You are on page 1of 33

Welcome to the HIGH SCHOOL for IRIS Manager

Preview of coming ISO/TS 22163 requirements


(NOTE: this information are not finally released yet;
changes may occur after publishing the norm in May 2017)

Andreas Heinzmann International Competence Centre Rail GmbH


Mitteldorfstrasse 17
CH 6315 Obergeri
Switzerland

Mobil (D): +49 172 622 32 73


andreas.heinzmann@cc-rail.com
www.cc-rail.com
Your tutor

First and last name Citizenship

Andreas Heinzmann German


Special strength / knowledge in the area of quality, certification, IRIS etc.

one of three initiators of the IRIS standard and 1st President of the IRIS Group,
responsible for the content and the successful launch of the IRIS certification (2006)
from the beginning until today consistently involved in all IRIS revisions;
one of the 5 member core team, which were commissioned to draft the new IRIS /
ISO standard (2015/2016),
more than 800 IRIS internal auditors trained and 38 companies (~52000 employees)
were successfully prepared for IRIS certification,
IRIS witness auditor for supervision of IRIS approved certification bodies.
Professional career

Masters degree (Dipl.-Ing.) in Electrical Engineering.


1990 AEG-Westinghouse Berlin > AEG in Hennigsdorf, (Shanghai Metro, BR12X, VT 611/612).
1998 head of QHSE in Adranzs Light Rail Vehicles Business Unit in Nuremberg.
2000 Bombardier (DWA) as General Manager for Quality & Customer Service.
2002 Senior Director Quality at Bombardier Transportations headquarters
> 35 years professional experience > network of suppliers, operators, approval authorities and registrars,
also in the automotive, aerospace and food industries.
I have been working in a second capacity as lead auditor, trainer and consultant as far back as 1995
2009 foundation of iCC-Rail GmbH, the global market leader in IRIS training, coaching and mentoring.
Introduction

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 2
IRIS elements integrated in ISO high level structure
Plan Do Check Act

4. 9
5 6 7 8 10
Context of the Performance
Leadership Planning Support Operation Improvement
organization Evaluation

Understanding Actions to Operatlonal Monitoring,


Leadership &
the organization address risks and Resources plannlng and measurement, General
commitment
and its context opportunities control analysisa and
Process for risk Budget planning, approval Outsourcing or transfer of evaluation
management and controlling processes Nonconformity
Understanding
Policy Contingency planning Maintenance of equipment Tender management Mandatory / optional KPIs and corrective
the needs and
Monitoring and measuring Project management Customer satisfaction action
expectations of
interested parties Safety policy Ouality objectives ressources Configuration management Probelm solving
and plannlng to Organizational knowledge Change management methods
achieve them Internal audit
Organizational Requirements for
Determining the
roles, Safety objectives Competence products and Continual
scope of the
responsibilities services Audit programme improvement
quality Planning of Process for competence Auditors management
and authorities
management changes (to the management Customer communication
system Responsibilities and QMS) Process for requirement
authorities of mgmt. Management
process owners Awarenesss review
Quality Design and
Business development of
management Management review inputs
system and its
planning Awareness for safety products and
policy and objectives Management review
processes services outputs
Requirements to Design and development or
documented introduction of new Process reviews
processes Communication technologies
Design reviews
Design verification
Design validation
Documented
Classification of ext. provider and
information Control of EPPPS
externally Evaluation of external provider
Process for control of Approval of external provider
documented information provided
processes, External provider offer selection
Information for external provider
products and EPPPS approval of release
services EPPPS verification after release
(EPPPS) Monitoring of ext. provider
performance, re-evaluation and
Applicable also at customer premises ranking
Red = additional e.g. during commissioning or installation Control of Supply chain management
IRIS topics Production scheduling production and
Activities to ensure controlled conditions service provision
Verification of production processes
Validation of production processes Release of Inspection and testing activities
Special processes Acceptance
Production equipment products and
Identification and traceability services
Property belonging to customers or ext.
provider
Peservation Control of concessions
Post delivery activities nonconforming
outputs

First article
RAMS / LCC
inspection
overview
Innovation
Obsolescence
EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE
management CENTRE RAIL GmbH
management 3
(optional)
0.3.3 Risk based thinking

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 4
Implementation of risk based thinking (1)

Question:

Is it really necessary to
manage all external provided
products or services and all
external provider with the
same care?

