Performance Monitoring and Improvement

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
3A Requirements 3B Supplier 3C Part, Process and

Definition Selection Planning Service Qualification
Internal Design Reviews Supplier Comparison Technical Review
Identifying Requirements Potential Supplier Identification Supplier Relations

Supplier Selection Qualification Planning
Part Approval
Validate Requirements
3. Supplier Selection and Part Qualification Slide 2
3.
Supplier Selection A Product/Service Requirements
Definition
and Part
Qualification
B Supplier Selection Planning
(30 Questions) C Part, Process and Service

Qualification
3
3A.
Product/Service
Requirements 01 Internal Design Reviews
Definition 02 Identifying Requirements

Identify and apply common elements
of the design review process, including
roles and responsibilities of the
participants. (Apply)
Design Review
 Cost and the level of quality gets established at the
design stage.
 Review design internally prior to providing it to
supplier
 Does this meet the customer requirement?
 Review for cost, quality, reliability, manufacturing
 Design for X
 Design for cost, manufacturing, assembly, reliability, safety,
logistics etc
3A1 Internal Design Review Slide 5
Review
 ISO 9000:2015 defines
 Review: determination of the suitability, adequacy or
effectiveness of an object to achieve established
objectives.
 EXAMPLE Management review, design and development
review, review of customer requirements, review of
corrective action and peer review.
6
Verification
 ISO 9000:2015 – terms related to review
 Verification: confirmation, through the provision of
objective evidence, that specified requirements have been
fulfilled
 The objective evidence needed for a verification can be the result
of an inspection or of other forms of determination such as
performing alternative calculations or reviewing documents.
 The word “verified” is used to designate the corresponding status.
Validation
 ISO 9000:2015 – terms related to review
 Validation: confirmation, through the provision of objective
evidence, that the requirements for a specific intended use
or application have been fulfilled
 The objective evidence needed for a validation is the result of a
test or other form of determination such as performing alternative
calculations or reviewing documents.
 The word “validated” is used to designate the corresponding
status.
 The use conditions for validation can be real or simulated.
Review, Verification and Validation

 Reviews are conducted to evaluate the ability of the
results of design and development to meet
requirements;
 Verification activities are conducted to ensure that the
design and development outputs meet the input
requirements;
 Validation activities to ensure that the resulting
products and services meet the requirements for the
specified application or intended use;
9
Review, Verification and Validation
 Review: Will this design achieve the required
objective?
 Verification: Whether output meets input
requirements (e.g. codes, specifications)
 Validation: Does the product serve the required
purpose? (live test)
10
 Review: Will this

design achieve
the required
objective?
 Verification:
Whether output
meets input
requirements
(e.g. codes,
specifications)
 Validation: Does
the product
serve the
required
purpose? (live
test)
11
3A.
Product/Service
Requirements
Definition 01 Internal Design Reviews
Identify and apply internal

requirements (e.g. interrelated
02 Identifying Requirements
functional business units) for product
or service in collaboration with
stakeholders, including the
requirements for supply chain and sub-
tier suppliers. (Evaluate)
12
Typical Requirements
 Functional requirements  Documentation
 Reliability requirements requirements
 Physical requirements  Cost requirements
(size, shape, material)  Manufacturing
 Logistics – Label, requirements
packaging, preservation  Industry standards
etc.  Government regulations
 Inspection
3A2 Identifying Requirements Slide 13
13
Challenges
 Unclear or ambiguous requirements

 Conflicting requirements
 Passing the requirements to sub-suppliers
 Tolerances too tight or too loose
3A2 Identifying Requirements Slide 14
14
3.
Supplier Selection A Product/Service Requirements
Definition
and Part
Qualification
B Supplier Selection Planning
(30 Questions) C Part, Process and Service

Qualification
15
3B.
Supplier Selection
Planning 01 Supplier Comparison
Evaluate existing supplier’s capabilities,

