Questions Process Audit: P2. Project Management
Questions Process Audit: P2. Project Management
Questions Process Audit: P2. Project Management
3 Potenzialanalysis
2.2 Are all resources required for the project implementation planned and available and are changes reported?
Minimum requirements relevant for assessment Examples for implementation
Resource planning takes the customer requirements into account and Evidence of resource planning (taking other projects into account)
is based on the contract covering the project. Resource planning for equipment (e.g. development test stand)
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, scope of development
performance etc.). This applies to changes 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.
Product 1: n.a. red yellow green
Findings:
2.3 Is there a project plan and has this been agreed with the customer?
Minimum requirements relevant for assessment Examples for implementation
The project plan meets the specific customer requirements. Project plan with milestones
All internal and customer defined milestones are fully incorporated in Specific customer requirements regarding technologies and/or
the project plan. product groups
A review is carried out at the milestones defined in the project plan to Customer's project plan
check that all planned activities are carried out and that the level of Customer's deadlines
maturity required is achieved. Customer's milestones
If a statutory authorisation procedure for a product is specifically Customer's targets (measurements within the individual milestones)
required, the duration of this procedure is included in the project plan. Milestone assessments (reviews)
In-house communication is ensured when changes are made to the QM plan (e.g. from VDA MLA or APQP)
project plan. Changes made to the project plan which affect the Country specific certification requirements (ECE, SAE, DOT, CCC, …)
customer are coordinated with the customer. Legal and regulatory approvals process of critical systems
The critical path is generated from the project plan and takes account (electroplating, paint, ...)
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 prototypes and pre-launch
parts into account.
The project plan must include the detailed activities concerning
procurement. Detail plans may be in a separate document referred to
in the project plan.
Product 1: n.a. red yellow green
Findings:
2.4 Is the advanced Product quality planning implemented within the project and monitored for compliance?
Minimum requirements relevant for assessment Examples for implementation
Quality-related project activities must meet the specific customer Project plan
requirements. Customer milestones
Both product and process assurance measures are part of the Customer requirements in regard to quality plans
advanced product quality planning. Customer specifications
2.5* Are the procurement activities of the project implemented and monitored for compliance?
Minimum requirements relevant for assessment Examples for implementation
The activities have to ensure that only approved and quality-capable Make or buy decisions
suppliers are used in production. Supplier selection criteria
The level of activity depends on the risk classification of procured Supplier development plan
scope of supplies. List of suppliers for the project
These include the supplier selection and award criteria, award amount List of approved suppliers
and delivery target date. Risk appraisal of each supplier
The transfer of customer requirements in the supply chain is ensured. Quality agreement for directed suppliers
The activities also include customer required suppliers (directed Component classification
suppliers) as stated within the agreement. Suppliers for services such as development, laboratories and
The suppliers for facilities, machinery, tools, test and measurement maintenance etc.
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 coordinated with the overall schedule and the
progress is monitored.
Product 1: n.a. red yellow green
Findings:
2.6* Is change management within the project ensured by the project organisation?
Minimum requirements relevant for assessment Examples for implementation
Change management within the project meets the customer's specific Time schedules
requirements. Process description
Changes (initiated by the supplier, internally or by the customer) must Change management
be evaluated and if necessary the project plan must be adapted. This Change forms
evaluation must include the risk assessment for the product quality as Change history for the product and the process
well as the deadlines. Evaluation of change
Suppliers (critical supplies) are actively involved in change Approvals of changes
management.
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 to suppliers.
Product 1: n.a. red yellow green
Findings:
3.2* Is the feasibility comprehensively evaluated according to the Product and process requirements?
