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Quality and Improvement

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In Summary- Total Quality Management (TQM)

Total Quality Management (TQM) is an ongoing process of detecting and reducing or eliminating errors and defects. It is used to streamline supply chain management, improve customer service, and ensure that employees are trained. TQM can be summarized as a management system for a customer-focused organization that involves all employees in continual improvement. The focus of the process is to improve the quality of an organization’s outputs, including goods and services, through the continual improvement of internal practices. Most companies use TQM to improve customer value and to increase the sales and profitability from goods and services. In this article we summarize principles and tools of TQM. ...Read More

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In Summary- Lean Manufacturing- Principles and Tools

Lean manufacturing is a philosophy that seeks to establish reliable manufacturing activities to minimize process and production wastes. The successful implementation of Lean tools means that companies can accomplish their business goals using few resources. It is a customer-centric approach that companies use to deliver valuable products. Lean manufacturing is instrumental in strengthening operational excellence and asset reliability across facilities. It facilitates the reduction of manufacturing wastes, simplifies routine workflows and improves the consistency of operations. It helps standardize production activities, effectively manage production, operations and maintenance inventories, develop continuous improvement measures and create a value stream for products. In this article we summarize principles and top 20 tools of lean manufacturing. ...Read More

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Quality Gurus and their Contributions

Quality management is not a single doctrine derived from a particular individual or idea—it is a collection of ideas—but there is a core group of contributors known as the Quality Gurus. The Quality Gurus have all had a significant impact on the world through their contributions to improving not only businesses, but all organizations including state and national governments, military organizations, educational institutions, healthcare organizations, and many others. The following list contains some of the well-known quality pioneers and their key Contributions in no particular order of importance. ...Read More

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ISO 9001 2015 Documentation Structure- Downloadable Templates

Every organization wants to improve the way it operates, whether that means increasing market share, driving down costs, managing risk more effectively, or improving customer satisfaction. ISO 9001 quality management system (QMS) gives a framework you need to monitor and improve performance in any area you choose. The current version of the QMS standard, ISO 9001:2015, sets the standard not only for quality management systems but for management systems in general. In this article we explain ISO 9001:2015 documentation structure with +60 downloadable templates ...Read More

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Quality Management Dictionary

In this glossary we collected more than 200 common quality terms from different documentary sources including books, periodicals, websites and quality experts. The definitions contained herein should not be construed as replacing definitions and texts published by official bodies. They are provided here only for information in order to familiarize work teams with the language of quality that they will have to appropriate and master. ...Read More

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How to Prepare for the ISO 9001 Certification Audit

The certification audit tends to be a stressful experience and particularly challenging for department managers. Being well prepared for the audit and knowing what to expect not only reduces stress but also increases the chances for success. So be sure to prepare your company properly in the days leading up to the big day. ...Read More

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The Theory of Constraints (TOC)

The core concept of the Theory of Constraints is that every process has a single constraint and that total process throughput can only be improved when the constraint is improved. A very important corollary to this is that spending time optimizing non-constraints will not provide significant benefits; only improvements to the constraint will further the goal (achieving more profit). ...Read More

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The 10 most used Quality Improvement Methodologies

According to Juran, quality improvement is the third process of quality management processes: • Quality planning, • Quality control, • And Quality improvement Juran also defined improvement as “the organized creation of beneficial change”, such change can be regarding product features or Freedom from deficiencies. Currently there are a significant number of quality improvement approaches available and the improvement team should select the most appropriate one, the successful implementation of approaches, tools and techniques depends on their understanding, knowledge and proper application in organizational processes., it’s not always an easy task, The purpose of this article is to summarize the 10 most used approaches of quality improvement. ...Read More

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Lean Six Sigma Projects- Responsibilities- Success factors- DMAIC template (pptx)

Lean Six Sigma is a project-driven business system improvement method. Its successful implementation and the growing organizational interest in it have been exploding in recent years. It is rapidly becoming a major driving force behind the strategies of numerous successful organizations. Understanding the main responsibilities and success factors of LSS projects provides important opportunities for project professionals. It allows them to lead successful projects and better support their organizations' strategic direction. In this article, we summarize the responsibilities of the LSS project team, identify critical factors affecting project success, and provide a sample project template. ...Read More

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Metrology and Measurements- Definitions- Methods- Techniques- and Units

It goes without saying that correct dimensional measurement is a key factor in business. Performing measurements with the same reference throughout all processes-from material reception to processing, assembly, inspection, and shipping-makes it possible to create products that match the design exactly and to guarantee product quality. ...Read More

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In Summary- QA- QC- and Cost of Quality

To define the difference between quality assurance and quality control, one needs to understand two basic terms. First, many believe that quality assurance and quality control are actually the same thing, in fact even manufacturers often use the terms quality assurance and quality control interchangeably. Rather, as this article explains, quality assurance occurs upstream at the beginning of a manufacturer's product development project, while quality control occurs downstream during or even after production. Second, quality assurance and quality control are part of a manufacturer's overall, overall quality system, also known as a quality management system (QMS). According to ISO 9000:2015: "Quality Management Systems - Basics and Terms", a QMS is a compilation of business processes, methods, guidelines, documented information and tools that run through an entire company. ...Read More


