Benchmarking Quality in the Healthcare Sector: Risk Management

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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.

METHODOLOGY

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.

Industries Profiled:
Medical Device; Pharmaceutical; Diagnostic; Manufacturing; Consulting; Biotech; Biopharmaceutical; Health Care; Clinical Research; Laboratories


Companies Profiled:
Boston Scientific; idera pharmaceuticals; Astellas; seracare; GlaxoSmithKline ; GN Hearing; 3M Company; Neopharm; Amgen; NewLink Genetics; Abbvie; Takeda Pharmaceuticals; Daiichi Sankyo; DePuy Synthes; Baxter Healthcare; Novartis; Tesaro; Biogen; Sanofi; Abbott; Medtronic; Beckman Coulter

If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.