In manufacturing of Tablets

 If every tablet was tested for hardness, no tablet

would be left for sale.
 If, on other hand, none of tablets were tested
for hardness, malfunctions might occur, which
may lead to variation in results for
Dissolution test and
Disintegration test.
 A Seminar on

ACCEPTANCE SAMPLING
Presented By
Mr. Mohit G. Dewani
(M. Pharm, Quality Assurance, II Semester)

Under the Guidance of

Mrs. Mrinalini C. Damle

23rd April 2009

AISSMS College of Pharmacy, Pune-01

 CONTENTS
 Introduction
 When is accepting sampling employed?
 Sampling risks
 The O.C. Curve
 Quality indexes for sampling plans
 Types of Sampling
 Types of Sampling plans
 ANSI/ASQC Z1.4
 Example

AISSMS College of Pharmacy, Pune 01 3

 CONTENTS (contd…)
 Rules for switching inspection severity
 Dodge-Romig sampling plans
 Acceptance sampling – Method
 Reduces sampling costs with acceptance sampling
 Moving from 100% inspection to 0% sampling.
 Acceptance sampling standards
1) Military standards
2) International standards organization (ISO)
3) American national standards institute (ANSI)
 References

AISSMS College of Pharmacy, Pune 01 4

 INTRODUCTION

• Acceptance sampling is the process of evaluating

a small sample of the product in a given lot for
purpose of accepting or rejecting a lot, based on
the conformance or non-conformance of the
sample to quality specifications.
• The main purpose of acceptance sampling is to
decide whether or not lot is acceptable,
not to estimate the quality of the lot.

AISSMS College of Pharmacy, Pune 01 5

 When is acceptance sampling
employed?
1) Testing is destructive.
2) The Cost of 100 % inspection is very high.
3) 100 % inspection takes too long.
Acceptance sampling is the “middle of the road”
approach between no inspection and
100 % inspection.

AISSMS College of Pharmacy, Pune 01 6

• Acceptance sampling can be applied at any
point in production.
• The output of one stage is the input of the
next.

AISSMS College of Pharmacy, Pune 01 7

• Sampling plans decide which lots of product to
accept and release and which lots to reject and
either rework or discard.
• Ideally, a sampling plan should reject all "bad"
lots while accepting all "good" lots.
• However, because the sampling plan bases it
decision on a sample of the lot and not the entire
lot, there is always a chance of making an
incorrect decision.
• The behavior of a sampling plan is described by
the sampling plan's Operating Characteristic (OC)
curve.
AISSMS College of Pharmacy, Pune 01 8
SAMPLING RISKS

AISSMS College of Pharmacy, Pune 01 9

SAMPLING RISKS

AISSMS College of Pharmacy, Pune 01 10

The Operating Characteristic (O.C.)
Curve

AISSMS College of Pharmacy, Pune 01 11

 Quality Indexes for Sampling Plans

1) Acceptable quality level (AQL)

2) Limiting quality level (LQL)
3) Indifference quality level (IQL)
4) Average outgoing quality limit (AOQL)

AISSMS College of Pharmacy, Pune 01 12

 Quality Indexes for Sampling Plans

1. Acceptable quality level (AQL) –

• The AQL is a percent defective that is the base
line requirement for the quality of the producer's
product.
• The producer would like to design a sampling
plan such that there is a high probability of
accepting a lot that has a defect level less than
or equal to the AQL.

AISSMS College of Pharmacy, Pune 01 13

 Quality Indexes for Sampling Plans

2. Limiting quality level (LQL) –

• LQL defines unsatisfactory quality.
• Also called Lot tolerance percentage defective (LTPD).
• The probability of acceptance of LQL should be low.

3. Indifference quality level (IQL) –

• It is somewhere between AQL and LQL.
• The probability of acceptance of IQL is 0.5 for a given
sampling plan.

AISSMS College of Pharmacy, Pune 01 14

 Quality Indexes for Sampling Plans

4. Average outgoing quality level (AOQL) –

• When incoming quality is perfect, outgoing quality must
also be perfect.
• However, when incoming quality is bad, (assuming no
inspection errors) outgoing quality will also be perfect,
because the sampling plan will cause all lots to be
rejected and inspected in detail.
• Thus at either extreme – incoming quality excellent or
terrible – the outgoing quality will tend to be good.

AISSMS College of Pharmacy, Pune 01 15

AISSMS College of Pharmacy, Pune 01 16
Types of Sampling

AISSMS College of Pharmacy, Pune 01 17

AISSMS College of Pharmacy, Pune 01 18
 Types of Sampling plans

1) Attributes plans (“go no-go”)

 A random sample is taken from the lot, and each unit is
classified as acceptable or defective.
 The number defective is then compared with the
allowable number stated in the plan, and a decision is
made to accept or reject the lot.