02 Potential Suppliers Evaluation
capacities, past quality, delivery, price,
lead times, and responsiveness against
identified requirements. (Evaluate)
03 Supplier Selection
16
Current Suppliers
 Evaluate current supplier to see if the new order can
be placed to them.
 Evaluation is done based on their past performance
 Factors include Price, Quality, Delivery, Lead Time,
Responsiveness, Capability, Capacity
3B1 Supplier Comparison Slide 17
17
Price
 Discounts
 Cost of shipping, handling, stocking
 Bigger lots need additional cost for preservation, risk
of obsolescence, and the cost of cash
 Cost of additional inspections
18
Quality
 Variation Control
 Past rejection rate
 Field performance
 Warranty claims
19
Delivery
 Overages, Shortages and Damages (OSD)
 Delivery reliability
 Delivery documentation
20
Responsiveness
 Lead Time: Ability to provide on short notice
 Flexibility to allow for changes
21
Capability and Capacity
 Capability
 Quality system (e.g. ISO 9001) and product
certifications (e.g. ASME U Stamp)
 Skilled staff
 Technical knowhow
 Capacity
 Surge capacity to meet demand spikes
22
Comparison
Weightage Supplier 1 Supplier 2 Supplier 3
Price 2 7 3 9
Quality 2 9 9 4
Delivery 2 6 4 9
Lead Time 1 8 9 8
Responsiveness 1 6 4 4
Capability 1 9 5 5
Capacity 1 9 9 4
Total 76 59 65
23
3B.
Supplier Selection
02
Assess potential new suppliers against
identified requirements using tools such
Potential Suppliers Evaluation
as, self-assessments, audits and financial
03
analysis. Verify third-party certification
status and regulatory compliance and
analyze and report on results of
Supplier Selection
assessments to support the supplier
selection process. (Evaluate)
24
Supplier Evaluation Tools
 Assess potential new suppliers against identified
requirements using tools such as:
 Self-assessments
 Audits
 Financial analysis
 Third-party certification status and regulatory compliance
3B2 Potential Suppliers Evaluation Slide 25
25

 Self Assessment
 Organization details
 Staff/Contacts
 Capacity
 Quality Management System Requirements
 Health, Safety and Environment Requirements
 Quality and other certifications
 Compliance with legislations: Child labor, anti-bribery etc.
 Technology
 References
26

 Audits
27
Audit types
 First Party Audit

 Second Part Audit
 Third Party Audit
 Internal and External Audit
28
First-party Audit
 Internal audits
 Performed within an organization
 The focus is on improvement
 Auditors have no vested interest in the
area being audited
Suppliers Organization Customers

Types of Audits
29
Second-party Audit
 Performed by Customers on suppliers

 Before or after awarding a contract

Types of Audits
30
Third-party Audit
 Performed by an audit organization

independent of the customer-supplier
relationship
 Free from any conflict of interest
Third Party

Types of Audits
31
Auditor-auditee relationship
First Party • Internal
Second Party • By Client
• By a third party appointed by

Third Party client
Types of Audits Slide 32
32
Internal External
Audit Audit
Second-party Audit
First-party Audit
Third-party Audit
Types of Audits Slide 33
33
 Audits
34

 Audits
35

Financial Analysis
 Financial due diligence is important when selecting and
monitoring suppliers
 It is more important when buying business critical supplies
 Risk
 Business discontinuity / bankruptcy
 Poor cash situation leading to delays
 Early Indicators
 Late payment to suppliers, workforce reduction, loosing key
employees, order loss,
36
 Audits
37

Third Party Certifications
Examples of system certifications
 ISO 9001 – Quality Management System
 ISO 14001 – Environmental Management System
 AS9100D – Aerospace Quality Management System
 ISO 13485 – Medical Devices QMS
38

Product Certifications
 CE Mark
 CSA Mark
 FM Approved
 UL Certified
39
 Audits
40
3B.
Supplier Selection
Evaluate and select supplier based on

02 Potential Suppliers Evaluation
analysis of assessment reports and
existing supplier evaluations, using
decision analysis tools and selection
03 Supplier Selection
matrices. (Evaluate)
41
Existing Suppliers Potential Suppliers

 Assess potential new
suppliers against identified
Price 2 7 3 9
requirements using tools
Quality 2 9 9 4
such as:
Self-assessments
Delivery 2 6 4 9

Lead Time 1 8 9 8
 Audits
Responsiveness 1 6 4 4
Capability 1 9 5 5
Capacity 1 9 9 4
 Third-party certification
Total 76 59 65
status and regulatory
compliance
3B3 Supplier Selection Slide 42
42
Supplier Risk Analysis
 Strategic Risks: Country level risks, supplier motivation etc.
 Commercial Risks: Price variation, currency fluctuation, demand
fluctuation etc.
 Reputation Risk: Health and safety, child labor, legal violations,
Ethics etc.
 Functional Risks: Logistics, quality issues, unreliable production
schedule, communication etc.
43
Supplier Risk Analysis

