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.

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.

Quality culture assessment

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?