FORMELQ audit Report nr.

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Overall evaluation Audit date
Audited company: Auditor(s):
Address: Reason for the audit:

Representative:
Audit type:
Last audit results
Certification Date Audited by Result

Audit result / Statement

Product
Process step Process Failure class
Product group ED[%] EP[%] Grading
(Px)
A B C
ghjgjh 1 ghjghjg n/a 97 A
2 hjkghj
3
4
5
6
7
8
9
10
ED = product development process A = 92 - 100% quality capable

EP = serial production Grading: B = 82 - 91% partially quality capable

C = 0 - 81% non-quality capable

downgrading is possible (explanation in the Statements)

Statements

Completion of action plan/responsibility/scheduled date:

Explanation

Evaluation of the questions Causes of possible downgrading

10 - Full compliance with requirements 1. Audited company, which achieves a degree of compliance of 92 % (A) or more than
82% (B), but only achieves a degree of compliance of less than 75 % in one or more
8 - Predominant compliance with requirements; minor nonconformities * elements, are downgraded from A to B or B to C.

6 - Partial compliance with requirements; more severe nonconformities

4 - Unsatisfactory compliance with requirements, major nonconformities 2. For questions graded with zero points, which have a significant influence on the
product/process quality when not achieved, the auditee can be downgraded from A to B
0 - No compliance with requirements or B to C.

*) Predominant means, that more than ¾ of all requirements have proven to be

effective and no special risk is given. 3. Downgradings are to be justified in the Statements.
to be filled

FO-QA-034_v1 Issued: 04/NOV/2010 1/7. section Prepared by: Imre Malkovics

 Product audit evaluation Report nr.
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Prehistory / Packaging / Product Audit date
Audited company: Auditor(s):
Customer drawing nr: Part number:
version: Produced parts:
Prehistory / Packaging

Checking phase Method Evaluation Note

report
Latest internal product audit
checking

Packaging

Label identification
visual
inspection
Type identification

Quantity

Product (dimensional measurement)

Zone Selected Result Product failure class

Nr. LSL USL Sample Evaluation*
(drawing) dimensional parameter (from - to) A B C
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
* if evaluation is NOK then defined product failure class (A or B or C) shall be marked with X, and further immediate actions (if necessary) described in the Statements (on overall evaluation sheet)

Explanation

Fault description / effect Immediate action Follow-up action

• Continue analysing process / test activities
Fault will certainly result in customer complaints. • Develop and implement corrective action
• Prove process capability and zero defects
A • Safety risk, violation of legal regulations, no start conditions • Check effectiveness of initiated action
• Product cannot be sold / function not fulfilled • Quarantine / sorting out of existing parts
• Arrange for change of specifications, if necessary
• Extreme complaint • Information to purchasing plants and risk assessment
• Corrective action in the manufacturing / inspection process,
full inspection, if necessary
Annoyance of the customer or complaints can be expected. • Intensified test action on the process and the finished product
• Full inspection before delivery, if necessary
B • Foreseeable failure
• Reduced serviceability

Complaints from demanding customers can be expected.

C • Deviations that do not have an influence on the use or the operation
• Information to purchasing plants to coordinate action
• Serviceability not reduced

to be filled

FO-QA-034_v1 Issued: 04/NOV/2010 2/7. section Prepared by: Imre Malkovics

 "A" Product development process AUDIT CHECKLIST
Product development (design) - PRODUCT DEVELOPMENT PLANNING
Question point Observation
1.1 Are the customer requirements available?

1.2 Is a product development plan available and are the targets maintained?

1.3 Are the resources for the realization of the product development planned?

1.4 Have the product requirements been determined and considered?

1.5 Has the feasibility been determined based on the available requirements?

1.6 Are the necessary personnel and technical conditions for the project process planned/available?

Product development (design) - PRODUCT DEVELOPMENT REALIZING

Question point Observation
2.1 Is the design FMEA raised and are improvement measures established?

2.2 Is the design FMEA updated in the project process and are the established measures realized?

2.3 Is a quality plan prepared?

2.4 Are the required releases/qualification records available at the respective times?

2.5 Are the required resources available?

Process development - PROCESS DEVELOPMENT PLANNING
Question point Observation
3.1 Are the product requirements available?

3.2 Is a process development plan available and are the targets maintained?

3.3 Are the resources for the realization of serial production planned?

3.4 Have the process requirements been determined and considered?

3.5 Are the necessary personnel and technical preconditions for the project process planned/available?

3.6 Is the process FMEA raised and are improvement measures established?
Process development - PROCESS DEVELOPMENT REALIZING
Question point Observation
Is the process FMEA updated when amendments are made during the project process and are the
4.1
established measures implemented?
4.2 Is a quality plan prepared?

4.3 Are the required releases/qualification records available at the respective times?

4.4 Is a pre-production carried out under serial conditions for the serial release?

4.5 Are the production and inspection documents available and complete?

4.6 Are the required resources available?

"B" Serial production

SUPPLIERS / INPUT MATERIALS
Question point Observation
5.1 Are only approved quality capable suppliers used? 10

5.2 Is the agreed quality of the purchased parts guaranteed? 10 kléjklkjlé

Is the quality performance evaluated and are corrective actions introduced when there are deviations from
5.3 10
the requirements?
Are target agreements for continual improvement of products and process made and implemented with the
5.4 10
suppliers?
Are the required releases for the delivered serial products available and the required improvements
5.5 10
measures implemented?

5.6 Are the procedures agreed with the customer, regarding customer-supplied products, maintained? 10

5.7 Are the stock levels of input material matched to production needs? 10

5.8 Are input materials/internal residues delivered and stored according to their purpose? 10

5.9 Is the personnel qualified for the respective tasks? 10

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 Production - PERSONNEL / QUALIFICATION
point point point pont point point point point point point
Question P1 P2 P3 P4 P5 P6 P7 P8 P9 P10
Observation
Are the employees given responsibility and
6.1.1 authority for monitoring the product/process 10 10 10 10 10 10 10 10 10 10
quality?
Are the employees given responsibility and
6.1.2 authority for production equipment and 0 4 4 4 4 4 4 4 4 4 sadfdsds
environment?
Are the employees suitable to perform the
6.1.3 required tasks and is their qualification 10 10 10 10 10 10 10 10 10 10 d
maintained?
Is there a personnel plan with a replacement
6.1.4 10 10 10 10 10 10 10 10 10 10 d
ruling?
Are instruments to increase employee
6.1.5 6 6 6 6 6 6 6 6 6 6 d
motivation effectively implemented?
Production - PRODUCTION MATERIAL / EQUIPMENT
point point point pont point point point point point point
Question P1 P2 P3 P4 P5 P6 P7 P8 P9 P10 Observation

Are the product-specific quality requirements

6.2.1 10 10 10 10 10 10 10 10 10 10
fulfilled with the production equipment/tools?

