Benchmarking Quality in the Healthcare Sector: Risk Management

STUDY OVERVIEW

The quality function within biopharmaceutical and medical device companies is among the most costly and important within both industries. Quality leaders face a balancing act between managing risk and maintaining a cost efficient quality organization.

Best Practices, LLC conducted this study to probe ways in which high-performing quality groups are managing risk. The study addresses how these companies deal with supplier quality and supply chain risk; use audits to assess and prevent risks; perform effective root cause analyses and assess risk management performance.

Quality leaders can use this study to assess their quality practices regarding risk management.

KEY TOPICS

• Managing Supplier Quality & Supply Chain Risk
• Audit & Risk Evaluation Management
• Corrective and Preventive Actions
• Risk Management Metrics

SAMPLE KEY METRICS

• Metrics utilized to assess supply chain risk
• Effective practices for working with vendors
• Most valuable tools for evaluating vendor performance
• Effectiveness rating for audit tactics for assessing/preventing risks
• Importance rating for audit activities assessing GLP/GCP risk
• Number of open CAPAs and NCEs
• Most important elements for effective root cause analysis
• Approaches that work best to enable quality staff to perform effective root cause analysis
• Effectiveness of KQIs for assessing risk performance
• Metrics for determining risk of production processes

SAMPLE KEY FINDINGS

• Data accuracy, validity and integrity most important audit activity for GLP/GCP.
• Each 2nd NCE leads to a CAPA. Training of staff to identify and understand the problem is best way to enable effective root cause analysis.

The research employed a data gathering approach that reaps quantitative & qualitative data from
a diverse group of 22 companies. This study includes segmented data for biopharma and medical device companies.