Accessories Inspection 

refers to carefully examination or scrutiny of accessories to ensure

desire quality and quantity of buyer / customer. Inspection conducted by Quality Inspector
designated by QA Team.

Purpose of Accessories Inspection:

1. Control the quality effectively.

2. Ensure correct trim will be used.
3. Take Corrective Action as early as possible if there are any problem with accessories.

How to Check:

All Trims and Accessories should be inspected on arrival into the factory by lot/shipment.
Buyer/Customer can suggest different procedure for inspect a lot/shipment, requirement will be
clearly instructed in their Quality Manual with DCL. Almost all factories segment incoming
trims and accessories items into two, those are Countable and Uncountable like lace, elastic,
velcro, etc. Factory try to follow the method is AQL 1.5 (level II) for countable and uncountable
required Sample Size 10% then pass fail depends on minimum AQL Pass/reject criteria and on
there side Defect Tolerance 3% or 5% based on buyer’s guideline or factory SOP.

That means that if 10 cartons arrive, then 10% will be checked from each of the 10 cartons e.g. if
only 1 size article is found in a carton then 10% of each of the 10 cartons will be inspected. If
more than 1 size is found in each carton then 10% of each size will be checked. Just checking 1
carton (100%) out of the 10 carton (10%) doesn’t mean that the balance quantity of pieces in the
other 9 cartons is correct. Some special cases Inspector will be check 100%. If any critical
defects found will be “ZERO TOLERANCE”, whole lot will be rejected.

Inspection Tools: (Some of the Inspection tools are given below)

1. Approved Samples/Trims Card,

2. Style’s Technical File,
3. Defects Classification List (DCL),
4. Defects Picture (Color Pic/Swatch),
5. Weight Machine (Calibrated),
6. Measurement Tape (Calibrated),
7. Light Box (Calibrated),
8. Vernier Scale (Calibrated),
9. Pull-Test Machine (Calibrated), Etc.

Job Description/Responsibility of Trim & Accessory Inspector:

1. He/she should conduct inspection of the trims for quality & quantity.
2. He/she conducts 10% inspection of the goods. In case of discrepancy he/she will conduct
100% inspection as per SOP.
3. If any critical defects found will be “ZERO TOLERANCE”, whole lot will be rejected.
 4. He/she will document the result of inspection and send them to the appropriate authority
for onward submission to the supplier & buyer.
5. Hang tags having bar codes printed on them must be check 100% piece to piece properly
through bar code reader.
6. The trims have to be affixed on the bin card.
7. All trims have to be checked using buyer approved light source D65, TL84, UV, CWF,
FA, and UL3500.
8. All reject trims must be kept in reject area and disposed of following the buyer
recommended disposal process.
9. After completing Brand labels inspection its must keep in confirm area with lock and
key. Key must be handle store in charge only. If Store In-charge absent then Managing
Director will nominate person can to handle the key.
10. Every inspection record will be noted in register book accordingly. Responsible for trim
& accessory inspection is Quality Inspector and in-charge. 

Quality Acceptance: What is AQL?

Because ideas about quality vary between people, buyers need a standardized way to judge the
quality of their goods. This is where the AQL comes into play.

‘AQL’ stands for ‘Acceptance Quality Limit’ or ‘Acceptance Quality Level’ and sets the
international quality standard for product inspections. It helps determine your inspection
sampling size according to your order quantity and your product quality tolerance level.

Through the use of Statistical Sampling, inspectors and buyers can determine the overall quality
acceptance of a production lot without having to check every single item. This saves buyers time
and money, while still providing an accurate estimate of their overall production quality.

Reading the AQL Table

Table A:

In table A you can see:

Lot/Batch sizes: A lot or batch is named after your collection of products, from which a sample
will be pulled.
 

Special Inspection Levels: Special Levels consist of S-1, S-2, S-3 and S-4 and are used in cases
where only very limited number of samples can be checked. Some of these scenarios may
include a buyer requiring more packages inspected on only a few cartons, or time-consuming
tests that require samples to be disassembled or destroyed.

General Inspection Levels: This represents the general accuracy level of the Sampling Method.
There are three General Sampling Levels: II, III, and I.

GI Level-I

Level-I requires a smaller sample size, and helps decrease inspection time, but raises the
likelihood of defects not getting caught. You may consider using Level 1 inspection if you feel
confident with your supplier or they have consistently delivered good product quality.

Tip: Many buyers will feel tempted to skip through inspections in an effort to save a few bucks.
Instead, buyers can opt to check fewer samples by using a level-I inspection.

GI Level-II

L-II is the most common inspection level. This level covers a relatively large inspection scope
without forcing buyers to go over budget.

GI Level-III

Level-III uses a larger sample size, significantly increasing the time to perform inspection, while
increasing the probability of catching any defects.

Tip: This option is highly suggested when a supplier has a history of quality problems.

Table B

In Table B you will see:

 
Sample Size Code Letter:  The sample code letter is based on lot size and inspection level.
Sample size code letters and the corresponding AQL level designate sample sizes.

Sampling Size: The sampling size is the total number of units to be inspected.

AQL and Defect Classification: Let’s face it, defects will be found in almost every production
lot. Buyers can regulate the overall quality of their goods by arranging their AQLs for critical,
major, and minor defects.

Critical Defect: Any condition with the possibility to cause harm or injury to the consumer.

Major Defect: Any condition which can affect the product’s marketability, sale-ability, or
function, which can result in the consumer returning the product.

Minor Defect: Any condition, which may be less than desirable to the consumer. The defect
does not negatively impact marketability or function and is not likely to result in the product
being returned.

Now that you know the basics, let’s go over and apply what we covered.

Applying What We Know of Quality Acceptance

Example: Hiking Sticks
Let’s use a hypothetical order of 7,000 Hiking Sticks.

Determine the Lot Size:

First off, we need to identify the order quantity by referring to the AQL Chart, Table A.

Knowing our quantity is 7,000 pcs we can see that our order quantity falls in the between 3,201
and 10,000

Choosing Sample Level

Next, we need to decide what inspection level to use.

