Inventor(s)

Kenneth DavisFollow

Abstract

Field Computer-implemented systems for identifying which employees require requalification when standard operating procedures are updated, using workflow step definitions and employee authorization records as the primary lookup mechanism. Background In regulated environments, business workflows are modeled as sequences of steps, with each step linked to specific sections of standard operating procedures. When an SOP is revised, the challenge is identifying precisely which employees are affected. The approach described here uses the existing workflow-step-to-SOP configuration and employee authorization tables as the targeting mechanism. Technical Description The system maintains a workflow_definitions store where each business process (change control, incident management, CAPA execution, batch release) is represented as an ordered sequence of steps. Each step record contains: workflow_id, step_id, step_name, and one or more sop_doc_id plus sop_section_id references indicating which SOP content governs that step. These mappings are configured by process owners during workflow setup and updated whenever workflows are modified. A separate authorization table tracks which employees are permitted to execute which workflow steps. Each authorization record contains: employee_id, workflow_id, step_id, authorization_date, and authorizing_manager_id. Employees may be authorized for steps across multiple workflows. When a document management system signals that an SOP has been revised, it provides the changed sop_doc_id and sop_section_id pairs. A workflow impact analyzer queries the workflow_definitions store to locate all steps referencing those pairs. For each affected step, the system queries the authorization table to identify every employee currently authorized to execute that step. For each employee-step combination, the system creates a step_requalification record containing: requalification_id, employee_id, workflow_id, step_id, triggering_sop_doc_id, triggering_sop_section_id, required_training_artifact_ids, and due_date computed from the workflow's regulatory category. Employees who are not authorized for any affected step receive no requalification assignment, even if they are generally assigned to the parent workflow. Distinguishing Characteristics This system uses configured workflow-step-to-SOP mappings and authorization data as the primary lookup path. It does not maintain per-assessment source-attribution records binding individual assessment interactions to document sections. It does not perform reverse-index traversal by authority unit identifiers. The targeting precision comes from the intersection of which steps reference the changed SOP section and which employees are authorized for those steps. There are no proposition-level validity bitmaps or materiality evaluations.

Creative Commons License

Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.

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