MANUAL

ON
GENERAL GUIDELINES
ON SAMPLING

FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA

MINISTRY OF HEALTH AND FAMILY WELFARE
GOVERNMENT OF INDIA
NEW DELHI
2016

GENERAL GUIDELINES ON SAMPLING 2016

GENERAL GUIDELINES ON SAMPLING

TABLE OF CONTENTS
S.No.
1.0
1.1
1.2
1.3
2.0
2.1
2.2
2.3
2.4
2.5
3.0
3.1
3.2
3.3
3.4
3.5
3.6
4.0
4.1
4.2
4.3
4.4
4.5
4.6
5.0
5.1
6.0
6.1
6.2
6.3
6.4
6.5
7.0

8.0
9.0

TITLE
Introduction
Scope of Sampling
Purpose of Sampling
Category of analysis
Sampling Plan
Purpose
Target audience of the guidelines
Users of sampling plans recommended by the guidelines
Basic recommendations for the selection of sampling plans
Statistical design for sampling
Sampling Procedure
General Information
Employment of Food Safety officer or Sampling personnel
Material to be sampled
Representative sampling
Types of single sampling plans
Two and three class attributes plans for microbiological
assessments
Manner of collecting the sample
Sample taking and despatching
Time for Sample delivery to the Public Analyst/ Accredited lab/
Referral lab
Time for Sample Analysis and reporting by the Lab
Suitable container
Quantity of sample to be drawn as sufficient for analysis
Important Points to consider
Sample Preparation
Preparation of Samples
Other points of consideration
Sampling Report
Sample preservation/storage during transport
Define time
Frequency of sampling
Tolerance criteria with reference to sampling
Documentation
Sampling form (Refer Rule 3.3.2.(1))
Sampling form (Refer Rule 3.4.1.(3))
Sampling form (Refer Rule 3.4.3.(7))
References
Annexure:
Annexure I:Commonly Used Terms And Notions
Annexure II: Quantity of Sample To Collect For Each Commodity
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Pg.No.
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GENERAL GUIDELINES ON SAMPLING 2016

GENERAL GUIDELINES ON SAMPLING

1. INTRODUCTION
The Food Standards are aimed at protecting consumers health and ensuring fair
practices in the food trade. The prescribed method of sampling are designed to ensure that
fair and valid sampling procedures are used when food is being tested for compliance with
a particular commodity standard. The sampling methods are intended for use as methods
designed to avoid or remove difficulties which may be created by diverging legal,
administrative and technical approaches to sampling and by diverging interpretation of
results of analysis in relation to lots or consignments of foods, in the light of the relevant
provision(s) of the applicable standard. A lot is a definite quantity of some commodity
manufactured or produced under conditions, which are presumed uniform for the purpose
of these Guidelines.
The present guidelines have been elaborated to facilitate the implementation of these goals
by FSSA Food Safety officers, government and other users.
1.1 SCOPE OF SAMPLING
These Guidelines can be used by FSSA Food Safety Officers, government and other users
who can select from the recommended sampling plan the best suited for the inspection to
be made depending on the purpose of sampling.
1.2 PURPOSE OF SAMPLING
Label should mention purpose of drawing / collecting the sample i.e. whether its for
regulatory purpose or for monitoring only.
I. Regulatory:
Regulatory samples are picked for evaluation in case of certain concerns, issues.
The reports of these analyses are filed for legal actions. Keeping this in mind, the

GENERAL GUIDELINES ON SAMPLING 2016

sample integrity, homogeneity, and representativeness is vital for a fair and

meaningful inference and subsequent actions.
Formal samples will be taken where formal enforcement action may result if an adverse
report is received following examination or analysis. Hence formal samples have to be
purchased or procurred by suitably trained, qualified and experienced authorised officers.
The officer should strictly use the procedure for statistical sampling. The objective of the
sampling procedures is to ensure that any sample procured is a fair sample that accurately
reflects the constituents of the bulk material being sampled.Regulatory samples should be
collected in two sets and divided into four subsets.
II. Monitoring:
For samples to be drawn for the monitoring purpose, the notified institutions/labs
should be involved as per approved protocol based on susceptibility of the product.
Monitoring activity is an ongoing process and samples picked for this activity are large in
size. The sample number should be preferably in the range of 5 to 8 samples per
location/product. The reports of these monitoring samples help the system to review
quality, safety, freshness and preferencesin market place. It also helps in ascertaining
consumption pattern and exposures to food additives and unintended contaminants and
residues.
Routine sampling will take place to monitor the quality and safety of foods
manufactured, distributed and retailed. All routine samples will be purchased and
procurred anonymously by an authorised officer and should be analysed or examined in an
informal manner by the appointed Public Analyst or Food Examiner.
The label should also specify the nature of analysis to be conducted (Qualitative/
Quantitative/Microbiological / Chemical).

GENERAL GUIDELINES ON SAMPLING 2016

1.3 CATEGORY OF ANALYSIS

The category of analysis for foods should be defined according to the requirement for
regulatory or monitoring purpose.

Chemical analysis: Required chemical tests to prove the safety of the product. Nutritional
tests required if product exhibits a claim
Microbial analysis: Test for Absence of pathogens and safety in microbial counts
Physical analysis: Test for extraneous matter, damaged product
Sensory analysis: Test for retention of original characteristics including flavour, texture
etc. and other expected characteristics

2. SAMPLING PLAN
2.1 PURPOSE
Sampling plans are required which ensure that fair and valid procedures are used when
food is being controlled for compliance with a particular commodity standard. Since
numerous, yet often complex, sampling plans are available it is the purpose of these
guidelines to help those responsible for sampling to select sampling plans that are
appropriate for statistical inspections under specifications laid down in standards. No
sampling plan can ensure that every item in a lot conforms. These sampling plans are
nevertheless useful for guaranteeing an acceptable quality level. These guidelines contain
the elementary principles of statistical control at reception, which complete the basic
recommendations mentioned above.
2.2 TARGET AUDIENCE OF THE GUIDELINES
These Guidelines are above all aimed at FSSA Food Safety Officers, government and
other users who can select from the recommended plans those which appear to them best
suited for the inspection to be made. These Guidelines can also be used, if applicable, by
governments in case of international trade disputes.

GENERAL GUIDELINES ON SAMPLING 2016

2.3 USERS OF SAMPLING PLANS RECOMMENDED BY THE GUIDELINES

The sampling plans described in these Guidelines may be implemented either by
Governmental food control authorities, or by professionals themselves (self-inspection
performed by producers and/or traders). In the latter case, these Guidelines enable the
governmental authorities to check the appropriateness of the sampling plans implemented
by the professionals. It is recommended that the different parties concerned with sampling
come to an agreement on the implementation of the same sampling plan for the respective
controls.
2.4 BASIC RECOMMENDATIONS FOR THE SELECTION OF SAMPLING PLANS
The present clause represents a pre-requisite to the use of these Guidelines and is
intended to facilitate the selection of sampling plans, as well as to follow a systematic
approach for this selection. The following enumerates the essential points that the relevant
FSSA Food Safety Officers, Governments and other users should address for the selection of
appropriate sampling plans, when setting-up specifications.
1) Nature of the control
Characteristic applicable to each individual item of the lot
Characteristic applicable to the whole lot (statistical approach)
2) Nature of the characteristic to control
Qualitative characteristic (characteristic measured on a pass/failed or similar basis, i.e.
presence of a pathogen micro-organism)
Quantitative characteristic (characteristic measured on a continuous scale, for

example

a compositional characteristic)
3) Choice of the quality level (AQL or LQ)
In accordance with the principles laid down in the FSSA Manual and with the type of risk:
critical/non-critical non-conformities.

