Was Your Project a Resounding Success ?

A sterile liquids manufacturer was near the completion of a new purpose-built production facility, which comprising three manufacturing areas, occupying two floors, with a third floor for utilities containing all the associated plant and equipment.

Board approval was obtained in 2013 for an estimated design and build cost of £10m, primary equipment cost of £5m, other costs of £0.5m and a contingency of £1.0m. The building was scheduled for completion in late 2016. Due to project delays, the manufacturer engaged ZES to undertake an independent project review.

The primarily focus of the project review was to undertake an examination and gain an independent understanding and view of the appropriateness of the project management structure, timelines, approach, resources and costs, outlined in the project and validation plans. The main items under review included:

1. Project Budget & Timelines

Review of the project budget, including the remaining completion and validation activities, and any extra consultancy required. The key review standard was the availability of a suitable budget whilst providing best value for money, to complete the facility. ZES were also tasked to provide potential opportunities to reduce the project timeline balanced against any additional resource required.

2. Project and Validation Plans

Review of the project and validation plans, including structure, timelines and resources to deliver an operational facility. The review was: to include an assessment of whether the plans were above or below the required standard for a sterile manufacturing facility? The key review standard was can the plans deliver the proposed timelines and quality.

3. Validation Protocols

A sample review of key validation protocols was to be undertaken for appropriateness of standard, quality and completeness for intended use.

4. Resource Levels

A review of project resource levels including training and experience.

5. Scope Creep

A review of the documented project objectives and scope, whilst potentially identifying any scope creep.

6. Project Management

A review of the project management style. The day to day handling of project meetings and subsequent minutes and assigned actions.

7. Stake Holder Interest

A review of the interest and involvement level of senior management, including communication during project meetings, the reporting of the project’s progress, feedback, improvements and support.

8. Red Flags

ZES were also tasked to review project warning signs, highlighting those potentially missed by the project team.

During the review process, ZES openly interviewed key members of the project team and third parties, to understand the perceived project issues. ZES recorded many comments which ZES thought were in fact based on incorrect perceptions and possible ulterior motives. Due to their extensive experience, ZES were able to cut through the nonsense and uncover the root causes of the project problems. ZES also reviewed many documents relating to the project and validation program.

As the project was in progress at the time of the review, every effort was made by ZES not to impede the project progress.

ZES found multiple issues and factors which impacted the project. A final report containing extensive findings was submitted to the client.