AISSMS College of Pharmacy, Pune 01 19

 Types of Sampling plans

2) Variables plans (continuous)

 A sample is taken, and measurement of a specified
quality characteristic is made on each unit.
 These measurements are then summarized into a sample
statistic. (e.g., sample average), and the observed value is
then compared with the allowable value defined in the
plan.
 A decision is made to accept or reject the lot.

AISSMS College of Pharmacy, Pune 01 20

 Types of Sampling Plans

1) Single Sampling
2) Double Sampling
3) Multiple Sampling
4) Sequential Sampling
5) Skip – Lot Sampling
6) Random Sampling
7) Stratified Sampling
8) Sampling Bias
9) Bulk Sampling

AISSMS College of Pharmacy, Pune 01 21

SINGLE SAMPLING

AISSMS College of Pharmacy, Pune 01 22

DOUBLE SAMPLING

AISSMS College of Pharmacy, Pune 23

01
 MULTIPLE SAMPLING

• This is an extension of the double sampling plans

where more than two samples are needed to reach
a conclusion.
• The advantage of multiple sampling is smaller
sample sizes.

AISSMS College of Pharmacy, Pune 01 24

AISSMS College of Pharmacy, Pune 01 25
SEQUENTIAL SAMPLING

AISSMS College of Pharmacy, Pune 01 26

 SEQUENTIAL SAMPLING

 Also called “item-by-item” sequential sampling.

 If the plotted point falls within the parallel lines the process
continues by drawing another sample.
 If a point falls on or above the upper line, the lot is rejected.
And when a point falls on or below the lower line, the lot is
accepted. The process can theoretically last until the lot is
100% inspected.
 However, as a rule of thumb, sequential-sampling plans are
truncated after the number inspected reaches three times the
number that would have been inspected using a
corresponding single sampling plan

AISSMS College of Pharmacy, Pune 01 27

 SKIP – LOT SAMPLING

 Skip Lot sampling means that only a fraction of the

submitted lots are inspected.
 This mode of sampling is of the cost-saving variety in
terms of time and effort.
 However skip-lot sampling should only be used when it
has been demonstrated that the quality of the submitted
product is very good.

AISSMS College of Pharmacy, Pune 01 28

 RANDOM SAMPLING

 Samples are drawn at random, i.e., at any one

time each of the remaining uninspected units of
the product has an equal chance of being the next
unit selected for sample.
 E.g., for fluid or well-mixed bulk products, the
fluidity obivates the need for random numbers,
and the samples may be taken from “here and
there”.

AISSMS College of Pharmacy, Pune 01 29

 STRATIFIED SAMPLING

 When the “lots” are known to come from

different machines, production shifts, operators,
etc, the product is actually multiple lots which
have been arbitrarily combined.
 In such cases, an attempt is made to draw the
sample proportionately from each true lot.

AISSMS College of Pharmacy, Pune 01 30

 SAMPLING BIAS

 Sampling from same location in all

containers, racks or bins.
 Previewing the product and selecting only
those units which appear to be defective.

AISSMS College of Pharmacy, Pune 01 31

 BULK SAMPLING

 Bulk materials may be of gaseous, liquid

or solid form. Usually it is sampled by
taking increments into a single composite
sample and then, if necessary, reducing
this gross sample to a size suitable for
laboratory testing.

AISSMS College of Pharmacy, Pune 01 32

 ANSI/ASQC Z1.4 (1993)
• ANSI/ASQC Z1.4 is an attribute sampling system.
• ANSI (American National Standards Institute)
• ASQC (American Society of Quality Control)
• Its quality index is AQL.

AISSMS College of Pharmacy, Pune 01 33

 Suppose in a lot of 1500 pieces, purchasing
agency has contracted for a 1.5% AQL.

1) What should be the sample size?

2) From the corresponding sample size, what will be the
acceptance number and rejection number?
3) Explain the single, double and multiple plans
for the corresponding sample size.
4) What will be the switching procedure or
tightened plan for the above sample size?

NOTE: To solve the above problem, refer charts provided.

AISSMS College of Pharmacy, Pune 01 34

AISSMS College of Pharmacy, Pune 01 35
 Dodge – Romig sampling plans
• These plans differ from those in ANSI/AQC Z1.4 in that
the Dodge-Romig plans (1959) assume that all rejected
lots are 100% inspected and the defectives are replaced
with acceptable items.
• Plans with this feature are also called rectifying
inspection plans.
• It provides four sets of attribute plans:
1) LTPD – single sampling & double sampling
2) AOQL - single sampling & double sampling

AISSMS College of Pharmacy, Pune 01 36

Acceptance sampling: Method

AISSMS College of Pharmacy, Pune 01 37

 Reduce inspection costs with
acceptance sampling
 Generate sampling plan as an alternative to 100%
inspection.
 E.g; you plan to randomly sample 96 light bulbs from the
shipment. If you find two or fewer defective bulbs, you
will accept the entire lot of bulbs. Otherwise, the entire
lot of bulbs will be rejected.
Sample size – 96
Acceptance number - 2

AISSMS College of Pharmacy, Pune 01 38

AISSMS College of Pharmacy, Pune 01 39
 Interpretation made from the above
O.C. curve.
 By sharing this OC curve with your supervisor, you can
point out that the resulting consumer risk is much too
high for you to consider reducing your sample size to 50.
 The OC curve can also be shown to your supplier to
prove that the resulting consumer risk is much too high
for you to consider raising your acceptance number to 10.
 Perhaps you will evaluate other
acceptance numbers between 2 and 10.

