Professional Documents
Culture Documents
Core
Tool
s 1
Automotive Core Tools
Control Plan
(SPC)
2
Automotive Core Tools
3
Automotive Core Tools
Examples: Other Manuals
4
Core Tools in IATF 16949:2016
APQP: 8.3.2.1
MSA: 7.1.5.1.1
5
APQP
Advanced Product
Quality Planning
6
7
8
APQP
What is it?
Management of product development
9
Advanced Product Quality Planning
CONCEPT
PROGRAM
INITIATION APPROVA
L PROTOTYPE PILOT LAUNCH
/
APPROVA
L PLANNING
PLANNING
PRODUCT DESIGN AND DEV.
Planning Product
INPUTS Design & Product
| Dev. Process Feedback,
Planning Design & & Assessment &
INPUTS Dev. INPUTS
OUTPUTS | Process Corrective
| Validatio
Product Process Action INPUTS
Design n
Design & |
& Dev. INPUTS Feedback,
OUTPUTS Dev. OUTPUTS
| Assessment &
Product & Corrective
Process Action
Validation
OUTPUTS
10 OUTPUTS
APQP Plan and Define Phase
Concept Initiation/Approval
Inputs:
• Voice of the Customer
• Market Research (Including OEM Vehicle Timing and
Volume Expectations
• Historical Warranty and Quality Information
• Team Experience
• Business Plan/Marketing Strategy
• Product/Process Benchmark Data
• Product/Process Assumptions
• Product Reliability Studies
• Customer Inputs
11
APQP Plan and Define Phase
Concept Initiation/Approval
Outputs:
• Design Goals
• Reliability and Quality Goals
• Preliminary Bill of Materials
• Preliminary Process Flow Chart
• Preliminary Listing of Special Product and
Process Characteristics
• Product Assurance Plan
• Management Support
12
APQP Pr od uct Design and D e v e lo p m e n t Phase
Program Approval
Design Outputs: APQP Outputs:
• Design Failure Mode and Effects
• New Equipment, Tooling and
Analysis (DFMEA)
Facilities Requirements
• Design for Manufacturability
• Special Product and
and Assembly
Process Characteristics
• Design Verification
• Gages / Testing
• Design Reviews Equipment Requirements
• Prototype Build -- Control Plan • Team Feasibility
Commitment & Management
• Engineering Drawings
Support
(Including
Math Data)
• Engineering Specifications
• Material Specifications
• Drawing and
Specification Changes 13
APQP Process Design and D e ve l o pm e n t Phase
Prototype
Outputs:
• Packaging Standards and Specifications
• Product/Process Quality System Review
• Process Flow Chart
• Floor Plan Layout
• Process Failure Mode and Effects Analysis
(PFMEA)
• Characteristics Matrix
• Pre-Launch Control Plan
• Process Instructions
• Measurement System Analysis Plan
• Management Support
• Preliminary Process Capability Study Plan
14
APQP Pr od uct and Process Validation Phase
Pilot
Outputs:
• Significant Production Run
• Measurement Systems Evaluation
• Preliminary Process Capability Study
• Production Part Approval
• Production Validation Testing
• Packaging Evaluation
• Production Control Plan
• Quality Planning Sign-Off and Management
Support
15
APQP F e e d b a c k , A s s e s s m e n t a n d C o r r e c t i v e A c t i o n Ph a s e
Launch
Outputs:
• Reduced Variation
• Improved Customer Satisfaction
• Improved Delivery and Service
• Effective Use of Lessons Learned/Best
Practice
16
ADVANCED PRODUCT QUALITY PLANNING
Pitfalls
• APQP treated as a “Quality Department
Responsibility”
• APQP a separate process, not integrated into
product development
• Key stakeholders brought in late (quality, production,
suppliers)
• Milestones and deliverables ignored
• No top management involvement/support
17
FMEA
Failure Mode and Effects
Analysis
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FMEA
What is it?