Risk based thinking

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 5
Implementation of risk based thinking
( best practices part 1, see also page 68, processes for EPPPS)
classification of external provided products
RISK functional requirements degree of innovation manufacturing technology Availability at the market Supplier region Score
(Obsolescence)
Rank Points 30% 25% 25% 15% 5% 7,50
Increased functional requirements /
features Complicated production
New product development
technology with many special
(significant changes in
Safety-related material or material processes, Less than 5 years on the
HIGH 10 10 technology are required; 10 outside of Europe > 6.7 - 10
with serial numbers market
supplier has no experiences
Manufacturing processes with
with the new technology)
Specification / tender documents an increased failure rate
and / or 3.1 certificate required
Average number of functional Manufacturing process with
features, Product development is given, adjustments
MEDIUM 5 but modifications are 5 5-7 years yet available 5 Europe > 4.2 - 6.7
no specification / specification necessary Manufacturing processes with
required, e.g. Order by drawing medium failure
known process without
proven product, no significant adjustments
LOW 0 Standard Material Material is fully available your country 0 0 - 4.2
modifications necessary
No Q-problems in the past

classification of external provider


logical OR operation
Supplier
Material- Order
Scope of supplier approvals & certificates Dependence on Supplier Class
class Volume/year
Single Source
Special approvals required for manufacturing, eg
Development and production by the
A > 100.000 Welding (EN 15085), adhesion (DIN 6701), A
supplier to establish a second supplier it needs high
soldering, casting, etc.
invest

50.000 -
B or C
100.000
only production by the supplier no Q-history, a new supplier Change of supplier with cost / expenses B

2nd or 3rd backup supplier is available, it's


B or C < 50.000 Purchasing via dealer / trader no approvals & certificates C
simple to change the supplier

Risk based thinking

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 6
Implementation of risk based thinking (2)

Question:

Is it really necessary to
manage all projects with the
same care?

Risk based thinking

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 7
Implementation of risk based thinking
( best practices part 2)
Project classification scheme (see also process for project initiation & planning, page 51
Complexity Effort Strategy Degree of Novelty
Organizational Product- Characteristics of Production
Complexity Technical Risk Invest Design hours Customer Roadmap Product processes

Orders with

0 0 0 0 0 0 0
Variant within a known processes,
PM principles only one site involved low < 100.000 < 500 hours
without customer low strategic
family or technologies, types
requirements importance
modification of tools

extented

1 2 1 1 1 2 1
Regular order development and / or Customer medium or high technological
handling production at several medium or high > 100.000 > 500 hours requires Project strategic
new Product or new
requirements and / or
Product family
process sites involved Management importance new manufacturing
technology

mandatory NOTE: project management process


requirement
depends on the business model of an
organization. In most of the rail sector
companies it is from tender phase until
Project management principles must be applied when, the end of warranty period. However in
other cases it may be limited to design
the mandatory requirement is met, or and development only (e.g. for the
the sum of scoring is more than 4 development of a new product family or
platform)
Remark: Due to business decisions the upgrade of an order
to a project is possible at any time, even if the criteria are not met. But not visa versa! Risk based thinking

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 8
Further applications of risk based thinking

Is it really necessary to treat all customer with the


same care to make them happy?

Is it really necessary to manage all tender with the same care


to win orders?

Is it really necessary to verify all incoming goods with the same care to
ensure availability of materials in production?

Is it really necessary to test & inspect all work in progress with the same care to ensure
defect free products?

Is it really necessary to order 3.1 Certificates (EN10204) for all external provided products?

Is it really necessary to verify all 3.1 Certificates (EN10204) of raw materials by own lab-tests on a quarterly basis?
..

Risk based thinking

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 9
Risk management tools

When do we conduct a FMEA?


