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.
The unforeseen failings that instigate recalls typically fall into one of two categories:
Enjoying this article? You may also enjoy this White Paper:
Metrics That Matter For Quality ManufacturingDownload Free White Paper
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:
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)
There are four pivotal steps manufacturers must take to expediently recover from a recall and maintain customer confidence.
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.