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LOCATION IN LOCATION IN
# QUESTION * # QUESTION * PA ADDED REMOVED
NEW EDITION OLD EDITION
Project management Project management
P2 P2
• Changes in the project organisation (interface with customer) are • The technical personnel, with the relevant qualifications, are provided at the right
Are all resources required for the project implementation planned Are all resources required for the project implementation planned
2.2 X 2.2 X reported time by the specialist departments
and available and are changes reported? and available and are changes reported?
• “Quality plan” changed to “advanced product quality planning • The persons responsible for drawing up and maintaining the quality plan are
Is there a quality plan for the project? Is this implemented and Is the advanced product quality planning implemented within the activities” defined and in place
2.4 2.6 2.4 X 2.6
monitored regularly for compliance? project and monitored for compliance? • Process assurance methods included (not just for product) • The quality plan takes account of the timings in the overall project
Is there a QM plan and is it implemented and regularly monitored Is change management within the project ensured by the project • Adaptation of the project plan when changes occur • Defined process for documentation
2.6 2.3 & 2.4 2.6 X X 2.4
for compliance? organisation? • Time period for changes before SOP is considered
• Project risks are identified, assessed and reduced through appropriate
• The effectiveness of the function (escalation) is demonstrated by appropriate
Is there an escalation process established and is this effectively Is there an escalation process established and is this effectively measures
2.7 X 2.7 X documentation
implemented? implemented? • Measures are derived when deviations occur
P3 Planning the product and process development P3 Planning the product and process development
• All determined product and process specific requirements must be • A process must be implemented which ensures that all requirements relating to the
checked for feasibility product are determined (already included in 3.1)
• Material and personnel resources are considered in the feasibility study • Experience and forward-looking expectations are included in the study
Is the feasibility comprehensively evaluated according to the Is the feasibility comprehensively evaluated according to the • The results of the feasibility study must be available before tendering • The release process before a quotation is issued to a customer must be controlled
3.2 X 3.2 X X
product and process requirements? product and process requirements? • The feasibility of critical purchased parts must be ensured • Consideration capacity required for making samples, prototypes, etc. must be
• If customer requirements cannot be fulfilled the customer must be taken into account in the quotation phase
notified or deviations “allowed”/approved by the customer • Requirements from P7 are taken into account (new question: 3.4)
• Reference to software
• The level of detail in the planning is dependent on the
• Specific plans for product and process development are contained within the
component/software and complexity of the process
project plan
• Requirements of the product operational conditions are taken into
• The internal development plans are aligned with the relevant project timing plan
Are the activities for the product and process development planned account during the planning of new developments
3.3 Are there plans for product and process development? 3.3 3.5 integrated • Quality planning must be integrated in the development plans, including
in detail? • Methods for development release meet customer requirements and
test/inspection planning and the planning of test and inspection facilities
are clarified with the customer if deviations occur
• Experience in technology for serial production is demonstrated
• Activities related to the procurement scope are planned with the overall
schedule
• The customer requirements for the supply of parts across the product
life cycle are taken into account
• Concepts to continually ensure series supply including a contingency
plan are required
Have the necessary resources been taken into account for the Are the activities planned for customer care/customer
• A fall-back concept is provided for product and process innovation
3.4 product and process development? 3.5 3.4 satisfaction/customer service and field failure analysis? new
• The analysis process for 0-km and field complaints is planned and take
field failure analysis into account
• When introducing new technologies and products, employee training
and the creation of the necessary infrastructure are provided
• Outside processes and services must be taken into account in the resource planning
Have the necessary resources been taken into account for the
• Resource determination also for software and hardware • Personnel qualification requirements and the facilities to be made available must
3.5 Are there QM plans for the procurement scope? part of 3.3 3.5 product and process development? 3.4
be determined and documented before starting any development
P4 Implementation of the product and process development P4 Implementation of the product and process development
• The capacities required must be taken into account in the calculations for the
quotation
• Material resources for the realization of prototypes, sample building,
Are the material resources available and suitable to ensure the start • Required capacities are available or be planned to be available at the specified
Are the required approvals and releases for the product and process pre-production, series start and serial production are available
4.3 4.2 4.3 of serial production? X 4.4 times; the facilities required for this must be set up in the project
development available? • Outsourced processes are considered
• Transparency regarding the stages involved in determining the possible existence
of bottlenecks
Have target agreements for supplier performance been agreed upon Have target agreements for supplier performance been agreed upon • Supplier output must be checked and evaluated within defined periods
5.3 5.3
and implemented? and implemented?
