Glossary

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10-Foot, 3-Second Rule

10-Foot, 3-Seconds Rule is a lean manufacturing principle that promotes efficient material handling and reduces waste. It states that any item or material needed within the next 10 feet of a workstation should be accessible within 3 seconds. This rule helps to:

  • Reduce waste: By ensuring that materials are readily available, it eliminates the time and effort spent searching for them, which can lead to wasted time and resources.
  • Improve efficiency: When materials are easily accessible, workers can focus on their tasks without interruptions, leading to increased productivity.
  • Create a safer work environment: Having materials within reach reduces the need for workers to stretch or reach for items, which can help to prevent injuries.

The 10-foot, 3-second rule is often implemented through the use of shadow boards, kanbans, and other visual management tools that help to organize and locate materials efficiently.

100-Mile Rule

The 100-Mile Rule in lean manufacturing is a principle that encourages sourcing materials and components from suppliers within a 100-mile radius of the manufacturing facility. The goal of this rule is to reduce transportation costs, lead times, and environmental impact while fostering local economic development. By sourcing locally, companies can:

  • Reduce transportation costs: Shorter transportation distances mean lower fuel consumption and transportation fees.
  • Decrease lead times: Proximity to suppliers allows for faster delivery of materials and components, reducing the time it takes to manufacture products.
  • Improve inventory management: With shorter lead times, companies can maintain lower inventory levels, reducing storage costs and the risk of obsolescence.
  • Support local economies: By sourcing from local suppliers, companies contribute to the economic growth of their communities and create jobs.
  • Reduce environmental impact: Shorter transportation distances result in lower carbon emissions, contributing to a more sustainable supply chain.

While the 100-mile rule is a useful guideline, it may not always be feasible due to factors such as the availability of suppliers, product complexity, or cost considerations. In some cases, it may be necessary to source materials from suppliers located outside of the 100-mile radius. However, by striving to source locally whenever possible, companies can achieve significant benefits in terms of cost, speed, and sustainability.

100% Inspection

100% Inspection is a quality control method that involves examining every single unit of a product or batch to ensure it meets specific quality standards. This is often used in industries where product quality is critical and defects can have serious consequences, such as medical devices, aerospace components, or food and beverage products.

While 100% inspection provides the highest level of assurance, it can be time-consuming and expensive. It’s often used in conjunction with other quality control methods, like statistical sampling, to strike a balance between quality and efficiency.

1025/2012

Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation is a legislative act that establishes rules for European standardisation. It aims to create a legal framework for the development of voluntary technical specifications for products and services in the European Union (EU).  Key aspects of the regulation include:

  • Defining European standardisation: It establishes the principles and objectives of European standardisation, which include promoting innovation, improving product quality and safety, and facilitating trade.
  • Establishing European standardisation organisations: It recognizes the role of the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC), and the European Telecommunications Standards Institute (ETSI) as the primary organizations responsible for developing European standards.
  • Outlining the standardisation process: It sets out the procedures for developing European standards, including the involvement of stakeholders, the use of consensus-based decision-making, and the transparency of the process.
  • Ensuring coherence with international standards: It promotes the alignment of European standards with international standards developed by organizations such as the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).
  • Facilitating the use of standards: It encourages the use of European standards by businesses and public authorities, and provides for the recognition of conformity with these standards. 

Overall, Regulation (EU) No 1025/2012 plays a crucial role in supporting the EU’s single market by promoting harmonization and interoperability among products and services. It also contributes to improving product quality, safety, and innovation across various sectors of the EU economy.

