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4.

Performance Monitoring
and Improvement

3. Supplier Selection and 5. Supplier Quality Management


Part Qualification

6. Relationship Management
2. Risk Management

7. Business Governance, Ethics,


1. Supplier Strategy And Compliance
CSQP

CSQP Body of Knowledge Slide 1

4. Supplier
Performance A Supplier Performance
Monitoring

Monitoring and
Improvement
B Assess Nonconforming
Product/Process/Service

(30 Questions) C Supplier Corrective and


Preventive Action

4A.
Supplier
Performance
01 Supplier Metrics

Monitoring 02 Supplier Performance

Define, implement, and monitor supplier


performance metrics such as, quality,
03 Supplier Process Performance

delivery, cost and responsiveness.


(Evaluate)

3
Supplier Performance
 Typical Performance Parameters:
 Cost
 Under/over budget, cost savings
 Quality
 Defect rate, returns, failures, damages
 Schedule
 On time delivery, shortages
 Responsiveness
 Willingness to change the order details (quantity,
design etc.)

4A1 Supplier Matrices Slide 4

4A.
Supplier
Performance
01 Supplier Metrics

Monitoring 02 Supplier Performance

Analyze supplier performance data (e.g.


warranty analysis/field returns, defect
03 Supplier Process Performance

rates) and develop periodic reports (e.g.


scorecard, dashboards). (Analyze)

Supplier Performance
 Typical Performance Parameters:
 Cost
 Under/over budget, cost savings
 Quality
 Defect rate, returns, failures, damages
 Schedule
 On time delivery, shortages
 Responsiveness
 Willingness to change the order details (quantity,
design etc.)

4A2 Supplier Performance Slide 6

6
Supplier Performance
 The level of monitoring will depend upon the
risk level.
 High value, high risk good and services will require
higher level of monitoring
 Establish criteria for evaluating and monitoring
supplier performance against the contractual
obligations

4A2 Supplier Performance Slide 7

Decision Analysis

Weightage Supplier 1 Supplier 2 Supplier 3


Quality System 0.2 6 9 3
Cost 0.4 5 6 4
Delivery/ 0.2 3 7 3
Schedule
Safety 0.1 9 9 9
Past History/ 0.1 3 9 7
Responsiveness
TOTAL 1.0 5.0 7.4 4.4

4A2 Supplier Performance Slide 8

4A.
Supplier
Performance 01 Supplier Metrics

Monitoring 02 Supplier Performance

03
Apply lean principles and applications
such as 5S, Kaizen, value stream
mapping, single minute exchange of dies Supplier Process Performance
(SMED), kanban, muda, standardized
work, takt time and error proofing to
reduce waste and increase performance.
(Evaluate)

9
Lean Principles for Supplier Performance

 5S  Kanban
 Kaizen  Muda (Waste Reduction)
 Value Stream Mapping(VSM)  Standardized work
 Single minute exchange of dies  Takt time
(SMED)  Error proofing

4A3 Supplier Process Performance Slide 10

10

5S
 The 5S’s are simple but effective
methods to organise the workplace.
 It however, goes beyond this simple
concept, and is concerned with
making orderly and standardized
operations the norm, rather than the
exception.

5S

11

5S
 The 5S’s are simple but effective
methods to organise the workplace.
 It however, goes beyond this simple
concept, and is concerned with
making orderly and standardized
operations the norm, rather than the
exception.

5S
Seiri Seiton Seison Seiketsu Shitsuke

12
Seiri Seiton Seison Seiketsu Shitsuke

Sort Set in order Shine Standardize Sustain

Remove all of Organize in an Clean up the Ensure Ensure that 5S


the clutter from efficient and entire area standard ways principles are
the work place ergonomic removing all of working for part of the
manner. dirt the first three culture
stages.

5S Summary Slide 13

13

5S
1. Seiri (Sort)
Remove all of the clutter from the work
place
 This requires the classifying of items into
two categories, necessary and
unnecessary, and storing or removing
the latter.
5S
Seiri Seiton Seison Seiketsu Shitsuke

14

5S
2. Seiton (Straighten)
Organize in an efficient and ergonomic
manner.
• Arrange items to minimise search time and
effort.
• Each item should have a designated place
A place for everything and everything in its
place.
5S
Seiri Seiton Seison Seiketsu Shitsuke

15
5S
3. Seison (Shine)
Clean up the entire area removing all
dirt
 Seison means cleaning the working
environment.
 It can help in the spotting of
potential problems as well as
reducing the risk of fire/injury by
cleaning away the potential causes of
accidents.
5S
Seiri Seiton Seison Seiketsu Shitsuke

16

5S
4. Seiketsu (Standardize)
Ensure standard ways of working for the
first three stages.
 It can also be viewed as the
continuation of the work carried out
in Seiri, Seiton, and Seison.

5S
Seiri Seiton Seison Seiketsu Shitsuke

17

5S
5. Shitsuke (Sustain)
Ensure that 5S principles are part of the
culture
 Shitsuke means self-discipline.
 The 5 S’s may be viewed as a philosophy,
with employees following established and
agreed upon rules at each step.
 By the time they arrive at Shitsuke they will
have developed the discipline to follow the
5 S’s in their daily work.
5S
Seiri Seiton Seison Seiketsu Shitsuke

18
Seiri Seiton Seison Seiketsu Shitsuke

Sort Set in order Shine Standardize Sustain

Remove all of Organize in an Clean up the Ensure Ensure that 5S


the clutter from efficient and entire area standard ways principles are
the work place ergonomic removing all of working for part of the
manner. dirt the first three culture
stages.

5S Summary Slide 19

19

Lean Principles for Supplier Performance


 5S  Kanban
 Kaizen  Muda (Waste Reduction)
 Value Stream Mapping(VSM)  Standardized work
 Single minute exchange of dies  Takt time
(SMED)  Error proofing

4A3 Supplier Process Performance Slide 20

20

Kaizen

 An approach for improvement of quality and


productivity

Kai + Zen
 kai, which means 'change,' and
 zen, which means 'good.'

Kaizen

21
Daily Management
Improvement from daily
management and operations.
Small Improvement
Starts with small improvement

Kaizen
Participation
Participation of the employees

Humanized Approach
Eliminates hard work,
Motivates employees,
creating sense of belonging and
sense of fulfillment

Kaizen Slide 22

22

Identify Wastes Document the Present and


New State Celebrate

Repeat
The Process

Document the Make Changes Standardize


Current State The Process

Kaizen Slide 23

23

Kaizen Blitz

 A Kaizen Blitz, or rapid improvement,


is a focused activity on a particular
process or activity.
 The basic concept is to identify and
quickly remove waste.

Kaizen Blitz

24
Lean Principles for Supplier Performance

 5S  Kanban
 Kaizen  Muda (Waste Reduction)
 Value Stream Mapping(VSM)  Standardized work
 Single minute exchange of dies  Takt time
(SMED)  Error proofing

4A3 Supplier Process Performance Slide 25

25

1. Identify 2. Map the 3. Create 4. Pull 5. Seek


Value Value Flow Perfection
Stream

Specify what creates value Identify all the steps along Make the value process flow Make only what is needed by Strive for perfection by
from the customer’s the process chain the customer continually attempting to
perspective. produce exactly what the
customer wants

Lean Philosophy Slide 26

26

Value Stream Maps


 Type of Flow Chart showing how value
flows through the organization
 Flow of material
 Flow of information

Value Stream
maps

27
Created using SigmaXL® software

Value Stream Maps Slide 28

28

Current Lean Future


State Principles State

Value Stream Maps Slide 29

29

Lean Principles for Supplier Performance


 5S  Kanban
 Kaizen  Muda (Waste Reduction)
 Value Stream Mapping(VSM)  Standardized work
 Single minute exchange of dies  Takt time
(SMED)  Error proofing

4A3 Supplier Process Performance Slide 30

30
Setup Reduction
or
Single-Minute Exchange of Die - SMED

 For rapid and efficient way of converting


a manufacturing process from running
the current product to running the next
product.

