root cause investigation - pathwise · root cause analysis and documentation. there is also a...

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“After receiving training through PathWise, we certainly see a general improvement in our CAPA process, including Root Cause Analysis and Documentation. There is also a reduction in the number of open CAPAs, resulting in less people being involved and less pressure for our organization.” - Hans Willems VP Operations Boston Scientific Root Cause Investigation Our Root Cause Investigation training course is designed to meet the requirements mandated by world regulatory bodies to investigate problems. We use an interactive approach to show how to effectively apply risk-based methodology throughout the investigation process. Specifically, we focus on how to identify issues, assess and prioritize them, and investigate root cause. COURSE OVERVIEW 1. Introduction 2. Investigate LEARNING OBJECTIVES Participants will improve their ability to: Identify and distinguish between a correction, corrective action and preventive action. Investigate events. Conduct root cause analysis. Identify a process to verify root cause. HIGH IMPACT TOPICS How to gather specifics to support the investigation. How to assess impact to process and product. How to ensure the problem statement is effective. BENEFITS Reduce repeat investigations Improve root cause identification Shorten investigation cycle time AUDIENCE & DELIVERY Root Cause Investigation is appropriate for individuals who are regularly called upon to resolve problems, or whose input would aid in preventing problems. Examples include investigators, laboratory functions, QA functions, managers, manufacturing supervisors, technicians, and engineers. COURSE DURATION One Day 866.580.PATH www.pathwise.com

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Page 1: Root Cause Investigation - PathWise · Root Cause Analysis and Documentation. There is also a reduction in the number of open CAPAs, resulting in less people being involved and less

“After receiving training

through PathWise, we

certainly see a general

improvement in our

CAPA process, including

Root Cause Analysis

and Documentation.

There is also a reduction

in the number of open

CAPAs, resulting in less

people being involved

and less pressure for

our organization.”

- Hans Willems

VP Operations

Boston Scientific

Root Cause Investigation Our Root Cause Investigation training course is designed to meet the

requirements mandated by world regulatory bodies to investigate problems. We

use an interactive approach to show how to effectively apply risk-based

methodology throughout the investigation process. Specifically, we focus on

how to identify issues, assess and prioritize them, and investigate root cause.

COURSE OVERVIEW 1. Introduction

2. Investigate

LEARNING OBJECTIVES

Participants will improve their ability to:

• Identify and distinguish between a

correction, corrective action and

preventive action.

• Investigate events.

• Conduct root cause analysis.

• Identify a process to verify root

cause.

HIGH IMPACT TOPICS

• How to gather specifics to support

the investigation.

• How to assess impact to process

and product.

• How to ensure the problem

statement is effective.

BENEFITS

• Reduce repeat investigations

• Improve root cause identification

• Shorten investigation cycle time

AUDIENCE & DELIVERY

Root Cause Investigation is appropriate

for individuals who are regularly called

upon to resolve problems, or whose input

would aid in preventing problems.

Examples include investigators,

laboratory functions, QA functions,

managers, manufacturing supervisors,

technicians, and engineers.

COURSE DURATION

One Day

866.580.PATH

www.pathwise.com