S-9.4 Applying HACCP Assessment

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S9.4 - Applying HACCP

assessment
Version EN: 1 March 2021
gmpplus.org
S9.4 - Support GMP+ FC 2020: Applying HACCP assessment
Index
1. INTRODUCTION ................................................................................................................................ 3
1.1. STRUCTURE HACCP GUIDELINE........................................................................................................................................ 3
2. HACCP SYSTEM REQUIREMENTS ..................................................................................................... 4

2.1. MANAGEMENT RESPONSIBILITIES....................................................................................................................................... 4
2.1.1. Defining quality policy ......................................................................................................................................... 4
2.1.2. Defining the scope of the HACCP system ..................................................................................................... 5
2.1.3. Tasks, responsibilities and authorisation (TRA) ........................................................................................... 5
2.1.4. Making resources available ................................................................................................................................ 5
2.1.5. Management assessment of the HACCP system ........................................................................................ 5
3. HACCP BASED PLAN ......................................................................................................................... 6
3.1. PHASE 1: FORMING MULTI-DISCIPLINARY FEED SAFETY TEAM(S) AND VALIDATION TEAM(S) .................................. 7
3.2. PHASE 2: DESCRIPTION OF FEED ........................................................................................................................................ 9
3.2.1. Phase 2.1: Description of the end-product in charactaristics of end-products ................................ 9
3.2.2. Phase 2.2: Description of ingredients and processing aids .................................................................. 10
3.3. PHASE 3: DETERMINING THE INTENDED USE OF FEED .................................................................................................. 11
3.4. PHASE 4: DETERMINE PROCESS INFORMATION ............................................................................................................. 12
3.4.1. Phase 4.1: Preparing flow diagrams ............................................................................................................ 12
Symbols ............................................................................................................................................................................... 13
3.4.2. Phase 4.2: Preparing a floor plan .................................................................................................................. 14
3.5. PHASE 5: TESTING PROCESS INFORMATION .................................................................................................................. 15
3.6. PHASE 6: DEFINE PREREQUISITE PROGRAMME .............................................................................................................. 16
3.7. PHASE 7: HAZARD ANALYSIS........................................................................................................................................... 17
3.7.1. Phase 7.1: Hazard identification .................................................................................................................... 17
3.7.2. Phase 7.2: Risk assessment .............................................................................................................................. 19
3.8. PHASE 8: DETERMINING CRITICAL CONTROL POINTS (CCP’S) .................................................................................... 21
3.8.1. Phase 8.1: Determining control measure ................................................................................................... 21
3.8.2. Phase 8.2: Establishing critical control points ( CCP’s) ......................................................................... 21
3.9. PHASE 9: DETERMINING FEED SAFETY LIMITS FOR CCP’S ............................................................................................ 24
3.10. PHASE 10: MONITORING CCPS................................................................................................................................. 25
3.11. PHASE 11: DETERMINING / CORRECTIONS AND CORRECTIVE ACTIONS................................................................. 26
3.12. PHASE 12: VALIDATION AND VERIFICATION ............................................................................................................. 27
3.12.1. Phase 12.1: Validation of the HACCP system ...................................................................................... 27
3.12.2. Phase 12.2: Verification of the HACCP system .................................................................................... 28
3.13. PHASE 13: DOCUMENTATION AND REGISTRATIONS ................................................................................................ 30
APPENDIX 1 COMPLETING THE HAZARD ANALYSIS TABLE .............................................................. 31
APPENDIX 2 SUMMARY OVERVIEW OF CCP’S AND GENERAL CONTROL MEASURES ................... 32
Version EN: 1 March 2021 2/33

1. Introduction
1.1. Structure HACCP Guideline
The HACCP guideline is intended to support GMP+ FSA certified companies (or companies
who which to) in setting up their in-company HACCP system. The guideline provides an
explanation of the HACCP principles in sections.
The HACCP requirements in the GMP+ standard are predominantly based on the
HACCP criteria as laid down in the Codex Alimentarius. Meanwhile, based on new in-sights (as
ISO22000), some changes and additions were included in the HACCP
requirements.
The feed sector is already used to working with measures to ensure feed safety. The feed
regulations and the GMP+ Feed Safety Assurance module (GMP+ FSA) already cover a wide
range of quality requirements for feed. This concerns sector-wide measures. Company specific
situations cannot always be taken into account when preparing these measures.
Since the year 2000, the feed sector has taken the initiative of including the HACCP system in
the GMP+ Feed Safety Assurance module.
The scope of this guideline is to support in feed and food safety assurance. This guide-line is
intended specifically for the management and employees of companies within the feed sector
developing a company specific HACCP system. The manner in which HACCP is described in
current feed Regulations (in particular the EC Regulations 183/2005, (EC) Nr. 178/2002 and (EC)
Nr. 852/2004), the General Food Hygiene Guidelines recommended by Codex (CAP/RCP 1-1969,
Rev. 4-2003) and national and international requirements relating to HACCP management
systems (HACCP-NL and ISO 22000) served as a guideline in preparing this guideline.
For definitions and terminology please check F 0.2 Definition list.
Chapter 24 contains a further explanation of the requirements within the management’s scope
of responsibility. Chapter 3 is a phased plan for setting up a HACCP system. In preparing this
phased plan, the requirements as set out in current legislation or GMP+ FSA module have
been included as much as possible.
Every step of the HACCP process starts with an overview of which paragraphs in the normative
documents are applicable. Within the document the wording ‘must’ is used, this refers to the
HACCP principles that must be followed as described in the normative document.
Helpful tip :
This symbol signifies supplementary and specific attention for the relevant issue.