Setup Reduction

31

Setup Reduction
or
Single-Minute Exchange of Die - SMED

 Single-Minute here means less than 10


minutes (single digit), and not 1 minute
 Shigeo Shingo, created the SMED
approach

Setup Reduction

32

Setup Reduction
or
Single-Minute Exchange of Die - SMED

Benefits:
 Reduced inventory
 Even with higher number of turnovers,
the machine utilization increases
 Elimination of setup errors
 Reduces defect rates
 Lower setup expenses Setup Reduction

33
Setup Reduction
or
Single-Minute Exchange of Die - SMED
 Techniques in implementing SMED.
 Separate internal from external setup
operations
 Convert internal to external setup
 Use functional clamps or eliminate
fasteners altogether
 Adopt parallel operations
 Eliminate adjustments
Setup Reduction

34

Lean Principles for Supplier Performance


 5S  Kanban (and pull system)
 Kaizen  Muda (Waste Reduction)
 Value Stream Mapping(VSM)  Standardized work
 Single minute exchange of dies  Takt time
(SMED)  Error proofing

4A3 Supplier Process Performance Slide 35

35

Pull Systems
 Pull:
 Produce based on demand
 Providing product or service when
required by customer or the next
process.
 Push:
 Produce to stock
 Based on demand forecast
Pull System

36
Pull Systems
 Pull:
 Limits the Work In Progress and
Inventory. (JIT)
 Kanban cards

Pull System

37

Just in Time
 JIT is a methodology with an aim to:
 Reducing times within the production
system
 As well as reducing response times from
suppliers and to customers.

Just in Time

38

Kanban
 Kanban means Signboard (or billboard)
in Japanese.
 Kanban is an inventory-control system
 Taiichi Ohno developed it as a part of JIT

Kanban

39
Kanban
• Three bin system for supplied parts
• One bin is on the factory floor (the initial
demand point),
• One bin is in the factory store (the inventory
control point), and
• One bin is at the supplier.
• The bins usually have a Kanban card.

Kanban

40

Lean Principles for Supplier Performance


 5S  Kanban
 Kaizen  Muda (Waste Reduction)
 Value Stream Mapping(VSM)  Standardized work
 Single minute exchange of dies  Takt time
(SMED)  Error proofing

4A3 Supplier Process Performance Slide 41

41

Waste - Philosophy
 Waste exist in all processes at all levels
in the organization.
 Waste elimination is the key to
successful implementation of lean.
 Waste reduction is an effective way to
increase profitability.

Waste
elimination

42
Muda
An activity that is wasteful and
doesn't add value or is
unproductive
Mura
Any variation leading to
unbalanced situations.

Muri
Any activity asking
unreasonable stress or effort 3 Categories of
from personnel, material or Waste
equipment.

43

Muda
 Muda is a traditional Japanese term for
an activity that is wasteful and doesn't
add value or is unproductive
 Type I Muda: (Incidental Work)
 Non-value-added tasks which seam to be
essential. Business conditions need to be
changed to eliminate this type of waste.
 Type II Muda: (Non-Value-Added Work)
 Non-value-added tasks which can be
eliminated immediately. 3 Categories of
Waste

44

Mura
 MURA: Any variation leading to
unbalanced situations.
 Mura exists when
 workflow is out of balance
 workload is inconsistent

3 Categories of
Waste

45
Muri
 MURI: Any activity asking unreasonable
stress or effort from personnel, material
or equipment.
 For people, Muri means too heavy a mental
or physical burden.
 For machinery Muri means expecting a
machine to do more than it is capable of or
has been designed to do.

3 Categories of
Waste

46

Transportation Over Processing


Unnecessary movement of Processing beyond the demand
people or parts between from the customers.
processes.

Inventory Over Production


Materials parked and not having Producing too much, too early
value added to them. and/or too fast.

8 Types
of Wastes
Motion Defects
Unnecessary movement of Sorting, repetition or making
people or parts within a process. scrap

Wait Time Under Utilized Staff


People or parts waiting for a Failure when it comes
work cycle to finish. to exploiting the knowledge and
talent of the employees.

Eight Types of Muda Slide 47

47

Transportation
Unnecessary movement of
people or parts between
8 Types
processes. of Wastes

Eight Types of Muda Slide 48

48
Inventory
Materials parked and not
having value added to
8 Types
them. of Wastes

Eight Types of Muda Slide 49

49

Motion
Unnecessary movement of
people or parts within a
8 Types
process. of Wastes

Eight Types of Muda Slide 50

50

Wait Time
People or parts waiting for a
work cycle to finish.
8 Types
of Wastes

Eight Types of Muda Slide 51

51
Over Processing
Processing beyond the
demand from the
8 Types
customers. of Wastes

Eight Types of Muda Slide 52

52

Over Production
Producing too much, too
early and/or too fast.
8 Types
of Wastes

Eight Types of Muda Slide 53

53

Defects
Sorting, repetition or
making scrap
8 Types
of Wastes

Eight Types of Muda Slide 54

54
Under Utilized Staff
Failure when it comes
to exploiting the knowledge
8 Types
and talent of the employees. of Wastes

Eight Types of Muda Slide 55

55

Lean Principles for Supplier Performance


 5S  Kanban
 Kaizen  Muda (Waste Reduction)
 Value Stream Mapping(VSM)  Standardized work
 Single minute exchange of dies  Takt time
(SMED)  Error proofing

4A3 Supplier Process Performance Slide 56

56

Standard Work
 Doing work in a standard way
 All people do one work in one way only
 Improvement made in the process leads
to revised standard work

Standard Work

57
Lean Principles for Supplier Performance

 5S  Kanban
 Kaizen  Muda (Waste Reduction)
 Value Stream Mapping(VSM)  Standardized work
 Single minute exchange of dies  Takt time
(SMED)  Error proofing

4A3 Supplier Process Performance Slide 58

58

Takt Time
 Takt time is the time in which a product needs to be
produced in order to satisfy customer demand.
 Takt time =
Net Operating time per period
Customer demand per period

Takt Time Slide 59

59

Takt Time
 For example

 Customer wants 10 units per week,


 Plant operates 40 hour per week
 Takt Time = 40/10 = 4 hrs.

 Takt time is not related to how much time it takes to make


the unit.

Takt Time Slide 60

60
Takt Time
 For example
 Customer wants 10 units per week,
 Plant operates 40 hour per week
 Two breaks of 10 minutes and 40 minutes lunch break daily.
(5 days week)
 Net operating time = 40 hrs – 5x(1 hr)= 35 hrs
 Takt Time = 35/10 = 3.5 hrs.
 Takt time is not related to how much time it takes to make
the unit.

