Management Responsibility

Management Responsibility is about an leadership obligation to serve the people you manage, so they can continually provide high-quality medical devices for the patients and users the company serves. 

To be ‘responsible’ is to have an obligation to do something, or having control over or care for someone, as part of one's job or role. Every single person who works within the medical device industry bears some level of responsibility for the safety of the people who are the patients and users of the devices provided by the company for their care. That is truly a significant responsibility. There is, however, a significant difference in the level of responsibility, and accountability, between the people who control the company and the people who execute the everyday work within the company.

At the top of every organization there exists a management structure that identifies the individuals who are responsible for controlling and overseeing the entire organization. These are the people who develop goals, strategic plans, company policies, and make decisions on the direction of the business. These people are considered to be ‘top management’, and it is these individuals who are responsible for ensuring the Quality Management System (QMS) is capably designed and properly executed to fulfil the company’s obligation to ensure the safety of the people who are the patients and users of the devices provided for their care. Stated in another way… there are people who are responsible to make sure the system works, so that the people who work within the system can provide high-quality medical devices for the people who need them. People. Management responsibility is about people. Management responsibility is also about the system that good people use to do important work, resulting in high-quality medical devices. So how does top management ensure the system works for people working within their organization?

 “Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives.”   - origin unknown

I use this quote often because I believe it to be accurate and succinct. The “high intention, sincere effort, intelligent direction” must come from top management… those who are responsible to ensure that the “skillful execution” of the organization’s system, by the employees who work within the system, will yield high-quality results.

Responsible management must ensure the QMS is well designed and defined. Such a system must then be capably executed, measured, monitored, analyzed, reported, and reviewed to enable top management to address the constraints and issues of an the system. It is up to responsible management to ensure that this type of active management of the QMS exists, separate and beyond the ongoing execution of the system.

Top management is responsible for the creation, maintenance, and continual improvement of the Quality Management System to enable the people within their organization to come to work every day, day in and day out, and execute their defined work within a system that was designed to be compliant, effective and efficient. Such a system enables the company’s employees to fulfill their obligation to the company, and enables the company to fulfill its obligation to the patients and users who count on their products for safe and effective patient care.

The medical device industry utilizes the EN ISO 13485:2016[1] standard to define the foundational requirements of a Quality Management System (QMS). The documentation of a must include, at the top level, a Quality Manual. A Quality Manual is a policy level document that defines the structure of the QMS and serves the purpose of being the overarching document, or road map, that connects all of the component elements within the QMS structure. All to often, however, it seems that the element of management responsibility, 13485:2016, § 5.1 through § 5.6, is not given appropriate attention within the Quality Manual that establishes the top level policy of the Quality Management System.

The remainder of this paper is intended to provide both structure and guidance for the creation of the Management Responsibility section within a Quality Manual, that can be utilized to actively manage ‘quality’, utilizing a more technical and less superficial approach to management responsibility.  Each section will contain both policy and discussion elements that reflect the paradigm and opinion of this writer, nothing more. However, these were formed from significant experience and may hold meaning for those Quality Management Professionals who are working to improve the ‘quality’ of medical devices offered by their organization to the healthcare market.  

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5 – Management Responsibility

The responsibility of top management is to ensure a QMS that is built in accordance with the structural requirements set forth in 13485:2016 § 4 (Quality Management System), defined in accordance with13485:2016 § 7 (Product Realization), and resourced for execution in accordance with 13485:2016 § 6 (Resource Management), and managed in accordance with 13485:2016 § 8 (Measurement, Analysis and Improvement).

While activities can be delegated, responsibility for the QMS cannot. specific requirements of management responsibility within the standard are further defined per 13485:2016, § 5.1 through § 5.6, below.

5.1 – Management Commitment

Policy

Top Management provides evidence of its commitment to the Quality Management System (QMS) by meeting the requirements of this section within 13485:2016 § 5.1 (a-e), actively ensuring the ongoing effectiveness of the system in accordance with 13485:2016 § 8, describing measurement, analysis and improvement requirements, and ensuring the requirements within 13485:2016 § 6, resource management, are consistently met.

Discussion

Quality management (the management of quality) is an active endeavor that requires the sincere and personal commitment from top management. If top management cannot demonstrate commitment to the organization’s QMS, it would be inappropriate for them to expect the employees of the organization to be committed to the QMS.

5.2 – Customer Focus

Policy

Top management ensures that customer requirements are determined and met by actively ensuring requirements are met in accordance with 13485:2016 § 7.2, describing customer-related processes.

