Risk Management

Question 1

Reasons for an Enterprise Risk Management

Answer 1

• Legislation and jurisdiction
• Market developments
• Overall economic developments
• Social developments

Question 2

Def DIN ISO 31000 – Risk management

Answer 2

Risk management are coordinated activities to steer and control an organization with regard to risks (impact of uncertainty on targets).

Question 3

Def DIN EN ISO 9001 – Quality management systems

Answer 3

The quality management system has to act as a
preventive tool.
“The concept of preventive action is expressed through
the use of risk-based thinking in formulation quality management system requirements.

Question 4

Strategies to adress risks

Answer 4

• Taking risks in order to pursue an opportunity
• Avoiding risks
• Retaining risk by informed decision
• Eliminating the risk source
• Sharing the risks
• Changing the likelihood or consequences

Question 5

Goals of FMEA

Answer 5

 Detection of potential
failures, failure
consequences and
causes in products and
processes
 Minimizing risks by
deriving measures
 Creation of a uniform and
common understanding of
risk potentials

Question 6

Enhanced Approach of FMEA Creation Process

Name the 7 steps

Answer 6

1. Preparations
2. Structural analysis
3. Functional analysis
4. Failure analysis
5. Risk analysis
6. Optimization
7. Documentation

Question 7

Risk Assessment Based on SOD

What does SOD stand for ?

Answer 7

S Severity
O Probability of Occurrence
D Probability of Detection

–> Rating from 1 to 10
1 –> low risk/extremly good
10 –> high risk/very poor

Question 8

Calculation of the risk priority number:

Answer 8

RPN = S x D x O

Question 9

Weakness of the RPN

Risk Priority Number

Answer 9

 The cost of implementation is classified as high
 Interactions between risks are not reflected
 The rating is very subjective
 RPN scale from 1-1000
 88% of the number range is not occupied
 900 is the second largest occurring number
 “Holes” prevent the interpretation of a difference between two numbers
 Only 120 numbers out of 1000 are unique
 The RPN 60, 72 and 120 are available in 24 combinations

Question 10

Quality assurance agreement

Answer 10

Any agreement between customer and supplier regarding quality management and quality levels. It targets:
 Prevention at supplier
 Reduction of repeated quality inspections
 Overall cost reduction
 Trust building

Question 11

Def Resilience

Answer 11

Resilience is the ability of a company to permanently adapt to internal and external changes and disturbances in complex, rapidly changing production networks.

Question 12

What is affected :
Macro Resilience
Meso Resilience
Micro Resilience

Answer 12

Macro Resilience
Supply chains or industry networks

Meso Resilience
Value chain or company

Micro Resilience
Production unit

Question 13

Main Take-Aways from Today’s Lecture

Answer 13

 Risk management are coordinated activities to steer and control an organization with regard to risks and QMS have to act as a preventive tool.
 Design and Process FMEA are the main tools to identify, quantify and minimize risk.
 The risk consists of values for severity, detection and occurrence to quantify and assess risks.
 Resilience enables organizations to face unforeseen risks.

Question 14

What is considered in the Design-FMEA

Answer 14

 Consideration of:
 Customer specifications
• Functions
• Service life
• Safety/ Environmental aspects
 Manufacturing risks
• Manufacturing/ Assembly suitability
 Audit risks
 Material risks

Question 15

Process-FMEA

Answer 15

Object: Weak spots in the production
process
 Consideration of:
 Product quality
 Process capability/ stability
 Customer satisfaction
 Safety/ Environmental aspects
 Internal requirements

Question 16

FMEA – Failure Prevention

System Analysis - Name the Goals

Answer 16

 Clear structure of the product
 Recording and structuring of all relevant elements
 Demarcation and interface evaluation
 Definition of responsibilities
 Reuse of modules

Question 17

FMEA – Failure Prevention

Functional Analysis - Name the Goals

Answer 17

 Overview of the functionality of the product
 Overview of the verification against the specifications
 Basis for failure analysis

Question 18

FMEA – Failure Prevention

Malfunction Analysis - Name the Goals

Answer 18

 Overview of the failures of the product
 Overview of failure links and cause-effect relationships of
the system elements of a product

Question 19

Def malfunction

Answer 19

Every function of an element of the product has
malfunctions (failures), these failures are in a cause-effect
relationship to each other.

Question 20

Def function

Answer 20

Each element of the product has different functions, for which functions of
other elements are generally required

Question 21

How is the dependency called to create a failure network

Answer 21

Failure effect – Failure – Failure cause.

Question 22

FTA – Failure Tree Analysis - Goals

Answer 22

 Determine loadable reliability parameters
 Identifying and eliminating the causes of faults
 Early detection of potential errors

Question 23

FTA – Failure Tree Analysis - Procedure

Answer 23

1. Determining the unwanted event and the failure
   criteria
2. Setting up the fault tree
3. Evaluating the inputs of the fault tree with failure
   rates
4. Evaluation of the fault tree, initiation of measures

Question 24

FTA – Failure Tree Analysis - Result

Answer 24

 Assured statement about the behavior of a system
with regard to the occurrence of a defined error
 Possible estimation of the probability of default