HACCP Generic Model for Moulded Dark Chocolate with Almonds

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Table of Contents

Introduction

The General Principles of Food Hygiene, Composition and Labelling continues to be the current Canadian regulatory guide for chocolate manufacturers. The HACCP Generic Model for Moulded Dark Chocolate With Almonds and its companion document, Food Safety Practices Guidance for Moulded Chocolate Manufacturers were developed by a committee consisting of representatives from the Canadian Food Inspection Agency (CFIA) with input from a number of interested parties, including the Canadian chocolate industry, Health Canada and provincial government representatives. These documents are intended to be food safety resources for the chocolate industry.

The generic model was developed using the (CFIA) Food Safety Enhancement Program (FSEP) approach and tools: Sections 1, 2 and 3 of the FSEP Manual, including the ten forms it contains. Form 8, CCP Determination (based on the Codex Alimentarius Decision Tree), was used to determine the Critical Control Points (CCPs). It is expected that prior to the development of a facility-specific HACCP Plan, the manufacturer will first develop and implement Good Manufacturing Practices or prerequisite programs as they are called in the FSEP approach. This includes the development of programs and procedures associated with Premises, Transportation, Purchasing/Receiving/Shipping and Storage, Equipment, Personnel, Sanitation and Pest Control, Recall and Allergen Control. Following the development and implementation of the prerequisite programs, this generic model can be used as a practical example by the chocolate manufacturer to design a facility-specific HACCP Plan. Information on the FSEP approach can be found in the FSEP Manual.

The Food Safety Practices Guidance document was referenced by the committee during the development of the HACCP Generic Model for Moulded Dark Chocolate with Almonds. This guidance document incorporates Chapters 1 to 8 of the GPFHCL, in addition to other reference materials. Using a HACCP approach, it provides guidance to the chocolate manufacturer on controlling potential hazards. Chapter 1 provides information about developing operational controls for controlling hazards, while Chapters 2 to 8 provide information about developing Good Manufacturing Practices (GMPs). A hazard summary is provided after the Scope section in the guidance document.

Together, the generic model and its companion guidance document provide information for moulded chocolate manufacturers to use to review all potential health and safety hazards in their operations. It allows them to focus on controlling the points that are critical to the safety of the finished product. For additional information on prerequisite programs and the use of generic models, the FSEP Manual should be consulted.

I. Developing a Facility-Specific HACCP Plan

The HACCP team at each establishment is responsible for identifying and controlling all hazards specific to its operation and for determining how each hazard is controlled. In order to identify all possible hazards, the HACCP team should consult the Reference Database for Hazard Identification developed by the (CFIA), along with reference texts and scientific publications, as well as industry associations.

Using the HACCP Generic Model for Moulded Dark Chocolate with Almonds as a guideline, the HACCP team should develop a HACCP Plan specific to their facility beginning with Forms 1 to 4. A review of the manufacturer's processes and procedures should then be conducted to determine what hazards exist in the facility. Using the FSEP approach, these hazards are recorded on Forms 5, 6 and 7. Then using Form 8, the manufacturer determines how each of those hazards is controlled for incoming material and ingredients and at each step in the process. Where a step in the process is determined to be a CCP, the hazard is transferred to Form 10, and critical limits, monitoring procedures, deviation procedures and verification procedures should be developed. Following this process, the manufacturer should compare its facility-specific HACCP Plan to the generic model for completeness. If the manufacturer determines a prerequisite program is fully controlling a hazard in its facility but the generic model indicates a CCP as the control measure, the manufacturer should validate that the identified prerequisite program is able to fully control the hazard as described. For products or processes that differ significantly from this generic model, the HACCP team must still follow the seven principles of HACCP as described in the FSEP Manual.

II. Limitations for the Use of the Moulded Dark Chocolate with Almonds Generic Model

The committee wishes to emphasize that the model described here is a generic model. It does not cover all possible processes, nor does it list all possible associated hazards. This generic model is an example or guide that can be adapted to most facilities producing chocolate. The process flow diagram in this generic model does not reflect the characteristics of the specific manufacturing process of any one of the companies consulted by the committee, but rather represents the basic processing steps of all companies consulted. The model reflects the entire process from receipt of dark chocolate blocks through to the shipping/distribution of the moulded dark chocolate with almonds to hospitals, restaurants, institutions or retail outlets.

This generic model deals only with the manufacture of moulded dark chocolate with almonds from chocolate blocks. Where ingredients, procedures or processes in the facility differ from those in the generic model, the HACCP team should determine whether ingredients and/or process steps should be added or removed. Here are some examples:

Manufacture of chocolate from beans
This generic model does not include the manufacture of any intermediate products of chocolate or the manufacture of the chocolate blocks from cocoa beans. If these processes are conducted, the manufacturer should consider adding product information to Form 1, as well as adding the beans and/or the intermediate products to the list of incoming materials and ingredients (Form 2) and adding any additional process steps in the manufacturing process to the process flow diagram (Form 3).
Roasting of almonds
This generic model does not include the roasting of almonds. If almonds are being roasted at the facility, the HACCP team should consider making the required changes to the product information on Form 1 and Form 2 of the generic model as well as to the process flow diagram (Form 3) (adding the appropriate steps).
Fillings
This generic model does not include the addition of a filling to moulded chocolate. If a filling is being added with or without almonds (e.g. caramel, nougat, cherry), the HACCP team should consider adding the product information to Form 1 of the generic model, the filling and/or its components to the list of incoming ingredients and materials on Form 2 and, if required, adding the necessary process steps to the process flow diagram (Form 3).
Chocolate product with no inclusions
If a manufacturer is making moulded chocolate that does not contain almonds (an allergen), the HACCP team should consider whether a possibility exists of chemical cross contamination with allergens from other ingredients and/or other production lines within the facility. The HACCP team should consider whether any additional information is required on the label and whether this information should be identified on Form 1 of the generic model. Consideration should also be given to removing ingredients that no longer apply from the list of incoming ingredients and materials on Form 2 of the generic model, and, if required, renaming and/or removing any process steps on the process flow diagram (Form 3).
Presence of additional ingredients (e.g. milk ingredients, raisins, sweeteners)
This generic model does not include milk ingredients as a component of the dark chocolate blocks (see definition of dark chocolate below). Nor does it include raisins, sweeteners, or milk ingredients as ingredients in the moulded chocolate. If the manufacturer is adding any additional ingredients, or if a component of any ingredient differs from the generic model, the HACCP team should consider adding the ingredient and/or the component to the list of incoming ingredients and materials (Form 2) in the generic model, and if required, the HACCP team should consider adding any additional steps to the process flow diagram (Form 3).
Single product line
This generic model assumes that the moulded chocolate with almonds is being manufactured on a dedicated manufacturing line where no products, other than moulded dark chocolate with almonds, are manufactured. This generic model also assumes that the moulded chocolate with almonds is made in a facility that has several different product lines with different ingredients, including different allergens. If a manufacturer has only one product and there is no chance of contamination from other ingredients or processes, the HACCP team should consider whether any changes should be made to the generic model on Form 1, Form 2, Form 3 and/or Form 4.

For each change made to Forms 1 through 4, appropriate changes must be made to Forms 5, 6, 7, 8, 9 and 10 where applicable, to ensure that the hazard analysis is complete.

III. Validation of the HACCP System

The HACCP team at each establishment is also responsible for the validation of the HACCP system. The team should first validate the hazards that exist in the facility, and then validate the standards for the prerequisite programs (i.e. GMPs) as well as the critical limits of the critical control points. If the manufacturer is unable to find a scientific study or government regulation supporting the standards and critical limits used in the prerequisite programs and HACCP Plan, facility personnel should conduct a validation study to validate the control measure being contemplated through testing. This step is generally completed during the development of the HACCP system. Once the control measure has been established and validated, facility personnel should carry out a validation to show that the process is able to consistently meet the standard. The manufacturer should reassess the adequacy of the HACCP system at least once a year and whenever changes occur that could affect the hazard analysis or alter the HACCP system. For additional information on validation and reassessment of the HACCP system, the FSEP Manual should be consulted.

IV. Decisions and Assumptions Made During the Development of the Generic Model

During the development of the generic model, as it worked through hazard identification and analysis, the committee discussed and dealt with the several issues. The following decisions and/or assumptions were made and are reflected in the generic model:

  1. This generic model, while based on the FSEP approach, endeavoured to adhere to the GPFHCL and the information found in the guidance document wherever possible. However, the committee recognized that differences exist between the GPFHCL and the FSEP approach. For example, in the FSEP approach, transportation, receiving and storage of all incoming ingredients and materials is covered in the prerequisite program, Transportation, Purchasing/Receiving/Shipping and Storage. The GPFHCL and the guidance document consider the criteria for receiving of incoming ingredients and packaging materials to be process related. This information can be found in Chapter 1 - Operational Controls (Section 1.4.1 and Section 1.4.2). All other information for receiving is found in Chapter 6 - Transportation and Storage (Section 6.1) of the GPFHCL and the guidance document. In order to be consistent with the FSEP approach, it is assumed that manufacturers will identify the receiving step as a prerequisite program. A note has been added to both Chapter 1 and Chapter 6 of the guidance document to indicate that if a manufacturer chooses to do this, the information from Sections 1.4.1 and 1.4.2 should be included with the information found in Section 6.1 (a prerequisite program). If the manufacturer wishes to maintain a CCP at Receiving, this will be considered acceptable.
  2. Where applicable, in the "Controlled at" column on Forms 5, 6 and 7, and when answering the question, 'Is the hazard fully controlled by a prerequisite program?' in the second column on Form 8, the FSEP prerequisite program is identified by the name it is given in the guidance document (i.e. "Transportation and Storage" not "Transportation, Purchasing/Receiving/Shipping and Storage" as it is identified in the FSEP Manual).
  3. The committee recognizes the importance of document control; however, in an attempt to avoid prescribing a specific method, we have not recorded information such as 'Written By', 'Approved By', 'Version Number' or 'Revision Date' on each page of the Generic Model.
  4. Dark chocolate is received as blocks and is not manufactured at the facility. It is considered ready-to-eat as received. There is no step identified in the manufacture of the moulded dark chocolate with almonds that will eliminate or reduce the risk of pathogen contamination in chocolate; therefore, the manufacturer should ensure that chocolate, almonds and other ingredients are free from pathogenic microorganisms (e.g. Salmonella spp.) before use. This may include obtaining certificates of analysis for each lot of chocolate received or conducting appropriate testing on incoming ingredients.
  5. Chocolate, because of its low water activity, prevents the growth of microbial hazards and prevents microbial spoilage problems. However, there is potential for Salmonella contamination from added ingredients such as cocoa, coconut, milk powder, and egg albumen, all of which may contain Salmonella. The addition of nuts, peanuts and cocoa may also introduce mycotoxins (e.g. aflatoxins and ochratoxin A). In this generic model, only almonds have been added to the chocolate.
  6. For the purposes of this generic model, it is assumed that the facility does not roast almonds as part of the manufacturing process. In other words, only roasted almonds are received at the facility.
  7. Water, ice and steam do not appear on Form 2 because they are not used as ingredients in the process.
  8. The dark chocolate in this generic model does not contain 'milk ingredients'. Manufacturers are reminded that while the definition of dark chocolate indicates that it may contain less than 5 percent total milk solids from milk ingredients (see definition of dark chocolate below), milk ingredients are considered an allergen. Where milk ingredients are present in the dark chocolate, these must be declared on the list of ingredients (as per B.01.008 of the Food and Drug Regulations) for the benefit of those individuals who are allergic to, or have a sensitivity to, milk products.
  9. The cooling step in this generic model is assumed to be conducted using refrigerated air circulated by fans.
  10. This generic model includes a metal detector. It is considered a safety measure to control hazardous extraneous (metallic) materials that are not controlled by the prerequisite programs (e.g. wear and tear of equipment resulting in metal shavings in the product during the grinding process). If a metal detector is part of the process, the hazards associated with that metal detector should be evaluated and controlled. The manufacturer should realize that the metal detector is only considered a safety measure to the level of the sensitivity of the machine. Below the sensitivity level of the machine, the hazard can no longer be controlled by the metal detector and the facility should determine how the hazard is controlled.
  11. In an attempt to condense the generic model, where it was determined that a common hazard exists for multiple process steps on Forms 5, 6, 7, 8 and 9, the process steps are grouped together with a single hazard description.
  12. On Form 10, this generic model assumes that the manufacturer will develop facility-specific Standard Operating Procedures (SOPs) that are validated to ensure that when the procedures are followed as written, the critical limit will be met and therefore the hazard will be controlled.

