06 ISO 19443 FMEA Practical Application Handout

ISO 19443 Training
Practical Application of FMEA to determine products and services

important to nuclear safety (ITNS)
www.tuv-sud.com/nucleartraining
nucleartraining@tuvsud.com
TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022

Motivation
▪ Important to nuclear safety (ITNS) according to ISO19443:2018(E) means
“…characteristic of a product, service, item or activity, whose failure could result in undue radiation exposure of
people or the environment”
▪ Requirement of ITNS according to ISO19443:2018(E)
– The organization shall:

i. Break down ITNS products and services into items and activities, and
ii.Determine the items and activities, i.e. those whose potential failure or malfunction may jeopardize the product and /or
services safety function(s) specified by the customer in line with Licensee’s safety classification of Systems,
Structures and Components (SSC)
Classification Strategy Safety Class Requirements
TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 2

Module Objectives and Learning Goal
▪ Participants will learn:
– how to determine ITNS items and activities

– how to run a systematical risk and failure analysis with application of a powerful quality management tool
– how to consider specific nuclear aspects
– how this challenge can be met by the definition of quality related activities to minimize the potential failure causes and to
reduce the risk
▪ Participants will be able:
– to explain the practical application of the normative requirement regarding determination of ITNS activities
– to explain the top-down principle of system, function and failure analysis within FMEA
– to explain the determination process and the resulting quality and safety relevant measures
– to explain the nuclear sensitivity of nuclear safety culture and risk-based handling

Contents
1 Introduction & Basics
2 Example
3 Jobs for the working group
4 Determination and QRA
5 Summary

Introduction – Determination Process
▪ From the pracitcal side of view let us have a look to the determination process for the supplied products.
1 2 3
Dividing the SSC into Identification of the
Start relevant impact of failures and Analysis and Grading End
items/activities malfunctions

▪ STEP#1: Dividing the SSC
– The product or service would normally be broken down in different items or activities.
– When relevant and depending on the complexity of product and service, a Functional Analysis System Technique, Value
engineering, etc. can be applied
▪ STEP#2: Identification of the impact

– Identification of the impact of the potential failure or malfunction of each item or activity on the product or service
function(s) specified by the customer as related to nuclear safety
– A risk analysis, performed for each item or activity, would support this identification ➔ ITNS or non‐ITNS
– Recommended risk analysis methods are listed in CEI/ISO 31010
– Today: Failure modes and effects analysis (FMEA)
▪ STEP#3: Analysis and grading

– In this step the risk analysis is used to analyze the results of STEP#2 and to give a grading of the items and activities
under consideration of the aspects of the Graded Approach

Introduction – Graded Approach
▪ The intent of the ISO 19443:2018 is to define the graded approach as it should be applied by the organization
(TIER supplier) to the items constituting and/or activities resulting in the ITNS product or service ordered by the
customer.
▪ A practical understanding of the requirement would be:
– Are the items and/or activities produced, located and supplied by the organization (TIER supplier) itself
– Is an additional sub-supplier involved and are the items and/or activities supplied by an external provider
▪ For each of the suppliers a set of requirements in context to the ISO 19443 exists and should be analyzed in terms
of:
– Quality management requirements

– Documentation requirements
– Monitoring and measurement requirements

▪ What are we doing?
1 2 3
Dividing the SSC into Identification of the
Start relevant impact of failures and Analysis and Grading End
items/activities malfunctions
Application of a risk analysis with the most common Quality Management tool:
Failure Mode and Effects Analysis (FMEA)

Introduction – Combination of Process and FMEA
▪ Failure Mode and Effects Analysis (FMEA)
– Quality management tool under application in nuclear industry since 1975.

– Tool to evaluate all possible failure modes, failure-cause-effect-relationships and their impact on components, systems
or processes (interdisciplinary systematic qualitative analysis method).
– The three determination steps are built up within the five FMEA-steps
1 2 3
Dividing the SSC into Identification of the impact
Analysis and Grading
relevant items/activities of failures and malfunctions
1. Step 2. Step 3. Step 4. Step 5. Step

Structural Functional Failure Counter Measure Evaluation and
Analysis Analysis Analysis Analysis Optimization

