Each year, recalls cost companies millions of dollars in industries such as pharmaceuticals, food and beverage, cosmetics, medical devices, and more. They’re one of the biggest threats to profitability and associated with lost costs, delayed product delivery, and reduced consumer trust. Nonetheless, many risk management experts believe that more intricate product supply chains and better safety regulations mean that recalls are inevitable no matter the industry or the product. That’s why many companies invest in learning how to conduct mock recalls to better prepare for the actual event. Learn the 4 Major Steps to Properly Conduct Mock Recalls. Read on.
Any organization with a product on the market may one day get hit by a recall. Read on to discover what mock recalls are, how they can help you prepare for a live event, and how an automated SaaS-based management system can help.
What Are Mock Recalls and Why Do They Matter?
A mock recall is a routine, staged exercise conducted by a manufacturer and all pertinent stakeholders with the intent of assessing readiness and responsiveness at a supply chain level. As with emergency preparedness or disaster planning in service-based industries, they’re an important part of risk management in any organization with a product on the market. In some cases, they’re even required.
Mock recalls help companies prepare for an actual recall by identifying procedures that work well and opportunities for improvement in the current plan. When conducted across trading partners or vendors, they allow a company to create or test existing traceability procedures.
New FDA Guidance
The FDA recently published its final guidance outlining steps companies should take to develop recall policies and procedures that include training, planning, and record-keeping to help significantly reduce the time a recalled product remains on the market. The purpose of the guidance was 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 FDA guidance describes an array of best practices for creating, testing, and executing a recall plan. Because of the FDA’s heightened expectations, along with the greater risk and complexity involved in today’s recalls, training – including regular mock recall exercises – has become an essential part of the recall preparation process.
It is imperative that your organization plan, train and test for a product recall. This includes developing and executing mock recalls at least twice a year.
4 Major Steps to Properly Conduct Mock Recalls That Will Set Your Company Up for Success
A mock recall can save a company time, money, and embarrassment during the actual event. Therefore, it’s best to put thought and effort into crafting an effective drill that prepares the company for this worst-case scenario. Here’s how to conduct mock recalls in five steps.
1. Create a Centralized Task Force
As with other disaster planning procedures, the most important step is to first create a team assigned to handle the recall. This keeps efforts centralized, organized, and responsive.
Strongly consider equipping your task force with software management tools that support a centralized, rapid response. SaaS-based software deployed on-demand keeps the team, manufacturers, vendors, or other relevant stakeholders in communication.
2. Establish and Test Traceability Procedures
Establish and standardize traceability procedures that can be rapidly applied in the event of a recall. During a mock recall, your task force should be able to identify (at minimum) the:
- Reason for the recall
- Origin of the materials or product in question
- Extent of distribution – including which pallets, cases, and units are affected
- Product that has been sold and what’s still in the inventory
3. Carry Out the Recall to Completion Using Best Practices
Carry out the mock recall with an emphasis on applying recall best practices. For maximum success:
- Choose an item to recall using a vulnerability audit: Identify which product will have the most repercussions if it’s recalled.
- Mock-recall the product on a random day: This simulates a real recall and thus empowers a company to never be caught off guard.
- Keep detailed documents and notes of the process: Pay attention to deviations, problems, or instances where staff might not be taking the recall seriously.
- Use automated SaaS-based software: It will help you gain a sense of your traceability procedures, as well as where you lack visibility.
4. Analyze and Apply Insights from the Mock Recall
A mock recall should be a learning experience and you should apply those insights to your recall plan. Some things you may wish to consider in your review of the process include:
- Who needs access to the recall management software?
- What is the plan of action to communicate with vendors or suppliers?
- What information do you need to start tracking immediately?
- What features in your recall management platform are most helpful?
- Why did deviations from the plan occur and what can you learn from them?
- What input do stakeholders have of how the mock recall went?
Learn how to conduct a Mock Recalls with Mock Recall Development, Planning, & Testing with MockRecalls team.
Whether your product is a new or an existing medical device, pharmaceutical, cosmetic, food & beverage or chemical, MockRecalls is purely focused on protecting your product investment by working with you to create a new recall plan or analyze your current recall plan and then put it through a mock recall or recall simulation test to insure you are prepared for a possible product recall.
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