V. Definitions:

Dark Chocolate (as per B.04.006 of the Food and Drug Regulations)
  1. shall be one or more of the following combined with a sweetening ingredient,
    1. cocoa liquor,
    2. cocoa liquor and cocoa butter,
    3. cocoa butter and cocoa powder;
  2. shall contain not less than 35 per cent total cocoa solids, of which not less than 18 per cent is cocoa butter, and not less than 14 per cent is fat-free cocoa solids; and
  3. may contain less than 5 per cent total milk solids from milk ingredients, spices, flavouring preparations (other than those that imitate the flavour of chocolate or milk) to balance flavour, salt, and any of the following emulsifying agents, which singly shall not exceed the maximum level of use set out in column III of Table IV to section B.16.100, and in combination shall not exceed 1.5 per cent by mass of chocolate product, mono-glycerides and mono- and diglycerides, lecithin and hydroxylated lecithin, ammonium salts of phosphorylated glycerides, polyglycerol esters of interesterified castor oil fatty acids, and sorbitan monostearate.
Food Additives (as per B.01.001 of the Food and Drug Regulations)
Means any substance the use of which results, or may reasonably be expected to result, in it or its by-products becoming a part of or affecting the characteristics of a food, but does not include:
  1. any nutritive material that is used, recognized or commonly sold as an article or ingredient of food;
  2. vitamins, mineral nutrients and amino acids, other than those listed in the tables to Division 16,
  3. spices, seasonings, flavouring preparations, essential oils, oleoresins and natural extractives;
  4. agricultural chemicals, other than those listed in the tables to Division 16,
  5. food packaging materials and components thereof; and
  6. drugs recommended for administration to animals that may be consumed as food.
Pathogenic Microorganisms
In this generic model may include: Salmonella spp., Clostridium botulinum, Clostridium perfringens, Staphylococcus aureus, Bacillus spp., Escherichia coli, and viruses (Hepatitis A and Norovirus).
Prerequisite Program
Universal steps or procedures that control the operational conditions within a food establishment and promote environmental conditions that are favourable for the production of safe food.

HACCP Generic Model: Moulded Dark Chocolate with Almonds – Forms

Example of Completed Form 1: Example of Completed Product Description Process

1. Product name

Moulded Dark Chocolate with Almonds

Note: The manufacturer should list all products on Form 1, including all sizes of packages manufactured for each product, or the manufacturer may reference a computer file where a complete list of products including various package sizes can be accessed.

2. Important product characteristics (Aw, pH, preservatives, etc.)

Low water activity between X and Y

3. How the product will be used

Ready-to-eat

4. Packaging

  • plastic liners
  • plastic bags
  • cardboard tray (bar boat)
  • corrugated cardboard boxes
  • foil paper
  • cello or shrink wrap
  • plastic forms/trays
  • cardboard boxes

5. Shelf life

N/A

6. Where it will be sold

  • Retail
  • Restaurants
  • Hospital/Institutions

7. Labelling instructions

  • Lot code
  • "May contain X" (precautionary labelling where X refers to the allergens that may be present in the product)

8. Special distribution control

Temperature not to exceed X°C

Example of Completed Form 2: Example of Completed List of Product Ingredients and Incoming Materials

Legend: Explanation of Codes

  • (B) = Biological hazard
  • (C) = Chemical hazard
  • (P) = Physical hazard

Ingredients

  • dark Chocolate blocks [Cocoa, Chocolate Liquor, Sugar, Cocoa Butter, Food Additives (lecithin, emulsifying agents)] (BCP)
  • returned moulded dark chocolate with almonds (BCP)

Other Ingredients

  • roasted almonds (BCP)

Packaging Material

  • plastic liners (BCP)
  • plastic bags (BCP)
  • cardboard tray (bar boat) (BCP)
  • corrugated cardboard boxes (BCP)
  • foil Paper (BCP)
  • cello or Shrink Wrap (BCP)
  • plastic forms/trays (BCP)
  • cardboard boxes (BCP)

Example of Completed Form 3: Example of Completed Process Flow Diagram

Diagram- Process Flow Diagram. Description follows.
Description for Generic Process Flow Diagram for Moulded Chocolate

This diagram is a flow chart showing the process for producing moulded chocolate.

The diagram lists the necessary steps from 1 - 19 to be taken in the moulded chocolate production process.

Identified in pink ovals are the Critical Control Points (CCPs). These are next to boxes 6, Melting tank; 12, Mixing/blending; 16, Metal detection; and 17, Packaging/labelling/coding.

Identified in an orange oval is rework. This receives input from steps 13, Depositing/moulding; 14, Air cooling; and 15, Demoulding; and leads to steps 2, Chocolate storage; and 6, Melting tank.

Identified in a green oval is returned product which leads to step 1, Receiving.

Potential for Biological (B), Chemical (C) and/or Physical (P) hazards is indicated in parentheses next to each process step.

  1. Receiving (BCP). Leading to steps 2, Chocolate storage; 3, Almond storage; and 4, Packaging material storage. Receives input from returns.
  2. Chocolate storage (BCP). Leading to steps 5, Cutting/breaking chocolate blocks; and 6, Melting tank. Receives input from rework.
  3. Almond storage (BCP). Leading to step 12, Mixing/blending.
  4. Packaging material storage (BCP). Leading to steps 13, Depositing/moulding; and 17, Packaging/labelling/coding.
  5. Cutting/breaking chocolate blocks (BCP). Leading to step 6, Melting tank.
  6. Melting tank (BCP). CCP-1C. Leading to steps 7, Screening/magnet; and 8, Holding tank. Receives input from rework.
  7. Screening/magnet (BCP). Leading to step 8, Holding tank.
  8. Holding tank (BCP). Leading to step 9, Screening/magnet. Melted chocolate with rework leads to step 12, Mixing/blending.
  9. Screening/magnet (BCP). Leading to step 10, Tempering.
  10. Tempering (BCP). Leading to step 11, Screening/magnet.
  11. Screening/magnet (BCP). Leading to step 12, Mixing/blending.
  12. Mixing/blending (BCP). CCP-2C. Leading to and receives input from step 13, Depositing/moulding.
  13. Depositing/moulding (BCP). Leading to step 14, Air cooling; and rework.
  14. Air cooling (BCP). Leading to step 15, Demoulding; and rework.
  15. Demoulding (BCP). Leading to step 16, Metal detection; and rework. Product packaged prior to metal detection leads to step 17, Packaging/labelling/coding.
  16. Metal detection (BCP). CCP-3P. Leading to step 17, Packaging/labelling/coding. Product packaged prior to metal detection from step 17 is received. This product then proceeds to step 18, Storage; after metal detection.
  17. Packaging/labelling/coding (BCP). CCP-4C. Leading to step 18, Storage. Product packaged prior to metal detection leads to step 16, Metal detection.
  18. Storage (BCP). Leading to step 19, Shipping/distribution.
  19. Shipping/distribution (BCP).

Example of Completed Form 4: Plant Schematic

Construct the plant schematic diagram on Form 4.

Note: This form is to be specific for each establishment.

Indicate the flows of raw and finished products as well as employee traffic and, where a possible hazard exists, the movement of waste or garbage.

Include the flows of all ingredients and packaging materials from the moment they are received through storage, preparation, processing, packaging, finished product holding and shipping.

Indicate employee traffic patterns throughout the establishment from the time the employees enter the building. Include movement into change rooms, washrooms, lunchrooms, offices and maintenance, as well as the movement of employees through food production areas of the facility. Where applicable, it is important to clearly identify the traffic flow of employees handling raw products and those employees handling finished products.

This diagram should be your primary tool for identifying potential areas of cross-contamination (e.g. locations where allergen ingredients, food additives, waste or raw ingredients could come into unplanned contact or where employees could cross contaminate product).

(See Canadian Food Inspection Agency FSEP Manual – Chapter 3 – Section 3.2.4)

Note: The points of cross-contamination should be marked on the plant schematic and a full description of each of the identified hazards should be recorded on Form 5, 6 and/or 7, Form 8 and where appropriate, Form 10 (examples of possible hazards that could be identified on Form 4 are provided on Form 6).

Example of Completed Form 5: Biological Hazards Identification

Pathogenic microorganisms when used in this generic model may include: Salmonella spp., Listeria monocytogenes, pathogenic strains of Escherichia coli, Clostridium botulinum, Clostridium perfringens, Staphylococcus aureus, Bacillus cereus, and viruses (Hepatitis A virus and Norovirus).

Product name: Moulded Dark Chocolate with Almonds
List all biological hazards related to ingredients, incoming material, processing, product flow, etc.
Identified biological hazards (Bacteria, parasites, viruses, etc.)Controlled at
Dark Chocolate Blocks - Presence of pathogenic microorganisms in dark chocolate due to use of contaminated ingredients [e.g., lecithin, milk ingredients, sugar, cocoa beans and intermediate products (e.g., cocoa liquor)] at the supplier level.

- Transportation, Receiving and Storage B2.1.3 (of the FSEP Manual)

- Section 1.4.1 (of the guidance document)

Roasted Almonds - Presence of pathogenic microorganisms on almonds due to improper processing and/or handling at supplier level.

- Transportation, Receiving and Storage B2.1.3

- Section 1.4.1

Roasted Almonds - Presence of pathogenic microorganisms and/or mold on almonds due to time/temperature and/or humidity abuse at the supplier level and/or during transportation.

- Transportation, Receiving and Storage B2.1.3

- Section 1.4.1

Packaging Material - Presence of pathogenic microorganisms due to damaged or soiled packaging material as a result of mishandling at the supplier level.

- Transportation, Receiving and Storage B2.1.3

- Section 1.4.2

Packaging Material - Presence of pathogenic microorganisms due to contamination with faecal material from pests (rodents, birds and insects).

- Transportation, Receiving and Storage B2.1.3

- Section 1.4.2

Returned Product - Presence of pathogenic microorganisms on returned chocolate due to mishandling at restaurants, hospitals, institutions and/or retail and/or during transportation.