Note:
Introduction - FMEA On a multi dimensional FMEA, the failure mode of a higher level
is the failure effect of a lower one, and the failure mode of a lower
level is the failure cause on a higher level!
1. Step 2. Step 3. Step 4. Step 5. Step
Structural Functional Failure Counter Measure Evaluation
Analysis Analysis Analysis Analysis Optimization
Breakdown into relevant Assigning of functions to Assigning of all possible Brainstorm and Rating of Evaluate the mitigation
items and activities, sub- the system elements, sub- failure modes to each the Occurence and measures in terms of the
systems and system systems and component assigned function. First Detectability of failure requirements of QM/QA,
elements. Identification of characteristics on the step: Negate the function. causes or failure modes, Documentation and Monitoring
interfaces. lowest level. Functional Second Step: List all and Rating of the Severity of and Measurement and give a
Analysis has to be specific possible reasons for the failure effects. Define Rating for continual
for one scenario function failure mitigation measures. improvement

Contents
2 Example
5 Summary

Example – Electro-Mechanical Pump
▪ This example is a fictional example given to illustrate the expected determination activities to be performed by an
organization on an ITNS product.
▪ The pump is classified as an ITNS
product safety class 2,
▪ The pump is very nuclear specific
and thus not covered by any
conventional code or standard,
▪ Safety functions (SF) indicated in
pump technical specification issued
by the contractor.
Source: TÜV SÜD

Example – electro-mechanical pump
▪ Assignment of the underlying parts and sub-assemblies SAFETY FUNCTIONS:
▪ Requirements of the underlying Safety Functions 1=Impeller SF#1: Confinement of nuclear pressure
2=Weld joints boundary (primary circuit fluid)
3=Pressure sensor SF#2: Seismic stability
4=Controller
5=Rotation sensor SF#3: Functionality during harsh environment
6=Motor rotor/stator SF#4: Reliability and Availability MTBF/MTTR
7=Motor bearing/seal
8=Cooler
9=Cooler fan Relevant Activities:
10=Motor frame Welding of pump casing
11=Main shaft Non-destructive test of weld joints
12=Pump bearing/seal
13=Pump casing Hydro test of pump casing
14=Nozzle inlet Test of command system (controler)
15=Nozzle outlet Sensor test
16=Temperature sensor
Casing and frame painting
17=Skid
18=Bolts Assembled pump leakage test test
19=Bearing sensor Assembled pump functional test
20=Coupling Control of bolt tightening
Source: TÜV SÜD

Contents
2 Example
5 Summary

Practical Training – Description
▪ Some rules for practical Training:
– Please be efficient and effective, short discussions, be aware of the short time slot
– Times lot for each part of training: 10 minutes
– Write down the results directly into the Whiteboard Spreadsheet
– We will resolve your working results later
▪ In the focused example:
– The company/organization is a TIER 2 supplier with an additional sub-supplier-network supporting the construction of
the electro-mechanical-pumps.
– The company/organization is designing the pump, purchasing some of the components from external providers with their
own design and testing (e.g. welded pump casing, assembling/manufacturing/testing the pump).
TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 c15

Practical Training – Jobs
▪ You have four jobs to do (equivalent to the FMEA STEPS#1-4):
– Job#1: Structural analysis – breakdown of the electro-mechnical pump and assign items and activities
– Job#2: Assigning of functions
– Job#3: Assigning of possible failures/malfunctions by Negation of the functions and write down the possible reasons
– Job#4: Brainstorming and rating of Severity, Occurence and Detectability analysis of the RPN
▪ After successful work we will do the last FMEA STEP#5 together.
TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 c16

Practical Training – Job#1: Structural Analysis
▪ System cutting and dividing into items and Part or sub- Is it Is it Non- Safety function (SF) concerned
activities, sub-systems and system elements. assembly name ITNS? ITNS?
Identification of interfaces
▪ Is it ITNS or Non-ITNS item?
Source: TÜV SÜD

Part or sub-assembly name Is it ITNS? Is it Non-ITNS? Safety function (SF) concerned
Pump casing
Nozzle inlet
Nozzle outlet
Weld joints
Impeller
Main shaft
Pump bearing/seal
Coupling
Motor rotor/stator
Motor bearing/seal

Part or sub-assembly name Is it ITNS? Is it Non-ITNS? Safety function (SF) concerned
Cooler
Cooler fan
Pressure sensor
Rotation sensor
Bearing sensor
Temperature sensor
Controller
Motor frame
Skid
Bolts

Necessary activities Is it ITNS? Is it Non-ITNS? Safety function (SF) concerned

Welding of pump casing
Non-destructive test of weld
joints
Hydro test of pump casing
Test of command system
(controler)
Sensor test
Casing and frame painting
Assembled pump Leackage
test
Assembled pump functional
test
Control of Bolt tightening

