In addition to setting the AQL, the buyer should choose the inspection level.

The
difference between the inspection levels listed below is the number of samples to
inspect.
Normal inspection (or level-II inspection): It is the default level, and it is chosen
for 90%+ of inspections.
ISO 2859 definition for normal inspection:
Normal inspection is used when there is no reason to suspect that the [quality level]
differs from an acceptable level.
Unless otherwise specified, level II shall be used. Level I may be used when less
discrimination is needed or level III when greater discrimination is required.
Tightened inspection (or level-III inspection): more samples are checked. This
inspection level is used for suppliers that recently had severe quality problems, or for
high-value products.
ISO 2859 definition for tightened inspection:
Use of a sampling plan with an acceptance criterion that is tighter than that for the
corresponding plan for normal inspection.
Reduced inspection (or level-I inspection): less samples are inspected. This
inspection level is appropriate when the client is confident that the quality of the
products is acceptable.
Note: it is never appropriate for a re-inspection following a refusal.
ISO 2859 definition for reduced inspection:
The discriminatory ability under reduced inspection is less than under normal
inspection.
There are also four other special inspection levels. They are used in cases where the
inspector can only check very few samples. However, the risk of accepting products of
bad quality is higher.
For example: if the inspector has to do a very particular checking that takes him a long
time per product (e.g. dismantling a radio system to see all the components, check the
welding).
Another example: if a particular test ends up in destruction of the product (e.g. undoing
the stitching of a garment to check the cut pieces against the clients patterns).
ISO 2859 definition for special inspection levels:
Four additional special levels, S-1, S-2, S-3 and S-4 [] may be used where relatively
small sample sizes are necessary and larger sampling risks can be tolerated.

How to determine the correct quantity and acceptable fault levels

when inspecting a product
How to determine the quantity to be inspected
While we all would like to have every single unit of goods to be inspected, this is simply not
practicable or affordable for most products and companies.
The best approach, which is recommended by International Standards Agencies such as ANSI/
ASQ, is to use the AQL (Acceptable Quality Limit or Level) approach to determine both the sample
inspection size and the levels required to determine of an Inspection is a Pass or a Fail.
We use the internationally recognized Acceptable Quality Limit (AQL) standard for all product
inspections. For each inspection, this allows the client to set their acceptable quality tolerance levels.
What is AQL (Acceptable Quality Limit or Level)?
AQL is sometimes called Acceptable Quality Limit by some people or Acceptable Quality Level by
others. They both essentially mean the same thing.
To determine the AQL level of a product you need to use the measure table that is recommended by
ISO 2859, NF06-022, DIN 40080, BS 6001, ANSI/ASQC Z1.4.
This table allows you to determine the sample size (amount or quantity) that should be taken from an
order or batch to be inspected or tested. It then provides you with the values to determine whether a
product has met the buyers specifications and passes or fails the inspection.
You can then determine the tolerance levels in terms of Critical, Major and Minor levels for your
product. The tolerance levels is a fair and equitable method which gives the seller and the buyer
leeway to determine what is an Pass or Fail for an order.
The way to determine these are below:

Critical defects (totally unacceptable: a user might get harmed, or regulations are not
respected) 0% e.g. plug on an electrical device and it smokes, or a non-welded bar in a bed The

product is dangerous
Major defects (these products would usually not be considered acceptable by the end user)

usually 2.5% e.g. scratches that are noticeable and may prevent the product being sold
Minor defects (there is some departure from specifications, but most users would not mind
it). usually 4.0% e.g. a small scratch on the bottom of a leg of a bed, or on non-visual piece on an
electrical appliance
All Inspection reports generated by the inspection companies listed on Goodada.com will clearly
display the AQL standards and show you if the production has failed or passed.
How do I calculate the correct sample size and acceptance value?

For the majority of products the best suggestion is to use a Standard Level II. If this is the accepted
Level then the table below will provide the sample size, critical, major and minor vales (acceptable
value) see the page below

Sample Critical Major Minor

Size
Defects Defects Defects
0
0
0
2-8
2
0
0
0
9-15
3
0
0
0
16-25
5
0
0
1
26-50
8
0
1
1
51-90
13
0
1
2
91-150
20
0
2
3
151-280
32
0
3
5
281-500
50
0
5
7
501-1200
80
0
7
10
1201-3200
125
0
10
14
3201-10000
200
0
14
21
10001-35000
315
0
21
21
35001-150000
500
0
21
21
150001-500000
800
0
21
21
500000 and over 1250
Lot Size

For any non-standard products, or products where the buyer requires a more detailed inspection,
please refer to the tables below.
Our inspectors would be delighted to assist you to determine the correct levels, sample size and
acceptance numbers
Sample Size Chart this will allow you to determine the amount or quantity of your sample

Lot Size

General Inspection Levels

Specific Inspection Levels

II

III

S-1

S-2

S-3

S-4

2-8

9-15

16-25

26-50

51-90

91-150

151-280

281-500

501-1200

1201-3200

3201-10000

10001-35000

35001-150000

150001-500000

500000 and over

Use the letter identified in the Sample Size Chart to determine the Acceptance Values and
Sample Size

Code
Letter

Sample
Size

13

20

32

50

80

125

200

315

500

800

1250

2000

Standard Standard
Major
Minor
2.5%
4.0%
0
0

1.0%
0

1.5%
0

6.5%
0

10

10

14

10

14

21

10

14

21

21

10

14

21

21

21

14

21

21

21

21

21

21

21

21

21

21

21

21

21

21

2013 Green Dragon International Ltd (Republic of Ireland)

What is an inspection level in

ISO 2859-1 and ANSI/ASQC
Z1.4?
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This article introduces the different options available to

buyers, when it comes to the representativity of inspection findings.
Inspection level II (under normal severity) is appropriate for most inspections. But it is
sometimes necessary to increaseor or reducethe number of samples to check.

The need for sampling, rather than

100% checking
When controlling the quality of a batch of products, it is not practical to inspect 100% of
them (unless the quantity is very small). Inspecting a large number of products takes a
long time: it is expensive, and inspectors are less effective as they get tired. Actually, a

100% check does not yield that much more information than inspecting a statistically
representative sample.
The question becomes: how many products to check?

Why different inspection levels?