Minimum requirements relevant for assessment Examples for implementation
An interdisciplinary procedure for evaluating the feasibility must be Product/process development
used. Customer specifications and standards
All determined product and process specific requirements (technology, Schedules, timeframes
function, quality, logistics, software, ...) must be checked for feasibility. Regulations, standards, legislation, environmental impact
Material and personnel resources must be considered in the feasibility Requirements from product liability
study. Buildings, premises
The results of the feasibility study must be available before tendering. CAM, CAQ
The feasibility of critical purchased parts must be ensured. Product/process innovation
If customer requirements cannot be fulfilled the customer must be Interdisciplinary feasibility analysis (for example, sales,
notified or deviations “allowed”/approved by the customer (if the development, purchasing, production planning, production, QM
contract has been awarded). planning, logistics)
Product development
Laboratory/test equipment
Process development
Capacity monitoring
Availability of incoming materials
Manufacturing possibilities, manufacturing sites
Equipment, tools, production/test equipment, auxiliary materials,
laboratory facilities, transport, container, storage
Product 1: n.a. red yellow green
Findings:
requirements of the customer in terms of function, reliability etc. When Test planning
carrying out a risk analysis (for example a product FMEA) the Assembly test and system test
proposed manufacturing site for the production shall be involved. A, B, C samples
Special characteristics are defined and identified in the relevant Automotive SPICE
documents (FMEAs etc.) and necessary action is taken to ensure Endurance tests
conformity. Environmental simulation test (e.g. salt spray test)
In the overall plan, a test plan must be included for the components, Process development
assemblies, subassemblies, components, software and materials. The Control plan/inspection plan
overall plan must also include manufacturing processes from
prototype and pre-launch phase.
All purchased products and services are taken into account. The
implementation of product and process development is ensured in the
supply chain.
The documentation of lessons learned from the prototype phase and
the pre-launch phase are available for reference in the series phase.
The requirements for test equipment are defined and implemented.
Product 1: n.a. red yellow green
Findings:
4.3 Are the material resources available and suitable to ensure the start of the serial production?
Minimum requirements relevant for assessment Examples for implementation
A process to determine resources has been implemented. Product/process development
Resource determination refers to the availability of measuring and test Customer requirements
equipment, laboratory equipment, machinery, equipment, and the Technical interface to customer and suppliers
utilization of machinery and equipment. Supporting processes must be Product development
considered. Test planning
Within the resource determination the necessary infrastructure is taken Process development
into account. Facility planning
Regular needs assessment must be carried out during product and Facility layout
process development with regard to possible emerging bottlenecks Machinery and equipment planning
and additional needs. Quantities and throughput times
Material resources for the realization of prototypes and sample Transport routes
building are available. Material resources for pre-production, series Transport, containers, storage
start and serial production is planned and provided in accordance with Capacity before series start (initial stock)
the project plan. Supporting processes for example from logistics und IT
Outsourced processes must be considered.
The resources must be available with a suitable lead time before the
start of customer’s serial production.
Product 1: n.a. red yellow green
Findings:
4.4* Are the required approvals and releases for the Product and process development available?
Minimum requirements relevant for assessment Examples for implementation
The releases and verification of suitability is demonstrated for all the Product/process development
items, assemblies, software versions and purchased products and Test reports, protocols
services in accordance with development schedules. Evidence related to purchased parts/suppliers
The material data is confirmed and released. Sampling results
The actions from the risk analysis (for example FMEA) have been Product development
implemented and confirmed in their effectiveness. Specifications, technical drawings, requirement specifications
The production process and product approval (PPA) must be available FMEA
on the agreed date. For products with embedded software an IMDS, REACH, RoHS
additional software test report is available. Product test (e.g. assembly test, function test, endurance test,
Reference parts from sampling must be kept for at least the time laid environmental simulation)
down in the customer requirements. Prototypes
The verification and validation of the product and process are ensured Confirmation of conformity with legal requirements
before the customer SOP. Development releases from customers
Process development
Logistics concept (e.g. suitability of packaging through sample
shipping)
Proof of capability of special characteristics
Capacity studies
Tool approvals
Product 1: n.a. red yellow green
Findings:
In serial production it must be ensured that only approved suppliers are Defined and documented criteria are used for supplier selection
used. An evaluation of suppliers using defined criteria for the Evidence of a qualification programme for suppliers who did not
qualification capability must be available. meet the selection criteria
An analysis of the quality performance of existing suppliers has to be Evaluation of the quality capability (QM-System, Process) for
considered. example self-assessment, audit results, supplier certificates
Risks in the supply chain have been identified, evaluated and reduced Results of the potential analysis
using suitable measures (contingency strategy). Can also be used for:
Research and development suppliers/prototype suppliers
Suppliers of intangible products e.g. software
Suppliers of equipment, machinery, tools
Service providers (e.g. sorting companies)
External test labs
Suppliers in outsourced processes
Product 1: n.a. red yellow green
Findings:
5.2 Are the customer's requirements taken into account in the supply chain?
Minimum requirements relevant for assessment Examples for implementation
The communication of customer requirements must be regulated and Transmission of requirements, tolerances, time schedule, process
traceable. releases, releases, complaints etc. with ensuring change
Customer requirements also include requirements from technical management
drawings, components, software or component specifications, from Quality agreement
QM agreements and other valid standards. QAA (quality assurance agreements)
Change management must also be considered during serial Legal and regulatory requirements
production.
