation and Operation
•Structure and responsibility
•Training, awareness and competence
•Communication
•EMS documentation
•Document control
•Operational control
•Emergency preparedness and response
Checking and Corrective Action
•Monitoring and measurement
•Non-conformance and corrective
and preventative action
•Records
•EMS audits
Continual
improvement
Management Review

190. GENERIC STANDARDS
ISO 9001 and ISO 14001 are generic standards.
Generic means that the same standards can be
applied:
to any organization, large or small, whatever its
product or service,
in any sector of activity, and
whether it is a business enterprise, a public
administration, or a government department.

191. GENERIC STANDARDS (CONT.)
Generic also signifies that
no matter what the organization's scope of activity
if it wants to establish a quality management
system, ISO 9001 gives the essential features
or if it wants to establish an environmental
management system, ISO 14001 gives the essential
features.

192. MANAGEMENT SYSTEMS
Management system means what the organization
does to manage its processes, or activities in order
that
its products or services meet the organization’s
objectives, such as
satisfying the customer's quality requirements,
complying to regulations, or
meeting environmental objectives

193. MANAGEMENT SYSTEMS
To be really efficient and effective, the organization
can manage its way of doing things by systemizing
it.
Nothing important is left out.
Everyone is clear about who is responsible for
doing what, when, how, why and where.
Management system standards provide the
organization with an international, state-of-the-art
model to follow.

194. MANAGEMENT SYSTEMS (CONT.)
Large organizations, or ones with complicated
processes, could not function well without
management systems.
Companies in such fields as aerospace, automobiles,
defence, or health care devices have been operating
management systems for years.
The ISO 9001 and ISO 14001 management system
standards now make these successful practices
available for all organizations.

195. PROCESSES, NOT PRODUCTS
Both ISO 9001 and ISO 14001 concern the way an
organization goes about its work.
They are not product standards.
They are not service standards.
They are process standards.
They can be used by product manufacturers and
service providers.

196. PROCESSES, NOT PRODUCTS (CONT.)
Processes affect final products or services.
ISO 9001 gives the requirements for what the
organization must do to manage processes
affecting quality of its products and services.
ISO 14001 gives the requirements for what the
organization must do to manage processes
affecting the impact of its activities on the
environment.

197. BENEFITS OF ISO 9001 AND ISO 14001
International, expert consensus on state-of-the-art
practices for quality and environmental management.
Common language for dealing with customers and
suppliers worldwide .
Increase efficiency and effectiveness.
Model for continual improvement.

198. BENEFITS OF ISO 9001 AND ISO 14001
(CONT.)
Model for satisfying customers and other
stakeholders.
Build quality into products and services from design
onwards.
Address environmental concerns of customers and
public, and comply with government regulations.
Integrate with global economy.

199. BENEFITS OF ISO 9001 AND
ISO 14001 (CONT.)
Sustainable business
Unifying base for industry sectors
Qualify suppliers for global supply chains
Technical support for regulations

200. BENEFITS OF ISO 9001 AND ISO 14001
(CONT.)
Transfer of good practice to developing countries
Tools for new economic players
Regional integration
Facilitate rise of services

201. MORE INFORMATION
ISO 9000/ISO 14000 section on ISO Web site:
www.iso.org
ISO Management Systems magazine
www.iso.org/ims
IMS Alerts free electronic newsletter
www.iso.org/imsalerts