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SANS 10330:2020
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SOUTH AFRICAN NATIONAL STANDARD

Food safety management ― Requirements for


a food safety system based on prerequisite
programmes and Hazard Analysis and Critical
Control Point (HACCP) principles

WARNING
This document references other
documents normatively.

Published by the South African Bureau of Standards


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Table of changes
Change No. Date Scope

Foreword
This South African standard was prepared by National Committee SABS/TC 034/SC 17, Food
products – Hygiene practices in the food industry, in accordance with procedures of the
South African Bureau of Standards, in compliance with annex 3 of the WTO/TBT agreement.

This document was approved for publication in January 2020.

This document supersedes SANS 10330:2007 (edition 2.1).

This document is referenced in the Agricultural Product Standards Act, 1990 (Act No.119
of 1990).

Reference is made in 5.2.1(b) and in the note to 6.2.2(a) to the ″relevant national legislation". In
South Africa this means the Consumer Protection Act, 2008 (Act No. 68 of 2008).

Reference is made in 5.2.1(c), in the note to 6.2.2(b) and 10.1.2 to the ″relevant national
legislation". In South Africa this means the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act
No. 54 of 1972), the Meat Safety Act, 2000 (Act No. 40 of 2000), and the National Regulator for
Compulsory Specifications Act, 2008 (Act No. 5 of 2008).

Annexes A, B and C are for information only.

Introduction
People have the right to expect that the food they eat is safe. Food safety is related to the presence
and levels of food-borne hazards in food at the point of consumption.

Food safety for all food handling organizations (FHOs), which produce, manufacture, handle or
supply food, is paramount. Food safety should be supported by all types of organizations,
regardless of type, size and product provided within the food chain, together with organizations
interrelated to the FHO. This includes organizations directly involved (for example, but not limited to
feed producers, farmers, producers of ingredients, food producers, retailers, food services, catering
services, organizations providing cleaning, transportation, storage and distribution services) and
other organizations indirectly involved (such as suppliers of equipment, cleaning agents and
packaging material, and other food contact material) in one or more steps of the food chain.

An effective food safety system is designed, operated and updated within a framework of a
structured management system and incorporated into the overall management activities of the
organization. Full commitment and involvement of management and the work-force is required in
order to provide maximum benefit for the organization.

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Introduction (concluded)
This standard describes the principles of control needed to ensure the supply of safe food to the
consumer. The successful application of the principles described in this standard requires a solid
foundation of prerequisite programmes (PRPs). These principles are internationally recognized as
essential to ensure safe food products for the consumer, and to provide a generic base-line
structure for other specific requirements applicable to a particular food chain sector. The principles
described in this standard should be considered in all food chain sectors (from farm to fork) to
ensure food safety.

Hazard Analysis and Critical Control Point (HACCP) consists of seven principles which identify
specific food safety hazards (biological, chemical, physical or allergens) that can adversely affect
the safety of food and specific preventative measures for their control. These HACCP principles
have international acceptance, and the details of this approach have been published by the Codex
Alimentarius Commission (2009) and the National Advisory Committee on Microbiological Criteria
for Foods (NACMCF, 1992). This standard is based on the Codex Alimentarius Recommended
International Code of Practice General Principles of Food Hygiene – HACCP Annex to
CAC/RCP 1-1969 (Rev. 4 – 2009).

In accordance with CAC/RCP 1-1969, the HACCP system consists of the following seven
principles:

a) principle 1: Conduct a hazard analysis;

b) principle 2: Determine the Critical Control Points (CCPs);

c) principle 3: Establish critical limit or limits;

d) principle 4: Establish a system to monitor control of the CCP;

e) principle 5: Establish the corrective action to be taken when monitoring indicates that a particular
CCP is not under control;

f) principle 6: Establish procedures for verification to confirm that the HACCP system is working
effectively; and

g) principle 7: Establish documentation concerning all procedures and records appropriate to these
principles and their application.

Annex A indicates cross references between the CODEX HACCP principles and this standard.

