Instructor: Marla Phillips

Learning Objectives:

1. Understand how we, as humans, recognize and deal with risk.

2. Overview of tools used to assess the probability, severity, and detectability of risk.

3. Introduction to critical thinking.

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Instructor: Shannon Hoste

Learning Objectives:

1. Understand the concepts and terminology of risk management.

2. Learn how the risk management process scales with product complexity.

3. Practice methods to identify Hazards.

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R02c: Access the Class —>

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R02e: Access the Class —>

Instructor: Shannon Hoste

Learning Objectives:

1. Learn tools to explore causes of Hazards and Hazardous Situations.

2. Discuss the analysis of how a Hazardous Situation can lead to harm(s).

3. Consider risk controls at various levels to prevent or minimize the probability of harm.

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R03c: Access the Class —>

R03d: Access the Class —>

Instructor: Shannon Hoste

Learning Objectives:

1. Understanding the evaluation of risks when making product launch decisions.

2. Learn how the Risk Management File is completed and updated across a product lifecycle.

3. Consider the value of a robust RMF for failure investigations.

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Instructors: Shannon Hoste and David Toth

Learning Objectives:

1. Understand the value of risk management within your current/future companies.

2. Learn particular considerations within Risk Management of In-vitro Diagnostic (IVD) products.

3. Practice methods to practice Risk Management.

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R05c: Access the Class —>

R05d: Access the Class —>

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.

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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.

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R09b: 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

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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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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

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R14c: Access the Class —>

Instructor: Marla Phillips

Learning Objectives:

1. Standard Operating Procedures provide clear, consistent instructions for how all employees must perform specific functions so there is a consistent outcome.

2. Standard Operating Procedures are difficult to write such that they are interpreted consistently by every employee.

3. The failure to write clear and concise procedures leads to an increased opportunity for failure and risk.

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Instructor: Marla Phillips

Learning Objectives:

1. Good documentation practices are critical to ensuring your product is safe and effective.

2. You cannot rely on memory to keep track of what was done.

3. Documentation is needed to prove everything was done correctly.

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Instructor: Marla Phillips

Learning Objectives:

1. Understand what is considered as “good documentation practices”

2. Learn how poor documentation practices can impact the product and the business.

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R17c: Access the Class —>

R17d: Access the Class —>

Instructor: Marla Phillips

Learning Objectives:

1. Good documentation practices are critical for knowledge retention for your business.

2. Intentional falsification of records is a criminal offense.

3. Poor documentation practices have to be investigated to understand the full impact, including the people, timeframe and products involved.

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Instructor: Marla Phillips

Learning Objectives:

1. Writing great procedures is important, but effective training will increase the likelihood of success for your employees, your company and the patients you serve.

2. The level of training should be commensurate with the need.

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Instructor: Marla Phillips

Learning Objectives:

1. Summary of what we have learned.

2. Example of how to manage risk in a responsible way by building a heat map

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