Liliana Omar, Regulatory & Quality Project Manager
Recalls can be overwhelming but the use of best practices can help make the process more efficient and accurate.
Laying the Groundwork
Medical Device Manufacturers are required to implement a recall procedure under a Quality System. The procedure is audited and confirmed to be adequate by internal and external auditors. Recall and other supporting standard operating procedures and templates are critical to the recall process to ensure a consistent recall execution and support from the different areas participating in the recall. Nevertheless, it is not until companies must carry out the procedures that companies begin to realize the practical challenges they are facing. Using best practices can complement a compliant recall procedure and make the entire process much easier.
Things To Consider For Recall Programs
Principle 1: An effective recall starts with a robust Quality System that is supported by the company’s systems and records, often integrated using an ERP (Enterprise Resource Planning) system.
Making it work: The ERP system and other Quality System software are used to capture and integrate information from different areas within the organization, such as: complaints, returns, adverse event reports, distribution records, invoices, non-conforming product transactions, customer contracts, production orders, rework orders, supplier non-conformances, etc.
Principle 2: A recall is a complex activity that requires the interaction and participation of multiple functional areas including quality, regulatory, clinical affairs, legal, engineering, customer service, IT, shipping and receiving, manufacturing, sales, marketing, servicing and installation.
Making it work: Defining a recall team led by a member of management and comprised of representatives from each of the areas will support an effective recall process.
Principle 3: The establishment of a recall strategy is part of the recall process. Each recall strategy is unique and must describe the notification method to consignees and distributors.
Making it work: Notifications must be effective and timely. The content of the notification letter must address regulatory requirements. Logistics, including printing capabilities, availability of paper, printer ink, envelops, labels, fax machine availability, etc. must be considered. Obtaining and automatically populating the variable content (e.g. consignee information, lots shipped, etc.) from the ERP system into the notification letters expedites the process and prevents human error.
If the consignee is to be notified using phone calls, a script must be created. The script must be incorporated within the recall strategy and implemented as defined in procedures. Whether the notification method is a phone call or written communication, establishing customer hotlines will create a central source of incoming and outgoing information.
Tips To Make Managing a Recall Straightforward
- Maintaining a complete and accurate list of consignees is essential to the recall process. Updates to consignee information received as part of responses to recall letters should be planned. Notification of the “ship-to” and “bill-to” consignees may be needed if they have different addresses.
- Ensure the ERP transactions and inventory control are adequate for your business model; this includes control of trunk stock inventory.
- Establish quality agreements with distributors that include clauses related to recall actions and ensure these meet regulatory requirements. Additionally, have a plan in place for out-of-business distributors.
- When defining how to deliver the notification letters to the consignees, consider the services that the courier offers. Some couriers will provide label printing capabilities and limited time tracking information spreadsheets that can be exported and maintained for later analysis.
- Create a plan to address the packets that cannot be delivered; define who is to be informed, how to reach the consignees and where to send the returned packets.
- Use Quality Control techniques to ensure notification packages are accurate and complete. Implement verification steps where critical tasks must occur, e.g. identifying and securing returned product, verifying field correction, etc.
- Maintain an adequate control of the recall records i.e. recall response records, returned product records, recall communication records, to facilitate analysis and retrieval.
- Conduct periodic meetings to ensure the recall team remains informed. Monitor the recall strategy execution; discuss the investigation progress and corrective actions, and the challenges of the different recall activities to improve the process. Communicate findings to Senior Management in a timely fashion.
- Ensure adequate recall returned product identification and control.
- Use barcode readers to expedite product count of returned products. Spreadsheets can be used to track and analyze the recall responses; file integrity must be maintained to ensure a proper and accurate analysis.
While companies strive to prevent recalls, the reality is that they happen. Establishing procedures to manage recalls are a necessity should the need arise. Each recall is unique and presents its own challenges. Recall procedures, complemented with clear best practices will ensure timely and effective implementation of necessary actions and thus fulfill the company’s commitment to protect the public health from products found to be in violation.
21 CFR 7: Title 21: Food and Drugs Part 7 – Enforcement Policy
PART 7—ENFORCEMENT POLICY
Subpart C—Recalls (Including Product Corrections)—Guidance on Policy, Procedures, and Industry Responsibilities