ISO 9001 - A Process Interaction Matrix
Through my experience, as a professional auditor, with dozens of companies around the world, I found that very few businesses had developed practical 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 9001:2000 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 & 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 (see links below). The second tool was a well-known technique of flow-charting for those processes that required graphical illustration.
Afterword
Use of the Process Interaction Matrix at Quality Works proved that it is a helpful concise method of defining and documenting interaction of processes for an ISO 9001:2000 quality management system. Based on our experience, we also realized that the same matrix might be successfully used for other standards requiring definition of the interaction of the processes, such as ISO 13485:2003, ISO/TS 16949 [3] and others.
Acknowledgments
The author would like to express his gratitude to Maria Allen, the President of Quality Works, for her willingness to conduct and publish this case study.
References
[1] ISO 9001:2000 Quality management systems - Requirements
[2] ISO 13485:2003 Medical devises - Quality management systems - Requirements for regulatory purposes
[3] ISO/TS 16949 Quality management systems - particular requirements for the application of ISO 9001:2000 for automotive production and relevant service part organizations.
Copyright Quality Works
Figure 1 - Quality System Process Interaction Matrix. This simple quality tool can help your ISO Certification process.
Mark Kaganov was born and raised in Moscow, Russia. He graduated from Moscow University of Radio-electronics and Automation, where he earned his Bachelor's and Master's degrees in design and technology of electronic equipment. While attending the university, he worked for the Institute of Plastics, the former USSR's leading organization in the research and development of plastic materials. In 1981, Mr. Kaganov immigrated to the United States and continued his professional career in Quality Assurance and Research & Development in the plastics, electronics, and medical device manufacturing industries. He has worked for major US corporations such as Capitol Records, RCA, COBE Laboratories and Medtronic. Since 1990, Mark Kaganov is the Lead Consultant at Quality Works. The company specializes in providing businesses with consulting, training, implementation and auditing in the areas of ISO 9001, ISO 13485 and ISO 14001 management systems.
Initiation of the project
Quality Works, a small Internet-based publishing company, has set a goal to establish compliance with ISO 9001:2000 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 & 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 (see links below). The second tool was a well-known technique of flow-charting for those processes that required graphical illustration.
Afterword
Use of the Process Interaction Matrix at Quality Works proved that it is a helpful concise method of defining and documenting interaction of processes for an ISO 9001:2000 quality management system. Based on our experience, we also realized that the same matrix might be successfully used for other standards requiring definition of the interaction of the processes, such as ISO 13485:2003, ISO/TS 16949 [3] and others.
Acknowledgments
The author would like to express his gratitude to Maria Allen, the President of Quality Works, for her willingness to conduct and publish this case study.
References
[1] ISO 9001:2000 Quality management systems - Requirements
[2] ISO 13485:2003 Medical devises - Quality management systems - Requirements for regulatory purposes
[3] ISO/TS 16949 Quality management systems - particular requirements for the application of ISO 9001:2000 for automotive production and relevant service part organizations.
Copyright Quality Works
Figure 1 - Quality System Process Interaction Matrix. This simple quality tool can help your ISO Certification process.
Mark Kaganov was born and raised in Moscow, Russia. He graduated from Moscow University of Radio-electronics and Automation, where he earned his Bachelor's and Master's degrees in design and technology of electronic equipment. While attending the university, he worked for the Institute of Plastics, the former USSR's leading organization in the research and development of plastic materials. In 1981, Mr. Kaganov immigrated to the United States and continued his professional career in Quality Assurance and Research & Development in the plastics, electronics, and medical device manufacturing industries. He has worked for major US corporations such as Capitol Records, RCA, COBE Laboratories and Medtronic. Since 1990, Mark Kaganov is the Lead Consultant at Quality Works. The company specializes in providing businesses with consulting, training, implementation and auditing in the areas of ISO 9001, ISO 13485 and ISO 14001 management systems.
