Professional Documents
Culture Documents
STANDARD
ICS: 67.020
Descriptors: definition, corrective actions, critical control points, critical limit, document control,
verification, HACCP study and planning, operation of HACCP
© Copyright 2007
http://www.standardsmalaysia.gov.my http://www.sirim.my
E-mail: central@standardsmalaysia.gov.my
MS 1480:2007
CONTENTS
Page
Committee representation…………………………………………………………………… ii
Foreword………………………………………………………………………………………. iii
0 Introduction……………………………………………………………………………………. 1
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1 Scope………………………………………………………………………………………….. 1
2 Normative reference…………………………………………………………………………. 1
3 Definitions……………………………………………………………………………………… 1
4 Pre-requisite programmes…………………………………………………………………… 5
6 Other requirements…………………………………………………………………………… 12
Figures
Bibliography………………………………………………………………………………………… 25
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MS 1480:2007
Committee representation
The Food and Food Products Industry Standards Committee (ISC U) under whose authority this Malaysian Standard
was developed, comprises representatives from the following organisations:
Department of Agriculture
Department of Chemistry
Department of Standards Malaysia
Federal Agricultural Marketing Authority
Federation of Malaysian Manufacturers
Malaysian Agricultural Research and Development Institute
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The Technical Committee on Food Safety System which developed this Malaysian Standard consists of
representatives from the following organisations:
Department of Agriculture
Department of Fishery
Department of Veterinary Services
Federal Agricultural Marketing Authority
Federation of Malaysian Manufacturers
Malaysian Agricultural Research and Development Institute
Malaysian Association of Standards Users
Malaysian Institute of Food Technology
Malaysian Palm Oil Association
Malaysian Palm Oil Board
Ministry of Health Malaysia
SIRIM Berhad (Secretariat)
SIRIM QAS International Sdn Bhd
Universiti Kebangsaan Malaysia
Universiti Putra Malaysia
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MS 1480:2007
FOREWORD
This Malaysian Standard was developed by the Technical Committee on Food Safety System
under the authority of the Food and Food Products Industry Standards Committee.
This Malaysian Standard is the first revision of MS 1480, Food safety system according to
hazard analysis and critical control point (HACCP) system.
Compliance with a Malaysian Standard does not of itself confer immunity from legal
obligations.
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MS 1480:2007
0. Introduction
0.1 There are several considerations which should be discussed before proceeding to
sectors where significant, scientifically proven, public health risks are associated with a
particular food product or processing method. While Hazard Analysis and Critical Control
Point (HACCP) system should be voluntarily adopted throughout the food industry, HACCP
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need not be mandated for all products or industry sectors. Risk, along with the safety history
of a particular food, shall be used as the primary means of determining which food industry
segments should be required to develop and implement HACCP Plans. The need for HACCP
should be decided by expert panels who would consider whether food safety hazards of
public health significance are associated with a particular food industry segment. The risk
assessment exercise should be a cooperative effort between both the public and private
sectors and not the sole province of government bodies.
0.2 HACCP is not a stand alone system. It depends on management commitment and a
solid foundation of prerequisite programs such as GMP, GHP, and other relevant Codes of
Practice. HACCP is not intended to replace these programmes, nor to diminish their
significance. For HACCP to be effective, these prerequisite programmes shall be in place.
Before considering a safety management system such a HACCP, it is advisable to determine
if a particular industry segment is ready to build upon existing programmes, or whether
attention shall first be focused on basic hygienic practices.
1. Scope
This Malaysian Standard describes the requirements for food safety according to HACCP
system to ensure the safety of foodstuffs during preparation, processing, manufacturing,
packaging, storage, transportation, distribution, handling or offering for sale or supply in any
sector of the food chain.
2. Normative reference
The following normative reference is indispensable for the application of this standard. For
dated reference, only the edition cited applies. For undated reference, the latest edition of the
normative reference (including any amendments) applies.
3. Definitions
For the purpose of this Malaysian Standard, the following definitions shall apply.