Takt Time Slide 61

61

Lean Principles for Supplier Performance


 5S  Kanban
 Kaizen  Muda (Waste Reduction)
 Value Stream Mapping(VSM)  Standardized work
 Single minute exchange of dies  Takt time
(SMED)  Error proofing (poke-yoke)

4A3 Supplier Process Performance Slide 62

62

Poke-yoke
 Poke-yoke (pronounced "POH-kah YOH-
kay") was invented by Shigeo Shingo in
the 1960s.

 The term "poke-yoke" comes from the


Japanese words "poke" (inadvertent
mistake) and "yoke" (prevent).

Poke-yoke

63
Types of Poke-yoke
 Prevention.
 engineers the process so that it is impossible
to make a mistake.
 remove the need of correction.

 Detection.
 signals the user when a mistake has been
made.
 they do not enforce the correction.
Poke-Yoke

64

4. Supplier
Performance
Monitoring and A Supplier Performance
Monitoring

Improvement
Assess and evaluate nonconforming
B Assess Nonconforming
Product/Process/Service

C
materials to determine whether a
material review board (MRB) requires
Supplier Corrective and
disposition. Conduct risk assessments to Preventive Action
prevent future discrepancies. (Evaluate)

65

Nonconformity (ISO 9000:2015)


 Nonconformity: non-fulfilment of a requirement
 Defect: nonconformity related to an intended or specified
use
 The distinction between the concepts defect and nonconformity is
important as it has legal connotations, particularly those associated
with product and service liability issues.

4B Assess Nonconforming Product / Process/ Service


Slide 66

66
Classification of Nonconformity

 Minor: Minimum or insignificant impact


 Major: Could affect the function of an essential part
 Critical: Could lead to unsafe condition, or personal safety.

4B Assess Nonconforming Product / Process/ Service


Slide 67

67

Control of Nonconforming Outputs


(ISO 9001:2015)
 8.7.1 The organization shall ensure that outputs that do
not conform to their requirements are identified and
controlled to prevent their unintended use or delivery.
 Take appropriate action based on the nature of the
nonconformity and its effect on the conformity of products
and services.

4B Assess Nonconforming Product / Process/ Service


Slide 68

68

Disposition

 correction (repair, rework)


 segregation, containment, return or suspension
of provision of products and services; (reject)
 informing the customer; (regrade)
 obtaining authorization for acceptance under
concession. (use as is, regrade)

4B Assess Nonconforming Product / Process/ Service


Slide 69

69
Repair vs Rework
 Rework: action on a nonconforming product or service to
make it conform to the requirements.
 Repair: action on a nonconforming product or service to make
it acceptable for the intended use

 A successful repair of a nonconforming product or service does not


necessarily make the product or service conform to the requirements. It
can be that in conjunction with a repair a concession is required.
 Repair includes remedial action taken on a previously conforming product
or service to restore it for use, for example as part of maintenance.

4B Assess Nonconforming Product / Process/ Service


Slide 70

70

MRB
 The Material Review Board (MRB) consisting of quality and
engineering is responsible for the disposition of
nonconforming material.

4B Assess Nonconforming Product / Process/ Service


Slide 71

71

Risk Management

Plan and Implement


Identify Risks
• How these steps will be • Prioritize risks based on Risk Responses * Regularly review the
performed? the probability and identified risks and
Brainstorming is the impact. How to decrease the ensure that they are still
most common approach. • Qualitative* vs possibility and impact of relevant.
Quantitative risk negative risk affecting a
assessment business objectives?

Plan Risk Monitor and Control


Analyze Risks *
Management Risks

4B Assess Nonconforming Product / Process/ Service


Slide 72

72
Analyzing Risk
Very Low Low Medium High Very High
Probability

Very High Medium Medium High High High

High Low Medium Medium High High

Medium Low Medium Medium Medium High

Low Low Low Medium Medium Medium

Very Low Low Low Low Low Medium

Impact

4B Assess Nonconforming Product / Process/ Service


Slide 73

73

Risk Responses

Negative Risk Positive Risk


Avoid Exploit
Mitigate Enhance
Transfer Share
Accept Accept

4B Assess Nonconforming Product / Process/ Service


Slide 74

74

4. Supplier
Performance A Supplier Performance
Monitoring

Monitoring and
Improvement
B Assess Nonconforming
Product/Process/Service

(30 Questions) C Supplier Corrective and


Preventive Action

75
4C.
Supplier
Corrective and
Preventive Action 01Root Cause Analysis Tools
and Methods

Evaluate the root cause analysis of a problem


using tools such as, cause and effect diagrams
(CE), Pareto analysis, 5 Why’s, fault tree analysis,
02
Collaboration with supplier
design of experiments (DOE), brainstorming,
check sheets, measurement system analysis
(MSA), production records and review of process
flow. (Evaluate)

76

Topics Covered
The list of tools have been rearranged.

 5 Why’s
 Brainstorming
 Production records
 Root Cause Analysis –
 Review of process flow
Introduction
 Check sheets
 RCA Tools  Cause and effect diagrams (CE)
 Pareto analysis
 Fault tree analysis
 Measurement system analysis (MSA)
 Design of experiments (DOE)

4C1 Root Cause Analysis Tools and Methods


Slide 77

77

Root Cause Analysis

 RCA is a structured process to identify root causes of an event that


resulted in an undesired outcome and develop corrective actions.
 Instead of treating symptoms, it is much more effective to
systematically identify and prevent the underlying issues and solving
the problem permanently.
 There could be multiple root causes of a problem.
 Focus on process (what and how) instead of persons (who).

4C1 Root Cause Analysis Tools and Methods


Slide 78

78
Topics Covered
The list of tools have been rearranged.

 5 Why’s
 Brainstorming
 Production records
 Root Cause Analysis –
 Review of process flow
Introduction
 Check sheets
 RCA Tools  Cause and effect diagrams (CE)
 Pareto analysis
 Fault tree analysis
 Measurement system analysis (MSA)
 Design of experiments (DOE)

4C1 Root Cause Analysis Tools and Methods


Slide 79

79

Five Whys
Leakage from
Oil spill on floor
 Ask “why” multiple times pump
to reach to the root cause
of the problem.
Gasket Sub standard
damaged gasket

Policy of
ordering to
lowest bidder

4C1 Root Cause Analysis Tools and Methods


Slide 80

80

Topics Covered
The list of tools have been rearranged.

 5 Why’s
 Brainstorming
 Production records
 Root Cause Analysis –
 Review of process flow
Introduction
 Check sheets
 RCA Tools  Cause and effect diagrams (CE)
 Pareto analysis
 Fault tree analysis
 Measurement system analysis (MSA)
 Design of experiments (DOE)

4C1 Root Cause Analysis Tools and Methods


Slide 81

81
Brainstorming

 Brainstorming is a group or individual creativity technique by which


efforts are made to find a conclusion for a specific problem by
gathering a list of ideas spontaneously contributed by its member.
 Defer judgment,
 Reach for quantity

4C1 Root Cause Analysis Tools and Methods


Slide 82

82

Brainstorming

 Four Rules:

 Focus on quantity
 Withhold criticism
 Welcome unusual ideas
 Combine and improve ideas

4C1 Root Cause Analysis Tools and Methods


Slide 83

83

Topics Covered
The list of tools have been rearranged.

