effectively plan for medical device recalls

Create & Test Your Mock recalls

Medical Device Mock Recall Planning

MOCK RECALL PLANNING, YOUR LIFEGUARD

Develop and Effectively Test Your Product Recall Plan

Did you know that technological advances in medical device software and sterility are the top causes of medical device RECALLS?

The combination of operational challenges and increasingly aggressive safety regulators is leading to increased product recalls and enforcement actions across all industries. While some of the most publicized product recall cases are from well-known brands, one-third of product recalls are from companies with five or fewer employees.

If you are a medical device company, have you created or thoroughly tested your mock product recall plan?

Don’t put your entire company at jeopardy. If you have not yet prepared a product recall plan or your existing recall plan needs significant redrafting/re-development, Mock Recall’s streamlined recall platform, along with top crisis management partner, RQA, Inc., preparation, training and testing programs, can help develop and prepare a recall plan that documents your coporate and/or business unit recall policies and procedures within an industry “best practice” model.

This includes an assessment of your organizational structure, manufacturing, and distribution models and standard operating procedures integral to successful recall management.

Don’t wait until it’s too late! With our Mock Recall training program, we can help you get prepared in case your product is recalled.

Schedule a 1 Hour Recall Readiness Consultation

Don’t put your entire company at jeopardy

Do you meet industry best recall plan standards? Have you assessed against industry best practives as well as applicable agency (e.g., FDA, USDA, CPSC, CFIA, etc.) regulations and guidance. With Mock Recall planning and testing, you can:

Substancially reduce the impact of a recall
Assess supporting documentation and procedures (e.g. quality and safety policy, non-conforming proudct control, traceability, consumer customer response processes, and more.
Identify gaps and improvement opportunities

WHY USE US FOR MOCK RECALL TRAINING AND PLANNING?

Recall Planning and Testing could include:

Procedures for acquiring data that may lead to recall action
Product identification and lot code definition, lot trace systems
Recall process flow diagram or checklists available
Resources identified to perform health hazard assessment
Elements of recall strategy defined
Model communications available: press release, customer letters
Model effectiveness checks available: written, telephone interview, personal visit Procedure for performing post-recall review

Statement of Product Quality and Safety
Procedure for maintenance of Recall Manual
Relevant regulations and regulatory authority identified
Organizational training requirements identified
Mock recall requirements identified
Recall Team members identified with contact information
Roles and responsibilities identified for team and related functions

Mock Recalls VS Recall Simulations

Conducting a mock recall twice a year is the basic assurance that inventory can be traced in the event of a recall. A recall simulation ensures that the organization is trained and ready to respond with a robust recall plan.

Mock Recalls

A mock recall typically refers to an inventory-based traceability exercise. A product is selected and the organization conducts a complete tracking of the first ship to or all products used in, depending on if a raw material/ingredient is selected or a finished product or both. There are time and accountability goals – so ideally 100% of product is accounted for withing 2 hours.

Recall Simulation

A recall simulation tests the organization’s entire process, from receipt of the information that there may be a recall issue, through investigation, regulatory contact, media prep and response, etc. The simulation includes the mock recall elements as the product is traced with the same accountability and time goals. It challenges all roles and responsibilities of the recall team, ensures the plan is up to date and acts as a training tool.

A recall simulation involves a fictitious, but realistic, situation about one of your company’s products currently in the marketplace, created to test the Recall Team’s ability to efficiently and effectively conduct all aspects of a recall. The initial report of an incident is escalated into a true crisis situation as the simulation progresses. Because it involves “real” product, information and records, a realistic situation, and is conducted under time pressure, it is as close to a “real” recall as possible.

What's the Difference?

A lot-trace exercise (mock recall) 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 Recall Simulation includes all aspects of a “real” recall situation, and it tests people, processes and systems. One of the most important parts of a Recall Simulation is it puts the team in a situation which allows it to proactively practice its recall process and see how well it follows its plan. RQA will engage the team in complex and emotionally charged activities, such as initial issue investigation with limited information, decision making as a team of unique individuals, lot-trace exercise and root cause analysis, while sifting through an over-abundance of information and records, all under extreme time pressures.