EDITOR’S NOTE: This is one in a series of highly popular GxP Lifeline blog posts that we are republishing in order to share their important subject matter and insights with a wider audience.

If a person makes a mistake, a simple apology is often enough to fix the problem. When companies that manufacture drugs, medical devices, transportation equipment, chemicals or other regulated products slip up, saying sorry doesn’t cut it. Even the slightest failure can have a substantial impact on a product’s quality and effectiveness or — in every manufacturer’s nightmare scenario — possibly endanger public safety.

The implications of some errors are extensive enough to warrant a product recall, initiated by either the agency responsible for regulating the manufactured product or the manufacturer itself. One recent and prominent recall example saw the U.S. Food and Drug Administration (FDA) deliver multiple notifications to patients and health care professionals throughout 2018 to alert them to several companies’ recalls of dozens of irbesartan, losartan and valsartan angiotensin receptor blocker (ARB) drugs.(1) The ARB products were recalled due to the presence of N-Nitrosodiethylamine (NDEA), a suspected carcinogen. The NDEA scare had a global impact on companies of all sizes, including drug giant Novartis’ Sandoz subsidiary, which voluntarily recalled one lot of its antihypertensive drug Losartan HCT in November 2018 for possible carcinogenic contaminations found in drug ingredients obtained from the Chinese active pharmaceutical ingredient (API) manufacturer Zhejiang Huahai Pharmaceuticals.(2) The full financial repercussions of the affected pharmaceutical companies’ recalls aren’t likely to be conclusively determined anytime soon, but automobile, cellphone and other manufacturers have had analogous recall disasters in recent years that have precipitated billions of dollars in long-term financial losses.

If a minor lapse spirals into a product recall, manufacturers are faced with the challenge of recovering their brand and business from sweeping reputational and financial repercussions. The key to successful recall management lies in taking steps to avoid them altogether and having a plan in place to deal with them should they occur.

Problems That Lead to Recalls

The unforeseen failings that instigate recalls typically fall into one of two categories:

• • Quality defects: These types of failures occur when a manufactured product deviates from its intended design, which can trigger quality events like out-of-specification (OOS), out-of-expectation (OOE) or out-of-trend (OOT) results. Quality flaws may also occur due to the presence of contaminations or allergens or because of microbiological or hygiene impurities.
  • Safety-related hazards: Safety deficiencies can arise when unanticipated mechanical, chemical, electrical or fire risks are found in products. In rare cases, safety improprieties may be the result of product tampering, such as in the infamous 1982 case of the cyanide-laced Tylenol that killed seven people, precipitated one of the first large-scale recalls in the U.S., and instigated major safety changes in the pharmaceutical industry.(3)

Every industry handles the regulatory management of defects and hazards in different ways. For example, in an effort to protect the public while simultaneously tempering the impact of a recall on the culpable parties as much as possible, the FDA has instituted three classifications of recalls.(4) Each FDA classification is based on the associated level of hazard:

• Class I: These are defective or dangerous products that could foreseeably cause serious health problems or death. A Class I designation is the FDA’s most serious recall alert, and in recent high-profile instances has been levied against globally marketed products from massive life sciences companies like Roche Diagnostics(5) and Beckman Coulter.(6)
• Class II: The potential dangers of these products is considered minimal, although it is plausible they could cause an impermanent health problem.
• Class III: These are products that are unlikely to cause adverse health reactions, yet they violate manufacturing or labeling laws.

The National Highway Traffic Safety Administration (NHTSA), alternatively, has a singular safety recall threshold that is based on an intensive four-part investigative process (screening, analysis, investigation and management) that is conducted once an established number of safety problems have been reported that involve groups of motor vehicles or vehicle equipment.(7)

Steps to Recuperate from a Recall

There are four pivotal steps manufacturers must take to expediently recover from a recall and maintain customer confidence.

1. Prepare: The first step a company can take to be ready for and possibly avoid a recall is to pay close attention to the current relevant regulatory standards and safety regulations. In cases where a recall becomes necessary, a company should have a basic response plan in place that includes a designated recall response team with a specified chain of command. The plan should make it possible for communications with suppliers, retailers and other appropriate external parties to transpire at the same speed the recall is occurring. An established internal data management system can help ensure the effectiveness of these communications while also enabling recall teams to track progress and set goals for the targeted end of the recall. In most customer-focused industries, having a fast-responding social media mechanism at the ready can also be a critical component of recall preparation.
2. Report: The proper authorities must be notified of potential defects or safety concerns as soon as possible, even if the company doesn’t believe the circumstances will warrant a recall.Even the briefest of reporting delays may lead to further investigations and/or civil penalties down the road, so fast action is imperative. A company should be able to promptly notify regulators with relevant details like product descriptions, units involved, remedy plans, correspondence conducted with retailers and/or consumers, and any other industry-specific information that may be required for reporting on alleged hazards, defects or discrepancies.
3. Communicate: Companies that are transparent, consistent and responsive during recalls can maintain, or in some circumstances even increase, customer trust. The longer a company sits on recall information, the less likely consumers are to have confidence in that company’s products in the future. Not unlike normal marketing campaigns, companies can use their existing communication channels to publicly acknowledge a recall and reaffirm their commitment to consumer safety.
4. Respond: Take responsibility for the ramifications of a defect or hazard by recognizing customer concerns and acting on them. Accountability proves that your company stands by its products and demonstrates an abiding commitment to taking care of customers. A recall team’s first response should be to evaluate the predicament and quickly determine the type, scale and speed of the recall that should be conducted.

Leveraging EQMS to Avoid Recalls

The integration of multiple quality processes via a single-platform enterprise quality management system (EQMS) can empower a company to nip small problems in the bud before they blossom into recall-worthy disasters. Automated EQMS solutions allow companies to connect quality documentation with the customer complaint, audit, risk and quality event management activities at the heart of recall prevention. Effective, EQMS-enabled quality management makes it easier to find and fix glitches before products ever reach their intended consumers. It is far more likely that a company will avoid embarrassing and costly product problems, protect its reputation and build brand equity when its quality processes and documentation are consistently managed with efficiency.

An automated EQMS can be an indispensable tool if a recall occurs as it can enable companies to quickly access quality documentation, risk management data, product supply information and applicable OOS records from a centralized repository.

Learn how your company can prevent recalls and improve performance by automating production records and streamlining quality management.

 References

1. https://www.fda.gov/drugs/drugsafety/ucm613916.htm. Accessed Jan. 3, 2019.
2. https://www.fdanews.com/articles/189211-sandoz-announces-voluntary-recall-of-potentially-contaminated-losartan. Accessed Jan. 2, 2019.
3. https://www.upi.com/35-years-after-landmark-recall-Tylenol-deaths-still-unsolved/9661507150232/. Accessed Jan. 2, 2019.
4. https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049070.htm. Accessed Jan. 2, 2019.
5. https://www.fiercebiotech.com/medtech/fda-ups-ante-roche-blood-thinner-strips-recall. Accessed Jan. 2, 2019.
6. https://www.fdanews.com/articles/189317-fda-declares-beckman-coulters-flow-cytometer-recall-class-1. Accessed Jan. 2, 2019.
7. https://www-odi.nhtsa.dot.gov/owners/RecallProcess. Accessed Jan. 2, 2019.

James Jardine is a marketing communications specialist at MasterControl. He has covered life sciences and regulatory issues for more than a decade and has a bachelor’s degree in journalism from the University of Utah.