11 C’s

11 C’s are a set of principles used in lean manufacturing and management to improve efficiency and eliminate waste. They are designed to help organizations create a culture of continuous improvement and maximize value for customers. Here are the 11 C’s:

  • Cleanliness: A clean and organized work environment is essential for efficiency and safety.
  • Clarity: Clear communication and instructions are crucial for avoiding mistakes and delays.
  • Commitment: All team members should be committed to the Lean principles and goals.
  • Consistency: Consistent processes and standards are essential for quality and efficiency.
  • Continuous Improvement: Lean is all about striving for constant improvement in all areas of the business.
  • Customer Focus: The needs and satisfaction of customers should be the primary focus.
  • Creativity: Encourage creativity and innovation to find new ways to improve processes.
  • Courage: Be courageous enough to challenge the status quo and implement changes.
  • Collaboration: Work together as a team to achieve common goals.
  • Competence: Ensure that team members have the necessary skills and knowledge.
  • Cost: Minimize costs throughout the value stream to improve profitability.

By following these principles, organizations can create a culture of excellence and achieve significant improvements in efficiency, quality, and customer satisfaction.

Deming’s 14 Points

Deming’s 14 Points, originally proposed by quality guru W. Edwards Deming, have become foundational principles in lean manufacturing and continuous improvement. These points outline a comprehensive approach to achieving quality, productivity, and customer satisfaction. Here’s a brief overview of Deming’s 14 Points as applied to lean:

  • Create a constant purpose to improve quality and productivity. This involves a long-term commitment to continuous improvement, rather than short-term gains.
  • Adopt a new philosophy. This means moving away from a focus on inspection and rework towards a prevention-oriented approach to quality.
  • Cease dependence on inspection. Quality should be built into the process, not inspected after the fact.
  • Stop awarding business on the basis of price alone. Consider quality and reliability when selecting suppliers.
  • Improve constantly and forever every process. This involves a relentless pursuit of perfection through continuous improvement activities like kaizen.
  • Institute training on the job. Empower employees with the knowledge and skills they need to perform their jobs effectively.
  • Adopt leadership of a new style. Move away from authoritarian leadership and towards a more participative and supportive style.
  • Drive out fear. Create a workplace where employees feel safe to speak up and share their ideas.
  • Break down barriers between departments. Foster collaboration and teamwork across functional areas.
  • Stop slogans, exhortations, and targets for the workforce. Focus on creating a supportive and empowering environment.
  • Remove barriers to pride of workmanship. Give employees the tools and resources they need to do their jobs well.
  • Institute a vigorous program of education and retraining. Ensure that employees have the skills and knowledge they need to succeed.
  • Create a known future for everyone in the company. Provide employees with a clear vision of the company’s goals and direction.
  • Take action to accomplish the above. Implement these principles with a sense of urgency and commitment.

These points collectively emphasize a systemic approach to quality and continuous improvement. They are closely aligned with the principles of lean manufacturing, which seek to eliminate waste and maximize value.

2017/745 – Regulation (EU) 2017/745

Regulation (EU) 2017/745, also known as the Medical Device Regulation (MDR), is a European Union regulation that governs the safety, quality, and performance of medical devices intended for human use. It aims to ensure a high level of protection for patients and users, as well as to facilitate innovation in the medical device sector. Key aspects of the MDR include:

  • Classification: Medical devices are classified into four classes (I, IIa, IIb, and III) based on their risk level. Higher-risk devices require stricter conformity assessment procedures.
  • Conformity assessment: Manufacturers must demonstrate that their devices comply with the MDR through various conformity assessment procedures, such as quality assurance, clinical evaluation, and testing.
  • Clinical evaluation: Manufacturers must conduct a clinical evaluation to demonstrate that their devices are safe and effective for their intended use.
  • Post-market surveillance: Manufacturers are required to conduct post-market surveillance to monitor the safety and performance of their devices after they have been placed on the market.
  • Vigilance: Manufacturers must report any serious incidents or field safety corrective actions related to their devices to the competent authorities.
  • Unique device identification (UDI): All medical devices must have a unique device identifier (UDI) to facilitate traceability and identification.
  • Economic operators: The MDR defines the roles and responsibilities of various economic operators involved in the medical device supply chain, including manufacturers, importers, distributors, and authorized representatives.

The MDR is a comprehensive piece of legislation that has significantly impacted the medical device industry in the EU. It has led to increased scrutiny of medical devices, stricter requirements for manufacturers, and greater transparency for patients and healthcare professionals.

