FMEA Failure Mode And Effect Analysis

General

This Standard Operating Procedure (SOP) describes the procedure for conducting Failure Modes and Effects Analysis (FMEA) in order to identify, understand, control, and prevent potential risks in the use of COMPANY Products. FMEA is conducted throughout product design and development. It is one of a series of procedures that support the overall Design Control process.

 

Regulatory basis, reference documents

• 21 CFR Part 820 – Quality System Regulation, Subpart C – Design Controls, 820.30 Design controls
• ISO 13485:2016: Medical Devices – Quality management systems ¬Requirements for regulatory purposes
• FDA/CDRH – Design Control Guidance for Medical Device Manufacturers, March 11, 1997

 

Table of Content:

1 Purpose

2 Objective

3 Regulatory basis, reference documents

4 Responsibility and accountability

4.1 COMPANY Management

4.2 Design Review Committee

4.3 Quality Assurance 5

4.4 Project Leader (PL) / Head of Engineering (HE)

4.5 Function / Area Leaders

5 Related documents

6 Definitions

7 Procedure

7.1 FMEA Process (general)

7.2 FMEA Application

7.3 Severity Levels

7.4 Probability of occurrence

7.5 Probability of detection

7.6 The Risk Index

7.7 The FMEA Team

7.8 The FMEA Process

8 Attachments

FMEA Matrix Summary (1 page)

FMEA Matrix Detail (1 page)

9 SOP distribution

10 Health, safety and environmental considerations

 

Size and Format:

• Microsoft Office 2003
• Word File
• 17 pages procedure