#45 – MAKING DECISIONS THAT WORK FOR YOU! – ED PERKINS

OLYMPUS DIGITAL CAMERAThere is a lot of literature written on decision making, ‘how to’, best practices, process, factors and so to follow to make ‘good’ decisions.  We have been exploring ‘risk based’  decision making in these blogs.  We have looked at factors, process, frameworks, psychology and bias.

But we have not discussed perhaps the most important aspect of any decision – implementation or that double edged word ‘execution.’  (Of course this assumes that the decision maker wants something to actually happen as a result of the decision, but that is a topic for another day).

Let’s use the nicer word – Implementation – which implies there is a course of ACTION, with a timeframe for results to be produced or to occur. Continue reading

#44 -WHAT COULD GO WRONG? – JOHN MILLICAN

John Millican pixWhat could go wrong?  As an information security manager, I have often been asked that question.  But, there are two ways it is asked.

The first is my preferred way.  It is a genuine effort to identify and evaluate the risk associated with the item at hand.  That is a conversation I want to have.  That is a thought process I want to encourage. Continue reading

#44 – CAPA ISN’T JUST FOR MANUFACTURING ANYMORE – PATRICIA SANTOS-SERRAO

Most of us in the pharmaceutical and biopharmaceutical industry are very familiar with the terms corrective action & preventative action (CAPA) and commonly associate it exclusively with quality and manufacturing.

However, CAPA can be applied to many different business areas within an organization, including clinical research.  A CAPA consists of a collection of tasks and actions executed to ensure and sustain quality and compliance in day-to-day processes.  In clinical research, noncompliance can be extremely costly, both directly and indirectly. Continue reading

#44 – IN-PROGRESS PROCESS METRICS – UMBERTO TUNESI

Umberto Tunesi pixEspecially in quality business, we’re very much used to control processes via product characteristics when setting up the process, then let the process run under no control unless we sense some problem, ultimately checking the process again at the end of the production batch, via product characteristics once more, before delivery to customer.  This is the essence of process – control and SPC.

This preceding is typical both for tangible products and for services. Continue reading