Quality Risk Management (QRM)2.4.1

Quality Risk Management (QRM)2.4.1 Brief Description of QRM Methodologies UsedBasic risk management facilitation methods (flowcharts, checklist etc.):• Failure Mode Effects Analysis (FMEA); • Fault Tree Analysis (FTA); • Hazard Analysis and Critical Control Points (HACCP); • Hazard Operability Analysis (HAZOP); • Preliminary Hazard Analysis (PHA); • Risk ranking and filtering; and • Supporting statistical tools. It might be appropriate to adapt these tools for use in specific areas pertaining to the possible impact to product quality. Quality risk management methods and the supporting statistical tools can be used in combination (e.g., Probabilistic Risk Assessment). Combined use provides flexibility that can facilitate the application of quality risk management principles. The degree of rigor and formality of quality risk management should reflect available knowledge and be commensurate with the complexity and/ or criticality of the issue to be addressed. 2.4.2 Brief description of scope of QRM usedPotential applications for QRM during our routine work are below but not limited to: Comprehensive quality management Change control/management Quality deficiencies management Deviation management Continual improvement Routine activities Introduction of new product, new process or new equipment Qualification and management of facility/equipment/utilities Supplier management Production management Validation management