Saturday, June 15, 2013

Part 3: Five Obstacles to Management Oversight of the Pharmaceutical Quality System

Part 3: Five Obstacles to Management Oversight of the Pharmaceutical Quality System

This is the third of a a five-part series that addresses underlying obstacles to management oversight of the pharma quality management system as evidenced by the continuing serious compliance and product quality problems in our industry. Part 1 dealt with the management perception that cGMPs are not relevant to the business, and it laid out the defense that cGMPs enable a predictable quality outcome that serves the business and its patients very well. 

In Part 2, the quality function was indicated to be in the best position to make the defense of the relevance, but all too often it has problems of its own and should be the focus of serious organization development. 

But there nothing like a data-rich source of information to know how effective the quality system is. Otherwise one is flying blind.

Obstacle 3: There is an Inadequate Management Review of the Quality Management System Performance

The Supreme Court pierced the corporate veil and decided in United States vs. Dotterweich (1943) that the president of the company was personally responsible, not the corporation, for compliance to The Food and Drug Cosmetic Act, even though he did not directly participate in the violative act. The court reasoned that the president of a company ought to be aware of the regulations associated with their business. Again, in United States vs. Park (1975), the court decided that the CEO was strictly liable for the violative conditions at the company whether or not he delegated regulatory compliance to a specific function. Thus, management has a vested interest in knowing the effectiveness of the QMS and the state of cGMP compliance of their operation. No less than monitoring and reviewing the performance of sales territories, management must be continually informed and afforded the opportunity to intervene with timely decisions when QMS metrics appears unfavorable. No news is not necessarily good news.
It is not unexpected that management does not have the time to be involved in the details of the QMS and may not be sufficiently knowledgeable to establish a robust system or to select the right parameters, metrics, and frequency to detect unfavorable trends. Being personally responsible but lacking the time and the know-how to exercise that responsibility is a double bind.

The Opportunity?

So, what can be done to establish an effective review of the QMS that engages management?

The answer is for the QCU to provide a valuable and professional oversight experience and leverage this experience as the primary forum for cross-functional collaboration on matters relating to regulatory compliance. The quality management review (QMR) is a common system within the pharmaceutical industry that provides such a forum and process to keep management informed on the state of control. The QMR is designed to monitor carefully selected performance metrics of the QMS in order to make timely and data-driven decisions. It is the single most effective means to become an anticipating organization rather than reactive. When implemented well, the QMR becomes a valuable means to accrue knowledge and prevent future failure.

The following are features of an effective management review of the quality management system:
  •   The quality management system has a rational structure.

There is no single correct way to structure the QMS other than to ensure that the body of policies and procedures are organized and linked in a rational manner that reflects the operation. Think of the structure like the table of contents of the story about the manufacturing operation and the supporting systems that surrounding it. Some companies organize the QMS by functional or technical disciplines. Other companies may organize by the type of process, such as product lifecycle processes, process related specifically to organizations, and processes that cross the organization. Like any structure; however, effort must be put into maintaining architectural integrity and not permitting the QMS to deteriorate into a random collection of poorly written and disjointed procedures.

  •   Performance metrics are procedurally established.

The QMS is a web of interdependent systems, and performance metrics for each system must be carefully selected to maintain the integrity of each system and thus the QMS as a whole. However, the QMR does not review all possible metrics, nor is the QMR the only forum where metrics are reviewed. Performance metrics reviewed at the QMR should be skillfully selected and procedurally established to be indicators of the overall health of the operation. Avoid getting mired in trendy metrics and terms. The metrics should answer four basic management questions about the QMS and operational performance: 1) How well is the system being managed? 2) What unacceptable event or trend has the system detected? 3) What are the product quality and cGMP compliance implications and risks? 4) Where should we target specific action?

QMR metrics should be periodically re-examined particularly whenever a compliance problem was first revealed by a regulatory inspection rather than by the QMR.

  •   System owners present objective metrics; functional areas own the performance.

Each element of the QMS must have a named owner who is responsible for the daily management of the system, including gathering and ensuring the integrity of the data, analyzing and drawing conclusions, making recommendations, and presenting to the QMR forum. System owners must be experienced and capable of exhibiting behaviors characteristic of ownership. These behaviors include designing and applying the system, measuring and improving system performance, ensuring regulatory inspection readiness, and identifying and escalating unacceptable risks. However, functional area managers, where these many systems operate, have the responsibility for the overall performance for their area. Feedback from the QMR is instructive for proactive area managers and often provides leverage to express the need for additional support. To illustrate, the deviation management system owner is responsible for presenting the objective data on the unacceptable trend for a functional area, but the area functional manager is responsible for knowing about the problem, explaining the solution, preventing recurrence, and sharing the learning to the QMR at-large.

  •   Functional leadership and empowered decision makers are present and active.

The QMR forum must be comprised of the decision makers and must be results-oriented.  The common practice is for the QMR system to be owned by the quality function for objective measuring and reporting. The highest level of each functional area is present, including the general manager of the site. The forum is intentionally high-level to support the premise that the QMR is a mechanism to exercise management responsibility as well as to ensure timely decisions and cross-functional support. The operation of the QMR must be well planned and executed to the highest standard of professionalism. A dedicated coordinator who reports to the quality function is typically necessary to coordinate the QMR inputs, facilitate the meeting, and keep the records. The record includes decisions that are reviewed at subsequent QMRs until the effectiveness of each action taken has been verified and closed-out.

Management oversight responsibility for cGMP compliance goes all the way up the line. As challenging as it is for site management to exercise oversight responsibility, it is even more challenging when the site is part of a larger network of sites within a corporate structure. Thus, a system must be in place to ensure that cGMP compliance is part of corporate governance agenda and that communication of risk is fluid throughout the organizational hierarchy. In Part 4 we will look at the governance structure of the organization.

John Snyder
The QA Pharm

The QA Pharm is a service of John Snyder & Company, Inc.

John Snyder & Company, Inc., provides consulting services to companies regulated by the Food and Drug Administration. We help our clients to build an effective Quality Management System to enable reliable supply of quality products to their patients. We also help our clients to develop corrective action plans to address regulatory compliance observations and communication strategies to protect against accelerated enforcement action.

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