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Contents
Page

Foreword

Introduction

1 Scope ................................................................................................................................... 3

2 Normative references ........................................................................................................... 3

3 Definitions ............................................................................................................................ 3

4 Documentation requirements ............................................................................................... 6


4.1 General ........................................................................................................................ 6
4.2 Control of documents ................................................................................................... 6
4.3 Control of records……………………………………………………………………………… 7

5 Management responsibility ................................................................................................... 7


5.1 General ........................................................................................................................ 7
5.2 Food safety policy ........................................................................................................ 7
5.3 Food safety representative ........................................................................................... 8
5.4 Communication ............................................................................................................ 8
5.5 Management review ..................................................................................................... 8

6 Resources ............................................................................................................................ 9
6.1 General ........................................................................................................................ 9
6.2 Prerequisite programmes (PRPs)................................................................................. 9
6.3 Training ........................................................................................................................ 10

7 Corrective action .................................................................................................................. 10

8 Food safety measurement .................................................................................................... 11


8.1 General ........................................................................................................................ 11
8.2 Internal audits............................................................................................................... 11

9 Preliminary steps .................................................................................................................. 11


9.1 Establishment of the food safety team ......................................................................... 11
9.2 Description of the final product .................................................................................... 13
9.3 Description of the product’s intended use .................................................................... 13
9.4 Construction and approval of the flow diagram ............................................................ 14
9.5 Construction and approval of the floor plan ................................................................. 14

10 Application of the HACCP principles .................................................................................... 15


10.1 Hazard identification .................................................................................................... 15
10.2 Hazard assessment ..................................................................................................... 15
10.3 Determination of control measures .............................................................................. 15
10.4 HACCP plan ................................................................................................................ 16

Annex A (informative) Cross references between the CODEX HACCP principles


and this standard ...................................................................................................... 18

Annex B (informative) Guidance for the application of HACCP principles .............................. 20

Annex C (informative) Example of a decision tree used to identify CCPs ............................... 21

Bibliography ............................................................................................................................ 22

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Food safety management ― Requirements for a food safety system


based on prerequisite programmes and Hazard Analysis and Critical
Control Point (HACCP) principles

1 Scope
This standard specifies the requirements for the development, establishment, implementation,
maintenance and continual improvement of a food safety system based on prerequisite
programmes and the principles of Hazard Analysis and Critical Control Point (HACCP).
NOTE Where reference is made to "the food safety system" this is specific to this standard.

2 Normative references
The following referenced document, in whole or in part, is indispensable for the application of this
document. For dated references, only the edition cited applies. For undated references, the latest
edition of the referenced document (including any amendments) applies. Information on currently
valid national and international standards can be obtained from the South African Bureau of
Standards.

2.1 Standards
SANS 10049, Food safety management – Requirements for prerequisite programmes (PRPs).

SANS 22000/ISO 22000, Food safety management systems – Requirements for any organization in
the food chain.

3 Definitions
For the purpose of this document, the following definitions apply.

3.1
acceptable
suitable
acceptable to the authority administering this standard, or to the parties concluding the purchase
contract, as relevant

3.2
audit
systematic, independent and documented process for obtaining objective evidence and evaluating it
objectively to determine the extent to which requirements are fulfilled

NOTE 1 Internal audits, sometimes called first-party audits, are conducted by, or on behalf of the organization
itself for management review and other internal purposes, and may form the basis for an organization’s
declaration of conformity. In many cases, particularly in smaller organizations, independence can be
demonstrated by the freedom from responsibility for the activity being audited.

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NOTE 2 External audits include those generally termed second and third-party audits. Second-party audits
are conducted by parties having an interest in the organization, such as customers, or by other persons on
their behalf. Third-party audits are conducted by external, independent auditing organizations, such as those
providing certification/registration of conformity to SANS 9001 or SANS 14001.

3.3
competent
ability to apply knowledge and skills to achieve the intended results

3.3
control measure
action that can be used to prevent or eliminate a food safety hazard or reduce it to an acceptable
level

3.5
correction
action to eliminate a detected nonconformity (see 3.18)

NOTE 1 A correction includes the handling of potentially unsafe products and can therefore be made in
conjunction with a corrective action (see 3.6).

NOTE 2 A correction may be, for example, reprocessing, further processing, and/or elimination of the adverse
consequence of the nonconformity (such as disposal for other use or specific labelling).

[SANS 22000:2019]

3.6
corrective action
action to eliminate the cause of a nonconformity (see 3.18) and to prevent recurrence

NOTE 1 There can be more than one cause for a nonconformity.

NOTE 2 Corrective action includes cause analysis.

