Value Analysis Recall Advisor

Tracey Chadwell

Notification process/communication plan to end users, supply chain, and other key stakeholders

The protocol to address a product notice/recall once it is received

•Who will identify if the product has been purchased and is in use/in stock and affected locations within the organization; how will this be accomplished

•Who will perform remediation-collection, removal or correction of product, as indicated by supplier

•Who is responsible for the coordination of all actions taken and monitor the process

•How will closure/response back to supplier be handled

•How an issue can be escalated should a problem be encountered

Internal response time for each class of recall, i.e., Class 1< 24 hours, Class 2&3 within 3-5 days

Any process to address internally identified product failures (“internal recalls”)

A policy must also provide for the evaluation of consistency, sustainability, and compliance to the established process. It should accomplish this by addressing 3 additional areas. First, there needs to be a defined mechanism for the documentation of the process and all actions taken, ideally in a central repository. Whether it is a home-grown solution, or a third party offering, the process must be fully documented, from intake of the alert through completed actions/resolution, with the responsible party clearly indicated in the data. This information can serve as evidence to an accrediting organization that a process is in place and is being utilized in compliance with the policy. This data can also be used to create reports for all necessary leadership committees within the organization, as directed by the policy.

This documentation will also go a long way in supporting the next key element in the policy; compliance auditing. To ensure that the process is effective and efficient, auditing must be done at regular intervals. Auditing should be prescribed in terms of compliance to the policy and any performance metrics, and the metrics should be clearly defined and quantifiable. Some sample metrics would be:

 Response time to completion, at the organization and/or department level

 Completion rate

 Number of alerts received, % requiring action, % with potential to cause harm/ affect delivery of patient care, number unresolved

 Number of products destroyed, returned, replaced, corrected

 Feedback on the process

A corrective action process should also be outlined, including documentation of the review, remediation actions taken, and the effectiveness of those actions at correcting the problem.