Saturday, June 29, 2013

Part 5: Five Obstacles to Management Oversight of the Quality System

This is the fifth and final part in this series that addresses underlying obstacles to management oversight of the pharma quality system as evidenced by the 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, it was 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. 

   In Part 4, the case was made for the importance of a company to have channels throughout the corporate structure to be able escalate product quality and compliance risks, as well as disseminate corporate directives, since there are many examples in our industry of problems at one site affecting all the others.

   When it comes to taking site-wide and company-wide action, there are tools at hand to establish priorities and drive behaviors. The same tools can apply to improvements to and problems identified by the quality management system.

   Obstacle 5: Quality Planning and Performance Management Systems are not Leveraged for Large-scale cGMP Performance Improvement

Warning letter observations are commonly phrased as a failure of the QCU to establish an adequate system for the cited problem. Although it is the responsibility of the QCU to establish the QMS, a capable QMS and a continuous state of compliance rely upon everyone in the organization to do his or her part. Problems are often site-wide or corporation-wide, and it often requires multiple functions to collaborate. Unfortunately, the priority of one group is not necessarily the priority of another and initiatives stall from lack of support. Sometimes the lack of progress on a significant problem is barely perceptible. Regrettably, it comes to light too late when the same problem is detected at a subsequent regulatory inspection at the same or different site. The enforcement heat is turned up, and management is left wondering why all were not pulling together.

Aligning the organization to work with singleness of purpose to become a highly capable organization is one of the most important jobs of management and one of the most difficult. It is no less challenging for resolving cGMP compliance issues. The annual business planning process and performance management systems are often overlooked as management oversight tools for unifying support for important cGMP compliance initiatives, yet these processes are used throughout the industry to bring focus on the current priorities and to align resources. Tapping into the power of declaring what is important and rewarding achievement is a highly effective strategy for culture change by modeling and directing behavior since what is valued is rewarded.

The Opportunity?

So, what can be done to promote integration of cGMP initiatives into the business plan to affect meaningful change and achieve business results?

The answer is to use established QMS processes to identify the right initiatives, use established objective-setting processes to focus broad attention, and expect results because achievement is rewarded and there is accountability.

The following are important considerations when leveraging the business planning process and performance management systems as cGMP management oversight tools:

  • Use the established quality management review and governance processes to identify cGMP highly leveraged improvement targets as site-wide objectives.

If designed and operating properly, the QMR and quality council processes will point to problems that require a significant attention and collaboration to improve predictable quality and consistent compliance performance. These established systems should be the basis for identifying data-driven improvement targets rather than creating new processes that may serve only to agree on dominant opinions at one point in time. Spend site-wide focused attention judiciously on initiatives that leverage exceptional benefits that can be annualized. Thus, annual planning objectives should be directed toward developing a more capable organization than fire-fighting projects.

  • Partner with operations functions to develop mutually beneficial objectives.

The QCU is often criticized for not being interested in manufacturing efficiencies and productivity. Cycle times and unit cost are often considered business concerns, not quality or compliance. However, behind every inefficiency and lack of productivity could be a latent compliance problem. Consider, as examples, examining waste streams and permanently eliminating recurring deviations through engineered solutions. These are worthy targets of cross-functional collaboration as an operational goal. Every dollar of eliminated waste and redundancy is directly applied to the bottom line. The operation is more profitable and the cGMP compliance improvement is a side benefit.

  • Manage the work and remove impediments.

Team composition with the right leadership, subject-matter expertise, and team skills are tremendously important. Facilitation, OpEx, and project management may be additional support roles needed but are not a substitute for pharmaceutical quality system management and regulatory compliance knowledge and experience. Project teams also benefit from senior-level sponsors who will champion the effort and help to remove stumbling blocks that devour valuable time and energy. Sponsors also jealously guard the teams’ time to allow them to get the job done and protect them from insidious administrative and dog-and-pony show distractions. However, most important is for the team to have a clear picture and alignment on what “done” looks like and how to tell when it is reached. This requires agreement on the vision of the future and how success will be measured. Both are anchors to keep teams from going adrift.

  • Reward results, not the process.

Certainly, how work is done is important, and the tremendous effort by team members is appreciated. However, when it comes to compensation and public recognition, nothing less than accomplishing the objective should be rewarded. To do otherwise enables mediocrity and does not drive performance. Most important is to verify that the intended result was achieved in behavioral terms. In the cGMP environment, improvement initiatives usually result in changes to written procedures, yet, remember that changing words on a page does not necessarily change the behavior. Assess the performance metrics and records to determine if the objective was achieved. Capture the cost savings where possible to model compliance improvement as worthy targets that improve the bottom line.


This series has made the case for the intrinsic value to the business of compliance to cGMP regulations. Although there is a negative case to be made given the high stakes of non-compliance, the positive aspect of cGMPs as a business enabler is emphasized here. However, this is highly dependent upon the mindful and collaborative application of cGMP regulations by the QCU and the creation of an integrated QMS based on specific operational knowledge. Management has oversight responsibility of the QMS, which is facilitated by an action-oriented QMR and aligning the organization behind large-scale transformation objectives. Ultimately, through the combination of applying the underlying principles of cGMPs and the ongoing measuring, responding and learning from an effective QMS, additional benefits are obtained. These include accruing knowledge, preventing failure, enhancing organization capability, and increasing product quality predictability.

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.

Contact us at



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