 5 Why’s
 Brainstorming
 Production records
 Root Cause Analysis –
 Review of process flow
Introduction
 Check sheets
 RCA Tools  Cause and effect diagrams (CE)
 Pareto analysis
 Fault tree analysis
 Measurement system analysis (MSA)
 Design of experiments (DOE)

4C1 Root Cause Analysis Tools and Methods


Slide 84

84
Production Records

 Examples:
 Drawings, Sketches and procedures
 Shop travelers / Job ticket
 Calibration stickers
 Electronic records

4C1 Root Cause Analysis Tools and Methods


Slide 85

85

Topics Covered
The list of tools have been rearranged.

 5 Why’s
 Brainstorming
 Production records
 Root Cause Analysis –
 Review of process flow
Introduction
 Check sheets
 RCA Tools  Cause and effect diagrams (CE)
 Pareto analysis
 Fault tree analysis
 Measurement system analysis (MSA)
 Design of experiments (DOE)

4C1 Root Cause Analysis Tools and Methods


Slide 86

86

Review of Process Flow (Flow Chart)

What?
 Shows the processes as boxes connected by arrows and decision
boxes.
Why?
 Helps in understanding the process flow and interrelationships
between processes.

4C1 Root Cause Analysis Tools and Methods


Slide 87

87
Review of Process Flow (Flow Chart)
Start / Decision
Start
End

Process
Process 1
End
Delay Preparation

Process 2 Process 3
Inspect
Data Document Connector
Accepted

Rejected

4C1 Root Cause Analysis Tools and Methods


Slide 88

88

Topics Covered
The list of tools have been rearranged.

 5 Why’s
 Brainstorming
 Production records
 Root Cause Analysis –
 Review of process flow
Introduction
 Check sheets
 RCA Tools  Cause and effect diagrams (CE)
 Pareto analysis
 Fault tree analysis
 Measurement system analysis (MSA)
 Design of experiments (DOE)

4C1 Root Cause Analysis Tools and Methods


Slide 89

89

Check Sheet
What?
 A manual data-collection form
 Used to record the number of observations or occurrences of
certain events.
Why?
 To collect and display the data.
 To detect patterns.
 Solving a problem.

4C1 Root Cause Analysis Tools and Methods


Slide 90

90
Check Sheet

Defect
Defect Scratch Loose Cap Label Volume Leakage Frequency

Capacity

300 ml. || || |||| | | 11


500 ml. ||| |||| || | | 12
1000 ml. |||| |||| | | | 13
Sum 5 18 8 2 3 36

4C1 Root Cause Analysis Tools and Methods


Slide 91

91

Check Sheet

4C1 Root Cause Analysis Tools and Methods


Slide 92

92

Topics Covered
The list of tools have been rearranged.

 5 Why’s
 Brainstorming
 Production records
 Root Cause Analysis –
 Review of process flow
Introduction
 Check sheets
 RCA Tools  Cause and effect diagrams (CE)
 Pareto analysis
 Fault tree analysis
 Measurement system analysis (MSA)
 Design of experiments (DOE)

4C1 Root Cause Analysis Tools and Methods


Slide 93

93
Cause and effect diagrams (CE)

Also called as:


 Ishikawa Diagram
 Fishbone Diagram

4C1 Root Cause Analysis Tools and Methods


Slide 94

94

Cause and effect diagrams (CE)

4C1 Root Cause Analysis Tools and Methods


Slide 95

95

Cause and effect diagrams (CE)

What?
 A tool to display the relationship between an effect (e.g., a problem
statement) and the its causes.
Why?
 To identify the various causes affecting a problem, as a part of Root
Cause Analysis or Corrective Action plan.
 Helps a group reach a common understanding of a problem.

4C1 Root Cause Analysis Tools and Methods


Slide 96

96
Cause and effect diagrams (CE)

1. Start with the problem statement or the effect.


2. Select top categories
3. Brainstorm ‘potential causes’
4. Determine ‘actual causes’ based on data and facts. You might need
to use other quality tools for this purpose (such as check sheet to
collect data)

4C1 Root Cause Analysis Tools and Methods


Slide 97

97

Cause and effect diagrams (CE)

4C1 Root Cause Analysis Tools and Methods


Slide 98

98

Topics Covered
The list of tools have been rearranged.

 5 Why’s
 Brainstorming
 Production records
 Root Cause Analysis –
 Review of process flow
Introduction
 Check sheets
 RCA Tools  Cause and effect diagrams (CE)
 Pareto analysis
 Fault tree analysis
 Measurement system analysis (MSA)
 Design of experiments (DOE)

4C1 Root Cause Analysis Tools and Methods


Slide 99

99
Pareto Chart

4C1 Root Cause Analysis Tools and Methods


Slide 100

100

Pareto Chart

What?
 Similar to a bar chart, where the bars are arranged in descending
order of magnitude.
Why?
 To prioritize actions needed to solve complex problems.
 To sort out the “vital few” from the “trivial many.”
 To separate important from unimportant causes contributing to a
problem.

4C1 Root Cause Analysis Tools and Methods


Slide 101

101

Pareto Chart

Defect
Defect Scratch Loose Cap Label Volume Leakage Frequency

Capacity

300 ml. || || |||| | | 11


500 ml. ||| |||| || | | 12
1000 ml. |||| |||| | | | 13
Sum 5 18 8 2 3 36

4C1 Root Cause Analysis Tools and Methods


Slide 102

102
Topics Covered
The list of tools have been rearranged.

 5 Why’s
 Brainstorming
 Production records
 Root Cause Analysis –
 Review of process flow
Introduction
 Check sheets
 RCA Tools  Cause and effect diagrams (CE)
 Pareto analysis
 Fault tree analysis
 Measurement system analysis (MSA)
 Design of experiments (DOE)

4C1 Root Cause Analysis Tools and Methods


Slide 103

103

Fault Tree Analysis


Already covered in 2B1
 Most common gates are AND , OR gates

OR gate AND gate

4C1 Root Cause Analysis Tools and Methods


Slide 104

104

Fault Tree Analysis


AND gate
Output occurs if all inputs occur.
If any of the inputs fail, the system fail.  OR gate AND gate
represents series connection.
R1=0.90 R2=0.80

R series = R1 x R2 x R3 …. Rn

Image from Wikipedia

4C1 Root Cause Analysis Tools and Methods


Slide 105

105
Fault Tree Analysis
OR gate
Output occurs if any inputs occur.
If all of the inputs fail, the system fail. OR gate AND gate

represents parallel connection.


R1=0.90

R2=0.80

R parallel = 1 – (1 - R1 ) x (1 - R2) x (1 - R3)…. (1 – Rn)


Image from Wikipedia

4C1 Root Cause Analysis Tools and Methods


Slide 106

106

Topics Covered
The list of tools have been rearranged.

