Preparatory Stage A: Prerequisite food hygiene requirements

• The title of the document. For example “Policy for glass and plastic management.”
• A brief statement on the purpose of the prerequisite measure. For example “To prevent contamination of products from glass or plastic from the factory environment.”
• What measures are necessary to achieve the desired outcome. For example, ”No glass containers to be taken into production area.”
• Who will be responsible for ensuring that the requirements are met. For example, “Production supervisors must ensure that no glass containers are taken onto the production floor.”
• The nature and frequency of any checks that are to be made and by whom. For example, “Production supervisors must check the production area for any glass containers prior to commencing production each day.”
• What should happen if something goes wrong. For example, “Glass bottle found in production area. All staff provided with refresher training on glass policy to prevent recurrence.”
• How, where and by whom these checks are recorded. For example, “Production supervisors must record each pre-production glass check on form X1.”
• When and by whom the procedure must be reviewed for example, “This policy to be reviewed every 12 months by the Operations Manager.”

References

1. Codex alimentarius food hygiene (basic texts) Fourth edition
2. Canadian Food Inspection Agency: Guide to prerequisite control
3. Appropriate Industry guides

Preparatory Stage B: Obtain Management Commitment

Preparatory Stage B: Obtain management commitment

The preparation and effective implementation of a HACCP system requires both time and effort not just on the part of the HACCP development team but also by everyone who is involved in the preparation and handling of your food. As such, there should be a clear statement by management which commits their support to the process. The MyHACCP tool will ask you to provide evidence that such management commitment has been obtained.

It is best for the commitment to be made in the form of a clear written statement of management support for the HACCP process which gives authority to the HACCP team and can be referred to in staff briefings and training sessions. It would also be helpful to include details of the resources that will be made available for the process.

You might prefer to include the commitment to HACCP within a broader food safety policy that you make available to both staff and customers, for example on your website, to demonstrate your determination to develop and implement an effective food safety management. Smaller food businesses in particular may choose to simply make such a declaration.

The key elements of a declaration of management commitment might include:

• Allocation of sufficient staff resources to complete the HACCP study and implement the HACCP system.
• Recruitment of any specialist staff needed to support the HACCP team.
• Raising awareness of the HACCP process with all staff and provide sufficient training to those directly involved in the study.
• Involvement of members of the management team as necessary.
• A commitment to provide timely management decisions as required by the HACCP team to facilitate the development and implementation of the HACCP.
• Purchase of additional equipment as required to ensure the effective operation of the HACCP system.

Preparatory Stage C: Define scope of the study

• selecting an appropriate plan
• briefly describing the product
• identifying the start point and end of the study 
• considering the likely hazards to be encountered

1. Type of HACCP plan

Linear plan

1. Picking of fruit
2. Transport
3. Reception
4. Storage
5. Juice extraction
6. Clarification
7. Juice production
8. Packaging
9. Despatch

Modular plan

• Module 1: Fruit reception
• Module 5: Juice extraction

1. Unload
2. Prewash
3. Pregrade
4. Sampling
5. Storage
6. Final wash
7. Final grading

2. Type of product and how it is packed

3. Start and end points of study

4. What hazards will the HACCP plan cover?

• Physical hazards are specifically associated with a food, for example bones in fish or stones in fruit, or where a residual risk exists once appropriate pre-requisite controls have been put in place. For example, glass contamination in areas where products are packed in glass containers.
• Chemical hazards might include, for example, detergent residues from cleaning or chemical residues from farming practices such as antibiotic residues in milk.
• Microbiological hazards will include relevant bacteria, such as Salmonella, viruses such as norovirus and parasites such as nematodes. In most cases microbiological hazards should be specifically identified rather than merely classifying them by type such as “bacteria” or “viruses”. This is because different microorganisms will have different growth, death and survival characteristics which must be addressed separately in the HACCP plan.
• Food allergens: There are many foods which may cause allergies or intolerances to susceptible consumers but for the purposes of HACCP only the 14 allergens listed in Annex II of Regulation (EU) 1169/2011 need to be considered. These are: 

1. Named cereals containing gluten
2. Crustaceans
3. Sesame seeds
4. Sulphur dioxide & sulphites
5. Fish
6. Soybeans
7. Mustard
8. Peanuts
9. Celery
10. Eggs
11. Milk
12. Named nuts
13. Molluscs
14. Lupins