There is a fairly obvious principle in statistical quality control: the greater the order
quantity, the higher the number of samples to check.
But should the number of samples ONLY depend on the order quantity? What if this
factory had many quality problems recently, and you suspect there are many defects? In
this case, you might want more products to be checked.
On the other hand, if an inspection requires tests that end up in product destruction,
shouldnt the sample size be drastically reduced? And if the quality issues are always
present on all the products of a given batch (for reasons inherent to processes at work),
why not check only a few samples?
For these reasons, different levels are proposed by MIL-STD 105 E (the widely
recognized standard for statistical quality control).
It is usually the buyers responsibility to choose the inspection levelmore samples to
check means more chances to reject bad products when they are bad, but it also
means more days (and dollars) spent in inspection.

The 3 general inspection levels

Level I
Has this supplier passed most previous inspections? Do you feel confident in their
products quality? Instead of doing no quality control, buyers can check less samples by
opting for a level-I inspection.

However, settling on this level by default, in order to spend less time/money on

inspections, is very risky. The likelihood of finding quality problems is lower than
generally recommended.
Level II
It is the most widely used inspection level, to be used by default.
Level III
If a supplier recently had quality problems, this level is appropriate. More samples are
inspected, and a batch of products will (most probably) be rejected if it is below the
quality criteria defined by the buyer.
Some buyers opt for level-III inspections for high-value products. It can also be
interesting for small quantities, where the inspection would take only one day whatever
the level chosen.

The 4 special inspection levels

These special levels can be applied in cases where only very few samples can be
checked. Four additional special levels, S-1, S-2, S-3 and S-4 [] may be used where
relatively small sample sizes are necessary and larger sampling risks can be tolerated
(ISO 2859 standard).
Under S-3 level, the number of samples to check is lower than under S-4, and so on.
In practice: for consumer goods, quality control is usually performed under the general
levels.
The special levels are used only for certain tests that either take lots of time or destroy
the samples. Another situation where special levels are appropriate is a containerloading supervisionto have an idea of what is inside the cartons, without spending too
much time at that checking.

Two examples to get an clearer

understanding
Lets say you have ordered 5,000 pcs of a product. In the table below, you can see how
many samples would be drawn under each of the 7 inspection levels.
General inspection levels

Special inspection levels

II

III

S-1

S-2

S-3

S-4

80pcs

200pcs

315pcs

5pcs

8pcs

20pcs

32pcs

As you can see, the numbers of samples to check vary from 5pcs to 315pcs. But a
trained inspector might be able to do it in one day, whatever the inspection level you
choose.
Now lets say you have ordered 40,000pcs of a product. Again, you can see the
differences in sample sizes.
General inspection levels

Special inspection levels

II

III

S-1

S-2

S-3

S-4

200pcs

500pcs

800pcs

8pcs

13pcs

32pcs

80pcs

In this case, the inspection might take one day of work (for S-1, S-2, S-3, S-4, or
reduced level), two days (under level II), or three days (under level III).

What is the AQL, and when it is

applicable?
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The AQL tables are statistical tools at the disposal of

buyers (for product inspections). They are an industry standard. Most suppliers involved
in international trade are familiar with it.
They help determine two key elements:

How many samples should be picked and inspected, among a batch of product or parts?

Where is the limit between acceptability and refusal, when it comes to defective
products?

The need for an objective

measurement of quality
In certain product categories, there will be defective products in virtually every
production batch. It is often true even after the manufacturer has checked each
individual product and has repaired the defective ones, since visual inspection is not
100% reliable.
Therefore, in many supplier/buyer relationships (particularly when the application does
not result in life or death outcomes), the supplier is not expected to deliver defectfree goods. The buyer needs to control the quality of purchased goods, since he does
not want too many defects. But what does too many mean?
How to set the limit between acceptability and refusal in a way that can be agreed upon
and measured?

Definition and application of AQL

The limit, as described above, is called the AQL. It stands for Acceptance Quality Limit,
and is defined as the quality level that is the worst tolerable (source: ISO 2859-1
standard).
For example: I want no more than 1.5% defective items in the whole order quantity, on
average over several production runs with that supplier means the AQL is 1.5%.
In practice, three types of defects are distinguished. For most consumer goods, the
limits are:

0% for critical defects (totally unacceptable: a user might get harmed, or regulations are
not respected).

2.5% for major defects (these products would usually not be considered acceptable by
the end user).

4.0% for minor defects (there is some departure from specifications, but most users
would not mind it).

These proportions vary in function of the product and its market. Components used in
building an airplane are subject to much lower AQL limits.
Note that this tool is used mostly during final outgoing inspections (when the products
are ready to be shipped out), and sometimes during production (when the number of
products is sufficient to have an idea of the batchs average quality).

Getting familiar with the AQL tables

Before using the AQL tables, you should know three parameters:

The lot size. If you ordered different products, the quantity of each product is a lot size,
and it is advised to perform separate inspections for each lot. If you ordered only one
product, the lot size is the total batch quantity.

The inspection level. Different inspection levels will command different numbers of
samples to inspect. In this article, we will stick to the so-called level II under normal
severity and to single sampling plans.

The AQL level appropriate for your market. If your customers accept very few defects,
you might want to set a lower AQL for both major and minor defects.

There are basically two tables. The first one tells you which code letter to use. Then,
the code letter will give you the sample size and the maximum numbers of defects that
can be accepted.
First table: sample size code letters

How to read this table?

If you follow my example, I assume your lot size is comprised between 3,201 pcs and
10,000 pcs, and that your inspection level is II. Consequently, the code letter is L.
Second table: single sampling plans for level II inspection (normal severity)

How to read this table?

Your code letter is L, so you will have to draw 200 pcs randomly from the total lot size.

Besides, I assume you have set your AQL at 2.5% for major defects and 4.0% for minor
defects. Therefore, here are the limits: the products are accepted if NO MORE than 10
products with major defects AND NO MORE than 14 products with minor defects are
found.
For example, if you find 15 products with major defects and 12 products with minor
defects, the products are refused. If you find 3 with major defects and 7 with minor
defects, they are accepted.
Note: in quality inspections, the number of defective products is only one of the criteria.
It is sometimes called quality, or quality findings. The other criteria are usually on the
inspectors checklist, which typically includes:

Packaging conformity (barcodes, inner packing, cartons, shipping marks).

Product conformity (aspect, workmanship). If all the products are in red color instead
of orange, there is no need to count each sample as a defect. It makes more sense to
refuse for product conformity.

Specific tests defined in the inspection checklist (they might not be performed on all
inspected samples if they are time-consuming or destructive).

Frequently Asked Questions about

AQL
Q: So, basically I have to authorize the factory to
produce some defects?
A: In theory no. Thats why the AQL was renamed, from acceptable quality level to
acceptance quality limit. It is a limit (and a loose one at that).
Here is what the ISO2859 standard says:

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 [] are designed to
encourage suppliers to have process averages consistently better than the AQL.
Note that, in practice, using these statistics means you assume the factory cannot
reasonably be expected to turn out 100% good quality.
Alternatively, you can choose an acceptance on zero plan. As soon as one defect is
found, the inspection is failed. But you can impose this to suppliers only in situations
where quality requirements are very high (in the auto industry, in aerospace).

