Medical device manufacturing is one of the most competitive markets there are and also one of the most highly regulated. In the past few years, the market has faced 510(k) reforms and a new meaning to substantial equivalence, steadily increasing operational costs, a new 2.3% sales tax on medical device supplies, and other significant changes.
With all there is to stay abreast of, considering your competition is also important. You can stay ahead of your competitors, as well as conform to the changes listed above, with the use of internal quality audits.
What is an Internal Audit Program?
An internal audit program is a department within your company that ensures everyone working under the umbrella of your business is conducting their practices safely and correctly and that the processes being used are up to the FDA’s standards. The internal audit program can be made up of several individuals or one auditor, depending on how large your company is.
Benefits of the Internal Auditor
This program will actually benefit your company in many ways, some of which will help keep you ahead of your competitors, who may not choose to take on the expense of an extra department. These benefits include:
- Holding mock audits within your company that:
- Prepare employees for the real thing
- Generate knowledge about the discrepancies between your business’ actual practices and those in your official paperwork
- Allow more transparency throughout the company as well as a way for managers to test how employees are performing on a basic level
- Helping you discover practices that are not in compliance with the FDA regulations, avoiding issues that would have been addressed during an official audit
- Allowing you to discover better procedures that could be more beneficial, less costly, etc., even if the original procedures are not, in themselves, unsafe
- Having a person whose sole job it is to be aware of and prepare for the possibility of an audit, allowing you to focus on other areas of the company
The cost of an internal auditor is much lower than the costs you would incur by failing an FDA audit. In addition, actually providing your auditor with the power to make changes is incredibly crucial. In some companies, the auditor only makes suggestions, but giving the individual the ability to force changes without approval from the management can actually cause better practices to occur more quickly. In some rare cases, an auditor may even be given the power to shut down a whole department if there are enough violations, and this kind of action will definitely generate the change you want to see.
The Auditor and Your Competition
While having regular internal quality audits can clearly save you money, time, and protect you from a failed government audit, it also gives you a leg up on the competition. Companies that do not use this kind of service will likely continue with the same bad procedures for years with the management team not realizing that tweaking these procedures somewhat or changing them altogether could help the overall company in many ways.
In addition, you will have an individual in your company who is seeing it from an outside perspective. This means they can compare your company with another’s in a way that is both fair and informed, giving you an idea of how you can improve with direct comparisons to other companies. It can be hard to step away from your own business and see it for what it is; that is why this is the auditor’s job.
Your auditor will also be able to stay on top of any regulation changes made by the FDA and keep you aware of them as well. This is something your competitors may struggle with if they do not have an auditing system, making your company stand out as more forward-thinking and compliant.
It is difficult to stay ahead of your competition and comply with the regulatory and financial changes that are constantly being made in your market. However, with the addition of an internal auditing program, you can more easily do both.