2. HACCP system requirements

In order to successful implement a HACCP system, a fundament must be created to fully
support the involved employees. This support falls under the responsibility of top
management. This includes defining quality policy, defining the scope of the HACCP system,
determining tasks, responsibilities and authority, making resources available and management
assessment.
The quality policy, which forms part of the complete business policy, is the platform for the
management to record the organisation's goals in the area of feed safety. The management is
responsible for defining the quality policy by means of practicable objectives and
communicating these to the employees.
The scope and extent of the HACCP system should be indicated. Scope relates to the activities
that the company is responsible or accountable for. This can or will be broader than the scope
of the GMP+ certificate because also non-feed related activities, processes, products or
services, can have a negative impact on the feed safety and should be managed by the HACCP
system (R1.0 & 4.3).
Management should review requests of the Feed Safety Team(s) relating to resources and
facilities required for the creation, implementation and maintenance of the HACCP system and
make these resources available. The employees will be enabled to implement the HACCP
system and comply with work agreements by resources and facilities being made available by
the management. This may pertain to making control equipment available as well as making
personnel and time available in order to allow for inspections to be carried out.
When the entire HACCP system has been developed and implemented, the management must
ensure that the HACCP system is updated and revised if necessary.
For more information on top management responsibilities can be found in the document R
1.0 Feed Safety Management Systems Requirements.
2.1. Management responsibilities

Relating to feed safety, a number of requirements fall directly within the scope of
management responsibility.
2.1.1. Defining quality policy

The quality policy, which forms part of the complete business policy, is the platform for the
management to record the organisation’s goals in the area of food and feed safety. The
management is responsible for defining the quality policy by means of practicable objectives
and communicating these to the employees.
The quality policy should match customer expectations and it should convey that the
organisation is aware it is part of the food and feed chain.

The management subsequently ensures that development and implementation of the HACCP
system progresses according to plan and is updated and adjusted as and when required.
R 1.0 Feed Safety Management Systems Requirements
2.1.2. Defining the scope of the HACCP system

§ 5.2. Feed safety policy
2.1.3. Tasks, responsibilities and authorisation (TRA)

When setting up a HACCP system, it is important to record the tasks, responsibilities and
authorisation of employees relating to food and feed safety.
This pertains to employees involved in the manufacturing process of the animal feed or
involved in control and monitoring of feed safety.

§ 5.3.1 Top management’s Responsibilities and Authorities
§ 5.3.2 Responsibilities of the Feed Safety Team Leader
§ 5.3.3 Responsibilities of the Validation Team
§ 5.3.4 Responsibilities of all persons involved
2.1.4. Making resources available

Where corrective measures, verification procedures or customers indicate that operational
improvements are required, the organisation should review and assess these aspects and
where necessary make adequate resources available in order to guarantee feed safety.
The employees will be enabled to implement the HACCP system and comply with work
agreements by resources and facilities being made available by the management. This may
pertain to making control equipment available as well as making personnel and time
available in order to allow for inspections to be carried out.

§ 7.1. Resources
2.1.5. Management assessment of the HACCP system

The quality objectives, where necessary, may be further specified where possible. This will provide
a mechanism allowing for assessing the effectiveness of the HACCP system at regular intervals.

3. HACCP Based plan

Hazard Analysis & Critical Control Points, HACCP, is a process control system relating to
feed and food safety and may be set up and applied in combination with other quality
systems. The HACCP plan consists of the following phases:
HACCP based plan

Phase 1 Forming multi-disciplinary Feed Safety Team(s) and
Validation Team(s)
Phase 2 Description of feed
Phase 3 Determining the intended use of feed
Phase 4 Determine process information
Phase 5 Testing process information
Phase 6 Define prerequisite programme
Phase 7 Principle 1 Hazard analysis
Phase 8 Principle 2 Determining critical control points (CCP’s)
Phase 9 Principle 3 Determining feed safety limits for CCP’s
Phase 10 Principle 4 Monitoring CCP’s
Phase 11 Principle 5 Determining corrections and corrective actions
Phase 12 Principle 6 Validation and verification
Phase 13 Principle 7 Documentation and registration
These phases will be described in detail in the following paragraphs.

3.1. Phase 1: Forming multi-disciplinary Feed Safety Team(s) and

Validation Team(s)

§ 5.3.1 Top management's Responsibilities and Authorities
§ 5.3.2. Responsibilities of the Feed Safety Team leader
§ 5.3.3 Responsibilities of the Validation Team
As described in the standards, the management of the company is ultimately responsible for
the Feed Safety Management System of the company. Management must appoint Feed Safety
Team(s) and Validation Team(s). The management shall ensure that members of both the Feed
Safety and validation Teams will have adequate time and (if necessary) resources available for
setting up and implementing, respectively validating, the Feed safety Management System
including the HACCP system.
The Feed Safety Team is a team within the organisation that supervises setting up and
implementation of the HACCP system. In addition to implementation, the Feed Safety Team is
designated a role in updating and verification of the HACCP system. The HACCP system is
specific for each company.
The Validation Team is also a team within the organisation. The Validation Team’s aim is to
determine if the HACCP system as set up by the Feed Safety Team will perform as intended in
practice. This is referred to as validation (see phase 12).
Both large and small businesses are required to compose both a Feed Safety Team and a
Validation Team. The size of these teams depends on the organisation’s size as well as the
expertise of the team members. The implementation of a HACCP system requires technical
expertise as well as expertise in feed and food chemistry, toxicology, microbiology and quality
management. The more comprehensively these fields of expertise are represented in both
teams, the more complete the HACCP system can be expected to become.
Helpful tip :
If necessary, companies should deploy the services of qualified external experts.

