P2 Project management

Minimum requirements relevant for assessment

A process for project

management exists.
An interdisciplinary
project organisation is
specified and contacts
are defined.
The responsibilities and
authority of the project
Is a project management established leader and team
2.1
with a project organisation? members are defined.
The team members of
the project are qualified
to carry out their tasks.
The project organisation
meets the customer
requirements.
Suppliers are involved in
project management.
 Resource planning takes
the customer
requirements into
account and
is based on the contract
covering the project.
Resource planning for
project members is
established and
implemented. The staff
workload has to be
considered.
Review and where
necessary adjustment of
resource planning is
carried out when
changes occur (dates,
Are all resources required for the scope of development
project performance etc.).
2.2
implementation planned and available This applies to changes
and are changes reported? that are triggered by the
customer as well as
internal changes or
supplier changes.
The critical path is given
special consideration
within the resource
planning.
The necessary project
budget for personnel
and equipment (e.g. test
and laboratory
equipment) is planned
and released.
Changes in the project
organisation (interface
with
customer) are reported.
 the milestones defined
in the project plan to
check that all planned
activities are carried out
and that the level of
maturity required is
achieved.
If a statutory
authorisation procedure
for a product is
specifically required, the
duration of this
procedure is included in
the project plan. In-
house communication is
ensured when changes
are made to the project
plan.
Is there a project plan and has this been Changes made to the
2.3 agreed
project plan which affect
with the customer?
the customer are
coordinated with the
customer.
The critical path is
generated from the
project plan and takes
account of critical
delivery items.
Detailed quality-related
project activities must
be part of the project
plan. This may be in a
separate document (QM
Plan) that is referred to
from the project plan.
The plans must take
prototyp+C7es and pre-
launch parts into
 Quality-related project
activities must meet the
specific customer
requirements.
Both product and
process assurance
measures are part of the
advanced product
quality planning.
Verification and
Is the advanced product quality validation of the
planning customer requirements
2.4
implemented within the project and are contained within the
monitored for compliance? quality related planning.
The planning also
addresses critical
components and
scope of supply (internal
and external suppliers).
The planning is regularly
monitored for
compliance
and for target
achievement.
 are used in production.
The level of activity
depends on the risk
classification
of procured scope of
supplies.
These include the
supplier selection and
award criteria, award
amount and delivery
target date.
The transfer of customer
requirements in the
supply
chain is ensured.
The activities also
include customer
Are the procurement activities of the
project required suppliers
2.5* (directed suppliers) as
implemented and monitored for
stated within the
compliance? agreement.
The suppliers for
facilities, machinery,
tools, test and
measurement systems
as well as services are
integrated.
The appointment of
suppliers must be
traceable
through appropriate
documentation.
Dates for the
assignment, supplier
milestones and
release have been laid
down in the plan and
 the
customer's specific
requirements.
Changes (initiated by the
supplier, internally or by
the
customer) must be
evaluated and if
necessary the
project plan must be
adapted. This evaluation
must
include the risk
assessment for the
product quality as
well as the deadlines.
Suppliers (critical
supplies) are actively
Is change management within the involved in
2.6* project
change management.
ensured by the project organisation?
Changes are reported in
a timely manner and are
agreed upon with the
customer.
Adherence to defined
design freeze steps must
be
ensured. Exceptions
must be agreed upon
and documented
between the customer
and the supplier.
All changes must be
documented.
The persons responsible
for change management
are defined for the
customer, internally and
 The escalation process in
the project meets the
specific customer
requirements.
An escalation model
(risk management) must
be
available for deviations
in the project affecting
the
overall schedule. Project
risks are identified,
assessed and reduced
Is there an escalation process through appropriate
2.7 established and is measures.
this effectively implemented? The criteria for
escalation are defined,
responsibilities
and authorities are
regulated and measures
derived
when deviations occur.
If risks have been
identified in
technologies, suppliers
or supplied countries,
these risks have to be
considered within the
escalation management.

