IV Product and Process

Control (25 Questions)

 Product and Process Control
❖ Product and Process Control Methods
1. Control Plan development
2. Critical Control Point identification
3. Work Instructions development
4. Validation
 1. Control Plan
❖ A Control Plan is a written document of
actions for controlling product and
processes
❖ Control Plan helps in maintaining the
process characteristics.
❖ Process owner needs to be involved in
the making of Control Plan.
❖ Control Plan should be reviewed and
revised time to time, based on lessons
learned.
Controls Plan Example
 2. Critical Control Points Identification
❖ Critical Control Point (CCP) is the point
where the failure of Standard Operation
Procedure (SOP) could cause harm to
customers and to the business, or even
loss of the business itself.
❖ Critical Control Points are sometimes
referred to as the “Stop Sign” of the
process.
❖ The term is usually associated with food
safety HACCP.
 HACCP
❖ Hazard Analysis Critical Control Point is an
effective way to assure food safety from
harvest to consumption.
❖ Preventing problems from occurring is the
underlying goal of any HACCP system.
❖ Seven principles to meet this goal are:
❖ Hazard Analysis
❖ Critical Control Point Identification
❖ Establishing Critical Limits
❖ Monitoring Procedures
❖ Corrective Actions
❖ Verification Procedures, and
❖ Record Keeping and Documentation
 CCP Examples
❖ Examples of CCP in food industry:
❖ thermal processing
❖ chilling
❖ testing ingredients for chemical residues
❖ product formulation control
❖ testing product for metal contaminants
 3. Work Instructions Development
❖ A work instruction describes how to
perform a task within a process
❖ More detailed than procedures,
explaining each step.
Documentation Structure

Quality Manual

Procedures

Standard Operating Procedures

Work Instructions

Records
 4. Validation
Covered in Section IIID

ISO 9001:2015 Requirement: (8.3.4d)

❖ validation activities are conducted to
ensure that the resulting products and
services meet the requirements for the
specified application or intended use;
Review, Verification & Validation

Validation activities are

Reviews are conducted to Verification activities are
conducted to ensure that the
evaluate the ability of the conducted to ensure that the
resulting products and services
results of design and design and development
meet the requirements for the
development to meet outputs meet the input
specified application or
requirements requirements;
intended use;
 IV-B Material Control

1. Material identification, status, and traceability

2. Material segregation
3. Material classification
4. Material review board (MRB)
Material identification, status, and traceability
❖ Identification: the ability to determine
that the specified material grade and
size are being used.

❖ Positive Material Identification (PMI)

test for critical material.
Material identification, status, and traceability
❖ Status:
❖ approved, quarantined, or rejected
Material identification, status, and traceability
❖ Traceability: the ability to identify a
specific item, throughout the life, and its
specific mill test report (MTR).
❖ ISO 9000:2015 Definition
ability to trace the history, application or
location of an object.
Note 1 to entry: When considering a product or
a service, traceability can relate to:
— the origin of materials and parts;
— the processing history;
— the distribution and location of the product
or service after delivery.
Material identification, status, and traceability
❖ ISO 9001:2015 Requirement
❖ 8.5.2 Identification and traceability
❖ The organization shall control the
unique identification of the outputs
when traceability is a requirement, and
shall retain the documented information
necessary to enable traceability.
 Material Segregation
❖ Segregation: the practice or policy of
keeping things separate from each
other.
❖ Material Segregation:
❖ Pass / Fail
❖ Quarantine material (waiting for decision)
❖ Different material classes (e.g. Carbon Steel,
Stainless Steel)
 Material Classification
Classify product and process defects and
non-conformities.

❖ ISO 9000:2015 Definitions:

❖ Nonconformity: non-fulfilment of a
requirement
❖ Defect: nonconformity related to an
intended or specified use
❖ Defects adversely affect the functionality of
the product
 Nonconformities – ISO 9001:2015
❖ 8.7 Control of nonconforming outputs
❖ 8.7.1 The organization shall ensure that outputs that do not
conform to their requirements are identified and controlled to
prevent their unintended use or delivery.
❖ The organization shall take appropriate action based on the
nature of the nonconformity and its effect on the conformity
of products and services. This shall also apply to
nonconforming products and services detected after delivery
of products, during or after the provision of services.
 Nonconformities – ISO 9001:2015
❖ 8.7 Control of nonconforming outputs
❖ The organization shall deal with nonconforming outputs in
one or more of the following ways:
a) correction;
b) segregation, containment, return or suspension of provision of
products and services;
c) informing the customer;
d) obtaining authorization for acceptance under concession.
❖ Conformity to the requirements shall be verified when
nonconforming outputs are corrected.
 Nonconformities – ISO 9001:2015
❖ 10.2.1 Nonconformity and Corrective Action
❖ a) react to the nonconformity and, as applicable:
❖ b) evaluate the need for action to eliminate the cause(s) of
the nonconformity, in order that it does not recur or occur
elsewhere,
❖ c) implement any action needed;
❖ d) review the effectiveness of any corrective action taken;
❖ e) update risks and opportunities determined during planning,
if necessary;
❖ f) make changes to the quality management system, if
necessary.
 Material Review Board
❖ MRB (Material Review Board) is usually
the name given to a committee of
people who collectively discuss the
treatment of material that has been
labeled as nonconforming.
 Material Review Board
❖ MRB Members may include
representatives from:
❖ Engineering
❖ Quality Assurance
❖ Manufacturing
❖ Material
❖ Purchasing