In addition to the various fields of expertise, team members should come from the various
hierarchical levels of the company. This should ensure that the HACCP system will be
supported throughout the company.
The following fields of expertise may be represented in the Feed Safety and/or Vali-dation
Team:
a. Management representative: Decision-maker
b. Process expert: An employee responsible for, or closely involved in, the production
process (for example the production manager). This employee should have knowledge of
the operating methods on the production floor.
c. Quality coordinator, with insight into quality of ingredients and end-product, with
knowledge of microbiological, chemical and physical hazards relating to specific products
/ processes.
d. Production employee: an employee (for example production supervisor) with knowledge
of the hygienic status of the company, production spaces and installations.
e. Other: Depending on the company’s activities, i.e. if applicable, the following fields of
expertise should also be represented: Expert relating to purchasing, storage, forwarding,
sales, nutritional and agricultural issues.
Members of the Feed Safety Team may be a member of the Validation Team too. However,
the Validation Team must preferably also contain independent members who are not a
member of the Feed Safety Team in order to prevent influence: Select employees not directly
involved in preparing the HACCP plan.
Helpful tip :
Companies with a limited number of employees (or companies without any staff) should hire external
support for the implementation and validation of their HACCP system (for examples suitable persons
working within the sector or external consultants).
Both the management representative and the quality coordinator within the Feed Safe-ty
Team must attend HACCP training or the team members must have attained a simi-lar level
based on experience.
According to the standard, the company must record the members of both the Feed Safety
and Validation Teams as well as the fields of expertise of their team members in a document
or add this to existing documentation. The fields of expertise must be verifiable, for instance
based on diplomas or demonstrable work experience. If the required expertise is not available
within a company, external experts may be involved in the team’s activities. External expertise
must also be recorded in the documentation.

3.2. Phase 2: Description of feed

3.2.1. Phase 2.1: Description of the end-product in characteristics of
end-products

§ 8.5.1.2 Characteristics of end-products
TS 1.2 Purchase
TS 1.3 Product list
TS 1.4 Forbidden Products and Fuels
TS 1.5 Specific feed safety limits
Information regarding end-products is required in order to be able to correctly assess the

hazards that may occur during the manufacturing process or the type of hazards that the end
products (the feed) may entail to humans or animals. The HACP Feed Safety Team shall chart
this information based on characteristics of end-products of
Characteristics of end-products provide an initial indication of possible hazards. In addition to

the ingredients used (raw materials, additives) and nutritional values of the end product, other
features must be mentioned that may influence food and feed safety. This may relate to
chemical, physical and microbiological features (in the sense of polluting or undesirable
substances) or the required conditions for production, storage and transport. The feed safety
limits from TS 1.5 must be taken into account and included in the specification. The
characteristics of the end-products must be considered by the Feed Safety Team when setting
up and implementing the company-specific HACCP system.
In principle, each end-product must be described separately in a specification. For practical

reasons, creating product groups is allowed. However, the products must be classified into
groups in such a manner that differences in ingredients or processing steps do not lead to
additional hazards.
Characteristics of end-products can be prepared based on a so-called three- category system.

1. Generally applicable requirements and features for feed can be recorded once. These
features can then apply to all feed manufactured in a company. This applies, for example,
to Microbiological requirements, such as ‘salmonella not present in 25 grams’.
2. The same can be done for features similar for a certain animal species (often a product group).
3. Features specific to a product can be recorded at article level.

3.2.2. Phase 2.2: Description of ingredients and processing aids

§ 8.5.1.1 Characteristics of ingredients
TS 1.2 Purchase
TS 1.3 Product list
TS 1.4 Forbidden Products and Fuels
The requirements that apply to the end-product (for example feed safety limits of
contaminants) are partially determined by the ingredients and processing aids used. This
includes feed materials, premixes, additives and processing aids. Inspection of ingredients and
processing aids based on specifications is necessary.
The information relating to the ingredients and processing aids, and their growing/
harvesting/mining process is required for the execution of the hazard identification of the
company’s manufacturing process (see phase 7 of the HACCP analysis).

3.3. Phase 3: Determining the intended use of feed

§ 7.4.2 External communication
§ 7.4.3 Internal Communication
§ 8.5.1.3 Intended use
TS 1.8 Labelling
Considering the target group(s) prevents hazards from being overlooked. This concerns
hazards to animals as well as hazards that may be incurred by the human customer of the
animal products.
The characteristics of the end-product serve to record the target species of the feed. Not all
feed are (in their normal form) suitable to all animals. For example in the case of raw soy
beans. Before being used as an ingredient in piglet feed, these must be toasted in order to
remove the harmful trypsin inhibitor. Another example is that high copper levels in sheep feed
have a toxic effect, whereas copper must be added to the feed of many other animal species.
The characteristics of the end-product must also record the animal species, the age of the
animal and the instructions of use (including storage conditions). This may also be subject to
varying requirements.
The Feed Safety Team shall review how the feed is to be stored and used as in-tended without
any hazards to animal or public health occurring.
The information on the label must at least comply with the applicable feed legislation, but if
improper use of feed may lead to unsafe animal products, a (supplementary) set of
instructions relating to transport, storage, processing and feeding must be sup-plied with the
relevant products.

3.4. Phase 4: Determine process information

The Feed Safety Team shall prepare a comprehensive and up to date description of all
business processes in the form of flow diagrams and a floor plan.
3.4.1. Phase 4.1: Preparing flow diagrams

§ 8.5.1.4 Flow diagrams and description of Processes
§ 8.5.1.4.1 Preparing flow diagrams
The Feed Safety Team shall prepare a flow diagram of the production process for each
product (or product group). These flow diagrams must indicate the process phases to be
followed in order to create a certain end -product. The process diagram should also indicate
the ingredients, processing aids and auxiliary substances used and any by-products created by
the process.
Each process, production or processing phase must be indicated separately in the flow
diagrams. Hazards can be identified based on these company specific flow diagrams (see
phase 7 and further).
When preparing the flow diagrams, the following are key issues.
a. select a end-product or product group
b. define the description of the process (start - end)
c. prepare simple, clear diagrams
d. to enhance clarity and overview, restrict the number of symbols
e. use uniform terminology for products and/or processes
f. try to work top down and left to right as much as possible
g. prepare a core process for the end-product or product group
h. divide the core process into sub-processes
i. indicate the links between sub-processes with start and end symbols
j. indicate ingredients, processing aids, auxiliary substances, semi-finished products, by-
products, end-products, return flows and waste flows
A flow diagram may be subdivided into a core process and sub-processes. Defining a core
process may be useful if the process is complicated and includes many process phases and/or
a large number of inbound and outbound flows.
The key process phases of the production process are included in the core process diagram.
Each core process phase is specified in a sub-process diagram, where all process steps are
indicated separately.

