We led the implementation of ERP based receiving, inventory management, quality release, production control, internal transfers, supply chain planning and master data management within 6 months in a highly validated environment.

Challenge

The startup biotech client expected FDA approval of their first product, but supply chain processes were not ready for the anticipated growth and volume increase. Implementation of ERP supply chain modules had been initiated, but the project was continuously delayed and not managed well.

Evaluation

Simply stated, the company found itself with minimal operational business processes that happens with many start-ups. The initial evaluation of the project revealed, among other problems, that the ERP implementation project had just entered the “code freeze” stage, yet business processes had not yet been developed.

Focus had been placed on training each department on their transactions in siloes, but with minimal knowledge regarding the process flows outside their immediate area. In addition, subject matter experts could not independently perform their assigned transactions, which they should have achieved much earlier in the project.
Team members had become jaded regarding the constant, ineffective meetings they had attended for months with little progress.

Approach

As a result, we made the following changes. First, we immediately developed cross-functional teams focused on end-to-end business processes, such as Receive to Stock, Plan to Make, External Make to Ship. Second, we held regular workshops to quickly define the planned future state processes given the locked configuration constraints.

A rigorous training schedule for subject matter experts quickly created the necessary capability to pass the subsequent conference room pilot. In addition, we initiated a “sprint” type approach to validation deliverables to minimize delays and quickly highlight issues to be addressed.

Additionally, we developed work instructions with process maps to standardize business processes, provide learning tools to the users and clarify post-go-live responsibilities.

Finally, we developed a cross-functional team to assign field responsibility, train assignees, and populate data values for each of the 80 fields within the item master.

Results

We implemented an ERP system with minimal post-go-live issues. Although initially delayed, we completed the project to the extreme satisfaction of the executive team.

Every supply chain process was redesigned, developed, and implemented. All business processes had training materials developed, including instructor-led sessions, video, and SOP training.

About the Author

Steve is a leading expert in life science supply chain operations with over 25 years of experience in the industry. Learn more about Steve and his team at BioSupply Consulting.

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