Strategic Risks 4 7 3 9
Commercial Risks 3 9 9 4
Reputation Risks 2 6 4 9
Functional Risks 1 8 9 8
Total 75 56 74
44
3.
Supplier Selection A
Product/Service Requirements
Definition
and Part
Qualification
B
Supplier Selection Planning
(30 Questions) C
Part, Process and Service
Qualification
45
3C. 01 Technical Review
Part, Process and

Service
02 Supplier Relations
Qualification 03 Process and Service

Qualification Planning
Interpret and evaluate technical
specification requirements and
characteristics such as, views, title
04 Part Approval
05
blocks, dimensioning and tolerancing
and GD&T symbols as they relate to
product and process. (Evaluate)
46
Topics Covered
 Views – First angle and Third angle projections
 Title Block
 Lines
 Dimensioning
 Tolerances
 GD&T (Geometric Dimensioning and Tolerancing)
3C1 Technical Review Slide 47
47
First and Third Angle Projection

 Let’s look at a part, from different sides.
 Front view
 Top view
 Side view
 Solid line for the edge which is visible and dotted line
for the hidden edge.
48
 Types of views.
 Plan view (top/bottom)
 Elevation view (front and side)
 In the Plan view you see length and width

 In elevation view you see the height and length/width
49

 Four quadrants
50
First Angle Projection
First Angle
Object is first quadrant
Object lies between the
observer and the plane of
projection
Plane of projection is non
transparent
51
First Angle Projection
First Angle
Object is first quadrant
Object lies between the
observer and the plane of
projection
Plane of projection is non
transparent
52
Third Angle Projection
Third Angle
Object is third quadrant
The plane of projection
lies between the observer
and object
Plane of projection is
transparent
53
Third Angle Projection
Third Angle
Object is third quadrant
The plane of projection
lies between the observer
and object
Plane of projection is
transparent
54
 First Angle vs Third Angle Projection
First Angle Third Angle
Object is first quadrant Object is third quadrant
Object lies between the The plane of projection
observer and the plane of lies between the observer
projection and object
Plane of projection is non Plane of projection is
transparent transparent
55
Topics Covered
 Title Block
 Lines
 Dimensioning
 Tolerances
56
Title Block
 Typical Title Block information:
 Organization’s name/logo
 Drawing title
 Drawing number
 Sheet number
 Revision number
 Approvals – Checked, Approved
 Units of measurement
 Scale/ Not to scale
 First angle/Third Angle projection
 Other details as applicable: Tolerances, Finish, Weight, Heat treatment etc.
57
Title Block
 Additional information:
 Bill of materials
 Notes
 Zones – e.g. A5, B3
58
Title Block
 Additional information:
 Bill of materials
 Notes
 Zones – e.g. A5, B3
59
Topics Covered
 Title Block
 Lines
 Dimensioning
 Tolerances
60
Lines
 Construction line – light solid
 Outline – Object boundary
 Hidden details – dotted
 Centerline
61
Lines
 Dimension line
 Break line
 Cutting Plane
 Section lines / Hatch lines
62
Topics Covered
 Title Block
 Lines
 Dimensioning
 Tolerances
63
Dimensioning
Chain Dimensioning Parallel Dimensioning Running Dimensioning

Where the accumulation of A number of single dimension lines Similar to parallel dimensioning.
tolerances does not affect the are drawn parallel to one another Dimensions are superimposed in one
functional requirements. line.
Origin point should be marked.
64
Dimensioning
 Avoid unnecessary or unimportant
dimensions.
 Do not duplicate
 Provide tolerances only when
important.
65
Topics Covered
 Title Block
 Lines
 Dimensioning
 Tolerances
66
Tolerances
 Tolerance provide the lowest and the highest value a dimension can
have.
 Two common ways to show tolerance
 Plus /minus tolerance
 Upper and lower value
 Tolerances allow for interchangeability of parts.
67
Tolerances
 Clearance Fit
 When there is extra space between
two mating parts.
 Interference Fit
 When two mating parts interfere
when assembled.
 Transition Fit
 It can be clearance or interference
fit depending upon the actual
dimension.
68
Unilateral vs Bilateral Tolerances

