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Quality Assurance - Process

Control-tools & techniques

Srinivasan Nenmeli-K

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Q A through Process Control
◆ Process control is the key for QA
◆ Identify the key processes & their parameters
◆ Set limits to the parameters-higher and lower;
sometimes only one of these.
◆ Suppose you make cakes---take baking step as a
key process
◆ Set lower and higher limits for baking
temperature--say 50 degrees and 60 degrees
centigrade--the "tolerance"
◆ What are the other key processes in baking?-list
now! QA-2 NKS 2
Tolerance -What it means?
◆ Based on experience or testing, you fix the
◆ As a rule,.closer the tolerance, costlier and
difficult is the process
◆ Suppose you make shafts for automobiles rear
axle Suppose you set the length of shaft as: 120
mm with tolerance + or - 3mm.This may be
suitable for a farm tractor.
◆ For passenger cars ,you may set 120 mm with
tolerance + or - 1mm
◆ For smooth-riding,expensive car [Rolls-Royce
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,say] you may set 120 mm with tolerance + or -
Quality Control--Old Style
◆ Quality control and inspectors go together!
◆ What did old style inspectors do for the
shafts mentioned?
◆ Suppose the length is 120 mm ,tolerance +
or - 1mm
◆ Upper specification limit [USL]is 121
mmLower specification limit [LSL] is 119
mm------Tolerance is: USL-LSL=2mm--
◆ Inspectors checked a shaft with two gages
of 121 and 119 mm-- 'gages' called 'Go-
NoG0' gages QA-2 NKS 4
QC- Old style
◆ Inspectors passed if the length was within
specs: between 121 mm and 119 mm.
◆ Others were rejected.
◆ Do you want most of the shafts close to
120 mm?
◆ Do you check for variation of length
between 121 mm and 119 mm?
◆ How many are close to the mean,120 mm?

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Variability of parameters
◆ Statistics is a science of variations.
◆ If all of us are of same height at certain age,there
is no need for statistical analysis.
◆ How do we approach the variations?
◆ Suppose your auto-plant makes 1000 shafts a
day.You take a sample of 100 shafts and
measure their lengths.
◆ Most probably, you will find the average or mean
value of the lengths.Suppose the mean is 120
mm .Are you satisfied?
◆ The old-style inspectors found the number falling
within 121mm and `119 mm--let us say 68 shafts
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were within the limits and accepted.
Mean and Sigma
◆ The old style inspector would reject the remaining
32 shafts--outside the limits--32% rejection!
◆ Suppose you find the "standard deviation" or
sigma from the 100 measurements of length.
{Find the formula for sigma--most calculators and
computer programs give this}
◆ sigma squared = sigma x sigma = variance --->
remember this
◆ Now our Engineer Tom finds that the sigma value
turns out to be 0.98 mm, take it as 1mm--> sigma
= 1mm
◆ Aha! you have got the clue now:
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Tolerance and Sigma
◆ Tom found that tolerance was mean + /- sigma.
◆ Tom talked to his Stats Professor, Prof. Variant,
and he told that if you take those pieces with this
tolerance ,you will get only 68.2% acceptable
within tolerance.The rejection will be 32% [or
nearly 2/3rd fall within tolerance , 1/3rd outside
the limits---easy to remember]
◆ Prof Variant told that the lengths of the shafts
followed "Normal Distribution" [the bell -shaped
curve]with mean as 120 mm and sigma or
Standard Deviation as 1mm.
◆ How to reduce rejections with the same
tolerance?No use looking
at the mean.The sigma 8
Process Control-sigma
◆ QA means "process control".
◆ Process control means "reduce sigma to the desired level"
◆ This is the great lesson the Japanese learnt from
Deming,Juran and others...control variability--reduce
◆ Tom improved the process of making shafts . Now Tom
finds sigma = 0.5 mm for 100 shafts .
◆ Then tolerance limits are: 121 = 120 + 2x0.5 mm and 119
=120 - 2x0.5 mm.Within 2sigma above and below the
◆ Prof Variant told now: Normal distibution tells that nearly
95 % of shafts will pass .Tom is sure that only 5% of
shafts will be rejected.Great improvement! but not
sufficient. QA-2 NKS 9
Sigma control
◆ Reducing sigma or control of variance is the key to QA
◆ From 1930's and particularly since World War II [say
1945] in most industries,many learnt this lesson..The
Japanese applied to almost all manufacture-
toys,electronics,optics,steel and the automobiles.Some
did not learn and lost to competition their business.
◆ A standard rule was developed:
Tolerance/sigma =6
◆ 'Maintain this -dummies '---told the Quality gurus.
◆ Performance Index = tolerance/ 6 (sigma)
◆ PI should be greater that 1 [can be 1.2 or more]
◆ Suppose tolerance = 2mm sigma should be 2/6=0.33mm
or less! QA-2 NKS 10
Taguchi and Quality Cost

◆ Taguchi was a great quality guru.