- Transportation, Receiving and Storage B2.1.3

- Section 1.4.2

Dark chocolate blocks, roasted almonds, returned products and/or packaging materials - Presence of pathogenic microorganisms due to use of unclean/damaged containers and/or unclean vehicles for transportation from supplier to manufacturer.

- Transportation, Receiving and Storage B1.1.1 and B2.1.3

- Sections 1.4.2 and 6.1.1

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 - Contamination of dark chocolate blocks, roasted almonds, returned product, rework, in-process dark chocolate, moulds, packaging materials and/or finished product with pathogenic microorganisms (e.g., Salmonella spp.) due to improper employee handling and hygiene.

- Personnel D1.1.1 and D2.1.1

- Sections 5.1.2 and 5.2.1

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 - Contamination of dark chocolate, roasted almonds, returned product, rework, in-process dark chocolate, packaging materials and/or finished product with pathogenic microorganisms due to contamination from overhead structures (e.g., leaking pipes).

- Premises A2.1.1, A2.1.2 and A2.3.1

- Sanitation and Pest Control E1.1.1

- Equipment C1.1.1 and C1.2.1

- Sections 2.1.1, 2.1.3, 3.2.1, 3.2.3 and 4.1.1

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 - Contamination of dark chocolate blocks, roasted almonds, returned product, rework, in-process dark chocolate, packaging materials and/or finished product with pathogenic microorganisms due to contact with pests (flies, rodents, birds).

- Sanitation and Pest control E2.1.1

- Section 4.2.1

1 Receiving - Acceptance of incoming materials and ingredients not meeting specifications (i.e. not meeting firm's standards) as described on specification sheets for each incoming material and/or ingredient.

- Transportation, Receiving and Storage B1.1.2 and B2.1.3

- Personnel D1.2.1

- Sections 1.1.4, 1.4.1, 1.4.2, 5.2.2 and 6.1.1

1 Receiving - Contamination of dark chocolate blocks, roasted almonds, returned product, and/or packaging materials at receiving with pathogenic microorganisms from raw products (non-ready-to-eat) carried on the same truck.

- Transportation, Receiving and Storage B1.1.1 and B2.1.3

- Sections 1.4.2 and 6.1.1

1 Receiving - Contamination of dark chocolate blocks, roasted almonds, packaging material and/or returned product due to damaged containers/packaging material resulting in exposed product.

- Transportation, Receiving and Storage B1.1.2 and B2.1.3

- Sections 1.4.2 and 6.1.1

2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 - Contamination of dark chocolate blocks, roasted almonds, returned product, rework, in-process dark chocolate, packaging materials, and/or finished product with pathogenic microorganisms due to damaged containers, packaging material and /or moulds resulting from improper storage procedures.

- Transportation, Receiving and Storage B2.2.2

- Sections 1.5.1, 1.6.1, 1.8.1, 6.2.1 and 6.2.3

2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 - Contamination of dark chocolate blocks, roasted almonds, returned product, rework, in-process dark chocolate, packaging materials, and/or finished product with pathogenic microorganisms due to damaged containers, packaging material and /or moulds resulting from improper employee handling and hygiene.

- Personnel D1.1.1 and D2.1.1

- Sections 5.1.1 and 5.2.1

2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 - Contamination of dark chocolate blocks, roasted almonds, returned product, rework, in-process dark chocolate, packaging materials and/or finished product with pathogenic microorganisms due to contact with unclean utensils, tools, moulds and equipment as a result of improper sanitation procedures.

- Sanitation and Pest Control E1.1.1

- Section 4.1.1

2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 - Contamination of dark chocolate blocks, roasted almonds, returned product, rework, in-process dark chocolate, packaging materials and/or finished product with pathogenic microorganisms due to contaminated air.

- Premises A2.3.1

- Section 3.2.3

2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 - Contamination of dark chocolate blocks, roasted almonds, returned product, rework, in-process dark chocolate, moulds, packaging materials and/or finished product with pathogenic microorganisms due to inadequate separation from equipment cleaning and sanitizing facilities.

- Premises A2.1.1

- Section 3.3.2

2, 3, 18 - Contamination of roasted almonds, dark chocolate blocks and/or finished product in storage due to a failure to identify and/or isolate returned, defective or suspect product.

- Premises A2.1.1

- Transportation, Receiving and Storage B2.1.2 and B2.2.2

- Sections 1.6.1, 1.8.1, 3.2.1, 6.2.1 and 6.2.3

3 Almond Storage - Growth of pathogenic microorganisms in roasted almonds due to time/temperature abuse and/or elevated humidity levels during storage.

- Transportation, Receiving and Storage B2.2.2

- Sections 1.8.1 and 6.2.1

3 Almond Storage - Growth of pathogenic microorganisms due to failure to rotate incoming roasted almonds (first in, first out).

- Transportation, Receiving and Storage B2.2.2

- Sections 1.8.1 and 6.2.1

5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17 - Contamination of dark chocolate with pathogenic microorganisms present on equipment surfaces due to the availability of water for bacterial growth as a result of incomplete removal of water and/or incomplete drying of equipment (including moulds) after sanitation procedures.

- Sanitation and Pest Control E1.1.1

- Section 4.1.1

5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17 - Contamination of dark chocolate with pathogenic microorganisms present on equipment surfaces (e.g. utensils and moulds) due to the use of non-potable water during sanitation.

- Premises A4.1.1

- Sections 3.4.1 and 7.4.1

6, 7, 8, 9, 10, 11, 12, 13 - Contamination of dark chocolate as a result of presence of pathogenic microorganisms at specific points in the process where improper line design and incomplete cleaning allow product and moisture to accumulate (i.e., dead-end pipes).

- Equipment C1.1.1

- Sanitation and Pest Control E1.1.1

- Sections 2.1.1, 2.1.2 and 4.1.1

6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17 - Contamination of dark chocolate blocks, in-process dark chocolate, rework, returned product, finished product and/or packaging materials with pathogenic microorganisms due to presence on damaged and/or deteriorating surfaces of equipment, moulds, conveyors, tools and/or utensils (i.e., presence of pathogenic microorganisms in cracks and crevices).

- Equipment C1.1.1

- Sanitation and Pest Control E1.1.1

- Sections 2.1.1, 2.1.2 and 4.1.1

6 Melting Tank - Contamination of in-process dark chocolate, rework, returned product and/or dark chocolate blocks due to contact with returned, defective or suspect product that was not appropriately identified and/or isolated to prevent its use.

- Premises A2.1.1

- Transportation, Receiving and Storage B2.1.2 and B2.2.2

- Sections 1.6.1, 1.8.1, 3.2.1, 6.2.1 and 6.2.3

14 Air Cooling - Contamination of dark chocolate with pathogenic microorganisms due to contact with inappropriately sourced and/or contaminated air used for cooling.

- Premises A2.3.3

- Section 3.2.3

19 Shipping/Distribution - Contamination of finished product with pathogenic microorganisms as a result of loading product onto a carrier that is unacceptable for the transportation of food (e.g., carrier in unclean condition, carrier in poor state of repair).

- Transportation, Receiving and Storage B1.1.1

- Section 6.1.2

19 Shipping/Distribution - Contamination of finished product with pathogenic microorganisms as a result of transporting on same carrier with non-ready-to-eat product (i.e., raw meat or other product contaminated with pathogenic microorganisms).

- Transportation, Receiving and Storage B1.1.1

- Section 6.1.2

19 Shipping/Distribution - Contamination of finished product with pathogenic microorganisms as a result of improper loading/stacking resulting in damaged containers/packaging and exposure of finished products.

- Transportation, Receiving and Storage B1.1.2

- Sections 6.1.1 and 6.1.2

Example of Completed Form 6: Chemical Hazards Identification

Product name: Moulded Dark Chocolate with Almonds
List all chemical hazards related to ingredients, incoming material, processing, product flow, etc.
Identified chemical hazardsControlled at
Dark Chocolate Blocks - Presence of environmental contaminants (e.g., pesticides and herbicides) in dark chocolate blocks above the maximum allowable residue limits.

Form 9

Dark Chocolate Blocks - Presence of food additives in dark chocolate blocks above the maximum allowable residue limits.

- Transportation, Receiving and Storage B2.1.3 (of the FSEP Manual)

- Sections 1.1.4 and 1.4.1 (of the guidance document)

Dark Chocolate Blocks - Presence of heavy metals and other chemicals in dark chocolate blocks.

- Transportation, Receiving and Storage B2.1.3

- Section 1.4.1

Dark Chocolate Blocks - Presence of undeclared allergens in dark chocolate blocks (e.g., milk ingredients) could impact on sensitive individuals.

- Transportation, Receiving and Storage B2.1.3

- Section 1.4.1

Dark Chocolate Blocks - Presence of food additives not permitted for use by government regulations in dark chocolate blocks.

- Transportation, Receiving and Storage B2.1.3

- Sections 1.1.4 and 1.4.1

Roasted Almonds - Presence of food additives not permitted for use by government regulations in roasted almonds.

- Transportation, Receiving and Storage B2.1.3

- Sections 1.1.4 and 1.4.1

Roasted Almonds - Growth of aflatoxins or ochratoxin A producing mould on roasted almonds due to improper handling at supplier level and/or during transportation (i.e. time/temperature and/or humidity abuse).

- Transportation, Receiving and Storage B2.1.3

- Section 1.4.1

Roasted Almonds - Presence of undeclared allergens in roasted almonds could impact on sensitive individuals (e.g., tree nuts, peanuts).

- Transportation, Receiving and Storage B2.1.3

- Section 1.4.1

Roasted Almonds - Presence of environmental contaminants (e.g., pesticides, and herbicides) in roasted almonds above the maximum allowable residue limits.

Form 9

Packaging Material - Not food grade and/or not appropriate for intended use.

- Transportation, Receiving and Storage B2.1.3

- Section 1.4.2

Returned product - Contamination of returned chocolate with non-food chemicals as a result of contamination at restaurants, hospitals, institutions and/or retail and/or during transportation.

- Transportation, Receiving and Storage B2.1.3

- Section 1.4.1

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 - Contamination of dark chocolate blocks, roasted almonds, rework, returned products, in-process dark chocolate, moulds, packaging materials and/or finished product with allergenic ingredients (e.g., peanuts, milk ingredients) not declared in the list of ingredients as a result of improper employee hygiene and handling procedures.

- Personnel D1.1.1, D1.2.1 and D2.1.1

- Sections 5.1.1, 5.2.1 and 5.2.2

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17,18, 19 - Contamination of dark chocolate blocks, roasted almonds, rework, returned products, in-process dark chocolate, packaging materials and/or finished product with non-food chemicals, cleaning solutions, sanitizers and/or their residues during sanitation procedures as a result of damaged containers and/or open containers and/or exposed product or packaging materials.

- Sanitation and Pest Control E1.1.1

- Transportation, Receiving and Storage B2.2.2

- Sections 1.5.1, 4.1.1, 6.2.1, 6.2.2 and 6.2.3

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17,18, 19 - Contamination of dark chocolate blocks, roasted almonds, rework, returned products, in-process dark chocolate, packaging materials and/or finished product with non-food chemicals, cleaning solutions, sanitizers and/or their residues due to improper storage procedures.

