Change Management Framework is built on the foundation of facilitating change. Change is inevitable and required within organizations to stay abreast of the evolving regulatory guidelines. Company XYZ is required to change its formula due to crop shortages of a particular ingredient. Micro-parameters have been updated per regulatory guidelines. These all require changes that must be communicated and facilitated from the company to the manufacture.

Change Control is the method in how this is accomplished. There are permanent changes, temporary changes, and deviations. Permanent changes are everlasting and require a one-time change. Temporary changes may be identified as a blanket change that is set for a predetermined length of time. Deviations are changes but for a singular situation. For example, a deviation may occur when an ingredient in a formula temporarily deviated from the original recipe. The formula in question will revert to the original formula after the deviation has been completed. This one-time change is known as a deviation.

Change Management

The key points within a good Change Management Framework can be identified as follows:

  1. Communication – Communicate verbally and in writing the change needed. Communication provides the necessary action required to facilitate the change.
  2. Organize – Organization is a skill not to be taken lightly. Change Management Framework requires an organized approach to collecting information, gathering documents, outlining details, and preparing for the change.
  3. Documenting – Documenting internal records, filing paperwork, and sharing the required documentation with the parties involved.
  4. Approval – Change Management requirements involve approval at various levels depending on the complexity of the change. When the change involves sensitive information, it could take a long time to execute the change. Quality always has the final approval to sign off on all change controls in the food industry.
  5. Quality Management – Quality plays a crucial role in Change Management. Quality is the team that receives the change communications, documents the change, and helps organize and assist in executing the change through team collaboration with cross- functional teams.
  6. Closure – Closing the change control and signing off that the change has been completed.
Change controls help organizations execute customer needs, follow regulations, and pivot in an unpredictable industry. Change Control is our area of expertise! Do you need help developing a change framework, or do you have questions about the process? Let our experts know! PSC Biotech® has been doing this for over 25 years.

Authored by: Candice Harris

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