GENERAL GUIDELINES ON SAMPLING 2016

The Acceptable Quality Level (AQL) for a given sampling plan is the rate of nonconforming items at which a lot will be rejected with a low probability, usually 5 %.The
Acceptable Quality Level (AQL) is used as an indexing criterion applied to a continuous
series of lots which corresponds to a maximum rate of acceptable defective items in lots (or
the maximum number of defective items per hundred items). This does not mean that all
the lots having a rate of defective items greater than the AQL will be rejected at the control,
but this means that the higher the rate of defective items exceeds the AQL, the greater is the
probability of rejection of a lot.
4) Nature of the lot
Bulk or pre-packed commodities
Size, homogeneity and distribution concerning the characteristic to control
5) Composition of the sample
Sample composed of a single sampling unit
Sample composed of more than one unit (including the composite sample)
6) Choice of the type of sampling plan
Sampling plan needs to be specified. Single sampling plans for inspections of percent
non-conforming items by attributes can be used. Sampling should be done considering the
no. and nature of parameters to be assessed. Attribute sampling plan can be used when
evaluating isolated lots. Variable method can be used if less no. of parameters is to be
assessed. Sampling plan for lots moving in international trade are to be selected by
attributes indexed by limiting quality level. For microbiological assessment, inspection by
two or three class attributes is to be done:
acceptance sampling plans for statistical quality control
for the control of the average of the characteristic
for the control of per-cent non-conforming items in the lot
- Definition and enumeration of non-conforming items in the sample (attribute plans)
- Comparison of the mean value of the items forming the sample with regards to an
algebraic formula (variable plans)
Convenience (or pragmatic, empirical) sampling plans

GENERAL GUIDELINES ON SAMPLING 2016

The two flow-charts in the following pages sum up a systematic approach for the selection
of a sampling plan and reference to the appropriate sections in the document, which does
not cover sampling of heterogeneous bulk lots.

FLOW-CHART FOR CHEMICAL AND PHYSICAL CHARACTERISTICS

Qualitative Characteristics (e.g. commoditydefects)

Inspection of isolated lots

E.g., inspection of the aspects of a piece
of fruit, or of a can in isolated lots
To be sampled by attribute sampling
plan for isolated lots,

Inspection of a continuous series of

lots
E.g., inspection of the aspects of a piece
offruit, or of a can in continuous lots
To be sampled by attribute sampling
plans
for continuous lots, see section 4.2

Quantitative characteristics
(e.g. compositional characteristics)
Inspection of a continuous series of
lots

Inspection of isolated lots

bulk
E.g. : fat
content of
milk in a tank
To be sampled
by
variable
sampling
plans for a
isolated lots

item

bulk
E.g.: fat
content
of milk in a
tank.
To be sampled
by variable
sampling
plans
for a
continuous
series of lots
sections

E.g. : sodium
content of a
dietary cheese
Sampling by
attributes,

item
E.g. : sodium
content of a
dietary cheese
To be sampled
by attribute
sampling
plans

Ref. CAC/GL 50-2004 Page 5 of 69

GENERAL GUIDELINES ON SAMPLING 2016

FLOW-CHART FOR MICROBIOLOGICAL CHARACTERISTICS

Micro-organisms with severe hazard

or withmoderate direct health
hazard of potentially
extensive spread in food.

Micro-organisms with no or low direct

health hazard (spoilage, shelf-life and
indicator organisms) or with moderate
direct health hazard (limited spread).
E.g., aerobic microorganisms,
psychrotrophic microorganisms
lactic acid bacteria, yeasts, moulds
(exceptfor
Mycotoxins),
coliform,
thermotolerantcoliforms

E.g., pathogenic E. coli, Salmonella

spp,Shigella, Clostridium botulinum,
Listeriamonocytogenes (risk
groups)

Sampling by three-class attributes

plans

Sampling by two-class attributes

plans,

Ref. CAC/GL 50-2004 Page 5 of 69

7) Decision rules for the lot acceptance/rejection: Ref. CAC/GL 50-2004
2.5 STATISTICAL DESIGN FOR SAMPLING (Applicable for monitoring and not for
regulatory samples)
Sampling should be done as per Section 47 defined in the FSSA act. Food inspectors
should buy samples from vendors/owners in presence of external witnesses.These samples
are appropriately divided, packed, sealed. A sample pick up report, with other observations
and comments is prepared and signed by the inspector, vendor/owner and the witness. As
only one sample is picked up randomly, no statistical inferences can be concluded.
However, based on findings for one sample test,it would be relevant to have at least 5 to 8
samples randomly picked up for reconfirmation and have some statistical inferences.
For packed foods it is necessary to decide the number of samples to be sampled. The
generic formula used is:
i) For number of packages < 100,minimum of 10 samples has to be sampled

GENERAL GUIDELINES ON SAMPLING 2016

ii) For number of samples > 100 in a batch, root of total number of samples need to be
sampled
iii)

After deciding the number of packages to be sampled, the numbers of packages are to

be selected from the bulk consignment in a random manner so that each package in a lot
has an equal chance of being selected.
iv)

For package weight less than 5 kg the entire contents can be taken as incremental

sample. For > 5kg the samples are transferred to a clean surface and mixed before sampling
v) The incremental samples are mixed together, the size of the sample is then reduced by
either riffling, or conning and quartering
vi)

Final laboratory samples must be prepared and transmitted to the laboratory for

testing without delay.

Based on the vendor being inspected the location for pick up or shop should be one that is
handling a large volume of business for that vendor.The generic formula should be used:
i) For number packages < 100,minimum of samples has to be sampled
ii) For number samples > 100 in a batch,root of total number of samples need to be
sampled
The number of units that comprise a representative sample from a designated lot of a
food product must be statistically significant.The composition and nature of each lot affects
the homogeneity and uniformity of the total sample mass. The proper statistical sampling
procedure, according to whether the food is solid, semisolid, viscous, or liquid, must be
determined by the collector at the time of sampling. [Refer Microorganisms in Foods:
Sampling for Microbiological Analysis: Principles and Specific Applications, 2nd ed.
University of Toronto Press, Toronto, Ontario, Canada]. Sampling should be done with a
proper statistical design which will help cover the regulatory and monitoring issues for safe
food production and maintain the transparency in the sample selection procedure. Samples
should be despatched to the Public Analyst as soon as practically possible to avoid any
discrepancies in testing.

GENERAL GUIDELINES ON SAMPLING 2016

3. SAMPLING PROCEDURE
3.1 GENERAL
Sampling procedures should be performed in accordance with appropriate Standards
related to the commodity of concern (for example ISO 707 for sampling of milk and milk
products, other official methods of sampling like BIS etc).
3.2 EMPLOYMENT OF FOOD SAFETY OFFICER OR SAMPLING PERSONNELS
Sampling should be performed by persons trained in the techniques of sample collection by
the importing country.
3.3 MATERIAL TO BE SAMPLED
Each lot that is to be examined must be clearly defined. The appropriate regulatory body
should stipulate how a consignment should be handled in instances where no lot
designation exists.
3.4 REPRESENTATIVE SAMPLING
The representative sampling is a procedure used for drawing or forming a
representative sample. The requirements of this clause shall be, if needed, completed by
procedures (such as how to collect and to prepare a sample). Random sampling involves
the collection of n items from a lot of N items in such a way that all possible combinations of
n items have the same probability of being collected. The randomness can be obtained by
use of table of random number which can be generated by using computer software.In
order to avoid any dispute over the representativeness of the sample, a random sampling
procedure should be chosen, whenever possible, alone, or in combination with other
sampling techniques. Assuming the items can be numbered or ordered, even virtually when
it is not possible to have individual items (e.g., in the case of a tank of milk or of a silo of
grains), the choice of the items or of the increments entering into the sample should be
done as follows:

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GENERAL GUIDELINES ON SAMPLING 2016

1. To number all the items or increments of the lot (true or virtual)

2. The numbers of the items or increments to be sampled are determined randomly.
The collection of samples is to be performed in a random manner, whenever possible
during the loading or unloading of the lot. If the lot is heterogeneous, a random sample may
not be representative of the lot. In such cases, stratifiedsampling may be a solution.
Stratified sampling consists of dividing the lot into different strata or zones, each stratum
being more homogenous than the original lot. Then a random sample is drawn from each
ofthese strata, following specified instructions which may be drafted by relevant regulatory
body (for ex. APEDA has given guidelines for sampling of peanuts specifically to detect
Aflatoxin levels). . Each stratum can then be inspected by random sampling which usually
includes from 2 to 20 items or increments per sample. When it is not possible to sample at
random, for example in a very large store where the goods are badlytidied or when the
production process includes a periodic phenomenon (e.g. a contaminant which
isspecifically located in a particular area of the silo or a regulator detuned every each k
seconds, such as every k seconds the products packaged by this regulator have defaults), it
is mandatory:
1. To avoid preferentially choosing items which are more easily accessible or which can be
differentiated by a visible characteristic.
2. In the case of periodic phenomena, to avoid sampling every k seconds or every kth
package, orevery kth centimetres, to take a unit from every nth palette, pre-package.

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GENERAL GUIDELINES ON SAMPLING 2016

Table I: Selection of Sampling Plan

3.5 TYPES OF SINGLE SAMPLING PLANS
3.5.1 Single sampling plans for inspections of percent non-conforming items
3.5.1.1 Principles of inspection by attributes of percent non-conforming items
The following text and curves present simply the principles of inspection by single
sampling plans byattributes and by variables of percent nonconforming as well as their
efficacy.

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GENERAL GUIDELINES ON SAMPLING 2016

A sampling plan for inspection by attributesis a method for evaluating the quality of a lot
which operatesby classifying each increment of the sample as a conforming or
nonconforming characteristic or attribute,depending on whether the standard specification
is complied with or not. This characteristic is either qualitative (for example the presence of
a blemish on fruit) or quantitative (for example the sodium contentof a dietary food,
classified as conforming or non-conforming in relation to a limit noted). The number
ofincrements having the nonconforming attribute are then counted and if the acceptance
number set by the planis not exceeded the lot is accepted, otherwise it is refused.
3.5.1.2 Comparative advantages and disadvantages of attribute plans and variable
plans
When it is possible to implement either an attributes plan or a variables plan, for
example for the inspection of the sodium content of a dietary cheese, the selection must be
made after having consulted in particular the following Table on the comparative
advantages and disadvantages of the plans.
Table: Comparison of attribute and variable sampling plans
ADVANTAGES

DISADVANTAGES

ATTRIBUTES

No condition on the mathematical Less effective than variables plans

PLANS

law of distribution of the variable

for a same sample size of n

inspected

increments (the LQ is higher);

Greater simplicity of processing more costly than variables plans

the results on the sample

because

the

collected

sample

requires more increments than

those required, for the same
efficacy, by a variables plan
VARIABLES

More effective than attributes They cannot be used in all cases

PLANS

plans for the same sample size of because to validate the calculation
n increments (the LQ is lower); for formulas the mathematical law of
the same AQL they are less distribution

of

the

inspected

expensive than attributes plans variable must necessarily follow or

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GENERAL GUIDELINES ON SAMPLING 2016

because

the

sample

collected approximately follow a normal law

requires fewer increments than

those required, for a same efficacy,
by attributes plans
Decision tree for the selection of an attributes or a variables sampling plan

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GENERAL GUIDELINES ON SAMPLING 2016

3.6 TWO AND THREE CLASS ATTRIBUTES PLANS FOR MICROBIOLOGICAL

ASSESSMENTS
3.6.1 Two-class Attributes Plans
Two-class attributes plans provide a simple means of inspection where the sampling plan
is defined by twovalues, n and c. The value of n defines the sample size in terms of the
number of items; and the value cdenotes the maximum number of nonconforming items
permitted in the sample. When undertaking amicrobiological assessment, a maximum
concentration of micro-organisms permitted in any item is denotedby m; any item
contaminated at a concentration greater than m is considered to be nonconforming.
For a given value of c, the stringency (probability of rejection) of the plan will increase as
n increases.
The application of a two-class attributes plan can be summarized as follows:
Set the value of m, n and c
Collect the sample with n items
Inspect each item in the sample
Accept the lot if: number of defective items c
3.6.2 Three-class Attributes Plans
Three class attributes plans are defined by the values n, c, m and M (see below); and are
applied to situationswhere the quality of the product can be divided into three attribute
classes depending upon the concentrationof micro-organisms within the sample:

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GENERAL GUIDELINES ON SAMPLING 2016

Unacceptable quality, with a concentration of micro-organisms above the value, M (which

must not be exceeded by any items in the sample).
Good quality, where the concentration must not exceed the value, m.
Marginally acceptable quality. Marginal items have a concentration which exceeds m, but
which isless than M (such concentrations are undesirable but some can be accepted, the
maximum numberacceptable being denoted by c).
The value m is the concentration of the micro-organism which is acceptable and
attainable in the food underinspection, as reflected by Good Commercial Practice (GCP). For
3-class plans, m will be assigned a non zero value.
The value M is a hazardous or unacceptable level of contamination caused by poor
hygienic practice, including improper storage. There are several approaches to choosing
the value of M:
(i) As a utility (spoilage or shelf-life) index, relating levels of contamination to detectable
spoilage (odour, flavour) or to an unacceptably short shelf-life;
(ii) As a general hygiene indicator, relating levels of the indicator contaminant to a
clearlyunacceptable condition of hygiene;
(iii) As a health hazard, relating contamination levels to illness. A variety of data may be
used forthis purpose including, for example, epidemiological, experimental animal feeding
and human feeding data.
The values m and M may be independent of each other.The choice of values for n and c
varies with the desired stringency (probability of rejection). For stringentcases, n is high
and c is low; for lenient cases n is low and c is high. The choice of n is usually acompromise
between what is an ideal probability of assurance of consumer safety and the work load
thelaboratory can handle.If the concentration of micro-organisms in any item of the sample
is greater than M, the lot is directly rejected.
The application of a three-class attributes sampling plan may be summarized as
follows:

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GENERAL GUIDELINES ON SAMPLING 2016

Set the values of m, M, n, c

Collect the sample with n items
Inspect each item in the sample
Accept the lot if: number of marginally defective items (i.e. a concentration of microorganismsbetween m and M) c
Immediately reject the lot if the concentration of micro-organisms in any item >M
and/or the numberof marginally defective items > c

3.6.3 The Application of Two and Three-class Attributes Plans

Two and three-class attributes plans are ideally suited for regulatory, port-ofentry, and other consumerorientedsituations where little information is available
concerning the microbiological history of the lot.The plans are independent of lot size if the
lot is large in comparison to sample size. The relationship between sample size and lot size
only becomes significant when the sample size approaches one tenth of thelot size, a
situation rarely occurring in the bacteriological inspection of foods. When choosing a plan
one must consider:
(i) The type and seriousness of hazards implied by the microorganisms, and
(ii) The conditions under which the food is expected to be handled and consumed after
sampling.

4. MANNER OF COLLECTING THE SAMPLE

The current practice of sample collection should be modified to include more
transperancy, confidence and involvement of vendor/owner.