[SANS 22000:2019]

3.7
critical control point
CCP
step at which control can be applied and is essential to prevent or eliminate a food safety hazard or
reduce it to an acceptable level

3.8
critical limit
criterion which separates acceptability from unacceptability

3.9
decision tree
sequence of questions applied to each step in the food handling process relating to an identified
food safety hazard to determine which steps are critical control points (CCPs)

3.10
documented procedure
written procedure, in any form or type of medium, of a specified way to carry out an activity or a
process

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3.11
effectiveness
extent to which planned activities are realized and planned results achieved

3.12
food handling organization
FHO
business, which during its operations, processes, manufactures, stores, transports, distributes or
sells foodstuffs or is engaged in any activity which may impact on the safety of such foodstuffs

3.13
food safety hazard
biological, chemical or physical agent in food, or condition of food, with the potential to cause an
adverse health effect

NOTE 1 The term "hazard" is not to be confused with the term "risk" which, in the context of food safety,
means a function of the probability of an adverse health effect (for example, becoming diseased) and the
severity of that effect (for example, death, hospitalization or absence from work) when exposed to a specified
hazard. Risk is defined in ISO/IEC Guide 51 as the combination of the probability of occurrence of harm and
the severity of that harm.

NOTE 2 Food safety hazards include allergens.

NOTE 3 In the context of feed and feed ingredients, relevant food safety hazards are those that might be
present in or on feed or feed ingredients (or both) and that could subsequently be transferred to food through
animal consumption of feed and thus have the potential to cause an adverse human health effect. In the
context of operations other than those directly handling feed and food (for example, producers of packaging
materials or cleaning agents), relevant food safety hazards are those hazards that can be directly or indirectly
transferred to food because of the intended use of the provided products or services (or both) and thus have
the potential to cause an adverse human health effect.

3.14
HACCP plan
document prepared in accordance with the principles of HACCP to ensure control of hazards which
are significant for food safety in the segment of the food chain under consideration

3.15
hazard analysis
process of collecting and evaluating information on hazards and conditions leading to their
presence to decide which are significant for food safety and therefore shall be addressed in the
HACCP plan

3.16
Hazard Analysis and Critical Control Point
HACCP
system that identifies, evaluates, and controls hazards that are significant to food safety

3.17
monitor
act of conducting a planned sequence of observations or measurements to assess whether a CCP
is under control

3.18
nonconformity
non-fulfilment of a specified requirement

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3.19
prerequisite programme(s)
PRP(s)
basic conditions and activities that are necessary to maintain a hygienic environment throughout the
food chain suitable for the production, handling and provision of safe end food products and safe
food for human consumption

NOTE The prerequisite programmes needed depend on the segment of the food chain in which the
organization operates and the type of organization. Examples of equivalent terms are: Good Agricultural
Practice (GAP), Good Hygiene Practice (GHP), Good Laboratory Practice (GLP), Good Manufacturing Practice
(GMP), Good Distribution Practice (GDP), Good Veterinarian Practice (GVP), Good Production Practice (GPP),
and Good Trading Practice (GTP).

3.20
record
document that provides objective evidence of actions undertaken or results achieved

3.21
validation
obtaining evidence that the control measure managed by the HACCP plan are capable of being
effective

3.22
verification
confirmation, through the provisions of objective evidence, that specified requirements have been
fulfilled

4 Documentation requirements
4.1 General
The organization shall establish and maintain documentation that includes

a) a food safety policy,

b) the scope of the food safety system,

c) additional documentation or reference there to, to indicate conformity with the requirements of
this standard, and

d) documents needed by the organization to ensure the effective development, implementation and
maintenance of the food safety system.

4.2 Control of documents


The food safety team shall ensure the establishment of a documented procedure for the control of
documents. The document control procedure shall address at least the following:

a) approval of documents for adequacy before being issued;

b) review and update of documents as necessary and re-approval of these documents;

c) changes to documents and their current revision status shall be identified;

d) ensuring that the current versions of applicable documents are available at points of use;

e) ensuring that documents are legible and readily identifiable;

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f) ensuring that documents of external origin are identified and their distribution controlled; and

g) prevention of the unintended use of obsolete documents and application of suitable identification
to them if retained for any purpose.

4.3 Control of records

4.3.1 The food safety team shall ensure the establishment of a documented procedure for the
control of records. Records shall be established and maintained to provide evidence of conformity
to requirements and of the effective operation of the food safety system. Records shall be

a) clearly identified for traceability and easy access,

b) suitably stored to prevent deterioration and easy access,

c) protected to prevent damage,

d) easily retrievable,

e) kept for a retention period of a minimum of 1 year, or in accordance with other requirements,
including customer requirements, and

f) suitably disposed of.

