ISO 22000:2018 Food safety management systems

Requirements for any organization in the food chain

ISO 22000:2018 was developed within the ISO high level structure (HLS) to improve alignment between ISO management system standards. This similarity makes integrating the Quality requirements of ISO 9001 into an ISO 22000 Complaint Food Safety Management System far easier, and vice versa. Key Elements of ISO 22000:2018 (Sections 4 to 10) requirements for a Food Safety Management System by section are:

• 4) Context of the organization
• 5) Leadership
• 6) Planning
• 7) Support
• 8) Operation
• 9) Performance evaluation
• 10) Improvement

Key Elements of ISO 22000:2018 (Sections 4 to 10) requirements for a Food Safety Management System by section are:

4 Context of the organization

• 4.1 Understanding the organization and its context
• 4.2 Understanding the needs and expectations of interested parties
• 4.3 Determining the scope of the food safety management system
• 4.4 Food safety management system

5 Leadership

• 5.1 Leadership and commitment
• 5.2 Policy
• 5.2.1 Establishing the food safety policy
• 5.2.2 Communicating the food safety policy
• 5.3 Organizational roles, responsibilities and authorities

6 Planning

• 6.1 Actions to address risks and opportunities
• 6.2 Objectives of the food safety management system and planning to achieve them
• 6.3 Planning of changes

7 Support

• 7.1 Resources
• 7.1.1 General
• 7.1.2 People
• 7.1.3 Infrastructure
• 7.1.4 Work environment
• 7.1.5 Externally developed elements of the food safety management system
• 7.1.6 Control of externally provided processes, products or services
• 7.2 Competence
• 7.3 Awareness
• 7.4 Communication
• 7.5 Documented information

8 Operation

• 8.1 Operational planning and control
• 8.2 Prerequisite programmes (PRPs)
• 8.3 Traceability system
• 8.4 Emergency preparedness and response
• 8.5 Hazard control
• 8.5.1 Preliminary steps to enable hazard analysis
• 8.5.2 Hazard analysis
• 8.5.3 Validation of control measure(s) and combinations of control measures
• 8.5.4 Hazard control plan (HACCP/OPRP Plan)
• 8.6 Updating the information specifying the PRPs and the hazard control plan
• 8.7 Control of monitoring and measuring
• 8.8 Verification related to PRPs and the hazard control plan
• 8.9 Control of product and process nonconformities

9 Performance evaluation

• 9.1 Monitoring, measurement, analysis and evaluation
• 9.1.2 Analysis and evaluation
• 9.2 Internal audit
• 9.3 Management review

10 Improvement

• 10.1 Nonconformity and corrective action
• 10.2 Continual Improvement
• 10.3 Update of the food safety management system

About Technical Specification ISO/TS 22002-5:2019 Prerequisite programmes on food safety

Part 5: Transport and Storage

Technical Specification ISO/TS 22002-5:2019 Prerequisite programmes on food safety — Part 5: Transport and Storage is intended to be used when establishing, implementing, and maintaining the PRPs specific to transport and storage activities.

Key elements of ISO/TS 22002-5:2019 requirements for prerequisite programmes include:

• 4.1 General Requirements
• 4.2 Facilities
• 4.2.3 Utilities
• 4.3 Equipment
• 4.3.3 Maintenance
• 4.4 Management of Purchased Materials and Services
• 4.5 Transport and Storage Operations
• 4.5.7 Nonconforming Goods, Damages and Returns
• 4.6.1 Personnel Hygiene
• 4.6.2 Cleaning and Disinfection
• 4.6.3 Waste Disposal
• 4.6.4 Pest Control
• 4.7 Goods Identification
• 4.8 Withdrawal/Recall of Goods
• 4.9 Safeguarding of Goods

About Food Safety System Certification 22000 Part II: Requirements for Certification Version 5.1 November 2020

Part 2 Additional requirements:

Additional FSSC requirements for the food safety management system are included in the Scheme. These are elaborations of the clauses in ISO 22000 and technical specifications for sector PRPs or additional requirements incorporating the GFSI benchmark requirements version 2020.1. Examples include Management of Allergens, Product Labelling and PRP Verification.

