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Tolerance Analysis/PPAP
Six Sigma
M Product Design and Analysis
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 Objectives

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• Basic theory and statistics behind six sigma
• How six sigma affects design

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• Detailed use of six sigma in design and product support
• Relationship between Six Sigma/Tolerance Analysis and Design
Approval

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• Provide further reading for additional learning (Additional Information)
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 Overview

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• Originally created as a process improvement tool
• Six Sigma (6σ) strives for perfection

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• Provides techniques and tools to improve capability and reduce defects
• Ensures 99.9997% of all products produced in a given process are
within design limits (Assuming a 1.5 sigma shift in nominal is taken into account)

–
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• Provides a proactive approach to design
Focuses on prevention of issues
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 Basics

• Define Standard 6σ Theory

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– Determine Customer requirements
– Set baseline
• Measure

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– Develop measurement and collection
process
– Collect data
• Analyze
– Review data
– Determine root cause (if necessary)
–
• Improve
–
–
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Determine potential improvements

Validate potential improvements

Implement improvements
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• Control
– Monitor improvements
– Assess effectiveness
– Determine needed Adjustments
 Basics

Design for 6σ (DFSS)

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• Define
• Measure

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• Analyze
• DESIGN
– Implement design to meet customers
needs

• VALIDATE
M – Test design against customer needs

• All DFSS methods use the same types of

design tools. Examples include:
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– Quality Function Deployment
– Failure Modes and Effects Analysis
(FMEA / PFMEA)
– Design of Experiments (DOE)
 Basics

6σ Statistics

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• Focuses on a shift of nominal and
reduction in variation

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• Based upon Average ( x ) and
Standard Deviation (σ or s) of a
sample
– Assumes a normal distribution over
time

x=
∑x
i =1
i
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– Assumes a large sample size
n

σ=
n

∑ (x − x )
i
2
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i =1
n n −1
 Basics

• Key process factors include Cp and Statistics - Cp and Cpk

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Cpk
– Directly linked (Cp) to defects and 6σ
• Cp determines if the process can fit

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within its limits (tolerances)
– Ratio defining the process spread
(width)

Cp =
(USL − LSL )
6σ
• Cpk determines how close the M
process is to its center (nominal)
– Capability is spread AND location
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C pu =
(USL − x )
C pl =
( x − LSL )
[1]

3σ 3σ
– Cpk = Minimum of Cpu and Cpl

[1] – Statistical Process Control. 2000-2009. MoreSteam.com. <http:// http://moresteam.com/toolbox/t402.cfm>

 Basics

Cp and Cpk Distribution

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PL
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 Basics

Process / Defect Metrics

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• DPPM = Defective parts per million
d 
( )
Does NOT take into account the

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DPPM =   × 1×106 complexity of the “system”
 dt 
• DPHU = Defects per hundred units
d 
DPHU =   ×100
u

opportunities
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• DPMO = Defects per million Provides a Direct link to
statistical control
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and 6σ
 d 
DPMO =   × 1×10 (
6
)
 u×o 
Conversion
 Design and 6 Sigma

MANUFACTURING DESIGN

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• Part level manufacturing validation • Used to validate and improve design
at a subsystem level
• Statistical Process Control (SPC)

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used as method for process • Constraint Matrix
validation
• Tolerance Analysis
– Includes Cp and Cpk

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 Design and 6 Sigma

Manufacturing

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SPC is Process control ensuring a process is stable over time

• Two types of process control issues

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– Common Cause are Predictable causes accounting for 85% of all issues
• Changes to common cause items require a PROCESS change
– Special Cause are Sporadic causes accounting for 15% of all issues
• Special causes cannot be prevented by process
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– Deal with the EVENT, not the process
– Engineer can only lessen the effect with proper CONTINGENCY PLANNING

• Only Common Cause variation is taken into account during sigma

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calculations (See causes, below/right)

“causes”
 Design and 6 Sigma

MFG Use

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• Part level validation
– Focuses on producing a part

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within limits

• Supplier SPC Use/Charting

– Long term data gathering [1]

– True process control over time

• Engineering SPC Use/Charting

– Short term data analysis
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– Predicted process control based
on small sample size
• Typically 30 pieces from 300

Sample Size Example

[1] – Statistical Process Control. 2000-2009. MoreSteam.com. <http:// http://moresteam.com/toolbox/t402.cfm>

 Design and 6 Sigma

Design / Mechanical Sub-Assy(s)

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• Theoretical tools to validate and
improve design at part and
subsystem levels

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• Preventative design approach
– Utilizes part production methods and
part interaction to predict design
quality

•
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– Constraint Matrix
Defines the interaction between every
part in an assembly
Aids in determining tolerance loop for
the Tolerance Analysis (TA)
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– Tolerance Analysis
• Closed loop analysis determining
variation between chosen items
 Design and 6 Sigma

Design - Constraint Matrix

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• How do parts interact?
• What parts and gaps are critical?

