HACCP Plan
The organization\SME’S shall have a documented HACCP plan which includes following information for each identified critical control point (CCP):a) Food safety Hazard(s) to be controlled at the CCP) Control measure(s)c) Critical limit(s)d) Monitoring procedure(s)e) Corrections and Corrective action(s) to be taken if critical limits exceeded
f) Responsibility for monitoring) Record(s) of monitoring
Note:
HACCP plan manages those control measures that the hazard analysis identifies as necessary to control identified hazards to acceptable levels, and which are applied at critical control points (CCP’s).
WHY do you need HACCP ? Globally there has been an increasing demand for HACCP to reduce food borne
incidents caused by contaminated products
that have implications for human health ,
and increased costs to the supplier and to
the community .
Identification of critical control points
The Organization/ SME shall control each hazard by the HACCP plan while CCP(s) shall be identified for the control measures identified.
Note:
The Hazard Analysis will determine the Critical Control Points (CCPs) of raw materials in different locations of the SME process at which safety control is critical. There isno limit to the number of CCP’s and it will vary considering on complexity of the SME process and the type of procedure. It is hence advisable to keep the number of CCP to a minimum and attention is given to PRP’s (preventive measures) that are essential for food safety.
DIFFICULTIES AND BARRIERS IN THE IMPLEMENTATION
There are barriers that impede HACCP’s implementation at the national, business,and consumer level in each country. At the national level, legislative approval is requiredfor mandatory implementation. At the business level, training, new equipment andtechnology must be funded. At the consumer level, buyers may be resistant tounnecessary changes in national customs and habits. Once governments, businesses andconsumers understand what is needed to assure food safety, each can then be a supporterof the HACCP systems. The following points address the objections and barriers to theimplementation of HACCP.
Government commitment
is the most important factor in the development andthe implementation of HACCP. Government awareness may be influenced by epidemiological data on foodborne diseases and food contamination and especially by the need for food safety and HACCP in order to export foods to othercountries. Advocacy by international organizations, (
i.e. Codex Alimentarius Commission, WHO, FAO and World Trade Organization (WTO
)), may also help agovernment to commit.
Government intervention
and an active help network to provide technical,scientific and educational support is necessary for success. Legal requirements vary from country to country. Large food industries in places other than the UnitedStates and the European Union, for example, may introduce HACCP without any legal backup; most of the time they do it for their profit. But small businesses may need an active government intervention in order to promote and facilitate thechange from traditional to modern food safety management systems. Moreover,the government and the trade associations should provide help and support whichmay include education for the managers and staff, and/or scientific knowledge. Whether HACCP is implemented under voluntary or mandatory schemes, thegovernment should train regulatory authorities in HACCP for proper third partauditing.
Experts and technical support
are necessary in the food industry. The mostimportant human barrier for the implementation of HACCP is the lack of management commitment and understanding of HACCP systems. Thereforeduring the early stages of the HACCP plan development, businesses need tocommit additional staff time and resources, for experts and technical support.Moreover the new food safety roles and responsibilities need to be explicitly identified and handled. For guidance on training and model curricula, reference ismade to the WHO document entitled “
Training Aspects of the Hazard Analysis Critical Control Point System
15
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Appropriate infrastructure and facilities
within the business itself and within the community are necessary for the implementation of HACCP. It is clear that no HACCP or GHP/GMP system can ever be implemented without roads,electricity and a safe water supply. It is the role of government to ensure that the appropriate infrastructure is in place before issuing a licence for a food business operation. Likewise business should ensure that premises, work surfaces and equipment are designed, constructed and maintained to facilitate cleaning and tominimise any possibility of cross contamination. In functioning, GHP is aprecondition for an effective HACCP system implementation.