❖ Could include external parties such as

Client, Government representative,
 Material Review Board
❖ MRB decision could include:
❖ Accept under concession
❖ scrap material
❖ rework
❖ return purchased items to the supplier
❖ regrade material
 Acceptance Sampling
❖ Sampling will again be covered in VI.B.1
Quantitative Concepts.
❖ In this topic the focus is on acceptance
sampling.
❖ Purpose is just to accept or reject the lot
based on samples, without quantifying the
quality of product or processes.
Attribute Sampling
Example
• Lot size : 1,000, General inspection level
II
• Acceptable Quality Limit(AQL): 1.5%
• Take 80 random samples:
• Accept the lot if 3 or less are rejected.
• Reject the lot if 4 or more rejected.
 Sampling
Sample: Part
Population: Sampling of population
Complete Process
collection to
be studied

Inference
Parameter Statistic
Characteristic of Characteristic
a population of a sample
 Why Sampling?
❖ Because of the cost and time involved in
studying the entire population.
❖ If the test to be preformed is destructive
test.
❖ Lots to be tested are large, and the impact
of wrong judgement is low.
 Errors of Acceptance Sampling
Actual Lot Condition

Good Lot Bad Lot

Correct Type II Error

Accept the Lot
Conclusion Conclusion (Buyer’s Risk)
Based on
Sampling Type I Error Correct
Reject the Lot
(Producer’s Risk) Conclusion
 Errors of Statistical Tests
Type I error (alpha) Type II error (beta)
Name Producer’s risk Consumer’s risk

Example of Fire False fire alarm leading to Missed fire leading to

Alarm inconvenience disaster
Control method Usually fixed at a pre- Usually controlled to <
determined level, 1%, 5% 10% by appropriate
or 10% sample size
Simple definition Innocent declared as guilty Guilty declared as
innocent
 Alpha vs Beta
❖ As the value of α (producer’s risk of
good lot getting rejected) increases (say
0.01 to 0.05) β (consumer’s risk of bad
lot getting accepted) goes down.
❖ To reduce both Type I and II errors
increase sample size.
 Acceptance Sampling Standards

Standards
Attribute Sampling MIL-STD-105 (withdrawn) – AQL based
ANSI/ASQ Z1.4 – AQL based
Dodge-Romig – LTPD or AOQL based

Variable Sampling MIL-STD-414 (withdrawn) – AOQ based

ANSI/ASQ Z1.9
 Acceptable Quality Limit (AQL)
❖ MIL-ST-105 and 414 called it
“Acceptable Quality Level”.
❖ The Acceptable Quality Limit (AQL) is
the defect/defective rate that we wish
to accept ……….
AQL = 1.5%
we would expect to accept lots that had
1.5% defective units or less and reject lots
which have more than 1.5% defective units.
 Acceptable Quality Limit (AQL)
❖ The Acceptable Quality Limit (AQL) is the
defect/defective rate that we wish to
accept a high proportion of the time (1 –
α)
When Producer’s Risk alpha = 0.05, and
AQL = 1.5% it means:
❖ we would expect to accept lots that had
1.5% defective units 95% of the times.
 Rejectable Quality Limit (RQL)
❖ Also called LTPD (Lot Tolerance Percent
Defective)
❖ The Rejectable Quality Level (RQL) is the
defect/defective rate that we wish to
reject a high proportion of the time (β)
When Consumer’s Risk beta = 0.10, and
RQL = 8% (or 0.08) it means:
❖ we would expect to accept lots that had
8% defective units 10% of the times
max.
 OC Curve
❖ The Operating Characteristics Curve
❖ It’s a sampling plan which identifies risk
or the probability of acceptance vs the
lot quality.
 OC Curve
❖ Why can’t we have ideal curve?
❖ That will need 100% inspection.
 OC Curve
❖ Three zones of OC Curve: Acceptable,
Rejectable and indifferent quality.
 Plotting OC Curve
❖ Based on Binomial, Poisson or
Hypergeometric Distribution. Let’s use
Poisson Distribution to plot OC Curve:
❖ Sample size: 80, Acc = 3
❖ Condition for Poisson Distribution:
❖ The experiment results in outcomes that
can be classified as successes or failures.
❖ The average number of successes (μ) that
occurs in a specified region is known.
 Plotting OC Curve
❖ Sample size: 80, Acc = 3
❖ P(x; μ) = (e-μ) (μx) / x!
❖ e: A constant equal to approximately
2.71828.
❖ μ: The mean number of successes that
occur in a specified region.
❖ x: The actual number of successes that
occur in a specified region.
❖ P(x; μ): The Poisson probability that exactly
x successes occur in a Poisson experiment,
when the mean number of successes is μ.
 Plotting OC Curve
❖ Sample size: 80, Acc = 3
❖ P(x; μ) = (e-μ) (μx) / x!
❖ If the lot has 1% rejected items, what is
probability of acceptance of this lot?
❖ μ = 0.01 x 80 = 0.8
❖ P (0; 0.8) = (e-0.8) (0.80) / 0! = 0.449
❖ P (1; 0.8) = (e-0.8) (0.81) / 1! = 0.359
❖ P (2; 0.8) = (e-0.8) (0.82) / 2! = 0.144
❖ P (3; 0.8) = (e-0.8) (0.83) / 3! = 0.038
❖ Prob of accepting this lot Pa= 0.99
❖ Excel Formula = POISSON.DIST(3, 0.8, TRUE)
= 0.99092
 Plotting OC Curve
❖ Sample size: 80, Acc = 3
Lot Percent Probability of Acceptance Pa 1.2

