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Conformance Observations & Objective

Clause Requirement Doc ref
Evidence
Y N
4 FOOD SAFETY MANAGEMENT SYSTEM
4.1 GENERAL REQUIREMENTS
4.1.1 Scope of the FSMS defined
4.1.2 Scope of the FSMS specifying:
 Product categories
 Processes
 Production sites
4.1.3 Any outsourced processes related to food
safety are controlled, identified and
documented within the FSMS
4.2 DOCUMENTATION REQUIREMENTS
4.2.2 Control of documents
A documented procedure for control of
documents required by the FSMS,
includes:
a) Approval of documents for adequacy prior
to issue
b) Review, update and re-approve
c) Changes and current revision status
identified
d) Relevant versions of documents available
at points of use
e) Legible and readily identifiable
f) Identification and control of external
documents
g) Prevent unintended use of obsolete
documents, and to suitably identify them
if they are retained for any purpose
4.2.3 Control of Records
Procedure for efficient and accurate
record keeping to provide evidence of
conformity to requirements and of the
effective operation of the FSMS
Records legible, readily identifiable and
retrievable
Control of the correction, identification,
storage, protection, retrieval, retention
time and disposition of records
5 MANAGEMENT RESPONSIBILITY
5.1 MANAGEMENT COMMITMENT
Evidence of top management
commitment to FSMS and its continual
improvement: objectives (5.3) –
communicating (5.6.2) – policy (5.2) –
management review (5.8) – resources (6)
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Conformance Observations & Objective

Clause Requirement Doc ref
Evidence
Y N
5.2 FOOD SAFETY POLICY
a) Appropriate to the role in the food chain
b) Commits to comply with statutory,
regulatory and customer FS requirements
c) Communicated and understood within the
organization (5.6)
d) Reviewed for continual suitability (5.8)
e) Supported by measurable objectives
5.3 FOOD SAFETY MANAGEMENT SYSTEM
PLANNING
a) To meet the objectives
b) To maintain the FSM integrity when
changes are implemented
5.4 RESPONSIBILITY AND AUTHORITY
R&A are defined and communicated
within the organization
Identified person(s) to receive reports
problems with the FSMS
Designated personnel to initiate and
record actions
5.6 COMMUNICATION
5.6.1 External Communication
Implemented effective arrangements for
communicating with:
a) Suppliers and contractors
b) Customers/Consumers:
 Product Information (see 7.3.3.2)
 Enquiries
 Contracts/Order handling
 Customer feedback/complaints
c) Food authorities
d) Other organizations that could be affected
Provided information on FS aspects of
products that may be relevant to other
organizations, especially to hazards that
need to be controlled. Record maintained.
Legal and customer FS requirements
recorded
Designated personnel to manage the
external communication
5.6.2 Internal communication
The Top management has communicated
to the organization the importance of
meeting this standard, legal and customer
FS requirements
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Conformance Observations & Objective

Clause Requirement Doc ref
Evidence
Y N
Implemented effective arrangements for
communicating with relevant personnel in
FS:
FST is informed of changes, especially:
a) Products or new products
b) Raw materials, ingredients and services
c) Production systems and equipment
d) Production premises, location of
equipment, surrounding environment
e) Cleaning and sanitation programs
f) Packaging, storage and distribution
systems
g) Personnel qualification level/allocation of
responsibilities and authorizations
h) Regulatory requirements
i) Knowledge regarding food safety hazards
and control measures
j) Customer, sector and other
k) Relevant enquiries from external
interested parties
l) Complaints indicating hazards associated
with the product
m) Any condition which have an impact on
food safety
5.8 MANAGEMENT REVIEW
5.8.1 At planned intervals
Records maintained
5.8.2 Inputs:
a) Follow-up actions from previous reviews
b) Verification activities (8.3.3)
c) Changes related FS (see 5.6.2)
d) Emergency situations, accidents (see 5.7)
and recalls (see 7.10.4)
e) System up-dating activities (see 8.5.2)
f) Communication activities including
customer feedback (see 5.6.1)
g) External audits or inspections
5.8.3 Outputs:
a) Assurance of Food Safety (see 4.1)
b) Improved effectiveness of the FSMS (see
8.5)
c) Resource needs (see 6.1)
d) Revisions of the FSP and objectives
(see 5.2)
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Conformance Observations & Objective

