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
