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The Food Safety Enhancement Program approach to a preventive control plan

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Introduction

The Food Safety Enhancement Program (FSEP) is one example of a type of preventive control plan (PCP). FSEP is based on the Hazard Analysis and Critical Control Point (HACCP) principles and, for many years, this program has been implemented by meat, dairy, processed fruits and vegetables, shell eggs, processed eggs, honey and maple food operators as well as hatcheries. FSEP specifies the requirements for an effective HACCP system to ensure food is prepared under sanitary conditions and is safe to eat.

It is important for businesses operating under an FSEP plan developed prior to the Safe Food for Canadians Regulations (SFCR) to:

Once reviewed and revised, as necessary, businesses may continue to use their written FSEP as their PCP and be in a good position to demonstrate compliance with the preventive control requirements of the SFCR.

Purpose

The Canadian Food Inspection Agency (CFIA) created this document as guidance to help regulated parties comply with the Safe Food for Canadians Regulations.

It's your choice

You may use other guidance developed by provincial governments, industry associations, international partners or academic bodies as long as they can achieve the outcomes identified in the regulations. Always ensure that the guidance you choose is relevant for your particular business, product or products, and market requirements.

What is included

The document describes the key components of a written Food Safety Enhancement Program, as well as information on program changes to consider under the SFCR.

Refer to the Tell me more! section for additional sources of information that may help you update your FSEP.

What's not included

The document does not discuss the municipal and provincial processing requirements that may apply to your activities.

Roles and responsibilities

Food businesses are responsible for complying with the law. They demonstrate compliance by ensuring that the commodities and processes for which they are responsible meet regulatory requirements. If a written PCP is required, the food business develops a PCP with supporting documents, monitors and maintains evidence of its implementation, and verifies that all control measures are effective.

CFIA verifies the compliance of a food business by conducting activities that include inspection, and surveillance. When non-compliance is identified, the CFIA takes appropriate compliance and enforcement actions.

The Food Safety Enhancement Program

  1. General
  2. Program responsibilities
  3. Prerequisite programs
  4. Market fairness requirements
  5. HACCP plans
  6. Validation documentation/Evidence of effectiveness
  7. Maintaining your FSEP
  8. Forms

I. General

You prepare, keep and maintain a written FSEP plan that meets the requirements of section 89 of the SFCR. The plan outlines the control measures you develop and implement to ensure that your food is safe and fit for consumption and the measures you apply to ensure compliance with the consumer protection and animal welfare requirements, as applicable. Your FSEP outlines:

Requirements /critical limits

The criteria that have to be met or the critical limits that have to be met for each critical control point (CCP) in your HACCP plans.

Keep in mind

You need to review and update, as necessary, the requirements with the preventive control requirements in Part 4 of the SFCR.

Preventive controls

A description of the control measures to ensure compliance with the requirements set out in sections 47 to 84 of the SFCR. The written preventive controls describe:

Keep in mind

Under the SFCR (section 89):

  • In your PCP you are only required to describe the control measures that prevent, eliminate or reduce to an acceptable level the hazards you identify as presenting a risk of contamination to your food, and the evidence of their effectiveness.

Monitoring procedures

A description of the monitoring procedures to ensure that the control measures are carried out correctly and consistently. The written monitoring procedures describe:

Note: The document Monitoring procedures provides additional information on key elements to consider in the development of monitoring procedures and types of monitoring procedures.

Corrective action procedures

A description of the corrective actions when there's a deviation or deficiency with:

The corrective procedures:

Note: The document Corrective actions outlines the steps for establishing corrective action procedures and preparing corrective action records.

Keep in mind

Under the SFCR (section 89):

  • Written monitoring and corrective actions procedures are required only for CCPs, however, these procedures help ensure the effective implementation of any control measure you apply and are recommended for your prerequisite programs as well.
    • Monitoring activities can provide evidence on the implementation and effectiveness of any control measure you apply.

Verification procedures

A description of the verification activities to confirm and demonstrate that all preventive controls, monitoring activities and corrective actions outlined in your program are consistently implemented and are effective in achieving the intended outcome.

Verification procedures apply to the:

Your verification procedures:

Note: the document Verification procedures outlines the steps for developing verification procedures.