Clause Requirement Doc ref
Evidence
Y N
6 RESOURCE MANAGEMENT
6.2 HUMAN RESOURCES
6.2.2 For personnel relevant in FS
a) Identify necessary competencies
b) Training
c) Specific training for personnel responsible
of monitoring, corrections, and corrective
actions
d) Evaluation of implementation and
effectiveness
e) Awareness of contribution to FS
f) Awareness of need for effective
communication
g) Records of training and other actions
6.2.1 Agreement or contracts with external
experts involved in FSM
6.3 INFRASTRUSTURE (see 7.2.3)
6.4 WORK ENVIRONMENT (see 7.2.3)
7 PLANNING AND REALIZATION OF SAFE
PRODUCTS
7.2 PRPs
7.2.2 PRPs shall be
a) Appropriate to the organizational needs
b) Appropriate to the size and type of
operation and product
c) Implemented across:
 General programmes
 Specific programmes
d) Approved by FST
7.2.3 According to
 Legal requirements
 Customer requirements
 Recognized guidelines
 CODEX Alimentarius
 Codes of Practices
Specific documents to manage PRPs
7.5 ESTABLISHING THE OPERATIONAL PRPs
Documentation for each programme:
a) Hazard controlled
b) Control measures (s)
c) Monitoring procedures
d) Corrections/corrective actions
e) Responsibility and Authority
f) Records of monitoring
7.2.3 ELEMENTS OF PRPs
a) Lay-out, design and construction of
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buildings and facilities:

 Location
 Perimeter and grounds
 Walls
 Floors
 Ceilings
 Windows
 Doors
 Lighting
 Ventilation
b) Lay-out of premises, including workspace
and employee facilities:
 Process flow
 Working space and storage
 Segregation Low/High risk
areas/process
 Segregation design
 Washing and cleaning locations
 Changing facilities
 Hand washing facilities
 Toilets
 Catering facilities
c) Supplies of air, water, energy and other
utilities
d) Supporting services including waste and
sewage disposal
e) Equipment including its preventive
maintenance, sanitary design and
accessibility for maintenance and cleaning
for each unit
f) Management of purchased materials,
disposals and handling of products:
 Raw materials
 Ingredients
 Packaging
 Chemicals
 Waste
 Sewage
 Storage of raw
materials/packaging/in
process/end products
 Transportation
g) Measures for the prevention of cross
contamination
h) Cleaning and sanitizing:
 Cleaning practices
 Cleaning schedules
 Control and verification of
effectiveness
 Documented procedures/records
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Conformance Observations & Objective

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Evidence
Y N
i) Pest Control:
 Competent pest control
 Documented procedures/records
 Physical measures: drains,
hermetically sealed doors,
screens, security perimeter for
inspection in storage, etc.
 Location of all measures
 Plan/diagram for electric fly
killers/baits/traps
 Risk of product contamination
with chemicals
j) Personnel Hygiene:
 GMPs
 Protective clothing
 Jewelry
 Cuts and grazes
 Hand Cleaning
 Notification of relevant infectious
disease or conditions
 Medical screening
 Training
7.3 PRELIMINARY STEPS TO ENABLE HAZARD
ANALYSIS
7.3.1 General
Relevant information needed to conduct
the hazard analysis documented,
collected, maintained and updated
7.3.2 Food Safety Team (FST) (see 5.5)
FST Leader appointed by Top
Management with responsibility:
a) To manage the FST
b) Training and education of FST members
c) To ensure that FSMS is established,
implemented, maintained and updated
d) To report to Top Management about
FSMS
Multi-disciplinary knowledge and
experience
Records demonstrate the required
expertise for all team members
7.3.3 Product characteristics
7.3.3.1 Raw materials, ingredients and product-
contact materials
Specifications with:
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Conformance Observations & Objective

Clause Requirement Doc ref
Evidence
Y N
a) Biological, chemical and physical
characteristics
b) Ingredients including additives and
processing aids
c) Origin
d) Method of production
e) Delivery methods and packaging
f) Storage conditions and shelf-life
g) Preparation and/or handling before use or
processing
h) Food safety related acceptance criteria or
specifications of purchased materials and
ingredients appropriate to their intended
uses.
Relevant legislation/regulations
documented
Specifications updated
7.3.3.2 Characteristics of end products
Specifications with:
a) Name
b) Composition
c) Biological, chemical and physical
characteristics
d) Intended shelf-life and storage conditions.
Intended use (see 7.3.4)
e) Packaging
f) Labeling relating to food safety and/or
instructions for handling, preparation and
usage
g) Method(s) of distribution
Relevant legislation/regulations
documented
Specifications updated
7.3.4 Intended Use
Identified and documented appropriate
information about:
 The reasonably expected handling
of the product
 Any unintended but reasonably
expected mishandling and misuse
of the product
Group of consumers identified, especially
vulnerable groups of population
Descriptions updated
7.3.5 Flow diagrams, process steps and control
measures
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Conformance Observations & Objective

