Quality Management Systems (QMS) Fundamentals


Before doing business in a regulatory environment, one must first have a thorough comprehension of quality management systems (QMS) fundamentals. Automated QMS management systems give regulated companies a huge advantage by electronically facilitating QMS best practices and compliant quality processes.

Watch Related Videos

Download Free Resources
White Paper: Six Ways to Optimize Your Quality Management System and Ensure FDA and ISO Compliance
White Paper: Cost of Inaction - Taking Quality Management Processes Digital
White Paper: The Pros and Cons of Buying Vs. Building a Quality Management System
White Paper: 5 Tips for Getting Executive Backing for a New or Expanded EQMS
White Paper: Noncompliance to FDA Quality Standards: What's the Risk to Executives?
Analyst Report: Closed Loop Quality Management: Connecting the Value Chain (LNS)
Interactive Graphic: Evolution of a QMS
Product Data Sheet: MasterControl Suite Overview
Interactive and Live Demonstration: MasterControl Quality Management System (QMS) Overview
Toolkit: 25 Free Resources to Boost Your Quality Management System


Common QMS Problems

Many companies struggle with quality management systems fundamentals because of recurring quality issues. For instance, a company may have difficulty determining the actual root cause of a quality event. As a result, the company ends up addressing the same event over and over again with ineffective corrective and preventive action (CAPA) processes.

“Death by CAPA,” a frequently heard euphemism for another common quality management predicament, occurs when a company doesn’t have an effective mechanism for differentiating between critical and non-critical issues. When a company lacks the adequate quality management system fundamentals to deal with such issues, they end up running through full CAPA processes that should have never been instigated in the first place. This results in wasted time and increased costs because valuable resources are being focused on the wrong problems.

Another QMS fundamental blunder is workflow inefficiency. Most quality event management (QEM) systems are manual and, invariably, inefficient. They demand the dedication of an exorbitant amount of time and resources just to search for, retrieve, route, and approve documents during audits and inspections.

Collaboration on key quality data and the execution of quality tasks becomes increasingly complicated when systems, tasks, and personnel are disconnected. For instance, a CAPA is often triggered by an out of specification event, a customer complaint, or a trend analysis. When a manual system is in use, these sources are disconnected, making data collection slow, incomplete, or—even worse—inaccurate.

The inability to track and monitor CAPA cases is another common quality management system fundamental problem that can result in the delayed resolution of issues. Without a consistent and integrated reporting system, managers lack visibility because they are unable to see the quality management system’s “big picture”. To compound the problem, by the time reported data makes it through a manual QMS, it is often obsolete.

The Solution: A Solution Based on Quality Management System Fundamentals

A state-of-the-art quality management software solution allows a regulated company to enhance the efficiency of its quality systems while also ensuring that those systems are also compliant, connected, and cost effective. A proven QMS management software solution is a vital component of maintaining quality management system fundamentals and achieving regulatory compliance. Plus, QMS software can be invaluable in helping companies keep pace with industry trends. Companies may vary in scope and size, but if they’re doing business in environments where regulatory bodies are pushing toward the usage of electronic systems, they all need effective quality management software solutions to enhance and harmonize their overall quality processes.

An automated QMS management system also connects all departments, product lifecycles, and quality processes. User-friendly quality software systems help simplify, streamline, and effectively manage quality control processes. An electronic system’s ability to automatically route tasks and escalate them when necessary ensures that task completion, approval cycles, and inter-departmental input occur in a timely manner. Plus, when quality is built directly in to the QMS system, every department—from engineering to quality assurance and manufacturing to regulatory —stays connected.

A QMS software solution helps companies overcome the common challenges discussed above and also establish solid quality management systems fundamentals. Consider, for instance, that an electronic system can help users effectively determine root causes by providing problem-solving algorithms based on critical thinking logic, thus preventing those issues from reoccurring. Electronic QMS systems connect processes and propagate the CAPA process throughout the entire organization. The resolution of a CAPA, for example, can cause the system to automatically trigger a change control that prompts a change in a standard operating procedure (SOP) and coordinates retraining of employees on that SOP.

MasterControl Covers All the QMS Fundamentals

MasterControl’s compliance-focused QMS management software brings all documents- and forms-based quality processes together within a united, secure platform. It guarantees that users have instant access to an electronic quality management system that practically runs itself. In addition to the core MasterControl Documents™ module, MasterControl also offers other valuable software solutions to companies doing business in regulatory environments, i.e., MasterControl Audit™, MasterControl CAPA™, MasterControl Change Control™, and MasterControl Customer Complaints™, MasterControl Process™, MasterControl Training™, and other related applications. To complement its robust software offerings, MasterControl also provides a wide range of implementation, migration, validation, training and technical support services.

When a QMS management system supported by MasterControl’s quality methodology is implemented, all departments throughout the enterprise can execute required tasks and no single department is at fault for the company’s failure or success. On top of the assurance that MasterControl solutions are covering all the necessary quality management systems fundamentals, customers also get the peace of mind that MasterControl will give them the compliance results their organizations demand. In fact, hundreds of companies around the world rely on MasterControl to help them meet regulatory requirements such as the FDA’s 21 CFR parts 11, 210-211, 820, and 606 and ISO quality standards such as ISO 9000, ISO 13485, ISO 14000, and ISO/TS 16949.

Automated routing, escalation, approval, and tracking are other valuable benefit of MasterControl. In addition to those benefits, MasterControl’s web-based platform features advanced analytics and reporting capabilities, streamlined root cause investigation procedures, an efficient risk-filtering “gateway” process, integration with training programs, and the availability of best practices QEM training and consulting from a world-class team of industry professionals.

With the right set of QMS management tools like those offered by MasterControl, companies can improve both quality and speed to market. MasterControl meets quality management system fundamentals and makes it possible for companies to manufacture more products of a higher quality at a greatly reduced cost.

To learn more about MasterControl’s quality management systems, contact a MasterControl representative.