5. Details of any documents used in the HACCP plan

• Regulation (EC) 852/2004: General food hygiene requirements (HACCP, structure, training etc)
• Regulation (EC) 178/2002: General food law (Safe food, traceability, product withdrawal etc)
• Regulation (EC) 2073/2005: Microbiological criteria for food
  • Food Standards Agency Guidance
  • Chilled Food Association guidance on microbiological testing and interpretation

Preparatory Stage D: Select the HACCP team

• Members of the team should be drawn from all relevant areas of the business and from all relevant staff levels. There should be, where possible, a healthy mix of management and operators from different parts of the business. 
• The team should possess adequate technical knowledge to identify relevant hazards and appropriate controls. The team should also include members with sufficient practical knowledge of the process to advise on the practicalities of implementing such controls.
• Members of the team should be provided with sufficient training and management support to allow them to participate freely in the HACCP team.

Choosing members of the HACCP team

• the necessary technical expertise
• knowledge of what actually happens in practice during the manufacture of the food 
• knowledge of the practicalities of any controls suggested by the HACCP team

Roles of HACCP team members

• Administrative – Members of the administrative group will be responsible for ensuring that the HACCP process is completed in a logical way and adequately documented. They will typically need a detailed understanding of the HACCP process.
• Technical – Members of this group will have a detailed understanding of food science, technology and hygiene as well as a good knowledge of HACCP.
• Operational – Members of this group should have a detailed knowledge of how the business operates in practice.
• Other – Additional expertise should be recruited into the HACCP team as necessary. 

Preparatory Stage E: Describe the product

• physical and chemical properties of the food
• the food packaging
• conditions of storage and distribution
• required shelf life 
• information to be provided to the consumer regarding appropriate storage, handling and use.

• Intrinsic factors: those found within the product itself such as its structure and composition.
• Extrinsic factors: those which are external to the food such as temperature control, packaging and method of processing.

1. List all the ingredients and the name of the supplier for each one

2. State the physical properties of the product

• Physical state – Is the food a liquid, solid, foam, emulsion etc
• Water activity (a_w) – this is the water that is available to microorganisms in the food. Whilst some foods may appear moist, the presence of sugar or salt in the liquid component of the food may prevent microorganisms from accessing the water thus restricting their growth. This is why the use of sugar, for example in jam making, or salt in the case of smoked salmon can be very effective at controlling the outgrowth of both spoilage and dangerous bacteria. Drying foods has an effect on both the moisture content and the a_w. Pure water has an aw of 1.0 and the addition of salt or sugar will reduce this value closer to 0. Most bacteria require an aw value > 0.92 to successfully grow in food but some moulds may be able to grow below this. The aw value is most easily determined in liquid and homogenous foods where the sugar/salt content is likely to be evenly distributed throughout the food. Difficulties in determining a representative aw value may arise in composite foods which contain different varieties of ingredient distributed in an uneven way through the food, for example a meat stew. This will be a matter for your HACCP team to consider.
• pH – This is the measure of the acidity of a food and many bacteria are unable to grow in acidic conditions. For example, Salmonella species will typically grow well at neutral pH (7.0) but are unable to grow in acid conditions of 4.0 or below. As for aw, care should be taken to ensure that any pH measurements taken are representative of the food. For example, in a ready meal the pH of the curry sauce may be 5.5, which would inhibit the growth of some bacteria, but within clumps of vegetables it might be 7.0 which might permit the outgrowth of dangerous bacteria.
• Salt content – Whilst this affects the aw of the food, salt can also have an inhibitory effect on some bacteria in its own right.

3. Describe how the product is processed and/or other preservation methods used

• Heat treatment – Microorganisms can be affected by heat in different ways. Some, such as Salmonella and Campylobacter, will be easily killed by normal cooking temperatures (70°C for 2 minutes) whereas others, such as Clostridium botulinum and Bacillus cereus, will survive such temperatures by forming spores
• Hot smoking – Typically used for fish and meat products at temperatures of approximately 70°C – 80°C and often used in combination with brining
• Brining – Can involve the immersion of food into salt water or the direct application of salt crystals to the outside of the food
• Drying – used for a range of products including milk, egg, herbs, fish and meat products
• Fermentation – the production of alcohol and/or acids in foods, used in the production of meats such as salami as well as in bakery and brewing products

