How to Handle Scope Creep??

Project Description:

This project was implement to effectively implement an learning management system that would facilitate GMP training, which is mandated by the FDA, to provide accurate electronic training records for auditing purposes, to increase management’s  visibility of the Training system compliance state and to strengthen the sites compliance position by reducing the number of deviations.   

The objective of the project was:

·         to reduce the human error related deviations related to lack of training.

·         to improve the site’s compliance state by providing evidence of knowledge transfer and training effectiveness

·         and,  to ensure all job position have adequate training requirements in their curricula

Two phases of the project were established, but phase I was planned to address a critical state of the manufacturing area for the products.  The plan and project milestones included:

1.      Provide training to managers on how to perform Curriculum Development analysis for department and position specific training requirements (PSTR).

a.      49 Employees

2.      Perform an assessment of job descriptions compared to current position specific training requirements forms by position to confirm that employees are assigned appropriate position specific training. 

3.      Develop electronic training modules for SOPs to be uploaded and maintained in Noven University for 184 courses.

4.      Develop Curriculum with assigned position specific training in the learning management system for 28 positions affecting 70 employees.

5.      Convert training records from paper to electronic records to be maintained in an electronic repository for auditing purposes.

6.      Eliminate the use of training records forms for audits to reduce the possibility of misplaced training records; and, to reduce the time invested in the  maintenance of training records in different repositories used during audits to verify training.

a.      Current Training Forms Being Used: 

·   New Employee Introductory Training Form

·   Group Training Form

·   Individual Training Form

·   Required Training/Re-training Form

7.      Testing and Implementation of courses, curriculum and learning management system

8.      Monitor Compliance

The timeline was very aggressive since the FDA had committed to a reinspection in 90 days.  The project was time lined for a 45 days completion and implementation to allow for system and user trouble shooting. 

Scope Creep:

During the assessment of position and job descriptions it was identified that there were only job descriptions for 60% of the positions, making it almost impossible to meet the September 15th deadline since job description would have to be created from scratch.  The stakeholders requested that new job descriptions be developed and used for the curriculum building process.  Several meetings were held with the stakeholders and the team to identify how to manage the timeline and the new deliverable/tasks.  Because this was an FDA requirement, there was no negotiating with the timeline. 

How  to managed the issue and control the project timeline:

As the project manager I prepare a request for staff (additional resources) that would become shared costs by each department who did not provide the required job descriptions for each position being addressed.  I prepared a resource allocation plan identifying 3 persons, 1 from each department affected, included the amount of time it would take to develop a job description and presented it as a change of scope to the stakeholders.  The stakeholders agreed that it was the responsibility of each manager to have a job description for each position in their department, and Human Resources role to verify this task is completed.  As a result, the stakeholders divided the expense of the 3 additional resources needed between each department, QA, QC and Manufacturing, as well as Human Resources since it was identified as a hole in their system.  A Change of Scope was signed by the Project manager and Stakeholders. 

Additional Advice:

It happens in every project, you begin with a specific goal or objective and as you rollout the project something else needs to be done, or it’s a great opportunity to do an additional task.  One of the biggest challenges that I have experienced is balancing the timeline or budget.  Research indicates that 65% of project do not successfully meeting the timeline or budget. (Portny).

A successful project manager will always determine the scope, consistently review the project plan and communicate to the team and stakeholder(s); formally address any changes immediately and in writing; do not sway from the approved timeline; and finally be realistic when developing the timeline and budget, and be flexible.