If you look to the right, you have two inspection levels to choose from:

Special levels: S1->C, S2->D, S3->F, S4->G and General Inspection Levels: G1 -> J, G2 -> L,
and G3 -> M.

Let’s stick with the General Inspection levels, as this is the standard AQL sampling plan used by
default for conducting normal product inspections.
What General Inspection to Choose:

Up next, we have the choice of General inspections I, II and III. Level III is the strictest testing
and Level I, the most lenient.

We will use AQL Standard Level II, as this is standard for consumer products – it’s also the
minimum sampling size you should inspect to minimize your risks.

Table A indicates our sample size code letter should be L, which directs us to Table B, which
indicates our sample size should be 200 units.

Determine the Maximum and Minimum Defects:

On the top of AQL Table B you will see defect levels ranging from 0.065 to 6.5, with the
strictest parameters on the left and more lenient parameters on the right.

You also have a row with “Ac,” meaning Accepted levels and “Re,” meaning Rejected levels.

You can select which level to use based on defects: critical, major and minor. We will be using
Major 2.5/Minor 4, which most buyers will typically use for most consumer products.

Note: There is no universal rule about AQL requirements. With that in mind, strict AQL
requirements can increase the pricing from your supplier; this is due to higher production and
rework costs on your supplier.

Setting your quality requirements too high may influence suppliers to refuse to manufacture your
products, as they will view your AQL requirements as too stringent or unreasonable. It’s best to
work out your requirements with the suppliers prior to the start of production.

According to our quality standards for Critical 0, Major 2.5, and Minor 4:

Accepted     Rejected

Major defect acceptable standard is 10 pcs Major defect acceptable standard is 11 pcs
Minor defect acceptable standard is 14 pcs Minor defect acceptable standard is 15 pcs

Any major defects over 10pcs or the minor defects over 14pcs, will result in a failed production
lot.

With an understanding of AQL tables, buyers can plan and negotiate their overseas production
with confidence and accuracy.

Have a product being made in China? Guided Imports can assist with your quality control
measures by offering the best QC Inspection services in China!

 What is the defect classification?

The defetcs are classified within 3 categories, "Minor", "Major" and "Critical".

-Minor defects:

A defect that is not likely to reduce the usability of the product, but is likely to reduce the
salability or a discrepancy from the defined quality standard or not same as the original
sample.Minor defects are usually small, in most cases the customer wouldn’t even notice a minor
defect on a product. 

-Major defects:

A defect that is likely to result in product failure, reduction the usability of the product and
obvious appearance defect affecting the salability of the product. A product with a major defect
departs significantly from the buyer’s product specifications.  Major defects are those which
could adversely affect the function, performance or appearance of a product.

-Critical defects:

A defect that fails to meet mandatory regulations and / or affects the safety of the consumer
when using the product.Critical defects render an item completely unusable and/or could cause
harm to the user.These defects put businesses at serious risk of product liability issues and
product recalls.

Use ctrl + scroll to zoom the map

ISO 2859-1:1999(en)

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.

Draft International Standards adopted by the technical committees are circulated to the member bodies
for voting. Publication as an International Standard requires approval by at least 75 % of the member
bodies casting a vote.

International Standard ISO 2859-1 was prepared by Technical Committee ISO/TC 69, Applications of

statistical methods, Subcommittee SC 5, Acceptance sampling.

This second edition of ISO 2859-1 cancels and replaces the first edition (ISO 2859-1:1989) of which it
constitutes a technical revision.

Significant changes in this edition include:

 — a new procedure for switching from normal to reduced inspection;

 — a reference to skip-lot sampling as an alternative to reduced inspection;
 — the term "limiting quality" has been changed to "consumer's risk quality" in the heading of
Tables 6-A, 6-B, 6-C, 7-A, 7-B and 7-C;
 — a new table has been added giving producer's risk as the probability of rejection of lots with
percent nonconforming equal to the AQL;
 — optional fractional acceptance number plans have been added; the purpose of these plans is
to provide a consistent progression from the plans for acceptance number zero to the
acceptance number 1 plans. The fractional acceptance number plans are found in Tables 11-A,
11-B and 11-C, where they take the place of the arrows in the corresponding positions in
tables 2-A, 2-B and 2-C;
 — reduced plans have been changed to eliminate the gap between the acceptance and rejection
numbers;
 — some changes have been made to the double sampling plans to provide a smaller average
sample size;
 — multiple sampling plans have been changed to five stages rather than seven. The change has
not increased the average sample size. Some of the new plans have a smaller average sample
size than their counterparts in the previous edition;
 — scheme operating characteristic curves have been added as Table 12.
ISO 2859 consists of the following parts, under the general title Sampling procedures for inspection by
attributes:

 — Part  0: Introduction to the ISO 2859 attribute sampling system

 — Part  1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
 — Part  2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection
 — Part  3: Skip-lot sampling procedures

It is highly recommended that this part of ISO 2859 be used together with ISO 2859-0, which contains
illustrative examples.
Annex A of this part of ISO 2859 is for information only.

1   Scope
1.1   This part of ISO 2859 specifies an acceptance sampling system for inspection by attributes. It is
indexed in terms of the acceptance quality limit (AQL).

Its purpose is to induce a supplier through the economic and psychological pressure of lot non-
acceptance to maintain a process average at least as good as the specified acceptance quality limit,
while at the same time providing an upper limit for the risk to the consumer of accepting the occasional
poor lot.

Sampling schemes designated in this part of ISO 2859 are applicable, but not limited, to inspection of

 — end items,
 — components and raw materials,
 — operations,
 — materials in process,
 — supplies in storage,
 — maintenance operations,
 — data or records, and
 — administrative procedures.

1.2   These schemes are intended primarily to be used for a continuing series of lots, that is, a series long
enough to allow the switching rules (9.3) to be applied. These rules provide:

 a) a protection to the consumer (by means of a switch to tightened inspection or discontinuation

of sampling inspection) should a deterioration in quality be detected;
 b) an incentive (at the discretion of the responsible authority) to reduce inspection costs (by
means of a switch to reduced inspection) should consistently good quality be achieved.