Keep in mind

Under the SFCR:

  • verification procedures are not required for prerequisite programs that are not established as control measures to address hazards identified, however, these procedures help to ensure that you are maintaining and operating your establishment in compliance with SFCR sections 50 to 81.
  • you may verify your program at a frequency appropriate for your business however it is recommended that you verify your program at least annually.

Record keeping

A description of the documents (records) completed to substantiate that your preventive control plan has been implemented and to provide evidence that your control measures are effective. You ensure the integrity of the records by:

The document Record keeping provides guidance that may help you establish records and ensure the integrity of all the records you generate. 

Keep in mind

Under the SFCR:

  • the documents (records) you generate to show your preventive controls are implemented and effective have to be retained for a period of 2 years (rather than 36 months).
  • documents (records) on the treatment of low-acid foods packed in hermetically sealed package, that are not kept refrigerated or frozen, have to be retained for 3 years.

II. Program responsibilities

Developing, implementing and maintaining an effective program depends on knowledgeable, experienced and committed management and employees working together to identify food safety hazards and determine how to control them.

Senior management commitment

The responsibilities of senior management include:

Senior management demonstrates commitment to their FSEP by:

A letter of commitment signed annually by a member of senior management confirms the:

HACCP team

The responsibilities of a HACCP team include:

Keep in mind

While the SFCR do not have PCP requirements on management roles and responsibilities, it is a recommended practice and you are encouraged to outline these in your FSEP.

FSEP document

Having the first page of the prerequisite programs, HACCP plans and process controls signed and dated by the HACCP team leader or a member of senior management provides the confirmation that the HACCP system is approved and will be implemented as specified. It is recommended that the document be signed:

Dating all pages of the prerequisite programs, HACCP plans, process controls and supporting documentation such as standard operating procedures ensures that the correct version is implemented. It is recommended that the document be dated:

Note: for the use of electronic signatures or signature stamps, it is a good practice to have measures to ensure their integrity and authorized access. You may incorporate the date with the electronic signature or signature stamps.

III. Prerequisite programs

The design and construction of an establishment and equipment, as well as the condition of the premises and equipment, have to be suitable for the production of safe food production. The establishment also has to be maintained and operated in a clean sanitary condition that prevents the contamination of a food. The requirements that apply to the maintenance and operation of an establishment can be found in Division 4, sections 49 to 81, of the SFCR. The following prerequisite programs address these requirements:

  1. Premises
  2. Food conveyances, purchasing, receiving and storage
  3. Conveyances and equipment in the establishment
  4. Personnel
  5. Sanitation and pest control
  6. Recall System
  7. Operational prerequisite programs

A. Premises

This prerequisite program is intended to address the requirements set out in sections 56 to 71 of the SFCR.

1. Outside property (section 56 of the SFCR)

The land that forms part of your establishment and the location of your establishment may be a source of hazards such as pests and airborne microbial or chemical contaminants. These hazards may enter your establishment and present a risk of contamination to your food. To prevent or eliminate the hazards you:

If your establishment is located near a source of contamination such as livestock or agricultural activities, you can protect your food from the hazards these activities may present by:

2. Establishment (sections 57 to 71 of the SFCR)
2.1 Design, construction and maintenance (sections 57 to 58 and 60 to 62 of the SFCR)

The design and construction of your establishment prevents hazards that may be present from posing a risk of contamination to your food. For example:

The size and layout of your establishment is adequate and accommodates the activities conducted. For example:

Note:

Movement of persons and things (section 59 of the SFCR)

The movement of persons and things is controlled to prevent contamination of the food.

Note: the document Preventive control plan templates for domestic food businesses provides additional information on traffic and process flows.

You maintain your facility in good repair to prevent the contamination of your food. For example:

2.2 Lighting (section 63 of the SFCR)

The natural or artificial lighting you use in your establishment is appropriate for your food. For example, the lighting does not:

The placement and intensity of lighting in your establishment is appropriate for the activities conducted. For example, the lighting allows you to:

The artificial lighting you use does not present a risk of contamination to your food. For example, light fixtures are:

The guidance document Lighting in an establishment provides additional information on light intensity levels and colour known to be adequate for conducting activities.

2.3 Ventilation (sections 64 and 65 of the SFCR)

The natural or mechanical ventilation system in your facility provides a good air exchange. For example, the ventilation system:

The document condensation provides information on measures you may apply to prevent condensation and the contamination of your food with condensation that cannot be prevented.