Can the quality requirements be monitored

effectively during serial production with the
6.2.2 10 10 10 10 10 10 10 10 10 10
implemented inspection, measuring and test
equipment?
Are the work and inspection stations
6.2.3 10 10 10 10 10 10 10 10 10 10
appropriate to the needs?
Are the relevant details in the production and
6.2.4 inspection documents complete and 10 10 10 10 10 10 10 10 10 10
maintained?
Are the necessary auxiliary means available
6.2.5 10 10 10 10 10 10 10 10 10 10
for adjustments?
Is an approval for production starts issued and
6.2.6 are adjustment details, as well as deviations 10 10 10 10 10 10 10 10 10 10
recorded?

Are the required corrective actions carried out

6.2.7 10 10 10 10 10 10 10 10 10 10
on schedule and checked for effectiveness?

Production - TRANSPORT / PARTS HANDLING / STORAGE / PACKAGING

point point point pont point point point point point point
Question P1 P2 P3 P4 P5 P6 P7 P8 P9 P10
Observation
Are the quantities/production lot sizes
matched to the requirements and are they
6.3.1 10 10 10 10 10 10 10 10 10 10 sdfdsfsdfds
purposefully forwarded to the next work
station?

Are products/components appropriately stored

and are the transport means/packaging
6.3.2 10 10 10 10 10 10 10 10 10 10
equipment tuned to the special properties of
the product/components?

Are rejects, rework and adjustment parts, as

6.3.3 well as internal residues strictly separated and 10 10 10 10 10 10 10 10 10 10
identified?
Is the material and parts flow secured against
6.3.4 mix ups / exchanges by mistake and 10 10 10 10 10 10 10 10 10 10
traceability guaranteed?
Are tools, equipment and inspection,
6.3.5 measuring and test equipment stored 10 10 10 10 10 10 10 10 10 10
correctly?
Production - FAILURE ANALYSIS / CORRECTION / CONTINUOUS IMPROVEMENT
point point point pont point point point point point point
Question P1 P2 P3 P4 P5 P6 P7 P8 P9 P10
Observation
Are quality and process data recorded
6.4.1 8 8 8 8 8 8 8 8 8 8 sdfdsfdsfdsfdsfds
complete and ready to be evaluated?
Are the quality and process data statistically
6.4.2 analyzed and are improvement program 10 10 10 10 10 10 10 10 10 10
derived from this?

Are the causes of product and process

6.4.3 nonconformities analyzed and the corrective 10 10 10 10 10 10 10 10 10 8
actions checked for their effectiveness?

Are processes and products regularly

6.4.4 10 10 10 10 10 10 10 10 10 8
audited?
Are product and process subject to continual
6.4.5 10 10 10 10 10 10 10 10 10 10
improvement?
Are target parameters available for product
6.4.6 and process and is their compliance 10 10 10 10 10 10 10 10 10 10
monitored?
Production - CUSTOMER SERVICE / CUSTOMER SATISFACTION / SERVICE
Question point Observation
7.1 Are customer requirements fulfilled at delivery? 10

7.2 Is customer service guaranteed? 10

7.3 Are complaints quickly reacted to and the supply of parts secured? 10
Are fault analyses carried out when there are deviations from the quality requirements and are improvement
7.4 10
measures implemented?
7.5 Is the personnel qualified for each task? 10

3/7. section
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4/2. page
 "A" Product development process
Product development (design) - PRODUCT DEVELOPMENT PLANNING
Question Requirements / explanations What to look for
- Drawings, standards, specifications, performance specification
- Logistic concepts
- Technical specifications, test specifications
All customer requirements for the product to be
- Quality agreements, target agreements
1.1 Are the customer requirements available? developed must be known and included in the
- Important product/process characteristics
development.
- Purchase order documents with parts lists and delivery dates
- Legislation/Directives
- Waste management plans, environmental aspects.

- Customer requirements
The product development plan is an integral part of the - Costs
project plan and stands in correlation with the process - Deadlines: Planning/Purchasing release, modification stoppages
Is a product development plan available and development plan. All activities, including those for - Prototype/Pilot production, start of serial production
1.2
are the targets maintained? suppliers, are to be established until start of series. The - Resources studies
targets must be derived from the requirements and - Setting and monitoring the target
maintained at the established project phases. - Regular information to the company management
- Simultaneous Engineering Teams (SET).

- Customer requirements
The resources required are already to be determined - Qualified personnel
and considered in the quotation phase. After award of - Lost time through absenteeism
Are the resources for the realization of the contract, the details are to be precisely stated. When - Through put/Processing times
1.3
product development planned? requirements are altered, an update of the resources - Buildings, premises (for trial/prototype construction)
study is to be carried out, if necessary. The required - Tools/Equipment
means to be planned and made available. - Test/Inspection/Laboratory equipment
- CAD, CAM, CAE.

The requirements on the product are to be determined,

through interdisciplinary - Customer requirements
cooperation/benchmarking, for which QFD and DOE are - Company objectives
exemplary - Simultaneous Engineering
methods. Previous experiences and future expectations - Robust design/safe process
Have the product requirements been
1.4 must be - Regular customer/supplier meetings
determined and considered?
included in the consideration. The product requirements - Important characteristics, legislation requirements
must meet the - Functional measurements
market requirements and customer expectations, the - Fitting measurements
product must be - Material.
competitive.

- Design/Engineering
- Quality
- Process equipment, resources
The known requirements must be checked for feasibility - Special characteristics
Has the feasibility been determined based on
1.5 through interdisciplinary cooperation, here the customer - Company objectives
the available requirements?
requirements have special significance. - Directives, standards, legislation
- Environmental aspects
- Delivery dates/Time frames
- Cost frame.

- Project management, project planning team/responsibilities

- Qualified personnel
- Communication means (Electronic data transfer)
Are the necessary personnel and technical The required personnel qualifications and means are to
- Information flow from and to the customer during planning
1.6 conditions for the project process be determined prior to the start of the project and to be
(regular meetings, conferences)
planned/available? included in the project plan.
- Tools/equipment
- Test/inspection/laboratory equipment
- CAD, CAM, CAE.

Product development (design) - PRODUCT DEVELOPMENT REALIZING

Question Requirements / explanations What to look for

The product risks are to be pointed out and continually

- Customer requirements/performance specifications
reduced with appropriate measures, through
- Function, safety, reliability, maintainability, important characteristics
interdisciplinary cooperation, also with the customer and
Is the design FMEA raised and are - Environmental aspects
2.1 suppliers. For complex parts or complete function
improvement measures established? - Involvement of all affected areas
systems, the use of a system FMEA is sensible (see
- Trial and test results
VDA Volume 4, Part 1 and 2). Other comparable
- Product-specific measures from the process FMEA.
analysis techniques are to be agreed with the customer.

- Customer requirements
Amendments to the product and process must be - Important parameters/characteristics, legal requirements
Is the design FMEA updated in the project evaluated by the project management. In agreement - Function, fitting measurements
2.2 process and are the established measures with the FMEA Team, a new analysis, if necessary, is to - Material
realized? be initiated. An update is also necessary after - Environmental aspects
realization of measures (Design Review). - Transport (internal/external)
- Product-specific measure from the process FMEA.

