GMP Quality Manual质量手册

1、GMP Quality ManualThis quality manual for Good Manufacturing Practices is based on the ISO 9001 standard, and addresses the requirements of FDA's medical device regulations.此GMP质量手册是基于ISO 9001标准，叙述FAD医用仪器的法规要求。Table of Contents 目录POLICY 方针QUALITY SYSTEM DESCRIPTION 质量系统描述QUALITY DEFINITIONS 质量定义

2、QUALITY ACHIEVEMENT 质量目标QUALITY VERIFICATION 质量确认QUALITY IMPROVEMENT 质量改进ADMINISTRATIVE CONTROLS 行政控制Comparison Matrix 比对矩阵Organizational Matrix for Quality System Functional Responsibilities 质量系统功能图Quality Systems Organizational Chart 质量系统组织机构图Parent Category 上级分类Quality Manuals 质量手册POLICY 方针Qualit

3、y Policy质量方针We are dedicated to achieving customer satisfaction through an uncompromising commitment to quality. 我们致力于让客户满意，承诺对质量永不妥协。（保证产品质量，让用户满意）These high standards are realized through the following practices:通过下列实践达到高标准1. An open door policy that enables all personnel to bring to management

4、9;s attention any concerns regarding quality achievement and customer satisfaction. 保证产品质量，让用户满意应成为每一员工的工作关注点。2. Personnel performing their work in a manner that ensures products and services meet all quality requirements. 员工的操作方式、行为规范要以满足所有质量要求为基本准则。3. Enabling personnel to carry out their responsi

5、bilities by providing the necessary training, resources, and work environment. 为员工提供必要的培训、资源及工作环境以保证员工履行其职责。4. The development of a multi-disciplinary collaborative team structure throughout all activities of the company. 构建多种学科协作的专业团队和组织架构。5. The application of high standards to business conduct, i

6、ncluding contacts with customers, co-workers, and collaborators. 建立和实施较高的企业营运（包括与与客户、合作商及合作人的联系与合作）操作标准。References:§ ISO 9001, 4.1.1, Quality PolicyManual Objectives 质量目标We have established a quality system that is designed to meet domestic and worldwide regulatory standards for its products in

7、 the market place. The key applicable regulatory standards include:§ 21 CFR Part 820, Quality System Regulations for Medical Devices § 93/42/EEC, European Medical Device Directive § ISO 9001, ISO Quality Management Systems Requirements § EN ISO 13485:2001, ISO Quality Systems for

8、 Medical DevicesThe quality system addresses the elements necessary for implementing quality management including the organizational structure, responsibilities, procedures, processes and resources.The Quality Manual describes our quality system. The central objective of the Quality Manual is to hel

9、p employees meet all applicable regulatory requirements and to understand the quality commitments. In Appendix A, the requirements of 21 CFR 820, ISO 9001 and the Medical Device Directive 93/42/EEC have been cross-referenced to the sections of this Quality Manual.The manual describes an overall proc

10、ess approach of planning for quality, application to activities, verification, and improvement (Deming's PDCA cycle). Where applicable, Standard Operating Procedures (SOPs) applicable to each section are cited. The Quality Manual is updated, reviewed and approved every 2 years. The current versi

11、on of the Quality Manual is distributed to all personnel.References:§ 12-0048-SOP, Controlled External Document File § ISO 9001, 4.2.1, Develop Quality System DocumentsQUALITY SYSTEM DESCRIPTIONScopeThe quality system applies to all our products and services. We have a single, global quali

12、ty system applicable to all worldwide locations.CommitmentOur commitment to quality is demonstrated with a comprehensive system that satisfies all applicable regulatory requirements. Assurance of quality and its continuous improvement requires the support of the entire organization. Quality is assur

13、ed by working in a systematic manner to eliminate defects, errors, and nonconformance through proper product and process design and implementation, and following formalized procedures and work instructions.Employees are encouraged to bring to management's attention any concerns regarding quality

14、 achievement and customer satisfaction. We enables all employees by providing the following support: § Specific job skill training, § Quality System training, § The necessary tools and equipment, § An environment and the resources that promote continuous improvement.Quality Plann

15、ingThe quality planning process defines product specifications, meets the specific requirements for projects and contracts, and ensures customer needs and expectations are met or exceeded. Quality planning is achieved through a combination of business and product planning, project teams, quality imp

16、rovement plans, review of Device Master Record documents, internal and supplier audits, and employee training. The quality system is fully documented to ensure that quality planning is consistent with all other requirements.References:§ 12-0050-SOP, Design Control Guideline § 12-0072-SOP,

17、Inspection and Test Requirements § 12-0073-SOP, Process Control General Requirements § ISO 9001, 4.2.3, Control Quality System DocumentsOrganizationResponsibility and AuthorityExecutive management is responsible for ensuring that an effective Quality System is established and implemented.

