HACCP (Hazard Analysis Critical Control Point)

Definition
1. Hazard
● A property which may cause a product to be unsafe for consumption
● A biological, chemical or physical agent that is responsibly likely to cause illness or
injury in the absence of its control
2.Control Point (CP)
● Any step at which biological, chemical or physical factors can be controlled
3.Critical control point (CCP)
● A step at which control can be applied and is essential to prevent or eliminate a food
safety hazard or reduce it to a acceptable level

Seven steps/principles involved in HACCP

1.Hazard Analysis 2.Critical Control Point
● Exam the entire food production ● Identify stages where hazards can
process to identify potential hazards be controlled such as purchasing of
to food safety (biological, chemical, raw materials, cold storage of raw
physical) materials
● Evaluate risk and severity for each
hazards

3.Critical Limits 4.Monitoring Procedure

● Set specific limit to ensure safety ● Include frequency, responsibility and
such as cooking or storage methods for tracking CCPs
temperature and time ● Include visual inspection and
● As well as appearance and texture physical measurement such as
parameter temperature reading
● Aims to detect deviations promptly

5.Corrective Actions 6.Verification Procedures

● Define actions to correct deviations ● Regular audit, testing and review to
from established limits to prevent confirm the HACCP system’s
unsafe products from reaching the effectiveness
market

7.Record system
● Maintain accurate records for reference and review, including food safety details,
monitoring data and corrective actions.
Why Use HACCP?
1.Management of product safety
2.Prevention of safety incidents
3.Limitation of traditional quality control
● Inspection lacks full accuracy, relies on human oversight
● Often use random sampling, which has inherent risk
● Sampling depends on sensitive and reproducible technique but can’t fully represent
batch variations
4.External Pressure
● Government policies
● Enforcement authorities
● Customer Requirement
-Safety assurance in purchased food
-Supplier audits to manage risks
-Confidence in problem-free supply chain
● Media
-Media amplify food safety issues, pushing industries to ensure high transparency
-Manufacturers need thorough documentation to response effectively to complaint
including HACCP plan, ingredients specifications, monitoring records and robust
training programs
5.Many benefits
6.Foundation for the development of effective product management system

Benefits of HACCP
● Provide a preventative system with a systematic and science-based approach
● Increase confidence for food safety processes
● Facilitates efficient and effective government oversight with proper record-keeping,
aiding in regulatory inspection and external audit
● Assigns responsibility for food safety to manufacturers and distributors
● Assists food companies in competing effectively in the global market
● Reduce barriers to international trade
● Strengthens quality management system through the active participation of
personnel across all food operation areas
● Promote the efficient use of resources and cost-effective control system, focusing on
critical processing areas
HACCP Program Prerequisites

1.Facilities 2.Supplier control

● Proper location, design, construction ● Suppliers should have GMP or a
and sanitation to minimise food safety program in place,
cross-contamination risks subject to audits
● Location: Away from contamination
sources
● Building design: Prevent entry of
pests and maintain sanitary condition 3.Specification
● Employee facilities: Provide ● Written specifications are required
hand-washing station, toilets and for all ingredients, products and
changing room packaging materials
● Storage facilities: Avoid
contamination 4.Production equipment
● Equipment must follow sanitary
design and have regular
maintenance and calibration
schedule

5.Cleaning and Sanitation 6.Pest Control

● Written procedures must be follow for ● A documented pest control
cleaning and sanitation of equipment program is necessary
and facilities, with clearly defined ● Focuses on detection, exclusion,
schedule elimination of pests
● Includes daily housekeeping and ● Prevent contamination from pest
comprehensive facilities cleaning control chemicals
● Requires safe cleaning chemical, tools ● Maintain records of pest control
and trained personnel

7.Personal Hygiene 8.Training

● All employees and visitors must strictly ● Both management and personnel
adhere to personal hygiene practices need regular training in food safety
● Hand-washing is essential and should and HACCP practices
be practised frequently ● Cover hygienic food handling,
personal hygiene requirements and
dangers of poor hygiene
● Equipement operation,
maintenance, and cleaning