Defective
(p) 1

1% POISSON.DIST(3, 0.8, TRUE) 0.99092 0.8

2% POISSON.DIST(3, 1.6, TRUE) 0.921187

0.6
3% POISSON.DIST(3, 2.4, TRUE) 0.778723 Pa
4% POISSON.DIST(3, 3.2, TRUE) 0.60252 0.4

5% POISSON.DIST(3, 4.0, TRUE) 0.43347

0.2
6% POISSON.DIST(3, 4.8, TRUE) 0.29423
7% POISSON.DIST(3, 5.6, TRUE) 0.190622 0
0 1 2 3 4 5 6 7 8 9 10

8% POISSON.DIST(3, 6.4, TRUE) 0.118919

9% POISSON.DIST(3, 7.2, TRUE) 0.071917
 Plotting OC Curve
❖ Sample size: 80, Acc = 3
1.2

α
1

0.8

0.6

P(a)
0.4

0.2

β
0
0 1 2 3 4 5 6 7 8 9 10
AQL RQL or LTPD
 Plotting OC Curve
❖ (n = 80, c = 3) vs (n = 150, c = 3)
n = 150, c = 3
1.2 1
α 0.9

α
1
0.8

0.7
0.8
0.6

0.6 0.5

P(a) 0.4
0.4
0.3

0.2
0.2

β β 0.1

0 0
0 1 2 3 4 5 6 7 8 9 10 0 1 2 3 4 5 6 7 8 9 10
AQL RQL or LTPD AQL RQL or LTPD
 Average Outgoing Quality (AOQ)
❖ For a particular process average, the
AOQ is the average quality of outgoing
product including all accepted lots or
batches, plus all rejected lots or batches
after the rejected lots or batches have
been effectively 100 percent inspected
and all defectives replaced by non-
defectives. (MIL-STD-105)
 Average Outgoing Quality (AOQ)
❖ Sample size = 80, acc. number = 3
1.2

❖ Take an example of 2% rejection 1

❖ Probability of acceptance of such lots is 0.8

0.921187 (round it to 0.92 or 92%) 0.6

Pa
0.4

❖ If we inspected 100 such lots, then 0.2

92% of the received lots have 2% 0

0 2 4 6 8 10

defectives and balance 8% are

perfect lots (lot sizes are same, we
screen and replace rejected lots)
 Average Outgoing Quality (AOQ)
❖ Sample size = 80, acc. Lot Percent
Defective
P(a) Average Outgoing Quality (AOQ)

number = 3 (p)
1% 0.99092 0.99092 x 0.01 = 0.0099
❖ Take an example of lots with 2% 0.921187 0.921187 x 0.02 = 0.0184
2% defectives 3% 0.778723 0.778723 x 0.03 = 0.0234
❖ Hence AOQ = 0.92 x 0.02 + 4% 0.60252 0.60252 x 0.04 = 0.0241
0.08 x 0 = 0.0184 5% 0.43347 0.43347 x 0.05 = 0.0217
6% 0.29423 0.29423 x 0.06 = 0.0177
❖ AOQ = p . Pa (simplified 7% 0.190622 0.190622 x 0.07 = 0.0133
version) 8% 0.118919 0.118919 x 0.08 = 0.0095
❖ AOQ = p.Pa (N-n)/N (formal 9% 0.071917 0.071917 x 0.09 = 0.0064
calculation)
 Average Outgoing Quality (AOQ)
Lot Percent P(a) Average Outgoing Quality (AOQ)
AOQ Defective
0.03
(p)
0.025 1% 0.99092 0.99092 x 0.01 = 0.0099
2% 0.921187 0.921187 x 0.02 = 0.0184
0.02
3% 0.778723 0.778723 x 0.03 = 0.0234
0.015
4% 0.60252 0.60252 x 0.04 = 0.0241
0.01 5% 0.43347 0.43347 x 0.05 = 0.0217
6% 0.29423 0.29423 x 0.06 = 0.0177
0.005
7% 0.190622 0.190622 x 0.07 = 0.0133
0
0 1 2 3 4 5 6 7 8 9 10
8% 0.118919 0.118919 x 0.08 = 0.0095
9% 0.071917 0.071917 x 0.09 = 0.0064
 Average Outgoing Quality Limit (AOQL)
❖ The AOQL is the maximum AOQ for a
given acceptance sampling plan.(MIL-
STD-105)
AOQ
0.03

