Category: CAPA and Root Cause Analysis

Root Cause Analysis: It’s About More Than Simply Asking “Why?”

This is the last post in a 4-part blog series on medical device root cause analysis. If you want to start at the beginning, read our first post on the basics. We’ve also combined all four posts into one easy-to-read PDF, plus added some extras. Download it here.

Getting Root Cause AnswersOne of the cute annoyances of 4-year-olds is their persistent inquisitive nature. Why can’t I have another piece of cake? Why do a I need to take a nap now? Why can’t I have Froot Loops for dinner?…

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All Topics, CAPA and Root Cause Analysis

Medical Device Root Cause Analysis: Assembling Your Team and Coming Up with a Plan

This is the third post in a 4-part blog series on medical device root cause analysis. In our first post we covered the basics, followed by a discussion on how to do problem scoping. We’ve also combined all four posts into one easy-to-read PDF, plus added some extras. Download it here.

Now that you have convinced management that they should dedicate resources to solving a specific problem, it’s time to get started on solving it.

Woohoo, let’s go!

Not so fast…you’ll probably need some help.…

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All Topics, CAPA and Root Cause Analysis

How to Define and Scope Problems: A Primer for Medical Device Manufacturers

This is the second post in a 4-part blog series on medical device root cause analysis. In our first post we covered the basics and in subsequent posts we will talk about formulating a plan, and root cause verification. We’ve combined all four posts into one easy-to-read PDF, plus added some extras. Download it here.

“If I had an hour to solve a problem I’d spend 55 minutes thinking about the problem and 5 minutes thinking about the solution.”

Define_Scope_RootCauseAnalysisPretty smart advice from Albert Einstein.…

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All Topics, CAPA and Root Cause Analysis

Dig Deep and Do Medical Device Root Cause Analysis the Right Way

This is the first post in a 4-part blog series on medical device root cause analysis. In subsequent posts we will talk about problem scoping, formulating a plan, and root cause verification. We’ve combined all four posts into one easy-to-read PDF, plus added some extras. Download it here.

“Never try to solve all the problems at once — make them line up for you one-by-one.”

Planning root cause analysisThis quote by author Richard Sloma captures the essence of effective root cause analysis.…

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All Topics, CAPA and Root Cause Analysis
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