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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)

 

 

Results and Benefits

  • CAPA process related findings successfully closed
  • Easy, live tracking and management of CAPAs through the CAPA dashboard
  • Process improvements driven through the effective implementation of CAPAs
  • CAPA Review Board empowered and resourced to support CAPA owners
  • Timely closure of CAPAs increased to above 95%
  • CAPA owners supported through periodic CAPA Review Board meetings
  • Effective CAPA metrics and reporting providing clarity to the organisation
  • Senior management informed on CAPA progress and risks through the dashboard
  • CAPA cultural shift – CAPA now viewed as a business improvement tool

Challenges:

  • 16 Findings relating to the CAPA process have been issued in the past three years
  • The organisation is under FDA consent decree
  • 267 open CAPAs exist within the CAPA system
  • CAPA forms are not fully aligned to 21 CFR 820
  • On-time CAPA closure is below 30%
  • Findings relate to:
    • CAPAs not addressed in a timely manner
    • CAPA tracking
    • Adherence to the CAPA process
    • Handling of corrective actions
    • Effectiveness of corrective actions

Implications

  • Risk of non-compliance, further findings result in FDA fines and potential removal of product from the market
  • Potential to implement much needed improvements and remediation at risk

Objectives

  • Potential to implement much needed improvements and remediation at risk structure and the metrics used to track manage and report
  • Develop clear metrics and KPIs for the CAPA process
  • Define clear triggers and escalation paths
  • Develop the correct governance and tools to support effective CAPA management

The Approach:

  • Map the current CAPA process and identify gaps and areas of improvement
  • Build a CAPA toolkit based on industry best practice
  • CAPA management team installed & empowered to support the organisation CAPAs
  • CAPA findings addressed and closed
  • CAPA process audited for compliance

Toolkit

  • CRB (CAPA Review Board) Installed
  • Roles & responsibilities defined
  • CAPA management metrics & KPIs
  • Escalation triggers developed
  • CAPA dashboard developed & launched
  • 4 Square CAPA reporting template
  • Effectivity tracking to closure
  • CAPA integrated into the business process
  • Implementation of trend analysis
  • CAPA training rolled out