1. HACCP Introduction – 7 Principles
OBJECTIVES
Participants will be able to:
introduce themselves and share each other’s experiences related to non-carbonated beverages
understand the general layout of the NCB Quality Tool
understand the basic Guiding Principles upon which the NCB Tool is founded
MATERIALS NEEDED
Set of overheads and projector
PREPARATION
Review the Facilitator Guide and overheads
TIME REQUIRED
(30) minutes
MODULE OUTLINE
1) Where this Tool fits into the PI Quality Vision
2) Minimum mandates
3) Tool organization
4) Guiding principles and our responsibility with respect to production of NCBs
HACCP Introduction - 7 Principles
VERSION 2, June 2008
Page 1

2. HACCP stands for Hazard Analysis & Critical Control Points
The History of HACCP
The most common template (tool) for a food safety plan follows principles laid out under a program called HACCP
Back in 1959, the US space agency NASA faced a simple but mundane problem when planning its first manned space flights: How and what was it going to feed astronauts ?
The American food company Pillsbury (now part of General Mills) was called into help.
Food particles floating around the space capsule in zero gravity was one issue. That was relatively easy to solve. Pillsbury coated bite size pieces of food to prevent crumbs.
Then there was the problem of avoiding food poisoning. That’s unpleasant at the best of times. But imagine vomiting or having diarrhoea in a tiny space capsule. Investigators found that standard quality control methods weren’t good enough to prevent food contamination. So Pillsbury developed the Hazard Analysis and Critical Control Point concept. After the first lunar landing in 1969, Pillsbury adopted HACCP in its ordinary food plants. The firm developed training courses for the US Food and Drug Administration (FDA). In the mid-1970s, the FDA incorporated HACCP into its regulations on low-acid canned-food production
HACCP stands for Hazard Analysis & Critical Control Points

3. US Space Agency - NASA

4. How did they know that the Food is Safe?
US Space Agency - NASA
How did they know that the Food is Safe?
Is End Product Testing Sufficient?
How Many Samples to Test?
NASA concluded…..
“With standard QC..No way we could be sure that there would not be a problem”
“Our present QC system is testing Raw Material and Finished Product”
“Sampling and testing of each batch of food is impractical”
Conclusion:
With standard Quality Control- can not be sure that there will not be a problem
Sampling and testing of each batch of food is impractical

5. ! Example If 1 of 1000 batches was defective (0.1%)…..
If test 60 batches…..
If we say “Yes” for release…….>94% chance for release
Then still would miss defective batches!
How many finished batches do you test? !
Example:
If 1 of 1000 batches were defective and we test 60 batches, most likely we will release (94%) and we would still miss finding the defective batches!
Raw Material
Processing
Finished Product
Storage & Transport
QC?
QC ?
QC?
QC?

6. HACCP Introduction
HACCP was developed by Pillsbury Company (USA) in 1959
The HACCP concept was pioneered in the 1960s by the Pillsbury Company, the US Army and NASA as a collaborative development for the production of safe foods for the United States space program.
1973 Pillsbury published comprehensive document on Hazard Analysis
FDA used HACCP principles in development of low-acid regulations.
1980’s – major food companies began to utilize HACCP Principles
1993 the Codex Alimentarius Commission adopted Guidelines for the application of the Hazard Analysis Critical Control Point (HACCP) system – to include 7 Principles. Further updates were provided in 1997.
The HACCP system for food safety is now adopted as national guidelines or required regulations in many countries.
This PepsiCo International HACCP Training is based on
1997 Codex and NACMCSF HACCP Guidelines
CAC ( FAO + WHO)
National Advisory Committee on Microbiological Criteria for Foods

7. Systematic Approach for:
HACCP
Systematic Approach for:
Identification and assessment of Hazards associated with Manufacturing, Distribution, and use of Food Products as well as the definition of Preventative Measures for their
Control
HACCP focuses solely on Significant Hazards that are Reasonably Likely to result in unacceptable health risk to consumers
HACCP:
Identification and assessments of hazards associated with the manufacturing, distribution, and use of food products as well as Preventative Measures for their control.
HACCP focus is solely on Significant Hazards that are reasonably likely to result in unacceptable health risks

8. HACCP is a Tool
Hazard Analysis Critical Control Points (HACCP) is a tool and is not designed to be a stand alone program.
To be effective, other tools must include: adherence to good manufacturing practices, sanitation standard operating procedures, and a personal hygiene program.

9. Why is Food Safety so Important ?
More countries will incorporate Food Safety principles into their food legislations
Food Safety Plans will be made mandatory for more categories of products
In the long run, food business operations not based on Food Safety will not be acceptable by the industry, consumers, government and other stakeholders
HACCP as an effective food safety system will gain wider acceptance worldwide
Need to look at food safety throughout the whole food chain
The know-how and protocols/templates to implement HACCP for the manufacturing operation is now readily available for many product categories.