The MDR is applicable to all medical devices placed on the market or put into service in the EU after 26 May 2021. However, there are transitional periods for certain devices and economic operators.

2017/746 – Regulation (EU) 2017/746

Regulation (EU) 217/746, also known as the In Vitro Diagnostic Medical Devices Regulation (IVDR), is a European Union regulation that governs the placing on the market and putting into service of in vitro diagnostic medical devices (IVDs). It aims to improve patient safety and ensure that IVDs meet high standards of quality and performance.

The IVDR replaces Directive 98/79/EC (IVDD) and introduces several significant changes, including:

  • New classification system: IVDs are now classified into four risk classes based on their intended use and potential risk to patients.
  • Conforming assessment procedures: Manufacturers must undergo different conformity assessment procedures depending on the risk class of their IVDs.
  • Clinical evidence: Manufacturers must provide clinical evidence to demonstrate the safety and performance of their IVDs.
  • Post-market surveillance: Manufacturers are required to conduct post-market surveillance activities to monitor the safety and performance of their IVDs after they are placed on the market.
  • Notified bodies: Notified bodies are designated by Member States to assess the conformity of IVDs.
  • Unique device identification (UDI): IVDs must have a unique device identifier (UDI) to facilitate traceability.

The IVDR is a complex regulation with significant implications for manufacturers, importers, distributors, and healthcare providers. It is important to understand the requirements of the IVDR to ensure compliance and protect patient safety.

3 Reals

The “3 Reals” is a fundamental principle in Lean manufacturing that emphasizes the importance of firsthand observation and analysis in problem-solving and process improvement. It is based on the Japanese concept of “3 Gen,” which refers to three specific elements:

  1. Genchi (Real Place): This means going to the actual location where the problem or process occurs. By observing the situation firsthand, you can gain valuable insights into the root causes and potential solutions.
  2. Genbutsu (Real Thing): This involves examining the actual product, component, or process being studied. By seeing the problem or issue up close, you can better understand its characteristics and identify areas for improvement.
  3. Genjitsu (Real Facts): This refers to gathering accurate and verifiable data about the situation. By collecting real facts, you can avoid assumptions and make informed decisions based on evidence.

The 3 Reals principle is essential for effective Lean implementation because it helps to:

  • Avoid assumptions: By going to the real place and seeing the real thing, you can avoid relying on hearsay or preconceived notions.
  • Identify root causes: By observing the process firsthand and collecting real facts, you can uncover the underlying causes of problems.
  • Implement effective solutions: By understanding the problem in depth, you can develop and implement solutions that are tailored to the specific situation.

In essence, the 3 Reals principle encourages a data-driven, hands-on approach to problem-solving and process improvement. By following these guidelines, organizations can identify and eliminate waste, improve efficiency, and deliver higher-quality products and services.

3P – Production, Preparation, Process

3P (Production, Preparation, Process) is a lean manufacturing method that focuses on eliminating waste through product and process design. Unlike traditional lean methods that seek to improve existing processes, 3P aims to redesign processes from the ground up to achieve optimal efficiency and quality.

Key aspects of 3P include:

  • Concurrent development: 3P encourages simultaneous development of products, processes, and standards, ensuring that they align from the outset.
  • Waste elimination: By analyzing the entire value stream, 3P identifies and eliminates unnecessary steps, reducing costs and improving productivity.
  • Continuous improvement: 3P fosters a culture of continuous improvement, encouraging teams to seek new ways to optimize processes and enhance quality.

Overall, 3P is a powerful tool for organizations seeking to achieve significant improvements in their operations through innovative design and process optimization.

3PL – Third-Party Logistics

3PL (Third-Party Logistics) is a company that provides outsourced logistics services to other companies. These services can include transportation, warehousing, freight forwarding, customs brokerage, and supply chain management.

Essentially, a 3PL acts as a logistics partner, handling the complexities of the supply chain on behalf of other businesses. This allows companies to focus on their core competencies while outsourcing the logistics operations to experts.