Symbols
Using the following symbols when preparing flow diagrams is recommended.
Symbol Explanation
Opening or closing symbol This symbol indicates the beginning and end of the
process diagram. If it is used as a start symbol, the
name of the relevant sub-process can be entered. If
it is used as an end symbol, the name of the next
sub-process can be entered. This shows how the
various sub-processes are interlinked.
Core process phase This symbol indicates the main activities or actions
within a section of the process in the core (global)
process diagram. The core (global) process phases
are described in further detail in sub-process
diagrams.
Process phase This symbol indicates an activity or action (a process

phase). Based on the process phases, the hazards are
always identified (see phase 7).
Product This symbol indicates a tangible product (for example

an ingredient, semi-end product or end product) or
other tangible matter (for example steam or air) that
enters or exits the process.
Connection symbol This symbol indicates that the specific product flow is
shown in detail in a different place in the process
diagram. It is also possible that the product flow is
derived from a different place in the production
process.
Indicating a letter or digit in the symbol can help distinguish the connections.
For a detailed example, please refer to the risk assessments as part of the Feed Support
Products on the website of GMP+ International.

3.4.2. Phase 4.2: Preparing a floor plan

§ 8.5.1.4 Flow diagrams and description of Processes
§ 8.5.1.4.2 Preparing a floor plan
A floor plan of the company units offers support when systematically charting and verifying
the production processes.
A floor plan serves to indicate the company’s infrastructure. This concerns an over view of:
a. The various company units (for example production and storage) and personnel facilities.
b. Machines and equipment present (for example technical drawings of the conveyor
installations).
c. The routing of feed and ingredients through the company, of waste and of personnel in
order to make any cross-contamination points visible.

3.5. Phase 5: Testing process information

§ 8.5.1.4.3 On-site conformation of Flow diagrams and Floor plan
After preparing process information (flow diagram and floor plan), these must be tested
against practice by the Feed Safety Team.
This ‘reality check’ entails for the Feed Safety Team to walk through the processes during
working hours on site (verification of the process diagram). If the same actions are carried out
by various persons and/or teams, it is important to test the flow diagrams against the working
methods of all these persons and/or teams - for example, does the night shift work in exactly
the same manner as the day shift?
If practice indicates that process phases were overlooked, the process flows
must be adjusted.
The accuracy of the lay-out of the floor plan must be checked and adjusted where needed.
Furthermore, when a process is updated or changed, the process must be retested to practice
and re-validated (see phase 12). The changes must also be implemented in the flow diagrams.
This test is intended in order to ensure that the further HACCP steps are followed with the
correct process information. If the process information and the observations in working
practice are matches, the teams may proceed with the next phase.

3.6. Phase 6: Define prerequisite programme

§ 8.2 Prerequisite programmes (PRPs)
TS 1.1 Prerequisite programme
A minimum level for controlling feed safety must be applicable before implementing HACCP.
This basic level must be realised by determining and applying a prerequisite programme.
Prerequisite programmes create environmental and operating conditions required for delivery
of safe feed. The prerequisite programme is part of the GMP+ FSA module.
The prerequisite programme consists mainly of general control measures for controlling
general hazards. These include pest control plans, cleaning and sanitising plans, training plans
and buying procedures. These general control measures form a basis for effective application
of the hazard analysis for each feed company (Principle 1).
The prerequisite programme as included in the GMP+ FSA module is based on the
HACCP Certification Scheme Foodstuffs, the General Principles of Food Hygiene’ of the Codex
Alimentarius and the applicable feed legislation (Animal Feed Hygiene Regulation 183/2005).
The GMP+ certified company must check which elements in the prerequisite programme are
applicable to the company.
The GMP+ certified company must determine if the prerequisite programme is an adequate
basis for successful application of the HACCP principles. If this is not the case, the certified
company must specify and implement supplementary prerequisites.

3.7. Phase 7: Hazard analysis

§ 8.5.2 Hazard analysis
§ 8.5.2.1 Hazard identification
§ 8.5.2.2 Risk Assessment
The hazard analysis consists of 2 components, the hazard identification (possible hazards) and
risk assessment (from possible hazard to realistic risk). Phase 7.1 further specifies hazard
identification and phase 7.2 further explains risk assessment.
3.7.1. Phase 7.1: Hazard identification
Based on the information collected until this moment (during phases 2 through 6) and the
flow diagrams, a list is prepared of the hazards that may realistically be expected in each
phase of the process. This activity is referred to as hazard identification and forms part of the
hazard analysis.
The Feed Safety Team determines the hazards for each process phase as comprehensively as
possible. Where necessary it is recommended to deploy external experts in these brainstorm
sessions in order to preclude incompleteness, as external people will notice things overlooked
by those working in a company every day.
Identified hazards are to be described. When defining the hazard, a brief description of the
cause and/or source/root cause of the hazard can be included. This makes deter-mining
subsequent control measures simpler (see phase 8).
A hazard can be described as a contamination of feed, or a condition leading to

contamination of feed, with possible negative implications for human or animal health.

