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Problem Solving Blog March - 2016

The document discusses different approaches to problem solving, noting that while there is no single best approach, methods from fields like Six Sigma, CAPA, and risk management follow similar step-by-step processes. It outlines the common stages - problem identification, evaluation of causes and impacts, investigation, resolution development and implementation, and verification. Adopting an industry-standard approach can help effectively solve problems, though customization may be needed. The document promotes the services of ProPharma Group to improve organizational problem-solving skills.

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Steve Speer
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56 views2 pages

Problem Solving Blog March - 2016

The document discusses different approaches to problem solving, noting that while there is no single best approach, methods from fields like Six Sigma, CAPA, and risk management follow similar step-by-step processes. It outlines the common stages - problem identification, evaluation of causes and impacts, investigation, resolution development and implementation, and verification. Adopting an industry-standard approach can help effectively solve problems, though customization may be needed. The document promotes the services of ProPharma Group to improve organizational problem-solving skills.

Uploaded by

Steve Speer
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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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.

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