 A unilateral tolerance exists when
a target dimension is given along
with a tolerance that allows
variation to occur in only one
direction.
 A bilateral tolerance exists if the
variation from a target dimension
is shown occurring in both the
positive and negative directions.
69
Topics Covered
 Title Block
 Lines
 Dimensioning
 Tolerances
70
GD&T (Geometric Dimensioning and Tolerancing)

 Structured language of symbols, rules and
definitions that allows the geometrical
features of mechanical parts to be defined
according to functional limits of imperfection.
 Provides universal language for supplier,
checker, and the buyer.
71

 A simple example of 1000 mm +/- 5 mm
a glass sheet
500 mm +/- 5 mm
72
1000 mm +/- 5 mm
500 mm +/- 5 mm
73

1000 mm +/- 5 mm
500 mm +/- 5 mm
74

1000 mm +/- 5 mm
500 mm +/- 5 mm
75
1000 mm +/- 5 mm
500 mm +/- 5 mm
76

1000 mm +/- 5 mm
500 mm +/- 5 mm
77
Datum vs Datum Feature

 A Datum is a perfect point, line, plane or
surface.
 Datum only exists theoretically
 However a Datum Feature is a tangible
surface, point or axis on a part where that
theoretical datum is located. Datum Feature
Datum
78
Datum Reference Frame
 Six degrees of freedom
 Primary datum – controls 3 degrees of freedom
 Secondary datum – controls 2 degrees of freedom
 Tertiary Datum – controls 1 degrees of freedom
79

 Three perpendicular datum planes.
z
y
80
The 3-2-1 Rule and Points of Contact

 The 3-2-1 rule defines the minimum number of points of contact
required for a part datum feature with its primary, secondary,
and tertiary datum planes.
 It only applies when all three plains are used.
 The primary datum feature has at least 3 points of contact
with its datum plane.
 The secondary datum feature has at least 2 points of contact
 The tertiary datum feature has at least one point of contact
81
 Three perpendicular datum planes.
z
y
82
GD&T Symbols
 Reference: ASME Y 14.5 - 2018
83
MMC and LMC

 Maximum Material Condition (MMC) refers to a
feature-of-size that contains the greatest amount of
material, yet remains within its tolerance zone.
Some examples of MMC include:
 – Smallest hole diameter
 – Largest pin diameter
84
MMC and LMC
 Maximum Material Condition (MMC) refers to a
feature-of-size that contains the greatest amount of
material, yet remains within its tolerance zone.
Some examples of MMC include:
 – Smallest hole diameter
 – Largest pin diameter
85
MMC and LMC

 Least Material Condition (LMC) refers to a feature-
of-size that contains the least amount of material,
yet remains within its tolerance zone. Some
examples of LMC include:
 – Largest hole diameter
 – Smallest pin diameter
86
MMC and LMC

 This is additional bonus
tolerance.
 This reduces unnecessary
rejection of “usable”
parts.
87
MMC and LMC
 This is additional bonus
tolerance.
 This reduces unnecessary
rejection of “usable”
parts.
88
3C. 01Technical Review
Part, Process and

Service
02Supplier Relations
Qualification 03Process and Service

Collaborate with suppliers to define,

interpret, and classify quality
04Part Approval
05
characteristics for the part/ process/
service. (Evaluate)
89
Supplier Relationship
 It is important to have a good relationship with
supplier at the early stage to:
 Clearly convey requirements
 Just having the requirements in the contract might
not be good enough
 Kick-off meeting might help
 Ensuring that the requirements are understood
 Contact persons are clearly defined/identified
3C2 Supplier Relations Slide 90
90
3.
Supplier Selection AProduct/Service Requirements
Definition
and Part
Qualification
BSupplier Selection Planning
(30 Questions) CPart, Process and Service

Qualification
91
Part, Process and

Service

Develop a part/process/service qualification plan with supplier and

internal team, that includes calibration requirements, sample size, first
article inspection, measurement system analysis (MSA), process flow
04 Part Approval
05
diagram (PFD), failure mode and effects analysis (FMEA), control
plans, critical to quality (CTQ), inspection planning, capability
studies, material and performance testing, appearance approval and
internal process validation. (Analyze)
92
Elements of the Qualification Planning