The quality plan must contain components,

subassemblies, assemblies, parts and materials,
including the production process from prototype and - establishing and marking of significant characteristics
pilot production phase, which belong to the product. The - raising of an inspection and test plan
quality plan is a living document and must be - provision of equipment and fittings
2.3 Is a quality plan prepared?
raised/updated for new/amended products. A quality - timely, planned provision of measuring equipment
plan (according to DIN EN ISO 8402/3.13) is generally - inspections at appropriate points during the production
to be raised for the following phases: - clarification of acceptance criteria
prototype phase
prelunch (pilot) phase

- Product trials (e.g. fitting inspections, functional tests, durability

checks, environmental simulations)
Are the required releases/qualification records The releases/qualification records of all individual parts, - Status of the prototype parts
2.4
available at the respective times? subassemblies and purchased parts are to be proven. - Pilot series model
- Production/inspection, measuring and test equipment in experimental
installation.

- Customer requirements
- Qualified personnel
The required resources are to taken from the quotation - Lost time through absenteeism
calculation and the preplanning. They must be - Through put/Processing time
2.5 Are the required resources available? available, or planned and provided at the respectively - Buildings, premises
appointed time. The required means for this must be - Experimental installation
included in the project. - Prototype construction
- Tools/Equipment
- Test/Inspection/Laboratory equipment.

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 Process development - PROCESS DEVELOPMENT PLANNING
Question Requirements / explanations What to look for
- Customer requirements
- Legislation, standards, directives
- Logistic concepts
All requirements of the product to be produced, must be - Technical specifications
3.1 Are the product requirements available?
known and included in the planning. - Quality/target agreements
- Important characteristics
- Material
- Waste management plans, environmental aspects.

- Customer requirements
- Costs
The process development plan is an integral part of the - Deadlines: Planning/Purchasing release, Prototypes/pilot productions,
project plan and stands in correlation with the product Start for serial production
Is a process development plan available and development plan. All activities until start of series are to - Resources studies
3.2
are the targets maintained? be determined. The targets must be derived from the - Provision of production/testing equipment, software, packaging
requirements and maintained at the established project - Safeguard concept for amendments (startup problems etc.)
phases. - Logistic/delivery concept
- Setting and monitoring the target
- Regular information to the company management.

- Customer requirements
- Availability of input material
- Qualified personnel
The required resources are already to be determined
- Lost time through absenteeism/Standstill times
and considered in the quotation phase. After award of
- Through put times/Processing times/No. of production pieces per
Are the resources for the realization of serial contract, the details are to be precisely stated. When
3.3 plant/Equipment
production planned? requirements are altered, an update of the resources
- Buildings, premises
study is to be carried out, if necessary. The required
- Plants, tools, production/testing equipment, auxiliary tools,
means are to be planned and made available.
laboratory equipment
- Transport means, containers, store
- CAM, CAQ.

- Customer requirements
The process requirements are to be determined through
- Legislative requirements
interdisciplinary cooperation, for which QFD and DOE
Have the process requirements been - Capability records
3.4 are exemplary methods. Previous experiences and
determined and considered? - Suitability of plants, tools, inspection and test equipment
future expectations must be included in the
- Arrangement of work and inspection stations
consideration.
- Handling, packaging, storage, marking.

- Project management, project planning team/responsibilities

- Qualified personnel
- Plants, tools, production/testing equipment, auxilliary tools, laboratory
Are the necessary personnel and technical The personnel qualification requirements and means to
equipment
3.5 preconditions for the project process be provided, are to be determined prior to the start of
- Communication means (e.g. electronic data transfer)
planned/available? the project and included in the project plan.
- Information flow from and to the customer during the planning
(regular meetings, conferences)
- CAM, CAQ.

- All production stages, including those of suppliers

The process risks are to be pointed out and continually - Customer requirements, function
reduced with appropriate measures, through - Important parameters/characteristics
Is the process FMEA raised and are
3.6 interdisciplinary cooperation, also with the customers - Traceability, environmental aspects
improvement measures established?
and suppliers. For complex parts or complete function - Transport (internal/external)
systems, the use of a system FMEA is sensible. - Involvement all affected areas
- Process-specific measures from the design FMEA.

Process development - PROCESS DEVELOPMENT REALIZING

Question Requirements / explanations What to look for
- Customer requirements
- All production phases, including those of suppliers
Amendments to product and process must be evaluated
Is the process FMEA updated when - Important parameters/characteristics, legislative requirements
by the project managers. In agreement with the FMEA
amendments are made during the project - Fitting measurements
4.1 Team a new analysis, if necessary, is to be initiated. An
process and are the established measures - Material
update is also required after measures have been
implemented? - Traceability, environmental aspects
realized.
- Transport (internal/external)
- Process-specific measures from the design FMEA.

The quality plan must contain components,

subassemblies, assemblies, parts and materials,
including the production process from prototype and
- establishing and marking of significant characteristics
pilot production phase, which belong to the product. The
- raising of an inspection and test plan
quality plan is a living document and must be
- provision of equipment and fittings
4.2 Is a quality plan prepared? raised/updated for new/amended products. A quality
- timely, planned provision of measuring equipment
plan (according to DIN EN ISO 8402/3.13) is generally
- inspections at appropriate points during the production
to be raised
- clarification of acceptance criteria.
for the following phases:
prelunch (pilot) phase
serial production phase

- Product trials (e.g. fitting inspection, functional test, durability

check, environmental simulations)
- Pilot production parts
The releases/qualification records of all individual parts,
- First sample
Are the required releases/qualification records subassemblies and purchased parts, production,
4.3 - Capability records of important product/process characteristics
available at the respective times? inspection , measuring and test equipment, are to be
- Logistic concept (e.g. checking suitability of packaging by a test
proven.
dispatch)
- Tools, machines, equipment, inspection, measuring and test
equipment.

- Customer requirements
- Establishing minimum numbers of production pieces
- Process capability analysis
A pre-production is required to be able to evaluate and, - Measuring equipment capability
if necessary, correct all production factors and - Readiness of the production materials and equipment for series
Is a pre-production carried out under serial
4.4 influences at an early stage. In serial production, (measuring records)
conditions for the serial release?
bottlenecks and quality impairment, shall become - First sample inspection
avoidable. - Handling, packaging, marking and storage
- Personnel qualification
- Work/Inspection instructions
- Arrangement of work/inspection stations.

- Process parameters (e.g. pressures, temperatures, times,

speeds)
- Machine/tool/auxiliary means data
Process parameters/inspection characteristics are - Inspection requirements (important characteristics, inspection,
always to be given with tolerances, the production and measuring and test equipment, methods, inspection frequencies)
Are the production and inspection documents
4.5 inspection documents must be available at the - Intervention limits in process control charts
available and complete?
work/inspection station. The implemented corrective - Machine and process capability records
actions for nonconformities are to be documented. - Operating instructions
- Work instructions
- Inspection instructions
- Information on the current nonconformities.

- Customer requirements
- Availability of input material
- Qualified personnel
- Lost time through absenteeism/Standstill times
The resources required are to be taken from the
- Through put times/Processing times/No. of production pieces per
4.6 Are the required resources available? quotation calculation and the current process
plant/equipment
development.
- Buildings, premises
- Plants, tools, production/inspection equipment, auxiliary tools,
laboratory equipment
- Transport means, containers, store.