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3.1 Control
3.1.1 Control as a noun, means the state wherein correct procedures are being followed
and criteria are being met.
3.1.2 Control as a verb, means to take all necessary actions to ensure and maintain
compliance with criteria established in the HACCP Plan.
Any action and/or activity that can be used to prevent or eliminate a food safety hazard or
reduce it to an acceptable level.
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Any action to be taken when the results of monitoring at the CCP deviate from the critical
limits. Corrective action includes cause analysis and is taken to prevent recurrence.
A point, operational step or stage in the food chain at which control can be applied and is
essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.
A sequence of questions which can be applied to each process step to identify at which
process step the significant hazards shall be controlled as a CCP.
3.7 Deviation
Assurance of the food against chemical, biological or physical conditions which may expose
the user or consumer to a health hazard.
Specific realistic targets that can be measured and achieved within specified time frame by
the establishment to support the food safety policy.
Overall intentions and direction of an organisation related to food safety as formally expresses
by top management.
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HACCP audit is a systematic examination process to determine whether the activities of the
HACCP system and the related results comply with planned arrangements and whether these
arrangements are implemented effectively and are suitable to achieve food safety objectives.
A system which identifies, evaluates, and controls hazards which are significant for food
safety. The system consists of seven principles:
3.13.1 Principle 1
Conduct hazard analysis (see 3.14) to identify the potential hazard(s) associated with food
production at all stages, from primary production, processing, manufacture and distribution,
until the point of consumption. Assess the likelihood of occurrence and severity of the
hazard(s) and identify control measures.
3.13.2 Principle 2
3.13.3 Principle 3
Establish critical limit(s) which shall be met to ensure the CCP is under control.
3.13.4 Principle 4
Establish a system to monitor control of the CCP by scheduled testing, measurement and/or
observations.
3.13.5 Principle 5
Establish the corrective actions to be taken when monitoring indicates that a particular CCP is
not under control.
3.13.6 Principle 6
Establish procedures for verification which include supplementary tests and procedures to
confirm that the HACCP system is working effectively.
3.13.7 Principle 7
Establish documentation for all procedures and records appropriate to these principles and
their application.
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3.14 Hazard
A biological, chemical or physical agent in, or condition of, food with the potential to cause an
adverse health effect.
The process of collecting and evaluating information on hazards and conditions leading to
their presence to decide which are significant for food safety and therefore should be
addressed in the HACCP Plan.
3.16 Nonconformity
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The absence of, or the failure to implement and maintain, one or more required system
elements, or situation which would, on the basis of available objective evidence or evaluation,
raise doubt as to the safety of food.
3.17 Establishment
Any premises comprising groups of people and facilities that are involved in the food
preparation, processing, manufacturing, packaging, storage, transportation, distribution,
handling or offering for sale or supply in any sector of the food chain.
Universal steps or procedures that control the operational conditions within an organisation
allowing for environmental conditions that are favourable to the production of safe food (see
0.1).
Materials forming part of a product, e.g. primary produce, additives, processing aids as well
as packaging and similar materials that could result in an unacceptable food safety risk to
consumers and need to be controlled.
Hazards that could result in an unacceptable food safety risk to consumers and need to be
controlled.
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3.23 Step
A point, operation or stage in the food chain, raw materials receipt and/or production,
harvesting, transport, formulation, processing, storage to final consumption.
3.24 Validation
Obtaining evidence that the elements of the HACCP plan are effective.
3.25 Verification
The application of methods, procedures, tests and other evaluations, in addition to monitoring,
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4. Pre-requisite programmes
Pre-requisite programmes (PRP) are required to be established and implemented before the
HACCP system can be established. These programmes should conform to the MS 1514
and/or other relevant documents related to individual field or products , for example Codes of
Practice (COP) such as COP for frozen, cooked, peeled prawns, COP for processing and
refining palm olein and palm stearin and any other national and Codex COP. The basic
recommended PRPs are in Annex A.
