Process Data Recorder Batch Validation for Real-Time Compliance
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Solution Overview
Problem
Existing batch processing systems lack real-time validation capabilities to ensure compliance with predefined criteria, leading to inefficiencies and potential non-conformities in manufacturing processes.
Innovation Solution
A system and method for real-time batch validation using a digital process data recorder/controller that analyzes process values against predefined criteria, providing immediate feedback and secure recording of validation results.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If real-time batch validation is implemented using a digital process data recorder/controller, then compliance monitoring and process efficiency are improved, but device complexity increases
Solution Approach 1:
The patent combines the batch validation functionality directly into the digital process data recorder/controller, merging data acquisition, recording, and validation analysis into a single integrated device. This eliminates the need for separate validation systems while providing real-time compliance monitoring through unified processing of process data against batch recipes and validation rules.
2Loss of time
If real-time analysis of process values is performed to validate batch process, then compliance detection speed is improved, but processing time and computational load increase
Solution Approach 1:
The system performs preliminary actions by pre-loading batch recipes, validation rules, and acceptance criteria into the digital process data recorder/controller before batch execution. During batch processing, the system compares real-time process data against these pre-configured parameters, enabling rapid compliance detection without extensive real-time computational analysis.
3Loss of information
If validation information is securely recorded in memory along with process data, then data integrity and traceability are improved, but storage requirements and system complexity increase
Solution Approach 1:
The patent merges the validation information storage with the existing process data storage in the digital historical process data record. Validation results, compliance status, and analysis outcomes are recorded alongside the corresponding process data in the same memory structure, ensuring data integrity and traceability without requiring separate storage systems or complex data management architectures.
Data Source
AI summary
A method and system are provided for validating process data on a process recorder/controller. The method and system involves: configuring the validation criteria of the process variables, by defining value and time tolerances with respect to an ideal performance; receiving in real-time process data, including one or more process values, for a batch process at the recorder/controller responsible for recording the process data; performing a batch validation process on the recorder/controller, the batch validation process analyzing in real-time the one or more process values to validate the batch process based on at least a batch validation criteria; and transmitting from the recorder/controller validation information including a validation result for presentation on a device to a user, and/or recording at least on the recorder/controller the validation information including at least the validation result, wherein the validation result indicates whether the batch process is conformant or non-conformant.