Business Process Management - The Six Sigma Approach

Managing a business entails a wide variety of responsibilities and project managers have to be up to the task. Fortunately, there are Business Process Management technologies in place to help processes run more smoothly. However, Six Sigma does more than just help processes run more smoothly. Six Sigma is a methodology. It allows for continuous of improvement of processes, on a project-by-project basis.

Implementing Six Sigma into your business takes a high level of commitment, because it does not go project-to-project. There needs to be 100% commitment from all levels of management, especially upper management. Six Sigma is intended to be a methodology that is implemented throughout the entire organization, and without full support from the very top of the management chain down, the resistance to the change that is inevitable in any organization will triumph and Six Sigma will just be another business management project that had limited success.

What Makes Six Sigma Truly Different

Six Sigma is truly different from the average BPM technology because it is a methodology and a program of mentorship that begins with top management and funnels down to the people who really make things happen in an organization. With the full support of upper management, business managers are able to support their own teams of managers to learn and implement the Six Sigma technology.

There is intensive training involved prior to the deployment of Six Sigma and through out the process. Six Sigma likens the leaders of the implementation process to the belt levels in martial arts, because to implement Six Sigma properly requires dedication and training to ensure success. Greenbelts are those who have undergone two weeks of training in the Six Sigma methodology. Blackbelts undergo four weeks of training and they are able to oversee the Greenbelts. Then, the Master Blackbelt is highly trained to be the Six Sigma program manager for the entire organization. There is a chain of mentorship from top to bottom that will ensure that the deployment goes smoothly and that there is continued success with the program. In fact, deployment does not even begin until the appropriate people are trained to the Greenbelt level.

The business leaders become the Champions, and are there to support the Master Blackbelts. One key with Six Sigma is that the Champion does not just sit back and take a passive role. They are concerned with how the processes are managed. They are concerned with the method of implementation, not just the end results. And this is how Six Sigma intends it to be. They want to create a BPM that is designed from the needs of the business, by the Champions, based on hard numbers.

Six Sigma Methods

Six Sigma has two unique methods through which their product is deployed. The first one is called DMAIC - Define, Measure, Analyze, Improve, and Control. This is ideal if a business has an undefined problem within existing products, services, or processes. The second is DFSS - Design for Six Sigma. DFSS is still in the developmental stage. The aim of DFSS is to create a new product, service, or process that is defect-free in the eyes of the customer.

An organization determines its objectives in terms of numerical value to the company and then they take this information and the method they have chosen to the training table where the belt trainees will use these to amass knowledge and learn to put these objectives and methods into deployment.

Summary

Six Sigma's client list speaks volumes for the effectiveness of the Six Sigma method. These clients include Honeywell, Sears, GE, 3M, Home Depot, the Bank of America, and JPMorgan Chase. Six Sigma is also moving into the public and health care sectors.

Six Sigma is not a company that moves in and takes charge, deploying BPM technology based on what they see as the needs of the business. Instead, they allow the business leaders to tell them what they need Six Sigma to do and they essentially design Six Sigma to tailor fit the needs of their business. Not only do the allow this approach, but they train the business leaders and the staff of the company in the knowledge they need to see what needs to be done. Only then is Six Sigma deployed.

Peter Peterka is President of 6 Sigma us. For additional information on Six Sigma Black Belt or other Six Sigma Online Training contact Peter Peterka.

Six Sigma Defined - Praises and Criticisms

Consumer outlook has undergone considerable changes due to business globalization and revolutionary information exchange paradigms. Changing business conditions created by the flurry of increasing competition has led to diminishing margins for error. Exceeding the expectation levels of customers assumes the central position in the current and future era of business. It is for this reason that Six Sigma has assumed critical importance in the current business environment.

What is Six Sigma?

Six Sigma is a two-way quality management approach towards achieving zero errors by removing process defects for existing products and by designing verified process flow for new products. From a consumer's point of view, Six Sigma is a highly disciplined process that enables product and service deliveries to a near perfect standard.

The term Six Sigma (also 6 sigma) signifies the statistical benchmark for quality assurance. Sigma is the standard deviation (allowable, standardized figure from the mean acceptance level), and when the measured number of deviations beyond the mean tolerance limit is six, you are barely producing quality products. Simply put, this means that if you found six defects in your products, you are very close to poor quality production.

Implementation Of Methodology

The choice of implementation of Six Sigma methodology depends on whether improvement is required on existing processes (DMAIC) or on new process/product design creation (DMADV).

DMAIC

In Six Sigma, DMAIC methodology involves defining improvement goals, measuring the existing standards at baseline for future reference and analyzing the relationship between defects and their causes. This Six Sigma methodology also entails improving processes to deliver consistent goal achievement in accordance with company strategy and consistent with customer demand. The analysis process of this Six Sigma methodology sets the stage for midway course correction, called improvement.

DMADV

This 6 sigma methodology applies to the creation of new processes for product development. This Six Sigma implementation differs from the DMAIC methodology at the final two stages. Defining and measuring the design and product goals and capabilities are the first two stages. The next stage is analyzing alternatives and evaluating to choose the best product design. The next stage consists of implementing the best design. The final stage entails verifying the design, pilot (or test) runs and testing implementation before the final presentation.