10. Roles & Responsibilities
Management commitment
A clear understanding of the principles of Food Safety system
Provide for sufficient resources for training
Allocate resources for implementation
Take ownership of the Food Safety system
The need to share experiences with other sectors to ensure that adequate provision is made for food safety.

11. 2. Pre-requisite Programmes
Module 2
1. Introduction to HACCP
2. Pre-requisite Programmes
Developing a HACCP System
What are the Hazards
5. Assessing the Risk
6. Critical Control Points (CCPs)
7. Validation, Verification and Review
8. Implementation, Communications and Maintenance
IPS
EXPLAIN:
One of the key elements for any HACCP system is having a set of Pre-requisite Programmes in place.
DISCUSS: 
What do we mean by the term 'Pre-requisite Programme?

12. Prerequisite Programs
Steps or procedures that control the operational conditions within the food establishment, allowing for environmental conditions that are favorable for safe and wholesome food manufacturing
Prerequisite programs are the foundation for establishment of HACCP and guidelines for production of safe products.
Prerequisite Programs:
Steps or procedures that control the operational conditions within the food establishment, allowing for environmental conditions that are favorable for safe and wholesome food manufacturing.

13. How Do These Programs Fit Together ?
The Umbrella shows the programs and how they link together -now we will look at some of these programs in more detail
A common diagram of a quality / food safety system: the Umbrella.

14. Prerequisite Programs
Prerequisite Programs address operational conditions providing a foundation of a HACCP System
Manufacturing Facility Design
Receiving and Storage
Equipment Performance and Maintenance
Sanitation and Pest Control
Recall and Traceability
Personnel Training
Prerequisite Programs address operational conditions providing a foundation of a HACCP System

15. Prerequisite Programs
There are five (5) basic requirements :-
Documented – all aspects written down (what, how, where, when, who)
Effectively implemented - monitored and supervised
Assessed for effectiveness
Corrective action must be taken when problems are identified
Records kept of monitoring & corrective action

16. Pre-requisite Programmes
Systems that are normally in place before the HACCP plan is developed to ensure the business is operating according to:
Codex General Principles of Food Hygiene
Relevant Codes of Practice
Relevant Food Safety Legislation
EXPLAIN:
The points on the slide…
Lets look at the benefits of having Pre-requisite Programmes in place….

17. Food Safety Pre-requisite Programmes
Also called “Good Manufacturing Practices”
Provides a sound foundation of HACCP
Covers ‘Low Risk’ hazards
Allows the HACCP plan to be focused & specific
Give a formal support network for HACCP team
Enables stream-lined HACCP plans
DISCUSS:
The Points on the slide…..
ASK:
Given this information, can you name some of our pre-requisite programmes?
LIST:
Answers on a flipchart
EXPLAIN:
We will now look at some of these in more detail…

18. Food Safety Programmes
What programmes do we have?
EXPLAIN:
Our Food Safety programmes are designed to cover the whole supply chain from “CROP to CONSUMER”
We will focus mainly on the Manufacturing Operations part of this chain. Here we manage Food Safety using the CRP programme….
CROP to CONSUMER

19. HACCP GMPs Expert sites AIB and Internal Audits EXPLAIN:
All of these programmes underpin the HACCP system on site. They are part of the Control mechanisms for many of the hazards identified in the HACCP plan. For example, the periodic glass and hard plastic audit is a routine GMP, as are regular checks of rodent bait points, or the cleaning of ventilation units as per the Master Sanitation Schedule. There are hundreds of potential GMPs and every person in the plant contributes towards them and needs to abide by them.
The monitoring and documentation requirements in our GMP programmes also contribute to the information supplied to the HACCP team as part of the management and communication of the HACCP system.
So we can clearly see how our pre-requisite programmes support the HACCP system in operation and are vital in ensuring that it works. The links between our food safety programmes are essential and this is why we view them as components of an overall food safety management system and why HACCP should not be treated as a stand-alone programme - they are part of a 'big picture', joined together like pieces in a jigsaw puzzle.
The other points of the slide including the role of AIB…

20. QAS Other Pre-requisites Vendor Assurance All raw materials
People Programmes
Hygiene Training
Site Experts and Trainers
EXPLAIN:
In addition to GMPs, there are other pre-requisites for HACCP.
VENDOR ASSURANCE:
ASK: What does this do? How Does This Support HACCP?
PEOPLE PROGRAMMES:
ASK: How do these support HACCP?
QUALITY MANAGEMENT:
Our IPS (Improved Product Specification system) and SOS (Standard Operating Systems) are pre-requisites.
ASK: How do they support HACCP?
The fundamental objective of a Quality Management system is to ensure that the company achieves the consistent manufacture of its products to the specification and design that they have set themselves as the standard.
Quality Management
QA systems
QAS