Sampling plans in this part of ISO 2859 may also be used for the inspection of lots in isolation but, in this
case the user is strongly advised to consult the operating characteristic curves to find a plan that will
yield the desired protection (see 12.6). In that case, the user is also referred to the sampling plans
indexed by limiting quality (LQ) given in ISO 2859-2.
2   Normative references
The following normative documents contain provisions which, through reference in this text, constitute
provisions of this part of ISO 2859. For dated references, subsequent amendments to, or revisions of,
any of these publications do not apply. However, parties to agreements based on this part of ISO 2859
are encouraged to investigate the possibility of applying the most recent editions of the normative
documents indicated below. For undated references, the latest edition of the normative document
referred to applies. Members of ISO and IEC maintain registers of currently valid International
Standards.

 ISO 2859-3:1991, Sampling procedures for inspection by attributes — Part 3: Skip-lot sampling

procedures.
 ISO 3534-1:1993, Statistics — Vocabulary and symbols — Part 1: Probability and general
statistical terms.
 ISO 3534-2:1993, Statistics — Vocabulary and symbols — Part 2: Statistical quality control.

3   Terms, definitions and symbols

3.1   Terms and definitions

For the purposes of this part of ISO 2859, the terms and definitions given in ISO 3534-1 and ISO 3534-2
and the following apply.

NOTE For ease of reference, the definitions of some of these terms are quoted from ISO 3534-1
and ISO 3534-2, while others are redefined or newly defined.

3.1.1

inspection

activity such as measuring, examining, testing or gauging one or more characteristics of a product or
service, and comparing the results with specified requirements in order to establish whether conformity
is achieved for each characteristic

3.1.2

original inspection

first inspection of a lot according to the provisions of this part of ISO 2859

Note 1 to entry: This is to be distinguished from the inspection of a lot which has been resubmitted after
previous non-acceptance.

3.1.3

inspection by attributes
inspection whereby either the item is classified simply as conforming or nonconforming with respect to
a specified requirement or set of specified requirements, or the number of nonconformities in the item
is counted

Note 1 to entry: Inspection by attributes includes inspection for conformity of items as well as inspection
for number of nonconformities per hundred items.

3.1.4

item

that which can be individually described and considered

EXAMPLE:

 — a physical item;
 — a defined quantity of material;
 — a service, an activity or a process;
 — an organization or a person; or
 — some combination thereof. Transform

3.1.5
nonconformity

non-fulfilment of a specified requirement

Note 1 to entry: In some situations specified requirements coincide with customer usage requirements
(see defect, 3.1.6). In other situations they may not coincide, being either more or less stringent, or the
exact relationship between the two is not fully known or understood.

Note 2 to entry: Nonconformity will generally be classified according to its degree of seriousness such
as:

 Class A: those nonconformities of a type considered to be of the highest concern; in acceptance

sampling such types of nonconformities will be assigned a very small acceptance quality limit
value;
 Class B: those nonconformities of a type considered to have the next lower degree of concern;
therefore, these can be assigned a larger acceptance quality limit value than those in class A and
smaller than in class C, if a third class exists, etc.

Note 3 to entry: Adding characteristics and classes of nonconformities will generally affect the overall
probability of acceptance of the product.
Note 4 to entry: The number of classes, the assignment into a class, and the choice of acceptance quality
limit for each class, should be appropriate to the quality requirements of the specific situation.

3.1.6

defect

non-fulfilment of an intended usage requirement

Note 1 to entry: The term "defect" is appropriate for use when a quality characteristic of a product or
service is evaluated in terms of usage (as contrasted to conformance to specifications).

Note 2 to entry: Since the term "defect" now has definite meaning within the law, it should not be used
as a general term.

3.1.7

nonconforming item

item with one or more nonconformities

Note 1 to entry: Nonconforming items will generally be classified by their degree of seriousness such as:

 Class A: an item which contains one or more nonconformities of class A and may also contain
nonconformities of class B and/or class C, etc.;
 Class B: an item which contains one or more nonconformities of class B and may also contain
nonconformities of class C, etc. but contains no nonconformity of class A.

3.1.8
percent nonconforming

one hundred times the number of nonconforming items in the sample divided by the sample size, viz:

where

dis the number of nonconforming items in the sample;

nis the sample size
3.1.9

percent nonconforming

one hundred times the number of nonconforming items in the population or lot divided by the

population or lot size, viz:

where

p is the proportion of nonconforming items;

Dis the number of nonconforming items in the population or lot;
Nis the population or lot size
Note 1 to entry: In this part of ISO 2859 the terms percent nonconforming (3.1.8 and 3.1.9) or
nonconformities per 100 items (3.1.10 and 3.1.11) are mainly used in place of the theoretical terms
"proportion of nonconforming items" and "nonconformities per item" because the former terms are the
most widely used.
Note 2 to entry: This definition differs from that found in ISO 3534-2.

3.1.10

nonconformities per 100 items

one hundred times the number of nonconformities in the sample divided by the sample size, viz:

where

dis the number of nonconformities in the sample;

nis the sample size
3.1.11

nonconformities per 100 items

one hundred times the number of nonconformities in the population or lot divided by the population or
lot size, viz:

where

p is the number of nonconformities per item;

Dis the number of nonconformities in the population or lot;
Nis the population or lot size
Note 1 to entry: An item may contain one or more nonconformities.

3.1.12

responsible authority

concept used to maintain the neutrality of this part of ISO 2859 (primarily for specification purposes),
irrespective of whether it is being invoked or applied by the first, second or third party

Note 1 to entry: The responsible authority may be:

 a) the quality department within a supplier's organization (first party);

 b) the purchaser or procurement organization (second party);
 c) an independent verification or certification authority (third party);
 d) any of a), b) or c), differing according to function (see Note 2) as described in a written
agreement between two of the parties, for example a document between supplier and
purchaser.