Q: Based on my AQL, I calculated the proportion of

defects authorized. Why dont they correspond to the
maximum number of defects authorized?
A: It is true. In our example above, 2.5% of 200 samples is 5 samples, but we accept the
goods even if 10 samples are found with a major defect.
Why this difference? There are heavy statistics behind this issue. To keep it simple, the
producers risk is his risk of rejection (based on the random element when drawing the
sample) even though his products (if they were all checked) would be accepted. That
risk is about 5% in this standard. And, along the same logic, there is a consumers risk
and is is around 10%. As you can see, this standard is favorable to the producers side.

Q: Why not just say, well check 10% of the quantity,

or whatever percentage deemed appropriate?
A: Here again, the statisticians tell us it is not that simple. As we go up in the total
quantity, the proportion of products checked can decrease, for the same confidence in
the inspection results.

As you can see in the chart below, the number of samples to check (vertical axis)
increases at a slower pace than the total quantity (horizontal axis).

Q: How to choose an AQL limit for my products?

A: See this article. It depends on your distribution channel and your products end
use. Note that your supplier might refuse AQL limits they estimate as too tight (i.e. too
low).

Q: What are the reduced and tightened severities?

A: They are designed to be used in very specific situations, when a producer is
particularly reliable, or on the contrary fails too often.
In practice, these severities are seldom used. Most inspections are done in normal
severity. Thats unfortunate, because the rules to switch from normal to reduced or
tightened are considered a very important part of the standard (actually the evolutions of
these rules constituted the main changes from MIL-STD 105A and MIL-STD 105E).

Q: What are the limits of a quality control approach

based on random sampling and AQL limits?
A: There are several limits:

1. An AQL limit is a target rather than a maximum. The buyer might have a nasty
surprise when receiving a batch of products that passed the inspection. Read more in
this article.
2. A statistical QC approach does nothing to reduce the defects in the first place. Read
more in this article.

Q: Where can I learn more about the AQL?

If you really want to understand the concept of the AQL, you should spend about 20
minutes (total) watching these 3 videos on Youtube.

How to Read the AQL Tables

When Applying the AQL tables Does or Doesnt Make Sense

Why the AQL tables are not in favor of the buyer

The Special Inspection Levels in

the AQL Tables
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A few years ago I wrote about the inspection levels, but

some people are still confused about the special levels (S1, S2, S3, and S4).

Here is what the ISO 2859-1 standard says (emphasis mine):

The inspection level designates the relative amount of inspection. Three inspection
levels, I, II and III, are given in Table 1 for general use. Unless otherwise specified, level
II shall be used. Level I may be used when less discrimination is needed or level III
when greater discrimination is required.Four additional special levels, S-1, S-2, S-3
and S-4 are also given in Table 1 and may be used where relatively small sample
sizes are necessary and larger sampling risks can be tolerated.
Here are a few examples where these special levels come in handy:

You want to check the packaging in full, but only on a few cartons.

You want to perform some time-consuming tests (e.g. a full function test on an electrical
product), and you dont have time to run these tests on all the samples you inspect
visually (in level II, usually).

You want to perform destructive tests (e.g. inspecting bullets by firing them), and
obviously you dont want to destroy too many samples.

How to read the AQL tables when

using special inspection levels
Short answer: it works just the same as general levels, as I described before.
Long answer: I am going to walk you through an example.
Lets say you are buying 50,000 salt & pepper sets in ceramic.
There are several color combinations, some booklets are included, etc. which means
many ways the packing can go wrong. So you want to check the packing in great detail,
but only on an S3 level.
In the table below, you see that the code letter is G.

Then lets go to the other table, and you can find this information:

You should check the packing on 32 samples.

If you dont want to accept a defective packing on more than 1.5% of the quantity, the
limit is 1.

In other words, you accept the batch (as far as packing conformity is concerned) if you
find 0 or 1 defective cartons. And you reject it if you find 2 or more.

Note that, when it comes to tests on products and these tests are conducted on a
special level, they are considered critical (i.e. they are failed as soon as 1 sample
fails).
It makes things more simple and avoids lengthy discussions with Chinese suppliers who
dont fully understand how the statistics work.
I hope this explanation was clear. Questions are welcome in the comment section.

Sampling by Attributes Using the

ANSI/ASQ Z1.4-2008 Standard |
IVT
By
Eugenie Webster (Khlebnikova)

Nov 24, 2013 12:39 pm PST

Peer Reviewed: Sampling

The views and opinions expressed in this paper are those of the individual author and
should not be attributed to any company with which the author is now or has been
employed or affiliated.

Abstract
This paper discusses the application of American National Standards Institute
(ANSI)/American Society for Quality (ASQ) Z1.4-2008: Sampling Procedures and
Tables for Inspection by Attributes. It provides simple instructions on how to correctly
select the sampling plan based on the population size and the acceptable risk. In

addition, this paper provides a general overview of statistics behind the development of
sampling plans. The intent of this paper is to present a quick refresher on sampling by
attributes using the ANSI/ASQ Z1.4 2008 standard and to educate a reader on the
common mistakes users make during the use of this standard.

Introduction
Attribute sampling plans are often used to inspect the effectiveness of the
product/process and to determine the rate of compliance with established criteria. It is a
common pharmaceutical industry practice to employ American National Standards
Institute (ANSI)/American Society for Quality (ASQ) Z1.4-2008: Sampling Procedures
and Tables for Inspection by Attributes for inspection of product/process defects.
ANSI/ASQ Z1.4-2008: Sampling Procedures and Tables for Inspection by Attributes is
an acceptance sampling system that provides tightened, normal, and reduced plans to
be applied for attributes inspection for percent nonconforming or nonconformities per
100 units. The use of sampling tables provides a quicker way of selecting the sampling
plan instead of developing a sampling plan using complex statistics. The standard
provides instructions on how it is supposed to be applied; however, it is often
misinterpreted. The common mistakes include, but not are limited to, the selection of
incorrect sampling size, selection of incorrect acceptance criteria, or attribute plan used
for variable data, etc. Therefore, it is very important to properly interpret the standard
and apply the inspection rules as they are prescribed. Incorrect application can result in
regulatory observations.