Management Commitment -
Provide resources
Approve and drive the HACCP or food safety policy
Approve the business issues and ensure the project
continues to move forward and remains valid Appoint a Project Manager and HACCP team
Ensures adequate resources are made available
Establishes a progressive reporting procedure
Ensures that the project plan is realistic and achievable
Develops & drives the HACCP or food safety policy
Ensures the HACCP project continues to move forward
and remains valid Elects a HACCP team leader
Reports on progress regularly
Ensures a correct balance of technical/industrial
experience Asses the need for specialized expert knowledge and engages this resource as required
requiring Specialist knowledge may be required of:
1. Raw materials and ingredients
2. Finished product
3. Processing equipment
4. Processing procedures
5. Pre-requisite programs
6. The production environment ( premises and
surroundings)
Specialists will need full knowledge of:
Hazards associated with the raw material, the
product and the process The likelihood and probability of these hazards occurring A knowledge of regulatory requirements and applicable to the food Be trained in and have a thorough technical knowledge
Describe the Product :
Describe the product providing
details of its composition,
physical/chemical structure, packaging,
safety information, processing
treatments, storage and method of
distribution
Codex guidelines:
A full description of the product should be drawn up, including relevant safety information such as: oComposition
Physical/chemical structure (e.g. pH, aw, etc.)
Mode of preservation (e.g. chilling, freezing, heat
treatment, smoking, etc.) oPackaging and shelf life
Storage conditions
Method of distribution
Identify the intended use of the product and its target consumers with reference to sensitive sectors of the population
The intended use should be based on the expected normal use of the product by the end user or consumer In specific cases, vulnerable groups of the population: e.g., the old, the very young, the sick or hospitalized have to be considered
Construct a Process Flow Diagram
covering the full scope of the HACCP
study
The flow diagram should be constructed by the HACCP team, with the help of people working in the immediate areas The flow diagram should cover all steps in the operation When applying HACCP to a given operation, consideration should be given to steps preceeding and following the specified operation
CONSTRUCT THE PROCESS FLOW DIAGRAM
The process flow diagram should depict: Details of all process activities including tasks, inspections, transportation, storage, etc. Inputs into the process in terms of raw materials, packaging, water, and chemicals Outputs from the process e.g. finished product, waste product-in-progress, re-work and rejected products
Confirmation :
process against the flow diagram during
hours of operation and amend the flow
diagram where appropriate
It should be done by all members of the HACCP team during all stages and hours of operation Golden rule:MISS A STEP – MISS A HAZARD
VERIFY THE PROCESS FLOW DIAGRAM Verify the Process Flow Diagram A HACCP team responsibility
Observe process flow
Sample activities
Conduct interviews
Cover all routine/non routine operations
HACCP Principle
1 List all potential hazards associated with each step Conduct a hazard analysis; and determine the significance of each hazard Consider any measure to control identified hazards
HAZARD ANALYSIS
A- Hazard Identification List all potential hazards Sources of potential hazards:
Raw materials
Plant and equipment design
Intrinsic factors in the product or raw materials
Process design (Procedures)
Personnel (Staff/Visitors)
Storage and distribution
Examples of raw materials are:
Live animals
Food ingredients (chilled, frozen meat, etc.)
Water (used in formulation or to wash or rinse
product) Cleaning chemicals
Packaging
Pesticides, insecticides
Hazard Evaluation Conduct hazard analysis and determine the significance of the identified hazards * Determine likelihood of occurrence
* Determine severity
* Influence of pre-requisite
- A significant hazard has the potential
to cause serious illness or injury when
the food-stuff is consumed
Assessment of Hazard Significance – Method 1 The significance of the hazard can be determined by considering the likelihood of hazard occurrence and its severity. Likelihood of hazard occurrence may be rated as high (H) or low (L) Severity is also rated as (H) or (L) If likelihood and severity are both high (H), then the significance is (H) or critical (CCP) when planning control measures and critical limits
Assessment of Hazard Significance – Method 2 Matrix Method for Food Safety: Severity (consequence) Likelihood (frequency) Fatality A. Common repeating Serious sickness B. Known to occur Product recall C. Could occur Customer complaint D. Not expected to occur Not significant possible E. Practically
Hazard Significance Matrix for Food Safety
FREQUENCY X CONSEQUENCE of attempt index form...