0.025

0.02

0.015

0.01

0.005

0
0 2 4 6 8 10
 Average Total Inspection (ATI)
❖ ATI depends on: Lot Percent P(a) Average Outgoing Quality (AOQ)
❖ Incoming quality (e.g. 2% Defective
(p)
defectives)
1% 0.99092 0.99092 x 0.01 = 0.0099
❖ Probability that the lot will be 2% 0.921187 0.921187 x 0.02 = 0.0184
accepted (0.921187) 3% 0.778723 0.778723 x 0.03 = 0.0234
❖ Sample size (80) and lot sizes 4% 0.60252 0.60252 x 0.04 = 0.0241
(1000) 5% 0.43347 0.43347 x 0.05 = 0.0217
❖ Out of 100 such lots you: 6% 0.29423 0.29423 x 0.06 = 0.0177
❖ Inspected 80 items each for 92 7% 0.190622 0.190622 x 0.07 = 0.0133
lots (accepted lots) 8% 0.118919 0.118919 x 0.08 = 0.0095
9%
❖ And 1000 items for 8 lots 0.071917 0.071917 x 0.09 = 0.0064
(rejected lots)
 Average Total Inspection (ATI)
❖ Total inspections of p = 0.02 Lot Percent Pa Average Total Inspection (ATI)
Defective
❖ n.Pa + N.(1-Pa) (p)
1% 0.99092
❖ Inspected 80 items each for 92 88.35347
lots (accepted lots) 2% 0.921187 152.5084
3%
❖ And 1000 items for 8 lots 0.778723 283.5749
4% 0.60252 445.6819
(rejected lots)
5% 0.43347 601.2075
❖ Same formula written as: 6% 0.29423 729.3085
❖ n + (1-Pa)(N-n) 7% 0.190622 824.6274
8% 0.118919 890.5947
9% 0.071917 933.8363
 Average Total Inspection (ATI)
❖ Total inspections of p = 0.02 ATI
1200

❖ n.Pa + N.(1-Pa)
❖ Inspected 80 items each for 92 1000

lots (accepted lots) 800

❖ And 1000 items for 8 lots 600

(rejected lots)
❖ Same formula written as:
400

❖ n + (1-Pa)(N-n) 0.03
AOQ 200

0.025 0
0.02 0 2 4 6 8 10 12 14

0.015
0.01
0.005
0
0 2 4 6 8 10
 Acceptance Sampling Standards

Standards
Attribute Sampling MIL-STD-105 (withdrawn) – AQL based
ANSI/ASQ Z1.4 – AQL based
Dodge-Romig – LTPD or AOQL based

Variable Sampling MIL-STD-414 (withdrawn) – AOQ based

ANSI/ASQ Z1.9
 Attribute Sampling
❖ You need to decide
❖ Level (e.g. I, II, III, S1, S2, S3 or S4)
❖ AQL (Acceptable Quality Limit) – e.g. 1.5%
❖ Single, Double or Multiple Sampling Plan
❖ Reduced, Normal or Tightened inspection
Attribute Sampling
Example
• Lot size : 1,000, General inspection level
II
• Acceptable Quality Limit(AQL): 1.5%
• Take 80 random samples:
• Accept the lot if 3 or less are
rejected.
• Reject the lot if 4 or more rejected.
Attribute Sampling
Example
• Lot size : 50, General inspection level II
• Acceptable Quality Limit(AQL): 1.0%
• Take 13 random samples:
• Accept the lot if 0 rejected.
• Reject the lot if one or more rejected.
Attribute Sampling
Example
• Lot size : 50, General inspection level II
• Acceptable Quality Limit(AQL): 2.5%
• Take 5 random samples:
• Accept the lot if 0 rejected.
• Reject the lot if one or more rejected.
 Inspection Levels
❖ The inspection level determines the 1.2
n = 80, c = 3

relationship between the lot or batch 1

size and the sample size. 0.8

0.6

❖ Three inspection levels: I, II, and III, are 0.4

0.2

given in Table I for general use. 0

0 2 4 6 8 10

❖ Normally, Inspection Level II is used. n = 150, c = 3

❖ However, Inspection Level I may be used 1

0.8
when less discrimination is needed, 0.6

❖ or Level III may be used for greater 0.4

discrimination. 0.2

0
0 2 4 6 8 10
Attribute Sampling
Example
• Sample size for Inspection Level 3 > Level 2
>Level 1

❖ Normally, Inspection Level II is used.

