EH 452 FSH

Hazard Analysis and Critical

Control Point (HACCP)

Chilufya Muya
 Introduction – Prerequisite Programmes (PRPs)

• HACCP systems must be built upon a firm foundation of existing compliance with
prerequisite programmes.

• PRPs are codes of good practice that comprise the fundamental principles,
procedures and means needed for safe food production.

• PRPs can be defined as basic conditions and activities that are necessary to maintain
a hygienic environment throughout the food chain suitable for the production,
handling and provision of safe end products and safe food for human consumption.
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 Introduction – Prerequisite Programmes (PRPs)

• Examples of PRPs in food safety systems may include essential preconditions such
as Good Manufacturing Practices (GMPs), Good Agricultural Practices (GAPs), Good
Hygiene Practices (GHPs), Good Veterinary Practices (GVPs) acceptable Sanitation
Standard Operating Procedures (SSOPs) and appropriate industry practices
(GDP,GSP, GPP etc).

• These form an integral part and basis for the implementation of quality and safety
assurance system – QA, HACCP, ISO 22000 among others and their audits.
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 Prerequisite Programmes (PRPs)
• PRPs refer in general to control measures that are not specific to a given point in the production
process. They are cross-cutting measures which, in accordance with ISO 22000, cover as a minimum
the following 10 points;
✓ Construction and layout of the building and associated utilities
✓ Layout premises, including workspace and employee facilities
✓ Supplies of air, water, energy and other utilities
✓ Cleaning and sanitizing
✓ Measures for the prevention of cross-contamination
✓ Management of purchased materials – i.e. raw materials, ingredients, chemical products
✓ Pest control
✓ Personal hygiene
✓ Suitability of equipment and its accessibility for cleaning and maintenance
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✓ Waste disposal systems
 Prerequisite Programmes (PRPs)
• GMPs
• may be defined as that part of a food control operation aimed at ensuring that products are
consistently manufactured to a specified quality appropriate to their intended use
• It has two complementary and interacting components;
• the manufacturing operation itself
• and the control system and procedures. (IFST, 1998)

• GMPs are the minimum sanitary and processing requirements necessary to ensure the production
of wholesome food.
• GMPs address general provisions, building and facilities, equipment, production and process
control and defect action levels. GMPs are documented in SSOPs.
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The areas addressed
through GMPs are:
• good hygiene
practices
• personal hygiene
• buildings and
facilities
• equipment and
utensils
• production and
process controls

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 SSOPs (Sanitation Standard Operating Procedures)
• are part of documented GMPs for hygiene and sanitation, required to meet regulatory
requirements for food control

• are documented descriptions of the programmed cleaning and maintenance

procedures which are carried out in the processing plant
• They are designed to prevent direct contamination or adulteration of the food
product
• SSOPs include pre-operational and in process measures and specify the frequency of
enactment of all measures specified
• The SSOP must give clear responsibility for the cleaning to an individual(s) and any
alternations must be recorded
• They are best applied to the plant environment (e.g. plant cleaning and hygiene)
whereas HACCP is targeted towards the hazards which are identified as posing a
particular threat to the particular product or process characteristics

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 ...cont’d
The SSOP should address at least the following conditions and practices:
• safety of water
• condition and cleanliness of food contact surfaces
• prevention of cross contamination from unsanitary objects to food
• maintenance of facilities for personal hygiene, protection of food and
food contact surfaces from adulteration
• proper labeling, storage and use of toxic compounds, control of
employee health conditions, exclusion of pests.