Several organizations such as Motorola, (which is a pioneer of Six Sigma), Microsoft, GE and the United States Navy have successfully implemented Six Sigma and reaped huge dividends. Six Sigma has benefited corporations with multiple products across various business sectors. Healthcare, banking and insurance, telecommunications, software, and construction are just some of the industries successfully implementing Six Sigma.

Six Sigma implementation requires organizations to play five key roles at various levels. At the top is executive leadership which includes the CEO, champions, master black belts, and black belts. Then there are the green belts, which dedicate 100% of their efforts towards the concerted implementation of the program until the end of the project. The difference between the green belts and the rest of the team is that the employees in the green belt level share the additional responsibility for Six Sigma implementation along with their normal work responsibilities.

Criticisms Of Six Sigma

Despite its scientific approach towards quality improvement, there are criticisms against Six Sigma. The most vocal one is the viewpoint that there is nothing new about Six Sigma as it imitates already existing and proven techniques. To a certain extent, this argument has some credibility. But proponents of Six Sigma believe that as long as 6 sigma achieves more predictable results with far lower effort, there is no harm in accepting and implementing it. Criticisms notwithstanding, what Six Sigma does is apply concerted efforts at utilizing existing techniques with new approaches.

Tony Jacowski is a quality analyst for The MBA Journal. Aveta Solutions - Six Sigma Online offers online six sigma training and certification classes for lean six sigma, black belts, green belts, and yellow belts.

Six Sigma Training Basics

The need for Six Sigma training has arisen following two reasons. One, the demands of industry could not be met with the existing limited quality assurance methods and two, the tremendous financial opportunities for corporations that the 6 sigma methodology is creating of late.

Many well-known organizations have developed their own Six Sigma training institutes, for in house training of their employees. Realizing the demand that could not be met by companies by themselves, many training institutes and universities have come forward and developed basic Six Sigma training courses.

Differences In Six Sigma Training Basics

A quick look at the Six Sigma training course contents of various institutes immediately shows that they vary widely in their central focus, while still keeping the fundamentals of Six Sigma training content intact. However, this is hardly surprising when one realizes that corporations devise courses for training their own employees for more flexibility. However, the Six Sigma training curricula prepared by independent training institutes and universities closely resemble each other, brining credence and uniformity to all Six Sigma training.

The Basics Of Six Sigma Training

Differences notwithstanding, the central theme of Six Sigma training required for certification must remain same. These are the six core basic elements of Six Sigma training:

1. A thorough and complete training on the DMAIC process and 6 sigma methodology: This involves familiarizing trainees on statistics and its applications, the five key elements of the DMAIC process, and the implementation of this methodology.

2. The roles of each key person: Each person in the organization plays a critical role in the implementation of 6 sigma. Thus, Six Sigma training needs to focus on understanding the key elements of every person's role and the skill to communicate with key players across the organization.

3. Developing abilities to define and work on projects: In Six Sigma training, the emphasis is placed on the streamlining of processes, focusing on the core competencies of each of these. Six Sigma training also focuses on identifying and developing breakthrough processes, products and/or services. As a result, root cause analysis and crisis management abilities become the key to developing versatile management abilities.

4. Cross training necessity: The deployment of Six Sigma methodologies puts the emphasis on a team-based approach. Naturally, qualities such as interpersonal skills, ability to communicate effectively, and ability to transfer knowledge and clarify issues are also important. Sharing of knowledge across the organization is crucial for to the success of 6 sigma implementation.

5. Problem Solving Tools: In Six Sigma methodologies, problem-solving tools are statistical. Six Sigma training essentially teaches all those involved in the implementation how to use statistical tools in order to analyze a problem and solve it. Six Sigma training techniques assume that all candidates do not necessarily have formal training in statistics.

6. Presentation and closing techniques: In Six Sigma training, everyone is taught how to make presentations to management and other decision-makers. Six Sigma training also focuses on how to make the transition to closing projects after their conclusion or abandonment.

All Six Sigma training objectives are tied to a quality-first policy. In a nutshell, Six Sigma training instructs students on how to dissect information, analyze it, validate the results, and implement.

Tony Jacowski is a quality analyst for The MBA Journal. Aveta Solutions - Six Sigma Online offers online six sigma training and certification classes for lean six sigma, black belts, green belts, and yellow belts.

Statistical Software in Six Sigma

Six Sigma is about numbers. Six Sigma produces a flood of data about your process that are critical to your success. If you don't measure it and understand what you are measuring, you can't manage it. Six Sigma's clear strength is a data-driven analysis and decision-making process -- not someone's opinion or gut feeling.

The value of statistical analysis cannot be underestimated. Through an analysis of all of that data, you begin to understand your process and develop methodologies to identify and implement the right solutions to improve your process. Statistical evaluation of the data identifies key areas which can have an adverse effect on product quality if not controlled. Once you have identified these key areas you can focus your process improvement efforts

Given the importance of intelligently handling all of this data, you need to find an efficient and powerful method of crunching the numbers. Naturally, you want to avoid the drudgery of manual calculations and save a whole lot of time by using a statistical software application. You may be tempted to use Excel or another spreadsheet application as a calculator and database to store your statistical process control data. However, you will quickly find out that a basic spreadsheet is too cumbersome to handle the volume and sophistication of the data keeping and analysis you need to perform in a Six Sigma project.

