Hazard Analysis Critical Control Point (HACCP)

TOPIC 5: HAZARD ANALYSIS CRITICAL CONTROL POINT (HACCP) ▪ History, Definition & Importance of HACCP ▪ HACCP Principles ▪ Developing a HACCP program ▪ Risk Analysis

HISTORY 

It began in 1955 with a collaborated effort between the Pillsbury Company and NASA with the objective to provide safe food for space expeditions.

Method Development 1.Sampling for Pathogenic microorganisms.

2.The Zero Defect Concept 3.Modes of Failure

WHAT IS HACCP? 

Management system for food safety assurance

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Focus on identifying the critical points in process where food safety problems or hazards could arise and putting steps in place to prevent things going wrong

DEFINITION HACCP is a systematic preventive approach to food safety (and pharmaceutical safety) that identifies hazards that can cause the finished product to be unsafe, and designs measurements to reduce these risks to a safe level.

HACCP focuses on prevention of hazards rather than finished product inspection.

The HACCP system can be used at all stages of a food chain

IMPORTANCE A properly functioning HACCP system will result in the production of safer food. ◦ ◦ ◦ ◦ ◦

Improved food safety Increased market access Enhanced process control Protection against liability Drive for continuous improvement

SAFE FOOD

HACCP PRE REQUISITE PROGRAM (GMP)

Traceability & Recall

Employee Hygiene

Sanitary Facilities

Lighting Employee Traffic Pest Control Waste Management

Premise (plant layout) Equipment

PRP

(Pre-Requisite Program)

Cleaning Storage

Supplier Evaluation Transportation

Material Flow

HACCP PRINCIPLES Consists of 7 principles Principle 1: Conduct a hazard analysis Principle 2: Identify critical control points Principle 3: Establish critical limits for each critical control point Principle 4: Establish critical control point monitoring requirements Principle 5: Establish corrective actions Principle 6: Establish procedures for ensuring the HACCP system is working as intended Principle 7: Establish record keeping procedures

7 HACCP Principles

1.Conduct a hazard analysis

1.Conduct a hazard analysis o Identify steps in process where hazards of significance occur o List all identified hazards (biological/ chemical/ physical) associated with each step o List preventive measures to control hazards

Identifying hazards and preventative measures

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Hazard identification

◦ Hazard - A biological, chemical or physical property of the food that is reasonably likely to cause illness or injury in the absence of control ◦ Objective: Make complete list of all hazards for each

process step. It is crucial that no hazards are missed!

Note: Focus on safety issues rather than quality

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Identifying hazards and preventative measures (cont.) ◦Good hazard analysis requires multidisciplinary expertise  Knowledge on occurrence of hazards in raw materials  Understanding of processes  Technical knowledge of equipment  Food science in general; food microbiology and toxicology in particular  This wide expertise should be present in the HACCP team or be hired in ◦Sources of information for the HACCP team: Experience of team members, books, journals, previous data

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Identifying hazards and preventative measures (cont.) Hazard identification involves a crude type of risk analysis Risk = likelihood that a hazard will happen  If likely → include in HACCP study  If unlikely → do not include in HACCP study 

Consider:  Probability of occurrence  Severity of consequences

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Identifying hazards and preventative measures (cont.)

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Identification of preventative measures

◦ Preventative measure = factor which can be used to control an identified health hazard ◦ Objective: Make a complete list of possible measures to control each of the hazards listed. Includes both measures that are already in place and new measures

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2.Identify the Critical Control Point (CCP) in the food preparation

2. Identification of critical control points (CCP) ◦ CCP = a point in the process where control can be applied and a hazard can be prevented, eliminated or reduced to acceptable levels • CCP’s can be determined using expert judgement • It is important not to miss CCP’s as this could lead to unsafe food • It is also important not to identify more CCP’s than really necessary as this could lead to dilution of efforts CCPs are not necessarily located where the hazard occurs, they may be located at a subsequent step.

Some hazards cannot be controlled by the operator.