P3 Planning the product and process development

 requirements and the
statutory and regulatory
requirements relevant
for the product that are
necessary to
meet specific customer
requirements.
The organisation must
take into account and
use requirements on the
product and the process
known
from previous
experience.
Special characteristics
must be identified on
the basis of their own
requirements, customer
Are the specific product and process requirements, legal
3.1 requirements
requirements,
available?
manufacturing
technology
and characteristics that
arise from the
purpose/use of
the product.
The quality
requirements from the
customer for the
product and the process
must be available.
Inquiry and contract
documents are checked
for
completeness.
If customer
requirements cannot be
fulfilled the customer
 An interdisciplinary
procedure for evaluating
the feasibility must be
used.
All determined product
and process specific
requirements
(technology, function,
quality, logistics,
software, ...) must be
checked for feasibility.
Material and personnel
resources must be
considered in the
Is the feasibility comprehensively
evaluated feasibility study.
3.2* The results of the
according to the product and process
feasibility study must be
requirements? available
before tendering.
The feasibility of critical
purchased parts must be
ensured.
If customer
requirements cannot be
fulfilled the customer
must be notified or
deviations
“allowed”/approved by
the customer (if the
contract has been
awarded).
 development
so that when the
product goes into serial
production
it fulfils the operational
conditions (function,
reliability,
safety). This must be
considered in the
planning.
Risk analysis (Product
FMEA and process FMEA
or
similar methods) are
part of the planning.
At the planning stage,
the development of new
products and processes
Are the activities for the product and should take into account
3.3 process
the requirements of the
development planned in detail?
product operational
conditions.
The time schedules
contain all information
for product and process
development (including
deadlines
and length of time,
milestones within the
overall project plan,
performance testing,
PPA-date, Software
standards…).
Methods for
development release
meet customer
requirements and must
be clarified with the
 The customer
requirements for the
supply of parts
across the product life
cycle are taken into
account in
the planning.
Concepts to continually
ensure series supply
including a contingency
plan are provided in the
planning
phase.
A fallback concept is
provided for product
Are the activities planned for customer
care/customer and process innovation.
3.4 The analysis process for
satisfaction/customer service and field 0-km and field
failure analysis? complaints is
planned for delivery. The
customer requirements
are
taken into account for
field failure analysis.
When introducing new
technologies and
products,
employee training and
the creation of the
necessary
infrastructure are
provided also in
customer service.
 The process for
determination of
resources is
implemented.
Determination of
resources refers to the
availability of
qualified personnel,
budget, infrastructure
such as
building, test and
inspection equipment
(hardware
and software),
Have the necessary resources been laboratory facilities,
taken into account machinery and
3.5
for the product and process equipment, ...
development? Capacity for the
implementation of
prototypes and
prototype construction,
pitot-run, performance
test
and serial production
must be planned and
considered.
The resource planning is
regularly adapted to
changes in the project
and potential
bottlenecks are
to be considered.

Implementation of the product and

P4 process
development
 and
process comply with the
requirements of the
customer in terms of
function, reliability etc.
When carrying
out a risk analysis (for
example a product
FMEA) the
proposed manufacturing
site for the production
shall
be involved.
Special characteristics
are defined and
identified in
the relevant documents
(FMEAs etc.) and
Are the actions from the product and necessary
4.1* process
action is taken to ensure
development plans implemented?
conformity.
In the overall plan, a test
plan must be included
for
the components,
assemblies,
subassemblies,
components, software
and materials. The
overall plan
must also include
manufacturing
processes from
prototype and pre-
launch phase.
All purchased products
and services are taken
into
 A staff schedule must be
available.
Personnel must be
qualified for their
respective
tasks. This also applies
to the staff of external
service providers.
Appropriate evidence
must be available.
Needs assessments will
be carried out regularly
during product and
process development
with regard to
Are personnel resources available and
are they possible emerging
4.2 bottlenecks and
qualified to ensure the start of serial
additional requirements.
production? Qualified workforce
resources are available
for prototype building
and sample building.
Workforce resources for
pre-launch, production
start-up and serial
production are planned
and personnel are
qualified
in accordance with the
project plan.
Processes that have
been outsourced must
be considered.
 measuring and test
equipment, laboratory
equipment, machinery,
equipment, and the
utilization of
machinery and
equipment. Supporting
processes
must be considered.
Within the resource
determination the
necessary infrastructure
is taken into account.
Regular needs
assessment must be
carried out during
product and process
Are the material resources available development with
4.3 and suitable to regard to
ensure the start of serial production? possible emerging
bottlenecks and
additional needs.
Material resources for
the realization of
prototypes
and sample building are
available. Material
resources
for pre-production,
series start and serial
production
is planned and provided
in accordance with the
project plan.
Outsourced processes
must be considered.
The resources must be
 verification of suitability
is demonstrated for all
the items, assemblies,
software versions and
purchased products and
services in accordance
with development
schedules.
The material data is
confirmed and released.
The actions from the risk
analysis (for example
FMEA) have been
implemented and
confirmed in
their effectiveness.
The production process
Are the required approvals and releases
for the and product approval
4.4.* (PPA)
product and process development
must be available on the
available? agreed date. For
products
with embedded
software an additional
software test
report is available.
Reference parts from
sampling must be kept
for at
least the time laid down
in the customer
requirements.
The verification and
validation of the product
and
process are ensured
before the customer
 The manufacturing and
inspection specifications
contain all
characteristics from the
product and process
development (including
special characteristics).
These must take into
account all the
components,
assemblies,
subassemblies, parts,
software and materials
including the processes
for manufacturing of
the products.
Are the manufacturing and inspection Results of the risk
specifications analysis are considered.
4.5 derived from the product and process The specifications
development and are they include information for
implemented? product
control, manufacturing
process control,
methods and
reaction plans and
corrective actions.
Product audits, layout
inspection and
functional testing are
defined.
The specifications must
be available for all
phases:
prototype phase (if
required by the
customer), prelaunch
and series phase.
 A performance test must
be carried out in time to
assess all production
factors and influences
and if
necessary corrections
must be made.
The performance test
has provided evidence
that the
quality capability of the
entire production
process is
given under serial
production conditions
(tools,
Is a performance test carried out under equipment, cycle time,
4.6 series conditions
personnel,
for the series release?
manufacturing and
inspection specifications,
measuring and test and
inspection
equipment ...).
Note: Depending on the
time of the audit some
parts
of the relevant
production test could
still be at the
planning stage!
The question is not
relevant for the product
development (n. a. – not
applicable)!
 processes.
The planned processes
for the continuous series
supply
including safety margins
for emergencies are
available.
The analysis process for
0-km and field
complaints is established
for the scope of delivery.
The customer
requirements for field
failure analysis are taken
into account.
The requirements for
Are the processes established for the analysis capability at
securing customer the site
4.7 care/customer satisfaction/customer have been agreed with
service as well as the field failure the customer.
analysis? If external sites are used
for analysis, the
interfaces are
defined and evidence of
the presence of the
required
equipment and capacity
is available.
New technologies and
products are also taken
into account in customer
support.
The employees
designated for these
processes are qualified.
The infrastructure is
available.
 For products with
embedded software, the
results of
the development
(including the
intermediate results
and their
documentation) are
documented.
Prerequisite for project
delivery is a successful
internal PPA process.
Prerequisite for a series
delivery
release is the successful
customer approval.
Resulting actions from
Is there a controlled method for the internal and external
4.8* product handover releases are
from development to serial production? implemented on time.
Proof of capability can
be shown for all special
characteristics.
The personnel resources
are available in
accordance
with the planning and
are qualified.
The material resources
include buildings, test
facilities, laboratory
facilities, equipment,
facilities, etc.
These are available and
have been released.
Releases for
procurement volumes
P5 Supplier management
 In serial production it
must be ensured that
only approved suppliers
are used. An evaluation
of suppliers
using defined criteria for
the qualification
capability
must be available.
5.1 Are only approved and quality-capable suAn analysis of the quality
performance of existing
suppliers has to be
considered.
Risks in the supply chain
have been identified,
evaluated and reduced
using suitable measures
(contingency strategy).
 The communication of
customer requirements
must
be regulated and
traceable.
Customer requirements
also include
requirements
from technical drawings,
Are customer requirements taken into
components, software
5.2 account in the
or
supply chain?
component
specifications, from QM
agreements and
other valid standards.
Change management
must also be considered
during serial production.
Interfaces are identified
and secured.