2.4 Waste and inedible/food disposal (section 66 of the SFCR)

You handle and dispose of waste, such as garbage, discarded packaging, broken pallets, discarded construction materials, and inedible products or food waste in a manner that prevents the contamination of your food. For example:

The document Specified risk material provides information on the handling of specified risk material to comply with the Health of Animals Regulations.

3. Sanitary facilities (section 67 of the SFCR)
3.1 Employee facilities

Your establishment has the necessary sanitary facilities for employees to maintain personal cleanliness such as:

The sanitary facilities:

For example:

3.2 Hand-washing stations and sanitizing installations

Your facility has and maintains the necessary installations for the cleaning and sanitizing of hands and footwear to prevent the contamination of a food. For example:

4. Water/ice/steam (sections 70-71 of the SFCR)

The water, ice and steam used that can come into contact with food do not present a risk of contamination to the food. For example:

Note: the following documents provide additional information:

B. Food conveyances, purchasing, receiving and storage

1. Food conveyances (sections 72-73 of the SFCR)

The conveyances used to transport food to and from your establishment do not present a risk of contamination to a food and protect the food from contamination from other food, dust, pests and the exterior environment. For example, the conveyances:

The food is loaded on and unloaded from a conveyance in a manner that does not present a risk of contamination to the food. For example:

2. Purchasing, receiving and storage
2.1 Purchasing and receiving (section 47(2) of the SFCR)

The incoming ingredients, products and materials you receive in your establishment are suitable, permitted for use and do not present a risk of contamination to your food. For example:

You verify the incoming ingredients, products and materials when they are received to ensure that they:

Note: the documents Incoming ingredients, materials and non-food chemicals and Supplier food safety assurance program outline the control measures that may be used to ensure the incoming food, ingredients, materials and non-food chemicals are safe and suitable for use.

You identify and isolate, in a designated storage area, the food received as returns (food you prepared that has left your establishment) to prevent it from posing a risk of contamination to other food, as a result of mishandling and inadequate storage that may have occurred after the food left your establishment.

2.2 Storage (section 74 of the SFCR)

You store your food in a manner that protects it from contamination and you store non-food materials and chemicals in a manner that does not present a risk of contamination to your food. For example:

C. Conveyances and equipment in the establishment

1. Equipment general (sections 53 to 55 of the SFCR)

The equipment you use is appropriate to the food and activity you conduct and function as intended.

1.1 Design and installation

The conveyances or equipment you use are designed, constructed and maintained in a manner that prevents contamination of your food. For example:

1.2 Equipment maintenance and calibration

The equipment and conveyances are maintained, and if necessary, calibrated, so that they function as intended and do not present a risk of contamination to the food. For example:

D. Personnel

1. Training (section 75 of the SFCR)

Your personnel have the competencies and qualifications necessary to carry out the tasks and duties assigned to them to deliver the control measures needed to prevent, reduce or eliminate hazards from presenting a risk of contamination to your food. This includes the procedures outlined in your prerequisite programs, CCPs, process controls and the monitoring and verification activities. To ensure your personnel are trained you:

1.1 General food hygiene training

Your employees are trained on food hazards, food hygiene, clean and sanitary conditions and the hygienic practices to follow to prevent the contamination of food. For example:

1.2 Technical training

Your employees, including contractors, have the competencies, qualifications and accreditations necessary to carry out technical tasks. For example, they are trained on:

2. General food hygiene program (sections 76 to 81 of the SFCR)

You have a food hygiene program that employees, contractors and visitors are expected to follow to prevent the contamination of your food. It describes, for example:

E. Sanitation and pest control

1. Sanitation (sections 50 and 52 of the SFCR)

You have a sanitation program to maintain your establishment and equipment in a clean and sanitary condition, free from the accumulation of dust, dirt, food residue, grease and other debris that may contaminate your food. For example, you:

Note: the document Cleaning and sanitation program provides additional information that may help you develop a cleaning and sanitation program.

2. Pest control (sections 51 and 52 of the SFCR)

You have a pest control program that protects your facility against the entry and presence of animals that present a risk of contamination to the food. For example:

Note: the document Pest control provides additional information on control measures for pests and information on pest control programs.

