Perform Process Audit using eAuditor
A Process Audit is a systematic examination of how activities within a specific process are planned, executed, controlled, and improved to ensure they meet defined objectives, quality standards, and regulatory requirements. Unlike product or system audits, a process audit focuses on the efficiency, effectiveness, and consistency of the process itself rather than just its outcomes.
Performing Process Audit using eAuditor ensures a highly detailed, structured, and systematic evaluation of business processes, focusing on efficiency, compliance, and continuous improvement. A process audit is not only about confirming adherence to written procedures but also about identifying whether these processes are practical, optimized, and aligned with organizational objectives. With eAuditor, the process becomes far more efficient because audits are digitized, data is centralized, and corrective actions can be tracked seamlessly across the entire organization.
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Purpose of Performing a Process Audit using eAuditor
The main purpose is to verify that business processes are being carried out as intended, ensuring they remain effective, compliant, and continuously improving. Using eAuditor provides organizations with tools to:
- Standardize audit procedures across teams and locations.
- Collect real-time evidence (photos, notes, videos) for accuracy.
- Identify non-conformities, inefficiencies, or risks.
- Assign corrective tasks and monitor their progress.
- Use analytics to make data-driven decisions for improvement.
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Scope of Process Audit using eAuditor
A Process Audit with eAuditor spans all areas where procedures must be followed consistently and efficiently. It typically covers:
- Compliance: Adherence to international standards (ISO 9001, GMP, OSHA, etc.), internal SOPs, and regulatory requirements.
- Workflow Consistency: Evaluating whether teams follow processes uniformly across shifts, departments, or sites.
- Operational Efficiency: Identifying delays, bottlenecks, or unnecessary steps.
- Resource Optimization: Ensuring effective use of people, equipment, and materials.
- Controls and Documentation: Verifying approvals, logs, and records are accurate and complete.
- Output Quality: Checking whether processes deliver expected outcomes and meet customer requirements.
- Risk Identification: Pinpointing vulnerabilities that may result in compliance failures or operational disruptions.
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Step-by-Step Breakdown of Performing Process Audit using eAuditor
3.1 Planning and Preparation
- Define audit objectives: compliance validation, efficiency improvement, or risk reduction.
- Identify processes for review: production, procurement, quality assurance, HR, or supply chain.
- Select auditors and establish responsibilities.
- Build or customize eAuditor digital checklists based on specific process requirements and industry standards.
3.2 On-Site Process Observation
- Auditors use the eAuditor mobile app to collect live data while observing workflows.
- Capture visual evidence such as photos of equipment use, operator practices, and documentation.
- Record notes, audio, or even barcode scans directly into the platform.
- Evaluate whether employees follow SOPs without shortcuts.
3.3 Evidence Review and Verification
- Examine whether inputs, controls, and outputs align with defined standards.
- Confirm update and proper use of process documents (manuals, logs, records) .
- Test whether internal controls (approvals, checkpoints, verifications) are effective.
3.4 Process Efficiency and Risk Analysis
- Evaluate process timelines, rework rates, and error frequency.
- Identify wasteful practices (duplicate tasks, overprocessing, delays).
- Detect risks such as safety gaps, compliance breaches, or potential system failures.
3.5 Reporting and Communication
- Generate structured digital reports instantly after the audit.
- Use auto-generated summaries to highlight compliance rates, risks, and gaps.
- Share reports across departments or with management in real-time.
- Attach photos and videos for visual proof of findings.
3.6 Corrective and Preventive Action (CAPA) Tracking
- Assign corrective actions directly from eAuditor to responsible individuals.
- Set deadlines, reminders, and follow-up checks.
- Ensure preventive measures are in place to avoid repeat issues.
- Track CAPA completion through eAuditor’s built-in dashboard.
3.7 Post-Audit Analysis and Continuous Improvement
- Use eAuditor’s analytics dashboard to monitor trends across multiple audits.
- Spot recurring issues and identify systemic weaknesses.
- Compare performance across sites or teams.
- Use insights to redesign processes, update SOPs, and enhance training.
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Benefits of Performing Process Audit using eAuditor
- Digital Standardization: All process audits follow a unified structure.
- Increased Accuracy: Evidence capture ensures objective findings.
- Real-Time Visibility: Managers can access audit results instantly.
- Accountability: Assigned actions create ownership of issues.
- Efficiency Gains: Faster audits, instant reporting, and automated follow-ups.
- Continuous Improvement: Data analytics provide long-term insights for process optimization.
- Scalability: Audits can be applied consistently across multiple sites or departments.
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Summary
Performing a Process Audit using eAuditor empowers organizations to systematically evaluate whether processes are compliant, efficient, and consistently executed. Through digital checklists, real-time reporting, and CAPA management, eAuditor not only streamlines the audit itself but also ensures findings translate into measurable improvements. Over time, this enhances process reliability, reduces risks, ensures compliance, and strengthens organizational performance through continuous improvement.