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?

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.