控制类别 CONTROL TYPE 控制号 CONTROL NO.
ZEL/QS-2002.12
扎努西电气机械天津压缩机有限公司 Zanussi Elettromeccanica Tianjin Compressor Co., Ltd.
质 量 手 册
QUALITY MANUAL 第0版 Edition 0, 2002
Publication Dec.2002
2002 年 12 月发布
总经理 塔米亚索先生 批准发布: Approved by General Manager
Mr. Fernando Tamiazzo
Implementation Dec .2002
2002 年 12 月实施
编制:
Issued:
Z E L / QS 2002.12 Edition 0 Revision No. 0 ( 2002/12/11 )
Quality Manual
LIST No 1. Of Total 1 pages
CATALOGUE
1.
Brief Introduction Company
1.1 Quality Policy 1.2 Quality Target 2. The scope of quality system 3. Company organization chart and flow chart 4. Quality management system 5. Management responsibility 6. Resource management 7. Product realization 8. Measurement analysis and improvement 9. Appendix
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1.General Introduction of the company Zanussi Elettromeccanica Tianjin Compressor Co. Ltd. is the first Sino –Italy joint venture company in Chinese refrigerator industry. The company was founded in 1993, the registered found is 28 million USD, the main product is R12 all closed one million sets. At year 1998, the company improved its manufacturing capacity, the annual production capacity reach 3 million sets, and it also has more than one series of products. We sell the products to all over the world, and become one of the and compressor, and the annual capacity is
biggest refrigerator compressors manufacturers. We have R134a
R600,the non-ozone-destroy products and other environmental protecting compressors, which have the new, non-green housing refrigerator. Through more than 10 years’ efforts, we now have a lot of experienced managers, technician, and operators. They help our customers to get biggest boon, by using the latest techniques, manufacturing devices and testing equipment , and chasing for high quality and low cost. Our company passed ISO9001quality system certification, China Germany VDE、Italian IMQ、American UL and Environment system certification. Our company put the customer satisfaction as our goal. CCC、
at year 2000-passed ISO14001
Address: Phone:
No.25 JiuJing Road ,Hedong District, Tianjin, China 0086-022-24308771
Postal code : 300171 ZE L / QS2005 .6 QUALITY MANAUAL CHAPTER 1
EDITION 1 NO.2 OF TOTAL 4PAGES REVISION NO .0(2002/12/11) Table 1:Q u a l i t y M a n u a l M o d i f i c a t i o n T a b l e No.of modification Modifications Contents S7p1 S7p2 S5p3 S5p4 S8p1 S8p2 S8p3 S8p4 A Note: Modifications Symbol: Example: * list QS05.1 Controlling program.When the modification exceeds 10 times, we should have new edition . *The original quality manual and program should be kept by engineer department forever. ZEL / QS2002 .12 QUALITY MANAUAL CHAPTER 1 S=Chapter S3P4
Wang Yugang
Approval
Date
2004/4/11 2004/4/11 2004/7/21 2004/7/21 2005/6/14 2005/6/14 2005/6/14 2005/6/14 2004/7/21 A=Annex
Wang Yugang
Wang Yugang
Wang Yugang
Wang Yugang
Wang Yugang
Wang Yugang
Wang Yugang
Wang Yugang
P=页 Page
Means the 4th page of chapter
The modification of quality manual are modified according to the
EDITION 0 NO.3 OF TOTAL 4PAGES REVISION NO .0(2002/12/11) DISTRIBUTION SCOPE OF QUALITY MANUAL NO. NO. ZM0001 ZM0002 ZM0003 ZM0004 ZM0005 G.M. V.G.M. P&PE
Q.C. EXECUTIVE MANAGER CHIFE OF CUSTORMER SERVICE
HOLDER SYSTER MAINTENANCE CHIFE OF PROCESS SAFETY DEP.LEADER PACKAND WORKSHOP CHIFE OF EQUIPMENT MAINATENANCE
HOLDER