Top management ensures that applicable regulatory requirements are determined and met by actively ensuring QMS is designed to satisfy applicable regulatory requirements, by ensuring the ongoing effectiveness of the QMS in accordance with 13485:2016 § 8, describing measurement, analysis and improvement requirements, ensuring the requirements within 13485:2016 § 6, resource management, are consistently met.

Discussion

Customer focus = patient-centric

The formula for a responsible patient centric approach within the medical device industry fundamentally resides in the ability to foster an organizational culture to strategically measure, manage and improve the quality of process and product. Otherwise stated, a patient-centric quality culture requires a strategic approach to quality management that can be applied individually to the work of every single person who contributes the quality of products and/or process, and of which the results are capable of being measured both individually and collectively.

5.3 – Quality Policy

Policy

Top management ensures Quality Policy requirements are met in accordance with 13485:2016 § 5.3 (a-e), and per § 5.4.1, quality objectives.

Discussion

A Quality Policy can be very inspiring when properly established within an effort of establishing a culture of quality, however, it can be a meaningless and useless tool if superficially established, and not associated with the quality objectives established within the organization per § 5.4.1, quality objectives. A quality policy should be something every individual who works within the company can internalize. Here is an example:

‘I ensure the quality of patient-care through the compliant, effective and efficient execution of the processes within the (company name ) Quality Management System’

Why not? Are quality policies designed specifically for marketing propaganda any more effective?

5.4 – Planning

Specific requirements of management responsibility for planning are further defined per 13485:2016, § 5.4.1 and § 5.4.2, below.

5.4.1 – Quality Objectives

Policy

Top management ensures that quality objectives needed to meet regulatory requirements for product and process compliance and effectiveness are established in accordance with relevant functional levels within the organization, and that these objectives are consistent with the established Quality Policy. Additionally, quality objectives that measure the efficiency of operations are established as a business measure.

Data resultant from quality objectives is managed in accordance with 13485:2016 § 8, describing measurement, analysis and improvement requirements, inclusive of data focused on ensuring the requirements within 13485:2016 § 6, resource management, are consistently met.

Discussion

Product quality is simply a reflection of process quality. People execute processes. High-quality processes, well executed, systemically produce high-quality products. Quality objectives must be established at the process level, and be measured in such a manner so they can be aggregated to sub-system levels and at the system level. This enables the ‘quality’ of the Quality Management System to be measured, monitored, analyzed, reported, and reviewed by responsible top management.

5.4.2 – Quality Management System Planning

Policy

Top management ensures that Quality Management System (QMS) planning requirements are met by determination if the system is compliant to regulatory requirements, effective in meeting defined quality objectives, and efficient in operational execution. This is accomplished in accordance with 13485:2016 § 8, describing measurement, analysis and improvement requirements, and by ensuring the requirements within 13485:2016 § 6, resource management, are consistently met.

Discussion

QMS planning involves the creation of a system for management control, utilizing a process based approach, to manage product and process quality that is designed to  satisfy the regulatory requirements and business requirements alike. As stated above, in § 5.4.1, product quality is simply a reflection of process quality. People execute processes. High-quality processes must be designed such that they can be well executed by the people within the organization to systemically produce high-quality products. Many considerations exist:  

  • Process roles must be established such that skill-set(s) are defined that will satisfy the needs for process execution.

  • People, with the appropriate skill-set(s), must be trained and determined to be competent in the ability to appropriately operationally execute the processes in order to obtain the results necessary to meet the quality objectives defined above, in § 5.4.1

  • Quality objectives must be established at the process level, and be measured in such a manner so they can be aggregated to sub-system levels and at the system level.

    Measure | Monitor | Analyze | Report | Review

  • People, with the appropriate skill-set(s) for Quality Systems management, must be trained and determined to be competent in the ability to appropriately assess the quality of the results obtained in regard to meeting the quality objectives defined above, in § 5.4.1, and in accordance with 13485:2016 § 8, describing measurement, analysis and improvement requirements, and also by ensuring the requirements within 13485:2016 § 6, resource management, are consistently met.

  • Emerging issues where failure to meet the established quality objectives must be escalated via the mechanisms established to Measure | Monitor | Analyze | Report | Review, in accordance with 13485:2016 § 8, describing measurement, analysis and improvement requirements.

  • Ongoing continual improvement of the QMS must address emerging issues and issues of systemic constraint associated with process and product ‘quality’, inclusive of requirements associated with 13485:2016 § 6, resource management.

5.5 – Responsibility, Authority and Communication

Specific requirements of management responsibility for defining responsibility, authority and communication are further defined per 13485:2016, § 5.5.1, § 5.5.2 and § 5.5.3, below.

