Quality Control in the Electronic Cigarette Industry in 2016
Already In 2016, the electronic cigarette industry has bad PR through several reported stories of exploding products. In California, a nineteen year old suffered first and second degree burns after an e-cigarette exploded in his pocket at work. According to the teen, the incident occurred after the e-cigarette came in contact with his keys. In Indiana, a semi-truck crashed, causing hours of clean up because an e-cigarette exploded in the driver’s hand. Although nobody else was hurt, the driver did sustain injuries to his hand from the exploding device. For the electronic cigarette industry, stories like these could not come at a worst time.
The FDA has been working on regulations to develop standards for quality control similar to that of the tobacco products for some time. It first proposed regulations for e-cigarettes back in April 2014, and it submitted final rules to the White House Office of Management and Budget last October for review. The OMB has 90 days to review the rules before they can be implemented and enforced by the FDA. A majority of Americans do believe that the electronic cigarette industry should be regulated as other tobacco products, so we should see final rules that are very similar to tobacco products.
The Meteoric Rise of the Electronic Cigarette Industry
Since 2003 when the electronic cigarette was invented by a Chinese man looking to quit his three pack-a-day habit, the electronic cigarette industry has boomed to a multi-billion dollar industry. Millions of Americans and millions more across the world have said they have tried or currently use electronic cigarettes in some capacity. Some doctors and medical researchers believe that it could be used as a smoking cessation device, and the BBC reports that the NHS may even prescribe electronic cigarettes to patients looking to curb their bad habit.
However, the electronic cigarette industry must do more to ensure quality control as there will certainly be compliance issues in the near future as well as PR problems for those whose customers experience adverse events from use. In the decade where the FDA and other organizations were trying to play catch up with the emerging popularity of e-cigarettes, the industry had to police itself. There have been a number of obstacles in play. The lack of regulatory oversight meant that companies could potentially bypass quality best practices to maximize profits. In addition, many companies use suppliers overseas to create the nicotine juice and other components to offset production costs.
When the proposed FDA rules do go into effect, the electronic cigarette industry will have to address quality issues and should look to implement a best-in-class quality management system to enhance traceability, supplier quality, and accountability across the organization. Companies that automate their quality processes through enterprise quality management software (EQMS) will be the ones best able to adapt as the industry enters this new stage of quality control. EQMS negates many of the inherent risks that come from manual paper systems such as lost paperwork and lack of transparency among departments. It can help organizations create a holistic, closed-loop system that prevents adverse events and optimizes quality processes. As the electronic cigarette industry readies itself for upcoming regulations, EQMS can help make the transition much easier.