Type of Description Examples

hazard
Chemical Undesirable chemical substances that Undesirable Substances and

hazards may render the product unsafe for Products:
consumption. These may be present Residues of pesticides, hormones,
in the ingredients or contaminate the antibiotics, heavy metals, environ-
product during production, for mental pollution, mycotoxins, PCB’s,
example due to carry-over. dioxins, cleaning agents, lubricants,
mineral oils etc.
Higher concentrations of desirable
substances may also form a hazard, Residues of additives and veterinary
making the product unsafe for medicinal products
consumption.
Processing aids
Biological degradation products
Criteria for fat fraction
Minerals and acid residues
Microbiological Pertaining to presence of undesirable Veterinary risks

hazards micro-organisms. The micro- (animal diseases)
organisms may cause contamination
or growth due to their (natural) Pathogenous organisms: Salmonella,
presence, making a product unsafe Enterobacteriaceae and Fungi (the
for consumption. Consumption of latter group as indicator organisms).
the product may in such cases cause
food infections or food poisoning.
We can distinguish vegetative micro-
organisms, toxigenous (toxin-
forming) micro-organisms and
spore-forming micro-organisms.
Physical hazards Foreign bodies that may be present Glass, plastic, metal parts, stones,
in ingredients or may enter the bone, pieces of packaging
product.
This makes the product unsafe for
the animal.
Helpful tip 1:
The hazard should be described in as much detail as possible. In the case of pathogens, the description
should indicate if it concerns for example salmonella or listeria. In the case of contamination with foreign
particles, the description should indicate if it concerns glass, plastic or metal for example. These details
are also required for any chemical contaminants.
This detailed description is desirable because various possibilities for monitoring and control
may be required. For example, metal may be separated by means of magnets, but this control

measure would be ineffective for glass. This is why general terms such as ‘foreign bodies’
cannot be used.
As mentioned above, the information resulting from phases 2 through 6 (end-product and
ingredients specifications including intended use and process information, a list of possible
hazards must be prepared.
Helpful tip 2:
Generic risk assessments such as those recorded in the Feed Support Products may be used as a source
of information. These generic risk assessments describe any generic hazards per process phase.However,
each company should review which (additional) hazards would apply to their specific situation.
Other sources of information are the GMP+ International quality series with details on various
subjects, including a study into drying processes within the feed sector. These information
sources may be consulted on the website of GMP+ International.
Helpful tip 3:
The hazards as identified must be recorded per process phase, using the hazard analysis table. For an
example of such a table, see Appendix 1 of this guideline.
3.7.2. Phase 7.2: Risk assessment

Subsequently, the Feed Safety Team should determine which possible hazards as defined
under 7.1 are actually a risk. The term risk is defined by two elements: severity and likely
occurence of a potential hazard. The hazard must be of such a nature that eliminating or
reducing to an acceptable level is essential for manufacturing safe feed (severity and which
realistically could be expected to occur (likely occurence).
Severity is the effect on the target animal's health as well as the consequential damage for
humans when products of animal origin are consumed. Severity must be based on literature,
practical experience and/or experimental data etc., and is classified into three levels:
Severity Explanation
High Serious diseases, harmful effects and/or wounds, both occurring immediately
and long-term effects, possibly with fatal consequences.
Medium Substantial diseases, harmful effects and/or wounds, both occurring
immediately and long-term effects.
Low Minor diseases, harmful effects and/or wounds, not or hardly occurring, or only
long-term effects after extremely high doses.
Both the severity for the target animal as the severity (consequential damage) for humans must
be determined. The highest value is leading.
Helpful tip 1:

The Fact Sheets undesirable substances and products may be used as a source of information. These can
be consulted on the website of GMP+ International.
Likely occurence is the chance of a hazard being present in the end-product at the time of
consumption by the target animal and/or human. Likely occurence is based on measurements,
observations or expectations of the company specific situation and may be classified in three
levels:
Likely occurence Explanation
Low theoretically possible, but hardly occurs in practice

Medium may occur, it has been known to occur with some frequency
High occurs frequently
Severity x Likely oocurence results in Risk, which may be classified in four levels:
Likely occurence of presence in product
Low Medium High

↓ →
Severity of the High 3 4 4
hazard Medium 2 3 4
Low 1 2 3
A company can ensure that likely occurrence of risk is reduced and controlled by
taking (control) measures. The next section provides more information about this.
If the risk assessment of the hazard results in 4, it does not involve a critical control
point (CCP). This determination will be made during the next phase in HACCP
analysis. This serves to determine if a risk actually concerns a CCP. However, the
company must realise that action is required for higher risks.
Helpful tip 2:
Risk assessment must be recorded for each process phase, including a brief motivation of the elements
probability and seriousness. This motivation serves to clarify the choice that the Feed Safety Team made
using the hazard analysis table. For an example of such a table, see Appendix 1 of this guideline.

3.8. Phase 8: Determining critical control points (CCP’s)

§ 8.5.2.3 Establishing Critical Control Points (CCPs)
3.8.1. Phase 8.1: Determining control measure

After determining the risk category, the Feed Safety Team must determine which measures are
required at which part of the manufacturing process in order to control these risks, i.e.
prevention or reduction to an acceptable level. These measures are called control measures.
Classification into risk categories determines the control measures to be implemented. The
following may be discerned:
Risk category Control measures
1 No control measures required
2 No control measures required, but conclusion must be re-assessed

periodically during the annual verification audit.
3 Control measures required In general, control by means of general
control measures from the prerequisite programme will suffice.
4 Specific control measures are required, specifically developed in order to
control risk.
Control measures may vary from technical / technological solutions to organisational and/or
procedural measures.
Helpful tip :
Various control measures may be required in order to control a single determined risk. It is also possible
for a single control measure to control various risks.
3.8.2. Phase 8.2: Establishing critical control points ( CCP’s)

Subsequently, for each risk and associated control measure, the Feed Safety Team must assess
if this control measure is to be the last measure in the process for controlling the risk. If yes,
that point in the process is a critical control point (CCP).