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GENERAL GUIDELINES ON SAMPLING 2016

Information concerning the powers of the officer making an investigation, the legal
rights of the occupier of a food premises and the Food Authoritys Enforcement Policy
should be included in any post inspection report.
A formal sample for analysis should as soon as possible, be carefully divided into four
representative parts, preferably on the premises of the seller/owner of the food and giving
the owner the opportunity to witness the sampling taking place.Each part must then be
labelled and sealed to ensure that any evidence of tempering can be identified.
One part of the formal sample must be given to the owner, his agent or employee incharge of the food with notice that the sample will be analysed. The second final part of the
sample must be submitted for analysis to the Public Analyst of the Food Authority
concerned. The third final part must be retained by the authority for possible future
analysis by the referee analyst (Govt. Chemist). In the event of any dispute over the
composition or other alleged defect in the sample, as decided by the court, or by mutual
agreement of the authorised officer and the owner of the food. For sealed containers
wherein opening of the container could impede analysis the unopened containers might
make the actual sample to be sent to the analyst. Also, cases where it is not practically
possible to have a uniform mixing of samples from the three containers then the single part
sample is to be submitted for analysis.
Samples to be taken, as far as possible, using sterile techniques (wherever
microbiological tests are applicable) i.e., sampling personnel should use sterile gloves,
sealed sterilised bags or sterile bottles.To avoid contamination from lot to lot, the sampling
equipment has to be clean, dry and free from foreign odours.Using sharp objects should be
avoided to prevent the possibility of damage to the surface of the equipment. BIS
documents (wherever applicable) can also be considered for guidance purpose [Refer IS
5404-1984 (RA 2013)].
Samples to be taken for microbial analysis should be collected in sterile containers.
The adequacy and condition of the sample or specimen received for examination are of
primary importance. If samples are improperly collected and mishandled or are not

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GENERAL GUIDELINES ON SAMPLING 2016

representative of the sampled lot, the laboratory results will be meaningless. Because
interpretations about a large consignment of food are based on a relatively small sample of
the lot, established sampling procedures must be applied uniformly. A representative
sample is essential when pathogens or toxins are sparsely distributed within the food or
when disposal of a food shipment depends on the demonstrated bacterial content in
relation to a legal standard.
The number of units that comprise a representative sample from a designated lot of a
food product must be statistically significant. The composition and nature of each lot affects
the homogeneity and uniformity of the total sample mass. The proper statistical sampling
procedure, according to whether the food is solid, semisolid, viscous, or liquid, must be
determined by the collector at the time of sampling.
Whenever possible, submit samples to the laboratory in the original unopened
containers. If products are in bulk or in containers too large for submission to the
laboratory, transfer representative portions to sterile containers under aseptic conditions.
There can be no compromise in the use of sterile sampling equipment and the use of aseptic
technique. Sterilize one-piece stainless steel spoons, forceps, spatulas, and scissors in an
autoclave or dry-heat oven. Use of a propane torch or dipping the instrument in alcohol and
igniting is dangerous and may be inadequate for sterilizing equipment.
Use containers that are clean, dry, leak-proof, wide-mouthed, sterile, and of a size
suitable for samples of the product. Containers such as plastic jars or metal cans that are
leak-proof may be hermetically sealed. Whenever possible, avoid glass containers, which
may break and contaminate the food product. For dry materials, use sterile metal boxes,
cans, bags, or packets with suitable closures. Sterile

plastic

bags

(for

dry,

unfrozen

materials only) or plastic bottles are useful containers for line samples. Take care not to
overfill bags or permit puncture by wire closure. Identify each sample unit (defined later)
with a properly marked strip of masking tape. Do not use a felt pen on plastic because the
ink might penetrate the container. Whenever possible, obtain at least 100 gm for each
sample unit. Submit open and closed controls of sterile containers with the sample.

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GENERAL GUIDELINES ON SAMPLING 2016

Deliver samples to the laboratory promptly with the original storage conditions
maintained as nearly as possible. When collecting liquid samples, take an additional sample
as a temperature control. Check the temperature of the control sample at the time of
collection and on receipt at the laboratory. Make a record for all samples of the times and
dates of collection and of arrival at the laboratory. Dry or canned foods that are not
perishable and are collected at ambient temperatures need not be refrigerated. Transport
frozen or refrigerated products in approved insulated containers of rigid construction so
that they will arrive at the laboratory unchanged. Collect frozen samples in pre-chilled
containers.
Place containers in a freezer long enough to chill them thoroughly. Keep frozen samples
solidly frozen at all times. Cool refrigerated samples, except shellfish and shell stock, in ice
at 0-4C and transport them in a sample chest with suitable refrigerant capable of
maintaining the sample at 0-4C until arrival at the laboratory. Do not freeze refrigerated
products. Unless otherwise specified, refrigerated samples should not be analyzed more
than 36 h after collection. Special conditions apply to the collection and storage of shucked,
unfrozen shellfish and shell stock (1). Pack samples of shucked shellfish immediately in
crushed ice (no temperature specified) until analyzed; keep shell stock above freezing but
below 10C. Examine refrigerated shellfish and shell stock within 6 h of collection but in no
case more than 24 h after collection.
Sample amount collected should be sufficient enough for the required analysis. Public
analyst consent should be taken in case of doubt. The officer needs to consider what
analysis needs to be requested and whether opening the sealed container would prevent
the analysis. Examples were the analysis may be affected include the following:
a) Foods containing evanescent ingredients e.g. soft drinks containing vitamin C, dried fruit
containing sulphur dioxide;
b) Foods containing or suspected of containing, volatile substances ex. solvent, alcohol;
foods packed in modified atmospheres where gas analysis is required or loss of the
protective atmosphere could alter preservative levels;
c) Foods packaged in aerosols
d) Aerated foods e.g. carbonated soft drinks

20

GENERAL GUIDELINES ON SAMPLING 2016

e) Products where it is necessary to have an unopened container in order to carry out a

particular test e.g.condensed milk where there is a statement that the contents are
equivalent to a quantity of whole milk;
f) Products which are difficult to extract from the container and where there is possibility
of a considerable quantity of the food remaining in the container e.g., salad cream, sauces,
treacle.
For microbiological analysis, different sampling plans may be implemented considering
the nature of microorganism/microorganisms to be tested. Sampling is followed according
to the food category. Aseptic sampling should be done for microbiological analysis. General
procedure for aseptic sample follows the use of sterile equipments; care should be taken
while using propane torch or other flame while sterilizing the equipments on site. On site
conditions should be evaluated for explosive vapours, dusty air, flame restricted area,
firm's policy or management wishes. All flammable liquids should be kept in metal safety
cans and not in breakable containers. Handle the item being sampled using sterile gloves
[rubber, vinyl, plastic, etc. surgeon's gloves are good]. Use fresh glove for each sub sample
and submit an unopened pair of glove as a control.
Sterile sampling containers should be opened with care. Open it only to introduce the
sample and close immediately. Do not touch the inside of the containers, lip or lid. Submit
one empty sterile container opened and closed in the same manner as a control. Do not
collect the sample in dusty areas. Dried powders like dried yeast, dried milk powder, dried
eggs, and similar products are packed in multi layered poly bags or containers so care
should be taken to dust the bag by brushing, wipe it with alcohol using a cloth, remove the
seam and open the bag enough to withdraw the sample. Water samples should be collected
in sterile bottles. Decholrination if necessary should be done by placing 100mg/L of sodium
thiosulphate in bottles before sterilization. Carefully inspect the faucet. Do not collect from
the faucet which leak. Clean and dry the outside of faucet allow the water to run for 1/2 a
min or 2-3 min if the pipeline is too long. Partially close the faucet to collect the sample
without splashing the water. Take care while opening and closing the bottle. Rodent
contaminated, Insect contaminated and Bird contaminated samples should be taken as
given in relevant compliance policy guide.

