Ensuring Quality: The Responsibility of Top Management in Medical Device Manufacturing

Before we begin our discussions of top management responsibility relative to a medical device manufacturer’s quality management system in earnest, let’s take a close look at what a quality management system is.

A quality management system (QMS) is how your organization directs and controls those activities that are related, either directly or indirectly, to achieve its intended results. Broadly, it consists of your organization’s structure and the planning, processes, resources and documents or records you use to achieve your quality objectives (such as meeting your customer and applicable regulatory requirements, establishing and maintaining your QMS, or improving your product).

Risk management (including cyber-security and data integrity) and risk-based decisions are the foundation of an effective quality management system. A simplified “circle of life” of a medical device is depicted in Figure 1. Existing and emerging customer, regulatory, and internal expectations are assessed for risk and input into the product realization process – design inputs include applicable output(s) of risk management. Throughout the device lifecycle, internal and external feedback is assessed through production and post-market surveillance for any indication that device safety has been compromised – i.e., the device is no longer free from unacceptable risk. When feedback indicates a safety concern, the intelligence is fed back into the risk management process for estimation, assessment, and control as necessary – completing the circle of life and beginning a new one.

A medical device manufacturer’s quality management system must strive to achieve - and, hopefully, exceed - the existing and emerging expectations of 1) the customer (including the patient, clinician, and others), 2) regulatory authorities (of the jurisdictions where the device will be authorized), and 3) its internal expectations while maintaining a high level of protection of health and safety to patients, users, or others.

Top management take-home point #1

A quality management system is dynamic and complex. Top management must be prepared for ever-evolving customer, regulatory, and internal expectations; and understand the interactions of the various quality management system processes – particularly the symbiotic relationship between risk management and other QMS processes such as design and development and post-market surveillance. This will allow top management to constantly assess contemporary resource needs and demonstrate a continuous commitment to the quality management system.

Top management take-home point #2

Top management must realize that quality management system requirements are no longer EU and FDA-centric. Global regulatory authorities have developed or are developing sophisticated regulatory schemes that must be understood and complied with if a manufacturer intends to do business within their jurisdictions. For example, if you market or intend to market your device beyond the EU and USA, then EU and FDA-centric internal audits are a thing

of the past. Additional resources, training, and audit time must be considered to meet the evolving regulatory expectations of target markets worldwide – as an internal audit (in addition to confirming internal requirements are achieved) must also confirm that “applicable regulatory requirements” of the jurisdictions where a product will be marketed are achieved.

The benefits of a quality management system can be summarized using the pneumonic “SECURES.” A quality management system secures your organization just as a lock, fence, and guard secure your facility. Will this security fail now and then? Yes. However, a well-established and maintained QMS prepares you to recognize and react to excursions without undue delay.

Secures

1. Safety – Assures devices are and remain free from unacceptable risk.
2. Efficacious – Assures clinical evidence supports device labeling claims, and assures the device does what it is purported to do.
3. Customer Satisfaction – Improved quality of life for patients resulting in satisfied customers, maintains or improves market share resulting in satisfied shareholders.
4. Uniformity – Assures the device is designed and manufactured consistently ‘over and over’ again.
5. Regulatory Compliance – Satisfies existing market expectations, and makes new markets available.
6. Educates – Allows for continuous improvement through monitoring, measurement, post-market surveillance, data analysis, management involvement/review, etc.
7. Self-Assurance – Colleagues understand their responsibilities and authorities, expectations of their roles, understand device defects, etc.

Top Management take-home point #3

Commitment and investment in your quality management system are investments in the quality of life of patients and your brand’s reputation.

Top Management take-home point #4

In the eyes of your customers, regulatory authorities, and others, top management is ultimately responsible for assuring an effective quality management system is established and maintained. Maintaining a quality management system requires vigilant monitoring of evolving customer, regulatory, and internal expectations, and reaction where necessary.

Top management can be defined as a person or group of people who direct and control an organization at the highest level. Top management can delegate authority and provide resources within the organization. Regulatory authorities may hold site-specific top management and corporate top management (among others) responsible when actions are taken based on regulatory inspections or audits.

Regulatory authorities often depict Top Management as the centerpiece of a quality management system as is depicted in Figure 2 below – an FDA depiction. Without Top Management’s commitment to the quality management system and its continued provision of resources necessary to keep up with an evolving customer, regulatory, and internal expectation landscape, QMS gaps may develop leading to erosion of customer satisfaction and/or risks of regulatory action. If risk management and risk-based decision-making are the foundation of an effective quality management system, then Top Management commitment is the keystone to an effective quality management system.

Top management must provide evidence of its commitment to the development, implementation, and maintenance of an effective quality management system.

Communication is key to achieving this expectation. Communicating the importance of meeting customer, regulatory, and internal expectations should be considered whenever top management engages with its team. This can be done during team meetings, town hall meetings, and annual plenary meetings. Top management should also periodically take the time to “walk the shop floor” and other departments, sit in on planning meetings, risk management reviews, design reviews, shift change meetings, daily, weekly, monthly, and quarterly department performance meetings, etc. This allows top management early visibility to any emerging challenges and to celebrate successes with the people responsible for those successes. Walking the shop floor and visiting other departments will also visibly demonstrate top management’s interest in and commitment to the quality management system – something that cannot be done sitting in an office.

Other communication tools include establishing and periodically reviewing a quality policy; ensuring measurable quality objectives (not just business objectives) are established and cascaded throughout the organization; and conducting management reviews. As we learned, a quality management system is dynamic and complex – this means policies, objectives, management review deliverables, etc. will evolve as the landscape of expectations evolves.

Top Management take-home point #5

Top management should lead by example. Top management must clearly communicate expectations relative to quality; and its commitment to quality – and then, visibly demonstrate this commitment throughout the organization.

Another method top management uses to demonstrate its commitment to the quality management system is the provision of resources. Resources must be provided to implement and maintain an effective quality management system as well as to meet customer, regulatory, and internal expectations.

Resources include monetary, human, infrastructure, and others. Top management must stay tuned to contemporary resource needs. For example, adding a new product to an organization’s portfolio through acquisition or internal development may necessitate new resource needs. The new product may represent a new technology that the organization is not familiar with necessitating the need to identify new human resources with expertise in that technology to assess risk, guide complaint investigations, propose design changes, etc. A new product may also necessitate new infrastructure requirements. New regulatory expectations also often lead to resource needs. For example, the FDA’s evolution from the Quality System Regulation to the Quality Management System Regulation may require additional resources or training. Standards used to support your quality management system also evolve – additional resources may be necessary to keep up with these evolving expectations.

Top Management take-home point #6

As we know, a quality management system is dynamic and complex. The resources required to implement and maintain an effective quality management system; and meet customer, regulatory, and internal expectations will change as those expectations evolve.

Proactive top management engagement with its quality management system beats prolonged top management engagement with a regulatory authority any day of the week.

NSF offers succinct virtual instructor-led or face-to-face training targeted to understanding medical device manufacturers top management regulatory responsibilities relative to quality management systems.