Designing a non-conformity reporting system for quality assurance and compliance tracking
I designed a QA system that captures incidents, routes them through review stages, tracks corrective actions, and maintains full audit trail. The challenge: make compliance workflows clear without overwhelming operators.
The compliance challenge in manufacturing
Electroson, a manufacturer of electronic medical equipment, needed a digital system to replace paper-based non-conformity tracking. The company operated under strict regulatory requirements (ANVISA, ISO 13485) where every incident, from material defects to process deviations, required documented investigation, corrective actions, and audit trails. Manual processes created risks: lost paperwork, unclear ownership, missed deadlines, and insufficient evidence for compliance audits.
Stage-based workflows with clear ownership
Designed a four-stage workflow system:
Incident Capture Operators report non-conformities with photos, descriptions, affected batches, and severity classification. The interface below shows the initial incident submission form, which emphasized ease of reporting to encourage transparency rather than hiding problems.
Review Assignment Quality managers receive notifications, assess severity, assign responsibility, and set investigation deadlines. Dashboard surfaced aging incidents and overdue reviews.
Corrective Action Tracking Assigned team members document root cause analysis (Ishikawa diagrams supported), propose corrective actions, implement solutions, and mark completion. The system provided visibility across all investigation stages, as shown in the quality evaluation view below.
Closure and Documentation Quality auditors verify effectiveness of corrections, approve closure, and archive complete incident record. All stages maintained explicit ownership, deadline tracking, and status visibility.
Audit trail as design constraint
Every action required traceability for regulatory compliance. Designed the audit interface to capture who changed what, when, and why, without cluttering the main operational workflows. The detailed information view provided comprehensive incident tracking capabilities.
Log views showed complete incident history: status transitions, field edits, document attachments, and user actions. This satisfied auditor requirements while keeping daily workflows clean and focused.
Information architecture for different user roles
Operators saw simplified incident submission forms. Quality managers had dashboard views showing incident distribution by type, department, severity, and aging. Auditors accessed filtered reports, statistical summaries, and complete audit logs. Each role saw contextually relevant information without overwhelming complexity.
Design decisions and trade-offs
Prioritized structured data capture over free-form text to enable filtering, reporting, and trend analysis. Balanced validation rules (required fields, attachment requirements) against operator friction. Too strict would discourage reporting. Chose progressive disclosure for advanced features (bulk actions, statistical exports) to keep primary workflows simple.
Validation and handoff
Created clickable prototypes demonstrating complete incident lifecycle. Tested flows with actual quality team members to validate terminology, field requirements, and role-based permissions. Delivered detailed Figma specs with state diagrams, field validations, and permission matrices. Worked with development team to ensure production implementation maintained compliance requirements while keeping interfaces usable.