Statistical Process Control

Douglas M. Stewart, Ph.D.

The Anderson Schools of Management
The University of New Mexico
Quality Control (QC)
Control the activity of ensuring
conformance to requirements and taking
corrective action when necessary to
correct problems
Importance
Daily management of processes
Prerequisite to longer-term improvements
Designing the QC System
Quality Policy and Quality Manual
Contract management, design control and
purchasing
Process control, inspection and testing
Corrective action and continual improvement
Controlling inspection, measuring and test
equipment (metrology, measurement system analysis
and calibration)
Records, documentation and audits
Example of QC: HACCP System
1. Hazard analysis
2. Critical control points
3. Preventive measures with critical limits for
each control point
4. Procedures to monitor the critical control
points
5. Corrective actions when critical limits are
not met
6. Verification procedures
7. Effective record keeping and documentation
5
Inspection/Testing Points
Receiving inspection
In-process inspection
Final inspection
6
Receiving Inspection
Spot check procedures
100 percent inspection
Acceptance sampling
7
Acceptance Sampling
Lot received for inspection
Sample selected and analyzed
Results compared with acceptance criteria
Accept the lot
Send to production
or to customer
Reject the lot
Decide on disposition
Pros and Cons
of Acceptance Sampling
Arguments for:
Provides an assessment
of risk
I nexpensive and suited
for destructive testing
Requires less time than
other approaches
Requires less handling
Reduces inspector fatigue
Arguments against:
Does not make sense for
stable processes
Only detects poor quality;
does not help to prevent it
I s non-value-added
Does not help suppliers
improve
9
In-Process Inspection
What to inspect?
Key quality characteristics that are related
to cost or quality (customer requirements)
Where to inspect?
Key processes, especially high-cost and
value-added
How much to inspect?
All, nothing, or a sample
10
Economic Model
C
1
= cost of inspection and removal of
nonconforming item
C
2
= cost of repair
p = true fraction nonconforming

Breakeven Analysis: p*C
2
= C
1

If p > C
1
/ C
2
, use 100% inspection

If p < C
1
/ C
2
, do nothing
Human Factors in Inspection
complexity
defect rate
repeated inspections
inspection rate
Inspection should never be a means of assuring
quality. The purpose of inspection should be to gather
information to understand and improve the processes
that produce products and services.
12
Gauges and
Measuring Instruments
Variable gauges
Fixed gauges
Coordinate measuring machine
Vision systems
Examples of Gauges
Metrology - Science of Measurement
Accuracy - closeness of agreement
between an observed value and a
standard
Precision - closeness of agreement
between randomly selected individual
measurements

Repeatability and
Reproducibility
Repeatability (equipment variation)
variation in multiple measurements by an
individual using the same instrument.
Reproducibility (operator variation) -
variation in the same measuring
instrument used by different individuals
Repeatability and
Reproducibility Studies
Quantify and evaluate the capability of a
measurement system
Select m operators and n parts
Calibrate the measuring instrument
Randomly measure each part by each
operator for r trials
Compute key statistics to quantify
repeatability and reproducibility
Reliability and Reproducibility
Studies(2)
all of range average
operator each for range average
operator each for part each for range ) ( min ) ( max R
averages operator of (range) difference ) ( min ) ( max
operator each for average
r) to 1 from (k Trials
in n) to 1 from (j Parts
on m) to 1 from (i Operators
by made (M) t Measuremen
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Reliability and Reproducibility