The organisation’s management with executive responsibility shall define and document its
policy and commitment with regard to identification, evaluation and control of hazards related
to food safety.
a) define the scope of the HACCP system. The scope shall specify the products/product
categories and production sites and all activities which are covered by the system from
the beginning to the end;
b) ensure that its policy and objectives are relevant to and in compliance with the business
goals of the organisation and the food safety requirements of customers, authorities and
the organisation itself; and
c) ensure that the policy with regard to food safety objective is understood, implemented
and maintained at all levels of the organisation.
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5.1.2 Organisation
The organisation shall appoint a HACCP team whose tasks, responsibilities and authority
shall be defined, documented and communicated to ensure the effective operation of the
HACCP system.
The organisation shall also ensure that the HACCP coordinator and/or a member of the
HACCP team are formally trained in HACCP principles and its application.
The organisation’s management shall also provide adequate resources and training for the
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Where resources do not permit, assistance of the external experts shall be acquired for the
operation of or the input in establishing the HACCP system. An agreement shall be made to
document the responsibility and authority of such experts with regard to the HACCP system.
The appointed staff shall have clearly defined responsibility and authority including to:
a) identify and record any problems with regard to products, processes and the HACCP
system;
b) initiate corrective actions and control of nonconforming products until the deviation or
the unsatisfactory condition regarding food safety has been corrected; and
c) initiate action to prevent the occurrence and recurrence of any non conformances
relating to the product, processes and the HACCP system.
The organisation management shall appoint a HACCP Coordinator/team leader who shall
have the responsibility and authority to;
b) report on the effectiveness and suitability of the HACCP system to the organisation’s
management for review and as a basis for improvement of the HACCP system; and
A multi-disciplinary HACCP team shall be set up to develop, maintain and review the HACCP
system. The HACCP team shall have knowledge and experience with regard to the
organisation’s products, processes and hazards within the scope and field of application.
Documentation to this effect shall be maintained.
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a) determine the necessary competence for personnel performing work affecting food
safety;
c) ensure that its personnel are aware of the relevance and importance of their activities
and how they contribute to the safety of the final product(s);
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5.2.1 General
The organisation shall establish, document and maintain a HACCP system to ensure that all
known potential hazards within the field of application of the HACCP system are identified and
that all significant hazards are controlled in such a manner that the products of the
organisation do not harm the user/consumer.
The organisation shall establish and maintain documentation to the effect that the HACCP
system is established in compliance with the requirements as laid down in this Malaysian
Standard.
Where the organisation incorporates the HACCP system into an existing management
system, their relationship shall be described.
The organisation shall establish documented procedures and a HACCP plan to ensure
consistency and compliance with the requirements of this Malaysian Standard and the
organisation’s stated food safety policy and food safety objectives. The organisation shall
ensure that the documented procedures take into account current issues and developments
relating to food safety, including regulatory requirements.
5.2.3 Validation
The objective of validation is to ensure that the significant hazards identified are complete and
correct and that they will be effectively controlled under the proposed HACCP plan.
Validation shall be carried out on the following, but not limited to:
b) When there are changes to the operation (e.g. processes, raw materials, ingredients,
packaging, equipment, etc.) that could adversely affect food safety;
c) Control measures;
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e) Corrective actions.
The organisation shall draw up a HACCP Plan according to the 7 principles of the HACCP
system.
All potential hazards likely to occur within the scope of the HACCP system shall be identified,
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recorded and evaluated according to their severity and likelihood of occurrence. The
evaluation shall be documented. On the basis of the evaluation, the significant hazards which
require control are identified with regard to the stated food safety policy.
Examples of the Hazard Analysis Worksheet formats are given in Figure 1a and 1b.
Control measures shall be established for each identified hazard. The control measures shall
prevent or eliminate the hazard or reduce it to an acceptable level. The control measures
shall be managed either under PRP(s) or the HACCP Plan.
If no suitable method is available for preventing or eliminating the hazard, or for reducing it to
an acceptable level, the process or product shall be modified.
