Maria Wingren, Rechons most skilled and experienced Project Manager, gives her story about Rechon Project Management.
Rechon’s Project Management approach is based on the principle that every project is unique, with clear objectives, a defined schedule and full cost allocation. Projects are managed via a structured process that helps to accelerate completion and reduce costs while enhancing the end product and fulfilling project objectives. The Management is responsible for all strategic project decisions, including stop-or-go decisions. The Management evaluates project ideas, reviews progress, identifies problem areas and makes resource assessments throughout the project process.
Several years of experience with different kinds of Technology Transfer projects, both from and into the site, has made us gain a lot of know how regarding these types of projects. It has also given us the possibility to focus on critical items and optimise the project plan already in the early planning phase of the project and thus minimise the risk of delays. Risk Management is included as a tool throughout the entire project.
The Rechon Project Management System is developed in such a way to have complete follow up on all activities as well as batches, material and stability.
The project group is gathered infrequently during the projects different phases in order to list and evaluate possible GMP and project risks and if necessary perform risk reducing measures in good time.
It is incredibly important to have an open communication and problem solving atmosphere between the Contract Giver and Rechon as well as within Rechon.
When called for, specialist from different departments are in direct contact with the Contract Giver to give the best solution to a concern. Besides the scheduled meetings, all critical questions are addressed as soon as they are observed in order not to let the project face a delay.
Focused Project Meetings
The aim is to have short Project Meetings were the Project Group and Contract Giver is informed about the main activities and to follow up on timelines and project progress. Discussions regarding specific activities in-house are preferably held in smaller groups with only specialist involved to optimise the recourses. This gives the possibility to have QC personnel involved in projects without steeling too much time from laboratory work. Each Project Member is responsible for the communication in the department and also to split the workload within the group.
Project Manager Responsibilities
The task for the Project Manager is to closely follow up on timelines and activities and to support the Project Group in discussions and communication both internally and with the Contract Giver.
Typical Project Set Up
Typical standard set ups are available for different kinds of projects; Clinical Trial supply, Technology Transfer, Large scale manufacturing etc. and are adapted to fit the specific project. A project plan is set and a project document file is established. This file is used throughout the entire project and includes at a minimum:
* Activity list with on-going and completed items
* Meeting minutes
* Change control
* Batch data (batch size, aim of batch, stability follow up etc)
* Material info (lot no, supplier etc for all raw material, API, primary and secondary packaging material)
* Contact information for Contract Giver and Rechon
Project Follow Up
One very important task for the Project Manager and the team is the follow up and “lessons learned” after the completion of a project and the following questions are answered:
* Which are the lessons learned that can be used in projects to follow?
* Did we have the right competences on the project?
* Did we make the right recourse estimations compared with the outcome?
* How can we plan the next project in order to optimise even more?
In larger projects the entire Project Group is gathered during a half day after project completion to follow up on the initial risk analyses and to have opinions regarding optimisation and follow up activities.