1. Calibration requirements 7. Control plans
2. Sample size, 8. Critical to quality (CTQ)
3. First article inspection 9. Inspection planning
4. Measurement system analysis 10. Capability studies
(MSA) 11. Material and performance
5. Process flow diagram (PFD) testing
6. Failure mode and effects analysis 12. Appearance approval
(FMEA) 13. Internal process validation
3C3 Process and Service Qualification Planning Slide 93
93
1. Calibration Requirements
Purpose:
 To ensure consistency
 To make the accuracy measurements
 Can measurements be trusted?
94
Metrology
 Metrology is the science of measurements. (Meteorology is
science of weather forecasting)
 Involves three Main activities:
 Definition of internationally accepted units of measurement
 Realization of these units of measurement in practice
 Application of chains of traceability linking measurements
made in practice to reference standards
95
Seven Base Units

Unit name Unit symbol
metre The distance travelled by light in vacuum in 1/299792458 second.
Set by fixing the numerical value of the Planck constant to be equal to exactly 6.626 069… × 10–34 when it is
kilogram
expressed in the SI unit s–1 m2 kg, which is equal to J s.“ (New definition - 2019)
The duration of 9192631770 periods of the radiation corresponding to the transition between the two
second
hyperfine levels of the ground state of the caesium-133 atom.
The constant current which, if maintained in two straight parallel conductors of infinite length, of negligible
ampere circular cross-section, and placed 1 m apart in vacuum, would produce between these conductors a force equal
to 2×10−7 newtons per metre of length.
kelvin 1/273.16 of the thermodynamic temperature of the triple point of water
The amount of substance of a system which contains as many elementary entities as there are atoms in 0.012
mole
kilogram of carbon-12
The luminous intensity, in a given direction, of a source that emits monochromatic radiation of frequency
candela
5.4×1014 hertz and that has a radiant intensity in that direction of 1/683 watt per steradian.
96
SI Units
Traceability
National Labs
 “Property of a measurement result
whereby the result can be related Third Party Labs
to a reference through a
documented unbroken chain of Metrology Department
calibrations, each contributing to
the measurement uncertainty.” Working Instruments
97
SI Units
Traceability
National Labs
 “Property of a measurement result
whereby the result can be related Third Party Labs
to a reference through a
documented unbroken chain of Metrology Department
calibrations, each contributing to
the measurement uncertainty.” Working Instruments
98

2. Sample size 8. Critical to quality (CTQ)
99
2. Sample Size
Why to sample?
 Because of the cost and time involved in studying the entire
population.
 If the test to be preformed is destructive test.
 Lots to be tested are large, and the impact of wrong judgement
is low.
100
2. Sample Size
Population: Sampling
Complete Process Sample: Part
collection to of population
be studied
Inference
Parameter Statistic
Characteristic of Characteristic
a population of a sample
N number of members n
101
2. Sample Size
Actual Lot Condition
Good Lot Bad Lot
Correct Type II Error

Accept the Lot
Conclusion Conclusion (Buyer’s Risk)
Based on
Sampling Type I Error Correct
Reject the Lot
(Producer’s Risk) Conclusion
102
2. Sample Size
Standards
Attribute Sampling MIL-STD-105 (withdrawn) – AQL based
ANSI/ASQ Z1.4 – AQL based
Dodge-Romig – LTPD or AOQL based
Variable Sampling MIL-STD-414 (withdrawn) – AOQ based

ANSI/ASQ Z1.9
103

104
3. First Article Inspection

 First articles are mass-produced units of a first production run.
 Prototypes or other pre-production samples are not
considered first articles.
 First article inspection involves inspecting a random sample of
the first production run.
 The requirements for the FAI are typically included in the
contract.
 The report may include the product dimensions, finish, color,
weight, density etc.
105
106
Measurement
 You need measurement to see how the
process is performing.
 Process has variation.
 What about measurement error /
variation?
4. Measurement
System Analysis
(MSA)
107
Measurement System
 Measurement System includes:
 Operator
 Measuring Instrument
 Procedures
4. Measurement
System Analysis
(MSA)
108
True vs Reference Value
 True Value – Actual value, which is
unknown
 Reference Value – Accepted value or
substitute of true value.
4. Measurement
System Analysis
(MSA)
109
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
4. Measurement System Analysis (MSA) Slide 110
110

111
5. Process Flow Diagrams (PFD)
 It is similar to a Flow Chart
 It shows production process steps, to provide a high-level
overview.
 Process numbers are aligned with the FMEA and Control
Plan.
112
5. Process Flow Diagrams (PFD)
113