• 2.5.1 Management of Services and Purchased Materials – in addition to 7.1.6 Control of externally provided processes, products or services
• 2.5.2 Product Labelling – in addition to 8.5.1.3 Characteristics of end products
• 2.5.3 Food Defense
• 2.5.4 Food Fraud Mitigation
• 2.5.4.1 Vulnerability assessment
• 2.5.5 Logo Use – Relevant to certified organizations
• 2.5.6 Management of Allergens (Categories C, E, FI, G, I & K)
• 2.5.7 Environmental Monitoring (for categories C, I and K only)
• 2.5.8 Formulation of Products (for category D)
• 2.5.9 Transport and Delivery (for category FI only)

All the following Requirements are New in V5.1

• 2.5.10 Storage and Warehousing (All Food Chain Categories)
• 2.5.11 Hazard Control and Measures for Preventing Cross-Contamination (Food Chain Categories C & I)
• 2.5.12 PRP Verification (Food Chain Categories C, D, G, I & K)
• 2.5.13 Product Development (Food Chain Categories C, D, E, F, I & K)
• 2.5.14 Health Status (Food Chain Category D only)
• 2.5.15 Requirements for Organizations with Multi-Site Certification (Food Chain Category A, E, FI & G)

Version 5.1 of the FSSC 22000 scheme was published in November of 2020. The scheme is organized in to six parts. Our focus will be on part two, the requirements for organizations to be audited. It defines the requirements to achieve and maintain FSSC 22000 certification. There are nine different categories of the scheme. They are:

• 3.1) Farming of animals (Category A)
• 3.2) Food Manufacturing (Category C)
• 3.3) Animal Feed Production (Category D)
• 3.4) Catering (Category E)
• 3.5) Retail and Wholesale (Category F)
• 3.6) Transport and Storage (Category G)
• 3.7) Production of Food Packaging and Packaging Materials
• 3.8) Production of Biochemicals
• 3.9) FSSC 22000 – Quality

You need to identify into which category your organization falls. For more information on this and all the subcategories you need to look at table in section 3 of the scheme overview you will find that on page 8 onwards of the scheme. With the requirements you will see a table there and you need to identify the category and the subcategory that your organization falls under. There’s a description and a little example of the type of production taking place. If you’ve identified in which category and subcategory you fall in to or your organization falls into then on the right hand side you will find the PRP specified for that exact subcategory.

The FSSC previous version had seven additional requirements and this new version 5.1 has 15 additional requirements so there’s a considerable increase in the number of additional requirements that we should adhere to.

The first additional requirement is the management of services and purchased materials. There is specific care about purchase material, firstly about the laboratories you use. Any laboratories that we use for validating or verifying food safety have to be competent, and competent means that they have to be capable to produce precise and repeatable test results using validated test methods. What this essentially means is that your lab has to be accredited or your lab has to be a part of a proficiency scheme. You can’t just do microbiology on an on-site lab without that lab demonstrating that those results are repeatable so you can’t merely just have a corner in your facility where you do testing. Your laboratory results have to be compared to an accredited laboratory that uses accredited methods for that test.

One side is validation but when we look at the verification of food safety that’s looking at final product testing, your hand swabs, your equipment swabs, and essentially any micro test that you do. You’re only doing it to validate or verify so needs to be done by competent lab. If you have an on-site lab the ideal thing would be that lab being accredited however you can have an unaccredited lab on site but then you need to make sure that your lab is doing either inter-lab testing with other accredited labs or on a proficiency scheme so that the results are proven or shown to be valid. They must be shown to be repeatable.

So for categories C, D, I, G and K there needs to be a documented procedure to procure in the event of an emergency, to ensure the final product conforms to specification. You have to control your suppliers so that when you run out of something you have approved suppliers ready to supply you. You can’t just randomly approve or randomly procure something from someone without them being approved on your approved suppliers list. We can’t just go to someone else and quickly get something, for instance tomato sauce. If you use this particular tomato sauce in your product and you’ve been buying for the last 15 years from the same client and everything’s been perfect. Then all of a sudden the factory burns down and they can’t supply you because they run out of stock, you need to have a plan in place to make sure that the supplier you’re going to buy your new tomato sauce to make your product, is approved.

For each and every raw material that you’re going to use you need at least two suppliers on that approved buyer list so that you’ve always got a backup supplier in place for all your raw materials. When procuring animal, fish and seafood there’s a need for a policy to control prohibited substances. We know for a fact that in the beef industry cows can often get sick with bovine tuberculosis and brucellosis. When they are sick the get injected with vitamin residues or veterinary medicines that create residues so you have to make sure that you’ve got a program in place to ensure that sick cows are not entering the supply chain.