4. Describe how the product is packed and the packaging materials

5. How is the product going to be stored and distributed?

• ambient
• chilled
• frozen

6. What is the shelf life of the product?

Durability date

7. State what your advice is to the purchaser for storing, handling and preparing the product

• Storage instructions prior to opening packaging
  • “Store in a cool dry place”
  • “Keep refrigerated”
  • “Keep frozen”
• Storage instructions once packaging has been opened
  • “once opened, keep refrigerated and use within 3 days”
• Cooking instructions
  • “Cook at 200°C for 30 minutes. Check that food is piping hot before serving”

Preparatory Stage F: Identify intended use of the product

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Statement

The HACCP team need to have a thorough understanding of the intended use of the product(s) included in the HACCP study so that they may undertake an accurate hazard evaluation as part of the Hazard Analysis.

How is this stage achieved?

There are two key factors which are relevant here:

1. The nature of the intended customer.

2. The extent of any further processing of the food prior to consumption.

 Note this list is not exhaustive

Again, the HACCP team should consider the likely abuse/unintended use of the product by the customer or final consumer (See guidance on this under Preparatory Stage E).  You should consider if the product you produce could result in it being sold to a market other than that intended.

2. The extent of any further processing of the food prior to consumption.

Different microbiological criteria will apply depending on whether the food product is supplied raw, processed or ready to eat to the final consumer. The HACCP team will need to clearly define which of these categories applies to the food and what, if any, instructions will need to be provided to the customer to assure the safe consumption of the food.

For example, if the product is supplied to the customer as a ready to eat food, this should be clearly stated on the labelling. Most importantly, however, the HACCP team will need to ensure that any decisions made during the hazard analysis element of the HACCP study takes into account the fact that the food will receive no further processing prior to consumption. Critical control points identified by the HACCP team in the production of such foods will need to “prevent or eliminate” hazards arising from the presence of pathogens such as Salmonella and E.coli o157.

For other types of food, clear information, typically on the food label, should be provided to the consumer where steps are required to be taken prior to the consumption of food to make it safe. For example, a product containing raw poultry should be clearly labelled as such and include clear, validated cooking instructions. It may be that the identified critical control points for a raw or processed food are sufficient to reduce a hazard, such as Salmonella, to an “acceptable level” rather than total elimination because the food will be subjected to further processing by the customer.

Preparatory Stage G: Construct a flow diagram

Statement

A process flow diagram shows all the steps involved in the process outlined in the Scope of the study (Preparatory Stage C).

How is this stage achieved?

The HACCP team or person leading the development of the HACCP study should construct a flow diagram.  Whatever format chosen to do this,  all steps in the process outlined in the Scope of the study should be included.

You may wish to use a schematic layout of the factory to help you but knowledge of what actually occurs is essential.

• List each step in the process/module typically from receiving the raw materials intake to at least despatch or to point of final consumption.  Think about:

  • Preparation
  • Packing
  • Storage
  •  Distribution

• You could also consider the following:

  • Raw material addition (including water)
  • Services (air, water, steam)
  • Any temporary product storage or hold periods (particularly during peak production times)
  •  Recycle / rework loops
  •  Process delays

Draw a rough paper sketch of the product flow.  Consider the way in which the process is managed and what could realistically occur i.e. optional and or intermittent activities.

The inclusion of relevant technical data will depend on the complexity of the operation.  This data is useful at the Critical Control Points that you will identify later.  Technical data could include:-

• Time  for process or process element (e.g. fry for 2 minutes at 190⁰C or cool to <5⁰C in 4 hours)

• Temperature at different parts of the process (e.g. fry at 190⁰C  for 2 minutes or cool to <5⁰C in four hours)

• Line speed

• Floor plan, equipment and services layout

• Segregation of low/high risk operations

• Personnel routes

• Flow conditions for liquids and solids (psi=pounds per square inch or temperature in ⁰C)

• Waste flows

• Movement routes for raw materials/ingredients

A piece of equipment may have several functions (e.g. a bottle filling machine including rinsing, volumetric/gravity/vacuum/hot fill and capping functions).  All functions should either be included in the description at the process step OR each function entered as a different process step.

Preparatory Stage H: On-site confirmation of flow diagram

Statement

The flow diagram must be checked to verify that it is correct and shows all steps involved in the process as outlined in the Scope of the study (Preparatory Stage C).