Note 2 to entry: The duties and functions of a responsible authority are outlined in this part of ISO 2859
(see 5.2, 6.2, 7.2, 7.3, 7.5, 7.6, 9.1, 9.3.3, 9.4, 10.1, 10.3, 13.1).
3.1.13
lot

definite amount of some product, material or service, collected together

Note 1 to entry: An inspection lot may consist of several batches or parts of batches.

3.1.14

lot size

number of items in a lot

3.1.15

sample

set of one or more items taken from a lot and intended to provide information on the lot

3.1.16

sample size

number of items in the sample

3.1.17

sampling plan

combination of sample size(s) to be used and associated lot acceptability criteria

Note 1 to entry: A single sampling plan is a combination of sample size and acceptance and rejection
numbers. A double sampling plan is a combination of two sample sizes and acceptance and rejection
numbers for the first sample and for the combined sample.

Note 2 to entry: A sampling plan does not contain the rules on how to draw the sample.

Note 3 to entry: For the purposes of this part of ISO 2859, a distinction should be made between the
terms sampling plan (3.1.17), sampling scheme (3.1.18) and sampling system (3.1.19).

3.1.18

sampling scheme

combination of sampling plans with rules for changing from one plan to another

SEE:   

3.1.19

sampling system

collection of sampling plans, or of sampling schemes, each with its own rules for changing plans,
together with sampling procedures including criteria by which appropriate plans or schemes may be
chosen
Note 1 to entry: This part of ISO 2859 is a sampling system indexed by lot-size ranges, inspection levels
and AQLs. A sampling system for LQ plans is given in ISO 2859-2.

3.1.20

normal inspection

use of a sampling plan (3.1.17) with an acceptance criterion that has been devised to secure the
producer a high probability of acceptance when the process average (3.1.25) of the lot is better than the
acceptance quality limit (3.1.26)

Note 1 to entry: Normal inspection is used when there is no reason to suspect that the process average
(3.1.25) differs from an acceptable level.

3.1.21

tightened inspection

use of a sampling plan (3.1.17) with an acceptance criterion that is tighter than that for the
corresponding plan for normal inspection (3.1.20)

Note 1 to entry: Tightened inspection is invoked when the inspection results of a predetermined
number of consecutive lots indicate that the process average (3.1.25) might be poorer than the AQL
(3.1.26).

3.1.22

reduced inspection

use of a sampling plan (3.1.17) with a sample size (3.1.16) that is smaller than that for the corresponding
plan for normal inspection (3.1.20) and with an acceptance criterion that is comparable to that for the
corresponding plan for normal inspection

Note 1 to entry: The discriminatory ability under reduced inspection is less than under normal
inspection.

Note 2 to entry: Reduced inspection may be invoked when the inspection results of a predetermined
number of consecutive lots indicate that the process average (3.1.25) is better than the AQL (3.1.26).

3.1.23

switching score

indicator that is used under normal inspection to determine whether the current inspection results are
sufficient to allow for a switch to reduced inspection

SEE:   

3.1.24

acceptance score

indicator that is used for fractional acceptance number plans to determine lot acceptability
SEE:   

3.1.25

process average

process level averaged over a defined time period or quantity of production

[SOURCE: ISO 3534-2:1993, 3.1.2]

Note 1 to entry: In this part of ISO 2859 the process average is the quality level (percent nonconforming
or number of nonconformities per hundred items) during a period when the process is in a state of
statistical control.

3.1.26

acceptance quality limit

AQL

quality level that is the worst tolerable process average when a continuing series of lots is submitted for
acceptance sampling

Note 1 to entry: This concept only applies when a sampling scheme with rules for switching and for
discontinuation, such as in ISO 2859-1 or ISO 3951, is used.

Note 2 to entry: Although individual lots with quality as bad as the acceptance quality limit may be
accepted with fairly high probability, the designation of an acceptance quality limit does not suggest
that this is a desirable quality level. Sampling schemes found in International Standards such as this part
of ISO 2859, with their rules for switching and for discontinuation of sampling inspection, are designed
to encourage suppliers to have process averages consistently better than the AQL. Otherwise, there is a
high risk that the inspection severity will be switched to tightened inspection under which the criteria
for lot acceptance become more demanding. Once on tightened inspection, unless action is taken to
improve the process, it is very likely that the rule requiring discontinuation of sampling inspection
pending such improvement will be invoked.

3.1.27

consumer's risk quality

CRQ

lot or process quality level that in the sampling plan corresponds to a specified consumer's risk

Note 1 to entry: Consumer's risk is usually 10 %.

3.1.28

limiting quality

LQ
when a lot is considered in isolation, a quality level which for the purposes of sampling inspection is
limited to a low probability of acceptance

3.2   Symbols and abbreviations

The symbols and abbreviations used in this part of ISO 2859-1 are as follows:

Ac acceptance number
AQL acceptance quality limit (in percent nonconforming items or in nonconformities per hundred
items)
AOQ average outgoing quality (in percent nonconforming items or in nonconformities per hundred
items)
AOQ average outgoing quality limit (in percent nonconforming items or in nonconformities per hundred
L items)
CRQ consumer's risk quality (in percent nonconforming items or in nonconformities per hundred items)
d number of nonconforming items (or nonconformities) found in a sample from a lot
D number of nonconforming items in a lot
LQ limiting quality (in percent nonconforming items or in nonconformities per hundred items)
N lot size
n sample size
p process average
px quality level for which the probability of acceptance is x, where x is a fraction
Pa probability of acceptance (in percent)
Re rejection number

NOTE The symbol n may be accompanied by a subscript. Numerical subscripts 1 to 5 denote the
first to the fifth sample, respectively. In general, ni is the size of the ith sample in double or
multiple sampling.
 Inspection by attributes:
 Inspection whereby either the unit of product is classified simply as defective or no-defective or
the number of defects in the unit of product is counted, with respect to a given requirement or
set of requirements.
  Acceptable Quality Level (AQL):
 The AQL is a percent defective that is the baseline 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 Acceptable Quality Level (AQL).

