Most organizations face the challenge of successfully configuring their Quality organizations to deliver optimal performance, impact and efficiency in today's market. Increasing regulations and pressure for organizational cost reduction further compound this issue. Companies across various industries can use information uncovered in this study to benchmark and improve their performance in critical quality areas such as:
- Organizational Size and Management Structure- assesses size, structure, scope of service and roles & responsibilities of the Quality organization. Metrics covered include: organizational effectiveness ratings, corporate and non-corporate quality budgets, staffing levels (aggregate as well as segmented by manufacturing sites and total products).
- Risk Measurement and Management- addresses topics such as Quality audits and self-assessments as well as critical-to-quality factors unearthed through analyzing voice of the customer. This section includes executive insights on effectively developing and managing a formalized risk management process. Metrics include: combinations of regulatory/certification audits with quality audits, frequency of site and vendor audits and product recall/failure rates.
- Organizational Impact, Value and Performance- assesses financial impact of the Quality organization as well as performance management, measurement and value communication. Metrics include: percent of companies utilizing various quality tools and methods, quality cost savings and value communication tactic effectiveness ratings
- Lessons Learned- highlights the key challenges and insights uncovered by executives at benchmarked quality organizations.
One client was facing extraordinary attention from regulators, inspectors, stock analysts, and shareholders due to perceived and real shortcomings in the company's manufacturing quality. Our customer was looking for a mechanism to research and understand how the quality function was organized and staffed at top pharma companies. Issues such as structure, staffing levels at corporate and site, span of control, career path planning and retention, education levels and depth of experience in its quality people were of interest.
For this engagement, our research team conducted detailed surveys of top pharma companies to understand the exact staffing levels, distribution, education backgrounds and tenure in the quality role. Study participants also were interviewed to understand the organizational structure, assignment of responsibilities, lessons learned, and top influencers in maintaining a world-class quality system. Our research presented not only how our client stood with respect to others on the performance metrics, but also identified scores of detailed best practices in quality management.
This study was conducted on behalf of a global pharmaceutical company. Six highly regarded companies participated as benchmark partners. With our insights in hand, our client was well positioned to optimize its quality structure and organization, focus efforts on career development and retention of quality personnel, and fine-tune hiring and training efforts. In turn, our research has a direct bearing on product quality, expense management, and reputation enhancement.c
A key element in delivering consistent product quality relies on writing validation and operating procedures, and keeping these procedures updated in the context of advancing technologies and reducing production variability. Our research delves deeply into this topic, often called "technical services." One client recently created a vice president position to oversee this critical aspect in manufacturing quality. To prepare for the position, to further their industry knowledge on the subject, and to plan for potential staffing needs and organizational changes, our client engaged us to research the topic.
Specifically, this study looked at technical services structure, staffing, roles and responsibilities, information exchange among sites, career path development, training, data handling, future technologies and the evaluation/adoption process, challenges and lessons learned. Our research involved surveying and interviewing executives from six top pharma companies. In addition, senior inspectors from the U.S. Food and Drug Administration were interviewed for their insights on the subject. Site visits to two leading participants were also conducted to observe, first hand and in great detail, the winning practices of these top companies. With our insights in hand, our client was able to identify a specific action plan to maximize the success of their department and to prepare it for a very challenging road ahead.
Depending on the company studied, the laboratory function in the quality organization accounts for between 1/3 and 2/3 of all quality staffing. As a major source of investment, not to mention a critical aspect in ensuring product quality, the laboratory function is a area for analysis and optimization. The Best Practices LLC research team profiled a highly-regarded group of six companies, along with a set of contract manufacturers, to understand their performance in the lab.
As with other such projects, our client in this case was keenly interested in structural issues, staffing levels, spans of control, career path planning, and retention. Our research also delved into issues such as sample management, emerging lab technologies, part 11 compliance, scheduling, yields and rework, documentation and data management.
Other hot topics on the radar screen of our research team includes part 11 validation, quality cost optimization/containment, deviation and event management, quality culture, variability reduction, internal auditing, and emerging technologies (automation, electronic signatures and record keeping, etc.) affecting manufacturing quality, data handling, and staffing.