Explic8 Consultants Help Medical Device Company to Avert FDA Penalties and Protect Market Position

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, Minor Finding:408. All business areas Impacted

Challenges:

  • The organisation had engaged with a number of contractors, structure was fragmenteda 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 by 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 program structure to facilitate effective remediation
  • Coordinate resources in an effective manner
  • Design a program 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

remediation study

Success Enabling Systems Leaned:

  1. CAPA system
  2. Complaints Mgmt. System
  3. Change Control System
  4. Nonconformances
  5. NVA steps removed processes refined

Toolkit

  • Lean tools and techniques from VSM – Utilised to address critical processes
  • Workload balancing for team scope development
  • Program Management Team installed
  • Work Breakdown Structures & Status Report Templates
  • Progress & Compliance Tracking Database

Results and Benefits

  • Program structure designed & implemented based on 21 CFR 820
  • Easy, live tracking and management of the remediation program
  • 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 program management team
  • Internal team – Complete ownership & management of the remediation program