Succeeding in any industry is more than a little challenging. Succeeding in heavily regulated industries such as the medical, manufacturing, food, aerospace, or pharmaceutical industries requires constant diligence and vigilance as standards change. These industries are heavily-regulated so consumers know that the products they are using or ingesting are up to the latest safety standards.
Regulations for these industries add an extra layer of difficulty that does not concern other businesses at all. Even with these additional hurdles, success can be found for the companies that know to navigate the rules.
Although no single key to success exists, companies in regulated industries can implement some broad practices to make life in the industry easier and adherence to regulations less difficult. Here are 5 key practices for success in regulated industries.
1. Know the regulations inside and out
Regulated industries have dozens of regulations. This is relatively obvious. Just because certain regulations were part of your industry last year doesn’t guarantee those same regulations will be in place next year. Regulations are a dynamic concept, so knowing what the most up-to-date regulations require is key to success.
In 2021, this will be incredibly crucial. Much happened in 2020 bringing about changes that have already come or are coming to many regulated industries. The biggest events of the past year (of which you surely are already well-aware) include the global COVID-19 pandemic and, in the U.S., the 2020 election.
These two major events may have more impact on industry regulations than any combination of events in the past. The election results produced a transition between two administrations that may be more diametrically opposed than any back-to-back administrations the US has ever seen. Couple that with a pandemic we haven’t seen in generations and you have a recipe for big regulation changes. Know these regulations or you risk getting on the wrong side of them in 2021.
2. A focus on quality assurance
In the era of COVID, it is not longer possible to control certain aspects of operations. Companies are dealing with closed offices, weakened demand, retrofitting spaces, local restrictions on factories and plants, stressed supply chains, and much more. This makes it incredibly important for all companies to do their best to control and excel in any aspect of their business they can control. In regulated industries, one of these elements is quality control.
Whether fewer products coming off your line because of COVID, as in the aerospace industry, or way more, as is the case in the pharmaceutical and healthcare industries, quality control continues to be a major factor. The best way to ensure quality control is to have standards and procedures in place to ensure that your company is producing products that comply with all industry regulations.
3. A sustained commitment to GxP
Another significant way a company in a regulated industry can demonstrate a commitment to quality assurance is with a sustained commitment to GxP. This term means good practices with the x standing for the area of the company in which these good practices are implemented. By substituting the ‘x’ for the area in question, one can know which segment of the chain is under study (ex., good manufacturing practices (GMP) or good laboratory practices (GLP)).
GxP varies by industry but the general idea is that following these practices in regulated industries will increase traceability, accountability, and data integrity in the creation of regulated products. GxP includes working towards these three pillars inside your own organization.
This includes using GxP in the “5 P’s” of an organization: people, procedures, products and primary materials, premise and equipment, and processes. This Dickson article is a good primer for anyone wanting to familiarize themselves with GxP best practices.
4. Leveraging technology
The good news for companies in regulated industries is that many readily available tools can help drive success in 2021. Technology can give companies a leg up on the competition and make complying with regulations much easier and less costly. Companies that embrace technology in the 21st century are likely to find more long-term success.
Technology in regulated industries can help with collecting, managing, and analyzing data that will then help an organization make better data-driven decisions. With cloud-based systems, AI, and machine learning, companies can use data like never before and, when done right, it can drive serious success.
The Internet of Things (IoT) is another technology powering success for companies in regulated industries. This network of internet-connected devices allows machines to “communicate” to make processes more interconnected and efficient. It also allows companies to reduce manpower because machinery and systems can be monitored and controlled from central locations.
5. The human element
All the processes, procedures and technology in the world might be great, but at some point, a person has to execute, control, interact, or direct the action. In addition to implementing processes and tech to help companies succeed in regulated industries in 2021, companies also need to commit to proper training to make all these other elements work properly.
Training should be thorough and conducted with specific goals in mind. It should start with great onboarding training but, as happens in some companies, it shouldn’t stop there. Training needs to be a continuous process whereby employees are constantly trained in new practices and procedures and are tested on their knowledge and comprehension of the training at regular intervals throughout their time with the company. Without the proper training, the other four items on this list will not be nearly as effective as they will be when combined with a great corporate training program.
Finding success in regulated industries may be more difficult than in less regulated ones, but when you follow a few best practices, remaining in tip awareness condition and acting accordingly should become easier. Having a comprehensive understanding of industry regulations, committing the company to quality assurance and practices such as GxP, using the right technology, and proper training in these areas are all practices that will help companies become more successful.