114
6. Failure Mode and Effects Analysis (FMEA)
 Already covered in 2B1 – Risk Management - Analysis
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
115

116
7. Control Plan
 Control Plan helps in maintaining the
process characteristics.
 Process owner needs to be involved in
the making of Control Plan.
 Control Plan should be reviewed and
revised time to time, based on lessons
learned.
Control Plan
117
CM
7. Control Plan Slide 118
118

119
VoC
 Voice of the customer (VOC) is a term

used to describe the in-depth process
of capturing a customer's
expectations, preferences and
aversions. (stated and unstated)
8. Critical to
Quality (CTQ)
120
CTQ
 VOC’s can be vague and difficult to

define, that’s where CTQ’s come in.
 The customer may identify a
requirement that is difficult to
measure directly so it will be
necessary to break down what is
meant by the customer into
identifiable and measurable terms
8. Critical to
Quality (CTQ)
121
VoC Drivers CTQ

Time –
Registering to
calling < 5 mins.
Timely
Time – Doctor
consulting > 10
mins
Good service in
Cleanliness
clinic
Cost
Less Specific More
Hard Hard/Easy to Measure Easy
8. Critical to Quality (CTQ)

Slide 122
122

123
9. Inspection Planning
124

125
Process Performance
Natural process limits
Distribution Plot
Normal, Mean=150, StDev=2
0.20
0.15
Density
0.10
0.05
0.00
145.0 147.5 150.0
X
152.5 155.0 157.5
10. Process
Capability
126
10. Capability Studies
Area under the Normal curve
 About 68% of the area under the curve falls Distribution Plot
within 1 standard deviation of the mean.

0.20
0.15
 About 95% of the area under the curve falls
Density
0.10
within 2 standard deviations of the mean. 0.05
 About 99.7% of the area under the curve 0.00

145.0 147.5 150.0 152.5 155.0 157.5
falls within 3 standard deviations of the X
mean.
127
Process Performance
Specification: 140 to 160
Distribution Plot
1.000
0.20
0.15
Density
0.10
0.05
0.00
140 150
X
160
10. Process
Capability
128
Process Performance
Rejections: 1-0.6827 = 0.3173
Distribution Plot
0.6827
0.20
0.15
Density
0.10
0.05
0.00
148 150 152
10. Process
Capability
X
129
Process Performance
Rejections: 1-0.9876 = 0.0124
Distribution Plot
0.9876
0.20
0.15
Density
0.10
0.05
0.00
145 150
X
155
10. Process
Capability
130
Process Performance
Rejections: 1-0.9759 = 0.0241
Distribution Plot
Normal, StDev=2
Mean
0.20 150
151
Specification: 145 to 155 0.15
Rejections: 1-0.9875 = 0.0124

Density
0.10
Distribution Plot
Normal, Mean=150, StDev=2 0.05
0.9876
0.20
0.00
145.0 147.5 150.0 152.5 155.0 157.5
X
0.15
Density
Distribution Plot
0.10
0.20
0.05 0.9759
10. Process
0.15
0.00
145 150 155
Density
X
0.10
0.05
Capability
0.00
145 151 155
X
131
Process Performance
Process sd = 1
Rejections: 1-1 = almost zero
Distribution Plot
1.000
0.4
Process sd = 2
0.3

Density
0.2
Rejections: 1-0.9875 = 0.0124 0.1
Distribution Plot
0.0
0.9876 145 150 155
0.20 X
0.15
Process sd = 3
Rejections: 1-0.9044 = 0.0956
Density
0.10
Distribution Plot
0.05
0.14
0.9044
0.00
145 150
X
155
0.12
0.10 10. Process

Capability
0.08
Density
0.06
0.04
0.02
0.00
145 150 155
X
132
Capable Process
LSL LCL UCL USL
Distribution Plot
1.000
0.4
0.3
Density
0.2
0.1
10. Process
0.0
145 150
X
155 Capability
133
Is this process capable? .. No

LCL LSL USL UCL
Distribution Plot
0.9876
0.20
0.15
Density
0.10
10. Process
0.05
Capability
0.00
145 150 155
X
134

LSL LCL UCL USL
Voice of Customer:
 LSL – Lower Specification Limit
 USL - Upper Specification Limit Distribution Plot
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
135
LSL LCL UCL USL
 Four indices: Cp, Cpk, Pp, Ppk
 Ratio of the spread between
the process specifications to Distribution Plot
the spread of the process 0.4