4.3.2 Records of all processes required to ensure the safety of food shall be verified at suitable
pre-determined intervals by a suitably qualified and experienced person, who shall sign the records
to show that the verification has taken place, and to demonstrate that the process has been carried
out under the required conditions.

5 Management responsibility
5.1 General
Top management shall provide evidence of its commitment to the development, implementation,
maintenance and continual improvement of the food safety system by

a) establishing a food safety policy,

b) appointing a food safety representative, who will take the responsibility of leading the food safety
team,

c) providing resources,

d) communicating, and

e) conducting management review.

5.2 Food safety policy

5.2.1 The food safety policy shall include commitment to

a) application of PRPs and the principles of HACCP,

b) complying with the relevant national legislation (see foreword) and with mutually agreed
requirements of customers,

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c) complying with the relevant national legislation (see foreword) and with mutually agreed
requirements of customers,

d) the development, implementation, maintenance and continual improvement of this food safety
system, and

e) the food safety requirements of the products or activities (or both) of the FHO.

5.2.2 The food safety policy shall be reviewed for its continued suitability and shall be supported by
measureable food safety objectives.

5.3 Food safety representative

5.3.1 A member of the management of the FHO shall be appointed as a food safety representative
who, irrespective of other responsibilities and duties, shall have the responsibility and authority to

a) appoint the food safety team,

b) manage and coordinate the food safety team's work,

c) ensure that the food safety system is established, implemented, maintained and continually
improved in accordance with the requirements of this standard, and

d) report on the performance of the food safety system to management and any need for improving
the system.

5.3.2 The food safety representative shall be adequately trained in the requirements as set out in
this standard.

5.4 Communication
Top management shall develop, implement and maintain effective arrangements for communicating
with all personnel on issues impacting on food safety. As a minimum, the following shall be
included:

a) the food safety policy;

b) outcomes of the application of the HACCP principles, for example, updates, changes, or new
procedures, processes, roles and responsibilities; and

c) customer food safety requirements.

5.5 Management review


5.5.1 Top management shall, with the aim of continual improvement, review the food safety
system at least annually, or as frequently as is deemed necessary, to ensure its continued
suitability, adequacy and effectiveness. This review shall include assessing opportunities for
improvement and the need for change to the food safety system, including the food safety policy.

5.5.2 Records of management review shall be maintained. These records shall include discussion
points, reviewed reports and data, action items and due dates.

5.5.3 Review inputs include:


a) matters arising from previous management review;

b) a review of results of the verification activities (see 8.1);

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c) results of corrective actions ( see 7.3);

d) a review of the effectiveness of PRP's (see clause 6);

e) a review of changes to the food safety system and its impact on food safety;

f) food safety incidents, emergencies, withdrawals or recalls (or both); and

g) a review of the impact of other management system(s) activities on food safety.

5.5.4 Review outputs include:


a) a statement on the suitability, adequacy and effectiveness of the food safety system or
recommendations for improvement (or both);

b) resource needs; and

c) revised food safety policy and related objectives, where required, or recommendations for
revision (or both).

6 Resources
6.1 General
6.1.1 Top management shall commit in writing to provide the necessary resources.

6.1.2 The resources shall include time, competent personnel, suitable and adequate infrastructure,
work environment, equipment and funding in order to develop, implement, maintain and continually
improve the food safety system.

6.1.3 Prior to the application of the HACCP principles, the food safety representative shall assess
which resources are needed for the development, implementation, maintenance and continual
improvement of the food safety system.

NOTE Annex A indicates cross references between the CODEX HACCP principles and this standard.

6.2 Prerequisite programmes (PRPs)


6.2.1 The production of safe food requires the food safety system to be built on a solid foundation
of PRPs.

6.2.2 In establishing PRPs, the requirements set out in SANS 10049 or an equivalent
internationally recognized standard, shall be used as a minimum.

NOTE When establishing PRP(s), the organization should also consider the following (other relevant
information):

a) relevant national legislation (see foreword);

b) relevant national legislation (see foreword);

c) customer requirements;

d) recognized guidelines,

e) Codex Alimentarius Commission (Codex) principles and codes of practices, and

f) relevant national and international standards or guidelines.

6.2.3 The FHO shall, prior to the application of the HACCP principles, have in place pre-requisite
programs which shall be well established, be fully operational and be verified.

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6.3 Training
6.3.1 Training needs shall be identified and training provided for all personnel involved in the
development, implementation, maintenance and continual improvement of the food safety system.

