HOW QMS AND LEAN SIX SIGMA FELL IN LOVE!

HOW QMS AND LEAN SIX SIGMA FELL IN LOVE!


Early in my career in quality management, I encountered an idea that fundamentally changed my perspective on Quality Management Systems (QMS). I was part of a team working to achieve certification for our company, and our efforts were recognized with the Bronco Booster for the Malcolm Baldrige Award. Subsequently, I led the implementation of ISO 14001 and OSHA 18001, supported other facilities in obtaining their certifications, and started to deploy a Lean Six Sigma Philosophy.

During this time, I had a thought-provoking conversation with a colleague in the quality circle. He suggested that our Quality (QMS) and Environmental Management Systems (EMS) were stifling creativity and enthusiasm for innovation and hindering our ability to meet the company's needs. What struck me was that we were working for the system instead of making the system work for us.

This insight has influenced and fundamentally shaped my approach to quality management, emphasizing the importance of creating systems that genuinely support and enhance the organization's objectives.

As a company, it is easy to lose sight of what the client truly wants and to focus on symptoms rather than root causes. While our goal is to delight customers and demonstrate control and compliance through a Quality Management System (QMS), this is only part of the picture. Meeting quality standards should be distinct from being effective, responsible towards employees, and environmentally conscious.

Although ISO standards, particularly clause 10, emphasize continual improvement, the methods for achieving this are not strictly enforced or mandatory. It is fascinating how ISO 9004 describes this concept, highlighting the importance of a holistic approach to quality management that goes beyond mere compliance.

Often, quality systems encounter numerous issues, such as irregular maintenance for non-applicable or unnecessary activities and an accumulation of temporary fixes that clutter the system. Abundant documented systems can lead to duplications between procedures and work instructions, writing ISO requirements as processes and introducing redundancies without ensuring proper process flow within and across documents. Frequently, requirements are a copy of the “Norm” without reflecting employee practices or clearly defined responsibilities. Managers must clearly define responsibilities. Quality Management Systems (QMS) are sometimes designed more for auditors' satisfaction than company efficiency, with some auditors prefer overly complex QMS structures, etc.?

Remember that the philosophy behind the Quality Management System (QMS) ISO 9001 is based on consistently meeting customer requirements and enhancing satisfaction. It emphasizes a process-driven approach to quality management, focusing on continuous improvement and adherence to regulatory and customer requirements. Here's a clear and engaging explanation:

1. Customer Focus: ISO 9001 prioritizes understanding and fulfilling customer needs, aiming to exceed their expectations. The goal is to ensure customer satisfaction by delivering consistent quality.

2. Leadership: Effective leadership is crucial. Leaders establish a clear vision and direction, creating an environment where everyone understands their role in achieving quality objectives.

3. Engagement of People: Everyone in the organization is involved in quality management. Engaged and empowered employees contribute to improving processes and achieving better results.

4. Process Approach: ISO 9001 emphasizes understanding and managing interrelated processes as a system. This approach helps achieve consistent and predictable results more efficiently.

5. Continuous Improvement: Ongoing improvement is a core principle. Organizations are encouraged to continually seek ways to enhance their processes and systems to boost overall performance.

6. Evidence-Based Decision Making: Decisions should be based on the analysis of data and information. This helps ensure that actions taken are practical and aligned with the organization's goals.

7. Relationship Management: Good relationships with suppliers and other stakeholders are essential. These relationships can significantly impact the performance and quality of the organization's products or services.

By integrating these principles, ISO 9001 helps organizations create a structured yet flexible framework for quality management that promotes efficiency, effectiveness, and continual improvement.

These principles are remarkably aligned with Lean principles, rooted in the same foundational concepts. They complement each other, enhancing overall organizational performance and fostering continuous improvement.

Lean principles focus on maximizing value while minimizing waste and streamlining processes to improve efficiency and effectiveness.?

"If a company improves quality, it will increase production, reduce cost, and increase profit."

Edward Deming,

For many years, I was troubled by the misalignment between our system deployments and the foundational principles of Lean and Quality Management Systems (QMS). Then, I had a unique opportunity to work on a project where a QMS was neither a requirement nor a consideration for the company. However, the organization urgently needed to streamline and organize its processes.?

I proposed creating a mock QMS based on Lean Six Sigma principles—something new and unfamiliar to the team. Quickly, they began to understand that without standardization, improvement is impossible. This realization started a long journey towards greater efficiency and effectiveness.

It wasn't until 2010 that I discovered a crucial guide in this approach: "Lean ISO 9001" by Mike Micklewright, published by ASQ Quality Press. This book provided invaluable insights on integrating Lean principles with ISO 9001, effectively combining the strengths of both philosophies. It illustrated how to create a robust system where the QMS defines the "what," and Kaizen focuses on the "how," ensuring that each complements the other seamlessly. This integration has been instrumental in developing a comprehensive and efficient approach to quality management and continuous improvement.

There is no other book quite like this one. I've read many others, but this one satisfied the need to explain practical applications more effectively. I contacted Mike Micklewright months ago, but I did not receive any reply to my question. Therefore, I am still not sure if he plans to update his book to align with the ISO 9001:2015 revision. Regardless, the book remains highly relevant.?

One of the most valuable ideas I encountered is viewing your project as your Value Stream Map (VSM), which aligns perfectly with ISO 9001:2015's emphasis on 0.3 Process approach / 0.3.1 General / Second paragraph - "Understanding and managing interrelated processes as a system to contribute to the organization's effectiveness and efficiency in achieving its intended results." Another fantastic approach is comparing the eight waste types to improvement opportunities. While defects are the only ones that prompt corrective actions, the other seven wastes also present significant opportunities for enhancement. We often encounter QMS with few Corrective actions and no preventive actions, so why not use these others as opportunities for improvement or as preventive actions??

I particularly loved this approach: working on these opportunities ensures you delight your customers 100% of the time. The Lean Six Sigma arsenal offers numerous tools, all of which aid in improving your QMS. The system, in turn, helps sustain these improvements through documented procedures.

Ultimately, this made me realize why companies often have separate areas that do not act as one. Why have quality areas and continuous improvement been separated? Both are aimed at the same goal: delighting the customer. Therefore, they should be integrated. The book highlights many opportunities for synergy, but organizational silos and power dynamics often hinder collaboration. Working together is essential to generate value for the customer.

Are you ready for this challenge? I want to be part of that transformation in your company.?

Juan Uribe

Sources:?

  • "Lean ISO 9001" book from Mike Micklewright’s ?

  • " Integrating ISO9001 with Lean Six Sigma” Jay P. Patel's article

https://qpsinc.com/resources/articles/integrating-iso-9001-with-lean-six-sigma/

Both stand out as gold mines of information in this field.?

  • ISO 9001:2015

?


Amy Faucon, CSCP, Green Belt

Contracts Specialist for Professional Services

9 个月

Thank you, Juan Uribe, for sharing your ingenious insights and experience! How often do we work for the system and forget that its purpose is to work for us? Your article gave me new perspectives. #qualityinsights

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