- Transportation, Receiving and Storage B2.2.2 and B2.2.3

- Sections 1.5.1, 6.2.1, 6.2.2 and 6.2.3

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17,18, 19 - Contamination of dark chocolate blocks, roasted almonds, rework, returned products, in-process dark chocolate, packaging materials and/or finished product with non-food chemicals, cleaning solutions, sanitizers and/or their residues due to improper employee handling procedures.

- Personnel D1.1.1 and D2.1.1

- Sections 5.1.1 and 5.2.1

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17,18, 19 - Contamination of dark chocolate blocks, roasted almonds, rework, returned products, in-process dark chocolate, packaging materials and/or finished product with non-food chemicals, cleaning solutions, sanitizers and/or their residues due to improper sanitation procedures.

- Sanitation and Pest Control E1.1.1

- Section 4.1.1

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 - Contamination of dark chocolate blocks, roasted almonds, rework, returned product, in-process dark chocolate and/or packaging materials with lubricants, oil and/or hydraulic fluid from poorly maintained equipment.

- Equipment C1.1.1 and C1.2.1

- Sections 2.1.1, 2.1.2, 2.1.3 and 2.1.4

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 - Contamination of dark chocolate blocks, roasted almonds, rework, returned products, in-process dark chocolate, packaging materials and/or finished product with chemicals from food contact surfaces, including equipment, moulds, tools and utensils, that are not food grade.

- Equipment C1.1.1 and C1.2.1

- Sections 2.1.1, 2.1.2, 2.1.3 and 2.1.4

1 Receiving - Acceptance of incoming materials and ingredients not meeting specifications (i.e. not meeting firm's standards) as described on specification sheets for each incoming material and/or ingredient.

-Transportation, Receiving and Storage B2.1.3

- Personnel D1.2.1

- Sections 1.1.4, 1.4.1, 1.4.2 and 5.2.2

1 Receiving - Contamination of dark chocolate, roasted almonds, returned product and/or packaging materials with non-food chemicals being received at the same time.

- Transportation, Receiving and Storage B2.2.3

- Section 6.2.2

2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 - Contamination of dark chocolate blocks, roasted almonds, returned product, rework, in-process dark chocolate, packaging materials and/or finished products with non-food chemicals (e.g., lubricants oils, sanitizers, cleaning chemicals) as a result of improper storage of non-food chemicals.

- Transportation, Receiving and Storage B2.2.3

- Section 6.2.2

2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 - Contamination of dark chocolate blocks, roasted almonds, returned product, rework, in-process dark chocolate, packaging materials and/or finished products with non-food chemicals (e.g., lubricants oils, sanitizers, cleaning chemicals) as a result of improper handling of non-food chemicals by employees.

- Transportation, Receiving and Storage B2.2.3

- Section 6.2.2

2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 - Contamination of dark chocolate blocks, roasted almonds, returned product, rework, in-process dark chocolate, packaging materials and/or finished products with non-food chemicals (e.g., lubricants oils, sanitizers, cleaning chemicals) as a result of improper usage of non-food chemicals.

- Sanitation and Pest Control E1.1.1 and Equipment C1.2.1

- Sections 2.1.3, 2.1.4 and 4.1.1

2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 - Contamination of dark chocolate blocks, roasted almonds, returned product, rework, in-process dark chocolate, packaging materials and/or finished products with non-food chemicals as a result of poor equipment design.

- Equipment C1.1.1

- Section 2.1.1

2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 - Contamination of dark chocolate blocks, roasted almonds, returned product, rework, in-process dark chocolate, packaging materials and/or finished products with non-food chemicals as a result of improper equipment maintenance.

- Equipment C1.2.1

- Sections 2.1.1, 2.1.3 and 2.1.4

2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17 - Contamination of dark chocolate blocks, roasted almonds, rework, returned product, in-process dark chocolate, packaging materials and/or finished product with non-food chemicals due to inadequate separation from equipment cleaning and sanitizing facilities.

- Premises A2.1.1

- Section 3.3.2

2, 3, 4, 18 - Contamination of dark chocolate blocks, roasted almonds, returned product, rework, moulds, packaging materials and/or finished products with allergens due to inadequate separation from allergens or product containing allergens in storage.

- Premises A2.1.1

- Transportation, Receiving and Storage B2.2.2

- Sections 3.2.1, 3.2.3 and 3.3.1

3 Roasted Almond Storage - Growth of mold resulting in production of mycotoxins (e.g., aflatoxin and ochratoxin A) on roasted almonds due to time/ temperature and/or humidity abuse during storage.

- Transportation, Receiving and Storage B2.2.2

- Section 6.2.1

5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17 - Contamination of dark chocolate blocks, roasted almonds, returned product, rework, in-process dark chocolate, finished product, moulds and/or packaging materials with allergens from one production line to an adjoining line due to inadequate facility design resulting in inadequate separation.

- Premises A2.1.1

- Sections 1.8.1, 3.2.1, 5.1.1 and 5.2.2

5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17 - Contamination of dark chocolate blocks, roasted almonds, returned product, rework, in-process dark chocolate, finished product, moulds and/or packaging materials with allergens from one production line to an adjoining line due to inadequate training of employees.

- Personnel D1.1.1 and D2.1.1

- Sections 5.1.1 and 5.2.1

5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17 - Contamination of dark chocolate blocks, roasted almonds, returned product, rework, in-process dark chocolate, finished product, moulds and/or packaging materials with allergens from one production line to an adjoining line due to improper sanitation procedures.

- Sanitation and Pest Control E1.1.1

- Section 4.1.1

5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17 - Contamination of dark chocolate blocks, roasted almonds, returned product, rework, in-process dark chocolate, finished product, moulds and/or packaging materials with allergens from one production line to an adjoining line due to cross utilization of moulds, scoops, utensils and/or equipment between products and/or between product lines.

- Premises A2.1.1 and Personnel D1.1.1 and D2.1.1

- Sections 1.8.1, 3.2.1, 5.1.1, 5.2.1 and 5.2.2

5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17,18 - Cross contamination of dark chocolate blocks, roasted almonds, rework, returned products, in-process dark chocolate, finished product and/or packaging materials with allergens (e.g. milk ingredients, peanuts) not declared in the list of ingredients as the result of improper cleaning of equipment, moulds and utensils and/or failure to use dedicated equipment, moulds and utensils.

- Sanitation and Pest Control E1.1.1

- Premises A2.1.1

- Personnel D1.2.1

- Sections 1.8.1, 3.2.1, 4.1.1, 5.1.1 and 5.2.2

6 Melting Tank - Presence of undeclared allergens in finished products due to the incorrect addition of allergens and/or the incorrect addition of rework and/or returned product containing allergens that do not appear on the recipe/formulation.

CCP-1C

12 – Mixing/Blending - Presence of undeclared allergens in finished products due to the incorrect addition of allergens that do not appear on the recipe/ formulation. CCP-2C
14 Air Cooling - Presence of non-food chemicals (e.g., refrigerant) on in-process dark chocolate due to a refrigerant leak during cooling.

- Premises A2.1.1. A2.1.2 and A2.3.3

- Equipment C1.1.1

- Sections 2.1.1, 3.2.1, 3.3.1 and 3.2.3

17 Packaging/Labelling/Coding - Presence of undeclared allergens in finished product due to incorrect label applied to package and/or incorrect list of ingredients on the label and/or illegible label (e.g., failure to identify almonds as an ingredient on the label).

CCP-4C

17 Packaging/Labelling/Coding - Contamination of finished product with inks/solvents as a result of equipment that is not properly maintained and/or set up.

- Equipment C1.1.1 and C1.2.1

- Sections 2.1.1, 2.1.2, 2.1.3 and 2.1.4

17 Packaging/Labelling/Coding - Contamination of finished product with inks/solvents as a result of improper storage of inks/solvents.

- Transportation, Receiving and Storage B2.2.3

- Section 6.2.2

19 Shipping/Distribution - Contamination of finished products with non-compatible goods carried on the same transport vehicle (i.e. non-food or food grade chemicals).

- Transportation, Receiving and Storage B1.1.1

- Section 6.1.1

Form 4 - Plant Schematic - Contamination of dark chocolate blocks, roasted almonds, rework, returned product, in-process product, packaging material and/or finished product with undeclared allergens due to improper employee hygienic procedures at entrance to rooms and/or between production lines (e.g., failure to change clothing when moving between a line containing an allergen and a line that does not). See Note below.

- Personnel D1.1.1 and D2.1.1

- Sections 5.1.1 and 5.2.1

Note: The manufacturer should indicate the hazards using letters and/or numbers, for example C1 (for the first chemical hazard identified on the Plant schematic) and C2 (for the second chemical hazard identified on the Plant Schematic), and record each of the hazards on the Plant Schematic (Form 4) at the point where it occurs.

Example of Completed Form 7: Physical Hazards Identification

Product name: Moulded Dark Chocolate with Almonds
List all physical hazards related to ingredients, incoming material, processing, product flow, etc.
Identified physical hazardsControlled at
Dark Chocolate Blocks - Presence of hazardous extraneous material (metallic and/or non-metallic) in dark chocolate blocks due to mishandling at the supplier (e.g., metallic shavings, glass, plastic) and/or during transportation.

- Transportation, Receiving and Storage B2.1.3 (of the FSEP Manual)

- Sections 1.4.1 and 1.4.2 (of the guidance document)

Roasted Almonds - Presence of hazardous extraneous material (metallic and/or non-metallic) in roasted almonds due to mishandling at the supplier (e.g., shells, metal, stones, glass, wood) and/or during transportation.

- Transportation, Receiving and Storage B2.1.3

- Sections 1.4.1 and 1.4.2

Packaging Material - Presence of hazardous extraneous material (metallic and/or non-metallic) in packaging material due to mishandling at the supplier (e.g., metal, plastic, glass) and/or during transportation.

- Transportation, Receiving and Storage B2.1.3

- Sections 1.4.1 and 1.4.2

Returned Product - Presence of hazardous extraneous material (metallic and/or non-metallic) in returned product due to mishandling at the restaurant, hospital, institution and/or retail and/or during transportation.

- Transportation, Receiving and Storage B2.1.3

- Sections 1.4.1 and 1.4.2

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 - Contamination of dark chocolate blocks, roasted almonds, rework, returned product, in-process dark chocolate, packaging materials and/or finished products with hazardous extraneous material (metallic and/or non-metallic) as a result of dirty or poorly maintained overhead structures.

- Premises A2.1.1 and A2.1.2; Sanitation and Pest Control E1.1.1

- Sections 3.2.1 and 4.1.1

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 - Contamination of dark chocolate blocks, roasted almonds, rework, returned product, in-process dark chocolate, packaging materials and/or finished products with hazardous extraneous material (metallic and/or non-metallic) as a result of improper equipment maintenance procedures.

- Equipment C1.1.1 and C1.2.1

- Sections 2.1.1, 2.1.2, 2.1.3 and 2.1.4

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 - Contamination of dark chocolate blocks, roasted almonds, rework, returned product, in-process dark chocolate, packaging materials and/or finished products with hazardous extraneous material (metallic and/or non-metallic) due to improper employee handling (e.g., metal, wood, glass, plastic).