21. Plant Food Safety Systems (CRP)
HACCP and Quality Management
Quality Management ensures the level of QUALITY is consistently met
Plant
Quality
Systems
(IPS)
Traceability
Calibration
Document control
Record keeping
Plant Food Safety Systems (CRP)
HACCP & CRP ensures the manufacture of SAFE products
EXPLAIN:
It is important to understand the relationship between our Food Safety and Quality Management Systems.
HACCP & CRP ensure the manufacture of SAFE products.
Quality Management – ensures that the level of quality is consistently met. In considering GMPs, we looked at the CRP triangle. Our plant quality systems have a similar structure, referred to as the IPS triangle. These two systems link together in complete alignment to provide a total solution for food quality and food safety for the business.
There are four key quality programmes within the IPS system that must be in place to ensure an effective plant based HACCP can be established : Document Control, Record Keeping, Traceability and Calibration
Lets look at each of these in more detail…

22. Many documents in a HACCP system Need to keep updated and current
Document Control
Many documents in a HACCP system
Need to keep updated and current
Methods for withdrawal and destruction of obsolete/out of date documents
Vital to ensure correct records kept
SUMMARISE:
The points on the slide…..
Document Control
 There will be many documents in a plant HACCP system. The method used to keep these updated and current, and the method of withdrawal and destruction of obsolete/out of date documents is vital to ensure that the correct records are kept.
Document control is a quality management programme, laid down in an IPS standard, and it is clear that the document control requirements of HACCP will be adequately supported if a satisfactory quality management system is in place.

23. Some records need only be kept for shelf life + 6 months
Record-keeping
All monitoring forms for CCPs or SCPs need to be maintained in retrievable format for 3 years (see local requirements)
Some records need only be kept for shelf life + 6 months
SUMMARISE:
The points on the slide…..
Record-keeping
 All monitoring forms, covering C.C.P.'s or Specific Control Points need to be maintained in a retrievable form for a minimum of 3 years ( or whatever the local requirements are).
Some records need only be kept for the shelf life of the product plus six months, as this can be seen as the maximum time that a reference is likely to be made following identification of a non-conformance.

24. Traceability
Ability to track where materials have come from, and go to
‘One step up and one step down’
All materials labelled by batch and lot
Segregate each batch and lot from similar materials
Trail to link raw material batches and final product codes
SUMMARISE:
The points on the slide…..
Traceability
 No matter where in the process you are starting from, it should be easy to track where the materials have come from and where they go to. This is called 'one step up and one step down'.
To ensure this, all materials should be labelled by batch and lot. Procedures must be in place to ensure batch and lot segregation from all other similar materials. There should be a trail to enable a link between raw material batches and final product codes.
 The traceability programme, implemented as part of the quality management system on site, clearly supports HACCP by enabling the assessment of food safety risks upstream and downstream of any given point in the process. Without a satisfactory traceability programme, there would be an resulting weakness in the HACCP system.

25. Calibration Not all technical equipment electronically controlled
Other equipment needs to be calibrated by trained staff, e.g. :
Laboratory analytical equipment
On-line moisture meters
Metal detectors
Hand-held engineering test apparatus
Without calibration, information given may be inaccurate and our records are worthless!
SUMMARISE:
The points on the slide….
Calibration
 Our manufacturing environments are full of technical equipment, a lot of it controlled by software programmes, but many are not - analytical test equipment in the laboratories, on-line moisture meters, metal detectors, hand-held engineering test apparatus. All of these need to be calibrated periodically by trained staff, otherwise the information you receive will be wrong.
These pieces of equipment not only measure quality aspects of the product, but also provide important food safety measures. This equipment enables us to monitor the effectiveness of our HACCP system and in some instances, metal detectors for example, provides a control point to prevent unsafe product reaching our consumers. .

26. Pre-requisite Programmes
HACCP will work well if supported by other sound practices
Need to evaluate these practices and activities
Deficiencies and gaps in existing systems need to be identified
“Gap Analysis” will help to identify these so that a complete framework exists on which to build the HACCP system
Evaluation of Pre-requisites in place
Completed pre-requisite programmes need to be validated in the same way as HACCP to confirm their effectiveness
Procedures for verification will include audit, inspections, testing and analysis
Documentation and records are required
Effectiveness of Pre-requisites
EXPLAIN:
The evaluation of these programmes should form part of the planning for, and operation of, the site HACCP system :
SUMMARISE:
The points in the first box
The effectiveness of pre-requisite programmes is key to managing food safety, and for this reason these programmes should be validated as part of the HACCP planning process and subsequently verified. This should be undertaken as thoroughly for each programme as the validation and verification of the HACCP system and appropriate records kept. We will look at this in detail later in the training.
ASK and DISCUSS:
How are pre-requisites validated/verified in your plants?

