Breaking down organizational silos and improving plans to reach compliance 

//Breaking down organizational silos and improving plans to reach compliance 

Breaking down organizational silos and improving plans to reach compliance 

The Challenge

A global manufacturer client moved into a new factory/facility in the spring of 2019. They entered into an agreement with one of their customers to utilize some of the new factory space to relocate manufacturing of some of the customer’s products from a factory in another part of the state.  The move included a complex variety of products and materials made on vintage equipment.  At the same time, the client was working to bring additional products into their new factory. This created an unprecedented complexity in their new product introduction process.

The Project 

The client chose a three phased approach to move the manufacturing equipment and perform Good Manufacturing Practice (GMP) validation for production on the same equipment in a new location.  This global manufacturer engaged Management Solutions during the first half of the initial phase and as a result, project management staff were  assigned to the client’s Sr. Program Manager.  In this roll, Management Solutions developed detailed schedules to plan and execute the remaining phases, manage risk, and provide other technical support.  The rapidly expanding scope of work resulted in assignment of additional project management support to manage the documentation and launches required.

Management Solutions Response

Key in managing this process was to ensure that the customer did not experience an out of stock situation in their distribution centers.  Routine meetings with the staff project manager resulted in frequent schedule adjustments to prioritize product validation to meet their needs.  This process was complicated in the third quarter of 2019 as the company announced the sale of the product line being moved to the new manufacturing facility to another entity. Managing stakeholder expectations for both entities became a critical activity for the project, and the project managers’ duties. Phase three of the project required several meetings, each week with all stakeholders involved to identify changing priorities and manage through the validation process.

The Results

During the planning and execution of this project, the Management Solutions project managers helped coordinate the staff augmentation required by the surge.  Tracking the critical path through the complex list of activities helped to bring resolution to material issues and document processing constraints that would have caused significant delays otherwise.  The company’s initial guidance on the validation and manufacturing project requirements were inadequate since the working process in their factories had been grandfathered and the new client process would need to comply with current GMP.  Team building and coordination with the client staff and contracted resources allowed the project team to begin to break down organizational silos and improve the plans to reach compliance. Phase one and phase two have been successfully completed and phase three is nearing completion.

By |2020-05-04T16:30:20-04:00May 4th, 2020|Uncategorized|0 Comments

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