Clause Requirement Doc ref
Evidence
Y N
7.3.5.1 Flow diagrams
For each product/process category
covered by the FSMS
Sufficient detail/schematic overview
including:
a) Sequence/interaction of steps
b) Outsourced processes and subcontracted
work
c) Inputs (raw materials, ingredients,
intermediate products)
d) Reworking and recycling
e) Outputs (end, intermediate, by-product,
waste)
Verified by FST (records)
7.3.5.2 Description of process steps and control
measures
Control measures/process
parameters/procedures related to food
safety described
Legal and customer requirements
described
Descriptions updated
7.4 HAZARD ANALYSIS
7.4.2 Hazard Identification and Determination
of acceptable levels
7.4.2.1 Identified and recorded
Specific for the type of product/process
and facilities
Based on:
a) Preliminary information about
product/process and control measures
(7.3)
b) Experience
c) External information including
epidemiological and other data historical
d) Information from the food chain
e) Step (s) related which each hazard in the
end product defined in compliance with
legal/customer requirements, and the
intended use (Records)
7.4.3 Hazard Assessment
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Conformance Observations & Objective

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Evidence
Y N
To identify which hazards are of such a
nature that their elimination or reduction
and control is essential.
Including:
 Likely occurrence
 Severity of the adverse health
effects
Methodology described and results
recorded
7.4.4 Selection and assessment of control
measures
Identified and document control measures
that are to be applied, selected from the
control measures defined in 7.3.5.2
Categorized in General Control Measures
(managed through PRPs) or Specific
Control Measures (related to CCP’s),
regarding to:
a) Effect on identified food safety hazards
relative to the intensity applied
b) Feasibility for monitoring
c) Place within the system relative to other
control measures
d) Likelihood of failure in the functioning
e) Severity of the consequence
f) Specifically to eliminate/reduce the level
of hazard(s)
g) Synergistic effects
Methodology of categorization
documented and results recorded
7.6 ESTABLISHING HACCP PLAN
7.6.2 IDENTIFICATION OF CCPs
Hazard to be controlled by specific control
measure – CCP (7.4.4)
7.6.3 DETERMINATION OF CRITICAL LIMITS
For the monitoring of each CCP

Requirement of legislation-regulations-
internal risk analysis-clients are met
In terms of measurable parameters
supported by instructions, specifications,
education/training
Selection documented
7.6.4 MONITORING OF THE CCPs
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Conformance Observations & Objective

Clause Requirement Doc ref
Evidence
Y N
A monitoring system for effective and
efficient control of CCPs (measurements
relative to the critical limits) established
and maintained
Procedures + instructions + records
including:
a) Measurements that provide results within
an adequate time frame
b) Monitoring devices identified
c) Calibration methods (3.3)
d) Frequency
e) Records and methods
7.6.5 Actions when monitoring results exceed
critical limits
7.10 CONTROL OF NONCONFORMITY
7.10.1 Corrections
A procedure to:
a) Identify and assess of affected end
products
b) Review the corrections carried out
Approved by the responsible person
Records with information on the nature of
the nonconformity, cause and
consequence and traceability
7.10.2 Corrective Actions (CAs)
Data derived from the monitoring of PRPs
+ CCPs evaluated by designated person to
initiate corrective actions
Initiated when critical limits are exceeded
or lack if conformity with PRPs. Records
A procedure to:
a) Review NCs (complaints included)
b) Review trends
c) Determine cause of NCs
d) Evaluate the need for CAs
e) Determine and implementing CAs
f) Records of CAs
g) Reviewing CAs
7.10.3 Handling of potentially unsafe products
7.10.3.1 NCs product don’t enter the food chain
unless it is possible to assure that the
hazards have been reduced to acceptable
levels, and the product is safe
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Conformance Observations & Objective

Clause Requirement Doc ref
Evidence
Y N
All lots of products affected by NC
identified and controlled until they have
been evaluated
A procedure with responses +
authorization + actions and controls
7.10.3.2 Evaluation for release
Product is released as safe when:
a) Others evidence indicates that the control
measures have been effective
b) Combined effect of the control measures
has been effective
c) Analysis (or other verification activities)
indicate that the product is safe
7.10.3.3 Disposition of nonconforming products
Products not acceptable for release have
to be:
a) Reprocessed to ensure that the hazards
are controlled
b) Destroyed
7.9 TRACEABILITY SYSTEM
Identification of product lots and their
relation to batches of:
 Raw materials (from the
immediate suppliers)
 Processing
 Distribution records (to the
immediate distributors)
Records maintained for a defined period
Meet customers and regulatory
requirements. Based on the shelf life
7.10.4 WITHDRAWALS
To facilitate a recall:
a) Authority and Responsibility appointed by
top management
b) Procedure for:
 Notification
 Handling of recalled products as
well as involved products still in
stock
 Defining the sequence of actions
Recalled products held under supervision
until their treatment
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Conformance Observations & Objective

