2. The Food Safety Plan - HACCP
2.1. Appropriate facilities and procedures shall be in place to control the risk of chemical or physical contamination of product.
FUNDAMENTAL
1
Clause 2.1.1
The HACCP or food safety plan shall be developed and managed by a multi-disciplinary food safety team that includes those responsible for quality assurance, technical management, production operations, engineering and other relevant functions.
Outcome Docs Actions Notes
Yes No N/A
Is the HACCP or food safety plan developed and managed by a multi-disciplinary food safety team?
Does the multi-disciplinary food safety team include those responsible for:
Does the team leader demonstrate competence in Codex HACCP principles (or equivalent)?
Does the team leader have experience in Codex HACCP principles (or equivalent)?
Has the team leader received training in Codex HACCP principles (or equivalent)?
What are the legal requirements of training?
Are the training legal requirements in place?
Do the team members have specific knowledge of: - HACCP?
Is there a designated person to oversee external experts?
Clause 2.1.2
The scope of each HACCP or food safety plan, including the products and processes covered, shall be defined.
Outcome Docs Actions Notes
Yes No N/A
Is the scope of each HACCP or food safety plan defined?
Does the scope of each HACCP or food safety plan cover the products and processes?
Clause 2.10
Establish a Monitoring System for each CCP (equivalent to Codex Alimentarius Step 9, Principle 4)
Outcome Docs Actions Notes
Yes No N/A
2.2. Calibration and Control of Measuring and Monitoring Devices
FUNDAMENTAL
1
Clause 2.2.1
The site shall establish and maintain environmental and operational programmes necessary to create an environment suitable to produce safe and legal food products (prerequisite programmes). As a guide these may include the following, although this is not an exhaustive list:
Outcome Docs Actions Notes
Yes No N/A
Does the site have a cleaning and sanitising programme?
Is the cleaning and sanitising programme maintained?
Does the site have a pest management programme?
Is the pest management programme maintained?
Does the site have maintenance programmes for equipment and buildings?
Is the programme for maintenance of equipment and buildings maintained?
Does the site have a programme for personal hygiene requirements?
Is the programme for personal hygiene requirements maintained?
Does the site have a programme for staff training?
Is the programme for staff training maintained?
Does the site have a programme for purchasing?
Is the programme for purchasing maintained?
Does the site have a programme for transportation arrangements?
Is the programme for transportation arrangements maintained?
Does the site have a programme re processes to prevent cross-contamination?
Is the programme re processes to prevent cross-contamination maintained?
Does the site have a programme for allergen controls?
Is the programme for allergen controls maintained?
Which other programmes are needed to create an environment suitable to produce safe and legal food products?
Which other programmes are needed to create an environment suitable to produce safe and legal food products?
Are these additional programmes maintained?
Are the control measures for these programmes: - clearly documented?
Are the monitoring procedures for these programmes: - clearly documented?
2.3. Chemical Control
FUNDAMENTAL
1
Clause 2.3.1
A full description for each product or group of products shall be developed, which includes all relevant information on food safety. As a guide, this may include the following, although this is not an exhaustive list:
Outcome Docs Actions Notes
Yes No N/A
Does this description include information on:
origin of ingredients?
Which other information needs to be included?
Is this additional information included?
Clause 2.3.2
All relevant information needed to conduct the hazard analysis shall be collected, maintained, documented and updated. The company will ensure that the HACCP or food safety plan is based on comprehensive information sources, which are referenced and available on request. As a guide, this may include the following, although this is not an exhaustive list:
Outcome Docs Actions Notes
Yes No N/A
Is the HACCP or food safety plan based on comprehensive information sources?
Are these sources referenced?
Are these sources available on request?
Is the latest scientific literature included?
Is information about:
Which other information needs to be included?
Has this additional information been included?
2.4. Cleaning In Place (CIP)
FUNDAMENTAL
1
Clause 2.4.1
The intended use of the product by the customer, and any known alternative use, shall be described, defining the consumer target groups, including the suitability of the product for vulnerable groups of the population (e.g. infants, elderly, allergy sufferers).
Outcome Docs Actions Notes
Yes No N/A
Is the intended use of the product, and any known alternative use, described?
Are the consumer target groups defined?
Is the suitability of the product for vulnerable groups of the population defined?
2.5. Complaint-handling
FUNDAMENTAL
1
Clause 2.5.1
A flow diagram shall be prepared to cover each product, product category or process. This shall set out all aspects of the food process operation within the HACCP or food safety plan scope, from raw material receipt through to processing, storage and distribution. As a guide, this should include the following, although this is not an exhaustive list:
Outcome Docs Actions Notes
Yes No N/A
Is there a flow diagram that covers each product, product category or process?
