Written by: Tom Kelland, Director of Southwest Operations at PSC Biotech™ Utilizing outsourced professional services can help boost your company in many different ways. This is especially true when working in a heavily regulated industry where expertise will save time...
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.
The key points within a good Change Management Framework can be identified as follows:
- Communication – Communicate verbally and in writing the change needed. Communication provides the necessary action required to facilitate the change.
- 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.
- Documenting – Documenting internal records, filing paperwork, and sharing the required documentation with the parties involved.
- 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.
- 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.
- Closure – Closing the change control and signing off that the change has been completed.
Authored by: Candice Harris
PSC Software Solutions
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