QualityOne Vaults provide a management system that allows users to establish and maintain safe food production practices more efficiently using the HACCP (Hazard Analysis Critical Control Points) methodology. This allows users to ensure that food is manufactured, processed, packaged, and stored in sanitary conditions to prevent post-process contamination. Users can create HACCP plans in their Vault to define principles and procedural requirements for maintaining the HACCP system. To save time and effort, users can reuse existing HACCP plans as templates when creating new HACCP plans.
Note: This feature is currently available only to Early Adopters. Contact your Veeva Representative for more details.
Configuration Overview
Configuring your Vault to use HACCP Management involves the following steps:
- Configure objects
- Configure picklists
- Configure object layouts
- Configure lifecycles
- Configure workflows
- Configure object actions
- Configure the HACCP Flow Diagram
- Configure HACCP Document Generation
- Configure user permissions
Note: Depending on your Vault’s creation date and which features are currently enabled and configured, some of the steps described in this article may be unavailable or already complete in your Vault.
Configuring Objects
You must activate the HACCP Plan and HACCP Plan Design object types on the HACCP Plan object in order to run the Create HACCP Plan from Design and Create HACCP Plan Design from Design actions.
To use the HACCP Flow Diagram and perform hazard analysis, you must also activate object types for the following objects:
- HACCP Plan Process Step
- Process Step
- CCP-Hazard Analysis
- CCP Library
- PRP/CM - Hazard Analysis
- HACCP Hazard Control
To create HACCP Plan Process Steps from the HACCP Flow Diagram and run the Create HACCP Plan Design from Design and Create HACCP Plan from Design actions, you must enable the System manages field value (read-only) checkbox on the Name (name__v) field on the following objects:
- CCP-Hazard Analysis
- HACCP Plan Ingredient
- HACCP Plan Process Step
- Process Hazard Analysis
- Ingredient Hazard Analysis
- PRP/CM - Hazard Analysis
- HACCP Hazard Control
Configuring Hazard Analysis
To perform hazard analysis using the HACCP Flow Diagram, you must ensure the following fields on the Process Hazard Analysis object are activated:
- Significant Hazard
- Potential Hazard Identified
- Hazard Classification
- Hazard Classification Group
- Origin & Nature of the hazards
- Risk Category
- CCP
- PRP
- OPRP
- Control Measure
- Subsequent Step
- Modification
- Hazard Analysis Complete
- Hazard Analysis Complete Reason
You must assign the Hazard Analysis Complete and the Hazard Analysis Complete Reason fields to all HACCP Plan Process Step object types, and to the HACCP Plan Process Step Group object.
You can define rules for showing and hiding each outcome section of a hazard analysis on the HACCP Flow Diagram. To configure, add a business rule to the following fields on the Process Hazard Analysis object:
- CCP
- PRP
- OPRP
- Control Measure
- Subsequent Step
- Modification
Configuring Picklists
Your Vault includes the following picklists for categorizing and filtering hazards as part of the hazard analysis process, which you can customize as needed to fit your business needs:
- Hazard Analysis Complete Reason: Users can select from multiple values to give a reason for the hazard analysis completeness status on a Process Hazard Analysis record.
- Step Hazard Analysis Complete Reason: Users can select from multiple values to give a reason for the hazard analysis completeness status on a HACCP Plan Process Step record.
- Group Hazard Analysis Complete Reason: Users can select from multiple values to give a reason for the hazard analysis completeness status on a HACCP Plan Process Step Group record.
- Hazard Analysis Type: Users can select either Material Hazard Analysis or Process Hazard Analysis to classify the hazard analysis type on a Process Hazard Analysis record.
- Hazard Classification Group: Users can select from multiple values to classify a hazard on a Process Hazard Analysis and Hazard record.
- Hazard Classification: Users can select from a list of pre-defined values determined by their selection for Hazard Classification Group to further classify a hazard.
- Origin & Nature of the hazards: Users can select from multiple values to describe hazards in a Process Hazard Analysis record.
Configure the Hazard Classification Group or both the Hazard Classification Group and Hazard Classification picklists with values applicable to your organization’s business needs, or use the values provided in Configuring Material Verification Checklists.
If you configure both picklists, you must also configure a picklist dependency on the Hazard Classification Group picklist to make values available to select for the Hazard Classification field.