Product design FMEA Production process FMEA
significant new development (e.g. new platform significant new technologies in production
product) production process with significant changes /
design with significant changes / modifications modifications
new or significantly modified production problems with similar production processes in the
requirements past
problems with similar parts in the past production of new products or new parts assembly
new materials or parts processes with particular safety aspects
particular safety aspects special processes (gluing, crimping, soldering,
high complexity regarding functional or integration plating, etc.)
requirements automatic or semi-automatic processes with high
FMEA is required by customer or standards complexity
outsourced processes with high impact on product
quality or safety
FMEA is required by customer or standards
monetary weighted Project FMEA
starting in tender phase (baseline FMEA) Business risk assessment and contingency plan
regular updates (e.g. monthly, quarterly or once per regular update at least once a year
project phase) @ defined month in acc. with strat. business cycle
till end of project life Risk based thinking

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 10
Actions to address risks
and opportunities

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 11
Definitions

Issue = moose
x
x
t +1 containment action
= immediate action to correct
t +2 corrective action
= action to eliminate the root
cause in order it doesnt
happen again
t -1 preventive action
= action to eliminate the root cause of a potential
issue in order it doesnt happen

t -1 mitigation action
= action to reduce the impact/damage
when the risk occurs

Chapter 6.1.3

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 12
Risk & Opportunity Management
Process Owner:

Management
Process title:

Risk/opportunity Management process


Process number Doc-ID . revision index:

6.1.3 000001.001
1 involve customer and external providers
Input Process flow Documents to be retained in joint work on risk assessment and
organization and its context response.
needs and expectations of interested parties

1 Business Project Product Process 22) Determine the risks and opportunities
that need to be addressed to:
invitation
give assurance that the business
checklist risk/opportunity
2 management system can achieve its
identification intended result(s);
enhance desirable effects;
(e.g. FMEA) prevent, or reduce, undesired effects;
template incl. assessment achieve improvement.
risk/opportunity
risk/opps record
(analysis)
scale 32) Actions taken to address risks and
opportunities shall be proportionate to the
risk/opportunity
3 action plan, potential impact on the conformity of
planning
incl. updates products and services.
The organization shall plan:
actions to address these risks and
risk/opportunity regular review and
4 opportunities;
response update of risks/
review report how to:
implementation opportunities 1) integrate and implement the actions
into its quality management system
processes,
regular risk/
2) evaluate the effectiveness of these
opportunity response
tracking & reporting actions.
define criteria to determine the type
and extent of controls in its processes
measurement, 5
QDC data
analysis and
QDC analysis
42 multidisciplinary approach for risk
improvement of QDC
reviews

Management
lessons learnt
5 evaluate the effectiveness of risk
of organizational management based on QDCs
Knowledge
Chapter 6.1.3

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 13
Planning of risk responses
risk avoidance

risk prevention

risk mitigation
accepted risks
TOTAL risk transfer
action directed against
RISK the probability of
acceptance of risk
occurrence or detection actions to minmize the
potential impact transfer of risks, e.g. by
insurance contracts REMAINING
RISK

identified risks
target: exclude risk prevention of the causes reduction or limitation of minimizing the hope for the best and
of occurrence or improve the demage consequences of the prepare for the worst
the possibility for demage
detection constitute risk provisions
PREVENTIVE REACTIVE

Chapter 6.1.3

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 14
Risk management - measurements of effectiveness

Quantitative
Identified Risk response Risk Risk
risk
risks implementation tracking closure
assessment

NO Risk
end occurred
?

YES
NO

Not Risk QDC analysis,


YES Impact of Recording
identified occurred actions for
issues of QDC
risks ? improvements

AH: Im convinced that Quality Management is profoundly logical. It's basically all
about getting the risks under control.
Chapter 6.1.3

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 15
Business Risk and
Contingency Planning

This topic is currently


omitted in this
sample

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 16
Project Risk

recommended lecture:

http://www.cc-rail.info/wp-content/uploads/2016/10/iapm_pm-guide2_en.pdf

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 17
Monetary weighted RISK ANALYSIS

monetary evaluation of risks:

Project Risks

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 18
Risk - causes
1) Risks due to stakeholders
fields of risks:
(resource):
There is a risk of external
Quality- influences due to non-project
Risk relevant reasons (political,
Technical personal, power-related ...)
Risk There is a risk that there are
Cost problems with internal or
Risk external staff (expertise,
availability, motivation ...).
2) Risk of confusion, changes in
goals or inadequate conditions :

Risk due to There is a risk that unwanted


Schedule / not accepted results are
int/ext achieved.
Risk
Resources 1) There is a risk a project fails
Risk
due to a lack of resources or
due to confusion support.
Risk due to
2)
a lack 3) Risk through lack of information:
of information3) There is a risk that things are
not considered due to a
poorly managed project file
or that they will be processed
in parallel or re-invented.

Project Risks

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 19
Example: Define and Mitigate

example: define and mitigate

Define clearly and concisely


There is a risk that your warehouse
will catch fire, the risk is caused by 3Cs = Condition,
very old gas works and electrical
Cause and
works in the house. Also you smoke
60 cigarettes a day! The direct Consequence
impact of the risk occurring will be
the house burning down.

Mitigate practically and cost effectively: Does the action target:


replace gas & electrical works and Transfer the Risk?
ban smoking in warehouse! Target the Risk Cause?
Reduce the Risk Impact?
Accept the Risk?

Project Risks

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 20
Response date

Consider the response date!

Response date Impact date

The latest date by


which we must do
something.

Project Risks

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 21
Exercise 3: case study - Project FMEA

Please split into groups.

You now have time to complete a project-based risk assessment (FMEA


methodology) in accordance with a case study. Please use your laptop and this
Excel Tool

Your goal is to support the decision-making process of your company prior to


the first gate, i.e. before the offer will be launched.
What do you suggest? Offering or not?
Im looking forward to your answers!

Project Risks

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 22
Process Risk

Chapter 8.5

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 23
Process FMEA

Example: foundry process of track pads for excavators

Risk based thinking

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 24
Process FMEA template & inputs

SIPOC Fishbone Inspection and Risk evaluation


test plan and action plan
Re-
evaluation
Process flow chart
Chapter 8.5

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 25
Manufacturing process of track pads - flow chart

1 2 3 4 5 6 7 8
Modellbereitstellung Formen Gieen Strahlen Brennen Abschlagen Normalglhen Fugenhobeln
Pattern preparation Molding Casting Shot blasting Flame cutting flog Normalizing gouging

16 13 11 10 9
Fugen Strahlen Vergten Putzen Strahlen
Jointing Shot blasting Quenching and tempering fetting Shot blasting
15 14 12
Ultraschallprfung Rissprfung Kontrolle mechanische Werte
Ultrasonic testing Magnetic crack detection Check of mechanical properties

17 18 19 20 22
Fertigungsschweien Putzen Spannungsarmglhen Strahlen Visuelle Kontrolle und Endkontrolle
Production welding Fetting Stress relief heat treatment Shot blasting Visual examination and final inspection
21
Rissprfung
Magnetic crack detection

26
27 23
Oberflchenhrten
Farbgebung Bearbeitung
Surface hardening
Coloring machining
outsourced
25 24
28 Vermessung Rissprfung
Verpackung und Versand Measurement Magnetic crack detection
Packing and release for dispatch Chapter 8.5

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 26
SIPOC
coloring (SIPOC) (Supplier, Input, Process, Output, Customer)
step supplier input process critical functions / parameters output customer
eye function
lighting
traveller accompanying documents matching identification on
Surface employee check identity / compare traveller with component labeling castings and
1
hardening sample castings training & qualifications accompanying
castings and samples suitability and condition of the documents
slings
environmental conditions
spray system
2 system cleaning cleanliness of spray system clean spray system
cleaning material
casting
3 visual check and cleaning as necessary cleanliness of casting clean casting
solvent
4 oven predrying temperature dry casting
color material
viscosity
color
mixing ratio
spray systems
mixed technique
5 color mixer 1st primer primed part
layer thickness
paint instruction
adhesiveness
color comb
primer method
Purity of color
oven time
6 1. dry dry part
carousel temperature
7 more priming and dry as in 1st primer
part with correct film
8 dry film thickness gauge inspection dry film thickness
thickness
slings part painted / finished and
stacking sequence & technology
9 crane put on local storage ready for transport to next
state of storage
storage location stage
employee
slings
10 prepare for transport slings prepared part
crane
palette
traveller
11 entry in traveller filling of template dokumented information
employee
employee packing and
12 workstation data entry in ERP system data errors confirmed part release for
time ticket dispatch
Chapter 8.5

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 27
Cause / effect diagram (Fishbone / Ishikawa)
Measurement

