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Written by Dawn Gabriel, Ph.D., Director of Quality and Compliance, QPharma
A quality management system can be defined as the organizational structure, procedures, processes, and resources needed to implement quality management in an organization. By establishing a quality management system, a company ensures that its processes are robust, and that its systems function as they were designed while addressing customer needs, complying with applicable laws and regulations, and meeting internal company standards.
The foundation that leads to a comprehensive quality management system has many elements. It is a given, for example, that a commitment to proactive, continuous improvement must be integrated into the culture of any company that strives to maintain an effective system. It is necessary to have the proper expertise on staff, to cultivate a Quality culture, and to keep current on the latest regulation developments, as well as industry best practices and trends. Periodic auditing is also essential, both internally, on the products and services delivered by in-house resources, and externally, on the contractors and other third-parties working on your behalf. Equally important is a validation process to verify that your systems are compliant and function according to specifications.
There is one element that is not part of processes, procedures, or systems, but that I consider an integral component of a successful and effective quality management system: a continuous focus on partnership.
In my career as a Quality Leader, I have always built partnerships with different business functions and units. This is accomplished through spending time with business stakeholders, and by demonstrating — through actions and decision-making — a collaborative and flexible approach to solving problems to meet both compliance and business needs. In a previous position, I received an “Innovators Circle Award” from a senior business leader for the partnership approach I demonstrated in identifying effective solutions to problems.
When colleagues and customers view Quality personnel strictly as an enforcement entity, the relationship between them will not foster compliance and continuous improvement. That is why, when QPharma is helping its clients in the life sciences industry to implement their own quality management systems, I work to instill a culture of partnership in my team that emphasizes the importance of listening carefully, keeping an open mind, and avoiding black-and-white thinking. By adopting this approach, we can help colleagues and customers remember that Quality’s role is to help — and to advance the goals and mission of the organization.
A quality management system can be defined as the organizational structure, procedures, processes, and resources needed to implement quality management in an organization. By establishing a quality management system, a company ensures that its processes are robust, and that its systems function as they were designed while addressing customer needs, complying with applicable laws and regulations, and meeting internal company standards.
The foundation that leads to a comprehensive quality management system has many elements. It is a given, for example, that a commitment to proactive, continuous improvement must be integrated into the culture of any company that strives to maintain an effective system. It is necessary to have the proper expertise on staff, to cultivate a Quality culture, and to keep current on the latest regulation developments, as well as industry best practices and trends. Periodic auditing is also essential, both internally, on the products and services delivered by in-house resources, and externally, on the contractors and other third-parties working on your behalf. Equally important is a validation process to verify that your systems are compliant and function according to specifications.
There is one element that is not part of processes, procedures, or systems, but that I consider an integral component of a successful and effective quality management system: a continuous focus on partnership.
In my career as a Quality Leader, I have always built partnerships with different business functions and units. This is accomplished through spending time with business stakeholders, and by demonstrating — through actions and decision-making — a collaborative and flexible approach to solving problems to meet both compliance and business needs. In a previous position, I received an “Innovators Circle Award” from a senior business leader for the partnership approach I demonstrated in identifying effective solutions to problems.
When colleagues and customers view Quality personnel strictly as an enforcement entity, the relationship between them will not foster compliance and continuous improvement. That is why, when QPharma is helping its clients in the life sciences industry to implement their own quality management systems, I work to instill a culture of partnership in my team that emphasizes the importance of listening carefully, keeping an open mind, and avoiding black-and-white thinking. By adopting this approach, we can help colleagues and customers remember that Quality’s role is to help — and to advance the goals and mission of the organization.
