4 Keys to Effective Product Recall Management

If life sciences manufacturers make mistakes during the production of their regulated products, the consequences can be catastrophic. Even a minor oversight can have a devastating impact on a pharmaceutical, biotech, or medical device product’s quality, effectiveness, or safety. Errors that have the potential to endanger public health and necessitate product recalls are the worst-case scenario in life sciences manufacturing.

One recent high-profile product recall sent shockwaves throughout the life sciences world when Philips Respironics recalled certain CPAP and BiPAP machines due to potential health risks associated with the foam used in the devices. Those recalls involved 15 million devices, affected millions of users worldwide, and renewed the entire industry’s focus on product recall prevention strategies. As a result of the far-reaching issues, the U.S. Food and Drug Administration (FDA) required Philips Respironics to implement a remediation plan and has since restricted the production and sale of new products — actions that have caused many in the industry to reevaluate the robustness of their own product recall prevention practices.¹

When even the smallest mistake snowballs into a product recall, a life sciences manufacturer is faced with the challenge of recovering their brand and business from sweeping reputational and financial repercussions. The key to successful product recall prevention lies in taking steps to avoid them altogether and having an actionable plan in place to handle them effectively should they occur.

Problems That Result in Product Recalls

The kinds of failures that ultimately necessitate product recalls usually fit into two categories:

• Quality defects:

  These types of failures often occur when a manufactured product diverges from its intended design or recipes, which can trigger quality events like out-of-specification (OOS), out-of-expectation (OOE) or out-of-trend (OOT) outcomes. Quality defects may also happen because of the presence of contaminations, allergens, etc., or because of impurities caused by hygienic or microbiological issues.

• Safety hazards:

  Safety-related deficiencies can arise when unanticipated hazards occur in products, such as chemical, electrical, or mechanical risks.

Product recall management, and the defects and hazards that lead to recalls, are handled differently in different industries. For life sciences companies regulated by the FDA, the agency has established three classifications of product recalls in an effort to safeguard public health whilst minimizing as much as possible the impact on all parties involved.²

Each FDA classification is based on the relative level of hazard that a product may cause:

• Class I: A Class I designation is the FDA’s most serious product recall alert. It is reserved for defective or dangerous products that could foreseeably cause serious health problems or death.
• Class II: The potential dangers of these products are considered minimal in that they may cause temporary or medically reversible adverse health consequences or other kinds of impermanent health problems.
• Class III: While unlikely to cause adverse health reactions, these products are in violation of manufacturing or labeling laws.

4 Steps for Effective Product Recall Management

There are four critical keys for a life sciences company to recover from a product recall expeditiously and retain or regain customer confidence.

1. Prepare:

   The first step every life sciences company should take to be ready for and possibly avoid a recall is to have a thorough awareness of the current safety regulations and regulatory standards relevant to their products. In cases where a product recall becomes necessary, the company should have a basic response plan in place. The plan should designate a recall response team and include a specified chain of command. Detailed plans should be developed in advance for communications with suppliers, vendors, and other parties involved so they can stay informed at the same speed the recall is occurring. Establishing an internal data management system will help ensure the effectiveness of these communications while also enabling the recall response team to track progress and set goals for bringing it to a conclusion. In customer-focused industries like life sciences, having a responsive social media mechanism ready to activate can also be a critical component of effective product recall management.

2. Report:

   The appropriate regulatory bodies and authorities must be notified of potential defects or safety concerns as soon as possible, even if the company doesn’t believe the circumstances will result in a product recall. A prompt response is imperative because the slightest delay in reporting may lead to further investigations and/or penalties later on. Life sciences companies must notify regulators with relevant details like product descriptions, units involved, correspondence conducted with retailers and/or consumers, remedy plans, and any other industry-specific information that may be required for reporting on potential defects, discrepancies, or hazards.

3. Communicate:

   A 2024 recall report reflects that the recent rise in product recalls has caused 77% of survey respondents to question the quality or safety of the medical products they use, which has raised the stakes in the life sciences. The longer a company delays communicating product recall information, the less likely its customers are to have confidence in that company’s products in the future. Companies that are transparent, consistent, and responsive during recalls are in a better position to maintain — or in some circumstances even increase — customer trust. As with their typical marketing campaigns, life sciences companies can use existing communication channels to publicly acknowledge a product recall and reaffirm their commitment to customer and patient safety.

4. Respond:

   Recognizing customer concerns and acting on them quickly are the two critical elements of taking responsibility for and responding to a defect or hazard. Taking accountability proves that a company stands by its products and demonstrates an abiding commitment to meeting customer needs and expectations. A recall response team’s first action should be to conduct a timely evaluation of the situation and effectively determine the type, scale, and velocity of the product recall to be conducted.

Your Product Recall Prevention Solution: eQMS for Life Sciences

Integrating your quality processes within a single-platform electronic quality management system (eQMS) for life sciences can empower your company to nip small problems in the bud before they bloom into recall-necessitating disasters. A proven eQMS for life sciences solution enables companies to connect and make easily accessible the quality data and documentation that is vital to product recall prevention and response. Effective eQMS-enabled quality management makes it easier to find and fix glitches rapidly, and usually before products even reach the consumer. It is far more likely that a life sciences company will maintain strong brand equity and avoid expensive and embarrassing product problems when its quality processes, data, and documentation are consistently managed efficiently and effectively.

A fully digitized eQMS for life sciences is an indispensable tool if a product recall occurs as it enables companies to quickly access quality documentation, risk management data, product supply information, and applicable quality event records from a centralized and easily accessible system.

Want to protect your reputation, minimize financial losses, and most importantly, ensure public safety? Learn how your company can prevent recalls by digitizing and optimizing quality management.

 References

1. “Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines,” FDA website, updated April 2024.
2. “Recalls Background and Definitions,” FDA website, content current as of Aug. 31, 2014.