Background
A Fortune 500 medical device manufacturer identified the necessary updates needed to ensure their Quality Management System met state of the art compliance with EN ISO 14971:2019 and pending EU Medical Device Regulations (EU MDR).
The company indicated 43 product families that required risk management file conversion to the state of the art and 45 that required Post Market Surveillance Plan generation. These products were manufactured at 6 different global manufacturing sites. The client indicated that the following documents would require updates per the Quality Management System changes:
- Risk Management Plan
- Hazard Analysis
- Task Analysis
- Design FMEA
- Risk Management Report
- Post Market Surveillance Plan
Approach and Solution
The ECI team of twelve quality engineers led by a senior project manager was engaged to support the risk management file remediation to the newly updated Quality Management System documents. The first task was to complete an impact assessment on the necessary steps to complete the risk management file remediation. This assessment identified additional Design History File documents impacted by the changes, namely:
- Design Output Summary Record
- Risk Thresholds
- Material Controls & Risk Assessment
- DV Assessment Matrix/Report
- Usability Assessment
- Process Failure Mode Effect Analysis Updates (Design Failure Mode Effect Analysis/Hazard Analysis update review with manufacturing site)
- Process Validation Remediation
- Obsoletion of historic Risk Management documents
- Design change assessments of documentation updates
Comprehensive Action
Some of the products within the scope of the review crossed multiple divisions of the company and not all divisions were prepared to implement Risk Management File updates immediately. Therefore, it was decided to execute the updates using a two-phase approach.
- Phase One: Create draft versions of the Risk Management File to highlight the changes necessary to comply with the QMS and regulatory standards. The manufacturing sites would use this information to plan process updates and/or necessary validations.
- Phase Two: Implement the updated RMF with the new processes/validations in place.
Results
This multi-year effort spanned from July 2019 to May 2023.
Phase I required over 190 Change Notices to pre-release versions of the necessary Risk Management File documentation.
Phase II culminated with over 310 new documents being implemented across all 45 product families.
The team required for this project included both ECI and support from client resources for drafting, reviewing, and approving the multi-phase documentation review and implementation. In the end, the client identified the efforts put forth by the ECI Project Manager, team leads and personnel as "Herculean!"
.svg.png){kind=logo}