The ISO certification has become a fundamental requirement for doing business throughout the world. In their quest for quality, many companies are adopting lean manufacturing methodologies including 5S, Kaizen events, and Six Sigma projects to help improve internal processes and productivity levels. But in their zeal to launch new quality-improvement initiatives, some businesses are inadvertently putting their quality management system (QMS) on the back burner.
Lean principles are business tools and, in fact, should blend seamlessly into the QMS. An integrated approach enjoys consistency without redundancy and does not jeopardize a company's ISO 9001:2000 or other certifications. When operating independently, lean processes can create a fragmented business approach that hurts the company's core quality standards.
The Costs of Fragmentation
An ISO 9000 registration confirms a structured business management system with an eye toward continuous quality improvement. As a third-party auditor, I review every facet of a company's business system. To do this, as a minimum, a company must provide its policy, goals, objectives, procedures, and work instructions for review.
During audits, it's not uncommon to uncover weak areas in the system that give company management valuable opportunities for improvement. Yet, a high percentage of registered companies I audit have not appropriately integrated their lean manufacturing system or other quality initiatives into the existing QMS. This, in turn, creates a negative impact and affects the integrity of the QMS. This fragmentation occurs for one of two reasons:
• The company is unaware its QMS has taken different directions because the new initiatives are not part of the management review process.
• Senior management has assigned priority and focus on the newly embraced quality initiative, inadvertently stranding its QMS.
A fragmented approach as shown in Figure 1, may not necessarily impact a company's production, quality, or delivery of product or services. However, it can definitely affect its sales. If a company fails an ISO/TS 16949:2002 audit, its customers are notified. Failure to maintain a registered QMS, for whatever reason, may be cause enough for a customer to take its business elsewhere.
The Rise of the QMS
The International Organization of Standardization (ISO) is synonymous with quality. After ISO 9000:1987 launched in Europe, its popularity eventually spread worldwide due to the globalization of once localized markets.
In the 1990s, U.S. manufacturers, urged by their European customers, began registering for ISO 9001 with product design or ISO 9002 without product design. Registration, they learned, offered a major incentive: the ability to continue doing business with their European customers.
Looking forward, U.S. industries recognized additional benefits of ISO. Registration forced companies to continuously focus on quality, giving them an advantage in an increasingly competitive global market.
ISO's influence became evident when American industries used the requirements as a self-regulation guide. For example, the Joint Commission on Accredited Healthcare Organizations adopted standards based on ISO 9000 and today certifies more than 15,000 healthcare organizations and programs in the United States.
ASTM International, another U.S. based standards body, addresses technical industries that took cues from ISO to develop its requirements. The Department of Defense replaced all of its military standards during the 1990s with ISO-based standards.
Additionally, U.S. manufacturers have worked with ISO to develop standards specifically for their industries. The American National Standards Institute, a conglomeration of standards bodies in the United States, has worked to adopt national standards based on ISO 9000.
Today, aerospace OEMs must have an AS 9100 Rev B registration while automotive manufacturers and even dealerships require TS 16949:2002 registration. The electronics, telecommunications, and papermaking industries are examples of other industries heavily influenced by ISO in the effort to maintain quality. These businesses need an ISO registration and must meet specific standards influenced by ISO 9001:2000.
The Growth of Lean
In a lean manufacturing system, companies literally are doing more in less time with fewer employees. Companies, agencies, and organizations apply lean principles to produce goods and deliver services, creating value with a high amount of efficiency and quality.
In fact, it was an American, Henry T. Ford, who first implemented lean in 1913. He developed flow production to streamline the automotive assembly process. The system was adapted later and updated, but the essence of lean remains today the constant focus on value, quality, and flow production.
After World War II, Toyota Production System in Japan further refined the lean approach to develop Kanban or cell manufacturing techniques. In this methodology, personnel stop their moving production line when they encounter a defect or abnormality. Working with their supervisor, they suggest improvements to resolve the problem.
Another popular lean approach is the 5S program, which aims to improve productivity, quality, and safety through visual order, organization, cleanliness, and standardization. 5S usually is a part of Kaizen and includes the following:
• Sort—clean up and organize the space.
• Set in Order—organize, identify, and arrange everything in a work area.
• Shine—regularly clean and maintain.
• Standardize—simplify to make the process easy to maintain.
• Sustain—maintain what has been accomplished.
Overall, the eagerness to introduce a lean system sometimes leads companies to temporarily forget the rules they already have established. In one example, a company implementing 5S required all its workers to tape outlines and label common objects such as the coffee machine, telephones, and staplers.
The extra steps required to implement this system and others like it created additional work and documentation that had nothing to do with the quality and delivery of the product. The lean manager did not effectively integrate 5S into the QMS because of a misguided understanding of the concepts.
In the rush to implement lean, this company took a shortcut and abandoned the QMS. It failed to incorporate the new lean initiative into the existing system by neglecting where the focus should have been placed—toward the customer, their processes, and their product. Value stream mapping is fine and very effective as long as it coincides with the already established sequence and interactions of the QMS processes as defined in the QA manual.
Putting the Pieces Together
The goal of the new lean system is to streamline work effectively and efficiently with whatever resources you have at your current disposal. This coordinated approach is shown in Figure 2. When companies fail to integrate a new initiative, no warning bells are sounded or red flags waved. Senior management may not recognize that the fragmentation process is occurring.
