I want to emphasize it is important to have procedures written down. It is important, as you said, to have those protocols put in place. When it comes to assessing whether things are being done safely, it is insufficient to simply review paper documents. This doesn't necessarily need to be a regulatory action, but there is a need that somewhere in the process, somewhere in the system, there is a culture of checking up on how we are doing and whether we have drifted away from what we said we were going to be doing.
There would be very good, practical reasons why that occurs. This is not people being nefarious, getting away with things. It's that things change. There can be competing directives and procedures and, as an organization, it is important that there be this continuous process of renewal and checking and re-establishing that the processes in place are safe. In my opinion, from my perspective, that's one of the great things that the philosophy of SMS tries to imbue into the culture of organizations. We can't just rest on our laurels. We can't just say we were safe last year and that's good enough. We have to keep on checking and be vigilant.