Many models are available for establishing a quality system in regulated industry, whether for pharmaceuticals, medical devices, or biologics. Each company establishes a set of standard operating procedures (SOPs) that enables it to manage operations and then implements a quality system around its product and process. But why do some quality systems work well, whereas others falter or fail miserably? Does the fault lie in procedures, implementation, or maybe training? Perhaps the answer can be found by examining the involvement of senior management.

Global Expectations for Quality Systems Management

The FDA’s GMPs for pharmaceutical manufacturers under 21 CFR 211.180(f) requires that “responsible officials of the firm are notified either in person or in writing via an investigation when deviations occur” (1). Section 211.180(f) requires that “responsible officials of the firm … are notified in writing of any investigations concerning failures, complaints, returned product, or salvaging operation” (1). The preamble to the pharmaceutical CGMPs indicates that the agency included this section because it had found instances when “corporate officials have not been advised of potential or real adverse conditions brought to light either by the firm’s own quality control system or by FDA” (2).Therefore, senior managers who had the authority to take corrective action were unaware of any problem.

Before Part 211 became effective, the FDA had received comments that 211.180(f) represented an “unwarranted intrusion into corporate duties.” However, the agency determined that this section “provided added assurance that efforts are being directed toward prevention and/or correction of conditions that could affect the quality of the drug product.” It is interesting to note that in the preamble, the FDA had deleted the proposed requirement for “quarterly written reports” because it wanted to provide greater flexibility to industry, “in establishing procedures to keep appropriate management fully informed.” The agency also made another compromise in providing an exception from reporting requirements for officials who are involved or already aware of real or potential problems.

Medical device manufacturers also have notification requirements under 21 CFR 820.100, the Corrective and Preventive Action section, which include “disseminating information related to quality problems or nonconforming product to those directly responsible for assuring the quality and prevention of problems” as well as inclusion for management review (3). In addition, 21 CFR 820.22 of the medical device GMPs requires that results of all internal audits are reported for management review (3).

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In September of 2006, the FDA also issued a guidance-for-industry document called Quality Systems Approach to Pharmaceutical CGMP Regulations (4). Although this document does not have the same statutory requirement as a regulation, it does illustrate the agency’s expectations. The Management Responsibilities section states that “management is responsible for establishing the quality systems structure appropriate for the specific organization” and “has ultimate responsibility to provide the leadership needed for the successful functioning of a quality system.” But in focusing on what the FDA expects from senior management in a fully integrated quality system, the guidance goes on to state that “senior management should demonstrate commitment to developing and maintaining their quality system.”

In addition, the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) published a draft of Q10, Pharmaceutical Quality System, in May 2007 (5). This document describes “management responsibility” in the context that “leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pharmaceutical quality system.” Beyond ultimate responsibility, the draft of Q10 lists seven activities that demonstrate management’s commitment to a quality system, including participating in its design and implementation, demonstrating strong and visible support, communicating effectively and in a timely manner, conducting management reviews, and committing appropriate resources (5).

The European Union is also in alignment with both the FDA and ICH in advising that management engagement is crucial to an effective quality system. EudraLex (the rules governing medicinal products in the European Union) states that “attainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels of the company” (6). Concerning corrective and preventative actions, the same document states, “There should be management procedures for the ongoing management and review of these actions and the effectiveness of these procedures verified during self-inspection” (4).

Who Is “Senior” Management?

Senior management has been a difficult term for regulators to define. Its use can vary a great deal depending on the size of a company and its organizational structure, so the phrase can have different meanings in different companies. In today’s business environment, some organizations are giving the title of vice president more freely as a means of retaining personnel without increasing compensation. It doesn’t always mean that an individual has the authority regulators intend when they say “senior management.”

The guidance document mentioned above defines senior management as “top management officials in a firm who have the authority and responsibility to mobilize resources” (3). In 21 CFR Section 820.20 is greater detail on the FDA’s requirements for medical device manufacturers. However, pharmaceutical and biologics manufacturers should not shy away from that just because it’s a medical device requirement (3). The same section requires that executive management appoint and document a management representative 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, (ii) reporting on the performance of the quality system to management with executive responsibility for review.” It should be noted that appointment of a management representative is not an act of total delegation on the part of senior management. The regulation is quite clear that “management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals” (3).

