What is a Quality Management System?
With inflation driving up the costs of raw materials, more manufacturers realize that it is not enough to compete on price alone. Instead, the most successful manufacturing firms are competing on the quality of their products and supporting services to attract and retain customers while preserving margins.
However, competing on quality requires investments in ensuring that quality metrics are achieved across manufacturing processes and can be documented to maintain compliance with customers’ specifications, as well as any applicable industry standards and government mandates. To automate this process, manufacturers are increasingly turning to a quality management system (QMS).
Defining a Quality Management System
A quality management system, as defined by the American Society for Quality, is a formalized system that documents the processes, procedures, and responsibilities required to achieve quality policies and objectives. It provides a management framework designed to direct and coordinate an organization’s activities toward meeting customer and regulatory requirements, improving production effectiveness, and ensuring continuous improvements in shop floor efficiency. The gold standard in QMS is certification by the International Standards Organization (ISO) for ISO 9001:2015, which details QMS standards.
The ultimate goal of a QMS is to create a product or service that consistently delivers on its intended purpose and meets customer expectations. To achieve this, the QMS relies on real-time production and process data to continually assess how each step in the production process contributes to consistent quality while meeting regulatory and industry requirements. The foundation of the QMS is the quality policy, a brief statement outlining an organization’s overall purpose, mission, and strategic direction. This quality policy serves as the framework for the entire QMS.
By implementing a QMS, manufacturers can systematically define, improve, and control their processes, document quality to assure customers and meet compliance demands, and reduce waste and mistakes while lowering costs.
Let’s look closer at the primary ways that manufacturers are using a Quality Management System today
- Identify quality gaps. A QMS enables manufacturers to identify product and process quality issues using statistical quality management techniques in order to eliminate unnecessary activities and close gaps in performance. Statistical quality control (SQC) and statistical process control (SPC), which apply statistical methods to monitor and control the quality of a production process, are essential for improving the quality of products and services in manufacturing.
- Facilitate compliance. Compliance with customer requirements and regulatory standards is essential to maintaining a manufacturer’s reputation and avoiding costly fines and lost business. In fact, non-compliance with regulatory standards is 2.71 times more costly than compliance, with an average difference of $9.35 million annually, according to a study by Ponemon and Globalscape. A QMS not only helps to identify potential quality issues before they reach the customer; it also streamlines the documentation of supplies, products, and processes to support audits that validate compliance.
- Improve operations. A QMS provides manufacturers insights into where to streamline and standardize their operations, reduce variability and errors that could result in product defects or recalls, and identify opportunities to reduce waste. In this way, it helps manufacturers to maintain consistency and quality standards across their operations, procedures, and processes while lowering production costs.
- Make more informed decisions. A QMS provides an integrated view of how each production process improves quality. This helps manufacturers to collect, track, and analyze data, as well as measure key performance indicators (KPIs) and identify areas that require improvement, in order to make more informed decisions.
- Increase team productivity. A QMS enables manufacturers to establish clear roles and responsibilities, accountability of management, and a defined training system. In this way, it contributes to a more satisfied, informed, and motivated staff, which leads to higher productivity.
- Reduce the cost of poor quality. Manufacturers can reduce the cost of poor quality (CoPQ) by using a QMS to implement effective quality improvement programs for identifying and addressing the root causes of poor quality that carry either direct or indirect costs. Direct costs of poor quality include non-value-added appraisal and prevention, internal error costs such as scrap and rework, or external error costs due to warranty issues. Indirect costs include excessive overtime, sales loss, and brand reputation damage.
- Reduce risks associated with poor quality. A QMS can alert manufacturers to potential quality risks and safety hazards, so they can be addressed before becoming problems. Additionally, it helps to prevent issues from arising in the first place by providing a structured approach for managing quality throughout the manufacturing process and ensuring the same information, methods, skills, and controls are used every time a process is performed. Leveraging a QMS in these ways enables manufacturers to build a strong reputation for quality and reliability while reducing the risks of legal liability and lost business.
Manufacturers who compete on the quality of their products and services have reported that they are not only growing business with their existing customers but also winning out over competitors in attracting new buyers. Increasingly, these manufacturing firms are relying on a QMS to automate many of the functions required to ensure quality.
Using a Quality Management System, manufacturers are quickly identifying potential quality issues related to materials, processes, or products, so they can be addressed before anything is shipped to the customer. This helps to ensure customer satisfaction while reducing costs through greater efficiency and productivity. At the same time, the QMS enables manufacturers to provide customers visibility into their operations and produce any documentation required for compliance, further building the trust that leads to more sales, increased profitability, and higher growth.