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1、ISO9001：2015 全套程序文件英文版(本人辛苦原创 ) Document Name Control of Documents Procedure Page Code 1/8Version A/0 Document Code QM-COP-01 Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 1.0 Purpose All the documents required by the Company s quality management system should be controlled to ensure the ver
2、sion applied by all the relevant departments is valid. 2.0 Scope It is applicable to all the documents pertaining to the quality management system including external documents. 3.0 Definition 3.1 Controlled document: The document applied in and out of the Company is controlled in modifications, iden
3、tities, versions, version numbers, formats, fonts, etc. 3.2 DCC: Document Controlling Center 3.3 External document: It refers to the document that has been handled by outside individuals like national/international standards, laws and regulations, documents provided by customers or suppliers, materi
4、al certificates, amendment advice, etc. 3.3.1 Administrative documents on quality management system or product, released from local government authorities and regulatory agencies such as the notices from Guangdong Food and Drug Administration. 3.3.2 National laws and regulations such as Product Qual
5、ity Law of the People s Republic of China, Regulation on the Supervision and Administration of Medical Devices, 93/42/EEC, etc. 3.3.3 International standards such as Medical devices Quality management systems Requirements for regulatory purposes. 3.3.4 National standards such as Medical electrical e
6、quipment Part 1: General requirements for safety. 3.3.5 Regulations and standards provided by customers such as agreements and commitments signed with customers. 3.3.6 Drawings provided by customers such as drawings, mold drawings provided by a certain customer. 3.3.7 Other important external docume
7、nts relating to the product, including official materials like customer s notice. 4.0 Duties 4.1 General Manager: Responsible for approval of the Company s quality manual. 4.2 Management Representative: Responsible for the Company s procedure files, quality plans and cross-department three-order fil
8、es and approval of external documents. 4.3 Principals of each department: Responsible for approval of three-order files and all kinds of tables as well as department-related external documents. 4.4 Department: Responsible for compilation, number and review of the documents dominated by the departmen
9、t. If this manual is printed, it is an UNCONTROLLED copy.Document Name Control of Documents Procedure Page Code 2/8Version A/0 Document Code QM-COP-01 Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 4.5 Quality Management Department: Responsible for all the controlled documents of the Company
10、to ensure the electronic document is the latest version, and responsible for the updating of the controlled document list of all the departments. 5.0 Procedures 5.1 Document classification: The management system documents includes four layers and external documents 5.1.1The Quality Manual (including
11、 policies and goals) is a principle-based and master document guiding the implementation of the quality management system. As the first level document, it does not just explain the scope of application but also describe the interaction among all the procedures in the quality management system. 5.1.2
12、 The procedure document is the expansion and specification of the Quality Manual, providing the process, methods and controlling means for carrying out quality management. It belongs to the second level document. 5.1.3 Supporting documents (operation/technical specifications, process/inspection stan
13、dards, technical guidance and position description) specify the quality management goals, duties of the posts of all levels and specific operation methods. It belongs to the third level document. 5.1.4 The table is applied to record the state and result of activities, belonging to the fourth level d
14、ocument. 5.1.5 External document: It refers to the document directly obtained from outside and cited by the Company, including national/international standards, laws and regulations, documents provided by customers or suppliers, material certificates and amendment advice. 5.1.6 The document is drawn
15、 up mainly in written or electronic form, and both shall be under control. 5.2 Document compilation and approval 5.2.1 The formats of the second and third level documents are the same as that of the document. 5.2.2 The date of the document must be written in the form of “ year month day” . 5.2.3 Lim
16、its for examination and approving authority for documents S/N Order Type of document Prepared by Reviewed by Joint reviewed by Approved by Remark 1 First Management Manual Quality Management Department Management Representative Supervisor of each department Top management 2 Second Procedure document
17、 All departmentDepartment Relevant department Management If this manual is printed, it is an UNCONTROLLED copy.Document Name Control of Documents Procedure Page Code 3/8Version A/0 Document Code QM-COP-01 Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 5.3 Document s number and version/version
18、 number 5.3.1 Number: The document compiler numbers the newly compiled documents according to the Basic Rules for Numbering the Controlled Documents and the document list of the department, and confirms the uniqueness of the numbers with the controlling center. 5.3.2 Version/Version number: The vers
19、ion or version number of the controlled document is compiled in s manager manager Representative 3 Third Management document All departments Department manager Relevant department manager and Management Representative Management Representative Job Description of the personnel below the manager level
20、 is reviewed by the department manager and approved by the manager of HR Department. 4 Third Process, inspection standard document and specification (including external document) All departments Quality Management Department Department manager 5 Fourth Tables All departments Quality Management Depar
21、tment Department manager Additional remarks: 1) The document can be compiled by the compilers or above the compiler level but must be approved by the personnel upper than the compiler. 2) The relevant department refers to the departments having ties with others involved in this system. 3) When the a
22、pprover of the above documents is absent, his agent or Management Representative can sign it up instead to make the document effective. If this manual is printed, it is an UNCONTROLLED copy.Document Name Control of Documents Procedure Page Code 4/8Version A/0 Document Code QM-COP-01 Edited/Revised D
23、ate 2018.10.24 Issued Date 2018.10.24 the form of 26 alphabets from A to Z. The initial version number is “ A/0” , the next revised version is “ A/1” and so on. Changing Arabic numbers is enough for minor revisions while changing alphabets, for instance, from “ A” to “ B” , is necessary in case of m
24、ajor revisions. 5.4 Document distribution and storage 5.4.1 The document compiler sends the copy of the approved document and its electronic version to the Quality Management Department where the document will be checked whether it has been approved by designated personnel. After that, the document
25、will be registered, controlled with the controlled document list updated. 5.4.2 The document controller determines the scope of distribution, makes copies of the electronic file in a required number according to the List of distributed controlled documents, add the watermarks of correspondent depart
26、ments on these copies, save them to the folder for controlled documents of each department and notify the departments for making and using the documents by email. 5.4.3 All the department are responsible for checking if the controlled document is correct or not. 5.4.4 The authority for the controlle
27、d document folder of each department shall be set as follows: Document controller is permitted to modify, delete the content or add new content to the document. Each department can only read but cannot delete, modify or add the content of controlled documents. 5.4.5 The document controller must copy
28、 the electronic document as a backup. 5.4.6 Visual management of documents As for the documents which are frequently applied at production site, all the departments should take correspondent measures such as hanging them on the wall, beside the equipment or enveloping them with plastic so to make it
29、 easy for operators to use. 5.5 Document reading 5.5.1 In case of reading the documents, the relevant personnel can open the PDF file which are saved in the Company s share disk. 5.6 Document review, modification, recovery, invalidation and destruction 5.6.1 Review The documents of the quality manag
30、ement system should be reviewed once a year by the Quality Management Department and internal review team organized by the Management Representative along with the Company s internal review and reviewed with the result put down in the internal review record. In case of special circumstances, some do
31、cuments should be reviewed by the relevant department. The review must take into account the influence of both the internal factors like the Companys organization and position changes and the external factors like laws, regulations, relevant standards and market demands upon the sufficiency and appl
32、icability of the documents with the Review Record filled in. 5.6.2 Revision/alteration The director and executor of each unit should check the effect after implementing the documents. If the documents are not applicable or in doubt in addition to the opinions on the content of the documents from oth
33、er units, the documents can be revised or modified by the department which revised or compiled If this manual is printed, it is an UNCONTROLLED copy.Document Name Control of Documents Procedure Page Code 5/8Version A/0 Document Code QM-COP-01 Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 the
34、m last time after the discussion among the relevant departments. Relevant approval process is the same as that in 5.2.2. All the modifications or alterations must be underlined (“_”). In case of version change, the previous underline should be substituted by the latest one. The revision record shoul
35、d be written on the first page of the documents, containing the content of the revision, identification of the affected documents, signature of the approver, date of approval and effective time. The relevant departments shall be notified of review and confirmation of the alteration, and personnel tr
36、aining will be provided if necessary. In the following circumstances that there is any alteration to the documents of the quality management system or the documents relating to the Company s medical device products, the top management or Management Representative of the Company should be notified of
37、 deciding whether to inform the competent authority or notified bodies about it. If it is necessary, the notification should be implemented in accordance with the local laws and administrative regulations. a. Major alterations to the Quality Manual. b. Major alterations to the product s functions, p
38、erformance, safety, reliability and electromagnetic compatibility, caused by altering product standards. c. Major alterations to the product s functions, performance, safety, reliability and electromagnetic compatibility, caused by changing key components of products. d. Stipulated by laws and regul
39、ations. 5.6.3 Once the new version of controlled document is distributed, the old one becomes invalid automatically. The document controller should delete the copies of invalid controlled documents in the controlled document folder, upload the latest version and keep the original documents printed w
40、ith an “ invalid” stamp at the document controlling center till the expiry date (at least five years) before destruction. 5.6.4 As for the invalid original documents, the document controlling center should destruct them uniformly after Document/Record Destruction Registration Form filled in by the c
