Working with HACCP Management (QMS)

QualityOne Vaults provide a management system that allows you to establish and maintain safe food production practices efficiently by using the HACCP (Hazard Analysis Critical Control Points) methodology. You can create HACCP plans in your Vault to define principles and procedural requirements for maintaining your HACCP management system. To save time and effort, you can reuse existing HACCP plans as a reference when creating new HACCP plans.

Depending on your Admin’s configuration, object, field, and section labels may appear differently than the labels mentioned in this article.

HACCP Management Overview

The general process of working with HACCP Management involves the following steps:

Creating & Maintaining HACCP Reference Records

You must define library records used as references to select when creating a HACCP Plan. Ensure you create and maintain the following reference records as part of your organization’s regular operations:

  • Material
  • Material-Process
  • Hazard
  • Formulation
  • Formulation Composition
  • Process
  • Process Step
  • Process Step Connection
  • CCP Library
  • Action Item

Creating a HACCP Plan Design

You can create a master design for a HACCP plan that can then be copied and customized to suit the needs of different regions or individual factories.

To create a HACCP Plan Design:

  1. Navigate to Business Admin > Objects > HACCP Plans or to a custom tab.
  2. Click Create.
  3. Select the HACCP Plan type and click Continue.
  4. Enter a Name.
  5. Optional: Enter a Description and Title.
  6. Select a Material.
  7. Select a Process.
  8. Select a Facility.
  9. Select a HACCP System Standard.
  10. Click Save, or to create another HACCP Plan, click Save + Create.

After you’ve created your HACCP Plan Design, you must add the following records to the design. These records are specific to your HACCP Plan but can draw on information in library records. When users deep copy your HACCP plan design, Vault copies over these records, saving time and ensuring consistency:

How to Create HACCP Plan Process Steps

To create a HACCP Plan Process Step:

  1. Navigate to the HACCP Plan Process Step section of a HACCP Plan.
  2. Click Create.
  3. Select the HACCP Plan Process Step Type:
    • Process Step: Signifies a regular processing step.
    • Material Step: Process step that introduces a raw material, such as an auxiliary material or the receipt of a raw material.
    • Logistics Step: Process step that involves distribution or storage of raw material.
    • Connector: Indicates the start or end of a process flow, or a step used to connect two flows or modular HACCP Plans together.
  4. Enter a Name.
  5. Select a Step Type.
  6. Optional: Enter a Description.
  7. Optional: Select a Process Step from the library.
  8. Select a CCP or OPRP label, if applicable.
    • CCP (Critical Control Point) and OPRP (Operational Prerequisite Program) steps are marked clearly on the HACCP Flow Diagram.
  9. Click Save, or to create another HACCP Plan Process Step, click Save + Create.

You can also create and edit HACCP Plan Process Steps using the HACCP Flow Diagram. After creating your HACCP Plan Ingredients and HACCP Plan Process Steps, you can use the Ingredient Involved object to specify the ingredients used in each process step in your HACCP plan.

How to Create HACCP Plan Process Step Connections

After you’ve created HACCP Plan Process Steps, you can connect them using HACCP Plan Process Step Connections. To create a HACCP Plan Process Step Connection:

  1. Navigate to Business Admin > Objects > HACCP Plan Process Step Connections.
  2. Click Create.
  3. Select an Input Step. This is the step preceding the connection.
  4. Select an Output Step. This is the step following the connection.
  5. Click Save, or to create another HACCP Plan Process Step Connection, click Save + Create.

You can also create and edit HACCP Plan Process Step Connections using the HACCP Flow Diagram.

How to Create HACCP Plan Ingredients

To create a HACCP Plan Ingredient:

  1. Navigate to the HACCP Plan Ingredient section of a HACCP Plan.
  2. Click Create.
  3. Enter a Name.
  4. Enter a Description and Formulation, if applicable.
  5. Click Save, or to create another HACCP Plan Ingredient, click Save + Create.