Does the flow diagram include a plan of the premises and equipment layout?
Does the flow diagram cover:
Which other information needs to be included?
Has this additional information been included?
2.6. Construct a Process Flow Diagram (equivalent to Codex Alimentarius Step 4)
FUNDAMENTAL
1
Clause 2.6.1
The HACCP food safety team shall verify the accuracy of the flow diagrams by on-site audit and challenge at least annually. Daily and seasonal variations shall be considered and evaluated. Records of verified flow diagrams shall be maintained.
Outcome Docs Actions Notes
Yes No N/A
Does the HACCP food safety team verify the accuracy of the flow diagrams by on-site audit?
Has the HACCP food safety team challenged the flow diagrams at least once in the last year?
Are daily variations considered?
Are daily variations evaluated?
Are seasonal variations considered?
Are seasonal variations evaluated?
Are records of the verified flow diagrams maintained?
2.7. Container Cleanliness -Glass jars, cans and other rigid containers
FUNDAMENTAL
1
Clause 2.7.1
The HACCP food safety team shall identify and record all the potential hazards that are reasonably expected to occur at each step in relation to product, process and facilities. This shall include hazards present in raw materials, those introduced during the process or surviving the process steps, and consideration of the following types of hazard:
Outcome Docs Actions Notes
Yes No N/A
Does the HACCP food safety team identify potential hazards that are reasonably expected to occur at each step?
Are these hazards recorded?
Are hazards present in raw materials considered?
Are hazards introduced during the process or surviving the process steps considered?
Are microbiological hazards considered?
Are physical contamination hazards considered?
Are chemical and radiological contamination hazards considered?
Are fraud hazards considered?
Are allergen risks considered?
Are steps preceding the process plan considered?
Are steps following the process plan considered?
Which other potential hazards need to be considered?
Have these additional potential hazards been considered?
Clause 2.7.2
The HACCP food safety team shall conduct a hazard analysis to identify hazards which need to be prevented, eliminated or reduced to acceptable levels. Consideration shall be given to the following:
Outcome Docs Actions Notes
Yes No N/A
Does the HACCP food safety team conduct hazard analyses to identify hazards which need to be prevented, eliminated or reduced to acceptable levels?
Is the likely occurrence of hazard considered?
Is the severity of the effects on consumer safety considered?
Is the vulnerability of those exposed considered?
Is the survival and multiplication of micro-organisms of specific concern to the product considered?
Is the presence of production of toxins, chemicals or foreign bodies considered?
Is the contamination of raw materials, intermediate/semi-processed product, or finished product considered?
Which other hazards need to be prevented, eliminated or reduced to acceptable levels?
Have these additional potential hazards been considered, with relevant justifications documented?
Where elimination of the hazard is not practical, is the justification for acceptable levels of the hazard determined?
Is this justification documented?
Clause 2.7.3
The HACCP food safety team shall consider the control measures necessary to prevent or eliminate a food safety hazard or reduce it to an acceptable level. Where the control is achieved through existing prerequisite programmes, this shall be stated and the adequacy of the programme to control the specific hazard validated. Consideration may be given to using more than one control measure.
Outcome Docs Actions Notes
Yes No N/A
Has the HACCP food safety team considered the control measures necessary to prevent or eliminate a food safety hazard; or reduce it to an acceptable level?
For controls achieved through existing prerequisite programmes: - is this stated?
Is consideration given to using more than one control measure?
2.8. Control of Non-conforming Product
FUNDAMENTAL
1
Clause 2.8.1
For each hazard that requires control, control points shall be reviewed to identify those that are critical. This requires a logical approach and may be facilitated by use of a decision tree. Critical control points (CCPs) shall be those control points which are required in order to prevent or eliminate a food safety hazard or reduce it to an acceptable level. If a hazard is identified at a step where control is necessary for safety but the control does not exist, the product or process shall be modified at that step, or at an earlier step, to provide a control measure.
Outcome Docs Actions Notes
Yes No N/A
Are CCPs those control points which are required in order to prevent or eliminate a food safety hazard or reduce it to an acceptable level?
For hazards that require control, are control points reviewed to identify those that are critical?
Does the identification use a logical approach, possibly facilitated by the use of a decision tree?
For hazards that are identified where control is necessary but does not exist, has the product or process been modified to provide a control measure?
Which document lists the hazards that require control?
Is this documented regularly updated?
2.9. Product Legality
FUNDAMENTAL
1
Clause 2.9.1
For each CCP, the appropriate critical limits shall be defined in order to identify clearly whether the process is in or out of control. Critical limits shall be:
Outcome Docs Actions Notes
Yes No N/A
Which document lists the CCPs?
