The U.S. Food and Drug Administration announced the availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies or REMS, which are required for certain drugs or biologics.

The Food and Drug Administration Amendments Act of 2007 (FDAAA) granted the FDA the authority to require the submission and implementation of a REMS if the FDA determines a REMS is necessary to ensure that a drug’s benefits outweigh its risks. Read entire article…

With 104 existing nuclear reactors operating in the U.S. today and another 25+ potential new plants that are currently being reviewed by the U.S. Nuclear Regulatory Commission (NRC), the future of hiring in this industry is a bright spot in an otherwise soft labor market. Read entire article…

The Panel of Judges for the Malcolm Baldrige National Quality Award, the nation’s highest recognition for organizational performance excellence, has selected 15 organizations for the final review stage for the 2009 Award. Starting this month, teams of business, education, health care and nonprofit experts will make site visits to two organizations in the manufacturing category, two in small business, one in education, eight in health care and two nonprofits. There were no organizations chosen for site visits in the service category. Read entire article…

Q1 – You have said that ERR is about increasing organizational reliability, but can it be implemented on a small scale?

A1 – The ERR approach can certainly be applied to a single activity; in fact, that’s how the process begins. However, many RIFs cross organizational boundaries, and so ERR becomes increasingly effective as more activities are included.

Q2 – Can you tell us about times when ERR has not worked well?

A2 – Yes there have certainly been some. ERR relies on a fine-grained understanding of activities, and this can not be achieved without active participation of those whose work is being addressed. The “core team” are agents of transformation, but they cannot impose it. Where managers have tried to build a “core team” without including some people with recent hands-on experience of the kinds of activities being addressed, they generally struggle to succeed. A diagonal cross section of people from across the organization offers the best prospect for success. Another way to fail is by asking the “core team” to work on the most serious and pressing problems first, before they have built up their skill and experience.

Q3 – You have said that ERR does not address errors of judgement, but is there a way of avoiding that sort of error?

A3 – There are many ways of trying to avoid conscious errors and most organizations already use a variety of strategies to combat them. Errors of execution are generally dealt with much less effectively, and that is why we have tended to concentrate on them. However, we do offer advanced training that can offer fresh insights into avoiding conscious errors.

Q4 – Is ERR an alternative to Six Sigma, or can they work together?

A4 – Although ERR works well as a stand-alone approach, it is also complementary to Six Sigma, and they work well together. Some of the same people are likely to be involved in both.

Q5 – How quickly would ERR pay for itself?

A5 – Add up the cost of time spent on damage limitation when errors occur and you have a sense of how much you might save. If human error is implicated in 50% of your measured quality failure costs, and you reduce that by a few percent in the first year, you will have covered your costs. However, most costs associated with human error are not usually measured, although their effects are felt as efficiency burdens and frustrations.

Q6. Is top management’s support of error-proof activities usually from their experience with past and current failures, or are they looking at industry practices?

A6. I would really like to say that most people are looking at error proactively because they realize its value. Of course the reality is most people only start to look at human error when it becomes a big problem for them. Perhaps it is because they’ve experienced an error with serious consequences. Often, work on error is kicked off by something that needs immediate attention, but the lessons learned from studying those RIFs can often be applied throughout the organization. This encourages further work to improve human reliability, once its value becomes obvious.

Q7. I work in the railroad industry, and often, our locomotive engineers fail to cut out on the initial operating locomotive when changing directions. This, in turn, leads to delays. How would you address this type of issue?

A7. The work of a locomotive engineer is systematic. The use of a checklist is useful for avoiding forgetting steps in a process but cannot guarantee compliance, even where this is intended. The reality is that people will tend to rely on their memory and this creates vulnerability. We can look for ways in which we can better direct the attention of the engineers to “risk critical” parts of the task by reducing relevant RIFs. You will need to develop a core team, comprised of people from across the organization with relevant experience. Once these folk understand why human error happens, and have a systematic way of exploring the relevant activities, they will have no difficulty of reducing the probability of the kind of error that you describe. (Not 100% but a definite improvement) If you need help to develop a “core team,” details of a training program can be found on the SAM Group website: www.statamatrix.com

Q8. Are there specific work scenarios where ERR is best applied (i.e., call center, data entry, manufacturing, etc.)?

