Value Analysis Recall Advisor A Blueprint for a Successful Recall Management Program

Tracey Chadwell, BSN, RN, CVAHP, HACP Value Analysis Recall Management Advisor and Owner, TACH Consulting

Building upon the foundation that we laid in my previous article, let’s now discuss the blueprint for the program that rests on that foundation. Like all successful and sustainable projects, there must be a setting of guiding principles and policies that delineate the roles and responsibilities of those involved, as well as outlining a systematic, repeatable process by which success can be measured. Having a documented process with accompanying policies also addresses requirements of accrediting agencies, such as the DNV and TJC. Their standards call for every organization to have a process to respond to product recalls and notices, with corresponding documentation to demonstrate compliance with that process and related policies.

In the last article, the importance of having a strong foundation for a recall management program was reviewed. It began by defining the key core elements: leadership and ownership. This should be the first part of the organization’s policy around recall management. The leadership/ownership structure should be defined, along with the roles and functions around management, oversight, and escalation. All necessary job titles/positions that are part of the program should be named and if they are permanent or ad hoc members of this process. If there are any additional groups, such as the Safety Alert Response Team, mentioned in the last article, the roles and functions of this team should be addressed.

The next essential component of the policy is an outline of the process that is to be followed – how will product notices or recalls be handled? Is the program centralized or decentralized? (see previous article) How will alerts be evaluated and prioritized and by whom? More specifically, these process steps need to be defined:

How alerts/notices may be received, including the role of any third-party vendors

The person/role who is designated to receive and “triage” the alerts

The process used to prioritize and address alerts based on the type/level of the alert

•Product recalls (Class 1-3)

•Field corrections/notices