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6/5. page
 "B" Serial production
SUPPLIERS / INPUT MATERIALS
Question Requirements / explanations What to look for

Prior to determining the suppliers, an evaluation of the

quality system (certification/auditing) must be available. - Supplier discussions/regular support
Are only approved quality capable suppliers
5.1 During serial application, it must be ensured that only - Evaluation of the quality capability e.g. audit results/certificates
used?
suitable suppliers are used. Experiences from quality - Assessment of the quality performance (quality/costs/service).
performance assessments must be considered.

- Sufficient inspection and test possibilities (Laboratory and measuring

equipment)
- Internal/external inspections and tests
- Supplied gauges/surveys
Is the agreed quality of the purchased parts - Drawings/order details/specifications
5.2
guaranteed? - Quality assurance agreements
- Coordination of inspection and testing procedures, proceedings
and frequencies
- Analysis of nonconformity focal points
- Capability evidence.

The capabilities and performances of a supplier are to

be checked at defined intervals and recorded and - Records about quality meetings
Is the quality performance evaluated and are
evaluated in a part-specific listing (supplier catalog). - Agreements about and monitoring of improvement programs
5.3 corrective actions introduced when there are
Qualification programs are to be established when - Inspection and measuring records of improved components
deviations from the requirements?
negative results are found. The implementation is to be - Analysis of nonconformity focal points/problem suppliers.
proven.

- Workshops (interdisciplinary working groups)

- Establishing measurable target parameters for quality, price, service
e.g.:
Are target agreements for continual
- Reducing the inspection and testing magnitude whilst raising process
5.4 improvement of products and process made
safety
and implemented with the suppliers?
- Reducing rejections (internal/external)
- Reducing the stock in circulation
- Increasing customer satisfaction.

- Construction model, trial testing releases

- First sample report according to VDA
Are the required releases for the delivered For all supplier products, a release of new/amended - Capability evidence for important characteristics
5.5 serial products available and the required products/processes, must be carried out prior to serial - Consideration of the safety data sheets, EC guidelines
improvements measures implemented? application. - Reliability assessments
- Re-qualification inspection reports and the resulting improvement
measures.
- Control, verification, storage, transport, maintenance of quality
Are the procedures agreed with the customer, The customer-supplied product requirements are to be
and properties
5.6 regarding customer-supplied products, taken from the quality agreements and strictly
- Information flow, in cases of nonconformity or loss
maintained? implemented.
- Quality documentation (quality status, quality history).
- Customer requirements
The required stock levels must already be determined
- KANBAN/Just in time
Are the stock levels of input material matched and considered during process planning. When
5.7 - Storage costs
to production needs? requirements change, the analyzed stock levels, if
- Emergency strategy when input material bottlenecks occur
necessary, are to be updated.
- FIFO (first in/first out).

- Packaging
- Storage administration system
- FIFO (first in/first out)
- Tidiness and cleanliness
- Climatic conditions
Are input materials/internal residues delivered
5.8 - Protection against damage/contamination
and stored according to their purpose?
- Identification
- (Traceability/Inspection status/Sequence of
operations/Application status)
- Safety against mix ups
- Secure storage (fitted and used).

- Product/specifications/special customer requirements

Personnel responsible for the following areas, for
- Standards/legislation
example, are to be considered:
- Packaging
Is the personnel qualified for the respective - Supplier selection, evaluation, qualification
5.9 - Processing
tasks? - Product inspection, measuring and testing
- Evaluation methods (e.g. audits, statistics)
- Storage/Transport
- Quality techniques (e.g. 8D-Method, Cause/Effect diagram)
- Logistics.
- Foreign languages.

Production - PERSONNEL / QUALIFICATION

Question Requirements / explanations What to look for
- Cooperation on improvement programs
- Worker self assessments
Are the employees given responsibility and
- Process approval/release
6.1.1 authority for monitoring the product/process
- Set up release/First/last production piece testing)
quality?
- Process control (Interpretation of control charts)
- Authority to stop production.
- Tidiness and cleanliness
Are the employees given responsibility and - Carrying out or ordering repair and maintenance work
6.1.2 authority for production equipment and - Providing parts/storage
environment? - Carrying out/ordering the installation and calibration of inspection,
measuring and test equipment.

- Introduction/Training/Qualification records about the process

- Knowledge of the product and nonconformities which have
occurred
Are the employees suitable to perform the
- Instructions in health and safety at work/Environmental aspects
6.1.3 required tasks and is their qualification
- Instructions for the handling of „components with special verification
maintained?
requirements“
- Qualification records (e.g. Welder certificates, sight tests, driving
license for industrial trucks).

When planning personnel, the absentee figures

- Shift plan (contract related)
Is there a personnel plan with a replacement (illness/holidays/training courses) are to be considered.
6.1.4 - Qualification records (Qualification matrix)
ruling? The required qualifications of replacement personnel
- Work analyses/Time and motion studies.
are also to be ensured.
- Quality information (Specified/Actual values)
- Improvement suggestions
The willingness to work must be promoted through
Are instruments to increase employee - Voluntary activities (Training courses, quality circles)
6.1.5 targeted information and thereby, the quality awareness
motivation effectively implemented? - Low illness frequency rate
increased.
- Contribution to quality improvement
- Self assessments.

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 Production - PRODUCTION MATERIAL / EQUIPMENT
Question Requirements / explanations What to look for
- Machine/Process capability evidence important characteristics/
process parameters
- Compulsory control/regulation of important parameters
Are the product-specific quality requirements - Warnings when deviations from specified values occur (e.g.
6.2.1
fulfilled with the production equipment/tools? lamps, sirens, shutdown)
- Feed and delivery equipment
- Maintenance and repair status of tools/plants/machines (including
scheduled maintenance).

- Reliability, function and corrosion resistance tests

Can the quality requirements be monitored
- Measuring accuracy/inspection, measuring and test equipment
effectively during serial production with the
6.2.2 capabilities
implemented inspection, measuring and test
- Data acquisition and analysis
equipment?
- Calibration records.
- Ergonomics
The environmental conditions (also for repairs/rework) - Lighting
Are the work and inspection stations are to be tuned to the work contents and the products, - Tidiness and cleanliness
6.2.3
appropriate to the needs? to avoid contamination, damage and mix - Environmental protection
up/misinterpretation. - Surroundings/Handling of the components
- Health and safety at work.

- Process parameters (e.g. pressures, temperatures, times,

speeds)
- Machine/tool/auxiliary means data (Tool and machine numbers)
Process parameters and inspection and testing
- Inspection requirements (important characteristics, inspection,
characteristics are always to be given with tolerances.
Are the relevant details in the production and measuring and test equipment, methods, frequencies)
Manufacturing and inspection documents must be
6.2.4 inspection documents complete and - Intervention limits in process control charts
available at the work/inspection stations.
maintained? - Machine and process capability records
Nonconformities and implemented corrective actions
- Operating instructions
must be documented.
- Work instructions
- Inspection instructions
- Information on the current nonconformities.

- Tooling plans
Are the necessary auxiliary means available - Tool setting aids/comparison aids
6.2.5
for adjustments? - Flexible Tool change equipment
- Limits patterns.