The Importance of Sampling

Sampling is a regulatory requirement in the pharmaceutical industry. The current good
manufacturing practice (cGMP) requires sampling plans to be defined as well as
samples to be representative of the population and based on appropriate statistical
criteria. For instance, as per Code of Federal Regulations Title (CFR) 21 Part 211.165(d),
Acceptance criteria for the sampling and testing conducted by the quality control unit
shall be adequate to assure that batches of drug products meet each appropriate
specification and appropriate statistical quality control criteria as a condition for their
approval and release. The statistical quality control criteria shall include appropriate
acceptance levels and/or appropriate rejection levels.
Acceptance inspection is performed at many stages in the pharmaceutical process, from
testing raw materials to the final packaging stage. Acceptance testing is necessary since
100% inspection is not practical and would be very costly. In acceptance testing by
attributes, a sample is randomly taken and inspected against established specifications

(allowable number of defects). If the number of defects exceeds the allowable number of
defects, then the entire lot is rejected.

ANSI/ASQ Z1.4-2008 Sampling For Attributes

ANSI/ASQ Z1.4-2008: Sampling Procedures and Tables for Inspection by Attributes is
one of the most frequently used plans by many pharmaceutical companies as well as
other industries. It is recognized by the US Food and Drug Administration and Health
Canada. The standard provides various inspection plans without getting into complex
statistics.
The standard is intended for inspection of final product, components and raw materials,
materials in process, and data and records.
Acceptance sampling procedures became popular during World War II. Sampling plans,
such as MIL-STD-105, were developed by Harold F. Dodge and others and became
frequently used as standards. MIL-STD-105 was a United States defense standard that
provided procedures and tables for sampling by attributes (pass or fail characteristic).
The standard was cancelled in 1995 but the content was adopted by ANSI/ASQ Z1.42008: Sampling Procedures and Tables for Inspection by Attributes.
The Z1.4 provides acceptance sampling tables based on the acceptable quality level
(AQL) designation that is generally specified in the company standard operating
procedure (SOP). Different AQLs may be designated for different types of defects
(critical, major, and minor). AQL is defined as the maximum percent defective (or the
maximum number of defects per hundred units) that, for purposes of sampling
inspection, can be considered satisfactory as a process average.

Inspection Level
The inspection level determines how the lot size and the sample size are related. The
standard divides inspection levels into two main categories: special inspection levels (S1, S-2, S-3, and S-4) and general inspection levels (I, II, III). According to the standard,
inspection Level II should be used unless otherwise specified. The sampling acceptance
criteria discrimination increases from special levels to general levels with Level III
having the greatest discrimination. Special levels shall be used when relatively small
sample sizes are required and large sampling risks can be tolerated.

Inspection Rules
Provisions for each sampling plan include normal, tightened, or reduced inspection.
Normal inspection should always be conducted at the start of inspection. When normal

inspection is applied, tightened inspection can be implemented when two out of five or
fewer consecutive lots failed normal inspection. When tightened inspection is applied,
normal inspection can be implemented when five consecutive lots pass the tightened
inspection. The reduced inspection can be used conditionally when the normal
inspection passes for more than two consecutive lots. Inspection can be discontinued
when 10 consecutive lots remain on tightened inspection. The switching rule diagram is
provided below.
Figure 1: Switching Inspection Rules.

Sampling Plan Types

Three types of sampling plans are provided: single, double, or multiple. Figure 2
outlines the differences of each plan.
Figure 2: Types of Sampling Plans.
Single

Double Sampling Plan

Multiple Sampling Plan

Sampling
Plan

This
plan is
based on
accepting or
rejecting the
lot on one
sample only.

These plans combine single

sample plans. With double sampling
plans, there are three different
conclusions: accept the lot, reject
the lot, and resample the lot. If the
lot is resampled, the results are
combined with the first sample. A
new Accept/Reject level number is
determined with the second
sampling. At the end of the second
sample the lot is then either
accepted or rejected.

Similar to double
sampling, there may be many
sampling sequences to
determine whether to accept or
reject the lot. Although
complicated, initially, they may
utilize smaller sample sizes to
accept the lot. However, if
there are rejects, then multiple
sampling plans become very
complicated.

Inspection Procedure
The general procedure (Figure 3) in designing the sampling plan is the following.
Figure 3: Inspection Procedure.

Table I: Table I Sample Size Letter Codes

Special Inspection Levels

Lot or Batch Size

S-1

S-2

S-3

S-4

General Inspection Levels

II

III

2 to 8

9 to 15

16 to 25

26 to 50

51 to 90

91 to 150

151 to 280

281 to 500

501 to 1200

1201 to 3200

3201 to 10000

10001 to 35000

35001 to 150000

150001 to 500000

500001 to over

Table II: Table II Single Sampling Plans for Tightened Inspection

Note: Use first sampling plan below arrow. If sample size equals or exceeds lot or
batch size, do 100% inspection.
Ac = Acceptance Number
Re = Rejection Number

Caution: Note, the sampling plan consists of a sample size and acceptance criteria at
particular AQL. It is common to select one or another; however, this application of the
sampling procedure is incorrect. The correct use of these tables is discussed further.

Application of a Single Sampling Plan for Packaging Defects

An example of the application of ANSI sampling is the inspection of packaging defects.
The packaging defects can be classified into three major categories: critical, major, and
minor. Defect categories are divided based on criticality to product quality attributes.
Each defect category is assigned a different AQL level. Table III provides a list of typical
tablet packaging defect classifications.
Table III: Defect Classification.

Defect
Class

Definition

Description

AQL

Critical A defect that can compromise

product safety, purity, or identity
that may be harmful to the
consumer.

Incorrect label, carton, insert,

foreign tablet, incorrect code

0.01
%

Major

A defect that jeopardizes the

integrity or function of the
package.

Missing band, deformed/cracked 0.65

closure, no foil, short
%
count/overfill, etc.

Minor

A defect that does not affect

product safety, purity, or identity,
or package integrity of function.

Grease on the bottle, double

4.0%
code on the label, flaps not glued
on the carton.

For each defect category, defects are also classified into different types. For instance, if
inspecting a bottle for tablet count, closure, seal, label and carton defects, these defects
are not added together since they are results of different packaging processes. Instead,
these defects are added based on the product attribute (tablet count, closure, etc.).

