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VETEC Ventiltechnik GmbH Siemensstrae 12 D-67346 Speyer Telefon: 06232 6412-0 Fax: 06232 42479 Internet: www.vetec.de VA002.004 Erstellt: B.Beier(QMB) Datum: 11.11.2009 Revision: 0 Genehmigt: N.Hock(GL) Datum: 11.11.2009
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TABLE OF CONTENTS STATEMENT ON THE QUALITY MANUAL AND QM SYSTEM CERTIFICATE ISO 9001:2008 NOTES CONCERNING IMPLEMENTATION OF THE QUALITY MANUAL
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1 Table of contents
General
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01
QM system
02
Employee qualification and human resources Measurement, analysis, and improvement of the QM system Customer support and communication
03
04
05
06
Processes
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08
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THE COMPANY AND ITS PRODUCTS OBJECTIVES AND GUIDELINES DECLARATION BY TOP MANAGEMENT
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01
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01
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4.1 4.2 4.3 4.4 4.5
GUIDELINES AND OBJECTIVES OF MANAGEMENT RESPONSIBILITIES REQUIREMENTS FOR OUR QM SYSTEM QM SYSTEM STRUCTURE
Quality Manual In-house QMS documents Control of QMS documents Hierarchy and structure Control of records
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5.1 5.2 5.3 5.4
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REFERENCED PROCEDURES
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Responsibilities
All employees are responsible for the successful application of the QM system. The following areas of responsibility for managers have been appointed: Top Management supports all courses of action which are required for a successful implementation of the quality policy. It ensures the appropriate resources are available, regularly defines the guidelines and objectives, and makes them known. It is responsible for determining and constantly developing the operational chart and for appointing the decision-makers in the company. Top management appoints employees responsible for key processes. They are to actively involve those employees working in their field and to keep them informed. They determine the appropriate corrective action and control the processes. The quality representative of VETEC Ventiltechnik GmbH monitors the effectiveness of all processes and the QM system in its entirety and reports to top management. He issues and manages the system documentation.
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QM system structure
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Quality Manual
VA Procedure Instruction
BN Works specification
A Procedure specification
Refer to ...
Influence
Work equipment and resources. Attachments FB Forms Listings and Codebook's Handbooks and Operating Instructions PP Inspection plan
Specifications
Customer standards
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Management processes
Quality policy, quality planning, resource management Management evaluation
Supporting processes
Work equipment, HR management, information management, work environment, training, accounting, maintenance
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Q u a lity A s s u ra n c e (Q W ) (Q W L )
D is p a tc h
S a le s /M a rk e tin g (V ) (V L )
S ta n d a rd iz a rtio n
P ro d u c tio n p la n n in g (A V ) (A V L )
A p p o in tm e n t p la n n in g (T P )
H u m a n R e s o u rc e s (P W ) (P W L )
(..) = R e s p o n s ib le fo r th e p ro c e s s
F in a n c e a n d A c c o u n tin g (F W ) (F W L )
In c o m in g G o o d s (W E )
P u rc h a s in g (E K ) (E K L )
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Determine corporate guidelines Plan corporate development and release business plans Define the process responsibilities Guarantee the general conditions for structural and personnel matters for the effective and successful implementation of the QM system Regular assessment of effectiveness and suitability of the QM system Responsible for entire financial matters Draw up a business plan and plan budgets
Mr. Grol, substitute Mr. Valcu
Sales/marketing /dispatch
21 employees
Pinpoint and open up new market and product potential Secure productive relationship with customers Record market requirements Draft and implement marketing strategies Support and consult customers Draw up and check quotations Plan, record, and execute customer orders Take on and follow up customer complaints
Mr. Konzack, substitute Mr. Dausmann
Determine and execute new developments in coordination with Sales department Responsible for engineering matters of all products and projects Develop, verify, and validate products Supervise series production
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Manufacture, assemble, and check products to meet requirements and deadlines Plan and monitor production and assembly Optimize production cost, ability to deliver on schedule, process capabilities, and stock levels Pick and pack order-related parts for assembly and dispatch them Plan and validate processes for new, revised products or for new procedures Plan, purchase, and maintain work equipment and facilities Manage stocks and inventories Pack and dispatch products Plan and monitor assembly at external location
Mr. Weik, substitute Mr. Hrtel
Purchasing
2 employees
Select and assess suppliers for purchased parts and services Monitor delivery schedules Manage incoming goods Purchase specially required parts
Measure and assess effectiveness and efficiency of quality management system Control interdepartmental projects to improve quality Issue quality management system documentation Apply quality methods Contract reviews (supporting function) and plans QM training Record and analyze process capabilities Measuring equipment Monitor inspection, measuring, and test equipment as well as assess their capabilities Support final inspections by customers Obstruct the use of non-conforming products or materials Initiate and monitor corrective action Check purchased parts Check, draw up, and manage quality documentation Revision: 1/2011 Page 8 of 9
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IT
Provide support in IT matters Data back-up Data protection Maintain of document management system
Plan and support human resources development regarding quality and quantity File personnel-related qualification certificates, etc. Manage training courses Responsible for accounting and costing Determine corporate results and analyze any deviations
