Thus, I’d like to share what I’ve learned about the form, fit, and function of the quality role.
The following are excerpts from the U.S. Food and Drug Administration (FDA) Quality System Regulation:
• Sec. 820.5 Quality system.
Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part.
Note: “This part” refers to Part 820 of the Title 21—Food and Drugs, Chapter I—Food and Drug Administration Department of Health and Human Services— Subchapter H—Medical Devices.
• Sec. 820.20 Management responsibility.
(a) Quality policy. Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure the quality policy is understood, implemented, and maintained at all levels of the organization.
(b) Organization. Each manufacturer shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part.
(1) Responsibility and authority. Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.
(2) Resources. Each manufacturer shall provide adequate resources, including the assignment of trained personnel, for management, performance of work, and assessment activities, including internal quality audits, to meet the requirements of this part.
(3) Management representative. Management with executive responsibility shall appoint and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for:
(i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and
(ii) Reporting on the performance of the quality system to management with executive responsibility for review.
(c) Management review. Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure the quality system satisfies the requirements of this part and the manufacturer’s established quality policy and objectives. The dates and results of quality system reviews shall be documented.
(d) Quality planning. Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met.
(e) Quality system procedures. Each manufacturer shall establish quality system procedures and instructions. An outline of the structure of the documentation used in the quality system shall be established where appropriate.
• Sec. 820.22 Quality audit.
Each manufacturer shall establish procedures for quality audits and conduct such audits to assure the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s), including a reaudit of deficient matters, shall be taken when necessary. A report of the results of each quality audit, and reaudit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited. The dates and results of quality audits and reaudits shall be documented.
• Sec. 820.25 Personnel.
(a) General. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.
(b) Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.
(1) As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs.
(2) Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.
Let’s examine these excerpts, starting with Sec. 820.5 Quality system. Although this section requires the quality system follow 21 CFR Part 820 Quality System Regulations, it bypasses the issue of quality function organization. The remaining sections of 21 CFR Part 820 include requirements for design controls; document controls; purchasing controls; identification and traceability; production and process controls; inspection, measuring, and test equipment; acceptance activities: nonconforming product; corrective and preventive action; labeling and packaging control; handling, storage, distribution, and installation; records; servicing; and statistical techniques. None of these requirements specify the form the quality function should take. Subsequent sections of 21 CFR Part 820 support the need to have an independent, qualified, quality organization.
Sec. 820.20 Management responsibility provides some clarity on the form of the quality function. It demands that the organizational structure ensures devices are designed and produced according to requirements of this part, and that personnel who manage, perform, and assess work affecting quality be independent and have the necessary authority to perform these tasks. Sec. 820.20 also requires organizations to have personnel trained in assessment activities, including internal quality audits. In addition, this section commands a member of management to serve as the management representative; this agent is given the authority and responsibility for ensuring quality system requirements are effectively established and maintained. The management representative reports to executives on quality system performance. And while the management representative’s tasks are “irrespective of other responsibilities,” this role (in practice) is almost always performed by a member of management involved with quality function.
Sec. 820.22 Quality audit requires quality audits be performed by “individuals that do not have direct responsibility for matters being audited.” Most quality professionals believe this requirement frees them from audited areas. Although this section does not mandate that auditors be from the quality organization, most of them usually are associated in some way with quality. Small firms often hire capable quality consultants to perform this role to ensure independence.
Sec. 820.25 Personnel, element (2), states that “personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.” But it does not specify that verification and validation personnel be part of the quality organization. In practice, the quality function plays a key role in all verification and validation activities.
Based on my experience with FDA regulatory actions, the FDA unquestionably expects an independent quality organization. The level of independence, however, is a matter of regulatory discretion for the FDA. The agency recognizes that personnel at small companies often wear multiple hats, and it makes allowances for such multi-tasking. The point at which a company is no longer considered small is a matter of inspector discretion. Nevertheless, the FDA does not give any company a pass on proving their compliant quality function.
To ensure a proper fit, the quality function organization must be aligned with a company’s overall organization. A large medical device manufacturer, for example, cannot have an underdeveloped quality organization and be considered compliant. Similarly, it would not be compliant for a company to have vice presidents of sales, marketing, finance, manufacturing, human resources, and IT without having an equivalent counterpart for quality or quality and regulatory affairs.
Also, the qualifications of those filling quality roles must be aligned with the skills of their colleagues in other roles. Granted, there may be Ph.D.s in some areas (not necessarily for quality function), but quality professionals nonetheless should be well-qualified for their roles. Usually, when the quality function is not valued by management, it becomes diluted. As a result, the aptitude of those hired for quality roles are sometimes not aligned with the qualifications of their peers in other areas of the company.
I once observed a company organizational chart where the heads of sales, marketing, finance, manufacturing, human resources, IT, and quality were shown on a row of boxes below the CEO but the quality box was noticeably lower than those for all other functional heads. I’m hoping it was a misprint.
What does the quality function do? What roles does the quality function employ for execution?
When I discuss the quality function with company leaders not associated with quality, many think of verification and validation activities, or even inspection. Companies are often unclear about the definition of quality functions, interchanging quality control, quality assurance, and quality without differentiating. There is a school of thought that believes the terms quality control and quality assurance are archaic, and only the term quality should be used. Personally, I don’t agree, but I understand why this position is popular.
Some quality roles are questioned by management and staff not associated with the quality function. A very competent design engineer once asked me why his company was using the term quality engineer. In his opinion, the quality engineer did not “engineer” anything. His question illustrates the importance of fit: The organization did not define the quality engineer role appropriately, triggering confusion about that position’s role in company, and in the overall industry.
Quality function roles and responsibilities must be aligned within the quality function and also with the company’s overall organizational structure. For example, the responsibilities for quality executives (vice president, directors, managers) must align with their level within the company. In a corporate hierarchical structure, this alignment can help the company with high-level planning, decision-making, and leadership. Quality engineers should design verification and validation activities as well as the company’s quality tools. Quality engineers should play a critical role in designing and developing function, as they are often an important part of supply chain management activities. Quality inspectors should be experts on material and product inspections, and have a solid understanding of the product and the associated production processes. Quality auditors should be independent of the activities they audit but understand a company’s systems and processes. Also, quality personnel should be knowledgeable about software-based tools such as Enterprise Resource Planning (ERP), electronic Quality Management Systems (eQMS), and Software as a Service (SaaS), since these systems are typically central components of a company’s infrastructure.
Collaboration is an important component of any organization’s quality function. Nobody works in a vacuum; collaboration within the company is crucial to success.
Finally, planning is critical to success regardless of the corporate environment.
None of these points are game-changing revelations, but they do warrant revisiting periodically. Companies, along with their people, roles, and expectations, change. It is necessary to take a fresh look at the inputs, processes, and outputs of the quality function that drive both the medtech industry and the companies that operate within it.
James A. “Jim” Dunning’s consulting career began in 2001. He has provided quality and regulatory consulting services for various companies ranging from Fortune 500 medical device firms to startups. Dunning’s passion, however, lies with startups and small companies, especially those in regulatory distress. He has amassed significant experience in preparing 510(k) applications, developing complete Quality Management Systems, providing Quality System Training, and advising on quality, business, and leadership issues. Dunning is a senior member of the American Society for Quality (ASQ) and a member of the Regulatory Affairs Professional Society (RAPS). He can be reached at firstname.lastname@example.org.