CAPA指南GHTFSG3N18：2010

GHTF/SG3/N18:2010 FINAL DOCUMENT Global Harmonization Task Force Title: Quality management system –Medical Devices – Guidance on corrective action and preventive action and related QMS processes Authoring Group: Study Group 3 Date: 4 November 2010 Dr. Larry Kelly, GHTF Chair The document herein was produced by the Global Harmonization Task Force, which is comprised of representatives from medical device regulatory agencies and the regulated industry. The document is intended to provide non- binding guidance for use in the regulation of medical devices, and has been subject to consultation throughout its development. There are no restrictions on the reproduction, distribution or use of this document; however, incorporation of this document, in part or in whole, into any other document, or its translation into languages other than English, does not convey or represent an endorsement of any kind by the Global Harmonization Task Force. Copyright © 2010 by the Global Harmonization Task Force Guidance on corrective action and preventive action and related QMS processes GHTF/SG3/N18:2010 November 4, 2010 Page 2 of 26 Table of Contents Preface ........................................................................................................................................................................3 Introduction.................................................................................................................................................................3 1.0 Scope...............................................................................................................................................................4 2.0 Definitions.......................................................................................................................................................4 2.1 Correction .........................................................................................................................................4 2.2 Corrective action...............................................................................................................................4 2.3 Data Sources .....................................................................................................................................4 2.4 Concession ........................................................................................................................................4 2.5 Preventive action...............................................................................................................................5 2.6 Nonconformity..................................................................................................................................5 2.7 Verification .......................................................................................................................................5 2.8 Validation..........................................................................................................................................5 3.0 Overview .........................................................................................................................................................5 4.0 Phase I: Planning.............................................................................................................................................7 4.1 Plan for Measurement, Analysis and Improvement Processes..........................................................8 4.2 Establish Data Sources and Criteria ..................................................................................................9 5.0 Phase II: Measurement and Analysis within and across Data Sources..........................................................10 5.1 Measure...........................................................................................................................................10 5.2 Analyze ...........................................................................................................................................10 6.0 Phase III: Improvement .................................................................................................................................14 6.1 Investigate .......................................................................................................................................14 6.2 Identify Root Cause ........................................................................................................................16 6.3 Identify Actions ..............................................................................................................................17 6.4 Verify Identified Actions ................................................................................................................18 6.5 Implement Actions..........................................................................................................................18 6.6 Determine Effectiveness of Implemented Actions..........................................................................19 7.0 Phase IV: Input to Management ....................................................................................................................19 7.1 Report to Management....................................................................................................................19 7.2 Management Review.......................................................................................................................20 Annex A: Examples of Phase Activities ...................................................................................................................21 Annex B: Examples of Data Sources and Data Elements.........................................................................................22 Annex C: Examples of Contributing Factors............................................................................................................24 Annex D: Examples for Documentation of the Improvement Processes ..................................................................25 Guidance on corrective action and preventive action and related QMS processes GHTF/SG3/N18:2010 November 4, 2010 Page 3 of 26 Preface The document herein was produced by the Global Harmonization Task Force, a voluntary group of representatives from medical device regulatory agencies and the regulated industry. The