Advanced statistical software such as Minitab (http://www.minitab.com/) or Statgraphics (http://statgraphics.com), are very useful if not essential for gathering, categorizing, evaluating, and analyzing the data collected throughout a Six Sigma project. Both Minitab and Statgraphics are powerful full standalone statistical process control software applications for performing statistical analysis. Both are highly recommended for Six Sigma use as they are tools that can help you utilize one of Six Sigma's biggest advantages: the ability to make better decisions based upon data. They will work with the DMAIC Define-Measure-Analyze-Improve-Control methodology and Lean Six Sigma.

Both Minitab and Statgraphics are designed to support the Six Sigma philosophy offering a range of tools for graphical analyses, collecting powerful statistics, quality analyses with potential for a range of custom designed uses.

• Statistical Process Control Charts
  
• Analysis of Variance and Regression Analysis
  
• Design of Experiments
  
• Factorial and Matrix Plots
  
• Relationships between variables
  
• Life Data Analysis and Reliability
  
• Process Capability Analysis
  
• Hypothesis Testing
  
• Correlation and regression
  
• Time Series Analysis and Forecasting
  
• Measurement Systems Analysis
  
• Regression Analysis
  
• Multi-variation analysis
  
• ANOVA tools and techniques
  
• Six Sigma Quality Assessment

Both applications provide you with nearly real time statistical data, enabling you to respond quickly to prevent further defects. Statistical evaluation of the data identifies key areas to focus process improvement efforts on, which can have an adverse effect on product quality if not controlled.

However, while it is easy to purchase a statistical software application, it is harder to use it effectively. It is <EM>smart </EM>analysis of the data that create real change. All too often, Six Sigma/DMAIC teams collect and load data into Minitab or Statgraphics only to find themselves overwhelmed by the prospect of where to start and how to use their new tool to successfully analyze their data that comes up with, not just any answers, but meaningful and useful answers. As a result, Six Sigma/DMAIC projects often fall far short of the productivity expectations associated with statistical software.

Training in use of Minitab is often offered integrated with Six Sigma training. Minitab training will focus on solving practical problems with Minitab. This includes learning the practical aspects of major statistical tools like Control Charts, Capability Analysis, Regression Analysis, and ANOVA. There is a strong emphasis on learning how to get data into Minitab, learning how to manipulate data once in Minitab and learning how to display graphically major findings from the data. Proper training will teach you how to drive Minitab like a pro and thus bring greater statistical power to your Six Sigma projects.

Peter Peterka is President of Six Sigma us. For additional information on Six Sigma Master Black Belt or Minitab Training programs contact Peter Peterka

Company Politics And Six Sigma

No grouping of human beings is without some amount of politics. Managing deployment of Six Sigma in your organization will unavoidably run into some personal issues and conflict. However, with deft handling of the personal and political issues that come up, along with patience and perseverance, your Six Sigma deployment will not get derailed.

Political factors that can affect a Six Sigma project include personal resistance to change, inflexible company policies, and incompatibility with existing organizational methods and goals. Not surprisingly, all of these factors also affect business processes of any kind. They are not unique to Six Sigma. This is one of Six Sigma's strengths: realistically acknowledging the way politics work in an organization. Six Sigma is not just number crunching. It understands the importance of and encourages the involvement of people throughout and at all levels of the organization working together toward a common goal. Six Sigma encourages planning, communication, and openness about processes, procedures, and information.

Many people see change, any change, as loss?a loss of their power or a loss of the security of the old way of doing things. Thus, people are prone to defend the old way, out of habit and out of unease. They wonder how change will affect them and what exactly happens behind the scenes and if they don't know, become apprehensive. This is a problem that can be overcome through communication. Six Sigma successes require clear and open communication at all levels. Any change in an organization will meet some resistance, either intentional or just from inertia. When management can effectively communicate that it is behind that change and can communicate the positive aspects of the change, resistance and ?turf? politics can be countered and overcome.

Another problem is people who disregard the value and power of Six Sigma and consequently, they are reluctant to support Six Sigma projects. To the uninitiated, Six Sigma may appear similar to or simply an evolution of other quality programs. There have been so many quality improvement fads over the years. It is not surprising that people are now a little jaded. Others may see Six Sigma as solely another cost-cutting or productivity enhancement fad. This is a short-sighted view. Six Sigma is neither a fad nor just another quality initiative. It is a ?way of life.? It is a multi-level, cyclical movement toward continual process improvement. The quality improvement fads sell themselves as cheap and easy quick fixes. The reality is that there are no quick fixes to significant process improvement. Six Sigma understands that; it is not a simple quick process. However, the right Six Sigma training and information will help people to understand that Six Sigma is significantly different; it is a robust continuous improvement strategy and process.