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2. Identification of critical control points CCP 

CCP decision tree • Tool to identify CCP’s using a standard structured procedure • Is to be applied for each of the hazards identified previously

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3.Establish critical limits for CCP

3. Establish critical limits ◦Critical Limit = criterion for a preventative measure at a CCP, which specifies the absolute tolerance for safety ◦Critical Limit =

1. measurable 2. have to be validated

• It’s a boundary between a safe and an unsafe product

• If critical limit is exceded, product is to be considered unsafe

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Validation of critical limits : • • • •

Based on scientific data OR Based on literature OR Based on experimental data or trial AND Be measurable and easy to monitor

• • • • • • • • • •

Examples: Temperature cooking time holding time physical dimension water activity pH humidity available chlorine visual parameter titrable acidity salt concentration

3. Establish critical limits (cont.) ◦ e.g.: • meat cooking • hazard: survival of vegetative pathogens • preventative measure: cook to sufficient temperature and time

• critical limit: 70°C/2 min at the center of product

• cooling after pasteurisation • hazard: growth of surviving spores • preventative measure: cool rapidly to low temperature • critical limit: cool entire product to < 7°C within 2 hr

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3. Establish critical limits (cont.) ◦ Criteria must be measurable factors, preferably by routine methods. e.g.:  chemical limits: pH, aw, level of residues, allergens  physical limits: sieve retention, temp./time, metal particle size • microbiological limits: to be avoided because slow analysis, except: • control of non-perishable raw materials • additional verification (step 7): slow analysis is not a problem • rapid alternative tests: e.g.: ATP measurement

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3. Establish critical limits (cont.)

Verification Of Critical Limits 

Need to be carried out to verify the chosen critical limit can result in the product being safe

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Safety can be verified by microbiological testing

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Result must be within acceptable microbiological criteria

4.Establish monitoring procedure (for CCP)

4. Identify CCP monitoring procedures ◦ Monitoring results are the basis of decisions ◦ Early warning that the process out of control ◦ Should reliably detect any loss of control (deviation) ◦ Monitoring Methods or Equipments ◦ ◦ ◦ ◦ ◦ ◦ ◦

Observation/visual Measurement : sensory, physical, chemical, microbiological Time recorder/stop watch Temperature recorder/thermometer Flow meter/pressure gauge pH meter, aW meter Rapid microb test I781 - 2002-2003

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Types of monitoring

On-line monitoring: parameter is measured in the process line • continuous: allows rapid detection of drift for early intervention e.g.: temperature, pH, metal detection • discontinuous e.g.: temperature, pH

Off-line monitoring: sample is taken and analysed in the laboratory  e.g. microbiological analysis, residue analysis

4. Identify CCP monitoring procedures (cont.)

• All analytical measurements have a certain level of error.

• Thus, sufficient number of measurements and frequency of monitoring necessary • If monitoring shows that critical limits are not met, then the process is out of control and the food may be unsafe.

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5.Establish corrective action(when monitoring shows a critical limit has been exceeded)

5. Establish corrective actions 

Actions to prevent exceding the critical limit

◦ Action is taken when target level is exceded, to keep process under control 

e.g.: automatic valve that sends milk back to start of pasteuriser if target T not reached

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5. Establish corrective actions (cont.)

•

Actions after exceding the critical limit • If critical limit exceded, food is to be considered hazardous. Act quickly, before food is released • Adjust process to bring it back under control

• • • • • • • •

Corrective action taken may include : Increasing process temperature Extending process time Adjusting quantities of certain ingredient (eg:chlorine in water) Adjusting the process at later stage-reprocessing Rejecting incoming lots Recalling distributed lots Changing process recipe or process instructions I781 - 2002-2003

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5. Establish corrective actions (cont.)