Practical Training – Job#2: Functional Analysis
▪ Assigning of functions to the system elements, sub-systems and component characteristics on the lowest level
▪ Functional Analysis must be specific for one scenario
▪ Example of assigning functions (green)

▪ Assigning of functions to the system elements, sub-systems and ITNS Item/ Assigned Function
component characteristics on the lowest level, Functional Analysis Part name
must be specific for one scenario
Source: TÜV SÜD

Part or sub-assembly name Safety function (SF) concerned Assigned Function

Pump casing
Nozzle inlet
Nozzle outlet
Weld joints
Impeller
Main shaft
Pump bearing/seal
Coupling
Motor rotor/stator
Motor bearing/seal

Part or sub-assembly name Safety function (SF) concerned Assigned Function

Cooler
Cooler fan
Pressure sensor
Rotation sensor
Bearing sensor
Temperature sensor
Controller
Motor frame
Skid
Bolts

Practical Training – Job#3: Failure Analysis
▪ Assigning of all possible failure modes to each assigned function
▪ First step: Negate the function.
▪ Second Step: List all possible reasons for function failure
▪ Example of assigning failures (red)

▪ Assigning of all possible failure modes to each assigned function. ITNS Item/ Assigned Failure or Malfunction
▪ First step: Negate the function. Part name
▪ Second Step: List all possible reasons for function failure
Source: TÜV SÜD

Part or sub-assembly name Safety function (SF) concerned Assigned Function Assigned Failure or Malfunction
Pump casing
Nozzle inlet
Nozzle outlet
Weld joints
Impeller
Main shaft
Pump bearing/seal
Coupling
Motor rotor/stator
Motor bearing/seal

Part or sub-assembly name Safety function (SF) concerned Assigned Function Assigned Failure or Malfunction
Cooler
Cooler fan
Pressure sensor
Rotation sensor
Bearing sensor
Temperature sensor
Controller
Motor frame
Skid
Bolts

Practical Training – Job#4: Counter Measure Analysis
▪ To get an impression about the influence factors we must analyze, the:
– SEVERITY (S) of Failures or Malfunctions

– OCCURRENCE (O) or Failures or Malfunctions
– DETECTABILITY (D) of the Failures or Malfunctions.
▪ Please rate S and O between 1…10 (1 = low … 10 = high); D between 1…10 (1 = high … 10 = low)
▪ Built the so-called RISK PRIORITY NUMBER as a mathematical product of the single factors S, O and D.
▪ RPN = S•O•D
▪ Please discuss the results of the different RPN-Numbers regarding the analysis-paths.
▪ Which counter measures would you define to reduce the potential risk path?

▪ Analysis of the consequences of failures/malfunctions ITNS Item/ S O D RPN
▪ First step: Rating the severity (S), occurrence (O) and detectability Part name
(D) of a malfunction with values between 1 and 10
▪ Second step: Calculate the Risk Response Number (RPN)
Source: TÜV SÜD

Item Assigned Function Assigned Failure or Severity Occurence Detectability RPN =
Malfunction S=1…10 O=1…10 D= 1…10 S*O*D
Pump casing
Nozzle inlet
Nozzle outlet
Weld joints
Impeller
Main shaft
Pump bearing/seal
Coupling
Motor rotor/stator
Motor bearing/seal

Item Assigned Function Assigned Failure or Severity Occurence Detectability RPN =
Malfunction S=1…10 O=1…10 D= 1…10 S*O*D
Cooler
Cooler fan
Pressure sensor
Rotation sensor
Bearing sensor
Temperature sensor
Controller
Motor frame
Skid
Bolts

Contents
2 Example
5 Summary

Determination and QRA – Example F: Casing leak tight
D=2
O=2
Forged casing
S=10 MF: Casing not leak tight
Safety objective:
Protection of human and Pump casing RPN=S•O•D=10•2•2=40 lower risk
environment against SF#1: Confinement
radiation of nuclear pressure
▪ Control of reactivity boundary (primary
Electro-mechanical Pump circuit fluid)
▪ Removal of heat from
the core SAFETY FUNCTIONS:
▪ Confinement of SF#1: Confinement of nuclear pressure
boundary (primary circuit fluid)
radioactive material
SF#2: Seismic stability
F: Leak tightness of
SF#3: Functionality during harsh Inlet Nozzle connecting weld seam
environment
SF#4: Reliability and Availability
weld joint MF: Connecting weld D=7
MTBF/MTTR seam not leak tight O=5
RPN=S•O•D=10•5•7=350 high risk!
1. Step 2. Step 3. Step 4. Step
Structural Analysis Functional Analysis Failure Analysis Counter Measure Analysis

Determination and QRA – Example F: Casing leak tight
D=2
O=2
Forged casing
S=10 MF: Casing not leak tight
Pump casing RPN=S•O•D=10•2•2=40 lower risk

SF#1: Confinement
of nuclear pressure
boundary (primary
SAFETY FUNCTIONS:
SF#1: Confinement of nuclear pressure
SF#3: Functionality during harsh Inlet Nozzle connecting weld seam
environment
weld joint MF: Connecting weld D=7
MTBF/MTTR seam not leak tight O=5
RPN=S•O•D=10•5•7=350 high risk!

