医疗器械CAPA指南 质量管理体系

GHTF/SG3/N18:2010 FINAL DOCUMENT Authoring Group: Study Group 3 Date: 4 November 2010 Global Harmonization Task Force Title: Quality management system –Medical Devices – Guidance on corrective action and preventive action and related QMS processes 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

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

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Guidance on corrective action and preventive action and related QMS processes GHTF/SG3/N18:2010

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 com-pliance with regulatory requirements. It is expected that the reader is familiar with regulatory Quality 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.

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Japanese Ministry of Health Labor and Welfare US Food and Drug Administration

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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).

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Guidance on corrective action and preventive action and related QMS processes GHTF/SG3/N18:2010

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 enables 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.

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