The same goes with fish. There’s been serious studies done globally that different levels of fish are actually picking up pesticide residues and heavy metals from the different water sources so you must make sure that you’ve got a program in place to mitigate the potential risks. Luckily Europe and North America have very strong standards when it comes to heavy metals, pesticide residue levels and veterinary medicines. You just have to make sure that you’ve got documents in place to specifically manage those hazards.

There might be certain countries that don’t have the correct pesticide residue levels. The FSSC requires that if you want to meet these additional requirements you need to make sure you have a process in place for any hazards. That will involve you needing to research which hazards are associated with the products you are making and what sort of best practices you should implement.

Probably one of the best places to look at that would be codex elementaries. Lastly there needs to be a review process for product specifications to ensure compliance with food safety, legal and customer requirements. That basically means that if we have a specification in place but it’s been like that for years we can’t just leave it there and let it sit. We have to actually go back to it and review it exactly, so from a product specification perspective let’s think of our tomato sauce example again. You have a specification in place, you procure that specification and you’ve used it for the last 10 years and it’s fine but you need to make sure that at a predefined interval, probably annually but it depends on the nature of the product and the risk of the product, that you revise it and make sure that it’s still current.

The whole point of this is really making sure that the ingredients that are coming in, especially when it’s a compound ingredient like tomato sauce, have not changed. This is not necessarily just with ingredients but also maybe the laws have changed, maybe the heavy metal limits have changed and now all of a sudden your specification that used to be at a certain level is now illegal. So you need to make sure that it becomes current.

So it does form part of the HACCP review process if you’re doing that properly however the FSSC additional requirements say you need emphasis on making sure that you review your specs at a predefined interval. So whether it is every year or every three years, it doesn’t matter, you need to determine that based on your risk but you need to justify your risk.

Senior management should be implementing a “It is how we do things here” food safety culture. This can be achieved by:

• Leadership – starting from the top
• Demonstrating visible commitment
• Effective communication of company philosophy and policy
• Ensuring there is accountability from the top of the organization to the bottom
• Developing employee confidence and mutual trust
• Developing reward schemes including ‘Employee of the Month’ award
• Ensuring all employees are accountable, engaged and understand the value of integrity and proactivity
• Developing an action plan for the development and continuing improvement of food safety culture

To ensure success Senior Management should be directly responsible for food safety by ensuring adequate; organization and support, equipment and facilities, training and education of all employees, reviewing and auditing performance, and driving continuous improvement.

All employees should be empowered and individually responsible for the quality of their work, resulting in a continual improvement culture and working environment for all. Employees should be encouraged and required to notify management about actual or potential food safety issues and are empowered to act to resolve food safety issues within their scope of work.

The philosophy of Food Safety should be promoted throughout the organization and in particular the Food Safety Policy.

Communication processes for promoting food safety include:

• Team briefings
• Staff reviews
• Daily Management meetings
• Feedback mechanisms
• Newsletters
• Notice boards

Senior management should monitor and measure through reports and trend analysis the degree of development of the food safety culture by analyzing information including KPIs from:

• Hygiene & Housekeeping Audits
• Internal Audits
• External Audits
• Non-conforming products
• Environmental monitoring
• Review of implementation plan and numbers trained
• Employee reviews
• Staff surveys on values and culture
• Customer Complaints
• Staff Turnover
• Staff Exit Interviews

All employees should undergo individual food safety culture development which can include:

• Food Safety Policy
• Food Safety Objectives
• Food Safety Management System Overview
• Job Descriptions
• Job Training
• Employee Briefing
• Individual Objectives
• CCP Controls – Training Procedures & Record Completion
• PRP Controls – Training Procedures & Record Completion
• Employee Review

A training matrix can be used for Food Safety Culture Planning:

Records of all training should be maintained, including those of induction, on-the-job, refresher and external training. Training schedules and records should be managed by Department Managers and where applicable include the following records:

• Training register
• Operator training review
• Training matrix
• Department training matrix
• Individual Training records including:
  • Description of training
  • Skills description
  • Name of trainee
  • Confirmation of training
  • Date and duration of training
  • Trainer details
  • Verification that the trainer has assessed the trainee and found them to be competent
• Identifying the competencies needed for specific roles
• Reviewing and auditing the implementation and effectiveness of the training and the competency of the trainer with a view to taking action to improve the training.

