Five Obstacles to Managing a Pharmaceutical Quality System, Part 3

Inadequate management review of quality management system performance

Published: Tuesday, August 27, 2013 - 17:05

Editor’s note: This is the third in a five-part series exploring issues that affect management’s ability to detect the warning signals of current good manufacturing practice (cGMP) compliance problems in the pharmaceutical industry.

In part one of this series, we considered the management perception that current good manufacturing practices (cGMPs) aren’t relevant to the business, and laid out the defense that cGMPs enable a predictable quality outcome that serves the business and its patients very well. Part two explained how the quality function was in the best position to defend the relevance of cGMPs, but all too often it has problems of its own and should be the focus of serious organizational development. Here we make the case for a data-rich source of feedback to determine how effective the quality system is. Otherwise one is flying blind.

Obstacle 3: Inadequate management review of quality management system performance

The Supreme Court pierced the corporate veil and decided in United States vs. Dotterweich (1943) that a company’s president, not the corporation, was personally responsible for the corporation’s compliance to the Federal Food, Drug, and Cosmetic Act, even if he does not directly participate in violating the terms of the act. The court reasoned that a company’s president ought to be aware of the regulations associated with the business.

Again, in United States vs. Park (1975), the court decided that the CEO was strictly liable for the violations at the company, regardless if he delegated regulatory compliance to a specific function. Thus, top managers have a vested interest in knowing the effectiveness of the QMS and the state of cGMP compliance of their operations. Just as they must monitor and review the performance of sales territories, managers must be continually informed and given the opportunity to intervene with timely decisions when QMS metrics appear unfavorable. No news is not necessarily good news.

It’s understood that CEOs can’t be expected to be involved in the details of the QMS and may not be sufficiently knowledgeable to establish a robust system or 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 quality control function to provide the needed oversight experience and use it to establish a 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 to make timely and data-driven decisions. It is the single most effective means to become an anticipating organization rather than reactive one. When implemented well, the QMR becomes a valuable means to accrue knowledge and prevent future failures.

The following are features of an effective QMS management review:

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 is 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 its supporting systems. Some companies organize the QMS by functional or technical disciplines. Others may organize by the type of process, such as product life cycle processes, processes related specifically to departments, and processes that cross the organization. Like any structure, 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 it 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 reexamined, 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 include designing and applying the system, measuring and improving system performance, ensuring regulatory inspection readiness, and identifying and preventing unacceptable risks. However, functional area managers, where these many systems operate, have the responsibility for the overall performance for their areas. Feedback from the QMR is instructive for proactive area managers and often provides leverage to express the need for additional support. To illustrate, the risk-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 QMR’s operation 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. These include 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 a corporate governance agenda and that communication of risk is fluid throughout the organizational hierarchy.

In part four we will look at the governance structure of the organization.

About The Author

The QA Pharm

The QA Pharm is a service of John Snyder & Co. Inc., provider of consulting services to FDA-regulated companies to build quality management systems and develop corrective actions that address regulatory compliance observations and communication strategies to protect against enforcement action. John E. Snyder worked at the lab bench, on the management board, and as an observer of the pharmaceutical industry for more than 30 years. His posts on The QA Pharm blog are straight talk about the challenges faced by company management and internal quality professionals. Synder is the author of Murder for Diversion (Jacob Blake Pharma Mystery Series Book 1).