• Deal with hazardous product • destroy • reprocess • animal feed • rework into another less sensitive product • release after sampling and testing (release without further analysis)

• Keep records of all stages • Investigate and correct cause of the deviation • Assign responsible persons for monitoring and corrective actions

6.Establish verification procedures

6. Establish procedures for ensuring the HACCP system is working as intended 

Validation ◦ Ensures that the HACCP plan is complete and valid ◦ Ensures that the plan is effective in achieving expected food safety outcomes

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Ongoing verification ◦ Ensures that the HACCP plan is working effectively ◦ Confirms that the plan is operating according to written procedures

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Auditing ◦ Overall review of the HACCP plan ◦ To be performed whenever any changes occur that could affect the hazard analysis or alter the HACCP plan I781 - 2002-2003

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6. Establish procedures for ensuring the HACCP system is working as intended (cont) 

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Verification : the use of methods, procedures or tests in addition to those used in monitoring to determine if the HACCP activities/system complies with the written HACCP plan Verification activities include : ➢HACCP system audits ➢Management review ➢Equipment calibrations ➢Targeted sample collection and testing validation

6. Establish procedures for ensuring the HACCP system is working as intended (cont) 

Level of Verification:

Level 1:carried out daily on the process by worker (review process) Level 2:carried out monthly to six monthly by process verifier (review CCP’s) Level 3:carried out yearly by external reviewer/senior technical manager. (all aspects of HACCP program reviewed)  Level 4:carried out yearly by external reviewer. (to endorse HACCP program)

6. Establish procedures for ensuring the HACCP system is working as intended (cont) HACCP Internal Audit ➢ Carried out at planned intervals – scheduled ➢ Carried out by personnel trained in PRP, HACCP and internal auditing techniques (preferably other than HACCP team) ➢ If HACCP team need to conduct, need to ensure they do not audit their own department ➢ Focus on food safety implementation-(CCP, PRP, records,verification, corrective action) ➢ Internal audit findings presented to manager review

7.Establish record keeping procedures (Written HACCP Plan)

7: Establish record keeping procedure Record keeping must be complete and accurate and includes: • Documentation pertaining to all steps, including the HACCP principles • Appropriate record storage procedures • A log book to keep track of changes

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Developing a HACCP Plan I. Preliminary Steps II. Applying the 7 principles of HACCP

Assemble the HACCP Team Product Description Identify Intended Use

Develop a Flow Diagram Describes the Process & Plant layout Verify the Flow Diagram

Preliminary Steps

I. Preliminary Steps 1.

Assemble the HACCP team

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A group of people who will oversee the implementation and maintenance of the HACCP programme (develop, maintain, review) Multi-disciplinary (i.e. production, sanitation, management, etc.)

Including HACCP-trained person/experts

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I. Preliminary steps (cont.)

2. Product Description  

Full description of the product(s) being manufactured under the programme Product information assists with hazard analysis

I. Preliminary steps (cont.)

3. Identify Intended Use 

 

Which group(s) will be consuming the food product Where will the product be sold How will it be prepared

I. Preliminary steps (cont.)

3. Develop a Flow Diagram Describes the Process & Plant layout 

The flow diagram should ◦ Outline all processing steps ◦ Include all processing steps

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The plant schematic should ◦ ◦

Outline where all of the processing steps occur Display the movement of products, people and waste

4. Verification of the process flow diagram(s) . On-site confirmation

II. Applying the 7 principles of HACCP Completion of all steps will result in a properly functioning HACCP plan

RISKS ANALYSIS Risk - A function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard(s) in food.

Risk Analysis: A process consisting of three components: I. risk assessment II. risk management III. risk communication

I. Risk Assessment: A scientifically based process consisting of the following steps: i.

hazard identification • The identification of biological, chemical, and physical agents (hazards)

ii.

hazard characterization •

The qualitative and/or quantitative evaluation of the nature of the adverse health effects associated with hazards

I. Risk Assessment: iii.

exposure assessment The qualitative and/or quantitative evaluation of the likely intake of hazards

iii.

risk characterization The qualitative and/or quantitative estimation of the probability of occurrence and severity of known or potential adverse health effects in a given population

Risk assessment should take into account: • Relevant production storage and handling practices used throughout the food chain • Should include traditional practices, method of analysis, inspection and the prevalence of specific adverse health effect

II. Risk Management The process, distinct from risk assessment, of weighing policy alternatives, in consultation with all interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options.

III. Risk Communication The interactive exchange of information and opinions throughout the risk analysis process concerning hazards and risks, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions.