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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)
IRIS elements integrated in ISO high level Check Act
structure
4.
Context of the
5 6 7 8
9
Performance
10
Leadership Planning Support Operation Improvement
organization Evaluation
Plan Do
Understanding Leadership & Actions to Resources Operatlonal Monitoring, General
the organization commitment address risks and plannlng and measurement,
and its context opportunities control analysisa and
Process for risk Budget planning, approval Outsourcing or transfer of evaluation
management and controlling processes
Understanding Policy Nonconformity
Contingency Maintenance of equipment Tender management Mandatory / optional KPIs
the needs and and corrective
planning Monitoring and measuring Project management Customer satisfaction
expectations of action
Ouality objectives ressources Configuration
interested parties Safety policy Probelm solving
and plannlng to Organizational knowledge management
Internal audit methods
achieve them Change management
Organizational Competence Requirements for
Determining the Safety objectives products and Continual
roles,
scope of the responsibilities services Audit programme improvement
quality and authorities Planning of Process for competence Auditors management
management changes (to the management Customer communication
system Responsibilities and QM S) Process for requirement Management
authorities of mgmt. review
process owners Awarenesss Design and
Quality Business
management planning development of
Awareness for safety Management review inputs
system and its products and
policy and objectives Management review
processes services
outputs
Requirements to Design and development or Process reviews
Communication
documented introduction of new
processes technologies
Design reviews
Design verification
Design validation
Documented
Classification of ext. provider and
information Control of
EPPPS
externally
Process for control of Evaluation of external provider
provided
documented information Approval of external provider
processes,
External provider offer selection
products and
Information for external provider
services EPPPS approval of release
(EPPPS) EPPPS verification after release
Monitoring of ext. provider
Red = additional Applicable also at customer premises performance, re-evaluation and
g. during commissioning or installation Control of
IRIS topics production and ranking
Production scheduling Supply chain management
Activities to ensure controlled conditions service provision
Verification of production processes
Release of Inspection and testing activities
Validation of production processes
products and Acceptance
Special processes
Production equipment services
Identification and traceability
Property belonging to customers or ext. concessions
Control of
provider
nonconforming
Peservation
outputs
Post delivery activities
EXTRACT: Risk 3
Management
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?
EXTRACT: Risk 4
Management
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
HIGH 10 Increased functional requirements / 10 New product development 10 Complicated production Less than 5 years on the outside of Europe > 6.7 - 10
features (significant changes in technology with many special market
technology are required; processes,
Safety-related material or material supplier has no experiences
with serial numbers with the new technology) Manufacturing processes with
an increased failure rate
Specification / tender documents
and / or 3.1 certificate required
MEDIUM 5 Average number of functional Product development is given, Manufacturing process with 5 5-7 years yet available 5 Europe > 4.2 - 6.7
features, but modifications are adjustments
necessary
no specification / specification Manufacturing processes with
required, e.g. Order by drawing medium failure
LOW 0 Standard Material proven product, no known process without Material is fully available your country 0 0 - 4.2
modifications necessary significant adjustments
EXTRACT: Risk 5
Management
Implementation of risk based thinking (2)
Question:
Is it really necessary
to manage all
projects with the
same care?
EXTRACT: Risk 6
Management
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 Technical Risk Invest Design hours Customer Product- Characteristics Production
Complexity Roadmap of Product processes
< without customer
requirements
Orders
with PM
0 0 0
principles
Regular
only one
involved
0 0 0 0
site low
100.
<5
hours
00 im
portance low
strategic
mo
cation
difi
Variant
within
family or
a tools known
processes,
of
technologies,
order 000 types
handling > extented
process Customer
1
requires Project
new
1 1
Management
2 1 1 2
m anufacturi
NOTE: project
sites involved med ium >5 00 im port Prod uct
1 00. management process ng technological
requirements and / or
development and / or
hours
depends
organization.
ance
or medium
high onnewthe
family
or new
In business
most of the
Product
production at several or high technology
000 model
rail sector
strategic
of an companies it is
Project management principles must be mandator from tender phase until the
y
applied when, requireme
end of warranty period.
nt However in other cases it
the mandatory requirement is met, or may be limited to design and
the sum of scoring is more than 4 development only (e.g. for
the development of a new
Remark: Due to business decisions the
to a project is possible at any time, even if the criteria product
are notfamily met. But or not
platform)
visa
upgrade of an order
versa! Risk based thinking
EXTRACT: Risk 7
Management
Further applications of risk based thinking
IsIsit it really
really necessary
necessary to testto verify all
& inspect allwork
incoming goods
in progress with
with the same the care
same to ensure
care availability of
to ensure
materials in production?