6 Referenced procedures
VA002.001 Quality manual VA002.002 Quality-relevant documents VA005.001 Drawing administration VA005.003 Administration of internal instructions VA005.004 Data processing, data back-up and data protection VA016.001 Quality records VA017.001 Internal audit
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3.1 3.2 3.3 3.4 3.5
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2 Areas of responsibility
For the management process of Employee qualification and human resources , thethe following responsibilities have been defined: Top management supports and promotes the provision of resources as per their guidelines and objectives. They plan the corporate personnel development. The Human Resources department is responsible for selecting personnel according to the job specifications laid down by managers and top management as well as for organizing all training actions. Each manager is responsible for maintaining the required qualifications and competence of the employees. The manager must ensure that the required resources and work environment exist and are suitable for achieving the managements objectives. They promote the awareness of the employess for there influence for customer satifaction and continuos process improvements. This includes actions involving health and safety as well as environmental protection. The QM representative verifies the effectiveness of training and the provision of resources during the management review.
3 Human resources
3.1 Employee qualifications
The job specifications and qualifications necessary for a position include: Knowledge of the QM processes affecting them Competence in their field Product-specific knowledge Specialized knowledge and familiarization with activities. Quality awareness
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The qualifications necessary for an area of activities is determined by the head of the department concerned together with Human Resources in job descriptions or in the task matrix (VA001.01). The Human Resources department verifies the necessary qualification certificates. Recruitment
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VA018.001 determines how the training actions are to be planned, executed, and documented. In-house training is performed by managers themselves or delegated employees. Training on the QM system is usually performed by the employees responsible for the respective process. External training actions are proposed to Human Resources department by departmental managers. The Human Resources department organizes external training.
4 Supporting resources
In addition to personnel qualifications, the infrastructure and work environment are regularly reassessed and defined. New investments are planned for the long term in accordance with the corporate policy. The conditions of environment protection are fulfilled. There are no critical applications at VETEC. The residues of paint etc. are to be disposed separately. The work environment is to be designed according to the ergonomic requirements and newest findings concerning accident prevention and is to be tested regularly concerning this aspect. Employees are required to draw attention to any irregularities. The production facilities at VETEC are regularly and systematically monitored and serviced. Should any irregularities occur, an accuracy inspection of the equipment concerned is performed.
5 Referenced procedures
VA001.01 Job description VA018.01 Personnel
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3.1 3.2 3.3
GUIDELINES AND OBJECTIVES OF TOP MANAGEMENT AREAS OF RESPONSIBILITY PROCESS PERFORMANC AND SYSTEM EFFECTIVENESS
Process performance System effectiveness Improving efficiency
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4.1 4.2
ANALYSIS OF DATA
Process-related indicators Indicators of customer satisfaction gathered in interviews
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REFERENCED PROCEDURES
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2 Areas of responsibility
The following responsibilities have been defined for the management process Improving efficiency: Top management performs the management review. Together with the employees responsible for the processes, the guidelines and objectives are defined for the continual improvement process and announced by the top management. The QM representative monitors the efficency of the QM system, determines the indicators and analyses them. He plans and implements corrective and preventive actions, performs audits, and takes charge of the continual improvement process. The employees responsible for processes from all departments measure, analyze, and monitor the strategic control variables and indicators. They analyze deviations and improve process performance.
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Customers requirements
Record changes
Define actions
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Customer satisfaction
Process planning
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5.
Referenced procedures
VA014.01 Corrective and preventive actions VA014.001Customer satisfaction VA017.01 Internal audit VA020.001 Statistical methods
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3.1 3.2 3.3
GUIDELINES AND OBJECTIVES OF TOP MANAGEMENT AREAS OF RESPONSIBILITY DETERMINATION OF CUSTOMER REQUIREMENTS
Contact Customer acquisition, customer information, and consultation Continual improvement
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4.1 4.2 4.3
CUSTOMER SUPPORT
Order-related customer requirements After-sales service and repair Customer complaints
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REFERENCED PROCEDURES
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2 Areas of responsibility
The following responsibilities have been defined for the management process Customer acquisition and support: Top management generally decides on all matters concerning finance and the fundamental sales policy. The Sales department is responsible for any direct contact with customers and coordinates all further internal actions, during which, the Sales department is directly supported by all other departments. The Quality Assurance department supports by consulting in all quality-relevant matters. It is responsible for the assessment of claims, customer complaints, and customer satisfaction.
