Category: CAPA and Root Cause Analysis

Medical Device CAPA Owners Need Love Too! Creating a Problem-Solving Culture in Your Organization

CAPAThere are two kinds of problem solving in the medical device world:

1 – Solving for improvements in effectiveness and efficiency

2 – Solving for corrective action/preventive action (CAPA) compliance

The transition from #1 to #2 seems to perplex organizations entering the medical device arena for the first time. CAPA is too often seen as a burden, stealing valuable time from scientists and engineers who would rather focus on what they know best – designing and making new products.

Ironically, many of these same wannabe medical device companies have a robust Lean and Six Sigma culture, where a large percentage of employees hold Green Belts.…

» Read more
All Topics, CAPA and Root Cause Analysis, Medical Device Quality Assurance

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?…

» Read more
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.…

» Read more
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.…

» Read more
All Topics, CAPA and Root Cause Analysis
1 2