• Without the application of PRPs, an effective HACCP program cannot

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 Good Hygiene Practices (GHPs)
• All practices regarding the conditions and measures necessary to ensure
the safety and suitability of food at all stages of the food chain. Examples
may include;
1. Personal hygiene

2. Product packaging and labelling

3. Internal audits for hygiene, food safety and quality

4. Pest control

5. Waste removal

6. Hygiene and sanitation

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 Hazard Analysis and Critical Control Point (HACCP)
• Hazard Analysis and Critical Control Point (HACCP) is an internationally
recognized system for reducing the risk of safety hazards in food
• It was developed to systematically identify food hazards and take action to
prevent, minimize or remedy them
• The aim of HACCP is to focus on potential problems and put in place specific
control and preventive measures
• An appropriately qualified person should carry out the analysis
• HACCP ensures food safety by identifying all the critical control points in a
food process where contamination can occur
• A critical control point (CCP) is simply any step in a food process where
control can be applied to eliminate a hazard or reduce it to an acceptable
level
• In practice, an effective HACCP system requires good manufacturing
processes (GMP) and good hygiene practices (GHP) to be in place, including
personal hygiene, cleaning and sanitation, training, the design of food
premises and pest control, etc.
Benefits of HACCP (Quality & Safety Systems
• Improved hygiene standards
• Reduced microbial counts in products
• Higher customer satisfaction
• Providing a formal basis for developing a relationship between food
companies and regulatory authorities
• Providing a basis for a legal defense in court
• Prevent food-related diseases and deaths
• Reduce costs and allow better resource utilization
• Improve potential for growth and participation
The key stages of establishing HACCP system

• Stage 1: Planning and Preparation

• Stage 2: HACCP Studies and development of a HACCP Plan

• Stage 3: Implementing the HACCP Plan

• Stage 4: Maintaining the HACCP System

Planning and preparation
• This is where the foundations are laid and it is important to take time here
to:
1. Identify and train appropriate people
2. Establish present support systems and evaluate need for development.
3. Consider the most appropriate structure for the HACCP system
4. Plan the entire project, including a realistic timetable for development
and implementation of the HACCP plan
Personnel and Training
• HACCP is described as a people-based system
• Thus people should be properly educated, experienced, and trained
resulting in an effective and sound HACCP system
• The right experts also need to be identified.
The HACCP team
• It is important that HACCP is not carried out by one person alone but is the result of
a multidisciplinary team effort
• Thus the need to identify and train the HACCP team; made up of experts with
knowledge and experience from the following areas:
• Quality Assurance/Technical: providing expertise in microbiological, chemical, and
physical hazards, an understanding of risk and hazard significance assessment, and
knowledge of measures that can be taken to control the hazards
• Operations or Production: with responsibility and detailed knowledge of
operational activities required to produce the product
• Engineering: with knowledge of process equipment and environment with respect
to hygienic design and process capability
• Additional expertise: may be provided from both within or external consultancies.
o Supplier Quality Assurance: raw materials; Distribution/Logistics: storage and
handling; Procurement; Microbiologist; Toxicologist; HACCP experts; Other:
Human Resource, training departments, notetaker
Personnel attributes required
• Being able to evaluate data in a logical manner using expertise within
the team and perhaps using published data for comparison
• Being able to analyze and solving the root cause of problems
effectively and permanently
• Creativity: seeking information and ideas within and outside the box
• Being able to get things done and make recommendations happen
• Communication skills
• Leadership abilities
 Baseline audit and gap analysis
• It is important to evaluate the resources and systems in place and compare
with the requirements to manage HACCP effectively
• This will include a review of your facility environment as well as an
assessment of the current systems and personnel resources
• The differences between them are the gaps that will need to be filled
• To identify the gaps, a baseline audit of current control measures for food
safety and quality management is done
• This is done using external auditors with expert knowledge of the
standards and systems required to support HACCP
Gap analysis check list
1. Environment
• Facility design: buildings, floor, equipment, cross-contamination
o Traffic patterns: people, equipment
o Air and drain flow
o Personnel hygiene facilities
o Hand washing stations
o Rest room and cafeteria
oStorage and distribution practices
oEquipment: suitable for cleaning, preventative maintenance,
oCalibration
oLighting
2. Programs
• Supplier quality assurance: raw materials used, approved supplier list, handling,
any tests carried out and is the lab certified/approved?
• Cleaning and disinfection (sanitation): sanitation schedules, cleaning procedures
• Allergen control: allergens clearly identified in raw material, specifications
• Pest control: building protection against pests, third-party contract with a
licensed provider.
• Good laboratory practice
• Preventative maintenance
• Food defense and bioterrorism: unauthorized access
• Trace, recall, and incident management
• Quality management systems
• Other good practice program references e.g., for warehousing and distribution
3. People
• Personal hygiene
• Personal behavior: rules
• Training
• Culture: noncompliance
 Guidelines for the application of HACCP system:
1. Assemble the HACCP team
2. Describe product
3. Identify intended use Preliminary Steps
4. Construct flow diagram
5. On-site verification of flow diagram
6. List all potential hazards, conduct a hazard analysis and determine control measures
7. Determine CCPs
8. Establish critical limits for each CCP
9. Establish a monitoring system for each CCP HACCP Principles
10. Establish corrective actions
11. Establish verification procedures
12. Establish record keeping and documentation
Principles of HACCP
1. Conduct a hazard analysis
2. Determine the CCPs
3. Establish critical limit(s)
4. Establish a monitoring system
5. Establish corrective actions
6. Establish verification procedures
7. Establish documentation