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4 Customer support
4.1 Order-related customer requirements
All the information necessary for product realization, which is requested by the customer or necessary due to the application as well as statutory regulations and other internal requirements, are determined and defined by the Sales department. In the quotation and order phase, the requirements are reviewed concerning their completeness and the ability to fulfill them. Differences between agreements and the order need to be clarified. The delivery and intermediate dates are followed from a central point and adapted as the order progresses. Regular consultation with the departments concerned is made for critical orders.
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5 Documented procedures
VA014.02 Customer satisfaction
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3.1 3.2 3.3 3.4 3.5 3.6 3.7
GUIDELINES AND OBJECTIVES OF TOP MANAGEMENT AREAS OF RESPONSIBILITY DESIGN & DEVELOPMENT
Objective and scope New developments Design verification and release for production Changes Project-related design and development Product sustainement Outsourced Design & Development processes
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4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8
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5.1 5.2 5.3
PURCHASING
Objective and scope Selection of suppliers Requirements for evidence of suitability
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2 Areas of responsibility
The heads of the departments listed are responsible for fulfilling the individual tasks of the management process Planning and executing customer orders. See section 02 5.2. The areas of responsibility and points of contact are related to the departments as determined below: Top management promotes all levels of product realization by providing the appropriate resources and specifying priorities. The Finance department provides a sound financial basis and takes care of bank transactions and invoicing, etc. The Engineering Office reacts to any market requirements by developing products or develops customer-specific solutions. It takes care of orders with special requirements or projects and advises the departments, if necessary. The Sales department is responsible for marketing, contract reviews, monitoring delivery schedules, customer support as well as additional components provided by the customer. The Purchasing department takes care of orders, monitors delivery schedules, and selects suppliers. The Prodution Planning department drafts the production orders and operation sheets, monitors the deadlines as well as the availability of materials and stock-keeping. During the course of production, the inspection stages are integrated and outsourced services are initiated. The Production department ensures that the production runs under controlled conditions. It carries out production tests and takes care of work equipment. The Quality Assurance department is responsible for the inspection and monitoring of processes. It is also in charge of monitoring suppliers, inspection costs, and quality records. The IT department supports the departments in all IT matters and provides a secure information flow. Section_6.DOC Revision: 072008 Page 3 of 13
3.2
New developments
New developments are inspired by the requirements of our customers. The inputs for this purpose are therefore usually ascertained by the Sales department. A product idea is reviewed concerning its feasibility and economic viability. All requirements are summarized in a list of design specifications, which also takes into account the statutory regulations, standards, and safety regulations. Design features essential for a safe and reliable functioning of the product are taken into special consideration. It is essential that the product can be manufactured without any negative effects on quality at reasonable cost. A prototype production with sufficient testing of function and reliability is carried out. Development and test activities are only performed by qualified staff. Appropriate means for development work are provided. On planning the development, organizational and technical points of contact between individual groups are to be determined. Discussion results are documented. Results of developments are recorded in the form of drawings, parts lists, calculations, experimental and test protocols, specifications, and instruction procedures. Finally an assessment by means of a FMEA (failure mode effect analysis) will be performed to evaluate inadequatenesses of the product occuring during start-up. A final assessment follows by means of customer feed-backs.
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3.4
Changes
Changes are carried out in the same manner when drawing up the original documents. More details can be found in section 5 of the Quality Manual.
3.5
3.6
Product sustainement
If it is necessary for the sustainement of the product quality, adequate notes will be allocated to the product and published. This is also applicable for spare parts and modifications. Reasonable improvements of the product will be highlighted and announced to the customer. Mounting and operation instructions as well as transport instructions are provided, in case of potential harmful effects by inappropriate handling.
3.7
Outsourced Design & Development processes Outsourced Design & Development processes are subject to the same quality procedures
as the internal processes.The realization is defined in functional specifications. The proceedings and the results are subject of an assessement by VETEC.
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Type and design approvals are processes which are performed by independent accredited bodies on behalf of VETEC. These process follow and are assessed according to legal regulations and laws.
