The Quality Function: Structures, Staffing and Execution
Knowledgeably improve the quality function of your company by using the benchmark metrics, managerial observations and benchmark study trend analysis in this report. The U.S. Food and Drug Administration has recently cited manufacturers for a variety of deficiencies in quality control, such as data handling, computer system validation, and manufacturing review processes. These deficiencies have resulted in extraordinary attention being placed on companies’ quality functions. Missteps in this area can potentially lead to manufacturing shutdowns by the U.S. government, severely impacting product launch, supplies, patient health, and corporate profitability.
Best Practices, LLC studied the systems, approaches and practices of seven pharmaceutical and medical device companies known for exceptional quality execution. By applying the knowledge obtained from these companies, your company can dramatically improve it's overall quality function.
Business Operations > Benchmarking and Quality d
Industries Profiled:
Health Care; Pharmaceutical; Diagnostic; Biotech; Medical Device
Companies Profiled:
Abbott; Alcon; GlaxoSmithKline; Johnson & Johnson; Medtronic; Wyeth
Study Snapshot
Best Practices, LLC examined the world-class practices of pharmaceutical companies and compared structure, staffing, roles and responsibilities in the quality function. Insights in this report will help executives at pharmaceutical and medical device companies identify critical performance gaps and provide specific direction for marked improvement.
"Good quality is life enhancing. Bad quality is life threatening."
- Interviewed Executive
The Best Practices LLC research team identified seven top companies to participate in this study, each of which were noted for exceptional quality execution and overall standing in the quality arena. The research team conducted oral interviews and written surveys of executives at each of these companies, seeking details on each aspect of the quality function. The study identified the systems, approaches, and practices to which these leading executives attribute their success as well as performance gaps. These insights give executives a path along which a company may pursue quality excellence. This insight will aid in making informed budget, resource allocation and process improvement decisions.
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Key Findings
This research on the quality function uncovered important insights affecting pharmaceutical companies. Best Practices, LLC identified and profiled many of the tactics and most effective practices embedded in these companies' winning strategies. Here are just a couple of practices that survey data and best practice interviews revealed:
- Beef up training and certification programs-- Knowledgeable employees who are prepared to make tough decisions are crucial to an organization’s overall success in the quality arena. Training and certification programs take center stage as companies seek to integrate new hires and promotions within the quality function as well as keep existing employees current on advancements in the field.
- Strengthen auditing roles -- A well-developed auditing function is the greatest defense that any company has against regulatory difficulties, production shutdowns, recalls and other such manufacturing difficulties. Building an effective auditing function requires going beyond merely identifying issues with batches before they leave the plant. While this is a crucial task, successful auditing functions also uncover larger systemic problems and monitor improvement efforts.
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Related Research:
Best Practices in Developing the Benchmark Function
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Understand optimal structures for benchmarking, successful approaches to prioritizing research requests, methods for building buy-in for benchmarking as a concept and ways to track process improvements resulting from benchmarking efforts... (ID KM-39)
Companies Profiled: AstraZeneca, Eastman Kodak, PSEG, BT Group, more ...
Price: $2098.00 Free Excerpt Available
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