Once projects are begun, Six Sigma projects can become a battle of wills for control over which strategy, approach, or tool is used. Team meetings can devolve into arguments over which measurement to use, how it will be calculated, which charts will be generated, whether to use DMAIC or DMADV, etc. Six Sigma is not about making things more difficult. It is about using common sense to make things easier. It is certainly about recognizing that there is more than one road to improvement and more than one right answer to a problem.

In overcoming political problems, the leadership of senior management is critical. Successful Six Sigma programs are built on a solid organizational foundation. The organizational structure and system needs to be clearly identified and communicated to the entire organization to successfully implement Six Sigma Quality. Becoming a Six Sigma organization doesn't just happen. Planning and training goes into setting up a successful Six Sigma organization. Employee roles and responsibilities must be established and clearly communicated to all. For many companies successful in Six Sigma, the key factor has been the direct involvement of their top leaders.

Six Sigma is about getting everyone involved. A Six Sigma project forms a team of people who work together to identify problems and develop solutions. Such teams are not isolated teams rearranging the world for everyone else to live in. These teams are serving the organization by employing the skills and tools they have learned to increase quality and reduce defects. Instilling the team concept along with expert training will go a long way toward solving potential political troubles in your organization. Peter Peterka is the principal Six Sigma Consultant in practice areas of DMAIC and DFSS. Peter has over 15 years experience including implementation of Six Sigma in Healthcare.

Design for Six Sigma by Peter Peterka

Design for Six Sigma (DFSS) is the application of Six Sigma principles to the design of products and their manufacturing and support processes. Whereas Six Sigma by definition focuses on the production phase of a product, DFSS focuses on research, design, and development phases. DFSS combines many of the tools that are used to improve existing products or services and integrates the voice of the customer and simulation methods to predict new process and product performance.

DFSS can be compared to DMAIC (Design, Measure, Analyze, Improve, Control) and often the acronym DMADV (Define, Measure, Analyze, Design, Verify) is used to describe the strategy of DFSS. The precise phases or steps of a DFSS methodology are not universally defined. Most organizations will implement DFSS to suit their business, industry, and culture. DFSS methodology, instead of the DMAIC methodology, should be used when: * A product or process is not in existence at your company and one needs to be developed * The existing product or process exists and has been optimized (using either DMAIC or not) and still doesn't meet the level of customer specification or six sigma level DFSS is a way to implement the Six Sigma methodology as early in the product or service life cycle as possible. It is a strategy toward extraordinary ROI by designing to meet customer needs and process capability. DFSS can produce the same order of magnitude in financial benefits as DMAIC. But it also greatly helps an organization innovate, exceed customer expectations, and become a market leader.

DFSS is the Six Sigma approach to product design--namely, designing products that are resistant to variation in the manufacturing process. Using DFSS means designing quality into the product from the start. You are preventing wasteful variation before it happens, thus being able to identify and correct problems early when the solution costs are less. A successful DFSS implementation requires the same ingredients as any other Six Sigma project: a significant commitment and leadership from the top, planning that identifies and establishes measurable program goals and timeline, and the training and involvement of everyone.

Planning for DFSS requires collecting the necessary information that will allow for error free production of defect-free products and processes that satisfy the customer profitably. DFSS attempts to predict how the designs under consideration will behave and to correct for variation prior to it occurring. That means understanding the real needs of your customers and translating those needs into vital technical characteristics of the product and ultimately into critical to quality (CTQ) characteristics of the product and process. You can then use design of experiments (DOE) to develop a robust design that optimizes efficiency and reduces defects.

Valid and reliable metrics to monitor the progress of the project are established early in the project, during the Measure phase if using DMADV. Key inputs are prioritized to establish a short list to study in more detail. With a prioritized list of inputs in hand, the DFSS team will determine the potential ways the process could go wrong and take preemptive action to mitigate or prevent those failures. Through analysis, the DFSS team can determine the causes of the problem that needs improvement and how to eliminate the gap between existing performance and the desired level of performance. This involves discovering why defects are generated by identifying the key variables that are most likely to create process variation. Failure Mode and Effect Analysis (FMEA) and Anticipatory Failure Determination (AFD) can be used for both the design of the product and the design of the process.

DFSS provides a structured way to constructively use the information learned from these analyses. Armed with real data produced by the DFSS process, you can develop competent manufacturing processes and choose processes that are capable of meeting the design requirements. Further analysis can verify and validate that the product design will meet the quality targets. This can be accomplished through peer reviews, design reviews, simulation and analysis, qualification testing, or production validation testing.

The benefits of DFSS are more difficult to quantify and are more long-term. It can take over six months after the launch of the new product before you will begin to see the true measure of the project improvements. However, the eventual return on investment can be profound. This is especially true when the organization can use the DFSS project as a template for fundamental changes in the way it develops new products and processes across the organization.

Peter Peterka is a Master Six Sigma Black Belt for Six Sigma us and has implemented Six Sigma in a variety of organizations. For additional information for Six Sigma Training and Design for Six SIgma please contact Peter Peterka at http://www.6sigma.us

Peter Peterka is the principal Six Sigma Consultant in practice areas of DMAIC and DFSS. Peter has over 15 years experience including implementation of Six Sigma in Healthcare with a variety of organizations. For additional information please contact Peter Peterka at Six Sigma us.

