🇦🇪UAE

تكاليف إعادة العمل والتعويضات بسبب فشل الجودة (Rework & Compensation Costs from Quality Failures)

2 verified sources

Definition

Under ISO 13485:2016 and DoH MDR requirements, manufacturers must conduct root cause analysis and implement corrective/preventive actions (CAPA). Manual complaint evaluation delays identification of quality defects, allowing faulty devices to remain in use, causing additional incidents, patient injury claims, and expensive recalls.

Key Findings

  • Financial Impact: AED 100,000–500,000 annually (device recall logistics, patient compensation, rework, liability insurance claims)
  • Frequency: Per CAPA cycle (typically 2–8 CAPAs/year; each CAPA costs 1,000–10,000 AED if involves recall)
  • Root Cause: Delayed complaint investigation, manual RCA documentation, slow CAPA execution, inadequate complaint tracking

Why This Matters

This pain point represents a significant opportunity for B2B solutions targeting Medical Equipment Manufacturing.

Affected Stakeholders

Quality Manager, Product Engineer, Supply Chain/Logistics, Legal/Risk Compliance

Deep Analysis (Premium)

Financial Impact

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Current Workarounds

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Methodology & Sources

Data collected via OSINT from regulatory filings, industry audits, and verified case studies.

Evidence Sources:

Related Business Risks

تأخير تقارير الأحداث الضائرة والغرامات التنظيمية (Delayed Adverse Event Reporting & Regulatory Fines)

AED 50,000–200,000 annually (estimated based on typical DoH penalties for non-compliance + operational recovery costs)

خسارة الإنتاجية بسبب معالجة الشكاوى اليدوية (Capacity Loss from Manual Complaint Processing)

AED 30,000–80,000 annually (200–400 FTE hours/year at AED 150–200/hour loaded cost for QA staff)

عدم الامتثال للوائح المراقبة اللاحقة للسوق (Post-Market Surveillance Non-Compliance Penalties)

AED 50,000–300,000 (direct regulatory penalties + legal defense + operational disruption + potential license suspension impact)

أخطاء القرار بسبب نقص البيانات (Decision Errors from Incomplete Complaint Analytics)

AED 40,000–150,000 annually (estimated opportunity cost from delayed supplier corrective actions, misdirected engineering resources, and preventable repeat failures)

فقدان العملاء بسبب بطء معالجة الشكاوى (Customer Churn from Slow Complaint Resolution)

AED 200,000–1,000,000 annually (estimated 2–5% revenue churn due to lost customer repeat orders and account downsizing)

تجاوز التكاليف

40-80 hours/month overtime at AED 200/hr; AED 20,000+ Nafis non-compliance fees.

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