27. Role of Quality Pre-requisites A HACCP plan must stick to its scope:
Key quality systems need to be in place to ensure an effective HACCP system
HACCP plans should only cover food safety not quality
There is an essential relationship between quality and food safety programmes, but……..
SUMMARISE:
The points on the slide…
During the construction of your HACCP plan control charts, it is often easy to fall into the trap of describing 'quality controls' and not food safety controls. The point of discussing the quality programme here is to emphasise the connection and relationship between food safety and quality programmes but care should be exercised to ensure a HACCP plan sticks to its scope - FOOD SAFETY.
EMPHASISE:
The Importance of keeping to the scope of Food Safety when completing a HACCP Plan
ASK:
What questions do you have about pre-requisites?
EXERCISE:
Refer the delegates back to their Training Goals Worksheet Handout 1a and ask them to note in the boxes key ideas and learning points gained from this module that they can utilise in plant. Briefly discuss what the group have noted and transfer significant points to the Training Goals Poster for reference.
A HACCP plan must stick to its scope:
FOOD SAFETY 1a

28. Hazard Analysis & Critical Control Point
What is HACCP?
Hazard Analysis & Critical Control Point
Structured, preventative system
Achieves Food Safety through:
Hazard Identification
Control of Hazards
ASK:
So what is HACCP?
EXPLAIN:
HACCP (Hazard Analysis Critical Control Point) is a powerful food safety management technique which provides us with a structured, preventative system in our food manufacturing plants. Its structure enables us to take an organised, co-ordinated approach to food safety and monitor it efficiently.
It promotes food safety through hazard identification and control - at the heart of food safe practice is knowing what and where your hazards are, and knowing how to avoid them causing an incident.

29. To protect the consumers of our products
Why do we need HACCP?
To protect the consumers of our products
Eliminate Food Safety Risk to the business
Legal Requirement in many countries (EU food legislation applied from 1 January 2006)
PepsiCo chosen system for Food Safety and Risk Assessment:
Simple
Effective
Understandable
ASK:
So why do we need HACCP?
EXPLAIN:
The points on the slide..
We mentioned CODEX – there are 7 key principles in CODEX which describe the HACCP process

30. Seven Principles of HACCP
Principle 1 Hazard Analysis
Principle 2 Identified CCP’s
Principle 3 Establish Critical Limits
Principle 4 Monitor CCP’s
Principle 5 Establish Corrective Action
Principle 6 Verification
Principle 7 Record Keeping

31. Principle 1 - Hazard Analysis
Identify the potential hazard(s) associated with food production at all stages, from primary production, processing, manufacture and distribution until the point of consumption.
A flow diagram of the complete process is important in conducting the hazard analysis. The significant hazards associated with each specific step of the manufacturing process are listed.
Preventive measures (temperature, pH, moisture level, etc.) to control the hazards are also listed.
Assess the likelihood of occurrence of the hazard(s) and identify the measures for their control.
If you don’t know what the
hazards are, then find out !

32. Principle 2 - Identified CCP’s
Determine the points, procedures or operational steps that can be controlled to eliminate the hazard(s) or minimize its (their) likelihood of occurrence.
A "step" means any stage in food production and/or manufacture including the receipt and/or production of raw materials, transport, formulation, processing, storage, etc.
Failure at a CCP has a direct
impact on food safety !

33. Principle 3 - Establish Critical Limits
Establish critical limit(s) which must be met to ensure the CCP is under control.
Critical limits are the operational boundaries of the CCPs which control the food safety hazard(s).
All CCP's must have preventive measures which are measurable!
The criteria for the critical limits are determined ahead of time in consultation with competent authorities.
If the critical limit criteria are not met, the process is "out of control", thus the food safety hazard(s) are not being prevented, eliminated, or reduced to acceptable levels.
Unless you can MEASURE,
you can’t control!

34. Principle - 4 Monitor CCP’s
Establish a system to monitor control of the CCP by scheduled testing or observations.
It allows processors to assess trends before a loss of control occurs. Adjustments can be made while continuing the process.
The monitoring interval must be adequate to ensure reliable control of the process.
Monitoring is effective data
collection to enable decision making!

35. Principle - 5 Establish Corrective Action
Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control.
HACCP is intended to prevent product or process deviations. However, should loss of control occur, there must be definite steps in place for disposition of the product and for correction of the process.
These must be pre-planned and written
Failure requires: stopping the process,
hold the products, correcting the problem
and recording the action!

36. Principle - 6 Verification
Establish procedures for verification to confirm that the HACCP system is working effectively
The system should be subject to periodic revalidation using independent audits or other verification procedures.
Proving the system is effective
and product is safe!