Interfaces are identified and secured.
Product 1: n.a. red yellow green
Findings:
5.4* Are the necessary releases available for purchased products and services?
Minimum requirements relevant for assessment Examples for implementation
A release must be available for all purchased products and services Specifications/standards/test instructions
before serial production of new/changed products/processes. PPA-Reports when necessary with software test reports
Unless otherwise specified, the supplier for the supply of modules has Proof of capability for special characteristics
the full quality control responsibility for all individual components. Legal/country specific requirements (e.g. CCC, Inmetro, IMDS,
REACH)
Qualification tests/reports
Model releases
Change management in the supply chain
Approval agreements for the scope of small batches and individual
requirements
Product 1: n.a. red yellow green
Findings:
5.5* Is the agreed upon quality of the purchased products and services ensured?
Minimum requirements relevant for assessment Examples for implementation
To monitor the quality of purchased products and services, regular Coordination of test/inspection procedures, processes and
checks are carried out, documented and evaluated. frequencies
Deviations from the supplier quality are processed through a standard Reference parts
complaint process. Sample size (e.g. Skip Lot)
Layout inspections and functional testing are carried out according to Evaluation of main failures
customer requirements. ppm evaluations, 8D reports
Test and measuring equipment must be sufficiently available to check Agreement and tracking of improvement programmes
purchased products. The equipment must be stored in an orderly Test possibilities (internal and external laboratories and test
manner and associated workstations must be laid out appropriately facilities, testing in accordance with ISO/IEC 17025) for raw
(e.g. climate control, lighting conditions, cleanliness, and protection materials (material certificates) and finished parts
against damage and contamination). Gauges/fixtures
Technical drawings/specifications
Ordering and packaging specifications
Proof of capability
Layout inspections and functional testing/reports
Test certificates
Product 1: n.a. red yellow green
Findings:
6.2.2 Does a repeat release for the restart of production take place?
Minimum requirements relevant for assessment Examples for implementation
The production repeat release is the order-related approval for Release of a batch
production start-up. Release of reworked parts
Criteria for triggering a production repeat release must be defined e.g. First piece release/first part release
after an interruption of production. Tooling diagrams/reference parts/installation parts (e.g. defect
A repeat release is necessary for product and process and must be identification)
carried out and documented by authorised employees using Possible triggering criteria for a repeat release:
acceptance criteria. Deviations and measures taken are to be Production interruption (e.g. night time in two shift operations,
documented. tool changes, material/batch/product change)
A repeat release inspection must be carried out using clear inspection Repair, tool change
instructions (quantity and method). Setting data
If production is continued after collection of samples, parts should be
isolated until the samples are approved.
At the time of release the necessary reference and tolerance samples
must be available.
Product 1: n.a. red yellow green
Findings:
6.4. What means are used to implement the process? Material resources
6.4.1* Can the Product-specific requirements from the customer be met with the manufacturing equipment?
Minimum requirements relevant for assessment Examples for implementation
Evidence must be shown that the processes are implemented in Evidence of machine/process capability for special characteristics
accordance with the customer requirements using the existing or process-determining parameters (e.g. pressure, time,
production facilities and that the resulting products meet the customer temperature)
specifications. Output/production capacities
The production facilities, machinery and equipment must be able to Warning at deviations from limit specifications/parameters (e.g. an
comply with the specified tolerances for the respective product and alarm, lamp, automatic shut-down, unloading)
process characteristics. Feed and removal systems
Process capability must be determined for selected product and Capability of replacement tools
process characteristics and their performance verified. Reproducibility of gauges, fixtures etc.
The process capability must meet the customer requirements. For long Cleanliness requirements
term process capability the minimum requirement of CRpkR ≥ 1,33
must be met. In the case of significant characteristics where no
capability level can be proven, 100% inspection is required.
Layout and condition of the equipment, tools, fixtures and handling
facilities meet the requirements under real production conditions.
Product 1: n.a. red yellow green
Findings:
Findings:
6.4.3* Can the quality requirements be effectively monitored with the measurement and test facilities in use?
