Process eless element Pment P4: 4: CarryCarrying ouing out the prt the product oduct and prand procesocess devs developmeelopmentnt
Minimum requirements / assessmentrelevant Minimum requirements / assessmentrelevant
Possible examples of Possible examples of requirements and evidence, requirements and evidence, depending on product risk depending on product risk
Notes (inputoutput) Notes (inputoutput) and references and references P4.1
P4.1 Have thHave the Produe Product FMEA / Procct FMEA / Process FMEA ess FMEA been drabeen drawn up ? Are they uwn up ? Are they updatpdated as the projed as the project progect progressresses andes and are corrective actions laid down ?
are corrective actions laid down ?
In the development phase it must be ensured by means of FMEAs that the product and process meet the customer's requirements in terms of function, reliability, etc.
Changes to the product and process must be evaluated afresh . If appropriate, a new analysis should be carried out in
agreement with the FMEA team and the project manager . Once actions have been completed, and updated FMEA is required in regard to the probability of occurrence and the probability of detection, with the focus on the verification / validation of the Product in the project.
The FMEA must be part of the development plan.
The start phase, the interface to the Process FMEA, updating loops, etc. must be clear from the Product FMEA.
The execution of FMEAs must be controlled.
Interfaces to customer and suppliers are defined.
Any evaluation requirements set by the customer are documented and applied.
Personnel from production planning and the future production location are members of the FMEA team.
When drawing up the Product FMEA the proposed production location must be involved.
Special characteristics (SCs) are identified, highlighted in the FMEA and secured by appropriate actions.
The effectiveness of the actions must be demonstrated.
Customer requirements, special characteristics, important parameters
Functions, installation dimensions, materials
Environmental aspects
Customer requirements for assessments
Legal requirements
Experience from previous projects
Experience from similar products already in serial production
Productspecific actions from the Process FMEA
Processspecific actions from the Product FMEA (Design FMEA)
Transport (internal / external) and its effect on product characteristics
Tracking actions
Documentation of FMEA meetings
Change record
Lessons learned
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Interfaces between Product and Process FMEAs are controlled There is a control loop for updating FMEA s (frequency and reasons).
P4.2
P4.2 ArAre the stipulae the stipulations artions arising frising from the planom the plans for prods for product and pruct and procesocess develos developmenpment put into effet put into effect ?ct ? In the development of new products and processes, quality
planning takes account of installation requirements for the product from the very earliest stages.
The methods set out in the development planning for product development are used so that, after accumulated experience has been implemente d and the product has gone into serial production, it will meet the specified installation conditions in terms of function, reliability and safety/security.
The QM planning must include a trialling plan for the parts, subassemblies and materials, including the manufacturing processes from the prototype and preproduction phases.
There is a QM plan (to DIN EN ISO 9000) for the prototype and preproduction phases.
There are records of knowledge gained from the prototype phase and preproduction phase, to be taken into account in the serial production phase.
The planning of test, checking and inspection equipment is part of the QM planning. Requirements covering this equipment have been laid down and implemented.
Project sequence planning
Trial planning
Methods (QFD, DOE; FMEA;
statistical trial planning, ...)
Fitment trials and system tests, more secure installation of individual components
Use in the entire supply chain
Poka Yoke principles
Life / endurance tests
Environment simulation test, ...
Environmental compatibility investigations, inc. disposal
Test/inspection plan
Process description to permit QM planning
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P4.3
P4.3 ArAre the the pere personnsonnel reel resoursources ices in pln place aace and qnd qualifualified ?ied ? There must be a process covering general personnel planning.
The personnel resources must be planned and available at the specified timing dates.
Personnel must be qualified for the relevant tasks. This also applies to the service personnel employed in the product development process. Appropriate certification must be available.
Determining resources is associated with the availability of qualified personnel.
During product development a regular analysis must be carried out of possible bottlenecks and additional demand.
Outside processes and services must be taken into account.
There is capacity to achieve the prototype build, sample build, 0production, production test and serial production
Customer requirements
Requirements profile for the relevant locations
Determine the need for training
Proof of training
Knowledge in the various departments
Project management
DOE, QFD
FMEA,
Statistical trial planning
Statistical process control(SPC)
Suitability of test processes
CAD/CAM, CAE
Six Sigma
Knowledge of foreign languages
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P4.4
P4.4 Is tIs the inhe infrastfrastructuructure in re in place place and and apprappropriaopriate ?te ? There must be a process to determine resources. This refers to the availability of test equipment, laboratory facilities, machinery and plant and the loads on machinery and plant.
An infrastructure (i.e., a system of facilities, process equipment and supporting services such as transport or communication) must be determined and provided.
The capacities required must be taken into account in the calculations for the quotation. They must be available, or be planned to be available at the specified times.
The facilities required for this must be set up in the project.
Regular analyses of demand are carried out in the course of the product development, covering possible bottlenecks and additional demand.
There must be transparency regarding the stages involved in determining the possible existence of bottlenecks (take account of variant structures !).
Note :
Capacities must be available at an appropriate time before the customer's production launch.
Prototype builds
Planning of trials
Trialling facilities/ test laboratory/
test equipment
Inspection facilities / equipment
Buildings, space
Factory structure plan
Planning plant & machinery
Customer requirements/
quantities
Quantities per facility/ machine (max. quantity achieved in the process operation)
Production cycle times
Availability of incoming materials
Down times
Logistics capacity calculation
Transport paths
Transport facilities, containers &
stores
Availability of materials
Capacity before production launch (system loading)
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P4.5
P4.5 Based on the reBased on the requirequirementsments, are the necess, are the necessary evary evidencidence and release and releases availaes available for the varble for the various phasious phases ? *es ? * Releases / evidence of suitability must be produced for all parts,
subassemblies and boughtin items, in accordance with the development timing plans.
