Current through Register 1531, September 27, 2024
(1)
Scope.
(a)
Purpose.
220 CMR 36.00 establishes
sampling plans and procedures for inspection by attributes. When specified by
the responsible authority,
220 CMR 36.00 shall be
referenced in the specification, contract, inspection instructions, or other
documents and the provisions set forth in
220 CMR 36.00 shall govern.
The "responsible authority" shall be designated in one of the above
documents.
(b)
Application. Sampling plans designated in
220 CMR 36.00 are applicable,
but not limited, to inspection of the following:
1. End items;
2. Components and raw materials;
3. Operations;
4. Materials in process;
5. Supplies in storage;
6. Maintenance operations;
7. Data or records; or
8. Administrative procedures.
These plans are intended primarily to be used for a continuing
series of lots or batches. The plans may also be used for the inspection of
isolated lots or batches, but in this latter case, the user is cautioned to
consult the operating characteristic curves (see MIL STD-1916, "[Department of
Defense] Preferred Methods for Acceptance of Product"; ANSI/ASQ Z1.4, "Sampling
Procedures and Tables for Inspection by Attributes") to find a plan that will
yield the desired protection.
(c)
Inspection.
Inspection is the process of measuring, examining, testing, or otherwise
comparing the unit of product (see 220 CMR 36.08(1)(e)) with the
requirements.
(d)
Inspection by Attributes. Inspection by attributes is
inspection whereby either the unit of product is classified simply as defective
or non-defective, or the number of defects in the unit of product is counted,
with respect to a given requirement or set of requirements.
(e)
Unit of Product.
The unit of product is the item inspected in order to determine its
classification as defective or non-defective or to count the number of defects.
It may be a single article, a pair, a set, a length, an area, an operation, a
volume, a component of an end product, or the end product itself. The unit of
product may or may not be the same as the unit of purchase, supply, production,
or shipment.
(2)
Classification of Defects and Defectives.
(a)
Method of Classifying
Defects. A classification of defects is the enumeration of
possible defects of the unit of product classified according to their
seriousness. A defect is any nonconformance of the unit of product with
specified requirements. Defects will normally be grouped into one or more of
the following classes, but defects may be grouped into other classes, or into
subclasses within these classes.
1.
Critical Defect. A critical defect is a defect that
judgment and experience indicate is likely to result in hazardous or unsafe
conditions for individuals using, maintaining, or depending upon the product;
or a defect that judgment and experience indicate is likely to prevent
performance of the tactical function of a major end item such as a ship,
aircraft, tank, missile or space vehicle. NOTE: For a special provision
relating to critical defects, see 220 CMR 36.08(6)(c).
2.
Major Defect. A
major defect is a defect, other than critical, that is likely to result in
failure, or to reduce materially the usability of the unit of product for its
intended purpose.
3.
Minor Defect. A minor defect is a defect that is not
likely to reduce materially the usability of the unit of product for its
intended purpose, or is a departure from established standards having little
bearing on the effective use or operation of the unit.
(b)
Method of Classifying
Defectives. A defective is a unit of product which contains one or
more defects. Defectives will usually be classified as follows:
1.
Critical
Defective. A critical defective contains one or more critical
defects and may also contain major and/or minor defects. NOTE: For a special
provision relating to critical defectives, see 220 CMR 36.08(6)(c).
2.
Major Defective.
A major defective contains one or more major defects, and may also contain
minor defects, but contains no critical defect.
3.
Minor Defective.
A minor defective contains one or more minor defects, but contains no critical
or major defect.
(3)
Percent Defective and Defects
per 100 Units.
(a)
Expression of Nonconformance. The extent of
nonconformance of product shall be expressed either in terms of percent
defective or in terms of defects per 100 units.
(b)
Percent
Defective. The percent defective of any given quantity of units of
product is 100 times the number of defective units or product contained therein
divided by the total number of units of product, i.e.:
Percent defective = Number of defectives / Number of units
inspected X 100
(c)
Defects per 100 Units. The number of defects per 100
units of any given quantity of units of product is 100 times the number of
defects contained therein (one or more defects being possible in any unit of
product) divided by the total number of units of product, i.e.:
Defects per 100 units = Number of defectives / Number of units
inspected X 100
(4)
Acceptable Quality Level
(AQL).
(a)
Use. The AQL together with the Sample Size Code
Letter, is used for indexing the sampling plans provided in
220 CMR 36.00.
(b)
Definition. The
AQL is the maximum percent defective (or the maximum number of defects per 100
units) that, for purposes of sampling inspection, can be considered
satisfactory as a process average. A process average is the average percent
defective or average number of defects per 100 units (whichever is applicable)
of product submitted by the supplier for original inspection. Original
inspection is the first inspection of a particular quantity of product as
distinguished from the inspection of product which has been resubmitted after
rejection.
(c)
Note on
the Meaning of AQL. When a consumer designates some specific value
of AQL for a certain defect or group of defects, it indicates to the supplier
that the consumer's acceptance sampling plan will accept the great majority of
the lots or batches that the supplier submits, provided the process average
level of percent defective (or defects per 100 units) in these lots or batches
is no greater than the designated value of AQL. Thus, the AQL is a designated
value of percent defective (or defects per 100 units) that the consumer
indicates will be accepted most of the time by the acceptance sampling
procedure to be used. The sampling plans provided in
220 CMR 36.00 are so arranged
that the probability of acceptance at the designated AQL value depends upon the
sample size, being generally higher for large samples than for small ones, for
a given AQL. The AQL alone does not describe the protection to the consumer for
individual lots or batches, but more directly relates to what might be expected
from a series of lots or batches, provided the steps indicated in
220 CMR 36.00 are taken. It
is necessary to refer to the operating characteristic curve of the plan to
determine what protection the consumer will have.