 Sampling Plan:
 A lot sampling plan is a statement of the sample size or sizes to be used and the associated
acceptance and rejection numbers.

 Representative Sampling:
 When appropriate, the number of units in the sample shall be selected in proportion to the size
of sub-lots or sub-batches, or parts or the lot or batch, identified by some rationale criterion.
When representative sampling is used, the units from each part of the lot or batch shall be
selected at random.

 Defects:
 A defect is any non- conformance of the unit of the product with the specified requirement.

 Critical Defect:
 A critical defect is one which is likely to result in a hazardous or unsafe condition for individual
using, maintaining or depending upon that product.

 Major Defect:
 A major defect is one, other than critical, that is likely to result in failure or to reduce materially
and usability of the unit of product for its intended purpose..

 Minor Defect:
 A Minor defect is one that is not likely to reduce considerably 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 of product.

 Part Lot:
 Distinct portions of a whole lot, i.e. a whole lot of core tablets divided into an equal portion for
the purpose of coating – each portion of the coated tablets is a distinct lot. I

 Inspection Levels:
 The standards provide for three general inspection levels (i.e. Level I-Reduced Inspection, Level
II- Normal/General Inspection, Level III- Tightened Inspection) and four special inspection levels.
These levels permit the user to balance the cost of inspection against the amount of protection
required.

PROCEDURE FOR ACCEPTABLE QUALITY LEVEL (AQL):

 Acceptable Quality Level (AQL) checks shall be performed semi-finished for commercial batches
of tablets and capsules.
 QA shall perform the Acceptable Quality Level (AQL) checks in the respective area and based on
findings,

 QA shall decide the need & extent of inspection for the subjected batch and details shall be
recorded.

 In the case of Process validation batches, 100% visual inspection shall be performed and the
same shall be addressed in the Batch record.

 During Process validation, Segregate the visual inspection rejection and evaluate the type of
rejection i.e. Critical, Major and Minor.

 If the visual inspection trend of process validation is satisfactory, then based on process
validation (report) recommendations, Acceptable Quality Level (AQL) sampling shall be
performed in commercial batches.

 Selection of Containers for Acceptable Quality Level (AQL) Sampling of Tablets/Capsules:

 Production Officer shall submit duly filled and signed BMR to QA for review and intimate for
visual inspection of the bulk product as per Acceptable Quality Level (AQL).

 QA shall ensure Product name, Batch No, Manufacturing date, Expiry date and select the
containers of product for Acceptable Quality Level (AQL).

 The samples to be withdrawn for the bulk approval from the number of the container shall be
based on the following criteria :

 Determine the “total number of containers to be sampled” per part lot (for coated tablets) or
per batch (for capsules and uncoated tablets) by using the formula  10+√n +1, Where “n” is the
total number of containers per part lot/Batch.

 If the total number of the container is less than or equal to 10 Nos (per batch/lot), then samples
shall be checked from all the containers.

 In case of the total number of the container is more than 10, then for Acceptable Quality Level
(AQL) sampling of 10 containers shall be done 100% and the remaining container shall be AQL as
per formula √n+1.

 For Example Number of the container is 35 then AQL of 10 (Frist 5 + Last 5) container is 100%
and for remaining (35-10=25) 5 containers, as per formula (√25+1=5+1), 6 containers shall be
checked.

 If any value of √n is above the whole number, the number shall be rounded off to the next
whole number).
  For coated tablets, if coating performed in multiple lots then individual lot size shall be
considered as batch size and accordingly Acceptable Quality Level (AQL) samples shall be
withdrawn.

 E.g. If 1 part lot contains 28 containers ( e.g. coating is performed in two lots) then the number
of containers to be sampled shall be 10+√18+1 = 10+4.24+1 =15.24 Therefore the total number
of containers to be sampled shall be 16 from each lot.

 If one batch contains 50 containers (e.g. uncoated tablets/capsules) then the number of
containers to be sampled will be 10+√40+1 = 10+6.32+1 = 17.32, therefore, the total number of
containers to be sampled shall be 18 from the whole batch.

 Collection of samples and acceptance criteria for Acceptable Quality Level (AQL)

 Collect the samples from each selected container in equal quantity in a duly labeled
polyethylene bag.

 Check each collected tablet (coated and uncoated) or capsule for the quality attributes specified
as per Acceptable Quality Level (AQL) on the inspection trolley.

 e.g. In case of uncoated tablets/ capsules if Acceptable Quality Level (AQL) sample quantity
requirement is 1250 and no. of containers to be sampled is 9 then from each container 1250/9
i.e. 138.9=139 samples (Withdrawn of samples = No. of Sample X Avg. weight of sample or by
Manual Counting) shall be withdrawn and composite sample of 1250 bulk units shall be
prepared.

 In case of coated tablets if the coating is performed in two lots and lot size is 500000 then 800
tablets from each part lot shall be withdrawn.

 If samples are to be withdrawn from 5 containers then from each container 800/5=160 coated
tablets (Withdrawn of samples = No. of Sample X Avg. weight of sample or by Manual Counting)
shall be withdrawn.

 For the purpose of the Acceptable Quality Level (AQL). Consider the sampling standard weight of
tablets as average weight.

 QA Officer shall check the bulk product for visual defects as per the below-mentioned
procedure. ( Check the visual defects on both the sides of tablets in case of tablet products ).

 Collect the sample quantity from each selected container in equal quantity and inspect on the
inspection trolley.

 The acceptance criteria for Acceptable Quality Level (AQL) shall be as given below based on the
classification of the defect.

Sr. No. Classification of defect Acceptance criteria

01 Critical 0.010%

02 Major 0.40 %

03 Minor 1.50  %

 The sampling quantity for bulk approval and number of defects observed against acceptance
criteria to determine whether batch passes or fails shall be as per the below table.

 The below table is equivalent to the General Inspection Levels -LEVEL II.

Table-1

 In case batch size is more than 10,00,000 Tablets/Capsules sample size quantity is doubled as
compared to if batch size is between 5,00,001 to 10,00,000 Tablets/ Capsules.