A8. ERR can be applied to any kind of work in which people are very familiar with the tasks. It has been used across all kinds of sectors and organizations (e.g. pharmaceuticals, aerospace, healthcare, financial services, transportation, food processing, IT providers, etc.) and at all levels. It has also been applied in all sorts of environments ranging from laboratories, to administrative areas, production areas, high security areas, hospital wards, and so on.

Q9. How do you handle resistance to cultural change when implementing ERR?

A9. To enhance an organization’s reliability, of course, there has to be cultural change. But that cultural change is a result of work on error, as much as it is a driver. When work begins on addressing RIFs, those that are easiest to identify and deal with tend to be those that are relatively tangible and “mechanical.” Many of these will have been an irritant to people and they will be pleased to see them being addressed. This reinforces the message that, “the focus is on activities rather than individuals,” which begins to dissipate a blame culture. This lays a foundation for starting to address more sensitive issues that might need attitudinal shift and a willingness to change deeply rooted ways of operating. Some occupational groups may well be more resistant than others but as those more willing to change demonstrate the benefits, those inclined to resist find their position increasingly untenable and difficult to defend. This is especially true where the consequences of error cause physical harm and/or damage reputations.

Q10. If you have a choice between starting with ERR, or say, something like Six Sigma, where would you start?

A10. I think it would depend on the organization and what kinds of issues it is trying to address. In areas where there may be a lot of repeat errors going on across the boards, I might start with something like Six Sigma, especially if the causal factors are relatively “mechanical.” For organizations worried about lower probability errors with serious consequences, I might be inclined to start with ERR. Or better yet, run and ERR program in conjunction with Six Sigma initiative, if both approaches can be useful. ERR tends to favor organizations with mature continuous improvement programs, but has worked well as a stand-alone.

Q11 – If an organization is constantly taking on too many projects and people have too much to do, can the organization ever make good progress?

A11 – To begin with, let me remind you of differences between stressors and structural Risk Influencing Factors (RIFs). While stressors might make life uncomfortable, they alone (usually) do not cause error. What they do is expose vulnerabilities in the design of processes, information systems, workplace facilities, and specific competence deficits. If your organization often takes too much on, that seems unlikely to change soon. However, that doesn’t mean that you cannot work on all of those other issues, so that everyone can better tolerate the pressures. As I explained during the Webinar, I was focusing on “errors of execution” (everyday slip-ups and lapses), and so my remarks apply in particular to that kind of error (and they are 85% of errors). However, errors of judgement and other more conscious kinds of errors are also affected adversely by stressors. The more conscious activities can also be made more robust, although an additional range of techniques is likely to be needed. In summary I would say, life in lots of organizations is too hectic for comfort, but you can still drive down your vulnerability to error with a systematic and well-informed program.

Q12 – Does your model also include some form of standard work?

A12 – I’m not clear about what this question is asking, although there seem to be two possibilities. (A) Does the ERR model address routine activities at work, like repetitious task? Yes very much so. Many errors of execution happen on familiar activities on which it is difficult to focus and sustain undivided attention. (B) Does the ERR model itself have any standard “off the shelf” fixes for common RIFs? Yes it does, although they might need adapting to specific kinds of work.

Q13 – Where can I find the 60 questions for the Error Risk Survey?

A13 – On the Stat-A-Matrix website: www.statamatrix.com

Q14 – Where can I find the list of the 400 RIFs?

A14 – The PIRCOS Knowledge Base (which details the RIFs) is licensed to SAM Group clients who want to train “core teams.” It is not normally supplied on any other basis.

Q15 – Can/how does the Failure Mode and Effects Analysis (FMEA) methodology support ERR?

