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.
Note: This feature is currently available only to Early Adopters. Contact your Veeva Representative for more details.
HACCP Management Process Overview
The general process of working with HACCP Management involves the following steps:
- Assemble a cross-functional HACCP team
- Create and maintain HACCP reference records
- Create an initial HACCP Plan Design that describes each step and ingredient in the manufacturing process for a product
- Verify the design on the HACCP Flow Diagram and perform hazard analysis for the ingredients and process steps in the HACCP plan
- Copy and distribute the finished HACCP Plan Design
- Create translated HACCP Plans for local factory use
- Display and update the HACCP Plan using the HACCP Flow Diagram
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
- Severity
- Risk Matrix
- Detectability
- Occurrence
- Risk Level
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:
- Navigate to Business Admin > Objects > HACCP Plans or to a custom tab.
- Click Create.
- Select the HACCP Plan Design type and click Continue.
- Enter a Name.
- Optional: Enter a Description and Title.
- Select a Material.
- Select a Process.
- Select a Facility.
- Select a HACCP System Standard.
- 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:
- HACCP Plan Process Step
- HACCP Plan Process Step Connection
- HACCP Plan Ingredient
- HACCP Plan Process Step Group
How to Create HACCP Plan Process Steps
To create a HACCP Plan Process Step:
- Navigate to the HACCP Plan Process Step section of a HACCP Plan.
- Click Create.
- 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.
- Enter a Name.
- Select a Step Type.
- Optional: Enter a Description.
- Optional: Select a Process Step from the library.
- 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.
- 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:
- Navigate to Business Admin > Objects > HACCP Plan Process Step Connections.
- Click Create.
- Select an Input Step. This is the step preceding the connection.
- Select an Output Step. This is the step following the connection.
- 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:
- Navigate to the HACCP Plan Ingredient section of a HACCP Plan.
- Click Create.
- Enter a Name.
- Enter a Description and Formulation, if applicable.
- 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:
- 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.
- Click Create.
- Select the HACCP Plan.
- Optional: Enter a Description.
- Optional: Select a Copy Source.
- 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.
Verifying the HACCP Plan & Performing Hazard Analysis
After creating the foundation of your HACCP Plan by creating process steps, ingredients, groups, and connections as needed, you can verify your plan by viewing and updating it using the HACCP Flow Diagram.
Once your plan is verified, you can perform hazard analysis to assess the risks of the hazards in your plan and create records that specify how you will control the significant hazards. After you perform these steps, your HACCP Plan is ready to copy and distribute.
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 a single record, 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
- PRP/CM - Hazard Analysis
- PHA - Subsequent Step
- HACCP Hazard Control
- PHA - HHC
- HACCP Process Modification
- HACCP Plan Process Step Position
- HPPSC Position
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.
About Comparison IDs
When you copy a HACCP Plan, Vault stores the unique system ID of the originating HACCP Plan in the system-managed Comparison ID field on the objects included in the deep copy action, excluding some join objects. Subsequent copies of the HACCP Plan reference this same ID. In contrast, Vault sets the Source HACCP Plan field value on HACCP Plan object records to reference only the most recent HACCP Plan from which the copy was made; Vault clears this field value if the source HACCP Plan is deleted.
For instance, an R&D team creates a HACCP plan design, HACCP Plan A, and copies it to create HACCP Plan B to account for regional differences in HACCP practices. Next, a local factory copies HACCP Plan B to create their own HACCP plan, HACCP Plan C. The newly created HACCP Plan C has the unique Comparison ID value of the originating HACCP Plan A, and a Source HACCP Plan value of HACCP Plan B.
How to Copy an Existing HACCP Plan Design
When configured by your Admin, you can copy existing HACCP Plan Designs and HACCP Plans through a lifecycle state change or a user action on a HACCP Plan record.
To copy an existing HACCP Plan Design:
- Navigate to the appropriate HACCP Plan.
- Select Create HACCP Plan Design from Design or Create HACCP Plan from Design from the All Actions menu.
- In the dialog, enter a Name.
- Optional: Enter a Title, External ID, and Unique Field.
- 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.
Note: Vault will not copy a HACCP Plan record if the total number of related records to copy is greater than 4,000.
Translating the HACCP Plan
Once your HACCP Plan Design is finalized, you can generate translated copies for factory users in their local language. Learn more about Translating HACCP Plans.
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:
- The Create HACCP Plan Design from Design and Create HACCP Plan from Design actions cannot run on HACCP Plans that contain more than 4,000 related records to copy.
- You cannot associate a HACCP Plan Process Step with more than ten (10) HACCP Plan Process Step Groups.
- The Create HACCP Plan Design from Design and Create HACCP Plan from Design actions do not copy values stored in Attachment fields.