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

19、ated Management Representative. The duties of the Management Representative include the final disposition/determination of products and processes, as well as, developing a set of measurements which are used by senior management to ensure the quality system is meeting or exceeding established require

20、ments. Functionally, the Director of QA/QC reports directly to the Vice President of Operations. In addition, the Director of QA/QC has an unambiguous reporting relationship to the CEO/President for all matters related to the company's quality system and to resolve any quality issues that may ar

21、ise due to a conflict of interest created by the direct reporting relationship to his/her Vice President.The European QA/RA Manager assures compliance with the Quality Manual and appropriate regulatory requirements for local activities. The European QA/RA Manager functions as the local management re

22、presentative and has an indirect reporting relationship with the QA/QC Director in all matters pertaining to quality policy and compliance. Functionally, the European QA/RA Manager reports to the VP, General Manager, Europe, however, he/she has direct access to the CEO/President through the QA/QC Di

23、rector in matters pertaining to quality.An integral part of the duties of department managers and personnel is the implementation of the quality system requirements and procedures into their daily activities. A matrix identifying functional responsibility for each of the areas listed in this quality

24、 manual is shown in the Organizational Matrix for Quality System Functional Responsibilities. An organizational chart showing the functional relationships between departments in shown in the Quality Systems Organizational Chart.References:§ ISO 9001, , Responsibility and Authority §

25、 Organizational Matrix for Quality System Functional Responsibilities § Quality Systems Organizational ChartResourcesSenior management ensures that resources are identified and assigned to appropriate tasks as needed to execute the requirements of the quality system. Each functional task is ass

26、igned to employees whose responsibilities are summarized and documented in job descriptions. Job descriptions establish the requirements of the task to be performed as well as the education and skill requirements. Functional tasks assigned to consultants are defined in contracts and the consultant&#

27、39;s qualifications to perform the assigned task(s) are defined by their credentials.References:§ ISO 9001, , ResourcesQuality System VerificationQuality Assurance monitors the implementation and maintenance of the quality system by performing verification procedures to ensure compliance

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

29、quate resources assigned to meet the requirements of the quality system. Appropriate corrective action is taken by senior management if the audit reveals inadequacies in any area of the quality system.References:§ 09-0009-SOP, Internal Quality Systems AuditingManagement ReviewThe quality system

30、 is reviewed at least once each calendar quarter by senior management to determine the effectiveness and suitability of the quality system to meet or exceed customer and product specifications. Specific measurement tools are used at senior management review meetings to ensure consistent commitment t

31、o continuously improve the product and process quality. These measurement tools include but are not limited to: results of internal and supplier audits, established quality objectives, customer complaints, corrective action results, and specific product performance reviews. Meeting records, includin

32、g action item assignments, are created from the Senior Management Review meetings. Timelines are established as a way to follow action items and ensure action items are resolved and satisfactorily closed.References:§ ISO 9001, 4.1.3, Management ReviewQuality System ProceduresReferences:§ I

33、SO 9001, 4.2.2, Prepare Quality System ManualDocumentationThe quality system is documented through a combination of procedures and instructions. The diagram below provides an overview of the relationship of the documentation within the company's quality system. A matrix of top level SOPs in the

34、Quality Manual cross referenced to the applicable regulatory requirements is shown in Comparison Matrix.Level 1 - At the apex of the pyramid, the Quality Manual is a summary of the company's quality system and provides an overview of how the applicable regulatory requirements are addressed.Level

35、 2 - Top-level Standard Operating Procedures (SOPs) that describe key aspects of the company's quality system are referenced throughout the Quality Manual. Additional Standard Operating Procedures (SOPs) are accessed through the Master Document File index. These additional SOPs are usually more

36、specific in nature and may contain procedures that are department, method, or equipment specific.Level 3 - Work instructions are documented as Manufacturing Batch Records (MBRs), Part Number Specifications (PNSs), Drawings (DWGs), Qualification and Validation Documents (QVDs), and Standard Operating

37、 Procedures (SOPs). Access to these documents is also through the Master Document File index. In addition, a number of Departmental Desk Guides are in use. The content of these desk guides is revision controlled by the department head as evidenced by a signature and revision date.Level 4 - Quality r

38、ecords generated by the company's quality system are collected and archived primarily by Document Control. These records include, but are not restricted to, completed Device History Records, QC test and inspection records, Qualification and Validation Reports, quality system audit reports, Instr

39、ument History Records, equipment calibration and maintenance records, and customer complaints.The Master Document File index is maintained by Document Control. Copies of current revisions of all documents are issued to Authorized Document Manuals located throughout the company to provide access for

40、employees who use the documents in the performance of their work.Technical DocumentationThe technical documentation that supports CE approvals and demonstrates conformance to the Medical Device Directive are also part of our quality system documentation. The technical documentation is located at the