doc- ument is intended to provide non-binding guidance for use in the regulation of medical devices, and has been subject to consultation throughout its development. There are no restrictions on the reproduction, distribution or use of this document; however, in- corporation of this document, in part or in whole, into any other document, or its translation into languages other than English, does not convey or represent an endorsement of any kind by the Global Harmonization Task Force. Introduction This guidance document is intended for medical device manufacturers and regulatory authorities. It is intended for educational purposes and is not intended to be used to assess or audit compli- ance with regulatory requirements. It is expected that the reader is familiar with regulatory Qual- ity Management System (QMS) requirements within the medical devices sector. For the purposes of this document it is assumed that the medical device manufacturer has a QMS which requires the manufacturer to have documented processes to ensure that medical devices placed on the market are safe and effective. For example ISO13485 Medical Devices – Quality Management Systems – Requirements for regulatory purposes, Japanese Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and in vitro Diagnostics (MHLW1 Ministerial Ordinance No. 169), the FDA2 Quality System Regulation 21 CFR Part 820 or the respective quality system requirements of the European medical Device Di- rectives. For this purpose the manufacturer will establish processes and define appropriate controls for measurement and analysis to identify nonconformities and potential nonconformities. Also, the manufacturer should establish processes defining when and how corrections, corrective actions, or preventive actions should be undertaken. These actions should be commensurate with the sig- nificance or risk of the nonconformity or potential nonconformity. The terms risk, risk management and related terminology utilized within this document are in accordance with ISO 14971 “Medical Devices-Application of Risk Management to Medical De- vices.” The acronym “CAPA” will not be used in this document because the concept of corrective action and preventive action has been incorrectly interpreted to assume that a preventive action is re- quired for every corrective action. 1 Japanese Ministry of Health Labor and Welfare 2 US Food and Drug Administration Guidance on corrective action and preventive action and related QMS processes GHTF/SG3/N18:2010 November 4, 2010 Page 4 of 26 This document will discuss the escalation process from different “reactive” sources which will be corrective in nature and other “proactive” sources which will be preventive in nature. The manufacturer is required to account for both types of data sources whether they are of a correc- tive or preventive nature. Regardless of the nature of the data source, if there is a decision to escalate the information to further evaluation and investigation, the steps of investigation, identification of root causes and actions needed, verification, implementation, and effectiveness checks will be similar. This guidance document will describe measurement, analysis and improvement as complete and integrated processes. 1.0 Scope This document provides guidance for establishing adequate processes for measurement, analysis and improvement within the QMS as related to correction and/or corrective action for noncon- formities or preventive action for potential nonconformities of systems, processes or products. 2.0 Definitions The references to clauses in this section refer to ISO 9000:2005. 2.1 Correction Action to eliminate a detected nonconformity (3.6.2) Note 1 A correction can be made in conjunction with corrective action (3.6.5) Note 2 Corrections can be, for example, rework (3.6.7) or re-grade (3.6.8) 2.2 Corrective action Action to eliminate the cause of a detected nonconformity (3.6.2) or other undesirable situ- ation Note 1 There can be more than one cause for nonconformity Note 2 Corrective action is taken to prevent recurrence whereas preventive ac- tion (3.6.4) is taken to prevent occurrence Note 3 There is a distinction between correction (3.6.6) and corrective action 2.3 Data Sources The processes within a Quality Management System that provide quality information that could be used to identify nonconformities, or potential nonconformities 2.4 Concession Permission to use or release a product that does not conform to specified requirements (3.6.11). Guidance on corrective action and preventive action and related QMS processes GHTF/SG3/N18:2010 November 4, 2010 Page 5 of 26 2.5 Preventive action Action to eliminate the cause of a potential nonconformity (3.6.2) or other undesirable sit- uation Note 1 There can be more than one cause for nonconformity Note 2 Preventive action is taken to prevent occurrence whereas corrective ac- tion (3.6.5) is taken to prevent recurrence 2.6 Nonconformity Non fulfillment of a requirement (3.1.2) 2.7 Verification Confirmation through provision of objective evidence (3.8.1) that specified requirements (3.1.2) have been fulfilled Note 1 The term “verified” is used to designate the corresponding status. Note 2 Confirmation can comprise activities such as: - performing alternative calculations, - comparing a new design specification (3.7.3) with a similar proven design specification, undertaking tests (3.8.3), performing demonstra- tions, and reviewing and approving documents prior to issue. 2.8 Validation Confirmation through provision of objective evidence (3.8.1) that the requirements for a specific intended use or application have been fulfilled Note 1 The term “validated” is used to designate the corresponding status. Note 2 The use conditions for validation can be real or simulated. 