ZM0026 ZM0028 ZM0029 ZM0030 ZM0031
ZM0033 ZM0034 ZM0035
CHIFE OF AUXILIAR Y CHIFE OF ENERGY WELDING WORKSHOP LEADER
ZM0006 ZM0007
CHIFE OF PRODUCTION PURCHASING EXECUTIVE MANAGER
ZM0009
HUMAN RESOURCES EXECUTIVE MANAGER
ZM0036
MECHANICAL WORKSHOP LEADER
ZM0010
F&C EXECUTIVE MANAGER
ZM0037
STATOR WORKSHOPLEADER
ZM0012 ZM0013
CHIFE OF Q.E. DOCUMENT MANAGING ENGINEER
ZM0038
ASSE MBLY WORKSHOP LEADER
ZM0040 ZM0041 ZM0045 ZM0046 ZM0049 ZM0051
LOGISTIC EXECUTIV E MANAGE CHIFE OF PURCHASI N G CHIFE OF CONTROLL E R CHIFE OF FINANCE LABOUR DEP. TRADE UNION
ZM0016
PRODUCTION EXECUTIVE MANAGER
ZM0019 ZM0020 ZM0022 ZM0023 ZM0024
INCOMING INSPECTION CHIFE OF Q.C. CHIFE OF CHEMICAL PRODUCT LABORATOR Y CHIFE OF PRODUCTION
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Appointment
In order to carry out ISO9001-2000 requirement of Quality management system ,strengthen the management of quality system ,the General Manager appoints the Executive Manager of Quality control department company。 Representative’s responsibility: 1. Be sure to establish and implement quality management system according to ISO9001:2000 standard; 2.Report to the General Manager about operating situation quality system 3.When (include requirement of the improvement); General manager is on business travelling management Mr. Wang Yugang as Management Representative of the
representative is responsible for dealing with all the quality related outside company affairs about quality management system on behalf of the company.
MANAGER:
DATE:
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Quality Policy In order to reach and maintain a stable leading position in the world market of Hermetic compressors for refrigeration, We have to be: Capable to design the best suited to the market Able to produce the best at the lowest cost Able to establish long term relationships with our customers Therefore the main principles are:] *Customer orientation *Product performance *Technology orientation *Total Quality management *Continuous quality improvement *Employee participation *Zero defect approach *ISO9000 Standard
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2. Quality Systems Scope and Cancel Explanation 2.1 Company establish and executes Quality Management Systems according to ISO 9001:2000 standard and the actual conditions of our company. We have reached the following targets: 1) Demonstrate its ability to consistently provide product that meets customer and applicable requirements. 2) Aims at enhoncing customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements. 2.2 the scope of company Quality System serves for the design and production of compressor and it includes all the requirements of ISO9001:2000 Standard. 2.3 any exclusion of this standard is not made and company complies with the standard’s requirements completely.
ZEL GENERAL ORGANIZATION CHART
G.M & V.G.M.
MANAGEMENT REPRESENTATIVE
PURCHASING
LOGISTIC.DEP
PRODUCTION
QUALITY CONTROL
FINANCE
P&P
HUMAN RE.
TRADE UNION
FINI.WAREOUS E
MAIN.WAREH.
AUX..WAREH. L
MAINTENANC
WORKSHOP
INTERNAL AFF.
QUALITY MANAGER
QUALITY CON.
INCOMING
QUALITY ENGI.
PRODUCT LAB.
CHEMICAL ROOM
Human resource
PRODUCT
PROCESS
SERVICE DEP.
SYS.MAINTAIN
PERFORMANCE
MEASURE ROOM
LINE INSPE.
QUALITY IMP.
ANALYSIS
MEASURE
LIFE TEST
SECURITY
ENERGY
E
QUALITY SYSTEM PROCESS
Customer
Continuous improvement.