CCPs shall be identified for each significant hazard. There may be more than one CCP at
which control is applied to address the same hazard, or one CCP can address more than one
hazard. All significant hazards shall be controlled by the control measures established at one
or more CCPs.
The determination of a CCP can be facilitated by the application of a decision tree (See
Figures 2a and 2b), which indicates a logic reasoning approach. It should be used as
guidance when determining CCPs. Other approaches may be used. Documentation shall be
available to show the determination of the CCPs.
Critical limits shall be specified for each CCP based on the selected monitoring parameters
(See 5.2.3.5).
Critical limits shall be validated to ensure the hazard is prevented, eliminated or reduced to an
acceptable level.
Critical limits shall be measurable. However if the critical limit is based on subjective data
such as visual inspection of product, process, handling, etc, it shall be supported by
instructions, specifications or validation and/or training.
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A monitoring system shall be established for each CCP relative to its critical limits. The
monitoring system shall consist of a sequence of planned measurements or observations to
detect loss of control at the CCP.
The monitoring system with the necessary monitoring instructions shall comprise the
following:
b) Monitoring method;
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Where relevant, the location of the monitoring should be recorded. The monitoring methods
and frequency shall be capable of identifying any nonconformity in time for the product to be
controlled and isolated before it is used or consumed.
Monitoring results shall be recorded (see 7.1). Where possible, process adjustments should
be made when monitoring results indicate trend towards nonconformity. The adjustments
should be taken before a deviation occurs.
For each CCP, specific, documented corrective actions shall be established to be applied
when the monitoring result shows that a critical control point deviates from the critical limits.
Corrective actions shall ensure that the CCP is brought back into control, and that products
manufactured while the CCP was out of control are handled according to the procedures
established for controlling nonconforming products.
The organisation shall establish and maintain documented procedures for verification. The
procedures shall include verification of the monitoring results at each CCP as well as planning
and performing periodical verifications to determine whether the HACCP system is
implemented in accordance with the HACCP plan.
d) Compliance of the actual flow diagrams and layout with the documented situation;
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h) Review of gaps between current and desired level of knowledge, awareness and
training of staff with respect to food safety; and
c) management review.
Verifications shall be planned based on the state and importance of the activities and shall be
performed by qualified personnel. Verification results shall be recorded (see 7.1).
The organisation shall conduct internal audits at planned intervals to determine whether the
HACCP system:
An audit programme shall be planned, taking into consideration the importance of the
processes and areas to be audited, as well as any updating actions resulting from previous
audits. The audits criteria, scope, frequency and methods shall be defined. Selection of
auditors and the conduct of audits shall ensure the objectivity and impartially of the audit
process. Auditors shall not audit their own work.
The responsibilities and requirements for planning and conducting audits, and for reporting
results and maintaining records, shall be defined in a documented procedure.
Where internal auditors are not available within the organisation, assistance from qualified
external sources can be obtained.
The management responsible for the area being audited shall ensure that actions are taken
without undue delay to eliminate detected nonconformities and their causes. Follow-up
activities shall include the verification of the actions taken and the reporting of the verification
results.
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The organisation’s management with executive responsibility1 shall review the continuing
suitability, adequacy and effectiveness of the HACCP system at defined intervals, of not more
than 12 months, to fulfill the requirements of customers and authorities and to satisfy the
organisation’s stated food safety policy and food safety objectives.
Note 1. In a situation where the management with executive responsibility is also a HACCP team coordinator or
leader, management review still needs to be conducted.
Management review shall include, but shall not be limited to the following:
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b) analysis of results of verification activities including internal audit, external audits and
inspections;
The data shall be presented in a manner that enables top management to relate the
information to stated objectives of the food safety management system.
The outcome from the management review shall include decisions and actions related to:
5.2.4.8.1 Documentation
The establishment shall establish a documented HACCP system and shall maintain the
HACCP system and corresponding documentation in order to ensure conformity with the
requirements of this standard and applicable legislation and regulations.