- Personnel D1.1.1 and D2.1.1

- Sections 5.1.1 and 5.2.1

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 - Contamination of dark chocolate blocks, roasted almonds, rework, returned products, in-process dark chocolate, finished product and/or packaging materials with hazardous extraneous material from deteriorating food contact surfaces, equipment, moulds, tools, and/or utensils (e.g., measuring cups, plastic spatulas, brushes used for dry cleaning).

- Equipment C1.1.1

- Sections 2.1.3 and 2.1.4

1 Receiving - Acceptance of incoming materials and ingredients not meeting specifications (i.e. not meeting firm's standards) as described on specification sheets for each incoming material and ingredient.

- Transportation, Receiving and Storage B2.1.3

- Personnel D1.2.1

- Sections 1.1.4, 1.4.1, 1.4.2 and 5.2.2

5, 6, 10, 12 - Presence of hazardous extraneous material in dark chocolate (e.g., metal shavings) due to rubbing of metal on equipment parts.

- Equipment C1.1.1

- Sections 2.1.3 and 2.1.4

7, 9, 11 - Screening/Magnet - Presence of hazardous extraneous material (metallic and/or non-metallic) in dark chocolate due to accumulation of hazardous extraneous material and/or damage as a result of inadequate inspection and/or cleaning of the screens.

- Equipment C1.1.1

- Sanitation and Pest Control E1.1.1

- Sections 2.1.3, 2.1.4 and 4.1.1

7, 9, 11 - Screening/Magnet - Presence of hazardous extraneous material (metallic) in dark chocolate due to failure of the magnet to remove metal.

- Equipment C1.1.1

- Sections 2.1.3 and 2.1.4

7, 9, 11 - Screening/Magnet - Contamination of dark chocolate with hazardous extraneous material (i.e., metal accumulated on magnet is released into final product) due to inadequate inspection and/or cleaning of magnet to remove accumulated metal.

- Equipment C1.1.1

- Sanitation and Pest Control E1.1.1

- Sections 2.1.3, 2.1.4 and 4.1.1

13, 15 - Contamination of dark chocolate with metallic and/or non-metallic (e.g., plastic) hazardous extraneous material from broken/cracked chocolate moulds.

- Equipment C1.1.1

- Sections 2.1.3 and 2.1.4

16 Metal Detector - Presence of hazardous extraneous material (metallic) in dark chocolate due to failure of the metal detector to detect metal. CCP-3P
16 Metal Detector - Presence of hazardous extraneous material (metallic) in chocolate due to failure of the metal detector to function as intended when metal is detected (i.e. line stops, alarm sounds, product is kicked off the line). CCP-3P
16 Metal Detector - Presence of hazardous extraneous material (metallic) in finished product due to improper calibration.

- Equipment C1.2.2

- Sections 2.1.3 and 2.1.4

19 Shipping/Distribution - Contamination of finished products with metallic and non-metallic hazardous extraneous material due to unacceptable condition of transportation vehicle.

- Transportation, Receiving and Storage B1.1.1 and B1.1.2

- Section 6.1.1

19 Shipping/Distribution - Contamination of finished products with metallic and non-metallic hazardous extraneous material due to improper loading and arranging procedures resulting in damaged or exposed product.

- Transportation and Storage B1.1.2

- Section 6.1.1

Example of Completed Form 8: Critical Control Point (CCP) Determination

Product name: Moulded Dark Chocolate with Almonds
Incoming materials/process steps / hazards on schematic diagram

Category and identified hazard

Determine if fully controlled by prerequisite program.

* If yes = indicate "Prerequisite Program" and proceed to next identified hazard.

* If no = proceed to question 1 (Q1).

Q1. Could a control measure(s) be used by the operator at any process step?

* If no = not a CCP. Identify how this hazard will be controlled before and after the process. Then proceed to the next identified hazard.

* If yes = describe the measure and proceed to Q2.

Q2. Is it likely that contamination with the identified hazard could occur in excess of the acceptable level or could increase to an unacceptable level?

* If no = not a CCP. Proceed to the next identified hazard.

* If yes = proceed to Q3.

Q3. Is this process specifically designed to eliminate or reduce the likely occurrence of the identified hazard to an acceptable level?

* If no = proceed to Q4.

* If yes = CCP. Enter its number in the last column.

Q4. Will a subsequent step eliminate the identified hazard or reduce its likely occurrence to an acceptable level?

* If no = CCP. Enter its number in the last column.

* If yes = not a CCP. Identify subsequent (controlling) step and proceed to the next identified hazard.

CCP number

* Proceed to next identified hazard.

Dark Chocolate blocks

Biological

Presence of pathogenic microorganisms in dark chocolate blocks due to use of contaminated ingredients [e.g., lecithin, milk ingredients, sugar, cocoa beans and intermediate products (e.g., cocoa liquor)] at the supplier level.

Yes

Prerequisite Program

Transportation, Receiving and Storage B2.1.3

Dark Chocolate blocks

Chemical

Presence of environmental contaminants (e.g., pesticides, and herbicides) in dark chocolate blocks above the maximum allowable residue limits.

No

No

Form 9

Dark Chocolate blocks

Chemical

Presence of food additives in dark chocolate blocks above the maximum allowable residue limits.

Yes

Prerequisite Program

Transportation, Receiving and Storage B2.1.3

Dark Chocolate blocks

Chemical

Presence of heavy metals and other chemicals in dark chocolate blocks.

Yes

Prerequisite Program

Transportation, Receiving and Storage B2.1.3

Dark chocolate blocks

Chemical

Presence of undeclared allergens in dark chocolate blocks (e.g., milk ingredients) could impact on sensitive individuals.

Yes

Prerequisite Program

Transportation, Receiving and Storage B2.1.3

Dark chocolate blocks

Chemical

Presence of food additives not permitted for use by government regulations in dark chocolate blocks.

Yes

Prerequisite Program

Transportation, Receiving and Storage B2.1.3

Dark chocolate blocks

Physical

Presence of hazardous extraneous material (metallic and/or non-metallic) in dark chocolate blocks due to mishandling at the supplier (e.g., metallic shavings, glass, plastic) and/or during transportation.

Yes

Prerequisite Program

Transportation, Receiving and Storage B2.1.3

Roasted Almonds

Biological

Presence of pathogenic microorganisms on roasted almonds due to improper processing and/or handling at supplier level.

Yes

Prerequisite Program

Transportation, Receiving and Storage B2.1.3

Roasted Almonds

Biological

Presence of pathogenic microorganisms and/or mold on roasted almonds due to time/temperature and/or humidity abuse at the supplier level and/or during transportation.

Yes

Prerequisite Program

Transportation, Receiving and Storage B2.1.3

Roasted Almonds

Chemical

Presence of food additives not permitted for use by government regulations in roasted almonds.

Yes

Prerequisite Program

Transportation, Receiving and Storage B2.1.3

Roasted Almonds

Chemical

Growth of aflatoxins or ochratoxin A producing mould on roasted almonds due to improper handling at supplier level and/or during transportation (i.e., time/temperature and/or humidity abuse).

Yes

Prerequisite Program

Transportation, Receiving and Storage B2.1.3

Roasted Almonds

Chemical

Presence of undeclared allergens in roasted almonds could impact on sensitive individuals (e.g., tree nuts, peanuts).

Yes

Prerequisite Program

Transportation, Receiving and Storage B2.1.3

Roasted Almonds

Chemical

Presence of environmental contaminants (e.g., pesticides and herbicides) in roasted almonds above the maximum allowable residue limits.

No

No

Form 9

Roasted Almonds

Physical

Presence of hazardous extraneous material (metallic and/or non-metallic) due to mishandling at the supplier (e.g., shells, metal, stones, glass, wood) and/or during transportation.

Yes

Prerequisite Program

Transportation, Receiving and Storage B2.1.3

Packaging Material

Biological

Presence of pathogenic microorganisms due to damaged or soiled packaging material as a result of mishandling at the supplier level.

Yes

Prerequisite Program

Transportation, Receiving and Storage B2.1.3

Packaging Material

Biological

Presence of pathogenic microorganisms due to contamination with faecal material from pests (rodents, birds and insects).

Yes

Prerequisite Program

Transportation, Receiving and Storage B2.1.3

Packaging Material

Chemical

Not food grade and/or not appropriate for intended use.

Yes

Prerequisite Program

Transportation, Receiving and Storage B2.1.3

Packaging Material

Physical

Presence of hazardous extraneous material (metallic and non-metallic) in packaging material due to mishandling at the supplier (e.g. metal, plastic, glass) and/or during transportation.

Yes

Prerequisite Program

Transportation, Receiving and Storage B2.1.3

Returned Product

Biological

Presence of pathogenic microorganisms on returned chocolate due to mishandling at restaurant, hospital, institution and/or retail and/or during transportation.

Yes

Prerequisite Program

Transportation, Receiving and Storage B2.1.3

Returned Product

Chemical

Contamination of returned chocolate with non-food chemicals as a result of contamination at restaurants, hospitals, institutions and/or retail and/or during transportation.

Yes

Prerequisite Program

Transportation, Receiving and Storage B2.1.3

Returned Product

Physical

Presence of hazardous extraneous material (metallic and/or non-metallic) in returned product due to mishandling at the restaurant, hospital, institution and/or retail and/or during transportation.

Yes

Prerequisite Program

Transportation, Receiving and Storage B2.1.3

Dark chocolate blocks, roasted almonds, returned products and/ or packaging materials

Biological

Presence of pathogenic microorganisms due to use of unclean/damaged containers and/or unclean vehicles for transportation from supplier to manufacturer.

Yes

Prerequisite Program

Transportation, Receiving and Storage B1.1.1 and B2.1.3

1, 2, 3, 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16,17, 18, 19

Biological

Contamination of dark chocolate blocks, roasted almonds, returned product, rework, in-process dark chocolate, moulds, packaging materials and/or finished product with pathogenic microorganisms (e.g., Salmonella spp.) due to improper employee handling and hygiene.

Yes

Prerequisite Program:

Personnel D1.1.1 and D2.1.1

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16,17, 18, 19

Biological

Contamination of dark chocolate blocks, roasted almonds, returned product, rework, in-process dark chocolate, packaging materials and/or finished product with pathogenic microorganisms due to contamination from overhead structures (e.g., leaking pipes).

Yes

Prerequisite Programs:

Premises A2.1.1, A2.1.2 and A2.3.1

Sanitation and Pest Control E1.1.1

Equipment C1.1.1 and C1.2.1

1, 2, 3, 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16,17, 18, 19

Biological

Contamination of dark chocolate blocks, roasted almonds, returned product, rework, in-process dark chocolate, packaging materials and/or finished product with pathogenic microorganisms due to contact with pests (flies, rodents, birds).

Yes.

Prerequisite Program

Sanitation and Pest Control E2.1.1

1, /2, 3, 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16,17, 18, 19

Chemical

Contamination of dark chocolate blocks, roasted almonds, rework, returned products, in-process dark chocolate, moulds, packaging materials and/or finished product with allergenic ingredients (e.g., peanuts, milk ingredients) not declared in the list of ingredients as a result of improper employee hygiene and handling procedures.

