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ISO 9001

Process Interaction Matrix

ISO 9001:2000 - A Process Interaction Matrix
A Case Study

By Mark Kaganov

This article was originally published by Quality Progress in October 2004, p 194

Download a .pdf copy of this paper

Abstract

This article presents a case study of development and implementation of a process interaction matrix to address one of the requirements of ISO 9001 2000 standard [1]. Going beyond a simple case study model, this tool may also be used for quality management systems (QMS) compliant with ISO 13485 2003 standard [2]. This article will be of interest to companies developing or improving their quality management system for such standards.

Introduction

One of the requirements of ISO 9001 2000, specified in the paragraph 4.2.2 c), requires a company to develop a quality manual that, among other elements, shall contain “a description of the interaction between the processes of the quality management system.” Through my experience, as a professional auditor, with dozens of companies around the World, I found that very few businesses had developed practical process approaches to address this requirement. Attempts to document process interactions range from busy and hard to read flow charts to establishing cross-reference tables in the quality manual. I observed one of the best tools to address process interaction requirement at Quality Works, a small on-line publishing company.

Initiation of the project

Quality Works, a small Internet-based publishing company, has set a goal to establish compliance with ISO 9001 standard. The Management Team assigned the company’s Business Manager to develop and implement documentation to address new requirements of the standard. While most of the new requirements were simply addressed through preparation of the corresponding procedures and work instructions, documentation of the interaction of the processes created some difficulties. Attempts to document interaction of processes through traditional flow-chart resulted in a hard to read busy document that did not impress the management team.

Brainstorming

To address this issue, the management group conducted a brainstorming session to search for a new tool. The group determined that there were two types of the processes: processes related to product realization and processes related to the management system as follows:

Business management processes:

  • Documentation management

  • Management review

  • Internal audit program

  • Non-conformity and Corrective and Preventive Action (NC-CAPA) System

  • Communication

  • Resource management

  • Record management

  • Information technology

Product realization processes:

  • Market analysis

  • Product design

  • Verification

  • Validation

  • Product release

  • Order processing

  • Product delivery

  • Customer satisfaction

  • Continual improvement

Identification of process interactions

Analyzing system and product realization processes, the management team concluded that virtually all system processes are interrelated. For example, management review may receive inputs from corrective actions, communication, internal audits, etc. Internal audit process receives inputs from all processes within the company and provides feedback or input into all those processes.

Product realization process was found to be more linear than system processes. For example, results of the market analysis initiate product design. Product design leads to verification. If verification is successful, validation of the product takes place. Validation of the product results in product release and finally communication regarding availability of the product. Customer satisfaction and continual improvement close this sequence with a possibility of providing inputs into Product delivery, Order processing, Product release, etc.

To document process interactions, the company elected two tools. The first, top-level definition of the process interaction was documented in the Process Interaction Matrix shown in Figure 1. The second tool was a well-known technique of flow-charting for those processes that required graphical illustration.

Figure 1

ISO 9001

This Process Interaction Matrix can be used for ISO 9001, ISO 13485, ISO 14001 and other management systems. Order your copy of the editable MS Excel Process Interaction Matrix today!

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