In another example, an automotive manufacturer is registered to TS 16949:2002. An in-house engineer is promoted as the new lean manufacturing manager and receives formal training on the lean approach. The company creates a new organizational chart, and the new lean manager assembles a team. At this point, the fragmentation process often begins.
The team quickly introduces a lean system into the factory so that the company can begin seeing some cost benefits immediately. Unfortunately, it was launched without considering how to align the initiative with the quality policy; define the process and include it in the tier I, II, and III documentation; and schedule internal audits to assess the effectiveness of the lean launch. Ultimately, the team also neglected to present the results during management review.
As auditors, we like to refer to W. Edward Deming's Plan, Do, Check, Act continuous improvement wheel. The automotive company in the example did follow through on the first two steps. Once the automotive manufacturer reached the Check aspect of the wheel, the continuous improvement process was abandoned.
Without internal audits to continuously assess the new initiative, no information was gathered. With no data, there were no lessons learned, and consequently, the company gave itself no reason to Act.
To be fully integrated, the new lean system must avoid the ad hoc, shoot-from-the-hip approach and instead correlate with the existing management system. Otherwise, it becomes a satellite system. A registered QMS operates under a company's own imposed rules to avoid a system or interface disconnect.
Some steps to lean integration include the following:
• Define the process and include it in the existing system diagram.
• Assign responsibilities and authorities.
• Establish goals and measure the process.
• Summarize progress for management review.
• Schedule internal audits to assure the new system operates within the rules.
• Take corrective actions when needed.
Discipline Through Frequent Audits
Integration requires discipline as well as some nurturing. The lean manager should be accountable, certain that the left hand knows what the right hand is doing. To do so, he or she should understand how the QMS operates before launching the initiative. This support and education are the responsibilities of the company's management representative.
Companies run through the initial registration process with a third-party auditor. Once successfully registered, that business then is placed on a six-month or annual audit schedule, whichever it chooses, and undergoes a surveillance audit. At the end of a three-year cycle, the company must submit to another third-party audit to reregister. The process continues for as long as the company opts to keep its registration current.
A schedule of internal audits should be developed based on the new initiative's impact on the business management system and its level of importance to the company. I like to compare the internal auditor's role to that of a parent. The internal auditor should review the new initiative with tightened frequency during its infancy. As the system grows and matures, internal audits can be scheduled farther apart.
Without this rigorous evaluation, a business may be left with a system that never matures. An immature system can stall progress, become management's problem child, and ultimately lead to ISO registration failure.
Nine Tips for Lean Integration
With ISO, your key processes, the process owner, inputs, outputs, tools, and procedures, must be defined and then measured against key performance indicators. When lean is introduced, it is important to define what the lean process is and how it will operate within the current QMS.
Some tips on how to successfully integrate lean include the following:
1. Create a Quality Planning Procedure
The lean manager must develop a quality planning process that dictates how to implement new initiatives such as 5S or Kaizen. This documentation will become the guide for future initiatives.
2. Don't Forget the Rules
Lean does not mean that your business is starting fresh. Use the methods that were developed when you first registered your management system. Referencing the basics, such as introducing formal procedures and forms and identifying where records are kept, will ensure you have not jeopardized your ISO registration.
3. Write It Down
Changes usually require some form of adaptation. If this is the case, revise and update the applicable documentation in a timely manner, especially before your next scheduled audit. Most importantly, define and measure every process involved with the new lean system.
4. Set Goals and Track Them
It may appear redundant to state that a business should record the goals and objectives of its new lean system. However, it is a step that often is overlooked. Additionally, the company must implement a measurement system to gauge this new initiative's successes or failures. This ensures the company is on a continuous quality-improvement cycle.
5. Remember Who Comes First
It is one of the oldest sayings in the business world, but there is merit in repeating it here: The customer always comes first. Changes to a QMS can positively affect the bottom line but ultimately should never impact the company's capability to serve its customers. Always remember that the focus is on the customer, and the rest should follow.
6. Assign Responsibilities
Senior management must assign responsibilities to all those who oversee continuous quality improvement. The lean manager must develop a plan that uses the existing management system as a starting point. In turn, the internal audit process must police the initiative to ensure it has been integrated.
7. Focus Internal Audits on the Initiative
Internal audits should be scheduled appropriately for a newly implemented lean system or any new initiative for that matter. Internal audits must take into account status and importance and assess the system's effectiveness and whether it plays by the rules of the QMS.
8. Be Disciplined
ISO registration can be a time-intensive, tedious, and bureaucratic process. Regardless, you can't cut corners and take shortcuts. The QMS must be kept current, and this may include revising or adding documentation and updating control plans.
If no one is looking at the bigger picture, a lean system can go out of control quickly and become an entity on its own. Implementing any quality initiative such as lean should always coincide with the current methods defined in the QMS.
Adjustments must be followed by updating or introducing documentation and examined during the internal audit process. In the end, everyone in the company can be confident that it has maintained its QMS and its ISO registration by integrating the new lean initiative into its business management system.
About the Author
Richard Strouse currently is an ISO 9001:2000-, TS 16949:2002-, and AS 9100 Rev B-qualified lead auditor at T ?V Rheinland. With 30 years experience in the manufacturing sector starting on the manufacturing floor, Mr. Strouse has progressively moved up to positions such as supplier quality engineer, SPC coordinator, process engineer, quality engineer, senior quality engineer, and quality manager for the automotive and aerospace markets. He has a degree in manufacturing and industrial engineering. T ?V Rheinland, North American Headquarters, 12 Commerce Rd., Newtown, CT 06470, 203-426-0888, e-mail: [email protected]