The inspection procedure should include the sampling plan with inspection level, type,
and accept/reject criteria. For instance, if the expected packaging lot size is 36,000
bottles, it would be impossible to test all 36,000 bottles, so a representative sampling
size should be selected. To determine an inspection sample size, ANSI/ASQ Z1.42008Sampling by Attributes Plan, General Inspection II, Tightened Plan can be used.
A lot of 36,000 bottles corresponds to letter N (General Inspection Level II) (see Table I.
A sample size from Table II (Table II-B, Single Sampling Plans for Tightened
Inspection) is selected. Letter N corresponds to sample size of 500. If AQL level desired
is specified as 0.010%, it means that 2000 samples need to be inspected and all 2000
samples should have no defects to pass a lot. For AQL 0.65%, 500 samples require
inspection failing a lot if six defects are found. For AQL 4%, only 315 samples require
inspection failing a lot if 19 defects are found.

Statistics Behind Sampling Plans

Sampling by attributes is based on binomial distribution. The performance of sampling
plan is given by the operating characteristic (OC) curve. The OC curve shows the
probability, Pa, that a submitted lot will be accepted for any given fraction defective p.
To construct an OC curve, one needs to know the sample size (n) and the number of
defects (c) one is willing to accept. For example, with n=100, if c=2, p would equal to
2/100=0.02. Therefore, to compute probabilities for c below and above 2, to bracket
0.02, Pa versus p is plotted.
Since the sample with up to c defects is accepted, the cumulative binomial distribution is
used to compute the probability of acceptance, P.

The Excel function BINOMDIST(c, n, p, TRUE) can be used, where c = number of

defects, n = sample size, p = probability of defect occurring, and TRUE is for cumulative
distribution. Figure 4 shows how BINOMDIST function is used.

Figure 4: Calculating Binomial Distributing Using Excel.

Figure 5 shows the OC constructed by plotting Pa vs. p.

Figure 5: OC Curve Constructed Using Excel.

As shown in Figure 5, the probability of accepting a lot containing 2% defectives is 68%

(i.e., out of 100 lots, it is expected to accept 68 and reject 32 when the sample size is 100
and the acceptance number is two).

Figure 6: OC Curve for n=100.

Figure 7 demonstrates that if n is increased while c is constant, we obtain a lower

acceptance level with increasing n. As n increases, we approach 100% sampling. As
shown in Figure 7, the probability of accepting a lot containing 2% defectives is 68% for
n=100, 24% for n=200, 1% for n=400, and 0% for n=800 at c=2.
Figure 7: OC Curve for n=100, 200, 400, and 800 with c=2.

Warning
Since the regulatory requirements are very strict when it comes to defects that are
related to safety, purity, etc., it is a common misconception that the sample inspected
must not contain any non-conformance units for the lot to be accepted.
For example, as shown in Figure 8, the OC curves show that lots that are 2% defective
will be accepted 90% of the time inspecting five samples, 82% of the time inspecting 10

samples, 67% of the time inspecting 20 samples, and 13% of the time inspecting 100
sample. With more samples we test, the probability of accepting a lot with defects
decreases. Thus if we claim that we accept zero defects and test a very small sample, in
this case five samples, there is a high probability that we are accepting defects in the lot
without being able to detect them.
Figure 8: Operating Characteristic Curve.

Summary
In summary, correct statistical sampling is required by the pharmaceutical industry
regulations. Understanding of ANSI sampling by attributes and correct application will
help to avoid sampling mistakes and potential observations.

Acronym Listing
AQL
ANSI
ASQ
FDA
GMP

Average Quality Limit

American National Standard Institute
American Society for Quality
US Food and Drug Administration
Good Manufacturing Practice

General References
ASQ, ANSI/ASQ Z1.4-2008: Sampling Procedures and Tables for Inspection by
Attributes, 2008.
Code of Federal Regulations, Title 21, Food and Drugs (Government Printing Office,
Washington, DC), Part 211.
K. Stephens, The Handbook of Applied Acceptance Sampling: Plans, Procedures, and
Principles, ASQ Quality Press, 2001.

Quality control tools - faq

Can you briefly present your company?
Asia Quality Focus is a Western 3rd party inspection company focusing on quality control and quality
assurance in Asia. We specialize and are experts in product inspections, factory audits and product
testing. We can inspect any order and audit any factory within 48H, anywhere in Bangladesh, India,
Pakistan, China, Taiwan, Vietnam and Thailand.

Why do I need Quality Control ?

We suggest you to view our presentation: 10 tips for Quality Control, and then see if you are looking for
answering to one of the following question:

Is my factory following international and local rules and regulations? (Social Audit)
Has production started correctly? (First Article inspection)
Is my order produced according to my specifications? (Product Inspection)
Is the container well loaded? (Container Loading Inspection)
How to make sure there are no defects? (Defect Sorting Service)
How to ensure the factory introduces the right quality checks? (Production Monitoring)

How do I get started?

Register online in order to create your private account on our website; it is free of charge
and requires no commitment.

After activation of your account, you will be able to choose your desired service and provide us
with your requirements, instructions, specifications, criteria and attachments online (24/7).

Our Operations team will prepare, coordinate and arrange your booked service and you will
receive a confirmation email. If you have any questions, you can contact us at any time.

The day of the requested service you will receive your fully illustrated report by email and it
will also be posted on your secured private account.

You will receive one invoice per month, at the end of the month (however, if it is your first time
working with us we ask you to pay in advance).

Register now!

Why should I choose Asia Quality Focus?

Expertise: we focus on consumer products.

Management: Both Western & local teams.
Personalization: custom-made solutions when needed.
Flexibility: only 2 days notice needed, online booking & tracking.
Cheaper: our fee is $298 per Man-Day (1 inspector / 1 day).
Faster: easy online booking, Pre results, Same-day Reports.
Safer: our services adhere to recognized international standards: ISO2859, ISO9000, SA8000
A dedicated and experienced team of inspectors, auditors and engineers.
Read more about Asia Quality Focus

Do you offer sourcing services to find suppliers and

manage projects?
We do not offer any sourcing services. All information about our clients vendors and factories is
confidential and shall not be transmitted to any other party. All information shall not be sold or used for
any other purpose than the quality control service you are paying for. If you are in need of these
services, please consult our Endorsed partners page for relevant company information.

Can I discuss with you in detail my criteria and my product

specifications?
Of course, and we invite you to contact us in order to explain your quality needs.

What information does your inspection report include?

Our reports are very detailed, illustrated with pictures and cover the following:

Product appearance (AQL), workmanship quality

Product specifications review: quantity, material, color, size, measurements, labeling &
marking, packaging, packing, accessories, shipping marks etc.

On site testing and special checks.

Important remarks and professional feedback.

How long does it take to obtain the inspection results?

For inspections in China, results are sent within 24 hours after completing the inspection. If clients
need rush service, they can obtain same day reporting for a $30 surcharge.

Who will approve or reject the shipment?

