According the recently published FDA Guidance, the purpose of this guidance is to clarify FDA’s recommendations for industry and Agency staff regarding timely initiation of voluntary recalls under 21 CFR part 7, subpart C – Recalls (Including Product Corrections) – Guidance on Policy, Procedures, and Industry Responsibilities. The guidance discusses what preparations firms in [...]
Information on Recalls of FDA Regulated Products Guidance for Industry and FDA Staff: Questions and Answers Regarding Mandatory Food Recalls Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls Guidance for Industry and FDA Staff Public Warning [...]
Conducting a mock recall is not a formal regulatory requirement of the FDA. The FDA recently released its FDA guidance that stresses the importance of being “recall ready” and outlines steps companies should take to develop recall policies and procedures that includes recall planning, training, and record-keeping across all departments to reduce the time [...]
As a part of a recall simulation exercise, mock recalls confirm that your company can trace products throughout the supply chain and determine whether or not your communications plan is efficient. Ultimately, mock recalls are about mitigating risk and measuring your ability to react to an emergency event with as much precision as possible.
A mock recall is an internal exercise to test a company‟s ability to trace and recall product or ingredients using their documented traceability and recall plan. When performing a “mock recall” one needs to create a scenario of a problem with a delivered product. A lot-trace exercise tests a company’s ability to either forward trace [...]
It is recommended your company conduct Recall Simulations at least once a year, with different products and triggers.
A Recall Simulation tests a company’s entire recall plan, process and execution. The entire team assesses how well it performed and is able to collaboratively identify needed corrective actions. A Simulation is a great refresher for seasoned team members and an excellent training tool for new team members, resulting in an increased awareness of [...]
The core recall team and top-level decision makers, alternate core team members for training, and other people needed to provide information or tools.
The typical simulation takes one full day.
A lot-trace exercise tests a company’s ability to either forward trace a component from receipt to finished product or backward trace a component of a finished product back to the supplier. This exercise tests a company’s record keeping procedures and systems as well as the internal tracking systems for components and finished goods. A [...]