6.3.2 Effectiveness of training provided shall be evaluated and competency demonstrated.

6.3.3 Refresher training shall be provided at least annually.

6.3.4 Records of training and evaluation of competence shall be kept.

7 Corrective action
7.1 The organization shall ensure the development of a documented procedure for corrective
action.

7.2 The procedure shall define the requirements for the following:
a) immediate correction when required;

b) review of the non-conformity (materials, products, procedures, customer or consumer


complaints, etc.);

c) determination of the cause of the non-conformity;

d) evaluation of the need for action to ensure that the non-conformity does not recur;

e) determination and implementation of the action needed;

f) recording results of the action taken (correction and corrective action); and

g) reviewing the effectiveness of the corrective action taken.

7.3 The corrective action activities shall, as a minimum, address the following:
a) customer and consumer complaints;

b) internal and external audits;

c) non-conformances or non-conformities;

d) verification results indicating non-compliance;

e) failure of CCPs;

f) failure of PRPs; and

g) food safety incidents, emergencies, withdrawals or recalls (or both).

7.4 Corrections may need to be applied before corrective action is formally required, so as to
maintain the process or handling activities, (or both). Corrections shall be reviewed to determine
their effectiveness, and shall form part of the corrective action records. Details for the handling of
customer or consumer complaints shall be specified in a documented procedure.

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8 Food safety measurement


8.1 General

8.1.1 The food safety team shall establish a system for the verification of the food safety system,
including the PRPs.

8.1.2 Verification methods and documented procedures shall be established to confirm that

a) PRPs are implemented and are effective,

b) the information to apply the HACCP principles are effective, and

c) the steps controlling significant food safety hazards are implemented, and are effective.

8.1.3 Records of verifications shall be kept.

8.2 Internal audits

8.2.1 Documented procedures for planning and carrying out internal audits shall be established
describing the methodology, frequency, responsibility and management of the audit programme.
These audits shall determine whether the food safety system adequately meets food safety
requirements and the requirements established by the FHO.

8.2.2 Internal audits shall be conducted in accordance with the audit programme and shall be
carried out by personnel who are independent of the activity being audited. The selection of auditors
and the conduct of audits shall be such that objectivity and impartiality are ensured during the audit
process.

8.2.3 The results of the audits shall be recorded and discussed with the personnel responsible for
the activity being audited. Records of internal audits shall be maintained and shall be brought to the
attention of personnel that are responsible for corrective action.

NOTE SANS 19011 gives details on requirements for internal audits.

9 Preliminary steps
9.1 Establishment of the food safety team

9.1.1 General

Management shall ensure the establishment of documented criteria for the selection of team
members to assist with the establishment, implementation, maintenance and continual improvement
of the food safety system. Every team member shall accept, in writing, his or her assignment and
commitment to the food safety team.

9.1.2 The food safety team


9.1.2.1 The team shall be multidisciplinary and members shall be drawn from each part of the
organization likely to be affected, for example from production, purchasing, finance, technical,
engineering, quality and distribution.

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9.1.2.2 The food safety team shall consist of personnel with specific knowledge of and expertise
with regard to, HACCP principles, the product, the food handling process and food safety hazard
categories of the organization.

NOTE Where appropriate, team members with knowledge in the following areas should be considered for
inclusion in the team:

1) food science;

2) microbiology;

3) quality control;

4) engineering;

5) chemistry;

6) risk assessment;

7) production;

8) marketing or sales;

9) distribution (dispatch and transport);

10) food service management;

11) purchasing; and

12) human resources.

9.1.2.3 The food safety team shall establish a documented procedure defining the team’s activities
in establishing the food safety system.

9.1.2.4 The procedure shall as a minimum include the following:

a) the rules and guidelines for team meetings;

b) establishment and management of the PRPs;

c) methodology of the application of HACCP;

d) the methodology for reporting on the status of the food safety system; and

e) the methodology for the establishment of procedural requirements or integration with other
relevant management system procedures.

9.1.2.5 Where the necessary skills or knowledge are not available within the FHO, the services of
an external expert may be used. An agreement or contract defining the role, responsibility and
authority of the expert shall be in place.

9.1.2.6 The food safety team shall establish a documented procedure for the review of the HACCP
plan. This procedure shall include events that will automatically trigger a HACCP plan review
(internal and external factors shall be considered) or at least as a minimum, be conducted annually.
The HACCP plan shall be updated after such a review. The review may lead to a reduction in or the
addition of CCPs, or the inclusion of additional critical limits in order to improve the HACCP plan.