 5 Why’s
 Brainstorming
 Production records
 Root Cause Analysis –
 Review of process flow
Introduction
 Check sheets
 RCA Tools  Cause and effect diagrams (CE)
 Pareto analysis
 Fault tree analysis
 Measurement system analysis (MSA)
 Design of experiments (DOE)

4C1 Root Cause Analysis Tools and Methods


Slide 107

107

MSA (Accuracy vs Precision)


 Accuracy
 “Closeness” to the true value, or to an accepted
reference value.
 Bias
 Linearity
 Stability
 Precision
 “Closeness” of repeated readings to each
other
 Repeatability
 Reproducibility

4C1 Root Cause Analysis Tools and Methods


Slide 108

108
Topics Covered
The list of tools have been rearranged.

 5 Why’s
 Brainstorming
 Production records
 Root Cause Analysis –
 Review of process flow
Introduction
 Check sheets
 RCA Tools  Cause and effect diagrams (CE)
 Pareto analysis
 Fault tree analysis
 Measurement system analysis (MSA)
 Design of experiments (DOE)

4C1 Root Cause Analysis Tools and Methods


Slide 109

109

Introduction
We conduct experiments in our daily life.
 Car:
 Does AC affect the car mileage?
 Does number of passengers affect the car
mileage?
 What about tire pressure, speed …..
 Course selling:
 Does intro video affects the sale?
 What about course length, quizzes, closed Design of
captions …..
Experiments

110

Design of Experiments
Design of Experiments (DOE) is a method
to find out the relation between factors
affecting a process and the output of the
process.
A/C – ON Tire
or OFF Pressure

Number of
Passengers
Car
Speed
Design of
Mileage
Experiments

111
Design of Experiments
Conventional approach to deal with this
type of question is OVAT (One Variable at
a time) / OFAT (One Factor at a Time)

A/C – ON Tire
or OFF Pressure

Number of
Passengers
Car
Speed
Design of
Mileage
Experiments

112

Design of Experiments
Using the Design of Experiments we seek
the answer to such questions with
minimum effort and expenditure.

A/C – ON Tire
or OFF Pressure

Number of
Passengers
Car
Speed
Design of
Mileage
Experiments

113

A/C – ON Tire
or OFF Pressure

Number of
Speed
Passengers
Car
Mileage

Y X
Y = f (X)
Output Input
Output (Y) is the
Dependent Variable Independent Variable function of inputs (X)
Response (or Outcome) Factor

Independent vs Dependent Variables Slide 114

114
 Response: The output(s) of a
process. Sometimes called
dependent variable(s).

 Factor: A factor of an
experiment is a controlled
independent variable; a variable
whose levels are set by the
experimenter. These can be
numeric or categorical.
Response and
Factors

115

 Level: Settings of 25 psi


each factor in the
ON 30 psi
study.
OFF 35 psi
A/C – ON Tire
or OFF Pressure
1
2 60 Km/hr
Number of
Speed
3 Passengers 80 Km/hr
Car
4 Mileage 100 Km/hr
5 120 Km/hr

Levels Slide 116

116

 Treatment: A treatment 25 psi


is a specific combination
of factor levels whose ON 30 psi
effect is to be compared OFF 35 psi
with other treatments.
A/C – ON Tire
or OFF Pressure
1
2 60 Km/hr
Number of
Speed
3 Passengers 80 Km/hr
Car
4 Mileage 100 Km/hr
5 120 Km/hr

Treatments Slide 117

117
For first two factors only you will
need to conduct 10 experiments 25 psi
Treatment # passengers A/C
ON 30 psi
1 1 ON
OFF 35 psi
2 1 OFF
3 2 ON A/C – ON Tire
4 2 OFF or OFF Pressure
5 3 ON
1
6 3 OFF 2 Number of
60 Km/hr
Speed
7 4 ON 3 Passengers
Car 80 Km/hr
8 4 OFF
4 Mileage 100 Km/hr
9 5 ON
10 5 OFF 5 120 Km/hr

Treatments Slide 118

118

For first three factors you will


need to conduct 5x2x3 experiments 25 psi
Treatment #
passengers
A/C Tire
Pressure ON 30 psi
1 1 ON 25 psi
OFF 35 psi
2 1 ON 30 psi
3 1 ON 35 psi A/C – ON Tire
or OFF Pressure
4 1 OFF 25 psi 1
5 1 OFF 30 psi
2 Number of
60 Km/hr
6 1 OFF 35 psi Speed
7 2 ON 25 psi 3 Passengers
Car
80 Km/hr
8 2 ON 30 psi 4 Mileage 100 Km/hr
9 2 ON 35 psi
5 120 Km/hr
.. .. .. ..

Treatments Slide 119

119

 Number of experiments = Level Factors


 4 Factors 2 Level experiment requires
24 = 16 experiments (full factorial)
 5 Factors 2 Level experiment requires ON 25 psi
25 = 32 experiments (full factorial) OFF 35 psi
A/C – ON Tire
or OFF Pressure

1 Number of
60 Km/hr
Speed
Passengers
5 Car 100 Km/hr
Mileage

Number of Experiments Slide 120

120
 Response: The output(s) of a
process. Sometimes called
dependent variable(s).
Treatment # A/C L/100 km
passengers
1 1 ON 13.8
2 1 OFF 13.6
3 2 ON
4 2 OFF
5 3 ON
6 3 OFF
7 4 ON
8
9
4
5
OFF
ON
Response
10 5 OFF

121

 Errors: Anything that tends to


make our estimate of the
difference to be different from
the "true" difference.
 Related terms are common
causes, noise or nuisance factors

A/C L/100 km
ON 13.8

Errors
OFF 13.6

122

 Two types of inputs


 Inputs in which we are
interested to study the effect
of these on the output or
response. (Factors)
 Inputs which are not of
interest in the study.
(Nuisance Factors or Noise)

Errors

123
 How to deal with nuisance factors?
 Controllable
 Blocking (e.g. city vs Highway
drive, male/female)
 Uncontrollable
 Randomization (e.g. order of
treatment)

Errors

124

16 males Experimental
Treatment A
Group
Compare Results
Males
Control
Placebo
Group
Patients
Experimental
Treatment A
Group
16 males Females
Compare Results
14 females Control
Placebo
14 females Group

Randomized Block Design Slide 125

125

Run order Treatment # passengers A/C L/100 km


4 1 1 ON 13.8
5 2 1 OFF 13.6
6 3 2 ON
1 4 2 OFF
3 5 3 ON
9 6 3 OFF
… … …

Randomization Slide 126

126
 Replication / Repetition
Performing the same treatment
combination more than once.

Run order Treatment # passengers A/C L/100 km


4 1 1 ON 13.8
5 2 1 OFF 13.6
6 3 2 ON
1 4 2 OFF Replication and
3
9
5
6
3
3
ON
OFF
Repetition
… … …

127

 Replication: measurements are


taken during identical but
different experimental runs
 Repetition: measurements are
taken during the same
experimental run or consecutive
runs.
Run order Treatment # passengers A/C L/100 km
4 1 1 ON 13.8
5 2 1 OFF 13.6
6 3 2 ON
1 4 2 OFF Replication and
3
9
5
6
3
3
ON
OFF
Repetition
… … …

128

 Coffee making process – 150cc

 Milk : 40 cc vs 80 cc

 Sugar : 10 gms vs 20 gms

DoE Graphs and


Plots

129
 Coffee making process – 150cc

 Milk : 40 cc (-) vs 80 cc (+)

 Sugar : 10 gms (-) vs 20 gms (+)

DoE Graphs and


Plots

130

 Coffee making process – 150cc

 Milk : 40 cc (-) vs 80 cc (+)

 Sugar : 10 gms (-) vs 20 gms (+)

# Sugar Milk
1 - -
2 - +
3 + - DoE Graphs and
4 + + Plots

131

 Coffee making process – 150cc

 Milk : 40 cc (-) vs 80 cc (+)

 Sugar : 10 gms (-) vs 20 gms (+)

