GMPQualityManual質(zhì)量手冊(cè)

1、GMP Quality Manual1 / 39This quality manual for Good Manufacturing Practices isbasedon the ISO 9001 sta ndard, and addresses the requireme nts of FDAs medicaldevice regulati ons.此 GMP 質(zhì)量手冊(cè)是基于 ISO 9001 標(biāo)準(zhǔn)，敘述 FAD 醫(yī)用儀器的法規(guī)要求。Table of Contents 目錄POLIC Y 方針QUALITY SY STEM DESCRIPTION量系統(tǒng)描述QUALITY DEFINITIO

2、NS 質(zhì)量定義QUALITY ACHIEVEMENT量目標(biāo)QUALITY VERIFICATION 質(zhì)量確認(rèn)QUALITY IMPROVEMENT量改進(jìn)ADMINISTRATIVE CONTROL 行 政控制Comparison Matrix比對(duì)矩陣Organizational Matrix for Quality System FunctionalRespo nsibilities質(zhì)量系統(tǒng)功能圖Quality Systems Orga ni zatio nal Chart質(zhì)量系統(tǒng)組織機(jī)構(gòu)圖Quality Ma nuals質(zhì)量手冊(cè)2 / 39Pare nt Category上級(jí)分類POLIC

3、Y 方針Quality Policy 質(zhì)量方針Weare dedicated to achieving customer satisfactionthrough anun compromis ing commitme nt to quality.我們致力于讓客戶滿意，承諾對(duì)質(zhì)量永不妥協(xié)。（保證產(chǎn)品質(zhì)量，讓用戶滿意）These high sta ndards are realized through the follow ingpractices:通過(guò)下列實(shí)踐達(dá)到高標(biāo)準(zhǔn)1.An open door policy that enables all personnel to bring to man

4、 agements atte nti on any concerns regard ing quality achieveme nt and customersatisfacti on.保證產(chǎn)品質(zhì)量，讓用戶滿意應(yīng)成為每一員工的工作關(guān)注點(diǎn)。2.Personnel performing their work in a manner that ensures products andservices meet all quality requireme nts.Quality Ma nuals質(zhì)量手冊(cè)3 / 39員工的操作方式、行為規(guī)范要以滿足所有質(zhì)量要求為基本準(zhǔn)則。3.Enabling perso

5、nnel to carry out their responsibilities byproviding the necessary training,resources, and work environment.為員工提供必要的培訓(xùn)、資源及工作環(huán)境以保證員工履行其職4 / 394.The development of a multi-disciplinary collaborative team structurethroughout all activities of the compa ny.構(gòu)建多種學(xué)科協(xié)作的專業(yè)團(tuán)隊(duì)和組織架構(gòu)。5.The applicati on of high s

6、ta ndards to bus in ess con duct,in cludi ng con tacts with customers, co-workers, and collaborators.建立和實(shí)施較高的企業(yè)營(yíng)運(yùn)（包括與與客戶、合作商及合作人的 聯(lián)系與合作）操作標(biāo)準(zhǔn)。Refere nces:?ISO 9001,4.1.1, Quality PolicyManual Objectives 質(zhì)量目標(biāo)We have established a quality system that is desig ned to meetdomestic and worldwide regulator

7、y standards for its products in the market place.The key applicable regulatory sta ndards in clude:?21 CFR Part 820 , Quality System Regulations for Medical Devices?93/42/EEC, European Medical Device Directive?ISO 9001 , ISO Quality Management Systems RequirementsThe quality system addresses the ele

8、me nts n ecessary for impleme nting?EN ISO 13485:2001 , ISO Quality Systems for Medical Devices5 / 39quality man ageme nt in clud ing the orga ni zati onal structure, resp on sibilities,procedures, processes and resources.The Quality Manual describes our quality system. The cen tral objective ofthe

9、Quality Manual is to help employees meet all applicable regulatory requirements and to un dersta nd the quality commitments. In Appendix A, therequirements of 21 CFR820, ISO 9001 and the Medical Device Directive93/42/EEC have bee n cross-refere need to the secti ons of this Quality Manu al.The manua