Is this document regularly reviewed?
Are the appropriate critical limits for each CCP defined, thus identifying whether the process is in or out of control?
Are critical limits measurable wherever possible?
Are critical limits supported by clear guidance or examples where measures are subjective?
Clause 2.9.2
The HACCP food safety team shall validate each CCP. Documented evidence shall show that the control measures selected and critical limits identified are capable of consistently controlling the hazard to the specified acceptable level.
Outcome Docs Actions Notes
Yes No N/A
Which documents are used to demonstrate CCP validation?
Are these documents/validations regularly reviewed?
Is the monitoring system able to detect loss of control of CCPs?
Is the monitoring system able to, wherever possible provide information in time for corrective action to be taken?
Is online measurement considered?
Is offline measurement considered?
Is continuous measurement considered?
Where discontinuous measurement is used, does the system ensure that the sample taken is representative of the batch?
2.10. Product labelling shall comply with the appropriate legal requirements and contain information to enable the safe handling, display, storage and preparation of the product within the food supply chain or by the customer.
FUNDAMENTAL
1
Clause 2.10.1
A monitoring procedure shall be established for each CCP to ensure compliance with critical limits. The monitoring system shall be able to detect loss of control of CCPs and, wherever possible, provide information in time for corrective action to be taken. As a guide, consideration may be given to the following, although this is not an exhaustive list:
Outcome Docs Actions Notes
Yes No N/A
Is there a monitoring procedure for each CCP, to ensure compliance with critical limits?
Which document lists the CCPs that need to be monitored?
Is this document regularly reviewed?
Is the monitoring system able to detect loss of control of CCPs?
Is the monitoring system able to, wherever possible, provide information in time for corrective action to be taken?
Is online measurement considered?
Is offline measurement considered?
is continuous measurement considered?
Which other points should be considered?
Are these additional points considered?
Where discontinuous measurement is used, does the system ensure that the sample taken is representative of the batch of product?
Clause 2.10.2
Records associated with the monitoring of each CCP shall include the date, time and result of measurement and shall be signed by the person responsible for the monitoring and verified, when appropriate, by an authorised person. Where records are in electronic form, there shall be evidence that records have been checked and verified.
Outcome Docs Actions Notes
Yes No N/A
Which documents are used to record CCP monitoring?
Are these documents regularly reviewed?
Do the records include:
Are the records signed off by the person responsible for monitoring?
Are the records verified by an authorised person, where appropriate?
For records that are in electronic form, is there evidence that they have been checked and verified?
2.11. Approval and Performance Monitoring of Manufacturers/Packers of Traded Food Products
FUNDAMENTAL
1
Clause 2.11.1
The HACCP food safety team shall specify and document the corrective action to be taken when monitored results indicate a failure to meet a control limit, or when monitored results indicate a trend towards loss of control. This shall include the action to be taken by nominated personnel with regard to any products that have been manufactured during the period when the process was out of control.
Outcome Docs Actions Notes
Yes No N/A
Are there documented corrective actions to be taken when monitored results indicate a failure to meet a control limit?
In which document are these corrective actions detailed?
Are there documented corrective actions to be taken when monitored results indicate a trend towards loss of control?
Does the documentation include the action to be taken with regard to products that were manufactured during the period when the process was out of control?
2.13. Building Fabric in High-Risk and High-Care Zones
FUNDAMENTAL
1
Clause 2.13.1
Documentation and record-keeping shall be sufficient to enable the site to verify that the HACCP and food safety controls, including controls managed by prerequisite programmes, are in place and maintained.
Outcome Docs Actions Notes
Yes No N/A
Is the documentation sufficient to verify that the HACCP and food safety controls, including controls managed by prerequisite programmes, are: - in place?
2.14. Building Fabric, Raw Material Handling, Preparation, Processing, Packing and Storage Areas
FUNDAMENTAL
1
Clause 2.14.1
The HACCP food safety team shall review the HACCP or food safety plan and prerequisite programmes at least annually and prior to any changes which may affect food safety. As a guide, these may include the following, although this is not an exhaustive list:
Outcome Docs Actions Notes
Yes No N/A
Is there a review procedure that states how and when reviews are done?
Is this procedure regularly reviewed?
Does the review procedure specify that reviews need to take place: - at least once every 12 months?
In terms of considering and incorporating in the food safety plan, including full documentation and validation, has this been done with: - changes in raw materials or supplier of raw materials?
Which other changes that may affect food safety need to be considered?
Have these additional changes been considered and incorporated in the food safety plan, including full documentation and validation?
Which changes should be reflected in the company's product safety policy and food safety objectives?
Have these additional changes been reflected in the company's product safety policy and food safety objectives?