Problem Solving: Whats the Best Approach?

Those of you in the pharmaceutical, biotech and medical device industries encounter process and
product problems on a regular basis. You likely grimace when one lands in your lap. There is a
degree of dread associated with a problem solving requirement as it represents a diversion from
other pressing matters and will require effort you hadnt necessarily budgeted for yourself.
Indeed, effective problem solving takes time and attention; but thats generally a small
investment compared to the impact and ramifications of a serious problem not solved.

So, the reality being what it is, what is the best approach to problem solving? Thats a rhetorical
question for sure as theres not a one-size-fits-all answer; however, one can form a foundation of
problem solving skills and techniques that can be tweaked to fit the specific nature of the
problem at hand.

The table below lists the step-by-step approaches used in 3 different disciplines: Six-Sigma,
CAPA and Risk Management. Although terminology differs slightly, notice how very similar
each discipline utilizes essentially the same problem solving approach: problem identification
(Houston, we have a problem!), evaluation (how bad is the problem?), investigation (what
caused the problem?), resolution (how do we fix the problem?), improve (whats the plan for
fixing the problem?), and verification of the effectiveness of the implemented remediation plan
(did we truly fix the problem?).

Six Sigma (DMAIC) CAPA Risk Management

Define Identify Identify

Measure Evaluate Analyze

Analyze Investigate Evaluate

Improve Resolution Plans Risk Response

Control Implementation Review/Control

 Monitor/Control for
Effectiveness

As mentioned, there is not a universally accepted problem solving approach, especially one that
will guarantee the problem will be solved effectively every time; however, one could do worse
by not using the industry accepted / best-practice approaches used by those who are six-sigma,
CAPA and Risk Management experts.

ProPharma Group has the expertise to assist your organization improve its problem solving
capabilities.