10、l describes an overall process approach of pla nningfor quality, applicati on to activities, verificati on, and improveme nt (Demi ngsPDCA cycle). Where applicable, Stan dard Operat ing Procedures (SOPs)applicable to each secti on are cited.The Quality Manual is updated, reviewed and approved every

11、2 years.The curre nt vers ion of the Quality Manual is distributed to all pers onn el.References :?12-0048-SOP, Con trolled External Docume nt File6 / 39?ISO 9001,421, Develop Quality System DocumentsQUALITY SY STEM DESCRIPTIONScopeThe quality system applies to all our products and services.Wehave a

12、 single, global quality system applicable to all worldwide locati ons.Commitme ntOur commitme nt to quality is dem on strated with a comprehe nsive systemthat satisfies all applicable regulatory requireme nts.Assura nee of quality and its continu ous improveme nt requires the support of theentire or

13、ganization. Quality is assured by working in a systematic manner to eliminate defects, errors, and noncon forma nee through proper product and processdesig n and impleme ntatio n, and followi ng formalized procedures and work instructi ons.Employees are encouraged to bring to managements attentionan

14、yconcerns regard ing quality achieveme nt and customer satisfacti on.We en ables all employees by provid ing the follow ing support:?Specific job skill training,?Quality System training,?The necessary tools and equipment,?An environment and the resources that promote continuous improveme nt.7 / 39Qu

15、ality Pla nningThe quality pla nning process defi nes product specificatio ns, meets thespecific requireme nts for projects and con tracts, and ensures customer needsand expectations are met or exceeded. Quality pla nning is achieved through acomb in ati on of bus in ess andproductpla nning, project

16、 teams, quality improveme nt pla ns, review of Device MasterRecord docume nts, i nternal and supplier audits, and employee training. Thequality system is fully documented to ensurethat quality pla nning is con siste nt with all other requireme nts.References :?12-0050-SOP, Desig n Control Guideli ne

17、?12-0072-SOP, I nspection and Test Requireme nts?12-OO73-SOP, Process Control General Requireme nts?ISO 9001,4.2.3, Control Quality System DocumentsOrga ni zatio nResponsibility and AuthorityExecutive management is responsible for ensuring that an effective QualitySystem is established and implement

18、ed. The success of the Quality System isimpacted through commitment, and the demonstration and communication of thatcommitment, by senior staff.8 / 39The responsibility of ensuring that the quality system is established,implemented, practiced, and maintained lies with the Director, QA/QC, who is the

19、designated Management Representative. The duties of the ManagementRepresentative include the final disposition/determination of products andprocesses, as well as, developing a set of measurements which are used bysenior management to ensure the quality system is meeting or exceedingestablished requi

20、rements. Functionally, the Director of QA/QCreports directly tothe Vice President of Operations. In addition, the Director of QA/QC has anunambiguous reporting relationship to the CEO/President for all matters related tothe companys quality system and to resolve any quality issues that may arise due

21、to aconflict of interest created by the direct reporting relationship to his/her VicePreside nt.The European QA/RAManager assures complianee with the Quality Manualand appropriate regulatory requirements for local activities. The Europea nQA/RA Man ager fun cti ons as the local man ageme nt represe

22、ntative and has anin direct report ing relati on ship with the QA/QC Director in all matters pertainingto quality policy and complia nee. Fun cti on ally,the Europea n QA/RAManager reports to the9 / 39VP, Gen eral Man ager, Europe, however, he/she has direct access to theCEO/President through the QA

23、/QCDirector in matters pertaining to quality.An in tegral part of the duties of departme nt man agers andpersonnel is the implementationof the quality system requirementsand procedures into their daily activities. A matrix identifying functionalresponsibility for each of the areas listed in this qua

24、lity manual is show n in theOrga ni zati onal Matrix for QualitySystem Fun cti onal Resp on sibilities. An orga ni zati onal chartshow ing the fun cti on al relati on ships betwee n departme nts in show n in theQuality Systems Orga ni zati onal Chart.Refere nces:?ISO 9001,4.121, Responsibility and A