# Sugar Milk Sequence


1 - - 2
2 - + 4
3 + - 1 DoE Graphs and
4 + + 3 Plots
Randomization

132
 Coffee making process – 150cc

 Milk : 40 cc (-) vs 80 cc (+)

 Sugar : 10 gms (-) vs 20 gms (+)

# Sugar Milk Rating Sequence


1 - - 3 2
2 - + 6 4
3 + - 6 1 DoE Graphs and
4 + + 9 3 Plots

133

6 9
# Sugar Milk Rating Sequence +
1 - - 3 2
Milk

2 - + 6 4
3 + - 6 1 -
4 + + 9 3 3 - Sugar + 6

DoE Graphs and Plots Slide 134

134

6 9
# Sugar Milk Rating Sequence +
1 - - 3 2
Milk

2 - + 6 4
3 + - 6 1 -
4 + + 9 3 3 - Sugar + 6

Interaction Chart 10 Interaction Chart 9


10 9
8
8 6 6
6 6 6
6
3 4 3
4
Milk - Sugar -
2 2
Milk + Sugar +
0 0
Sugar - Sugar + Milk - Milk +

DoE Graphs and Plots Slide 135

135
6 9
# Sugar Milk Rating Sequence +
1 - - 3 2

Milk
2 - + 6 4
3 + - 6 1 -
4 + + 9 3 3 - Sugar + 6

 Y = B0 + B1X1 + B2X2
 Y = B0 + BsXs + BmXm
 Y = 6 + 1.5 Xs + 1.5 Xm

DoE Graphs and Plots Slide 136

136

# Sugar Milk Rating Sequence 7.2 8.8


+
1 - - 3.7 2
Milk

2 - + 7.2 4
3 + - 7.9 1
-
4 + + 8.8 3 3.7 - + 7.9
Sugar

DoE Graphs and Plots Slide 137

137

# Sugar Milk Rating Sequence 7.2 8.8


+
1 - - 3.7 2
Milk

2 - + 7.2 4
3 + - 7.9 1
-
4 + + 8.8 3 3.7 - + 7.9
Sugar

Interaction Chart 10 Interaction Chart 8.8


10 8.8 7.9
7.2 8
8
7.2
7.9 6
6
3.7 3.7
4 4
Milk -
2 2 Sugar -
Milk +
Sugar +
0 0
Sugar - Sugar + Milk - Milk +

DoE Graphs and Plots Slide 138

138
7.2 8.8
+
 Y = B0 + B1X1 + B2X2

Milk
 Y = B0 + BsXs + BmXm
 Y = 6.9 + 1.45 Xs + 1.1 Xm -
3.7 - Sugar + 7.9

DoE Graphs and Plots Slide 139

139

7.2 8.8
 Y = 6.9 + 1.45 Xs + 1.1 Xm +
 For low milk, low sugar
Milk

Y = 6.9 + 1.45 (-1) +1.1 (-1) = 4.35 (against


3.7) -
Hence something else is playing here … 3.7 - Sugar + 7.9

called interaction or Xs . Xm
 Interaction Xs . Xm = (8.8-7.2)-(7.9-3.7)/2 Zero Interaction
6 9
+
Milk

-
3 - Sugar + 6

DoE Graphs and Plots Slide 140

140

 Y = B0 + B1X1 + B2X2
7.2 8.8
 Y = B0 + BsXs + BmXm +
 Y = 6.9 + 1.45 Xs + 1.1 Xm
Milk

 Interaction is half the difference in the


effect of sugar when milk is high or low is -
= (8.8-7.2)-(7.9-3.7)/2 = -1.3 3.7 - Sugar + 7.9
 Report of half of this in the equation as
multiple of Xs . Xm or -1.3/2 = -0.65
 Y = 6.9 + 1.45 Xs + 1.1 Xm – 0.65 Xs . Xm

DoE Graphs and Plots Slide 141

141
 Y = 6.9 + 1.45 Xs + 1.1 Xm – 0.65 Xs . Xm
7.2 8.8
 For high (+) sugar high (+) milk +
 Y = 6.9 + 1.45 (+1) + 1.1 (+1) – 0.65 (+1).(+1)

Milk
 Y = 6.9 + 1.45 + 1.1 – 0.65 = 8.8
-
3.7 - Sugar + 7.9
 For high (+) sugar low (-) milk
 Y = 6.9 + 1.45 (+1) + 1.1 (-1) – 0.65 (+1).(-1)
 Y = 6.9 + 1.45 - 1.1 + 0.65 = 7.9

DoE Graphs and Plots Slide 142

142

4C.
Supplier
Corrective and
Preventive Action 01 Root Cause Analysis Tools
and Methods

Evaluate and implement corrective/ preventive


action, and review its effectiveness and
robustness with supplier. Understand the
02 Collaboration with supplier
process of updating failure mode and effects
analysis (FMEA) and process control plan,
understand statistical process control (SPC),
product and process design change. (Evaluate)

143

Topics Covered

 Update FMEA (already covered


in 2B1)
 Correction  Update Control Plan (already
 Corrective Action covered in 3C3)
 Preventive Action  Product and Process Design
Change
 Statistical Process Control (SPC)

4C2 Collaboration with supplier Slide 144

144
Topics Covered

 Update FMEA (already covered


in 2B1)
 Correction  Update Control Plan (already
 Corrective Action covered in 3C3)
 Preventive Action  Product and Process Design
Change
 Statistical Process Control (SPC)

4C2 Collaboration with supplier Slide 145

145

Correction vs Corrective Action


 Correction
 action to eliminate a detected
nonconformity
 A correction can be made in advance of, in
conjunction with or after a corrective
action.
 A correction can be, for example, rework or
regrade.

Corrective Action

146

Correction vs Corrective Action


 Corrective Action
 action to eliminate the cause of a
nonconformity and to prevent
recurrence.
 There can be more than one cause for a
nonconformity.
 Corrective action is taken to prevent
recurrence whereas preventive action is
taken to prevent occurrence.
Corrective Action

147
Corrective Action – Key Steps
 Identify the problem
 Contain the problem,
 Determine the causes of the problem,
 Propose solutions to eliminate them or
prevent their recurrence
 Verify that the solutions are
implemented
 Confirm their effectiveness.
Corrective Action

148

Topics Covered

 Update FMEA (already covered


in 2B1)
 Correction  Update Control Plan (already
 Corrective Action covered in 3C3)
 Preventive Action  Product and Process Design
Change
 Statistical Process Control (SPC)

4C2 Collaboration with supplier Slide 149

149

Preventive Action
 Action to eliminate the cause of a
potential nonconformity or other
potential undesirable situation
 There can be more than one cause for a
potential nonconformity.
 Preventive action is taken to prevent
occurrence whereas corrective action is
taken to prevent recurrence.