How is this stage achieved?

The flow diagram should be confirmed as being correct. It is recommended that this is carried out by someone not familiar with the process in addition to members of the HACCP team. The advantage of having someone not familiar with the process to check the diagram is that “they are a fresh pair of eyes”, and may identify a step that has been overlooked.

You may wish to consider the following:-

• Ensure it is a current and accurate representation of the process/module
• Ascertain if practices are the same for all shift patterns, differing staff levels, seasonal variations, all production patterns (e.g. high and low production volumes)

Documentation and Records

1. Record that the flow diagram has been confirmed as being correct
2. Record the date it was confirmed as correct
3. Record who confirmed the flow diagram as being correct

Records of out-of-date flow diagrams must be kept.

Review

The flow diagram shall be subject to review and should be current and accurate at all times. Amend the flow diagram as the process changes.

Principle 1.1: Identify and list potential hazards

What does this mean?

How is this stage achieved?

• The likely presence of the hazard in raw materials
• Whether the hazard may be introduced during a process step
• Potential for the survival, multiplication or increase in frequency of a hazard at a process step

What will be the result?

Principle 1.2: Conduct a hazard analysis

What does this mean?

How is this stage achieved?

1.   Write a hazard description for each hazard

Presence:

• Presence of Salmonella in raw chicken pieces
• Presence of E.coli o157 in raw beef mince
• Presence of stones in sacks of chick peas
• Presence of bones in fish

Introduction:

• Introduction of E.coli o157 by cross-contamination from utensils
• Introduction of glass from broken light fittings
• Introduction of Listeria from condensate dripping into open food

Growth:

• Growth of Salmonella during ageing process
• Growth of Clostridium perfringens during cooling
• Growth of moulds during maturing process

Survival:

• Survival of Clostridium botulinum spores
• Survival of Trichenella parasites
• Survival of spoilage spore-forming bacteria

2.   Provide a severity score for each hazard

Score 1: Low severity

• Taints in food where there is no actual chemical contamination;  for example, exposure to diesel exhaust fumes or taints from packaging
• Discolouration of food
• Use of wrong ingredient (except if this introduces an undeclared allergen)
• Incorrect “Best before date” applied

Score 2: Medium severity

• Foreign objects which are unlikely to be ingested or to present a choking hazard
• Residual detergent in process equipment
• Enteric viruses such as Norovirus 
• Pathogenic bacteria such as Campylobacter, Bacillus cereus and Staphylococcus aureus which rarely cause serious illness
• Pesticide or heavy metal residues in food

Score 3: High severity

• Pathogenic bacteria or their toxins which cause serious illness or may kill such as E.coli o157 and other VTEC, Salmonella, Clostridium botulinum.
• Protozoa such as Cryptospiridium
• Sharp glass or metal fragments which might be ingested
• Food allergens

3.   Provide a likelihood score for each hazard

• The product description as set out in Preparatory Stage E and in particular any chemical or physical properties of your food which might encourage or inhibit microbial growth
• Any published guidance on the likelihood of the hazard, such as food poisoning statistics or information produced by the Food Standards Agency
• The history of such hazards associated with your food

• Score 1 indicates “Low” likelihood. Here it is unlikely, although still possible, that the event will occur. In other words, it is possible but not probable that the hazard will occur in practice. 
• Score 2 indicates“Medium” likelihood. Here it is reasonably foreseeable that the hazard will occur. It could happen although there may not be any evidence of it having happened before.
• Score 3 indicates “High” likelihood. It is very likely that the hazard will occur.

4.   Determine your significant score

Principle 1.3: Specify the control measures for each hazard

What does this mean?

How is this stage achieved?

Control measure

Any action and/or activity that can be used to prevent or eliminate a food safety hazard or reduce it to an acceptable level.

Monitoring

Conducting planned observations or measurements to assess whether a CCP is under control.

• More than one control measure may be necessary to effectively manage a specific hazard. For example, use of a metal detection system, maintenance of the detection system, and training on using it might all be needed to avoid the hazard of metal pieces in food. 
• One control measure may manage more than one hazard.  For instance, oil temperature and fry time can be an effective control for reducing both numbers of Salmonella and Campylobacter in fried food.
• Control measures are not always carried out at the same Process Step where the hazard arises.  For example a hazard at Process Step 1 may be ‘presence of metal in raw material from supplier’; this may have several controls including the use of only pre-approved suppliers, or supply to an agreed specification.  These controls will appear at Process Step 1, however a control measure at Process Step 15 ‘effective working metal detector and rejection system’ is also a control for this hazard.