Source: CODEX
 1. Assembling a HACCP team
• Small owner-operated businesses: can produce good food safety
programmes without the help of a HACCP team
• Medium to large-sized food businesses: may have experience and
knowledge needed to put together a HACCP team
• Larger businesses: the HACCP team should include a manager, quality
assurance manager, or supervisor responsible for the process under study
• All team members should receive at least a basic introduction to HACCP.
• Training can be formal classroom training, on-the-job training, information
from college courses, and/or HACCP books or manuals
2. Describe the product
• Describe the product giving detail of its composition, physical/chemical structure,
packaging, safety information, processing treatments, storage and method of
distribution:
• Product Name
• Composition
• End Product Characteristics
• Method of Preservation
• Packaging – Primary
• Packaging – Shipping
• Storage Conditions
• Distribution Method
• Shelf Life
• Special Labeling
• Customer Preparation
3. Identify the intended use
• Identify the intended use of the product, its target consumer with
reference to sensitive population
• Five sensitive groups in the population
• Elderly
• Infants
• Pregnant
• Sick; and
• Immunocompromised
4. Construct a process flow diagram
• Details of all process activities
including inspections, transportation,
storage and delays in the process
• Inputs into the process in terms of raw
materials, packaging, water and
chemicals
• Output from the process e.g. waste –
packaging, raw materials, product-in-
progress, rework and rejected
products.
• Flow diagram showing sources of contamination
with Salmonella and CCP in processing of Poultry
Meat
 5. On site verification of the process flow
diagram
• It should be done by all members of the HACCP team during all stages
and hours of operation.
• Validate process flow diagram
1. By HACCP Team
2. Observe process flow
3. Sample activities
4. Interviews
5. Routine / non routine operations
Principles of HACCP

1. Conduct a Hazard Analysis

2. Determine Critical Control Points
3. Establish Critical Limits
4. Establish Monitoring Procedures
5. Establish Corrective Actions
6. Establish Verification Procedures
7. Establish Recordkeeping and Documentation Procedures
 1. Hazard analysis
• A hazard is defined as a biological, chemical or physical agent that will
cause illness or injury when it occurs, in the absence of its control
• A "step" is a point or activity in an operation within the production process
that is essential to the proper production of the finished product
• Hazard analysis is a process used to develop a list of hazards which have a
reasonable likelihood to cause injury or illness if not effectively controlled
• It is important to consider the ingredients, raw materials, product storage,
distribution, final preparation and use by the consumer
• Risk characterization is vital in the process.
1. Hazard analysis
 RISK ASSESSMENTS

