Chapter 5 — Quality Assurance (QA)

Chapter 5 — Quality Assurance (QA)

5.1 Policy Statement

ARmed for Medical Training and Consultancy – LLC – OP.C shall maintain a comprehensive Quality Assurance (QA) system to monitor, evaluate, and continuously improve all CME/CPD activities. QA ensures compliance with DOH CME/CPD Quality Assurance Manual requirements, protects learners, and guarantees that education remains free from commercial bias, scientifically accurate, and outcome driven.

Reference: DOH mandates that accredited providers implement robust internal QA systems, conduct audits, and demonstrate continuous quality improvement through documented CAPA (Corrective and Preventive Actions) processes.

5.2 Rationale

  • DOH Quality Assurance Manual: requires providers to adopt policies for auditing, compliance monitoring, and reporting.
  • Activity Development Guide: emphasizes evaluation of activities for measurable impact on competence, performance, and outcomes, which feeds into QA systems.
  • QA ensures that ARmed UAE activities are not only compliant but also progressively aligned with Abu Dhabi healthcare priorities and global benchmarks.

5.3 QA Objectives

  1. Ensure compliance with DOH CME/CPD standards.
  2. Maintain independence and integrity in all activities.
  3. Validate the effectiveness of educational activities.
  4. Identify risks and prevent non-compliance.
  5. Drive Continuous Quality Improvement (CQI) through evidence-based changes.

5.4 QA Structure and Responsibilities

  • Scientific Director: Accountable for QA program oversight.
  • QA Officer: Responsible for implementing audits, maintaining CAPA logs, and reporting findings.
  • Oversight Committee: Reviews QA reports, approves corrective actions, and ensures system-level improvements.
  • CME/CPD Coordinator: Supports QA with documentation, records management, and follow-up actions.

5.5 QA Processes

5.5.1 Internal Audits

  • Conducted biannually.
  • Cover at least 25% of activities delivered in the review period.
  • Focus areas:
    • Needs assessment documentation.
    • Gap analysis linkage to objectives.
    • COI disclosures and mitigation records.
    • Attendance verification systems.
    • Assessment and evaluation data.
    • Certificate accuracy and credit calculation.
  • Findings documented in Audit Report Template.

 

5.5.2 Spot Checks

  • Random checks during live activities to observe:
    • Faculty compliance with approved slides.
    • Independence from commercial bias.
    • Attendance tracking accuracy.

5.5.3 Learner Feedback Monitoring

  • Post-activity surveys analyzed for red flags (e.g., reports of bias, low satisfaction, technical issues).
  • Patterns identified and escalated to Oversight Committee.

5.6 Corrective and Preventive Actions (CAPA)

5.6.1 CAPA Process

  1. Identify issue (from audit, learner feedback, or DOH inspection).
  2. Log in CAPA Register.
  3. Root Cause Analysis conducted by QA Officer.
  4. Corrective Action: fix current non-compliance.
  5. Preventive Action: system-level change to avoid recurrence.
  6. Effectiveness Check: follow-up audit within 3 months.

5.6.2 Examples

  • Issue: Missing COI disclosure → Action: mandatory pre-activity checklist, automated reminders.
  • Issue: Low learner engagement → Action: introduce simulation-based elements.
  • Issue: Late DOH reporting → Action: automated 30-day deadline tracker.

5.7 Risk Management in QA

  • Risk Identification: (e.g., faculty with unresolved COI, inadequate LMS time tracking).
  • Risk Matrix: categorize by likelihood and impact (Low–Medium–High).
  • Mitigation: assign preventive strategies (extra faculty training, IT controls, double verification of attendance).

5.8 QA Reporting

  • Quarterly QA Reports: submitted to Oversight Committee; include audits, CAPA status, learner feedback analysis.
  • Annual QA Report: incorporated into the CME/CPD Annual Report for DOH submission, including:
    • Number of activities audited.
    • Common findings.
    • CAPA effectiveness rates.
    • Lessons learned and systemic improvements.

5.9 Documentation and Retention

  • All QA records (audit reports, CAPA logs, QA meeting minutes, corrective actions) are retained for 6 years.
  • Dual storage system: secure electronic repository + hard copies.
  • DOH auditors must be given full access upon request.

 

 

 

5.10 Continuous Quality Improvement (CQI)

  • QA findings feed into planning and implementation cycles (Chapter 2 & 3).
  • Trends monitored annually to improve:
    • Faculty performance.
    • Learning design (e.g., more interactive methods).
    • Learner outcomes.
  • Benchmarking against international CME/CPD standards (ACCME).
  • Documented in CQI section of the Annual Report and discussed in Oversight Committee meetings.

5.11 Templates & Tools (Appendices)

  • CAPA Log.
  • Internal Audit Checklist.
  • Document Control Metadata.
  • QA Risk Matrix Template.
  • QA Quarterly & Annual Report Formats.

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