ZenQMS Blog

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.

The true costs of paper based Quality Management Systems are shocking. Investing 6 figures and 12 months to fix that problem can be shocking too. ZenQMS can solve your run-away costs faster than you realize and with an Instant Return on Investment. Take a look at this infographic which outlines many of the costs of a paper based Quality Management System

The true cost of paper-based quality management systems is quite varied when you consider that using paper creates a vast ripple effect on companies. It extends all the way from how papers get filed to how a manager communicates with employees. What's problematic is some of these costs are possibly invisible until you fully understand the duties of your document manager.

That's why it's important to always analyze your company and processes if you've used paper documents for years. You may discover certain procedures your managers and other employees use out of habit cost you more money and time than you realized.

While there has been some debate about the security of data stored in the cloud, the reality is that there is a great deal of emphasis put on ensuring security with cloud applications.

The real question that you should be asking is, "Is your QMS at risk if it is not in the cloud?" The answer to that question is, "Absolutely." Why can that be said?

Paper-Based Systems and Business Continuity Planning

Organizations that use on-premise, paper, and spreadsheet-based quality management systems face a challenge when designing a viable business continuity plan.

An essential part of a comprehensive risk management strategy, a solid business continuity plan is designed to protect the assets and processes of a business in the event of a crisis or disaster.

Ignoring the necessity of a business continuity plan puts a company at considerable risk. At the least, a disruption in business processes caused by a disaster event may cause you to lose clients. At the worst, it could spell the end of your business entirely.

According to FEMA estimates, 40 percent of businesses do not reopen following a disaster. On top of that, another 25 percent fail within one year. These statistics underscore the seriousness of failing to adequately plan to protect your business in the case of disaster.

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.

Government requirements from the Food and Drug Administration to regulators such as the International Organization of Standards (i.e., ISO 9001) mandate that companies execute and thoroughly document employee training. These requirements ensure that employees know how to do their jobs in a way which will meet industry guidelines. The documentation provides a paper trail that can be audited to find gaps in the training. The system will minimize the risk of noncompliance with quality and safety standards.

Here's where the gap between automated computer-based documentation and paper based systems documentation becomes glaringly apparent. Post hoc explanations are of little value when an important gap in training leads to a mishap. The system auditor will look at the record. Auditors will need documented proof of compliance with training standards. Paper documents are hard to trace and collect and for the auditor "if it isn't documented, it didn't happen." 

What is the Cost of Poor Quality? Analyzing What Needs Improving to Save You Money

Figuring the cost is of poor quality in your company is neither an easy or enjoyable task, yet it's necessary to factor into the cost of overall quality to manage compliance. The only way to get a complete 

picture regarding the cost of quality is by calculating the sum of both good quality and poor quality for a bigger picture of where your problem areas exist. It's nearly impossible to assemble this on your own without using an electronic quality management system (eQMS) to help you get organized.

With Quality Management Software (QMS), you can identify all quality costs in order to identify vulnerabilities. Because of the complexities involved in what could be costing your company money, you need tech that helps you piece everything together to find answers of why poor quality exists. 

In many cases, you could be losing money without knowing it in various areas you haven't yet audited. With that in mind, let's take a look at the cost of poor quality and why maintaining a higher percentage of good quality is a smart goal to set for the coming year to save you money.

The life of a training supervisor in a paper-based system isn't an easy career when stuck in a situation that has no efficient way to manage a regulated environment. Your own training supervisor arguably has the most stressful job of all when you realize the magnitude behind keeping training records up to date. However, that's only starters once you place other aspects behind training management into perspective.

Paper-based quality management systems are fairly common, especially in small to mid-sized operations. Three years ago an estimated 80% of managers were using spreadsheets and word processors to manage their auditing and compliance systems. These systems require a steady flow of paper documents from office to office. Whereas, paper-based systems may be minimally sufficient for managing product and process quality, they are prone to error and significantly increase the risk of non-compliance when production is regulated. The rigidity of paper-based Quality Management systems makes them a bottleneck that impedes progress as a company grows.  

Problems with Paper Based Systems:

• Poor document control. In a paper-based system documents are often opaque to all except the person filling them out.Any change in standard operating procedures means that a manager will have to go from office to office to track down the progress of documents that might be stuck somewhere in the review cycle. Manual documents can be prone to copy errors that are difficult to check. Such errors can make cause accidental compliance violation.