4-10 Workweek

The 4-10 workweek (lean) is a work schedule model where employees work 40 hours per week, distributed over 4 days instead of the traditional 5. This often involves working longer hours each day (e.g., 10 hours), but with an additional day off per week.

This model is often associated with Lean principles, which emphasize efficiency, waste reduction, and continuous improvement. By concentrating work into a shorter period, organizations can potentially:

  • Increase productivity: Employees may feel more focused and energized with fewer interruptions.
  • Reduce overhead costs: Fewer days of operation can lead to lower utility bills and other fixed costs.
  • Improve work-life balance: Employees enjoy a longer weekend, which can contribute to their overall well-being.
  • Attract and retain talent: This schedule can be attractive to individuals seeking a better work-life balance.

However, it’s important to note that this model may not be suitable for all industries or individuals. Factors to consider include the nature of the work, employee preferences, and legal requirements.

4 P’s of Marketing – Product, Price, Place, Promotion

The 4 P’s of marketing are a framework used to develop a marketing strategy. It is a popular tool for understanding the key elements that influence a product’s or service’s success in the marketplace. The four P’s are:

  1. Product: This refers to the actual product or service being offered. It involves considering factors such as features, benefits, branding, packaging, and quality.
  2. Price: This is the amount a customer pays for the product or service. It involves setting a price that is both profitable and appealing to the target market.
  3. Place: This refers to the distribution channels used to reach customers. It includes factors such as retail stores, online platforms, and direct sales.
  4. Promotion: This is the communication strategy used to promote the product or service. It involves activities such as advertising, public relations, sales promotions, and social media marketing.

By analyzing and managing these four elements, businesses can create a comprehensive marketing plan that effectively reaches their target audience and drives sales.

4 WD – Four-Wheel Drive

4WD stands for Four-Wheel Drive. It’s a type of automotive drivetrain system where power is distributed to all four wheels of a vehicle. This provides enhanced traction and stability, making it particularly useful in off-road conditions, snowy or icy roads, and other challenging terrains.

There are several types of 4WD systems:

  • Part-time 4WD: This system is typically engaged manually by the driver and is only used in specific conditions. It can be switched between 2WD (two-wheel drive) and 4WD modes.
  • Full-time 4WD: This system continuously sends power to all four wheels, providing constant traction and stability.
  • Automatic 4WD: This system automatically engages 4WD when it detects wheel slip, providing improved traction in varying road conditions.

4WD systems are often equipped with features like low-range gearing, differential locks, and traction control systems to further enhance off-road capabilities and performance in challenging environments.

483 – FDA Form 483

FDA Form 483 is a document issued by the U.S. Food and Drug Administration (FDA) during inspections of regulated facilities. It lists observations made by FDA investigators that indicate potential violations of FDA regulations. These observations can be related to a variety of factors, including:

  • Product quality: Issues with manufacturing processes, testing, or labeling.
  • Good Manufacturing Practices (GMP): Non-compliance with standards for manufacturing and quality control.
  • Recordkeeping: Inadequate or inaccurate documentation of processes and procedures.
  • Facility conditions: Unsanitary or hazardous conditions in the manufacturing environment.

Receiving an FDA Form 483 is a serious matter and can lead to further regulatory action, including warning letters or injunctions. Companies that receive Form 483s are expected to investigate the issues and implement corrective actions to address the violations.

5 Principles of Lean

The 5 principles of Lean are a set of guiding principles that aim to eliminate waste and improve efficiency in processes. These principles were developed by Toyota and have been widely adopted by businesses around the world. Here’s a breakdown of the 5 principles of Lean:

  1. Identify Value: The first principle is to identify what the customer values in a product or service. This involves understanding their needs and preferences and eliminating any activities that do not add value from their perspective.
  2. Map the Value Stream: Once value has been identified, the next step is to map the value stream. This involves documenting all the steps involved in delivering a product or service, from raw materials to the customer’s hands. This helps identify waste and inefficiencies in the process.
  3. Create Flow: The goal of Lean is to create a smooth flow of work through the process. This means eliminating interruptions and bottlenecks that slow down the process. It also involves creating a continuous flow of work, so that products or services are delivered in a timely manner.
  4. Pull: Lean emphasizes a “pull” system, where work is only initiated in response to customer demand. This helpsavoid overproduction and ensures that products or services are only produced as needed.
  5. Strive for Perfection: The final principle of Lean is to strive for perfection. This means continuously improving processes and eliminating waste. It involves a culture of continuous improvement and a commitment to excellence.