25、uthority?Organizational Matrix for Quality System FunctionalResp on sibilities?Quality Systems Organizational ChartResourcesSenior man ageme nt en sures that resources are ide ntified andassigned to appropriate tasks as needed to execute the requirements of thequality system. Each functionaltask is

26、assigned to employees10 / 39whose resp on sibilities are summarized and docume nted in job descriptions. Jobdescriptions establish the requirements of thetask to be performed as well as the education and skill requirements.Fun cti onal tasks assig ned to con sulta nts are defi ned in con tractsand t

27、he consultantsqualificationsto perform the assigned task(s)are defined by their credentials.Refere nces:?ISO 9001,4.122, ResourcesQuality System Verificati onQuality Assurance monitors the implementation and maintenance of thequality system by performing verification procedures to ensure compliance,

28、suitability, and effectiveness of established requirements that pertain to the qualitysystem.The internal audit process is a verification procedure used by QualityAssurance to determine if elements of the quality system are effectively achievingthe stated quality objectives and if there are adequate

29、 resources assigned to meetthe requirements of the quality system. Appropriate corrective action is taken bysenior management if the audit reveals inadequacies in any area of the qualitysystem.11 / 39References :?09-0009-SOP, Internal Quality Systems AuditingManagement ReviewThe quality system is re

30、viewed at least once each calendar quarter by seniormanagement to determine the effectiveness and suitability of the quality system tomeet or exceed customer and product specifications. Specific measurement toolsare used at senior management review meetings to ensure consistentcommitmentto con ti nu

31、 ously improve the product and process quality. These measureme nttools in elude but are not limited to: results of in ternal and supplier audits,established quality objectives, customer complaints, corrective action results, andspecific product performanee reviews. Meeting records, including action

32、 itemassignments, are created from the Senior ManagementReview meetings.Timelines are established as a way to follow action items and ensure action itemsare resolved and satisfactorily closed.Refere nces:?ISO 9001,4.1.3, Management ReviewQuality System Procedures12 / 39Refere nces:?ISO 9001,4.2.2, P

33、repare Quality System ManualDocume ntati onThe quality system is docume nted through a comb in ati on ofprocedures and instructions.The diagram below provides an overviewof the relati on ship of the docume ntati on with in the compa nys quality system. Amatrix of top level SOPs in the Quality Manual

34、cross referenced to the applicable regulatory requirements is shown inComparison MatrixLevel 1 - At the apex of the pyramid, the Quality Manual is a summary of thecompa nys quality system and provides an overview of how the applicableregulatory requireme nts are addressed.Level 2 - Top-level Standar

35、d Operating Procedures (SOPs) that describe key13 / 39aspects of the companys quality system are referenced throughout the QualityManu al. Additi onal Stan dard Operati ng Procedures (SOPs) are accessedthrough the Master Docume nt File in dex. These additi onal SOPs are usuallymore specific in n atu

36、re and maycontain procedures that are department, method,or equipment specific.Level 3 - Work instructions are documented as ManufacturingBatch Records (MBRs), Part Number Specifications (PNSs), Drawings (DWGs),Qualification and Validation Documents (QVDs), and Standard OperatingProcedures (SOPs). A

37、ccess to these documents is also through the MasterDocument File index. In addition, a number of Departmental Desk Guides are inuse. The content of these desk guides is revision controlled by the departmenthead as evidenced by a signature and revision date.Level 4 - Quality records generated by the

38、companys quality system arecollected and archived primarily by Document Control. These records include, butare not restricted to, completed Device History Records, QCtest and inspectionrecords, Qualification and Validation Reports, quality system audit reports,InstrumentHistory Records, equipment ca

39、libration and maintenance records, and customer14 / 39complaints.The Master Document File index is maintained by Document Control. Copiesof current revisions of all documents are issued to Authorized Document Manualslocated throughout the company toprovide access for employees who use the docume nts

40、 in the performa nee oftheir work.Tech ni cal Docume ntati onThe tech ni cal docume ntati on that supports CE approvals anddem on strates con forma nee to the Medical Device Directive are alsopart of our quality system docume ntatio n. The tech ni cal docume ntati on islocated at the compa nys worldwide headquarters locati on and a summary file islocated at the Europe headquarters.The docume ntati on is available upon request by compete nt au