In a previous post, we discussed a process for developing a project charter in 90 minutes. Now I am going to show you how I used this process to develop a project charter for a recent project that I helped out on. The client company was having an issue with a growing number of overdue CAPAs (Corrective and Preventative Actions) and needed to eliminate the backlog, as well as reduce the rate at which they were being generated.

Let’s focus on how I got the project charter written and I will share with you the actual contents of the charter.

Step 1: Participants

Given that the overdue CAPAs were related to one function, I approached the director of that function and explained the benefit of a project charter and that we could develop one in 90 minutes. They then worked with me to identify the key stakeholder and recruit them to committing the time required. A short sharp session with a defined output.

Step 2: Preperation

I then set about getting the meeting room for the workshop ready and choose who I would appoint as the scribe and timekeeper. I myself facilitated the session. I also ensured that the room was laid out for a standing meeting and that we had markers that worked and giant post it notes to write on.

Step 3: Kick Off

Once everyone arrived, I kicked off the meeting by introducing the purpose of the session and how we would be proceeding. I explained the process we would follow and guaranteed that we would have a fit for purpose project charter coming out of the workshop.

Step 4: No distractions – Parking Lot

We agreed as a group to have a standing meeting with no laptops or mobile phones.
Given that we would be addressing 8 key questions, anything that did not contribute to answering these would be placed in the parking lot for addressing at a future point outside of this meeting.

Step 5: Allocation of time

We have 8 questions to address and we will complete each within 10 minutes. That was our commitment to each other.

Step 6: The 8 key questions

Here is the output from our session:

Purpose:
The purpose of CAPA Storm is to eliminate the CAPA backlog at our Irish facility within the next three months, while concurrently developing a new, refined CAPA process within 6 months (that is, the refined CAPA process will be fully effective).

Desired Outcome:

  • Zero overdue CAPAs by April 30, 2015
  • A new CAPA process that is effective by July 31st, 2015

Target Group & Value:
The group which will be affected in a positive way by a successful project are:

  • IS & Automation
  • Manufacturing
  • Quality
  • Operations
  • Patient

Roles:
Project Sponsor: William Lacey
Subject Matter Experts: Quality, Manufacturing, Automation, Process Development
Project Lead: Graham O’Keeffe

Note that I have changed names here for the obvious reason.

Milestones & Budget:

– Project Charter approved by Jan 30, 2015
– Zero overdue CAPAs by Apr 30, 2015
– Improved CAPA process effective by Jun 30, 2015

The expected budget for the project is 290-365k based on an +/-25% estimation review.

Plan of action to Feb15, 2015

We will develop a high level scope, WBS, and BOE in order to develop a more precise budget by February 15, 2015.

How – project execution

Approval of documentation and change controls will be by a dedicated team.

The estimate of resources and budget for the project will be established by mid February and brought to the site Quality council for approval.

A high level schedule will be maintained based on the approved Work Breakdown Structure. This will be maintained weekly.

A dedicated team and project office will be established.

Governance will be through the site Quality council.

Reporting: Weekly reporting will highlight achievements and any slippage.

Constraints/Dependencies: None identified.

Risks & Assumptions

  • Dedicated team.
  • Major process improvements are outside of scope.

Success / Fiasco Criterias

  • Zero CAPAs by Apr 30, 2015
  • Effectiveness of new CAPA process – key metrics to be established and confirmed for first three months of operation

Fiasco would be if there was still greater than 25% of the current number of CAPAs overdue.

Connected Projects

The ongoing investigation into the root cause of the CAPAs related to media failures will be critical to the success of this project.

Any new large projects need to be aware that they cannot draw on the resources of this team until after Jul 31, 2015.

Step 7: Next steps

I then agreed to take the output and capture it into a digital document and issue it for review and approval. Approval signatures are defined by our project management process.

Step 8: Check-Out

We concluded with a round the room review to make sure that we had captured all thoughts, risks and concerns.

That was it. Hope you found that useful.