5.5.1 – Responsibility and Authority

Policy

Top management ensures the responsibilities and authorities are defined and documented, by functional role, within each process within the system of processes that comprise the Quality Management System. The QMS process documentation works in conjunction with departmental organizational charts that documents the responsible and accountable individuals within each department, in association with each role.

Top management communicates these responsibilities and authorities by ensuring the QMS process documents and organizational charts are maintained within a formal documentation system. the QMS process documents and organizational charts also document the interrelation of all personal who manage, perform and verify work affecting quality and identify the independence and authority of the people who perform these tasks.

Discussion

Within a processes based system, every role defined within each process requires a description of its responsibilities and authorities, in addition to the required skill-set of the role. All job descriptions must also correspond to the roles identified within the processes.

5.5.2 – Management Representative

Policy

Top management has appointed a member of management who, irrespective of other responsibilities, has responsibilities and authorities as defined within 13485:2016, § 5.5.2 (a-c), Management Representative, and in accordance with 13485:2016 § 8, describing measurement, analysis and improvement requirements. That individual is identified as follows: Name | Title

Discussion

This individual must receive as input, feedback information regarding the status and performance of the Quality Management System (QMS), process ‘quality’, in addition to the ‘quality’ of products that are produced as a result of the QMS. This individual is responsible and accountable to provide as output, reporting and review of product and process ‘quality’, with specific attention drawn to emerging issues and systemic constraint(s).  

5.5.3 – Internal Communication

Policy

Top management ensures that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the Quality Management System, in accordance with 13485:2016 § 8, describing measurement, analysis and improvement requirements, through the utilization of:

  • process inputs and outputs that define the sequence and interaction between each process;

  • defined requirements for the ‘quality’ of the inputs and outputs of each process, inclusive of timing;

  • measurement of processes effectiveness;

  • reporting mechanisms, and;

  • mechanisms of management review.

Discussion

Proper and adequate communication mechanisms must be built into each process, and must be properly utilized within the associated organizational structure at all levels within the company. 

5.6 – Management Review

Specific requirements of management review activities are further defined per 13485:2016, § 5.6.1, § 5.6.2 and § 5.6.3, below.

5.6.1 – General

Policy

The organization has documented the following procedure(s) for management review: SOP #xxx

Top management reviews the organization’s Quality Management System at planned intervals, as documented within SOP #xxx, to assess the ‘quality’ of the system, and to ensure its continuing suitability, adequacy, and effectiveness.

Top management will identify opportunities for improvement of emerging issues and systemic constraint(s) that are presented within the management review. Improvement will include consideration of potential changes to the QMS, Quality Policy, and Quality Objectives.

Discussion

Management review activity should be designed to challenge the QMS in order to facilitate continual and ongoing improvement of the system through addressing product and process quality issues as they arise, in addition to systemic constraint. 

5.6.2 – Review Input

Policy

The inputs to Management Review are in accordance with information identified within 13485:2016, § 5.6.2 (a-l), and in accordance with 13485:2016 § 8, describing measurement, analysis and improvement requirements, inclusive of requirements associated with 13485:2016 § 6, resource management

Discussion

The active measurement of product and process ‘quality’ will enable the appropriate monitoring, analysis, reporting, and review of the ‘quality’ of the QMS and the medical devices produced as a result.

5.6.3 – Review Output

Policy

The output to Management Review are in accordance with information identified within 13485:2016, § 5.6.3 (a-d).

Discussion

Product and process quality issues, in addition to systemic constraint(s), must be targeted with specific improvement initiatives.

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Summary | Conclusion

“Top Management” is defined as the person or group of people who directs and controls an organization at the highest level. Management Responsibility begins with Top Management accepting their responsibility to manage responsibly… strategically, technically, and in accordance with the regulation and standards that govern the medical device industry.

As stated earlier, top management is responsible for the creation, maintenance, and continual improvement of the Quality Management System to enable the people within their organization to come to work every day, day in and day out, and execute their defined work within a system that was designed to be compliant, effective and efficient. Such a system enables the company’s employees to fulfill their obligation to the company, and enables the company to fulfill its obligation to the patients and users who count on their products for safe and effective patient care.

A superficial approach to Management Responsibility will yield superficial results, appearing to be true or real only until examined more closely. Any examination by outside parties that does not end well can always be traced back to top management failing to responsibly manage. Always. However, it is rare that a company’s leadership is actually cited for their failure to responsibly manage. Regardless, any finding of nonconformance by an outside entity should be viewed as a systemic failure to responsibly manage. A change is required.

The transformational journey to transition an organization away from a culture of compliance, and into a culture of quality begins with management responsibility… or ends with the failure to responsibly manage.

[1] EN ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes

Larry Mager