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CAPA and the White Space

What is white space? It’s the blank space around the process chart and it’s full of activity. There’s a tendency to try to make every step of the process precise and defined, and to attach a raft of scorecards and KPIs, but the white space remains as big as ever, and people will fill it. Sometimes usefully – but occasionally causing disaster.

When you look at the last “human error” CAPAs filed in your database, you’ll see some common challenges:

  • Conclusions obscured by heaps of text
  • Assumed causes masquerading as proof
  • Irrelevant data

At its simplest, your CAPA process will look something like this:

The important thing to focus on is the quality of the work at each step, especially:

  • Initial data capture
  • Symptom description and measurement details
  • Sampling rate
  • Impact assessment
  • Verifying corrective actions

This is especially important when dealing with problems that are perceived as human error. People try their best,  but are often defeated by unworkable systems. Mistakes can only be corrected with careful evaluation – and that requires useful data, which is often missing.

What does your CAPA scorecard look like? How many CAPA quality measures are there, or are you simply tracking things like timing and completion?

Learn more about the necessary components for successful CAPAs and continuous improvement.  Check out our whitepaper!

Kepner-Tregoe has been the industry leader in problem-solving consulting and training for over 60 years, working with companies around the globe and across industries to solve some exciting (sometimes scary) problems and provide employees with the skills they need to confidently deliver results.  KT’s experience-based learning methods integrating tools such as simulations and mentoring of in-tact teams have led to countless success stories for companies just like yours.


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