Are the necessary releases available for purchased products and Are the necessary releases available for purchased products and • Evidence must be provided of comprehensive change management, from the
5.4 services? X 5.4 services? X X customer to the sub-supplier
Is the agreed upon quality of purchased products and services Is the agreed upon quality of purchased products and services • Standard complaint process • For safety-relevant parts, specific agreements must be made with the supplier
5.5 X 5.5 X X
ensured? ensured?
Are personnel qualified for their respective tasks and are Are personnel qualified for their respective tasks and are • “Qualification requirements” rather than “training requirements” must
• A job description must be available for functions
5.7 responsibilities defined? 5.7 responsibilities defined? be determined for each employee
Are the necessary quantities/production batch sizes of incoming Are the necessary quantities/production batch sizes of incoming
materials available at the agreed upon time and at the correct materials available at the agreed upon time and at the correct
6.1.2 6.1.2 No changes to the content
storage location/ work-station? storage location/ work-station?
Are incoming materials stored appropriately and are the means of Are incoming materials stored appropriately and are the means of
6.1.3 transport /packing facilities suitable for the special characteristics of 6.1.3 transport /packing facilities suitable for the special characteristics of No changes to the content
the incoming materials? the incoming materials?
• Customer-specific regulations for the release of products must be taken into
account
• “Test results of characteristics” instead of “characteristics” with special
Are the necessary identifications/records/releases available and Are the necessary identifications/records/releases available and • Traceability of releases must be ensured
6.1.4 6.1.4 requirements for documentation and archiving are recorded accordingly
allocated appropriately to the incoming materials? allocated appropriately to the incoming materials? • Special requirements for the identification of spare parts must be taken into
account
• The production and test documents are based on the control plan
• Access to the production and test documents is available at all times • The quality checking/inspection concept complies with the customer's
Are all the relevant details listed in the production and Are the requirements of the control plan complete and have they
6.2.1 X 6.2.1 X • Required measures for process disturbances are known and initiated requirements
test/inspection documents, based on the control plan? been effectively implemented?
and documented by the responsible employees
• Now also applicable for software • Containers for scrap and rework must be appropriately identified
• “Risk analysis” rather than “Process/Product-FMEA” • The use-by date and longest storage time for materials must be observed
Is the flow of materials and parts secured against mixing/wrong
6.2.5 Are scrap, rework and setting parts kept separate and identified?” 6.2.4 6.2.5 6.2.6 • Regulations for reintroducing parts of outsourced processes (e.g. sorting• Internal residual quantities must be logged by quantity and suitably identified and
items?
service) must be available stored
• Maintenance activities that have been carried out are analysed for • Clean working surroundings and work-places are integral to an overall care for the
Are the maintenance and overhaul of production facilities / tools Is the maintenance of the manufacturing equipment and tools
6.4.2 X 6.4.3 6.4.2 X 6.4.1 improvement measures facilities
controlled? controlled?
6.4.5 6.4.5 Are tools, equipment and test equipment stored properly? 6.4.4 No changes to the content
• Special incidents are documented • Quality control charts and monitoring charts are in use and are maintained in
• The recorded data can be related to a product and process, the data is accordance with requirements
available, accessible and traceable • In the event of a problem or non-conformance, corrections are made
6.5.2 Is quality and process data collected in a way that allows analysis? 6.5.2 Is quality and process data collected in a way that allows analysis? • Risk orientation when initiating improvement measures automatically
• The potential for improvement must be continuously determined from • Non-conformance with an effect on the characteristics of the product must be
findings on quality, costs, and services approved by the customer
P7 Customer care, customer satisfaction, service P7 Customer care, customer satisfaction, service
• The actions must be taken at the right time and in accordance with the customer's
7.3 Is the supply of parts guaranteed? X 7.3 Is the supply of parts guaranteed? X X requirements