“Release to serial production“ is the contract-related first

and re-release for the start of the production. The
- New, changed product
release is necessary for product and process and must
- Standstill of the equipment/process interruption
be carried out, in writing, by authorized employees with
- Repair, tool change
the help of acceptance criteria. At this point, known
- Material change (e.g. Batch/heat change)
problems in the product/ process planning and/or
Is an approval for production starts issued and - Changed production parameters
previous serial production must be eliminated. The
6.2.6 are adjustment details, as well as deviations - First production piece testing with documentation
release inspection and tests must be made according to
recorded? - Topicality of the parameters
clear inspection instructions, to ensure their
- Tidiness and cleanliness at the work station
reproducibility. Here, the use of a checklist is
- Packaging
recommended. If production is continued after the
- Release /modification status of tools and inspection, measuring
extraction of test pieces, the products must be placed
and test equipment.'
on hold until release of the test pieces. Reworked
products are to be included in the release process.

- Risk analyses (Process FMEA) Fault analyses

- Improvement programs from audits
Corrective actions relate to the entire process chain,
- Information to the responsible party
Are the required corrective actions carried out from input material through to use by the customer. The
6.2.7 - Interface discussions internal/external
on schedule and checked for effectiveness? effectiveness of corrective actions carried out, must be
- Internal complaints
checked and proven.
- Customer complaints
- Customer surveys.

Production - TRANSPORT / PARTS HANDLING / STORAGE / PACKAGING

Question Requirements / explanations What to look for
- Sufficiently suitable transport means
- Defined storage areas
- Minimal/no intermediate store
- KANBAN
Are the quantities/production lot sizes
- Just in time
matched to the requirements and are they
6.3.1 - First in/first out
purposefully forwarded to the next work
- Storage administration
station?
- Modification status
- Only transfer of satisfactory parts
- Recording production pieces numbers/evaluation
- Information flow.

- Stock levels
Are products/components appropriately stored - Protection against damage
and are the transport means/packaging - Parts positioning
6.3.2
equipment tuned to the special properties of - Tidiness, cleanliness, overstocking (storage areas, containers)
the product/components? - Monitoring of the storage time
- Environmental influences, air conditioning.
- Holding store, holding areas
Are rejects, rework and adjustment parts, as - Marked containers for rejects, rework parts and adjustment parts
6.3.3 well as internal residues strictly separated and - Nonconforming products and nonconformity characteristics
identified? - Identification/marking
- Defined transfer/rework stations in the production department.

- Identification/Marking of parts
- Identification/Marking of the operational, inspection and test and
Is the material and parts flow secured against Appropriate to the product risk, the traceability along the application status
6.3.4 mix ups/ exchanges by mistake and entire process chain from supplier to customer, must be - Batch/heat numbering
traceability guaranteed? guaranteed. - Expiry date
- Removal of invalid identification/marking
- Working documents with parts/production data.

- Storage without risk of damage

- Tidiness and cleanliness
Are tools, equipment and inspection, Tools, machinery, inspection, measuring and test - Defined storage location
6.3.5 measuring and test equipment stored equipment, not in use and not released, must also be - Administered issue
correctly? correctly stored and administrated. - Environmental influences
- Identification/Marking
- Defined release and revision status.

4/7. section
FO-QA-034_v1 Issued: 04/NOV/2010 Prepared by: Imre Malkovics
8/5. page
 Production - FAILURE ANALYSIS / CORRECTION / CONTINUOUS IMPROVEMENT
Question Requirements / explanations What to look for
- General charts
- Nonconformity lists
- Control charts
Quality and process data must be completely available
- Data acquisition
Are quality and process data recorded to prove the compliance with requirements. They must
6.4.1 - Recorders for process parameters (e.g. temperature, time,
complete and ready to be evaluated? be able to be evaluated. Special events are to be
pressure)
documented
- Plant standstill
- Parameter changes
- Power cuts.

- Process capabilities
- Failure modes/failure frequencies
- Nonconformity costs
Are the quality and process data statistically Findings and problem points are to be related to the
- Process parameter
6.4.2 analyzed and are improvement program responsible departments, which must then work out and
- Rejects/rework
derived from this? implement improvements.
- On hold notifications/Sorting actions
- Cycle, through put/processing times
- Reliability/Failure conduct.'

- Additional dimensional, material, functional, endurance tests

When product/process failures have occurred,
- Cause/effect diagram
appropriate immediate actions (such as placing on hold,
Are the causes of product and process - Taguchi, Shainin
sorting, informing) must be carried out, to ensure
6.4.3 nonconformities analyzed and the corrective - FMEA/Fault analysis
compliance with the requirements, until the cause of the
actions checked for their effectiveness? - Process capability analysis
failure has been removed and the effectiveness of
- Quality Circle
corrective actions has been proven.
- 8D-Method.

- Customer requirements
- Important characteristics
Are processes and products regularly Audit plans for the product and it’s manufacturing - Function
6.4.4
audited? process must be available. - Process parameters/capabilities
- Marking/identification, Packaging
- Established processes/procedures.

- Cost optimization
- Reduction of waste (e.g. rejects and rework)
Are product and process subject to continual The improvement potential must be determined from - Improving of process safety (e.g. process analysis)
6.4.5
improvement? previous findings about quality, costs and service. - Optimizing set-up times, raising plant availability
- Reducing through-put/processing times
- Reducing stock levels.

- Presence and absence of personnel

Target parameters must be agreed and feasible, the - Number of production pieces produced
Are target parameters available for product
topicality is to be guaranteed. Special measures - Quality indices (e.g. failure rates, audit results)
6.4.6 and process and is their compliance
required are to be established and implemented, if - Through-put/processing times
monitored?
necessary. - Nonconformity costs
- Process characteristic values (e.g. process capability).
Production - CUSTOMER SERVICE / CUSTOMER SATISFACTION / SERVICE
Question Requirements / explanations What to look for
- Quality agreements
- Dispatch audits
- Endurance testing (Investigating failure conduct)
Are customer requirements fulfilled at All requirements are considered, especially those which - Storage/Call off processing/parts provision/dispatch
7.1
delivery? go into the supplier evaluation by the customer. - Functional testing
- Suitability of inspection, measurement and test equipment
- Agreed inspection and testing procedures
- Topicality of the specifications.

- Records of customer visits, if necessary, deriving measures

- Knowledge of product application
It is to be guaranteed, that competent contact people for
- Knowledge of product problems
the various organization departments of the customer
- Implementation of new requirements
are available. Customer support is also a measure of
7.2 Is customer service guaranteed? - Notification of improvement measures
active cooperation. The sub-supplier has the duty to
- Notification of product/process changes/redeployments, (also of
observe and, if necessary, improve, his products across
suppliers)
all development and application phases.
- First/repeat samplings (Trial/Series)
- Information about nonconformities.

- Emergency plans
Concepts to secure the supply of parts, also for
- Resources and reaction times for sorting actions
Are complaints quickly reacted to and the unscheduled problems, are already to be worked out
7.3 - Plant modification possibilities, special production means and
supply of parts secured? during process planning. These are to be guaranteed in
tools
the series phase.
- Use of subcontracted resources.