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• What items are included in a
tolerance loop?

• What is the nominal gap between

each part?
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• Matrix provides individual part
interaction and nominal gap, but no
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link to tolerance loop

• Bubble Chart (not shown) provides visual

map of part interaction and clear
path for tolerance loop
 Design and 6 Sigma

Design - Tolerance Analysis

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• Critical Items
– Is the loop correct?

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– Are the correct tolerances used?
– Is the nominal gap correct?
– Are user defined limits included?
– Is the calculated sigma value
adequate?
•

•
possible M
Strive for six sigma wherever

Final sigma value is engineering

judgment
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– HOWEVER, deviations to very low
sigma levels are dangerous and
require detailed analysis and
technical explanation for proper
consideration
 Design and 6 Sigma

6σ / PPAP Relationship

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• Tolerance analysis will help define critical dimensions to include on drawings
– Any feature / dimension used in a tolerance analysis must be included on the part
drawings and documented in a Production Part Approval Process (PPAP) document

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– Part and drawing changes affecting TA items should be analyzed prior to change to
ensure they do not negatively affect quality
• Tolerance Analyses are critical in determining assembly capabilities, including
– Tolerances of visual gaps
– Proper function of latches and mechanisms
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• SPC items are used to determine process capability (not necessarily tied to TA
items)
– Select critical dimensions flagged as SPC to provide overall process capability
– Any PPAP measurements near upper or lower limits must be accompanied by SPC
analysis to demonstrate adequate process control and to maintain proper quality
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• Low sigma values / low SPC values directly relate to poor quality.

Poor Quality Cost

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BACKUP
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 Conversion Charts

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PL
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 Cost of Quality

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• Lower sigma levels mean more
defects and poor quality

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• Poor quality comes at a cost
– Refer to comparison at right to see
an estimated cost impact of poor
quality on company sales

Six Sigma Quality Level Comparison

M Sigma
6 Sigma
5 Sigma
4 Sigma
Defects Per Million
Opportunities
3.4 defects
233 defects
6,210 defects
Cost of Poor
Quality
< 10% of sales
10-15% of sales
15-20% of sales
Notes
World Class

Industry Average
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3 Sigma 66,807 defects 20-30% of sales
2 Sigma 308,537 defects 30-40% of sales Non-Competitive
1 Sigma 690,000 defects
Source: Harry, pg 61
 1.5 Sigma Shift

... 6 sigma actually translates to about 2 defects per BILLION

opportunities, and 3.4 defects per million opportunities, which we

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normally define as 6 sigma, really corresponds to a sigma value of 4.5.
Where does this 1.5 sigma difference come from?

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• Motorola determined, through years of process and data collection, that
processes vary and drift over time – what is commonly called “Long-
Term Dynamic Mean Variation”. This variation typically falls between
1.4 and 1.6.
– Early in the project cycle, the standard deviation and sigma value of the
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process is measured. This early measurement is considered a short-term
value, as it can only be attributed to common cause variation. A full project
and the associated collection of process data covers a much longer period
of time (years, rather than months). This long term data contains both
common cause AND special cause variation. Because short term data
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does not contain this special cause variation, it will typically yield a higher
process capability than is realistic long-term.
• The difference is the 1.5 sigma shift…
 MFG Example

Statistical example “significance”

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• Sample sizes should contain a
minimum of 30 pieces to provide any
significant information

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• The larger the sample size, the
smaller the opportunity for error

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 Additional Information

Further Six Sigma Reading:

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• http://moresteam.com/toolbox/index.cfm
• http://www.isixsigma.com/library/content/six-sigma-newbie.asp

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• Six Sigma: The Breakthrough Management Strategy Revolutionizing the
World’s Top Corporations, Mikel Harry and Richard Schroeder, 2000

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