 This is Sun in-house stringent criteria with respect to sample quantity in order to increase
sample size in proportion to batch size.

 Note: If batch/part lot fails in Acceptable Quality Level (AQL) acceptance criteria then 100 %
inspection of the part lot/batch shall be performed. Raise the event to find out the root cause.

 The classification of defects as per the nature of dosage forms as given below:

 Classification of core tablets defects are as follows:

(1) Critical
A. Wrong appearance

Foreign product Pharmaceutical material is either a component,

 powder on the finished dosage that is not a
normal part of the batch being processed

Anything other than Pharmaceutical material

Foreign material that is not a normal part of the batch being
processed.

Product appearance is not as per product

Wrong appearance
specification.

The tablet that is notably thinner, thicker, larger,

Tablets not in  uniform size /Wrong punch shape smaller or a different shape than the other in
the sample.

Abnormal discoloration of products Discolored tablets

  Note: Broken tablets are considered as critical criteria

and 100% inspection shall be performed prior to
loading bulk units into the hopper for primary
packaging.

(2) Major :

Chipping or Minor It is the breaking of tablet edges, while the tablet leaves the press or during
breaking subsequent handling and coating operations.

Illegible de-bossing Characters in the de-bossing are not legible.

Illegible embossing Characters in the embossing are not legible.

Layer separation In the bilayer tablet, one layer is separated from the other layers.

Lamination It is the separation of a tablet into two or more distinct horizontal layers.

Small, fine cracks observed on the upper and lower central surface of
Cracking/broken tablet
tablets, or very rarely on the sidewall are referred to as ‘Cracks’.

‘Double Impression’ involves only those punches, which have a monogram

Double impression
or other engraving on them.

Soft tablets  The tablets are susceptible to hydrolysis will develop soft nature.

The small amount of material from a tablet is sticking to and being removed
Picking
off from the tablet-surface by a punch face.

The tablet material adhering to the die wall. Filming is a slow form of
Sticking
sticking and is largely due to excess moisture in the granulation

Dark
Stains or spots will appear on the tablet surface. Migration of coloring agent
Spot/Blackspot/Colour
upon storage.
particles
 Capping happened when the upper or lower segment of the tablet
separates horizontally, either partially or completely from the main body of
Capping
a tablet and comes off like a cap, during ejection from the tablet press, or
during subsequent handling.

Tablets adhere, seize or tear in the die. A film is formed in the die and
Binding ejection of the tablet is hindered. With excessive binding, the tablet sides
are cracked and it may crumble apart

(3) Minor :

‘Mottling’ is the term used to describe an unequal distribution of color on a

Mottling
tablet, with light or dark spots standing out in an otherwise uniform surface.

Rough surface The tablet surface is rough.

The tablet that is visibly a different shade or color than the others in the
Shade variation
sample.

Dust on Tablet The powder found on the tablet.

De-bossing or score is
Characters in the de-bossing / crease have slight imperfections but are legible.
not well defined

 Classification of Coated tablets defects are as follows:

(1) Critical :
A. Wrong appearance

Pharmaceutical material is either a component,

Foreign product powder on the finished dosage that is not a
normal part of the batch being processed.

Anything other than Pharmaceutical material that

Foreign material is not the normal part of the batch being
processed.

The tablet that is notably thinner, thicker, larger,

Tablet not in uniform size smaller or a different shape than the other in the
sample.

Missing debossing Debossed characters are missing from the tablet.

Abnormal discoloration of products Discolored tablets

Large dark staining on product Stains found on the products

  Note: Broken tablet is considered as critical criteria

and 100% inspection shall perform prior to loading
bulk units into the hopper for primary packaging.

(2) Major :

It is a defect where the coating becomes dull immediately or after prolonged storage
Blooming
at high temperatures.

This occurs when the coating fills in the lettering or logo on the tablet and is typically
caused by improper application of the solution, poor design of the tablet embossing,
Bridging
high coating viscosity, a high percentage of solids in the solution, or improper
atomization pressure.

It is a defect where the film becomes chipped and dented, usually at the edges of
Chipping
the tablet.

Colour Variation A defect which involves variation in the color of the film.

It is a defect of film coating whereby volcanic-like craters appears exposing the

Cratering
tablet surface.

Flaking Film flakes off exposing the tablet surface

‘Mottling’ is the term used to describe an unequal distribution of color on a tablet,

Mottling
with light or dark spots standing out in an otherwise uniform surface.

Orange It is a surface defect resulting in the film being rough and nonglossy. Appearance is
Peel/Roughness similar to that of an orange

Splitting The film splits usually around the edges of the tablet

An indentation in the surface of the tablet that can cause a dimple resulting in
Sticking
weight variation.

Twinning When two tablets stick tighter. It usually happens with capsule-shaped tablets.

(3) Minor :

Blistering The film becomes detached from substrate forming a blister

Blushing  It is a defect best described as whitish specks or haziness in the film.

It is a defect in which the film either cracks across the crown of the tablet (cracking)
Cracking/Splitting
or splits around the edges of the tablet (Splitting)

Peel off The film peels off exposing the best tablet surface

It is a defect where isolated areas of the film are pulled away from the surface when
Picking
the tablet sticks together and then part.

It is a defect whereby pits occur in the surface of a tablet core without any visible
Pitting
disruption of the film coating

Shade variation The tablet that is visibly a different shade or color than the others in the sample.
Infilling It is a defect that renders the integrations indistinct.

 Classification of Capsules defects are as follows:

(1) Critical :
A. Wrong appearance

Pharmaceutical material is either a component, powder on the finished dosage

Foreign Product
that is not a normal part of the batch being processed.

Anything other than Pharmaceutical material that is not a normal part of the
Foreign Material
batch being processed.

Missing Imprint On All imprint characters are missing from the cap & body of the capsule that
Cap & Body precludes product identification. Wrong imprint.

Capsule Empty Capsules with little or no contents or the body & cap are disengaged.

Partially filled capsule Capsule not properly filled.

