Version Date

1.0 09.04.2013
Description
First version after adding file naming convention and version management pages
Author
Michael K. Madsen
 Item / Requirement
Subsystem Function

Pressure stage PN16

Substation
Pressure stage PN16
Substation
Pressure stage PN16
Substation
Pressure stage PN16
Substation
Pressure stage PN16

Substation
Pressure stage PN16
Substation
Secondary side HE Flow Stable temperature Temp. sensor
Accurate measurement temperature, Placement of temperature sensor as
Fast responds of sensor near as possible to the HEX
DHW
Pressure stage PN16
Substation
Pressure stage PN16
Substation
Pressure stage PN16
Substation
Pressure stage PN16
Substation
Pressure stage PN16
Substation
Substation Pressure stage PN16
Pressure stage PN16
Substation
Stable temperature Temp. sensor
Secondary side HE Flow
Pressure stage PN16
Substation
Substation Pressure stage PN16
Pressure stage PN16
Substation
Pressure stage PN16
Substation
 Potential Potential Cause(s)/
Failure Effect(s) of Mechanism(s)
Mode Failure of Failure

Broken gaskets External leakage, possible injuries 10 Wrong material selection

Broken gaskets External leakage, possible injuries 10 Wrong tickness

Broken gaskets External leakage, possible injuries 10 Wrong tightening torque

Broken screws on flanges External leakage, possible injuries 10 Wrong tightening torque

Broken valves External leakage, possible injuries 10 Wrong instalation position of pressure
controller - to high temperature

Broken screws on flanges External leakage, possible injuries 10 Wrong material selection

Heating fails Too hot 10 Wrong sensor selection type

Supplying the DHW not accurate Too hot water 10 Bad design

Broken pipes External leakage, possible injuries 10 Wrong design for welding

Broken pipes External leakage, possible injuries 10 Wrong design of end-forming

Broken valves External leakage, possible injuries 10 Wrong selection

Broken HEX External leakage, possible injuries 10 Wrong selection

Broken HEX Internal leakage 10 Wrong selection

Broken ISPs External leakage, possible injuries 10 Wrong material selection

Broken threaded assemblies External leakage, possible injuries 10 Too short thread

Heating fails Too hot 10 Wrong sensor fixing

Broken pipes External leakage, possible injuries 10 Wrong selection of pipe( lack of
knowledge)
Broken pipes External leakage, possible injuries 10 Wrong design of bending
Broken ISPs External leakage, possible injuries 10 Wrong design

Broken threaded assemblies External leakage, possible injuries 10 Wrong design of nuts
 Recommended

Occurance

Detection
Controls Controls Action(s)
Prevention Detection

Supplier recommandation 5 Field test 8 400 Contact supplier for gasket

Supplier recommandation
Supplier recommandation
Calculating the torque
Design reviews
recommandation
5 Field test 8 400 Contact supplier for gasket
recommandation
5 Field test 8 400 Contact supplier for gasket
recommandation
5 Field test 8 400 Contact supplier for gasket
recommandation
1 Field test 8 80

Using the standards 2 Burst test 3 60

Electrical design review 2 Prototype testing 3 60

Design reviews 2 Prototype testing 3 60

Design reviews 2 Pressure test of prototypes( burst test) 2 40

Design reviews 2 Pressure test of prototypes( burst test) 2 40

Design reviews 2 Pressure test of prototypes( burst test) 2 40

Design reviews 2 Pressure test of prototypes( burst test) 2 40

Design reviews 2 Pressure test of prototypes 2 40

Design reviews 2 Burst test 2 40

Using the standards 2 Prototype production 2 40

Practice 1 Prototype assembly 3 30

Calculations 1 Pressure test of prototypes( burst test) 2 20

Calculations 1 Pressure test of prototypes( burst test) 2 20

Calculations 1 Burst test 2 20

Calculations 1 Burst test 2 20

Responsibility Action Results
& Target Actions S O D R.
Completion Taken e c e P.