❖ However, Inspection Level I may be
used when less discrimination is
needed,
❖ or Level III may be used for greater
discrimination.
 Inspection Levels
❖ Four additional special levels: S-1, S-2, S-
3, and S-4, are given in the same table
and may be used where relatively small
sample sizes are necessary and large
sampling risks can or must be tolerated.
 Inspection Levels
❖ So far you have decided on the:
❖ Level (e.g. I, II, III, S1, S2, S3 or S4)
❖ AQL (Acceptable Quality Limit) – e.g. 1.5%
❖ Single, Double or Multiple Sampling Plan
(so fat we were talking about Single
Sampling)
❖ The fourth thing you need to decide is:
❖ Reduced, Normal or Tightened inspection
 Reduced, Normal or Tightened Inspection
❖ Inspection Procedures
❖ Start with Normal
❖ Change to Tightened inspection more (?)
number of lots gets rejected. (There are
rules for this)
❖ Change to Reduced if more (?) lots are
accepted. (There are rules for this)
❖ You continue as Normal, Reduced or
Tightened procedures till until the criteria
to switch is met.
 Reduced, Normal or Tightened Inspection
ALL CONDITION TO
MEET
- Proceeding 10 lots Start
accepted 2 of 5 or fewer 5 lots not accepted
- Number of defectives consecutive lots are not while on tightened
less than in Table VIII accepted inspection
- Production at steady
rate
- Reduced inspection
desirable
Terminate

R Reduced N Normal T Tightened X

ANY CONDITION
- A lot or batch is
rejected
- A lot or batch is
considered
acceptable but 5 consecutive lots are Corrective action taken
rejections between accepted by supplier
Ac and Rej
- Production becomes
irregular
- Other conditions
 Types of Sampling?
❖ Single Sampling
❖ Double Sampling
❖ Multiple or Sequential Sampling

❖ Attribute Sampling (MIL-STD-105,

ANSI/ASQ Z1.4)
❖ Variable Sampling (MIL-STD-414, ANSI/ASQ
Z1.9)
 Single, Double or Multiple Sampling
❖ Single Sampling: Inspect n pieces

Reject the lot.

Yes Defectives
No
Accept the lot
Do 100% screening >= Re

❖ Double Sampling:
❖ Multiple Sampling:
 Single, Double or Multiple Sampling
❖ Double Sampling: Inspect first sample of
n1 pieces

d1 < = Ac1 d1 > = Re1

Re1 > d1 > Ac1

Inspect second sample

of n2 pieces

d1 + d2 <= Ac2 d1 + d2 > =Re2

Accept the lot Reject the lot
Single, Double or
Multiple Sampling

• Double Sampling
Example:
• N = 1000, AQL =
1.5%, General
Inspection II
• Code Letter J
• First sample of 50
items. Ac1 = 1 Re1 = 4
• Second sample 50
with Ac2 = 4, Re2 = 5
 Single, Double or Multiple Sampling
❖ Multiple Sampling:
❖ Max 7 samples
Dodge Romig Sampling Plan

MIL-STD-105 Dodge Romig

(or Z 1.4)
Based on AQL Based on LTPD/LQL/RQL (and consumer’s risk
beta) and AOQL
Single, Double and Multiple Single and Double
Protects the producer protects the customer
Intent is to minimize the ATI
To use these tables you need the estimate of
process average. Use recent data to estimate this
value. If no value is available use the largest value
in the table.
LTPD - Lot Tolerance Percent Defectives
LQL - Limiting Quality Level
RQL - Rejected Quality Level
 Dodge Romig Sampling Plan
AOQ – Using MIL-STD-105 / n=80,
❖ Example: AOQL = 3%, Lot size = 1,000, Ac = 3 – For demo only

Process Average = 1.5% 0.03

0.025

N = 44, c = 2, LQL = 11.8% 0.02

0.015
0.01
0.005
0
0 2 4 6 8 10

1.2
α 1

0.8

0.6
Pa
0.4

0.2

β 0
0 2 4 6 8 10
AQL LQL, RQL or LTPD
 Dodge Romig Sampling Plan
❖ Example: LTPD = 3%, Lot size = 1,000,
Process Average = 1.5%
N = 290, c = 5, AOQL = 0.78
 Variable Sampling
❖ ANSI/ASQ Z1.9 (based on MIL-STD-414)
❖ Measures continuous Variable (assumes
Normal Distribution)
❖ Single and Double Sampling Method
available.
Standards
Attribute Sampling MIL-STD-105 (withdrawn) – AQL based
ANSI/ASQ Z1.4 – AQL based
Dodge-Romig – LTPD or AOQL based