A15 – You might remember that during the Webinar I explained the futility of trying to guess (forecast/predict) where low probability errors might occur. ERR works by identifying as many RIFs as possible in an area or stream of activity, and dealing with them proactively. FMEA works reactively, or speculatively, to understand contributory causes of a specific outcome and as such does not have a place in the ERR model. However, FMEA is a powerful technique and there is no reason why the PIRCOS Knowledge Base (which details the RIFs) cannot be “plugged into” FMEA to extend it’s utility when addressing human failure modes. We have done so many times, to good effect.

Q16 – Have you seen more errors from the results of routine/repetitive work rather than performing multiple or various tasks for a person?

A16 – Both kinds of work are vulnerable to errors of execution although the specific failure modes may differ. In the case of routine/repetitive work where people become very familiar and/or skilled at it, it might become almost impossible for them to focus consciously on it for more than a few moments at a time, however hard they try. Indeed if they try to it might disrupt their fluency on the task. They will also suffer decay of vigilance beyond (typically) about 20 minutes or so. It takes detailed and well informed design to maintain attention to detail on this sort of work, although ironically this kind of work is often regarded as “simple,” at least by those who don’t have to do it. In the case of somebody who has to perform multiple tasks, the problem is more so one of division of attention. This is especially difficult where these tasks are carried out concurrently, so that several things have to be “borne in mind” at the same time. Frankly, unless structural support is built into such work, it is just a matter of time before something gets missed, or mixed up.

Q17 – The presentation was very fast paced. Will handouts be available? It would be useful to spend more time reviewing some of the slides.

A17 – This material is only available on license to our clients. However, if you have any specific questions, we would be pleased to try to answer them. Many of the concepts mentioned during the Webinar are addressed in our white paper, “The Final Frontier: Improving Reliability by Reducing Human Error,” which is available for download on our websites: www.statamatrix.com

Background Questions

How is that different from the Six Sigma leadership steps?
The Six Sigma leadership steps happen at discrete points in time, usually related to specific improvement events. The Process Management infrastructure is a closed-loop, continuous process that can’t be accidentally discontinued if temporarily side-lined by short-term business priorities.

What is involved in establishing a Process Management infrastructure?
The top management team leads three steps: 1) Identify the PM elements already existing in the business. 2) Identify the PM elements that are weak or missing. 3) Fix or develop the PM elements identified in 2.

Who would be involved in implementing PM in an organization?
The top management team and the owners of the core (value-added) business processes. With help from several PM staff members.

What obstacles might have to be overcome to successfully implement PM?
1) Lack of strategic business goals for accomplishment of specific competitive differentiators. 2) Lack of a Process Management wheel, components and implementation roadmap. 3) Lack of leadership commitment and involvement. 4) Lack of PM coaching assistance. 5) Misaligned enabling processes (support systems) that cause the organization to under-perform on critical PM functions.

Participant Questions

How do you tie in the alignment with a strategic planning process (such as Hoshin)? Does this get real projects that are worthwhile to the business out on the table and deployed to teams who can work them?
We think of alignment as the activities and behaviors that senior management need to incorporate in order to guide the process improvement effort. Hoshin planning could be one of the tools that management uses to prioritize and deploy real projects, but it may not be the only one. For example, management can decide that it is going to delegate project selection to the operating units, and only be involved in assessing whether these projects support the business and are providing adequate ROI. We do not restrict ourselves in the model to a particular approach. The purpose of the model is to identify and use the best approach for the current circumstances for the organization.

This sounds a lot like Deming’s “path of frustration.” Has that been investigated? Short term or “special cause” firefighting activities have short term results. I would think that would be one of the most consistent issues. True?
Yes – this is exactly true. The Process Management model is intended to help companies build the profound knowledge Deming talks about that really helps organizations build a culture of continual improvement after the obvious opportunities have dried up.

This is starting to sound like “management by results” which has been profoundly rejected by such authors as Brian Joiner. The key is to not look too closely at the results, but to look more closely at what drives results. The point made by Brian about metrics is a key ingredient here. Is that what you are doing?
It is not about management by results, but about process management for the “right” results. By the time “results” happen, it is too late to act. So finding up-stream metrics that monitor what drives results is very important. Other than measuring “cost savings,” most organizations do not measure the effectiveness of their improvement initiatives and improvement practices. PM is about assessing and measuring the effectiveness of the organization’s improvement actions to make sure that what is being done improves the bottom line, has a positive impact on customers, and does a better job of engaging employees.

