Consent Decree Remediation

Consent Decree Remediation

Project Teams
Major Findings
Minor Findings
Global Locations


  • 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 and the FDA
  • Identify the required resources required to support the remediation works
  • Address the systemic issues – CAPA and complaints system backlogged and non-compliant

The Challenges

A global medical devices company under consent decree for two years across two sites. The organisation had engaged with a number of contractors, but the 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 and status report templates
  • Progress and 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 organisation’s largest sales income market

The Trinzo Apex Approach to Managing an MDR Project

  • Base the initial state
  • Build structure
  • Launch – move to planning
  • 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

Nine program teams (two design teams) developed based on the 15 Subparts – 21 CFR 820

Success-enabling systems learned:

  • CAPA system
  • Complaints management system
  • Change control system
  • Non-conformances
  • NVA steps removed, processes refined

Project Teams


Program structure designed and implemented based on 21 CFR 820

Easy, live tracking and management of the remediation program

Critical processes – backlogs 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 and management of the remediation program