For our purposes we define senior management as individuals who have the organizational authority to establish a quality system, who can approve changes and make decisions about prioritization of workloads in the quality system, and who have the financial authority to allocate capital and human resources to a quality system to ensure that it functions effectively.

Example: Deviation Management

Using deviation management systems as an e
xample, what would management engagement look like? A deviation system is not a stand-alone process; it is one part of a company’s quality system. This system will have established written SOPs that identify responsibilities and tasks for deviation management throughout a product life-cycle. The deviation management system requires an effective method for fact gathering and data collection to ensure that all deviations are tracked and investigated. Investigation of deviations includes document review, interviews of personnel, determination of the true root cause, creation of a corrective action plan, conduct of effectiveness checks, and continued monitoring of the affected process.

Engagement of senior management would be to provide enough resources, (e.g., staffing, training, hardware and software) to ensure that those deviation management tasks are completed within necessary time-frames. Inadequate staffing can backlog pending investigations, creating inaccurate counts of open deviations and possible lapses in monitoring time frames. In addition, it can lead to tardy or rushed investigations, resulting in weak root causes and unsupported corrective actions. A common mistake is not determining proper user requirements for a deviation management tracking tool in advance of its implementation. Thus a company may purchase software that will not allow the deviation management process to function as intended due to system overload resulting in computer crashes, sluggish function, or transaction freezes. The purpose of management engagement is to prevent such problems.

Senior managers at many companies, however, make the mistake of creating a system and then delegating away the responsibility for its function. In such cases, senior management passively oversees the system, and its success depends on the caliber of those selected to manage the process. This type of minimal oversight can represent a significant compliance risk to a company’s regulatory status. Still ultimately responsible for the effective functioning of the deviation management system, senior managers must become engaged in it.

A deviation management system needs an established method of communicating significant deviations to senior management. In addition to reporting of significant problems, monitoring and trending of all deviations is important. Trending can signal early patterns of performance discrepancies that are easier to resolve before they become full-blown investigations. And an effective deviation management system ensures that all the necessary information is communicated to senior management. It provides them with the chance to review data, evaluate functionality, and decide whether any intervention or additional resources are required for the deviation management system to be successful.

Management Engagement in a Deviation System

Management engagement is active oversight of senior managers using a systematic evaluation of issues and quality trends for continuous improvement. This involves executive management, an appointed management representative, quality systems managers, and department managers. With a deviation management system, this can be accomplished through the use of routine reports and periodic meetings with that system’s manager. Those reports and meetings are necessary for senior management to be aware of these key indicators:

When those indicators suggest that a deviation management system is operating ineffectively, senior managers must act to correct the system.

What Does It Really Look Like?

The most evident activity in management engagement is attendance at meetings dedicated for deviation management. This provides real-time evidence to senior management of how departments are collaborating to comply with deviation management procedures. The value in attending such meetings is that it provides senior managers with direct knowledge and timeliness of a faltering or failing system. This is when they can determine the reason for poor system performance and take action to rectify a problem before it becomes more serious. That might include bringing resources and departments together to make improvements or rearranging responsibilities of personnel involved in deviation management — or, worst-case scenario, reassigning ownership of the deviation management system.

Another opportunity for senior management engagement is participation in material review boards, which are routinely convened as part of deviation management. As a member of a materials review board, a senior manager can determine effects on finished product inventory and learn how problems affect manufacturing processes, which can then be fed back into a deviation management system to create a more meaningful corrective action.

Management engagement also includes being listed for distribution of all monitoring reports concerning a deviation management system. The effectiveness of the system should be tracked using key metrics, which are reviewed monthly, and the reports generated should be sent to senior management for review. Such review and evaluation of trends is another form of management engagement. This keeps senior managers informed of how a system is functioning and lets them take necessary actions if the system is faltering.

Consequences of Inadequate Management Engagement

Management engagement is inadequate if all responsibility for overseeing a deviation management process is delegated away. Senior management would no longer know what problems exist, the level of product impact, and resulting implications to inventory. Lack of management engagement can also lessen the priority to close investigations and implement urgent corrective actions, which ultimately allows additional nonconforming product to be made. This represents a deviation management system that is not in a state of control.