37. Principle - 7 Record Keeping
The HACCP system requires the preparation and maintenance of a written HACCP plan together with other documentation.
Usually, the simplest record keeping system possible to ensure effectiveness is the most desirable.
Not documented -
it did not happen!
This must include all records generated during the monitoring of each CCP and notations of corrective actions taken.
Establish documentation concerning all procedures and records
“Not documented, it did not happen”

38. “Farm Fork” 7 Principles Summary Prevention rather than Inspection
Systematic Approach
Identifies Hazards in the Process
Identifies Critical Points for Control and Monitoring
Focus is on Safety and not Quality
HACCP:
Prevention rather than Inspection
Systematic Approach
Identification of Hazards
Identifies Critical Control Points for Monitoring
Focus is on Safety and not Quality
Raw
Material
Processing
Transportation
and Storage
Shelf life/
Consumption
Processing
Heat Treatment
Filling
“Farm
Fork”

39. 12 Codex steps & 7 principles
12. Establish documentation & record keeping 6
Establish verification procedures 5
Establish corrective actions 4
9. Establish monitoring system for CCP’s 3
8. Establish critical limits for CCP’s 2
7. Determine Critical Control Points (CCP’s) 1
6. List hazards, conduct hazard analysis, consider control measures
5. On-site confirmation of flow diagram
4. Construct flow diagram
EXPLAIN:
In the CODEX guide there are the 12 steps to develop a HACCP system.
REVEAL: – the steps on the slide.
You can see that steps 6 to 12 are the same as the 7 principles we looked at earlier.
The first five steps are needed to prepare for the Hazard analysis and Risk assessment.
SHOW:
Show the HACCP Project Implementation Plan
This is a standard project plan in Gannt chart form that gives a realistic idea of the timelines for Implementing a HACCP system. Timelines can be shorter if it an update of an existing system or the HACCP team are already trained and in place. (refer to this as we go through the steps)
3. Identify intended use
2. Describe product
1. Assemble HACCP Team 3a

40. Codex step 1 Multi-disciplined Individual Expertise HACCP-Trained
Familiar with Process
EXPLAIN:
So… Starting with step 1. Assembling the HACCP team….
the points on the slide…
ASK:
Who do you think should be in a HACCP team?
WRITE: answers on a FLIPCHART and discuss.
Then compare to next slide…..
1. Assemble HACCP Team

41. Who needs to be part of the HACCP team?
Process line representative(s)
Packaging representative
Support services (Engineers)
Production management representative (e.g. FLM)
HACCP Project Leader
Subject Specialist (Microbiologist, Regulatory affairs)
Who needs to be part of the HACCP team?
DISCUSS:
The two lists (slide and flipchart) of HACCP Team members.
There should be a core team that manage all stages of the HACCP development process. Other specialists may come into the team for key activities (eg. Microbiologists, Regulatory specialists)
ASK:
What do you think the main responsibilities of the HACCP TEAM are?
WRITE: answers on a FLIPCHART and discuss.
Then compare to next slide…..

42. Codex steps 2 to 4 Describe Product Intended Use Process Flow
Specification
Ingredients (incl. Allergens)
Processing requirements
Labelling requirements
4. Construct flow diagram
EXPLAIN:
Once the team is set up, the first tasks are to define the products and their intended use. This is an obvious point that is often 'glossed over' in the development of the system.
The nature of the product, how it is manufactured and presented, how it is consumed and by whom are all factors that have an impact on the hazards and risks that we will consider in the HACCP study. As experienced Pepsico staff we know these aspects well, but regulators inspecting our systems may not, and a clear definition should be stated in our HACCP documentation. Input from R & D should be sought at this stage to ensure that this information is correct, up-to-date and complete.
DISCUSS: The requirements of the Product Definitions and Intended Use. Then.REVEAL: the points on the slide…
STATE: The next step is to construct the Process Flow Diagram
3. Identify intended use
2. Describe product
1. Assemble HACCP Team

43. Process Flow Charts 3b EXPLAIN:
To be able to conduct the HACCP study we must have a complete understanding of the process flow. We illustrate this with a process flow chart for each product that we manufacture on our site. The process flow chart should be drafted by the HACCP team, and is then produced as an outline schematic onto which we mark the hazards.
REVEAL: Points on the slide.
These flow charts are not suitable. It should be Simple and include all the points in the box.
SHOW: Blank Process Flow Chart
EXERCISE: (could use a plant process instead of, or after this)
Use the sheets in the HACCP Flow Chart Exercise to draw up a process flow for making a sandwich. The fillings should be chosen. Extra steps may be needed (refrigeration of final pack). Give blank sheets to write these on and put in the flow
REVIEW and DISCUSS: the flow the team produces
EXPLAIN: The final draft should show raw materials input, location of services and sections of responsibility/activity (unit operations). 3b