9.Traceability and Recalls 10.Chemical Control

● Batch numbers for traceability ● Proper segregation and usage of
● Written recall procedure to handle non-food chemical such as cleaning
recall products agents, fumigant and pesticide
● Ensure quick and complete retrieval ● Only use government-approved
pesticides or chemicals
of potentially unsafe food product
11.Receiving,Storage and Shipping

Receiving
● Ensure the receiving area for raw materials is separate from processing areas and
finished product to avoid cross-contamination
● Limit activities at receiving area to inspection and sampling of raw materials if
necessary
Storage
● Ensure storage condition meet HACCP plan requirements(prevent damage and
contamination
● Maintain proper and sanitary conditions such as temperature and humidity for raw
material and products
● Monitor storage condition including pest control and maintain record of monitoring
Shipping
● Only ship products that meet all food safety requirements
● Takes measures to prevent damage, contamination, deterioration during
transportation
● Ensure transportation temperature requirements are met and recorded

Why a pre-requisite program?

● Ensures better control over food processing and handling, making HACCP plans more
streamlined and manageable
● Acts as a foundational step for companies not yet ready to implement HACCP
● Helps smaller factories identify and focus on essential food safety activities
● Addressing general hygiene and safety issues upfront make the HACCP process more
straightforward and the plans easier to manage
● Small and medium-sized enterprises (SMEs) gain significant advantages by
establishing robust prerequisite foundations before tackling HACCP
12 steps in HACCP development

1.Assemble and HACCP Team

● Form a multidisciplinary HACCP tem consisting 4-8 expertise
● Include members with expertise in QA/QC, food microbiology, food processing, GMP
and maintenance
● Team members must possess the ability to evaluate risks and make informed safety
judgement
● Appoint one coordinator as team leader with comprehensive training in HACCP plan
development including developing, implementing and maintaining an HACCP system
● If required, hire outside experts or consultants due to the technical nature of the
information involved
● Ensure the team is support by management to provide necessary training, resources
and time

2. Describe the food product

● Product name
-Clearly state the product’s name
● Ingredients and Manufacturing process
-Detail the components and steps involved in creating the products
● Composition
-pH level, water activity, preservatives
● Packaging
-Packaging unit size, material used, storage condition during packaging
● Shelf life and storage condition
-State the expected shelf-life of the product
-Include optimum storage temperature and conditions
● Labelling instructions
-Provide clear guidelines for handling, storage and use(cooking time and
temperature) of product
● Distribution condition
-Condition required for safe transportation and storage during distribution
● Actual use of the product
-Ready-to eat
-Requires cooking before consumption
-Intended for industrial use for a raw material
● Sales information
-Indicate how the product is sold such as bulk, retail or larger operation

3.Intended use of the product

● Common use of the product must be known for the hazards analysis to be done
● Typical use: Household consumption, food service or industrial processing
● Targeted consumer: Determine who will use the product
 ● Consider at-risk group: Pay attention to vulnerable populations such as elderly,
pregnant women, infants who may be more susceptible to biological and chemical
hazards

4. Construct a process flow diagram

● Step by step outline of the manufacturing process
● Should identify all the key steps from raw material receive, all handling, sorting,
preparation, processing, packaging and shipping
● Any rework materials to be used also be identified in the flow diagram

5. Conduct a on-site verification of the flow diagram

● Review on-site of the manufacturing operation to verify the flow diagram
● Based on the result of this review, the process of flow diagram should be modified if
required
● Any missing processing steps means that the step is never subjected hazard analysis
and cause inaccurate HACCP plan
6. Conduct Hazard analysis

Two-Step Process
1.Identify Hazards
-The first step is identifying potential threats to human health (biological, chemical and
physical hazards) introduced into food during production.
Key Aspects to identify hazards
-All raw materials and ingredients use
-The activities and operations including storage, handling and distribution at each of the
steps in the flow diagram
-The intended use of the products, their consumers
-The hazards that are likely associated with the product if not controlled
-Safety records of the products

2.Preventive measures/Hazard Evaluation

-The second step involves identifying measures to control or eliminate these hazards and
reduce them to acceptable levels
-The hazards should be evaluated based on published information or prior experiences
-Severity of health consequences and impact on consumers

