Description
What is the Evaluation Activities Policy in a Quality Management System?
The four major components in a Quality System Model are:
- Management Responsibilities
- Resource Management
- Manufacturing Operations
- Evaluation Activities (this document)
Please download and print our QMS Flowchart for ease of reference. q00-00-01_qms_flowchart
Q08-0000 Product Evaluation Activities in QMS
The purpose of the Evaluation Activities Policy is to provide an overview of our company’s policy:
- on the monitoring, trending and evaluation of collected information on quality system processes,
- on applying a science based and risk-based approach to identifying, resolving and preventing problems.
They are to ensure continuous improvements to our quality management system and product quality. The policies create the path for subsequent procedures (SOP’s), systems and forms to develop all the processes for Evaluation Activities.
Industry/Regulatory guidance and requirements:
- FDA Guidance for Industry – Quality Systems Approach to Pharmaceutical CGMP Regulations, September 2006, Section IV/D Evaluation Activities.
- ISO 9001 Section 8, Measurement, analysis and improvement.
- PIC/S Guide to GMP for Medicinal Products, PE009-8, Chapter 1 and 9.
There are two parts to this document:
- Part 1 (2 pages) – Introduction to document template – describes the rationale of why this policy statement is required; cross reference relevant regulatory clauses.
- Part 2 (5 pages) – the document template and Quality System flowchart.
Who benefits from this document?
- Senior Management and Quality Assurance – who develop quality system policies.
- All other departments who has to employ policies to develop procedures (SOP’s).
Associated documents:
Q00-01 Quality Management System
Q05-0001 Management Responsibilities
Q06-0001 Resources Requirements
Q07-0001 Manufacturing Operations
Q08-0001 Evaluation Activities (this document)
Keywords:
Quality management system evaluation activities