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9.1.2.7 The following potential events can influence food safety and shall automatically trigger a
HACCP plan review:

a) any report from the marketplace that indicates a health or spoilage risk associated with the
product (customer and consumer complaints);

b) an anticipated change in customer and consumer use;

c) a change in raw materials or product formulation;

d) a change in the food handling process activities;

e) a change in the FHO layout and environment;

f) any modification to food handling equipment;

g) a change in the cleaning and disinfection programme;

h) a change in the packaging, storage and distribution system;

i) changes to staff levels and responsibilities relevant to the HACCP plan;

j) changes in legislation;

k) results of validation and verification activities; and

l) any changes pertaining to PRPs.

9.1.2.8 Records of HACCP plan reviews shall be kept, and the results shall be discussed at
management review.

9.2 Description of the final product


A complete final product description, including the following food safety information, shall be given:

a) composition (for example, list of raw materials, ingredients, additives, allergens etc.);

b) physical and chemical properties (for example, water activity, pH etc.);

c) microcidal or static treatments (for example, cooking, freezing, salting, smoking etc.);

d) packaging and related systems (for example, vacuum, hermetic, modified atmosphere etc.);

e) storage conditions (for example, room temperature, chilled, frozen etc.);

f) shelf life under prescribed storage and usage conditions; and

g) distribution conditions (for example temperature controlled, etc.).

9.3 Description of the product's intended use


The intended use and possible abuse of the product by consumers, consumer groups or customers
shall be described. Attention shall be focused on the likely uses and abuses of the product after it
has left the control of the FHO. Factors such as the vulnerability of the consumer and instructions
for use shall be taken into account.

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9.4 Construction and approval of the flow diagram


9.4.1 The food safety team shall prepare a detailed process flow diagram for each of the specified
food products or process categories relevant to the defined scope of the food safety system.
Process flow diagrams shall provide a basis for evaluating the possible occurrence, increase or
introduction of food safety hazards.

9.4.2 The following, as a minimum, shall be included in the process flow diagram(s):
a) the sequence and interaction of all process steps;

b) where raw materials, ingredients, including water, and packaging materials enter the flow;

c) any outsourced processes;

d) where rework takes place; and

e) where final products, intermediate products, by-products and waste are released or removed.

9.4.3 The food safety team shall confirm the accuracy of the flow diagram/s on site during all
stages and hours of operation, so as to ensure that the flow diagram(s) and technical data as
described in 9.4.1 gives an accurate representation of the operation. The flow diagram(s) shall be
amended to take into account any deviations. The confirmed flow diagram(s) shall be signed off by
the food safety team.

9.4.4 Records shall be kept.

9.5 Construction and approval of the floor plan


9.5.1 The food safety team shall prepare a detailed floor plan indicating all process areas relevant
to the defined scope of the food safety system. Floor plans shall provide a basis for evaluating the
possible occurrence, increase or introduction of food safety hazards resulting from cross flows.

9.5.2 The following, as a minimum, shall be included when preparing the floor plan:
a) layout of equipment;

b) flow of effluent and drainage,

c) product flow indicating where raw materials, ingredients, including water, and packaging
materials enter the process;

d) flow of personnel;

e) flow of product rework;

h) flow or high care or high risk area segregation;

i) storage areas; and

j) receiving and distribution areas.

9.5.3 The food safety team shall confirm the accuracy of the floor plan on site during all stages and
hours of operation, so as to ensure that the floor plan and technical data as described in 9.5.1 gives
an accurate representation of the operation. The floor plan shall be amended to take into account
any deviations. The confirmed floor plan shall be signed off by the food safety team. Records shall
be kept.

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10 Application of the HACCP principles


10.1 Hazard identification

10.1.1 When identifying the food safety hazards, that are reasonably expected to occur, the food
safety team shall give consideration to the following:

a) raw material;

b) food contact packaging material;

c) final product and its intended use;

d) process flow diagram and processing requirements;

e) floor plan;

f) equipment in contact with the food;

g) contact by food handlers; and

h) outsourced processes.

10.1.2 Food safety hazards shall be considered in the light of their acceptable levels in the final
product. This shall be in accordance with relevant national legislation (see foreword) and other
relevant requirements.

10.1.3 The identification of food safety hazards shall be recorded.

10.2 Hazard assessment

10.2.1 The food safety team shall determine the significance of each identified food safety hazard,
and shall consider the likelihood of its occurrence and its severity of the adverse health effects.