Date v c t N.
TAN/ June '14

TAN/ June '14

TAN/ June '14

TAN/ June '14

Effect

Failure to meet
safety and or
regulatory
requirement

Loss or
Degradation of
primary function

Loss or
Degradation of
secondary
function

Annoyance

No effect
Criteria: Severity of Effect on Product (Customer Effect) Rank

Potential failure mode affects safe equipment operation and / or involves 10

non compliance with government regulation without warning
Potential failure mode affects safe equipment operation and / or involves 9
non compliance with government regulation with warning
Loss of primary function (equipment inoperable, does not affect safe 8
operation)
Degradation of primary function (equipment in operable, does not affect 7
safe operation)
Loss of secondary function (equipment operable but comfort / convenience 6
functions inoperable)
Degradation of secondary function (equipment operable but comfort / 5
convenience functions at reduced levels of performance)
Appearance or audible noise, equipment operable, item does not confirm 4
and noticed by most customers (>75%)
Appearance or audible noise, equipment operable, item does not confirm 3
and noticed by many customers (>50%)
Appearance or audible noise, equipment operable, item does not confirm 2
and noticed by discriminating customers (<25%)
No discernable effect 1
Likelihood
of failure Criteria: Occurrence of Cause
Very High New technology / new design with no history
Failure is inevitable with new design, new application
or change in duty cycle / operating conditions

Failure is likely with new design, new application or

High change in duty cycle / operating conditions

Failure is uncertain with new design, new application

or change in duty cycle / operating conditions

Frequent failures associated with similar designs or in

design simulation testing
Occasional failures associated with similar designs or
Moderate in design simulation testing
Isolated failures associated with similar designs or in
design simulation testing
Only isolated failures assiciated with almost identical
design or in design simulation and testing

Low
No observed failures assiciated with almost identical
design or in design simulation and testing

Failiure is eliminated through preventative control

Very Low
Alternative incidence
per item Rank
> 1 in 10 10

1 in 20 9

1 in 50 8

1 in 100 7

1 in 500 6

1 in 2,000 5

1 in 10,000 4

1 in 100,000 3

1 in 1,000,000 2
Failiure is eliminated
through preventative
control
1
Opportunity
for detection

No detection
opportunity
Not likely to
detect at any
stage
Post design
freeze and
prior to launch

Prior to design
Freeze

Virtual
Analysis-
Correlated

Detection not
applicable;
Failure
prevention
Criteria: Likelihood of Detection by Design Control

No current design control,cannot detect or is not analysed

Design analysis/detection controls have a weak detection capability;Virtual Analysis

(eg CAE, FEA etc) is not correlated to expected actual operating conditions

Product verification/ validation after design freeze and prior to launch with pass/fail
testing (sub system or system testing with acceptance criteria such as noise,
shipping evaluation etc.)

Product verification/ validation after design freeze and prior to launch with test to
failure testing (sub system or system testing until failure occurs, testing of system
interactions etc.)

Product verification/ validation after design freeze and prior to launch with
degradation testing (subsystem or system testing after durability test eg function
test)

Product vailidation (reliability testing, development or validation tests) prior to

design freeze using pass/ fail (eg acceptance criteria for performance, function
checks, etc.)

Product vailidation (reliability testing, development or validation tests) prior to

design freeze using test to failure (eg until leaks, yields, cracks etc)

Product vailidation (reliability testing, development or validation tests) prior to

design freeze using degradation testing (eg Data trends,before/after values etc.)

Design analysis /detection controls have a strong detection capability. Virtual

analysis (eg CAE, FEA etc) is highly correlated with actual or expected operating
conditions prior to design freeze

Failure cause or failure mode can not occur because it is fully prevented through
design solutions (eg proven design standard, best practice or common materials
etc)
Rank Likelihood of
Detection

10 Almost
impossible
9 Very Remote

8 Remote

7 Very Low

6 Low

5 Moderate

4 Moderately High

3 High

2 Very High

1 Almost certain