Target agreements have

been made with all
suppliers throughout the
supply chain for
products and
processes and have
been agreed upon and
implemented.
Have target agreements for supplier Supplier output must be
5.3 performance been checked and evaluated
agreed upon and implemented? within defined periods.
If deviations occur
actions must be agreed
upon and
their implementation
including deadlines is to
be
monitored.
 A release must be
available for all
purchased products and
services before serial
production of
new/changed
Are the necessary releases available for
products/processes.
5.4* purchased
products and services? Unless otherwise
specified, the supplier
for the supply of
modules has the full
quality control
responsibility for all
individual components.

To monitor the quality of

purchased products and
services, regular checks
are carried out,
documented
and evaluated.
Deviations from the
supplier quality are
processed
through a standard
complaint process.
Layout inspections and
functional testing are
carried
out according to
Is the agreed upon quality of purchased
customer requirements.
5.5* products and
Test and measuring
services ensured? equipment must be
sufficiently
available to check
purchased products. The
equipment must be
stored in an orderly
manner and associated
work-stations must be
laid out appropriately
(e.g. climate control,
lighting conditions,
cleanliness,
and protection against
damage and
contamination).
 be
stored in accordance
with their release status
so that
they cannot be damaged
or mixed.
For materials that could
be damaged by
temperature,
humidity, vibration, etc.
and affect the quality of
the
final product, the
transport and storage
conditions
must be defined and
evidence shown.
Terms of transport
should be determined
5.6 Are incoming goods delivered and stored
for critical
incoming materials.
“Suspect”/quarantined
products must be stored
securely to prevent
unauthorised access to
them.
FIFO and batch
traceability are to be
ensured when
the materials and goods
are further processed.
Material stock figures in
the inventory control
agree
with the quantities
actually in stock.
Storage conditions
conform to the product
 A description must be
given of what
responsibilities, tasks
and authority the
employees have in
their relevant work
areas (e.g. for incoming
inspection, complaint
processing, supplier
management, supplier
audit).
Are personnel qualified for their
Qualification
5.7 respective tasks and are
responsibilities defined? requirements must be
determined
for each employee in
relation to their tasks
and
qualifications carried out
accordingly.
Knowledge of previous
complaints is available
when appropriate for
purchased products and
services.

P6 Process analysis production

assessment