Another example of inadequate management engagement is when senior managers do not receive periodic monitoring reports. The risk of their not reviewing those reports is a resulting lack of awareness in how a company’s deviation management system is functioning. Senior management is missing an opportunity to step in and rectify a problem before it gets out of control.

Engagement of senior management is not limited to just an executive management team or quality assurance and regulatory department alone. Failure to manage a deviation process can happen at the production department level as well. This can be seen when production/operations representatives believe their workload is too overwhelming to allow them to take time to participate in root-cause analysis discussions or in the creation of corrective action plans.

Disengagement of senior management inadequately prepares department representatives for investigative meetings and provides minimal support for investigations. In such cases, senior production department managers need to reinforce the expectations of their employees to be available, knowledgeable, and prepared to participate in deviation management. Management engagement requires production managers to hold employees accountable for participating in a deviation system and includes related feedback in their yearly performance reviews.

Connecting the Dots: Active participation of assigned department representatives is critical to determining the true root cause of a deviation and to the creation of meaningful corrective action plans. Full engagement of senior management at the department level is also critical to the timely and effective imp
lementation of a corrective action plan. If senior management engagement is absent, then implementation of the corrective actions may not be perceived as important and can be delayed, resulting in the possible generation of more nonconforming product.

One way to improve management engagement at the department level is for senior managers to include deviation management as a standard agenda item for their routine meetings with production managers. This standard agenda item allows for open discussion on how departments are participating in deviation management. Another method to improve management engagement at this level is to include department managers in the deviation management communication chain. That ensures that they routinely receive department summaries and at least monthly deviation trend reports so they are informed on the types of deviations originating from their departments. Thus they can take necessary actions to improve their departments’ performance and contribute to the deviation management system overall.

Quality System = Quality Culture

Peter Drucker believes that effective leaders know four things: leaders need followers, followers must be led to do the right thing, leaders must be very visible and set examples, and leadership is about responsibility. It’s not about being popular or even liked; it’s about achieving results (7).

Active participation in a quality system gives senior managers the perfect opportunity to demonstrate their leadership abilities. However, Haidee Allerton points out that “the leader doesn’t have to do everything, doesn’t have to be the smartest person in the organization, or do all the work” (8). As a leader, you do have to create the conditions under which your followers can achieve set goals. What does your company’s culture look like? Is deviation management the business of quality assurance alone, or is it everyone’s responsibility?

According to Edgar Schein, the culture of a group can be thought of as a set of basic assumptions that defines what deserves attention, what things mean, how to react emotionally to what is going on, and what actions to take in various kinds of situations. “When a solution to a problem works repeatedly, it becomes taken for granted” (9). Shared assumptions derive their power from the fact that they begin to operate outside of awareness. They become routine (“the way we do things around here”) and the culture survives through imparting them to newcomers. So the power of culture comes about through hidden assumptions becoming so ingrained into the daily life of a group or organization that members find behavior based on any other premise inconceivable. “The bottom line for leaders is that if they do not become conscious of the culture in which they are embedded, those cultures will mange them” (9).

Leading a Quality Culture Change: “If what a leader proposes works and continues to work, what once was only the leader’s assumption gradually comes to be a shared assumption” (9). So culture change in the sense of changing basic assumptions is difficult, time-consuming, and anxiety-provoking. This point is especially relevant for leaders who set out to change any part of the culture of their organizations. But when you succeed in influencing a group to change its behavior, then you will later be deemed a true leader, even an originating founder. This is the ultimate demonstration of effective leadership.

A current industry trend is for senior management to form partnerships with quality management and other support personnel. Together these people can succeed at changing the mindset that deviation management is strictly a quality responsibility. Quality personnel are now involved in many management-related activities and have achieved “standing agenda item status” at multiple senior management review meetings.

A successful quality system is a fully integrated set of systems with established SOPs and meaningful metrics. It is adequately resourced and actively monitored through the leadership and engagement of senior management. An effective deviation process demonstrates a state of control for the deviation management quality system.

Full Circle

Management engagement can be thought of in terms of building blocks placed at the foundation of a pyramidal structure, with product quality at its pinnacle. The foundation comes from senior management creating a meaningful quality policy that includes the ultimate goal of a final product that consistently meets or exceeds specifications. The next step is to effectively communicate this quality policy to all employees companywide.