After creating your HACCP Plan Ingredients and HACCP Plan Process Steps, you can create Ingredient Involved records to join HACCP Plan Process Steps with HACCP Plan Ingredients to specify which ingredients are used in each Material process step in your HACCP Plan.

You can also create and add HACCP Plan Ingredients to a HACCP Plan Process Step using the HACCP Flow Diagram.

How to Create HACCP Plan Process Step Groups

To create a HACCP Plan Process Step Group:

  1. Navigate to Business Admin > Objects > HACCP Plan Process Step Groups or to the HACCP Plan Process Step Groups section of a HACCP Plan or HACCP Plan Process Step record.
  2. Click Create.
  3. Select the HACCP Plan.
  4. Optional: Enter a Description.
  5. Optional: Select a Copy Source.
  6. Click Save, or to create another HACCP Plan Process Step Group, click Save + Create.

To add HACCP Plan Process Steps to your HACCP Plan Process Step Group, navigate to the HACCP Plan Process Steps section of a HACCP Plan Process Step Group record and click Add to open a dialog in which you can select an existing process step or create a new one. You cannot add process steps from different HACCP Plans to the same group. HACCP Plan Process Step Groups without any process steps are not displayed on the HACCP Flow Diagram.

You can view and manage your groups using the HACCP Flow Diagram.

Performing Hazard Analysis & Defining Critical Control Points

Once the HACCP Plan has ingredients, process steps, connections, and groups defined, you must perform hazard analysis and define critical control points.

This process involves creating the following object records:

How to Create Process Hazard Analyses

You must add a Process Hazard Analysis to each step for each hazard that a process step manages. To create a Process Hazard Analysis:

  1. Navigate to Business Admin > Objects > Process Hazard Analyses.
  2. Click Create.
  3. Enter a Name.
  4. Enter one (1) or multiple Hazard Classification Groups.
  5. Optional: If available, select a Hazard Classification.
  6. Optional: Select a HACCP Plan Process Step Group. A Process Hazard Analysis associated with one (1) or more process step groups cannot subsequently be associated with process steps.
  7. If the hazard is significant, select the Significant Hazard checkbox.
  8. Add additional information about risk, control measures, and prerequisite plans.
  9. Click Save, or to create another Process Hazard Analysis, click Save + Create.

After you’ve created your Process Hazard Analysis records, you must associate them to Hazards by creating one (1) Process Hazard Analysis - Hazard record per hazard.

Next, if you did not specify a HACCP Plan Process Step Group, you must associate the Process Hazard Analysis with one (1) or more HACCP Plan Process Steps in your HACCP Plan by creating the HPPS - PHA join object.

How to Create Ingredient Hazard Analyses

You must associate an Ingredient Hazard Analysis with each HACCP Plan Ingredient in your plan that could introduce a hazard. To create an Ingredient Hazard Analysis:

  1. Navigate to Business Admin > Objects > Ingredient Hazard Analyses.
  2. Click Create.
  3. Enter a Name.
  4. Select an Ingredient.
  5. Select a Hazard.
  6. Add additional information about risk, control measures, and prerequisite plans.
  7. Click Save, or to create another Process Hazard Analysis, click Save + Create.

How to Define Critical Control Points

After you have performed hazard analysis for ingredients and process steps in your HACCP Plan, you can define the critical control points (CPPs) to control for identified hazards. To create a CCP-Hazard Analysis:

  1. Navigate to Business Admin > Objects > CCP-Hazard Analyses.
  2. Click Create.
  3. Select the CCP-Hazard Analysis Type.
  4. Enter a Name.
  5. Select a CCP from the library.
  6. Optional: Add additional information about the corrective actions to be taken and their frequency.
  7. Enter information about the Ingredient Hazard Analysis or Process Hazard Analysis for which you are defining the CCP.
  8. Click Save, or to create another CCP-Hazard Analysis, click Save + Create.

