Sampling Procedures

Inspection by Attributes
Peter Phillips

Surgical Materials Testing Laboratory

Princess of Wales Hospital
Bridgend
South Wales

Sampling procedures - Inspection by Attributes – p.1/23

Introduction
PDF file available at:
http://www.smtl.co.uk/˜pete
BS 6001-1 1999 (ISO 2859-1:1999) Sampling
procedures for inspection by attributes. Part 1:
Sampling schemes indexed by acceptance quality
limit (AQL) for lot-by-lot inspection.
ISO 2859-2:1985 Sampling procedures for
inspection by attributes. Sampling plans indexed
by limiting quality (LQ) for isolated lot
inspection.
ISO 2859-0:1995 - Part 0: Introduction to the
ISO 2859 attribute sampling system.
Sampling procedures - Inspection by Attributes – p.2/23
ISO 2859 Part 1
Acceptance sampling system for inspection by
attributes.
It is indexed in terms of acceptance quality level
(AQL)
Aim - to induce a supplier to maintain a process
average at least as good as the specified
acceptance AQL, whilst at the same time
providing an upper limit for the risk to the
consumer of accepting the occasional poor lot.
Applicable to end products, raw materials,
operations, maintenance operations,
administrative procedures.

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Usage of the Part 1 scheme.
Intended to be used for a continuing series of lots,
which will allow the application of switching
rules. The rules provide:
protection to the consumer should a
deterioration in quality be detected.
an incentive to the supplier to reduce
inspection costs should consistently good
quality be achieved.
Can also be used for inspection of lots in
isolation.

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Terminology
Inspection by attributes: inspection where an
item is classified as conforming or
nonconforming with respect to a specified
requirement or set of requirements.
Nonconformity: Non fulfillment of a specified
requirement. Usually classified according to the
degree of seriousness. More serious
nonconformities will usually be assigned a very
small AQL, whilst less serious nonconformities
will be assigned higher AQL values.

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Terminology (cont)
Normal inspection: Use of a sampling plan with
acceptance criteria devised to secure the producer
a high probability of acceptance when the process
average of the lot is better than the AQL. Used
when there is no reason to suspect the process
average differs from an acceptable level.
Tightened inspection: Use of a sampling plan
with an acceptance criteria that is tighter than that
for the corresponding plan for normal inspection.
Invoked when the inspection results of
consecutive lots indicate that the process average
might be poorer than the AQL.

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Terminology (cont)
Acceptable Quality Limit (AQL): Quality level
that is the worst tolerable process average when a
continuing series of lots is submitted for
acceptance sampling. AQL does not mean
’desirable level’. ISO 2859 is designed to
encourage suppliers to have process averages
consistently better than the AQL, otherwise there
is a risk of switching to tighter inspection.
The designation of an AQL does not imply that
the supplier has the right knowingly to supply any
nonconforming items.

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Terminology (cont)
AQL values shall not exceed 10%
nonconforming.
When the quality level is expressed as number of
nonconformities per 100 items, AQL values up to
1000 nonconformities per 100 items may be used.
Sampling:
Sample selection must be drawn from the lot
by simple random sampling.
When double or random sampling is to be
used, each subsequent sample shall be
selected from the remainder of the same lot.

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Inspection Levels
4 special inspection levels - S1, S2, S3, S4.
3 general inspection levels - I, II, III.
Special inspection levels used when sample size
must be kept small and larger sampling risks can
be tolerated.
Level II will be used unless another inspection
level is specified.
Level I is used when less discrimination is
required, Level III when greater discrimination is
required.

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Sample size code letters
Lot Size Special Insp Levels General Insp Levels
S1 S2 S3 S4 I II III
2-8 A A A A A A B
9 - 15 A A A A A B C
16 - 25 A A B B B C D
26 - 50 A B B C C D E
51 - 90 B B C C C E F
91 - 150 B B C D D F G
151 - 280 B C D E E G H
281 - 500 B C D E F H J
501 - 1200 C C E F G J K
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Sample size code letters (cont)
Lot Size Special Insp Levels General Insp Levels
S1 S2 S3 S4 I II III
1201 - 3200 C D E G H K L
3201 - 10000 C D F G J L M
10001 - 35000 C D F H K M N
35001 - 150000 D E G J L N P
150001 - 500000 D E G J M P Q
>= 500001 D E H K N Q R

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Single Sampling Plans
Selected segment of Normal Inspection table
Code Samp AQL
Let Size 0.010 0.015 0.025 0.040 0.065 0.10 0.15
Ac Re Ac Re Ac Re Ac Re Ac Re Ac Re Ac Re
G 32
H 50
J 80 01
K 125 01
L 200 01
M 315 01 12
N 500 01 12 23
P 800 01 12 23 34
Q 1250 01 12 23 34 56
R 2000 12 23 34 56 78