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
Risk based thinking
on a quarterly basis?
EXTRACT: Risk .. 8
Management
Risk management tools
EXTRACT: Risk 1
Management 0
Definiti
ons
Issue =
x
moose
x
t +1 containment
action
= immediate action to t +2 corrective
correct action
= action to eliminate
t -1 preventive action the root cause in
= action to eliminate the root cause of order it doesnt
a potential happen again
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 1
Management 1
Risk & Opportunity Management
Process Owner: Process title: Process number Doc-ID . revision index:
Management
Input
Risk/opportunity Management
process Process flow
6.1.3
000001.001 Documents to be retained
1in joint
involve customer
work and externaland
on risk assessment
organization and its context response.
needs and expectations of interested parties
providers
EXTRACT: Risk 1
Management 2
Planning of risk responses
risk avoidance
TOT
AL risk
action directed risk mitigation
prevention
RIS against the
probability of
K occurrence or actions to
minmize the
accepted risks
risk transfer
detection
potential transfer of risks, acceptance of
impact e.g. by insurance risk
contracts
REMAINI
NG
RISK
identified risks
targ exclude prevention of the reduction or minimizing the hope for the best
et: risk causes of limitation of the consequences and prepare for
occurrence or demage of the demage the worst
improve the constitute risk
possibility for
PREVENT REACTI provisions
IVE detection VE
Chapter 6.1.3
EXTRACT: Risk 1
Management 3
Risk management - measurements of effectiveness
NO Risk
end occurred
?
YES
NO
Not Impact of Recording QDC analysis,
identified Risk YES issues of QDC actions for
risks occurred improvements
?
This topic is
currently
omitted in this
sample
EXTRACT: Risk 1
Management 5
Project Ri
sk
recommended
lecture:
http://www.cc-rail.info/wp-content/uploads/2016/10/iapm_pm-gu
ide2_en.pdf
EXTRACT: Risk 1
Management 6
Monetary weighted RISK
ANALYSIS
monetary evaluation
of risks:
Project Risks
EXTRACT: Risk 1
Management 7
Risk - causes
1) Risks due to
fields of stakeholders (resource):
risks: There is a risk of external
Quality- influences due to non-
Risk project relevant reasons
Technica (political, personal, power-
l Risk related ...)
Cost There is a risk that there
Risk are problems with internal
or external staff (expertise,
availability, motivation ...).
2) Risk of confusion, changes in
goals or inadequate conditions :
EXTRACT: Risk 1
Management 8
Example: Define and Mitigate
Project Risks
EXTRACT: Risk 2
Management 0
Response date
Consider the
response date!
Response date Impact date
Project Risks
EXTRACT: Risk 2
Management 0
Exercise 3: case study - Project FMEA
Chapter 8.5
EXTRACT: Risk 2
Management 2
Process
FMEA
Example: foundry process of track pads for
excavators
EXTRACT: Risk 2
Management 3
Process FMEA template & inputs
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 fetting Shot blasting
tempering
15 14 12
Ultraschallprfung Rissprfung Kontrolle mechanische W erte
Ultrasonic testing Magnetic crack Check of mechanical properties
detection
17 18 20 22
19
Fertigungsschweien Putzen Strahlen Visuelle Kontrolle und Endkontrolle
Spannungsarmglhen
Production welding Fetting Shot blasting Visual examination and final inspection
Stress relief heat treatment
21
Rissprfung
Magnetic crack
detection
27 26 23
Farbgebung Oberflchenhrten Bearbeitung
Coloring Surface hardening machining
outsourced
25 24
28 Vermessung Rissprfung
Verpackung und Versand Measurement Magnetic crack
Packing and release for detection Chapter 8.5
dispatch
EXTRACT: Risk 2
Management 5
SIPOC
coloring (SIPOC) (Supplier, Input , Process, Output,
Customer)
step supplier input process critical functions / parameters output customer
1 Surface traveller check identity / compare traveller with eye function matching identification on
hardening employee castings lighting castings and accompanying
sample accompanying documents documents
castings and samples component labeling training &
qualifications
suitability and condition of the
slings
environmental conditions
2 spray system system cleaning cleanliness of spray system clean spray system
cleaning material
3 casting visual check and cleaning as necessary cleanliness of casting clean casting
solvent
8 dry film thickness gauge inspection dry film thickness part with correct film
thickness
9 slings put on local storage stacking sequence & technology part painted / finished and
crane state of storage ready for transport to next
storage location stage
