I am currently working on a project that I inherited from a former coworker about a month ago. Very high level, it is a software driven update to some manufacturing equipment. It seems like the people who controlled this project before me did not consider potential impact to process validation and all of the processes that interface with the equipment that will change. The subsequent activities to address all verified and validated processes basically blew our timeline out of the water.
To address this obstacle, first, I escalated the issue to management and asked for additional resources to help me even come close to my original deadline. I also pulled in a cross functional team of engineering, quality, and process validation to strategize how to approach the validation activities. Then I outlined all changes that needed to happen to support the project and distributed the task between all of the resources.
I think the original planning phase of this project should have been more developed. There should have been early on conversations between the software team, engineering and the validation team to strategize the best way to approach these production updates.