Crisis Prevention/Crisis Management

Planning for the possibility of product recalls and withdrawals is an essential risk management tool and Vitale Scientific Associates, LLC can assist in several ways.  Of course, prevention is the best strategy, but the unanticipated failure must be contemplated. We have been called upon to develop testing strategies to prevent contamination upstream and to assess the risk of post-production and post-release contamination.  Additionally we have been asked to assist in writing hold/recall/withdrawal decision matrices, and can tailor a number of recall/withdrawal plans to suit your needs.

In a product contamination event, the requirements for management are essentially to mount an emergency response.  Our project scientists, data managers, QA chemists, and QA biologists have manned and managed the sampling analysis and data management functions in some of the largest emergency responses in US history.  We mobilize quickly, arriving on the scene within hours, and provide support 24/7, working to move from relative chaos into a highly managed situation until things move to non-emergency status.

When an incident arises, the immediate reaction is to engage many “players” – such as consultants and laboratories – to gain information as soon as possible.  New procedures and new contracts that are atypical of non-emergency operations are often required due to the urgency of the response.  The volume of testing and data gathered is overwhelming and challenges the quality systems already in place.

Timely information and guidance is often a critical component in managing responses to chemical or biological contamination.  As first responders at emergency responses, VSA’s QA team of chemists who are sampling and data management professionals, provide assurance that the first response sampling data are accurate, defensible, and readily accessible.

By engaging VSA for preparedness, our clients can be assured that data quality is maintained from the very beginning and that defensible data, from which emergency response decisions are made, are readily available for and shared with stakeholders during the recall and root cause analysis.

From the first sample collected, our clients have the peace of mind knowing that they are working under quality assurance plan and managing data in a manner compatible with a data management plan.

Considerations for Planning

  • Reporting responsibilities under FDA Section 415(a) of the FD&C Act (21 U.S.C. 350d), when there is a reasonable probability that the use of, or exposure to, an article of food causing serious adverse health consequences or death to humans or animals.
  • 21 CFR Parts 7 & 107 Recall Guidelines (7/78).
  • USDA FSIS Reporting Requirements / FSIS Directive 8080.1 Revision 6.
  • GMA/GS1/FMI/Deloitte Recall Effectiveness Manual.
  • Establishing a decision matrix for deciding whether to conduct product holds, stock recovery, market recalls, or market withdrawals.
  • Establishing Hold/Recovery/Recall/Withdrawal Teams:

The team directs all company communication regarding the action; ensuring that all held or recovered products are under control, that recalled product has been brought back under control, and for responding to all customer questions, concerns, and complaints.

  • Establishing and updating an emergency contact list.
  • Developing a template product recall notification letter.
  • Recall drills (mock recalls) to be held periodically to practice the lines of communication and to practice various scenarios.
  • Incident investigations and root cause analysis.
  • Retailer/Distributor/Consumer Notifications.
  • Disposal/Destruction of the recalled products.
  • Assessing the Effectiveness of Hold/Recovery/Recall Actions.

VSA’s comprehensive Hold/Recovery/Recall and Withdrawal Response QA Oversight Program includes:

  • Establishing Repository for All Analytical Data
  • Establishing Sampling Procedures for All Samplers (All Matrices)
  • Providing an Authority Independent from Those Performing Sampling Work
  • Identifying and Contracting Analytical Testing Services
  • Auditing Performance of Laboratories
  • Creating Web-Based Data Sharing with Stakeholders
  • Independently Validating Data
  • Supporting Command Center Operations
  • Training for Samplers
  • Overseeing On-Site Sampling Operations
  • Preparing the Quality Assurance Plan (QAP)
  • Automating Chain-of-Custody (COC)
  • Supporting Public Meetings/Community Relations
  • Meeting with Regulatory Agencies and Project Stakeholders