◆ No use inspecting using tolerance only!;
◆ Any deviation from the mean entails cost-cost to
customers & cost to society
◆ To make it quantitative,Taguchi gave a simple
cost equation:
◆ If the mean is xo and the actual value is x, the
cost is : Cost = k( x - xo)^2 where k is a
◆ The cost increases as the square of the deviation
from mean --- a parabolic
curve or quadratic 11
How to reduce sigma ?
➢ QA involves reducing sigma for critical
➢ Reduction of sigma applies to both manufacturing
and service industry--examples follow
➢ Suppose you run a transportation company.The
delivery time from New York to Chicago may vary
with mean 32 hours ,with sigma +/-2 hours.Your
effort should be to reduce the sigma from 2 to 1
➢ In process control, first you reduce sigma ,then
you may shift the mean to lower or higher value---
first you control the process
,that is, reduce 12
Find sources for variation
◆ What are the sources of variation? What factors
increase sigma?
◆ In manufacturing: sigma squared = sum of sigma
squareds for material, machine,labor,tools and
◆ Find which sigma-squareds are high.If you are
using poor quality materials and worn-out
tools,their sigmas will be large.
◆ This is called variance analysisor Anova to
separate out the causes of variation or sigma.

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Simple QA tools
◆ Use check-lists as often as you can--for simplest
of tasks...checklist is a powerful QA tool.!
◆ Develop internal company-wide standards--they
should be written down,discussed and reviewed
◆ 'Auditing'--What is this? It is "checking against
specifications" --Encourage auditing and review
audit reports;train internal auditors;
◆ Do "quality audit" at least once a quarter[3
◆ Use the magnifient "Seven Q C tools"
QA-2 NKS 14
Process Flow Chart

◆ Draw a process flow chart--Can you simplify the

◆ Making cake: measure ingredients-->mix-->make
dough-->put in trays-->bake in oven
◆ For each process step,identify the critical
◆ Can you avoid some steps?Can you reduce
waiting times between steps?
◆ Involve your staff in making and analyzing
process flowcharts
◆ Can you combine steps?--example:
your 15
receptionist combines reception and phone-
Measurements and process control
◆ " What you can measure,You can control"
◆ Measure critical parameters of processes--not
just productivity
◆ Measurements relating to:1
materials,2machines,3methods & tool,4men &
◆ 5 Mother Nature--environment [humidity for
instance in some industries]
◆ Metrics is the word used for measurements and
their analysis

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Process Ownership
◆ Give process ownership to your
◆ Do they follow QC/QA concepts?
◆ Are they willing to follow Quality Audits?
◆ Do they write standards for their
◆ Do they perform defect measurement and
◆ Do they measure critical parameters?
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Q A for service industry
◆ Several service industries apply QA --health
care,information technology,hospitality,telecom
and education
◆ Measure mean and sigma for service parameters
and reduce the sigma value.The most important
service parameters are often 'time-related
factors'.We saw the example of transportation
◆ Response time to fix customer
complaints/problems is an important parameter to
control---find its mean & sigma.Can you reduce
this? QA-2 NKS 18
Practical means to reduce sigma

● See my other presentation : "QA- 5 tips"---Learn about

the Deming cycle or Plan-Do-Check-Act cycle
● Training of employees at all levels is the potent method to
reduce sigma.Without sufficient training ,they cannot
control processes.
● Develop the culture of 'Continuous Improvement'--Quality
is not a quick-fix program.
● Control the sigma of incoming raw material or products--
this is very essential for product industries---Control the
process sigma of equipment and tools used.
● In service industry, improve documentation and logging of
records.The documents serve as 'raw materials' to control
the sigma.
QA-2 NKS 19
● Above all, apply the 'magnificent seven' QC tool
◆ See the connection between quality and tolerance
and sigma values of process parameters
◆ Practice "Continuous Improvement"
◆ Identify key processes and their critical
◆ Use PDCA cycle and the seven QC tools to
reduce sigma of these parameters
◆ Emphasize training for all employees

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Suggested Reading

□ Dale Besterfield et al --- Quality

□ Dale Besterfield et al --- Total Quality
□ Peter Pande -- The Six Sigma way

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Contact me for further presentations

and info:
email ID:

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