• Company and contractor key contact personnel
• Description of contracted services and how they will be completed
• Term of the contract
• Equipment and material storage specifications
• A complete inventory of pesticides (must be approved by the regulatory authority for use in a food facility)
  detailing the safe use and application of baits and other materials such as insecticide sprays or fumigants
• Emergency call out procedures
• Records to be maintained
• Requirement to notify facility of any changes in service or materials used
• Service personnel including evidence of competency by exam from a recognized organization

The contracted Pest Management service should provide:

• Site visits and inspections (including the periphery and internal and external buildings) based on a documented
  risk assessment including service records describing current levels of pest activity and recommendations for
  taking corrective actions.
• The provision of a plan/diagram of the site showing the location of all pest control monitoring and prevention
  measures
• Flying insect controls including fly killing units
• Emergency 24-hour call-out service
• Quarterly biologist inspection reports, visit and trend reports with recommendations
• A current copy of the certificate of insurance that specifies the liability coverage
• Spill control materials and procedures
• Material safety data sheet information to ensure proper usage of pesticide chemicals.

A nominated manager or responsible employee should have overall responsibility for Pest Management on site so that Pest
Management is manged within site control rather than relying on contractors.

Before agreeing to a contract the Pest Management Contractor should be subject to Supplier Approval to ensure that the
contractor is qualified and the pest management programmes will comply with applicable legislation.

Copies of the Contract, Service Agreement, Pest Control Reports and Pest Management Contractor training records and
qualifications should be held in Pest Control File on site. At the start of the contract a detailed survey of the entire
facility should be completed by a qualified Field Biologist and the results documented and used to determine placement
of Pest Control devices.

Exterior Bait Stations

Exterior rodent bait stations should be set up to deter rodents from entering the facility. Based on the detailed
facility survey, exterior bait stations should be placed along the foundation walls on the exterior of the facility and
along the site boundaries. Exterior bait stations containing rodenticides should be tamper resistant, anchored in place,
locked, and labelled.

Interior Monitoring

Based on the detailed Field Biologist survey, interior monitoring devices should be placed in strategic sensitive areas
specific to the rodent species, and other areas of possible pest activity. Interior rodent monitoring devices identify
and capture rodents that gain access to the facility. Interior monitoring devices should be placed in areas where pest
ingress is first likely to be identified and secured in position.

Elimination of Pest Habitat

The Field Biologist should identify any possible pest habitat around the site in the quarterly inspections. The
nominated manager or responsible employee should take actions to remove or eliminate favourable conditions for pests
including eliminating any rodent burrows, rodent runs and areas that provide harbourage or may attract rodents or other
pests to the site or outside grounds.

Pest Management Reporting

Records of all Monitoring devices should be maintained, including services performed, to ensure that devices are
properly placed and inspected to allow trend analysis of activity.

Pest Management Contractor reports include:

• Signs of pest activity
• Proofing requirements
• Actions required by site
• Type of Pest
• Pesticide or material applied
• Pesticide registration number
• Rate of application or percent of concentration
• Specific location of application
• Method of application
• Amount of pesticide used at the application site
• Next action/follow up date
• Date and time
• Review and investigation of any missing baits
• Signature of pest controller

Temporary placement of any pest monitoring devices for short-term monitoring should be documented in pest management
action reports.

All personnel should be trained to identify potential issues caused by pests at induction. A pest reporting procedure
should be in place such that any incident or sign of pest activity is immediately reported to the nominated manager or
responsible employee and any potential product affected quarantined. The nominated manager or responsible employee
maintains a log of pest sightings and the action taken by the pest controller.

The Pest Control Contractor should provide reports for all visits and advise on any trends and corrective actions.

Site Standards

Pests pose a major threat to the safety of food. Pest infestations can occur where there are breeding sites and a supply
of food. Good hygiene practices should be employed to avoid creating an environment conducive to pests. Sanitation,
inspection of incoming materials and monitoring can minimise the likelihood of infestation.

Buildings should be kept in good repair and condition to prevent pest access and to eliminate potential breeding sites.
Holes, drains and other places where pests are likely to gain access should be protected or sealed. Screens for windows,
doors and vents should be used to reduce the risk of pest entry.

The availability of food and water encourages pest harbourage and infestation. Potential food sources should be
protected and stored above the ground and away from walls. Areas both inside and outside food premises should be kept
clean. Waste should be stored in covered, pest-proof containers whenever possible.

Pest infestations should be dealt with immediately and without adversely affecting food safety or suitability. Treatment
with chemical, physical or biological agents should be carried out without posing a threat to the safety of food.

Pesticides should not be used in food areas.