Man
untrained quality inspector
untrained operator
tracability of heat treater for each/batch link

missing batch data (foundry) that is linked to the track pad


mag particls inspection procedure and results are not documented
UT Inspection procedure and results are not documented
chemical composition measurements (are all the elemnts checked)
Link
missing inspection reports that is linked to the track pad chemical composition measurements (gas content)
Man Assembly Field probe calibration for ladel temperature data
missing batch data (heat treat) that is linked to the track pad properties of the sand
Material skip required process control detail due to time constraints moisture content of the sand
improper track tension (accumulator charge) mag particle inspection person untrained missing/no quality data sheets for assembled links
material inclusions from core maintenance does not replace parts when needed untrained quality inspector Foundry
time between quench and tempering (delaying tempering after quench) untrained operator
casting defects near the rail surface skip required process control detail due to time constraints pit floor grade
high humidity in air during heat treating (hydrogen embritalment) mag particls inspection procedure and results are not documented
material properties improper assembly technique measurement tools used (do they provide correct accuracy level)
incorrect hardening process machined prior to heat treating cristal structure check at the running surface (tempered martensite)
general casting defects Man Heat Treatment
untrained service person incorrect inspection protocol for wear of link
incorrect gas for flame hardening prior autenite grain size (to large prior to temper)
incorrect material proreties untrained quality inspector incorrect wear limit specified
incorrect heat of hardening temperature quench media
incorrect casting process Improper assembly techniqu
incorrect specified quench media Man Machine Maintenance time in quench media
incorrect pour improper quench media untrained operator Field
time between quench and temper
insufficient material during pour improper quenching
not following good travel procedure/protocol preheat of temper oven is correct is correct calculation of stress used in the part
location of gates, risers, chillers flame hardening Man Assembly factory time to temper
material inclusions from sand no tempering driving uphill with help of the attachment is correct machine dynamic load used
(Backhoe) and tipping over the edge skip required process control detail due to time constraints fluid properties for quench media
material inclusions from slag is correct machine weight used
Heat treat untrained quality inspector furnace profile study
incorrect raw material overload by driving over big rocks untrained operator
incorrect/poor microstructure hardening depth Design Inputs
hit with bucket to the tracks
mechanical Properties
excessive bainite Man Foundry
digging over the side crystal structure general location hinge angle
incorrect heat during pouring skip required process control detail due to
derailing at turn on spot with attachment track calibration of furnace press fit (bores)
delay in pouring time constraints
untrained untrained quality inspector agitation of quench media
sand humidity in mold
untrained operator Factory
incorect sand properties
Operator for machine
Material Man Machinating Heat Treatment Tracability of heat treater for each/batch link
Why do the the track pads have
cracks ?
Heat treatment Machinating
pit floor maintenance heat Treatment Overload

austenetizing time and temperature


worn tool allowing the bench to fill the tracks while digging
thermal mass of item being quenched doesn't change worn load roller Tension force
incorrect fixture device temperature
quench fluid doesn't change damaged load roller
incorrect setup humidity
-50 C temperature at mine incorrectly machined roller frame
quench fluid agitation incorrect cooling ambient temperature outside oven incorrect geometry
incorrectly machined load roller
part orientation in quench incorrect cutting tool incorrect ratio of track pitch and distance
soft ground to narrow link (High Kpa) turn on spot with attachment
time in quench Foundry
speed of the cutting tool stability of the machine
residual temperature exiting quench hard ground to wide track (Low Kpa)
incorrect feed rate of part insufficient track tension force/ to high track tension force Between rollers
improper setup for selective hardening
incorrect coolant for material type temperature incorrect geometry
number of passes per head incorrect ratio of track pitch and distance between rollers
ground that changes seasonally (Oil humidity
flame hardening quench properties incorrect track width for the application
Design incorrect track width for the application
heating rate of increased rail mass/surface
time/travel rate of heat treat Environment
flame strength/power incorrect stress calculation
distance between burner and part incorrect machine weight
repeatability of position part to burner incorrect drawing
induction hardening head position incorrect material specification
power of induction head incorrect heat treat specification
Machine
frequency of induction head incorrect load assumptions
heat treatment modeling methodology (relationship of residual stress to position)
selective hardening profile is not what we desire) Factory
improper modification of equipment form old design to new design Summary
Foundry Responsibility
assembly method factory
incorrect assembly tools
Assessment
sand process
resin ratio
incorrect protection of running surface after machining
press fit
MATERIAL (MATERIAL)
shakeout time
riser position Field Installation 1 incorrect material proreties tbd 34
gating and risering methodology
refining method
incorrect assmbly methods
2 incorrect casting process tbd 28 0 to 10 probably no High influence
normalizing cycle after casting
melting process
incorrect transport of link
incorrect handeling of link
3 incorrect pour tbd 26 11 to 19 probably significant influence
trace elements
incorrect tool to assemble the track chain
type of furnace melting
type of furnace refining
4 insufficient material during pour tbd 34 > 20 probably very High influence
solidification modeling methodology (relationship of residual stress to position)
Material
Field Service 5 location of gates, risers, chillers tbd 36
incorrect assmbly methods 6 material inclusions from sand tbd 24
geneal casting defects incorrect transport of link
material properties incorrect handeling of link 7 material inclusions from slag tbd 24
casting defects near the rail surface incorrect tool to assemble the track chain

