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 (MHLW Ministerial Ordinance No. 169), and the FDA Quality System Regulation 21 CFR Part 820.
For this purpose the manufacturer will establish processes and define appropriate controls for measurement and analysis to identify nonconformities and potential nonconformities. The manu-facturer should have established processes defining when and how corrections, corrective ac-tions, or preventive actions should be undertaken. These actions should be commensurate with the significance or risk of the nonconformity or potential nonconformity.
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. This document will discuss the escalation process from differ-ent “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 corrective or preventive nature.
Regardless of the nature of the data source, if...