The Ask:
A global medical devices company under consent decree for 2 years across two sites with a total of 112 Major findings and 408 Minor findings
- Complaints accounted for 17 of the major findings
- The Complaints handling department were struggling to close off complaints
- Over 1900 open complaints with almost 50% in arrears (backlog) – the oldest complaint being 779 days (over 111 weeks)
- On a daily basis, more complaints were being received than could be closed
The Head of Department could not see any way out other than to recruit
Challenges:
- The organisational structure within the Complaints handling department was flat with handlers taking the “next” complaint – but everyone was “cherry picking” the easier and younger complaints
- The process for Complaints handling was slow and complicated
- The focus from the team was on daily business so backlog never addressed
- Reliance on other stretched departments (RA) for information a bottleneck
- The Department Head was proposing doubling the size of the complaints team
Implications
- FDA findings would never close resulting in fines for non-compliance and risking future growth in their largest market (US)
- Losing the US market would impact market share significantly
- Existing complaints team members were suffering from stress, and absence due to illness in this department was the highest in the business
Objectives
- Split the complaints handling operation into two: daily business and backlog
- Coordinate resources in an effective manner – create new layered structure
- Design a program with measurable to close the findings and reduce arrears
- Redesign the complaints handling process using lean methodology
- Identify the required resources required to support the remediation works
- Address the systemic issues and internal constraints – both the CAPA & the Complaints system were backlogged & non-compliant
The Approach:
- Identified the trend and introduced clear measures and targets to remediate the backlog
- Reorganised resources with clear focus and objectives
- Redesigned the process to significantly reduce the time per complaint closure
Toolkit
- Workplace observations to determine closure methods, skills and rates
- Lean tools and techniques to streamline the Complaints process
- Team structure redefined and implemented
- Clear KPIs, tracking and focus on oldest backlog first
Results and Benefits
- Compliance to ISO 13485, 8.3 and FDA 820.198 restored
- Backlog reduced from ~900 to a manageable 100 with all oldest aged closed
- Daily business team operating to new process and back under control
- Total Complaints reduced from over 1900 to ~ 250
- Eliminated the need to hire any additional staff to the department (stopped 10-hires)
- Clear KPIs brought control to the department and allowed close tracking of progress
- Lean process absorbed some of the tasks from other constrained departments
- Complaints findings completely closed-off
- Team now focusing on achieving 98% closures of all complaints – industry Best Practice