Principle 2: Determine the Critical Control Points (CCPs)

What does this mean?

A Critical Control Point (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.

How is this stage achieved?

The correct determination of CCPs is vital to ensure that there is effective management of food safety. The number of CCPs in a process will depend on the complexity of the process itself and the scope of the study (for example, whether there are just a few types of hazard, or lots of different hazards).

CCPs should be determined through experience and judgement; this may be aided by the use of a decision tree.

If you decide to use a decision tree

There are many different decision trees to choose from.  The MyHACCP tool shows you the Codex decision tree or Campden BRI decision tree, but you are not restricted to using these.   You can use a decision tree of your choice, some businesses devise their own.

• Codex decision tree

• Campden BRI decision tree

Using MyHACCP to work through a decision tree (Codex or Campden BRI’s)

• Q1. Do control preventative measure(s) exist? This refers to control measures.
• Q2. Is the step specifically designed to eliminate or reduce the likely occurrence of a hazard to an acceptable level?  This refers to the process step (not the controls).
• Q3. Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable levels? Think about this in terms of 'if you lost control'.
• Q4. Will a subsequent step eliminate identified hazard(s) or reduce likely occurrence to an acceptable level?  This refers to whether there is another process step further on in the process flow diagram that will eliminate identified hazard(s) or reduce likely occurrence to an acceptable level.

Documentation and Records

Review

Principle 3: Establish the Critical Limits

Statement

A critical limit is the maximum or minimum value for the control measure at a CCP to prevent, eliminate, or reduce the hazard to an acceptable level.  It separates acceptable (safe) product from unacceptable (unsafe) product.

How is this stage achieved?

Once the CCPs in the product/process/module under study have been identified, critical limits should be specified for the control measure(s) at each CCP.

The critical limit is the value which separates acceptable (safe) product from unacceptable (unsafe) product and the level needs to be clearly defined.

Critical limits should be for the control measure and not the hazard.  They should be:

• Measureable

• Observable

• Able to monitor in “real time” (quickly)

Some critical limits are defined in:

• Legislation

• Industry guidelines and codes of practice

Others can be determined from:

• Collection of experimental data during trials

• Advice from specialists with expert knowledge

Criteria often used to set a critical limit include measurements of:

• Temperature

• Time

• Moisture level

• pH (level of acidity)

• Aw (level of water available to support the growth of a hazard such as bacteria)

• Chemical analyses

• Available chlorine

• Subjective data e.g. visual observations/assessments.  For sensory parameters such as visual appearance and texture clear guidance on the requirements for compliance is necessary with practices, procedures or pictorial examples (e.g. photographs) of what is acceptable.

In addition to a critical limit some businesses may set target levels.

Critical Limit    A criterion which separates acceptability (safe) from unacceptability (potentially unsafe).

Target Level    A predetermined value for the control measure which has been shown to eliminate a hazard at a CCP.

Tolerance        The values between the target level and the critical limit.

Deviation         Failure to meet a critical limit.

Example

Documentation and Records

Details of how the critical limit was established (including sources of information or data used) need to be recorded.

Review

A review of this principle should be scheduled and triggered if there are changes within the company or new information becomes available (e.g. legislation, emergence of a new hazard) see Principle 6.

Principle 4: Establish a Monitoring System

Statement

Monitoring is the act of conducting a planned sequence of observations or measurements of control parameters to assess whether a CCP is under control.

How is this stage achieved?

The monitoring system describes the methods by which the business is able to confirm that all CCPs are operating within the defined critical limit.

Monitoring actions must be able to detect a loss of control at the CCP and provide rapid results.  This should be in time to allow corrective action to be taken, to regain control of the process whilst the product is still under your control.

Examples:    On–line  time, temperature.

                     Off-line – Salt, pH, A_w, total solids.

Generally microbiological testing is not considered to be suitable as a monitoring activity because the results are not quick, even with the most rapid methods results are not instant.  Microbiological testing is useful as a verification activity (see principle 6).

