2013/2014 UL EduNeering ComplianceWire Client Benchmarking Study: Quality Metrics Being Used to Drive Continuous Improvement

Transcription

1 2013/2014 UL EduNeering ComplianceWire Client Benchmarking Study: Quality Metrics Being Used to Drive Continuous Improvement UL and the UL logo are trademarks of UL LLC 2013

2 Agenda About our benchmarking study Top learning priorities Quality-based learning maturity model Regulatory activity Our recommendations UL customer (aggregated) statistics

3 UL Practice Leaders Industry Experts Regulatory Agency Agendas Practice Leaders Client Feedback UL Experts New Courses New Programs Influence Product Strategy Thought Leadership

4 About Our Study Sixth annual study Life science quality/compliance trends based on: Customer survey: 85 respondents from >50 companies Analysis of how our 250 customers use our solution Our quarterly partnerships discussions with US FDA Market analysis and global regulatory trends

5 2013 Trends Many companies have advanced along a qualityfocused learning maturity model, in which the emphasis on check the box compliance is shifting to quality and performance metrics; The most-often cited learning priority is now Measuring Training Effectiveness, which provides an opportunity for training organizations to demonstrate relevance to their business partners; The impact of global regulators has resulted in increased numbers of inspections, the drive to improve audit readiness, and the need for consistent, repeatable and scalable training approaches

6 Top Learning Priorities for 2014 Priorities 2014 Priority 2013 Priority Measuring training effectiveness 67% 56% Collecting training data to support the organization's quality or compliance metrics Responding to inspections from global regulatory agencies Improving SOP and policy management Adding risk-based approaches to training programs 66% 59% 51% 46% 46% 52% 46% 26%

7 Do the Priority Trends Tell Us Anything? Learning Priorities 2012 Actual Rank 2013 Actual Rank 2014 Plan Rank Measuring training effectiveness Collecting training data to support the organization's quality or compliance metrics Responding to inspections from global regulatory agencies Improving SOP and policy management Our Takeaway: Global company training programs are advancing on the learning maturity model

8 From Compliance to Performance Stage 1 Goals: Addressing Basic Compliance Issues Moving from Paper to Electronic Records

9 From Compliance to Performance Stage 2 Goals: Align SOPs to Role- Based Curricula Build Qualification Curricula for high-risk job functions

10 From Compliance to Performance Stage 3 Goals: Measure training impact and identify knowledge gaps Add OJT assessments to high-risk operations

11 From Compliance to Performance Stage 4 Goals: Measure impact of training on continuous improvement metrics Demonstrate value of programs on performance and behavior

12 From Compliance to Performance Stage 5 Goal: Leverage data to demonstrate value of quality management to business growth

13 Global Regulatory Authorities are Driving that Maturity Model Since 2009, the FDA has made enforcement and compliance a top priority Since that time, FDA has hired 25% more field inspectors And increased their focus on Non-US inspections and supply chain FDA, MHRA, EMA etc are doing joint inspections and sharing information CDER s Quality Metrics and CDRH Case for Quality programs Shifting emphasis from compliance (check the box) to quality culture 13

14 Inspections on the Rise Audit Body US FDA 65% 57% 77% EMA 9% 22% ISO 30% 31% 37% OSHA 17% 19% 24%

15 As They Inspect, FDA is Finding More 15

16 Training-Related Audit Observations in 2013

17 Did you conduct training to support these Critical-to-Quality (CTQ) initiatives? CTQ % of Respondents CAPA Initiations 60% Audit/Inspection Findings 58% Adverse Events 44% Customer Complaints 41%

18 How Do You Measure Training Effectiveness? Method Used % of Respondents Regular Review of Quality Metrics 61% Quizzes (via Quiz Creator tool) 45% No Formal Measurement System in Place 23% Documenting On-site Observations (via Forms tool) 13%

19 ComplianceWire Activity in 2013 Completion Types Completions in 2013 CICS (Control Documents) 12,991,734 Main Use SOP Management CICS with Quiz Creator 3,855,062 Assessments Offline Events (ILC) 2,997,738 Computer Based Training (CBT) 753,464 Forms and Exams 684,584 In-person Training Regulatory Knowledge On-the-job Training 27 Million Completions in 2013 (18% increase over 2012)

20 Top 10 Pharmaceutical Courses in 2013 Rank Course Title 1 Handling an FDA Inspection 2 Introduction to GMPs 3 Principles of Good Documentation 4 Change Control 5 Orientation to GMP Compliance 6 GMP Principles of SOPs 7 GxPs 8 Part 11: Electronic Records; Electronic Signatures 9 DEA Compliance 10 Operating Room Conduct

21 Top 10 Medical Device GMP Courses in 2013 Rank Course Title 1 Orientation to GMP Compliance 2 Understanding GMPs for Facilities and Equipment 3 Meeting GMP Training Requirements 4 Principles of Auditing 5 Principles of Good Documentation 6 Handling an FDA Inspection 7 Introduction to the Quality System Regulation (QSR) 8 Part 11: Electronic Records; Electronic Signatures 9 Design Control Regulations for Medical Device Manufacturers 10 Quality Systems Inspection Technique (QSIT)

22 Top 10 Corporate Compliance Courses Rank Course Title 1 Global Anti-Bribery 2 AdvaMed Code of Ethics 3 PhRMA Code 4 FCPA: Doing the Right Thing: Anti-Bribery 5 HIPAA: General Awareness 6 Diversity in the Workplace 7 Violence in the Workplace 8 Substance Abuse 9 Code of Business Conduct 10 and Corporate Communications

23 Top 10 EH&S Courses Rank Course Title 1 Hazard Communication 2 Bloodborne Pathogens -- General Industry 3 Slips, Trips, and Falls 4 Personal Protective Equipment 5 Fire Extinguishers 6 Electrical Safety 7 Hearing Conservation 8 Ergonomics: Body Mechanics and Fitness 9 Access to Employee Exposure and Medical Records 10 Lockout/Tagout -- Affected

24 Thank You Questions?