Production Processes

Supplier Process

Third-Party Manufacturers Process

Supporting Processes—Processes That Support Production Process

• Audits, process assessments

• Change Control

• Documentation

• Qualification of Equipment, Facilities and Critical Systems

• Investigation and Corrective Action of Failures and Deviations

• Labeling—from Artwork to Use

• Maintenance

• Materials Management and the Supply Chain

• Introduction of a New Product and Product Transfer

• Product Release

• Product Performance—Complaints

• Quality Planning

• Recalls

• Returned Goods

• Stability and Expiration Dating

• Test Methods Validation and Control

• Training

• Trend Analysis and Annual Review

• Validation—Process, Cleaning, Computer Systems

Management Processes— Processes Related to the QS

• Communication of Quality Policy and Quality Objectives

• Review of the QS

• Development and Implementation of the Quality Plan

• Creation of the Quality Culture

• Determination of Customer Needs and Customer Satisfaction

• Allocation of Required Resources