41、enter is approved by the Management Representative. 5.7 The non-controlled document is identified as the “ Reference” . If a Company s customer or other personnel need it for their jobs, they must have the copies of the Company s controlled documents and get its copies approved by the Management Rep
42、resentative and stamped with the Reference seal by the Quality Management Department. The Reference documents will not be withdrawn or changed to the latest version. 5.8 Temporary document It is not yet official for some reasons but needed by each department. Such document should have a Temporarily
43、Controlled stamp as well as the time limit and distribution department on them. The temporary document cannot be valid for more than 3 months. If this manual is printed, it is an UNCONTROLLED copy.Document Name Control of Documents Procedure Page Code 6/8Version A/0 Document Code QM-COP-01 Edited/Re
44、vised Date 2018.10.24 Issued Date 2018.10.24 5.9 Management of external documents 5.9.1 Each department of the Company can collect external documents through the following channels. a. National, provincial, municipal governments and their relevant functional departments. b. All kinds of meetings, pr
45、ofessional newspapers, magazines, publishers and suppliers. c. Internet, telephone and fax. 5.9.2 The external document collected by each department should be selected timely and delivered to the relevant department to recognize its contents and decide whether make it a controlled document. a. The c
46、ollected technical standards on our products should be delivered to the Technical Department to recognize its year, version and applicable articles. b. The laws, regulations and rules that are issued by the state on the quality and safety of the product should be delivered to the Quality Management
47、Department to identify the required department and scope. c. Policy documents issued by the superior should be delivered to the administration department for recognition. d. The technical documents provided by suppliers or customers should be delivered to the Technical Department and Quality Managem
48、ent Department for recognition. f. The design input documents provided by customers should be delivered by the Market Department to the R&D Department for recognition. Saved in DHF format, they don t have to be controlled by document controller. 5.9.3 Numbering of external documents As for the exter
49、nal documents on technology and standards as well as other external documents, the Quality Management Department should number them in accordance with the Basic rules on numbering controlled documents. 5.9.4 Distribution of external documents a. After being recognized, the external documents should
50、be kept on a file and put down on a list. b. The external documents should be distributed after the distribution scope is confirmed according to 5.4 of this procedure. 5.9.5 Updating of external documents As for the external documents which need updating, the new version should be distributed with t
51、he invalid ones withdrawn immediately. 5.9.6 Preservation and destruction of external documents The preservation and destruction should be implemented according to 5.6.3 of this procedure. 5.10 The Quality Management Department should supervise and inspect irregularly the controlling process impleme
52、nted by each department. 6.0 Records and Tables 6.1 Controlled Document Directory If this manual is printed, it is an UNCONTROLLED copy.Document Name Control of Documents Procedure Page Code 7/8Version A/0 Document Code QM-COP-01 Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 6.2 Document/Rec
53、ord Destruction Registration Form 6.3 Review Record 7.0 Flow Chart If this manual is printed, it is an UNCONTROLLED copy.Document Name Control of Documents Procedure Page Code 8/8Version A/0 Document Code QM-COP-01 Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 Document compilationApprovalApp
54、roved or notAcquisition of external documentsRecognition of external documentsIdentificationDistribution and registrationImplementation and managementReviewUse or not InvalidationReserve or notIdentificationDestructChangeChange and approveImplement the changeNYYYNNIf this manual is printed, it is an
55、 UNCONTROLLED copy.Document Name Control of Records Procedure Page Code 1/4Version A/0 Document Code QM-COP-02 Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 1.0 Purpose All the records required by the Company s quality management system should be controlled to ensure evidence that products a
56、ccord with regulations and quality system operates effectively and their history are provided . 2.0 Scope It is applicable to all the records pertaining to the quality management system, including those designated by suppliers and customers. 3.0 Definitions Record: A document illustrating the result
57、s achieved or proving the activities finished. DHF: It refers to the records describing the design process of a finished medical device. DMR: It refers to the full record including the procedures and regulations of manufacturing a standard finished medical device. 4.0 Duties 4.1 Quality Management D
58、epartment: responsible for all the controlled record forms of the Company to ensure the record is comprehensively examined and numbered uniformly. 4.2 Each department shall be responsible for collection, archiving, marking, storage and disposal of the documents dominated by the department. 5.0 Proce
59、dure contents 5.1 Records and the establishment, record-keeping and identification of Record List 5.1.1 Establishment of Record List Quality Management Department compiles the Record List according to the requirement of quality management process. The name, number, storage department and expiry of t
60、he records should be explicit and shared in the servers so that each department can verify the consistency of the versions. 5.1.2 Record compilation Each department should design its own form according to requirements, including the name, number and version. The record compiler numbers the newly com
61、piled records according to the Basic Rules for Numbering the Controlled Documents. Quality Management Department examines the formats and contents of record documents drawn up by each department. Department manager approves it to ensure its qualification of quality management system regulation. 5.1.
62、3 The keeping, identification and distribution of record documents shall be done according to the Document Control Procedures. If this manual is printed, it is an UNCONTROLLED copy.Document Name Control of Records Procedure Page Code 2/4Version A/0 Document Code QM-COP-02 Edited/Revised Date 2018.10
63、.24 Issued Date 2018.10.24 5.1.4 When relevant departments receive electronic file forms, the new version should be applied immediately with the old one being invalid. 5.1.5 The invalidation of form must be reviewed by managers of the relevant department and the Management Representative. 5.2 Use of
64、 records 5.2.1 There will be recorder and verifier in all records. Time will be recorded in at least one place in the full records. 5.2.2 The records should be clear and the facts and data should be authentic, accurate and complete. Do not alter the records at will. Cross out the old contents by usi
65、ng “ ” if necessary. After that, write down the new contents, the signature of the person who alters the data and date, and make it clear as before. Give an account of the alteration if necessary. 5.2.3 The record form should be filled in a stipulated way. Use “ / ” in the places that do not have to
66、 be filled in. No blank should be left. 5.3 Collection and management of records 5.3.1 Each department is responsible for collecting, sorting out and archiving all its records, with establishing index and directory for ready reference. 5.3.2 The records filled out should be kept properly in case of
67、damage and loss. 5.4 Storage expiry of records 5.4.1 In accordance with laws and rules, the regulations for the record are as follows: Heads of each department compiling the form should be responsible for confirming the storage life of new table after referring to the following attached form. Upon i
68、ssuance of the new form, the Quality Management Department should take storage life into Record List for reference and performance of each department. 5.4.2 The storage life of account records and vouchers related to finance shall be 5 years, including the inventory of stock, purchase note, quotatio
69、n, etc. 5.5 Invalidation of records: With the approval of the principles of relevant department and management representative, Quality Management Department destructs the records exceeding storage life. Mark and make independent cover for the records needed to be kept for special requirement. 5.6 Qu
70、ality Management Department shall supervise and examine the control process of records of each Type of form Storage life Remark Account record or voucher related to finance At least 5 years Determine the storage life according to client s special requirements if necessary Record on products technolo
71、gy, quality and sales At least 3 years Equipment maintenance and check At least 1 years Weekly and monthly report At least 1 years Miscellaneous At least 1 months If this manual is printed, it is an UNCONTROLLED copy.Document Name Control of Records Procedure Page Code 3/4Version A/0 Document Code Q
72、M-COP-02 Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 department irregularly (at least 2 times a year/ can be conducted during internal review) . 6.0 Records and Tables 6.1 Record List 6.2 Document/Record Destruction Registration Form 7.0 Flow Chart If this manual is printed, it is an UNCON
73、TROLLED copy.Document Name Control of Records Procedure Page Code 4/4Version A/0 Document Code QM-COP-02 Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 Confirm the mode, keeping and marking of recordEstablish records listDestruct and recordUse records Collecting recordsNumberingArchivingExcee
74、ding expirty date?YNIf this manual is printed, it is an UNCONTROLLED copy.Document Name Management Review Procedure Page Code 1/4Version A/0 Document Code QM-COP-03 Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 1.0 Purpose The purpose of this procedure is to define DaMei s requirements for c
75、onducting Management Reviews. 2.0 Scope This procedure is the primary document meeting the applicable regulatory requirements for conducting Management Reviews as defined in DaMei s Quality System Manual (QM-A-01). References and Relationships ISO 13485:2016 21 CFR 820.20 3.0 Responsibilities and Au
76、thorities Role Responsibilities and Authorities Quality Management / Management Representative Primary responsibility for maintaining this process and ensuring that Management Review meetings are scheduled, conducted and the minutes are recorded. Top Management The Management responsible for attendi
77、ng Management Review Meetings as identified in DaMei s organization chart. These managers are responsible for participating in Management Reviews including the preparation of inputs to the Management Review and completion of action items resulting from Management Reviews. The organization chart shou
78、ld also identify the following personnel: Management Representative Deputy Management Representative Most Senior Executive Manager Second Most Senior Executive Manager It is not recommended to have the same person hold two of the above four positions. 4.0 Procedure 1 Management Review meetings shall
79、 be scheduled at least once a year. 2 The following inputs are required to the Management Review meeting for discussion: Quality policy Quality objectives Results of audits including internal, supplier, certification audits and FDA inspections Customer feedback including complaints and post-market s
80、urveillance Process performance If this manual is printed, it is an UNCONTROLLED copy.Document Name Management Review Procedure Page Code 2/4Version A/0 Document Code QM-COP-03 Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 Product conformity Supplier quality performance Status of corrective
81、and preventive actions Follow-up of action items from the previous Management Review(s) Changes that could affect the quality system Recommendations for improvement New and revised regulatory requirements Risk management process (ISO 14971) Overall quality system effectiveness 3 Management Review in