Communicat ion
Review for customer requirement
Planning arplement
Design supplier
Supplier Control
Internal communication .c ommunicationio
Sample
Purchasing
Management Responsibiltyity
n
Monitoring & .Measure
Monitoring & Measuring delivery
process
Process monitoring & measurement
Assemble wsp.
Rework
Testing
Delivery Measure
Product Realizat.
Product
Service
Customer Satisfaction
Management Review 管理评审
Analysis of data correct &preventive action
Reject
Non-quality control
Resource supply
Document Record
Machine wsp.
Stator wsp.
Box wsp,
ZEL / QS2002 .12 EDITION 0 REVISION NO .0(2002/12/11) 4.Quality Management System 4.1 General Requirements:
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To ensure product quality and meet customers regulation requirements, company establishes, documents, implements and maintains a Quality
Management System and comtinually improve it in accordance with the requirements of ISO9001: 2000 Quality Management System. 4.1.1 Identify the processes and determine the sequence and interaction relationship . a) Provide eligible compressor to customers, the process include market research,customer’s requirement identification, product development and design, purchasing, manufacture and subsequent service (refer to process flow chart) b) Determine criteria and documents, monitor and measure the process in accordance with the requirements related to product. c) Allocate resources according to the process of product realization.(refer to the chapter 6) d) Establish the process of monitor and measurement. (including customer’s satisfaction, internal auditing, process, monitor and measure of product) (refer to the chapter 8) e) Establish necessary measurement to achieve continual improvement of these processes of Quality Management Systems through all the actions. f) Outsourcing processes of product realization include: mould, assistant tools, inspection gauge, components gauge, the transport process of delivering products to customers, monitoring and validating the outsourcing processes. 4.2 Documentation requirements 4.2.1 documents of the quality management system should include a)quality policy and quality objectives b)A quality manual c)Procedure document of quality management system
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d)Executive document of quality management system (quality plan, task direction book, criterion, system, notice, report etc. e) Records required by quality management system (including records needed by other actions besides 21 records) 4.2.2 Quality manual a)Quality manual established by company is a directing document for ensuring system running effectively . It is a rule that quality management should act for the internal work and should offer confirming document for providing quality guarantees to customer.
b)Quality manual explains the scope and cancellation of quality system. (refer to the second charter) c)Quality manual formulate and illuminates the relationship among primary function department, their responsibility, authority, and the process . d)Quality manual is approved and issued by the general manager and the related representative .The quality manual can not be duplicated before supervisor representatives approvement. e)Quality manual use the terms and definitions of ISO 9001:2000. f)Quality manual is a part of quality system documents and its control methods (are as follow ) 4.2.3 control of documents company establishes and executes 《document control process》(include external documents) in order to control the documents needed by the implementing of quality system. Its main points are as follows: a)The Quality system document should be approved by the authorizer prior to issue, so that it can be suitable. b)To review and update as necessary when document is not appropriate during the course of the system running. c)To ensure that changes and the current revision status of documents are identified through edition and seal etc. so that it can be told from each
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d)To regulate distribution scope and ensure those relevant versions of applicable documents are available for all the required position. To workout document listing and ensure that documents remain legible and are ready for identification. e)To workout external document listing and to be sure that all the new edition are also distributed. All the useless documents should take back
and be destroyed by the taker. To prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose. 4.2.4 control of records records shall be controlled in order to provide evidences of effective