F. Recall system

A recall system outlines the procedures for receiving, investigating and responding to complaints and the procedures for recalling a food that presents a risk of injury to human health.

1. Recall plan

You have a recall plan in place that describes the:

Note: the Recall procedure: A guide for food businesses provides a step-by-step approach to consider when developing recall procedures.

Keep in mind

Under the SFCR:

The requirements for investigation, notification, complaints and recall (do not form part of the PCP requirements. You can include these procedures in your FSEP or prepare, keep and maintain them separately from your FSEP.

Note the requirements to:

  • immediately investigate a complaint when you suspect on reasonable grounds that a food presents a risk of injury to human health
  • immediately notify the CFIA of the results of your investigation and take immediate actions to mitigate any risk of injury to human health when the results indicate that the food presents a risk
  • conduct a recall simulation, based on your procedures, once every 12 months, document the results of the simulation, and keep that document for 2 years
2. Traceability system (Part 5 of the SFCR)

A traceability system includes the measures you take to ensure a food is labelled with the information necessary to trace it and to prepare and retain documents that allow you to trace the movement of a food 1 step back and 1 step forward.

2.1 Documents (sections 90 and 91 of the SFCR)

You prepare and keep documents (records) that:

Note: you can obtain additional information on traceability requirements from CFIA's Traceability for food web page.

2.2 Labelling for traceability (section 92 of the SFCR)

You have measures in place that ensure the information necessary to trace a food is on your food label:

Keep in mind

Under the SFCR:

Traceability requirements are not part of the PCP requirements. You can include your traceability measures, and the documents you prepare, in your FSEP or keep them separate from your FSEP.

G. Operational prerequisite programs

1.1 Allergens, gluten and added sulphites

Food allergens, gluten and added sulphites are chemical hazards that you need to consider during your hazard analysis and when determining critical control points. You have control measures in place to:

The document Preventive controls for food allergens, gluten and added sulphites provides guidance on measures that you may apply to:

Preventing cross-contamination plays an important part in your preventive controls for allergens.

The document Preventing cross-contamination provides information on the factors that may result in cross-contamination and measures you can apply to prevent cross-contamination.

1.2 Food additives, processing aids and added nutrients

Food additives permitted in Canada and their conditions of use are listed in the Lists of permitted food additives that are published on Health Canada's website.

Substances identified as processing aids are not mentioned in the Food and Drug Regulations and may be used as long as they do not result in an unsafe food. 

Vitamins, minerals and amino acids can be added to certain foods.

You have control measures in place that ensure you add, to a food, only:

You have control measures that:

2 Foreign material control program

Foreign materials are physical hazards that may present a risk of contamination to your food.  You prevent the contamination of your food with foreign materials by having procedures on:

Note: when you determine that a foreign material detector is not working properly, all the food that has passed through the detector, since it was last tested to be working properly, is segregated and visually inspected or passed through a working detector.

When filters, sieves or magnets are found to be defective, the potential for contamination of products shall be assessed and appropriate actions taken.

The rejection of food by the detectors is assessed to determine if trends exist, such as, multiple false rejections that may suggest a malfunction or a calibration issue with the detector.

IV. Market fairness requirements

You describe the measures you apply to meet the consumer protection requirements referred to in section 89(1)(a) and (b) of the SFCR that apply to your food:

Your measures ensure the labels applied to your foods are accurate, legible and not misleading. For example, as part of your control measure you:

Keep in mind

Under the SFCR:

These are measures required in a PCP to meet the applicable market fairness provisions of the Safe Food for Canadians Regulations which are the food labelling, standards and grades requirements. Refer to CFIA's Labelling, standards of identity and grades web page for additional information on these requirements and the Industry labelling tool for information on the labelling requirements.

V. HACCP plan

You conduct a hazard analysis to identify the biological, chemical, and physical hazards that present a risk of contamination of your food and to determine the control measures needed to prevent, eliminate or reduce to an acceptable level the hazards identified, as required under section 47 of the SFCR.

To develop the HACCP plan for a food, required under section 89(1)(c) of the SFCR, you follow the 12 steps below.

Note: several foods may share similar hazards, processing steps or equipment. In this case, the foods or processes may be grouped into 1 HACCP plan.

1. Assemble the HACCP team

Assemble a HACCP team to develop the HACCP plans. The HACCP team:

2. Describe the product and identify its intended use

Describe the food and its intended use:

You may use Form 1. Product description to document this information.