82、puts shall be documented in a presentation slide deck using a controlled template. The Management Representative shall assign responsibility for completing each slide of the presentation as an action item in the previous Management Review. These assignments shall be documented in the meeting minutes
83、. Each input slide shall be provided to the Management Representative at least 10 calendar days prior to the planned review date, and the Management Representative shall combine the slides into a draft presentation and electronically deliver the draft presentation to Top Management at least 7 calend
84、ar days prior to the planned review date. Any necessary corrections to slides should be communicated to the Management Representative as soon as possible so that corrections can be communicated to Top Management prior to the planned review date. 4 During the Management Review, Top Management shall r
85、eview the Quality Policy to ensure it: is appropriate to DaMei s purpose, includes a commitment to comply with requirements and to maintainthe effectiveness of the quality management system, provides a framework for establishing and reviewing qualityobjectives, is communicated and understood within
86、the organization, and is reviewed for continuing suitability during at least one Management Review meeting each year. 5 During the Management Review meeting, the Management Representative is assigned the role of scribe to record notes about the discussions. 6 Top management shall ensure that quality
87、 objectives, including thoseneeded to meet requirements for product, are established for all functions (i.e., departments) and all levels within the organization. The qualityobjectives shall be measurable and consistent with the quality policy. The status of quality objectives shall be reviewed duri
88、ng management reviews and when one objective is met, Top Management shall determine if the objective shall be maintained or if a new objective shall be set. 7 The risk management process should be reviewed by Top Management for effectiveness during If this manual is printed, it is an UNCONTROLLED co
89、py.Document Name Management Review Procedure Page Code 3/4Version A/0 Document Code QM-COP-03 Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 reviews, but it is allowed to schedule the review of the risk management process at another time. The risk management review should include a review of
90、risk management plans during design projects and as part of past-market data collection. Compliance with the risk management plans should be reviewed, and any corrective actions taken to improve risk controls and/or update a risk analysis should be reviewed as a possible opportunity to improve the r
91、isk management process or the risk management training of personnel. 8 The following items shall be documented as outputs from Management Review meetings in the meeting minutes: the date of the next scheduled Management Review Meeting and the rationale for the interval between reviews, actual attend
92、ance of Top Management, any changes to the quality policy required, any new quality objectives, any corrective actions recommended for initiation, improvements needed to maintain the effectiveness of the qualitymanagement system and its processes, improvement of product related to customer requireme
93、nts, changes needed to respond to applicable new or revised regulatory requirements, resource needs, assignments to Top Management for preparing the Management Review meeting inputs for the next meeting, and any additional action items identified during the review. Improvement required to maintain t
94、he effectiveness of the quality system may include changes to the following: the monitoring and measurement of processes, and the auditing schedule. 9 The draft meeting minutes shall be distributed to Top Management within 7 calendar days of the review, and Top Management shall provide corrections a
95、nd additional comments within 14 calendar days of the review. The Management Representative shall distribute the final version of the meeting minutes to Top Management with 21 calendar days and the minutes shall be maintained as a quality system record. 5.0 Records 5.1 Management Review Plan 5.2 Man
96、agement Review Report If this manual is printed, it is an UNCONTROLLED copy.Document Name Management Review Procedure Page Code 4/4Version A/0 Document Code QM-COP-03 Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 5.3 Management Review meeting record If this manual is printed, it is an UNCONT
97、ROLLED copy.Document Name Internal Audit Procedure Page Code 1/3Version A/0 Document Code QM-COP-0 4Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 1.0 Introduction & Purpose The purpose of this procedure is to define internal audits in order to assess the effectiveness of the application of I
98、SO13485:2016 & 21 CFR 820.20 and also to define the responsibilities for planning and conducting audits, reporting results and retaining associated records. 2.0 Terms & Definitions 2.1 Non-conformity: Non-fulfilment of a requirement. 2.2 Preventive Action: Action taken to eliminate a potential non-c
99、onformity. 2.3 Corrective Action: Action taken to eliminate the cause of a non-conformity. 2.4 Audit: A systematic, independent documented process for obtaining and evaluating audit evidence objectively to determine the extent to which audit criteria are fulfilled. 3.0 Application & Scope The scope
100、of this procedure is focused on assessing the effectiveness of DaMei QMS. Where such processes are found to be deficient, the audit will lead to improvement in those processes. 4.0 Requirements An audit of the QMS is conducted at planned intervals to: Determine whether the QMS conforms to planned ar
101、rangements Determine whether the QMS is properly implemented and maintained Provide information on the results of audits during Management Review 5.0 Process Internal auditing is undertaken at least once annually. Audits may be completed with a greater frequency if determined by the QA Officer or as
102、 determined by: Customer complaint QMS requirements Quality objectives/policy Corrective actions Statutory/legal requirements Management decisions Concerns raised by 3rd parties Results of 3rd party audits Employee concerns Management Review concerns 6.0 Management Review concerns 6.1 Auditors will
103、be trained in the auditing process, including the intent of the procedure. The completed If this manual is printed, it is an UNCONTROLLED copy.Document Name Internal Audit Procedure Page Code 2/3Version A/0 Document Code QM-COP-0 4Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 records will fo
104、rm part of the report presented to the Management Review meeting and be maintained by the QA Officer. Any conclusions derived from these reports will be explained more fully at the Management Review Meeting. The member of the auditing team with formal training will be responsible to instruct auditor
105、s of the other sections. 6.2 Audit Preparation The audit shall be carried out on all sections of the organisation regarding procedures as defined in the Quality Manual. The effectiveness of the procedures to accomplish the task will be appraised; highlight any need to change processes and ensure cha
106、nges are effective. The Audit Team is required to: Review relevant management system documents and records Review and prepare the internal audit checklist 6.3 On-site Audit Auditing will be completed as a step by step verification of the process or procedure. Unfavorable outcomes of the audit being
107、treated as a non-conformance. This will then be addressed with the corrective action required and/or be covered in the Management Review for conforming practices. The Auditor is required to: Sample and observe process inputs/outputs Record objective evidence to verify process compliance or non-confo
108、rmance Generate audit findings 6.4 Wrap-up Meeting The Auditor and/or responsible manager are required to: Review audit conclusions and discuss recommendations for improvement Decide whether any non-conformances observed should be included in correction reports or solved immediately Minor areas of n
109、on-conformance are taken care of immediately Prepare an audit report Review audit report during Management Review Corrective actions are reviewed by the responsible manager and close out action is agreed upon 6.5 Follow-up The Auditee/Responsible Manager is required to: Ensure corrective actions are
110、 implemented and are closed-out within the agreed timeframe Ensure non-conformances are closed-out within the agreed timeframe If this manual is printed, it is an UNCONTROLLED copy.Document Name Internal Audit Procedure Page Code 3/3Version A/0 Document Code QM-COP-0 4Edited/Revised Date 2018.10.24
111、Issued Date 2018.10.24 Ensure the status of corrective actions and any non-conformances are kept up-to-date 6.6 Reporting Responsibilities and intervals will be recorded in Status and scheduling documentation kept by the QA Officer. Records of these audits will be the responsibility of the auditor a
112、nd storage will be the responsibility of the QA Officer. All Audits will be presented in a report format to the manager of the section and an overview of the organization performance will be discussed in the Management review. The QA Officer is required to: Review audit conclusions Make recommendati
113、ons for improvement Finalise the internal audit report Issue internal audit report at Management Review 6.7 Review Management is required to: Consider and act upon audit findings during the management review process Use the internal audit report to promote best practice Ens ure records are maintaine
114、d 7.0 Records 7.1 Internal Audit Schedule 7.2 Internal Audit Checklist 7.3 Internal Audit Report If this manual is printed, it is an UNCONTROLLED copy.Document Name Customer Related Process Procedure Page Code 1/7Version A/0 Document Code QM-COP-0 5Edited/Revised Date 2018.10.24 Issued Date 2018.10.
115、24 1.0 Purpose To confirm and review the requests related to products, make its stipulations reasonable and explicit, form a file and ensure that Company has ability to meet customer s requirements. It aims to establish the Company s monitoring system, collecting relevant information and analyzing w
116、hether customers are satisfied with the Company so that company can take specific measures to meet the expectations and requirements of the customer and advance sustained and healthy development of the Company. 2.0 Scope It is applicable to the Company s procedure control concerned with customers an
117、d monitoring and measurement for external customer satisfaction. 3.0 Definitions 3.1 Special contract: It refers to the contract where there are new products or special requirements in the order. 3.2 General Contract: It refers to all the contracts apart from special contract. 4.0 Duties 4.1 General
118、 Manager: be responsible for approval of the Company s contracts involving profits and risks and production plan. 4.2 Marketing Center: be responsible for summarizing sales forecasting data per month and submitting it to the PMC Department; accepting customers orders, reviewing contracts; communicat
119、ing with customers, tracing order status and effecting the shipment; surveying customer satisfaction, collecting and solving complaints from the customer, dealing with and following up the return products. 4.3 PMC Department: be responsible for working out production plan and convening relevant depa
120、rtments for review; tracing order status. 4.4 Quality Management Department: be responsible for handling and following up complaints from the customer. 4.5 Engineering Department: be responsible reviewing the feasibility of technological process. 4.6 Purchasing Department: be responsible for reviewi
121、ng the production plan of inventory. 4.7 Production Department: be responsible for reviewing the production plan of inventory. 4.8 Development Department: be responsible for reviewing the technology required by the customer. 5.0 Procedure contents 5.1 Marketing Center should formulate Monthly Sales
122、Plan of next month before 30th per month according to requirements of customers. It should make the requests (name of commodity, item number, quantity) clear and submit production plan to PMC Department with the approval of Sales Director. If this manual is printed, it is an UNCONTROLLED copy.Docume
123、nt Name Customer Related Process Procedure Page Code 2/7Version A/0 Document Code QM-COP-0 5Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 5.2 Determination of requirements related to the product. 5.2.1 Marketing Center should know customer s requirements in time. 1) Marketing Center communic
124、ates with the customer any time or at regular intervals. The methods include written inquiry, fax, e-mail, telephone and site instruction for the customer. The contents include information, price and delivery date of products, handling and modification of the order, feedback and complaints from the
125、customer. Technical Center with communicate with the customer if there is any problem concerned with technology. 2) Ensure the order requirements of the customer. The requirements related to the product include: requirements specified by the customer, including the requirements for delivery and post
126、-delivery activities, such as the requirements for quality, functions, property, delivery date, supportive service (e.g. transportation) of products, etc. requirements not stated by the customer by necessary for specified or intended use. These are implicit requirements in practice and the Company s
127、hould make commitment for that. statutory and regulatory requirements applicable and related to the product. any user training required for ensuring the property and safe handling of medical devices. any additional requirements determined by the Company. 5.3 Review of requirements related to the pro
128、duct 5.3.1 Timing of the review This review should be conducted prior to our commitment to supply a product to the customer (e.g. before signing a contract) and shall ensure that the product requirements are defined and the Company has the ability to meet the defined requirements. 5.3.2 Review of ge
129、neral contract: it shall be signed by General Manager with his signature and seal and archived by the Marketing Center. 5.3.3 Review of special contract: the Marketing Center is responsible for convening relevant departments and conducting the review. Each department fills in the Review Sheet for Co
130、ntract and writes down their opinions, which will be approved by General Manager. 5.3.4 Main contents of the review 1) whether the requirements related to the product are included in the contract. 2) whether the requirements (e.g. quality requirement, methods for check and accept, warranty clause) o
131、f the contract or the order, which are stated in a different way from previous ones, have been solved through negotiation. 3) whether the Company is capable enough to meet the defined requirements (e.g. production equipment capacity, technical capacity, lead time, supply ability of raw material). 4)
132、 whether accord with the statutory and regulatory requirements. 5) whether any training requirements identified can be met. 5.3.5 Participants of the review If this manual is printed, it is an UNCONTROLLED copy.Document Name Customer Related Process Procedure Page Code 3/7Version A/0 Document Code Q
133、M-COP-0 5Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 The participant should be technician and administrative staff being responsible for or engaged in the production. They should fully express their opinions in terms of the clauses in the contract during the review. Marketing Center: be re
134、sponsible for reviewing the legitimacy, completeness, accuracy and special requirements whether there is training manual for the customer. PMC Department: be responsible for reviewing the supply of materials and production capacity and whether the lead time can be achieved according to this review,
135、etc. R&D Department: be responsible for reviewing whether the technical requirements conforming to the original design or meeting the expected use. Responsible for ensuring the statutory and regulatory requirements related to production and security, etc. Engineering Department: be responsible for r
136、eviewing the feasibility of technological process and capacity of production equipment. Quality Management Center: be responsible for reviewing whether there is unclosed quality problem and quality technical requirements can meet the customer s requirement standard. 5.3.6 The consequence of the revi
137、ew should be recorded. The solutions of the problems mentioned during the review and follow-up measures took to realize the review results should be recorded in the Review Sheet of Contract. 5.3.7 The oral requirements of the customer should be written in a file, which should be reviewed and confirm
138、ed by the customer to ensure the agreement by both parties. 5.3.8 Upon the review, the Marketing Center should distribute the relevant clauses of the contract to relevant departments, which should perform according to the clauses of the contract. 5.3.9 The Marketing Center communicates and negotiate
139、s with the customer if the review fails. The Sales Director or General Manager makes conclusive opinions according to the result of the negotiation. 5.4 Modification of the contract 5.4.1 When the customer or the Company puts forward the amendment request, the customer must replace an order to the M
140、arketing Center. The modified order will take effect after being signed by both sides, being reviewed again and signed. Then the original order loses efficacy. 5.4.2 After the modification, provide the relevant departments with the new contract. 5.5 Communications with the customer 5.5.1 Marketing C
141、enter provides the Company s publicity material and introduces the product for the customer through various channels. 5.5.2 When receiving the inquiry: Domestic: when receiving the inquiry, Marketing Center arranges the sales personnel to communicate with the customer and introduce the Company and t
142、he product in a proper way. The R&D Department and technical instructor shall offer proper assistance when necessary. If this manual is printed, it is an UNCONTROLLED copy.Document Name Customer Related Process Procedure Page Code 4/7Version A/0 Document Code QM-COP-0 5Edited/Revised Date 2018.10.24
143、 Issued Date 2018.10.24 International: Sales personnel send inquiry information to the sales people of each region. Sales personnel appointed contacts the customer and introduces the Company and the product in a proper way. R&D Department and the technical instructor shall offer proper assistance wh
144、en necessary. 5.5.3 Marketing Center should keep contacting the customer and inform of the situations, like production schedule of the product. 5.5.4 The complaints from the customer should be handled according to the Customer Complaints Handling Control Procedures. 5.6 Delivery of the product. Dome
145、stic: Transport company returns the signature form so that the Company can back up. International: Express: Take the receipt and feedback of goods in the official website as an evidence of delivery. Transportation by air or sea: Take the air or ocean bill of lading submitted to the customer as an ev
146、idence of delivery 5.7 Customer training The training is provided by the Marketing Center to operate and maintain the customer. The result of the training can be evaluated in a form of satisfaction survey. 5.8 Survey on the customer satisfaction. Sales Department should establish customer archive, i
147、ncluding all terminal customers and partners (e.g. dealers, alliance businesses) to ensure timely collection and feedback from the customers. 5.8.1 Items of monitoring and measurement. 1) quality of the product 2) customer communication and service 3) handling of complaints 4) timely delivery 5) pri
148、cing of the product 5.8.2 Marketing Center conducts a survey on customer satisfaction in December each year, calling back to the customer or letting customer fill in the Survey on Customer Satisfaction, which should be returned within 10 workdays. 5.8.3 When the customer comes to visit, the relevant
149、 contents of the communication with the customer should be recorded in the Survey on Customer Satisfaction, which must be confirmed by the customer or its representative. 5.8.4 Marketing Center summarizes and analyze the Survey on Customer Satisfaction. 5.8.5 Evaluation methods of customer satisfact
150、ion. Product Quality: 50%; Handling of Customer Complaints: 10%; Service Quality 10%; Timely Delivery: If this manual is printed, it is an UNCONTROLLED copy.Document Name Customer Related Process Procedure Page Code 5/7Version A/0 Document Code QM-COP-0 5Edited/Revised Date 2018.10.24 Issued Date 20
151、18.10.24 10%; Price : 10%; Technical Training: 10% Item Very satisfied Satisfied So-so Dissatisfied Very dissatisfied Product Quality 90-100 80-90 60-80 40-60 0-40 Handling of Customer Complaints 90-100 80-90 60-80 40-60 0-40 Service Quality 90-100 80-90 60-80 40-60 0-40 Timely Delivery 90-100 80-90
152、 60-80 40-60 0-40 Price 90-100 80-90 60-80 40-60 0-40 Technical Training 90-100 80-90 60-80 40-60 0-40 The point of a single item is the weighted average of all points according to the number of question. For example, there are two questions about the quality of the product, then each question accou
153、nts for 50%. A single customer s total point of satisfaction is the weighted average of six items above, it means satisfaction if the total point exceeds 80, otherwise, it means dissatisfaction. 5.8.6 The general result of the survey on customers: if the number of satisfied customer accounts for or
154、more than 85% of the whole number of participants, it reaches the standard. 5.8.7 In case of a “ Dissatisfaction” appeared on the Survey on Customer Satisfaction, the Marketing Center needs to investigate and handle it. If the dissatisfaction is caused because of the Company, the Report on Correctiv
155、e and Preventive Action should be filled in and modification requirements should be put forward. Deal with the problem as a complaint, where necessary. 5.9 The Marketing Center shall establish the customer-related archive including the contract, sales records, material and information, etc. The sale
156、s records should include the name, specification, model number and quantity of medical device, batch number, period of validity, sales date, name of purchasing unit, address, contact number, etc. 5.10 Marketing Center is responsible for keeping relevant records. 6.0 Records and Forms 6.1 Review Shee
157、t of Contract 6.2 Monthly Sales Plan 6.3 Survey on Customer Satisfaction 6.4 Report on Corrective and Preventive Action 7.0 Flow Chart If this manual is printed, it is an UNCONTROLLED copy.Document Name Customer Related Process Procedure Page Code 6/7Version A/0 Document Code QM-COP-0 5Edited/Revise
158、d Date 2018.10.24 Issued Date 2018.10.24 Determination of the requirements related to the productStartReview of the requirements related to the product Approval of Vice/ General ManagerGiven out to each departmentModification of ContractArchivingEndNYMonthly sales planProduction Plan (inventory)Gene
159、ral contractSpecial contractWhether there is any inventoryArrange the productionAdjust the production planEffect the shipment directlyApproval of Vice/ General ManagerDetermination of the requirements related to the productYNYNIf this manual is printed, it is an UNCONTROLLED copy.Dongguan DaMei Appl
160、iances LimitedDocument Name Customer Feedback And Complaints Handling Procedure Page Code 1/6Version A/0 Document Code QM-COP-0 6Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 1.0 Purpose To establish the handling process and duties of the complaint from the customer, adopt effective correcti
161、ve and preventive actions, timely deal with and eliminate the impact on the customer due to nonconforming or invalid product, prevent the nonconformity happening again, protect the product quality and service reputation of the Company and win the customer s satisfaction. 2.0 Scope It is applicable t
162、o the Company s feedback to the customer and handling of its complaint (including claims). 3.0 Definitions N/A 4.0 Duties 4.1 Marketing Center: be responsible for receiving feedback from the customer, accepting, collecting and handling the complaint and conveying it to relevant departments in time.
163、4.2 Quality Management Department: be responsible for investigating and handling the customer s complaint. 4.3 Relevant Departments: be responsible for reviewing the complaint and feedbacks from the customer, analyzing the causes, working out and taking the corrective and preventive actions, and ver
164、ifying the effect of those actions. 5.0 Procedure Contents 5.1 Reception of the complaint When receiving the complaint from the customer via formal letters, fax, e-mail or other oral and informal forms, or receiving the returned product carried by relevant people or sent by mail, courier, air transp
165、ort, Marketing Center should accept it and record it uniformly on the Customer Complaint and Track Handling Record Form. The returned product should be submitted to Maintenance Department and handled according to the Regulations on After-sale Maintenance. 5.2 Marketing Center shall evaluate whether
166、the complaint needs to be investigated according to following evidence and records the result on the Customer Complaint and Track Handling Record Form. 5.2.1 No investigation is required in the following situations: 1) a problem is caused due to improper use of the customer. 2) a complaint is caused
167、 because of the service attitude. (The same complaint from three or more customers needs investigation). If this manual is printed, it is an UNCONTROLLED copy.Dongguan DaMei Appliances LimitedDocument Name Customer Feedback And Complaints Handling Procedure Page Code 2/6Version A/0 Document Code QM-
168、COP-0 6Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 3) the specific situation and duty of a complaint can be judged obviously. 4) the similar complaints have been investigated and it s unnecessary to do it again. 5.2.2 When evaluating the complaint unnecessary to be investigated, record the
169、 reason and the name of the person who made the decision on the Customer Complaint and Track Handling Record Form. 5.2.3 Inform the Management Representative at once if the proportion of a complaint or feedback increases significantly. 5.3 Investigation of the complaint 5.3.1 Items to be investigate
170、d The investigation will be performed under the leadership of the Marketing Center and Quality Management Department with assistance of other departments. The records of the investigation should include: 1)The date of receiving the complaint, the name, address, and telephone number of the person who
171、 complained. 2)The name, model number, control number or serial number of the instrument complained. 3)The nature and details of the complaint, root cause and accountability. 4)The date and result of the investigation, name of investigator. 5)All temporary treatment measures and corrective and preve
172、ntive actions adopted. 6)All responses to the complaint. 7)Whether the instrument achieves the standard. (if the complaint need to be conveyed to the competent authority) 8)Is the instrument in use? (if the complaint need to be conveyed to the competent authority ) 9)The relations between the instru
173、ment and the accident or adverse event, if any. (If the complaint need to be conveyed to the competent authority) 10)Is there any connection between the complaint content and external factors? 5.4 Review of the complaint Marketing Center convenes the staff of relevant departments and conducts a revi
174、ew directed to different complaints: The problems of product quality: Convene the staff of R&D Department, Examining Department, Engineering Department, Production Department and Purchasing Department. The problems of service: Convene relevant staff like sales people, training instructor, engineer o
175、f after-sale maintenance. The problems of compensation: Convene relevant staff of business, finance and senior management. Review the cause and accountability of the complaint according to the investigation. Record the result and the signature of participants on the Customer Complaint and Track Hand
176、ling Record Form. If this manual is printed, it is an UNCONTROLLED copy.Dongguan DaMei Appliances LimitedDocument Name Customer Feedback And Complaints Handling Procedure Page Code 3/6Version A/0 Document Code QM-COP-0 6Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 The conclusion of the revi
177、ew should include: 5.4.1 The root cause of the complaint, accountability unit and the person in charge of the follow-up work. 5.4.2 The involved range and handling of the complained product. 5.4.3 The treatment of the complaint. 5.4.4 Whether the product sold has same problem and need to be recalled
178、. 5.4.5 Is it necessary to launch the corrective and preventive action procedure? The corrective and preventive action procedure need to be launched in following situations: The complaint is about equipment user security; The complaint is about equipment property; The complaint is about nonconformin
179、g label or package; The complaint has been repeated for 3 times or more; These complaints above should be handled according to the Control Procedures for Corrective and Preventive Actions. 5.4.6 Whether the complaint needs to be reported to the competent authority. 1) If the equipment in the market
180、may lead or has led to death or serious injury according to the conclusion that is made from the received information of the accident or previous information; 2) If a set of equipment breaks down, and this equipment or similar equipment in the market may lead to death or serious injury when the brea
181、k happens again. Inform the Management Representative in time if the situations above happen and handle them according to the Adverse Event Monitoring and Revaluation Control Procedures in China, the Warning System Control Procedures in the EU and the FDA Product Incidents Report Procedures in the U
182、S. 5.5 Handling of the complaint General requirements: Each department need to take specific measures directed at each complaint according to the result of complaint review. 5.5.1 If the complaint is not caused by the Company s production process and the customer should undertake the responsibility,
183、 Marketing Center should, according to the investigation result, explain to the customer to satisfy him with the additional explanation of Engineering Department or other departments if necessary, and then record the result on the form. 5.5.2 If the Company should be responsible for the complaint, t
184、he Marketing Center should pacify the customer the first time and inform him that our Company will handle the problem in time, the concrete process is the same as 5.5.3-5.5.7. 5.5.3 Where the customer returns the product or asks for on-site service, the Maintenance Department should handle these pro
185、blems according to the Regulations on After-sale Maintenance. 5.5.4 Handling of the inventories, work in process and raw materials If this manual is printed, it is an UNCONTROLLED copy.Dongguan DaMei Appliances LimitedDocument Name Customer Feedback And Complaints Handling Procedure Page Code 4/6Ver
186、sion A/0 Document Code QM-COP-0 6Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 The responsible departments should make temporary strategy according to the review and adopt relevant actions for the inventories, work in process and raw materials. The Quality Management Department supervises th
187、e progress of the actions. 5.5.5 Handling of the product that might be complained after delivery The Marketing Center sends suggestive notification to the user, if necessary. Recall the product if the equipment needs examination, repair, replacement, recall and destruction. If there is improvement m
188、easure for subsequent products or engineering change that will influence the property and security of the product, Marketing Center should give a notice to the customer immediately. The issue should be handled according to the Control Procedures for Compulsory Problem Notice and Recall. 5.5.6 Where
189、the complaint asks compensation and is approved, marketing staff apply for relevant compensation for the customer who complained. 5.5.7 If an apology is asked, marketing staff shall make apologies according to the reasonable requirement. 5.5.8 If the complaint has connection with external factors, c
190、onvey the relevant information to relevant organizations and exchange information. 5.6 Response to the complaint 5.6.1 Response to the complaint about intangible product According to the investigation, the result of the review, solutions and its effect, marketing staff should communicate with the cu
191、stomer who complained and convey his requirements to the Company in time. 5.6.2 Response to the requirements about returning the tangible product or asking for on-site services 1) According to the investigation, the result of the review, measures and its effect, marketing staff should communicate wi
192、th the customer who complained and convey his requirements to the Company in time. 2) Repair the returned product and return it to the customer. Refer to the Regulations on After-sale Maintenance. 3) Handling of the requirements for on-site services refers to the Regulations on After-sale Maintenanc
193、e. 5.7 Settlement of the complaint When the corrective and preventive actions are effective and the customer feels satisfied with our response, the case is settled. 5.8 Documents of the complaint 5.8.1 Upon the settlement, the Marketing Center should archive the relevant documents and records and ke
194、ep them uniformly. If this manual is printed, it is an UNCONTROLLED copy.Dongguan DaMei Appliances LimitedDocument Name Customer Feedback And Complaints Handling Procedure Page Code 5/6Version A/0 Document Code QM-COP-0 6Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 5.8.2 In terms of the pro
195、duct sold abroad, a piece of complete complaint record should be kept by the agents in the EU or the US. 6.0 Records and Forms 6.1 Customer Complaint and Track Handling Record Form 7.0 Flow Chart If this manual is printed, it is an UNCONTROLLED copy.Dongguan DaMei Appliances LimitedDocument Name Cus
196、tomer Feedback And Complaints Handling Procedure Page Code 6/6Version A/0 Document Code QM-COP-0 6Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 Customer complaintsAccept the complaintsInvestigate or notComplaint responseComplaint investigationComplaint responseReport to the competent authori
197、ty?Start CAPA or notCorrective and preventive actions Adverse event monitoring and revaluation control procedure否YYYEndCustomerCustomerEndNNComplaint handlingComplaint reviewCorrective and preventive actions reportIf this manual is printed, it is an UNCONTROLLED copy.Document Name Design and Develop
198、 Control Procedures Page Code 1/15Version A/0 Document Code QM-COP-0 7Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 1.0 Purpose To control the design and development process to ensure that the product designed and developed meets the functional, performance and safety requirements specified
199、for the intended use, and to ensure that the customers requirements and the relevant laws and regulations are satisfied. 2.0 Scope It is applicable to the medical devices designed and developed by the Company, including the development of new products and the technical improvement of old products. 3
200、.0 Definitions 3.1 Project 3.1.1 New Product/New Technology Project: a project for designing and developing a brand new product or new technology research. 3.1.2 Pre-research project: refers to a series of research projects that focus on a problem or a new technology. The outcome of the project does
201、 not necessarily form a finished product, but mainly for the purpose of technological breakthroughs and new ideas development. 3.1.3 Product Restructuring Project: refers to the projects in which the existing basic products of the Company will be changed to meet the requirements, such as cost improv
202、ement, design optimization, etc. 3.1.4 Special Project: refers to the projects with the temporary emergency tendering prototype design or special requirements proposed by users. The development process of such projects can be flexibly adjusted. 3.2 Design and Development: refers to a set of processe
203、s that convert requirements into the specified characteristics or specifications of a product. Design and development are sometimes synonymous, and sometimes used to define the different stages of the design and development process. 3.3 Design: specifically refers to the design process proceeded to
204、satisfy the special contract and product technical improvement based on the approved product. 3.4 Development: specifically refers to a process of new product required to be approved, and requiring a systematic, comprehensive and complete design. 3.5 Review: refers to an activity undertaken to deter
205、mine the suitability, adequacy and effectiveness of the subject matter in achieving the stated objectives. 3.6 Validation: refers to the determination that the required requirement has been satisfied by providing objective evidence. 3.7 Design Transfer: refers to the activities carried out to transf
206、er the new product from R & D stage to the production stage. 3.8 Validation: refers to a determination that a given intended use or application has been satisfied by providing objective evidence. 3.9 Risk Management: refers to a series of activities such as identifying, analyzing, evaluating and If
207、this manual is printed, it is an UNCONTROLLED copy.Document Name Design and Develop Control Procedures Page Code 2/15Version A/0 Document Code QM-COP-0 7Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 controlling the risks that may exist when designing, developing and using products. 3.10 Prod
208、uct Master Record (DMR): refers to the instructive and standard documents when a new product is manufactured. 3.11 Design History File (DHF) of product: refers to records describing the design process of a new product. 4.0 Duties 4.1 Marketing Center The Marketing Center is responsible for organizin
209、g market research and data collection. Based on the results of the survey, it proposes project plans and fills out the Project Demand Application Form for such project. 4.1.1 Head of the Marketing Center 1) be responsible for organizing the personnel of Marketing Center to collect information and es
210、tablish relevant samples; 2) participate in the Companys product planning, organize the formulation of competitive strategies and product business plans for the products, and increase their market competitiveness; 3) participate in the review of new product development and design processes, clarify
211、the functions and positioning of new products, and optimize and improve the product structure. 4.2 R & D Department 4.2.1 Manager of the R & D Department 1) establish a project development team and formulate a Project Development Proposal. 2) organize key node design reviews to make the design outpu
212、t indicators meet the requirements of the Design Input Specification. 3) be responsible for solving the coordination of technical supports by departments involved in the design, and to assist developers in completing the design plan. 4) be responsible for the companys technology platform constructio
213、n and technical management. 4.3 Project team 4.3.1 Project leader 1) be responsible for organizing and coordinating the overall activities of project development. 2) perform the longitudinal performance evaluation of project team members. 3) act as the main contact person for the project team and th
214、e various departments. 4) monitor the product development quality, schedule and cost control. 5) establish the product design and development history files. 6) be responsible for organizing the project team to conduct product design and development risk management activities. If this manual is print
215、ed, it is an UNCONTROLLED copy.Document Name Design and Develop Control Procedures Page Code 3/15Version A/0 Document Code QM-COP-0 7Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 4.3.2 Members of project team 1) Complete the design planning and design tasks based on the design requirements.
216、2) Participate in verification and review of all stages. 4.4 Review team 4.4.1 The project review team can be composed of senior executives, departmental backbones, and members of project team and experts to provide a clear judgment as to whether the effectiveness of each stage of design and develop
217、ment meets the requirements and provide clear information to determine whether to proceed to the next stage. 4.4.2 The leader of review team shall be appointed by top management of the Company. Before the project is designed and developed, the leader shall be responsible for or cooperate with the Co
218、mpanys top management to approve the projects to be developed. The leader of review team shall also be responsible for the final decision of all development stages, and decide whether the design and development approach into the next stage. 4.5 Quality Management Department 4.5.1 be responsible for
219、the testing and recording of the machine and prototype in design and development stage. 4.5.2 be responsible for product clinical research activities and summarizing the clinical research report. 4.6 Engineering Department 4.6.1 be responsible for the tracking of the small batch trial production and
220、 activities at production stage of the products designed and developed. 4.6.2 be responsible for the development of product technology standards, process flow chart and the verification and validation of special processes. 4.6.3 train production personnel and assist production personnel in solving c
221、orresponding technical problems. 4.7 Manufacturing Center Cooperate with the completion of batch trial production and transfer of production, and summarize the problems arising during the trial production and production transfer, put forward suggestions for modification, and procure the R & D Depart
222、ment to continuously improve the design quality. 5.0 Procedures 5.1 Design and development planning According to customer demand or market development trend, the Marketing Center conducts targeted market research, puts forward suggestions on developing new product, and forms the Application Form If
223、this manual is printed, it is an UNCONTROLLED copy.Document Name Design and Develop Control Procedures Page Code 4/15Version A/0 Document Code QM-COP-0 7Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 for Project Requirements, which is approved by the director of Marketing Center and approved
224、by the general manager. 5.1.1 The General Manager shall designate the project leader, who shall prepare the Project Development Proposals. The specific content shall include the followings: 1)project leader, project name, project source, project category, market positioning, intended use, project ou
225、tput and implementation time limit; 2)design and development of each stage; 3)required reviews for each design and development stage; 4)verification, validation and design transfer activities for each design and development stage; 5)the role, interface, responsibility and authority of the key person
226、nel of the project team; 6)the role, name and department of the main members of the review team; 7)the methods used to ensure that the design and development are output to design and development input traceability; 8)the resources required for the entire project, including the necessary capacities o
227、f personnel. 5.1.2 review of the Project Development Proposal The project leader organizes review of the Project Development Proposal on the basis of the customers needs and the intended use, and solve the imperfect, ambiguous or contradictory requirements. Review will take the form of countersignin
228、g. After the review, the Project Development Proposal and the review records should be filed and provided to relevant personnel. 5.1.3 The project team identifies, analyzes and evaluates the risks existing in the design and development of the product, and takes corresponding measures to reduce and a
229、void the related risks, also, it tracks regularly and outputs the Risk Management Report. Refer to the Risk Management Control Procedures for details. 5.2 Design input 5.2.1 After the project is approved, the project team will extract the design input requirements based on the customer needs and int
230、ended use in the Project Development Proposal. The project design and development tasks shall be refined and distributed, to form the Design Input Specification and the Project Schedule for the design and development, and to ensure that the project will be completed as planned. 5.2.2 Inputs include:
231、 1)The main contents of the project, including the intended use of the product, function, performance, availability, safety, user and customer requirements, the market scope of products and reference materials for design and development; 2)Applicable legal and regulatory compliance requirements; 3)T
232、he system design requirements, including the name and model name of the complete machine, and the design specifications for the entire structure, industry, software, hardware, and human-machine interface; If this manual is printed, it is an UNCONTROLLED copy.Document Name Design and Develop Control
233、Procedures Page Code 5/15Version A/0 Document Code QM-COP-0 7Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 4) The experiment requirements of the machine; 5) Clinical evaluation program; 6) Labelling and identifications; 7) Requirements for packaging, storage and transportation; 8) Risk Manag
234、ement Report; 9) Record changes to the design specifications during the development process; 10) Where appropriate, the information provided by the previous similar designs. 5.2.3 The project team outputs the Design Input Specification based on the design input to identify the full scope of work and
235、 to disassemble the tasks; while review them to determine that the requirements are not contradictory and can be verified or validated. 5.2.4 Changes of the Design Input Specification In case of following circumstances, the Design Input Specifications shall be modified: 1) The customer or other depa
236、rtment makes a change request. 2) There are major changes (including design plan, quality, specification, completion date, etc.) during the design review of some new products. 3) Difficulties in purchasing of some components or materials. The department or person who proposed the change must fill ou
237、t the Internal Contact List, state the reasons for the change, and related issues such as the time delay caused by the change and the cost of scrapped materials. The manager of R & D department will organize the review and review the content of the change, the corresponding impact, the potential imp
238、act of the change, whether a new risk will be introduced, as well as the change feasibility. Upon the approval by the General Manager, the reason and content of the change shall be stated in the change column of the Design Input Specification. If the development time, personnel distribution and risk
239、 management are affected, the Project Progress Schedule shall be changed accordingly. The project leader shall make change and record the reason and content of the change on the relevant form, which will be reviewed by the Marketing Center and approved by the higher management. If it is customized,
240、the change content and plan will be communicated with the customer and confirmed by the other party. 5.2.5 The project leader shall arrange the product design and development intervals according to the Project Development Proposal, the Design Input Specifications and the requirements of the Company,
241、 and formulate a detailed Project Progress Schedule. 5.2.6 Review at design input stage The project leader shall review the design input stage and make and record according to the requirements of customers and the intended use. 5.3 Design output 5.3.1 Perform the design and development based on the
242、design content. Each process needs to be reviewed and documented. If this manual is printed, it is an UNCONTROLLED copy.Document Name Design and Develop Control Procedures Page Code 6/15Version A/0 Document Code QM-COP-0 7Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 Develop the Design Outpu
243、t Schedule according to the Design Input Specification and its review records. The contents shall include: a. samples, processing plans, production and assembly process and process design; b. standard classification details of the purchased materials; c. Product specifications or standards, product
244、acceptance criteria, packaging requirements, use & maintenance requirements. d. According to product characteristics, the product characteristics that are essential for safe and normal use shall be specified, including requirements for storage, use, handling, maintenance, and disposal. 5.3.2 Design
245、development output files should be expressed in terms of validating design development inputs in order to justify that they meet input requirements and to provide appropriate information for production operations. The design and development output files must be compared with the Design Output Schedu
246、le, including but not limited to the following documents: 1) Hardware design a. Schematics and schedules b. PCB drawings and schedules 2) Industrial design 1)Interface design drawing 2)Instrument appearance and structural design drawings 3) Wire specifications and schedules 4) Instruction manual 5)
247、Packing list of product 6) Technical requirements of product 7) Component inspection standards 8) Key components list 9) Special Process Validation Report 10) Operating instructions and schedules 11) Control plan 5.3.3 Output documents of design and development (including sample labelling and docume
248、ntation) should be approved by the project leader. 5.4 Design review The person leader should promptly organize the assessment and recording of the assessment results at all stages of development and design, and gradually solve problems appeared in the development process to ensure that the products
249、 comply with the input requirements. 5.4.1 Review at input stage: After the activities of project design input stage are completed, the review team is organized to review the adequacy and suitability of the Design Input Specification, and all participants shall sign it, and form a review record. If
250、this manual is printed, it is an UNCONTROLLED copy.Document Name Design and Develop Control Procedures Page Code 7/15Version A/0 Document Code QM-COP-0 7Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 5.4.2 Review at the output stage: The members of Project Team should complete the works of al
251、l stages in accordance with the schedule, and hand over the completed results such as schematic, PCB diagram, exterior design, interface design, structural drawings, software design and prototype to the project leader, who will then organize the relevant personnel to inspect and evaluate according t
252、o the corresponding design input requirements and confirm whether the design input requirements are met, and perform the risk management analysis for the design stage. The results and the optimization process are recorded in the Design Review Form and the Management Report. 5.4.3 Review at design tr
253、ansfer stage: the final review to the process and design before design transfer, to decide whether the mass production can be proceeded; the participants will sign the relevant document, which is to be reviewed by the project leader, and approved by the General Manager, and finally shall be archived
254、. 5.4.4 Review at design change stage: review the material changes in medical devices, including the effects of changes on product components and work-in-process or delivered products, and changes on the risk management inputs / outputs and the product realization process. 5.4.5 For the departments
255、participating in the assessment at each stage, the project leader shall select the relevant department from the following departments: A. Production Department B. Marketing Center C. Quality Management Department D. Engineering Department E. Purchasing Department F. Marketing Center G. Finance Depar
256、tment H. R & D Department Participants of the review: All functional representatives related to the design and development stages reviewed; People who are not directly responsible for the design stage being reviewed; Experts, as necessary. 5.4.6 Record the results of the review and any necessary act
257、ions. 5.5 Design verification 5.5.1 Design verification is used to prove that the design output meets the requirements of the design input. The object to be verified shall include hardware modules, software functions, structural components, interface design, and the functions and performance of the
258、complete machine; verification plans should be developed, including the verification methods and acceptance guidelines. Design verification should be done following the Verification Plan. 5.5.2 The methods that can be used for design verification shall include: 1) design review; 2) calculate using t
259、he transformation method to verify the correctness of the original calculation structure and analysis; 3) compare new designs with proven similar designs when possible; 4) perform tests and verifications, such as model and sample tests; If this manual is printed, it is an UNCONTROLLED copy.Document
260、Name Design and Develop Control Procedures Page Code 8/15Version A/0 Document Code QM-COP-0 7Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 5) perform the independent verification to verify the original calculation results and the correctness of other design activities; 6) review the pre-rele
261、ase design stage documents. Project Team should carefully analyze the verification needs, determine the correct method to obtain effective and economical verification results. 5.5.3 Design verification must retain the necessary verification records, so as to verify the correctness and feasibility of
262、 the design verification. Records include the contents of activities of the design verification stage, and should include at same time: 1) the object of verification; 2) verification steps and methods; 3) validation data and results; 4) verification of the existing problems and treatment measures; 5
263、) name of personnel and date of verification; 6) summary of verification and signature and approval by the project leader. 5.5.4 Trial production in small batches 1) According to the progress of the project, the project leader shall notify the Purchasing Department, R & D Department, Engineering Dep
