Regulated industries, life sciences in particular, have experienced significant changes in the regulatory environment in the past decade. The standards themselves haven’t really changed very much at all- whether it’s ISO 9001 which is focused on quality management, ISO 13485 which is focused on medical device quality management, or the technical standards such as ISO 27001. What has changed over the past 10 years is that the businesses responsible for implementing and maintaining the above standards are increasingly aware that not everyone can apply the same priority to all of the controls. The result is an increased focus on risk-based methodologies.
Why pursue ISO?
I am frequently in meetings with quality leaders and regulatory experts where I find myself wishing I could share some part of the conversation or findings with a broader audience. Something about the current state of affairs, best practice or just a really eloquent description of a pain point and how they are managing.
Pressures are increasingly mounting for life science companies from multiple directions- customers, internal business stakeholders, and regulators. Quality leaders need to keep up with the latest regulatory updates in the life sciences industry and simultaneously scale and automate internal compliance and document control processes.
Trouble with your Training Matrix?
Pharmaceutical companies use large training matrices to track employee's proficiency on SOPs, manufacturing processes, quality controls, and product reviews. When these training matrices are out of order, inefficient for employees, and do not deliver the right information to management, they cause multiple problems.
These seven problems are symptoms that your company's system needs to be updated and upgraded in order to maintain high quality product delivery. How many of these signs does your organization suffer from?1. Human Entry Errors
Trouble with a training matrix occurs when people enter information regarding SOP training, or in the entry of other information they should have been trained on. Statistically predictable variations in quality information are almost always a result of management systems.
According to the Journal of Pharmacy, the average pharmaceutical company has 1250 Standard Operating Procedures (SOPs) and over 150 employees. This makes a typical Excel training matrix responsible for at least 187,500 combinations of training (1250 x 150). These combinations do not account for tracking revisions of SOPs, managing relationships between different offices, or integrating research and development with SOP updates.
Maintaining a non-validated Training matrix at even a fraction of that size is a prime area to fail an audit or fall out of compliance. Good Quality Management Systems (QMS) reduce the time
Perhaps the biggest challenge facing a quality management team today, especially in the Life Sciences, is how to comply with regulations and take advantage of new cost-saving opportunities when the regulatory environment is fluid.
Maybe it’s time to do some Monday morning quarterbacking to see how your quality management system can grab every opportunity to regain possession of the ball. You may find that the true cost of your paper-based quality management system is ready for a game-changer.
Pivoting to comply or capture a new opportunity
In a recent “Monday Morning Regulatory Review,” the Federal Regulations Advisor reports that “the United States Court of Appeals for the Second Circuit held that the Department of Health and Human Services (HHS) 2000 regulation barring certain hospital reclassifications violated the plain terms of the Medicare Act and, therefore, was invalid….” As a result, HHS is now under some pressure to review its reclassification system for the purpose of reimbursement under the Medicare Act.
Consider the steps you have to take now, with your company’s current paper-based quality management system, to comply with a new regulation.
- Depending on the extent to which a new regulation alters the field, pivoting may require your calling a great number of “time-outs” from the routine workflow to comply or to take advantage of a new opportunity.
In order to gain a competitive edge, businesses often find themselves in a position where they're asked to make decisions that are rewarded with some sort of short-term gain at the cost of the quality of their product or service. Yes, a competitive business climate demands that participants be flexible and fluid, but as it turns out, compromising on quality has lasting negative effects that have the potential to sink your business.
What is the cost of poor quality? You can't begin to value things like solid business planning and methods until you've begun to properly measure and understand the ways that settling on poor quality can hurt your business. How can you do this? The answer is complicated. If you own a restaurant, and insist on purchasing cheap, low-quality food and paying your staff next to nothing, then you'll find that it'll be difficult to attract business and keep your restaurant staffed. Investing in the products/services you provide and the people you work with is smart business, because it's a decision you're making with the future in mind.
Cutting corners and compromising on quality are choices you can make now that'll help you in the short term, but you'll regret it later. Customers forget good experiences and will remain loyal, but they'll never forget bad experiences. Displeased customers can and will bring their complaints to public internet forums. One bad Yelp review too many can cost you lots of money.
A recent article in Entrepreneur Magazine claims, "On average, a one-star increase on Yelp leads to a 5 to 9 percent increase in a business's revenue, according to an infographic provided by Chatterbox, a company that builds customer-engagement platforms for marketing purposes. On the flip side, one negative review can cost you 30 customers."
Opting for poor quality doesn't just hurt people in the service industry, but also businesses that provide products. One bad product experience has the potential to drive customers and clients away for years. From a customer's perspective, if they've made the choice to purchase a product from you, they're planning on that product to be good. If the product they purchase is of low quality, they'll go out of their way to not do business with you again.
The same goes for vendors and other business owners. If a vendor has made the decision to purchase goods from you, they're planning on those goods being able to meet the needs of their customers. There's nothing that'll drive business away faster than letting down vendors and customers just because you wanted to save some time or money in the short term.
Here are some sensible ways you can earn and keep business and make sure you're not cutting corners:
- Create a Dialogue With Your Customers and Employees: It's vital that you continually check in with your customers and employees. For your customers, ask questions like, "Are you happy with the products/services we've provided? How can we improve?" For your employees, you should ask questions like, "What ideas do you have to make this a better workplace?", and, "Are you happy in your position?" Yes, asking questions like these might make you a little vulnerable as a business owner/manager, but it's important to hear from your customers and staff. Improving the quality of your business means doing some investigative work on your part.
- Break Down Your Business Bit by Bit and Find Ways To Make Improvements: Once you've started a dialogue with your employees and customers, take the time to break down everything your business does and find ways to make meaningful improvements. The improvements you make may be small and seemingly insignificant, but the cumulative positive changes in your business could end up being huge.
Everyone thinks they are compliant, until they find out they are not. Nobody believes that a slight aberration here or a miscue there will cause any lasting harm. When the FDA or client audit comes, all of those seemingly minor errors quickly add up to huge fines, delays and headaches for your company. Without proper and relatively inexpensive compliance procedures, your firm could be in store for a huge penalty.
Anyone regulated by the FDA will find that an inspection is like a train. There is always another one coming down the track. It might not be for another day or it might be another year, but you know they are on their way. The FDA agents will show up, and they will inspect places at random. If you're stuck with the question, The FDA is at my door - What do I do?, don't panic. We have the answers for you.
What to Expect
When you know what to expect, you can feel better prepared for a visit. The FDA may or may not announce their arrival; some agents have been known to perform surprise visits. Whether the visit is planned or not, be sure to check credentials. All agents will have identification, and you should be presented with the FDA Form 482. This form clearly highlights what the inspector is allowed to inspect, what he or she is allowed to collect, and what areas are strictly off limits.
Be accepting of the inspection. This is not a reflection of your business - it is simply a federally regulated and necessary check. It's human nature to take an inspection a