Chet Meyers

FDA regulatory oversight and enforcement have never been more intense or potentially more costly. According to the business intelligence firm FDAzilla, the agency is on pace in 2011 to break its record for 483s for the third year in a row, issuing well over 10,000 citations a year—that's one every 52 minutes. For biopharmaceutical companies, with their highly complex and expensive operations, the total cost of cGMP compliance continues to constitute a significant percentage of the cost of goods sold. 

Meanwhile, a variety of factors have made compliance and quality more challenging. Complex global supply chains increase the likelihood of lapses. Economic pressures to cut costs can result in compromised processes and increased operational as well as quality risk. Conversely, anxiety about regulatory action and inadequate understanding of risk can lead to expensive gold-plating and redundancy in quality and compliance activities. Company growth, the introduction of new products, and entry into new global markets can also attract an increase in regulatory scrutiny. In mergers and acquisitions, achieving consistency in quality and compliance can be especially daunting, particularly when a traditional small-molecule manufacturer acquires a biologics manufacturer or licenses a biologic product, thereby requiring interaction and compliance with a totally different branch of FDA with which it has little or no prior experience.  

In the face of these pressures, the business case for optimal quality and compliance is compelling: improved operating performance, greater productivity, less compliance risk, less rework, and fewer interruptions of supply to the market resulting in lost revenue. Yet, in many companies, compliance problems persist, often because the company culture consists more of fighting fires than of thinking right-first-time and maintaining a reliable state of quality and compliance throughout the company. For an organization to do this successfully—and sustainably—this mindset and behavior focused on quality compliance must start at the top and be emulated by individuals at all levels and in all functions within the company. Moreover, in a culture of quality, it is important that employees adopt this mindset, not because they have to, but because they understand the importance and benefits of this thinking and behavior and appreciate the risks of not adopting it.   

Consider the wildly divergent views of quality that were uncovered when a major biopharmaceuticals manufacturer undertook a comprehensive assessment of quality across a number of its global operations. The company's manufacturing sites, as well as corporate headquarters, were polled on such questions as how well leadership defined and communicated their vision of the desired quality culture, whether management had identified what was required to create and sustain a quality culture, whether the individual had the tools and resources to get his or her job done correctly, and much more. When asked whether the right behaviors were encouraged for sustaining a quality culture, a strong majority of respondents at one site responded favorably, yet overall, barely one third of the staff polled at several other sites, including their corporate headquarters, responded positively.  

Not every dimension that was assessed turned up such divergence. For example, nearly everyone agreed that they were held accountable for the quality of their work; and by overwhelming majorities throughout the company, respondents agreed that if they observed noncompliant activities they felt comfortable calling it to someone's attention. But in many areas there were wide divergences and in others—like whether the company's people had the skills to do a high quality job—there was low favorability almost across the board. It also emerged that the company was perceived by employees as focusing on short-term fixes in quality issues, and that personal development, teamwork, rewards, and recognition were inadequate for promoting a quality culture. Instead of a single, unified environment, the company had many disparate cultures. 

Transforming organizations to obtain and sustain a quality culture begins with a comprehensive evaluation of the various organizational, procedural, staffing, and other parameters that impact quality within the organization. In other words, all of the activities, attitudes, and interactions that together constitute culture must be considered, including elements such as:									

Quality/compliance governance structures: Are there effective mechanisms for such activities as global change management for new product introductions, processes for regulatory changes, pharmacovigilance, product complaints, quality related councils, and material review boards?

cGMP compliance activities: These include batch/lot issuance, batch review and disposition, deviation management, corrective and preventive action, change control, document control, internal auditing/inspection, risk identification/remediation, annual product review and all of the other relevant processes and procedures. Are they uniform, compliant, and effective at each site, across sites, and across the entire organization? 

Quality metrics: These include such measures as right first time, cycle time, product complaints, regulatory events, action plan attainment, reportable events, and the like. Quality metrics should be appropriate and provide the basis for effective review of quality performance. 