Variable Sampling MIL-STD-414 (withdrawn) – AOQ based

ANSI/ASQ Z1.9
 Variable Sampling
❖ MIL-STD-414
❖ Example source MIL-STD-414 Page 37
❖ Example: Max Temp 209 F. Lot size of 40,
AQL is 1%
❖ Inspection Level IV is Normal
❖ Sample size code = D
❖ Is variability unknown?
❖ In case of unknown there are standard
deviation and range methods.
 Variable Sampling
❖ MIL-STD-414
❖ Example: Max Temp 209 F. Lot size of 40,
AQL is 1%
❖ Inspection Level IV is Normal
❖ Sample size code = D
❖ Sample size = 5, Acceptability Factor
1.53
❖ Measurements for these 5 are: 197, 188,
184, 205, 201
 Variable Sampling
❖ Sample size = 5, Acceptability Factor 1.53
❖ Measurements for these 5 are: 197, 188, 184, 205, 201
❖ Mean = 195
❖ Sd = 8.80
❖ Calculate Quality index = (Max – mean)/sd = (209-195)/8.8 = 1.59
❖ Acceptability Factor was 1.53
❖ Accept the lot as acceptability factor is lower than the calculated.
 Maintaining Sample Integrity
❖ Sample should be the true
representation of population
❖ Sample should be drawn randomly.
❖ Consider post sampling activities:
❖ Labelling to avoid mix ups
❖ Some samples may need to be preserved.
 Measurement Tools
❖ Scale or tape
❖ Vernier Caliper
❖ Micrometers
❖ Gage blocks
❖ Optical Comparators
Tape or Scale
Measuring least count of 1 mm or
0.5mm
 Verniers
Measuring least count of 0.1 mm or
0.05mm
 Micrometer
Measuring least count of 0.01 mm
 Gage Blocks
or Slip Blocks
Measuring least count of 0.001 mm

By Glenn McKechnie - Own work, CC BY-SA 3.0,

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Wringing
Slip Gages
• Wringing is the process of
sliding two blocks together
so that their faces lightly
bond.
• Properly wrung blocks may
withstand a 75 lbf (330 N)
pull.
 Rule of 10
❖ Measuring instrument should be better
than the tolerance by a factor of 10.
❖ Calibration instrument should be better
than the measuring instrument by a
factor of 10.
 Optical Comparators
❖ In a comparator, the magnified
silhouette of a part is projected upon
the screen, and the dimensions and
geometry of the part are measured
against prescribed limits.
 Destructive vs Nondestructive Tests
❖ Destructive Tests (examples)
❖ Tensile Test
❖ Impact Test
❖ Fatigue Test
❖ Non Destructive Tests
❖ Radiography (including X-ray)
❖ Ultrasonic
❖ Magnetic Particle Test
❖ Liquid Penetrant
❖ Hardness
 Tensile Test
❖ Stress-Strain Curve
❖ Stress = Force/ Area (1 pascal = 1 Pa = 1
N/m2)
❖ Strain = change in length / length (unitless)
 Tensile Tests
❖ Stress Strain Curve
❖ Non ferrous material
❖ Structural Steel or Ductile Material
❖ Brittle material – concrete, carbon fiber
 Impact Test
❖ Charpy Impact Test also called Charpy V-
notch Test
❖ Measurement of notch toughness
 Fatigue Test
❖ Fatigue occurs because of cyclic loading

By Nicoguaro - Own work, CC BY 4.0,

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 Destructive vs Nondestructive Tests
❖ Destructive Tests (examples)
❖ Tensile Test
❖ Impact Test
❖ Fatigue Test
❖ Non Destructive Tests
❖ Radiography (including X-ray)
❖ Ultrasonic
❖ Magnetic Particle Test
❖ Liquid Penetrant
❖ Hardness
 Radiography
❖ Performed using
❖ X-rays
❖ Gamma Rays
❖ Industrial use includes: Material and
Weld Tests

https://en.wikipedia.org/wiki/Industrial_radiography
 Ultrasonic Testing
❖ Uses sound waves with frequency higher
than 20K. Human can hear sound
frequencies 20 to 20,000.

By No machine-readable author provided. Romary assumed (based on

copyright claims). - No machine-readable source provided. Own work
assumed (based on copyright claims)., CC BY 2.5,
https://commons.wikimedia.org/w/index.php?curid=997839
 Magnetic Particle Test
❖ Used for testing surface defects in
magnetic material.
 Liquid Penetrant Test
❖ Used for testing surface defects in
magnetic or non magnetic material.
❖ Works on the principle of capillary
action.
 Hardness Test
❖ Testing Methods include:
❖ Vickers, Brinell, or Rockwell Test
❖ Different shapes of indenters used in these
tests
❖ Portable devices also available.
❖ Rebound method also used in some.
2022 – Changes in the BoK – 4D/E/F
2022 – Changes in the BoK – 4D/E/F
❖ Topics removed from the BoK
❖ None
❖ Topics added to the BoK
❖ CMM (Coordinate Measuring Machines)
Coordinate Measuring Machines
❖ CMM is used to measure the geometry of an object by
sensing discrete points on the object using a probe.
❖ CMM measures dimensions in 3 perpendicular axes.
❖ It is used to inspect a complex object that can not be
measured by linear measurements.
Coordinate Measuring Machines
Y Moving Bridge