Pointers

As well as carrying bacteria, rodents can gnaw their way into materials and can cause substantial damage to buildings.

It is important to prevent access to pests, all access doors should be adequately proofed and/or screened.

Adequate measures in place to prevent birds from entering buildings or roosting.

Establishments and surrounding areas should be regularly examined by a competent person for evidence of infestation.

The first step is to collate all of your complaint data. Your data should then be categorized by product type, complaint type and size. Analyzing complaints by numbers alone will not give you a real picture of your performance. What you need to know is the proportion of complaints you are getting for each product. By far the most practical way of doing this is by using the sales volumes to calculate the proportion of complaints you get for each product. Some people use weight or volume such as complaints per ton or 1000 Liters. My preference is to use complaints per million units.

So, you analyze your complaint data product type, complaint type and size per million units. From this data, you can easily spot the worst performing product lines.

You should then analyze the results for the worst performing products:

Are they all the same size?

Are they produced on the same filling machine/production line?

Is it the same type of complaint?

The answers to these questions will generate your corrective action plans. If products with the highest complaint levels are all the same size it could be a particular problem with that size of packaging. If it is all the same type of complaint then why are some product lines worse than others? If product from one particular production line is generating the highest number of complaints per million units then there must be a reason for this, it needs investigating.

You should compare product performance and if there are significant differences you should ask the question why? At this point complaint trends are useful. For example, when I worked with fresh pasteurized milk sour complaints were higher in larger sized containers. The reason for this was not related to the quality of the product but the fact they took longer to consume and spent more time in and out of the fridge. Such products would be targeted for improvement projects as opposed to corrective action to remedy a problem area.

A few words of caution though, your analysis needs to take into consideration the comparative value of the products and the market. People are more likely to complain about higher value products. Also, some retail customers are much better at reporting complaints from customers to the extent that I used to get 10 times the complaint levels from one particular retailer compared to another for exactly the same product.

My last tip the more data you analyze the better. In the past I have analyzed 3 year’s worth of data. Why? It gives a year on year performance so you can see if things have been improving or deteriorating and also it shows any effects of seasonality. For example, it is not reasonable to compare summer levels of “off” complaints on a fresh product with winter levels. This is why in the Northern Hemisphere I would compare August complaint performance with the complaint levels for August in the previous year.

The complaint analyzer that I have developed based on over 30 years’ experience in the food industry is included in our Food Safety Management System Implementation Packages.

Prerequisite Programs/GMPs

Environmental and operational programs necessary to create an environment suitable to produce safe and legal food products should be established. Good Manufacturing Practices that should be implemented prior to Hazard Analysis include:

1. Environment controls
2. Construction and layout of buildings and utilities
3. Layout of premises, including workspace and employee facilities
4. Supplies of air, water, energy and other utilities
5. Supporting services, including waste and sewage disposal
6. Suitability of equipment
7. Management of purchased materials
8. Measures for the prevention of contamination/cross-contamination
9. Cleaning and sanitizing
10. Pest control
11. Personnel hygiene
12. Control of rework
13. Product recall procedures
14. Warehousing
15. Product information and consumer awareness
16. Food defense, bio vigilance and bioterrorism
17. Training and Supervision

HACCP Preliminary Steps

1. Assemble the HACCP team, with at least one team member who is HACCP trained

A core multidisciplinary team should be utilized within the company to develop the Food Safety Management System. This core team should be supplemented by other staff when specific areas or products are being analyzed.

2. Make a description of the product, how it is processed or manufactured and the storage and distribution process

The HACCP team should document the end product characteristics, including legal food safety requirements, for the purpose of conducting the Hazard Analysis.

3. Identify the intended use of the products

The HACCP team should identify all possible users and consumers for each product and process category.
Vulnerable groups of the population may have to be considered. The HACCP team should consider the consumers of the product:

• Is the product intended for babies or infants, children or adults?
• Is the product intended for a wide spectrum of the population?
• Is the product likely to be consumed by high risk groups?

4. Identify consumers of the products

The intended use should be based on the expected uses of the product by the end user or consumer.
Consider the intended use of the product:

• Is the product intended as an ingredient for further cooking?
• Is the product ready to eat?

5. Confirm the HACCP Scope

HACCP team should define the scope of the HACCP study. For each different type of product or process the HACCP team should define the scope of each HACCP plan, including the products and processes covered.

6. Consider the process and draw a flow diagram

The HACCP Team should construct flow charts for the products and process categories covered by the scope of the food safety management system. For each step in the flow chart the Food Safety team should describe the step and the control measures.