3. List product ingredients and materials that come into contact with the food

List all ingredients used in the food and materials that come into contact with the food or are used in preparing the food such as:

You may use Form 2. List of product ingredients and incoming material to document this information and indicate whether there are biological (B), chemical (C) or physical (P) hazards associated with them using the letters B, C or P.

4. Construct a process flow diagram

Prepare a flow diagram for each food or process category covered by the HACCP plan.

A flow diagram helps identify the possible occurrence or introduction of and/or increase in food safety hazards.

Your flow diagram shows:

You may use Form 3: Process flow diagram to document this information and indicate whether there are biological, chemical or physical hazards associated with each processing step using the letters B, C or P.

The accuracy and completeness of the flow diagrams may be verified on-site.

5. Construct a schematic of the establishment

Prepare a schematic of the establishment for the foods or process categories covered by the HACCP plan. Schematics provide a basis for evaluating potential areas where cross-contamination by pathogens, foreign materials, chemicals or allergens may occur.

The schematic of your establishment shows the:

You may use Form 4. Plant Schematic to document this information and indicate whether there are biological, chemical or physical hazards associated with cross-contamination points using the letters B, C or P.

The accuracy and completeness of the plant schematic may be verified on-site.

6. Identify and analyze hazards (HACCP principle 1)

Conduct a hazard analysis to identify the biological, chemical, and physical hazards that present a risk of contamination of your food, based on:

You may use:

Note: the document Conduct a hazard analysis provides additional information on how to conduct a hazard analysis, identify all potential hazards and evaluate the significance of a hazard identified.

7. Determination of Critical Control Points (CCPs) (HACCP principle 2)

Identify each step at which control measures may be applied and are essential to prevent a food safety hazard or reduce its occurrence to a level that would not compromise food safety.

You may use Form 8 Decision tree – CCP determination to:

You may use Form 9. Hazards not controlled by the establishment to identify the hhazards that are out of your control and describe how the hazard is controlled before or after the processing steps shall be documented on form 9 or equivalent.

Note: the document Determining critical control points and their critical limits provides additional information on the steps involved in determining CCPs.

8. Critical limits (HACCP Principle 3)

Critical limits are clear and measurable criteria that distinguish between what is acceptable and/or unacceptable for a hazard identified by a CCP. The effectiveness of the control measures applied to prevent, eliminate or reduce to an acceptable level a hazard depends on their ability to keep the hazard within critical limits. 1 or more critical limits may be applied to control the identified hazards.

Establish critical limits that:

You may use Form 10 Critical control points to document:

Note: the document Determining critical control points and their critical limits provides additional information on the steps followed to establish critical limits for the CCPs.

9. Monitoring procedures (for CCPs) (HACCP principle 4)

Establish monitoring procedures for each CCP, as outlined in the General sections of a prerequisite program and HACCP plan, to ensure the control measures applied are functioning as intended.

Note: the document Monitoring procedures provides additional information on elements to consider in the development of monitoring procedures and the types of monitoring procedures.

10. Corrective action procedures (for CCPs) (HACCP principle 5)

Establish corrective action procedures for each CCP, as outlined in the Sections of a prerequisite program and HACCP plan. They specify planned or appropriate corrective actions to be taken when monitoring results demonstrate that:

When there's a deviation at a CCP, as a corrective action you:

Note: the document Corrective actions outlines the steps for establishing corrective action procedures and preparing corrective action records.

11. Verification procedures (for CCPs) (HACCP principle 6)

Establish verification procedures for each CCP, as outlined in the section Elements of a written prerequisite program and HACCP plan.

The frequency of your verification activities provides the evidence you need to show that the CCP(s) remain in control of the hazards.

Note: the document Verification procedures outlines the steps for developing verification procedures.

12. Record keeping (for CCPs) (HACCP Principle 7)

Keep records, as outlined in the section Record keeping to demonstrate the effective application of a critical control point.

Note: the document Record keeping provides guidance that may help you establish records and ensure the integrity of all the records you generate.

Process controls

You may apply process controls, a series of steps that contribute to the reduction of a hazard(s), prior to the CCP step at which the hazard(s) are controlled. These process controls are linked to the CCP.