- Analysis possibilities (Laboratory, inspection/test equipment, personnel)

- PARETO Analyses of failure characteristics (internal/external)
Are fault analyses carried out when there are - Involvement of all affected departments (internal/external)
7.4 deviations from the quality requirements and - Use of problem solving methods (e.g. 8D Report)
are improvement measures implemented? - Correction of sampling deviations
- Revision of the specifications
- Check of effectiveness.

Responsible personnel, for example, for the following

- Product/specifications/special customer requirements
areas are to be considered:
- Standards/Legislation
- Customer service
- Processing/Application
7.5 Is the personnel qualified for each task? - Product inspection and testing
- Evaluation methods (e.g. audit, statistics)
- Storage/Transport
- Quality techniques (e.g. 8D Method, Cause/effect diagram)
- Logistics
- Foreign languages.
- Fault analysis.

4/7. section
FO-QA-034_v1 Issued: 04/NOV/2010 Prepared by: Imre Malkovics
9/5. page
 logo
Process audit evaluation Report nr. Punkte
Product Development Process / Serial Production Audit date: max.
"A" Product development process
###
1 Product development (design) degree of
.1 .2 .3 .4 .5 .6 .1 .2 .3 .4 .5 conformity [%]

1. Planning 2. Realizing EDE n/a ###

2 Process development
.1 .2 .3 .4 .5 .6 .1 .2 .3 .4 .5 .6
3. Planning 4. Realizing EPE n/a ###

EDE + EPE
ED [%] = ED n/a
No. of evaluated elements

"B" Serial production

.1 .2 .3 .4 .5 .6 .7 .8 .9

5 Suppliers / input materials 10 10 10 10 10 10 10 10 10 EZ 100 ###

6 Production (evaluation of every process)

personnel/qualification production material/equipment transport/parts handling… failure analysis/correction…

1.1 1.2 1.3 1.4 1.5 2.1 2.2 2.3 2.4 2.5 2.6 2.7 3.1 3.2 3.3 3.4 3.5 4.1 4.2 4.3 4.4 4.5 4.6

Process 1 (P1): ghjghjg E1

10 0 10 10 6 10 10 10 10 10 10 10 10 10 10 10 10 8 10 10 10 10 10 89 ###
Process 2 (P2): hjkghj E2
10 4 10 10 6 10 10 10 10 10 10 10 10 10 10 10 10 8 10 10 10 10 10 90 ###
Process 3 (P3): E3
10 4 10 10 6 10 10 10 10 10 10 10 10 10 10 10 10 8 10 10 10 10 10 90 ###
Process 4 (P4): E4
10 4 10 10 6 10 10 10 10 10 10 10 10 10 10 10 10 8 10 10 10 10 10 90 ###
Process 5 (P5): E5
10 4 10 10 6 10 10 10 10 10 10 10 10 10 10 10 10 8 10 10 10 10 10 90 ###
Process 6 (P6): E6
10 4 10 10 6 10 10 10 10 10 10 10 10 10 10 10 10 8 10 10 10 10 10 90 ###
Process 7 (P7): E7
10 4 10 10 6 10 10 10 10 10 10 10 10 10 10 10 10 8 10 10 10 10 10 90 ###
Process 8 (P8): E8
10 4 10 10 6 10 10 10 10 10 10 10 10 10 10 10 10 8 10 10 10 10 10 90 ###
Process 9 (P9): E9
10 4 10 10 6 10 10 10 10 10 10 10 10 10 10 10 10 8 10 10 10 10 10 90 ###
Process 10 (P10): E10
10 4 10 10 6 10 10 10 10 10 10 10 10 10 10 10 10 8 10 8 8 10 10 89 ###

Assesment of the sub-elements with quality system reference Element BG (Mean Process step 1-n)
1.1 .2 .3 .4 .5 2.1 .2 .3 .4 .5 .6 3.1 .2 .3 .4 .5 4.1 .2 .3 .4 .5 .6
10 3 10 10 6 10 10 10 10 10 10 10 10 10 10 10 10 8 10 10 10 10 10

EU1 [%] 78 EU2 [%] 100 EU3 [%] 100 EU4 [%] 100

.1 .2 .3 .4 .5 EK
7 Customer service / customer satisfaction / service 10 10 10 10 10 100 ###

Degree of conformity EPG according to product groups Element B6 (%) Mean E1 - En

Product group ghjgjh

Process step 1,2

EPG [%] 90

EP [%] 97

EZ + EPG + EK
Overall degree of conformity EP [%] according to product groups: EP [%] =
No. of evaluated elements

Comment: Question is not applicable = no entry (empty cell)

FO-QA-034_v1 Issued: 04/NOV/2010 5/7. section Prepared by: Imre Malkovics

 "A" Product development process AUDIT CHECKLIST
Product development (design) - PRODUCT DEVELOPMENT PLANNING
Question point Observation
1.1 Are the customer requirements available?

1.2 Is a product development plan available and are the targets maintained?

1.3 Are the resources for the realization of the product development planned?

1.4 Have the product requirements been determined and considered?

1.5 Has the feasibility been determined based on the available requirements?

1.6 Are the necessary personnel and technical conditions for the project process planned/available?
Product development (design) - PRODUCT DEVELOPMENT REALIZING
Question point Observation
2.1 Is the design FMEA raised and are improvement measures established?

2.2 Is the design FMEA updated in the project process and are the established measures realized?

2.3 Is a quality plan prepared?

2.4 Are the required releases/qualification records available at the respective times?

2.5 Are the required resources available?

Process development - PROCESS DEVELOPMENT PLANNING
Question point Observation
3.1 Are the product requirements available?

3.2 Is a process development plan available and are the targets maintained?

3.3 Are the resources for the realization of serial production planned?

3.4 Have the process requirements been determined and considered?

3.5 Are the necessary personnel and technical preconditions for the project process planned/available?

3.6 Is the process FMEA raised and are improvement measures established?
Process development - PROCESS DEVELOPMENT REALIZING
Question point Observation
Is the process FMEA updated when amendments are made during the project process and are the
4.1
established measures implemented?
4.2 Is a quality plan prepared?

4.3 Are the required releases/qualification records available at the respective times?

4.4 Is a pre-production carried out under serial conditions for the serial release?

4.5 Are the production and inspection documents available and complete?

4.6 Are the required resources available?

"B" Serial production

SUPPLIERS / INPUT MATERIALS
Question point Observation
5.1 Are only approved quality capable suppliers used?

5.2 Is the agreed quality of the purchased parts guaranteed?

Is the quality performance evaluated and are corrective actions introduced when there are deviations from
5.3
the requirements?
Are target agreements for continual improvement of products and process made and implemented with the
5.4
suppliers?
Are the required releases for the delivered serial products available and the required improvements
5.5
measures implemented?
5.6 Are the procedures agreed with the customer, regarding customer-supplied products, maintained?

