You have struggled with your CMO for the last six months; slowly, but surely, your requested manufacturing dates for your newly transferred process have edged further and further out. You chose this CMO based on several factors: a capability match, good regulatory history, a passing quality systems audit, a capacity match, and their ability to meet your critical and aggressive timelines. Now, the looming reality is that your critical timeline will not be met, and you are struggling to get a believable commitment from the CMO so you can report back to your own organization.
Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system is the integration of risk-based thinking. While the concept of risk management is not new, previous practice was more reactionary, primarily focusing on detection after the fact, root cause analysis, corrective actions, and preventing recurrence of the failure. Contemporary thinking places the emphasis on considering risks up front (prevention) and having a solid approach to address risk in planning, managing, and driving actions.