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
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
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
- 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
- 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.