In Summary- Overall Equipment Effectiveness (OEE) Calculations- Example

In an ideal environment, all equipment would operate all the time at full capacity producing good quality product. In real life, however, this situation is almost non-existent due to hidden losses and wastes. OEE is a simple yet powerful roadmap that helps production floor people and management to visualize and eliminate equipment losses and wastes. Basically OEE is about effectiveness; it is the rate between what a machine/Process theoretically could produce and what it actually did. The three main categories of OEE are: ...Read More

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In Summary- 10 Most used time terms in manufacturing and service

Understanding different processing times help you finding your next improvement opportunity. All these times are interconnected, and sometimes confusing, here we describe the most important 10 measures of time used in process improvement, although definitions are widely vary from organization to another, this summary may at least help you finding hot spots to start reducing waste time. ...Read More

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Lean Manufacturing- the 8 Deadly Wastes with examples

Wastes are all those activities/entities which can be removed from the workflow stream without impacting its productivity negatively, simply, anything that does not add value to the customer is a waste, Lean focuses on 8 types of wastes commonly referred to as ‘TIMWOODS’. In the following section we will summarize with examples each of these wastes. ...Read More

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5 Tips for Creating a Culture of Continuous Improvement

Continuous improvement is an ongoing effort to move products, services, or processes from one state to a state considered to be better, a healthy company culture is the cornerstone of continuous improvement, But how do you establish a culture that support improvement initiatives? We’ve put together a few tips. ...Read More

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9 Behaviors to Start and Sustain an Improvement Culture

It is not surprising that culture is contagious. Your company’s culture sets the standards and expectations for everyone. The actions that you take each and every day speak louder than words and it is consistent behaviors over time that reinforces the culture. Due to its importance, managers must be cognizant and careful about how their behaviors impact the organization’s culture. Here are 9 behaviors that can help start and sustain a continuous improvement culture. ...Read More



While some Lean Six Sigma (LSS) practitioners consider 5S a tool, it is more than that. 5S, abbreviated from the Japanese words seiri, seito, seiso, seiketsu, shitsuke, is not just a methodology, it is a culture that has to be built in to any organization which aims for spontaneous and continuous improvement of working environment and working conditions. It involves everyone in the organization from the top level to bottom. The Japanese developed this simple and easily understandable words religiously practiced the philosophy of 5S at every aspect of their life and have made it a world wide recognizable system. Too often in LSS the 5S philosophy is confined to one classroom training session or, at best, used as a one-time implementation methodology that then dies its own death due to negligence. 5S is not a list of action items that has to be reviewed at some interval of time. Instead, it has to be practiced as a daily activity, which requires concentration, dedication and devotion for sustaining it and ultimately making it a company-wide culture. A proper and step-by-step process has to be followed to make 5S a practice and a success. ...Read More


In Summary- How to calculate a Sigma level

Business performance indicators have evolved over the last decades, not considering only the financial perspective because of the main reason in particular: to quantitatively reveal the effectiveness in achieving goals in the face of the improvement actions implemented. Through them, a company can scale the effective capacity of its actions and decisions, so that a current reference value is known before any improvement strategy is executed. It is on the basis of this initial control that the proposed and performed actions for the combat of waste and the increase of performance can be faithfully be evaluated, revealing clearly what the new index of improvement achieved. In this way, there can be evidence of the progress of an area, company or sector over time, where hasty decisions are revealed and effective actions are measured and analyzed. It is only by relying on benchmarks of performance that an organization can prove its success and increasingly stimulate its sustainability in the market. In this article, you will learn a very efficient performance indicator when assessing the new level of performance achieved through the solution actions performed. You will ...Read More

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The 7 Fastest Ways to Fail an ISO Audit

"Good luck!" It's a common word of encouragement you'll hear from colleagues when they find out that you're facing an ISO audit. Of course, trusting in luck isn't a great strategy with this much on the line. You should prepare in every way possible so that luck won't play into the results. And one of the best ways to prepare is to learn from the mistakes of others. Too many life sciences companies find themselves under scrutiny because they thought they had all of their bases covered, but, in fact, failed to pay attention to common nonconformities cited during ISO audits. Let's take a look at the ISO audit blooper reel so that you can avoid these mistakes and pass with flying colors. ...Read More


JIT (Just in Time) Production System

Just in Time (JIT), as the name suggests, is a management philosophy that calls for the production of what the customer wants, when they want it, in the quantities requested, where they want it, without it being delayed in inventory. So instead of building large stocks of what you think the customer might want you only make exactly what the customer actually asks for when they ask for it. This allows you to concentrate your resources on only fulfilling what you are going to be paid for rather than building for stock. Within a Just in Time manufacturing system, each process will only produce what the next process in sequence is calling for. ...Read More

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In Summary- Quality Function Deployment (QFD)

