A major medical device manufacturer was experiencing quality issues in the field and receiving an increasing number of complaints related to products manufactured for them by a supplier in Mexico.
The client engaged Tefen to structure and lead a Process Excellence program aimed at improving their supplier’s validation processes. The goal was to identify weaknesses within validation processes and formulate action plans to close the identified gaps, which ultimately strengthened the supplier’s validation system.
The challenge lies in identifying improvements, which can be made to the supplier’s already compliant validation system. The customer does not want to just replicate its validation system at the supplier site, but to ensure the supplier’s system is:
How Tefen Helped
The customer and supplier jointly sponsored the project and assigned the necessary resources to support the analysis and design phase. The teams followed a comprehensive methodology to ensure no opportunity was left behind. Extensive process mapping of the validation system and sub-systems ensued.
Key activities included:
Performance Excellence Delivered
Three months after the implementation, the supplier was able to increase First Pass Yield for validation protocols by 47%. Cycle Time improved by 58% leading to a 95% completion rate within 5 days. In addition, the team gained a deeper understanding, appreciation, and insight into each others’ validation systems which will improve communication and cooperation of the parties involved.
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