What is a Quality Management System?
What is a quality management system (QMS)?
A modern quality management system is a workflow-based software platform that delivers a centralized means for tracking, managing and controlling product quality. Additional elements, including sensors and other hardware and software components, feed critical data from the manufacturing lifecycle into the QMS. Prioritizing quality within the overall PLM strategy will drive an array of positive business outcomes.
What is the purpose of a quality management system?
More specifically, the purpose of a QMS is to centralize, integrate, and automate an array of data streams and work processes critical to safeguarding and advancing product quality. These may include document control, audit management, supplier quality, non-conformance tracking, corrective action, and even risk management. Most QMSs are also designed to facilitate and continuously improve ongoing training processes.
The benefits of quality management systems
By formalizing and centralizing all the business processes required to continuously improve quality throughout an organization, QMSs generate a myriad of benefits to manufacturers and their customers, most critically the ability to more consistently meet the customer's requirements.
Improved quality
The first and most obvious benefit is improved product quality, which in turn feeds a higher-quality customer experience overall. The downstream effects of this include the reputational strength that accrues over time as a manufacturer consistently delivers fully compliant orders, on time and on budget. A QMS also provides the ability to track quality and control related workflows to specific standards, which is also necessary to meet compliance in more regulated industries.
Reduced costs
Sub-optimal quality management is expensive – and it’s an unnecessary expense. A QMS that properly streamlines relevant manufacturing processes can drive down these costs. Higher first-pass yields, reduced rework, less scrap, and fewer field failures all bolster financial performance and improve customer satisfaction.
Increased communication and collaboration
A sound approach to QMS deployment starts with a single source of real-time information, accessible to every stakeholder when and where they need it. The QMS’ centralization and automation of quality data and activities across an enterprise eliminates internal friction, streamlines collaboration, and allows for lessons learned to be applied systematically across a product portfolio.
Identification of future training opportunities
Regardless of how much time and energy is invested in improving quality management systems, the “human factor” can introduce unpredictable variables and inconsistent processes, absent effective staff training. A QMS can improve employee training, ensuring appropriate and sufficient instruction in the context of an employee’s role, education level, location, and department.
Furthermore, a well-provisioned QMS will provide the ability to track the results of proficiency tests so you can keep your staff well-calibrated to the needs of the system, individually and as a team, and to show compliance to regulatory training standards in your industry.
Prevention of risks and mistakes
Effective risk management is a critical aspect of quality control. Risk-based decision making is essential in quality control and can be an effective tool for determining whether a body of work has adequately reduced the risk of a given approach. Your QMS should enable the development of risk management tools within any process, such as decision trees, risk matrices, and bowtie analyses.
What are the different types of QMSs?
As an enterprise considers its approach to quality management, many different types of QMSs exist to address the needs of the particular business and its goals. However, the difference in these systems usually comes down to the inclusion of industry-specific tools and processes that are required to meet regulatory compliance or customer expectations – more on that to come. It’s also important here to distinguish between two principal approaches to managing quality: quality assurance and quality control.
Quality assurance is the preparation and establishment of a systematic approach to quality that is used internally and shared externally with customers and other third parties to provide confidence that the product or service will meet expectations and/or regulatory standards. Quality control, on the other hand, is the reactive process by which goods and services are inspected, that data is analyzed, and, if necessary, changes are made to ensure that products and services indeed meet said requirements.
What are the main elements in a QMS?
The main elements of a QMS include an interdependent set of processes, tools, and metrics. Each system will differ in its specific components and capabilities, as it’s tuned to the needs of the business and customers. Among the most common elements subject to standardization, centralization, and automation via QMS are the following:
Internal processes
Internal processes are under the most immediate purview of the manufacturer. Thus, they often present the most immediate path to quality management per se, and the benefits in speed, compliance, and agility that a QMS can fuel. Targeted functional capabilities within the QMS address specific activities and are generally delivered by discrete modules integrated within the overall system.
Corrective and preventative action (CAPA)
Corrective and preventative action processes are foundational to most QMSs. CAPA is intended to enable the enterprise to rigorously investigate failures, determine their root causes, and implement change management to prevent identified or similar failures in the future.
Document control
Effective management of quality documents is also fundamental. The QMS must establish best practices for the definition of document types and ensure that only correct versions of documents are circulated and accessible to the right staff members.
Document control processes must also protect sensitive IP. Tracking of training, compliant electronic signature capabilities, change control, and overall enterprise collaboration are all fueled by strong document control systems within the QMS.
