|Is your QMS primitive, civilized or somewhere in between?
Quality management systems (QMSs) have steadily evolved over time. The sophisticated systems of today are a far cry from the primitive paper-based systems of the past. They're faster, leaner, greener and just plain better. How did we get to where we are today? And is your company at the top or bottom of the QMS evolutionary chain? View the infographic, or keep reading to learn more about the evolution of the enterprise QMS.
Emergence of the Manual/Paper-based QMS
While quality management practices have been around since the Middle Ages, the quality management systems we think of today started to emerge in the 1920s.1 Driven by the need to ensure customer satisfaction and safety, as well as product quality, companies began to standardize and formalize their production policies and procedures. This involved adopting manual or paper-based methods to document product information and carry out a slew of quality-oriented tasks.
This article is related to the Infographic:
Evolution of a QMS
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As companies began to manufacture more products, a more sophisticated algorithm was needed. Thus, the concept of total quality management (TQM) was born. TQM switched the focus from merely inspecting the end product for problems to preventing problems during production. Although TQM was developed in the United States, Japan soon adopted, and even improved, its principles.
At the first international quality management conference, held in Tokyo in 1969, Japanese quality management pioneer Kaoru Ishikawa proclaimed that quality was the responsibility of all employees within a company—not just the quality department. Ishikawa’s proclamation was somewhat revolutionary at the time. Even today, many companies fail to acknowledge that quality is—or should be—a company-wide effort. According to the 2013-2014 LNS Quality Management Survey, completed by more than 500 life science executives and senior leaders, this misconception is one of today’s top five quality management challenges.2
|Some view quality as a department, not a process.
In the ’70s and ’80s, growth and change began to expose the deficiencies of the paper-based QMS: it's inefficient and prone to human error and data silos. Still, it was only system available at the time.
Fortunately, times have changed—largely driven by the emergence of sophisticated IT tools—but many companies have not.
According to LNS, 77% of regulated companies still rely on primitive paper processes—“technology” that’s almost 100 years old—to stay compliant. Even more surprising, 78% of these same companies admit to existing in a state of quality management disconnect, using a variety of fractured data sources for managing quality.
Point/Homegrown Systems and the Build vs. Buy Dilemma
Companies who decided to take advantage of new technology to maintain quality faced a dilemma: Do we need a point solution or an enterprise platform? Is it more cost-effective to build or to buy?
A point solution addresses a particular need such as document control or CAPA. It is offered as out of the box, configurable off the shelf (COTS) or tool kits. While digitizing some of your quality processes and functionalities is preferable to relying solely on paper, a point solution has limitations. It offers no connectivity, forcing you to manage the flow of data manually, which in turn forces your IT department to support multiple platforms. The more point solutions you use, the more difficult and labor intensive this becomes, and the less visibility you have into quality performance across your value chain. According to LNS, real-time visibility translates into a 10% higher rate of successful new product introductions; a 5% improvement in manufacturing OEE (overall equipment effectiveness), and a 2% improvement in customer complaints. In other words, it's not something you want to do without.
A homegrown solution is a step up from a point solution, but it requires a significant time and resource investment to build, integrate and maintain. “Building” a homegrown QMS means you will develop the system in-house, possibly with the help of consultants. You may write your own software from scratch, or use templates as a framework. Building has its advantages, but it also presents unique challenges and raises important questions: Will you build it yourself or work with a consultant? Who will write the software? Will it be reliable? Will it fulfill regulatory requirements? Will it scale? Will routine maintenance consume too much precious IT staff time? Ultimately, will it work?
Point/Homegrown solutions are more evolved than paper, but their limitations will eventually force you to migrate to a tool with broader offerings like an enterprise QMS. An enterprise solution allows you to address an immediate need with a point solution and add solutions within the same platform as needed. It can integrate processes and connect different terms for improved visibility and a more unified approach to compliance. LNS reports that 40% of regulated companies without an enterprise QMS plan to implement one in the near future.
|Projected QMS adoption rates.
Benefits of an Enterprise QMS
If your business has taken the evolutionary leap from a paper or point solution to an automated one, you are among the 22% of regulated companies enjoying the proven business benefits of closed-loop quality management. These benefits include increased efficiency; connectivity to other sites; lower total cost of ownership (one complete, connected solution requires only one validation, which increases ROI); and better quality management and compliance. Listed below are some additional benefits taken from my post “Making the Business Case for Implementing an Enterprise QMS.”
- You’ll save time—lots of it: Manual or paper-based systems are time-consuming, inefficient and error-prone. These issues are compounded when your teams or suppliers are geographically dispersed. By making data available across the enterprise in an easy-to-access central repository and allowing employees to view the information in real time, compliance simply becomes an everyday part of doing business.
- You’ll improve profitability: When you save time, you save money. Whether you save that money by avoiding costly product recalls or cutting your corrective action cycle time in half, you have already seen a return on your software investment.
- You’ll improve agility: Being agile means being able to respond swiftly and adequately to change, which is inevitable on highly regulated business environments. Implementing change manually can be a tedious endeavor, but an enterprise QMS can streamline the entire change control process. Geographically dispersed employees or virtual teams can access documents, enter data and initiate changes from any location, allowing for faster turnaround.
- You’ll deliver safer, higher quality products: Managers in best-of-breed life sciences and manufacturing companies are realizing that a robust QMS solution supports the next generation of quality management, which views improving product safety and efficacy as important as satisfying regulatory requirements. Automating your quality processes will help you produce and deliver higher quality products to your customers.
- You’ll attract (and retain) more customers: As consumers become more sophisticated and demanding, only organizations that can demonstrate and sustain product superiority will be able to win sales and retain customers.
|Most adopted and useful QMS functionalities.
Don’t Just Survive, Thrive
No doubt implementing an enterprise QMS gives you a competitive edge. However, not all enterprise systems are created equal. Few provide all of the tools and advanced features required for comprehensive, closed-loop quality management. If you are planning to implement an enterprise QMS, make sure the solution you choose includes functionality for document control, employee training, CAPA, and other essential quality modules (see graph on left), or you may end up regretting your choice.
How evolved is your current QMS? Leave a comment below or interact with me on LinkedIn.
Lisa Weeks, a marketing communications specialist at MasterControl, writes extensively about technology, the life science industry and other regulated environments. Her two decades of healthcare marketing and advertising experience include work with McNeil Pharmaceuticals, SAP AG, SCA Mölnlycke Health Care, Crozer-Keystone Health Systems, and NovaCare Rehabilitation/Select Med.
(1) The History of Quality Management, http://qualitymanagementsystem.com/total-quality-management/the-history-of-quality-management/ (accessed March 10, 2015).
(2) "Closed-Loop Quality Management: Connecting the Value Chain," LNS Research Report, LNSResearch.com, 2014.