You may use Form 11 Process controls to document your process controls and describe the following information:

VI. Validation documentation/Evidence of effectiveness

You validate, prior to implementing your HACCP plan, the effectiveness of the critical limits established for each CCP in controlling the hazard(s) identified. You have evidence showing that all the control measures you apply, to prevent, reduce or eliminate hazards, are effective.

The information used to conduct a validation includes:

Note: the document Evidence showing a control measure is effective outlines the general steps involved in obtaining evidence of effectiveness for control measures, as outlined in Codex Alimentarius.

Keep in mind

Under the SFCR, you must have and document evidence showing that all the control measures you apply to eliminate, prevent or reduce a hazard(s) to an acceptable level, are effective.

VII. Maintaining your FSEP

Reassess and update your FSEP when there's a change or situation that could affect the hazard analysis or the effectiveness of your FSEP, such as when:

Your reassessment activities include a review of the written program, records completed as well as on-site assessments. You review:

Your reassessment procedures describe the:

Keep in mind

Under the SFCR, you can verify that your control measures are consistently implemented and are effective at a frequency appropriate for your food business. It is recommended that you verify your entire FSEP program at least annually.

Revisions to your FSEP

You have procedures for amending your FSEP that describe:

New HACCP plan

When you include a new HACCP plan or a new process to an existing HACCP plan, document:

Keep in mind

Under the SFCR, you are not required to keep a list of the amendments you make to your FSEP plan, however it is considered a good practice.

Tell me more!  Further reading

The following references contain information that helps explain food safety controls, demonstrates how to develop them, and provides examples. The CFIA is not responsible for the content of documents that are created by other government agencies or international sources.

CFIA references

Other references

VIII. Forms

Form 1: Product description

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Description of Form 1: Product description

Form 1 can be used to provide a description of each process or product type. The name of the process or product is described on the first line. You should describe the following:

  • Product name
  • Important product characteristics
  • Intended use
  • Packaging
  • Intended shelf life and storage conditions
  • Where the product will be sold
  • Labelling instructions relating to food safety
  • Special distribution control.

Form 2: List of ingredients and incoming materials

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Description of Form 2: List of ingredients and incoming materials

Form 2 can be used to list all ingredients, including composition of formulated ingredients (with reference to other documents if needed), additives, processing aids and incoming materials that come in contact with or are used in preparing a food. The name of the process or product is described on the first line.

Form 3: Process flow diagram

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Description of Form 3: Process flow diagram

Form 3 can be used to illustrate the flow of your operation using a diagram. The name of the process or product is described on the first line. Your process flow diagram on line 2 should illustrate:

  • the sequence and interaction of all steps in the operation from receiving to final shipping
  • the introduction of ingredients and intermediate products into the process flow
  • the introduction of products for reworking

Form 4: Plant schematic

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Description of Form 4: Plant schematic

Form 4 can be used to illustrate the plant schematic. The name of the process or product is described on the first line. Your plan schematic should illustrate:

  • the flows of raw products, ingredients and finished products
  • the flows of packaging materials
  • the employee traffic pattern throughout the establishment including change rooms washrooms and lunchrooms
  • the flows of the waste, inedible products and other non-food products that could cause cross-contamination
  • the hand/boot washing and sanitizing installations

Form 5: Biological hazard Identification

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Description of Form 5: Biological hazard Identification

Form 5 can be used to describe the biological hazards associated with the ingredients and incoming materials, processing steps or cross-contamination points. The name of the process or product is described on the first line.

Column 1
In column 1 you list and describe the biological hazards identified.

Column 2
In column 2 you identify the processing step at which each biological hazard (listed in column 1) is controlled.

Form 6: Chemical hazard identification

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Description of Form 6: Chemical hazard identification

Form 6 can be used to describe the chemical hazards associated with the ingredients and incoming materials, processing steps or cross-contamination points you identify. The name of the process or product is described on the first line.

Column 1
In column 1 you list and describe the chemical hazards identified.

Column 2
In column 2 you identify the processing step at which each chemical hazard (listed in column 1) is controlled.

Form 7: Physical hazard identification

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Description of Form 7: Physical hazard identification

Form 7 can be used to describe the chemical hazards associated with the ingredients and incoming materials, processing steps or cross-contamination points you identify. The name of the process or product is described on the first line.