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5.2.4.8.2 Records
A documented procedure shall be established to define the controls needed for identification,
storage, protection, retrieval, retention time and disposal of records.
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Documents and data that relate to the HACCP system shall be reviewed and approved by
authorised personnel prior to issue and revision.
A master list of documents and records identifying the current revision status of documents
and records shall be established and be readily available to preclude the use of obsolete
documents and records.
a) issues of appropriate documents and records are available at all locations where
operations essential to the effective application of the HACCP system are performed;
b) obsolete documents and records are promptly removed from all points of issue or use,
or otherwise assured against unintended use;
c) records and obsolete documents retained for legal and/or reference purposes are
suitably identified;
d) documents and records are retained for a specified time depending on the shelf life of
the product, statutory and/or customer requirements; and
The application of the 7 HACCP principles can be summarised in a HACCP Plan Summary,
an example of which is given in Figure 3.
6. Other requirements
6.1 General
When establishing the HACCP system, the establishment shall conduct and document a
HACCP Plan (see 5.2.4). In addition, the following shall also be considered:
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A complete description of each food product should be made to assist in the identification of
all possible hazards associated with the product. The following should be taken into
consideration where relevant:
e) process type;
6.1.2 Identification of the intended use of the product and intended consumers
Potential users and consumers shall be identified for each product/product category.
Consumer groups known to be especially vulnerable shall be indicated.
The intended use with regard to storage, preparation and, where appropriate, serving shall be
described.
To ensure optimum consumer safety, unintended handling and use of the product with
specific requirements such as temperature, shelf-life etc shall be taken into consideration by
the provision of preparation instructions and distinctive product labelling (refer to 6.1.1 f).
The establishment shall make available a complete and actual description of the operation
and establishment in the form of process flow diagrams and plant layout.
The process flow diagram and plant layout shall be sufficiently clear and detailed for the
potential hazards to be identified, assessed and shall be verified by the HACCP team, other
than the person(s) who prepares them.
Process flow diagrams shall be prepared for all products or product categories covered by the
scope of the HACCP system.
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The process flow diagram provides a schematic overview of the operation and shall include
the following:
b) where raw materials and intermediate products (input) join the flow (including
subcontracted work);
d) where intermediate products, by products and waste (output) are removed (where
necessary);
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e) CCPs; and
All facilities, such as the production lines, storage areas and personnel facilities, shall be
depicted in the plant layout.
a) the areas where cross contamination of and incidental contact with in-process and
finished products by raw materials, additives, lubricants, cooling agents, non food
chemicals, packaging, pallets and containers, can occur;
b) The routing of raw materials, intermediate products, products, personnel, air flows (in
the case of high care area);
d) Other facilities, e.g quarantine area for nonconforming products, sanitary facilities, pest
control, lighting, etc.
Records shall be maintained to document the operation of the HACCP system (see 5.2.4.8.2).
A documented procedure shall be established and maintained to define how it is ensured that
the handling and control or disposal of products manufactured while the critical limits are
exceeded, prevents the non-conforming products from presenting a hazard to food safety.
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The establishment shall establish and maintain documented procedures for notification to the
relevant interested parties (authorities/customers/consumers), and product recall in situations
where products after delivery are found to present a hazard to food safety,
When establishing the procedures, consideration shall be given to the degree of detail
regarding traceability in production and post-delivery.
Maintenance of the documented procedure for notification and recall shall include challenging
this system (e.g. mock recall).
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7.4 Traceability
The establishment shall establish and apply a traceability system that enables the
identification of product lots and their relation to batches of raw materials, processing and
delivery records.
The traceability system shall be able to identify incoming material from the immediate
suppliers and the initial distribution route of the end product.
The establishment shall establish and maintain a documented procedure for the control of
measuring equipment and methods used in the monitoring of CCPs and in connection with
validation and verification activities. The measuring equipment shall be calibrated or verified
at specified intervals prior to use against measurement standards traceable to international or
national measurement standards.