heat treating errors 8 material inclusions from core tbd 24


9 incorrect raw material tbd 34
wrong temperature
exessiv velocity, hot metal 10 incorrect/poor microstructure tbd 30
surface cracks
11 excessive bainite tbd 28
Method
12 incorrect heat during pouring tbd 26
13 delay in pouring tbd 32
14 sand humidity in mold tbd 20
15 incorrect sand properties tbd 10
16 casting defects near the rail surface tbd 32
17 material properties tbd 36
18 general casting defects tbd 30 Chapter 8.5

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 28
Risk evaluation scheme
severity
10 5 1
10 10 10

10
5 5 5

occurence
1 1 1
10 10 10
5 5 5

5
1 1 1
10 10 10
5 5 5

1
1 1 1
detection
action mandatory
action recommended
no action required

severity occurrence detection


MEANING If damage or loss occurs, what is the effect on the What is the probability that the How is our confidence that we know the cause, or the
internal and external customers or the next production cause occurs? cause of failure before it goes to the next step?
step?
10 irreparable part leads to scrap failure often occurs almost impossible - no failure detection; can not be
machinery failure leads to production downtime (min. 1x / month) detected or is not checked.
accident at work resulting in lost work time (sick leave)
"I do not know..." "I do not know..."

5 component failure causes (unplanned) overtime failure occurs low - inspection is not planned, it is checked indirectly or
equipment damage resulting in no loss of production by sampling
injury leads to time loss (no sick leave)
1 no discernible effects failure is very rare high - inspection or test reliably detects the error
(max. 1x / year)
Chapter 8.5

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 29
Process-FMEA (1/2)
s o d s o d
e t e t
critical e i c e e i c e
n actual preventive actual corrective i risk prevetive / mitigation responsibl n i risk
Process step functions / failure impact v t cause c t budget target date v t c t
c action action o class action e c o class
parameters e y u e e yu e
e n e n
r r c r r c
wrong gathering of
poor eye function, no
identity check eye function casting data from no traceability 5 1 eye test every 2nd year 1
glasses
labeling
wrong gathering of
lighting casting data from no traceability 5 poor lighting 1 cleaning schedule 1
labeling
poor illumination wrong gathering of regular check by
lighting 5 poor lighting 1 1
(mind. 300lx) casting data maintenance
wrong gathering of poor component a unique alignment of
component investigation by shift
casting data from no traceability 10 labeling, mirrored 10 enlarge the font field 10 the title block, e.g. as Hr. Miller, N. 01.10.2014 5 1 10
labeling supervisor
labeling reading underscore
missing loss during transport Information of the shift
accompanying
accompanying non-acceptance 5 no duty to bring docs to 1 supervisor 1
documents
documents the next station worker gets papers
training
concept of stacking
head of
sequence &
accompanying wrong accompanying shift supervisor is department
non-acceptance 5 lack of care 5 1 technology 01.11.2014 5 1 1
documents documents responsible for care heat
(countersign of
treatment
transported castings on
traveler)
poor quality / capability regular training 1 x /year
training & no traceability of tutor / content of the traveler is also
worker not trained 5 1 1
qualifications rework / repair training mentioned in other
sickness / holidays training
suitability and external review
condition of the casting fall down accident at work 10 demaged sling 1 (annually); daily internal 1
slings review by workers
environmental dirt particles in the paint;
dirty work station 5 missing cleannes 1 1
conditions inclusions
blistering (small craters;
predrying
environmental porosity)
too high humidity 5 open hall system 1 measurement of 1
conditions poor binding ability of
humidity
color
too long drying time; measuring the
environmental
too low temperature Viscosity of the color is 5 open hall system 1 temperature 1
conditions
too high Heaters in winter
missing qualification
training & qualification deficiency training
pint instructuion not paint not to instruction 5 10 product-related training 10
qualifications lack of training skill matrix
known/available
paint residues in the Functional test before
system cleanliness of
intake and coloring inoperability 5 lack of care 10 1 each shift and after
cleaning spray system
system each break
improve stacking
visual check contamination (dust, lack of order and sequence &
cleanliness of Particle inclusions in the blow with compressed
and cleaning rust, test equipment 5 cleanliness in 5 1 technology to avoid
casting color layer air
as necessary residues) production contact points and
residual moisture