Minimum requirements relevant for assessment Examples for implementation
Test and measuring equipment/facilities used are suitable for the Control plan
planned purpose and handling in production. They are included in the Capability of test equipment
control plan. Capability of measuring equipment
Capability studies are carried out on the test and measuring Capability of measurement process
equipment/facilities employed. There is an identification system for Data collection and interpretability
test and measuring equipment. Administration of this equipment is Evidence of the calibration of inspection equipment
based on the identification. Comparison of inspection equipment/measurement processes with
A process for the periodic monitoring of measurement and inspection the customer (e.g. interlaboratory comparisons)
equipment is installed and implemented (responsibility for collection Inspection stickers or certificates
and return is defined). This process also takes into account the Reference component/setup parts (e.g. error test pieces)
calibration of process-integrated measurement technology with an
influence on the product characteristics.
Auxiliary equipment for measuring and test equipment that have an
influence the measurement result are monitored in the same way.
Product 1: n.a. red yellow green
Findings:
6.4.4 Are the work and inspection stations appropriate for the needs?
Minimum requirements relevant for assessment Examples for implementation
Conditions for the workplaces and their surroundings are appropriate Lighting
for the products and the work carried out, in order to prevent or Cleanliness and tidiness
eliminate contamination, damage, mixing-up of parts and Climate control
misinterpretations. Noise pollution
This also applies to permanent and temporary established rework, Clean rooms
sorting and inspection stations. Workplace lay-out
In addition, the workplace layout is adapted ergonomically to the work Surroundings/handling parts at the workplace
to be carried out. Work safety
Product 1: n.a. red yellow green
Findings:
6.5. How effective is the process being carried out? Effectiveness, efficiency, waste avoidance
6.5.3* In the case of deviations from Product and process requirements, are the causes analysed and the corrective actions checked for
effectiveness?
Minimum requirements relevant for assessment Examples for implementation
If deviations from product and process requirements occur, immediate 8 D method
containment actions must be taken to comply with the requirements, Cause and effects diagram
until the causes of failure are eliminated and evidence has been Taguchi, Shainin
provided of the effectiveness of the corrective actions. These actions 5 Why method
are known by the employees. FMEA/error analysis
Suitable methods for root cause analysis are in use. Process capability analysis
Corrective actions are derived, their implementation is monitored and Quality control circles/quality circle
the effectiveness verified. Analytical assessment methods
Control plan and risk analysis (e.g. FMEA) are updated as needed. Information flow to the customer
Non-conformities that affect the properties of the delivered product are Product FMEA and process FMEA
communicated to the customer. Waivers/concessions
Additional dimensional material, functional and endurance checks
and tests
Product 1: n.a. red yellow green
Findings:
products. In the product audit specified characteristics are examined Process audit
and tested according to defined specifications. Process parameter/capability
Non-conformities that affect the properties of the delivered product are Product audit
communicated to the customer. Labelling, packaging
Capacity of the test equipment
Software version
Product 1: n.a. red yellow green
Findings:
6.6.4* Are customer requirements met at the delivery of the final Product?
Minimum requirements relevant for assessment Examples for implementation
The customer specific requirements of the final product (delivery Quality agreements with the customer
reliability, quality goals, quality performance etc.) are known and Customer specific requirements
monitored. Customer requirements for the identification of special
If deviations occur, corrective actions are defined and implemented. characteristics
Final products are shipped in accordance with the customer Shipping audit
requirements. Storage/recall processing/parts supply/shipping
The handling of supplied products is regulated and implemented. Target agreements
Customers should be informed of delivery stops which affect them and
further procedure should be coordinated with them.
Product 1: n.a. red yellow green
Findings:
7.4* If there are deviations from quality requirements or complaints, are failure analyses carried out and corrective actions implemented
effectively?
Minimum requirements relevant for assessment Examples for implementation
A complaint process that meets the customer requirements (e.g. 8D) is Process for processing complaints
used for 0-km and field complaints. 8D process
Procedures for failure analysis are defined. The necessary personnel Internal/external analysis facilities (laboratories, test and inspection
and material resources are available to ensure punctual processing. facilities, personnel)
The customer has to be informed when deviations to the agreed upon Use of problem solving methods
time limits occur. Performance tests
In the case of field complaints a failure analysis is to be carried out Flow of information to the customer in the case of deviations
according to customer requirements (e.g. VDA Volume Field Failure Knowledge store, lessons learned
Analysis). Quality control loop
FMEA
Access to the necessary release documents (e.g. PPA)
Test concept for defective parts in the field (standard test/stress
test/NTF test)
NTF guidelines
Performance indicators for processing of complaints
Product 1: n.a. red yellow green
Findings: