Problem Solving: What’s the Best Approach?

June 20, 2016

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 hadn’t necessarily budgeted for yourself. Indeed, effective problem solving takes time and attention; but that’s 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? That’s a rhetorical question for sure as there’s 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 (what’s the plan for fixing the problem?), and verification of the effectiveness of the implemented remediation plan (did we truly fix the problem?).

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.


Learn more about ProPharma Group's Compliance services.
Contact us to get in touch with our subject matter experts for a customized presentation.

 




Process Validation Life Science Consulting

June 20, 2016

Business Sustainability: A Case for Process Validation

Business sustainability is an often heard buzz phrase, but how does it apply when a costly process validation is imminent? Process validation is not only a regulatory compliance issue; it is also a...

Read More
Technology Transfer Life Science Consulting

June 20, 2016

How critical is the Technology Transfer phase of new drug development?

During the development phase of a new drug, great pains are taken to characterize the molecule and to run a myriad of laboratory and animal tests to determine the product attributes, toxicology...

Read More
Qualification & Validation Life Science Consulting

June 20, 2016

Are you spending too much on lifecycle costs?

ASTM E2500 – Risk-based testing has been in play for several years now.  By design, there is a significant opportunity to avoid many lifecycle costs without creating an adverse impact to quality or...

Read More