Configuring Object Layouts
HACCP Management provides a default object layout for the HACCP Plan object to allow users to create, analyze, and review food safety-related procedures. You can customize object layouts or create custom object layouts from Admin > Configuration > Objects > HACCP Plan > Layouts.
- For the CCP-Hazard Analysis (
ccp_hazard_analysis__v) object:- Detail Form Section: Include the HACCP Plan field so Vault can populate the HACCP Plan value from the Ingredient Hazard Analysis or Process Hazard Analysis specified in the CCP-Hazard Analysis record.
- Related Object Section: Insert the CCP-Hazard Analysis (
ccp_hazard_analysis__v) object to create a list of critical controls.
- For the HACCP Plan (
haccp_plan__v) object:- Related Object Section: Insert the HACCP Plan Process Step, HACCP Plan Ingredient, and HACCP Plan Process Step Group objects.
- For the HACCP Plan Process Step (
haccp_plan_process_step__v) object:- Detail Form Section: Add the Hazard Analysis Complete and Hazard Analysis Complete Reason fields.
- Related Object Section: Insert the HACCP Plan Process Step Group (
haccp_plan_process_step_group__v) object to display a list of groups associated with the process step.
- For the HACCP Plan Process Step Group (
haccp_plan_process_step_group__v) object:- Detail Form Section: Add the Hazard Analysis Complete and Hazard Analysis Complete Reason fields.
- For the Hazard (
hazard__v) object:- Detail Form Section: Add the Hazard Classification Group field. If your configuration uses the Hazard Classification field, you must also add it.
- For the Process Hazard Analysis (
process_hazard_analysis__v) object:- Detail Form Section: Add the Hazard Classification Group, Significant Hazard, Hazard Analysis Type, Hazard Analysis Complete, Hazard Analysis Complete Reason, and HACCP Plan Process Step Group fields. If your configuration uses the Hazard Classification field, you must also add it.
- For the Process Hazard Analysis - Hazard (
pha_hazard__v) object:- Detail Form Section: Add the Brief Description field.
HACCP Management Lifecycles
HACCP Management includes the HACCP Plan Lifecycle object lifecycle, which your organization can use and customize to suit your specific needs.
HACCP Management Workflow
The HACCP Plan Lifecycle includes standard object workflows which your organization can use and customize to suit your specific needs.
Configuring HACCP Management Object Actions
The HACCP Plan object lifecycle contains the following standard actions:
- Create HACCP Plan Design from Design: Copies the hierarchy of a HACCP Plan Design and its related records into a new set of records. The Source HACCP Plan field in the new HACCP Plan record will contain the ID of the copied HACCP Plan.
- Create HACCP Plan from Design: Offers the same functionality as the Create HACCP Plan Design from Design action except HACCP Plan is the target object type rather than HACCP Plan Design.
- HACCP Flow Diagram actions: Support the functionality of HACCP Flow Diagrams, enabling users to launch, lock, and unlock diagrams directly from a specific HACCP Plan.
Configuring the Create HACCP Plan from Design & Create HACCP Plan Design from Design Actions
Depending on your business needs, add these actions as a record action on the HACCP Plan object to:
- Add these actions as user actions on any HACCP Plan Lifecycle state
- Add these actions as entry actions on any HACCP Plan Lifecycle state
When users run the Create HACCP Plan Design from Design or Create HACCP Plan from Design actions, the Source HACCP Plan field in the new HACCP Plan record will contain the ID of the copied HACCP Plan Design. Vault does not copy:
- System-managed fields.
- Inactive object types.
- Inactive object fields.
- Any fields with the Do not copy this field in Copy Record checkbox selected.
Configuring HACCP Flow Diagram Actions
The following actions support the HACCP Flow Diagram:
- Launch Process Flow Diagram: Allows users to launch the HACCP Flow Diagram for a HACCP Plan record.
- Lock HACCP Flow Diagram and Unlock HACCP Flow Diagram: Prevents users from editing the HACCP Flow Diagram and unlocks the diagram so users can make updates.
To make these actions available to users on a HACCP Plan, first add them as record actions on the HACCP Plan object. You can then add these actions to the relevant HACCP Plan lifecycle states as user actions or entry actions.