10.2.2 When conducting the assessment, the food safety team shall also take into account:

a) operational historical data;

b) data on food-borne diseases;

c) effectiveness of food handling processes to meet acceptable levels in the final product; and

d) the qualitative or quantitative evaluation (or both) of the presence of hazards.

10.2.3 The methodology, the decision making criteria used and the results of the hazard
assessment shall be recorded.

10.3 Determination of control measures


10.3.1 The food safety team shall select a control measure or combination of control measures (or
both) that can be applied for each identified food safety hazard.

10.3.2 The control measure or combination of control measures (or both) for significant food safety
hazards shall be further assessed to determine the level of their control. The level of control shall be
determined by either identifying the step as a critical control point or that the control measure or

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combination of control measures (or both) applied are capable of preventing, eliminating or reducing
these food safety hazards to defined acceptable levels.

10.3.3 The methodology, the decision making criteria used and the results for the selection of
control measures or their combinations (or both) shall be recorded.

NOTE For guidance, see annex B.

10.4 HACCP plan


10.4.1 Determination of whether a production step is a CCP

10.4.1.1 The food safety team shall assess the step controlling the significant food safety hazards
to determine whether this step is a CCP.

10.4.1.2 The methodology, the decision making criteria used and the results for the determination
of the CCP shall be recorded.

10.4.1.3 Significant food safety hazards which are not identified as CCPs shall also be controlled
by appropriate control measures.

NOTE The decision tree in annex C can be used as a guideline.

10.4.2 Establishment of critical limits for each CCP


10.4.2.1 The food safety team shall establish specific and measurable critical limits appropriate for
each CCP. Critical limits that can be measured quickly and easily shall be used. Measurements can
include sensory examination, mass measurements, temperature measurements, time, moisture
level, pH value and chemical analyses.

10.4.2.2 Records of the determination of critical limits shall be kept.

10.4.3 Establishment of a monitoring system for each CCP


10.4.3.1 The food safety team shall establish a monitoring system to ensure that control of the CCP
is effective.

10.4.3.2 The control measures established as part of the monitoring system shall be such that they
can confirm that all CCPs are under control.

10.4.3.3 The following shall be addressed in establishing the monitoring system:

a) Responsible person or equipment. Responsibilities and authorities for the monitoring of a


specific CCP shall be identified. This person or equipment shall have the knowledge or capability
to ensure effective monitoring of the CCP. A person shall be given the responsibility and
authority to take the necessary corrective action when the specified critical limit of the CCP is
exceeded. A responsible person other than the person doing the monitoring shall verify records
associated with the monitoring of a CCP. Equipment used for the monitoring of a CCP shall be
calibrated.

b) Frequency of monitoring. The frequency of monitoring shall be specified. The frequency shall
be adequate to ensure the control of the CCP.

c) Monitoring methodology. A detailed description shall be given to indicate precisely how the
monitoring shall be done.

10.4.3.4 Records shall be kept to prove effectiveness of the monitoring system.

NOTE Microbiological testing is seldom effective for the routine monitoring of CCPs, because it can be time
consuming and that there are problems related to the detection of contaminants.

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10.4.4 Establishment of corrective action plans


10.4.4.1 The food safety team shall establish corrective action plans for each CCP when
monitoring of the critical limits indicates deviation from the limits. The responsibility for and manner
of handling the potentially unsafe product shall be clearly identified.

10.4.4.2 Records shall be kept of all corrective actions.

10.4.5 Validation
10.4.5.1 Validation activities shall include actions to confirm that the established critical limit(s) for
each CCP will be effective and capable of achieving the intended control of the identified food
safety hazard(s).

10.4.5.2 If validation results show that one or more of the above elements cannot be confirmed, the
relevant elements shall be modified and reassessed.

10.4.5.3 When any elements of a CCP is modified, validation shall be carried out.

10.4.5.4 Records shall be kept of validations.

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Annex A
(informative)

Cross references between CODEX HACCP principles and this standard


Table A.1 — Cross references between CODEX HACCP application steps and the application
steps of this standard

1 2 3
CODEX HACCP
CODEX HACCP application steps Relevant clause/subclause
Principles
Assemble the HACCP team (Step 1) Establishment of the food safety team (see 9.1)
Describe product (Step 2) Description of the final product (see 9.2)
Identify intended use (Step 3) Description of the product’s intended use (see
9.3)
Construct flow diagram (Step 4)
On-site confirmation of flow diagram Construction and approval of the flow diagram
(Step 5) (see 9.4)