RISK ASSESSMENTS = LIKELIHOOD X CONSEQUENCE

The hazard analysis accomplishes three main objectives:
1. To identify hazards and associated control measures
2. To analyze and identify the modifications needed to the initial
process or product so that product safety is assured
3. To provide a basis for determining Critical Control Points (CCP)
2. Determining critical control points
• A hazard is controlled by one or more critical control points (CCPs)
• Critical control points are locations in a food process at which control
can be applied to prevent/eliminate a food safety hazard to
acceptable levels
• Examples of CCPs: product temperature, certification of incoming
product, microbiological testing, testing for foreign objects, chemical
concentration of a carcass rinse or spray, etc.
3. Establish critical limits
• The next step in the development of a HACCP plan is to establish
critical limits for each critical control point
• Critical limits (CL) are the parameters that indicate whether the
control measure at the CCP is in or out of control.
• The establishment of critical limits must consider the food safety
standard that must be met at each CCP
• Critical limits are designed to ensure applicable targets or
performance standards pertaining to the specific process or product
Examples of parameters for critical limits
• Humidity
• pH
• Salt concentration
• Chlorine level
• Time and temperature control: Temperature recording devices should be
checked
onature of the food
ointended shelf-life of the product
omethod of packaging and processing
oCooked/ cooled products
4. Establishment of monitoring procedures
• Once critical limits are set for each CCP, procedures must be
established to monitor the CCPs to determine whether the critical
limits are being met
• If the critical limit is a numerical value, then monitoring usually
involves a measurement
• If the critical limit is defined as the presence or absence of an
attribute, then the monitoring procedure may involve observation
• Monitoring procedures should be designed to determine when
deviations from the critical limit occur so that appropriate corrective
actions can be initiated
Objectives for monitoring
1. To track the control process
2. To determine when there is a loss of control and a deviation occurs
3. To provide a written document to be used in verification
Monitoring will go smoothly if :
1. employee(s) responsible for monitoring are identified
2. Train the employee(s) monitoring in the testing procedures
3. established, the methods of recording test results, and actions to be
taken when critical limits are exceeded
4. Ensure that the employee(s) understand the purpose and importance
of monitoring
Steps in establishing monitoring procedures
• For each CCP, identify the best monitoring procedure
• Determine the frequency of monitoring for each CCP
• Determine what testing procedures need to be done for each
monitoring function
• Identify and train the employee(s) responsible for monitoring
• Make sure that the employee doing the monitoring sign all records
and documents associated with CCP monitoring at the time the
monitoring takes place.
Monitoring system
• A monitoring system shall be established for each CCP to demonstrate
that the CCP is in control
• Monitoring system must include all scheduled measurements or
observations relative to the critical limit(s)
• Monitoring methods and frequency must be capable of determining
when critical limits have been exceeded in time for the product to be
isolated before it is used or consumed.
5. Establish corrective actions
• The corrective actions must be determined for each CCP in cases
where the CL is not met or deviated
• The specific corrective actions depend upon the process used and
type of food produced
• The corrective actions consist of:
oIdentifying and eliminating the cause of the deviation,
oEnsuring that the CCP is under control after the corrective action is
taken,
oEnsuring that measures are established to prevent recurrence, and
oEnsuring that no product affected by the deviation is shipped.
• The corrective actions should include:
oDetermining the disposition of non-complying product;
oCorrecting the cause of the non-compliance to prevent a recurrence;
oDemonstrating that the CCP is once again under control
oMaintaining records of the corrective actions
 6. Establish verification procedure
Some things you can do to verify your HACCP system are:
1. Analytically test or audit your monitoring procedures
2. Calibrate your temperature/test equipment
3. Sample your product, including microbiological sampling
4. Review your monitoring records
5. Review your records of deviations and product dispositions
6. Inspect and audit your establishment’s operations
7. Sample for environmental and other concerns
Steps in establishing verification procedures
• Determine the appropriate verification procedure to ensure that each
CCP and critical limit is adequately controlled and monitored
• For each CCP, determine procedures to ensure that employees are
following your established procedures for handling product deviations
and for recordkeeping
• Identify the frequencies for conducting any verification checks and
the records where the results will be recorded
• Enter the details on the appropriate verification form for future
reference.
Verification and validation
• Validation is the gathering of evidence to justify elements of the
HACCP plan and demonstrating that it has been carefully prepared
based on sound scientific and technical evidence.