In a service organization, what elements in Process Management might be unique, and therefore influence which tools are selected and how they are employed?
Service organizations are different from manufacturing companies, but the core concepts of Lean and Six Sigma apply in both worlds. Likewise, there are no Process Management elements that are unique to service organizations. EVERY organization that seeks to be successful at process improvement needs to address ALL elements of the Process Management model. However, the tools (Lean, Six Sigma, SCM, ISO, etc.) that are selected for use within the PM model will depend on what the gaps are and a collaborative dialog on the best way to address the gaps. The way the elements get discussed and the examples used in a service environment should differ from a manufacturing environment. In PM, consistent performance of the PM steps is paramount to decisions on which tools to use within the steps.

How would you counsel an organization to address the inertia that exists in company after several unsuccessful attempts to implement a Continuous Improvement process?
This is a very good question. Over the last twenty years, 70% of leadership teams have stated the results of their improvement initiatives failed to meet their expectations. The approach that we have followed is to identify the “missing ingredients” that cause this frustration. We have then done work to shore up the missing pieces without labeling it as a “continuous improvement” effort. Once more of the infrastructure is in place, and it is possible to demonstrate with obvious visible results that the “missing ingredients” have been addressed, it is then more likely that the organization will engage better in the next attempt. Actions speak louder than words, and in time, the people seeing them begin to accept that things really are different; that they can be empowered to make positive changes.

The Process Management wheel represents a continuous effort, as I understand it, it is “never ending”?
Yes it does – that is the idea of “continuous” improvement

Do you have examples or recommendations for how to measure/capture ROI?
The ROI institute (see website below) provides many tools for measuring ROI. http://www.roiinstitute.net/. We offer support on measuring ROI for process improvement efforts through one of our partner companies.

For more information, please visit www.statamatrix.com

STAT-A-MATRIX
One Quality Place
Edison, NJ  08820
800-669-8326
Contact:  Christine Jersild

For immediate release
February 27, 2008

STAT-A-MATRIX Announces Publication of Our Latest White Paper: Making Improvement Work: Using Process Management to Transform Your Performance Improvement Initiative

Edison, NJ—A recent study by the Gartner group indicated that CIO’s greatest priority is business process improvement. Yet many senior executives are not satisfied with the returns they get from their quality improvement efforts. Our experience shows that the problem is not the improvement methodologies but effective execution of the process improvement program.
In our latest white paper, STAT-A-MATRIX presents a process management approach to help your organization “super charge” your process improvement initiative. If your organization already has a process improvement program, our approach will ensure better focus, alignment, and sustainability. If your organization is starting from scratch, our approach defines a road map for designing an effective process improvement program.

Dr. Stephen Spear, a Harvard University professor who has extensively researched Toyota’s way of working said recently: “One of the underpinnings of the culture that Toyota has developed is their ability to tightly couple the work they do with how to do the work better.” Similarly, the STAT-A-MATRIX approach helps you set up the infrastructure to give your organization the ability to “improve the way you improve.”

Founded in 1968, U.S.-based STAT-A-MATRIX, a SAM Group Company, is the world’s leading consulting and training organization dedicated to the pursuit of business process improvement, performance excellence, and regulatory compliance.  STAT-A-MATRIX offers ongoing consulting and training in every aspect of business process improvement, from the basics to the specialized tools needed to assure both customer satisfaction and regulatory or standards compliance.

For more information on how STAT-A-MATRIX can help your organization improve its processes, please visit www.statamatrix.com, email cjersild@statamatrix.com, or call
1-800-472-6477.

These are the Questions and Answers from STAT-A-MATRIX’s Lean Six Sigma webinar held on January 23, 2007.  You can review the presentation slides in PDF format: Lean Six Sigma Integration for Business Excellence.

