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A Process Interaction Matrix
by Mark Kaganov

ne of the requirements of ISO 9001 and ISO 13485, specified in paragraph 4.2.2c, requires a company to develop a quality manual that contains “a description of the interaction between the processes of the quality management system.”

I have encountered few businesses with developed, practical approaches that address this requirement. I have seen companies do everything from creating confusing flowcharts to establishing cross-referenced tables in their quality manuals. One useful approach, however, was developed by Quality-Works, a small internet based publishing company.

Quality-Works set a goal to establish compliance with ISO 9001:2000. The management team asked the business manager to develop and implement documentation to address the standard’s requirements, including documenting the interaction of the processes. This presented some difficulties as attempts to document the interactions in a traditional flowchart resulted in a hard to read document that did not impress the management team.

To address this issue, the team conducted a brainstorming session to search for a new tool. The group determined the company had two types of processes: those related to product realization and those related to the management system. Its product realization processes included market analysis, product design, verification, validation, product release, order processing and product delivery.

Its business management system processes included documentation management, nonconformity and corrective and preventive action system, management review, internal audit program, communication, record management, resource management and information technology.

After analyzing the company’s processes, the management team concluded that most of its business management system processes are interrelated. For example, management review may receive inputs from corrective actions, communications or internal audits, and the internal audit process receives inputs from all processes within the company and provides input into all those processes.

The product realization processes were 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, product validation takes place. Product validation results in product release and finally communication regarding the product’s availability.

To document a top level definition of the process interaction, the team used the process interaction matrix shown in Figure 1. The team then flowcharted the processes that required graphical illustration.


MARK KAGANOV is an IRCA certified QMS 2000 lead auditor and RAB certified environmental management systems lead auditor. He earned a master’s degree in design and technology of electronic equipment from Moscow University of Radio-Electronics and Automation.


FIGURE 1

104 I OCTOBER 2004 I www.asq.org

Process Interaction Matrix 20094 Rev. 02

Use this tool to address one of ISO 9001 and ISO 13485’s requirements.

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The figure is too small to be of any use.
--Lily Sieu, 08-30-2017

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