Clause Requirement Doc ref
Evidence
Y N
Records with the cause, extent and result
of a recall. Reported to the top
management as input to management
review (see 5.8.2)
Effectiveness of the programme recall
verified. Records.
5.7 Emergency preparedness and response
Procedures to manage potential
emergency situations established by Top
Management
7.8 VERIFICATION PLANNING
Establish, document and implement
procedures for verification of the HACCP
system: purpose-methods-frequencies-
responsibilities-records
Shall to confirm that:
a) The PRPs are implemented
b) The hazard analysis is continually updated
c) The operational PRPs and the elements
within the HACCP plan are implemented
and effective
d) Hazard levels are within identified
acceptable levels
Records communicated to the FST
NCs results in test samples of end
products – affected lots handled as
potentially unsafe
8.4.2 EVALUATION OF INDIVIDUAL
VERIFICATION RESULTS
Are evaluated systematically by the FST
NCs with the planned arrangements –
actions to achieve conformity. Review
a) Procedures and communication channels
(5.6/7.7)
b) Conclusions of the hazard
analysis/operational PRPs/HACCP Plan
c) PRPs
d) Human resources/Training
8.4.3 ANALYSIS OF RESULTS OF VERIFICATION
ACTIVITIES
Are analyzed by the FST, including the
results of internal and external audits, in
order to:
a) Confirm that FSMS meets the planned
arrangements
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Conformance Observations & Objective

Clause Requirement Doc ref
Evidence
Y N
b) Identify the need for updating/improving
the FSMS
c) Identify trends
d) Establish information for planning internal
audits
e) Confirm effectiveness of corrections and
CAs
Records reported Top Management. Input
to the management review and for
updating the FSMS
8 VALIDATION, VERIFICATION AND
IMPROVEMENT OF THE FSMS
8.2 VALIDATION OF CONTROL MEASURE
COMBINATIONS
Prior to implementation and after any
change of General/Specific Control
Measures, ensure that:
a) Associate hazards are effectively
controlled
b) End Products meet the defined acceptable
levels
If a/b failed, modification and
reassessment of:
 Control measures
 Raw materials
 Technologies
 Product characteristics
 Distribution
 Intend of use
8.3 CONTROL OF MONITORING AND
MEASURING
To ensure valid results (if necessary),
measuring equipment have to be
controlled:
a) Calibrated/verified against measurement
standards; where no such standards exist,
the basis used shall be recorded
b) Adjusted or re-adjusted as necessary
c) The calibration status identified
d) Safeguarded
e) Protected from damage
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Conformance Observations & Objective

Clause Requirement Doc ref
Evidence
Y N
Records of calibrations
If no conformance – assess the validity of
the previous results + treatment of the
equipment/product. Records
Suitability of software confirmed: prior to
initial use + reconfirm
8.4 FSMS VERIFICATION
8.4.1 Internal Audit
Documented procedure that defines
responsibilities – reporting – records
To determine whether FSMS system:
a) Conforms with the planned arrangements
b) Is effectively implemented and
maintained
Audit programme planned: considers
status, importance of processes and areas
to be audited, and results of previous
results
Criteria, scope, frequency and methods
defined
Objectivity and impartiality of auditors
Corrective actions carried out on time by
responsible for the area
Verification of actions recorded
8.5 IMPROVEMENT
8.5.1 Continual Improvement
FSMS continually improved through:
communication (5.6) – management review
(5.8) – internal audit (8.4.1) – evaluation of
individual verification results (8.4.2) – analysis
of results of verification activities (8.4.3) –
validation of control measure combinations
(8.2) – CCAA (7.10.2) – FSMS updating
8.5.2 Updating FSMS
FST evaluate the FSMS at planned
intervals, and if it is necessary review the
HA, PRPs and the HACCP Plan
Consider:
a) Communication (5.6)
b) Suitability-adequacy –effectiveness of
FSMS
c) Analysis of results of verification activities
d) Management review (5.8.2)
Updating of FSMS recorded and reported:
input of management review (5.8.2)