We inspect the shipment according to AQL international standards and also according to your
instructions, specifications and criteria. Then, our results are given to you through a fully detailed and
illustrated report, which should allow you to decide whether to allow the shipment of your products.
You can accept or reject your shipment directly online.

Which areas do you cover?

Asia Quality Focus provides quality control and quality assurance services in 14 countries in Asia: from
Indonesia to Pakistan and from China to Thailand.
Read more about our coverage area in Asia. We always suggest to contact us minimum 48 hours prior
to the desired inspection date for final cost confirmation.

How much does it cost?

Product Inspections and Factory Audits start at $298 all inclusive. Product inspections are usually
performed within 1 man-day.
The number of man-days needed depends on the total ordered quantity, the complexity of your
product and the number of references to inspect. FYI, while booking your product inspection online,
you will get a quotation before confirming your order.
Read more about the man-day calculation and check our price conditions

How can I pay?

You will receive one invoice at the end of the month with all the inspections we performed on your
behalf. This invoice is payable upon receipt by TT or PayPal. We invoice in USD but you can pay us in
any major currency.

Do you offer any discounts?

We offer special packages for our VIP clients who book regular inspections and have been working with
us for an extended period of time.

What happens if non-conforming goods are found when

the shipment arrives?
It is extremely rare that non-conforming goods make it out of the factory if AQF is hired. In the vast
majority of cases, the root cause turns out to be damage during shipping or shipments were approved
after a failed inspection and the buyer trusts the factory (who was likely supposed to rework the
goods) enough to ship without having performed a re-inspection or a defect sorting service. Therefore,
we highly recommend you to book re-inspection or defect sorting service after a failed inspection and
to work with your shipping partners to insure the product against damage in transit. AQF guarantees
that we will inspect the product to the standard and methods approved by the client (including chosen
sampling size). In the event that our inspectors do not follow the agreed standards, AQF will make a
refund of up to 5 times the price of the inspection.

Why doesn't AQF provide a warranty on behalf of the

supplier?
As it is not economically viable for most clients to inspect every unit in the order, AQL tables determine
the number of units to be inspected which will yield a statistically reliable sample size. In other words,
if the inspection on the randomly selected lot goes well, then it is statistically unlikely that defects will
be found in the rest of the order. For example, if there are 100 master cartons in an order and 50 units
per master carton for 5000 units total. Our inspectors would open at random a select set of master
cartons (the square root of the total number of cartons) and further select at random a set of individual
units inside that master carton as per sampling size chosen by the client. However, if the supplier
knew they had a few dozen defects and packaged the defects all together in one section of one master
carton, then it would be statistically unlikely that our inspector would find this pocket of defects. For
this reason, AQF does not provide a warranty on behalf of the supplier. But we stress to our clients that
they should have robust POs, warranty terms and payment terms with their suppliers that protects
their interests. Negotiating such terms with the supplier is outside of the scope of our business at AQF,
but our Endorsed Partners can help with the negotiations and contract review.

Where do I send golden / reference / pre-production /

approval samples?
It is best to send them directly to your factory, in a sealed package to our attention. In China, you can
also send samples to our office, where we will seal them and send them to the factory to the attention
of our inspector. AQF will absorb courier fees up to 5 USD. Help us identify the package by writing the
AQF order number on it. Verify which office to send it to by checking our offices address on your
dashboard or contact your account manager directly.

How can I get production samples collected during an

inspection?
Let us know that you would like us to collect production samples. This can be done either online or by
contacting your account manager. We can pick "normal" samples at random or select defective
samples for your reference. This service is free of charge and samples are sent to you using your
courier account. Alternatively, we can send the samples to you or to our office and you cover any
courier fees exceeding 5 USD.
We can also pick up production samples without performing an inspection. The cost is roughly 1/2 manday.

Please contact us with any further questions.

Qualitycontroltermsandglossary

A
Acceptance Number
Acceptance Sampling
Approval Sample
AQL

B
Batch/Lot/Sampling

C
Container Loading Inspection (CLI)
Continuous Sampling Plan
Cost of Poor Quality
Cost of Quality

D
Defects and Defectives
Defects per Hundred Units
Double Sampling Plan
Drawing of Samples
During Production Inspection (DPI)

E
Expression of Nonconformance

F
Factory Audit
First-Articles Inspection

Inspection

Inspection
Inspection
Inspection
Inspection
ISO

by Attribute
Check List
Levels
Protocol

L
Lot or Batch

Nonconformance

Normal Inspection

P
Percent Defective
Pre Shipment Inspection (PSI)

R
Random Sampling
Reduced Inspection
Rejection Number
Representative Sampling
Resubmitted Lots or Batches

S
SA8000
Sample
Sampling Plans
Severity of Inspection
Single Sample Plan

T
Tightened Inspection

Unit of Production

Acceptance Number
The acceptance number is the maximum number of defects or defective units in the sample that will
permit acceptance lot or batch.

Acceptance Sampling
Acceptance Sampling is used to decide whether to accept or reject a production lot. After selecting a
sampling from a production lot, we inspect the units, we count how many defects are found among this
sampling and we use the result (number of defects found versus maximum number of defects allowed)
to decide whether or not to accept or reject the lot.

Approval sample
The approval sample, also called golden sample, pre-production sample or PP-sample, is usually sent
by the buyer to the third party inspection company and manufacturer. It is the product of reference
and will be compared to the production samples. The production and the approval sample should be
very similar. An inspection report will point out the differences.
Read more about the role of the approval sample during an inspection.

AQL
The AQL has two different definitions due to standard changes.

Acceptable Quality Level / MIL-STD-105E / ISO 2859-1 (1999)

The acceptable level (AQL) is defined as the maximum percent defective (or the maximum number of
defects per hundred units) that, for purpose of sampling inspection, can be considered satisfactory as
a process average. The sampling plans most frequently used by the department of Defense are based
on the AQL.

Acceptance Quality Limit / ANSI/ASQC Z1.4-2003

The AQL is the quality level that is the worst tolerable process average when a continuing series of lots
is submitted for acceptance sampling. The following note on the meaning of AQL was introduced with
the ANSI/ASQ Z1.4-2003 revision:
The concept of AQL only applies when an acceptance sampling scheme with rules for switching
between normal, tightened and reduced inspection and discontinuance of sampling inspection is used.
These rules are designed to encourage suppliers to have process averages consistently better than the
AQL. If suppliers fail to do so, there is a high probability of being switched from normal inspection to
tightened inspection where lot acceptance becomes more difficult.