510(k) – Section 510(k) of the FD&C Act

Section 510(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) is a premarket submission process required by the U.S. Food and Drug Administration (FDA) for medical devices. It is used to demonstrate that a device is substantially equivalent to a legally marketed device (called a “predicate device”).

Key points about Section 510(k):

  • Substantial Equivalence: Devices must be shown to be at least as safe and effective as their predicate device.
  • Premarket Notification: Manufacturers must submit a 510(k) notification to the FDA before marketing a new medical device.
  • Classification: Devices are classified into three categories (Class I, II, or III) based on risk level. 510(k) is primarily used for Class II devices.
  • Exemptions: Some devices may be exempt from 510(k) requirements, such as certain low-risk devices or devices that are substantially equivalent to a previously cleared device.

The 510(k) process is designed to ensure that medical devices meet safety and effectiveness standards before they are made available to the public.

513(g) – Section 513(g) of the FD&C Act

Section 513(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) provides a mechanism for medical device manufacturers to seek information from the Food and Drug Administration (FDA) regarding the classification of their devices. This classification determines the regulatory requirements that the device must meet before it can be marketed in the United States.

Key Points of Section 513(g):

  • Device Classification: Manufacturers can submit a written request to the FDA to determine the appropriate classification for their device.
  • Regulatory Requirements: The FDA’s response will outline the specific regulatory requirements that apply to the device based on its classification.
  • Premarket Submission: The classification will help determine the type of premarket submission (e.g., 510(k), PMA, de novo) that is necessary for FDA approval.

Why is Section 513(g) important?

  • Clarity: It provides manufacturers with a clear understanding of the regulatory pathway for their device.
  • Efficiency: By knowing the classification and requirements upfront, manufacturers can plan their development and approval process more effectively.
  • Compliance: Adhering to the correct regulatory requirements helps ensure that the device is safe and effective for use.

In essence, Section 513(g) is a valuable tool for medical device manufacturers to navigate the complex regulatory landscape and bring their products to market.

5M Model – Man, Machine, Medium, Method, Mission

The 5M model is a problem-solving and risk-management framework commonly used in various industries, especially in aviation and manufacturing. It stands for:

  • Man: The human element, including personnel, training, and behavior.
  • Machine: The equipment, tools, and technology used.
  • Medium: The environment, including weather conditions, infrastructure, and surroundings.
  • Method: The procedures, processes, and techniques employed.
  • Mission: The overall objective or purpose of the activity.

By analyzing these five factors, individuals or teams can identify potential causes of problems, assess risks, and implement corrective actions. The 5M model is often used in conjunction with other tools like the fishbone diagram or the 5 Whys technique to delve deeper into the root causes of issues.

5MT – 5-Speed anual Transmission

5MT in automotive terms stands for 5-Speed Manual Transmission. It refers to a type of transmission that uses five gears to connect the engine’s power to the wheels. The driver manually shifts these gears using a clutch pedal and a gear lever.

5MT transmissions are popular for their direct driving experience, fuel efficiency, and often lower cost compared to automatic transmissions. However, they require more driver engagement and skill to operate effectively.

5P’s of Effective Meetings

The 5 P’s of effective meetings are a framework used to ensure that meetings are productive and efficient. These principles are often used in lean methodologies to minimize waste and maximize value.

Here’s a breakdown of the 5 P’s:

  1. Purpose: Clearly define the meeting’s objective. What specific outcomes or decisions are expected?
  2. Participants: Invite only those individuals who are essential to achieving the meeting’s purpose. Avoid unnecessary attendees.
  3. Plan: Create a detailed agenda with specific topics and time allocations. This helps keep the meeting focused and on track.
  4. Process: Establish ground rules and guidelines for the meeting, such as time limits for speaking and participation expectations.
  5. Positive Environment: Foster a positive and inclusive atmosphere where everyone feels comfortable contributing and participating.