Principle 1 List all potential hazards associated with


each step, conduct a hazard analysis, and Hazard identification (see 10.1)
Conduct a hazard consider any measures to control
analysis identified hazards (Step 6)
Hazard assessment (see 10.2)

Determination of control measures


(see 10.3)
Principle 2 Determine CCPs (Step 7) Determination of whether a production step is a
CCP (see 10.4.1)
Determine the critical
control points (CCPs)
Principle 3 Establish critical limits for each CCP (Step Establishment of critical limits for each CCP
8) (see 10.4.2)
Establish critical limit(s)
Principle 4 Establish a monitoring system for each Establishment of a monitoring system for each
CCP CCP (see 10.4.3)
Establish a system to (Step 9)
monitor control of the
CCP
Principle 5 Establish corrective actions (Step 10) Establishment of corrective action plans (see
10.4.4)
Establish the corrective
action to be taken when
monitoring indicates that
a particular CCP is not
under control

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Table A.1 (concluded)

1 2 3
CODEX HACCP CODEX HACCP application steps Relevant clause/subclause
Principles
Principle 6 Establish verification procedures (Step 11)
Food safety measurement (clause 8)
Establish procedures for
verification to confirm
that the HACCP system Validation (see 10.4.5)
is working effectively
Principle 7 Establish documentation and record Documentation requirements
keeping (Step 12) (see clause 4)
Establish documentation
concerning all
procedures and records
appropriate to these
principles and their
application

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Annex B
(informative)

Guidance for the application of HACCP principles

B.1 Table B.1 can be applied to document hazard identification, hazard assessment and the
determination of the level of control.

Table B.1 — Documentation of hazard identification, hazard assessment and the


determination of the level of control (see 10.1 to 10.3)

1 2 3 4 5 6 7
Acceptable
Hazard
level of the Is the hazard Level of
Food safety assessment Control
Identify from food safety significant? control
hazard (likelihood/ measure(s)
hazard in the (Yes/No)a
severity)
final product

a If yes, move to columns 2 of table B.2.

B.2 Table B.2 can be applied to document the HACCP plan.

Table B.2 — Documentation of the HACCP plan (see 10.4.1 to 10.4.4)

1 2 3 4 5
Food safety
Critical control Monitoring Corrective
hazard to be Critical limit
point (who/when/what/how) action
controlled

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Annex C
(informative)

Example of a decision tree used to identify CCPs


Figure C.1 is an example of a decision tree used to identify CCPs.

Questions (Q) should be answered in sequence.

a Proceed to the next identified hazard in the described process.


b Acceptable and unacceptable levels need to be determined within the overall objectives in identifying the
CCPs of the HACCP plan.

Figure C.1 — Example of a decision tree used to identify CCPs

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Bibliography
Standards
ISO/IEC Guide 51, Safety aspects – Guidelines for their inclusion in standards.

ISO 21469, Safety of machinery – Lubricants with incidental product contact – Hygiene
requirements.

SANS 241-1, Drinking water – Part 1: Microbiological, physical, aesthetic and chemical
determinands.

SANS 1827, The safety of water treatment chemicals for use in the food industry.

SANS 1828, Cleaning chemicals for use in the food industry.

SANS 1853, Disinfectants and detergent-disinfectants and antiseptics for use in the food industry.

SANS 9001/ISO 9001, Quality management systems – Requirements.

SANS 9004/ISO 9004, Managing for the sustained success of an organization – A quality
management approach.

SANS 10133, The application of pesticides in food-handling, food-processing, and catering


establishments.

SANS 19011/ISO 19011, Guidelines for auditing management systems.

SANS 14001/ISO 14001, Environmental management systems – Requirements with guidance for
use.

SATS 22002-1/ISO/TS 22002-1, Prerequisite programmes on food safety – Part 1: Food


manufacturing.

SATS 22002-2/ISO/TS 22002-2, Prerequisite programmes on food safety – Part 2: Catering.

SATS 22002-4/ISO/TS 22002-4, Prerequisite programmes on food safety – Part 4: Food packaging
manufacturing.

Other publications
CAC/RCP 1, Codex Alimentarius Commission, Recommended international code of practice –
General principles of food hygiene.

Codex Alimentarius Commission, Guidelines for the management and health surveillance of food
handlers. National Department of Health, Directorate: Food Control.

Codex Alimentarius Commission, Policy guidelines: National food safety alerts and official food
product recalls in South Africa. National Department of Health, Directorate: Food Control.

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