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Project

Managed risk and compliance remediation of multiple FDA-certified sites for production of sterilized products

Read Time
2 minute read

Situation

  • The company had received poor inspection reports and warning letters from the authorities and needed to remediate multiple FDA-certified sites
  • Genioo was asked to run a remediation program to mitigate the critical situation

Solution

  • Genioo established a large cross-site, cross-functional remediation program with over 30 projects in eight workstreams focused on transparency and progress tracking
  • The program ran over an 18 month period to fundamentally change processes, controls and employee behaviours focused on quality, closely managing culture change through all layers of a production site

Impact

  • The remediation efforts led to great subsequent FDA inspection audits, where results showed great quality culture exhibited on site
  • Key success factors included the rigorous tracking of KPIs supported by an active change culture leading to a greatly improved focus on quality laying out the fundament for further quality enhancements and a culture of continuous improvement of quality performance