44. Process Flow Charts Flow Charts Simple All inputs All outputs
Peeling
Slicing
Frying
Seasoning
Peel
Waste oil
Oil 1. 3. 4. 7. 2. 6. 5.
Flow Charts
Simple
All inputs
All outputs
All process steps
Numbered steps
Describe process
Not equipment
EXPLAIN:
To be able to conduct the HACCP study we must have a complete understanding of the process flow. We illustrate this with a process flow chart for each product that we manufacture on our site. The process flow chart should be drafted by the HACCP team, and is then produced as an outline schematic onto which we mark the hazards.
REVEAL: Points on the slide.
These flow charts are not suitable. It should be Simple and include all the points in the box.
SHOW: Blank Process Flow Chart
EXERCISE: (could use a plant process instead of, or after this)
Use the sheets in the HACCP Flow Chart Exercise to draw up a process flow for making a sandwich. The fillings should be chosen. Extra steps may be needed (refrigeration of final pack). Give blank sheets to write these on and put in the flow
REVIEW and DISCUSS: the flow the team produces
EXPLAIN: The final draft should show raw materials input, location of services and sections of responsibility/activity (unit operations). 3b

45. What does Codex say about Hazard Analysis ?
“The process of collecting and evaluating 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 plan”
REVEAL and DISCUSS:
The points on the slide
EXPLAIN:
We use Risk Assessment to decide the significance of hazards. This will be covered in Module 5.
For the rest of this module we will look at what hazards are and where they come from. We will look at possible controls and how to apply this to a process

46. Collecting and evaluating information
Brainstorming (use the HACCP team)
Research (R&D and scientific and trade literature, public health statistics)
Analysis of available data (AIB reports , internal SOS audits)
Consumer complaints data
Consumer surveys and reports
Talking to people on the line
Practical observation
Shelf life and challenge studies
Consider users and abusers
EXPLAIN:
Firstly – where can we get information about hazards and their significance to our products and ingredients?
REVEAL and DISCUSS:
The points on the slide

47. A property which may cause a product to be unsafe for consumption
What is a Hazard?
A HAZARD is...
A property which may cause a product to be unsafe for consumption
EXPLAIN:
Before we go any further – what is a Hazard?
REVEAL and DISCUSS:
The points on the slide

48. There are 3 main types of Hazard………
What are the three types of Hazard?
There are 3 main types of Hazard………
Chemical
Physical
EXPLAIN:
Hazards fall into three categories…..
REVEAL and DISCUSS:
The points on the slide
We will look at each of these in more detail…
Biological

49. Identify the Hazards at each step in the process
Peeling
Slicing
Frying
Seasoning
Peel
Waste oil
Oil 1. 3. 4. 7. 2. 6. 5.
EXPLAIN:
Hazards fall into three categories…..
REVEAL and DISCUSS:
The points on the slide
We will look at each of these in more detail…

50. Hazards fall into three categories….. REVEAL and DISCUSS:
EXPLAIN:
Hazards fall into three categories…..
REVEAL and DISCUSS:
The points on the slide
We will look at each of these in more detail… 3.

51. Hazard Analysis
The process of hazard analysis is the result of:
þ collecting information on hazards
¨ evaluating their significance
Using a Risk Assessment Model to determine what goes into the HACCP plan
EXPLAIN:
Once we have completed our hazard-spotting, which we did in the last module, we need to review the hazards that we have identified and conduct a risk assessment. The purpose of this is to judge which of the hazards need to be addressed in the HACCP plan.
We can do this by using a standard risk assessment model to enable us to be objective and to 'rank' hazards correctly according to their importance.

52. RISK = Severity x Frequency
Risk assessment
A Risk Assessment Model should be used so that the risk assessment can be as objective as possible and to enable the ‘ranking’ of hazards as to their importance
ASK and DISCUSS:
Why do we need to rank the hazards?
REVEAL: the first point on the slide.
It is vital that we prioritise the most serious risks to our consumers and our business - the controls that we put in place must ensure the highest level of protection against potential incidents. We also need to recognise those hazards which are already controlled by GMP's, our pre-requisite programmes that we considered earlier.
REVEAL: the second point on the slide
The risk model that we use uses the two factors of Severity and Frequency to describe the RISK
Lets look at how we get to this equation…..
RISK = Severity x Frequency

53. Is the Hazard significant?
1. Ask yourself:
“What will be the severity of the outcome?”
2. Ask yourself:
“How often does it happen, what is the frequency?”
EXPLAIN:
After completing the list of potential hazards: Biological, Chemical and Physical - we need to analyse them. To help in this process we can use a risk assessment approach and we apply a model to help us.
Using two questions we asked ourselves when considering a hazard :
1. "what will be the severity of the outcome?“ and
2.  "how often does this happen - what is the frequency?"
Combining these two together, we get the SIGNIFICANCE of the Hazard – also known as RISK
ASK:
What questions do you have about this model?
These two together = Significance or RISK

