Quality Risk Management Services
- QRM Program Design and Implementation: Development of site-wide or project-specific QRM frameworks aligned with Regulatory Agency and Notified Body expectations.
- Facilitation of QRM Exercises: Hands-on support in applying risk tools such as FMEA, FMECA, HACCP, Fault Tree Analysis, HAZOP and Risk Ranking & Filtering for processes, systems, or deviations.
- Risk Register Creation and Maintenance: Establishment of centralized, auditable risk registers to track, prioritize, and communicate risks across functions.
- QRM Training for Cross-Functional Teams: Custom training sessions for QA, manufacturing, engineering, and R&D teams to ensure consistent understanding and application of risk principles.
- Post-Audit or Post-Incident Risk Reviews: Structured assessments to identify root causes, reassess controls, and integrate risk-based decision-making in CAPA planning.