质量手册英文版

1 Control program of (management) document and dataXLC/QP07.01-02 Page 1 Total: 2 pages 1.1 Aims and applicable scopeIn charge of documents and data about quality system and guarantee the related Dept. use the available edition.1.2 Obligations1.2.1 Quality Dept. is responsible for the delivering and controlling of quality manual and program file.1.2.2 Every functional Dept. is in charge of the delivering and controlling of each files and dada.1.3 Working Procedures1.3.1 Classification and serial numbers of files and data1.3.1.1 Controlled and uncontrolled files are divided into. Quality manual and programmed filethe responsible belong to the controlled. “Controlled files checking list” should be proposed by people in related Dept and then checked by the director in that Dept. Finally, representative supervisor approve that. The controlled files should be marked with ID, numbers, whereas, the unrolled files on the contrary.1.3.1.2 Quality Dept. makes “document number regulation” (without technical files) and that canbe carried out after obtaining the approval of the representative supervisor.1.3.2 Composing, examining, approving and delivering of documents1.3.2.1 The representative supervisors organize the composing of the quality manual and programmed files and the functional departments are responsible of composing each document.1.3.2.2 The representative supervisor check the quality manual and the General Manage approve it;every functional manages make a joint checkup for programmed files and directors approve thosefiles; the other files should be checked by each functional supervisors according to sufficiency and adaptation.1.3.2.3 Quality manual and programmed files will be delivered by Quality Dept. and alsoby the data administrators “Borrowing files registration form”. The other files should be deliveredin each functional department in the certain range.1.3.2.4 “Inner Notice” as the main form of XLC inner management document will be delivered in certain scope which is approved by examiner and the getters will sign on the original files and then get the copy one.1.3.3 Altering and cancellation1.3.3.1 The representative supervisor organizes the altering of quality manual and programmed files. After altering of the documentation, the altering marks and valid time will be given. The original files will be taken back document administrator in Quality Dept and the obvious markswill be stamped on.1XLC/QP07.01-02 Page 2 Total: 2 pages1.3.3.2 The other altering files will be carried out by each department and then checked by thedirector of each department after altering. Serial numbers and valid time should be marked. Eachdocument administrator take bake all the files and destroy them completely. Then new files can begiven out. Meanwhile, the altering reasons and contents should be told to representativesupervisors in the form of Inner Notice. “The controlled files checking list” of each Dept. should also be changed when it is necessary.1.3.4 Files management1.3.4.1 The document administer in every department is responsible the files management.1.3.4.2 The document should be easily recognized and referred to.1.3.4.3 When the user?s files seriously damaged, the document administrator should be informedimmediately for altering and reissuing.1.3.4.4 The document administrator should check the efficiency of the files regularly and change“controlled files check list” in time.1.3.5 Controlling the external filesDirect use the external files should be approved by the director of document management department. Marks should be added and fill in the check list and control delivering.1.4Relevant Documents1.4.1 “Quality Manual”ty Records Controlling Program1.4.2 “QualiProcessing methods about internal files in Company”1.4.3 “1.4 Quality Records1.4.1 Files Using Registration Form1.4.2 Inner Notice1.4.3 Controlling data checking list22 (technical) documents and data control procedureXLC/QP07.02-02 Page 1 Total: 2 pages 2.1 Aims and applicable scopeControl the technical files related to quality system and guarantee the valid versions of those documents.It can be applied to the controlling technical data about quality system.2.2 ObligationsDocument controller is responsible for delivering, controlling and supervising technical files. Thetechnical department is in charge of making, changing and controlling drawings and part lists (Inthe form of Product BOM).2.3 Working Procedures2.3.1Files under control (included the electronic document)Drawings and part lists, technical process sheet, modification notice.2.3.2examining and approving of documents2.3.2.1Technical Department make drawings and part lists and enter Product BOM(part list) in toERP system.2.3.2.2Technical director examines and approves drawings and part lists.2.3.3documents management2.3.3.1 Document controller provides drawings and part lists according to part list(BOM) and delivery to the relevant departments.2.3.3.2The technical files under control can be delivered in a certain range made by document maker after the approving of technical manager. For the altered production drawings or part lists,the document administer delivery files in the approved range which written in the applying list forchanging. At the same time, cancel and destroy the returned drawings.2.3.4Altering of filesThe applicant gives the ID Numbers and changing conditions for the damaged drawings and partlists. The document administrator changes them according to “Managing Regulations of drawings and part lists”. The drawing only can be printed but no copying.2.3.5 Altering of files2.3.5.1 The applicant who wants to change the files should fill in a form (that?s a pplying list for changing) and describe changing reasons, contents and delivering range. The related changing technical data should be enclosed on. It can be changed after the approving of technical manager.3XLC/QP07.02-02 Page 2 Total: 2 pages2.3.5.2 After modifying the technical documents, the modifying condition marks must be noted.files modification 2.3.5.3 After modifying documents, the document controller delivery” Technicalin relevant delivering scope.notice”2.3.6 Management of technical files2.3.6.1 In daily time, technical documents are often charged by document administrator. The technical drawings will be recorded in the tapes as copies from working net by technical managerwho is responsible for controlling the technical drawings.2.3.6.2 The technical department is responsible for entering new data in XLC management system(ERP) and preserves them. The using rights shall be guaranteed by microcomputer managementsystem.2.3.7 The controlling of external technical filesThe external technical files such as standard, drawings offered by customers, technical dada supplied by sub-contractor should be kept by technical Dept. Technical Manager?s approval should be obtained when they will be used.2.4 Relevant Documents2.4.1“Technical documents serial numbers regulations”2.4.2“Drawings and part lists managing rules”2.5 Quality Records2.5.1 Document modification notice43 Quality records control programXLC/QP07.03-02 Page 1 Total: 2 pages 3.1 Aims and applicable scopeEfficiently control and manage the quality records, which can demonstrate the products quality meeting certification and quality system running efficiently.Quality Systems are suitable for all related records.3.2 ObligationsQualities Dept. is responsible for making program document and supervises the controlling condition of every department towards quality records.Every functional department is in charge of each quality records.3.3 Working Procedures3.3.1 Quality records are the true records of forming product quality. They prove that products have reached the quality requirement level and demonstrate the proof of our company quality system running efficiently.3.3.2 The range of quality records:Every department work out each quality records checking list and hand in to Quality Dept.3.3.3 Intermediary form of quality records:Quality records can be taken down in the forms of tables, reports, documents and E-media.3.3.4 The filling requirements of quality records:Fill in the quality records carefully and clearly for easy recognizing and meanwhile guarantee thecorrection of whole contents. Faking fillings are not allowed. The signature confirmation by quality recording personnel has to be obtained when necessary.3.3.5 Collection of quality records, labels and conservation:Every functional department collect quality records according to the range of quality record checking list and make on each quality records for easy looking for. The quality records have to bekept well. The suitable environment which can prevent for damp and damage has to be offered byeach functional department for keeping quality records well.3.3.6 File and sort out the quality recordsFor easy management controlling, quality recorder should file the quality records. After filing, every functional department sort out and mark the quality records according to certain standard.5XLC/QP07.03-02 Page 2 Total: 2 pages3.3.7Quality records should be provided to customers for referring to when there isrequirement in contracts.3.3.8Conservation terms and dealing methods of quality records:The keeping period of Quality records should not be less than three years (except the products files).When there is a changing on quality records, the quality recorder propose aapplying in the form of inner notice and give it to each department director to approve.Casual changing is not allowed on quality records. The people who change the recordsshould sign on the changing place and mark on the exact changing time. When destroythe quality records, the quality recorder make a checking list and hand in to every functional director for approving.Products files should be preserved for all the time. The products files which have beenkept more than 3 years will be conserved in the form of E-media.(CD, Disk saving).3.4Relevant Documents(Management) documents and data controlling program3.5 Quality Records3.5.1 Quality records checking lists64 Quality management system planned programXLC/QP07.04-02 Page 1 Total: 3 pages 4.1 Aims and applicable scopeQuality management plan aims for realizing our company?s quality policy and aim.Identify and plan the processes and resources which are applicable for ensuring realizing qualitypolicy and process and resource of aims.4.2 Obligations4.2.1 General Manager is responsible for approving the quality planned outputs documents whichare made by the related departments according to our company?s quality policy, aims and the necessary resources.4.2.2 Management representative is responsible for reviewing the related documents which are made for quality management plan.4.2.3Quality department is responsible for organizing each department to manage and plan and make the corresponding planned documents. Supervising and checking shall be implemented.4.2.4 The managing people of each department shall be responsible for quality plan of their departments.4.3Working Procedures4.3.1 Quality aims4.3.1.1 In order to realize the quality policy of organizations, the general quality object of organization is:(1) finished products delivering pass percent is 100℅for one time(2) Components and parts(3) customer?s satisfaction rate shall be no less than 90％(4)the feedback rate of malfunction is less than 5％in early time (3 months)(5)20％has been increased ( product market expanding rate)(6) Explore the new products successfully at the first time4.3.1.2 Each department which related to quality shall divide the whole object of the organizationinto several small exact objects. In order to reach the quality goal successfully, the correspondingquality plan shall be implemented.4.3.2 The appropriate opportunity for making quality planQuality plan shall be carried out when company is in the following situations:a)Quality management system shall be established and improved according to qualitymanagement standard.7b)Important changes of company?s quality policy, quality aim and company?s organization.c)Important changes of company?s resource arrangement and market situation.d)The present document of system can?t cover the special items.e) 4.3.3 Quality planned contentsThe General Manager should identify and plan the necessary resources which ensure realizing thequality aim. Quality planned contents shall include:a)Quality aim and corresponding quality management processes; inputs, outputs and activitiesof processes and make regulations.b)Identify the established resources arrangement of processes which are required for realizingquality aim.c)Review rules regularly for realizing the whole quality aim and phrase or partial quality aim.The improvement of processes and activities shall be focused on in review processes.d)Find the distance of quality aim according to review results and ensure improvingcontinuously for enhancing the efficiency and effectiveness of quality management system.e)The planned results shall be filed (includes changing) such as quality manual, programmeddocuments and so on.4.3.4 The principle of making quality planned outputs documents and the following principlesshall be complied with:a) Complying with company?s aim, the exact practice of product and process shall be madeaccording to GB/T19001-2000quality management system for satisfying operability.b) The character and scope shall comply with the requirements of law and rules and the otherrelated requirements and expectation of customers, and that shall be applicable for company forsatisfying applicability and efficiency.4.3.5 Making, audition and delivering of quality planned outputs documents4.3.5.1 Quality department is responsible for organizing each department to make quality planneddocuments according to XLC-QP07.01-02 “Management documents and data control program”．4.3.5.2 Name, serial numbers, organizer, auditor, approval and issuing data shall be written on thecovers of quality planned outputs documents.4.3.6 Implementation of quality plan, supervising and changing4.3.6.1 In the process of implementation, each department shall control according to the stipulatedcontents, schedule and requirements of quality planned results. The feedback of existed problemsand present situations shall be informed to quality department.4.3.6.2 Quality department shall inspect and check the present situations of quality plan.84.3.6.3Quality planned changea) The changing of quality planned output documents shall be carried out in the controlledcondition and the related department issue “Internal Notice” and finally it shall be implemented according to “Management documents and data control program”b) Keep the quality management system running completely in changing period, e.g. thecorresponding changing shall be done through organization adjustment4.3.6.4 The related documents resulted form quality plan shall be turned to quality department andthen file them.4.4Relevant Documents4.4.1 “Management documents and data control program”4.4.2 “Planned control program of realizing process”4.5 Quality Records4.5.1 Quality planner of each department output documents95 Management review procedureXLC/QP07.05-02 Page 1 Total: 3 pages 5.1 Aims and applicable scopeGeneral Manager assess regularly to the present situation of company?s quality system, adaptability and efficiency, which guarantees that is suitable for company?s policy and aim.This program is applicable for management review.5.2 Obligations5.2.1General manager is in charge of managing review5.2.2 Management representative is responsible for reporting the quality system running situationto General Manager and5.2.3 Director of each department shall be responsible for preparing the demanded and related datafor reviewing and raising corrective and preventative measures for implementation in review.5.3Working Procedures5.3.1 Management review shall be carried out per 12 months.5.3.2 When some important unusual situations about company?s quality system happening, the related personnel shall be called in for management review if General Manager thinks it?s necessary.5.3.3 Management representative organizes making management review plan and report to General Manager. Then general manager approve for issuing and implementing.5.3.4 The review plan shall be delivered to company?s leaders and each department director in tendays before.5.3.5 Management representative organizes every director of each department to collect and prepare the necessary materials for reviewing according to the review plans.5.3.6 Review contents include:a) Review results include internal quality system audition, the third party?s audition of customer?sreview and the results of product quality audition. The quality department provides the related data.b) Customer?s feedback includes the measuring results of customer?s satisfaction or dissatisfactionand customer?s complaints. The after-sales department offers the related data.c) Process outstanding achievement and product conformity, which include the results of process,product measurement and monitoring results. Each department offers the related data.10d) Improving, preventive and corrective measures. Every department offers the related data.e) Implementation and efficiency of the tracking measures to management review in the past.Quality department offers records and the comprehensible report.f) All various changes include inner and outside environment, law and rules, new technology, newtechniques, new equipment exploration and so on, which perhaps influence quality managementsystem. Every department offers the related data.g) The running situation of quality management system, which include the applicability andefficiency of quality policy and objectives.5.3.7 There are many forms of management review such as meeting and local reviews can beadopted. The general manager appoints some special personnel to make the exact review recordsin review process.5.3.8 Management review outputsapproved by General Manager is treated as the review5.3.8.1 “Management review report”　outputs. Quality management system improving requirements, product improving requirements,and resources arrangement requirements shall be included in the report as the corrective andpreventive action for improving continuously.a) Improvement of quality management system and processes, which include the assessment toquality policy, quality aim, organization structure, process control and so on.b) the improvement of products which is required by customers; assessment to present productconformity include whether product process review is needed or the related contents about reviewcontents.c) Resources requirements and so on.5.3.8.2 Quality department conclude and then make “Management review report”　according to management review outputs after ending the meeting. The management representative audits thereport and turn to General Manager for approving and then delivery to the related departments formonitoring and implementing. The outputs of management review in this time can be taken as theinputs of next management review.5.3.9 Implementation and verification of improving, corrective and preventative measures.Quality department tracks and verifies the implementation effects of improving, corrective and preventative measures according to the rules in “Improved control program”．5.3.10 Management of managing review documentsAll the documents and data of management review belong to controlled documents and managethem according to “Management documents and data control program”. All records and review results shall be controlled according to “Quality record control program”．115.4Relevant Documents5.4.1 “Management documents and data control program”5.4.2 “Quality record control program”5.4.3 “Internal quality system review program”5.4.4 “Improved control program”5.5 Quality Records5.5.1 Management review plan5.5.2 Management review notice5.5.3 Management audition report5.5.4 Corrective and preventative measures processes list126 Conscious, ability and training control programXLC/QP07.07-02 Page 1 Total: 3 pages 6.1 Aims and applicable scopeTo make the persons being trained be up to the regulations and requirements of related jobs.It is applied to educate and train all kinds of persons who work in and are related with quality jobs,including the supplier if necessary.6.2 Obligations6.2.1 Personnel Dept. is a vital ministry in a company to control human resources, and it is responsible to regulate and specify job responsibilities, to plan, identify and control the human resource demand of all departments, to organize, coordinate, implement and evaluate all kinds oftraining activities, as well as to make an overall assessment regularly.6.2.2 Engineering Dept. should cooperate with Personnel Dept. to implement technique training,safety education and special working procedure training.6.2.3 Quality Dept. should cooperate with Personnel Dept. to implement the training on workers? consciousness and management knowledge of quality.6.2.4 All departments should assist Personnel Dept. with their own professional technique training,to put forward training demand and keep employee training records, as well as to make humanresource plan and employee?s training, demand, assessment and ect on quality.6.2.5 Personnel Dept. is responsible to make job assessment standard ( including job description, qualification and technique standard ) and work responsibility.6.3Working Procedures6.3.1 Identification of ability and consciousnessIdentify ability requirements of all workers related with quality activities and make different job responsibilities and training according to different working positions, such as new workers, old workers, all kinds of professional workers, special technique workers, assessor and so on.6.3.1.1 Workers responsible for quality management system regulation should have capabilities,which are estimated by education, training, technique and experience.6.3.1.2 Every department is responsible to compile its own ,position responsibilities?, which is submitted to personnel dept. for collection and carried out with company leaders? approval.6.3.2 Training136.3.2.1Training PlanPersonnel department make and carry out training plan which base on the wide suggestions fromrelated departments and further investigation. From the practical situations of our company, the training contents, aims and checking system should be identified.6.3.2.2Training formsVarious forms of staff training can be adopted such as off-job-training, day releasing, off-hours and outgoing and short-term temporary arrangement.6.3.2.3Training contentsStaff training contents can be divided into quality conscience, quality management training; professional knowledge, skills training; safety educational training before work; special processing traininga ) training to leadersTo all directors in company?s departments, the training will be given according to GB/T19001-IS09001 combing with the quality manual and programmed files which made out form the quality system. All the leaders will know more about the quality system and every element in that system. From the training, they can use the methods, technical and efficient evaluation in the quality system.b) Technical and managing staff trainingThe technicians and managing staff included designer, technique people, purchasing, and qualitystaff should be given training from professional knowledge and quality management. Then theycan know our company?s quality system contents and obtain managing ways, technique, and requirements of their work.c) Training to production section supervisors and operatorsWorking skills and quality management basic knowledge training will be given to section supervisors and operators. This can make them know how to use equipment, tools, tolling, apparatus and instrument and testing equipment. Meanwhile, they are able to maintain those equipment well. Through learning our company?s quality manual, related procedure and guidancebooks and discussing each quality responsibility, people can record rightly and analyze the qualitysituation in production.d ) Train to new staffsSafety production training, working skills training should be given to new staffs. Basic concept ofquality management should be mentioned.e ) Special trainingSpecial training included welder, forklift truck driver, inspector, designer and so on). After specialtraining, the workers can start their work after obtaining the certificates.6.3.2.1evaluate the efficiency of offered training14Though theory examining, operation testing, working evaluation, the trainer will be judged whether they are capable of doing the work. In the end, staff training files will be established and preserved.6.3.3Worker?s daily working performance will be evaluated through personnel department organization. Spot-checking can be carried out to the staff in each department. To the unqualifiedpeople, train, test or change work position which can make the people are suitable for their abilities.6.4Relevant Documents6.4.1 “Quality Manual”6.4.2 “Management files and data control program”6.4.3 “Quality records controlling program”6.4.4 “Procedures of controlling program”6.5Relevant Documents6.5.1Staff temporary training applying6.5.2The theory and operation examining records of special workers6.5.3Yearly training applying form6.5.4Statistics form of special workers6.5.5Training attendance book157 Infrastructure and work environmentXLC/QP07.07-02 Page 1 Total: 2 pages7.1 Aims and applicable scopeIn order to realize meeting standard requirements of products continuously, identify and managethe factors of people and things in work environment for achieving conformity to product requirements.This program is applicable for the infrastructure needed to achieve conformity to product requirements. Infrastructure includes workspace, hardware and software, tools and equipment,supporting service such as communication or control of transporting facility and so on. Controlfactors of people and things in work environment.7.2 Obligations7.2.1 The maintenance section in Production Dept. is responsible for monitoring the neededfacilities which achieve conformity to product requirements.7.2.2 Personnel Dept. assists Production Dept. to monitor the needed work environment whichachieve conformity to product requirements.7.3Working Procedures7.3.1Identify and manage producing infrastructure.7.3.1.1 Identify infrastructureThe needed infrastructure which achieve product conformity include: work space (workshop,offices and so on), equipment and tools (includes working, clamp apparatus, measuring tools),software (computer net), supporting service (water, electricity, gas supplying), communicationfacilities, transporting facilities.7.3.2Infrastructure management7.3.2.1Every section director in Production Dept. makes the infrastructure investment plan fornext year in October. The investment plan will be reported to production manager. The PurchasingDept. purchases those facilities after obtaining leader?s approval.7.3.2.2The departments which use apply for self-making infrastructure, and technical departmentdesigns the drawings. After production manager approving, maintenance section organizes implementation.7.3.2.3For the purchasing and self-making infrastructure, maintenance section in Production Dept.organizes department which use to fix and adjust. After confirmation, both sides sign for checkingand accepting on “Infrastructure receiving report” and establish the basic information registration of producing equipment. For the working, clamp and measuring tools of low value and easydamage, the using departments should check by themselves16。