CAPA and Root Cause Analysis Archives - Oriel STAT A MATRIX

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

usr192162
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on Jan 29, 2023

Dig Deep and Do Medical Device Root Cause Analysis the Right Way ├óΓé¼┼ôNever try to solve all the problems at once ├óΓé¼ΓÇ¥ make them line up for you one-by-one.├óΓé¼┬¥ This quote by author Richard Sloma captures the essence of effective root cause analysis. When presented with a vexing problem, many RA/QA managers feel overwhelmed, make […]

Creating a Problem-Solving Culture in Your Organization

usr192162
0
on Dec 17, 2022

Creating a Problem-Solving Culture in Your Organization There are two kinds of problem solving in the medical device world: 1 ├óΓé¼ΓÇ£ Solving for improvements in effectiveness and efficiency 2 ├óΓé¼ΓÇ£ 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 […]

Oriel STAT A MATRIX
0
on Jun 22, 2017

What can FDAΓÇÖs data tell you’ Sometimes you learn something new ΓÇÆ other times the data validates what you already know. FDAΓÇÖs CY 2016 Annual FDA Medical Device Quality System Data reveals that Corrective and Preventive Action (CAPA) and Production and Process Controls (P&PC) continue to cause compliance headaches for medical device manufacturers. The data […]

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Category: CAPA and Root Cause Analysis

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

Creating a Problem-Solving Culture in Your Organization

CAPA and P&PC: How to Handle These Two Medical Device Compliance Troublemakers

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