54. RISK = Severity x Frequency
Risk Assessment Model - Severity
Severity
RISK = Severity x Frequency
EXPLAIN:
We use a semi-quantitative assessment that allows us to rank the hazards into different categories of risk.
SHOW:
Handout 5A – Risk Assessment Model
Looking at Severity first – we have 6 levels of Severity from 1 – Little Damage (eg. Hair) through to 6 – Catastrophic (Death by severe anaphylaxis shock or Botulism).
ASK and DISCUSS:
Can you think of examples for the other categories?
Eg. 2 – Stone or small foreign object
3 – Small piece of glass or mild food poisoning
4 – Larger, sharp foreign object or longer duration food poisoning. Mild allergic reaction
5 – Choking, Severe Food Poisoning or Allergic reaction 5a

55. Risk Assessment Model - Frequency
RISK = Severity x Frequency
EXPLAIN:
The other category – FREQUENCY – is based on the probability that the hazard will occur.
DISCUSS: the points on the slide identifying examples for each number.
Eg. 1 – never been known to occur.
2. Occurs sometimes
3. Wrong seasoning / film used
4.Metal-to metal contact if not controlled
5. Wrong pack/wrong product – a whole reel-wroth of bags will definitely be wrong!

56. Guideline Actions from the Risk Assessment
1 –5
Probably controlled by a Good Manufacturing Practice (GMP).
Check nature of problem against existing pre-requisite programmes
6 – 9
A consumer issue. With some risk to consumer safety.
Certainly needs control by a GMP, could be a
Specific Control Point (SCP)
10 – 16
Use Codex decision tree for hazards. Implications for corrective
action procedures. Report/resolve and record at next HACCP review.
Definitely either a GMP or an SCP, may be a CCP
EXPLAIN:
This gives simple guidance of the level of control needed for the hazard depending on the Risk Assessment score.
REVEAL and DISCUSS:
The points on the slide
We will look at the CODEX decision tree in the next module, but first we will look at definitions for GMPs, SCPs and CCPs….
16 +
Likely to be a Critical control point (CCP). Use Codex decision tree
for hazards. Failure may result in food poisoning incidents or
Product Recall. Initiates special HACCP review.

57. CCP SCP GMP GMPs, SCPs and CCPs Magnets
A step in the food production process where a control measure can be applied
Must control the hazard to a safe level, or eliminate it completely.
CCP
Critical Control Point
Magnets
Specific Control Point
May occur at several points in the process
Do not give complete control of a Hazard
Will need a high level of checking.
SCP
Good Manufacturing
Practice
METAL
Contact
Also called “Pre-Requisites”
Provide a sound foundation for HACCP
Control ‘Low Risk’ hazards
GMP
EXPLAIN:
We will use the Hazard of Metal Foreign Objects to illustrate the different levels of control…
REVEAL and DISCUSS:
The points on the slide
GMPs – In place across the whole plant provide some level of control – but is not complete. For some hazards such as Plastic there is no higher level of control possible so it has to be controlled by GMP.
SCPs – Are like CCPs but do not fully control the hazard and may occur at several points in the process. A metal detector will be an SCP if there is another metal detector later in the process
CCPs – Must meet the requirements of the CODEX decision tree. Will not be many of these in a process.
ASK:
What questions do you have?

58. ‘Engineering out’ hazards - examples...
Making alterations to equipment to prevent metal-to-metal contact
Modifying equipment to prevent Allergen cross-contamination
Re-designing equipment to make it easier to clean
EXPLAIN:
Wherever possible we need to “Engineer out” the hazards we find.
REVEAL and DISCUSS:
The points on the slide
ASK:
Can you think of other ways to engineer out a hazard
DISCUSS and WRITE:
the answers on a FLIPCHART.

59. Preventing or reducing hazards - key questions
Is this controlled by a pre-requisite GMP programme?
Is there equipment or processing which prevents the hazards being present at later stages?
If we cannot prevent the hazard occurring, is our only option to monitor potential contamination to ensure that unsafe product cannot leave our factory?
EXPLAIN:
Here are some key questions we use to identify appropriate controls for a hazard.
REVEAL and DISCUSS:
The points on the slide

60. Critical Control Points – CODEX definition
What is a CCP?
Critical Control Points – CODEX definition
“A step where control can be applied and is essential to prevent, eliminate or reduce a food safety hazard to acceptable levels”
EXPLAIN:
This is the Codex definition of a CCP.
DISCUSS: the definition
We use both the Risk assessment Matrix and the Decision tree to identify which of the many possible controls are CCPs.
CCP’s should be identified with the aid of a Decision Tree and/or Risk Assessment Matrix