The assessment if a control measure relates to a critical control point should take place
systematically. One of the instruments to be used is the CCP decision tree. Each phase in the
manufacturing process with associated risk and control measure must be run through the CCP
decision tree.
1 None
Quest ion 1
What type of control measure 2 None
(phase 8.1) is required
Are the relevant
according to the risk control measures and
assessment have these been
(phase 7.2)? Prerequisite If required, prepare include in
3 control validation verification
(Phase
4 Control measure
Quest ion 2 Stop production

Are the relevant control change the process
measures present and have NO product and start with
these been implemented?
YES
Quest ion 3
Is this control measure
specifically intended for
eliminating this risk or YES CCP
reducing it to an acceptable
level during this process
phase?
NO
Quest ion 4
Will the risk be eliminated or
reduced to an acceptable NO CCP
during one of the subsequent
process phases?
YES
No CCP include in validation

and verification procedures
(Phase 12)

Measures related to critical control points (CCP’s) are classed as Control Measures. Control
measures may relate to (process) parameters that can be controlled in such a manner that
hazards relating to feed safety are prevented, eliminated or reduced to an acceptable, for
example time, temperature, humidity and pH.
Control measures must be supported by instructions or specifications, training and education.

Control measures must be monitored (see phase 10), accompanied by corrective measures
(see phase 11) and the control measures must be validated and verified (phase 12). These
obligations will be described in detail in
the following phases.
Control measures not related to critical control points (CCP’s) are classed as Prerequisite
control measures. Prerequisite control measures are actions or activities that are often part
of the prerequisite programme, such as training of personnel, lay-out and interior of the
company premises, pest control and cleaning and sanitising programmes, purchasing, etc. In
general, these prerequisite control measures ensure and acceptable control level.
Prerequisite control measures must be validated in order to demonstrate adequate

performance of the prerequisite programme (see step 12.1). The prerequisite control
measures are approved after validation by the Feed Safety Team.
The effectiveness of controlling the identified hazard by means of prerequisite control

measures must be verified (see phase 12.2) by means of planned regular intervals.
Helpful tip :
Determining a critical control point (CCP) must be recorded. The hazard analysis table may be used for
this purpose. For an example of such a table, see Appendix 1 of this guideline.

3.9. Phase 9: Determining feed safety limits for CCP’s

§ 8.5.3 CCP control
§ 8.5.3.1 Determine feed safety limits for CCPs
Based on the decision tree, the critical control points (CCP’s) within the process have been
determined. This concerns the (process) parameters (for example time and temperature) that
can be controlled to such an extent that risks are prevented, eliminated or reduced to an
acceptable level.
During this phase, the measuring values for these CCP’s where safe product can be delivered
must be determined. Within the GMP+ FSA module, these values are referred to as the
rejection limits. A rejection limit is a value indicating the line between acceptable and non-
acceptable product. If this limit is exceeded, the product is not suitable for use as feed.
In order to limit the presence of risks as much as possible and prevent rejection of product, an
action limit can also be determined. An action limit for the relevant product or process
parameter is derived from the rejection limit and must be substantially lower. When this limit
is exceeded, the cause must be found and corrective measures must be implemented in order
to either resolve or limit the cause.
When determining the action and rejection limits relating to CCP’s, it is mandatory to comply
with requirements as set out in the relevant feed legislation and the GMP+ FSA scheme. In TS
1.5 Specific feed safety limits) of the GMP+ FSA scheme, these action and rejection limits are
included in an overview.
If action or rejection limits are not set out in legislation or the GMP+ FSA scheme, the feed
safety limits relating to the CCP’s must be set, supported and recorded based on internal
research.
Helpful tip :
See Appendix 2 for an example of a summary overview of a CCP.

3.10. Phase 10: Monitoring CCPs

§ 8.5.3 CCP control
§ 8.5.3.2 Monitoring CCPs
TS 1.2 Purchase
TS 1.6 Sampling
TS 1.7 Monitoring
The feed company must prepare and implement a monitoring plan. Monitoring is measuring,
analysing and/or observing (visual supervision) of process parameters according to a plan in
order to be able to determine if a CCP is controlled.
Monitoring CCP’s may relate to continuous, semi-continuous or random sample measuring,

depending on the process phase and the nature of the (process) parameter to be measured.
The results of monitoring must be documented.
Helpful tip :
See Appendix 2 for an example of a summary overview of a CCP.

3.11. Phase 11: Determining / corrections and corrective actions

§ 8.7 Control of Product and Process nonconformities
§ 8.7.1 Define corrections and Corrective actions
§ 8.7.2 Handling of potentially unsafe products
After determining the action and rejection limits and preparing a monitoring programme, the
company must determine which corrections and corrective actions must be carried out when
a limit is exceeded in spite of the measures. The safety of the end-product is then no longer
controlled.
Corrections
Corrections are actions to eliminate a detected nonconformity. A correction may be, for
example, reprocessing, further processing and/or elimination of the adverse consequences of
the nonconformity (such as disposal for other use or specific labelling).
Corrective actions
Corrective actions: eliminates the cause of a non conformity and prevents recurrence. These
actions ensures that the cause of the nonconformity is detected and eliminated and can
therefor not result again in an exceeded limit. Corrective actions can be, for example,
adjustments to equipment, adjusting the production process and/or choosing different
suppliers or country of origin of feed ingredients.
In the absence of continuous monitoring, corrections and corrective actions must relate to
the relevant lot from the previous measuring moment.