C- Identify Control Measures Control measures are any factors, actions and activities that can be used to control an identified food safety or quality hazard Control measures must eliminate, control or reduce the effect of a hazard to an accetable level
Control Measures For Biological Hazards: Pasteurization – application of time/temperature Fermentation
Acidification – pH control
Pickling – addition of salt
Drying – Aw reduction
Freezing/chilling
Training to prevent cross contamination
Control Measures For Chemical Hazards:
Supplier quality Assurance Programs
Certificate of Analysis – signed & meet
specificat. Sanitation Program – approved food grade chemicals, visual inspection Pest Management Program – approved pesticides Antibiotic Testing Correct Labels – for products containing allergens
Control Measures For Physical Hazards:
Sieves
Screens
Magnets
Filters
Metal detectors
Glass control policy
GMP’s – personal hygiene procedures
Use of plastic (not wooden) pallets
HACCP Principle 2: Determine the Critical Control Points (CCP’s) A Critical Control Points (CCP) is a step at which control can be applied and is essential to
prevent or eliminate a food safety hazard or
reduce it to
an acceptable level A Control Points (CP) is a step in the process where control mabe lost without resentin
Critical Control Points For every significant hazard identified during hazard analysisthere must be one or more
Critical Control Points (CCP’s) where the
hazard is controlled
A CCP can be used to control more than one hazard. Likewise, more than one CCP may be needed to control one hazard
CCP Decision Tree A logical sequence of questions that is applied
to each hazard in order to aid in the
determination
of CCP’s and CP’s The HACCP team should ask an additional
question when using the decision tree at
question 1. Is this hazard controlled by
existing pre-requisite program. If yes then the
step is a measurement....
Establish Critical Limits
What is a critical limit? Critical limits are criteria which separate acceptable from unacceptable, safe from unsafe They are the tolerance parameters for safety or product acceptance, the boundaries for control
CRITICAL LIMITS Codex Guidelines Critical limits must be specified and validated for each critical control point In some cases more than one critical limit will be elaborated at a particular step Criteria often used include measurements of temp., time, etc.
Critical Limits Must be applied to All CCP’s
Must be validated
Must be measurable
Source of information on Critical Limits:
Published data
Expert advice
Experimental data
Regulatory guidelines
Mathematical modelling
Best practices
If the information needed to define the critical
limit is not available, a conservative value can be used
Types of Critical Limits:
Physical limits (temp., time, size, color, etc.)
Chemical limits (pH, aw, salt conc., etc.)
Microbiological limits
Microbiological limits are not often used as critical
limits because of the lengthy time needed to obtain
results. One exception to this is the rapid testing (e.g.
