Challenge: Medical Device manufacturer with software components facing FDA inspection with serious quality issues and a pile of overdue CAPAs
Result: With the help of StingOrg’s ad interim leadership, coaching, and both vertical and horizontal moderations the company obtained:
- A 100% clearance of the overdue CAPA backlog
- Zero CAPA-related findings after FDA inspection
- A sustainable and effective Complaint and CAPA workflow
This meant improved product quality, promotions for stakeholders, happy teams – and cake (yes, it was brought by management because now they could sleep on both ears)
The company was a listed multinational conglomerate, a manufacturer of diagnostic and therapeutic devices with a software component. The local team consisted of about 50 people.
The atmosphere was negative. Due to previous incidents with patient safety and unresolved customer complaints in the US market, the company was under high scrutiny by the European Health authorities and Notified bodies and was expecting an inspection by the FDA.
Complaint investigations were lacking clear problem descriptions, adequate impact assessments, root-cause analyses and evidence for conclusions.
CAPAs had been started for almost each customer complaint – without consulting the engineering department. Due to a lack of ownership and steering, this consistent supply of new CAPAs had resulted in a 120-sized backlog, each CAPA worth approx. 40 hours of work, summing up to 600 full days.
Internal attempts to improve the CAPA workflow encountered a lot of resistance because the major stakeholder was involved after unilateral decisions were made. In addition, arguments had arisen between internal team members, impeding task progress.
Department heads were not aligned: viewpoints ranged from “I really don’t see the problem here” to “we need to get help asap”. Some were really skeptical and reluctant about reaching out for external help. However – without a drastic change – the company would face warning letters, reputation damage and serious losses.
The QARA department contacted StingOrg because they knew we had addressed compliance issues before. After we had confronted the team with the risk they faced and shown them a way out – luckily, we could leverage the support of the CEO and Head of Operations – we received full support and took these actions:
- Established a CAPA task force per department, each with a designated head
- Created a CAPA decision board with the department heads
- Conducted training sessions
- Coached the existing CAPA team and department heads
- Established transparency by showing the situation as-is & to-be, plan forward, progress, and timeline for resolution
- Conducted in-person reporting each week in front of the whole group to show the progress made during the week, do a forecast and celebrate successes
The StingOrg team consisted of one lead coach involved in discussions with management – if needed in front of the whole team – and two consultants who took care of training, coaching and individual assistance.
Results and benefits
Sixteen months of hard team work, collaborations and discussions resulted in:
- Handling customer complaints in time with satisfying answers towards customers and all high risk issues under control
- All overdue CAPAs closed and open cases reduced from 120 to 10. Open cases were clear and easy to handle
- Established and implemented an improved Complaint and CAPA procedure and workflow, which has lead to a sustainable way of working to avoid going back to the situation how it was
- Creation of an internal CAPA team with employees coached to a level at which they were strong and confident enough to steer CAPA management
- Cost savings estimated at €12 million because of correct and realistic development of new products
- Well understood regulatory requirements and importance of CAPA by the team
- Distribution of responsibility across the entire team
- Growth opportunities for the team members leading to job promotions
- Secured reputation due to successful FDA inspection with no findings recorded on the CAPA system. The new system was even regarded as a role model by the authorities.
In summary, the team had levelled up in many professional as well as personal aspects. This success was celebrated all together in a companywide event with talks and cake, even brought by management.
StingOrg’s engagement with this company in the Medical Devices industry resulted in transformative changes, eliminating CAPA backlogs, enhancing operational efficiency, and establishing a reputation as a compliance role model. It illustrates the effectiveness of our approach to quality assurance and process optimization and shows how we help create organizations that improve themselves.
If you find your business or team in a similar situation, just know you are not alone. You’re neither alone in solving your challenges. Get in touch with us to explore how we can help your organization to improve itself.
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