(2) Major :

Capsule not free of cracks, breaks, The surface of the capsule is not intact & the contents of
notching, V notch cap, pinholes or splits. the capsule may fall out or have already fallen out.

Capsules not free of embedded surface Clearly defined particles embedded in the surface or the
spots. capsule.

Capsule not completely closed & the cap may slip off of the
Capsule not properly closed
body.

Translucent capsules with a crimped or smashed top.

Crushed Capsules
Content leaking/ missing.

Imprint illegible Characters in the imprint are not legible.

(3) Minor :

Capsule not free of dents Indentation in the surface of the capsule.

Clearly defined bumps, porous areas or lighter color areas

Capsule not free of surface blemishes
prone to breakage.

Capsule cap & body cutting into one A portion of the cap & body cutting the other, without loss of
another (Telescoping) contents.

Characters in the imprint have a slight imperfection,

Blurred imprint
including ink splatters, but are legible.
Inkspots Two or more ink spots on the capsule away from the imprint.

Double Cap The additional cap also observed on the body

Note: Refer annexure-5 for flow chart of Acceptable Quality Level (AQL) procedure.

 If the bulk is meeting the acceptance criteria, production shall precede for weighing of the bulk,
shall record batch reconciliation and yield data in the BMR and release the bulk for further
processing.

 After completion of Acceptable Quality Level (AQL) sampling, the double polyethylene bag of
sampled containers selected for AQL shall tie with fastener immediately.

 If the bulk is not meeting the acceptance criteria. QA shall ask the production Officer for visual
inspection and raise the event to investigate the Acceptable Quality Level (AQL) failure.

 After visual inspection, again Acceptable Quality Level (AQL) shall be performed. Based on AQL
results, Further proceed the bulk.

 If 3 consecutive batches fail in Acceptable Quality Level (AQL). Perform the investigation and
Stop the subsequent manufacturing of drug products.

 The Acceptable Quality Level (AQL) inspection shall be performed in inspection cubical and if the
Acceptable Quality Level (AQL) meets as per acceptance criteria then after the completion of
AQL inspection inspected good Tablets / Capsules shall add to the last container of good
Tablets / Capsules.

 100% Inspection (By production department) and Acceptable Quality Level (AQL) inspection (By
QA department) shall perform in the same condition i.e. area and inspection trolley etc.

 In the case of an event that may impact visual inspection, a 100% inspection shall be performed.

 In case of repetitive market complaints related to visual inspection defects based on

investigation findings AQL shall be discontinued and 100% visual inspection shall be performed.

 After completion of Acceptable Quality Level (AQL) inspection, QA Officer shall fill the AQL
inspection result in annexure-1 in case of core Tablet, annexure-2 in case of Coated Tablet,
annexure-3 in case of Capsules, and handover BMR to Production Officer for final yield and
accountability reconciliation.

 QA shall send the finished samples of the core, Coated Tablet, and Capsules along with test
requisition cum report to QC after AQL inspection.

 Production Officer shall submit duly filled and signed BMR to QA for the final release.

 QA shall check final yield, test requisition cum report and sign in reviewed by column in BMR
and release the bulk in ERP as per location SOP.
  During the visual inspection in case of any abnormality observed investigation shall be triggered
(like higher % of rejection for specific defect………etc.) to find out the root cause and initiate
appropriate corrective and preventive action.

 Issue the AQL inspections annexure along with each BMR.

 Concerned Production Officer shall prepare the Acceptable Quality Level (AQL) Product list and
QA shall check it as per Annexure-5.

 Perform AQL  only for those products mentioned in the AQL List and remaining products which
have problems as per their trend shall not be considered under AQL Product List and 100%
visual inspection shall be performed for those products.

 In case Acceptable Quality Level (AQL) inspection is discontinued and 100% inspection started
due to any failure then only upon implementation of CAPA. Start the AQL inspection in the
particular drug product.

 DISTRIBUTION OF ACCEPTABLE QUALITY LEVEL (AQL) SOP:

 Quality Assurance

 Production

ANNEXURES OF ACCEPTABLE QUALITY LEVEL (AQL) SOP:

Bulk release format for core Tablets (Annexure 1).

AQL bulk release format for Coated Tablets (Annexure 2)

AQL bulk release format for Capsules (Annexure 3).

Bulk Approval Procedure of Acceptable Quality Level (AQL) for Tablets & Capsules (Annexure
4).
Acceptable Quality Level (AQL) Product List (Annexure 5).

The acceptable quality limit (AQL) is the worst tolerable process average (mean) in percentage
or ratio that is still considered acceptable; that is, it is at an acceptable quality level.[1] Closely
related terms are the rejectable quality limit and rejectable quality level (RQL).[1][2] In a
quality control procedure, a process is said to be at an acceptable quality level if the appropriate
statistic used to construct a control chart does not fall outside the bounds of the acceptable
quality limits. Otherwise, the process is said to be at a rejectable control level.

In 2008 the usage of the abbreviation AQL for the term "acceptable quality limit" was changed
in the standards issued by at least one national standards organization (ANSI/ASQ) to relate to
the term "acceptance quality level".[3][4] It is unclear whether this interpretation will be brought
into general usage, but the underlying meaning remains the same.

An acceptable quality level is a test and/or inspection standard that prescribes the range of the
number of defective components that is considered acceptable when random sampling those
components during an inspection. The defects found during an electronic or electrical test, or
during a physical (mechanical) inspection, are sometimes classified into three levels: critical,
major and minor. Critical defects are those that render the product unsafe or hazardous for the
end user or that contravene mandatory regulations. Major defects can result in the product's
failure, reducing its marketability, usability or saleability. Lastly, minor defects do not affect the
product's marketability or usability, but represent workmanship defects that make the product fall
short of defined quality standards. Different companies maintain different interpretations of each
defect type. In order to avoid argument, buyers and sellers agree on an AQL standard, chosen
according to the level of risk each party assumes, which they use as a reference during pre-
shipment inspection.