ATP Bioluminescence) for hygiene assessment of
cleanliness of equipment and effectiveness of
cleaning procedures
Validation of Critical Limits Validation of Critical Limits is proving the critical limit will in fact, control the hazard Example 1: Microbiological analysis of meat before
and after chilling to ensure that
the critical limit of 1°C to 4°C,
does control the growth of pathogens
Validation of Critical Limits: Example 2: Sampling chicken meat for chemical residues
to ensure that the withholding period of
medication is appropriate
HACCP Principle 4: Establish a monitoring procedure for each CCP Monitoring is the act of conducting a planned sequence of observations or measurements of control parameters to assess whether a critical control point is under control
The 5 Aspects of Monitoring: 1. Why monitoring is important
2. Who monitors
3. How to monitor
4. When to monitor
5. Frequency of monitoring
Why monitoring is important
Know when CCP’s are out of control
Identify problems before they occur
Pinpoint the cause of problems
Part of verification
Proves due diligence
“ If it isn’t written down, it didn’t happen”
Monitoring involves: Asking the right questions
Analyzing data to get the right information
Knowing where to collect
Being unbiased
Training of data collectors/operators/monitors
Auditing the collection process
Who, How and When to monitor WHO HOW WHEN
*Trained *Observation *On-line
*Unbiased *Sight *Continuous
*Smell *Discontinuous
*Taste Measurement Off-line *Weight *Discontinuous
*Time
*Temperature
Establish the corrective action to be
taken when monitoring indicates that a
particular critical control point (CCP) is
not under control
Specific corrective actions must be delivered
for each critical control point (CCP) in the
HACCP system in order to deal with deviations
when
they occur
The actions must ensure that the critical control point (CCP) has been brought under control Actions taken must also include proper disposition of the affected product Deviation and product disposition procedures must be documented in the HACCP records
Corrective Action Any action to be taken when the results of
monitoring at a critical control point, or
process control point indicate a loss of control
CORRECTIVE ACTION The Two Levels of Corrective Action
Immediate Action – (short term control)
Adjust the process to regain control Deal with the suspect product Preventive Action – (long term control) Determine root cause Assign responsibility to complete preventive action Record details of actions taken and update HACCP as required Record details of the corrective actions taken
Establish procedures for verification to
confirm that the HACCP system is working
effectively
Verification is “Doing it Right” Verification is the application of methods, procedures, tests and other evaluations, in
addition to monitoring to determine
compliance with the HACCP Plan
Codex Guidelines – Verification Establish procedures for verification. To determine if the HACCP system is working correctly, verification that includes auditing methods, review procedures , tests, random sampling and analysis can be used. The frequency of verification should be sufficient to confirm that the HACCP
VERIFICATION Codex Guidelines – Verification Verification activities determine compliance with the HACCP Plan Examples of verification activities include: VII.Review of the HACCP system and its records VIII.Review of deviations and product disposition IX.Confirmation that the Control Points are under control
VERIFICATION Verification consists of (5) five types of activities: 3.Review of Monitoring results
4.Validation
5.Auditing
6.HACCP System Review
7.Product Testing
VERIFICATION Validation – “Are you Doing the Right Thing?” Validation is a formal process that must be carried out before implementation of the HACCP Plan Validation records should include:
List of skills used in preparation the HACCP plan
List hazards and supporting data
Critical limits for all CCP’s and supporting data
Evidence that monitoring system control the
hazards Evidence that Corrective Actions prevent shipment
Validation and Verification – Working Together The processes of verification and validation work together and can be seen as a means of continuous improvement of the HACCP plan Verification may indentify changes needed to the
HACCP plan . These changes will need to be
validated , the HACCP plan updated and
implemented
An Audit … Is a systematic and independent examination to determine whether activities and related results comply with planned arrangements. To determine whether these arrangements are implemented effectively and are suitable to achieve objectives .
VERIFICATION Verification of the HACCP plan provides : 1.Assurance that the system will result in the production of safe , quality food 2.Assurance that the HACCP plan in being applied 3.Information that can be used to improve the HACCP plan 4.Assurance that the HACCP plan as originally designed is still relevant to the process
Verification Benefits Include : Increase awareness and understanding of the system by all staff Provides documented evidence
Independent and objective review
Maintains confidence in the HACCP plan
Identifies opportunities for improvements
Ensures obsolete documents have been
removed Ensures continuous improvement through the ongoing audit cycle
Verification of Industry of Government Responsibilities : 3.Validation of critical limits
5.Validation within HACCP plans .
7.Revalidation
9.Government verification
Establish Documentation and Record Keeping
Codex Guidelines: Efficient and accurate record keeping
HACCP procedures should be documented
Documentation and record keeping should be
appropriate to the nature and size of the operation
RECORD KEEPING Records Records are written evidence that an act has taken place A form is the template on which the results of acts are recorded A completed form becomes a record
The type of HACCP records that should be kept as part of a HACCP system are: HACCP Plan and Support Documents
Monitoring Records
Corrective Action Records
Verification Records
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