Yes

Prerequisite Program

Personnel D1.1.1, D1.2.1 and D2.1.1

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16,17, 18, 19

Chemical

Contamination of dark chocolate blocks, roasted almonds, rework, returned products, in-process dark chocolate, packaging materials, and/or finished product with non-food chemicals, cleaning solutions, sanitizers and/or their residues during sanitation procedures as a result of damaged containers and/or exposed product, packaging materials.

Yes

Prerequisite Programs

Sanitation and Pest Control E1.1.1

Transportation, Receiving and Storage B2.2.2

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16,17, 18, 19

Chemical

Contamination of dark chocolate blocks, roasted almonds, returned product, rework, in-process dark chocolate, moulds, packaging materials, and/or finished product with non-food chemicals, cleaning solutions, sanitizers and/or their residues due to:

  1. improper storage procedures and/or
  2. improper employee handling procedures and/or
  3. improper sanitation procedures.

Yes

Prerequisite Programs

  1. Transportation, Receiving and Storage B2.2.2 and B2.2.3
  2. Personnel D1.1.1 and D2.1.1
  3. Sanitation and Pest Control E1.1.1
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16,17, 18, 19

Chemical

Contamination of dark chocolate blocks, roasted almonds, returned product, rework, in-process dark chocolate, moulds and/or packaging materials with lubricants, oil and/or hydraulic fluid from poorly maintained equipment.

Yes

Prerequisite Program

Equipment C1.1.1 and C1.2.1

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16,17, 18, 19

Chemical

Contamination of dark chocolate blocks, roasted almonds, returned product, rework, in-process dark chocolate, packaging materials, and/or finished product with chemicals from food contact surfaces, including equipment, moulds, tools and utensils that are not food grade.

Yes

Prerequisite Program

Equipment C1.1.1 and C1.2.1

1, 2, 3, 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16,17, 18, 19

Physical

Contamination of dark chocolate blocks, roasted almonds, rework, returned product, in-process dark chocolate, packaging materials and/or finished products with hazardous extraneous material (metallic and/or non-metallic) as a result of

  1. dirty or poorly maintained overhead structures and/or
  2. improper equipment maintenance procedures.

Yes

Prerequisite Programs

1) Premises A2.1.1 and A2.1.2

Sanitation and Pest Control E1.1.1

2) Equipment C1.1.1. and C1.2.1

1, 2, 3, 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16,17, 18, 19

Physical

Contamination of dark chocolate blocks, roasted almonds, rework, returned product, in-process dark chocolate, packaging materials and/or finished products with hazardous extraneous material (metallic and/or non-metallic) due to improper employee handling (e.g., metal, wood, glass, plastic).

Yes

Prerequisite Program

Personnel D1.1.1 and D2.1.1

1, 2, 3, 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16,17, 18, 19

Physical

Contamination of dark chocolate blocks, roasted almonds, rework, returned products, finished product, in-process dark chocolate and/or packaging materials with hazardous extraneous material from deteriorating food contact surfaces, equipment, moulds, tools, and/or utensils (e.g., measuring cups, plastic spatulas, brushes used for dry cleaning).

Yes

Prerequisite Program

Equipment C1.1.1

1 Receiving

Biological

Acceptance of incoming materials and ingredients not meeting specifications (i.e. not meeting firm's standards) as described on specification sheets for each incoming material and/or ingredient.

Yes

Prerequisite Programs

Transportation, Receiving and Storage B1.1.2 and B2.1.3

Personnel D1.2.1

1 Receiving

Biological

Contamination of dark chocolate blocks, roasted almonds, returned product, and/or packaging materials at receiving with pathogenic microorganisms from raw products (non-ready-to-eat) carried on the same truck.

Yes

Prerequisite Program

Transportation, Receiving and Storage B1.1.1 and B2.1.3

1 Receiving

Biological

Contamination of dark chocolate blocks, roasted almonds, returned products and/or packaging materials due to damaged containers/packaging material resulting in exposed product.

Yes

Prerequisite Program

Transportation, Receiving and Storage B1.1.2 and B2.1.3

1 Receiving

Chemical

Acceptance of incoming materials and ingredients not meeting specifications (i.e. not meeting firm's standards) as described on specification sheets for each incoming material and/or ingredient.

Yes

Prerequisite Programs

Transportation, Receiving and Storage B2.1.3

Personnel D1.2.1

1 Receiving

Chemical

Contamination of dark chocolate blocks, roasted almonds, returned products and/or packaging materials with non-food chemicals being received at the same time.

Yes

Prerequisite program:

Transportation, Receiving and Storage B2.2.3

1 Receiving

Physical

Acceptance of incoming materials and ingredients not meeting specifications (i.e. not meeting firm's standards) as described on specification sheets for each incoming material and ingredient.

Yes

Prerequisite Programs

Transportation, Receiving and Storage B2.1.3

Personnel D1.2.1

2, 3, 4, 5, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19

Biological

Contamination of dark chocolate blocks, roasted almonds, returned product, rework, in-process dark chocolate, packaging materials, and/or finished products with pathogenic microorganisms due to damaged containers, packaging material and/or moulds resulting from

  1. improper storage procedures and/or
  2. improper employee handling and hygiene.

Yes

Prerequisite Programs

  1. Transportation, Receiving and Storage B2.2.2
  2. Personnel D1.1.1 and D2.1.1
2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18

Biological

Contamination of dark chocolate blocks, roasted almonds, returned product, rework, in-process dark chocolate, packaging materials and/or finished products with pathogenic microorganisms due to contact with unclean utensils, tools, moulds and equipment as a result of improper sanitation procedures.

Yes

Prerequisite Program

Sanitation and Pest Control E1.1.1

2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18

Biological

Contamination of dark chocolate blocks, roasted almonds, returned product, rework, in-process dark chocolate, packaging materials and/or finished product with pathogenic microorganisms due to contaminated air.

Yes

Prerequisite Program

Premises A2.3.1

2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18

Biological

Contamination of dark chocolate blocks, roasted almonds, returned product, rework, in-process dark chocolate, moulds, packaging materials and/or finished product with pathogenic microorganisms due to inadequate separation from equipment cleaning and sanitizing facilities.

Yes

Prerequisite Program

Premises A2.1.1

2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19

Chemical

Contamination of dark chocolate blocks, roasted almonds, returned product, rework, in-process dark chocolate, packaging materials and/or finished products with non-food chemicals as a result of:

  1. improper storage of non-food chemicals and/or
  2. improper handling of non-food chemicals by employees and/or
  3. improper usage of non-food chemicals.

Yes

Prerequisite Programs

  1. Transportation, Receiving and Storage B2.2.3
  2. Transportation, Receiving and Storage B2.2.3
  3. Sanitation and Pest Control E1.1.1

Equipment C1.2.1

2, 3, 4, 5, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18

Chemical

Contamination of dark chocolate blocks, roasted almonds, returned product, rework, in-process dark chocolate, packaging materials and/or finished products with non-food chemicals as a result of:

  1. poor equipment design
  2. improper equipment maintenance.

Yes

Prerequisite Programs

  1. Equipment C1.1.1
  2. Equipment C1.2.1
2, 3, 4, 5, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18

Chemical

Contamination of dark chocolate blocks, roasted almonds, returned product, rework, in-process dark chocolate, packaging materials and/or finished product with non-food chemicals due to inadequate separation from equipment cleaning and sanitizing facilities.

Yes

Prerequisite Program

Premises A2.1.1

2, 3, 18

Biological

Contamination of roasted almonds, dark chocolate blocks and/or finished product in storage due to a failure to identify and/or isolate returned, defective or suspect product.

Yes

Prerequisite Programs

Premises A2.1.1

Transportation, Receiving and Storage B2.1.2 and B2.2.2

2, 3, 4, 18

Chemical

Contamination of dark chocolate blocks, roasted almonds, returned product, rework, moulds, packaging materials and/or finished product with allergenic ingredients due to inadequate separation from allergens or product containing allergens in storage.

Yes

Prerequisite Programs

Premises A2.1.1

Transportation, Receiving and Storage B2.2.2

3 Roasted Almond Storage

Biological

Growth of pathogenic microorganisms in roasted almonds due to time/temperature abuse and/or elevated humidity levels during storage.

Yes

Prerequisite Program

Transportation, Receiving and Storage B2.2.2

3 Roasted Almond Storage

Biological

Growth of pathogenic microorganisms due to failure to rotate incoming roasted almonds (first in, first out).

Yes

Prerequisite Program

Transportation, Receiving and Storage B2.2.2

3 Roasted Almond Storage

Chemical

Growth of mold resulting in production of mycotoxins (e.g. aflatoxin and ochratoxin A) on roasted almonds due to time/temperature and/or humidity abuse during storage.

Yes

Prerequisite Program

Transportation, Receiving and Storage B2.2.2

5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17

Biological

Contamination of dark chocolate with pathogenic microorganisms present on equipment surfaces due to the availability of water for bacterial growth as a result of incomplete removal of water and/or incomplete drying of equipment (including moulds) after sanitation procedures.

Yes

Prerequisite Program

Sanitation and Pest Control E1.1.1

5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17

Biological

Contamination of dark chocolate with pathogenic microorganisms present on equipment surfaces (e.g., utensils and moulds) due to the use of non-potable water during sanitation.

Yes

Prerequisite Program

Premises A4.1.1.

5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17

Chemical

Contamination of dark chocolate blocks, roasted almonds, returned product, rework, in-process dark chocolate, moulds, finished product and/or packaging materials with allergenic ingredients from one production line to an adjoining line due to

  1. inadequate facility design resulting in inadequate separation and/or
  2. inadequate training of employee and/or
  3. improper sanitation procedures
  4. cross utilization of moulds, scoops, utensils and/or equipment between products and/or between product lines.

Yes

Prerequisite Programs

  1. Premises A2.1.1
  2. Personnel D1.1.1 and D2.1.1
  3. Sanitation and Pest Control E1.1.1
  4. Premises A2.1.1

Personnel D1.1.1 and D2.1.1

5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18

Chemical

Cross contamination of dark chocolate blocks, roasted almonds, rework, returned products, in-process dark chocolate, finished product and/or packaging materials with allergenic ingredients (e.g. milk ingredients, peanuts) not declared in the list of ingredients as the result of improper cleaning of equipment , moulds and utensils and/or failure to use dedicated equipment, moulds and utensils.

Yes

Prerequisite Programs

Sanitation and Pest Control E1.1.1

Premises A2.1.1

Personnel D1.2.1

5, 6, 10, 12

Physical

Presence of hazardous extraneous material in dark chocolate (e.g., metal shavings) due to rubbing of metal on equipment parts.

Yes

Prerequisite Program

Equipment C1.1.1

6, 7, 8, 9, 10, 11, 12, 13

Biological

Contamination of dark chocolate as a result of presence of pathogenic microorganisms at specific points in the process where improper line design and incomplete cleaning allow product and moisture to accumulate (i.e., dead-end pipes).

Yes

Prerequisite Programs

Equipment C1.1.1

Sanitation and Pest Control E1.1.1

6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17

Biological

Contamination of dark chocolate blocks, in-process dark chocolate, rework, returned product, finished product and/or packaging materials with pathogenic microorganisms due to presence on damaged and/or deteriorating surfaces of equipment, conveyors, moulds, tools and/or utensils (i.e., presence of pathogenic microorganisms in cracks and crevices).

