Lessons Learned: Change Control Post- Implementation – Ensuring Documentation and Workflow Align to Compliance Requirements


By Dr. Willis H. Thomas

This article discusses:

  • Key learnings regarding change control
  • Hidden challenges with change control paperwork
  • Adapting change control to best practices, such as the PMBOK Guide 6th Edition
  • Workflow and systematic processes for change control
  • Opportunities to become more effective and efficient with change control

Regulatory agencies such as the FDA stress the importance of periodically holding lessons learned discussions to review compliance in change control. Change control is a systematic approach to managing changes to a Procedure (SOP), Quality System Policy (QSP), process, product, service or system. Change control should ensure the established process for change is followed, compliance is followed under a Right First Time methodology and resources are used effectively and efficiently.

In March 2019 these concepts were presented at the International Pharmaceutical Academy conference in Montreal. Tools presented here for lessons learned are based upon my Award Winning Book “The Basics of Project Evaluation and Lessons Learned” and the PMBOK® Guide 6th Edition (6M copies in print).

When classifying something as a lesson, here are a few things to “test” if it is in fact a lesson:

  • Knowledge gained from working with the change control can be applied in the future on a similar initiative or project
  • The change control documentation contains information on the competing demands of cost, time, scope, quality, risk or resources
  • The lesson is measurable in terms of Return On Investment (ROI) or Return On Quality (ROQ)

People can find themselves immersed in change control paperwork to the point of not being able to find documents, remembering due dates and overlooking important steps in workflow. This can impact organizational efficiency and thereby staff productivity. By using this matrix, each component of the change control process is mapped to the PMBOK® Guide 6th Edition to determine what went right, what went wrong and what could have been done differently. The goal here is continuous improvement, both tactical (change control) and strategic (change management).

The table below outlines some challenges and solutions with change control paperwork.















Experts have identified 10 steps for effective and efficient change control:

1. Identify need for change control

2. Categorize the change

3. Classify the change

4. Assess the impact of the change

5. Plan the change

6. Approve the change

7. Record the change

8. Implement the change

9. Close out the change

10. Evaluate the change

There is also an organizational imperative to develop a common language for change control. We can do this by publishing a glossary in a core SOP or QSP and then referencing this document across all policies and procedures to ensure consistency.

Here are 10 lessons that I have observed regarding change control.

1. If it is not properly documented, it wasn’t addressed appropriately
2. Be careful when grouping multiple changes together as one change initiative
3. Exercise caution in revising a change control when already in process
4. Determine the impact of the change before finalizing it
5. Evaluate the change control in some manner after completion
6. Engage the necessary stakeholders in change control
7. Monitor and control risk and uncertainties during change control
8. Gain commitment for a LEGIBILITY PLEDGE regarding all documentation
9. Take a deeper dive into “sub-changes” related to primary changes
10. Facilitate meetings in an agile fashion to enable quicker response

About the Author:

Willis H. Thomas

Willis H. Thomas, PhD, PMP, CPT has worked for large corporations and academic institutions in the areas of human resources, learning and development, quality assurance, project management, sales and marketing, measurement and evaluation, and operations.

He has been in senior management for life sciences companies for the past 15 years. Dr. Thomas is adjunct faculty at the Lake Forest Graduate School of Management, International Institute for Learning and Institute of Validation Technology.

His publications have received global recognition from associations such as the Project Management Institute (PMI) where he received the Cleland Award for “The Basics of Project Evaluation and Lessons Learned.” This book was an 8-year effort that enhanced the framework for the evaluation of projects using the PMBOK® Guide.

He has been a featured speaker on an international basis and has received the Apex Publication Excellence Award for implementing useful tools for project management, evaluation and training.