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.

Conclusion

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.


The QA Pharm

   

Cartoon: The QA Pharm, Myrtle the Change Control Coordinator (Part 2)

I introduced The QA Pharm Cartoon about Myrtle the Change Control Coordinator on December 14, 2010. Little did I know that it would become the fourth most viewed page in this blog.

Here is the next installment of life down on The QA Pharm. 

(Go back to Dec. 14, 2010, for the start of the story.)

Be gentle. I'm not an artists, but I hope you enjoy. 

The QA Pharm

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

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.


The QA Pharm

It's a Bullet Point World

No doubt you have concluded that I must be least a baby boomer. That I am, and so much has changed in the day-to-day work environment compared to when I was a young manager.

No, I'm not going to decry the "good old days" because so many of the changes have been for the better. I don't miss the rolls of stinky fax paper that connected my office with what was then called the Bureau of Biologic (BOB) for batch releases. I don't miss the tedious manual culling through records to compile data and slide rule calculations. The digital age of computers and the Internet provides instant communication and analysis.

Today I compose my own emails rather than dictating to my secretary. Oh, right---that's another change. There are no secretaries anymore. I don't even think the term administrative assistant is used much anymore.

But it's all good. Well---mostly.

In my opinion, the biggest loss is that we live in a bullet point world. There appears to be less time to think, reflect and defend our conclusions.

When was the last time you heard: "I will study the issue and prepare a paper that summarizes the situation, the problem that is created, the implications and recommendations." Nowadays, there seems to be far less individual reflection. There are no writers. There is no legacy of our thinking and obtaining knowledge. At best we capture decisions in minutes that were made by the most vocal team member through a process of flip charts and stick notes. Then it all gets reduced to a few bullet points in a PowerPoint for consumers of information who are just as happy with pre-digested information so they don't have to spend any energy chewing.

Perhaps I have sat through one too many management meetings where the multi-tasking members are looking at their computer screens or smartphones and barely paying attention. The presenter is delivering information on an important subject that is reduced to a handful of bullet points to folks that have an attention span of a two-year old. Someone clearly bored asks,"What's the bottom line?"

For me, it is just as important to know how a person or a team came to a conclusion, not just the final answer or recommendation. The thinking. The reflection. The debate. The struggles.

This is particularly important for the quality assurance professional. If you are sitting on the site senior leadership board and receiving important information that has a regulatory compliance and/or a product quality implication, you really need to understand the caliber of thinking that went into the presentation you are receiving.

The temptation is far too great in our fast-paced, next-agenda-item-please world to accept the dribble of bullet points, particularly if it's exactly what you want to hear.

So, the next time you hear a presentation on a significant topic, be sure to ask questions. Dig into the ways and means that the conclusion was derived. Get into their head so that you can have confidence in the conclusion. You may surprise the presenter who was hoping no one was paying attention.

The QA Pharm

Part 2: Five Obstacles to Management Oversight of the Pharmaceutical Quality System

Part 2: Five Obstacles to Management Oversight of the Pharmaceutical Quality System

This is the second 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. The quality function should be in the best position to make this defense, but all too often it has problems of its own.

Obstacle 2: The Quality Function Does not Fulfill its Regulatory Responsibility and is Detached from the Operation.

The QCU is the only pharmaceutical function that is established by the Code of Federal Regulations. It is required to exercise its regulatory mandate without a conflict of interest. Part of its responsibility is to establish the QMS, which, as described above, contains the body of procedures that declare how the company intends to operate in compliance with cGMPs. However, too often the QCU develops procedures in isolation, and the rest of the company is willing to let them do so. Without collaboration and integration with the business, the procedures will be disjointed and invite “workarounds.” In these cases, the QCU may actually contribute to compliance problems. Thus, the cycle continues and cGMPs are viewed as being disconnected from the business—primarily because they are.

The quality function has a responsibility to lead the effort to establish a compliant QMS that efficiently applies to the operation. Both are required to be competitive. The modern-day quality organization must have the ability to protect the business from compliance risks as well as the ability to be integrated with the business. It is not an adversary empowered by a sense of external authority, nor does it cross the line and lose its independence and objectivity. Rather, the QCU is a partner whose role adds a valued perspective. However, the quality organization may not have the skills to assess how to apply cGMPs to differing operations or how the QMS must evolve to meet the changing mission of the plant site.

The Opportunity?

So, what can be done to establish a business-integrated QCU that fully meets the intent of cGMPs?

The answer is that management must challenge the QCU to a higher performance level by establishing an organization development strategy. The strategy must include an objective assessment against factors critical to its success.

Critical success factors for the pharmaceutical QCU include:

• Roles mandated by cGMPs for the QCU are incorporated into the QMS and are faithfully practiced.

The regulatory mandated roles of the QCU center on its authority to operate independently and objectively as a reviewer and approver of matters related to cGMPs. This includes procedures, specifications, nonconformance and complaint investigations, and product release into the market. Such authority does not preclude collaboration with other functional departments and subject matter experts. The reporting relationship and financial incentives for the QCU must not create a conflict of interest.

Non-regulatory activities that divert time from their primary responsibilities should be challenged and properly positioned in the organization. For example, the QCU should not be the training function or the validation function simply because training and validation are important cGMP requirements. This would create a conflict of interest where the QCU would be approvers of its own work. Rather, the training and engineering departments must know how to apply cGMPs to the practice of their respective professions in a pharmaceutical company, and the QCU review and approve their procedures and records.

• QCU professionals have a working product and process knowledge.

Product and manufacturing process knowledge is essential to fulfill the responsibilities of the QCU. An effective review of procedures, batch records, and investigations is not possible without a fundamental understanding of the science and technology of the product portfolio. It is far better to transfer and promote experienced manufacturing personnel into the QCU who have demonstrated the ability to apply and practice cGMPs than to inbreed QCU personnel.

Compliance without product and process knowledge becomes legalism, and the QCU is often reduced to an administrative function that becomes distracted by minor issues; the significant risks that require management attention are lost in the noise.

• The QCU has the skills of quality science, not just cGMP compliance.

Engineers, microbiologists, chemists, and pharmacists have defined curricula for their professional degrees. The pharmaceutical quality professional may have a scientific or technical degree; however, there is no defined body of knowledge that is widely accepted across the industry to equip the QCU. Many individuals start as bench chemists or microbiologists and rise through the ranks. Many build their resumes by transferring between companies. Others are recruited from companies with high visibility compliance problems to benefit from their remediation experience.

Management must consciously enhance the core skills of the QCU to enable it to operate from product development through technical transfer and to daily manufacturing. They must know how to measure and control variation as well as understand the effect of change on a technical level. They must possess tools to assess risk, reduce waste, and calculate price of nonconformance. The QCU must know how to speak the language of finance and risk management to make the business case for its proposals using polished presentation skills. They must not continually resort to the scare tactics of presuming to know exactly what FDA does and does not like.

Even with a top-notch QCU and a QMS that effectively and efficiently supports the business, there is still the possibility that compliance problems will evade the attention of management without a formal review mechanism. In Part 3 we will look at the effectiveness of the Quality Management Review process.

The QA Pharm