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The orders are processed. All drawings, commentaries, and protocols are to be collected under this order number and/or filed in a data processing system. Inspection records and quality certificates are created and archived separately. In special cases, order handling is reviewed after the order has been completed.
4.4
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4.5
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4.7
4.8
Outsourced production processes All outside ordered production processes (extended work bench) will follow the same
quality requirements as the in house processes at VETEC.
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If it is required by the process the necessary protocols and certificates will be issued as a document of a proper procedure. A statistical assessment under the same test conditions as at VETEC takes place
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5. Purchasing
5.1 Objective and scope
A careful supplier management is necessary to guarantee that the usual requirements in the pressure equipment engineering sector are met. In the purchasing phase, it is to be guaranteed that the purchased products (raw material, semifinished products, individual parts, components, and assemblies) as well as services meet the given requirements concerning design, quality standards, price, delivery deadlines, and quantity. All parts which are directly or indirectly needed for the production of our products are affected by this rule. At the handling stage, however, a difference is made between standard parts and safety-relevant parts.
5.2
Selection of suppliers
The approved suppliers are reviewed and placed on a list. The suppliers must provide evidence of their quality capacity in the form of a functioning quality assurance system, which corresponds to the sort of products and services supplied. For particularly critical applications, a stricter selection of suppliers is made to meet the requirements. A cooperation on a partnership basis is strived for with suppliers regarded as suitable. The course of this cooperation regarding quality is traced with statistics. Prior to the start of series supplies, the supplier is to provide initial samples for inspection and approval. These initial samples are to be produced under series production conditions. Quality and general agreements are to be concluded with suppliers. For outsourced production processes the qualification for a certain production process takes place in conjunction with the supplier assessment.
5.3
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5.4
Orders
Requirements are usually registered including all required details in the Production Planning System (PPS-system). The entire order processing and tracking deadlines are performed using PPS. Orders are only placed with suppliers included in the list of approved suppliers or in agreement with the head of Quality Assurance department. The stipulated specifications are to be kept by suppliers. Any nonconformity must be provided with evidence of its similar suitability in agreement with VETEC. Suppliers are responsible for providing verification or documentation for their products within the framework of the recognized valid standards in our industry sector. Traceability must be guaranteed, including for orders that do not require quality verifications. Inspections at the suppliers are agreed upon for particularly critical applications. For projects, special requirements are discussed with suppliers.
5.5
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7. Referenced procedures
VA003.01 Contract review VA003.002 Order processing VA003.005 VETEC control valve according to PED 97/23/EC VA004.001 Design and development VA006.01 Supplier qualification VA006.02 Purchasing VA007.01 Goods provided by the customer VA008.01 Identification and traceability of parts VA009.01 Production planning VA009.002 Maintenance VA010.01 Incoming goods inspection VA010.02 Production inspections VA010.03 Control valve inspection VA011.01 Monitoring of test equipment VA013.01 Nonconforming products VA015.01 Packaging and dispatch VA015.02 Storage and in-house transportation
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1.
1.1. 1.2. 1.3. 1.4. 1.5. 1.6. 1.7.
PROCESSES
Process landscape and procedures Symbols Control of documents Control of quality records Internal audit Control of nonconforming products Corrective and preventive actions
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1. Processes
1.1. Process landscape and procedures
Documented procedure
VA002.02 VA016.01 VA017.01 VA013.01 VA014.01 VA014.01
Process (ISO 9001:2008 Section ... ) Control of documents (4.2.3) Control of quality records (4.2.4) Internal audit (8.2.2) Control of nonconforming products (8.3) Corrective action (8.5.2) Preventive action (8.5.3)
1.2.
Symbols
Process unit
Input or output
Information carrier
Data processing
Decision
Link
Display
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1.3.
Control of documents
Application phase
Comments Additionally valid procedures: VA002.01 VA002.02 Authors are supported by head of Quality Assurance. Documents can also be customer specifications or standard.
Author
No
Revision 0 Revision?
Yes
User Distributor
Quality Assurance
Yes
Process training
Information flow Original to the archives Saved data in data archives Distribution list as small as possible Information for all employees via Intranet Training if in need of explanation
No
Valid?
Yes
Data Processing
Finish
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1.4.
Objective is the verification of conformity with customer requirements and functioning of the QM system.
Process 4.2.4 ISO 9001:2000 Registration Realization Verification Comments Additionally valid procedures: VA005.01 VA005.02 VA016.01
Start
Finish
Standard handling: As per Quality Manual Max. 3.1B EN 10204 Special requirements: Inspection plans Drawings Additional information
Production
Yes
No
Assurance
Quality