Once on tightened inspection, unless corrective action is taken to improve product quality, it is very
likely that the rule requiring discontinuance of sampling inspection will be invoked. Although individual
lots with quality as bad as the AQL can be accepted with fairly high probability, the designation of an
AQL does not suggest that this is necessarily a desirable quality level.
The AQL is a parameter of the sampling scheme and should not be confused with a process average
which describes the operating level of a manufacturing process. It is expected that the product quality
level will be less than the AQL to avoid excessive non accepted lots. The AQL values are defined as
percent nonconforming or defects or nonconformities per hundred units.

Download the AQL table, and read more to get familiar with the AQL table:

The conditions to use the AQL table.

The AQL table history, definition and role.
The relation between man-day calculation and AQL table.

Batch/Lot/Sampling
A batch or lot is a collection of products, all identical in size, type, conditions and time of production.

Container Loading Inspection (CLI)

This inspection is performed at the manufacturer's warehouse or at the forwarder's premises. The aim
of this inspection is to verify your products, the quantity and the loading process.
This inspection includes:

an inspection of the container before the loading (container condition)

an inspection of your products (product check according to your P/O: quantity, appearance and
general quality)

an inspection of the loading process (cartons conditions, filling-up level etc)

Continuous Sampling Plan

This is an approach to sampling that is appropriate for the output of processes that deliver a
continuous flow of a product. In this plan, we start inspecting 100 % of the units coming from the
process. After a certain number of items that have been inspected with no defects, the plan goes to
inspecting only a fraction of items. This continues until we find a nonconforming unit. At that point, the
plan reverts back to 100 % inspection following the same pattern.

Cost of Poor Quality

These are the extra expenses caused by delivering poor quality goods to customers. These expenses
have two sources: internal failure costs (from defects before customers get the product) and external
failure costs (costs after a customer receives the poor product or service). Defect sorting, Rework,
repairs, image damage, brand damage, client confidence lost are a few examples of costs associated
with poor quality.

Cost of Quality
This refers to all costs involved in the prevention of quality issues, defects, assessments of process
performance, and measurement of financial consequences. Cost of quality is the cost justification of
quality efforts. Cost of quality should be seen as an investment more than a cost.

Defects and Defectives

A defect is any nonconformance of the unit of product with the specified requirements. A defective is a
unit of product which contains one or more defects. Failure to meet requirements with respect to
quality characteristics are usually described in terms of defects or defectives.
Critical defect - A critical defect is on that judgment and experience indicate is likely to result in
hazardous or unsafe conditions for individuals using, maintaining, or depending upon the products; or
prevent performance of the tactical function of a major end item. A critical defective is a unit of
product that contains one or more critical defects. You can provide your own list of Critical Defects to
be inspected. Asia Quality Focus' default Critical Defect AQL is 0.
Major defect - A major defect is one, 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. A major defective is a unit of
product that contains one or more major defects. You can provide your own list of Major Defects to be
inspected. Asia Quality Focus' default Major Defect AQL is 2.5.
Minor defect - A minor defect is one 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 of product. A Minor defective is a unit of product that contains
one or more defects. You can provide your own list of Minor Defects to be inspected. Asia Quality
Focus' default Minor Defect AQL is 4.0.
Read more about Major, Minor and Critical defect to easily differentiate them.

Defects per Hundred Units

The number of defects per hundred units of any given quantity units of product is one hundred 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.: (Number of defectives x 100) / (number of units
inspected)

Double Sampling Plan

This is an inspection technique in which you inspect a first lot of n1 size, which leads you either to
accept or reject it. If you reject it, then we inspect a second sample of a larger lot size n2, which in turn
leads to a decision to accept or reject the lot.

Drawing of Samples
Basic to sampling inspection is the assurance that the sample selected from a quantity of units
represents the quality of that quantity of units. Hence, the procedure used to select units from a lot
must be such that it assures a sample free of bias

During Production Inspection (DPI)

The inspection takes place when about 20% to 50% of the production has been completed. The aim is
to ensure that contractual obligations regarding specifications, packaging, packing and marking are
met and to check if the factory will be able to respect the production schedule. If recommendations
have been given during a First-Articles Inspection (FAI), the During Production Inspection determines
whether or not these corrective action plan has been successfully implemented.

Expression of Nonconformance
The extent of nonconformance of product shall be expressed either in terms of percent defective or in
terms of defects per hundred units (DHU).

Factory Audit
This is a full evaluation of your supplier according to the ISO standards. It covers: profile of the
supplier, internal organization, safety regulations, quality processes, performance, delivery terms and
R&D. The audit also includes extensive worker and manager interviews in the factory worker's
language.
Read about the difference between factory audit and inspection.

First-Articles Inspection
The Initial Production inspection is performed at the very first stage of the mass production. Asia
Quality Focus Inspectors will inspect the quality of the material and components used in the production
process and make sure it fits your requirements and is according to your approved sample (BAT). It
also includes a visual check on the quality of packing materials and accessories. The inspector will also
monitor the assembly process and check the first production run.
The First-Articles Inspection ensures that the customer's specifications are well-understood by the
supplier/factory. The IPC will detect production discrepancies very early in the production processes;
you will thus be able to take corrective actions sooner than later... saving time and securing your
business

Inspection
Inspection is the process of measuring, examining, testing, or otherwise comparing the unit of product
with the requirements.
Read about the difference between inspection and factory audit.

Inspection by Attribute
Inspection by attributes is inspection where by 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.

Inspection checklist
It is a document in which are listed all the details an inspector should check during an inspection. The
objective is to avoid missing any of them.
Read more about how useful is the inspection checklist for an importer.

Inspection Levels
The standards provides for three general inspection levels and four special inspection levels. These
seven levels permit the user to balance the cost of inspection against the amount of protection
required.
Read more and get familiar with the inspection levels:

The difference between the general and special inspection level of the AQL table by
reading this article.
How to choose the right AQL inspection level.
Inspection protocol
It defines all the process and steps the QC has to follow in order to perform the inspection. It includes
the list of the details to check and the order specification verification.

ISO
ISO is a network of the national standards institutes of 157 countries, on the basis of one member per
country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. ISO is a nongovernmental organization: its members are not, as is the case in the United Nations system,
delegations of national governments. Nevertheless, ISO occupies a special position between the public
and private sectors. This is because, on the one hand, many of its member institutes are part of the
governmental structure of their countries, or are mandated by their government. On the other hand,
other members have their roots uniquely in the private sector, having been set up by national
partnerships of industry associations.
ISO 9000 Standards: this is a set of quality standards developed in 1987 by the International
Organization for Standardization. The three major areas of certification are as follows:
ISO 9002: covers everything except design and development.