Abstract

This practice establishes lot or batch sampling plans and procedures for inspection by attributes
using MIL-STD-105E as a basis for sampling a steady stream of lots indexed by acceptance
quality limit (AQL). It provides the sampling plans of MIL-STD-105E in ASTM format for use
by ASTM committees and others and recognizes the continuing usage of MIL-STD-105E in
industries supported by ASTM. This practice also establishes lot or batch sampling plans and
procedures for inspection by attributes.

The sampling plans described in this standard are applicable to AQL’s of 0.01% or higher and
are therefore not suitable for applications where quality levels in the range of parts per million
levels can be realized. Sampling plans designated in this practice are applicable, but not limited,
to inspection of the end items, components and raw materials, operations or services, materials in
process, supplies in storage, maintenance operations, data or records, and administrative
procedures.

This abstract is a brief summary of the referenced standard. It is informational only and not an
official part of the standard; the full text of the standard itself must be referred to for its use and
application. ASTM does not give any warranty express or implied or make any representation
that the contents of this abstract are accurate, complete or up to date.

Significance and Use

4.1 Purpose—This publication establishes lot or batch sampling plans and procedures for
inspection by attributes. This publication shall not be interpreted to supersede or conflict with
any contractual requirements. The words “accept,” “acceptance,” “acceptable,” etc, refer only to
the contractor’s use of the sampling plans contained in this standard and do not imply an
agreement by the customer (formerly “Government” in original text) to accept any product.
Determination of acceptability by the customer shall be as described in contractual documents.
The sampling plans described in this standard are applicable to AQL’s of 0.01 % or higher and
are therefore not suitable for applications where quality levels in the range of parts per million
levels can be realized.

4.2 Application—Sampling plans designated in this publication are applicable, but not limited, to
inspection of the following: (1) end items, (2) components and raw materials, (3) operations or
services, (4) materials in process, (5) supplies in storage, (6) maintenance operations, (7) data or
records, (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 to find a plan which will yield the desired protection (see 6.11).

1. Scope

1.1 This practice establishes lot or batch sampling plans and procedures for inspection by
attributes using MIL-STD-105E as a basis for sampling a steady stream of lots indexed by
acceptance quality limit (AQL).

1.2 This practice provides the sampling plans of MIL-STD-105E in ASTM format for use by
ASTM committees and others. It recognizes the continuing usage of MIL-STD-105E in
industries supported by ASTM. Most of the original text in MIL-STD-105E is preserved in
Sections 4 – 6 of this practice.

1.3 No system of units is specified in this standard.

1.4 This standard does not purport to address all of the safety concerns, if any, associated with
its use. It is the responsibility of the user of this standard to establish appropriate safety, health,
and environmental practices and determine the applicability of regulatory limitations prior to
use.

1.5 This international standard was developed in accordance with internationally recognized

principles on standardization established in the Decision on Principles for the Development of
International Standards, Guides and Recommendations issued by the World Trade Organization
Technical Barriers to Trade (TBT) Committee.

The Acceptable Quality Level differs from process to process, product to product and buyer to buyer. In
this blog post, we'll take a closer ...
3. Select cartoons for inspection: In a PO, There have many cartons. But we only
select some of them by using cartons selection rules. Rules for selecting cartons;

The equation for cartons selection = √Total no. of cartons. If there are a total
of 121 cartons, then selected cartons = √121 = 11 cartons.

If there have two or more garments size then we select a total of 11 cartons from
different size cartons. Rules for size-wise cartons selection:

The rule of carton selection = (Sample carton quantity X Size carton

Quantity)/ (Total carton quantity) 

If there have a total of 121 cartons and S = 45, M = 35, L = 24, XL = 17 size cartons, then
find the no. of cartons selected according to size from the total cartons.

For S size, selected cartons = (11 ×45)/121 = 4.09 ≅ 4 cartons.

For M size, selected cartons = (11 ×35)/121 = 3.18 ≅ 3 cartons.
For L size, selected cartons = (11 ×24)/121 = 2.18 ≅ 2 cartons.
For XL size, selected cartons = (11 ×17)/121 = 1.54 ≅ 2 cartons. 

Total selected inspection cartons = 4+3+2+2 = 11 cartons.

The cartons will be selected randomly and have to sign with a fixed marker. According to
the PO sheet, the length, width, and height of the cartons should be measured by
a validated measurement tape. Whether cartons boxes are breaking, swelling,
wet, pushing, it has to be observed in a visual way. Using a sharp cutter to cut the
cartons tape.

4. Select garments for inspection: For the size wise garments selection, we follow
the AQL sample quantity. Here sample quantities are fixed according to the no. of
total shipping garments. Rules for selecting garments;

Selected garments = (AQL sample quantity × per size quantity)/(Total

quantity) 

If there have a total of 3000 garments and sample garments for this quantity are 32.
Here size S = 1200, M = 800, L = 650, XL = 350 Pcs garments, then find the no. of
garments selected according to size from the total garments.

For S size, selected garments = (32 ×1200)/3000 = 12.08 ≅ 12 Pcs.

For M size, selected garments = (32 ×800)/3000 = 8.53 ≅ 9 Pcs.
For L size, selected garments = (32 ×650)/3000 = 6.93 ≅ 7 Pcs.
For XL size, selected garments = (32 ×350)/3000 = 3.73 ≅ 4 Pcs.

Total selected inspection garments = 12+9+7+4 = 32 Pcs.

5. Check trims and accessories:  According to the master sample and BOM (Bill
of Materials), all trims and accessories are checks to ensure no trims & accessories are
missing in the garments production and packing. 

6. Check garments appearance and measurement point: The production

garment's external structure, color, shape, and accessories function have to visually
check with the master sample. Check stitch strength and quality of the seam. 

Measure all measurement points with a validated measurement tape by the

following measurement sheet. If we get any fundamental point measurement
problem, we will take another 5 pcs garments and check that point of measurement for 5
pcs.

If we get the same measurement problem in 1 pcs from 5 pcs then PO will fail. But in the
non-fundamental point of measurement,  there have 1 pcs garments allow and 2
pcs the same problem causes PO to fail.