Taking on Six Sigma Programs

There is very little doubt that a successful implementation of a Six Sigma program can benefit an organization. However, the probability and the level of success depend on several key factors including the overall strategy and approach, such as proper training and development of internal resources, and selection and appropriate utilization of outside resources. The strategy and approach include numerous vital considerations, including proper project selection, resource and management time requirements, relevant knowledge/experience, fair evaluation of results and cost/benefit analysis of the in- house vs. outsourcing options. We offer a handful of guidelines for making this crucial decision, taking into account unique issues and challenges in the Biopharma and Pharma industries. Both advantages and disadvantages of in- house and outsourcing options are provided along with critical success factors.

Based on a wild guess by a close associate of mine, there are well over 2,000 restaurants in the Manhattan area and its surrounding boroughs. Although I cannot validate the absolute accuracy of his count, I do trust it is in the ballpark, since he happens to be one of those guys who seem to know everything about everything in life (and more). His dream is to be on Jeopardy; if it ever happens, I already feel sorry for the other two contestants, who will undoubtedly be decimated on national TV. And, oh yes, he also happens to be a food- lover. There is definitely some credibility to his estimate.

There is a point to be made by this story (trust me!). Despite the overwhelming number of restaurants in the city-that-never-sleeps, there are only a dozen or so which I truly enjoy and actually look forward to visiting. I am certain that even if I try every single one of these 2,000 locations, the cant-miss list will be no longer than 50. So, assuming my buddys figure is
fairly accurate, what do I make of the other 1,950 establishments? Not much, I am afraid. Unfortunately, there are plenty of examples like this in life. Having spent many, many years in several universities (too embarrassing a number to admit), I have studied under approximately 100 professors. However, there are only three whom I regard as great teachersindividuals who have significantly influenced my life and whose lessons I actually remember.



Tragically, the example does not stop here. There are a plethora of Six Sigma experts out there. A simple search on Google on six sigma consultant yielded a whopping 70,000+ returns. Most of these folks, I am afraid, are mediocre at best.

So, as you consider or embark on a Six Sigma program, how do you select your competent and trust-worthy advisor(s)? With so many self-proclaimed experts, how do you find one who is right for you? Should you involve outsiders at all? How do you know if you can do this successfully only with your internal resources? As you ponder these fundamental questions, the following guidelines may be of interest.

Proper Training and Development of Internal Resources
The word internal should be emphasized here, since it is my strong belief that long term and/or ongoing dependence on external resources is not healthyfinancially or strategically. Rather, the external help should be utilized on an as-needed basis for very specific reasons. We do not depend on our medical doctors to keep us healthyrather, we best make use of them for regular check-ups and to help us quickly recover from an illness. A business organization utilizing external resources is no different. As a guideline, the rationale for external assistance can fall under two high- level categories. These are:

Assistance in Training of Internal Resources
For on- going success of your Six Sigma program, it is crucial that internal knowledge and competence are first developed then continually retained. Your specific training needs depend on your existing capabilities and the level and timing of your targets. First, get an idea for the number of certified master black belts, black belts and green belts currently in your organization. There are numerous ways out there to obtain these titles, so find out how, when and via which organization these individuals were certified. Next, consider the Six Sigma project experience of these individuals and the significance of the past results. As a basic rule of thumb, each black belt should deliver approximately $1M in savings or in cost-avoidance each year. As another rule of thumb, the ratio of black belt to green belt should be between 1:3 and 1:6. One master black belt for each division or location with as many as 1,000 to 1,500 people is often sufficient. In deciding which individuals should be trained,
consider the candidates interest level, current position and background on basic statistical tools (or willingness to learn). These individuals should also possess the knowledge of the
business (i.e., do not pick someone who just joined the company last week) as well as the respect from his/her peers (i.e., do not pick someone because you do not have any other plans for him/her). Lastly, resist the temptation to over-train. It is of no benefit to the organization to have everyone trained, unless the skills are put to use and bottom- line benefits are realized from early on.

- Assistance in Delivering Bottom-Line Results
In this role, you are asking the external resources to deliver specific results using Six Sigma and perhaps other tools and techniques. Prior to the selection of external resources, it is essential that you take the lead in defining the objectives and setting the success criteria. Having the consultants define their own scope of work can be a dangerous thing. Can you imagine getting in a cab and letting the driver decide on where you want to go? In this approach, clearly communicate your objectives and goalsthe cab driver (external resources) can decide and/or advise you on specific routes to take, but you need have a clear picture of your goal and destination.

Resource and Management Time Requirements
You can tell a lot about a person by observing where he/she spends most of his/her time and money. You spend your time and money on the things you regard as important. This point (other than being a reminder that I should give my fiance a call) has applicability in business as well. If you want to ensure a successful Six Sigma initiative, be sure to fall in love with the program. Allocate enough budget and resources to get it off the ground properly. If your organization already has a Six Sigma program (perhaps running for several years) that has hit a plateau, be the change agent to rejuvenate it and turn things around.