1.Biological Hazards 2.Chemical Hazards

Types: Types:
-Bacteria, viruses, parasites and their toxins -Naturally occurring: Mycotoxin, aflatoxin
that can make food unsafe -Added: Pesticide, Adulterants, veterinary
Sources: residues, cleaning chemicals, food additives
-Often originated from raw materials such Sources:
as birds and animals -Contamination during production process
-Processing environment -Ingredients used such as in packaging or
-Other ingredients or the processes cleaning process
themselves
Common hazards:
-Listeria, Salmonella, E.coli

3.Physical Hazards

Types:
-Foreign materials like glass, metal and plastic, stones, hair, button
Sources:
-Contaminated raw materials
-Poorly maintained equipment or facilities
-Contaminated packaging material
-Human error
Preventive Measures for Hazards
Chemicals
● Formulation control of food additives
● Testing for present of antibiotics and pesticides residue
● Use approved chemicals only
● Guarantee from suppliers
Biological
● Use of preservatives
● Thermal processing
● Frozen storage
Physical
● Random visual examination
● Screening or filtering to remove foreign body
● Detection of metal contaminants
● Guarantee from suppliers

7.CCP identification

What is CCP?
● A specific point, step or procedure in the food processing where control can be
applied. This ensures that a food safety hazard can be eliminated or reduced to an
acceptable level
● More than one step in process can be a CCP for the same hazards (pasteurisation
and refrigeration)
● One CCP can also control more than one hazards
Common Points of Control in Food Processing
● Chilling to temperature that minimise microbial growth
● Cooking to specific temperature to destroy microbial pathogen
● Product formulation such as the addition of cultures or adjusting pH and aw
● Processing method such as filling and sealing cans
● Slaughter Procedures such as antimicrobial intervention
CCP Decision Tree:
● A useful tool for identifying whether a step or raw materials is a CCP
● A set of questions (3 or 4 questions) are asked food each identified hazards
● Help to determine whether a specific step is critical to controlling a hazard
8.Establish Critical Limits

What is the Critical Limit?

● The maximum or minimum value to which a biological, chemical or physical
parameter must be controlled at a Critical Control Point (CCP) to prevent, eliminate
or reduce hazards ro acceptable levels
● Critical limits define the boundaries between safe and unsafe operating conditions at
a CCP
● These include physical parameters such as temperature, time, pH or chemical
properties such as water activity or salt concentration
● Critical limits need to be specific or exact, can’t be a range

Can be established through

● Regulatory requirements
● Technical and scientific literature, which are the bases of production processes
● Specific challenge studies or from recognised experts

Setting Operational Limits

● Once the criticals limits are established, operational limits should be set to prevent
deviations from these critical limits
● Tighter than critical limits
● Factor to consider
-Quality requirements that need to be met
-Product variation and process variation
-Accuracy and precision of measurement tools

9.Establish Monitoring procedures

● Monitoring provides an early warning when a process is losing control or is about to

go out of control
● If a deviation from a critical limit is detected, corrective action should be taken
Monitoring includes:
● Employee observation: Employees should check incoming materials,
documentation, or record readings from instruments such as thermometer
● Continuous Monitoring: This is preferred when feasible. It involves tracking the
process in real-time and should be precise. If continuous monitoring is not possible,
decide on non-continuous monitoring procedures
●
Purpose of Monitoring
● Facilitate tracking of operation
-Indicate the trend toward loss of control, action taken to bring the process back into
control
● Determine when is the loss of control
-If deviation occurs at CCP, need corrective action
 ● Provide written documentation
-Use in verification

● Prevent loss of product

-Monitoring prevents or minimises product oss when deviations in the process
occur. Also helps to pinpoint the cause of issues

Monitoring Procedures and Activities

● Need to be rapid on-line and real
People monitoring CCPs should include:
● Production- line supervisor, selected line workers
● Maintenance personnel
● QA/QC personnel

Examples of monitoring activities

● Raw material sampling and inspection
● Process control specification (time/temperature checking and documentation)
● Dry storage room temperature and humidity checking and inspection
● Cold room storage temperature
● Amount of additives/ingredients used
● Net weight checking and documenting