Preventive Action

150
Identifying Preventive Action
 Track data trends and patterns
 Use Failure Mode and Effects Analysis
(FMEA)
 Review product and process monitoring
reports
 Study the process to identify potential
failures, defects, or deficiencies

Preventive Action

151

Taking Preventive Action


 Improve the process by developing
error- or mistake-proofing methods
(Poka-yoke)
 Procedural changes
 Design change
 Redundant system
 checkpoints and controls

Preventive Action

152

Topics Covered

 Update FMEA (already covered


in 2B1)
 Correction  Update Control Plan (already
 Corrective Action covered in 3C3)
 Preventive Action  Product and Process Design
Change
 Statistical Process Control (SPC)

4C2 Collaboration with supplier Slide 153

153
Process / Failure Mode Failure Severity Cause(s) of Occurrence Current Detection R Recommende
Requirement Effect (1-10) failure mode (1-10) Controls (1-10) P d actions
(KPIVs) N
Perfume (1-10) • Unclear (1-10) • Review and 4 96
Making • Inconsistent specificatio 3 approve
quality 8 n specification
• Receiving • Wrong by design
ingredients
• Substandard 6 • Third party 4 192
material certification
supplied by • In house test
supplier lab
• Mixing

Failure Mode and Effects Analysis Slide 154

(FMEA)
154

CM

7. Control Plan Slide 155

155

Topics Covered

 Update FMEA (already covered


in 2B1)
 Correction  Update Control Plan (already
 Corrective Action covered in 3C3)
 Preventive Action  Product and Process Design
Change
 Statistical Process Control (SPC)

4C2 Collaboration with supplier Slide 156

156
Design Change

 Design changes could happen at the pre-production or post-


production stage.
 Reasons for post-production design changes:
 Design fault
 Market changes
 Customer feedback
 Field failures/ Warranty claims

4C2 Collaboration with supplier Slide 157

157

Design Change

 Documents need to be updated and revisions managed.


 Checking and approval of changes to ensure it resolves the problem
for which the change was made and does not add a new problem.
 Communicate changes

4C2 Collaboration with supplier Slide 158

158

Topics Covered

 Update FMEA (already covered


in 2B1)
 Correction  Update Control Plan (already
 Corrective Action covered in 3C3)
 Preventive Action  Product and Process Design
Change
 Statistical Process Control (SPC)

4C2 Collaboration with supplier Slide 159

159
10. Capability Studies
LSL LCL UCL USL
Voice of Customer:
 LSL – Lower Specification Limit
 USL - Upper Specification Limit Distribution Plot
Normal, Mean=150, StDev=1
1.000
0.4

Voice of Process:
0.3

Density
 LCL – Lower Control Limit 0.2

 UCL - Upper Control Limit 0.1

0.0
145 150 155
X

3C3 Process and Service Qualification Planning


Slide 160

160

Control Limits vs
Specification Limits

Control Limits Specification Limits


Voice of the process Voice of the customer

Calculated from the data Defined by the customer or the


collected design.
To monitor that the process is in To separate good and bad items
control
What the process is doing What we want the process to do

Control
Charts
161

Control Chart

107.44
108.00
107.00
106.00 UCL
X-Bar: Shot 11 - Shot 13

105.00 8
104.00
103.00
101.71
102.00
101.00
100.00
99.00
98.00
97.00
96.00
LCL 95.98

95.00

Control Chart Slide 162

162
Data Type

Attribute - Counts Variable - Measurements

# Pieces # Occurrences
# Defectives # Defects

Constant Variable Constant Variable n>9 n =2 to 9


n=1

np chart p chart c chart u chart Xbar - s Xbar - R I-MR/X-MR

n is subgroup size

Selecting Control Charts Slide 163

163

Data Type

Attribute - Counts Variable - Measurements

# Pieces # Occurrences
# Defectives # Defects

Constant Variable Constant Variable n>9 n =2 to 9


n=1

np chart p chart c chart u chart Xbar - s Xbar - R I-MR/X-MR

n is subgroup size

Selecting Control Charts Slide 164

164

Charts for # of Defectives

Total Defectives and Percent Defective


 Binomial Distribution
 Subgroup size is normally big compared to
variable charts

# Pieces
# Defectives

Charts for #
Constant Variable

np chart p chart
Defectives Slide 165

165
np Chart

Equal Subgroup size Control Limits


 Control limits are straight lines

10.931
12
10
NP - Defectives

8
6 4.680

4
2
0.000
0

Control Chart Slide 166

166

p Chart
Unequal Subgroup size Control Limits
 Control limits change with the number of items
in the subgroup (subgroup size)
 Larger Subgroup – narrow control limits
 Smaller Subgroup – wider control limits
0.100
P - Unplanned Return

0.080
0.053
0.060

0.040
0.021
0.020
0.000
0.000

Control Chart Slide 167

167

Data Type

Attribute - Counts Variable - Measurements

# Pieces # Occurrences
# Defectives # Defects

Constant Variable Constant Variable n>9 n =2 to 9


n=1

np chart p chart c chart u chart Xbar - s Xbar - R I-MR/X-MR

n is subgroup size

Selecting Control Charts Slide 168

168
Charts for # of Defects

Total Defects / Defects per Unit


 Poisson Distribution
 Subgroup size is normally big compared to
variable charts

# Occurrences
# Defects

Charts for #
Constant Variable

c chart u chart
Defects Slide 169

169

c Chart
Equal Subgroup size Control Limits

Average Defects

20.192
20
C - Defects

15
10.480
10

5
0.768

Control Chart Slide 170

170

u Chart
Defects per Unit Control Limits

Unequal Subgroup size


 Control limits change with the number of items
in the subgroup (subgroup size)
 Larger Subgroup – narrow control limits
 Smaller Subgroup – wider control limits
0.206

0.200

0.150
U - Defects

0.105
0.100

0.050
0.004
0.000

Control Chart Slide 171

171
Data Type

Attribute - Counts Variable - Measurements

# Pieces # Occurrences
# Defectives # Defects

Constant Variable Constant Variable n>9 n =2 to 9


n=1

np chart p chart c chart u chart Xbar - s Xbar - R I-MR/X-MR

n is subgroup size

Selecting Control Charts Slide 172

172

Continuous Data / Measurements


 I-MR or X-MR chart (Individual,
Moving Range)
 X bar - R chart (Average – Range)
 X bar - s chart (Average – Standard
deviation)

Variable - Measurements

n>9 n =2 to 9 n=1
Control Charts
for Variable
Data
Xbar - s Xbar - R I-MR/X-MR Slide 173

173

I-MR/X-MR Chart
Individual Control Limits Moving Range Control Limits

Variable Chart Slide 174

174
Xbar – R Chart
Xbar Control Limits Range Control Limits

Variable Chart Slide 175

175

Xbar – s Chart
Xbar Control Limits Std Dev. Control Limits

Variable Chart Slide 176

176

COMMON CAUSES SPECIAL CAUSES

Many Causes Few Causes


Each Having Each Having
minimum Impact Significant Impact

Economically
Un-economical viable to
to eliminate eliminate

Also Called: Also Called:


Random, Chance, Non-assignable Signal, Systematic, Assignable

Statistical Process Control Slide 177

177
Rule 1:
One point is more than 3 standard
deviations from the mean.

Probable Cause: New person, wrong setup Statistical


Process Control
https://en.wikipedia.org/wiki/Nelson_rules Slide 178

178

• Nelson Rules
Rule Pattern Probable Cause
1 1 point more than 3 Stdev from CL New person, wrong setup
2 9 (or more) points in a row on same side of CL Setup change, process change, prolonged bias
3 6 (or more) points in a row all increasing or all decreasing Trend, Tool wear
4 14 (or more) points in a row alternating up and down Over control, tempering
5 2 (or 3) out of 3 points more than 2 Stdev from CL (same side) New person, wrong setup
6 4 (or 5) out of 5 points more than 1 Stdev from CL (same side) New person, wrong setup
7 14 points in a row within 1 Stdev from CL (either side) Process change
8 8 points in a row more than 1 Stdev from CL (either side) Process change

Control Charts Slide 179

179

Rule 2:
Nine (or more) points in a row are on the
same side of the mean.
RUN - When several plotted points line up consecutively on one side of a
Central Line (CL).