21

GENERAL GUIDELINES ON SAMPLING 2016

Sample amount collected should be sufficient enough for the required analysis.
Public

analysts

consent

should

be

taken

in

case

of

doubt.

The officer needs to consider what analysis needs to be requested and whether opening the
sealed container would prevent the analysis. Examples where the analysis may be affected
include the following: (a) foods containing evanescent ingredients e.g. soft drinks
containing Vitamin C, dried fruit containing sulphur dioxide; (b) foods containing, or
suspected of containing, volatile substances, e.g. solvent, alcohol; (c) foods packaged in
modified atmospheres where gas analysis is required or loss of the protective atmosphere
could alter preservative levels; (d) foods packed in aerosols; (e) aerated foods, e.g.
carbonated soft drinks; (f) products where it is necessary to have an unopened containerin
order to carry out a particular test e.g. condensed milk where there is a statement that the
contents are equivalent toa quantity of whole milk; (g) products which are difficult to
extract from the container and where there is a possibility of a considerable quantity of the
food remaining in the container e.g. salad cream, sauces, treacle.
If the product is perishable and fresh or thawed, cool samples to 32-38F (0-3.3C) and
transport them in a protective insulated container. Pack samples with layers of frozen gel
packs in sufficient quantity to maintain the product at a temperature not to exceed 38F
(3.3C) for the duration of transportation to the lab. Any excess space should be filled so
that the samples and gel packs cannot shift and separate from one another. Crunched up
newspaper is recommended for filling up excess space because it is also a good insulator
and will help keep samples cold. The container should be marked Perishable Product and
shipped the same day of collection.
If the product is perishable and frozen, maintain samples in the frozen state -20 to 0F (28.9 to -17.8C) and transport them in a protective insulated container. Pack the samples
with layers of frozen gel packs or dry ice in sufficient quantity to maintain the product at a
temperature not to exceed 0F (-17.8C) for the duration of transportation to the lab. Any
excess space should be filled so that the samples and gel packs cannot shift and separate
from one another. Crunched up newspaper is recommended for filling up excess space
because it is also a good insulator and will help keep samples cold. The container should be
marked Perishable, Frozen Product.

22

GENERAL GUIDELINES ON SAMPLING 2016

If a lot inspection office or a company ships packages with dry ice, ensure that whoever
signs the shipping document has completed the DOT Hazardous Shipper Training and has a
copy of his or her current training certificate. Use dry ice (solid carbon dioxide) as the
refrigerant if the time spent in transport may lead to thawing. Any excess space should be
filled so that the samples and dry ice cannot shift and separate from one another. Crunched
up newspaper is recommended for filling up excess space because it is also a good insulator
and will help keep samples cold. Dry ice weighing approximately the sample weight is
sufficient for this purpose provided the container is insulated with 1 -2 inches of a foamtype material, and is tightly sealed. The container should be marked Perishable, Frozen
Product.
If the container is to be shipped to the laboratory by a common carrier, i.e. Federal
Express, it is imperative to send it FedEx Priority Overnight (next business morning), and
indicate the total number of packages and weight on the label. Also, if dry ice is used, the
words dry ice and weight of dry ice must be declared on package and label.
Please make sure to weigh the container and to round it to the nearest pound / kgs. In
order to avoid excessive shipping charges, DO NOT estimate the weight or ship a container
without indicating the actual weight.Include the sample information form in a sealable
plastic bag to avoid it from becoming wet and illegible. Include any reusable supplies inside
the shipping container on top of samples.
Preservatives like formalin (which is added to the milk to extend its shelf life) if added to
the sample the amount needs to be specified alongwith the purpose. In case the purpose of
sample collection is detecting the presence/absence of adulterants or microbial analysis
such preservatives are not recommended to be used.
4.1 SAMPLE TAKING AND DESPATCHING
Sampling should be random and without prior intimation to the food business operator.
Sample should be despatched in a manner that does not alter the character of the product.
Sample integrity should be maintained.Sampling can be done while inspecting the premises
itself. The owner need not be informed in advance. Samples should be taken in the right
manner to maintain the integrity and homogeneity of the sample. Sample can be taken
while conducting inspection of the premises. Prior notice is not mandatory. Receipt to be
23

GENERAL GUIDELINES ON SAMPLING 2016

given to the owner, in-charge, operator on completion of inspection and prior to leaving the
premises.
Sample taken should be divided into 4 parts immediately. There are exceptions where
the division of sample might not be possible:o Sample is insufficient
o Sample is unopened
o Sample is non-homogenous
Where practicable, the division should be carried out on the premises of the
seller/owner of the food, who, ifpresent, should be given the opportunity to observe the
sampling and division before being invited to choose one of the parts for retention.Care
should be taken to prevent contamination of samples and instruments and containers used
should be clean and dry. The use of cleaning and sterilising methods should be avoided as it
may leave residues on the instruments and containers which could affect the results of the
analysis (e.g. alcohol).
Samples which Present Difficulties in Dividing into Parts where there is insufficient
product available, where there is no way of storing a final part for further analysis as with
tests for previously frozen meat, where foods are not pre-packed and are not homogenous
and it is difficult to divide the food into three parts so that each part contains the same
proportion of each ingredient e.g. meat products with lumps of meat, pies where it is
difficult to divide the pastry and thefilling into three, fruit cocktail/yogurts with fruit where
an ingredient is to be quantified.When food is pre-packed, where the sample consists of
unopened containers and opening them would, in the opinion of the authorised officer,
impede proper analysis. In these circumstances the authorised officer should divide the
sample into parts by putting containers into three lots, and each lot should be treated as a
final part.
A sampling kit should be designed based on the nature of sample and the purpose of
sampling. Below enlisted are the basic requirements that are to be fulfilled by a sampling
kit:

24

GENERAL GUIDELINES ON SAMPLING 2016

Carrying case
Notebook
White coats
White hats
Chill packs
Lockable or secure freezer (-18 0C)
Insulated boxes
Adequate supply of hard frozen ice blocks
Food grade sampling bags
Sample Labels
Seals
Hair nets
Disposable paper towels
Measuring jug(s)
Funnel(s)
Scissors
Knives
Spoons
Can Opener
Sample containers (various sizes)
Glass bottles
Thermometer (Calibrated)
Disinfectant wipes
Sterile sample jars (various sizes)
Sterile knives and spoons as necessary
Swabbing equipment
Water sampling bottles
Latex gloves
Isopropanol (70%)

25

GENERAL GUIDELINES ON SAMPLING 2016

4.2 TIME

FOR

SAMPLE

DELIVERY

TO

THE

PUBLIC

ANALYST/ACCREDITED

LAB/REFERRAL LAB
Samples should be despatched to the Public Analyst as soon as practically possible to
avoid any discrepancies in testing. Perishable samples, samples for micro-testing and
samples which change with time should be considered on urgent basis for delivery to the
analytical lab.Water samples should be delivered for analysis within 24 hours.
Sample be transmitted as soon as practicable after sampling, particularly where tests are
to be made for substances which may deteriorate or change with time (e.g. certain
pesticides, sulphur dioxide, etc). In any case where doubt exists about suitable storage or
transport arrangements for samples for analysis, the public analyst should be consulted.
Since retained final parts may need to be stored for several months prior to submission to
the Government Chemist, it is important that they are appropriately stored.
4.3 TIME FOR SAMPLE ANALYSIS AND REPORTING BY THE LAB
Sample Analysis should be considered as per the urgency basis. Minimum time should be
taken to analyse and report the findings of the disputed sample. In either case the sample
should be analysed and reported within 7 - 14 working days from the date of receipt of
samples by the Public Analyst. Sample reporting should report the results in terms of: CONFORMS/DOES NOT CONFORM. The analysis report should be submitted as per the
format prescribed in Form B of FSS (Laboratory and Sampling) Regulations, 2011.
4.4 SUITABLE CONTAINERS
The laboratory sample must be placed in a clean, inert container which provides secure
protection from contamination, damage and leakage. The container should be sealed, the
sampling record must be attached and the sample delivered to the laboratory as soon as
practicable.
Solids: For packaged consumer packs, the samples should be collected as is without
opening the packs. This is true for solids and liquid packaged products. For open and loose