Type of monitoring
● Visual Observation
-To check work practices and raw material inspection
● Sensory Evaluation
-Include checks for off-flavours, off-colour, etc
● Physicochemical Evaluation
-This includes measurements like pH, acidity, viscosity, temperature and pressure
10.Establish Corrective Actions
● Actions to be taken when monitoring indicates a loss of control
● Pre-established correction action are needed to address deviations and ensure
production continuous safe
Steps to corrective action
● Identifying causes of deviations
● Determining product disposition (witness and documented)
● Recording the corrective action
Corrective Actions
● A specific corrective action plan should be created for each CCP due to various
causes of variation
● Actions include
-Isolating and holding product
-Diverting affecting product
-Reprocessing
-Rejecting raw materials
-Destroying products
● Warning system an alert operator and any product made during deviations should
be segregated and held until a decision is made

11.Establish HACCP verification

● Verification uses methods, procedures or test in addition to those used in monitoring
to see whether the HACCP system is in compliance with the HACCP plan or wether
the HACCP plan needs modifications
Objectives of verification
● To ensure HACCP plan works - confirm the implemented HACCP plan is identical
to written plan
● To ensure HACCP plan is valid- procedures are based on scientific review
● To ensure HACCP plan is relevant- Review periodically to ensure it remains
current and effective
Type of Verifications
● Validation
-Initial phase of testing and review aims to prevent or control identified hazards
-Involves microbial or residues testing to verify control and product acceptability
-Includes a scientific and technical review of critical limits to ensure they adequately
control hazards
● Ongoing verification
-Ensure the HACCP plan is effective on a daily basis
-Include activities like:
*Calibrating monitoring instruments
*Observing monitoring activities and corrective actions
*Review HACCP records to ensure compliance with plan
● Reassessment
-Overall review of the HACCP plan
 -Must be done at least annually or when changes occur that could affect the hazards
analysis or HACCP plan
-Evaluates whether the plan is adequate in general not just focusing on daily
operations

12.Establish Record-keeping procedures

● Requires the development and maintenance of records for both plan development
and system operation
● One approach is to review current records and adjust them to fit the HACCP system.

Developing the Record-Keeping System

● Who will make the record entry? Ensure right person is in charge of making record
● Where and when will the records be kept? Select appropriate storage
● Create simple and understandable forms for your team
● Ensure employees know the importance of signing and dating records at the time of
the event

Typical Records for HACCP plan

1.Ingredients
● Records from monitored CCPs
● Supplier certifications and audit records to verify compliance
● Temperature records for sensitive ingredients and time records for those with limited
shelf life
2.Preparation/Packaging
● Records verifying food preparation procedures
● Compliance with packaging materials and sealing specifications
3.Finished products
● Records for the efficacy of safety barriers and the safe shelf like of products
4.Storage and distributions
● Temperature records
● Records confirming no product is shipped after its shelf life date
5.Deviation and corrective Action
● Records of actions following deviations from CCPs
● Reassessment and modifications to the HACCP plan based on changes in ingredients,
processes or controls
6.Employee training
Requirements for HACCP Application
● Food premises must be licensed
● Company registration with Registrar of Companies
● Pre-requisite program must be in place and documented
● HACCP manual should be available, signed by company management
● HACCP system must meet Malaysia Standard MS 1480:2019
● HACCP system should be implemented at least 3 month before application

Application process
1. Submission of application
2. Appointment of auditors
3. Acceptance of application after verification by the MOH, followed by payment
4. Adequacy audit: Review of HACCP manual and pre-requisite Program
documentation
5. On-site audit : contacts the company for an audit, including plan visit and
corrective action requests(CARs)
6. Follow-up audit: Follow up within 2 weeks. Check for closure of CARs
7. Final recommendation: After closing all CARs, auditors send the final report to
MOH

Maintenance of certified HACCP

● Surveillance audit
-Conducted at least every 6 months to ensure the HACCP system is maintained
● Minor non-conformance(NC)
-Follow-up audit within the agreed period
● Major non-conformance
-If corrective action is unsatisfactory, certificate may be suspended
● Serious non-conformance
-Immediate suspension of the certificate
Minimum Contents of the HACCP manual
1.Company and food safety policy
● Company profile, plant layout and food safety policy
● Organizational chart and HACCP team responsibility
2.Product Description and Intended Consumer
● Product details and process flow chart
3.Hazard Analysis Worksheet and HACCP summary plan

4.Supportive documents
● Sanitarian procedure, training policy, customer complaints and product recall
procedure