A manufacturer’s success (or failure) relies on its ability to produce a quality product, and companies that produce products with rigorous quality requirements face numerous challenges associated with meeting quality objectives. These can range from the need to comply with quality standards (such as ISO 9001 and cGMP) to operating in highly-regulated and frequently audited environments.
In order to effectively manage the processes, information and other intricacies involved in manufacturing products based on quality and compliance requirements, many organizations employ a quality management system (QMS) to enforce a set of quality processes, resources, and controls.
Among our clients, quality management systems are most often leveraged by companies that operate in highly-regulated industries to help them meet compliance requirements as well as to ensure that quality processes are adhered to throughout the organization. QMS is about giving an organization a set of tools to control their quality processes which can range from document publishing and employee training, to managing audits, issues and risks — as well as tracking the resolution of issues and/or risks.
As Senior Product Manager for Compliance at M-Files, I work with numerous clients to improve their quality systems and processes. Here are the three questions I am asked most often during a customer engagement:
Who should use QMS? In particular, three types of organizations will benefit most by the application of a QMS. The first type is an organization who would like fine-grained control over which versions of documents are used and when they are used. These document types can vary from marketing materials and training materials to standard operating procedures (SOPs) and material data sheets. The second type of organization is one which needs to conduct and/or track audits, issues and risks and corrective and preventative actions (CAPAs). I see this usage most often in highly regulated industries like life sciences. The third type is an organization that needs to be able to easily specify sets of employees that must learn or be informed about new versions of documents.
How does training work? We view training as a matrix. This matrix consists of training materials—which are documents—and the people who must be trained on the materials. The organization’s quality rules determine which staff members must be trained on which materials. For example, a marketing employee must complete training related to branding. M-Files can ensure that the marketing employee is assigned the necessary training documents, and require that the employee sign-off upon completion. The marketing employee’s manager receives a notification about the completed training—and of course, this is all auditable. M-Files provides easy insight about which items each staff member has learned in the past, what they didn’t learn — and what they still might need to learn.
How does M-Files handle training? M-Files QMS offers a robust and elegant configuration of training features and capabilities. In addition to managing and tracking learning requirements, users can also be required in the same way to attend courses that cover multiple documents simultaneously. Additionally, M-Files can also require and track training for people who don’t have access to the system by requiring the instructor to sign-off of on attendance of people at meetings or training events where the documents were being covered.