Probe Z Controller

Stage X
Coordinate Measuring Machines
Types of Probes
❖ Touch Probe – Using material Ruby, Ceramic, Tungsten
Carbide
❖ Non-touch Probe – Optical, Laser
 Metrology
❖ Metrology is the science of
measurements. (Meteorology is science
of weather forecasting)

❖ Involves three Main activities:

❖ Definition of internationally accepted units
of measurement
❖ Realisation of these units of measurement
in practice
❖ Application of chains of traceability linking
measurements made in practice to
reference standards
 Seven Base Units
Unit name Unit symbol Quantity name Dimension symbol

metre m length L

kilogram kg mass M

second s time T

ampere A electric current I

thermodynamic
kelvin K Θ
temperature
mole mol amount of substance N

candela cd luminous intensity J

 Seven Base Units
Unit name Unit symbol

metre The distance travelled by light in vacuum in 1/299792458 second.

kilogram The mass of the international prototype kilogram.

The duration of 9192631770 periods of the radiation corresponding to
second the transition between the two hyperfine levels of the ground state of the
caesium-133 atom.
The constant current which, if maintained in two straight parallel
conductors of infinite length, of negligible circular cross-section, and
ampere
placed 1 m apart in vacuum, would produce between these conductors a
force equal to 2×10−7 newtons per metre of length.

kelvin 1/273.16 of the thermodynamic temperature of the triple point of water

The amount of substance of a system which contains as many elementary

mole
entities as there are atoms in 0.012 kilogram of carbon-12
The luminous intensity, in a given direction, of a source that emits
candela monochromatic radiation of frequency 5.4×1014 hertz and that has a
radiant intensity in that direction of 1/683 watt per steradian.
 Derived Units
❖ The derived units in the SI are formed by
powers, products or quotients of the
base units.
❖ For example velocity is a quantity that is
derived from the base quantities of time
and length, so in SI the derived unit is
metres per second (symbol m/s).
 Calibration
❖ Purpose:
❖ To ensure consistency
❖ To determine the accuracy readings
❖ Can measurements be trusted
 Traceability
❖ “Property of a measurement result
whereby the result can be related to a
reference through a documented
unbroken chain of calibrations, each
contributing to the measurement
uncertainty.”
Traceability

SI Units

National Labs

Third Party Labs

Metrology Department

Working Instruments
 Measurement System Analysis (MSA)
❖ You need measurement to see how the
process is performing.
❖ Process has variation.
❖ What about measurement error /
variation?
 Measurement System Analysis (MSA)
❖ Measurement System includes –
operator, measuring instrument and
procedures.
 Measurement System Analysis (MSA)
❖ True Value – Actual value, which is
unknown
❖ Reference Value – Accepted value or
substitute of true value.
 Resolution
❖ Resolution/ Discrimination
❖ Smallest readable unit of the measuring
instrument.
❖ 10 to 1 Rule of Thumb:
❖ “Rule of Ten” or “one to ten” is that the
discrimination (resolution) of the measuring
instrument should divide the tolerance of
the characteristic to be measured into ten
parts.
 Resolution
❖ 10 to 1 Rule of Thumb:
❖ Which of these two would you use if the
part tolerance is 52.00 +/- 0.05 (51.95 –
52.05)
 Resolution
❖ 10 to 1 Rule of Thumb:
❖ Which of these two would you use if the
part tolerance is 52.00 +/- 0.05 (51.95 –
52.05)
❖ Tolerance Range = 0.10
❖ Minimum Reading of Digital Vernier = 0.01
❖ Digital Vernier divides the tolerance into 10
parts, hence acceptable.
 Measurement System Analysis (MSA)
❖ Resolution

❖ Accuracy
❖ Bias
❖ Linearity
❖ Stability

❖ Precision
❖ Repeatability
❖ Reproducibility
 Accuracy vs Precision
❖ Accuracy
❖ “Closeness” to the true value, or to an
accepted reference value.
❖ Bias
❖ Linearity
❖ Stability
❖ Precision
❖ “Closeness” of repeated readings to each
other
❖ Repeatability
❖ Reproducibility
 Measurement System Analysis (MSA)
❖ Resolution

❖ Accuracy
❖ Bias
❖ Linearity
❖ Stability

❖ Precision
❖ Repeatability
❖ Reproducibility
 Bias
❖ Bias is the difference between the
observed average of measurements
and the reference value.
Reference Measured
Value (psi) Value (psi)
100 100
100 101
100 102
100 102
100 101
100 100
Average 101
Bias = 101 psi -100 psi = 1 psi
 Bias
❖ Bias is the difference between the
observed average of measurements
and the reference value.
Average
Reference
Value

Bias
 Bias
❖ Bias is the systematic error.
❖ Bias is addressed by calibration.
 Linearity
❖ Linearity measures the bias across
the operating range of a tool or
instrument.
Reference Average Bias BIAS
Value (psi) Measured 2.5

Value (psi)
2

0 0 0 1.5

50 50.5 0.5
1

100 101 1
0.5
150 151.5 1.5
0
200 202 2 0 50 100 150 200 250
 Stability
❖ Stability measures the bias over time.
Also known as drift.