3.0 Overview The manufacturer is responsible for the implementation and maintenance of a QMS which en- ables their organization to provide safe and effective medical devices meeting customer and regulatory requirements. A nonconformity as defined in 2.6 is a non fulfillment of a requirement. It is important to under- stand that requirements may relate to product, process or the QMS. When a nonconformity is identified, the manufacturer will determine the significance, the asso- ciated risk and the potential for recurrence. Once these have been determined the manufacturer may decide the nonconformity has little as- sociated risk or is unlikely to recur. In such cases the manufacturer may decide only to carry out a correction. Guidance on corrective action and preventive action and related QMS processes GHTF/SG3/N18:2010 November 4, 2010 Page 6 of 26 Should the nonconformity recur within the QMS, during manufacture or after the medical device has been delivered to a customer, it is an indication that improvement action(s) may be needed. In either case the QMS requires that a corrective action should be carried out with the aim to prevent recurrence. The corrective action may be as simple as retraining, or as complex as redes- igning the manufacturing process. The manufacturer may encounter situations that have not actually caused a nonconformity, but may do so in the future. Such situations may call for preventive action. For example, production or acceptance testing trend data indicates that control limits are being approached and revision of product or production (process, equipment or facilities) requirements may be necessary. These revisions could constitute a preventive action. Preventive action would not include planned process adjustments intended to return process performance to nominal values from the edges of the process control range. Actions taken to eliminate observed nonconformities within the scope of a single QMS (regard- less of whether the actions are taken at more than one site or facility operating within that QMS) would be considered corrective actions. However, similar actions applied within another QMS (regardless of whether it is the same site, facility, or organization) that has not yet experienced these nonconformities, would be considered preventive actions. Figure 1 illustrates typical Phases to be considered when planning, implementing and maintain- ing effective processes for measurement, analysis, improvement and providing input to manage- ment. See Annex A for a list of possible activities corresponding to the phases in Figure 1. As a check on the effectiveness of the processes defined, management should regularly review the outputs of processes and make adjustments as needed. Documented procedures, requirements and records should be maintained by the manufacturer to ensure and demonstrate the effective planning, operation and control of the processes. Docu- mented evidence of decisions and actions taken will be a part of the QMS. Guidance on corrective action and preventive action and related QMS processes GHTF/SG3/N18:2010 November 4, 2010 Page 7 of 26 Figure 1: Processes for measurement, analysis and improvement 4.0 Phase I: Planning Planning involves specifying processes and associated resources in order to meet specific objec- tives. Factors to consider during the planning phase should be aligned with the manufacturer’s overall business planning and include the device’s intended use, markets and users, as well as regulatory requirements. The involvement of management at appropriate levels (e.g. review, approval) in actions taken in response to nonconformities or potential nonconformities should be established. Management should ensure that measurement criteria are defined for identified data sources and communi- cated across the organization. Guidance on corrective action and preventive action and related QMS processes GHTF/SG3/N18:2010 November 4, 2010 Page 8 of 26 4.1 Plan for Measurement, Analysis and Improvement Processes Factors to consider during this planning phase should be aligned with the manufacturer’s overall business planning and as a minimum include the type of device being manufactured, intended markets and users, and regulatory requirements. As part of planning, management should review the processes critical to the operations with regard to quality and regulatory requirements and select relevant data sources to measure, analyze and facilitate improvement as necessary. In the process of planning measurement and analysis, a manufacturer needs to take into account data sources, the measurement of the data elements within each data source, the frequency of monitoring, and the analysis to be performed within a data source, or across data sources. The measurement of data elements should be done in a way that ensures the manufacturer is ef- fective in managing the operations and maintain an effective QMS. Each of the data elements should be planned and established with specific requirements for measurement that are moni- tored routinely. The scope of the QMS and the scope of the measurement, analysis and improvement processes will provide the boundaries as to whether the data source is reactive/corrective or proac- tive/preventive. The planning phase should ensure the following: ƒ Identification of relevant internal and external data sources that are indicators of process and product performance. ƒ Provision for adequate resources and establish responsibilities and authorities to enable the necessary actions. Resources may include technical experts, testing laboratories, data management, infrastructure, training, etc. ƒ Definition of requirements for each identified data source, including limits, acceptance criteria, escalation criteria and mechanisms for reporting of nonconformities or potential nonconformities. ƒ Analysis of data elements within data sources. ƒ Coordination and analysis of data across data sources. For each data element individual criteria should be defined; however, criteria may be defined for a combination of data elements. Criteria should be quantitative whenever possible in order to maximize consistency and reproducibility for subsequent analysis. If the criteria and data are qu- alitative, subjectivity should be eliminated or minimized. Acceptance criteria should be based on system, product and process specifications or require- ments which are typically identified during design and development activities. This includes the design of the Quality Management System, development and maintenance of assembly proc- esses, delivery processes, servicing and installation processes. Escalation criteria used for the purpose of initiating the improvement process (see 6.0) may often be called action levels, trigger points, thresholds, etc. These escalation criteria should be proce- duralized and would likely include certain generic action levels as well as specific action levels resulting from risk management activities. In particular, criteria should be established for imme- Guidance on corrective action and preventive action and relate