AISSMS College of Pharmacy, Pune 01 40

AISSMS College of Pharmacy, Pune 01 41
 ACCEPTANCE SAMPLING
STANDARDS
Sr. Military Standards Guidance
No.
1 MIL-STD-1916 (1996) Preferred Methods for Acceptance of Product
2 MIL-HDBK-1916 (1999) Companion Document to MIL-STD-1916
3 MIL-STD-105E (1989) Sampling Procedures and Tables for
Inspection by Attributes
4 MIL-STD-414 (1968) Sampling Procedures and Tables for
Inspection by Variables for Percent
Nonconforming
5 MIL-STD-1235C (1974) Single and Multi-Level Continuous Sampling
Procedures and Tables for Inspection by
Attributes
6 MIL-HDBK-781A Handbook for Reliability Test Methods,
(1 April 1996) Plans, and Environments for Engineering,
Development
AISSMS College Qualification,
of Pharmacy, Pune 01 and Production 42
 ACCEPTANCE SAMPLING
STANDARDS
Sr. International Guidance
No. Standards
Organization (ISO)
1 ISO 2859-0:1995 Sampling procedures for inspection by attributes –
Part 0 : Introduction to the ISO 2859 attribute
sampling system
2 ISO 2859-1:1999 Sampling procedures for inspection by attributes --
Part 1 :Sampling plans indexed by acceptable
quality level (AQL) for lot-by-lot inspection
3 ISO 2859-2:1985 Sampling procedures for inspection by attributes --
Part 2: Sampling plans indexed by limiting quality
(LQ) for isolated lot inspection
4 ISO 7966:1993 Acceptance control charts

AISSMS College of Pharmacy, Pune 01 43

 ACCEPTANCE SAMPLING
STANDARDS
Sr. ANSI Guidance
No.
1 ANSI/ASQC Z1.4-2008 Sampling Procedures and Tables for Inspection
by Attributes
2 ANSI/ASQC Z1.9-2008 Sampling Procedures and Tables for Inspection
by Variables for Percent Nonconforming
3 ANSI/ASQC Q3-1988 Sampling Procedures and Tables for Inspection
of Isolated Lots by Attributes
4 ANSI/ASQC S1-1987 An Attribute Skip-Lot Sampling Program
(R1995)
5 ANSI/ASQC S2-1995 Introduction to Attribute Sampling
6 ANSI/EIA 584-1991 Zero Acceptance Number Sampling Procedures
and Tables for Inspection by Attributes of a
Continuous Manufacturing Process
44
 REFERENCES
1) J. M. Juran, F. M. Gryna; Juran’s Quality Control
Handbook; Fourth edition; Mc Graw-Hill book
company, New York; PP. 25.1-25.103.
2) F. M. Gryna, R. C. H. Chua, J. A. Defeo; Juran’s
Quality planning and analysis for enterprise quality
(2009); Fifth edition; Tata Mc-Graw Hill publishing
company ltd., New Delhi; PP. 496-513.
3) Y. Anjaneyulu, R. Marayya; Quality assurance and
quality management in pharmaceutical industry (2005);
Pharma book syndicate, Hyderabad; P. 174.

AISSMS College of Pharmacy, Pune 01 45

 REFERENCES
4) S. W. Bergman, J. C. Gittins; Statistical methods for
pharmaceutical research planning; vol. 67; Marcel
Dekker Inc., New York; PP. 110,129,132.
5) http://www.itl.nist.gov/div898/handbook/pmc/section2/
pmc21.htm
(accessed on - 13th April 2010).
6) http://www.itl.nist.gov/div898/handbook/pmc/section2/
pmc22.htm
(accessed on - 14th April 2010).
7) http://www.mintab.com/uploadedFiles/Shared_Resourc
es/Documents/Articles/Acceptance_Sampling.pdf
(accessed on - 14th April 2010)
AISSMS College of Pharmacy, Pune 01 46
 REFERENCES
8)http://www.cimt.plymouth.ac.uk/projects/mepres/alevel/fs
tats_ch9.pdf (accessed on - 15th April 2010).
9) http://www.itl.nist.gov/div898/handbook/pmc/section2/
pmc2.htm (accessed on - 17th April 2010).
10) luisdi.files.wordpress.com/2009/08/quality-as.pdf
(accessed on - 20th April 2010).
11) www.ansi.org (accessed on – 21st April 2010)

AISSMS College of Pharmacy, Pune 01 47

Any Questions???

AISSMS College of Pharmacy, Pune 01 48