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Driving Productivity and Minimizing Rework in the Quality Control Laboratory

ID: OP-80


Features:

22 Info Graphics

31 Data Graphics

3 Metrics

14 Narratives

15 Best Practices


Pages: 84


Published: 2020


Delivery Format: Shipped


 

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919-403-0251

  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • STUDY SNAPSHOT
  • KEY FINDINGS
  • VIEW TOC AND LIST OF EXHIBITS
The study examines staffing levels, structures, sample testing and documentation processes, performance indicators and innovative workflow technologies of industry-leading quality-control laboratories. This Best Practices Benchmarking® Report includes best practices and performance metrics to enable QC labs to maximize productivity and minimize rework -- a key cost driver in bringing pharmaceutical products to market. In the face of increased regulation and FDA scrutiny of manufacturing and quality control processes, it is critical to understand how industry leaders implement best practices and performance benchmarks to gain a competitive advantage 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

Key Findings

Quality control labs contribute significantly to both manufacturing costs and timelines required to bring pharmaceutical products to market.  As such, quality control leaders seek to understand the key productivity and quality drivers affecting QC labs' abilities to serve internal clients with minimal levels of rework and cost.  Topics of particular importance include laboratory staffing, procedures, workflow and productivity.  Throughout research with the benchmark class, Best Practices LLC analysts identified three critical success factors for optimizing productivity and quality in the pharmaceutical laboratory.  The top three recommendations from this study are to:
  • 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.
Table of Contents

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

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

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

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

List of Charts & Exhibits

Benchmark Partners’ Staffing Levels By Classification
Laboratory Staffing Demographics
Laboratory Staffing Demographics
Benchmark Partners’ Staffing Levels By Role
Balancing Management and Analysts
Benchmark Partners’ Staffing Counts By Education Level (%)
Laboratory Staff By Education
Laboratory Staff with B.S. or Some College Education 
Rework Tracking
Assays Done Right First Time
Assays Done Right First Time Rate
Rework As Percent of Total Testing Costs
Causes of Rework By Company
Quality Techniques
Error Proofing
Six Sigma
Statistical Process Control
Total Quality Management
Employee Problem Solving Teams
Laboratory Technologies
Advanced Planning and Scheduling
Forecast/Demand Management Software
Product Data Management
Database Usage
Barcode Technologies
Driving Productivity and Minimizing Rework in the Quality Control Laboratory Survey Results
Placing Supervisors in the Lab
Training in the Lab
Teamwork in the Lab
Running a Sample Room
Communication in the Lab
Tying KPIs to Compensation
Establishing a Productivity and Quality Measurement System
Identifying Trends in Performance
Creating Accountability
Benchmark Partner Lessons Learned Matrix
Benchmark Partner Top Challenges Matrix
Benchmark Partner Interview Response Matrix
Benchmark Partner Performance Metrics Matrix
Company A Lab Sample Flow Chart
Company B Lab Sample Flow Chart
Company C Lab Sample Flow Chart
Company D Lab Sample Flow Chart
Company E Lab Sample Flow Chart
Company F Lab Sample Flow Chart
Company G Lab Sample Flow Chart