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. This allows you to ensure that food is manufactured, processed, packaged, and stored in sanitary conditions; to systematically control food safety hazards; and reduce the risk of contamination. 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.
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Note: This feature is currently available only to Early Adopters. Contact your Veeva Representative for more details.
About HACCP Plans
A HACCP plan is a food safety methodology that defines the procedures to follow in the manufacturing, processing, packaging, and storage of food and beverage products in order to control food safety hazards associated with specific ingredients and steps in a process. Most organizations have a HACCP team that will first define the scope of the HACCP study, identify the finished products and their associated ingredients, describe the finished products and their intended use, and define the acceptable limits of hazards in the finished products. Next, the HACCP team will create a process flow diagram by defining and verifying each step in the manufacturing process of the finished products. After this is complete, the HACCP team will undertake an analysis of the hazards associated with each ingredient and step in the manufacturing process, assessing the risk of each of these hazards and, when deemed significant, determining the step that provides sufficient control to ensure the hazards remain below critical limits established for a specific product. The team establishes critical control points to ensure that significant hazards are kept below predefined critical limits (for instance, keeping specified ingredients to a minimum temperature for a certain amount of time before pasteurization).
You can build, manage, review, and update HACCP plans using QMS functionality.
About the HACCP Management Data Model
HACCP Management relies on users creating and maintaining HACCP Plan records and additional associated records that inform and define the HACCP plan.
Core Data Elements
The core data elements of HACCP Management include the following:
- HACCP Plan: Stores information about a specific HACCP plan for a specific product.
- HACCP Plan Ingredient: Stores information about an ingredient required to manufacture a specific product. These are associated with a specific HACCP Plan record.
- HACCP Plan Process Step: Stores information about a step required to manufacture a specific product. These can also be steps to mitigate the hazards introduced by certain HACCP Plan Ingredients.
- HACCP Plan Process Step Connection: Informs the order in which a step of a process is performed, including the input and output steps.
- HACCP Plan Process Step Group: Stores information about a grouping of HACCP Plan Process Steps.
HACCP Management
You can develop, implement, and manage HACCP plans for your organization. See Working with HACCP Management for more details.
HACCP Flow Diagram
You can use the HACCP Flow Diagram to view and edit your HACCP plan in an easy-to-use visual interface. See Working with the HACCP Flow Diagram for more details.
Hazard Analysis
You can analyze hazards, assess risks, and define control measures for hazards in a manufacturing process in an easy-to-use visual interface on the HACCP Flow Diagram. See Performing Hazard Analysis & Defining Control Measures for more details.