Tag Archives: regulatory compliance

Tom Weaver, President, Weaver Consulting
CAPA Corner

Mistake Proofing

By Tom Weaver, Rob Weaver
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Tom Weaver, President, Weaver Consulting

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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CAPA Corner

CAPA Corner: The Case of the Defunct TV

By Tom Weaver
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A root cause investigation may be formal or informal. Things happen, at work, at home, anywhere. The investigation methodology remains the same. Only the level of documentation changes to fit the situation.

A root cause investigation may be formal or informal. Things happen, at work, at home, anywhere. The investigation methodology remains the same. Only the level of documentation changes to fit the situation.

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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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Tom Weaver, President, Weaver Consulting

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
CAPA Corner

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

By Tom Weaver
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Tom Weaver, President, Weaver Consulting

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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Ask the Engineer

Specification Requirements to Ensure Regulatory Compliance

By Julie Cameron
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There has been a sharp increase in regulatory oversight in the medical device industry. If your manufacturing requirements aren’t specific enough, your contract manufacturer might unknowingly make a problematic substitution. Which requirements are most important for your product? This week’s Ask the Engineer addresses material types, critical features and measurement methods.

There has been a sharp increase in regulatory oversight in the medical device industry. If your manufacturing requirements aren’t specific enough, your contract manufacturer might unknowingly make a problematic substitution. Which requirements are most important for your product? This week’s Ask the Engineer addresses material types, critical features and measurement methods.

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Devine Guidance

MHLW Ministerial Ordinance 169

By Dr. Christopher Joseph Devine
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There are so many tiny idiosyncrasies associated with regulatory compliance in Japan it is difficult to choose a place where to start the journey toward complying with all of the requirements.

There are so many tiny idiosyncrasies associated with regulatory compliance in Japan it is difficult to choose a place where to start the journey toward complying with all of the requirements.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Introduction to the Japanese Medical Device Market

By Dr. Christopher Joseph Devine
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Dr. Christopher Joseph Devine, President, Devine Guidance International

Well (deep subject, the doctor knows), I know many of the readers were wondering about Dr. D’s next series. The doctor really wanted to make this next series an enjoyable surprise. That being said, surprise, surprise, surprise (thank you Gomer Pyle USMC); the next series of Dr. D’s articles will be focused on complying with MHLW Ministerial Ordinance Number 169.

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