Risk Management

risk-management-processHey There!

The seventh & final pillar of the CQE Body of Knowledge is dedicated to the topic of risk management and it contains 3 main chapters within it, Risk Oversight, Risk Assessment & Risk Control.

The Risk Management Process can be seen below, and it is comprised of 3 primary processes, and 2 supporting processes.

The 3 primary processes include Risk Assessment, Risk Control & Risk Review. For the purposes of this discussion we’ve combined Risk Control & Risk Review into one chapter.

The supporting processes are vertical bars on the left and right, risk communication & risk management tools. These are applicable at any stage in the risk management process.

Quality Risk Management 2

Risk Management & the CQE Exam

In terms of the overall CQE body of knowledge, this pillar comprises 15 questions out of the total 160 which is almost 10% of the exam.

For each of 3 chapters below, you’ll find a quick summary below along with a link to the full chapter.  Each of these chapters will contain a practice quiz at the bottom of the page.

Before you start studying though – I want to encourage you to take advantage of a really cool learning technique – the Pre-Quiz!

Taking the quiz before studying will help you identify your knowledge gaps so that you know where you’ll need to spend your time studying.

The second and perhaps more interesting benefit that’s come out of the research shows that taking a quiz before studying helps improve memory retention.

You’ll actually learn faster, and remember the new concepts longer, by taking a quiz before studying even if you get the wrong answers.

I’ve put together a quiz that covers all 4 chapters. Once you’re done studying all the chapters, you can come back here and find another post-quiz that’s  bit more challenging!

Like I said above, this is the 1st of 2 quizzes that cover all 3 Risk Management topics, along with the Risk Management Tools chapter from the Product & Process Design section.

This quiz is substantially easier than the 2nd quiz – and it’s just meant to help you establish a baseline of your existing knowledge.

From this baseline you should be able to create a study plan!

Risk Management Word ScrambleRisk Oversight

The first chapter within risk management is all about Risk Oversight; and within this chapter there are there critical areas we will discuss.

Before we jump into those topics we need to lay the foundation for the entire risk management section & cover the concept of risk itself.

To do this, we will start by answering the question- what is Risk?

Then we discuss the different types of Quality Risks to be aware of.

Then the first major topic is the process & framework for the entire risk management pillar, and how risk management should be integrated into the Quality System(QS).

The second topic in this chapter is the Planning phase associated with Risk Management.

This is the foundation work that must be performed before you can start identifying and analyzing risk. This includes setting the context of your risk management program, and determining the level of acceptable & unacceptable risk.

The third and final section is all about Risk Communication; that is, who should be communicating what, to whom, by when, how often and why.

risk-assessmentRisk Assessment

Risk can only be effectively managed when it is identified, analyzed & considered for mitigation.

The collective process of identifying, analyzing and evaluating risk is known as a Risk Assessment & this process can be summarized into three questions:

  1. What might go wrong?

This is the Risk Identification question; what are those or sources of failure or failure modes that could reasonably occur.

  1. What is the likelihood that individual something might go wrong, and what are the consequences when that something does occur?

This is the Risk Analysis question and it seeks to quantify or analyze the risk for each identified failure mode.

As we will discuss, Risk is considered the combination of both the likelihood of occurrence of a failure & the severity of that failure.

  1. Finally, Is that risk ok?

This is the Risk Evaluation question. Once you’ve estimated the risk associated with each potential source of risk, you can then determine if any mitigations are needed to reduce that risk.

Risk Assessment

These three Risk Assessment process steps – Risk Identification, Risk Analysis & Risk Evaluation are the focus of this chapter and will be discussed in detail.

We will wrap up this chapter with a quick discussion about risk communicationrisk facilitation tools & the level of effort associated with the risk assessment process.

Risk Control

Here we are on the last chapter of the Risk Management which is dedicated to the Topics of Risk Control & Risk Review.

This chapter is broken down into two sections – Risk Control & Risk Review.

The first is Risk Control where we cover the concept of risk reduction and risk mitigation where you’ll learn the 4 step process to an effective risk reduction effort.

Within this section we also discussed many of the common Quality System Processes & how they can also contribute to your Risk Control strategy – including topics like Product Design, Process Design, Process Validation, Process Control, Supplier Management & the Control of Measurement Equipment.

Risk Control & Review

This first section will close out with a discussion of Risk Acceptance & Residual Risk.

The second major section of this chapter is the concept of Risk Review process & and on-going monitoring of the risk management process including Risk Events.

Conclusion

Alright – I hope you enjoyed this seventh & final pillar of the CQE Body of Knowledge that is dedicated to the topic of risk management and its 3 main chapters; Risk Oversight, Risk Assessment & Risk Control.

As discussed, the Risk Management Process is comprised of 3 primary processes, and 2 supporting processes.

The 3 primary processes include Risk Assessment, Risk Control & Risk Review.

The supporting processes are vertical bars on the left and right, risk communication & risk management tools. These are applicable at any stage in the risk management process.

Ready for the final practice exam??

This is the 2nd of the 2 quizzes that cover all 3 chapters of the Risk Management Pillar and it should have really challenged you.

This should be an effective exercise at exposing the weaknesses you should be focusing on.

Beware – you only get 90 seconds per question – so you’re on the clock!

Wanna continue studying – go here CQE Body of Knowledge?