operation of the quality management system. Company establishes 《records control process》. Records control scope includes all the necessary records of quality management system, correlated departments are responsible for saving their used records. Records saving should accordance with the following requirements: 1) All records should be integrity, exact and clear. 2) Records are saved by number ,so that it is easily for identifying and search. 3) Environmental temperature should be appropriate and damage and losing should be prevented. 4) Documents which exceeding the save time should be affirmed before destroyed. 4.3 reference document 1)QS02.1《Quality System Management Procedure》 2)QS05.1《Document Control Procedure》 3)QS05.1.02《Quality System Document List》 4)QS05.1.04《Executive Document Using Department List》 5)QS16.1《Records Control Process》 be in
ZEL / QS2002 .12 EDITION 0 REVISION NO .1(2004/7/21) 5.Management Responsibility 5.1 Mmanagement promises
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To ensure provide product and service complied with requirement, the general manager makes the following commitments: a)Communicate with the organization about the importance of meeting customer as well as statutory and regulatory requirements and enhance the quality consciousness and law consciousness by propaganda and meeting. b)Establish the quality policy and quality objective. c)Conduct management evaluation regularly to appraise the validity of quality management system. d)Ensure the availability of resources for all the process of quality system. 5.2 Customer focus 1) To Ensure that all personnel meets with the aim of satisfying customer through consciousness training offered by the general manager. 2) To Ensure that customer requirements are recognized through the establishment and execution of the quality management system by the general manager. 5.3 Quality policy the general manager is responsible for the establishment of quality policy and makes sure the policy a)fit the complies with the following requirements:
purpose of the our company
b)Includes a commitment to comply with requirements and continually improves the effectiveness of the quality management system. c)Provides a decomposable framework for establishing and reviewing quality objectives. d)Be communicated and understood within the personnel of the company. e)The suitability of quality policy is reviewed by management department. ZEL / QS2002 .12
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EDITION 0 REVISION NO .0(2002/12/11) 5.4 planning 5.4.1 Quality objectives
NO.2 OF TOTAL 4 PAGE
The quality objectives are established according to the quality policy and consistent with quality policy. Quality objectives are established at relevant function department and workshops. Quality objectives shall be measurable and include the content that can satisfy the product requirements. 5.4.2 Quality management system planning 1) quality management system planning’s tenet is to satisfy the target quality and the requirements of quality system are its achieve the requirements given in 4.1, as well as the rule. To quality
objectives. 2) When the quality target changes, or the quality system changes, we should plan it before, so we can keep its integrity . 5.5 Responsibility, authority and communication 5.5.1Responsibility and authority 1)The general manager sets up corresponding organization system according to management requirements (refer to 《Company Organization Chart》 2)to regulate 《Management Responsibility》,《Position Responsibility》and ensure responsibility ,authority and interrelationship. 5.5.2 Management representative the general manager appoint quality dept executive. As the representative of company and managers responsibility and authority are as follows:
a) To ensure that the processes needed for the quality management system are established, implemented and maintained. b) To report to the general manager of the performance of the quality management system and those points needed to be improved.
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c)To make sure that the meeting, promotion or other methods work well so that all the employees know very well: offering qualified products to satisfy our customers requirements is very important d)Responsible for dealing with matters related to the quality management systems. e)To sure the prodution with safty certification confirm the standard f)To sure the managenment and using for identification g)To sure the no-confirming and changed production without safty
certification 5.5.3 Internal communication
1)The General Manager should make sure there’s a good way for communication in the company. 2)Pass by each management layer and function Dept: Different management layer should communicate with functional department through: a.meeting 、production department leader meeting etc. b.documents delivered to different departments (production report 、 quality daily report、monthly report、technical file etc); c.having vertical and horizontal contraction; d.by using telephone、network、training、promotion etc. communication.