Continuous Monitoring Systems       e.g. process temperatures recorded on thermograph.

Discontinuous Monitoring System    e.g. sample collection and analysis such as  pH.

Samples must be representative of the bulk product.

When choosing a monitoring system the person/s responsible must ensure that the results obtained are directly relevant to the CCP and any limitations are fully understood and documented.

All monitoring equipment must be calibrated and working correctly.

Documentation and Records

Record who is to carry out each monitoring activity (specify job title or name).  Ensure they are competent to do this and that their training is appropriate to the task being performed.  There should be a detailed description of precisely how to carry out the monitoring.  They must have the knowledge and authority to take the prescribed corrective action if the critical limit is not achieved.  Records of training and competency assessment should be maintained.

Document what control parameter (i.e. temperature, flow, pH) is to be assessed, how the monitoring is going to be carried out and the frequency at which it is to be performed.  For the frequency state if it is continuous of discontinuous. If discontinuous state exactly how often the monitoring will be performed.  Ensure that this is adequate to confirm control.  Monitoring systems should be supported by specifications, procedures and work instructions.

Monitoring records should include the date and time the activity was carried out and actual result.

All records and documents associated with monitoring CCPs must be signed by the person(s) doing the monitoring and, where possible, by another nominated person that is responsible for reviewing the monitoring results  (typically this would be a Manager).

Review

A review of this principle should be scheduled and triggered if there are changes within the business (see Principle 6).

Principle 5: Establish a Corrective Action Plan

Statement

Document any action to be taken when the monitoring results  show that a CCP has deviated from the critical limit (indicating a loss of control).  In addition to this less stringent corrective actions may also be set for target levels.

How is this stage achieved?

You must decide upon and document specific corrective actions that are to be taken if monitoring results for a CCP show that there has been a failure to meet the critical limit.  The action to be taken must ensure that the CCP is brought back under control.

When deciding upon corrective actions for a CCP consider the following:

1. What are you going to do straight away?

Think about the need to stop the process, quarantine the product, quick adjustments to equipment (e.g. increasing the temperature).  Possible actions if unacceptable operating practices are found.

2. What are you going to do about affected product that has been produced since the last good check this may be in storage/despatch?  This does not include recalling the product because monitoring should be sufficient to capture the issue before the product has left site.

Think about the need to quarantine the product from the last good check i.e. product manufactured during out-of-control conditions, disposal of the product.

3. What are you going to do to in the future?

Think about reworking the product if this is appropriate, carrying out an investigation (review cause and correction to prevent recurrence), disposal of the product.

4. Consider who has the responsibility for the above, for instance who is authorised to dispose/rework the product or take the appropriate corrective action.

5. Think about training and competency of personnel involved with any of the above.

Documentation and Records

Document the corrective action to be taken when a CCP exceeds its critical limit and who is responsible for this action/s or other actions such as disposal, rework.  Relevant records must be kept including training records and what happened to the batch of product that was affected by the corrective action.

In a well-organised system it should be possible to identify a procedure which contains the details of the corrective action and who has the authority to authorise the corrective action.

Review

A review of this principle should be scheduled and triggered if there are changes within the business (see Principle 6).

Principle 6: Verification

Statement

Verification is the principle which confirms that the HACCP plan if followed will produce safe food for the final consumer.

How is this stage achieved?

Principle 6 Verification is split into three parts

1. Validation – "Will the HACCP plan ensure that safe food will be produced”?

2. Verification – “Is the HACCP plan working, is it producing safe food”?

3. Review  - “Is the HACCP plan up to date”?

Verification (overall-all 3 parts) looks at the HACCP system to ensure that it is set up in the correct way and that the business is following the HACCP plan, in particular ensuring that the CCPs are under control.  Very simply, verification involves performing tests, checking that procedures are being adhered to and reviewing the HACCP system to ensure that the food being produced is safe.

Validation

Obtain evidence that the elements of the HACCP plan are effective.

Prior to implementing HACCP the contents of the plan must be validated to ensure that the HACCP plan will ensure safe food is produced.  The main focus is to ensure that the hazards identified are complete, correct and have suitable controls in place (effectively managed if the specified controls are followed) i.e. confirmation that the CCPs have been correctly identified and can assure safe food.