Chapter 8.5

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 30
Process-FMEA (2/2)
residual moisture is too
predrying temperature too low temperature 5 burner defect 1 1
high
there are parts that can
not be blasted => wrong requirements production is
1st primer color material wrong shade of color 5 1 5
intensive washing working error controlled by QC later
process
Sample for target-
performance
wrong requirements
viscosity too high only limited processability 1 10 comparison; for new 1 no further actions
working error
parts measuring of
viscosity
Sample for target-
performance
viscosity too low extra work due to runners 1 wrong mixing ratio 10 comparison; for new 1 no further actions
parts measuring of
viscosity
data sheet missing
mixing ratio wrong mixing ratio affects the curing 5 working error 1 10 duty to provide training
calculation error
color wrong mixed lack of care
mixed technique affects the quality of paint 5 1 1
(time too short) time pressure
measurement of wet
minimum dry film paint too thinn film thickness at
layer thickness too less 5 10 10
thickness is not reached casting geometry defined measurement
points
paint too thick
layer thickness color runner rework / repaint 1 10 visual check 1
casting geometry
no adhesiveness of no clean underground
adhesiveness color flakes 5 1 visual check 10
color incorrect mixture
requirements (time, layer
no documented
primer method wrong method thicknesses, etc.) 5 10 10 paint instruction
information
unachievable
skinning through open
particle inclusions in the paint container
Purity of color pollution 5 1 1
color layer no order / cleanliness
in the workplace
shelf life of the request shelf life data
adhesiveness opened color affects the quality of paint 5 shelf-life is not known 10 10 for opened container
container exceeded from supplier
paint is not dry
temperature
1st dry time too short subsequent drying 5 1 1
humidity
delay
paint is not dry ambient temperature
temperature too low subsequent drying 5 burner failure 1 1
delay humidity
more priming
as in 1st primer
and dry
Sampling inspection of
minimum dry film
wet film thickness (to
inspection dry film thickness too thinn thickness is not reached 5 paint flaws / handling 5 1
be put in paint
claim
instruction)
casting geometry
dry film thickness color runner rework / repaint 5 10 1
technology-related
stacking
put on local sequence & no interlayer
castings are stacked damage to the paint 1 10 repainting 1
storage technology (no customer demand)
state of storage
state of storage pollution dirty surface 1 no top cover 10 blow off 1
missing
prepare for
traveller accompanying production stop 5 lack of care 1 1
transport
documents
improve ERP system
supervisor /
regarding machine
prepare for failure in data entry coordinator checks
filling of template search effort 5 human error 1 annual training 10 readable codes
transport poor legibility time ticket prior to data
sample checks by shift
entry
supervisor
no readiness of parts in
entry in reading the time wrong data gathering omission by machine
system possible 5 lack of care 10 1
traveller tickets on time ticket readable codes
scrutiny needed
no readiness of parts in
data entry in human error, lack of 2nd check after data shift
entry wrong data entry system possible 5 1 10 01.10.2014 5 1 1
ERP system care entry supervisor
scrutiny needed
wrong documented
entry too late data entry delayed process 5 1 1
information

Chapter 8.5

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 31
Conclusions

conclusively 2 formulas to reflect :

Quality = fulfillment of requirements x mind-set


(ability / skills) (want / behavior)

QM = process focus x risk based thinking x PDCA-approach


(effective & efficient (prevention) (continuous
processes) improvement)

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 32
Your contact:

Andreas Heinzmann International Competence Centre Rail GmbH


CH 6315 Oberaegeri
Switzerland
www.cc-rail.com

andreas.heinzmann@cc-rail.com

Mobil (D): +49 172 622 32 73


Phone (D): +49 333 977 33 37

I would be very happy to hear from you


again.

If you leave me a message, I will aim


to return within 24 hours.

EXTRACT: Risk Management confidential proprietary information INTERNATIONAL COMPETENCE CENTRE RAIL GmbH 33