by Mike Micklewright
The waste involved in having multiple systems serving the same purpose can be enormous. This is true in so many companies that are practicing lean and using an ISO 9001-based quality management system (QMS). The new revision to ISO 9001, expected to be published in 2015, will contain many major changes. It will also provide your company with an opportunity to merge lean practices into your QMS, thus making both systems more effective and driving out the system waste that is inherent in multiple systems with similar purposes.
Although there is no reason why this integration of two systems can’t be done today, the publication of a greatly revised and common ISO standard offers a perfect opportunity to integrate the two systems, since change will be required anyway.
Here are some examples of how this could be done, based on the draft version of ISO 9001:2015, which is still subject to minor changes.
Process approach
The process approach will be a key emphasis in 2015. The process approach was well hidden in ISO 9001:2008, and few companies and auditors took it seriously within their QMS. Now, there will be an opportunity, and an excuse, to organize the company into value streams, while de-emphasizing the departmental structure, which kills process flow. ISO 9001 and lean have always encouraged a true process approach, or value stream approach. Now, ISO 9001:2015 will emphasis it even more, and this provides a great opportunity to reorganize in the spirit of lean and ISO 9001.
Strategic direction
At the beginning of ISO 9001:2015, it states that an organization must determine “its strategic direction and what is affecting its ability to achieve the intended outcome(s) of its QMS.”
This is where the “lean” process of hoshin kanri, or “strategic process deployment” would fit magically. It currently fits well in the 2008 version of ISO 9001 and is aligned with the requirements of quality planning, quality objectives, quality policy, and internal communication. However, the specific requirement of determining strategic direction will offer a great opportunity to employ true hoshin kanri, which will direct kaizen activities through the corrective action system.
Lean and quality folks in top management should work together to understand the relationship between the overlapping requirements of ISO 9001 and hoshin kanri, and eliminate the redundancies in the two systems… and then deploy and execute a robust strategic plan.
Risk management
ISO 9001:2015 will focus a great deal on risk management. Risk identification and mitigation requires a systematic, methodical approach to determining risks and incorporating methods to address them. This will be required at multiple levels throughout the organization, from a strategic level to a product- or service-realization level. Tools like SWOT, which stands for strengths, weaknesses, opportunities, and threats analysis, as well as failure mode and effects analysis (FMEA) will need to be used to identify and mitigate these risks.
Risk is defined as “the effect of uncertainty.” Uncertainty is created by an unpredictable system, which often is caused by excessive clutter or waste in the system. Process and systems wastes (e.g., in transportation or excessive inventory) are drivers of the many risks encountered and should be removed from the system. A true lean approach and the constant focus on eliminating risk will help to both identify and mitigate those risks.
Mistake-proofing
One lean tool, which will definitely decrease the severity, likelihood, and detectability of potential risks encountered, is mistake-proofing, or in lean speak, poka-yoke. Poka-yoke as formalized by Shigeo Shingo is anything in a process that helps a person avoid mistakes.
A requirement in ISO 9001:2015 will be that organizations must address the “prevention of nonconformity due to human error, such as unintentional mistakes….” This requires that organizations mistake-proof the production of goods and provision of services. Auditors and organizations will need to become knowledgeable about the tools and methods to mistake-proof their processes.
One common lean tool, which is also a lower-level form of mistake-proofing and yet extremely effective when done right, is 5S, which has five easy-to-understand steps:
- Sort
- Set in order
- Shine
- Standardize
- Sustain
Given that the fifth S, sustain, is the most difficult of the steps, lean practices such as leader standard work, visual management, and gemba walks will be recommended methodologies for sustaining the prevention of nonconformity due to human errors.
A QMS and lean are both intended to improve the processes within which we work. It’s wasteful to have two different systems, driven by two different departments, attempting to drive toward the same objectives, while not being properly aligned. The new version of ISO 9001 will force organizations to change their QMS, and this offers an excellent opportunity to integrate lean into your ISO-based QMS. The time to start is now!
About the author
Mike Micklewright is an expert in lean and quality management systems. He teaches at universities and manufacturing extension programs (MEPs), and has implemented improvement systems in hundreds of organization. Mike operates his own consulting company, QualityQuest Inc. and is a senior business consultant for Kaizen Institute.
A dynamic international speaker, Micklewright has addressed thousands of people and specializes in creating lean and continuous improvement cultures, effective quality management systems, lean leadership, the principles of W. Edwards Deming, auditing, competency-based training through TWI, participative problem solving, global standardization, and root cause analysis.
He has advised a wide variety of industries from automotive to entertainment, from food to pharmaceuticals, from metals to medical devices, and from aerospace to warehousing. His clients have saved tens of millions of dollars in measurable quality and productivity gains.
This article appeared in Quality Digest Daily, an electronic publication from Quality Digest magazine (www.qualitydigest.com).