Transcription of Quality Risk Management
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Quality Risk Management
Quality Risk Management Transforming Quality into a Fundamentally New Approach These slides and the content of this presentation represent the work and opinions of the author and do not constitute official positions of Quality Risk Management Associates, LLC or any other organization. Graphics, figures and data contained herein are for illustrative purposes and are not representative of actual data. Objectives of this Presentation Transforming our approach to Quality How QRM will help us QRM Concepts QA/QC Governance Model Benefits of QRM. 2. Quality is managed between three constituencies . Management , QC and QA. The Quality Management Triangle Quality governance as part of Management Mgmt oversight Oversight Quality Quality Assurance Control (QA) (QC). Quality control built into Independent Quality business processes assurance through audits 3. What is a risk and what is Quality Risk Management ? Key Definitions Risk is defined as the combination of the probability of Risk occurrence of harm and the severity of that harm Quality Risk Management (QRM) is a systematic process consisting of Risk identification Risk assessment Quality Risk Risk mitigation Management Risk avoidance/reduction (QRM) Communication QRM supports better decision making by providing greater insight into risks and their impacts and helps to make proactive decisions 4.
• Q10 Pharmaceutical Quality Systems • May & June 2006 – ICH guidance documents recommended for adoption • Q9 – Quality Risk Management • Q8 – Pharmaceutical Development • Originally manufacturing focused but now being applied to the full development process • ISO 31000 (2009) – Risk Management Principles and Guidelines
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