10 employee prepare for transport slings prepared part
slings
crane Chapter 8.5
palette
11 traveller entry in traveller filling of template dokumented information
EXTRACT: Risk employee 2
Management 6
Cause / effect diagram (Fishbone / Ishikawa)
M eas urement
Lin
trac ability of heat treater for eac h/batc h link
M an mag particls ins pec tion proc edure and results are not doc umented
untrained quality ins pec tor UT Ins pec tion proc edure and res ults are not doc umented
mis s ing batc h data (foundry ) that is linked to the trac k pad
untrained operator c hemic al compos ition meas urements (are all the elemnts c hec k ed)
c hemic al compos ition meas urements (gas c ontent)
mis s ing ins pec tion reports that is linked to the trac k pad
k
probe c alibration for ladel temperature data
M an As s embly Field
mis s ing batc h data (heat treat) that is linked to the trac k pad properties of the s and
M aterial s k ip required proc es s c ontrol detail due to time c ons traints mois ture c ontent of the s and
improper trac k tens ion (ac c umulator c harge) mag partic le ins pec tion pers on untrained mis s ing/no quality data s heets for as s embled links
material inclusions from maintenanc e does not replac e parts when needed untrained quality ins pec tor Foundry
core time between quenc h and tempering (delaying tempering after quench) untrained operator
c as ting defec ts near the rail surfac e s kip required proc es s c ontrol detail due to time c ons traints pit floor grade
high humidity in air during heat treating (hydrogen embritalment) mag partic ls ins pec tion proc edure and res ults are not documented
material properties improper as s embly tec hnique meas urement tools us ed (do they provide c orrec t ac c urac y level)
inc orrec t hardening proc es s mac hined prior to heat treating c ris tal s truc ture c hec k at the running s urface (tempered martens ite)
general c as ting defec ts M an Heat Treatment
untrained s ervic e pers on inc orrec t ins pec tion protoc ol for wear of link
incorrec t gas for flame hardening prior autenite grain s ize (to large prior to temper)
incorrec t material proreties untrained quality inc orrec t wear limit s pec ified
inc orrec t heat of hardening temperature quenc h media
incorrec t cas ting proc es s inspector
Improper as s embly techniqu
inc orrec t s pec ified quenc h media M an Mac hine Maintenanc e time in quenc h media
inc orrec t pour improper quenc h media untrained operator
time between quenc h and temper Field
ins uffic ient material during pour improper quenc hing
not following good travel proc edure/protoc ol preheat of temper oven is c orrect is c orrec t c alc ulation of s tres s us ed in the part
loc ation of gates, ris ers, c hillers flame hardening M an As s embly fac tory time to temper
material inc lus ions from s and no tempering driving uphill with help of the attac hment is c orrect mac hine dy namic load used
(Bac khoe) and tipping over the edge sk ip required proc es s c ontrol detail due to time c ons traints fluid properties for quenc h media
material inc lusions from slag is c orrec t mac hine weight us ed
untrained quality ins pec tor furnac e profile s tudy
inc orrect raw material Heat treat
overload by driving over big roc ks untrained operator
hardening depth
incorrec t/poor mic ros truc ture Des ign Inputs
hit with buc k et to the trac k s
mechanic al Properties
exc es s ive bainite Man F oundry
digging over the s ide cry s tal s truc ture general loc ation hinge angle
inc orrec t heat during pouring skip required process control
track c alibration of furnac e pres s fit (bores )
derailing at turn on s pot with attac hment
delay in pouring detail due to
time
untrained quality ins pec tor
constraints agitation of quenc h media
s and humidity in mold untrained
untrained operator Fac tory
inc orect s and properties
Operator for mac hine
M aterial Man M ac hinating Heat Treatment Trac ability of heat treater for eac h/batc h link
power of induc tion head inc orrec t heat treat spec ific ation
EXTRACT: Risk 2
Management 7
Risk evaluation scheme
severity
10 5 1
o1 10 10 10
c0 5 5 5
c 1 1 1
u5 10 10 10
r 5 5 5
e 1 1 1
n1 10 10 detection
10
c action mandatory
5
action recommended 5 5
e no action required
1 1 1
severity occurrence detection
MEANING If damage or loss occurs, what is the effect on the W hat is the probability that How is our confidence that we know the cause, or
internal and external customers or the next the cause occurs? the cause of failure before it goes to the next step?
