Quality Best Practices
Best Practices, LLC has conducted extensive research in the field of Quality. Browse through and sample our published Quality research in the topics below:
| |  | Quality Metrics and Compliance Research Bundle  
Non-Members: Download a complimentary study summary of the Quality Metrics and Compliance Research Bundle at http://www3.best-in-class.com/de171.htm. The summary contains sample graphs and research findings from the separate research initiatives included in the bundle as well as an overview of Best Practices, LLC's Database service offering.
In light of increased FDA scrutiny, Quality and Compliance among pharmaceutical and healthcare companies have become an increased area of focus. Poor quality and compliance can lead to heavy fines, lost credibility, or even closed operations and organizations. In order to stay on top, it is essential that pharmaceutical and healthcare companies use the best and most efficient tactics when organizing and maintaining Quality and Compliance Programs.
The Quality Metrics Research Bundle presents a comprehensive look at the structure of manufacturing quality efforts at more than 25 pharmaceutical, healthcare and medical device companies. It includes survey and interview results from several of Best Practices, LLC's research initiatives.
This comprehensive Research Bundle contains benchmarks in the following areas: staffing, procedures, workflow, and productivity aspects of quality assurance/quality control laboratories. Specific metrics in this bundle include conversion costs, capacity utilization, quality control efficiency, staffing levels by function and management responsibilities, and levels of automation. In addition, the Quality Metrics Research Bundle includes research on how best-in-class companies restructured for improved quality and reduced costs, with specific emphasis on shared service implementations and the decision to outsource or off-shore operations.
Sample key findings from the research initiatives featured in this bundle include:
One study showed that most companies in the benchmark class have completed a major reorganization within the past three years. All of those that have not already reorganized plan to do so within the next three years.
Another study revelaed that most partners reported only average degrees of automation in their facilities. One company with a high degree of automation reported considerably better maintenance cost, headcount, and overtime performance when compared to other benchmark partners.
An effective way to drive continuous performance improvement is to tie key productivity and quality indicators to employee compensation. Benchmark surveys and best practice interviews reveal that most quality control laboratories already track a variety of productivity and quality indicators, including an assays done right first time yield (ADRFT), testing cycle times, analyst/chemist productivity and rework. However, only a few labs directly tie performance measures to employee compensation.
The information in this document is essential to any pharmaceutical or healthcare company looking to improve or maintain a successful quality and compliance program. The Quality Metrics Research Bundle is offered at significant cost savings and is a great way to begin evaluating and restructuring your own Quality and Compliance program.
Quality Training and IT Management: Creating Global Processes and Maintaining Software Excellence for Medical Device Companies
Non-members: Click here to review a complimentary excerpt from "Quality Training and IT Management: Creating Global Processes and Maintaining Software Excellence for Medical Device Companies"
STUDY OVERVIEW
In order to achieve higher efficiency, Medical Device and Technology companies are increasing their investment levels in both the tools that provide IT solutions and in the training of their employees within the Quality function. Both of these areas are an integral part of ensuring that products continually meet a certain level of quality standards and regulations.
Best Practices, LLC conducted this benchmarking study to assist medical device companies in their approach to both their IT solutions and training their employees. In addition, the research provides valuable insights into the centralization and automation of document control and the document storage model and levels within the Quality function. The study also includes different approaches companies are taking in order to mange software quality staffing and reporting.
Medical device leaders can use this study to evaluate the support they provide via training as well as their management of software quality and document control.
KEY TOPICS
Executive Summary
IT Solutions for Quality Activities
Managing Document Control
Deploying Quality Training
Managing Software Quality
SAMPLE KEY METRICS
Global structure for CAPA IT system
Global structure for Complaint Management IT system
Global structure for Corrections and Removals IT support
Global structure for Document Controls IT support
Global structure for Laboratory Data Management IT support
Annual number of Quality training sessions per Quality FTE
Percentage of quality training deployed through different channels
Usage of external vendors for training system
Centralization of and automation of Compliance/Document Control
Level of Compliance/Document Control work executed off-shore
Annual number of objects reviewed by the Quality function
Number of documents stored in different types of documentation systems
Percentage of documents changed and reworked over the last year
Number of change requests evaluated by Software Quality group in the last year
SAMPLE KEY FINDINGS
Deploying Quality Training: On average, 36 training sessions were performed per Quality FTE last year. Reviewing documents accounted for more than half of the training, followed by classroom training at 26% and e-learning at 18%.
Managing Software Quality: At nearly 30% of companies, the software quality group is a dedicated resource. Per billion dollars in revenue, software quality groups evaluated more than 750 change requests last year on average. More than half, or 58%, off shore some aspects of software quality management.
METHODOLOGY
For this benchmarking study, Best Practices®, LLC gathered insights and performance data from eleven executives from 11 medical device companies. Five executives participated in interviews.
Quality Management & Product Development: Ensuring Supplier Excellence and Scientific Quality Processes for Medical Device Companies
Non-members: Click here to review a complimentary excerpt from "Quality Management & Product Development: Ensuring Supplier Excellence and Scientific Quality Processes for Medical Device Companies"
STUDY OVERVIEW
Rising concerns about the quality of products and the management of the processes within the Quality function are forcing Medical Device companies to evaluate their resources and structure. As a result, supplier management protocols and the level of staff and budget allocation for different inspection activities and processes are becoming more valuable metrics to evaluate the efficiency of product release.
Best Practices, LLC conducted this study to the investigate how medical device companies manage important processes such as laboratory testing and outgoing inspections. In addition, the research presents benchmarks around the allocation of support product design and the manner in which it provides assistance across the commercialization lifecycle. The study provides meaningful metrics, such as the the optimal product mixes required at different testing levels within Quality function, coupled with key insights provided by leading executives through interviews.
Medical device leaders can use this study to evaluate their management of activities such as supplier quality and manufacturing inspections as well as the support they provide R&D.
KEY TOPICS
Executive Summary
Managing Supplier Quality & Incoming/Receiving Inspections
Managing Manufacturing/Outgoing Inspections
Managing Laboratory Testing & Scientific Quality Processes
Supporting R&D Clinical Trials
SAMPLE KEY METRICS
Number of suppliers currently serving the quality function
Number of supplier audits conducted annually
Number of suppliers managed at each organizational level
Level of integration for Supply Quality activities
Percentage of incoming batches requiring a detailed inspection
Percentage of suppliers certified to conduct Quality audits at the source
Standardization of protocols for managing supplier performance
Percentage of total budget and FTE resources dedicated to different Inspection Activities
Involvement of Quality organization in verifying day-to-day manufacturing performance
Percentage of products destructively tested
Percentage of product batches inspected by Quality organization that are released without rework
Percentage of production batches that undergo substantial quality analysis in an off-floor laboratory
Percentage of products requiring toxicology tests
Percentage of products requiring bicombatibility tests
Location of analytical and microbiology lab tests
Method of allocation for support of product design
SAMPLE KEY FINDINGS
Managing Supplier Quality & Incoming/Receiving Inspections: Most suppliers are managed by a centralized corporate group or specific manufacturing sites. A profile or self-survey is the most common supplier audit performed. Additionally, 54% of companies inspect more than 60% of incoming batches.
Managing Laboratory Testing & Scientific Quality Processes: For 43% of companies, 10% of or fewer of production batches undergo substantial analysis in an off-floor laboratory other than routine microbiology. On average, 69% of analytical lab tests and 65% of microbiology lab tests are performed at manufacturing sites.
METHODOLOGY
For this benchmarking study, Best Practices®, LLC gathered insights and performance data from eleven executives from 11 medical device companies. Five executives participated in interviews.
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