Case for Quality Initiative Industry Perspective Monica J. Wilkins April 30, 2013

2 Quality Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives. - William A. Foster

3 Industry Challenges Risk determination and interpretation Too many audits or inspections Increasing costs diminishing returns Supplier management Data collection and analysis

4 Industry Challenges Alignment of risk identification and interpretation Regulatory body differences Understanding of product and processes Determination of risk for events, issues or failures Maintaining risk documentation throughout the product lifecycle Focus on the right priorities

5 Industry Challenges Too many audits and inspections Resources focused on supporting audits Audits from many sources Findings that may not be significant Usually not risk based

6 Industry Challenges Increasing costs with diminishing returns Operate efficiently Maximize resources Develop the right products Focus on the right initiatives Effective corrective actions

7 Industry Challenges Supplier Management Prioritization on risk Monitoring Change management Supply chain integrity Material or component characterization

8 Industry Challenges Data collection and analysis Systems and processes Establishment of appropriate metrics Availability of external data and information Analysis and interpretation of internal and external data Regulatory bodies focus on lagging indicators Improve predictive measures

9 FDA Initiative Improve on risk based approach Find a way to collaborate and accept the inspection or audit reports of others Focus on systemic issues Improve on the knowledge of products and processes

10 FDA Initiative Clarify the type and use of post-market surveillance data available on FDA systems Improve on outcomes through Confirming the supporting data Allowing for communication with industry when viewpoints differ Reviewing additional data

11 FDA Initiative Improve enforcement specificity on highest risk areas Utilize strengths to communicate gaps in industry’s approach to quality

12 Questions or Comments… THANK YOU!