Driving Productivity and Minimizing Rework in the Quality Control Laboratory

Industries Profiled:
Pharmaceutical; Manufacturing; Biotech; Consumer Products; Diagnostic; Medical Device; Health Care


Companies Profiled:
AstraZeneca; Sanofi-Aventis (formerly Aventis); Bayer; Eli Lilly; GlaxoSmithKline; Pfizer; Pharmacia (now Pfizer)

Study Snapshot

As much as 25% of the cost of bringing a pharmaceutical product to market come from manufacturing expenses, according to conservative estimates. A mission-critical component of manufacturing organizations is the quality control (QC) laboratory, which makes certain raw materials, in-process components and finished health-care products meet strict specifications designed to ensure their safety and efficacy for public consumption.

Quality control is a mission-critical component of pharmaceutical manufacturing. The Food & Drug Administration (FDA) strictly regulates hundreds of aspects of drug manufacturing. During the manufacturing process, companies take samples of their products in raw material form, in-process form, and finished product form. These samples are then sent to the quality control laboratories for a series of tests to ensure their safety and efficacy.

This Best Practices Benchmarking^® Report examines productivity and quality issues in a highly-regarded group of pharmaceutical companies' quality control laboratories.  Best Practices LLC analysts analyzed various issues related to QC lab productivity, including levels of rework and their root causes, the productivity and quality metrics labs use to assess performance, laboratory staffing levels and demographics (including education breakdowns and management-to-analyst ratios), technologies and tactics labs employ to speed up workflow, and communication techniques used to manage schedules and ensure internal clients' needs are met.

By studying other organizations’ best practices in manufacturing quality control, your company can better understand how to organize its QC labs, allocate staffing resources, create a corporate culture driven by attentiveness to product quality, and gain recognition for QC innovation and leadership.

Metrics Included in the Study
Performance metrics enable executives to perform gap analyses and identify areas needing improvement. Metrics are an important complement to the qualitative best practices included in this study report.  Best Practices LLC analysts collected and analyzed the following key metrics for QC labs at each of the companies benchmarked in the study:

• How many products are supported by benchmarked labs
• How many different methods are employed in the labs
• How many tests (aka assays) are conducted per year
• How many reworks (aka retests) are conducted per year
• How many personnel are employed at each lab (categorized by full-time, part-time and contractor)
• Management-to-analyst/technician ratios for each lab
• Each lab's approximate ADRFT (assays done right first time, aka first-pass yield) yield
• Percentage of total testing costs consumed by rework
• Percentage of rework caused by a variety of root cause factors

• Tie key productivity and quality indicators to compensation to drive continuous improvement – This report shares best practice findings that detail which productivity and quality metrics benchmark partners use to assess individual and team performance.  The report discusses tactics used for linking key performance indicators to employee compensation, including which metrics companies tie to compensation, how much of an employee's compensation depends on performance, and other factors communicated during the performance review process. In addition to conveying which metrics QC labs track, the report also includes specific performance levels achieved by participating companies.
• Implement laboratory organizational, teamwork and management structures that streamline workflow processes and enhance productivity – This study report includes dozens of detailed practices on quality control laboratory organizational, teamwork and management structures designed to enhance productivity and minimize rework and operating costs.  Examples include a sample management room to handle sample receipt from manufacturing, sample preparation, and quality control lab scheduling and customer communications.  Other best practices identified in the study include placing supervisors in the lab with shared responsibilities, using team-based workstations, and methods for ensuring regular communication in the lab.
• Adopt innovative technologies to improve quality and productivity in the laboratory - A third key finding from this benchmark study entails a variety of technologies used to streamline workflow processes, improve accuracy, and enhance lab productivity.  The report details a variety of software, databases, robotics and other technologies employed by the world's top pharmaceutical companies in their manufacturing quality control laboratories.

• Study Background and Methodology
• Project Focus
• Benchmark Class
• Key Project Findings
• Report Structure and Organization
• Next Steps

• Introduction
• Participant Profiles
• Laboratory Staffing and Demographics
• Performance Measurement and Productivity Management
• Management Techniques and Technology
• Survey Response Matrix

• Managing Human Capital in the Lab
• Facilitating Schedules and Communication
• Measuring Productivity and Quality
• Improving Quality and Efficiency

• Lessons Learned Matrix
• Top Challenges Matrix
• Interview Response Matrix
• Performance Metrics Matrix
• Sample Process Flow Charts