26

GENERAL GUIDELINES ON SAMPLING 2016

food products, the containers should be of appropriate size, clean, sterile incase of
microbiological testing and should have tamper evident closures and seals. Sterile and
clean sampling gadgets, seals, and containers should be used. Aseptic sampling procedure
should be followed.
Liquids: Containers liquid/semi-solid products should preferably be of inert materials,
glass or plastic. The containers should preferably be of appropriate size, capable of air-tight
closure and preferably dark-coloured so as to prevent light-based degradation
4.4.1 Type of containers
Material of the container should be inert. Containers used for sampling should be air
tight for chemical analysis and sterile for microbiological analysis. Preferable type of
container used for chemical and microbiological analysis should be the same for ease.
Samples of food which are not pre-packed or opened cans or packets of foods should
first be placed in clean, dry leak-proof containers such as wide-mouth glass or food quality
plastic jars, stainless metal cans or disposable food quality plastic bags. Jars, bottles or cans
should be suitably closed. Disposable food quality plastic bags should be sealed securely
after filling so that they cannot leak or become contaminated during normal handling.
Samples of alcoholic drinks should be placed in glass bottles. Samples for microbiological
examination should be taken and handled in a manner that eliminates the risk of
contamination duringthe sampling process.
Food Safety officer or Sampling personnels should have regard to any advice provided
by the food examiner on the need to observe aseptic sampling techniques. The owner of the
food should be given the opportunity if present to observe the sampling procedure.
4.5 QUANTITY OF SAMPLE TO BE DRAWN AS SUFFICIENT FOR ANALYSIS
Quantity of sample to be drawn which will be sufficient for the required analysis. This
should be as per the FSSA for most samples. Odd expensive items can be given due
consideration. Quantity will vary according to product and type of analysis. It will also

27

GENERAL GUIDELINES ON SAMPLING 2016

depend on the purpose for which the analysis is undertaken.Twice the amount of samples
required for analysis should be taken. In case of large consignment of imported food,
modified protocol would be necessary. Minimum 100gm of sample must be sent for
analysis Samples for examination are not required to be divided into three parts since the
non-homogeneous distribution of bacterial contaminantsmeans that no two samples will be
the same. It is not appropriate to retain a part for examination later in the event of a
dispute, as bacteria may not survive prolonged storage or conversely, may greatly multiply.
4.6 IMPORTANT POINTS TO CONSIDER
a. No.of batches/ lot: A representative statistical sampling strategy should be made for
batches and lots based on the volume of material available on-site.
b. No. of batches or lot are decided as per the Investigations Operations Manual Sample
Plan.
c. Each lot that is to be examined must be clearly defined. In case of random sampling the
items are collected in such a way that all possible combinations have same probability of
being collected.If the lot is heterogeneous, stratified sampling may be a solution.
d. Protocol for labelling and sealing: Labelling and sealing should be appropriate to
maintain integrity and traceability of the sample. The identity of the sample should be
evident from the reference stated on the drawn sample container.
e. Representative number of subsamples should be made with the sample number,
collection date and your written initials. Similarly identify any outer packaging, labels or
circulars.
f. Transparent tape such as Scotch Magic Transparent tape accepts ball point ink and may
be used on glossy items such as glass, plastic, tin, etc. Glass, such as bottles, vials and
ampules, may be identified by using a very fine pointed felt or nylon marking pen and
covering

the

identification

with

transparent

tape

for

protection.

Do not use tape on very small containers such as ampoules, which must be snapped or

28

GENERAL GUIDELINES ON SAMPLING 2016

broken to remove the contents for analysis. Tape wrapped around the container may
interfere with assay. Do not use permanent type markers when identifying subs in
absorbent containers if the ink may penetrate into the product thus contaminating the
sample.Diamond or carbide tipped stylus pencils may be used to mark tin, glass, etc. Do not
use diamond or carbide tipped stylus to mark products in glass under pressure (i.e.,
carbonated beverages).
g. The contained final parts should each be secured with a tamper evident seal, and labelled
specifying the name of the food, the name of the officer, the name of the authority, the place,
date and time of sampling and an identification number. Where necessary, it should then be
placed in a second container, such as a plastic bag, which should be sealed in such a way as
to ensure that the sample cannot be tampered with. A copy of the food label if available and
any other relevant details should be submitted to the public analyst with a final part.
h. Sealing the edges: All the samples should be sealed immediately post sampling. A tamper
evident seal should be used like wax, adhesives etc.
i. Thread: Maybe used to identify any tampering taking place.
j. Seal of the owner Required.
k. Signature/Thumb impression of the owner/witness: Required.
l. Name and Address of the owner: Required on the container.
m. Batch No. /Lot No. Required.
n. Code No. and serial no.of Local authority: Code/ License of Local Authority is required.
o. Date and place of collection: Required.
p. Nature of article submitted: Required.

29

GENERAL GUIDELINES ON SAMPLING 2016

q. Nature and qty. of preservative added: Preservative should be added in amounts which
do not interfere with the chemical and microbial analysis. In case of doubt Public Analyst
should be consulted.
r. For Agmark sealed containers:-Grade, Agmark Label No. /Batch no., Name of packaging
station required.
s. Manner of packing: Packing of the sample should be done taking care to maintain the
integrity and homogeneity of the sample. Packing should avoid pilferage and should be
tamper evident. Clean inert container should be used offering adequate protection from
external contamination and protection against damage to the sample in transit. The
container should be sealed in such a manner that unauthorised opening is detectable and
sent to lab as soon as possible. Precautions should be taken against leakage and
spoilage.Storage conditions should also be maintained.
t. Define category of analysis: The category of analysis for foods should be done according
to the requirement for regulatory or monitoring purpose. Category of analysis to be chosen
should be done in sync with the Public Analyst.
i. Chemical
ii. Microbiological
iii. Physical
iv. Sensory
Final parts of food which are perishable should be kept refrigerated or in a frozen state, as
necessary. The method of storage used will differ depending on whether the final part is to
be submitted to the public analyst or retained for possible submission to the government
chemist.

5. SAMPLE PREPARATION
The preparation varies depending on the nature of sample. Primary sample/Composite
sample or Final sample. For detailed sample preparation test procedure refer manual for
Guidelines on Sample Preparation.

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GENERAL GUIDELINES ON SAMPLING 2016

5.1 PREPARATION OF SAMPLES

5.1.1 Primary Samples
A primary sample is the portion of product collected from a lot during the first stage of
the sampling process, and will normally be in the form of an item (if collected from a lot of
prepacked products) or of an increment (if collected from a bulk lot). (However, an
increment may be considered to be an item if measurements are made on individual
increments.) As far as is practicable, primary samples should be taken throughout the lot
and departures from this requirement should be recorded. Sufficient primary samples of
similar size should be collected to facilitate laboratory analysis. In the course of taking the
primary samples (items or increments), and in all subsequent procedures, precautions
must be taken to maintain sample integrity (i.e., to avoid contamination of the samples or
any other changes which would adversely affect the amount of residues or the analytical
determinations, or make the laboratory sample not representative of the composite sample
from the lot).
5.1.2 Composite Sample
When required by the sampling plan, a composite sample is produced by carefully
mixing the primary samples (items) from a lot of pre-packaged products; or by carefully
mixing the primary samples (increments) from a bulk (not pre-packaged) lot. Except for
economical reasons, this sampling technique is not to be recommended given the loss of
information on sample-to-sample variation due to the combination of primary samples.
5.1.3 Final Sample
The bulk or bulked sample should, if possible, constitute the final sample and be
submitted to the laboratory for analysis. If the bulk/bulked sample is too large, the final
sample may be prepared from it by a suitable method of reduction. In this process, however,
individual items must not be cut or divided.

