NOTE: Master Control GxP Lifeline first published this interview with John Chiechi, a Six Sigma Black Belt and Managing Consultant for Enterey, on December 1, 2020. Click here to read the original publication.
Q. When a business is getting ready to adopt new technology, what’s the biggest mistake they make?
One of the biggest mistakes I see is a business putting technology before process. In today’s world you download an app and immediately become proficient in how to use it. Because that’s happened in our personal lives, we carry that expectation into the business world, and that’s problematic. In business it’s essential for process to come first.
Q. What are the consequences of putting technology before process?
Software can be a valuable tool, but senior leadership is often so crunched for time they haven’t been able to fully evaluate new technology and even look to it as a way to speed things up. That approach skips a critical step – making sure they have the right processes in place. Those processes, such as standard operating procedures, should be supported and streamlined by technology. If it happens the other way around, and technology comes before process, automation speeds up a flawed process and just helps you make mistakes faster.
Q. In life sciences, automation can offer a competitive edge. But it sounds as though implementing technology without having the right process in place can actually reduce that competitive edge. Is that right?
Yes, and I’ll give you a couple of examples. Insurance companies are acquiring practitioners at a rapid rate. But what happens when each practitioner works from different systems? You can quite literally end up with two offices right across the street from one another that can’t talk to each other. A technician or receptionist can’t go across the street and do their job, for the same company, because their systems are completely different. That’s the opposite of efficiency and hinders a lot of the competitive edge gained through technology.
Let’s also look at two healthcare companies responding to COVID-19. Company A has grown organically while company B grows through acquisitions. Company B implements technology and doesn’t look at processes first, so they spend millions of dollars on integrating information like patient data, and project managers become buried. It’s never ending, and it’s never stabilized.
On the other hand, company B is focused on process and they aren’t losing money to manpower dedicated to frequent integrations. They are meeting the increased demand for services during the pandemic without any problem whereas company A isn’t competing against them as well.
In both examples, you have companies disregarding the fact that an effective process needs to be put in place before adopting new technology. The result is an inefficient hairball of systems that are nearly impossible to untangle.
Q. How does having a “hairball” of systems effect life sciences companies and their ability to ensure quality while maintaining regulatory compliance?
If you don’t untangle those hairballs by simplifying processes, you have increased complexity. This complexity creates gaps. For instance, regulatory compliance information like patient information or clinical trial data must be managed carefully, but the more processes you have to manage, the more likely it becomes that mistakes will be made and regulatory compliance is jeopardized.
Q. If a life sciences company is looking at adopting a new software, what are some specific things they should do to evaluate whether or not their processes are ready to take the next steps?
At Enterey, we believe the focus should be on people, process, and technology – in that order. It’s worth noting that if someone chooses to prioritize things differently, they should understand the implications of that risk. One of those might be the expense of untangling a sizeable hairball.
People are the ideal starting point because they are integral to the structure of an organization, so the question becomes whether or not the existing structure will allow a business to see the level of progress they’re hoping to achieve.
Then a question needs to determine if the software will be implemented throughout the company or simply within certain departments. This helps establish which processes should be automated. Regardless of the process, they should be sure and examine it closely by doing it manually first.
I compare it to knowing how to wash a car by hand and understanding an automatic carwash is a great convenience, but there are some things, like cleaning windows by hand, that automation can’t improve on yet. Similarly, a business needs to build out a process in detail and look at where things should be automated, semi-automated, or remain being done manually.
The crux of this entire exercise is having specific details. For instance, if a company wants to have insight into key performance indicators (KPIs), they should know exactly what KPIs they want to measure, how to calculate them, who needs to see the results, how the results should be presented, and what action needs to be taken if a KPI misses the mark.
Going back to the car analogy, a KPI is more than just reporting, it’s having target lines and action limits – like the check engine warning light on your car. When your car overheats and you see the light, you can choose to risk getting off the freeway and driving three miles to service station or pulling over immediately. That should be a decision you have made in advance based on the guidance in your owner’s manual. When you see KPIs going off course, a business should already know the specific process to remedy the problem because if that’s not in place, a company is simply being reactionary, which may be like rearranging deck chairs on the Titanic.
The bottom line is the importance of understanding processes before implementing new technology. Once a business understands their processes, the software can support those processes and provide efficiency exactly where it’s needed.
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