• Verification is the process by which conformity with the HACCP plan is
determined and its effectiveness observed in practice.
Verification
• Check that a verification schedule exists, describing the range of
verification activities.
• Check also that the schedule describes the activity, responsibility,
frequency and records.
• It should include some or all of the following:
overification of cleaning and sanitation
overification of CCP record compliance
overification of GMP policy compliance
overification of equipment accuracy.
Records of verification should include:
• operations (including calibration);
• deviations, corrective actions, and other measures taken with regard to the
product;
• internal audits;
• supplier audits; and
• changes to the system.
Common ways of gathering information include trend analysis on:
• data recorded at CCPs as part of the monitoring process the results of on-line
testing
• end-product testing
• consumer and customer complaints
• hygiene testing analysis or market-place samples
• equipment calibration checking
Summary
• Verification plan Details: tasks, responsibilities, frequencies, methods, procedures,
follow-up
• Demonstration of Regarding: executed corrective measures, monitoring,
conformity procedures, training, traceability, testing
• Information gathering Sources: registered complaints, results of monitoring and
end product testing, trade samples, random sampling, results of previous
conformity verification.
Principles of Auditing
• a “systematic and independent examination of how activities and related results
comply with planned arrangements and whether these arrangements are
implemented effectively and are suitable to achieve objectives”.
• Audits can be performed internally, externally or by a third party.
• The purposes of a competent authority audit of a HACCP system is to obtain
evidence that HACCP principles, and prerequisites are correctly implemented
and maintained.
• The approach to the audit should be based on the internationally agreed
standard format as described in ISO
 Auditing
• The process of auditing can provide a useful mechanism by which
supplier-customer (external and internal) trust is built up.
• The results of audits, certificates, or audit reports are a starting point
that aids communication.
 Purpose of Audits
• Explain how audits can be used to assess a wide variety of activities,
including;
oorganizational effectiveness,
osystem and process effectiveness,
operformance measurement,
orisk management, and
oconformance to requirements
Types of Audits Stages and steps involved
• various audit types; • Audit initiation
oproduct • Audit preparation
oprocess • Onsite auditing activities
osystem o Opening meeting
ofirst-, second-, and third- o Document review
party o Audit process
ocompliance etc. o Procedures/practices/records
o Recording non-compliance
o Closing meeting
• Report Preparation; Issue of report
• Closure of non compliance
7. Establish recordkeeping procedures
Reasons for establishing records
1. Records serve as written documentation of your establishment’s
compliance with its HACCP plan
2. They allow you to trace the history of an ingredient, in-process
operations, or a finished product, should problems arise
3. Records help you identify trends in a particular operation that could
result in a deviation if not corrected
4. If you were ever faced with a product recall, HACCP records could
help you identify and narrow the scope of such a recall
5. Well-maintained records are good evidence in potential legal actions
against an establishment
Steps in establishing recordkeeping procedures
• Review the records you currently maintain and determine which ones
adequately address the monitoring of the CCPs you have identified
• Develop forms to document your HACCP system
• Develop any forms necessary to fully record corrective actions taken
when deviations occur
• Identify the employees responsible for entering monitoring data into
the records and ensure that they understand their roles and
responsibilities
• Enter the record form name(s) on the appropriate HACCP Plan Form or
HACCP Worksheet under column adjacent to the appropriate CCP
• Enter the appropriate record form name(s) under the verification
procedures for the appropriate CCP
Failure of HACCP
• The food operation is not yet ready for HACCP
• Only some of the principles are applied
• a badly designed or badly run food operation can result in too many
CCPs
• failure to establish relevant monitoring systems or establish proper
corrective action
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HACCP Based System

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 Why HACCP fails
• The food operation is not yet ready for HACCP
• Only some of the principles are applied
• The principles have not been applied appropriately

Failure to consider all the hazards when conducting the hazard analysis

• A badly designed or badly run food operation can result in too many CCPs
• Failure to establish relevant monitoring systems or establish proper corrective
action.

The HACCP plan is perceived as a ‘paper exercise’ not implemented in practice

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Implications for Managing HACCP

• Training on its own is not enough

• Commitment to implementing HACCP

• Changes in behavior /working practice

• Involvement of all staff

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In Conclusion

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