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Double Sampling Plans
Normal Inspection
Code Sample Samp Cumul AQL
Let Size Samples 1.5 2.5 4.0 6.5 10
Ac Re Ac Re Ac Re Ac Re Ac Re
G First 20 20 02 03 13 25 36
G Second 20 40 12 34 45 67 9 10
H First 32 32 03 13 25 36 59
H Second 32 64 34 45 67 9 10 12 13
J First 50 50 13 25 36 59 7 11
J Second 50 100 45 67 9 10 12 13 18 19

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OC Curves
Operating Characteristic Curves
OC curve is a graph showing what any particular
sampling plan can be expected to do in terms of
accepting and rejecting batches.
An understanding of the implications of an OC
curve helps understand the risks to the
manufacturer, consumer, and in deciding
inspection levels and batch sizes.
Each possible plan has its own OC curve.
Horizontal scale - shows the percentage defective.
Vertical scale - shows the percentage of batches
that may be expected to be accepted if batches are
produced with that percentage of defects.
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OC Curve

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OC Curve Example
Code Letter M
AQL 1.5
Sample size - 315
Accept: 10, Reject: 11
What happens if a batch with 3% defectives is
submitted ?
Find 3% on the X axis, and follow a vertical line
up until it meets the 1.5% curve.
Take a horizontal line across to the Y axis, and
read off the value of 65%.
I.e., 65% of batches would be accepted and 35%
rejected.
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More OC curve examples
Pa AQL for sample plan M AQL for sample plan J
1.0 1.5 2.5 4.0 1.0 1.5 2.5 4.0
99.0 0.929 1.53 2.40 4.05 0.55 1.04 2.28 3.73
95.0 1.27 1.97 2.96 4.78 1.03 1.73 3.32 5.07
90.0 1.48 2.24 3.29 5.20 1.39 2.20 3.99 5.91
75.0 1.89 2.74 3.90 5.95 2.16 3.18 5.30 7.50
50.0 2.43 3.38 4.65 6.87 3.33 4.57 7.06 9.55
25.0 3.06 4.11 5.49 7.87 4.84 6.30 9.14 11.9
10.0 3.71 4.85 6.33 8.84 6.52 8.16 11.3 14.3
5.0 4.13 5.33 6.86 9.46 7.66 9.41 12.7 15.8
1.0 5.01 6.29 7.93 10.7 10.1 12.0 15.6 18.9
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Concrete examples
EN 455 Part 1 for medical gloves - Pinholes
General inspection level 1, AQL 1.5%.
Minimum sample size code letter L (200
gloves)
If a batch with 3% pinholes is submitted,
there is a 75% chance of them being accepted.
All Wales Universal Container contract
Agreed AQL of 0.65%, general Inspection
level I.
Sample code L (200 samples).
If a batch with 5% leakers is submitted, there
is a 99% chance of them being rejected.

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Setting an Inspection Level
Select the required AQL (as an average).
Decide what quality should have a high chance of
rejection.
Choose the appropriate sampling plan by
inspecting the OC curves.

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Setting an Inspection Level
Example
An AQL of 1.5% defective items has been chosen.
It is desired to have at least an 80% chance of rejecting a 6%
defective batch under normal inspection.
Code letters A->J fail to meet the requirement.
Code letter K almost meets it, codes L-P more than meet it.
Decide the batch size. If batch size is 1000, check sample size
code letters table - we can use general inspection level III.
The sampling plan would therefore be AQL=1.5%, General
Inspection Level=III.

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Switching Rules
Normal to tightened: Shall be implemented as soon as two out
of five (or fewer than five) consecutive lots have been
non-acceptable on original inspection.
Tightened to normal: Shall be reinstated when five consecutive
lots have been considered acceptable on original inspection.
Normal to reduced: implemented when the switching score is at
least 30, production is at a steady state, and reduced inspection is
considered desirable by the responsible authority.
Discontinuation of inspection: is implemented when the
number of lots not accepted in a sequence of consecutive lots on
original tightened inspection reaches 5.
Reduced to normal: if a lot is not accepted or irregular/delayed
production.
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Switching Scores
Single Sampling Plans
Used when deciding whether to switch to reduced inspection.
Set switching score to 0 at start of normal inspection.
Score updated following the inspection of each lot.
When the acceptance number is >= 2, add 3 to the switching
score if the lot would have been accepted if the AQL had been
one step tighter; otherwise reset score to 0.
When the acceptance number is 0 or 1, add 2 to the switching
score if the lot is accepted; otherwise reset score to 0.
As in the previous slide, when the switching score is at least 30
and production is at a steady state, switch to reduced inspection if
considered desirable by the responsible authority.
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Important points
Setting an AQL does not guarantee to the
customer that batches of a worse quality will not
be accepted.
If the average quality of batches being submitted
are a little worse than the AQL, a number of
batches will probably be accepted before a switch
to tightened inspection is called for.
In general, the customer gets a quality which is,
on average, better than the AQL, since the tables
are arranged to provide an economic incentive -
the manufacturer cannot afford to have more than
a small proportion of batches rejected, and so will
improve the quality if this proportion is exceeded.
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