Time

Time 2
Bias 2

Time 1
Bias 1
 Accuracy vs Precision
❖ Accuracy
❖ “Closeness” to the true value, or to an
accepted reference value.
❖ Bias
❖ Linearity
❖ Stability
❖ Precision
❖ “Closeness” of repeated readings to each
other
❖ Repeatability
❖ Reproducibility
 Repeatability
❖ Variation in measurements obtained
with one measuring instrument when
used several times by an appraiser.
❖ Also called Equipment Variation (EV)
❖ It’s the capability of the gauge to
produce consistent results.
 Reproducibility
❖ Variation in the average of the
measurements made by different
appraisers using the same gage
❖ Also called Appraiser Variation (AV)
❖ It’s the capability of the appraiser to
produce consistent results.
 Gage R&R (GRR)
❖ Combined estimate of repeatability and
reproducibility.
 Gage R&R (GRR)
❖ Combined estimate of repeatability and
reproducibility.
 Precision to Tolerance Ratio
❖ How capable your measurement system
is?
❖ Precision/Tolerance (P/T) is the ratio
between the estimated measurement
error (precision) and the tolerance of
the characteristic being measured.
 Precision to Tolerance Ratio
❖ P/T ratio is the most common
estimate of measurement system
precision Measurement
Tolerance System
Variation
P/T = 10%

P/T = 100%

P/T = 200%
LSL USL
 Precision to Tolerance Ratio
PTR
❖ PTR = 5.15 σms
USL-LSL

Why not 6σms ?

6 sigma includes 99.73% area
5.15 sigma includes 99% area
 Gage R&R (GRR)
Gage R&R Studies
❖ Repeatability and reproducibility
(R&R) studies are a method for
determining the variation of a
measurement system.
❖ There are three methods of
conducting GRR Studies.
❖ Range
❖ Average and Range
❖ ANOVA
 Gage R&R (GRR)
❖ The range method quantifies both
repeatability and reproducibility
together.
❖ The average and range method
provides separate estimate of
repeatability and reproducibility.
❖ The analysis of variance method
(ANOVA) estimates variation due to
repeatability and reproducibility and
parts, and also looks at the
interaction between those these.
 Gage R&R (GRR) – Range Method
❖ Provides quick estimate of GRR.
❖ This method does not split the GRR into
Repeatability and Reproducibility
❖ Two operators usually measure 5 parts
one time each.
 Gage R&R (GRR) – Range Method
❖ Two operators usually measure 5 parts
one time each.
Part Appraiser A Appraiser B Range
❖ GRR = R-bar/d2 = 1.6/1.19 = 1.34 #
❖ Process standard deviation = 2.23 1 100 101 1
2 99 102 3
❖ (From previous study)
3 97 99 2
❖ %GRR = 100 (GRR/process std dev) 4 103 103 0
❖ %GRR = 100 x 1.34 / 2.23 = 60% 5 101 103 2
R-bar = 1.6
❖ Measurement variation consumes 60%
of the process variation. Measurement
system needs improvement.
 GRR – Average and Range Method
❖ Average and Range method provides the
estimate of both repeatability and
reproducibility.
❖ Interaction between appraiser and gage
is not computed (ANOVA method does
that)
 GRR – ANOVA Method
❖ ANOVA is Analysis of Variance
 Number of Distinct Categories (NDC)
❖ Resolution:
❖ Using a meter stick to measure the height of
the students: (100cm to 130cm heights)
❖ Round to height to the nearest meter
❖ All students will have the same height.
❖ Round to the nearest decimeter
❖ We are 3 different heights.
❖ Round to the nearest centimeter
❖ We are 30 different heights.
 Number of Distinct Categories (NDC)
❖ NDC = 1.414 x σparts
σgage
 Number of Distinct Categories (NDC)
❖ NDC is the number of buckets your data
values would naturally drop into.
❖ What if The NDC is low?
❖ Analyze more distinct parts that truly
represent the entire range of the process.
❖ Increase the precision on your
measurement tool.
 Number of Distinct Categories (NDC)
❖ Value of NDC
❖ Less than 2, the measurement system is of
no value for controlling the process, since
one part cannot be distinguished from
another.
❖ Equal to 2, the data can be divided into two
groups, say high and low.
❖ Equal to 3, the data can be divided into 3
groups, say low, middle and high.
❖ More than 5, denotes an acceptable
measurement system.
 Measurement System Analysis (MSA)
Crossed gage R&R study
A study in which each operator
measures each part. (Non-destructive)

Nested gage R&R study

A study in which only one operator
measures each part, usually because
the test destroys the part. (Destructive)