Quality and Risk: A match made in clinical research heaven.

We will spend some time reviewing quality and risk on this website individually, but it can be helpful to understand how they are related:

Quality <> Risk

Quality is a goal (and should be a stretch goal, hence why I like to emphasize defining "high quality" outcomes). It can only be achieved through operational success. So how do we try and ensure the success of quality? ...soft toss: managing risks.

Risks are the potential roadblocks and minefields that could prevent quality from being achieved. Therefore it is important to assess and mitigate those quality-killing risks.

Here are some important stretch goals for your organization:

Always stretch for high quality. Do this through a robust Quality by Design process.

Always mitigate the risks of achieving high quality. Do this through a culture focused on risk assessment and mitigation as well as through a robust Risk-Based Quality Management process.

Always learn and improve. Don't let issues repeat, and try to reach for even higher levels of quality the next time around. Do this through a knowledge management culture, lessons learned process and continuous improvement process.

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