Leadership styles and behaviors: Do leaders take a comprehensive view of quality, communicate that vision effectively throughout the company, and behave in ways that foster and support the efforts of all employees?

Human-resource practices: Are personnel sourced, recruited, hired, and on-boarded in ways that promote a consistent, high-performing quality culture? This can be an even more challenging issue for manufacturers of seasonal vaccines, because they often hire many seasonal workers who may have little long-term allegiance to the company or exposure to the company's values in regard to quality. 

Learning and personal development systems: How broad, deep and effective is the organization's training program? Are personnel given opportunities for further professional development? 

Quality behavior reinforcing mechanisms:  Are performance management policies, rewards, and recognition designed to motivate individual employees as well as teams to consistently strive for quality? 

Quality-related information systems: These include not only IT and enterprise resource planning systems used for document management, deviation management, change control, and the like, but also the way in which information is shared. Are best practices and lessons learned at one site communicated to the other sites within the company to maintain a uniform, high-quality company culture?

Employees' perceptions in relation to quality at the company: As with the example of the biopharmaceuticals company described above, how do employees react to statements that describe the cultural norms and behaviors of a high performance organization with a strong quality culture? 

On the basis of this assessment, it is then possible to characterize the organization's quality culture, or more likely, cultures, as the basis for undertaking transformation. 

Key elements of a successful transformation

From the assessment there should emerge clear recommendations for improvement, including quick wins, and goals for the short-, medium-, and long-terms. Because organizations differ, the particulars of these recommendations for transforming any given culture will vary. But there are some constants in the execution of such recommendations. A centralized project management framework should be put in place to help guide the planning and successful implementation of the recommendations. 

To help drive and sustain changes, a compelling quality culture message must be developed—in effect, internally branding the effort. The message must be clear, relevant, understood by all, and designed to provide a point around which every employee can rally, motivating them to contribute to the effort. Best practices in human resources, organizational development, and leadership should be followed in order to maximize employee engagement, assure effective rewards and recognition, provide timely communication of progress, and institutionalize accomplishments. Finally, appropriate operational-excellence tools should be used to further help assure successful implementation and sustainability of these efforts—as well as to provide the metrics needed to monitor and report progress along the way. 

What should the resulting high performing, sustainable quality culture look like? Again, the particulars may vary from company to company, but such cultures should share the following characteristics (see Figure 1):									

Employees at all levels understand the organization's quality objectives, policies, and procedures and their individual roles in helping to achieve them. 

Leadership at all levels is visibly engaged in supporting the development of a quality culture and effectively engages and motivates others to do the same—leading to self-motivated accountability and sustainability.

Effective communication, enterprise-wide sharing of best practices, engagement of all employees, and rewards and recognition for both teams and individuals maintain the momentum and enthusiasm required for sustainability.

The organization hires people who possess the quality values, norms  and work practices the company desires. 

Staged on-boarding and technical and quality training are deployed at the company, business unit, functional area, and individual levels. 

Consistent and sustainable standards of quality are defined clearly and deployed across the organization in conjunction with quality and compliance systems that enable the organization to achieve those standards. 

The organization distinguishes between people and processes as the root cause of mistakes, and instead of blaming people looks to correct processes. 

Leaders and managers at all levels establish an environment of     trust and collaboration in which challenging issues can be raised without fear of reprisal. 

The organization institutionalizes a process for capturing, analyzing, and incorporating lessons learned from past successes and failures.

As the organization grows and changes, the quality culture is continually monitored and fine-tuned to ensure that it remains effective and sustainable.

The journey from quality culture assessment to transformation to sustainability need not take long or consume massive resources. But it does require the recognition that achieving quality and compliance is not a matter of a discrete, isolated process but of the larger environment in which it takes place.  

 are managing consultants at Tunnell Consulting, 

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