Q: I’m trying to determine what QMS is right for my company. What is the difference between ISO 9000 and other ISOs?
A: When people say ISO 9000, they are referring to the quality management systems (QMS) standards and requirements specified in ISO 9001:2000. It is a standard for providing assurance about the ability to satisfy quality requirements and enhance customer satisfaction in supplier-customer relationships.
The standard evolved to its current, more process-oriented form from the older version, which emphasized compliance with a list of requirements. The ISO 9000 standards are generic in terms of their application, meaning the same standards will apply to service, manufacturing or R&D organizations. They are also generic in terms of the industries they apply to, be it automotive, telecommunications, medical devices or pharmaceutical.
To address some special requirements from certain business sectors and areas of application, sector- and application-specific standards were developed by the International Organization for Standardization (ISO). The most noteworthy standard is ISO 14001:2004, which is a hybrid of the ISO 9001:2000 generic model and the environmental management systems standards. There are several ISO standards that are industry or application-specific, as listed in Table 1.
For further information on ISO standards, visit www.iso.org/iso/iso_catalogue/management_standards.htm
Shin Ta Liu, firstname.lastname@example.org
Principal Consultant, Lynx Systems
Q: I’ve heard the term a few times, but am wondering: What is a kaizen blitz?
A: A kaizen blitz (also called a kaizen event) is a team effort devoted to making a significant improvement in a short period of time. Targeted improvements can be manufacturing or administrative in nature, often centered on reducing or eliminating waste or nonvalue added activities. The time involved for a blitz is usually three to five days. The end goal is to formally standardize and implement the new or improved way of doing business.
One challenge is that improvement is expected with “low” cost—significant capital expenditures are usually not in scope.
Blitz events are often employed by organizations that have embraced lean manufacturing principles and have begun widespread training of these concepts and tools. However, a successful event can be held without such a framework, so don’t be scared off if you have identified an improvement opportunity and your company doesn’t already have a “big program” underway.
For a successful blitz:
- Identify the opportunity with preliminary data.
- Identify the team of people needed to fully define the opportunity and who have the ability to make any needed changes. Often, team members span several departments.
- Identify a leader for the team. The leader must have some familiarity with the tools to be employed during the event and be able to direct the group’s activities.
- Work with management to identify a time period of several days when this group can work together exclusively on this opportunity. Gain approval for the team to not only come up with ideas, but also to be empowered to make actual changes.
- Begin with some basic training. In many blitz events it is necessary to develop a process map (or value stream map), so participants should be trained to use this tool.
- Map the process. If possible, do this where the work is actually done rather than in a conference room. Have the team walk through the map and identify wasteful or nonvalue added activities. Gather specific data during the walkthrough and, if necessary, dig for additional data afterward.
- Lead the team in a brainstorming session to identify specific possible improvements. In many cases, people have had great ideas in their heads for years and just need an opportunity to express them in a receptive context.
- Shorten the list by looking at impact versus effort (or cost). Identify actions the team would be willing to actually try out.
- Trial the selected actions and evaluate their impact. The trial might be in the actual workplace or it might be simulated using props made by the team.
- Select the final recommended actions and meet with management to gain approval for implementation.
- Begin standardizing the new, improved way of doing the work. Document any necessary procedures and develop training plans for other people in the organization.
Steps 1-4 relate to planning and might be spread out over time. Steps 5-11 are the true blitz period in which the team is engaged.
Often, the benefits of a blitz extend beyond the specific process addressed to foster improved morale from the team effort and from the empowerment afforded by management.
FOR MORE INFORMATION:
- “Lean Lessons,” Quality Progress, February 2007, p. 47.
Peter E. Pylipow, email@example.com
Senior design excellence engineer
Vistakon—Johnson and Johnson Vision Care Inc.
Q: I am part of a young healthcare organization, and my team has been charged with getting a quality initiative off the ground. I don’t know where to start. How should I approach this?
A: Start with the end in mind: to create a sustainable system of continuous improvement that involves all employees and is viewed as an essential part of the organization’s success.
To do that, you will need to focus on four things: leadership, engagement, customer needs (in your case, patients and families) and competence in improvement methods.
- Ask your leaders why they want a quality initiative. Why is it important? What is their vision for it? Where does it fit relative to other aspects of organizational performance, such as finance? What role do they see themselves playing in leading the initiative? Get their personal commitment to learn about improvement methods by attending conferences, visiting other successful organizations, and reading.
- Ask employees and professional staff what they think needs to be improved. Seek to understand what they are passionate about and design initial efforts around those topics for the purpose of getting high levels of engagement right from the beginning of the effort.
- Engage all parts of the organization (top to bottom, all departments) in talking directly with their customers (patients, families and internal customers) about what they want from their interaction with the organization. Listen intently and seek to understand the experience from their point of view, rather than trying to convince them how great you already are. Compile and share the trends of unmet needs that emerge from these conversations. Match people’s passions with these needs as you design initial improvement projects.
- Learn about basic improvement methods, such as the Institute for Healthcare Improvement’s Model for Improvement and rapid-cycle Plan-Do-Study-Act (PDSA). See Resources below. Use these methods to address the issues that come out of the discussions described earlier. Keep it simple and be action-oriented. Your goal early on is to maximize engagement and foster people’s sense of accomplishment.
You will eventually learn of many more advanced methods for improvement. But these are of no real value without a foundation of leadership commitment and a sense that improvement is a foundational part of daily work for everyone in the organization. Concentrate on building this foundation first.
FOR MORE INFORMATION:
- Institute for Healthcare Improvement. www.ihi.org. A wealth of information, conferences, courses, short teaching videos, methods and tools, and case studies for leaders and improvement practitioners.
- American Society for Quality. www.asq.org. See especially the Healthcare Area of Use.
- M.J. Ryan and W.P. Thompson. CQI and the Renovation of an American Health Care System: A Culture Under Construction. ASQ Quality Press, 1998.
Paul Plsek, firstname.lastname@example.org
Consultant, Paul E. Plsek & Associates Inc.