5.6 Management evaluation 5.6.1 General regulation 1) The company should have a management evaluation each year ,to examine and comment company quality management system. This activity should be in charged by General Manager, and the quality system is the content should include whether adequate and effective the
suitable
implementation of the quality policy and quality target the recissity and opportunity of the quality management system. ZEL / QS2002 .12
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EDITION 0 REVISION NO .1(2004/7/21) 2) Keep the records of the management review 5.6.2 review inputting a) internal and external review b) customer feedback
NO.4 OF TOTAL 4 PAGES
c) processing outstanding achievement and product conformity d) status of correct and prevent measures e) follow the past management review f) possible alteration that may influence quality system g) the suggestion of improvement 5.62 review outputting a) the improvement of efficiency on quality management system and processing; b) the improvement on product related to customer requirements; c) the resource requirements; The supervisor representative should finish and delivery to all the related departments after GM’s approval. report, 5.6 Reference file 1) QS 01.1 《management responsibility procedure》 2) QS01.0.11-.60 3) QS01.2 《each Dept. Post responsibility》 the management review
《management review procedure》
4) 《quality policy》 5) 《supervisor representative appoint letter 》 6)《quality target、index management project list》
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6. Resource management 6.1 Provision of resource Resource is a necessary requirement that a company confirm, set up and implement the quality management system efficiently. the company confirm the required resource in quality management system in achieving the quality target. According to the producing process. includes: a. human resource 6.2 Human resource Human resource is the manager, technician and operator that an organization needed in efficiently running the them are related with quality. 1) Company establish and execute《human resource management process 》, determine the necessary competence for the persons who are responsible for quality, set the training and implement plan. 2) To evaluate the ability of those persons in period. 3) Have some action to those unqualified persons. 4) evaluate effectiveness of those actions. 5) improve stuff ability by training and other actions, so that they can be qualified. 6) Maintain the records of education of each employee. 6.3 Infrastructure Infrastructure is the guarantee of the company achieve product conformity, According to product implementing implement and provide process the company can quality system, all of b. Infrastructure c. work environment These resources
infrastructure and sustainable service device, at maintenance for infrastructure.
the same time the company should offer The company establish and execute
《Infrastructure and working environment management process》which requires: ZEL / QS2002 .12 EDITION 0 REVISION NO .0(2002/12/11) QUALITY MANAUAL CHAPTER 6 NO.2 OF TOTAL 2 PAGES
a) Determining the infrastructure needed to achieve conformity; b) Regulate that the equipment maintain Dept. should be responsible for equipment maintenance; c)Energy Dept. should be Responsible for production equipment maintain; Production Dep. Responsible for company interior transport tool’s d)Production Dept. should be internal use responsible for vehicle maintenance; e)EDP should be responsible for computer system maintenance;
6.4
Working environment necessary working environment is the support of to implementing product conformity’s , the company should identity the working
environment needed in achieving product conformity, human resource Dep is responsible for every part of working environment management.
6.5
Reference file 1) QS 01.1.11-. 60《each Dept. Post function》 2) QS 09.3procedure of infrastructure and work environment management》 3) QS 18.1《human resource management process》
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7. Product implementation By planning the whole process that form and realize the compressor, the company expected guide each department to work consistently to achieve the
purpose. The product department of technical engineering system jointly responsible for new product
and group headquarter should be development and planning.
7.1 Planning of product implementation a)According to the requirements of market or customer , determine the specific requirement for product, quantitize quality target. b)Establish the specific management document ,technical process document ,and provide resources needed in each stage. c)Specify the proper verification, confirmation, supervision, inspection and testing activity and product acceptance criteria in
accordance with the characteristics of product. d) Draft the quality record to 7.2 Customer-related processes Company establish and execute 《 product requirements review proof the product conformance;
procedure 》 to ensure fully understand and identify the customer requirements, offering qualified product and service.
7.2.1 Determination of requirements related to the product Product requirements are as follows: a) Requirement specified by the customer( required in the order/ contract )including the requirements for delivery and post-delivery activities. b)Requirements that are not stated by the customer but are necessary for specified or intended use, which are already known.
c)resolution or requirement related to the product. d)Any additional requirements determined by the organization. 7.2.2Review related to the product ZEL / QS2002 .12 EDITION 0 REVISION NO .1(2004/4/11) QUALITY MANAUAL CHAPTER 7
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1)Review that customer required should be conducted prior to the company’s commitment to provide the product( acceptance of contracts or order acceptance of the changes to contracts or orders). 2) Marketing department should be responsible for organize contract review work, technical engineering system, quality system, production system, procurement system, management system will all participate the contract
review. Each contract should be reviewed according to the following points: a) Product requirements are b) Contract or order defined;
requirements which are different from those
reviously expressed, are resolved; c) Company have the ability to meet the defined requirements; d) The record of result of review and actions caused by review aintained. If the customer's requirements changed, the market department should review and confirm the changed requirements and inform the relevant department about these. 7.2.3 Customer communication 1) In order to identify and satisfy the customer’s requirements, communicate with customer timely, Procedure 》 2)Marketing System, after-sales service department, application department are responsible for customer communication concerned with the following aspects: a) Product requirements of compressor and related information; b)Enquiries, contract or order handling, including changes; c) Customer’s feedback for required product including customer complaints; 7.3 Design and development 1)design can be reach the customer’s requirements and meet the stipulation. ZEL / QS2002 .12 QUALITY MANAUAL CHAPTER 7 EDITION 0 NO.3 OF TOTAL 6 PAGES REVISION NO .0(2002/12/11) 2) Product department of Technical engineering system and group headquarthe company established the 《 Service should be
ter should be jointly responsible for new product design and development. 7.3.1 Designs and development planning The design and development of the new product should include the following aspects: a) Product design and develop stage; b)Review, verification and confirmation activities c) Responsibility and authorities and technical interface. 7.3.2 Design and development input The design input are the documents formed after fully understand and proper identification, which including: a)The functional and performance requirements . b)The related legal regulations and requirements; c) Information derived from previous design ; d)Other requirements . These inputs should be reviewed for adequacy and suitability, input requirements should be complete, clear and not self-contradict. 7.3.3 Design and development outputs The design results shall be formed into documents, and provide to purchasing, production, inspection and testing departments after review, and transform into the product needed. Design outputs should: a) Meet the input requirements for b)Provide appropriate information design ; for purchasing , production ,
installation, usage and maintenance service; c) Stipulate or reference acceptance criteria d) Specify the important design characteristics that are essential for its safety and main function; 7.3.4 Designs and developments review Design review shall be performed in schedule in each design stage, in order to: ZEL / QS2002 .12 EDITION 0 REVISION NO .0(2002/12/11) QUALITY MANAUAL CHAPTER 7 NO.4 OF TOTAL 6 PAGES
a)To evaluate the ability of the result s of design and Development to
meet requirement; b)To identify any actions; 7.3.5 Design and development verification To make sure design output satisfy design input requirements, design verification shall be conducted, the verification method could be: In each stage of design and develop, design evaluation should be existing technical problems and propose necessary
performed or verification testing against samples should be conducted. 7.3.6 Design and development confirmation The design confirmation should be completed, when the product is delivering or prior to the delivery. The design confirmation should base on the testing of final product in the stipulated working conditions, to ensure that the product meet the customer and norm requirements. 7.3.7 The change of design and development The design changes should form into the document, when appropriate, verify and confirm to change the contents, and change should be implement
after approval, to make sure all the changes and modification are under control and records . 7.4 Purchasing
1)Company the establish and execute《 purchasing control procedure》 《 supplier evaluation and control procedure 》《 incoming inspection procedure》to ensure that the product meet the stipulated requirements. Purchasing department is responsible for materials purchase, and are responsible for supervising and controlling the supplier together with the material inspection department. 2)According to the supplier’s ability to provide products, evaluate and select the supplier, re-check periodically, and record the results. ZEL / QS2002 .12 QUALITY MANAUAL CHAPTER 7
EDITION 0 NO.5 OF TOTAL 6 PAGES REVISION NO .0(2002/12/11) 3) According to the standard and norm requirements, the product purchased should be inspected and recorded.
Arrange the inspection in supplier, or when customers ask for doing so, the company should arrange for it, and work out the provision for product passing method. 7.5 Production and service providing To ensure that product ,the company provided can satisfy the requirements of the provision and customer, the company should implement control the whole production process. Requirements:
a)Having the product drawing components list, material norm, draw up working document of the production process, determine the proper equipment, stipulate supervising and measuring method, determine measurement equipment, implement supervision, measure delivery and post-delivery activities. b) Company stipulate the pin in shell line and welding of foot strap are special process ,so the company should be sure that the equipment and employees are qualified. c) In the whole process of the production and service, we should take proper method to mark products and situations .when there’s tracing requirements, control and record the product's unique identification. d)For the property( including the drawing, data...etc.) provided customer, company should stipulate requirements of confirmation, storage, protect and maintenance to guarantee the customer properties are used properly. 4)According to the requirements of customers, the company should have regulations in conformation, storage ,protection and maintenance, aim at the product conformance 7.6 Control of monitoring and measuring devices Company the establish and execute 《 Monitoring and measuring devices 》 by
ZEL / QS2002 .12 QUALITY MANAUAL CHAPTER 7 EDITION 0 NO.6 OF TOTAL 6 PAGES REVISION NO .0(2002/12/11) control procedure, and identify the monitoring and measuring devices necessary for ensuring the product to meet provision requirements, so that we can guarantee that the measuring ability is in accordance with
measuring requirements. We should reevaluate monitoring and measuring devices, from purchase, verification, using, maintenance, adjustment to checking periodically according to 《 Monitoring and measuring devices 》 , and when find
deviation, we should reevaluate the validity of the previous results, and take the corrective actions. 7.7 Reference document: 1)QS03.1 《 product requirements review 》 2)QS01.1《 management responsibility 》 3)QS04.1 《 design control 》 4)QS06.1 《 purchasing control 》
5)QS10.1《 incoming inspection 》 6)QS08.1 《 identification and tractability 》 7)QS12.1 《 inspection and test status 》 8) QS09.4 《 production plan control 》
9) QS09.1 《 process control procedure 》 10)QS09.2《 production material to control 》
11)QS11.1《 monitoring and measure to equip to control the 》 12)QS15.1《 product preventive control 》 13)QS06.2 《 provides the square evaluation with control procedure 》 14)QS09.3《 foundation the facilities manage the procedure environment》 15) QS19.1 《 service procedure 》 with work
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8 Measurement analysis and improvement 8.1 General Regulations
To insure the accordance of the products and quality management system and improve the validity of the Quality management system, the
organization should make plan to monitor ,measure and analyze the quality management system and persist in improving the system. 8.2 Monitoring and measurement 1) The organization shall monitor the information from customers and convey the customers’ request by setting and carrying out<service
procedure>,which can be improved by using the information we have. Market dept and after-service dept shall be responsible for monitoring and measuring whether consumers satisfy or not. 2) The organization shall set <internal auditing procedure>to ensure the arrangement and Quality management system requirement in accordance with ISO9001:2000 and make plan for internal auditing determine the
scope,frequency and methods of auditing make clear the responsibilities of the auditors insure the objectivity and justness of internal auditing track, prove and modify the <internal auditing procedure> and keep the auditing records the system maintenance group shall be in charge of the internal auditing 8.2.3 process monitoring and measurement The organization shall formulate the procedure to monitor and measure the process of quality management system and confirm its methods and abilities to continually achieve the target in each process. If can not be achieved, proper measures shall be taken to insure the products quality. The process of quality management system are internel audit,management review, resource management, design, purchasing, production process, etc. a) The top manager should organize the review to monitor the quality management system effectiveness suitable ZEL /QS2002 .12 EDITION 0 REVISION NO .1(2005/6/14) QUALITY MANAUAL CHAPTER 8 NO.2 OF TOTAL 4 PAGES
b) system effectiveness suitable
c) Accorting to QS04.1 procedure requirement , the design department should monitor the design feasibility analysis process by cheking point 0(CP0), the design process by cheking point 1(CP1), the engineering process by cheking point 2(CP2), producting process by cheking point 3(CP3) d) The quality engineer monitor the pruduting process by CTQ e) The calibration room according QS11.1.17 monitor GRR. f) Monitor customer’s satisfy and improve quality by PDCA. All process monitor by each manager. 8.2.4 product monitoring and measurement The organization shall set<process test procedure><product test procedure> <incoming inspection procedure>to achieve the target of monitoring and measuring the products and shall measure the characteristic of products to prove whether the product requirements have been satisfied. During the producing process measurement and monitoring shall be taken according to the rules of inspection and test .Quality conditions shall be recorded accordingly. When tested and rectified by professional the products can be delivered. Quality control dept shall be responsible for monitoring and measuring the Production process. Lab shall be in charge of the product function.
8.3 Nonconforming control The organization sets the<nonconforing control procedure> and carries it out to identify and control the rejects and prevent them from unpropective. The rules will be set in the procedure about how to identify audit and deal with the rejects with records in each stage. The measures are as follows: A Take measures to eliminate the nonconforming QUALITY MANAUAL CHAPTER 8 NO.3 OF TOTAL 4 PAGES
ZEL /QS2002 .12 EDITION 0 REVISION NO .1(2005/6/14)
B With the permission from the professional and customers, nonconforming can be used, delivered and accepted,
C. Take measures to avoid using without permission D. Verify the products(service) again after corrected 8.4 data analysis The organization shall set < data analysis >and carry it out .by conforming, gathering and analyzing the advisable data the company ensures the fitness and validity of the quality management system and provides evidence to continual improvement. Data sources: 1.Customers satisfaction; 2. Conformity to product requirements; 3.Characteristics and trends of the process and products 4.Supplier; 8.5 Improvement a) Each department should make corrective actions for the problems found during system running. b) Accordsing the review of quality target, to make the new quality target. c) According the customer feed back, the date statistic, inter and external ausit, make the corrective actions. d) Manage review evaluate the improve result. e) The important item by ralative department cooperation. f) The improvement for the important design should make by all the ralative department The important improvement shall be responsible by execute manager.
ZEL /QS2002 .12 EDITION 0 REVISION NO .1(2005/6/14) 8.6 References Fill
QUALITY MANAUAL
CHAPTER 8 NO.4 OF TOTAL 4 PAGES
QS06<purchasing control>QS06.2<assessment and control of suppliers> QS10.1<incoming inspection>
QS10.2< process inspection> QS10.4<product test> QS13.1<control of nonconforming> QS14.1<correction and prevention action> QS17.1<internal auditing procedure> QS19.1<customer service> QS20.1<data analysis>
ZEL/QS2002.12 EDITION 0 REVISION NO .0(2003/12/11)
QUALITY MANAUAL
Appendix NO.1OF TOTAL 1 PAGES
List of
QS 01.1 QS 01.2 QS 02.1
Procedure document
procedure
Management responsibility Management review procedure
Quality system management procedure
QS 04.1 QS 04.2 QS 04.3 QS 05.1 QS 06.1 QS 06.2 QS 08.1 QS 09.1 QS 09.2 QS 09.3 QS 09.4 QS 10.1 QS 10.2 QS 10.4 QS 11.1 QS 12.1 QS 13.1 QS 14.1 QS 15.1 QS 16.1 QS 17.1 QS 18.1 QS 19.1 QS 20.1
Design control procedure Certification product control of confirming Idification of product management and issuring Document control procedure Purchasing control procedure Assessment and control of Suppliers procedure Product identification and tractability Process control procedure Auxiliary part control procedure Infrastructure & work environment Management procedure procedure
Production plan control procedure Incoming inspection procedure Process inspection procedure The product test procedure Control of monitoring and measuring devices procedure Inspection and test state procedure Control of nonconforming product Corrective and preventive action procedure Preservation of product procedure Record control procedure Internal auditing procedure Human resource management procedure Customer service procedure Analysis of data management procedure