(d)
Limitation. The
designation of an AQL shall not imply that the supplier has the right to supply
knowingly any defective unit of product.
(e)
Specifying AQLs.
The AQL to be used will be designated in the contract or by the responsible
authority. Different AQLs may be designated for groups of defects considered
collectively, or for individual defects. An AQL for a group of defects may be
designated in addition to AQLs for individual defects, or subgroups, within
that group. AQL values of 10.0 or less may be expressed either in percent
defective or in defects per 100 units; those over 10.0 shall be expressed in
defects per 100 units only.
(f)
Preferred AQLs. The values of AQLs given in these
tables are known as preferred AQLs. If, for any product, an AQL be designated
other than a preferred AQL, these tables are not applicable.
(5)
Submission of
Product.
(a)
Lot or
Batch. The term lot or batch shall mean "inspection lot" or
"inspection batch" (i.e., a collection of units of product from which a sample
is to be drawn and inspected to determine conformance with the acceptability
criteria), and may differ from a collection of units designated as a lot or
batch for other purposes (e.g., production, shipment, etc.).
(b)
Formation of Lots or
Batches. The product shall be assembled into identifiable lots,
sublots, batches, or in such other manner as may be prescribed (see 220 CMR
36.08(5)(d)). Each lot or batch shall, as far as is practicable, consist of
units of product of a single type, grade, class, size, and composition,
manufactured under essentially the same conditions, and at essentially the same
time.
(c)
Lot or Batch
Size. The lot or batch size is the number of units of product in a
lot or batch.
(d)
Presentation of Lots or Batches. The formation of the
lots or batches, lot or batch size, and the manner in which each lot or batch
is to be presented and identified by the supplier shall be designated or
approved by the responsible authority. As necessary, the supplier shall provide
adequate and suitable storage space for each lot or batch, equipment needed for
proper identification and presentation, and personnel for all handling of
product required for drawing of samples.
(6)
Acceptance and
Rejection.
(a)
Acceptability of Lots or Batches. Acceptability of a
lot or batch will be determined by the use of a sampling plan or plans
associated with the designated AQL or AQLs.
(b)
Defective Units.
The right is reserved to reject any unit or product found defective during
inspection whether that unit of product forms part of a sample or not, and
whether the lot or batch as a whole is accepted or rejected. Rejected units may
be repaired or corrected and resubmitted for inspection with the approval of,
and in the manner specified by, the responsible authority.
(c)
Special Reservation for
Critical Defects. The supplier may be required at the discretion
of the responsible authority to inspect every unit of the lot or batch for
critical defects. The right is reserved to inspect every unit submitted by the
supplier for critical defects, and to reject the lot or batch immediately, when
a critical defect is found. The right is reserved also to sample, for critical
defects, every lot or batch submitted by the supplier and to reject any lot or
batch if a sample drawn therefrom is found to contain one or more critical
defects.
(d)
Resubmitted Lots or Batches. Lots or batches found
unacceptable shall be resubmitted for reinspection only after all units are
reexamined or retested and all defective units are removed or defects
corrected. The responsible authority shall determine whether normal or
tightened inspection shall be used, and whether reinspection shall include all
types or classes of defects or of the particular types or classes of defects
which caused initial rejection.
(7)
Drawing of
Samples.
(a)
Sample. A sample consists of one or more units of
product drawn from a lot or batch, the units of the sample being selected at
random without regard to their quality. The number of units of product in the
sample is the sample size.
(b)
Representative Sampling. When appropriate, the number
of units in the sample shall be selected in proportion to the size of sublots
or subbatches, or parts of the lot or batch, identified by some rational
criterion. When representative sampling is used, the units from each part of
the lot or batch shall be selected at random.
(c)
Time of
Sampling. Samples may be drawn after all the units comprising the
lot or batch have been assembled, or samples may be drawn during assembly of
the lot or batch.
SAMPLE SIZE AND ACCEPT/REJECT LEVEL FOR SINGLE
SAMPLING PLAN GENERAL INSPECTION LEVEL II AQL = 2.5
LOT SIZE
|
SAMPLE SIZE
|
ACCEPT/REJECT
|
2 to 8
|
2
|
0/1
|
9 to 15
|
3
|
0/1
|
16 to 25
|
5
|
0/1
|
26 to 50
|
8
|
0/1
|
51 to 90
|
13
|
1/2
|
91 to 150
|
20
|
1/2
|
151 to 280
|
30
|
2/3
|
281 to 500
|
50
|
3/4
|
501 to 1,200
|
80
|
5/6
|
1,201 to 3,200
|
125
|
6/8
|
3,201 to 10,000
|
200
|
10/11
|
Note that the first number on each line in the "Accept/Reject"
column is the maximum number of defective meters allowable in a sample size for
the lot to be accepted. The second number on each line in this column is the
minimum number of defective meters in a sample size which requires that the lot
be rejected.