QA Process Review and Headcount Reduction

Tefen helped a top tier pharma company to identify causes for inefficiencies within their QA function and provide recommendations to reduce the QA head count without jeopardizing any processes or efficiency targets.

Problem
The company’s Support Functions were lagging behind production targets due to poor efficiency and recent issues such as high deviation levels were causing further inefficiencies.

The company needed to focus more on quality and strive to  enable anticipation of issues instead of having to perform “fire-fighting”  activities. The company had an initial target to reduce overall QA administrative workload and decrease workload from 30 to 25 FTEs (Full-Time Equivalent) by optimising 14 QA processes.

Response
Tefen supported Process Optimization by:

• Assessing potential improvement benefits in QA; understanding key priorities and stakeholder alignment
• Reviewing QA Performance using Kaizen methodology and Tefen’s benchmark©
• Identifying major reasons for performance gaps within QA and redesigning the process
• Providing strategic advice and developing roadmap with detailed efficiency recommendations to support the site reach the defined targets

Result
The potential for FTEs reduction from significant changes and improved efficiencies in processes has exceeded targets (totaling 10 FTEs across the department).

Recommendations are given for major quality improvements with a new process introduction and more time spent on the shop-floor.