5S – Sort, Set, Shine, Standarize, Sustain

5S is a workplace organization methodology that uses a list of five Japanese words:

  • Seiri: Sort
  • Seiton: Set in order
  • Seisō: Shine
  • Seiketsu: Standardize
  • Shitsuke: Sustain

These five steps help create a clean, uncluttered, and organized workspace, leading to increased efficiency, safety, and quality. The goal of 5S is to reduce waste and optimize productivity. It’s a foundational tool in lean manufacturing and is often used in various industries to improve workplace conditions and overall performance.

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5W – Who, What, When, Where, Why

5W is a mnemonic device used to ensure that all essential information is gathered and included in a story, report, or investigation. It stands for:

  • Who: Who is involved?
  • What: What happened?
  • When: When did it happen?
  • Where: Where did it happen?
  • Why: Why did it happen?

This technique is commonly used in journalism, but it can be applied to any situation where you need to gather and communicate information effectively. By answering these five questions, you can ensure that your message is clear, concise, and informative.

5 Why 

5WHY is a problem-solving technique that involves asking “why” five times to get to the root cause of a problem. It’s a simple but effective method used to drill down from the surface-level symptoms of a problem to its underlying causes.

The process involves:

  1. Identifying the problem: Clearly define the issue you want to solve.
  2. Asking “why” five times: For each answer, ask “why” again. This can help you uncover the underlying reasons for the problem.
  3. Analyzing the root causes: Once you’ve reached the fifth “why,” analyze the root causes identified. These are the fundamental issues that need to be addressed to solve the problem.

5W2H

The 5W2H method is a question-based approach used to thoroughly analyze a problem or situation. It is a helpful tool for brainstorming, decision-making, and problem-solving. The 5W2H stands for:

5W’s:

  1. Who: Who is involved or affected?
  2. What: What needs to be done or is happening?
  3. When: When should it be done or is it happening?
  4. Where: Where should it be done or is it happening?
  5. Why: Why is it necessary or important?

2H’s:

  1. How: How will it be done?
  2. How much: How much will it cost or how long will it take?

By asking these questions, you can gain a comprehensive understanding of the situation and identify potential solutions or challenges. The 5W2H method is often used in business, project management, and quality control.

6 Big Losses of OEE

The Six Big Losses are the primary causes of equipment-based productivity loss in manufacturing. They are categorized within the three components of Overall Equipment Effectiveness (OEE): Availability, Performance, and Quality.

Availability Losses

  1. Planned Stops: Scheduled downtime for maintenance, cleaning, or inspections.
  2. Unplanned Stops: Unexpected equipment breakdowns or failures.

Performance Losses

  1. Idling and Minor Stops: Short interruptions in production due to minor issues.
  2. Reduced Speed: Equipment operating below its ideal speed due to factors like wear, tool dullness, or material inconsistencies.

Quality Losses

  1. Process Defects: Products that don’t meet quality standards and require rework or scrap.
  2. Startup Rejects: Non-conforming products produced during the initial startup phase of a production run.

Addressing these Six Big Losses is crucial to improving overall equipment effectiveness and maximizing production efficiency. By identifying and mitigating these losses, manufacturers can reduce downtime, increase output, and enhance product quality.

6M – Machines, Manpower, Materials, Methods, Measurement, Mother Nature

6M is a framework used in Lean Six Sigma to identify potential root causes of problems or process variations. It stands for:

  • Machines: The equipment, tools, and technology used in the process.
  • Manpower: The people involved in the process, including their skills, training, and motivation.
  • Materials: The raw materials, components, and supplies used in the process.
  • Methods: The procedures, workflows, and standards followed in the process.
  • Measurement: The metrics, data collection methods, and analysis techniques used to monitor and evaluate the process.
  • Mother Nature: The environment, climate, and other external factors that can influence the process.

