Risk Management

All major industries are increasingly focusing on risk based approach integrated to the decision making and management review process. Our Risk Management module integrates such structured investigational approach, identification and analysis of root cause, failure mode and effect (FMEA) to categorize the criticality and thus helping management to prioritize the corrective and preventive action of deviation in a timely manner without adversely affecting the product safety, quality and /or efficacy.

Specifically in pharmaceutical industry, regulatory authorities such as FDA, TGA, MHRA, are advocating the use of risk management when it comes to any potential hazard to public health, scientific and regulatory issues. FDA demands risk management system to be defined by industries in as early as their Planning Process, Design Phase, Manufacturing Processes, and Delivery as well as Validation stage.

Risk Management Module primarily focuses on the evaluation of the risk to the quality and based on scientific knowledge that ultimately focuses on safety. Our Risk Management Module deals with, mainly,

• Failure Mode Effect Analysis
• Failure Mode, Effects and Criticality Analysis
• Fault Tree Analysis
• Preliminary Hazard Analysis
• Hazard Analysis and Critical control Points
• Hazard Operability Analysis
• Preliminary Hazard Analysis
• Risk Ranking and Filtering
• Supporting Statistical Tool

We at LeanRP possess years of strong business and regulatory expertise in both operational excellence and total quality management. We focus on designing lean risk optimized and controlled workflows which aim at maintaining high quality through cost competitive, risk mitigated lean processes and systems.