Perhaps your organization has had too many distractions in the past and never quite successfully implemented a Six Sigma program. These distractions, in the Biopharma and Pharma industries, can come in many flavors. Typical list of distractions for most FDA regulated organizations include:
Customer complaints (written and verbal)collection, analysis and closure;
CAPAboth externally (as a result of customer complaint, for example) and internally generated (as a result of non-conforming product, for example);
Supplier quality problems and/or inadequate process capability;
Potential major contract manufacturing decisions (especially important for many Biopharma companies at this point in time); and
Compliance issuesperhaps an adverse FDA audit results and/or receipt of warning letters.
Avoid the common mistake of believing that the Six Sigma program is yet another thing to worry about in addition to the urgent items listed above. Instead, view Six Sigma initiative as

a means to effectively resolve the above issues. For example, Six Sigma is not another separate effort on top of your ongoing attempt to improve your quality issues or to shorten a long turnaround time, etc. Rather, Six Sigma tools and techniques should be used as tools to help resolve your quality problems, shorten your lead time, etc.

Management also needs to devote some time on its own to learn the basics of Six Sigma. Management does not need to know how to perform DOE and ANOVA but, at a minimum, it

should be familiar with the key terms and be aware of the overall approach. There are many operational improvement tools and techniques availablehowever, understanding of Six Sigmas well-defined, consistently followed and established approach will prove exceptionally valuable.
If the management lacks either the knowledge or the experience of running Six Sigma programs, seek external help. In doing so, resist the temptation of letting the external resources taking control of your program. They are your helpers, but the client must take the ownership, set the direction and make the final key decisions. From a potential pool, seek out the ones with both Six Sigma and life science industry-specific knowledge/experience. During the initial screening, make sure that you will feel comfortable with your selection at a personal level. And most importantly, clearly communicate your expectations and demand bottom line results from early on.

Relevant Knowledge and Experience
There is no single, official Six Sigma training program or consistent requirements for green, black and master black belts. There are many organizations that certify people, but are not all the same. Make sure the consultants you are dealing with are certified with a reputable organization.
Avoid letting this be a training ground for your external resources. Certification may a good indication, but it is often insufficient. Being an expert means much more than just getting the required training and holding a certificate. It takes several years of applying various Six Sigma tools in real- life settings (specifically in life science industry) to be of true value. Remember one simple ruleany external resource you hire should be significantly better qualified in his/her specific area of expertise than your internally available capabilities.

Prior to making your final selection, insist on meeting the people who will actually be working with you and your team. This may not be an issue when you are dealing with independent contractors, but can be a major point when dealing with large consulting companies. Look for actual industry experienceavoid lifetime consultants. There is no suitable substitute for real- life experience. Although it is not impossible, it is very difficult for someone who lacks the actual experience to relate to the issues you may be facing. Someone who can recite a hundred cookbooks verbatim but has no real- life cooking experience is not a real chef, in my opinion.

Check your consultants background. Check references and speak with previous clients. Ask about a specific FDA requirement during your initial screening. If ever in doubt, politely walk awaythere are literally hundreds more who will be more than happy to do business with you. Some time and effort spent on the selection process will save you lots of headaches and easily hundreds of thousands of dollars (or perhaps millions) in the future.

Fair Evaluation of Results
If there is ever a doubt whether a program was a success or not, chances are that it wasnt. Success, when it comes to bottom line improvements, should not be an entirely subjective thing. A true Six Sigma success should transform the biggest doubters into enthusiastic believers.

Be sure to ask for and to check references. Have the former clients truly achieved success? How long did the relationship last? Any project lasting in excess of six to 12 months may indicate some potential issues ahead. Any good consultant should work him/herself out of a job. If the consultant you are dealing with seems more interested in finding ways to stick around longer, rather than helping you deliver results, then I am afraid you got the wrong person in there.

Ask very specific and pointed questions to judge their life science industry knowledge. Are they up-to-date on the latest biotech trends? How many other pharmaceutical clients have they had? Ask about one or two compliance issues they have solved (without compromising confidential agreements with other clients, of course). Have them provide case studies from other organizations that have faced similar situation/issues you are now attempting to resolve. Ask about their approaches, outcomes and the satisfaction of the clients. Ask for references and check them to make sure their clients share the same opinion.

Based on the external resources previous experiences, what range of lead time reduction can you expect? Have they performed significant projects dealing with complaints and/or CAPA? What were the results? What did it take them to implement these improvements? What level of success can you expect in three months? With respect to quality, what tools and techniques do they have to identify sources of variability? Once identified, how do they reduce/eliminate the variability? How many companies have they worked with that were operating under consent decrees? What (if any) specific Six Sigma tools and techniques do they adopt to help with FDA audit process? What (if any) specific experiences do they have in migrating from clinical to commercial production? If a productivity gain was achieved, has the client been able to sustain it after the initial jump? Be sure to get a rough estimate of what the consultants can deliver. Make sure they are consistent with your own expectations and, most importantly, hold them accountable for delivering real bottom line results.

