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
Inspection/Testing Points
Receiving inspection
In-process inspection
Final inspection
5
Receiving Inspection
Spot check procedures
100 percent inspection
Acceptance sampling
6
Acceptance Sampling
Lot received for inspection
Sample selected and analyzed
Results compared with acceptance criteria
Accept the lot Reject the lot
Send to production Decide on disposition
or to customer
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Pros and Cons
of Acceptance Sampling
Arguments for: Arguments against:
Provides an assessment Does not make sense for
of risk stable processes
Inexpensive and suited Only detects poor quality;
for destructive testing does not help to prevent it
Requires less time than Is non-value-added
other approaches Does not help suppliers
Requires less handling improve
Reduces inspector
fatigue
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
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Economic Model
C1 = cost of inspection and removal of
nonconforming item
C2 = cost of repair
p = true fraction nonconforming
Breakeven Analysis: p*C2 = C1
If p > C1 / C2 , use 100% inspection
If p < C1 / C2 , do nothing 10
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.
Gauges and
Measuring Instruments
Variable gauges
Fixed gauges
Coordinate measuring machine
Vision systems
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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)
Measuremen t (M) made by
Operators (i from 1 to m) on
Parts (j from 1 to n) in
Trials (k from 1 to r)
M ijk
xi j k average for each operator
n r
xD max ( xi ) min ( xi ) difference (range) of operator averages
i i
R ij max ( M ijk ) min ( M ijk ) range for each part for each operator
k k
Rij
Ri j average range for each operator
n
Ri
R i average range of all
m
Reliability and Reproducibility
Studies(3)
Control limit of ranges Rij D4 R
Use number trials (r) for n in table. Check
for randomness of errors.
Repeatability or Equipment Variation
EV K1 R K1 is a constant tied to # of trials
Reproducibility or operator (appraisal) variation
EV 2
AV K 2 xD
2
K 2 is a constant tied to # of operators
n r
Repeatability and Reproducibility
R & R EV AV
2 2
Results are in actual units measured. Customary to express
as percentages.
Under 10% - Acceptable
10 - 30% - ? based on importance and repair cost
Over 30% - Unacceptable
R&R Constants
Number of 2 3 4 5
Trials
K1 4.56 3.05 2.50 2.21
Number of 2 3 4 5
Operators
K2 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.
x1 0.830
x2 0.774
x3 0.829
R1 0.037
R2 0.034
R3 0.017
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
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
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Common
Causes
Special
Causes
Histograms do not
take into account
changes over time.
Control charts
can tell us
when a process
changes
Control Chart Applications
Establish state of statistical
control
Monitor a process and signal
when it goes out of control
Determine process capability
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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)
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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
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
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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
UTL LTL
Cp
6
if C p 1 is defined as capable (1.5 more often the minimum)
Example : Part specification is 10.75mm .25mm 0.0868mm
11 .00 10.50
Cp 0.96
6 0.0868
Process Capability (2)
UTL 11 .0 10.7171
C pu
3 C pu 1.086
3 0.0868
LTL
C pl
3 10.7171 10.5
C pl 0.834
C pk min C pl , C pu 3 0.0868
2 T
C pk C p 1 K where K
Tolerance
Example : same as above, but assume process is centered at 10.7171mm
Cp
C pm T is the Target
1
T 2
2
0.960
C pm 0.8977
1
10.7171 10.75 2
0.8682
Capability Versus Control
Control
Capability In Control Out of Control
Capable IDEAL
Not Capable
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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
Control Chart Selection
Quality Characteristic
variable attribute
defective defect
no
n>1? x and MR
yes constant
yes constant
p or sampling
sample
np unit?
n>=10 or no size?
x and R
computer? yes no
no
yes
p-chart with c u
x and s variable sample
size
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Control Chart Design Issues
Basis for sampling
Sample size
Frequency of sampling
Location of control limits
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Pre-Control
LTL UTL
Red Red
Zone Green Zone Zone
nominal
value
Yellow Zones 67
SPC Implementation
Requirements
Top management commitment
Project champion
Initial workable project
Employee education and training
Accurate measurement system
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