1.000
values, (6 process standard

deviations) .
0.3
Density
 Voice of customer / Voice of 0.2
process > 1 0.1
0.0
145 150 155
X
136

Process Capability Report for Coating
LSL USL
Process Data Overall
LSL 47 Within
Target *
USL 53 Overall Capability
Sample Mean 49.8829 Pp 1.19
Sample N 75 PPL 1.15
StDev(Overall) 0.838488 PPU 1.24
StDev(Within) 0.40608 Ppk 1.15
Cpm *
Potential (Within) Capability
Cp 2.46
CPL 2.37
CPU 2.56
Cpk 2.37
47 48 49 50 51 52 53
Performance
Observed Expected Overall Expected Within
PPM < LSL 0.00 292.72 0.00
PPM > USL 0.00 100.61 0.00
PPM Total 0.00 393.34 0.00
137

138
11. Material and Performance Testing
 Material test results include chemical, mechanical or metallurgical
test reports.
 This could be required for the raw material used in the
manufacturing of an item.
 Performance tests are conducted to evaluate the capability of the
product to meet the intended performance level. (Validation)
139

140
12. Appearance Approval

 It is applicable where the appearance of the part being purchased
is important.
 Important aspects are color, hue, gloss, texture, finishing etc.
141
12. Appearance Approval
142

143
13. Internal Process Validation

 Process validation is an on-going process to establish documented
objective evidence, which provides a high degree of assurance that
a system will consistently meet its predetermined specifications
and will perform repeatedly as intended."
144
Part, Process and

Service

Understand the production part approval process

(PPAP) requirements and ensure suppliers understand
the processes required to produce parts with
04 Part Approval
05
consistent quality during an actual production run at
production rates. (Understand)
145

3C4 Part Approval Slide 146
146
Production Part Approval Process (PPAP)

 A standardized process in the automotive and aerospace industries
that helps manufacturers and suppliers communicate and approve
production designs and processes before, during, and after
manufacture.
 It promotes a clearer understanding of the requirements.
 It ensures that the processes used by supplier can consistently
produce the parts meeting the contract requirements
 In the automotive industry, the PPAP process is governed by the
PPAP manual published by the Automotive Industry Action Group
(AIAG)
147
Purpose of PPAP:
 Component suppliers have clearly understood the
engineering requirements;
 The production process is capable of consistently producing
conforming product (quality and the production rate).
148

When to perform PPAP?:
 If a new part is ordered for the first time
 In case of a new supplier or a change of supplier
 After any part modification
 Following an interruption of production for more than one year
 Following a production process modification
 Relocation of production
 Use of new or relocated machinery and/or operating or test equipment
 Following the use of alternative materials
149

18 Requirements of PPAP:
1. Design Records 10. Records of Material / Performance Test

Results
2. Authorized Engineering Change Documents
11. Initial Process Studies
3. Customer Engineering Approval, if required
12. Qualified Laboratory Documentation
4. Design Failure Modes and Effects Analysis
(DFMEA), applied in special situations 13. Appearance Approval Report (AAR)
5. Process Flow Diagram 14. Sample Production Parts
6. Process Failure Modes and Effects Analysis 15. Master Sample
(PFMEA) 16. Checking Aids
7. Control Plan 17. Customer-Specific Requirements
8. Measurement System Analysis (MSA) 18. Part Submission Warrant (PSW)
9. Dimensional Results
150
Five Levels of PPAP:

 Level 1 – Part Submission Warrant (PSW) only submitted to the customer.
 Level 2 – PSW with product samples and limited supporting data.
 Level 3 – PSW with product samples and complete supporting data.
 Level 4 – PSW and other requirements as defined by the customer.
 Level 5 – PSW with product samples and complete supporting data
available for review at the supplier’s manufacturing location.
151
Part Submission Warrant (PSW)

 This is the form that summarizes the whole PPAP package.
 This form shows the reason for submission (design change, annual
revalidation, etc.) and the level of documents submitted to the customer.
 There is a section that asks for "results meeting all drawing and
specification requirements: yes/no" refers to the whole package.
 If there are any deviations the supplier should note on the warrant or
inform that PPAP cannot be submitted.
152
3C. 01
Technical Review
Part, Process and

Service
02
Supplier Relations
Qualification 03
Process and Service
Collaborate with internal team to interpret the results