A risk analysis of a part or process
19
Types of FMEAs
Design FMEA
Process FMEA
20
Types of FMEAs
Others:
System FMEA
Concept FMEA
Environmental FMEA
Machinery FMEA
Software FMEA
21
FMEA Process
Subsystem C Potential O S D
Current
Potential Potential l Cause(s)/ c e a e R. Recommended t Responsibility Action Results
Controls
Failure Effect(s) Mechanism(s) c v s P. Action(s) e & Target Actions S O D R.
Function Mode of Failure of Failure u Prevention Detection N. Completion Taken e c e P.
Requirements s r c Date v c t
N.
What can be
What are How bad done?
the Effects? is it?
–Design
What are the
Changes
Functions, Features
or Requirements?
– Process
Changes
– Special
Controls
How – Changes to
What are Standards,
often
the Procedures, or
does it
What can go Cause(s)? guides
happen?
wrong?
–No function
– Partial /
Over
/Degraded
Function How can this be How good is
prevented and this method at
–Intermittent
detected? detecting it?
Function
– Unintended
Function
22
Risk Action Strategies
23
Failure Mode and Effects Analysis
Pitfalls
• FMEA started late in the development process (just in
time
for PPAP!)
• FMEA never updated after release
• FMEA not updated from nonconformity corrective actions
• Right side (action area) is blank
• RPN thresholds
• FMEA written by one person
• FMEA treated as a “Quality Department Responsibility”
24
Control Plan
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Control Plan
What is it?
A summary of controls used to make sure my
customer gets good product
26
Control Plan
CONTROLPLA
Prototyp Pre-
e Plan Number Launch
Control
Production
N
Key Contact/Phone Date (Orig.) Date (Rev.)
MACHINE,
CHARACTERISTICS METHODS
PART/ PROCESSNAME DEVICE, SPECIAL
PROCESS / OPERATION JIG,TOOL CHAR.P RODUCT/PROCESS EVALUATION/ SAMPLE REACTIO
NUMBER DESCRIPTION S, NO. PRODUCT PROCESS CLASS SPECIFICATION/ MEASUREME SIZE FREQ. CONTRO N
FORMFG. TOLERANCE NT L PLAN
TECHNIQUE METHOD
27
Control Plan Elements
IATF 16949 AnnexA
A.2 Elements of the control plan
The organization shall develop a control plan that includes, as a minimum, the following contents.
a) General data
⎯control plan number,
c) Process control
⎯ issue date and revision date, if any,
⎯ process parameters,
⎯ customer information (see customer requirements),
⎯ process-related special characteristics,
⎯ organization's name/site designation,
⎯ machines, jigs, fixtures, tools for manufacturing.
⎯ part number(s),
d) Methods
⎯ part name/description,
⎯ evaluation measurement technique,
⎯ engineering change level,
⎯ error-proofing,
⎯ phase covered (prototype, pre-launch, production),
⎯ sample size and frequency,
⎯ key contact,
⎯ control method.
⎯ part/process step number,
e) Reaction plan and corrective actions
⎯ process name/operation description.
⎯ reaction plan (include or reference),
b) Product control
⎯ corrective action.
⎯ product-related special characteristics,
⎯ other characteristics for control (number, product or process),
⎯ specification/tolerance.
28
Control Plan
Pitfalls
• Control plan and PFMEA not aligned
• Control plan and operator instructions not aligned
• Control plan out of date
• Control plan not updated from nonconformity
corrective actions
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PPA
P Part Approval
Production
Process
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PPA
What is it? P
Requirements for approval of production parts.
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PPAP
1 Design Records
11 Initial Process Study
2 Authorized Engineering Change Documents
12 Qualified Laboratory Documentation
3 Customer Engineering Approval
13 Appearance Approval Report
4 Design FMEA
14 Sample Production Parts
5 Process Flow Diagrams
15 Master Samples
6 Process FMEA
16 Checking Aids
7 Control Plan
17 Customer-Specific Requirements (Records)
8 Measurement System Analysis Studies
18 Part Submission Warrant
9 Dimensional Results
Bulk Material Requirements Checklist
10 Material / Performance Test Results
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34
Production Part Approval Process
Pitfalls
• PPAP is treated as a separate process, rather than
integrated into product development
• Incomplete PPAP
• Assuming that submission levels are what’s required,
rather than what’s submitted
35
SPC
Statistical Process
Control
36
SPC
What is it?