7.Confirm the flow diagram is correct by following the process

Flow charts should be physically confirmed by the HACCP (Food Safety) Team

HACCP principles

All processes used in the manufacture of food products and product groups should be subject to hazard analysis incorporating the Codex Alimentarius HACCP principles

Principle 1

Prepare a flow diagram of the steps in the process. Conduct a hazard analysis by identifying potential hazards. Assess likelihood of occurrence of these hazards and identify control options.

Principle 2

Identify the Critical Control Points in the process using the decision tree.

Principle 3

PEstablish critical limits, which must be met to ensure each Critical Control Point is under control .

Principle 4

Establish a monitoring system to ensure control of the Critical Control Point by scheduled testing or observations.

Principle 5

Establish the corrective action to be taken when monitoring indicates that a particular Critical Control Point is moving out of control.

Principle 6*

Establish documentation concerning all procedures and records appropriate to these principles and their application.

Principle 7*

Verify that HACCP is working effectively.

* Note that in CODEX Annex Guidelines Principle 6 and Principle 7 are verify then document, from a practical point of view I find it easier to document then establish verification procedures which should also be documented.

The following steps should be implemented in establishing the HACCP System:

Hazard Analysis

The HACCP team should conduct a hazard analysis for food safety hazards that are reasonably likely to occur for each product and process category. Taking the confirmed process flow diagram your HACCP team will now need to conduct a Hazard Analysis for each step to identify the threats to human health, which might be introduced into products as they are produced.

Hazards are predominantly grouped into three categories:

• Biological (including microbiological)
• Chemical
• Physical

Allergens and radiological hazards may also need to be considered.

The next step in performing a hazard analysis is for the HACCP team to consider the list all of the hazards that may be reasonably expected to occur at each step.

This first step in identifying hazards which might be associated with your production process might be considered a “brainstorming” session.

For each Food Safety Hazard Identified, the acceptable level of the hazard in the end product is determined taking into account:

• Regulatory requirements
• Customer food safety requirements
• Historic information
• Scientific literature
• Professional experience
• Intended use by the customer

This hazard list is referred to as a Preliminary Hazard List and covers all hazards that could potentially occur in the product.

In conducting the hazard analysis, wherever possible the following should be considered:

• The probability of hazards occurring
• The severity of hazards by their adverse health effects
• The qualitative/quantitative evaluation of the presence of hazards
• Survival or multiplication of microorganisms of concern
• Production or persistence of toxins, chemicals or physical agents
• Conditions leading to the above
• Customer complaints and previous internal non-conformances
• Prerequisite programs that create hygienic and safe conditions

The HACCP team must then consider what control measures, if any, exist which can be applied for each hazard.

Each potential food safety hazard should now be risk assessed by the Food Safety Team to determine whether its elimination or reduction to acceptable levels is required to produce a safe product and also any controls required to achieve the acceptable levels.

Hazard Assessment

Each potential food safety hazard is risk assessed to determine whether its elimination or reduction to acceptable levels is required to produce a safe product and also any controls required to achieve the acceptable levels.

For each step grades of impact (severity of adverse health effects) and probability (likelihood of a food safety hazard occurring) need to be allotted and the combined matrix used to judge the significance and priority for elimination or minimization of the hazard.

First the Food Safety Team assess the probability of the hazard occurring and enter:

1 for Highly Unlikely

2 for Possible

3 for Likely

Then the Food Safety Team assesses the severity of the hazard and enters:

1 for Not Severe

2 for Could possibly cause illness

3 for Severe (Could be fatal)

Probability and Severity are Multiplied to give a Significance Score for the Hazard.

All of the food safety hazards that score a 9 are regarded as significant and form the Significant Food Safety Hazard List

Critical Control Points

HACCP Principle 2 is to identify the critical control points in the process. A CCP is a step in a food process at which control can be applied to prevent, eliminate, or reduce to acceptable levels a food safety hazard. Critical Control Points are established using the decision tree as the latest step in the flow path where controls can be effectively administered for a particular Significant Food Safety Hazards.

Note: You should still ensure that your control measure or prerequisite programs adequately control significant hazards even if not identified as controlled at CCPs. Each hazard on the Significant Food Safety Hazard list must be controlled by a control measure (or combination of control measures) that prevent, eliminate or reduce the hazard to the defined acceptable levels.