04
Part Approval
05
of the executed qualification plan for the part
/process/ service. (Evaluate)
153
 Supplier submitted PPAP documents/samples are reviewed by the
client to ensure:
 All required documents are submitted
 Latest design documents are used
 Documents such as PFMEA, Control Plans are comprehensive
 Conformance to requirements (e.g. dimensions, MSA, material
and performance test reports)
 Samples are of acceptable quality (visually, dimension, test
results if conducted etc)
3C5 Validate Requirements Slide 154
154

18 Requirements of PPAP:
1. Design Records 10. Records of Material / Performance Test

Results
2. Authorized Engineering Change Documents
11. Initial Process Studies
3. Customer Engineering Approval, if required
12. Qualified Laboratory Documentation
4. Design Failure Modes and Effects Analysis
(DFMEA), applied in special situations 13. Appearance Approval Report (AAR)
5. Process Flow Diagram 14. Sample Production Parts
6. Process Failure Modes and Effects Analysis 15. Master Sample
(PFMEA) 16. Checking Aids
7. Control Plan 17. Customer-Specific Requirements
8. Measurement System Analysis (MSA) 18. Part Submission Warrant (PSW)
9. Dimensional Results
155

PPAP Disposition: (three possible outcomes)
 PPAP Approved
 The Supplier is therefore authorized to build and ship production quantities, including
conforming parts built from the approved PPAP run.
 PPAP Conditionally Approved

 Considering the needs of the parts and the risk, the buyer could conditionally (specified time,
quantity or other conditions) accept the PPAP.
 PPAP Rejected
 If the samples or the documentation or both, do not meet all client specifications and
requirements, the PPAP could be rejected. In that case all parts made from the failed PPAP
run should be segregated as nonconforming.
156

Performance Monitoring and Improvement

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Performance Monitoring and Improvement

Uploaded by

Copyright:

Available Formats

4.

3. Supplier Selection and 5. Supplier Quality Management

7. Business Governance, Ethics,

CSQP Body of Knowledge Slide 1

3A Requirements 3B Supplier 3C Part, Process and

Internal Design Reviews Supplier Comparison Technical Review

Identifying Requirements Potential Supplier Identification Supplier Relations

3. Supplier Selection and Part Qualification Slide 2

(30 Questions) C Part, Process and Service

Definition 02 Identifying Requirements

3A1 Internal Design Review Slide 5

3A1 Internal Design Review Slide 6

3A1 Internal Design Review Slide 7

3A1 Internal Design Review Slide 8

Review, Verification and Validation

3A1 Internal Design Review Slide 9

3A1 Internal Design Review Slide 10

 Review: Will this

3A1 Internal Design Review Slide 11

Identify and apply internal

3A2 Identifying Requirements Slide 13

 Unclear or ambiguous requirements

3A2 Identifying Requirements Slide 14

(30 Questions) C Part, Process and Service

Evaluate existing supplier’s capabilities,

3B1 Supplier Comparison Slide 17

3B1 Supplier Comparison Slide 18

3B1 Supplier Comparison Slide 19

3B1 Supplier Comparison Slide 20

3B1 Supplier Comparison Slide 21

3B1 Supplier Comparison Slide 22

Weightage Supplier 1 Supplier 2 Supplier 3

3B1 Supplier Comparison Slide 23

3B2 Potential Suppliers Evaluation Slide 25

Supplier Evaluation Tools

3B2 Potential Suppliers Evaluation Slide 26

Supplier Evaluation Tools

3B2 Potential Suppliers Evaluation Slide 27

 First Party Audit

 Internal and External Audit

Suppliers Organization Customers

 Performed by Customers on suppliers

Suppliers Organization Customers

 Performed by an audit organization

Suppliers Organization Customers

First Party • Internal

Second Party • By Client

• By a third party appointed by

Types of Audits Slide 32

Types of Audits Slide 33

3B2 Potential Suppliers Evaluation Slide 34

Supplier Evaluation Tools

3B2 Potential Suppliers Evaluation Slide 35

Supplier Evaluation Tools

3B2 Potential Suppliers Evaluation Slide 36

3B2 Potential Suppliers Evaluation Slide 37

Supplier Evaluation Tools

3B2 Potential Suppliers Evaluation Slide 38

Supplier Evaluation Tools

3B2 Potential Suppliers Evaluation Slide 39

3B2 Potential Suppliers Evaluation Slide 40

Evaluate and select supplier based on