Situation Appraisal

Break down any situation into specific components, and determine who will do what, and by when. SA helps prioritize issues so immediate action can be taken to contain problems as mandated by FDA cGMP requirements.

  • Create a clear and complete list of all the issues related to a particular situation
  • Use three key criteria to put the list in priority order, so action can be taken on the right thing at the right time
  • Plan appropriate action for each concern and assign involvement to ensure the best outcome
  • Communicate priorities and ownership easily

Problem Analysis

A structured way to quickly find the cause when things are not working as they should. PA is the “gold standard” in Root Cause Analysis for FDA cGMP regulated organizations.

  • Define problem scope through setting up a simple description of the problem and then use four key categories of information to precisely describe the problem
  • Gather detailed information about the problem using Kepner-Tregoe’s unique approach to comparing items that do not have the problem to those that do, and use clues to identify specific changes that caused the problem
  • Create and test hypotheses about possible causes to eliminate ones that don’t support known facts
  • Confirm the true cause before taking action to fix it

Decision Analysis

Understand how needed benefits will influence your choice, see how well various options meet your needs, and ensure that your choice can stand the test of time. DA is particularly relevant for determining whether to undertake CAPAs that may be costly/time consuming to implement.

  • Identify criteria that will be used to evaluate choices, including clear measures of success
  • Understand which criteria are mandatory and which are not, and how much influence non-mandatory criteria will have
  • Use simple-but-robust techniques for comparing performance of alternatives
  • Consider risks associated with alternatives

Potential Problem Analysis

Consider what might go wrong with future actions, identify ways to keep bad things from happening, and/or minimize damage. Potential Problem Analysis is particularly relevant to efforts to ­correct and prevent causes as called for by FDA cGMP CAPA regulations.

  • Brainstorm a list of things that could impact the success of a plan or action and put the list in priority order so action can be taken on the right thing at the right time
  • Identify and prevent possible causes, then prepare actions to minimize effects if problems happen, along with triggers to ensure those actions happen only when needed
  • Learn Potential Opportunity Analysis: a similar process for identifying and leveraging future opportunities

Additional topics

Covered if time and learner interest are available.

  • Questioning Skills
  • Advanced topics for each process (e.g. for Problem Analysis (PA): Think Beyond the Fix; Using PA for Specific Types of Problems; etc.) 

 Download Problem Solving & Decisiond Making for CAPAs Outline

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