Once you create these records, your HACCP Plan Design is ready to be used. You can manage hazard analysis using the HACCP Flow Diagram.

Deep Copying an Existing HACCP Plan Design

You can save time and effort starting a new HACCP Plan or HACCP Plan Design by copying the details from an existing HACCP Plan Design and its related records using the Create HACCP Plan Design from Design and Create HACCP Plan from Design actions. The Copy Record action duplicates that one (1) record only, whereas these actions deep copy the source hierarchy of a HACCP Plan and its related records by cloning the following related records:

  • HACCP Plan Ingredient
  • HACCP Plan-Process Step
  • HACCP Plan Process Step Connection
  • Action Item
  • Ingredient Hazard Analysis
  • Process Hazard Analysis
  • HPPS - PHA
  • Ingredient Involved
  • Process Hazard Analysis - Hazard
  • CCP-Hazard Analysis
  • HACCP Plan Process Step Group
  • HPPSG - HPPS

You can pre-define mandatory fields for a HACCP Plan Design type record to use as a reference and use each action to reuse the details depending on your business needs:

  • Create HACCP Plan from Design: This action creates a new HACCP Plan record by copying from an existing HACCP Plan Design. You may use this action to create a HACCP plan for a specific manufacturing facility by copying the guidelines provided by the HACCP plan design.
  • Create HACCP Plan Design from Design: This action creates a new HACCP Plan Design record by copying from an existing HACCP Plan Design. You may use this action to make variations of a master HACCP plan design.

As an example, the R&D (research and development) team defines and distributes HACCP plan designs that manufacturers in various regions will use. First, the R&D team creates a HACCP Plan Design object type record for a specific manufacturing process to use as a reference by the manufacturing sites. Then, for similar manufacturing processes with slight regional differences, users can create a variation of the HACCP Plan Design record. The team accomplishes this by running the Create HACCP Plan Design from Design action on the initial HACCP Plan Design record to copy the design template to another HACCP Plan Design record for each regional difference required. After each copy is successful, regional manufacturers can customize a new HACCP Plan Design record to reflect the manufacturing process.

Meanwhile, an individual manufacturing site requires a HACCP Plan to start tracking their food production safety measures. The manufacturing site uses the Create HACCP Plan from Design action on the existing HACCP Plan Design record to copy the details to a new HACCP Plan object type record.

How to Copy an Existing HACCP Plan

When configured by your Admin, you can copy a HACCP Plan through either a lifecycle state change or a user action on a HACCP Plan record. Before copying an existing HACCP Plan, ensure you’ve created a HACCP Plan Design.

To copy an existing HACCP Plan Design:

  1. Navigate to the appropriate HACCP Plan.
  2. Select Create HACCP Plan Design from Design or Create HACCP Plan from Design from the All Actions menu.
  3. In the dialog, enter a Name.
  4. Optional: Enter a Title, External ID, and Unique Field.
  5. Click Save.

When the copy is complete, you’ll receive a notification that the HACCP Plan is created with a link to the new record or if it fails because of an error.

Working with the HACCP Flow Diagram

The HACCP Flow Diagram lets you view and edit the process steps and their connections, update information about process steps and connections, and see critical points for process steps in a HACCP Plan in an easy-to-use visual interface. See Working with the HACCP Flow Diagram for more details.

Limitations

The following limitations affect HACCP Management:

  • For the Create HACCP Plan Design from Design and Create HACCP Plan from Design actions, Vault will not copy a HACCP Plan record when it is related to more than 4,000 HACCP Plan, HACCP Plan Ingredient, HACCP Plan-Process Step, Ingredient Hazard Analysis, Process Hazard Analysis, HPPS - PHA, Process Hazard Analysis - Hazard, Ingredient Involved, CCP-Hazard Analysis, Action Item, HACCP Plan Process Step Group, and HPPSG - HPPS records.
  • You cannot associate a HACCP Plan Process Step with more than ten (10) HACCP Plan Process Step Groups.