I’m working on a project with a client regarding manufacturing process validation. The resulting product has some issues which we are trying to determine root causes of failure modes. Our team has been diligent with our efforts, examining each component and process and its relation, if any, to failure modes. The team has been methodical in our approach; we have a plan of attack.
And then the unthinkable happens. Another group gets involved with the product and processes (but not our validation efforts) and throws around their political weight within the organization. Our process validation team efforts are out the window. A new group is leading the charge and steps on the toes of many. This new group decides they know the root causes of failure modes and brashly begins to change process steps and equipment. This group takes and “ready, fire, aim” tactic. No plan. No sound, engineering rationale. Just actions. The work completed to date by our validation team tells me that the actions of this other group will not fully remedy the failure modes.
I hope I’m wrong and that the changes will resolve the failures.