Yes

Prerequisite Programs:

Equipment C1.1.1

Sanitation and Pest Control E1.1.1

6 Melting Tank

Biological

Contamination of in-process dark chocolate, rework, returned product and/or dark chocolate blocks due to contact with returned, defective or suspect product that was not appropriately identified and/or isolated to prevent its use.

Yes

Prerequisite Programs

Premises A2.1.1

Transportation, Receiving and Storage B2.1.2 and B2.2.2

6 Melting Tank

Chemical

Presence of undeclared allergenic ingredients in finished products due to the incorrect addition of allergenic ingredients and/or the incorrect addition of rework and//or returned product containing allergenic ingredients that do not appear on the recipe/formulation.

No

Yes

Monitor the addition of ingredients, rework and returned product into the melting tank to ensure that only those ingredients or rework/returned product that contains those ingredients that appear on the recipe / formulation for the product being produced are added

Yes No No CCP-1C
7, 9, 11

Physical

Presence of hazardous extraneous material (metallic and/or non-metallic) in dark chocolate due to accumulation of hazardous extraneous material and/or damage as a result of inadequate inspection and/or cleaning of the screens.

Yes

Prerequisite Programs

Equipment C1.1.1

Sanitation and Pest Control E1.1.1

7, 9, 11

Physical

Presence of hazardous extraneous material (metallic) in dark chocolate due to failure of the magnet to remove metal.

Yes

Prerequisite Program

Equipment C1.1.1

7, 9, 11

Physical

Contamination of dark chocolate with hazardous extraneous material (i.e., metal accumulated on magnet is released into final product) due to inadequate inspection and/or cleaning of magnet to remove accumulated metal.

Yes

Prerequisite Programs

Equipment C1.1.1

Sanitation and Pest Control E1.1.1

12 Mixing/Blending

Chemical

Presence of undeclared allergenic ingredients in finished products due to the incorrect addition of allergenic ingredients that do not appear on the recipe/ formulation.

No

Yes,

Monitor the addition of ingredients to ensure that only those ingredients that appear on the recipe/formulation are added.

Yes No No CCP-2C
13, 15

Physical

Contamination of dark chocolate with metallic and/or non-metallic (e.g. plastic) hazardous extraneous material from broken/cracked chocolate moulds.

Yes

Prerequisite Program

Equipment C1.1.1

14 Air Cooling

Biological

Contamination of dark chocolate with pathogenic microorganisms due to contact with inappropriately sourced and/or contaminated air used for cooling.

Yes

Prerequisite Program

Premises A 2.3.3

14 Air Cooling

Chemical

Presence of non-food chemicals (refrigerant) on in-process dark chocolate due to a refrigerant leak during cooling.

Yes

Prerequisite Programs

Premises A2.1.1, A2.1.2 and A2.3.3

Equipment C1.1.1

16 Metal Detector

Physical

Presence of hazardous extraneous material (metallic) in dark chocolate due to failure of the metal detector to detect metal.

No

Yes

Put all product through a functioning metal detector

Test metal detector at regular intervals with standard metal wands

Yes Yes N/A CCP-3P
16 Metal Detector

Physical

Presence of hazardous extraneous material (metallic) in dark chocolate due to failure of the metal detector to function as intended when metal is detected (e.g., line stops, product is kicked off the line, alarm sounds).

No

Yes

Test functioning of the metal detector a regular intervals

Yes No No CCP-3P
16 Metal Detector

Physical

Presence of hazardous extraneous material (metallic) in finished product due to improper calibration.

Yes

Prerequisite Program

Equipment C1.2.2

17 Packaging/ Labelling/Coding

Chemical

Presence of undeclared allergens in finished product due to incorrect label applied to package and/or incorrect list of ingredients on the label and/or illegible label (e.g., failure to identify almonds as an ingredient on the label).

No

Yes

Monitor the label on the product and/or packages to ensure that the ingredient list is accurate and the correct label is on the right product.

Yes No No CCP-4C
17 Packaging/ LabellingCoding

Chemical

Contamination of finished product with inks/solvents as a result of

  1. equipment that is not properly maintained and/or set up and/or
  2. improper storage of inks/solvents.

Yes

Prerequisite Programs

  1. Equipment C1.1.1 and C1.2.1
  2. Transportation, Receiving and Storage B2.2.3
19 - Shipping/Distribution

Biological

Contamination of finished product with pathogenic microorganisms as a result of loading product onto a carrier that is unacceptable for the transportation of food (e.g., carrier in unclean condition, carrier in poor state of repair).

Yes

Prerequisite Program:

Transportation, Receiving and Storage B1.1.1

19 - Shipping/Distribution

Biological

Contamination of finished product with pathogenic microorganisms as a result of transporting on same carrier with non-ready-to-eat products (i.e. raw meat or other product contaminated with pathogenic microorganisms).

Yes

Prerequisite Program:

Transportation, Receiving and Storage B1.1.1

19 - Shipping/Distribution

Biological

Contamination of finished product with pathogenic microorganisms as a result of improper loading/stacking resulting in damaged containers/packaging and exposure of finished products.

Yes

Prerequisite Program:

Transportation, Receiving and Storage B1.1.1 and B1.1.2

19 - Shipping/Distribution

Chemical

Contamination of finished product by non-compatible goods carried on the same transport vehicle (i.e. non-food or food grade chemicals).

Yes

Prerequisite Program

Transportation, Receiving and Storage B1.1.1

19 - Shipping/Distribution

Physical

Contamination of finished product with metallic and non-metallic hazardous extraneous material due to:

  1. unacceptable condition of transportation vehicle and/or
  2. improper loading and arranging procedures resulting in damaged or exposed product.

Yes

Prerequisite Programs:

  1. Transportation, Receiving and Storage B1.1.1 and B1.1.2
  2. Transportation, Receiving and Storage B1.1.2
Form 4 - Plant Schematic

Chemical

Contamination of dark chocolate blocks, roasted almonds, rework, returned product, in-process product, packaging materials and/or finished product with undeclared allergenic ingredients due to improper employee hygienic procedures at entrances to rooms and/or between production lines (e.g., failure to change clothing when moving between a line containing an allergen and a line that does not).

Yes

Prerequisite Program

Personnel D1.1.1 and D2.1.1

Example of Completed Form 9: Hazards not controlled by the Operator

Product name: Moulded Dark Chocolate with Almonds
List here any biological, chemical and physical hazards that are not controlled by the operator
HazardsIndicate how the hazard could be addressed (cooking instructions, public education, "use before" date, etc.)
Dark Chocolate Blocks - Presence of environmental contaminants (e.g., pesticides and herbicides) above the maximum allowable residue limits. Farm level - Educate farmers about Good Agricultural Practices (GAP)
Roasted Almonds - Presence of environmental contaminants (e.g., pesticides and herbicides) above the maximum allowable residue limits. Farm level - Educate farmers about Good Agricultural Practices (GAP)

Example of Completed Form 10: HACCP Plan - Critical Control Points

Product name: Moulded Dark Chocolate with Almonds
Process StepsCCP/Hazard NumberHazard DescriptionCritical LimitsMonitoring ProceduresDeviation ProceduresVerification ProceduresHACCP Records
6 Melting Tank CCP-1C Presence of undeclared allergenic ingredients in finished products due to the incorrect addition of allergenic ingredients and/or rework/returned product containing allergenic ingredients that do not appear on the recipe/formulation. Only those ingredients indicated in the recipe or formulation of the product being manufactured are added to the melting tank as per the SOP of Recipes and Formulations following procedures indicated in the SOP for Ingredient Addition at the Melting Tank. At the start of each new product and whenever rework, returned product and/or additional chocolate blocks are added to the melting tank, the CCP-1C Monitor adds the dark chocolate blocks, the rework and/or the returned product to the melting tank as per the SOP for Ingredient Addition at the Melting Tank, following the recipe or formulation for the product being made as per the SOP of Recipes and Formulations. Records the time and the ingredients added on the CCP-1C Monitoring Record. Signs and dates.

If an ingredient, rework and/or returned product is added to the melting tank that does not appear in the SOP of Recipes and Formulations and/or if ingredients, rework and/or returned product is not added to the melting tank as per the procedures as described in the SOP for Ingredient Addition at the Melting Tank, the CCP-1C Monitor notifies the CCP1C Authorized Person and records the deviation and the corrective action taken and the time of the corrective action on the CCP-1C Monitoring Record. Signs and dates.

The CCP-1C Authorized Person puts all affected product on hold as per Hold Procedures and makes an assessment as to whether food safety has been compromised as per written Food Safety Assessment Procedures. If food safety has been compromised, the product is held and subsequently reworked, relabelled or destroyed. If food safety has not been compromised, the CCP-1C Authorized person releases the product and, where required provides retraining for the CCP-1C Monitor as appropriate.

CCP-1C Authorized Person determines the root cause of the deviation to assess whether preventive measures must be developed to prevent reoccurrence.

Once corrective actions have been completed, the CCP-1C Authorized Person evaluates the effectiveness of the actions taken, including preventative measures. If any deviations are identified, follows the corrective action procedures as outlined above.

CCP-1C Authorized Person records any additional information concerning the deviation (including target dates for completion of corrective actions), corrective actions taken (including the results of the Food Safety Assessment and effectiveness checks), preventive measures (including target dates for completion), time(s) and date(s) completed and person(s) responsible on the CCP-1C Deviation Record. Signs and dates.

Once per Y time period, the CCP-1C Verifier observes the CCP-1C Monitor performing the monitoring functions to ensure the written procedures are being followed. Signs the CCP-1C Monitoring Record, dates and records the time the verification was conducted and "observation" to indicate it was an observation of the monitoring procedures.

Once per Y time period the CCP-1C Verifier reviews X number of CCP-1P Monitoring Records and X number of associated corrective actions and CCP-1C Deviation Records completed since the last verification for completeness, compliance. Signs and dates and records the time the verification was conducted.

Once per Y time period the CCP-1C Verifier reviews X number of CCP-1C Monitoring Records and compares the ingredients added to the list of ingredients for that product as identified in the SOP of Recipes and Formulations. Indicates on the CCP-1C Monitoring Record that the ingredient check was done by recording "Ingredient Check". Signs and dates and records the time the verification was conducted.

Once per Y time period the CCP-1C Verifier reviews X number of product labels found attached to the CCP-1C Monitoring Records to ensure that the ingredients identified on each of the labels continue to be an accurate reflection of the ingredients (and their components) used for that product. Compares the labels on the monitoring records to the master product labels found in the CCP-1C SOP for Label Check. Using the ingredient labels, compares the components of each of the ingredients (where applicable) to the product label for accuracy. Signs, dates and records the time the verification was conducted on the product label attached to the CCP-1C Monitoring Record to indicate the label was verified.

If deviations are found for any of the above procedures, the CCP-1C Verifier follows the Deviation Procedures for this CCP. Records the corrective actions, preventive measures, retraining (where required), date(s) completed, the time the corrective action was completed and person(s) responsible on CCP-1C Deviation Record. Signs and dates.

