Tuesday, September 15, 2015

The Four Pillars of a Quality Monitoring System


Memorandum from Ralph Fucetola JD

To: Vitamin Consultancy Contact List:

Excerpts from The Four Pillars of ICH Q10

International Conference on Harmonization
(ICH) Q10 model describes the elements of an effective
Quality Management System (QMS). 

1. Process Performance and Product Quality Monitoring System

ICH Q10 states that in order to ensure a maintained state of control, companies should plan and execute a system for the monitoring of process performance and product quality. The process performance and product quality monitoring system should, for example, use quality risk management in order to establish a control strategy. These controls must encourage an effective CAPA.

2. Corrective and Preventive Action (CAPA) System

ICH Q10 states that there should be a system in place to launch a CAPA stemming from complaints, rejection of products, nonconformance, audits, as well as trends from process performance and product quality monitoring.

3. Change Management System

Change is necessary to ensure continual improvement in the product lifecycle. ICH Q10 states that in order to properly evaluate, approve, and implement changes, an organization must have a Change Management system in place.

4. Management Review of Process Performance and Product Quality

Management reviews are necessary to provide assurance that process performance and product quality are efficiently managed throughout the lifecycle and that quality and compliance are being met across the organization. 

 A critical component to any quality system is creating visibility of the key challenges facing the organization to management. This should be conveyed in an effective manner and timely communication and escalation process to ensure that senior management is aware of quality issues that must be reviewed.


ICH Q10 strives to set forth the guidelines for an effective Quality Management System.

These notes summarize the major elements of ICH Q10 and identify the specific points in which the QMS’s tools come in. 

We discussed the four pillars of ICH Q10: [1] Process and Product Monitoring System, [2] CAPA, [3] Change Management System, and [4] Management Review.

The VitaminConsultancy.com's SOP Formats include the elements of the Four Pillars.

For health and freedom,

Ralph Fucetola JD

PS: I'd like to thank the Trustees of the Institute for Health Research for appointing me President of the Institute, founded in 1998. Its web site is: www.InHeRe.org.