“We need help with our audit program”. “Our internal auditing is expensive and leadership wants it to show value”. And finally, “Our auditors will audit where they know they’ll find the known problems”.
These are quotes that we hear routinely with DNVGL hospitals. These statements are coming from the individuals who are in charge of the audit program, the internal auditors, and of course, leadership. Continue reading
Context is a critical concept introduced and used extensively in ISO 9001:2015. ISO 31000 defines context as the environment in which the organization operates and achieves its business objectives.
In ISO 9001:2015, context may also include the following:
There is a game being played at work.
After witnessing thousands of promotions and job searches, this is the best analogy I have to describe what goes on: the office is nothing but a game.
As in any game, there are rules.
Make no mistake, the people at the top know the game and the rules, which is how they got there.
ISO 31000 is organized around 11 risk management principles. A management principle refers to a fundamental idea, rule, or truth about a subject. ISO 31000 risk principles serve as the guideline, method, logic, design, and implementation for the risk management framework and its process. Continue reading
HOW TO ESTIMATE RELIABILTY EARLY IN A PROGRAM
In a few discussions about the perils of the mean time between failures (MTBF), individuals have asked about estimating MTBF (reliability) early in a program. They quickly referred to various parts count prediction methods as the only viable means to estimate MTBF. Continue reading