Configuring the HACCP Flow Diagram
To perform hazard analysis from the HACCP Flow Diagram, you must configure the fields that display in the Hazard Analyses section of the Information panel.
To configure fields:
- Navigate to Admin > Configuration > User Interface > Pages > Process Flow Diagram > Side Panel Configuration.
- Click Edit.
- Select up to eight (8) Hazard Analysis Fields to display in the Potential Hazard Description section.
- Select a field for Severity.
- Select a field for Likelihood.
- Select a field for Local likelihood.
- Select up to five (5) Hazard Assessment Fields to display in the Hazard Assessment section.
- Click Save.
Configuring HACCP Document Generation
To configure HACCP Document Generation, do the following:
- Activate the HACCP Plan Reports document type.
- Create a HACCP Template document template. For more information about creating a document template and configuring Merge Fields, see Managing Document Templates, Using Merge Fields for Microsoft Word & Excel and Configuring Merge Fields for Microsoft Word & Excel.
- Configure the appropriate lifecycles and workflows for the HACCP Plan Report document types.
Limitations
HACCP Management has the following limitation:
- The Create HACCP Plan Design from Design and Create HACCP Plan from Design actions do not copy values stored in Attachment fields.
Configuring User Permissions
You must ensure users have the appropriate read and create permissions to access the appropriate objects and object fields in addition to the permissions outlined below:
- For the HACCP Plan object:
- Create, Edit, and Delete permission.
- For the HACCP Plan object fields: if a field needs to be unique, you must enable the field to be required as well. To do so, select the Values must be unique setting and the User must always enter a value (required) setting.
- For users to view a HACCP Flow Diagram and its associated hazard analysis information, they must have Read permission on the following objects; to modify a HACCP Flow Diagram, users must have Create, Edit, and Delete permissions on the following objects:
- HACCP Plan Process Step
- HACCP Plan Process Step Connection
- HACCP Plan Ingredient
- HACCP Plan Process Step Group
- HACCP Plan Process Step Position
- HPPSC Position
- Process Hazard Analysis
- Ingredient Hazard Analysis
- Hazard
- CCP-Hazard Analysis
- Ingredient Involved
- HPPS - PHA
- Process Hazard Analysis - Hazard
- HPPS - HPPSG
- PRP/CM - Hazard Analysis
- PHA - Subsequent Steps
- HACCP Hazard Control
- PHA - HHC
- HACCP Process Modification
- For the Create HACCP Plan Design from Design or Create HACCP Plan from Design actions: Create permissions for both the target object type and the target object.
- To run the Generate HACCP Plan Report action, users must have the following permissions:
- Create permission for the HACCP Plan Reports document type.
- Create permission for the following HACCP Plan Reports document subtypes:
- Generated HACCP Documents
- HACCP Templates
- Create permission for the following document classifications of the Generated HACCP Documents document subtype:
- HACCP Flow Diagrams
- HACCP Plan Binders
- HACCP Plan Reports
- Create permission for the HACCP Plan Data Documents document classification of the HACCP Templates document subtype.
- Create permission for the HACCP Plan Binder binder.
Related Permissions
You can complete all the steps in this article with the standard System Administrator or Vault Owner security profile. If your Vault uses custom security profiles, your profile must grant the following permissions:
| Type | Permission | Controls |
|---|---|---|
| Security Profile | Admin: Configuration: Document Fields: Create, Edit | Ability to create and modify document fields. |
| Security Profile | Admin: Configuration: Document Lifecycles: Edit | Ability to modify document lifecycles. |
| Security Profile | Admin: Configuration: Document Types: Edit | Ability to modify document types. |
| Security Profile | Admin: Configuration: Object Lifecycles: Create, Edit | Ability to create and modify object lifecycles. |
| Security Profile | Admin: Configuration: Object Workflows: Create, Edit | Ability to create and modify object workflows. |
| Security Profile | Admin: Configuration: Objects: Create, Edit | Ability to create and modify Vault objects. |
| Security Profile | Admin: Configuration: Templates: Create, Edit | Ability to create and modify document or binder templates. |
| Security Profile | Pages: All Pages: Process Flow Diagram | Ability to configure the HACCP Flow Diagram. |
| Security Profile | Pages: All Pages: Side Panel Configuration | Ability to configure fields on the Information panel of the HACCP Flow Diagram. |