Determination and QRA – Example: Failure Causes
ITNS Status = Yes, important!
▪ Identification of possible causes:
– Welding of the nozzles under subcontract of external
provider, sub-supplier is not qualified for welding of NPE
Inlet Nozzle connecting weld seam
– Wrong material selection of base material and welding
weld joint MF: Connecting weld D=7 consumables
seam not leak tight O=5 – Bad weld quality based on wrong welding consumables
RPN=S•O•D=10•5•7=350 high risk! – Welder not qualified
– Welding process not qualified
– Missing Heat treatment before or after welding
– Missing Quality control after welding
– Wrong Selection of NDT-Process
– NDT-personal not qualified
4. Step 5. Step ▪ Objective:
Counter Measure Evaluation – Potential risk reduction by counter measures
Analysis Optimization regarding the Detectability and Occurrence

Determination and QRA – Example: Counter Measures
Item ITNS Risk Supplier QMS Documentation Requirements Monitoring & Measurement Opti.
Requirements Requirements
Item ITNS RPN External QRA Documents Records Certificates Activity Re- RPN*
evaluation
Pump yes 350 yes Qualified provider Procurement Appraisal ISO 19443 before Start of O=4; D=2 80
casing – S=10 for welding of Specification Manufacturing
Inlet O=5 Nuclear pressure for external
Nozzle D=7 equipment acc. provider/
weld ISO 19443 Technical
joint Specification
Control of the Design code Preliminary i.e. EN ISO before Start of O=4; D=2 80
material Approval 10204 3.1 Manufacturing
combination Documentation/ certificate
WDP
Control of Calculation Approval of Approval before Start of O=4; D=2 80
structural integrity report (Weld calculation note Manufacturing
and calculation joints)
evidence
Determination and QRA – Example: Counter Measures
Item ITNS Risk Supplier QMS Documentation Requirements Monitoring & Measurement Opti.
Requirements Requirements
Item ITNS RPN External QRA Documents Records Certificates Activity Re- RPN*
evaluation
Pump yes 350 yes Qualification of WDP WDP Yes before Start of O=4; D=2 80
casing – S=10 welder Manufacturing
Inlet O=5 Qualification of Qualification of WDP Approval before Start of O=4; D=2 80
Nozzle D=7 welding process welding proc. Traveler Manufacturing
weld
joint Heat treatment Heat treatment Approved NDT- Note FUD before Start of O=4; D=2 80
procedure procedure Procedure, Manufacturing
EOMR
QA welding H/W QA welding QCP/ITP Approval of before Start of O=4; D=2 80
H/W Hold- and Manufacturing
Witnesses
NDT-Procedure NDT- Approved NDT- Approval within before Start of O=4; D=2 80
Procedure Procedure QCP/ITP Manufacturing
Qualification of Qualification of Certified Yes (ISO 9612, before Start of O=4; D=2 80
NDT-personel NDT-personel experiance SNT-TC-1A) Manufacturing
Determination and QRA – Example: Before & After
S=10
Pump casing weld joint MF: Connecting weld D=7
SF#1: Confinement seam not leak tight O=5
of nuclear pressure RPN=S•O•D=10•5•7=350 high risk!
boundary (primary
SAFETY FUNCTIONS:
SF#3: Functionality during harsh
environment
MTBF/MTTR

Determination and QRA – Example: Before & After
S=10
Pump casing weld joint MF: Connecting weld D=2
SF#1: Confinement seam not leak tight O=4
of nuclear pressure RPN=S•O•D=10•4•2=80 low risk!
boundary (primary
SAFETY FUNCTIONS:
SF#3: Functionality during harsh
environment
MTBF/MTTR

