Quality Risk Management Presentation

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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

Quality is managed between three constituencies – Management, QC and QA
The Quality Management Triangle

Mgmt Oversight

Quality governance as part of management oversight

“Independent” quality assurance through audits

Quality Assurance

Quality Control

Quality control built into business processes


What is a risk and what is Quality Risk Management?
Key Definitions

Quality Risk Management

 Risk is defined as the combination of the probability of occurrence of harm and the severity of that harm
 Quality Risk Management (QRM) is a systematic process consisting of – Risk identification – Risk assessment – Risk mitigation – Risk avoidance/reduction – Communication
 QRM supports better decision making by providing greater insight into risks and their impacts and helps to make proactive decisions

The objective of quality risk management is to ensure safety of patients and integrity of data

Objectives of Quality Risk Management in GCP & Pharmacovigilance

Core Objectives

Safety Processes
in all clinical trials and post-marketing surveillance activities
Data Integrity
of data created in these trials and activities

Derived Objectives

SOP and Regulatory Compliance

Robust processes

Consistency across all entities



Clear need to change our approach to Quality
Higher expectations of Quality across industry
Internal • Need for early detection of critical quality issues • Need for transparency and prioritization of quality risks • Limitations of current auditing approach, calling for range of new
“instruments” • Need to optimize resources in teams and functions
External • Increasing regulatory pressure – More inspections – Inspections in new territories – New approach to inspections: From trial/clinic-centered to systems review • Growing media scrutiny of compliance, or lack thereof: Compliance is sustainability factor

Major challenge #1: The numbers are against us Audits cover only about 2% of clinical related activities

Focus of Risk Mgmt
Inaccurate incomplete
Safety Processes
Patient Safety
Data Integrity

GCP & Pharmacovigilance Entities


101 HQ functions
102 Affiliates

CROs Labs Manuf . Others

103 Partners

104 Trial Centers

Audit Coverage
250-300 Audits ~20,000 Entities
= < 2% Audit Coverage


Major challenge #2: Rising rate of regulatory inspections
Early detection of risk is essential

Num ber of Inspections

35 30 25 20 15 10
5 0
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

Local Authority Inspection - USA (FDA) Local Authority Inspection - Japan Local Authority Inspection - France Other Inspections
Source: Health Authority Analyses (Last update December 21st, 2007)

FDA Foreign Inspection Local Authority Inspection - UK Local Authority Inspection - Germany

The FDA encourages Pharma Industry to develop and implement a prospective Quality Risk Management system …
‘Quality Risk Management Initiatives at FDA’
 FDA has the mandate to ensure regulatory compliance, but regulations – Set only the floor not the ceiling for quality – Should support risk based approaches
 Quality management always should keep the big picture in mind – Analyzing the significance/ impact of quality deviations/ risks – Detecting and correcting multi-system failures first
 Recommended approach is to develop and implement a “quality system, structured on risk identification and management, that is prospectively shared with and agreed to by FDA” – To “utilize the information that we routinely obtain during monitoring/ auditing/ inspection to improve quality” – To “conduct signal detection and follow-up”
9 Source: Adapted from Presentation of David Lepay, Senior Advisor for Clinical Science (FDA), at DIA: 43rd Annual Meeting, Atlanta 2007

Changes in the regulatory environment
• August 2013 • EMA Reflection Paper on Risk-Based Quality Management in Clinical Trials • FDA Guidance – Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring
• April 2009 • 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 • Generic Risk Management Guidelines • Applicable to any public, private or community enterprise
• EU GMP - Eudralex Volume 4, Annex 20, Quality Risk Management (2008) • Systematic approach to QRM for compliance with GMP and other quality requirements
• ISO 14971 (2007) - Application Of Risk Management To Medical Devices • Identify hazards associated with medical devices including in vitro diagnostics • To control the risks and monitor effectiveness 10

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Quality Risk Management Presentation