production 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 2
Management 9
Process-FMEA (1/2)
Process step critical failure impact s cause o actual preventive actual corrective d. t risk prevetive / mitigation budget responsibl target date s o d. t risk
functions / e i e action action class action e e i e class
parameters v t c
n
e. i v t c
n
e. i
e y e y
c t c t
r r
c o c o
u e u e
e n e n
r c r c
identity check eye function wrong gathering of no traceability 5 poor eye function, no 1 eye test every 2nd year 1
casting data from glasses
labeling
component wrong gathering of no traceability 10 poor component 10 enlarge the font field investigation by shift 10 a unique alignment of Hr. Miller, N. 01.10.2014 5 1 10
labeling casting data from labeling, mirrored supervisor the title block, e.g. as
labeling reading underscore
accompanying wrong accompanying non-acceptance 5 lack of care 5 shift supervisor is 1 training head of 01.11.2014 5 1 1
documents documents responsible for care concept of stacking department
sequence & technology heat
(countersign of treatment
transported castings on
traveler)
training & worker not trained no traceability 5 poor quality / capability 1 regular training 1 x /year 1
qualifications rework / repair of tutor / content of the traveler is also
training mentioned in other
sickness / holidays training
suitability and casting fall down accident at work 10 demaged sling 1 external review 1
condition of the (annually); daily internal
slings review by workers
environmental dirty work station dirt particles in the paint; 5 missing cleannes 1 1
conditions inclusions
environmental too high humidity blistering (small craters; 5 open hall system 1 predrying 1
conditions porosity) measurement of
poor binding ability of humidity
color
environmental too low temperature too long drying time; 5 open hall system 1 measuring the 1
conditions Viscosity of the color is temperature
too high Heaters in winter
training & missing qualification paint not to instruction 5 qualification deficiency 10 product-related training 10 training
qualifications pint instructuion not lack of training skill matrix
known/available
system cleanliness of paint residues in the inoperability 5 lack of care 10 1 Functional test before
cleaning spray system intake and coloring each shift and after Chapter 8.5
system each break
visual check
cleanliness of contamination (dust, Particle inclusions in the 5 lack of order and 5 blow with compressed 1 improve stacking
EXTRACT:
and cleaning Risk
casting rust, test equipment color layer cleanliness in air sequence & 3
Management
as necessary residues) production technology to avoid 9
Process-FMEA (2/2)
predrying temperature too low temperature residual moisture is too 5 burner defect 1 1
high
1st primer color material wrong shade of color there are parts that can not 5 wrong requirements 1 production is 5
be blasted => intensive working error controlled by QC later
washing process
viscosity too high only limited processability 1 wrong requirements 10 Sample for target- 1 no further actions
working error performance
comparison; for new
parts measuring of
viscosity
viscosity too low extra work due to runners 1 wrong mixing ratio 10 Sample for target- 1 no further actions
performance
comparison; for new
parts measuring of
viscosity
mixing ratio wrong mixing ratio affects the curing 5 data sheet missing 1 10 duty to provide training
working error
calculation error
mixed technique color wrong mixed affects the quality of paint 5 lack of care 1 1
(time too short) time pressure
layer thickness too less minimum dry film 5 paint too thinn 10 10 measurement of wet film
thickness is not reached casting geometry thickness at defined
measurement points
layer thickness color runner rework / repaint 1 paint too thick 10 visual check 1
casting geometry
primer method wrong method requirements (time, layer 5 no documented 10 10 paint instruction
thicknesses, etc.) information
unachievable
adhesiveness shelf life of the opened affects the quality of paint 5 shelf-life is not known 10 10 request shelf life data for
color container opened container from
exceeded supplier
inspection dry film thickness too thinn minimum dry film thickness
is not reached claim
5 paint flaws / handling 5 1 Sampling inspection of wet
film thickness (to be put in
Chapter 8.5
paint instruction)
EXTRACT: Risk 3
dry film thickness color runner rework / repaint 5 casting geometry 10 1
Management
technology-related 1
Conclusions
conclusively 2 formulas
to reflect :
EXTRACT: Risk 3
Management 1
Your contact:
EXTRACT: Risk 3
Management 2