5.7 Are the stock levels of input material matched to production needs?

5.8 Are input materials/internal residues delivered and stored according to their purpose?

5.9 Is the personnel qualified for the respective tasks?

 Production - PERSONNEL / QUALIFICATION
point point point pont point point point point point point
Question P1 P2 P3 P4 P5 P6 P7 P8 P9 P10
Observation
Are the employees given responsibility and
6.1.1 authority for monitoring the product/process
quality?
Are the employees given responsibility and
6.1.2 authority for production equipment and
environment?
Are the employees suitable to perform the
6.1.3 required tasks and is their qualification
maintained?
Is there a personnel plan with a replacement
6.1.4
ruling?
Are instruments to increase employee
6.1.5
motivation effectively implemented?
Production - PRODUCTION MATERIAL / EQUIPMENT
point point point pont point point point point point point
Question P1 P2 P3 P4 P5 P6 P7 P8 P9 P10
Observation

Are the product-specific quality requirements

6.2.1
fulfilled with the production equipment/tools?

Can the quality requirements be monitored

effectively during serial production with the
6.2.2
implemented inspection, measuring and test
equipment?
Are the work and inspection stations
6.2.3
appropriate to the needs?
Are the relevant details in the production and
6.2.4 inspection documents complete and
maintained?
Are the necessary auxiliary means available
6.2.5
for adjustments?
Is an approval for production starts issued and
6.2.6 are adjustment details, as well as deviations
recorded?

Are the required corrective actions carried out

6.2.7
on schedule and checked for effectiveness?

Production - TRANSPORT / PARTS HANDLING / STORAGE / PACKAGING

point point point pont point point point point point point
Question P1 P2 P3 P4 P5 P6 P7 P8 P9 P10
Observation
Are the quantities/production lot sizes
matched to the requirements and are they
6.3.1
purposefully forwarded to the next work
station?

Are products/components appropriately stored

and are the transport means/packaging
6.3.2
equipment tuned to the special properties of
the product/components?

Are rejects, rework and adjustment parts, as

6.3.3 well as internal residues strictly separated and
identified?
Is the material and parts flow secured against
6.3.4 mix ups / exchanges by mistake and
traceability guaranteed?
Are tools, equipment and inspection,
6.3.5 measuring and test equipment stored
correctly?
Production - FAILURE ANALYSIS / CORRECTION / CONTINUOUS IMPROVEMENT
point point point pont point point point point point point
Question P1 P2 P3 P4 P5 P6 P7 P8 P9 P10 Observation
Are quality and process data recorded
6.4.1
complete and ready to be evaluated?
Are the quality and process data statistically
6.4.2 analyzed and are improvement program
derived from this?

Are the causes of product and process

6.4.3 nonconformities analyzed and the corrective
actions checked for their effectiveness?

6.4.4 Are processes and products regularly audited?

Are product and process subject to continual
6.4.5
improvement?
Are target parameters available for product
6.4.6 and process and is their compliance
monitored?
Production - CUSTOMER SERVICE / CUSTOMER SATISFACTION / SERVICE
Question point Observation
7.1 Are customer requirements fulfilled at delivery?

7.2 Is customer service guaranteed?

7.3 Are complaints quickly reacted to and the supply of parts secured?
Are fault analyses carried out when there are deviations from the quality requirements and are improvement
7.4
measures implemented?
7.5 Is the personnel qualified for each task?
 "A" Termékfejlesztési folyamat AUDIT KÉRDÉSLISTA
Termékfejlesztés (design) - TERMÉKFEJLESZTÉS TERVEZÉSE
Kérdés pont Megfigyelés
1.1 A vevői követelmények rendelkezésre állnak?

1.2 Termékfejlesztési terv rendelkezésre áll és a kitűzött célokat betartják?

1.3 Az erőforrások rendelkezésre állnak a termékfejlesztés megvalósításához?

1.4 A termékre vonatkozó követelményeket meghatározták és figyelembe vették?

1.5 A rendelkezésre álló követelmények alapján történt a gyárthatóság meghatározása?

A szükséges személyi -és műszaki feltételeket megtervezték ill. rendelkezésre állnak a termékfejlesztés
1.6
számára?
Termékfejlesztés (design) - TERMÉKFEJLESZTÉS MEGVALÓSÍTÁSA
Kérdés pont Megfigyelés
A termék FMEA elkészült és a fejlesztéseket Elkészült-e a konstrukciós FMEA, és meghatározták-e a
2.1
helyesbítő intézkedéseket?
Aktualizálva lett-e a design FMEA a projekt folyamatában, és megvalósításra kerültek-e a meghatározott
2.2
intézkedések?
2.3 Elkészült-e az MB-terv?

2.4 Rendelkezésre állnak-e a mindenkori időponthoz szükséges felszabadítási / alkalmassági igazolások?

2.5 Rendelkezésre állnak-e a szükséges kapacitások?

Folyamatfejlesztés - FOLYAMATFEJLESZTÉS TERVEZÉSE
Kérdés pont Megfigyelés
3.1 Rendelkezésre állnak-e a termékre vonatkozó követelmények?

3.2 Rendelkezésre áll-e folyamatfejlesztési terv, és betartásra kerülnek-e a célelőírások?

3.3 Meg vannak-e tervezve a sorozatgyártás megvalósításához szükséges kapacitások?

3.4 Meg vannak-e határozva, és figyelembe vannak-e véve a folyamatra vonatkozó követelmények?
Meg vannak-e tervezve ill. rendelkezésre állnak-e a projektfejlesztés előfeltételeihez szükséges személyzeti
3.5
és műszaki előfeltételek?
3.6 Elkészült-e a folyamat-FMEA, és meghatározásra kerültek-e a helyesbítő intézkedések?
Folyamatfejlesztés - FOLYAMATFEJLESZTÉS MEGVALÓSÍTÁSA
Kérdés pont Megfigyelés
Aktualizálva lett-e a folyamat-FMEA a projekt lefutása közben történt módosítások esetén, és megvalósításra
4.1
kerültek-e a meghatározott intézkedések?
4.2 Készült-e MB-terv?

4.3 Rendelkezésre állnak-e az adott időpontra a szükséges felszabadítások / alkalmassági igazolások?

4.4 Végrehajtásra került-e egy előgyártás a sorozatgyártás feltételei mellett, a sorozat felszabadítása számára?

4.5 Rendelkezésre állnak-e és teljesek-e a gyártási és ellenőrzési dokumentációk?

4.6 Rendelkezésre állnak-e a szükséges kapacitások?

"B" Sorozatgyártás
BESZÁLLÍTÓK / BEJÖVŐ ANYAGOK
Kérdés pont Megfigyelés
5.1 Csak felszabadított, minőségképes szállítók kerültek alkalmazásra?

5.2 Biztosításra került-e a vásárolt alkatrészek megállapodás szerinti minősége?

Értékelésre került-e minőségteljesítmény, és bevezetésre kerültek-e intézkedések a követelményektől való
5.3
eltérések esetén?
Meghatározásra és megvalósításra kerültek-e a szállítókkal kötött célmegállapodások a termékek és a
5.4
folyamatok folyamatos fejlesztésére?
Rendelkezésre állnak-e a szállított sorozattermékek számára a szükséges felszabadítások, és bevezetésre
5.5
kerültek-e a szükséges helyesbítő intézkedések?
Betartásra kerülnek-e a vevőkkel megállapodott eljárások a rendelkezésre bocsátott termékekre
5.6
vonatkozóan?
5.7 Illeszkednek-e az előanyagok raktárkészletei a gyártási követelményekhez?
A célnak megfelelően kerülnek-e szállításra és raktározásra az előanyagok ill. az üzemen belüli maradék
5.8
mennyiségek?
5.9 Rendelkezik-e szakképzettséggel a személyzet az adott feladatok számára?
 Gyártás - SZEMÉLYZET / SZAKKÉPZETTSÉG
pont pont pont pont pont pont pont pont pont pont
Kérdés P1 P2 P3 P4 P5 P6 P7 P8 P9 P10
Megfigyelés
Átadásra került-e a munkatársak számára a
6.1.1 termék- ill. folyamatminőség felügyeletének
felelőssége és jogosultsága?