By examining each of these six areas, teams can identify potential sources of issues and develop targeted solutions to improve efficiency, quality, and overall performance.

6S – Sort, Set, Shine, Standardize, Sustain, Safety

6S is a workplace organization and management methodology that builds upon the well-known 5S system. It is a comprehensive approach that helps create a clean, organized, and efficient work environment by focusing on six key principles: 

  • Sort: Identify and remove unnecessary items from the workplace.
  • Set in order: Arrange necessary items in a logical and easily accessible way.
  • Shine: Clean and maintain the workplace to a high standard.
  • Standardize: Create and implement consistent procedures for maintaining order and cleanliness.
  • Sustain: Develop habits and systems to ensure that the 6S principles are followed on a daily basis.
  • Safety: Prioritize safety in all aspects of the workplace, ensuring that employees can work without risk of injury.

By implementing 6S, organizations can improve efficiency, reduce waste, enhance quality, and create a safer, more productive work environment.

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7 Basic Tools of Quality

The 7 Basic Tools of Quality are a set of simple, yet effective techniques used in quality management and process improvement. These tools are designed to help individuals and teams identify, analyze, and solve problems related to quality. They are considered essential for any organization that wants to improve its quality performance.

Here are the 7 Basic Tools of Quality:

  1. Check Sheet: A simple form used to collect and record data in a structured manner. It helps identify patterns, trends, and frequencies of occurrences.
  2. Histogram: A graphical representation of the distribution of a set of data. It shows how often different values occur within a dataset.
  3. Pareto Chart: A bar chart that is arranged in descending order of frequency. It helps identify the most significant contributors to a problem.
  4. Cause-and-Effect Diagram (Fishbone Diagram): A graphical tool used to identify the root causes of a problem. It shows the relationship between the problem and its potential causes.
  5. Flowchart: A diagram that illustrates the sequence of steps in a process. It helps visualize the flow of work and identify areas for improvement.
  6. Scatter Diagram: A graph that shows the relationship between two variables. It helps determine if there is a correlation between the two variables.
  7. Stratification: A technique used to divide data into subgroups based on relevant factors. It helps identify variations within the data and isolate the root causes of problems.

These tools are often used together to provide a comprehensive approach to quality improvement. They are easy to learn and apply, and they can be used in a variety of settings, from manufacturing to service industries.

7 Wastes

The 7 wastes are a set of inefficiencies often found in manufacturing and business processes. They are identified as the root causes of waste and inefficiency, leading to reduced productivity, increased costs, and decreased customer satisfaction. Here are the 7 wastes:

  1. Overproduction: Producing more than is needed or producing items earlier than required. This can lead to excess inventory, increased storage costs, and obsolescence.
  2. Waiting: Time spent waiting for materials, equipment, or information. This can cause delays, idle resources, and decreased productivity.
  3. Transportation: Moving materials or products unnecessarily. This can damage items, increase transportation costs, and lead to delays.
  4. Overprocessing: Performing more work on a product than is necessary to meet customer requirements. This can waste time, resources, and increase costs.
  5. Inventory: Having too much or too little inventory. Excess inventory can tie up capital and increase storage costs, while insufficient inventory can lead to delays and lost sales.
  6. Motion: Unnecessary movement of people or materials. This can cause fatigue, injuries, and decreased efficiency.
  7. Defects: Producing products that do not meet customer requirements. This can lead to rework, scrap, and decreased customer satisfaction.

By identifying and eliminating these wastes, businesses can improve their efficiency, reduce costs, and increase customer satisfaction.

