Product quality management software aims to automate and streamline the quality control process throughout the entire product lifecycle, based on compliance regulations and manufacturing standards.
More commonly referred to as quality management system (QMS) software, this category of software solution is designed to help businesses—specifically manufacturing and development teams—evaluate and maintain the quality of all produced goods, as well as the customer experiences. This kind of system is primarily used to define and implement product quality specifications according to customer requirements in compliance with standard operating procedures (SOPs) and industry-specific regulations. Product quality management tools are typically used by quality professionals, allowing them to conduct inspections as well as produce documentation and reports on product-related issues.
Product quality management software is also often used by product managers for implementing preventive and corrective actions, for optimizing the product quality planning process, as well as for managing continuous improvement initiatives for previously released products and/or professional service applications. For manufacturing and supply businesses, QMS software can be used for auditing the production process of a product, from beginning to end. The software system can help companies avoid a number of potential risks and issues through proper risk management. It can also help streamline various business processes and boost revenue by improving customer satisfaction.
A quality management system (QMS), or product quality management software, comes in many different shapes and sizes, from generic QMS with basic features and capabilities to enterprise quality management systems (EQMS) that offer greater scope in terms of functionality and usability, helping large businesses and enterprises with globalization by improving their quality control capabilities, as well as their document management and supplier management practices across the entire supply chain.
QMS software is used by quality professionals in conjunction with other software applications such as manufacturing software and/or manufacturing resource planning (MRP) systems. These software solutions can be implemented for general use by all types of manufacturing companies or they can be utilized for industry-specific quality management capabilities such as in chemical or pharmaceutical manufacturing.
Product quality management software, at its core, is a formalized system that records the various processes, tasks and responsibilities for realizing product quality plans, policies and product goals. It facilitates the coordination and direction of an organization’s initiatives and actions to meet both customer and regulatory requirements. The software also helps with improving the efficiency and quality of a product on a continuous manner.
One of the key approaches to product quality management systems is ISO 9001:2015, which is the international standard that specifies the requirements for quality management systems or QMS software. Although there are people who may use the term QMS to describe the ISO 9001 standard, or even the group of documents that specifically details the QMS, the term refers to the entirety of the quality management system itself. The documents detailing the QMS, in fact, only serve to describe or refer to the system.
However, QMS is not only limited to the ISO 9001:2015 standard. There are other standards that are also related to product quality management software, such as the entirety of the ISO 9000 series, the ISO 14000 series for environmental management systems, ISO 13485 for medical device QMS, ISO 19011 for auditing management systems and IATF 16949, which is a QMS for automotive-related products.
Quality management systems are equipped with a wide variety of features and tools designed to help businesses and organizations with implementing better quality control over their product development process, from the beginning stages all the way to product launch. One such feature is document control, which serves as a secure repository for documents containing the company’s best practices and standard operating procedures regarding product development. This function also provides key procedures, instructions and records for any risk evaluation and management.
Product quality management software also works to define and document expectations and deliverables for various core processes such as new product launches or introductions, employee training management and customer support services. By having the ability to efficiently track support tickets, preventive and corrective action forms, as well as other regulatory compliance elements, the software is able to grow and evolve with the organization, especially as new products are developed and launched or when the company itself tries to evolve in an effort to adapt to the current marketplace.
Compliance control is undoubtedly one of the fundamental functions offered by quality management systems. This particular component includes a wide variety of tools for scheduling, planning, documentation, auditing and reporting. All these tools are meant to ensure that all product development processes and strategies adhere to organizational policies, industry requirements and regulatory standards.
Corrective and preventive action or CAPA is another important feature that is crucial to every product quality management software solution in the market. Corrective and preventive actions are invaluable in providing a solid structure for what is effectively at the center of an organization’s manufacturing and developmental inefficiencies. QMS software helps companies with managing and keeping track of their CAPAs by automatically routing customers’ complaints and all corrective and preventive actions to quality managers and other qualified personnel with the expertise to create an effective workflow to quickly identify the root cause of a specific product-related issue.
Over time, the data collected by the quality management system can be broken down and analyzed in order to identify key improvement areas, such as safety initiatives, the redesign of the procedures and possible equipment or material changes.
Speaking of changes, change management is also a useful feature of product quality management software. Good QMS platforms are equipped with features and tools that can transform the change management process to make it more efficient and streamlined within the organization. With a change management function, product managers and quality professionals will have the ability to document the changes that are occurring during the product development process, create a summarized report as well as develop the necessary action plan.
Change management will also help product managers identify the potential impact of a proposed change and provide the appropriate workflows for all individuals and teams that have to make all the necessary changes.
The other inherent features of quality management systems are inspection management, audit management, compliance management, supplier quality control, employee training management, statistical process control, risk management and analysis, workflow management, customer complaint management, approval management, quality planning, document management, as well as reporting and business intelligence.
Good product quality management software focuses on facilitating business requirements and the complexities associated with the entire product development lifecycle. This particular management system is designed to serve different highly regulated industries, such as life science, biotech, pharmaceuticals and medical services products.
A robust and feature-rich quality management system is capable of fully evaluating an extensive set of standard operating procedures, processes and policies for any organization. By leveraging this innate software ability for proper evaluation, companies can work to enhance the different key business aspects of the organization, such as customer service, product development and production/manufacturing.
Among the key benefits of product quality management software is improved documentation. This is arguably one of the most significant benefits of using QMS software, its potential to enhance the documentation of all business, manufacturing and production procedures and processes. The system will provide users with a central repository for all relevant documents, which reduces potential security risks and increases visibility.
Another important benefit of using the right QMS software is ensuring strict and consistent regulatory compliance. Manufacturers, suppliers and development companies are typically subject to an overwhelming number of regulatory standards, especially when they’re operating on a global level. Depending on the industry they operate in, these regulatory standards can include ISO 9001, ISO 13485, NERC, HAACP, FDA, Title 21 CFR Part 11, etc. The ability to ensure compliance in any or a few of these regulatory standards is paramount to the continued operation and success of a company.
Risk analysis and reduction is also a key benefit of implementing good product quality management software. Product defects, errors, recalls, unexpected service work, customer complaints and lawsuits—all contribute to the sure decline in revenue and financial health of your business. The role of quality management systems is to prevent or minimize the occurrence of these scenarios and instead provide a better experience for all your customers. Proper quality management provides a strong chance for your organization and your development team to successfully avoid these risks, so they can focus delivering products with the highest quality possible.
QMS software doesn’t just provide the functional solutions and tools needed to effectively manage and aim for the delivery of better products with less issues. This type of software also offers analytical tools to help quantify the potential financial risks associated with quality exceptions.
Product quality management software provides a robust framework for both product and service development that optimizes for the implementation of continuous improvement of quality. The system provides quality professionals and development teams with an effective and practical approach to delivering quality products with great potential for continuous improvement, which benefits customers and end users.
Quality management systems are equipped with tools that enable companies to address specific product-related challenges, such as continuous change, the potential increase of reworks in production, potential errors incurred due to manual data entry, as well as the potential loss of customer usage data, requirement changes and customer feedback.