Studies(3)
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ble Unaccepta - 30% Over
cost repair and importance on based ? - 30% - 10
Acceptable - 10% Under
s. percentage as
express to Customary measured. units actual in are Results
&
ility Reproducib and ity Repeatabil
operators of # to ied constant t a is
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Variation Equipment or ity Repeatabil
errors. of randomness for
Check in table. n for (r) als number tri Use
ranges of limit Control
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R&R Constants
Number of
Trials
2 3 4 5
K
1
4.56 3.05 2.50 2.21
Number of
Operators
2 3 4 5
K
2
3.65 2.70 2.30 2.08
R&R Evaluation
Under 10% error - OK
10-30% error - may be OK
over 30% error - unacceptable
R&R Example
R&R Study is to be conducted on a gauge being used to
measure the thickness of a gasket having specification
of 0.50 to 1.00 mm. We have three operators, each
taking measurement on 10 parts in 2 separate trials.
017 . 0
034 . 0
037 . 0
829 . 0
774 . 0
830 . 0
3
2
1
3
2
1
=
=
=
=
=
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R
R
R
x
x
x
Calibration
Calibration - comparing a measurement
device or system to one having a known
relationship to national standards
Traceability to national standards
maintained by NIST, National Institute of
Standards and Technology
24
Statistical Process Control (SPC)
A methodology for monitoring a process
to identify special causes of variation and
signal the need to take corrective action
when appropriate
SPC relies on control charts
Common
Causes
Special
Causes
Histograms do not
take into account
changes over time.
Control charts
can tell us
when a process
changes
27

Control Chart Applications
Establish state of statistical
control
Monitor a process and signal
when it goes out of control
Determine process capability
28
Commonly Used Control Charts
Variables data
x-bar and R-charts
x-bar and s-charts
Charts for individuals (x-charts)
Attribute data
For defectives (p-chart, np-chart)
For defects (c-chart, u-chart)
Developing Control Charts
1. Prepare
Choose measurement
Determine how to collect data, sample size,
and frequency of sampling
Set up an initial control chart
2. Collect Data
Record data
Calculate appropriate statistics
Plot statistics on chart
Next Steps
3. Determine trial control limits
Center line (process average)
Compute UCL, LCL
4. Analyze and interpret results
Determine if in control
Eliminate out-of-control points
Recompute control limits as
necessary
36
Typical Out-of-Control Patterns
Point outside control limits
Sudden shift in process average
Cycles
Trends
Hugging the center line
Hugging the control limits
Instability
Shift in Process Average
Identifying Potential Shifts
Cycles
Trend
Final Steps
5. Use as a problem-solving tool
Continue to collect and plot data
Take corrective action when
necessary
6. Compute process capability
Process Capability
Capability Indices
mm mm mm
C
LTL UTL
C
p
p
0868 . 0 25 . 75 . 10 is ion specificat Part : Example
minimum) often the more (1.5 capable as defined is 1 if
6
=
>

=
o
o
96 . 0
0868 . 0 6
50 . 10 00 . 11
=
-

=
p
C
( )
Target the is T
1
2
2
o
T
C
C
p
pm

+
=
( )
( )
10.7171mm at centered is process assume but above, as same : Example
2
where 1
, min
3
3
Tolerance
T
K K C C
C C C
LTL
C
UTL
C
p pk
pu pl pk
pl
pu

= =
=

o

Process Capability (2)
086 . 1
0868 . 0 3
7171 . 10 0 . 11
=
-

=
pu
C
834 . 0
0868 . 0 3
5 . 10 7171 . 10
=
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=
pl
C
( )
8977 . 0
868 . 0
75 . 10 7171 . 10
1
960 . 0
2
2
=

+
=
pm
C
44
Capability Versus Control
Control
Capability
Capable


Not Capable
In Control Out of Control
I DEAL
Process Capability Calculations
Excel Template
Special Variables Control Charts
x-bar and s charts
x-chart for individuals

Charts for Attributes
Fraction nonconforming (p-chart)
Fixed sample size
Variable sample size

np-chart for number nonconforming

Charts for defects
c-chart
u-chart
64
Control Chart Selection
Quality Characteristic
variable attribute
n>1?
n>=10 or
computer?
x and MR
no
yes
x and s
x and R
no
yes
defective defect
constant
sample
size?
p-chart with
variable sample
size
no
p or
np
yes
constant
sampling
unit?
c u
yes no
65
Control Chart Design Issues
Basis for sampling
Sample size
Frequency of sampling
Location of control limits
67
Pre-Control
nominal
value
Green Zone
Yellow Zones
Red
Zone
Red
Zone
LTL UTL
68
SPC Implementation
Requirements
Top management commitment
Project champion
Initial workable project
Employee education and training
Accurate measurement system