Átadásra került-e a munkatársak számára a

6.1.2 gyártóberendezésekre ill. gyártási környezetre
vonatkozó felelősség és jogosultság?

Alkalmasak-e a munkatársak a felmerülő

6.1.3 feladatok ellátására, és megtörténik-e a
szakképzettségük szinten tartása?
Van-e létszámbővítési terv képviseleti
6.1.4
szabályzással?
Hatékonyan alkalmazásra kerülnek-e
6.1.5 eszközök a munkatársak motivációjának
növelésére?
Gyártás - ÜZEMI ESZKÖZÖK / BERENDEZÉSEK
pont pont pont pont pont pont pont pont pont pont
Kérdés P1 P2 P3 P4 P5 P6 P7 P8 P9 P10 Megfigyelés
Teljesítik-e a gyártási berendezések /
6.2.1 szerszámok a termékspecifikus minőségi
követelményeket?
El lehet-e végezni a minőségi követelmények
hatékony ellenőrzését sorozatgyártás közben,
6.2.2
az alkalmazott mérő és ellenőrző
berendezések segítségével?
Méretezve vannak-e a munka- és ellenőrző
6.2.3
-helyek a követelményekhez?
Meg vannak-e teljes mértékben határozva, és
6.2.4 be- vannak-e tartva a gyártó- és vizsgáló-
berendezésekben a legfontosabb adatok?

Rendelkezésre állnak-e a szükséges

6.2.5
segédeszközök a beállítási munkák számára?

Megtörtént-e a gyártásindítások
6.2.6 felszabadítása, és összegyűjtésre kerültek-e a
beállítási adatok valamint az eltérések?
Megvalósításra kerültek-e határidőre a
6.2.7 szükséges helyesbítő intézkedések, és
megtörtént-e a hatékonyság ellenőrzése?
Gyártás - SZÁLLÍTÁS / ANYAGKEZELÉS / RAKTÁROZÁS / CSOMAGOLÁS
pont pont pont pont pont pont pont pont pont pont
Kérdés P1 P2 P3 P4 P5 P6 P7 P8 P9 P10 Megfigyelés
Egyeztetve vannak-e a mennyiségek /
gyártási sorozatnagyságok az igényekkel, és
6.3.1
tovább vannak-e irányítva céltudatosan a
következő munkafolyamat felé?
A célnak megfelelően vannak-e a termékek /
alkatrészek raktározva, és egyeztetve
6.3.2 vannak-e a szállítóeszközök / csomagoló
berendezések a termékek / alkatrészek
speciális tulajdonságaival?
Következetes módon külön vannak-e
választva és meg vannak-e jelölve a
6.3.3 selejt-,utómegmunkálandó és beállítandó
alkatrészek, valamint az üzemen belüli
maradék mennyiségek?
Biztosítva van-e az anyag- és
alkatrészfolyamat a keveredés / cserélődés
6.3.4
ellen, és biztosítva van-e a
visszakövethetőség?
Szakszerűen vannak-e raktározva a
6.3.5 szerszámok, berendezések és
vizsgálóeszközök?
Gyártás - HIBAANALÍZIS / JAVÍTÁSOK / FOLYAMATOS FEJLESZTÉS
pont pont pont pont pont pont pont pont pont pont
Kérdés P1 P2 P3 P4 P5 P6 P7 P8 P9 P10 Megfigyelés
Teljesen és kiértékelhető módon
6.4.1 összegyűjtésre kerültek-e a minőségi- és
folyamat-adatok?

Statisztikailag kiértékelésre kerültek-e a

6.4.2 minőségi- és folyamat-adatok, és levezetésre
kerültek-e ezekből a helyesbítő programok?

Analizálva lettek-e az okok a termék- és

folyamat-követelmények eltéréseinél, és
6.4.3
ellenőrizve lett-e a módosító intézkedések
hatékonysága?
Auditálásra kerültek-e rendszeresen a
6.4.4
folyamatok és a termékek?
Folyamatos javulás alatt van-e a termék és a
6.4.5
folyamat?
Rendelkezése állnak-e a céladatok a termék
6.4.6 és a folyamat számára, és felügyelve van-e
azok betartása?
Gyártás - VEVŐELLÁTÁS / VEVŐI MEGELÉGEDETTSÉG / SZERVIZ
Kérdés pont Megfigyelés
7.1 Teljesítve van-e a vevők követelményeinek megfelelő kiszállítás?

7.2 Biztosítva van-e a vevői ellátás?

7.3 Reagálás történik-e rövid időn belül a reklamációkra, és biztosítva lett-e az alkatrészellátás?
Végrehajtásra kerülnek-e hibaanalízisek a minőségi követelményektől való eltérések esetén, és bevezetésre
7.4
kerültek-e helyesbítő intézkedések?
7.5 Szakképzéssel rendelkeznek-e a mindenkori feladatokhoz alkalmazott személyek?
 logo
Process audit evaluation Report nr.
Product Development Process / Serial Production Audit date
"A" Product development process
goal

minimum requirement

degree of
Evaluated elements conformity 60 70 82 92 100
[%]

Product development (design) EDE n/a

Process development EPE n/a

"B" Serial production

degree of
Evaluated elements / processes conformity 60 70 82 92 100
[%]

Suppliers / input materials EZ 100

Customer service / customer satisfaction EK 100

ghjghjg E1 89

hjkghj E2 90

E3 90

E4 90

E5 90

E6 90

E7 90

E8 90

E9 90

E10 89

Evaluation of the sub-elements with quality system reference (Mean Process step 1-n)
degree of
Evaluated elements conformity 60 70 82 92 100
[%]

personnel / qualification EU1 78

production material / equipment EU2 100

transport / parts handling / storage EU3 100

failure analysis / correction / CIP EU4 100

FO-QA-034_v1 Issued: 04/NOV/2010 6/7. section Prepared by: Imre Malkovics

 Nr. Question Observation Root cause analysis Corrective action Responsible Due date
Are the employees given responsibility and
6.1.2 authority for production equipment and sadfdsds
environment?
Are instruments to increase employee
6.1.5 d
motivation effectively implemented?
Are quality and process data recorded
6.4.1 sdfdsfdsfdsfdsfds
complete and ready to be evaluated?

Are the causes of product and process

6.4.3 nonconformities analyzed and the corrective
actions checked for their effectiveness?

Are processes and products regularly

6.4.4
audited?

FO-QA-034_v1 Issued: 04/NOV/2010 7/7. section Prepared by: Imre Malkovics

FO-QA-034_v1 Issued: 04/NOV/2010 7/7. section Prepared by: Imre Malkovics