Where no such standards exist, the basis used for calibration shall be documented.
Methods used in connection with monitoring, validation and verification of CCPs shall be
appropriate, and it shall ensure that reproducible and repeatable results are obtained.
The establishment shall establish and maintain documented procedures for calibration and
records (see 7.1) and documentation of the reliability of analysis results shall also be
available.
c) changes to the establishment’s food safety policy and objectives (see 5.2.4.7.2)
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The establishment shall establish and document procedures which ensure that the HACCP
team is informed or involved on a regular basis in the evaluation of:
b) new products;
e) changes in PRPs;
h) relevant enquiries from external interested parties and/or complaints indicating health
hazards associated with the product;
j) customer, sector and other requirements which the establishment have undertaken to
observe;
The HACCP team shall ensure that these conditions are included in the maintenance of the
HACCP system.
8.2 Training
The establishment shall prepare a training plan which will identify the need for training which
is essential for ensuring food safety, and provide for the fulfilment of the need. The need for
training shall be reviewed at appropriate intervals.
Training shall be maintained at a level that ensures all employees know their responsibilities
to maintain the food safety management system. Details of training sessions shall include, for
example, programme content, competency of the trainer, assessment of trainees and
establishment of the requirement for retraining.
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MS 1480:2007
1
1 2 3 4 5 6
Potential Hazard Rationale for Is this a What Measures Is this raw
Raw Material/ state whether inclusion or Significant can be applied to material/packaging
Packaging Material biological, exclusion as a Hazard? control this material a sensitive
chemical or Hazard (Yes/No) significant hazard? material
physical (Yes/No)
17
Note 1. Significant hazards controlled under PRPs need to be indicated in the worksheet
MS 1480:2007
Figure 1a. Hazard analysis worksheet for raw material/packaging material
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MS 1480:2007
MS 1480:2007
1 2 3 4 51 6
Process Step Potential Hazard Rationale for Is this a What Measures Is this process step
State whether inclusion or Significant can be applied to a Critical Control
biological, exclusion as a Hazard? control this Point?
chemical or Hazard (Yes/No) significant hazard?
physical (Yes/No)
18
Note 1. Significant hazards controlled under PRPs need to be indicated in the worksheet
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MS 1480:2007
Answer each question in the sequence given for each raw material/packaging material.
YES
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YES
Sensitive raw material/
packaging material
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MS 1480:2007
Answer each question in the sequence given at each process step for each significant
hazard.
Q2. Is the process step specifically designed to eliminate or reduce the likely occurrence
of the significant hazard to an acceptable level?
NO YES
NO CRITICAL CONTROL
POINT
* Proceed to the next process step
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MS 1480:2007
Product name :
MS 1480:2007
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CLAUSE
Get Management Commitment 5.1.1
Set Food Safety Policy/Scope/Objective
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Annex A
(informative)
Pre-requisite programmes
a) Location
b) Premises and rooms
c) Equipment
d) Facilities
a) Health status
b) Illness and injuries
c) Personal cleanliness
d) Personal behaviour
e) Visitors and workmen
a) General
b) Requirements
c) Use and maintenance
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a) Batch identification
b) Product information
c) Labelling
d) Consumer education
A1.8 Training
d) Refresher training
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Bibliography
Draft revised guidelines for the application of HACCP system, Codex Standard at step 8 of
the procedure
DS 3027 E - Management of food safety based on HACCP (Hazard Analysis and Critical
Control Points) – Requirement for a management system for food producing organizations
and their suppliers, Danish Standard, 2. Edition, 2002-12-20
ISO 22000: 2005, Food safety management systems – Requirements for any organization in
the food chain
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ISO/TS 22004: 2005, Food safety management systems – Guidance on the application of
ISO 22000:2005
Requirements for a HACCP based Food Safety System, Compiled by the National Board of
Expert – HACCP, The Netherlands
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Acknowledgements
Prof Madya Dr Nik Ismail Nik Daud/ Malaysian Institute of Food Technology
Cik Zahara Merican