Part 4: Five Obstacles to Management Oversight of the Pharmaceutical Quality System

This is the fourth 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. 

In Part 3, recognized that although management may be responsible for the quality system, they may not know how to exercise that responsibility. It is the responsibility of the quality unit to provide a forum where management can make data-driven decisions and monitor quality system performance.

But management oversight can still be handicapped if there are no governing bodies or processes to communicate regulatory compliance and product quality risks.

Obstacle 4: Governance throughout the Corporation does not Actively Review and Escalate cGMP Compliance Risks

When regulatory inspections turn up recurring violations, it becomes apparent that the company lacks the ability to permanently resolve problems that potentially or materially compromise product quality. The situation is exacerbated when FDA believes that unless the company is restrained, the company will continue violating regulations. In cases of consent decrees, it is a vote of no confidence in the management and the QCU; the effects are serious to the business. Penalty and remediation costs are extraordinary. A third-party consultant group is usually mandated to serve as a surrogate QCU with legal responsibility to review and approve investigation and batch records. The third-party conducts an extensive baseline audit and reports the findings directly to FDA. Consultants are retained to help lead a transformation of the QMS and the organization. Timetables to achieve milestones specified in the consent decree are aggressive, and additional resources flood in at an unmanageable rate. Delayed new product launches and disruption to market supply of existing products may be irrecoverable. Thus, corporations at the highest level cannot afford to be uninformed of cGMP compliance problems at any of its operations because the effect extends beyond a given operating site to the far reaches of the global network.

Governance in the broadest sense relates to how a company manages compliance to applicable laws and regulations. The term has come to mean self-oversight in areas that affect stockholders, such as accounting practices. However, cGMP compliance issues and operating in a state of control are also key issues that affect the profitability and viability of a company. The management agenda from operating sites to the corporate boardroom must effectively cover cGMP compliance risks, product quality implications, and regulatory enforcement action to get the true picture of company vulnerability.

The Opportunity?

So, what can be done to protect the extended corporate network from regulatory compliance risks that may exist at any given operating site?

The answer is to establish a governance process that creates a network throughout the organization that focuses product quality and cGMP compliance. The interdependence of the compliance performance among sites for consumer protection and the financial health of the company justify that there are governance boards to oversee this significant part of the business.

The following are features of an effective corporate governance body for cGMP compliance oversight:

•   There is a network of quality officers that represent each level of the company.

A top-level quality professional must be established for each level of the corporation. These typically are the operating site, the business unit, and the corporate levels. These individuals are designated as quality officers and have ultimate responsibility for the QMS and the QCU at their respective locations. A significant portion of their time is spent working together as a quality collegium to develop quality and cGMP compliance strategies for the company in an effort to support its current and future business. As such, evaluation of the personal performance of a quality officer is heavily weighted on their contribution to this collegium and effectively deploying its mission to their respective sites.

Quality councils are established at each level of the company to oversee matters relating to product quality and cGMP compliance. The local quality council is where the fullest understanding of process capability resides and initiatives for site improvement are driven. The quality officer chairs the quality council and membership is comprised of the ranking executive (e.g., general manager, president, etc.) and the functional department heads. The quality council should be a stand-alone forum in order to maintain the focus on a product quality and cGMP compliance agenda. The agenda should include topics such as establishing and deploying quality policies, review of regulatory inspection findings and verification of resolution throughout the network at a systemic level, setting quality goals and measuring progress, review of critical deviations and the status of associated corrective and preventative actions (CAPAs), and reviewing risks escalated from QMR and lower quality councils. Quality councils are focal points of knowledge assimilation and sharing.

•   A process and criteria are established to rapidly communicate critical issues.

The quality officers must establish channels of effective communication from the functional areas to the quality council and among the quality officers at all levels of the corporation. Conditions and criteria must be established for which direct and immediate escalation occurs. Although different for various levels of the corporation, the escalation criteria must be clear and embedded into quality council procedures. When it becomes necessary to exercise the escalation requirement, it is essential that it happens within a specified timeframe and is apolitical and unfettered by local approvals. After escalation has occurred, the added value is the assessment and mitigation of risk, notification to other sites, follow-up and network-wide verification, and closure.

•   Key quality metrics of importance to the corporate network are established.

During the course of the operation of the quality councils, the quality officers may determine key quality performance indicators (QPI) to be measured and reported across the corporation. The QPIs may vary year-to-year and focus on topics related to current FDA enforcement trends or areas of known recurring problems, such as supplier performance, recurring deviations, and CAPA effectiveness. Collecting corporate-wide QPIs is a challenge since sites are typically competitive and want to keep performance measures to themselves—or define the parameters and calculations to their advantage. Quality officers can address parochial behaviors by setting the expectation that their personal performance is based on working collectively as a quality officers in a collegium setting for the greater good of the corporation. A quality officer may wear a “site hat,” but the larger one is a “corporate hat” when the meet together as a collegium.

•   The corporation supports an Ombudsman program.

Ombudsman programs provide direct access between any company employee and a neutral third-party that takes reports of suspected conditions or activities that are illegal, unethical, or against company policy. Employee concerns about cGMP compliance fall into all of these categories and should be included in the program along with other areas such as finance, safety, and human resources. In order to preserve confidentiality and engender openness, the Ombudsman program should be managed independently by a third-party and coordinated by a neutral group such as the legal department. The quality officers and their respective quality councils will have a role to play in investigating and responding to reports.

The issues described thus far in this series have centered on management embracing the value of cGMPs and establishing the quality leadership roles and functions in order to organize, measure, and report on the performance of the QMS and govern this important aspect of the business throughout the corporation. However, some cGMP compliance problems may be so pervasive and entrenched that redirection of a large number of personnel and sites are required. The temptation is to embark on costly, trendy, and non-specific quality programs when some important tools are already on hand. In Part 5 we will look at leveraging these tools as a means of exercising responsibility and oversight of the quality system

The QA Pharm