Control of records
The secure creation, collation, and control of secure, auditable records must also be handled in a systematic fashion. This ensures that successful processes and practices can be replicated where appropriate, and that the history behind any failures is complete and accessible as required.
Risk management
A strong quality management system, particularly when well-integrated within an organization’s broader PLM strategy, helps manage operational risk across the entire product lifecycle. Failure mode and effect analysis (FMEA) capabilities are central to risk analysis, management, and mitigation, helping identify potential failure modes in a system, and their causes and effects.
Control of nonconforming product
Non-conformance management within the QMS eliminates the time-consuming, disconnected, and expensive manual processes that characterized an earlier era in manufacturing. Users benefit from enhanced visibility across many potential sources of quality issues and the actionable insights this provides.
Internal nonconformance
Internal nonconformance management targets issues related to manufacturing or other internal processes, allowing these to be more quickly resolved than otherwise. Root cause analyses, for example, can be coordinated with necessary PLM changes.
External nonconformance
Quality issues may also arise based on external nonconformances that originate elsewhere in the supply chain, beyond the manufacturers’ direct control.
Industry specific features and configuration models
The complexities of quality management have necessarily led to the development of industry-specific models targeting the specific quality challenges of a given manufacturing domain.
FRACAS (A&D)
Defined by the US Department of Defense in 1985, and widespread among A&D manufacturers, a FRACAS system (for Failure Reporting, Analysis, and Corrective Action) is a closed-loop management system that reports, identifies, organizes, and tracks the process by which quality problems are handled. It provides a means to classify and analyze failures and plan corrective actions in response.
8D (automotive)
In the automotive industry (as well as in healthcare, retail, finance, and other domains) quality systems are often configured around the “eight disciplines” (8D) problem solving process. These disciplines include planning; using a team; defining the problem, developing an interim containment plan; determining and verifying root causes, choosing correction(s); implementing and validating corrective actions; and taking preventative measures.
Training management
As mentioned above, training of staff is essential to consistently produce a quality product. In fact, the 2023 report “The Future of QMS in Industrie 4.0” from Dozuki cites the eye-opening statistic that 85% of all quality issues are caused by worker errors. Quality training also helps refine a company’s competitive edge, boost operational efficiency, and profitability.
Furthermore, various international standards (e.g. ISO 9001, 9002, and more) require manufacturers who seek that designation to maintain and document appropriately robust training programs. It stands to reason that training tracking and management is a crucial feature for an effective modern QMS.
How to implement a QMS?
Implementation of a QMS requires the manufacturer effect a clear series of steps or stages, largely sequential but with some concurrent feedback loops. The QMS system will encompass and automate these stages of activity for each product, ideally within the context of, and integrated within, the overall PLM strategy.
Design and build
First, you must understand your quality management needs based on how your products are designed, sourced, manufactured, and used – this includes explicit industry-based QMS requirements. These needs will dictate the design of your QMS system in terms of the elements described above. Having established that design, you can build a QMS system to meet it using a combination of out-of-the-box capabilities and custom configurations where necessary.
Deploy
Deployment is the set of all activities that make the QMS available to your enterprise for use. The magnitude of this workload will vary based on the design of system and the deployment model of choice. For example, On-premises or DIY cloud deployments will require significantly more back-end work than a SaaS option.
Control and measure
With the QMS deployed, quality activities and documents are generated – according to the standards identified in the design and build phase – to manage and control the end-to-end quality processes. Overall performance, both manufacturing process and the product itself, is rigorously measured and results recorded.
Review and improve
Thorough and ongoing review of those results leads to ongoing quality improvements and design enhancements, closing the loop and setting up the organization for continuing improvements. This is also an opportunity to evaluate the effectiveness of your overall QMS strategy, and to determine what changes, if any, need to be made.
The future of quality management systems
The future of quality management systems in manufacturing is being shaped by several technology trends that have emerged aggressively over the last several years and are gaining momentum.
- The remote work trend triggered by the COVID-19 pandemic, though now dissipating, is nevertheless energizing the digitization of QMSs, making them more adaptable and accessible across various geographies.
- Industry 4.0 technologies like artificial intelligence (AI), machine learning (ML), augmented reality (AR), and the Internet of Things (IoT), are being adopted rapidly and are poised to revolutionize QMS. These technologies provide real-time insights, predictive analytics, and enhanced automation capabilities that significantly improve product quality and reduce errors.
- The increasing demand for sustainability is pushing manufacturers to incorporate environmental considerations into their QMSs, driving the adoption of circular economy principles and green manufacturing practices.
- Supply chain transparency is an increasingly widespread trend, being driven by the need for improved traceability, ethical sourcing, and communication among partners.