31

GENERAL GUIDELINES ON SAMPLING 2016

6. OTHER POINTS OF CONSIDERATION

6.1 SAMPLING REPORT
The sampling report should include the reason for sampling, the origin of sample, the
sampling method and the date and place of sampling together with any additional
information like transport time and conditions. Any deviation from the specified sampling
procedure to be reflected in report.

6.2 SAMPLE PRESERVATION/STORAGE DURING TRANSPORT

The storage condition will be determined by the temperature control required for
individual products.
i. Perishable. Sample storage under chilled or frozen condition as the product demands.
Ice packs can be used during transportation and temperature is to be maintained between
4-6C.
ii. Non-perishable: Storage of non-perishables should maintain the originality of the
sample as is during the sampling conditions. Transportation should be done at
temperatures not more than 40C. Care should be taken to provide maximum protection
from pilferage.
6.3 DEFINE TIME
For microbiological samples analysis should initiate within 24 hours of sample being
drawn. For chemical tests analysis has to be initiated within 48 to 72 hours.
Samples should be transported and stored under conditionswhich inhibit changes in
microbial numbers and be delivered to the laboratory without undue delay.
The final part to be submitted to the public analyst should be transmitted as soon as
practicable after sampling, particularly where tests are to be made for substances which
may deteriorate or change with time (e.g. certain pesticides, sulphur dioxide, etc). In any
case where doubt exists about suitable storage or transport arrangements for samples for
analysis, the public analyst should be consulted. Since retained final parts may need to be
32

GENERAL GUIDELINES ON SAMPLING 2016

stored for several months prior to submission to the Government Chemist, it is important
that they are appropriately stored.
6.4 FREQUENCY OF SAMPLING
4 representative samples yearly for monitoring issues. For regulatory issues it should be
taken as and when required.
6.5 TOLERANCE CRITERIA WITH REFERENCE TO SAMPLING
Acceptable specifications for chemical tests are available in the PFA, need to be
reviewed. Once all the specifications are finalized, tolerance limits needs to be defined.

33

GENERAL GUIDELINES ON SAMPLING 2016

7. DOCUMENTATION
FORM III
[Refer rule 3.3.2.(1)]
(To keep any article of food in safe custody of the vendor)
To
(Name and address of the vendor)
.
.
.
Whereas *.intended for food which is in your possession appears to me
to be adulterated/misbranded:
Now therefore under clause (c) of sub-section (1) of section 38 of the Food Safety and
Standards Act, 2006 (34 of 2006), I hereby direct you to keep in your safe custody the said
sealed stock subject to such orders as may be issued subsequently in relation thereto.

Food Safety Officer

Area
Place:
Date:
*Here give the name of article of food.

34

GENERAL GUIDELINES ON SAMPLING 2016

FORM V
(Refer rule 3.4.1. (3))
To
..
.
Dear Sir/s/ Madam:
I

have

this

day

taken

from

premises

of

.situate

at...........................

..samples of food specified below to have the same analysed by the Food Analyst
for _______.

Details of food:
Code number:

Place:
Date:

(Sd/-) Food Safety Officer

Address:

35

GENERAL GUIDELINES ON SAMPLING 2016

FORM VI
(Refer rule 3.4.3 (7))
Memorandum to Food Analyst
From:
..
..
Date: _____
To
Food Analyst

..
MEMORANDUM
(Refer rule (v)a of 3.4.1(8))
1.

The sample described below is sent herewith for analysis under ___ of ___ of

section ____ of Food Safety and Standards Act, 2006

I.

Code Number

II.

Date and place of collection

III.

Nature of articles submitted for analysis

IV.

Nature and quantity of preservative, if any, added to the sample.

2.

A copy of this memo and specimen impression, of the seal used to seal the packet

of sample are being sent separately by post/courier/hand delivery (strike out whichever is
not applicable)
(Sd/) Food Analyst
Address:
36

GENERAL GUIDELINES ON SAMPLING 2016

8. REFERENCES
1. Food Safety and Standards Act, 2006, Rules 2011, Regulations 2011, 7th Edition
2. CAC/GL 50-2004; General Guidelines on Sampling by Codex Alimentarius Commission,
Pages 1-69
3. Microorganisms in Foods: Sampling for Microbiological Analysis: Principles and Specific
Applications, 2nd ed. University of Toronto Press, Toronto, Ontario, Canada
4. IS 5404-1984 (RA 2013)

37

GENERAL GUIDELINES ON SAMPLING 2016

ANNEXURE I
COMMONLY USED TERMS AND NOTIONS
Some of the more commonly used terms in acceptance sampling are described in this
section.
2.2.1 Lot
A lot is a definite quantity of some commodity manufactured or produced under
conditions, which are presumed uniform for the purpose of these Guidelines. For the goods
presumed heterogeneous, sampling can only be achieved on each homogeneous part of this
heterogeneous lot. In that case, the final sample is called a stratified sample.
NOTE: A continuous series of lots is a series of lots produced, manufactured or
commercialised on a continuous manner, under conditions presumed uniform. The
inspection of a continuous series of lots can only be achieved at the production or
processing stage.
2.2.2 Consignment
A consignment is a quantity of some commodity delivered at one time. It may consist in
either a portion of a lot, either a set of several lots. However, in the case of statistical
inspection, the consignment shall be considered as a new lot for the interpretation of the
results.
If the consignment is a portion of a lot, each portion is considered as a lot for the
inspection.
If the consignment is a set of several lots, before any inspection, care shall be given to the
homogeneity of the consignment. If not homogeneous, a stratified sampling may be used.
2.2.3 Sample (representative sample)
Set composed of one or several items (or a portion of matter) selected by different
means in a population (or in an important quantity of matter). It is intended to provide
information on a given characteristic of the studied population (or matter), and to form a

38

GENERAL GUIDELINES ON SAMPLING 2016

basis for a decision concerning the population or the matter or the process, which has
produced it.
A representative sample is a sample in which the characteristics of the lot from which
it is drawn are maintained. It is in particular the case of a simple random sample where
each of the items or increments of the lot has been given the same probability of entering
the sample.
2.2.4 Sampling
Procedure used to draw or constitute a sample. Empirical or punctual sampling
procedures are sampling procedures, which are not statistical-based procedures that are
used to make a decision on the inspected lot.
Item or increment of individualisable goods
a) Individualisable goods: Goods which can be individualised as items (see b) or in
increments (see c), for example:
a pre-package,
a flask or a spoon containing a quantity of goods determined by the sampling plan, and
taken from a lot, for example :
- a volume of milk or of wine stored in a tank,
- a quantity of goods taken from a conveyor belt,
b) Item: An actual or conventional object on which a set of observations may be made, and
which is drawn to form a sample.
Note: The terms individual and unit are synonymous with item
c) Increment: Quantity of material drawn at one time from a larger quantity of material to
form a sample.
2.2.8 Sampling plan
Planned procedure which enables one to choose, or draw separate samples from a lot, in
order to get the information needed, such as a decision on compliance status of the lot.