264、artment, Quality Management Department and Production Department to perform the trial production when the trial production is required according to the progress of the project, and introduce the product requirements, special processes, appearance structures and precautions to all departments, and di
265、stribute the design information to departments such as the Engineering Department and Quality Management Department. 2) The Engineering Department shall prepare the tools and fixtures, work instructions and process documents according to design data and prototype, the Quality Management Department s
266、hall prepare the inspection procedures and inspection standards based on the design data, and the Purchasing Department shall assists with the purchase of small batch of required materials required based on design data. All the records should be internally approved. 3) If there re special requiremen
267、ts over the product (especially small batch before transferring to production), the Engineering Department should carry out careful planning of the production process. The core of the planning is how to take control measures against the factors that affect product characteristics (people, machines,
268、materials, laws and links); 4) After the trial production begins, the Engineering Department should lead the trial production work, guide the production operations, follow up the production, and organize the analysis and handling for the abnormalities appeared in trial production process. Quality Ma
269、nagement Department and engineers from the project team shall track trial production, and be responsible for the handling and recording of trial production anomalies. 5) Upon the trial production, the Engineering Department should collect the problems of trial production data, and the R & D Departme
270、nt, Engineering Department, Production Department, Quality Management If this manual is printed, it is an UNCONTROLLED copy.Document Name Design and Develop Control Procedures Page Code 9/15Version A/0 Document Code QM-COP-0 7Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 Department and the P
271、urchasing Department will, led by the Project Team, hold the trial production meeting to assess whether the trial production results meet the design input requirements and conditions of change of production line, and to optimize the design and modify the existing problems. Meanwhile, they shall prep
272、are the Trial Production Report, which shall be signed by the attendees, and be approved by the project leader. Moreover, they shall follow up trial production problems handling and closing, and sort the design information to make it be controlled. 5.6 Design validation 5.6.1 The purpose of design v
273、alidation is to ensure that the device meets the specified user needs or intended use. A validation plan should be prepared that contains: a method of validation and acceptance guidelines. Design validation should be done in accordance with the Validation Plan. The general design validation should i
274、nclude: Clinical or performance evaluation required by applicable regulations (e.g. 94/43 / EEC); Testing of product under actual or simulated conditions of use. 5.6.2 Clinical assessment Clinical evaluation of medical devices refers to the process of validating whether the products meet the require
275、ments for use or scope of application by using the clinical literature, clinical experience data, clinical trials and other information. 5.6.3 Risk management Re-evaluate the risks at all stages of design and development and update the Risk Management Report. For details, please refer to the Risk Ma
276、nagement Control Procedures. 5.6.4 Software validation Validate the developed software according to customer needs and intended use, check whether the input requirements can be achieved, form the Software Validation Report, and record the validation program and the results. 5.6.5 Design validation m
277、ust retain the necessary validation records, to demonstrate the validity of the design validation. Records include the contents of design validation stage, including: 1) the object to be validated; 2) the steps and methods of validation; 3) validation data and results; 4) the problems validated and
278、treatment measures; 5) personnel and date of validation; 6) the conclusion of the validation and the signature and approval by the project leader. 5.7 Design transfer 5.7.1 The design transfer mainly involves the following activities: 1) Form the production specifications according to the design out
279、put document, and all departments of If this manual is printed, it is an UNCONTROLLED copy.Document Name Design and Develop Control Procedures Page Code 10/15Version A/0 Document Code QM-COP-0 7Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 manufacturing system shall perform the trial product
280、ion in small batches. 2) The project team shall offer training to the personnel of manufacturing system on design changes. 5.7.2 The design transfer should be completed jointly by the Production Department, Quality Management Department, Purchasing Department, Planning Department, Engineering Depart
281、ment, and R&D Department. 5.7.3 After the design transfer is completed, the R & D Department shall organize the relevant department to hold the review meeting, and control and issue the documents that are formed after the design transfer. 5.7.4 The Design Transfer Schedule shall be outputted. 5.8 De
282、sign change 5.8.1 Design change identification 1) Any relevant personnel involved in product design, design documents, process documents and products may apply for design changes to the existing defects in the design; 2) Due to the constraints in process adjustment, equipment testing capacity, diffi
283、culties in purchase, outsourcing and processing and design defects feedback made by customers, as well as changes in the applicable laws and regulations, the relevant departments apply the design changes; Applications for design changes are proposed in the form of Internal Contact List. They are sub
284、mitted to the R&D Department upon filling by the application department. The R&D Department should send the feedback information to the application department as to whether or not to accept the changes. 5.8.2 Planning and implementation of design changes 1) The R & D department analyzes the applicat
285、ion for change made in the Internal Contact List and determines the plan for the change. If the design changes are required, the R & D department should fill out the Notice of Engineering Change, review the Notice by signing, and evaluate the scope of the change and its impact, to identify whether t
286、here is a new risk. After signing by the departments, the head of R & D Department shall approve the Notice of Engineering Change, which shall be submitted to the Document Control Center for controlling and be issued to the departments. 2) If the change involves changes related to the customer, the
287、salesperson needs to communicate with the customer and inform the relevant personnel or obtain the consent from customer. 3) During the process of design and development, the design and development draft that has not been approved can be directly modified (signed) or re-compiled by the design and de
288、velopment staff on the draft of the design and development. 5.8.3 Verification and validation of design change When the change involves the main technical parameters, functions, performance, usability, personal safety and relevant laws and regulations, the design and development changes shall be rev
289、iewed, verified and confirmed according to the risks arising from the changes. Risk analysis shall be carried out if necessary. It can only be implemented after the approval of the General Manager. If this manual is printed, it is an UNCONTROLLED copy.Document Name Design and Develop Control Procedu
290、res Page Code 11/15Version A/0 Document Code QM-COP-0 7Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 5.8.4 Post-marketing product changes should be reviewed in accordance with local regulations (e.g. 21CFR 807 and 93/42 / EEC) to determine whether the change will affect the main performance
291、and intended use of the product and decide whether to re-submit the change instructions to the competent authority in place where the sales proceed. 5.8.5 The results of the review of the changed project and the recording of measures taken shall be kept by the Document Control Center for the purpose
292、 of management of technical conditions. 5.9 Design History File (DHF) Records related to the design process of medical device product, including the design planning documents, design input documents, records of design reviews, plans and reports of design verification and design validation, design ou
293、tput documents and risk management documents, should be documented in a DHF. The DHFs shall include as follows: 5.10 Product master record (DMR) Department Name of DHFs Marketing Center Project Requirements Application Form R & D Department Project Development Proposals Project team Risk Management
294、Report, Design Input Specification, Project Schedule, Design Output Schedule, Prototype Test Report, Commissioning Record of Complete Machine, Verification Plan, Validation Plan, Design Transfer Schedule Engineering Department Trial Production Report Clinical Department Laboratory Report Review Team
295、 Project Development Plan Review Form, Design Input Specification Review Form, Schematic Design Review, PCB Design Review, Instrument Exterior Design Review, Structural Design Review, Design Review Form, Prototype Evaluation Form, Design Review Form (Output) Department Name of DHFs If this manual is
296、 printed, it is an UNCONTROLLED copy.Document Name Design and Develop Control Procedures Page Code 12/15Version A/0 Document Code QM-COP-0 7Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 6.0 Records and Forms 4 6.1 Project Requirements Application Form 6.2 Risk Management Report 6.3 Design In
297、put Specifications 6.4 Project Schedule 6.5 Project Development Proposal 6.6 Prototyping Testing Report 6.7 Verification Plan 6.8 Validation Plan 6.9 Trial Production Report 6.10 Review Form 6.11 Notice of Engineering Change 6.12 PCB Drawings 6.13 Structural Drawings 6.14 BOM List 6.15 Product Instr
298、uction Manual 6.16 Product Packing List 6.17 Product Technical Requirements 6.18 Component Inspection Standards 6.19 Key Components List 6.20 Work Instructions and Schedules 6.21 Special Process Validation 6.22 Control Plan 7.0 Flow Chart R & D Department Engineering Change Notice, Machine Principle
299、 Frame Diagram, Schematic and Schedules, PCB Drawings and Schedules, Structural Drawings and Schedules, Interface Diagram, Wire Specifications and Details, BOM List and Schedule, Instruction Manual of Product, Product Packing List, Technical Requirements, Parts Inspection Standards, List of Key Comp
300、onents Engineering Department Work Instructions and Schedules, Special Process Validation Quality Management Department Control Plan, Inspection Specifications If this manual is printed, it is an UNCONTROLLED copy.Document Name Design and Develop Control Procedures Page Code 13/15Version A/0 Documen
301、t Code QM-COP-0 7Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 7.1 Design Change Flow Chart (Annex 1) Project completion Project approvalProject Requirements Application FormProject feasibility assessmentRisk Management ReportProject Development ProposalProject Development Proposal Review Fo
302、rmDesign InputDesign Input SpecificationDesign Input Specification Review Form Project Progress ScheduleDesign Output ScheduleDesign outputHardware Design and ReviewSoftware Design and ReviewIndustrial Design and ReviewSchematics and SchedulesSchematic design reviewPCB Drawings and SchedulesDesign r
303、eviewSoftware Program Schedule Software Design Review FormInterface DiagramInterface Design Review FormInstrument Appearance Design Review FormStructural designAssembly and debugging of complete machineComplete Machine Debugging RecordPrototype Test and ReviewPrototype Test ReportPrototype Review Fo
304、rmDesign reviewReview FormTrial Production ReportImprovement and OptimizationDesign verificationDesign validationDesign transferDesign Transfer ScheduleTrial Production Deport Schematics and SchedulesPCB Drawings and SchedulesInterface DiagramWire Specifications and SchedulesBOM list and SchedulesIn
305、struction ManualProduct Packing ListProduct technical requirementsComponent Inspection StandardsWork Instructions and SchedulesInductance Transformer ScheduleSoftware Program ScheduleKey components ScheduleSpecial Process Validation ReportQuality PlanValidation planClinical Laboratory Report Risk Ma
306、nagement ReportSoftware Validation ReportDesign Review FormOKNGNGOKProject cancellationSmall-batch trial production and reviewTrial Production ReportHardware debugging recordSoftware debugging recordSoftware test recordComplete Machine Debugging RecordPrototype test recordsIf this manual is printed,
307、 it is an UNCONTROLLED copy.Document Name Design and Develop Control Procedures Page Code 14/15Version A/0 Document Code QM-COP-0 7Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 7.2 Design Change Flow Chart (Annex 2) Implement the changeDesign change identificationDoes it affect the customers
308、 product?Make planning for change plan (to assess the scope of influence)Inform customers and communicateChange verificationChange validationChange reviewControlled at Document Control Center, and distributed to departmentsSign for approvalYNNot agreedAgreedIf this manual is printed, it is an UNCONT
309、ROLLED copy.Document Name Production Process Control Procedure Page Code 1/6Version A/0 Document Code QM-COP-0 8Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 1.0 Purpose To standardize the production process and control it effectively to ensure the process is under control and each productio
310、n process meets the requirements of the provisions, providing customers safe and effective products and services. 2.0 Scope It is applicable to all the activities that relate to the production process control. 3.0 Definition 3.1 Special process 3.1.1 The process of the product failing to pass the su
311、bsequent measurement or needing to be monitored for further confirmation. 3.1.2 The process of the product needing destruction experiment or failing to be measured or tested in an economic and convenient way. 3.1.3 The process of explosion of the poor quality after the product is used or delivered.
