Instructor: Marla Phillips, Ph.D.

Learning Objectives:

1. Recognize when an investigation is needed​

2. Introduction to risk categorization for failures​

3. To understand the basics of how to conduct and write a failure investigation​

4. Take you on a journey that uncovers common pitfalls​

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Instructor: Marla Phillips

Learning Objectives:

1. Understand how to react to failure appropriately.

2. Introduction to investigative methodology.

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Instructor: Scott Doucherty and Neil Lewis

Learning Objectives:

1. Tools that can help in writing an objective and complete problem statement.

2. The importance of identifying the true root cause in any investigation

3. Human Error is not a root cause. It can be a contributing factor.

4. Interviewing employees gives great insight into failure events.

R07a: Access the Class —>

R07b: Access the Class —>

R07c: Access the Class —>

Instructors: Scott Docherty and Neil Lewis

Learning Objectives:

1. Understand two failure investigation tools and their use to get to root cause.

2. Understand the importance of identifying root cause in any investigation

R08a: Access the Class —>

R08b: Access the Class —>

Instructors: Scott Docherty and Neil Lewis

Learning Objectives:

1. Put the investigation tools, learned previously, into practice.

2. Understand how to assess the breadth and depth of impact that a failure can have.

3. Identify ways to correct failure, prevent failure, and determine the effectiveness of those actions.

R09a: Access the Class —>

R09b: Access the Class —>

Instructor: Marla Phillips

Learning Objectives:

1. Explore the intricacies of different failure scenarios

2. Pull everything together you have learned so far to assess the situation and conclude the investigation

R14a: Access the Class —>

Instructor: Marla Phillips

Learning Objectives:

1. Explore the intricacies of different failure scenarios

2. Pull everything together you have learned so far to assess the situation and conclude the investigation

R14b: Access the Class —>

R14c: Access the Class —>

Instructor: Marla Phillips

Learning Objectives:

1. Understand how a failure investigation report is designed.

2. Begin completing an investigation report for a Laboratory Failure

R10a: Access the Class —>

R10b: Access the Class —>

Instructor: Marla Phillips

Learning Objectives:

1. Good detective work is needed to identify true root cause.

2. Fishbone diagram, interviewing employees involved, and design of experiments are excellent investigative methods.

3. Understand how to conduct a thorough impact assessment.

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Instructor: Marla Phillips

Learning Objectives:

1. Good detective work is needed to identify true root cause.

2. Fishbone diagram, interviewing employees involved, and design of experiments are excellent investigative methods.

3. Understand how to conduct a thorough impact assessment.

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Instructor: Marla Phillips

Learning Objectives:

1. The level of effort put into CAPA is based on the probability of the failure recurring, the severity/impact of the failure, and our ability to proactively detect the failure.

2. It is important to ensure the root cause is known before identifying how to “fix” the failure.

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Instructor: Marla Phillips

Learning Objectives:

1. Supplier Investigations must be initiated when failures experienced at your company are related to material supplied by your supplier.

2. Your company is responsible for ensuring your supplier conducts a thorough, scientific, defensible investigation.

3. Your Quality Department must assess all information for batch release decisions

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Instructor: Marla Phillips

Learning Objectives:

1. Compare “what not to do” versus what you have learned about proper investigation management

2. Understand the broad impact of poor investigation studies

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