3.12. Phase 12: Validation and verification

Before being implemented, the HACCP system must be assessed in order to ensure it can
perform as intended. This is referred to as validation. This is phase 12.1. Subsequently, the
HACCP system is implemented, whereupon the company must verify if it works as intended
within the operational environment. This is phase 12.2.
3.12.1. Phase 12.1: Validation of the HACCP system

§ 8.6 Validation & Verification
§ 8.6.1 Validation
§ 8.6.2 Verification
Before implementing the HACCP system, the company must determine if the HACCP system
can perform in the operating environment. The company must determine if the control
measures developed, including the cleaning programmes or the metal detectors present will
be adequate for controlling hazards. This is referred to as validation.
The following aspects must be assessed:

a. is the list of potential hazards based on sound scientific data and is it complete;
b. were the questions asked in order to test the impact of the risks answered based on
sound scientific data and technical knowledge;
c. are the control measures (both general and specific) sufficient to control the hazards;
d. will fluctuations within the features to be controlled (equivalent to process criteria)
within the recorded critical limit values have no impact on product safety;
e. are the features and methods used in order to monitor the control measures adequate;
f. are corrective measures adequate and will these prevent an unsafe product from being
released and do these demonstrate that the situation may be corrected immediately;
Each time the organisation implements changes that may have a negative impact on feed
safety, the assessment must be updated. Examples of changes are:
a. new ingredients or new products, the production conditions (company units and
buildings and the immediate surroundings of the company, cleaning programmes);
b. storage or transport conditions;
c. changes to the customer's use of the product;
d. all information indicating a new hazard relating to the product.
The validation must be conducted by the Validation Team. More information is included in
phase 1 Forming the Feed Safety Team and Validation Team.

3.12.2. Phase 12.2: Verification of the HACCP system

§ 8.6 Validation & Verification
§ 8.6.1 Validation
§ 8.6.2 Verification
After the HACCP system has been set up, verification of (elements of) the system must
periodically (at least annually) take place. Verification is the use of additional information in
order to test if the system is still effective and used as it was intended. Verification is
conducted by the Feed Safety Team and the findings must be recorded in writing.
Verification of (elements of) a HACCP system must consist of:

a. Evaluation of the HACCP system and the recorded registrations.
This includes testing all specific control measures, deviations and corrective measures in
order to confirm implementation and effective control of critical control points (CCP’s).
Testing all general control measures in order to confirm implementation and
demonstrating effective control of related hazards.
b. Assessment of the prerequisite programme.

The Feed Safety Team must review if the prerequisite programme as prepared still
matches the actual situation.
c. Assessment of product analysis data.

Periodical testing of end -products on microbiological and chemical features is a way to
check if the HACCP system still works as intended. The end product specification must be
used. If analysis results do not comply with end- product specifications, corrective
measures must be taken.
d. Verification of the hazard analysis.

The flow diagrams, floor plan and hazard analysis specific to the company must be
reviewed as often as required. This enables the company to ensure if these still match
reality and if any new or additional hazards may occur pertaining to ingredients or the
production process. The Feed Safety Team shall record how frequent such a revision
should be conducted, but must at least be re-
viewed once per year and immediately after new relevant information is available.
This revision is relevant when:

1. a crisis / calamity has occurred or is suspected;
2. a report is issued by the Early Warning System;
3. news in the media is released;
4. hazard analyses are updated at chain level;
5. other indications arise (own sampling, databases);
6. changes are made to the production process.

It is possible that hazards remain denied or undetected for years. At the time where a
company has gained insight into the potential hazard, it must immediately be included in
the company specific HACCP plan. Not only external factors also results of internal
sampling of ingredients, end- products and/or results from databases can provide input
to re-assess and, if necessary, revise, the internal hazard analysis.
e. Assessing implementation of legislation and regulations

The Feed Safety Team must review if all actions are still in accordance with the applicable
legislation and regulations relating to food and feed safety. The Feed Safety Team must
also continuously remain up to date with any changes to legislation and regulations,
including: if there are any changes to the legal or GMP+ standards.
More information is included in chapter 3 of this guideline.
f. Assessment of personnel’s knowledge level

The Feed Safety Team must assess if the current personnel knowledge level relating to
feed and food safety and hygiene still comes up to required standards. If not, training is
required.
g. Internal audits
A large number of hazards are controlled by general procedures, regulations and
instructions. These procedures and instructions define many elements of the prerequisite
programme. An audit also aims to check compliance with procedures and instructions. In
particular verification of the prerequisite programme, which covers a large number of
general hazards, is vital for the system’s performance.
h. Analysis of complaints relating to food and feed safety of products.

Processing complaints within a HACCP system also provides information relating to the
HACCP system’s effectiveness.
The results of verification must be documented. The Feed Safety Team, which will continue
to play a role in maintenance of the system, must assess the verification results and submit
its findings to the management. The management shall use their findings in its own
management assessment as described in chapter 4.1.5.

3.13. Phase 13: Documentation and registrations

§ 7.5 Documented information
All other sections of the scheme can also indicate the required documented information
Documentation plays a vital part in maintaining a process control system based on HACCP
principles. Documentation ensures the demonstrable presence of the HACCP system.
Documents also provide information to employees regarding the activities to be carried out
and agreements made within a company. The required documentation derived from the
implementation of HACCP can be included in the quality documentation as required by the
GMP+ standard.
The following documents can be considered as relevant document information related to the
HACCP system:
a. Document Feed Safety Team (members and fields of expertise)
b. Motivation of HACCP analyses with support of choices made, for example:
Minutes of the Feed Safety Team meetings
c. End- product specifications or end-product group specifications;
d. Flow diagrams and a floor plan
e. Prerequisite programme as applied by the company
f. Hazard analyses (tables)
g. Determination and description of CCP’s (in a table or overview and where required
supplemented by documentation
h. Determining action and rejection limits
i. Corrective measures
j. Description of validation and verification of the HACCP system
Registration
After implementation of the HACCP system, data are collected in various places that must be
registered. This concerns:
a. Monitoring data of CCP’s and general control measures
b. Verification of CCP’s
c. Verification of the HACCP system by means of taking samples and sample analysis of
products
d. Verification of the hazard analysis
e. Internal audits
f. Complaints analysis