A collection of statistical methods, especially
control charts, used to analyze and control a
process
38
Distributions can vary in Location
Mean = Average or X
39
Distributions can vary in Spread
Range = R
Standard Deviation =
or s
Variance = 2
40
Distributions can vary in Shape
Normal Distribution
68.25%
95.46%
99.73%
X 2 3
3 2
41
Control vs. Capability Com mon and Special Causes
42
Control vs. Capability
Statistical Control
In- Control Out-of-Control
(Common Cause) (Special Cause)
43
Cp, Cpk, Pp & Ppk
44
Measures of Process Capability
(Capability Index)
Within
Overall Subgroup
Within Variation Variation
Subgroup
Overall Variation Variation
if stable
Capability
Pp Cp
If centered
Overall Within
Kenneth J Kortge
45
Capability Metrics – Acceptance Criteria
Typical:
Not
Index 1.33
Acceptable
46
2 Types of Data
Va r i a b l e
Attribu
te
47
Va ri a bl e s C h a r t s
Typical
:
Chart X-Bar & R Median Individual &
Type Moving Range
(MR)
Plots the average size Plots the individual Plots the sample size
What Is and the range of the sizes of the parts and and the moving range
part sizes the median of the part of the sample size
Charted sizes
48
Attribu t e Charts
Typical
:
Chart Type P Chart nP Chart C Chart U Chart
Primary Used for Used for Used for Used for
Usage analyzing analyzing the analyzing analyzing
proportion or number nonconformities nonconformities
percent nonconforming or defects per unit
nonconforming or or defective
defective parts parts
What is Plots the Plots the Plots the count Plots the average
proportion or number of of all number of
Charted percent of the nonconforming nonconformities nonconformities
nonconforming items found in the in each sample
units sample
49
X & R Chart
50
How Control Charts Work
UCLX
LCLX
51
Special Cause Criteria
52
Special Cause Criteria
53
Statistical Process Control
Pitfalls
• Ignoring out of control conditions
• Comparing control limits to spec limits
• Making process adjustments without understanding
the source of the special cause variation
• Putting SPC charts on everything
54
MSA
Measurement Systems
Analysis
55
MSA
What is it?
A collection of statistical methods used to assess how
much I can trust the information from a gauge
56
Bias: difference between the measurement
and the "true" value
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Stability: change in bias over time
58
Linearity: change in bias across expected range of
measurements
59
Gage Repeatability and Reproducibility = GRR = R&R
Typical:
10 Parts
3 Appraisers
3 Trials
60
GRR / R&R
2
GRR =
2
Reproducibility
2
+ Repeatability
(NDC) 61
Repeatability: gage-induced variation
Appraiser A
Repeatability
62
Reproducibility: operator-induced variation
Reproducibility
Appraiser A C B
63
The Effect of Measurement Error
“Observed” “Actual”
Total Variation = Process Variation + Measurement Variation
2 2
2 Total = Process + Measurement
Think of a
right triangle
Measurement
Variation
P
Kenneth J Kortge
r
o 64
The Effect of Measurement Error
Measurement
Variation
W
Kenneth J Kortge
h
a 65
Gage R&R Acceptance Criteria (Typical)
% R&R
Under 10% error – Acceptable
10% - 30% error – May be acceptable based upon importance
of application, cost of measurement device, cost of repair, etc.
Over 30% error – Not Acceptable. Every effort should be
made to improve the measurement system
66
Measurement Systems Analysis
Pitfalls
• Using MSA to obtain a number, rather than to understand
gage variation
• Not documenting a conclusion and any actions needed,
as part of the study
• Not conducting MSA for all gages on the control plan
(IATF 16949 requirement)
• Not validating Software (IATF 16949 requirement)
• Using wrong analysis method (non-replicable, attribute,
etc.)
67
Automotive Core Tools
Control Plan
(SPC)
ASQ Automotive Division 68 Webinar
QUESTIONS
69