Regular status reports are issued for the project, based on the project plan and the customer's milestones.
Rules covering assessments/metrics must be defined.
PPAP (product and production process approval process) must have been carried out. PPAP is the final verification of the product, production and transport planning process and, if positive, results in release for serial production.
Reference parts and products from sample submissions must be retained in accordance with the customer's requirements.
Verification and validation for product and process are ensured.
Specifications; drawings, customer's specifications
FMEAs
Product trials (e.g., fitment check, functional test, life/endurance test, environment simulation)
Test/inspection reports
Preproduction parts
Trial samples
Commissioning
Packing
Logistics concept (e.g., suitability of the packaging checked by trial shipments)
Tools, machines, settings, test and inspection facilities
Proof of capability of significant product/ process characteristics
Production tests
Capacity studies
Certification covering boughtin items/ suppliers
Legal releases
Development releases from the customer
Results of sample submissions
Tooling acceptance checks
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P4.6
P4.6 ArAre the produe the production conction control plantrol plans used fos used for the varir the various phasous phases and ares and are produe production, tesction, test andt and inspection documents derived from them ?
inspection documents derived from them ? The production control plan must contain the parts, sub
assemblies, assemblies and materials, including the
manufacturing processes which are associated with the product.
The production control plan must be drawn up for the following phases :
Prototype phase
Prototype phase (if required by the customer) Preproduction phase
Preproduction phase Serial production phase Serial production phase
The question is not relevant for product development !
The production control plan must contain details of :
the sequence of the process stages
stipulation and identification of special characteristics
establishment of the test/
inspection sequence plan, the frequency of tests & inspection/
cycle
Gauges and test/inspection equipment to be used
Documentation of test / inspection results
Provision of facilities and equipment
Timely, forwardlooking provision of measurement technology
Checks at useful stages during the production of the product
Clarification of acceptance check criteria
Reaction plan
Rework
Serial production release
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P4.7
P4.7 Has a preHas a preprodproductiouction run been can run been carrierried out unded out under serial prr serial productoduction condion conditions to obitions to obtaintain production approval / release ?
production approval / release ?
A preproduction/ production test must be carried out in order to assess all production factors and influences at the appropriate time and make any necessary corrections.
It should be possible to prevent bottlenecks and quality problems in serial production.
The planning of a preproduction run and the agreements for executing a preproduction run are set out in P4.9 and P6.1.1 . Critical product features are taken into account.
Proof that the agreed quantities can be achieved has been provided.
Peak demands and agreed flexibility are taken into account.
Note :
Note : Depending on the phase at which the audit is carried out, certain production tests may still be in the planning stage ! The question is not relevant for product development !
Customer requirements
Specify minimum quantities
Process capability study
Measurement equipment capability
Production maturity of the production facilities and equipment (measurement reports)
Handling, packaging, identification, storage
Personnel qualification
Work/inspection instructions
Layout of workplaces and inspection stations
Initial sample checks
Planning the initial sample submission sequence and its contents
Production tests in accordance with the customer’s timing plan
Detect errors in parts lists and scheduling
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Qualifications matrix
Rapid detection of problems and elimination of defects
Eliminating failure
Supplier management
Measurement equi capability checks
Production programme planning
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P4.8
P4.8 ArAre the planne the planning activing activities assoities associateciated with sourd with sourcing oucing outside protside products anducts and servd services implices implementemented effeed effectively ctively The organisation must monitor regularly the progress at the
suppliers' premises with the execution of the project.
Appropriate milestones and checklists are included in the project management of suppliers.
Tracking activities at the suppliers' premises are carried out, deviations are detected and suitable actions are introduced.
Process development must define and verify the status of the products and processes to be used in the various phases.
Special characteristics, legal requirements (e.g., materials requiring declaration)
Reports of meetings to reach agreement, workshops,
simultaneous engineering teams.
Performance interface agreements
Items to be considered include :
Releases
Identification of tools
Layout/quantity of tools
Audit reports
Visit reports
Certification documents,
Supplier's project reports
Milestone assessments
Demonstrations of capability
Tolerance studies
Load tests
Reference samples
QM plan
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Process acceptance checks
APQP
Supplier management
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P4.9
P4.9 Is the trIs the transfer ansfer of the pof the projecroject to prt to productoduction coion controlntrolled in oled in order trder to secuo secure the pre the produroduct launct launch ?ch ? There must be a controlled process for the structured transfer of
responsibility between the development team and production.
The customer's requirements are taken into account.
An internal production process release check must have been carried out in full before the first shipment of production items.
A production test has been carried out at the production location in accordance with the customer's requirements.
Actions arising from the production test have been completed on time.
Proof is available of machine capability studies to cover all special characteristics.
Tools, test, measurement and inspection equipment are available in sufficient quantities.
A procedure to secure the launch must be described and installed in order to secure the launch phase and a robust production process.
A check on launch security must be carried out for all new and modified parts which need to be submitted for initial sample approval/release.
Specify responsibilities
Customer requirements
Transfer report/checklist
Acceptance check report
Specify additional, individual checks which are not carried out on the fullyassembled product
Specify test/inspection frequencies, quantities, parameters, duration
Specify a procedure for the immediate execution of failure analysis and introduction of corrective actions
Definition of failure rates
Specify the identification of parts from the launch phase
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Process FMEA
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