Senior management needs to participate in the design phase of building a quality system around a company’s products and processes. This activity will provide senior management with “buy-in” (ownership) in the quality system. For that system to be implemented effectively, senior management has to ensure that staffing and resources are sufficient to meet the needs of all processes that make it up. But senior managers cannot believe that their job ends at that point. Management engagement means that they continue to be involved in a quality system by active oversight to determine its effectiveness and evaluate the need for changes or additional resources.

One form of active oversight is attendance at high-level meetings covering key quality processes during each business quarter to personally view associated meeting dynamics. Another method is monitoring of the major quality processes that make up a quality system. Design of such a system needs to include identifying and collecting key metrics of each quality process. A quality system should include a process to summarize metrics periodically in a written report distributed to senior management. The purpose of such a report is to demonstrate effectiveness (or lack thereof) of the quality process and to document significant trends, both positive and negative. Use of graphs in these written reports to illustrate trends can be a tool for helping senior management understand how a quality process is functioning.

Metrics evaluation is the next step in management engagement and is crucial to a successful quality system. The criticality of senior management performing these evaluations is that they have the organizational and financial authority to make necessary changes for correcting problems before a process goes out of control.

It would be a mistake to leave out the final part of management engagement: providing feedback to personnel involved in a quality system. Employees cannot operate effectively in a vacuum of information. They need to know whether they are performing above expectations, as expected, or below expectations. With product quality as the ultimate goal, employee expectations can be set as they relate to that quality. And management engagement requires that senior managers take the opportunity to reward and recognize employees when goals are achieved as well as taking disciplinary action when necessary.

Regulators in all parts of the world are instituting requirements and/or stressing the benefits of an effective and successful quality system. We believe that what has been termed management engagement is critical to having an effective and successful quality system in a company.

REFERENCES

1.) 1978.Current Good Manufacturing Practice Regulation for Finished Pharmaceuticals Code of Federal Regulations, Title 21, Part 211, US Food and Drug Administration, Rockville.

2.) 1978.Preamble to Human and Veterinary Drugs: Good Manufacturing Practices and Proposed Exemptions for Certain OTC ProductsFederal Register.

3.) 1996.Current Good Manufacturing Practice Regulation for Medical Devices Code of Federal Regulations, Title 21 Part 820, US Food and Drug Administration, Rockville.

4.) 2006. Guidance for Industry: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations, US Food and Drug Administration, Rockville.

5.) 2007..

6.) Quality Management 2008. EudraLex: The Rules Governing Medicinal Products in the European Union, Volume 4, Part I, Chapter 1, rev..

7.) Drucker, P. Hesselbein, F, M and R 1996.The Drucker Foundation: The Leader of the Future, Jossey-Bass, San Francisco:xi-xv.

8.) Allerton, H. 2000. Leadership A to Z: An Interview with James O’Toole About Appropriately Ambitious Leaders. Training and Development:58-61.

9.) Schein, EH. 1992.Organizational Culture and Leadership, Jossey-Bass, San Francisco.

10.) Bossidy, L, and R. Charan. 2002.Execution: The Discipline of Getting Things Done, Crown Business, New York.

11.) Byham, WC. 2002. Fourteen Leadership Traps: Why CEOs Don’t Have the Leadership Bench Strength They Need. Training and Development:56-63.

12.) Collins, JC. 2002.Built to Last: Successful Habits of Visionary Companies, HarperCollins, New York.

13.) Covey, S. 1989.The Seven Habits of Highly Effective People, Simon and Schuster, New York.

14.) Covey, S. 2004.The Eighth Habit: From Effectiveness to Greatness, The Free Press, New York.

15.) Giuliani, RW. 2002.Leadership, Hyperion, New York.

16.) ORA 1999. Guide to Inspections of Quality Systems: Quality System Inspection Technique – QSIT, US Food and Drug Administration, Rockville.

17.) Oshry, B. 1996.Seeing Systems: Unlocking the Mysteries of Organizational Life, Berrett-Koehler, San Francisco.

18.) Suzaki, K. 1993.The New Shop Floor Management: Empowering People for Continuous Improvement, The Free Press, New York.