Appendix 1 Completing the hazard analysis table

When identifying hazards in each process phase and walking through the CCP decision tree, the hazard analysis table can be completed line by
line. This also ensures that the HACCP analysis has been demonstrably conducted (with documented evidence).
Please Note: The template below also applies to the company specific HACCP analysis. A different template should be used for completing the
hazard analysis in the context of the Risk Assessments as part of the Feed Support Products.
The hazards are identified For each hazard, A risk assessment is conducted The (control) Is the determined control This column should always
for each process step in indicate in which of for each hazard. Probability x measures for risk measure the last step in the contain a summary motivation
the flow diagram (phase 7) the three categories seriousness and the resultant class 3 or 4 are process to control the risk? This of the elements Likelyhood x
and entered into the the hazard is risk class are entered into the summarised in this assessment must take place severity. This motivation serves
hazard analysis table. The classified relevant columns. column. This may systematically. One of the to clarify the choice that the
columns Nr, Process phase (M: Microbiological, concern measures instruments to be used is the HACCP made. Additionally, this
and Description of Hazard C Chemical, that are part of the CCP decision tree. Each phase in information may be used for
are to be completed in the P Physical). prerequisite the manufacturing process with subsequent verifications and
table line by line. programme or associated risk and control also by later Feed Safety Team
measures included measure must be run through after their composition has
elsewhere in the the CCP decision tree. changed. This way, the
GMP+ FC Scheme. This column must be completed considerations remain
if it concerns a CCP. accessible and available.
(The questions below relate to
the decision tree)
Nr. Process Description Cat. Likelyhood Severity Risk Type of Reference Q1 Q2 Q3 Q4 CCP Motivation
phase of hazard of occurence measure
1 Purchasing C 1 2 2 2 - - - -
M 2 3 4 4 Y N N CCP 1

Appendix 2 Summary overview of CCP’s and general control measures

As is apparent from phases 9 through 10 of the phase plan, action and rejection limits, monitoring programmes and corrective actions must be
prepared for each CCP. In order to enhance clarity, this information can be entered in an overview for each CCP. This table may also contain a
reference to the required procedures, instructions and registration forms (documentation).
From the hazard analysis, it has become apparent that many general control measures (which are often part of the prerequisite programme) play
an essential role in reducing the hazard. It is recommended to summarise these control measures in a table as well. Where possible, indicate
monitoring frequency and corrective actions (this depends on the general control measure and will not be possible in all cases). Also report the
required procedures, instructions, registration forms and other documents.
• Reference to the GMP+ Feed Safety Assurance Scheme (process control)
Example of overview
CCP Description Standards Monitoring Corrective actions after deviations Documentation

of the
control measure
Action limit Rejection How Frequency Responsible Description of action Responsible
limit
CCP 1 P

At GMP+ International, we believe
everybody, no matter who they
are or where they live, should have
access to safe food.
GMP+ International
Braillelaan 9
2289 CL Rijswijk
The Netherlands
t. +31 (0)70 – 307 41 20 (Office)
+31 (0)70 – 307 41 44 (Help Desk)
e. [email protected]
Disclaimer:
This publication was established for the purpose of providing information to interested
parties with respect to GMP+-standards. The publication will be updated regularly. GMP+
International B.V. is not liable for any inaccuracies in this publication.
© GMP+ International B.V.

All rights reserved. The information in this publication may be consulted on the screen,
downloaded and printed as long as this is done for your own, non-commercial use. For other
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S9.4 - Applying HACCP

Version EN: 1 March 2021

1.1. STRUCTURE HACCP GUIDELINE........................................................................................................................................ 3

2. HACCP SYSTEM REQUIREMENTS ..................................................................................................... 4

3. HACCP BASED PLAN ......................................................................................................................... 6

APPENDIX 1 COMPLETING THE HAZARD ANALYSIS TABLE .............................................................. 31

APPENDIX 2 SUMMARY OVERVIEW OF CCP’S AND GENERAL CONTROL MEASURES ................... 32

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For definitions and terminology please check F 0.2 Definition list.

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2. HACCP system requirements

2.1. Management responsibilities

2.1.1. Defining quality policy

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R 1.0 Feed Safety Management Systems Requirements

2.1.2. Defining the scope of the HACCP system

R 1.0 Feed Safety Management Systems Requirements

2.1.3. Tasks, responsibilities and authorisation (TRA)

R 1.0 Feed Safety Management Systems Requirements

2.1.4. Making resources available

R 1.0 Feed Safety Management Systems Requirements

2.1.5. Management assessment of the HACCP system

R 1.0 Feed Safety Management Systems Requirements

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3. HACCP Based plan

HACCP based plan

These phases will be described in detail in the following paragraphs.

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3.1. Phase 1: Forming multi-disciplinary Feed Safety Team(s) and

R 1.0 Feed Safety Management Systems Requirements

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3.2. Phase 2: Description of feed

R 1.0 Feed Safety Management Systems Requirements

Information regarding end-products is required in order to be able to correctly assess the

Characteristics of end-products provide an initial indication of possible hazards. In addition to

In principle, each end-product must be described separately in a specification. For practical

Characteristics of end-products can be prepared based on a so-called three- category system.

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3.2.2. Phase 2.2: Description of ingredients and processing aids

R 1.0 Feed Safety Management Systems Requirements

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3.3. Phase 3: Determining the intended use of feed

R 1.0 Feed Safety Management Systems Requirements

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3.4. Phase 4: Determine process information

3.4.1. Phase 4.1: Preparing flow diagrams

R 1.0 Feed Safety Management Systems Requirements

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Process phase This symbol indicates an activity or action (a process

Product This symbol indicates a tangible product (for example

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3.4.2. Phase 4.2: Preparing a floor plan

R 1.0 Feed Safety Management Systems Requirements

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3.5. Phase 5: Testing process information

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3.6. Phase 6: Define prerequisite programme