Augmented Digital Procedure Guidance for Regulated Production
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Solution Overview
Problem
Current methods for augmenting procedures in regulated industries face challenges in efficiently capturing and recording data across various devices and environments, particularly in pharmaceutical production facilities, where operators have different comfort levels and preferences, and there is a need for flexible data collection and automated procedural guidance.
Innovation Solution
A method and system that utilize a range of mobile devices, including smartphones, tablets, and augmented reality headsets, to record and store procedure data, offering passive and active data capture, automated guidance, and flexible data collection methods, allowing operators to choose their preferred data collection method and level of guidance, while integrating with a remote computer system for centralized management and data processing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If multiple data collection methods are provided to accommodate different operator preferences, then operator comfort and ease of operation improve, but device complexity increases
Solution Approach 1:
The system provides multiple data collection methods including voice recording, image capture, and manual entry through a unified mobile device interface. Operators can choose their preferred method (voice, photo, or typing) while the system maintains a single integrated platform that handles all input types, thereby improving ease of operation without proportionally increasing complexity.
Solution Approach 2:
The system automatically processes different input types through automated workflows. Voice recordings are transcribed automatically, images are captured and stored with metadata, and data is synchronized across devices without requiring manual intervention. This self-service capability allows multiple collection methods to coexist without linearly increasing system complexity.
2Productivity
If automated data capture is implemented to reduce manual recording, then productivity improves, but measurement precision may deteriorate due to automated extraction accuracy
Solution Approach 1:
The system provides automated feedback mechanisms where extracted data from images or voice recordings is presented to operators for verification and correction. This feedback loop allows automated capture to maintain high productivity while preserving measurement precision through human-in-the-loop validation, catching and correcting extraction errors before final data storage.
Solution Approach 2:
The data capture process is segmented into automated extraction and manual verification stages. Critical data fields are automatically extracted for speed, while a subset requiring high precision is flagged for manual review. This segmentation allows the system to optimize for both productivity and precision depending on the specific data element being captured.
3Adaptability or versatility
If diverse mobile devices are supported to accommodate operator preferences, then adaptability improves, but device complexity increases
Solution Approach 1:
The system is designed to function as a universal platform that supports multiple mobile device types (smartphones, tablets, wearables) through a common interface. By implementing device-agnostic communication protocols and standardized data formats, the system achieves broad adaptability without requiring separate complex implementations for each device type.
Solution Approach 2:
The system employs an intermediary layer (mobile application) that sits between the diverse hardware devices and the core data management system. This intermediary handles device-specific variations in input methods, display formats, and connectivity protocols, thereby supporting diverse devices without increasing the complexity of the underlying centralized system.
4Reliability
If centralized data management is implemented to ensure regulatory compliance, then reliability improves, but loss of time increases due to data transfer and synchronization
Solution Approach 1:
The mobile application performs preliminary data validation, formatting, and encryption locally on the device before synchronization with the centralized system. By preparing data in advance according to regulatory requirements, the system ensures compliance is maintained during transfer, reducing the time penalty of centralized management while preserving reliability.
Solution Approach 2:
The system implements continuous background synchronization that transfers data incrementally as it becomes available, rather than requiring complete data sets to be transferred at once. This continuous action maintains regulatory compliance through persistent connectivity while minimizing time loss by utilizing available network bandwidth efficiently and allowing operations to continue during data transfer.
Data Source
AI summary
A method for augmenting procedures at production equipment includes: linking a first description of a first step in a procedure and a capture type to a first capture field; generating a digital draft procedure comprising descriptions of steps extracted from the procedure and the first capture field specifying data capture of the first capture type from an equipment unit; generating augmented guidance for the first step in the procedure based on visual content recorded by a mobile device—assigned to an exemplary operator—during completion of the first step in the digital draft procedure; linking the augmented guidance to a location proximal the equipment unit based on locations of the first mobile device during completion of the first step in the digital draft procedure; and generating an augmented digital procedure based on steps in the procedure, the augmented guidance, and definitions for data capture according to the first capture field.