Column 1
In column 1 you list and describe the physical hazards identified.

Column 2
In column 2 you indicate the processing step at which each physical hazard (listed in column 1) is controlled.

Form 8: CCP determination and other control measures

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Description of Form 8: CCP determination and other control measures

Form 8 can be used to determine CCPs and other control measures. The name of the process or product is described on the first line.

Column 1
Under column 1 you list each ingredient and incoming material, process step and cross-contamination point for which a hazard or hazards were identified. Use one line per hazard.

Column 2
In column 2 you identify the category of each hazard identified (biological, chemical or physical) and fully describe each hazard. Where multiple hazards exist, each one is subject to the questions that follow.

You determine if each hazard is controlled by one or more prerequisite program. If the answer is "yes", for each hazard you identify the prerequisite program and the control measures applied in that program that controls the hazard.

If the HACCP team determines that the hazard is not fully controlled by a prerequisite program, proceed to Question 1.

Question 1
For each hazard you ask the questions:

  • Could you apply a control measure at a process step?
  • Could a control measure be applied at this step, or at any other process step, to control the hazard? Do you have or could you add a process step to control the hazard?
    • If the answer is "yes", describe the control measure and proceed to Question 2.
    • If the answer is "no" (a control measure cannot be implemented at a process step), identify how the hazard will be controlled before or after the manufacturing process (see form 9) and proceed to the next identified hazard.

Question 2
For each hazard you ask the questions:

  • Can the hazard increase to an unacceptable level and present a risk of contamination to the food?

If information gathered suggests that the hazard could increase to an unacceptable level and present a risk of contamination to the food, the answer is "yes". Proceed to Question 3.

If the hazard is not likely to increase to an unacceptable level, or does not pose a risk of contamination to the food, the answer is "no". Proceed to the next hazard.

Question 3
For each process step you ask the following question:

  • Is the process step specifically designed to prevent, eliminate or reduce to an acceptable level the hazard?
    • If yes then the answer is "yes" and you designate this process step as a critical control point and indicate this in the last column.
    • If the answer is no, proceed to Question 4.

Note: Question 3 applies only to processing steps. For incoming materials, write "not applicable"and proceed to Question 4.

Question 4
You ask the following question:

  • Will a subsequent step eliminate the identified hazard or reduce it to an acceptable level?
    • If the answer is "no, " designate this process step a critical control point and identify it in the last column. Proceed to the next identified hazard.

If the answer is "yes", identify the subsequent step or steps that control the hazard. Then proceed to Question 5.

Question 5
You ask the following question:

  • Does this step provide partial control of the identified hazard?
    • If the answer is "yes", this process step is a process control. Enter the process control number in the last column then proceed to the next identified hazard.
    • If the answer is "no", proceed to the next identified hazard.

Form 9: Hazards not controlled by the establishment

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Description of Form 9: Hazards not controlled by the establishment

Form 9 can be used to list hazards that cannot be controlled by the establishment for each process or product. Identify the name of the process or product on the first line.

Column 1
In column 1 you list all the hazards that you can`t control.

Column 2
In column 2 you describe how the hazard can be controlled before or after the production process.

Form 10: Critical control points

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Description of Form 10: Critical control points

Form 10 can be used to document each critical control point. Identify the name of the process or product on the first line.

Column 1
In column 1 you indicate the critical control point number

Column 2
In column 2 you indicate the hazard(s) controlled at the critical control point and describe the control measure(s) applied

Column 3
In column 3 you indicate the critical limit(s).

Column 4
In column 4 you describe the monitoring procedures.

Column 5
In column 5 you indicate the corrective measures.

Column 6
In column 6 you describe the verification procedures.

Column 7
In column 7 you identify the HACCP records.

Form 11: Process controls

Description of this image follows.
Description of Form 11: Process controls

Form 11 can be used to document your process controls. Identify the name of the process or product on the first line.

Column 1
In column 1 you identify the process control number and the number of the critical control point associated to that process control.

Column 2
In column 2 you describe the hazard(s) controlled at the process control.

Column 3
In column 3 you indicate the standards that need to be met for the hazard (s).

Column 4
In column 4 you describe the monitoring procedures.

Column 5
In column 5 you describe the corrective measures.

Column 6
In column 6 you describe the verification procedures.

Column 7
In column 7 you identify the HACCP records.

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