Complaint and adverse event management is a critical business process for life sciences companies.
Regulatory authorities can and will shut down a business or impose significant restrictions (for example, delaying product introductions) if they determine that good post-market surveillance practices are not in place. If regulatory authorities find significant deficiencies, the timeframe for remediation and sanction lifting can extend to years. These best practices will ensure that your complaint and adverse event program is a success.
1. Ensure business awareness and commitment exists at the right level.
When embarking on a project to streamline or improve your complaint and adverse event process, it’s critical to have clarity and buy-in from top management and critical stakeholders on the problem, its priority, cost, estimated duration, and resources required. Document the key results to be accomplished (improved metrics and description of what success will look like) along with cost estimates, resource requirements, and timeframes.
If awareness and commitment by senior management on the problem and how to address it does not exist, bring in a senior consultant (not representing a system supplier) to facilitate recognition, prioritization, cost estimates, and assist with buy-in.
2. Determine the driving need for this project (begin with the end in mind).
Here are the major pain points or opportunities we often see apply to complaint and adverse event management.
- Compliance concerns like the difficulty and inability to meet internal metrics and/or regulatory requirements for processing complaints/adverse events (i.e., growing or overwhelming backlog, late reporting)
- Inconsistent data coding and data capture like too much content in text fields hinders the analysis
- The need to streamline the process is very labor-intensive, too long to process, or just too overwhelming
- The need for better data standardization and data capture to facilitate analysis and ensure accurate reporting lack prioritization
- Management needs a better system or tool for monitoring workflow volume, status, and aging
- The need to automate Medical Device Report (MDR) submissions to FDA or regulatory authorities
- Complaint and adverse event handling lack process or system standardization and there is a need to streamline multiple systems or databases to a single, enterprise system for visibility and compliance improvement
3. Define the current situation, issues, and opportunities.
Conduct and document an analysis of the ‘as-is state’ for the current complaint/adverse event system including:
- Process flow-chart
- Activity volume, aging, processing time range, and average metrics for critical activities
- Staffing levels and activity and volume metrics by staff
- Key Performance Indicators (KPIs)
- KPI actuals vs. plan
- Compliance requirements and performance to compliance
- Issue and opportunity identification
If you don’t have the internal staff with the expertise and tools (or time) to do the analysis, engage a knowledgeable consultant to provide guidance and assistance.
4. Thoroughly analyze the required data elements.
If you are converting from an existing system (or paper system), the new system will have different data structures, data coding, and required fields. Embrace this reality and don’t underestimate the effort, expense, and benefit of extensive data review and clean-up before data migration (i.e., garbage in/garbage out). It’s essential to address critical missing or inaccurate data (country codes, incorrect/missing zip codes, addresses, etc.) and fix it in the existing system before data migration. It’s also important to determine where you have duplicate records for the same customer, hospital, person, etc. in the existing system due to name/address misspellings or whatever reason and develop a strategy and plan to consolidate or link those records when converted to the new system. These fixes often need to occur as part of the data migration process.
5. Define the parameters around the data migration effort.
If you are moving from an existing system, you will probably have a lot of data that needs to be migrated and it probably will not be practical to enter all of it to the new system manually. It may be feasible (and best) to enter ‘open/active’ complaint/adverse event records, but it often isn’t possible to manually enter closed or historical records. For closed/historical data, the volume may preclude manual conversion, in which case automated data conversion using ETL (extract, transform, and load) software programs must be developed, tested, validated and used. Don’t underestimate the importance of analyzing and thoroughly understanding your data. It’s important to know where data can simply be copied from one system to another (i.e., addresses) and where data needs to be transformed using simple or complex rules (i.e., codes in the old system need to convert to different codes in the new system). Writing, testing, and validating the ETL programs (especially transformation logic) is critical along with multiple test loads and reconciliations to identify errors and additional data clean-up.
6. Understanding how much historical data is required.
How much historical data will you convert? Older data entered to different standards, may have more issues and clean-up requirements. It may not be possible, necessary, or practical to load data before a certain point to the new system. The value of that data may be less because it relates to older product versions. Regulatory authorities have different look-back requirements (i.e., ‘x’ number of years) and loading historical records beyond the look-back requirement may not be wise or desirable. Lastly, some older data may reside only in folders or hard copy requiring manual review, re-coding, and manual keying for upload. Think critically about what data requires conversion.
7. Incorporating automation in-take from additional sources.
Do you need the ability to automatically intake complaints and adverse events from more sources (i.e., email messages, web interfaces, mobile apps, social media, etc.)? This should be a consideration in your upfront strategy and ensure those requirements are built into your overall handling process.
8. Identifying process improvements or digital transformation efforts that can drive scalable efficiencies.
New system implementations provide the opportunity to significantly improve operations and outcomes like processing time and cost, compliance, data analytics/trend spotting, product improvements, patient safety, and cost reduction. Don’t make the mistake of just automating your current workflows ‘as is’ without careful consideration of the future quality state need. Take the opportunity to design a better process and leverage the essential capabilities enabled by the new system. Be aware that most 3rd party vendors are focused on installing the system and helping you to get it implemented ASAP. They are not incentivized or particularly skilled in assisting you with process redesign. Consider adding a resource trained and knowledgeable on goal-focused process improvement, redesign, and more wholistic enterprise quality management solutions, which can help you leverage higher value out of a new system for more than point solutions like NCs or complaints.
9. Assessing your availability of experienced internal staff to ensure success.
Significant process improvement and real transformation projects are not something most companies do routinely or know how to do well. Consider engaging a consultant to lead and/or provide the tools and staff for some aspects of this mission-critical project in areas such as:
- Planning, selling, and evangelizing the project
- Assisting with system and vendor selection
- Project planning and project management
- GxP Validation
Whether you need to outsource your entire complaint and adverse event processing or just get caught up with your backlog, you have multiple ways to achieve your goals with a trusted, outsourced vendor, like USDM.
10. Ensuring your complaints are re-coded in preparation for EU MDR.
With the impending EU MDR deadline approaching, you may need to recode your complaints and adverse events to address new EU MDR requirements. If you haven’t taken this workload into account, we can help fast-track this for you.
To learn more about USDM’s flexible, customized staffing and delivery options, click here. Or read our case study on how we enabled a large, global medical device company to address a Consent Decree and closeout a complaints backlog of over 600,000 service orders as well as develop a sustainable process that reduced the timeline to process, code, and closeout complaints.
About the Author
Marlowe Farrar is a Senior Project Manager of Delivery at USDM Life Sciences. In his role, he ensures customer projects are well-planned, well-executed, and meet or exceed the customer’s expectations. Marlowe is an accomplished IT leader with more than 30 years of experience in the medical device and healthcare industries and has led countless projects involving quality systems, high-tech manufacturing, validation, and FDA, SOX, ISO, and GxP compliance.