I read with
interest an article in last month’s (September) edition of American Society for
Quality (ASQ) Quality Progress which is about doing risk assessments throughout
an organization. (See Site Seeing by L.W. Yu,
E. Urkin, S. Lum, R.S. Kennett, and R. Ben-Jacob. www.quality progress.com). In it, the many (!) authors make the point that companies need to keep their
eye on RISK throughout the organization and that that is best done as part of
risk-based audits. Helpfully, they
present a number of tools that can be used, especially an example of a
probability of occurrence-severity grid which in my experience is very helpful
for setting priorities. Attack the
issues that have the highest (occurrence X severity) product first, and address
the lesser issues later.
I agree with
them. In the medical laboratory we have an ISO document ISO/TC 22367: 2008 Medical laboratories --
Reduction of error through risk management and continual improvement which
gives the same message. (Actually I agree with them so much that I
wrote on the subject over a year ago – see MMLQR: Medical Laboratory – Quality and Risk. September 25, 2010).
A few comments about measuring risk, especially for laboratories which do
not follow or understand ISO standards, in particular ISO15189:2007.
One of the expectations of Quality Systems as iterated in 15189 (and CLIA and CLSI GP26) is that the laboratory should demonstrate that it performs
preventive actions. Commonly this is an expectation
that laboratorians struggle with because they don’t understand where or why
they fit within the laboratory.
Risk analysis fits perfectly within the Quality Management systems as a
direct approach to Preventive
Action. Preventive actions are the process
of looking at new equipment, new procedures, new policies, or the existing
environment (think safety audits) to see if they have the potential to cause
more harm than good, and then addressing the problems BEFORE they occur (ergo
they are preventive).
I think that the reason that these are so difficult for laboratorians is
because thinking about problems before they occur seems like a lot of “blue-skying “ and a waste of time. Well it is blue-skying, but with a safety
mechanism built in. If you dream up a
potential problem that is either so implausible (very low occurrence) or so inconsequential
(very low severity) you don’t have to do anything about it. But on the other hand if you discover only one
thing that has a real potential impact on worker safety, or patient safety, or
test performance, or quality control, or finances, or liability, then the
risk-preventive action process has done you a real favour.
So how often do you go through the exercise? It depends.
How often do you do a safety audit?
When you are setting up your safety
program you probably do them frequently.
Once the system has settled in, you probably do them less often; same
with risk-prevention audits. The only
real problem is when you slow down to the point that you have essentially
stopped.
As a commitment, you can tie doing a risk-prevention audit to when you
introduce a new piece of equipment, a new procedure, or a new policy, and again
a few months later when it has settled in.
In addition, this can be really valuable when you have made changes
because of an imposed change in regulation or budget. Not that I am a “I told you so” kind of guy,
but recording and reporting potential risks in a constructive structure along
with a resource strategy of how to prevent them, can be both helpful and powerful.
Risk-prevention audits don’t have to take a lot of time. Often
you can work through the whole process in a few hours. But give yourself enough time to take the
task seriously.
You may be very glad you did.
PS: Some folks still write and sell software that includes the term CAPA which suggests that Corrective Actions and Preventive Actions are the same thing. They are not the same thing and those software packages are a waste of electrons and machine language and money.
This comment has been removed by a blog administrator.
ReplyDelete