Critical Limits for each CCP

For each CCP, the appropriate critical limits are defined. A critical limit is the maximum or minimum value to which a physical, biological, or chemical hazard must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.

Critical limits are exact and specify the limits required for food safety using the preventive measures put in place at CCPs.

A critical limit can be an upper limit where a set amount or level cannot be exceeded.

A critical limit can also be a lower limit where a minimum amount is required to produce the safe effect.

Validation of Control Measures

The HACCP team should confirm that the control measures (or combination of control measures) are capable of achieving the defined acceptable levels for each food safety hazard by validation activities.

Supporting validation documentation can consist of information from:

• Regulatory limits or Industry Code of Practice Guidelines
• Scientific journals
• Documented challenge studies
• In-house data

The HACCP documentation must identify:

• The hazard or pathogen, including the level of hazard prevention or pathogen reduction to be achieved
• The processing steps that will achieve the specified reduction or prevention

Establishing a Monitoring System for each CCP

A monitoring procedure should be established for each CCP to ensure compliance with critical limits.

The most commonly recognised monitoring procedures are from instruments but can be employee checks such as inspecting the documentation accompanying incoming materials.

Continuous monitoring is always preferred when it is available. This is normal when the process is continuous rather than by batch.

Monitoring should ideally provide information in time to make adjustments to ensure control of the process to prevent it exceeding the critical limits.

Ideally adjustments should be taken before a critical limit is breached.

Establishing a Corrective Action Plan

The corrective action to be taken when monitored results indicate a failure to meet a control limit is defined including responsibilities.

The corrective action plan needs ensure:

• the cause of the deviation has been identified and eliminated
• the CCP reverts to a controlled state after the corrective action has been taken
• measures to prevent recurrence of the deviation have been established
• product is quarantined until it is established that it is safe

Establishing HACCP Documents and Records

The HACCP team should establish procedures and records to ensure adequate food safety controls are in place. This includes documenting the HACCP plan which summarises all the critical control points, the monitoring procedures, critical limits, corrective actions, records and responsibility and authority.

Verification Planning

The HACCP team should define the methods, frequencies and responsibilities for verification activities (the simplest way to do this is by review of product analysis results and/or audit of HACCP documentation).

Review of the HACCP Plan

The HACCP team should review the HACCP plan and prerequisite programs at least annually and prior to any changes which may affect food safety.

References

“Hazard Analysis and Critical Control Point (HACCP) system and Guidelines for its Application” (Codex Alimentarius Commission, Geneva).

• Establishing and implementing a Food Safety Policy.
• Communicating and Maintaining the Food Safety Policy.
• Establishing and implementing Food Safety Objectives.
• Communicating and Maintaining the Food Safety Objectives
• Leading and supporting a food safety culture within the site
• Conducting regular pro-active management reviews and communicating outputs.
• Communicating commitment to satisfying customer requirements including food safety, quality and service
• Supporting and planning the development and operation of the Food Safety Management systems.
• Ensuring the food safety management system is maintained when changes are planned and implemented.
• Establishing documentation required for the effective development, implementation and updating of the food safety management system and communicating pertinent information throughout the organization.
• Providing the human and financial resources, and training, to manage the Policies and Objectives effectively.
• Providing the infrastructure and work environment to manage the Policies and Objectives effectively.
• Promoting an ethic of continuous improvement throughout the company.
• Ensuring the strict observation of all food safety system procedures, the use of correct materials and equipment, recording and reporting of both standard and non-standard events and compliance with the company rules.
• Providing the resources to audit the Food Safety Management system effectively.
• Providing the resources necessary for the food safety team to effectively implement a Food Safety HACCP plan.
• Carrying out regular Management Reviews.
• Implementing and maintaining Corrective Action, Preventative Action and Continuous Improvement Plans.
• Communicating effectively throughout the food chain from primary suppliers to end consumers including any relevant food safety information.
• Providing the resource to ensure the company is kept up to date with all industry codes of practice, legislative, scientific and technical information appropriate to the products in the countries of raw material supply, production and product sales.

Due diligence

An effective Food Safety Management System demonstrates due diligence of the company in the effective development and implementation of safe food operations. The Food Safety Management System documents are supported by the completion of specified records for the monitoring of planned activities, maintenance and verification of control measures and by taking effective actions when non-conformity is encountered.

