Helen Lowe
Helen Lowe
CAPA Corner

CAPA Management Can Save Resources and Reduce Expenses

By Helen Lowe
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Companies can make mistakes during drug and device development and in the post-marketing maintenance phase, but all too often, organizations apply a temporary solution to the problem and move on. In this article, Helen Lowe at Arriello addresses how Corrective and Preventive Action (CAPA) management provides a better approach to discover the root cause of the problem.

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Tom Weaver, President, Weaver Consulting
Tom Weaver, President, Weaver Consulting
CAPA Corner

Mistake Proofing

By Tom Weaver, Rob Weaver
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Mistake proofing is used in product, process, and service design and development as well as in ongoing operations and improvement applications. The goal with mistake-proofing is to find and correct mistakes, errors, or omissions as close to the source as possible, when the mistakes cost less to correct than if found later.

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Tom Weaver, President, Weaver Consulting
Tom Weaver, President, Weaver Consulting
CAPA Corner

Step 2 – Another Key Investment for Success with a Root Cause Investigation

By Tom Weaver
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In this third of a series of articles on conducting a root cause investigation, we explore a second key investment every investigator should make: assuring you have the facts! Unfortunately, investigators are often under tremendous pressure to complete the investigation and assume the information they have is entirely correct. As a result days, or weeks, are wasted going down the wrong path.

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Tom Weaver, President, Weaver Consulting
Tom Weaver, President, Weaver Consulting
CAPA Corner

Step 1 – Key Investment for Success with a Root Cause Investigation

By Tom Weaver
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In this second of a series of articles on conducting a root cause investigation we explore a key investment every investigator should make: understanding the problem before defining a solution! Unfortunately, investigations often begin by brainstorming possible causes and prioritizing them for further analysis – leading to a trial and error approach resulting in a prolonged, expensive, and often failed investigation. With Step 1 we try to truly understand the performance problem.

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