39

GENERAL GUIDELINES ON SAMPLING 2016

More precisely, a sampling plan is a scheme defining the number of items to collect and
the number of nonconforming items required in a sample to evaluate the compliance status
of a lot.
2.2.9 The Characteristic
A characteristic is a property, which helps to identify, or differentiate between, items
within a given lot. The characteristic may be either quantitative (a specific measured
amount, plan by variables) or qualitative (meets or does not meet a specification, plan by
attributes). Three types of characteristic and associated types of sampling plan are
illustrated in Table below.
Table: Sampling plans to be associated with the type of characteristic
Type of Characteristic

Type of Sampling Plan

Commodity defects: characteristics that may

ByAttributes

be expressed by two excluding situations as

passed/notpassed, yes/not, integer/not integer,
spoiled/not spoiled (e.g. as applied to visual
defects such as loss of colour, mis-grading,
extraneous matter etc)
Compositional characteristics: Characteristic Variables

with

that may be expressed by continuous variables.

standard

deviation

They maybe normally distributed (e.g. most

normally

analytically

characteristics

determined

compositional

unknown
for

distributed
and

characteristics such as moisture content) or

attributesfor characteristics

they may be non-normallydistributed.

whose distributions deviate

significantly from normal

Health-related

properties

(e.g.

in

the Specified sampling plans to be

assessment of microbial spoilage, microbial

proposed appropriate to each

hazards,

individual situation. Plans to

irregularly

occurring

chemical

contaminants etc.)

determine incidence rates in a

population may be used.
40

GENERAL GUIDELINES ON SAMPLING 2016

2.2.10 Homogeneity
A lot is homogenous relative to a given characteristic if the characteristic is uniformly
distributed according to a given probability law throughout the lot.
NOTE: A lot being homogeneous for a given characteristic does not mean that the value of
the characteristic is the same throughout the lot.
A lot is heterogeneous relative to a given characteristic if the characteristic is not
uniformly distributed throughout the lot. Items in a lot may be homogenous on one
characteristic whilst heterogeneous on another characteristic.
2.2.11 Defects (Nonconformities) and Critical Nonconformities
A defect (nonconformity) occurs within an item when one or more, quality characteristic
does not meet its established quality specification. A defective item contains one or more
defects. Lot quality may be judged in terms of the acceptable percentage of defective items
or the maximum number of defects (nonconformities) per hundred items, in respect of any
type of defects.
Most acceptance sampling involves the evaluation of more than one quality
characteristic, which may differ in importance with respect to quality and/or economic
considerations.

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GENERAL GUIDELINES ON SAMPLING 2016

ANNEXURE II
Quantity of Sample to Collect For Each Commodity
Quantity of sample to be sent to the public analyst:- The quantity of sample of
food to be sent to the public analyst / Director for analysis shall be as specified
in the Table below:
While defining these please bear in mind microbiological and chemical tests
Should you feel that fixed sample weights can be applied for dry, nonperishable and perishable foods, please categorize in general and not for
individual categories.
Sr. No

Article of food

Approximate
quantity
recommended in
FSSA

Milk

500 ml

Sterilized Milk/UHT Milk

250 ml

Malai/Dahi.

200 g

Yoghurt/Sweetened Dahi

300 gms.

Chhana/Paneer/Khoya/Shrikhand

240 gms.

Cheese/Cheese spread

200 gms.

Evaporated Milk/Condensed Milk

200 gms.

Ice-cream /Softy/Kulfi/Ice Candy/Ice lolly

300 gms.

Milk Powder /Skimmed Milk Powder

250 gms.

10

Infant Food /Weaning Food

500 gms.

11

Malt Food/ Malted Milk Food

300 gms.

12

Butter/ButterOil/Ghee/Margarine/Cream/

200 gms.

Bakery Shortening
13

Vanaspati, Edible Oils/Fats

250 gms.

14

Carbonated Water

600 ml.

15

Baking Powder

100 gms

16

Arrow root/Sago

250 gms.

42

GENERAL GUIDELINES ON SAMPLING 2016

17

Corn flakes /Macaroni Products/ Corn

200 gms.

Flour/Custard Powder
18

Spices, Condiments and Mixed Masala(Whole)

200 gms.

19

Spices, Condiments and Mixed Masala (Powder)

250 gms.

20

Nutmeg/Mace

150 gms.

21

Asafoetida

100 gms.

22

Compounded Asafoetida

150 gms.

23

Saffron

20 gm.

24

Gur/jaggery, Icing Sugar, Honey, Synthetic

250 gms.

Syrup, Bura
25

Cane sugar/Cube sugar /Refined sugar

200 gms

/Dextrose/ misri/dried glucose syrup

26

Artificial Sweetener

100 gms

27

Fruit Juice/Fruit Drink/Fruit Squash

400 ml

28

Tomato Sauce /Ketch up /Tomato Paste, Jam/

300 gms.

Jelly/Marmalade/Tomato Puree/Vegetable
Sauce
29

Non Fruit Jellies

200 gms.

30

Pickles and Chutneys

250 gms.

31

Oilseeds/Nuts/ Dry Fruits

250 gms.

32

Tea/Roasted Coffee/RoastedChicory

200 gms.

33

Instant Tea /Instant Coffee /Instant Coffee

100 gms

Chicory Mixture.
34

Sugar Confectionery /Chewing Gum/Bubble

200 gms.

Gum
35

Chocolates

200 gms

36

Edible Salt.

200 gms

37

Iodised Salt/ Iron Fortified Salt

200 gms.

38

Food Grains and Pulses (Whole and Split)

500 gms.

39

Atta/Maida/Suji/Besan/Other Milled Product

500 gms.

/Paushtik and Fortified Atta/Maida

40

Biscuits and Rusks

200 gms.

43

GENERAL GUIDELINES ON SAMPLING 2016

41

Bread/Cakes/Pastries

250 gms.

42

Gelatin

150 gms.

43

Catechu

150 gms.

44

Vinegar/ Synthetic Vinegar

300 gms.

45

Food colour

25 gms.

46

Food colour preparation (Solid/Liquid)

25 gms
Solid/100 ml
liquid

47

Natural Mineral water/Packaged Drinking water

4000 ml in
three minimum
original sealed
packs.

48

Silver Leafs

1 gm

49

Prepared Food

500 gms.

50

Proprietary Food, (Non-Standardised Foods)

300 gms.

51

Canned Foods

6 sealed cans

52

Food not specified

300 gms.

Contents of one or more similar sealed containers having identical labels to

constitute the quantity of food sample:Where food is sold or stocked for sale or for

means

pick

multiple

distribution in sealed containershaving identical

samples if pack size is

label declaration, the contents of one or more of

small, must be of same

suchcontainers as may be required to satisfy the

batch etc.

quantity prescribed in Rule 22shall be treated to

be part of the sample.
Quantity of sample to be sent considered as sufficient:Notwithstanding anything contained in Rule 22

unless reported by the

and rule 22C, the quantity of sample sent for

lab,

analysis shall be considered as sufficientunless

understood

44

sample
to

is
be

GENERAL GUIDELINES ON SAMPLING 2016

the public analyst or the Director reports to the

enough

contrary.

Quantity of samples of food packaging material

8x1000x9

to be sent to the public analyst :-

area

sq.cm.

surface

The quantity of sample of food packaging

material to be sent to Public Analyst / Director
for analysis shall be as specified
Note: In case of if any additional tests are required, additional amount of
sample (than the one specified above) can be collected

45

Food Safety and Standards Authority of India

(Ministry of Health and Family Welfare)
FDA Bhawan, Kotla Road,
New Delhi-110002
www.fssai.gov.in