Cost/Benefit Analysis of In-House vs. Outsourcing
Consider the level of knowledge, experience, available resources and bottom line improvements gained in the past. If an organization has consistently achieved the highest levels of success on its own, there are no compelling reasons to involve external resources. If, on the other hand, there are disputes as to the effectiveness of your program or you currently



lack the knowledge/experience/resources, having the right external resources to fill in the gap can be a very smart move.

In choosing external help . . . shop around! With so many providers, the difference in cost can be mind-boggling. If you are used to dealing with hourly rates for outside help, expect to pay anywhere between $100/hour (usually for an independent contractor who is getting desperate for work) and up to $500/hour (for a well-established and well marketed consultancy or an individual regarded as one of leading experts). Keep in mind that more expensive consultants or better known organizations do not necessarily deliver better results.

With the right approach during negotiations, most consultants will be more than happy to tie their paychecks to performance and/or savings delivered. This can create a mutually beneficial relationship. It will minimize your risk and give competent yet lesser known consultancies/organizations an opportunity to prove its capabilities. If you are willing to go this route, clearly define the roles for the outside consultants and communicate your expectations both verbally and in writing.

Another option may be to have your selected external resources to work for a few weeks at a deep discount with the understanding that after the trial period, the rates will increase to a pre-defined level provided that you, as the client, decide to continue the relationship. Despite the long-awaited uptick in the economy, the supply still far outnumbers the demand with regards to Six Sigma consultants. Use this to your advantage and be selective.

The success of the program depends mostly on you. Seek external resources to compliment specific areas where you currently lack sufficient knowledge/ experience/resources. Most importantly, be demanding of both your internal and your carefully selected consultants. The journey is not an easy one, but the rewards can be quite satisfying.

For more information or to contact us, email us at info@tefen.com.
Tefen ( www.tefen.com) is a publicly traded, international operations consulting firm with seven offices in United States, Europe and Israel. The firm has over twenty years of experience in improving the overall operational effectiveness of Fortune 500 clients around the world. Tefen designs and implements solutions that enhance operational performance throughout an organization. All of Tefen's support programs are ISO 9001 and TCS (Total Customer Satisfaction) certified. Our hands-on approach has achieved success in delivering quantifiable and value-driven results. For more information or to contact us, email us at info@tefen.com


Doing Business In Canada? The Quality of Your French is Key!lina mohamDoing business in Canada often involves translating various business related documents from English to French and French to English, as the case may be.

In Canada, the Official Languages Act awards equal official status to English and French. As a result, various trade documents, labels and operating/instruction manuals must be provided in both languages.

If youre doing business in Quebec, The Charter of the French language and various regulations make the use of French mandatory in various communications and business related situations.

Depending on your industry or the type of work do, choosing the right translation company might turn out to be a bigger challenge than you think.

Where can I find a translator who understands my business?

Dont kid yourself! Truly qualified translators are hard to find, especially for law, finance, medicine, science, engineering and most areas and industries involving any form of specialized knowledge.

In many industries, the single most important cause of product recall is mislabeling, often caused by inaccurate translations.

Product labels hardly qualify as complex technical documents. Now, if simple labels containing at most a few lines of text are so often botched, imagine what happens to really complex documents like commercial agreements, scientific research and technical reports when they are translated by the wrong people.

The translation industry is almost entirely unregulated

No special licence is required to work as a translator or operate a translation company.
Legally, anyone can offer translation services, on any subject-matter, in any language combination.
Unlike doctors, lawyers, charted accountants, actuaries and engineers, to name a few, translators are not required by law to belong to a professional order such as a Law Society, a College of Physicians or an Order of Engineers which verify qualifications and control admissions.
What does it mean to be certified?

The term "certified" is widely used by translation companies to promote their services. What does it mean?

This term may be used either to describe the translator or the translation itself.

When used to describe the translation itself, it often refers to an affidavit or other sworn statement provided by a translator to confirm the accuracy or correctness of the translation.

When translators are certified, it is usually through membership in an association of translators. Translators joins such associations freely and for various reasons. They are not obligated by law or statute to belong to a professional order or obtain a licence to practice their trade.

Hiring a "certified" translator does not guarantee the actual quality of the translation, especially for industry-specific and technical documents.

Technical translations require specific knowledge and relevant expertise

When the translation is legal, financial, medical, scientific or technical in nature, the most qualified translator will likely be a bilingual professional, with a degree in that field or a closely related area and industry specific experience, both in English and French.

A translator with the relevant technical background and industry knowledge will usually produce a better quality translation than a translator without similar qualifications, which is why so many companies using outside translators have an in-house review process to verify the accuracy and style of the translation.

Improve The Quality Of Your Technical Translations

Twelve Translation Facts

Certain documents require more attention than others. Generally speaking, the more specialized or technical your document, the more difficult it will be to find a qualified translator.

It takes more than a translation degree to be an effective translator of legal, financial, medical, scientific or technical material.

For specialized translation work, you should always use a translator with relevant academic knowledge and industry-specific experience.

Certain companies offer translation services in over 100 language combinations, on any subject, including most technical areas. The lack of regulations in the industry encourages some to overstate their qualifications.

