11 Aug 2020

Consent Decree Remediation


  • 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 Challenges

A global medical devices company under consent decree for 2 years across two sites. 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 by many. Resources across the organisation were heavily loaded with day to day operations

A Common Approach

  • 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

Project Implications

  • 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

The Trinzo Apex Approach to
Managing an MDR Project

  • Base the Initial State
  • Build Structure
  • Launch – Move to Planing
  • Work Package Deliverables
  • Work Breakdown Structures
  • Detailed Project Plan
  • Resource Plan
  • Stakeholder Analysis
  • Sign off Charter
  • All project teams move into execution
  • Project Teams Report on
  • Progress

Project Approach

9 Program teams (2 Design teams) developed based on the 15 Subparts – 21 CFR 820

Success Enabling Systems Leaned:

  • CAPA system
  • Complaints Mgmt. System
  • Change Control System
  • Nonconformances
  • NVA steps removed processes refined

Project Teams


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

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