The food safety team are required to carry out a number of preliminary steps in order to carry out the hazard analysis. In preparation for Hazard Analysis the HACCP team are required to describe the product characteristics including raw materials, ingredients, product contact materials, end products and the intended use of the end product as per ISO 22000 clauses 7.3.3 and 7.3.4. The food safety team will then need to prepare flow diagram and confirm the flow diagram physically on site.ISO 22000 clause 7.3.5.2 the food safety team to describe each process step and the existing control measures applied at each step.This is the last step required prior to hazard analysis.

ISO 22000 clause 7.4.2 requires the food safety team to identify hazard and determine their acceptable levels. The next step is for the food safety team to assess each hazard identified then consider and select the control measures required to achieve the acceptable level of hazard.Each control measure needs to be reviewed by the food safety team with respect to its effectiveness against the identified food safety hazards and then categorized as to whether they need to be operational prerequisite programmes or included in the HACCP plan. Operational prerequisite programmes must be documented and include the food safety hazard to be controlled, the control measure, the monitoring procedures, corrections and corrective actions to be taken if out of control, the responsibilities and authorities and the records to be completed as defined in ISO 22000 clause 7.5.

The next step of implementing an ISO 22000 compliant system requires the food safety team to establish the HACCP plan. Standard CODEX HACCP principles, identification of critical control points, determination of critical limits for each critical control point, monitoring of critical control points and actions when monitoring results exceed critical limits are included in ISO 22000 clause 7.6. Verification is included in clause 7.8. The food safety hazard to be controlled at the critical control point, the control measure, the monitoring procedures, critical limits the records to be used, the corrections and corrective actions to be taken if out of control, and responsibilities and authorities are all required to be included in the HACCP plan. Clause 8.2 describes the requirement for validation of operational PRP and HACCP plan control measures and combinations. Documentation requirements are specified in ISO 22000 clause 4.2.

Product characteristics, intended use, flow diagrams, process steps and control measures should be updated when the HACCP plan and/or operational prerequisite programmes have been completed as per the requirements of ISO 22000 clause 7.7. The HACCP plan and/or prerequisite programmes documents may need to be amended after updating the preliminary information and this should be decided by the food safety team.ISO 22000 Clause 8.4.2 requires the food safety team review the results of verification activities, if verification does not demonstrate conformity a review of the conclusions of the hazard analysis, operational PRPs and the HACCP plan. The last requirement is that the food safety team are to evaluate the food safety management system at planned intervals and then consider the need to review the hazard analysis, operational prerequisite programmes and the HACCP plan as described in ISO 22000 Clause 8.5.2 Updating the food safety management system.

To achieve ISO 22000 Certification an organization should have a documented food safety management system and not a system of food safety documents.Your food safety management system paperwork should be used for communication, demonstrating required groundwork and sharing experience or info. Food safety management system documents might be in any form or sort of medium and the steerage in ISO 22004:2004 clause 4.2 gives paper, electronic or picture as examples but states in any valid form. To achieve ISO 22000 authorization of its food safety management system an organization wants to address major elements of the standard.

Food Safety Management System, Management Responsibility, Resource Management, Planning and Awareness of safe Products, Authorization , Corroboration and Improvement are major elements of the ISO 22000 standardIn order to meet the necessities of ISO 22000 section four procedures for the control over records and documents as well as a documented food safety procedures should be included in the quality management system. Resources, coaching, infrastructure and work environment are major elements of ISO 22000 Section six Resource Management.

Clause 7.1 describes the requirement for realization of safe products by development and planning of food safety process.

ISO 22000 cites detailed document wants to conduct a hazard research. This info includes a food safety team, precondition programs, traits of raw materials, ingredients and product contact materials, outline of end products, intended use, flow diagrams, process steps and control measures. ISO 22000 specifies that in conducting a hazard research an organisation wishes to create operational requirement programs ( PRPs ), determine the HACCP plan then update the initial info.

ISO 22000 Section seven also has necessities for corroboration planning, a traceability system and control over nonconformity. Authorization , corroboration and improvement of the food safety management system are prescribed in ISO 22000 section eight. The food safety team are required to plan and implement processes to certify control measure mixes, control over monitoring and measuring including calibration, then confirm the food safety management system by techniques including internal audit, analysis of individual corroboration results and research of results of corroboration activities. The last wants are to ceaselessly improve and update the food safety management system. ISO 22000 ratification for your food safety management system obviously demonstrates dedication to guaranteeing that food is safe for human consumption.ISO 22000 verification should now be regarded as a chance for your food safety management system to concentrate on your food safety objectives, increase confidence in your products and systems through the pecking order and increase buyer satisfaction.