More than a few translation companies lack the required expertise to correctly evaluate the quality of their services in all the language combinations they offer.

Make sure at least one of their managers speaks your language combination, French and English, if you are doing business in Canada and ask about their actual qualifications. If the managers are not sufficiently qualified, they will be unable to assess the quality of their translators or of the work they produce.

Generally, a company specializing in only a few languages will provide better quality translations, in those languages, than a company working in a large number of language combinations. This is especially true when technical or specialized documents are to be translated.

For technical matters, sensitive issues and important documents, you should always look for a translation company with genuine experts who have studied and worked in your field or industry, even if this means you will have to use more than one translation service provider for all the language combinations you need.

Remember that the language barrier often prevents material errors and discrepancies from being detected immediately. Poorly written translations and material flaws usually end up being reviewed and corrected at extra cost.

Unless you are dealing with bilingual experts, you should always review your important translated documents with an employee or colleague who speaks the language of the translation to verify its quality and accuracy.

If your work is specialized and technical and must meet specific industry standards, dont expect an accurate and professionally written translation from someone who has never studied in your field or worked in your industry.

When translating technical or specialized documents, look for translators with specialized knowledge and professional experience which are relevant to your work or industry.  Bruno Gingras LL.B,

After a successful carrer as a commercial lawyer in the province of Qubec, Bruno Gingras is now chief operating officer of About Translations Ltd., a Canadian company providing industry-specific French and English translation services in the areas of law, business and finance, medicine and pharmacology, engineering, science and technology. The company is associated with Traductions propos Lte of Montral, Qubec.



Are you in search of the best help in relation to antique clocks. TomAre you in search of the best help in relation to antique clocks.
When you are on the lookout for top information relating to antique clocks, it will be easier said than done extricating the best information from foolish antique clocks submissions and help so it is wise to know how to moderate the information you are presented with.

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Here's several tips which we think you should use when you are searching for information about antique clocks. Please be aware that the advice we give is only relevant to internet information about antique clocks. We do not offer you any assistance or guidance if you are receiving information offline.

Find antique clocks
Your relevant result is a click away!



A terrifc piece of advice you can follow when offered help and advice regarding a antique clocks web site is to find out who owns the site. Doing this could reveal the owners antique clocks authorizations The easiest way to work out who is at the back of the antique clocks website is to look on the 'contact' page or 'about this site' information.

All respectable sites giving you information on antique clocks, will nearly always have an 'about' or 'contact' page which will list the people behind the site. The details should tell you some indication regarding the owner's proficency and credentials. This means you can conduct an appraisal about the webmaster's depth of experience, to advise you on the topic of antique clocks.
Peter Coates is the webmaster for http://www.antique-grandfather-clocks.info

Thinking Six Sigma

 

The sole purpose behind thinking Six Sigma is the uncovering of the mystery of process variations. Six Sigma professionals, starting from top down, must combine their goals so that they all think in unison about 2 things: maximizing customer satisfaction and minimizing wastage, both of which are the essence of Six Sigma thinking.

Six Sigma Mindset

The Six Sigma mindset is a special state of mind which looks at things in a rather critical way, analyzing rationally about the need for each elemental process and why and how they are what they are.

Defining Six Sigma metrics and processes with customer specifications as a target of achievement brings out what can be called the skillful uncovering of the process specifics that destabilize the end results. The irrepressible urge to question things to tie up all loose ends exposes the value of each of the process steps.

The guiding force behind defining and analyzing process steps is clearly the path to problem solving. Naturally, a Black Belt or a Master Black Belt is inclined to interact with all persons involved in Six Sigma implementation. Interpersonal skills take center stage as the mindset is focused on brainstorming to produce accurate data. A Six Sigma “belt” is never hesitant to make use of statistical tools.

The Art Of Six Sigma Thinking And Creating The Mindset

The fundamental quality of thinking Six Sigma is dependent on the ingenuity of all the professionals involved. Furthermore, it is through clear direction during Six Sigma training that such qualities are honed for better. Here are several steps to help you develop the Six Sigma mindset:

1. Identifying A Problem: Realize that problems fall into different categories. If one problem originates from customer, others are caused by internal organization reasons. Solving them requires developing a ‘problem focus,’ involving data collection, measurement systems and analyzing discrepancies.

2. Finding The Problems To Attack: Segregate the problems making use of available tools such as ‘Pareto Diagram’.

3. Formulating Measures: Analyzing why each problem could have occurred opens the doors on the steps required to work them out.

4. Perfecting Countermeasures: Before short-listing countermeasures for implementation, identify the discrepancies in them by trial and error. At this stage, you must be open to possibly scrapping a measure that fails and to start from scratch all over again.

5. Keeping The Wheel In Motion: When implementing the now ‘refined’ procedure is complete, a Six Sigma “Belt” cannot relax. Using feedback from the line staff and upper management, interpreting the feedback may expose further gaps in the process for improvements.

Tony Jacowski is a quality analyst for The MBA Journal. Aveta Solutions – Six Sigma Online ( http://www.sixsigmaonline.org ) offers online six sigma training and certification classes for lean six sigma, black belts, green belts, and yellow belts.