Validation activities could include:-

• Challenge testing the equipment / machinery

• Experimental trials e.g. thermal evaluations on the equipment either at high temperatures or low temperatures

• Mathematical modelling

Other areas where information can be obtained to support a validation study include:-

• Document review

• Legislation – confirm that the HACCP plan meets legal requirements, with regard to food safety.

• Codes of practices

• Accepted good practice

Ensure personnel carrying out the activities have the appropriate qualifications, training and experience i.e. they are competent to undertake the validation activity.

Verification activities

The application of methods, procedures, tests and other evaluations, in addition to monitoring to determine ongoing compliance with the HACCP plan.

Depending on the type of product and scale of business verification activities may include:

• Internal audits

• External audits on suppliers

• Undertaking chemical or microbiological sampling and examinations

• Evaluating customer feedback analysis including complaints

• Undertaking raw material or end product testing

• Analysis and confirmation that the controls, monitoring and corrective actions are being properly applied.

• Analysis of deviation from the critical limits

• Ensuring that the prerequisites are under control

• Ensuring that the personnel carrying out the verification activities have the appropriate qualifications, training and experience i.e. they are competent to undertake the verification activity

Review

Your HACCP plan should be up-to-date at all times and reflect any change.  A change is anything in the HACCP plan that is different to when the study was last carried out.

A review should be both scheduled and triggered.

Triggered,  prior to a change

There should be factors built into the plan that would initiate (trigger) a review.

Examples include:-

• Changes in raw materials or product formulation

• Introduction of new product

• Change raw materials supplier

• Change in processing system

• Change in layout or environment

• Modification to process equipment or new equipment

• Failures in system e.g. corrective action or product recall

• Anticipated change in customer or consumer

• Any report from the market place that indicates a health or spoilage risk associated with the product

• Emergence of a new food borne pathogen (eg bacteria that can cause illness) with public health significance  or other health issue

• Changes in legislation

Scheduled

• All HACCP plans should have built into them a scheduled review; this should take place at a prescribed time interval even if nothing has changed. At an absolute minimum this should be annually and cover all areas of the HACCP plan. Any changes should be recorded and a risk analysis done to ensure that the HACCP plan is still capable of producing safe food.

Once a review has occurred it must be documented even if nothing has changed.  Those responsible for carrying out a review (usually the HACCP team in larger businesses) need to ensure that the proposed change does not adversely affect conclusions reached in the HACCP study and compromise product safety, and that the HACCP study is kept up-to-date.

Documentation and Records

Records of validation and verification studies are to be kept as evidence that they have been carried out successfully and to assist with a due-diligence defence.

Principle 7: Establish documentation and record keeping

Statement

Efficient and accurate record-keeping is essential to the application of a HACCP system.

How is this stage achieved?

In the unfortunate event of a food safety incident that is connected to your products you may have to show that you have taken all reasonable precautions to produce food safely. Demonstrating that the principles of HACCP have been correctly applied as required by law and that documentation and records are kept, may provide evidence of due diligence in the event of legal action.

Documentation and record-keeping should be:

1. Appropriate to the nature and size of the operation – your local environmental health practitioner will be able to guide you on this requirement.

2. Sufficient to assist the business to verify that the HACCP controls are in place and being maintained.

What to consider regarding documentation

• What records need to be kept?

• How are they to be stored – eg hard copy, electronic?

• Where are the documents to be stored?

• How long are the records to be retained for ? (what is an appropriate time, think about the shelf-life of the product and possibly how the product may be misused)

• Who is responsible for the records?

• Who needs frequent access to the records?

Examples of documentation

• The HACCP plan

• List of hazards and details of the hazard analysis

• CCP determination

• Critical limit determination

• Training needs analysis

• Procedures – e.g. standard operating procedures, corrective action procedure

• Work Instructions

 Examples of records

• CCP monitoring activities

• Deviations and associated corrective actions

• Verification procedures performed

• Modification to the HACCP plan

• Training undertaken

• Daily records (glass and brittle plastic check)

• Visual inspection reports

• Team meeting records

• Processing records

Review

A review of this principle should be scheduled and triggered if there are changes within the company (see Principle 6).

During a review you may wish to consider the following:-

• Does the documentation cover all of the HACCP system operation?

• How is the document controlled with regards to update and issue etc?

• Are all documents accurate and current?

• Are verification procedures documented?

• How is change and version control managed?