SOP of Recipes and Formulations

SOP for Ingredient Addition at Melting Tank

CCP-1C Monitoring Record

CCP-1C Deviation Record

Hold Procedures

Food Safety Assessment Procedures

12 Mixing/ Blending CCP-2C Presence of undeclared allergenic ingredients in finished products due to the incorrect addition of allergen ingredients that do not appear on the recipe/ formulation.  No ingredients can be added to mixer/blender unless that ingredient is indicated on the recipe/ formulation for the product being manufactured as per the SOP of Recipes and Formulations. At the start of each new product and whenever additional ingredients (e.g. chocolate, almonds) are added to the mixer/blender , the CCP-2C Monitor adds the ingredients to the mixer/blender as per the SOP for Ingredient Addition at the Mixer/Blender, as indicated in the recipe or formulation for the product being made as per the SOP of Recipes and Formulations. Records the time and the ingredients added on the CCP-2C Monitoring Record. Signs and dates.

If an ingredient is added to the mixer/blender that does not appear in the SOP of Recipes and Formulations the CCP-2C Monitor notifies the CCP2C Authorized Person and records the deviation and the corrective action taken on the CCP-2C Monitoring Record. Signs and dates and records the time of the corrective action taken.

The CCP-2C Authorized Person puts all affected product on hold as per Hold Procedures and makes an assessment as to whether food safety has been compromised as per written Food Safety Assessment Procedures. If food safety has been compromised, the product is held, subsequently reworked, relabelled, or destroyed. If food safety has not been compromised, the CCP-2C Authorized person releases the product.

CCP-2C Authorized Person determines the root cause of the deviation to assess whether preventive measures must be developed to prevent reoccurrence.

Once corrective actions have been completed, the CCP-2C Authorized Person evaluates the effectiveness of the actions taken, including preventive measures. If any deviations are identified, follows the corrective action procedures as outlined above.

CCP-2C Authorized Person records any additional information concerning the deviation (including target dates for completion of corrective actions), corrective actions taken (including the results of the Food Safety Assessment and effectiveness checks), retraining where applicable, preventive measures (including target dates for completion), time(s) and date(s) completed and person(s) responsible on the CCP-2C Deviation Record. Signs and dates.

Once per Y time period the CCP- 2C Verifier observes the CCP-2C Monitor performing the monitoring functions to ensure the written procedures are being followed. Signs the CCP-2C Monitoring Record, records the date and the time the verification was conducted and records "observation" to indicate it was an observation of the monitoring procedures.

The CCP-2C Verifier once per Y time period reviews X number of CCP-2C Monitoring records and associated corrective actions and CCP-2C Deviation Records completed since that last verification for completeness and compliance. Signs and dates and records the time the verification was conducted.

Once per Y time period the CCP-2C Verifier reviews X number of CCP-2C Monitoring Records and compares the ingredients added to the list of ingredients for that product as identified in the SOP of Recipes and Formulations. Indicates on the CCP-2C Monitoring Record that the ingredient check was done by recording "Ingredient Check". Signs and dates and records the time the verification was conducted.

If deviations are found for any of the above procedures, the CCP-2C Verifier follows the Deviation Procedures for this CCP. Records the corrective actions, preventive measures, retraining (where required), date(s) completed, the time the corrective action was completed and person(s) responsible on CCP-2C Deviation Record. Signs and dates.

SOP of Recipes and Formulations

SOP for Ingredient Addition at the Mixer/Blender

CCP-2C Monitoring Record

CCP-2C Deviation Record

Hold Procedures

Food Safety Assessment Procedures

16 Metal Detector CCP-3P

Presence of hazardous extraneous material (metallic) in moulded chocolate with almonds due to failure of the metal detector to detect metal.

Presence of hazardous extraneous material (metallic) in moulded chocolate with almonds due to failure of the metal detector to function as intended when metal is detected (i.e., line stops, alarm sounds, product is kicked off the line).

All product must go through a functioning metal detector.

Metal detector must detect each of the following metal wands during a test of the metal detector as described in the CCP-3P SOP for Metal Detector:

X mm ferrous

X mm non-ferrous

X mm stainless

Metal detector must function normally when metal or metal wand is detected (Note: the manufacturer must define what "function normally" means for the metal detector at the facility (i.e., alarm must sound, conveyor must stop and product must be kicked off).

Facility employees are responsible for passing all product through a functioning metal detector as per the CCP-3P SOP for Metal Detector.

Once every Y time period, the CCP-3P Monitor observes the metal detector in use to ensure that all product is passing through the metal detector.

Once every Y time period, the CCP-3P Monitor, passes each of the following metal wands through the metal detector placing them on top of the product:

X mm ferrous

X mm non-ferrous

X mm stainless

as per the CCP-3P SOP for Metal Detector. For each metal wand, the CCP-3P Monitor observes the metal detector to ensure the metal detector is detecting the metal wand and observes the functioning of the metal detector to ensure that when the metal wands pass through the metal detector, the appropriate alarms and/or line stoppage/product kick out occurs.

Records the time of testing, all findings and observations on the CCP-3P Monitoring Record. Signs and dates.

If all product is not passing through a functioning metal detector the Monitor notifies the CCP-3P Authorized Person.

For each of the metal wands indicated in the critical limits when tested:

If the metal detector is not detecting the metal wand or if the metal detector is not functioning as intended (i.e., the appropriate alarms and/or line stoppage/product kick out does not occur) when each of the metal wands is passed through the metal detector, the Monitor repeats the test as per the CCP-3P SOP for Metal Detector. If the metal detector still does not detect the wand and/ or does not function as intended, notifies the CCP-3P Authorized Person.

If the metal detector at any time indicates that metal is detected in the product (i.e., the appropriate alarms and/or line stoppage/product kick out occurs), the Facility Employee stops the line and notifies the CCP-3P Monitor. The CCP-3P Monitor passes suspect product through the metal detector at least 2 more times to ensure that the metal detector is functioning normally and continues to detect metal. If the metal detector continues to identify metal in the product, notifies the Authorized Person. CCP-3P Monitor records all deviations and corrective actions and time of corrective actions on the CCP-3P Monitoring Record.

If any of the above deviations occurs, the CCP-3P Authorized Person puts all affected product and/or product produced since the last good check on Hold as per Hold Procedures and makes an assessment as to whether food safety has been compromised as per written Food Safety Assessment procedures. If food safety has been compromised the product is held, tested and subsequently released, reworked or destroyed.

If food safety has not been compromised the Authorized Person releases the product.

This may include notifying maintenance and/or the Outside Contractor to have the metal detector adjusted/recalibrated.

For each deviation identified, CCP-3P Authorized Person determines the root cause of the deviation to assess whether preventive measures must be developed to prevent reoccurrence.

Once corrective actions have been completed, the CCP-3P Authorized person evaluates the effectiveness of the actions taken, including preventative measures. If any deviations are identified, follows the corrective action procedures as outlined above.

CCP-3P Authorized Person records any additional information concerning the deviation (including target dates for completion of corrective actions), corrective actions taken (including the results of the Food Safety Assessment and effectiveness checks), retraining where applicable, preventive measures (including target dates for completion), time(s) and date(s) completed and person(s) responsible on the CCP-3PC Deviation Record. Signs and dates.

Once per Y time period, the Verifier observes the Monitor performing the monitoring function to ensure the written procedures are being followed. Signs and dates the CCP-3P Monitoring Record and records the time the verification was conducted and "observation" to indicate it was a procedure check.

The Verifier once per Y time period reviews X number of CCP-3P Monitoring Records and associated corrective actions and CCP-3P Deviation Records completed since the last verification for completeness and compliance. Signs and dates and records the time the verification was conducted.

If deviations are found for any of the above procedures, the Verifier follows the Deviation Procedures for this CCP. Records the corrective actions, preventive measures, retraining (where required), date(s) completed, the time the corrective action was completed and person(s) responsible on CCP-3P Deviation Record. Signs and dates.

CCP-3P Monitoring Record

CCP-3P Deviation Record

CCP-3P SOP for Metal Detector

Hold Procedures

Food Safety Assessment Procedures

17 Packaging/ Labelling/ Coding CCP-4C Presence of undeclared allergens in finished product due to incorrect label applied to package and/or incorrect list of ingredients on the label and/or illegible label (e.g., failure to identify almonds as an ingredient on the label). Each package or container of product must have a correct label that is legible and that accurately reflects the ingredients in the product.

CCP-4C Monitor, at Y frequency, checks the label in the packaging machine to ensure that the label (including ingredients listed) is legible and is an accurate reflection of the product being packaged. 

Matches the label in the packaging machine to the master product label as per CCP-4C SOP for Label Check.

Compares the ingredients identified on the CCP-4C Monitoring Record to the label as per the CCP-4C SOP Label Check.

Attaches a label to the back of the CCP-4C Monitoring Record and initials and dates.

Signs and dates the CCP-4C Monitoring Record indicating the time of the label check.

If an incorrect or illegible label is being applied to the product and/or

If the ingredients as listed in the CCP-4C SOP for Label Check do not match the ingredients on the label being applied, and/or

If the ingredients as listed on the label do not match the ingredients as identified on the CCP-4C Monitoring Record,

The CCP-4C Monitor notifies the CCP-4C Authorized Person. Records deviation, corrective actions and time corrective actions taken on the CCP-4C Monitoring Record.

CCP-4C Authorized Person performs a food safety assessment as per Food Safety Assessment Procedures. If food safety has been compromised, product is tested and subsequently relabelled, reworked and/or released or destroyed.

Authorized Person determines the root cause of the deviation to assess whether preventive measures must be developed to prevent reoccurrence.

Once corrective actions have been completed, the CCP-4C Authorized Person evaluates the effectiveness of the actions taken, including preventative measures. If any deviations are identified, follows the corrective action procedures as outlined above.

The CCP-4C Authorized Person records any additional information concerning the deviation (including target dates for completion of corrective actions), corrective actions taken (including the results of the Food Safety Assessment and effectiveness checks), retraining where applicable, preventive measures (including target dates for completion), time(s) and date(s) completed and person(s) responsible on CCP-4C Deviation Record. Signs and dates.

Once per Y time period the CCP-4C Verifier observes the CCP-4C Monitor performing the monitoring function to ensure the written procedures are being followed. Signs the CCP-4C Monitoring Record and the CCP-4C Deviation Record. Signs, dates and records the time the verification was conducted and records "observation" to indicate it was a procedure check.

The CCP-4C Verifier once per Y time period reviews X number of CCP-4C Monitoring Records and associated corrective actions and CCP-4C Deviation Records completed since the last verification for completeness and compliance. Signs and dates and records the time the verification was conducted.

Once per Y time period the CCP-4C Verifier reviews X number of labels found in the CCP-4C SOP for Labels to ensure that the ingredients identified on each of the labels continue to be an accurate reflection of the ingredients (and their components) used for that product. Signs and dates the Label in the CCP-4C SOP for Label Check to indicate the label was verified and records the time the verification was conducted.

If deviations are found for any of the above procedures, the CCP-4C Verifier follows the Deviation Procedures for this CCP. Records the corrective actions, retraining (where required), preventive measures, date(s) completed, the time the corrective action was completed and person(s) responsible on CCP-4C Deviation Record. Signs and dates.

CCP-4C Monitoring Record

CCP-4C Deviation Record

Hold Procedures

Food Safety Assessment Procedures

CCP-4C SOP for Label Check

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