41、 company's worldwide headquarters location and a summary file is located at the Europe headquarters. The documentation is available upon request by competent authorities and/or the Notified Body.References:§ 09-0001-SOP, Document Control and Change Procedure § 09-0180-SOP, EC Notificat

42、ion of Change Procedure § 09-0199-SOP, Technical Documentation for CE Marked Product § 09-0218-SOP, Classification and Conformity Assessment Route Determination for Medical Devices Intended for European Market § 09-0220-SOP, CE Marking of Medical Devices § 12-0059-SOP, Quality Re

43、cords Collection and Retention § Comparison MatrixQUALITY DEFINITIONSSales (Contract Review)All proposed business offerings to customers are appropriately reviewed to ensure that ourproducts are accurately represented, properly promoted, and fairly priced. When it is useful in the conduct of ou

44、r business, either to us or our customers, supply contracts may be entered into. These contracts are reviewed with particular regard to ability to supply and the appropriateness of economic terms and conditions to specific classes of trade. Customer purchase orders are reviewed to verify that we can

45、 meet all obligations as defined in the contract. All discrepancies between the customer and us are resolved prior to commencement of any work.References:§ 13-0001-SOP, Promotional Material and Advertising Procedure § 13-0004-SOP, Contract Review § 13-0007-SOP, Order Processing Europe

46、 § ISO 9001, 4.3, Contract ReviewDesign ControlOur strategy for design and development of quality products and services is to clearly define products and services in terms of customer expectations, medical treatments, product performance, marketing and distribution requirements, manufacturing/q

47、uality assurance, safety, legal, and regulatory requirements. The design of all new products or any significant changes to current products are controlled through a project management system with multi-disciplinary participation. Specifications, procedures and systems are established during product

48、development to insure that product and services consistently and reliably meet requirements. Design reviews are held during the development cycle. Senior management is responsible for administration and maintenance of design control.References:§ 09-0175-SOP, Software Validation § 09-0224-S

49、OP, Risk Analysis § 12-0027-SOP, General Qualification & Validation Guideline § 12-0049-SOP, Engineering Documentation, Change & Control § 12-0050-SOP, Design Control Guideline § 12-0058-SOP, Software Development Procedure § 12-0065-SOP, Design Stage Deliverables

50、67; 12-0066-SOP, Design Review § 12-0072-SOP, Inspection and Testing General Requirements § 12-0073-SOP, Process Control General Requirements § 18-0001-SOP, Clinical Documentation § ISO 9001, 4.4, Product Development and DesignPurchasingKey suppliers and subcontractors are identi

51、fied and chosen for their ability to provide product and service to defined requirements. Qualified suppliers are added to the Qualified Supplier List maintained by the Materials Control department. Through the use of established assessment procedures, we continuously monitors suppliers to ensure th

52、at they are conforming to specified purchaser requirements. The extent of assessment for a supplier is dependent upon the significance of the product and/or service purchased and, where applicable, upon previously demonstrated performance.All purchased materials and services intended for use in prod

53、uction processes are specified in the purchasing documents. All component/material specification documents are reviewed and approved by management personnel prior to use. Additional requirements not specified on component/material specifications are conveyed via purchase orders or contracts. Purchas

54、e orders and/or contracts convey the degree of control we establish with our suppliers to ensure quality product and/or service.References:§ 09-0003-SOP, Raw Material Quality Assurance Procedure § 09-0010-SOP, Supplier Qualification and Auditing Procedure § 10-0021-SOP, General Purcha

55、sing Guidelines for Inventory Control/Production § 10-0023-SOP, Supplier Performance Evaluation Procedure § 10-0026-SOP, General Purchasing Procedure - Europe § ISO 9001, 4.6, Purchasing RequirementsCustomer Supplied ProductProduct owned by a customer and held by us for further manufa

56、cturing is received, stored, handled, and maintained as defined in approved contracts. Prior to the manufacturing of customer supplied product, procedures and specifications are established and approved in concert with customer requirements. All activities involving customer supplied product are per

57、formed in a manner consistent with the Quality System.References:§ 12-0076-SOP, Contract Manufacturing § ISO 9001, 4.7, Customer-Supplied ProductsQUALITY ACHIEVEMENTManufacturingProcess ControlThe manufacturing processes are defined in production documents, planned with work orders, and pe

58、rformed by appropriately trained employees. These processes are performed under controlled conditions, with documented instructions, established workmanship criteria, and appropriate processes and equipment. Manufacturing documents also include requirements for health, cleanliness, and clothing of p

59、ersonnel, and the appropriate environmental requirements.During production, processes that can not be verified by end product testing are monitored and controlled. Inspections and tests are used at critical steps to prevent the production of substandard product.Procedures that control facilities, ut

60、ilities and the manufacturing environment are also established and documented to ensure that acceptable conditions exist for performing environmentally sensitive processes. Defined alert limits for environmental control exist and there are clear procedures for responding when the limits are exceeded. Critical processing equipment and ass