Implementing change in a quality focused organization

By Kelly Huckabone

October 2019

Implementing change in an organization can be very challenging. If the change is implemented in a way that is controlled and well communicated, it makes it easier for employees to accept the change and for it to stick. Having a mature quality system enables the change agent to use existing tools to assess and implement the change to ensure it is embraced and effective.

There are six key steps for implementing an organization change in a way that will ensure success.

  1. Vision — Ensure the change has been shared, understood and communicated 
  2. Accountability — Ensures the process owner(s) are held accountable for sustaining the change along with impacted stakeholders.
  3. Stakeholder Accountability — This step ensure stakeholders are committed to the change and that applicable stakeholder tasks have been translated into the project plan.
  4. Skills Development — This step ensures the change (if required) has been incorporated into the employee induction program and is a part of ongoing training.
  5. Metrics, Policies, Procedures —Ensure SOPs been updated, flow charts created and a KPI (key performance metric) established to assess the impact of the change.
  6. Reinforcing Behaviors — This step is a high-level step to ensure that the change can be incorporated into an employee’s workday. Examples could include updating of competencies, visual work boards, etc.

So now that you understand the key steps of implementing an organization change, you should leverage your quality team and quality management system to ensure the change is sustainable. Here is a quick list:

  • Use the Change Management Program to approve the change and assess impact to departments, functions, etc.
  • Use the Management Review process to report updates to Leadership
  • Use the internal audit process to validate effectiveness of the change
  • Use the document control system to ensure proper SOPs have been updated or created
  • Use your well-established training program to help ensure task competency
  • Use your CAPA program if you run into issues that need root cause analysis

Quality and Change Management should be entwined together, but many organizations make the mistake of approaching them as separate functions. Change can be meaningful and sustainable if implemented using a logical approach. The last thing I would recommend is connect the change to your employees. Help them see the big picture and the positive aspects of the change. Good Luck with your changes!

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About the author

Kelly Huckabone is the North American Audit Program Manager who oversees the Unity™ Lab Services internal and external customer and supplier audit programs. Kelly is a certified risk manager, lead auditor with the American Society for Quality (ASQ), and has been conducting audits for over 25 years for different quality systems, including ISO 9001, 13485, and 17025, as well as Health Canada and the FDA.

Contact me at if you have any questions.