The Ask:
A global medical devices company under consent decree for 2 years across two sites
Findings:
- FDA Audit in 2013 (21 483s were issued)
- Quintiles audit in 2015 (91 Findings were issued)
- Also included in the scope were Dekra & TGA findings
Summary: 112 Major Findings, 408 Minor Findings. All business areas Impacted
Results and Benefits
- Programme structure designed & implemented based on 21 CFR 820
- Easy, live tracking and management of the remediation programme
- Critical processes – back logs removed and operating effectively
- Project teams initiated, planned, and moved into successful execution
- Project team members engaged and motivated – 191 Team members
- Bi-Monthly communications with the FDA, format designed and implemented
- Effective project metrics and reporting providing clarity to the organisation
- Project tracking ahead of target – Transition of the programme management team
- Internal team – Complete ownership & management of the remediation programme
Challenges:
- The organisation had engaged with a number of contractors, structure was fragmented and not yielding results
- The systemic issues which had led to many of the findings were directly preventing the organisation from addressing the findings effectively
- The organisation had been living with these findings for the past four years – motivation was low and successful remediation seemed unlikely to many
- Resources across the organisation were heavily loaded with day to day operations
Implication
- Risk to patients due to non-compliant systems
- Fines for non-compliance from the FDA
- Risk of losing market share – Current Market Leader
- +$400 Million in annual sales at risk
- Risk to future growth in the organisations largest sales income market
Objective
- Design a programme structure to facilitate effective remediation
- Coordinate resources in an effective manner
- Design a programme with measurable outputs and milestones
- Develop a communications plan and format between the organisation & the FDA
- Identify the required resources required to support the remediation works
- Address the systemic issues – CAPA & Complaints system backlogged & non-compliant
The Approach:
- 9 Program teams (2 Design teams) developed based on the 15 Subparts – 21 CFR 820
Success Enabling Systems Leaned:
- CAPA system
- Complaints Management System
- Change Control System
- Nonconformances
- NVA steps removed processes refined
Toolkit
- Lean tools and techniques from VSM – Utilised to address critical processes
- Workload balancing for team scope development
- Programme Management Team installed
- Work Breakdown Structures & Status Report Templates
- Progress & Compliance Tracking Database