Contents
2 Example
5 Summary

Summary
▪ The learning objective of this practical module was the determination of items/activities important to nuclear safety
from a viewpoint of a nuclear supplier.
▪ We have explained the practical application of the normative requirement regarding determination of ITNS activities
▪ We have discussed the top-down principle of system, function and failure analysis within FMEA
▪ We have explained the determination process and the resulting quality and safety relevant measures
▪ We learned about the nuclear sensitivity of nuclear safety culture and risk-based thinking
▪ As an example, we analyzed a safety relevant electro-mechanical pump
− Dividing the System into items and activities relevant to ITNS (Breakdown structure)
− Assign functions
− Assign failures or malfunctions
− Do the counter measure analysis to find out relevant items/activities based on failure-cause-relationships
▪ Together we discussed the last step of the FMEA and the important graded approach to define useful quality related
activities, and how to revaluate this optimization measures
▪ We found out, that the FMEA has the option of a powerful quality tool which we can simply use to determine items/activities
ITNS

Copyright
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TÜV SÜD Energietechnik GmbH Baden-Württemberg reserves all rights resulting
thereof, especially with regard to reprinting, publication by photomechanical
reproduction or other means, and storage in data processing systems (in whole
or in part).
This document and any information it contains shall not be used for any other
purpose than the one for which they were provided.
’’
Stock photos and ClipArt's: Licensed by TÜV SÜD.com Image Database.

Electro-Mechanical Pump
4 1=Impeller
2=Weld joints
3 15 12 6 7 3=Pressure sensor
5 4=Controller
19 5=Rotation sensor
6=Motor rotor/stator
7=Motor bearing/seal
8=Cooler
9=Cooler fan
1 10=Motor frame
11=Main shaft
12=Pump bearing/seal
8 13=Pump casing
14=Nozzle inlet
15=Nozzle outlet
13 20 9 16=Temperature sensor
17=Skid
11 18=Bolts
2 19=Bearing sensor
16 20=Coupling
10
14
18 17 Source: TÜV SÜD

Abbreviations
▪ EOMR: End Of Manufacturing Report ▪ RPN: Risk Priority Number
▪ FMEA: Failure Mode and Effects Analysis ▪ SSC: Systems, Structures and Components
▪ FUD: Follow-Up Document ▪ SF: Safety Function
▪ H/W: Hold- and Witness points ▪ S,O,D: Severity, Occurance, Detectability
▪ ITNS: Important To Nuclear Safety ▪ QA: Quality Assurance
▪ ITP: Inspection and Test Plan ▪ QCP: Quality Control Plan
▪ MTBF: MeanTime Between Failure ▪ QMS: Quality Management System
▪ MTTR: MeanTime To Repair ▪ QRA: Quality Related Activities
▪ NDT: Non-Destructive Testing ▪ WDP: Welding Data Package
▪ NPE: Nuclear Pressure Equipment

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ISO 19443 Training

Practical Application of FMEA to determine products and services

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022

▪ Requirement of ITNS according to ISO19443:2018(E)

– The organization shall:

Classification Strategy Safety Class Requirements

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 2

– how to determine ITNS items and activities

▪ Participants will be able:

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 3

1 Introduction & Basics

3 Jobs for the working group

4 Determination and QRA

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 4

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 5

▪ STEP#2: Identification of the impact

▪ STEP#3: Analysis and grading

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 6

▪ A practical understanding of the requirement would be:

– Quality management requirements

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 7

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 8

– Quality management tool under application in nuclear industry since 1975.

1. Step 2. Step 3. Step 4. Step 5. Step

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 9

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 10

1 Introduction & Basics

3 Jobs for the working group

4 Determination and QRA

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 11

Source: TÜV SÜD

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 12

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 13

1 Introduction & Basics

3 Jobs for the working group

4 Determination and QRA

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 14

▪ In the focused example:

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 c15

▪ After successful work we will do the last FMEA STEP#5 together.

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 c16

▪ Is it ITNS or Non-ITNS item?

Source: TÜV SÜD

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 17

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 18

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 19

Necessary activities Is it ITNS? Is it Non-ITNS? Safety function (SF) concerned

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 20

▪ Functional Analysis must be specific for one scenario

▪ Example of assigning functions (green)

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 21

Source: TÜV SÜD

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 22

Part or sub-assembly name Safety function (SF) concerned Assigned Function

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 23

Part or sub-assembly name Safety function (SF) concerned Assigned Function

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 24

▪ First step: Negate the function.

▪ Second Step: List all possible reasons for function failure

▪ Example of assigning failures (red)

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 25

Source: TÜV SÜD

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 26

TÜV SÜD Academy UK | ISO 19443 Training 21-23/06/2022 27