Integrating ISO 9001 with Lean Six Sigma

By Jay P. Patel, ASQ Fellow, MBB, Lean Expert, SCRUM Master, CEO and President of Quality & Productivity Solutions, Inc.

Companies are always searching for a more efficient way to run their business. Cost cutting is the most popular way of getting ahead of the competition. This ideal management setting can be achieved by practicing the lean manufacturing principles.

Lean manufacturing is the concept that using resources for any purpose other than creating value for the customer is waste, and waste should be eliminated, or at least reduced. Lean methodologies are mainly based on the Toyota Production System, and have spread worldwide and advocates continual improvement as the base tenet.

The above figure depicts the 14 underlying Lean Six sigma methodology principles on which it is based.

As is known ISO 9001 standards have same tenet of improvement and process approach as their fundamental underlying.

Thus synergy is impeccable between the two.

ISO 9001 abets Lean Six Sigma implementation:

It is not an either/or choice between ISO 9001 and Lean. Both can be and should be used. Lean can help provide the process improvements that are required by the ISO 9001 quality management system.

Process approach with continual improvement:

The recent improvisation in ISO 9001 with adopting process approach and continual improvement does not specify specific methodology out of many available to be adopted to achieve them and it is left to the organization to select any of them as they suit to the organization. However the one of the most befitting methodology is found in lean six sigma which is widely used by most organizations.

The ISO 9001 standards process model is depicted in the figure below. According to the ISO, process model, any activity, or set of activities that uses resources to transform inputs to outputs can be considered a process. To manage a process, the process owner needs to control inputs, in process, and output as shown in the figure.

The most common benefits of implementing ISO 9001 quality systems include:

• Standardization, and repeatability of processes. This is important, for example, at the end of all the Kaizen Events (Lean tool), so as standardizing the results achieved;
• Improvement of customer satisfaction (lean Value stream mapping tool)
• Reduction of costs of poor quality (6 Sigma process control methods), including most of the eight Lean Wastes.

The Lean Six sigma projects are based on the use of the classical tools as a whole such as SMED, TPM, 5s, Heijunka and Takt Time, Judoka, 6 sigma process control etc. Each of these tools affect,
directly or indirectly, the ISO 9001 Quality System processes.

The impact of the Lean six sigma tools can be related to each of relevant ISO 9001 requirements:

• Quality management system;
• Management responsibility;
• Resource management;
• Product realization;
• Measurement, analysis and improvement.

Lean Six Sigma methodology could affect the so called “management of the processes”, the ISO 9001 process approach and its measurement through Key Performance Indicators (KPIs).

Many companies use KPIs to measure the performance of the most important elements of the ISO 9001 QMS processes, but few know that this concept came out of Lean thinking. Some examples of KPIS are zero defects, customer satisfaction scores or process throughput times. Many of the KPIs used by companies implementing ISO 9001 are focused on measuring the areas of:

• Safety;
• Productivity;
• Quality;
• Continuous improvement;
• Customer Satisfaction;

The Lean tools cannot only improve the processes of the quality, but also those of the management safety as aimed by ISO 9001 standards.

Leadership with engaging people:

Concerning the ISO 9001 requirements that describe the management responsibility the Lean can introduce some or all new roles in the organization chart, particularly Lean Specialist, Six Sigma Black Belt/green belt, Continuous Improvement Engineer, Application Engineer etc. which makes ISO 9001 QMS more robust.

The principal system to involve the whole personnel, as required by ISO 9001-engaging people, independently from the above roles, it is based on the Kaizen Events as applied under Lean Six Sigma environment where key personnel are trained in the various areas of ISO 9001 since the participation to a Kaizen Event under Lean Organization means involvement to every level.

Kaizen Events brings an improvement in the shops floor processes, improvement that are subsequently formalized in the procedures and work instructions as required for documentation requirements under ISO 9001.

Relationship Management:

Mutually beneficial supplier relationships is one of the key requirements of ISO 9001. Relationship management with its supplier and partner network is often of particular importance.

Lean principle of pull just does that for ISO 9001. Simply put, pull processing means that the products are pulled from the consumer end, not pushed from the production end. It’s all about relationships. The lean principle dictates the importance of building and maintaining a good, long term relationship with the company’s suppliers/partners through different management tactics like collaborative risk sharing, information sharing arrangements and cost sharing.

Evidence-based Decision Making:

Lean six sigma is data driven and thus focuses on evidence based decision process. As the ISO 9001 2015 rightly states “Decisions based on the analysis and evaluation of data and information are more likely to produce desired results.”

Effective decisions are always based on the analysis of data and information. Decision-making can be a complex process, and it always involves some uncertainty. It often involves multiple types and sources of inputs, as well as their interpretation, which can be subjective. Lean six sigma has many tools for the analysis of the process data based on which processes are formulated and controlled. Pareto chart, control charts, run charts are some of the examples.

As required under ISO 9001 and as followed by lean six sigma methodology, it is important to understand cause and effect relationships and potential unintended consequences. Facts, evidence and data analysis lead to greater objectivity and confidence in decisions made.

Lean six sigma excellence tools and ISO 9001 relationship:

It is most likely that an organization already has an effective quality management system but it is probably informal and not well documented. ISO 9001 with LSS principles provide a more systematic approach to achieving organization’s objectives as seen in the following table:

Conclusion:

The key to world-class QMS is to Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives. It helps in:

• Integration and alignment of the processes that will best achieve the desired results
• Developing ability to focus effort on the key processes
• Providing confidence to interested parties as to the consistency, effectiveness and efficiency of the organization

Integrating ISO 9001 with Lean six sigma, thus does it the following way:

About the author:

Jay P. Patel is an ASQ Fellow, Master BB, Lean Expert, PMP, Risk Management Professional with 10 ASQ Certifications, and many other certifications. He has over 30 years’ experience in improving processes, people and achieving breakthrough performance at many companies.

For more information or questions, contact jayp@qpsinc.com. (Website: www.qpsinc.com)