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.
Reference Data Elements
The key data elements that inform HACCP plans, which are not specific to a particular HACCP Plan, include the following:
- Material: Refers to a material record which is represented as a finished product specified in a HACCP Plan. See QMS Data Model for more details regarding these objects.
- Process: Represents a specific process.
- Process Step: Represents a step in a process.
- Process Step Connection: Connects an input and output step in a process.
- Hazard: Represents a possible food safety hazard in the manufacturing process.
- Critical Control: Stores a library of generic Critical Controls so they are available for selection in the CCP-Hazard Analysis.
- Action Item: Stores information about an action that needs to be taken to control significant hazards associated with a process step or ingredient, as specified in a CCP-Hazard Analysis.
- Facility: Refers to a specific manufacturing site within a company.
- Organization: Refers to an external supplier.
Hazard Analysis Reference Data Elements
The key library data elements that inform hazard analysis in HACCP plans, but which are not specific to a particular HACCP plan, include the following:
- Ingredient Known Hazard: Stores information about a specific hazard associated with an ingredient and the critical controls needed to control significant hazards. Must be associated with an Ingredient Hazard Template.
- Process Step Known Hazard: Stores information about a specific hazard associated with a process step and the critical controls needed to control significant hazards. Must be associated with a Process Hazard Template.
- Ingredient Hazard Template: Stores information about the hazards associated with a specific ingredient. These should be maintained and reused each time the ingredient is used in a HACCP plan.
- Process Hazard Template: Stores information about the hazards associated with a specific process step. These should be maintained and reused each time the ingredient is used in a HACCP plan.
Hazard Analysis Data Elements
The key data elements of performing a hazard analysis for a specific HACCP plan include the following:
- Ingredient Hazard Analysis: Analyzes a hazard introduced by an ingredient in a HACCP Plan and specifies controls to reduce the risk of the hazard. You must complete one (1) ingredient hazard analysis for each hazard introduced by an ingredient.
- Process Hazard Analysis: Analyzes a hazard introduced by a process step in a HACCP Plan and specifies controls to reduce the risk of the hazard. You can add the same Process Hazard Analysis to multiple process steps if the hazards are managed in a similar way within the same HACCP Plan.
- CCP-Hazard Analysis: Outlines critical controls to reduce the risk introduced by an ingredient or process step in a specific HACCP plan.
Join Data Elements
The key data elements that join relevant records include the following:
- Material-Process: Joins a Material with its relevant Process.
- Material-Hazard: Joins a Material with a relevant Hazard.
- Material-Organization: Joins a Material with a relevant supplier Organization.
- Process-Process Step: Joins a Process with a Process Step and specifies the order in which Process Steps of a Process must be completed.
- Product-Process Step: Joins a Product with a specific Process-Process Step.
- HPPS - PHA: Joins a Process Hazard Analysis with a Process Step.
- Process Hazard Analysis - Hazard: Joins a Process Hazard Analysis with a Hazard.
- Ingredient Involved: Joins a HACCP Plan Ingredient with a HACCP Plan Process Step.
About the HACCP Study Process
Your HACCP management process will vary depending on your organization, but will usually begin with a HACCP study, which generally involves the following steps:
- A cross-functional HACCP team creates and maintains records of various materials, processes, and their associated hazards.
- The team creates and maintains a HACCP Flow Diagram by defining each step in the manufacturing process for the finished products.
- The team conducts a hazard analysis of ingredients and process steps involved in making a finished product.
- After identifying the hazards, the team assesses the risk of each hazard and defines the critical controls for hazards deemed a significant risk. The team also defines any verification, validation, and monitoring actions that must be taken in response to each hazard.
- The team creates HACCP plans for specific products for different regions and individual factories to use.
HACCP Management relies on creating and maintaining different types of related object records. The following sections review some of the key records involved in the HACCP study process.
Finished Product & Process
The process of working with HACCP Management starts by selecting the finished product that will be the subject of your HACCP plan, and the associated Process for which you are creating the HACCP plan. HACCP plans are generally created for a finished product, and are sometimes used for semi-finished products.
Material and Process records should be maintained by the HACCP team or your Business Admin, who associate each record with relevant Processes using Material-Process records. Materials can be factory-specific, allowing individual manufacturing sites to tailor processes to their unique requirements.
Ingredients & Process Steps
Once you have created your HACCP Plan, you can add the HACCP Plan Ingredients (which reference pre-defined Formulations) and HACCP Plan Process Steps (which reference pre-defined Process Steps). You can connect HACCP plan process steps by specifying input and output process steps using the HACCP Plan Process Step Connection record.
Hazard Analysis & Critical Control Points
You must add an Ingredient Hazard Analysis or a Process Hazard Analysis to each HACCP Plan Ingredient or HACCP Plan Process Step that could introduce a hazard. For this task, select from pre-existing Hazard records in the Hazard Library. You can apply the same Process Hazard Analysis to multiple steps managing the same hazard in a similar manner as part of a HACCP Plan.
The Ingredient Hazard Template and Process Hazard Template store details about an ingredient or process step and the list of hazards that are being introduced or controlled at various stages of the manufacturing process. You can use these records to populate a HACCP Plan with the hazards associated with specific ingredients and process steps. When these records are maintained, users can use these as guidelines to perform an Ingredient or Process Hazard Analysis each time an ingredient or process step is used in a HACCP Plan.
Next, you can define critical limits and controls in a CCP-Hazard Analysis record by selecting the critical controls from the CCP Library. The associated CCP Library record specifies the critical limits, and control measures needed to manage each hazard. You can also manage a list of monitoring and verification actions for the critical controls.
See Working with HACCP Management for more details on creating HACCP Plans.