HACCP

What is commonly covered in GMP and GHPs?

- Calibration programme - Management of line stoppages - Supplier audit and approval programme - Hygiene monitoring - Standard operating procedures (SOPs) - Planned maintenance - Management of non-conforming product and re-work

What should be on a product description form?

1. Product name 2. Important product characteristics 3. How will the product be used 4. Packaging 5. Shelf life 6. Where will the product be sold 7. Labelling instructions 8. Special distribution control

What is the focus of quality CONTROL?

Legal and commercial assurance

What are the key issues of HACCp implication:

Transfer of ownership of HACCP plan from study team to operatives Training of operatives to implement the HACCP plan Maintenance and reviewing the HACCP plan

What does quality CONTROL rely upon to investigate food safety?

Measurement: - inspection - sampling/testing

Describe task 5: On-site confirmation of the flow diagram

Must confirm processing operations against the flow diagram at all stages & hours of operation (and be amended where appropriate) Confirmation should be performed by person(s) with sufficient knowledge of the processing operations

Give examples of potential chemical hazards:

Naturally occurring (e.g. allergens, mycotoxins) Added (e.g. agricultural chemicals) From packaging materials (e.g. plasticizers, adhesives)

Define hazard analysis:

The process, collecting and evaluating of information on hazards and conditions leading to their presence to decide which are significant for food safety and therefore should be addressed in the HACCP

Give examples of potential physical hazards:

e.g. glass, wood, stones, metal, insulation, bone, plastic, personal effects

Describe task 4: Construct flow diagram

The flow diagram should cover all steps in the operation for a specific product. The same flow diagram may be used for a number of products that are manufactured using similar processing steps. When applying HACCP to a given operation, consideration should be given to steps preceding and following the specified operation.

Define risk:

The likelihood of the occurrence of the hazard

Define a hazard:

A biological, chemical or physical agent in food with the potential to cause adverse health effects

How many tasks are there in the application of the HACCP principles?

12

How many principles are there of the HACCP system?

7

If 10 batches are tested and the true level of contamination is 1%, 5% and 10% respectively, what is the probability of accepting each of these batches?

90%, 60% and 35% respectively

If 5 batches are tested and the true level of contamination is 1%, 5% and 10% respectively, what is the probability of accepting each of these batches?

95%, 78% and 59% respectively

>? : preventive measures may be required to control hazard

>1

What are Operatonal pre-requisite programmes (OPRPs)?

A prerequisite programme identified by the hazard analysis as essential in order to control the likelihood of introducing food safety hazards and/or the contamination or proliferation of food safety hazards in the product(s) or in the processing environment

Describe task 7 (principle 2): determining critical control points

A single hazard may require control my multiple CCPs Example: acidification AND thermal processing of fruit purees to control Cl. botulinum growth and toxin formation Multiple hazards may be controlled by a single CCP Example: vegetative pathogenic bacteria and parasites in apple juice can be controlled by the same thermal process CCPs are product- and process-specific The determination of a CCP in the HACCP system can be facilitated by the application of a decision tree

What is a critical control point?

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.

Define HACCP (codex definition):

A system which identifies, evaluates, and controls hazards which are significant for food safety

Define a corrective action:

Any action taken when the results of monitoring at the CCP indicate loss of control (deviation fro the critical limit)

Give examples of preventative measures to control hazards

Biological hazard control: heating/cooking, refrigeration/freezing, drying Chemical hazard control: source control, formulation control, segregation Physical hazard control: source control, processing control (magnets, metal detectors, sifter screens) environmental control (GMP)

Define preventative measures:

Action of activity that can be used to prevent or eliminate food safety hazards or reduce them to an acceptable level

What is task 1?

Assemble the HACCP team (multi-disciplinary: cannot be one person)

Give examples of potential biological hazards:

Bacteria (spore-forming) Bacteria (non-spore-forming) Viruses Protozoa and parasites

What are the main hazards for product recall?

Biological e.g. bacteria, viruses, parasites Physical: e.g. foreign objects Chemical: e.g. intentionally added or contaminated e.g. mycotoxin, factory disinfectant

What are the requirements of HACCP (for it to work):

Commitment Resource Time Skills Technical data (product, process, hazards etc) External assistance More commitment for implementation and regular update Not a "cure all"

Describe task 2/3: Describe product and identify use

Complete derscription of the product Normal use by end-users or conumers (include consideration of high risk groups_ Create a product description form

What is principle 1 of the HACCP system?

Conduct a hazard analaysis

What is task 4?

Construct a flow diagram

What are the two stages of the traditional approach to food safety?

Control and compliance

Define a critical limit:

Criteria that separate acceptability from unacceptability (represents operating boundaries for a safe product)

Describe task 8 (principle 3): Establish critical limits for CCPS

Critical limits may be set for: Time Temperature Physical product dimensions Moisture level aw pH Titrateable acidity Salt conc. Water dropllet size Number/size of other physical contaminants Chemical residues Microbiological content Using sources of information including: scientific publications/research data, regulatory requirements & guidelines, environmental studies

What is task 2?

Describe the products

What is principle 2 of the HACCP system?

Determine the critical control points (CCPs)

Describe task 9 (principle 4): establish a monitoring system

Determines when there is loss of control in time for corrective actions (operating limits): continuous vs. amount/frequency Establish records and trend analysis Monitoring equipment: Thermometers, clocks, scales, pH meters, aW meters, chemical and analytical equipment: who will monitor? Microbiology testing is rarely feasible, except for: Raw materials Hygiene monitoring (e.g. ATP bioluminescence)

Why is HACCP effective?