312、3.2 Key processes 3.2.1 The process that has direct impact upon the quality, performance, function, life, reliability and cost of the product. 3.2.2 The processes that is formed by the important quality characteristics of the product. 3.2.3 The process that is complicated and makes the quality easy
313、to fluctuate, requiring worker s higher skill or resulting in more nonconforming products. 3.2.4 The process that is particularly required by customers. 3.3 5S Audit team: It is formed by R&D Department, Production Department and Quality Management Department by dispatching one staff each. 4.0 Dutie
314、s 4.1 Administration Department: be responsible for recruiting the staffs who meet the requirements of the production positions and training them into qualified employees. 4.2 Marketing Center: be responsible for collecting the monthly sales forecasting data and send it to the PMC Department timely
315、in addition to reception of customer s orders and review of the contracts and orders. 4.3 PMC Department: be responsible for making production plans, material plans and controlling the production progress. 4.4 Warehousing Department: be responsible for safety storage of materials or finished product
316、s, advance preparation and distribution of materials for production in a correct amount. 4.5 Purchasing Department: be responsible for purchasing materials and tracking the delivery time of materials. If this manual is printed, it is an UNCONTROLLED copy.Document Name Production Process Control Proc
317、edure Page Code 2/6Version A/0 Document Code QM-COP-0 8Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 4.6 Production Department: 1) Responsible for arranging production, manpower and equipment according to the Production Plan to make sure each production and process is carried out smoothly. 2
318、) Responsible for repairing and treating the nonconforming products in the production. 4.7 Quality Management Department: 4.7.1 be responsible for inspecting the incoming material to ensure the material on the production line are all qualified. 4.7.2 be responsible for inspecting the semi-products,
319、finished products and parts at random during the production. 4.7.3 be responsible for random inspection of the finished products that have been entered the warehouse. 4.8 Quality Management Department: be responsible for supervising and auditing each process (including key process and special proces
320、s) in the production to ensure the processes are under effective control. 4.9 R&D Department: 1) Responsible for controlling the processes, making the Process Specification and Control Plan, testing tools, maintaining and treating the anomalies of regular production equipment and technical problems
321、of each process in addition to the technical renovation projects of complicated processes. 2) Responsible for solving the design problem occurring in the production, assisting in the cause analysis of difficult problems and offering suggestions on improvement. 5.0 Process content 5.1 Preparation bef
322、ore production 5.1.1 The Production Department is responsible for regular inspection and maintenance of the Work Environment. The R&D Department is responsible for complete inspection of electrical circuits, mechanical equipment and facilities as well as elimination of hidden dangers. The details sh
323、ould refer to the Control Procedures for Equipment and Work Environment. 5.1.2 5S audit team should inspect the production site at least once a month and rate with a check list. 5.1.3 The PMC Department makes production plans and material plans according to the forecast data provided by the Marketin
324、g Center (For details refer to the Control Procedure on Production and Material Plans), distributing the plans to the Quality Control Center, R&D Department, Warehousing Department, Production Department and Purchasing Department so that technology, purchasing, test and inspection can be prepared we
325、ll. 5.2 Technical documents (DMR) 5.2.1 There should a complete set of DMR documents which comes from R&D Technology Center for each instrument before production. 5.2.2 The Process Specification should be hanged on each process for workers to follow. If this manual is printed, it is an UNCONTROLLED
326、copy.Document Name Production Process Control Procedure Page Code 3/6Version A/0 Document Code QM-COP-0 8Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 5.3 Tools and equipment 5.3.1 The tools, equipment and specifications are provided by R&D Department to ensure all the worker who use the too
327、ls can find the exact specification for the equipment to operate. For the details on how to use and manage refer to the Control Procedures for Equipment and Work Environment. 5.4 Post training 5.4.1 The Administration Department is responsible for organizing the skill training while R&D Department a
328、nd Production Department are responsible for implementing the skill training to the workers who shall not operate until qualified in the examination. For the details refer to the Control Procedures for Human Resource Management. 5.5 Preparation of materials: 5.5.1 The Production Department receives
329、materials according to the work order. 5.5.2 The personnel in the warehouse distributes materials according to the main work order and sub-work order. 5.5.3 If the Production Department requires excessive materials, the material operator must write a Material Borrow Sheet for the excessive part with
330、 reasons and send it to the director of his department before the Warehouse Keeper distributes the materials. The material which is more than RMB500 in price must be handed to the director for approval. 5.6 Verification of preparation for operation 5.6.1 The operators of each process must check the
331、name, quantity, specification, material number of the material to be processed and whether the IQC inspection seal is clear before formal production. Besides, they should check if the specification and material number meet the requirements of SOP, and shall not start operating until the first produc
332、t of each process of the day has been confirmed as qualified by the team leader. 5.7 Production operation: 5.7.1 The Production Department produces according to the Production Plan and fill out Daily Production Statement. 5.7.2 All the production workers should work strictly in compliance with the r
333、equirements of SOP and the Control Plan to ensure the product quality and the record in the production file tracking record after completion of each process. 5.7.3 The Production Department arranges the commissioning and QC inspectors on production lines according to the requirements of SOP and the
334、Control Plan. 5.7.4 For the commissioning in each stage as well as use and maintenance of inspection instruments, refer to the Control Procedures for Monitoring and Measuring Devices. If this manual is printed, it is an UNCONTROLLED copy.Document Name Production Process Control Procedure Page Code 4
335、/6Version A/0 Document Code QM-COP-0 8Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 5.8 Process monitoring 5.8.1 Each post needs to implement self-inspection according to the Process Specification, for example, by marking the nonconforming products if found, putting them in the nonconforming
336、 product area and notifying the team leader or director immediately. For details refer to the Nonconforming Product Control Procedures. 5.8.2 The Quality Management Department make judgment of the products in all processes and record the result with the quality characteristic control method in the C
337、ontrol Plan, for example, by marking the nonconforming products if found, putting them in the nonconforming product area and notifying the team leader or director immediately. For details refer to the Nonconforming Product Control Procedures. In addition, The department should inspect each process i
338、n the production and check if there is SOP hanged over in each workplace, if the workers operate according to the requirements of SOP, if the SOP is the latest version and if the workers understand the SOP, and record the result. 5.8.4 Each process needs to check if the previous process has been com
339、pleted and if not, it needs to return the semi-product to the previous process if not. 5.9 Special process control: 5.9.1 The R&D Department should determine the special process, makes a Confirmation Plan with record. The data obtained after the confirmation should be made into a file. The Productio
340、n Department should implement according to the file, supervise the Quality Management Department and leave a record. The Confirmation Plan should include: Principle used for review and approval of the process. Appraisal of equipment and qualification of personnel. Confirmation method in detail and a
341、cceptance criterion. The statistical technology and its principle adopted in determination of sampling amount when appropriate. The necessary measures and results of confirmation should be retained. Re-confirmation and the criterion for re-confirmation. Approval of process change. 5.9.2 Control on e
342、quipment and personnel of special process 1) The production equipment must be maintained properly and kept in a normal and stable state. For details refer to the Control Procedures for Equipment and Work Environment. 2) The measuring equipment should be calibrated to ensure its accuracy within the v
343、alidity. For the details, refer to the Control Procedures for Monitoring and Measuring Devices. 3) The operators or inspectors should be trained in advance with qualification recognized. For the details, refer to the Control Procedures for Human Resource Management. 5.9.3 The documents like confirmed scheme, records of the special process and the Process Specification If this manual is printed, it is an UNCONTROLLED copy.