Probable Cause: Setup change, process change, Statistical


Process Control
prolonged bias
https://en.wikipedia.org/wiki/Nelson_rules Slide 180

180
Rule 3:
Six (or more) points in a row are
continually increasing (or decreasing).
TREND - If there is a continued rise or fall in a series of points

Probable Cause: Trend, Tool wear Statistical


Process Control
https://en.wikipedia.org/wiki/Nelson_rules Slide 181

181

Rule 4:
Fourteen (or more) points in a row
alternate in direction, increasing then
decreasing.

PERIODICITY - If the plotted points show the same pattern of change


over equal intervals it is called "periodicity".

Probable Cause: Over control, tempering Statistical


Process Control
https://en.wikipedia.org/wiki/Nelson_rules Slide 182

182

Rule 5:
Two (or three) out of three points in a row
are more than 2 standard deviations from
the mean in the same direction.

Probable Cause: New person, wrong setup Statistical


Process Control
https://en.wikipedia.org/wiki/Nelson_rules Slide 183

183
Rule 6:
Four (or five) out of five points in a row are
more than 1 standard deviation from the
mean in the same direction.

Probable Cause: New person, wrong setup Statistical


Process Control
https://en.wikipedia.org/wiki/Nelson_rules Slide 184

184

Rule 7:
Fifteen points in a row are all within 1
standard deviation of the mean on either
side of the mean.

HUGGING - When the points on the control chart seem to stick close to
the center line or to a control limit line.

Probable Cause: Process change Statistical


Process Control
https://en.wikipedia.org/wiki/Nelson_rules Slide 185

185

Rule 8:
Eight points in a row exist, but none within
1 standard deviation of the mean, and the
points are in both directions from the
mean.

Probable Cause: Process change Statistical


Process Control
https://en.wikipedia.org/wiki/Nelson_rules Slide 186

186
Topics Covered

 Update FMEA (already covered


in 2B1)
 Correction  Update Control Plan (already
 Corrective Action covered in 3C3)
 Preventive Action  Product and Process Design
Change
 Statistical Process Control (SPC)
 Process Capability (Optional)

4C2 Collaboration with supplier Slide 187

187

Process Capability Indices


 Ratio of the spread between the process
specifications to the spread of the
process values, (6 process standard
deviations) .

 Voice of customer / Voice of process > 1

Process
Capability
Measures Slide 188

188

Process Capability Indices


 Voice of Customer:
 LSL – Lower Specification Limit
 USL - Upper Specification Limit

 Voice of Process:
 LCL – Lower Control Limit
 UCL - Upper Control Limit
Process
Capability
Measures Slide 189

189
Process Capability
 Conditions to be met:
 Sample to represent the
population
 Normal distribution of data
 The process must be in statistical
control
 Sample size must be sufficient

Process
Capability
Measures Slide 190

190

σ within σ overall
 Short term standard deviation  Long term standard deviation
 It should not be influenced by
changes to process inputs, such as
tool wear or different lots of
material.
𝑅 ∑ 𝑥 − 𝑥̅
𝜎 = 𝜎𝒐𝒗𝒆𝒓𝒂𝒍𝒍 =
𝑑 𝑛−1

For Cp, Cpk use Short-term sd For Pp, Ppk use Long-term sd

Short Term vs Long Term Std. Dev. Slide 191

191

Calculating Cp
An engineer wants to assess the capability of a
process that coats large rolls of paper with a thin
film. The engineer collects three measurements of
coating thickness from 25 consecutive rolls. The film
thickness must be 50 ± 3 microns to meet
engineering specifications.

The engineer performs the capability analysis to


evaluate how well the coating thickness meets the
customer requirements of 50 ± 3 microns.
Coating Roll
50.3175 1
50.1432 1 𝑅
50.4081 1 𝜎 =
49.5077 2 𝑑
50.2715 2
49.4091 2
… …
https://support.minitab.com/en-us/datasets/capability-data-sets/film-
thickness/

Calculating Cp Slide 192

192
Calculating Cp
𝑈𝑆𝐿 − 𝐿𝑆𝐿
𝐶 =
6×𝜎

53 − 47
𝐶 =
6 × 0.40608

𝐶 = 2.46

Calculating Cp Slide 193

193

𝐶 =
Process Mean − 𝐿𝑆𝐿 Calculating Cpk
3×𝜎
𝑈𝑆𝐿 − Process Mea𝑛
𝐶 =
3×𝜎

Cpk = Min (CpU, CpL )

49.8829 − 47 53 − 49.8829
𝐶 = 𝐶 =
3 × 0.40608 3 × 0.40608

𝐶 = 2.366 𝐶 = 2.558
Cpk = 2.366

Calculating Cpk Slide 194

194

Calculating Cp and Cpk


𝑈𝑆𝐿 − 𝐿𝑆𝐿 53 − 47
𝐶 = 𝐶 =
6×𝜎 6 × 0.40608
𝐶 = 2.46

Process Mean − 𝐿𝑆𝐿


𝐶 = 𝐶 = 4.01
3×𝜎
𝑈𝑆𝐿 − Process Mea𝑛
𝐶 = 𝐶 = 0.92
3×𝜎

Cpk = 0.92

Calculating Cp and Cpk Slide 195

195
σ within σ overall
 Short term standard deviation  Long term standard deviation
 It should not be influenced by
changes to process inputs, such as
tool wear or different lots of
material.
𝑅 ∑ 𝑥 − 𝑥̅
𝜎 = 𝜎𝒐𝒗𝒆𝒓𝒂𝒍𝒍 =
𝑑 𝑛−1

For Cp, Cpk use Short-term sd For Pp, Ppk use Long-term sd

Short Term vs Long Term Std. Dev. Slide 196

196

Process Capability Report for Coating


𝑈𝑆𝐿 − 𝐿𝑆𝐿 𝑈𝑆𝐿 − 𝐿𝑆𝐿
𝐶 = 𝑃 =
6×𝜎 LSL USL 6×𝜎
Process Data Overall
LSL 47 Within
Target *
USL 53 Overall Capability
Sample Mean 49.8829 Pp 1.19
Sample N 75 PPL 1.15
PPU 1.24
Process Mean − 𝐿𝑆𝐿 StDev(Overall) 0.838488
StDev(Within) 0.40608 Ppk 1.15
𝐶 = Cpm * Process Mean − 𝐿𝑆𝐿
3×𝜎 Potential (Within) Capability 𝑃 =
Cp 2.46 3×𝜎
CPL 2.37
CPU 2.56
Cpk 2.37

𝑈𝑆𝐿 − Process Mea𝑛


𝐶 = 𝑈𝑆𝐿 − Process Mea𝑛
3×𝜎 𝑃 =
3×𝜎

47 48 49 50 51 52 53
Cpk = Min (CpU, CpL ) Ppk = Min (PpU, PpL )
Performance
Observed Expected Overall Expected Within
PPM < LSL 0.00 292.72 0.00
PPM > USL 0.00 100.61 0.00
Process Capability PPM Total 0.00 393.34 0.00 Process Performance
Potential capability Overall capability

Cp, Cpk, Pp and Ppk Slide 197

197

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