1. How does standardized work fit into QSR, CFR 820, and ISO 13485? Is it part of QMS control or is it separate?
Lean and Six Sigma are integrated into the quality management process. Recall the ISO 9000 standards, particularly ISO 9004. Appendix B of ISO 9004 categorizes continual improvement in different ways. One is through breakthrough improvement, which can be related to Six Sigma. The other way is through small steps, which relate to people, which is essentially Lean. When we look at typical characteristics of Lean and Six Sigma, we see that Six Sigma is top down and Lean is bottom up.  If we look at other standards that derive from ISO 9000 like ISO 13485 and even QSR requirements that are similar to ISO 13485, the principles are the same. So, Lean and Six Sigma fit well into the ISO-based management systems since the management system requirements lay a foundation for effectiveness while Lean and Six Sigma rise above to build efficiency in organizational performance.

2. Is standardized work part of document control?
Yes, it is. One of the elements of document control is to ensure discipline.

3. Is the “Sustain” referred to in 5S part of QFR 820.22, Quality Audit?
One of the reasons we perform quality audits is to ensure that organizations meet quality criteria established for quality management systems such as ISO 13485 for FDA regulations. In addition, we need to learn whether or not organizations follow their own requirements and “Sustain” is one major requirement of any organization. Yes, “Sustain” is implicitly included in QFR 820.22, Quality Audit.

4. How does Lean Six Sigma apply to Process (re)Design?
Process (re)design is required when an organization does not have the existing capabilities to meet customer needs in developing new products or services. Lean Six Sigma provides a comprehensive set of tools, techniques, and approaches to allow an organization to gather customer requirements, develop specifications based on those requirements, develop and implement solutions to meet the requirements, and verify the requirements have been met by the new product or service. Solutions are built to drive out waste while aligning processes with customers.

5. If I have an existing Six Sigma program, can I incorporate Lean into it for an integrated Lean Six Sigma strategy?
Yes, many organizations that have started with Six Sigma are incorporating Lean into their programs. STAT-A-MATRIX can work with your organization to integrate Lean concepts and tools into your existing structure, giving you the ability to use the tools and techniques that are best suited for the specific problem being addressed. A primary benefit of incorporating Lean into a Six Sigma program is that Lean adds efficiency to the effectiveness provided by Six Sigma. The application of certain Lean tools (e.g., value stream mapping) leads to an optimization of resources through the elimination of waste.

6. How long does it take the Lean Six Sigma management philosophies to become established in an organization?
The integration normally takes two to five years; there are no shortcuts. Progress depends on how well top management leads the initiative. If top management is out front leading the effort, then Lean Six Sigma will permeate the organization quickly and more permanently.

STAT-A-MATRIX
For more information visit www.STAT-A-MATRIX.com.

For Immediate Release
Tuesday, August 21, 2007

Fundamentals of Customer Experience Management

Edison, NJ—The results of Six Sigma improvement efforts often fall short of senior management’s expectations. Likewise, the results of many customer surveys sit on shelves and fail to provoke action. Customer Experience Management effectively integrates survey research—specifically, Customer Value Analysis—with proven approaches to the improvement of process performance.

Customer Experience Management training is ideal for senior managers in market research, operations, customer service, quality, and financial forecasting as well as Six Sigma Black Belts and Master Black Belts. Our exciting two-day course, offered publicly or at your site, covers the fundamentals of Customer Experience Management and provides the knowledge needed to focus your organization’s improvement efforts for sustainable and profitable growth.

Founded in 1968, U.S.-based STAT-A-MATRIX, a SAM Group Company, is the world’s leading consulting and training organization dedicated to the pursuit of business process improvement, performance excellence, and regulatory compliance. STAT-A-MATRIX offers ongoing consulting and training in every aspect of business process improvement, from the basics to the specialized tools needed to assure both customer satisfaction and regulatory or standards compliance.

For more information on how STAT-A-MATRIX can help your organization improve its processes, please visit www.statamatrix.com, email wkinal@statamatrix.com, or call
1-800-472-6477.