Quality Function Deployment, or QFD, is a model for product development and production popularized in Japan in the 1960’s. The model aids in translating customer needs and expectations into technical requirements by listening to the voice of customer. ...Read More

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Challenges and Lessons to learn- Quality Management

Implementing and maintaining a Quality Management System (QMS) can be quite a challenge. It's not always easy to find the information, method, person or time to implement the QMS that best suits your needs. In this article, we wanted to share 8 common challenges you may face when designing and implementing your next QMS, and 8 lessons our Quality experts learned when facing these challenges during their projects. ...Read More


In Summary- Run Chart- Creation- Analysis- and Rules

A run chart is a line chart of data plotted over time. In other words, a run chart graphically depicts the process performance or data values in time order. Viewing data over time gives a more accurate conclusion rather than just summary statistics. A run chart is also known as trend chart or time series plot. Usually, run charts are used in measure phase of DMAIC project and it helps to identify trends or shifts in process and allows testing for randomness in the process. ...Read More

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Lean Six Sigma Projects- Success Factors

By: Simon Bodie Tools and methodology will only get a person so far. Experience gained from the practical implementation of Six Sigma solutions is priceless. A list of tips, tools and suggestions for Six Sigma practitioners can help avoid many pitfalls of project management. Some fundamental points for project success are: ...Read More

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In Summary- Kanban System

Kanban is a visual method for controlling production as part of Just in Time (JIT) and Lean Manufacturing. As part of a pull system it controls what is produced, in what quantity, and when. Its purpose is to ensure that you only produce what the customer is asking for and nothing more. It is a system of signals that is used through the value stream to pull product from customer demand back to raw materials. Its literal meaning is that of a flag or sign, when you see that flag you know that it is time to manufacture the next part. Kanbans can take many forms but in most production facilities they will use Kanban cards or bins to control the process, although there are no limits to how you can control and design kanbans; only your imagination. ...Read More


How to Create a Value Stream Map

Your company has recently switched to the Lean manufacturing method. You’re on board with this idea—everyone commits to less waste, making the company more efficient and your job a lot easier. But then you realize a key part of Lean methodology involves value stream mapping. You look at one example, and you’re not even sure where you’d begin recreating this diagram for your own process. If you find yourself stuck in the situation above or you just want to find out more, use this guide to learn about the value stream map process. ...Read More


5 Quality Failures that Shook the World

Quality assurance, control and management are key pillars of business stability and success. Failure to adhere to these principles can lead to cataclysmic and indeed tragic consequences, as these five events reveal. ...Read More


In Summary- Evaluating the Cost of Quality

Every regulated organization understands the need to implement a quality system. In fact, it’s a “shall” clause for all life sciences companies to ensure they are in compliance with industry regulations. The focus of any effective quality system is, and rightly so, all about ensuring patient safety. From there, as the organization matures, its people, processes and technology evolve from a compliance, to a correction, to a prevention mindset, eventually resulting in increased quality brand recognition and shareholder value. Consider a scenario in which a manufacturer maximizes the capabilities of its quality system. If that company really “did it right the first time;” if every motion, thought, and investment -- from the product development, through market approval, and through manufacturing at all production sites and along the value chain -- were spent “right the first time” -- the outcome would be “right.” Right for the consumer/patient and for the manufacturer. In the real world, companies need to engage quality system processes, such corrective and preventive action (CAPA), as the lifeline to feed improvements through the change management processes into the product li ...Read More


In Summary- What is Jidoka

Jidoka is one of the most important Lean methods for ensuring built-in quality. Learn how it can help you enhance your workflow. ...Read More


In Summary- Poka-Yoke Technique

Lean Management has adopted the principles and techniques originating as part of the Lean Manufacturing methodology and developed them further. Now we can experience Lean's benefits in management and transfer successful techniques from the times of post-war Japan to modern-day business conditions. One of the most valuable takeaways is Poka-Yoke. It has become one of the most powerful work standardization techniques and can be applied to any manufacturing or service industry. Its idea to prevent errors and defects from appearing in the first place is universally applicable and has proven to be a true efficiency booster. ...Read More


In Summary- What Is Takt Time

It wouldn’t be farfetched to say that Lean management owes a great deal of its success in pulling new work in progress instead of pushing it. This allows you to create and deliver value to your customers only when there is a demand. However, managing a pull system wouldn’t be possible without maintaining a continuous flow of work. This is not an easy task as demand is in a constant state of flux. In order to meet demand and run your process in the leanest and most efficient way, you need to define takt time for your work process. ...Read More

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Pareto Diagram- Scatter Diagram - The 7 QC Tools

The ability to identify and resolve quality-related issues quickly and efficiently is essential to anyone working in quality assurance or process improvement. But statistical quality control can quickly get complex and unwieldy for the average person, making training and quality assurance more difficult to scale. Thankfully, engineers have discovered that most quality control problems can be solved by following a few key fundamentals. These fundamentals are called the seven basic tools of quality. With these basic quality tools in your arsenal, you can easily manage the quality of your product or process, no matter what industry you serve. Learn about these quality management tools and find templates to start using them quickly. ...Read More

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