Based on my experiences in the industry, the risk to quality isn’t because of incompetence or neglect. I believe it is mostly because of the pressures from project deadlines and teams not incorporating all relevant departments in project planning. For example, I was recently working on a design change project to help the software team deploy new computer workstations into production. The software team did the software validation and pulled me into do the design change end of things. The software manager did not consider the potential impact to process validations in project planning and didn’t understand the magnitude of work that was required to assess all possible impact. It was almost like I was being strong armed every day to commit to unrealistic deadlines and was even asked “Is there any way we can cut corners because this is a paperwork exercise?” I believe the manager should have been aware of his limited knowledge of the design change process and pulled in the process validation team early on to discuss a strategy so we did not have to feel so much pressure or be faces with the idea of “speed vs quality.”