61. CRITICAL CONTROL POINT
CCP Decision Tree
Questions to be answered for each potential hazard at each process step. Do not proceed where the hazard is managed by a pre-requisite or GMP programme:
Q1. Are the control measures in place for the hazard?
Modify process or product
YES
Q2. Is the process step specifically designed to eliminate or reduce the hazard to an acceptable level?
YES NO
Is the control at this step necessary for food safety?
Not a CCP
Stop * NO
CRITICAL CONTROL POINT
YES
Q3. Could contamination with the hazard occur at unacceptable level(s) or increase to unacceptable level(s)? NO NO
EXPLAIN:
First we must ask ourselves “Is this hazard managed successfully by a pre-requisite or GMP programme?”
If it is – do not proceed to the other questions.
DISCUSS:
Then for each process step and high scoring hazard
Q1 – Is control really needed at this step?
Q2 – If the process step was not designed to control a hazard it is NOT likely to be a CCP?
Q3 – Is the hazard going to occur/increase to an unacceptable level in this step?
Q4 – Does a later step control/remove this hazard – eg. Is there another metal detector at the end of the process?
Be ruthless when deciding CCPs there should not be many in any process. Typically only 2 or 3.
YES
Q4. Will a subsequent process step eliminate or reduce the hazard to an acceptable level?
Not a CCP
Stop *
YES
Not a CCP
Stop * NO
* = Proceed to next hazard or step in the described process

62. What CCPs could we expect at suppliers?
Are the Metal Check Records completed fully?
Are the correct Test Pieces used by a trained person?
Is Corrective action taken if the test fails?
Is action taken for reject product?
EXPLAIN:
In a typical snack process we would expect two CCPs to be in the HACCP plan….
Firstly…
ALLERGEN CONTROL
DISCUSS:
The points on the slide…. This is covered in more detail in the Allergen Training Course.
Secondly….
METAL DETECTION
The points on the slide…. We will now look at Metal detection in more detail….
ASK:
Which sources of metal contamination can you remember from module 3?

63. CCP: Filtration *FDA Compliance Policy Guide #555.425 (FDA, 2001a).
Critical Control Limit:
Present and intact filters/screens that prevent passage of objects >7mm.
Process Step:
Inline filtration at closest point prior to filling.
PepsiCo Operational Target:
Gatorade “Clear”: 15 µm
Gatorade “Cloudy”: µm
Juices without added pulp: 2.4 mm
Juices with added pulp: mm
Hazard:
Foreign objects > 7mm*
Monitoring:
Filters/Screens are inspected (i) present and (ii) intact, at a defined frequency. Abnormal extraneous material with potential risks found on intact screens are noted for root cause and investigative proposes (i.e. gaskets, plastic, glass, or metal fragments)
Documentation:
Filter/Screen Inspection Log
Extraneous Material Log
Hold and Release Records
Corrective Action Records
Verification Records
Corrective Action:
If filter/screen is not (i) present or (ii) intact during verification, put the product produced since the last acceptable check on hold, stop the process, and replace with functional filter/screen.
Notify designated quality employee to determine disposition of the product. Establish statistical sampling plan to evaluate likelihood of hazard in product and for the disposition of product. Corrective action and disposition records must be documented.
*FDA Compliance Policy Guide # (FDA, 2001a).

64. Obtaining evidence that the elements of the HACCP plan are effective
Validation:
“verb; to validate, ratify; valid, sound, defensible of reasonable objection” (Oxford English Dictionary)
Which means…..
Obtaining evidence that the elements of the
HACCP plan are effective
The HACCP team will check that the HACCP study is valid and that if correctly followed will deliver safe food.
The aims of this audit are:
To ensure the scope of the HACCP is correct and still valid.
To ensure the HACCP study has been completed correctly according to the seven Codex principles.
To ensure that any changes to the process, product or equipment have been reflected in the HACCP study

65. Monitoring and Evaluating compliance
Verification:
“verb; to establish truth or correctness by examination or demonstration” (Oxford English Dictionary)
Which means…..
Monitoring and Evaluating compliance
with the HACCP plan
This is focussed on how well the CCPs are being controlled.
The aims of this audit are:
To check that monitoring records are complete for each CCP.
To check that the person completing the CCP checks and records has been trained.
To check that any equipment used for monitoring CCPs has been calibrated.
To check that appropriate corrective action has been taken where any of the CCP checks have failed.

66. Ten point Checklist for HACCP
1. Was a multi-disciplined team used for the HACCP study?
2. Are Product descriptions and intended use details available for all products?
3. Is the Process Flow Diagram up to date and signed off as correct?
4. Are all hazards listed including: Biological, Physical and Chemical (including Allergens)?
5. Have Hazards been risk assessed?
6. Have CCPs been identified using a decision tree or expert panel?
7. Are all CCPs controlled to within the Critical limits and monitored frequently?
8. Have corrective actions been taken for any CCP failures?
9. Are verification/validation procedures completed frequently (at last annually)?
10. Is the HACCP plan up to date (reviewed annually?)?
HACCP Control Plan