Enables cooperation between primary producer, industry, trade groups, consumer organisations, and responsible authorities is of vital important. Opportunities should be provided for the joint training of industry and control authorities to encourage and maintain a continuous dialogue and create a climate of understanding in the practical application of HACCP.

Describe task 12 (principle 7): establish documentation and record keeping

Essential for reviewing the adequacies of the HACCP system plan and adherence of the implemented HACCP system to the HACCP plan Four types of record should be kept: Support documentation for developing the HACCP plan Records generated by the HACCP system Documentation of the methods and procedures used Records of the employee training programmes

What is principle 5 of the HACCP system?

Establish a corrective action to be taken when monitoring indicates that a particular CCP is not under control

What is principle 4 of the HACCP system?

Establish a system to monitor control of the CCP

What is principle 3 of the HACCP system?

Establish the critical limit

What is principle 7 of the HACCP system?

Establish working documentation concerning all procedures and records appropriate to these procedures are in place

What is principle 6 of the HACCP system?

Establishes a procedure of verification to confirm that the system is working effectively

What are the consequences for the food industry of poor quality (spoiled) food products?

Food poisoning Customer complaints Product recalls Legal action Bad publicity Loss of business

Describe principle 1/task 6: conduct hazard analysis/list all hazards

For each raw material and process step consider: - microbiological, chemical (allergenic) and physical hazards - the likely occurrence of hazards and the severity] -qualitative and quantitative evaluation of the presence of hazards - survival or multiplication of organisms (of concern) - appropriate control/preventative measures e.g. which conditions would lead to the above occuring

Describe task 1: assemble the HACCP team

Full commitment from managers at all levels Assemble team with sufficient knowledge and skills Multidisciplinary (and multi-hierarchical) team e.g.: chairman/co-ordinator production/sanitation engineer development QA laboratory (External consultants can be used for smaller establishments)

What are PRPs synonymous with?

GMP- good manufacturing processes

What are PRPs -pre-requisite programmes?

General policies, practices and processes required to yield safe food. They are in operation at all times.

Give examples of pre-requisite programmes (PRPs):

Good Manufacturing Practices (GMP) Good Hygienic Practices (GHP) Good Agricultural Practices (GAP) Good Animal Husbandry Practices (GAHP) Good Catering Practices (GCP) Good Domestic Kitchen Practice (GDKP)

What does compliance involve in the traditional approach to food safety?

Good manufacturing practice (GMP) guidelines Codes of practice Food control laws

What is task 3?

Identify intended use

What does control involve in the traditional approach to food safety?

Inspection Sampling/testing

Define validation:

Obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome.

What is task 5?

Onsite confirmation of the flow diagram

What are the differences between PRPs and OPRPs?

PRPs are horizontal where as OPRPs are applied to a specific identified hazard and are applied to a specific product/process PRPs may contribute to reduction of hazard but are not essential for control whereas OPRPs are essential to reduce levels of a hazard.

What are operating limits?

Point at which operator takes action to prevent lose of control of the CCP More restrictive than critical limits

Describe task 10 (principle 5): establish corrective actions

Predetermined and documented set of actions to be implemented when a deviation occurs. Employees need to understand their responsibility

What is the quality ASSURANCE approach to food safety?

Preventative

What is task 6?

Principle 1

What is task 7?

Principle 2

What is task 8?

Principle 3

What is task 9?

Principle 4

What is task 10?

Principle 5

What is task 11?

Principle 6

What is task 12?

Principle 7

What is the focus of quality ASSURANCE?

The consumer

What is the quality CONTROL approach to food safety?

Reactive

What are the disadvantages of sampling/testing?

Specialist facilities Expensive Retrospective Spot check Measures effects not causes Microbial distribution False sense of security

What are the advantages of sampling/testing?

Specific Low detection level Authorities Trend analysis Detects gross defects

What does quality ASSURANCE rely upon to investigate food safety?

Standards and processes - design - operational control

What are the barriers to HACCP success?

Sufficient knowledge Right attitude Effective behaviour

What are the advantages of HACCP?

Systematic Preventative QA mechanism Reduced reliance on end-product testing Targets resource into critical areas (CCPs) Applicable to all hazard types Applicable throughout food chain Enhances responsibility and control Increases confidence in product safety - promotes international trade Integration of QA processes and GMP Accommodates change

What is HACCP?

The HACCP system is a management tool that provides a structured, systematic approach to the identification of hazards and methods of control that is not achievable by traditional testing and inspection approaches (quality control). - Food safety management system - Systematic and preventative approach - Reduced reliance on end-product inspection and testing - Safe design and operational control - Food industry standard

Define monitoring:

The act of conducting a planned sequence of observations or measurements of controlled parameters to asses whether the CCP is under control

Define verification:

The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure is or has been operating as intended.

Describe task 11 (principle 5): establish verification precedures

Verfication things are 'being done right', activities include: HACCP validation HACCP system audits: systematic independant examination including on-site observing interview and review of records Equipment calibration: instruments or equipment vs. standards Targeted sample collecting and testing: risk and confidence levels, regulatory requirements, customer/trade requirements Validation activities: 'doing the right things' , including: Review of hazard analysis CCP determination Justification of critical limits Appropriateness and adequacy of monitoring systems, corrective actions, record keeping procedures and verification activities.