It is easy to fall into the rhythm of receiving multiple spreadsheets from various sources – be it sales, regulatory, marketing or quality – and by having them in one place, feeling like the recall is “under control.” In working with more than half of the largest med-tech companies globally, Novasyte has discovered this is a common theme.
Despite the commonality of this approach, there are inherent associated risks with managing a recall across multiple spreadsheets. Here are the top four.
The Largest Risks:
1. Limited Real-Time Knowledge
Spreadsheet data may be accurate in the moment it is captured, but it does not provide real-time activity reporting between spreadsheet submissions.
In discussing real-time data availability, every organization needs alignment on the varying types of data reporting required.
Original equipment manufacturers (OEMs) must have the data available that is required for records retention and FDA status report submissions. These reports, submitted monthly to the district office, should include the following information:¹²
- Number of consignees notified of the recall
- Date of consignee notification
- Method of consignee notification
- Number of consignees responding to the recall communication
- Quantity of products on-hand at the time the communication was received
- Number of consignees that did not respond (note: the identity of non-responding consignees may be requested by the FDA)
- Number of products returned or corrected by each consignee contacted, and the quantity of products accounted for
- Number and results of effectiveness checks that were made
- Estimated time frames for completion of the recall
With the current approach (spreadsheets and faxes) consuming valuable time, it is clear that this method does not support real-time reporting on the data points identified above. Thirty minutes following report submission, there may be an adverse event that is not reflected in the data.
2. Customer Confusion and Brand Degradation
Having more than one group/department manage a recall across multiple spreadsheets increases the risk of repeat verbal notifications or confirmations. This can lead to consignee misunderstanding that a second product is being recalled.
Confusion resulting from a decentralized database can extend to the OEM teams as well – both in the communication talk tracks and in assessing consignee needs.
By not having a central place with outlined communication, sales reps can find themselves (intentionally or unintentionally) placing different levels of severity on the situation or perhaps even shelf sweep the product if they do not have clarity on the product ID. Additionally, by not having a centralized place for consignees to verify information and request a replacement, teams can spend hours sifting through the communications to obtain clarity on consignee needs and next steps.
3. Missed Reporting on Adverse Events
Upon hearing about an adverse event, sales reps or product marketing managers may be unclear on where to report the information. By having a decentralized recall management system, it is common for the information to be passed up through a sales leader and over to Regulatory, at which point the investigation must begin. Due to the lack of direct communication, it can create timing delays and room for potential miscommunication on the associated details of the adverse event.
4. Data Security Issues
By manually managing a recall across multiple spreadsheets, organizations expose themselves to a significant amount of risk with data security and a potential data leak or accidental email forward. This is true across any platform that is not password protected.
After reviewing the associated risks of managing a recall on multiple spreadsheets, it is important to understand the benefits of having a centralized, cloud-based database.
The Most Significant Benefits:
1. Flexibility + Collaboration
Having a system that allows a business to grow with varying demands is critical to its organizational success. By having a centralized, cloud-based recall database, cross-departmental communications and collaboration can improve. Additionally, it increases visibility into all real-time activities, as well as insights for remote employees. Lastly, there is the added benefit that it is more environmentally friendly than printed records.
2. Document Control
Version control is an inevitable issue if managing a recall across multiple databases or spreadsheets. A key benefit of a centralized, cloud-based database is instant accessibility to the most up-to-date information. Novasyte ensures the data is safe, secure and confidential. The value of having all of the documentation living in one centralized place (versus on independent desktops) proves especially important when teams are attempting to review and align the recall with the most current local, national and international regulations.
3. Process Automation
When evaluating processes, it is important to not let a fax machine run the recall. A centralized, cloud-based database can remove some of the manual processes associated with a traditional device recall – from consignee notification to manual data reporting. Automating certain steps can save valuable time and resources, making it easier to report out to senior leadership or the FDA.
4. Record Retention + Disaster Recovery
As mentioned previously, record retention is critically important following a recall, especially if it is an adverse event. Whether digital or physical copies are retained, they need to be easily accessible and retrievable following an FDA request. By centralizing this data on a cloud-based platform with a structured file system, organizations will be able to respond to the demands of the FDA quickly, accurately and confidently.
5. Integrated Communications and Activities
Whether manual or automated, integrated communications and activities can garner significant return in time and cost to close a recall. By having a cloud-based system that speaks to itself, organizations are able to:
- Import and validate consignee address lists
- Manage and track field-team deployment
- Prevent warehouse co-mingling
- Sync data in real-time from phone outreach, remediation and retrieval
12. Legal Information Institute; Recall Status Reports. 21 C.F.R. § 7.53 (2017). Retrieved from https://www.law.cornell.edu/cfr/text/21/7.53