ISO 9001: covers all the processes of a company from design and development to procurement,
production, testing, installation and service.
ISO 9003: covers only inspection and testing.

Lot or Batch
The lot size is the total number of units available for random sampling. The lot size only includes
packed products. Also called "inspection lot" or "inspection batch", it is a collection of units of product
from which a sample is to drawn and inspected to determine conformance with the acceptance
criteria.

Nonconformance
Nonconformance may be defined as the failure of a unit of product to conform to specified
requirements for any stated quality characteristic. The extent of nonconformance of product to the
required quality characteristics shall be expressed either in terms of percent defective or in terms of
defects per hundred units (DHU).

Normal Inspection
Normal inspection is what is used where there is no evidence that the quality of product being
submitted is better or worse than the specified quality level.

Percent Defective
The percent defective of any given quantity of units of product is one hundred times the number of
defective units of product contained therein divided by the total number of units of product, i.e.:
Percent defective = number of defectives x100 / number of units inspected.

Pre Shipment Inspection (PSI)

Also called Final Random Inspection (FRI), it is the most common inspection and it is performed when
100% of the goods ordered are finished, and at least 80% of the goods are packed into export cartons.
Samples are selected randomly, according to sampling standards (usually AQL table) and procedures.
They will be inspected according to your specifications, requirements and according to our protocols
and expertise.
This inspection ensures that the production is in accordance with the specifications, purchase orders or
letters of credit. It covers: product appearance (AQL), workmanship quality, size measurements, weight
check, functionality assortment, accessories, labeling & logos, packaging, packing and other tests and
special requirements, depending on the product and the export market.
Read about the role of the purchase order for sourcing in China more securely.

Random Sampling
This is a standard sampling method by which random samples of units are chosen such that all
combinations of these units have an equal chance of being chosen as the sample.

Reduced Inspection
Reduced inspection under a sampling plan uses the same quality level as for normal inspection, but
requires a smaller sample for inspection.

Rejection Number
The rejection number is the minimum number of defects or defective units in the sample that will
cause rejection of the lot represented by the sample.

Representative Sampling
When appropriate, the number of units in the sample shall be selected in proportion to the size of sublots or sub-batches, or parts or 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.

Resubmitted Lots or Batches

Lots or batches found unacceptable shall be resubmitted for re-inspection 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 only the particular types or classes of defects
which caused initial rejection.

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 product in the sample is the
sample size.

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

Severity of Inspection
The severity of inspection concerns the total amount, kind and extent of inspection specified by the
quality assurance provisions established for the unit of product, or as dictated by quality history.

Single Sample Plan

A single sampling plan is a type of sampling plan by which the results of a single sample from an
inspection lot are conclusive in determining acceptability. The number of sample units inspected shall
be equal to the sample size given by the plan.

Tightened Inspection
Tightened inspection under a sampling procedure plan uses the quality level as for normal inspection,
but requires more stringent acceptance criteria.

Unit of Production
The unit of product is the thing inspected in order to determine its classification as defective or nondefective 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.

International quality standards

for product inspections
How are AQF product inspections performed?
Asia Quality Focus performs product inspections services according to:

Recognized international quality standard for product inspections: ISO 2859-1

(ANSI/ASQC Z1.4-2003), also known as the AQL Tables, unless another standard is requested by the
client.
Client's requirements, specifications, criteria and instructions.
AQF team's expertise and experience in quality control.
AQF Western common sense.

What do we inspect during an inspection?

The quantity produced (semi finished, finished and packed)

The visual appearance (cosmetic check of the mass production)

The product specifications (size, dimensions, colors)

The labeling and marking

The packing and packaging

All possible functions and possible tests (safety, abuse, printing, etc.)

What quality standards do we use for inspections?

Based on the sampling size chosen from the AQL tables - highly recognised international quality
standards for product inspections - we carefully ensure to select production samples randomly. We
inspect the samples and classify the defects into critical, major and minor defects. We use detailed
check lists for these definitions - our clients are invited to make amendments.
According to the number of defects found for each type and according to the number of defects
allowed (figures given by the AQL tables), we will advise you to accept or to reject your shipment.
Then it is up to you to make your own decision based on the information and recommendations we
have provided to you. We suggest that you discuss the findings with your vendor and the manufacturer
and you ask him to pay attention/rework/re-produce/sort out the products.

How to use the AQL Tables?

The AQL tables belong to international quality standards for product inspections. They will help to
determine the sampling size we will need to inspect according to your ordered quantity and your level
of severity (I, II or III). The standard level, the one used by default and by 98% of the people is
the level II for a standard inspection. If your order has multiple references, ideally we should at
least inspect a level II on each reference.
Indeed, for a standard order, the standard level II from the AQL gives the minimum sampling size we
should check per reference if we do not want to take additional risks. If we inspect a general level II
sampling size on a multiple references orders, then the sampling size is diluted and divided by the
number of references, increasing the risks as the sampling size must be representative enough.
More information about:

How to use the AQL table

Choosing the right AQL inspection level

How to find your sampling size on the AQL table?

In order to find the necessary sampling size to be inspected, we look at the first chart and find on the
left side the range of items being produced in total. You have the choice of levels I, II and III, with Level
III being the most stringent testing and level I being the least. Level II is the standard and is most often
used. For example, if you are producing 8000 items, at level II you have the letter L, which in the
second table says to inspect 200 items.
On the top of the second chart are the defect levels, ranging from 0 to 6.5. You can choose which level
to apply for your type of defect: critical, major and minor. Usually most importers will choose standard
defect levels which are 0/2.5/4 but one can choose 1/1/1 if he wishes or 0/1.5/2.5 like in the
automotive industry. Using the standard 0/2.5/4 defect levels and a sample size of 200, we see that if
you have more than 0 critical defects, 10 major defects or 14 minor defects, you should reject your
shipment. Of course the decision about what to do after your received the inspection results belongs to
you. Most importers will wish to discuss all inspection findings with their vendor/manufacturer in order
to improve whatever possible. In case the inspection results are very close to AQL limits, it is important
that you double check if the level of found defects is acceptable to you or not.

Download the

AQL table.

Inspection Types
PPI to assure understanding of your product & order
FAI for a successful transition to mass production
DPI to improve quality during mass production
PSI to detect and solve problems before shipment
CLS to ensure punctual & safe transport
DSS to sort out all the most important defects
PM to continuously understand and improve processes

Product Expertise
Textiles & Apparel
Toys
Furniture & Homeware
Electronics & Electrical
Luxury Products
Promotional Goods & Gifts
Automotive Industry