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.
Whether your current system exists in nu merous file cabinets in multiple departments, or in a cavernous storage area, you have no sure way of knowing whether you can access all the documents you need. Perhaps a researcher found a different use for a file you need now. Perhaps staff turnover caused some files to go missing. Perhaps needed information never was filed in the first instance.
- If your current system exists in a siloed electronic format, the same questions arise: are all the files present and current? How can you be sure?
The role of time
Significantly, part of the new Second Circuit Court ruling specifies: “A hospital may challenge the application of the regulation to bar its application even 15 years after promulgation….”
In a fluid regulatory environment that now enables your company to take advantage of a ruling passed up to fifteen years ago, how strong is your ability to respond quickly?
- In both paper-based and electronically siloed systems, likely intervening staff turnover will affect your ability to pull together all the correct documentation you need, compromising your ability to respond accurately, completely, and in a sufficiently timely manner.
- If you can amass all the longitudinal documentation you may need, consider the staff time you would have to spend to determine completeness, look for and eliminate duplication, and then create the comprehensive package of documentation required.
- Consider the cost, too, of interrupting the staff’s normal workflow and spending time to pull all the documentation only to discover gaps in the data you need. Now that is an expensive system.
The difference good Monday morning quarterbacking can make
You understand, as the team’s quality management coach, that part of your job is taking the occasional step back to review the company’s approach to quality management. After all, in the event of either external or internal audits, you will have called the plays.
Any system designed for document management, training management, and CAPAs can work—but at what cost? Only a cloud-based eQMS system is designed specifically to enable a company to pivot to compliance and to respond to opportunities efficiently, thoroughly, and at the lowest possible cost.
Additionally, an eQMS system is easy to back up, which offers you the assurance you need that all the data will be available whenever it is needed.
- In other words, only an eQMS system optimizes its ROI.
Once you decide to pivot to a cloud-based quality management system, the next step is to bring your financial team on board. Our blog, From the Vocabulary of Quality to the Language of Finance, offers tips to quantify the loopholes in the current quality management process, and successfully present the case for a system that will improve the company's bottom line to your financial team.
The good news is that you need not manage the system transition alone. ZenQMS, an experienced leader in eQMS systems, will gladly assist you in making the financial case to your C-suite colleagues. Let us know how we can help.