Quality Risk Management (QRM)

Establish a defensible, repeatable QRM framework that prioritizes risk reduction across product, process and supplier dimensions. We align with ICH Q9 / ISO 14971 (and HACCP where applicable) to deliver FMEA-based prioritization, control plans, and eQMS-integrated monitoring that drive risk-based decisions.

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Key offerings

• Risk identification, scoring and prioritization (5×5 or equivalent)

• Process and product FMEAs, control plan and CCP definition

• Supplier risk assessment and incoming-material criticality analysis

• Risk-triggered CAPA and KPI dashboards integrated into eQMS
   

Typical deliverables

• Prioritized risk register with owners, mitigations and review cadence

• FMEA reports and recommended control plans for critical processes

• eQMS integration plan for risk items, KPIs and alerting rules

• Training module and governance schedule for periodic risk review
   

Client impact / outcomes

• Focused allocation of resources to highest-impact risks

• Faster response to excursions and fewer reactive emergency CAPAs

• Better evidence for regulators that risk is identified and controlled