7 Ways Comparison Form

The 7 Ways Comparison Form is a tool used to compare and contrast different options or ideas. It is a structured approach that helps individuals or groups identify similarities and differences, analyze potential outcomes, and make informed decisions. Here are the seven categories typically included in a 7 Ways Comparison Form:

  1. Cost: Evaluates the financial implications of each option, including upfront costs, ongoing expenses, and potential savings.
  2. Time: Considers the amount of time required to implement and maintain each option, as well as any potential delays or setbacks.
  3. Effort: Assesses the level of effort or resources needed to carry out each option, including manpower, equipment, and expertise.
  4. Quality: Evaluates the expected quality or outcome of each option, considering factors such as performance, reliability, and durability.
  5. Risk: Identifies potential risks or challenges associated with each option, including negative consequences or uncertainties.
  6. Benefits: Highlights the potential benefits or advantages of each option, such as improved efficiency, cost savings, or increased customer satisfaction.
  7. Overall Evaluation: Provides a final assessment of each option, considering all of the factors evaluated in the previous categories.

By systematically comparing options using these seven categories, individuals or groups can make more informed and objective decisions. The 7 Ways Comparison Form can be adapted to fit various situations and can be used for personal, professional, or academic purposes.

7 Ways Idea Generation Form

The 7 Ways Idea Generation Form is a brainstorming technique designed to stimulate creative thinking and problem-solving. It encourages individuals or teams to generate at least seven unique solutions to a given problem or challenge. Key principles of the 7 Ways form:

  • Quantity over quality: The focus is on generating a large number of ideas, rather than judging their quality immediately.
  • No judgment: All ideas are accepted without criticism, fostering a safe and open environment for creativity.
  • Divergent thinking: The goal is to explore a wide range of possibilities and avoid limiting oneself to conventional solutions.

How it works:

  1. Define the problem: Clearly identify the challenge or question you want to address.
  2. Set a timer: Allocate a specific amount of time for brainstorming.
  3. Generate ideas: Individually or as a group, come up with at least seven distinct solutions to the problem.
  4. Review and refine: Once the brainstorming session is complete, review the generated ideas and consider ways to combine or improve them.

Benefits of the 7 Ways Idea Generation Form:

  • Promotes creativity: Encourages participants to think outside the box and explore unconventional solutions.
  • Fosters collaboration: Can be used effectively in group settings to leverage diverse perspectives.
  • Overcomes mental blocks: Helps overcome barriers to creative thinking by forcing individuals to generate multiple ideas.

By following the 7 Ways Idea Generation Form, individuals and teams can generate innovative and effective solutions to a wide range of challenges.

8D Disciplines

8D is a structured problem-solving methodology used to identify, correct, and eliminate recurring problems, particularly in manufacturing and quality control. It’s a systematic approach that involves eight distinct steps or “disciplines” to address the root cause of a problem and implement long-term solutions.

The eight disciplines are:

  1. Form a team: Assemble a cross-functional team with the necessary expertise to address the problem.
  2. Define the problem: Clearly identify the problem, its severity, and its impact.
  3. Contain the problem: Implement temporary measures to prevent the problem from escalating or recurring.
  4. Identify the root cause: Use tools like Ishikawa diagrams or 5 Whys to determine the underlying causes of the problem.
  5. Develop permanent corrective actions: Create long-term solutions to eliminate the root cause and prevent the problem from happening again.
  6. Implement permanent corrective actions: Put the solutions into place and verify their effectiveness.
  7. Identify and implement future preventive actions: Develop strategies to prevent similar problems from occurring in the future.
  8. Recognition: Acknowledge the team’s efforts and celebrate their success in resolving the problem.

Key benefits of using 8D include:

  • Systematic approach: Provides a structured framework for problem-solving.
  • Root cause analysis: Helps identify the underlying causes of problems.
  • Permanent solutions: Focuses on implementing long-term solutions to prevent recurrence.
  • Teamwork: Encourages collaboration and knowledge sharing.
  • Continuous improvement: Supports a culture of ongoing improvement.

8D is commonly used in industries such as automotive, aerospace, and manufacturing, but it can be applied to a wide range of problem-solving scenarios.

8 Wastes / 8th Waste

The 8 Wastes, also known as the 7 Wastes and Muda, are a set of inefficiencies often found in manufacturing and business processes. Identifying and eliminating these wastes can lead to increased productivity, reduced costs, and improved quality. Here are the 8 Wastes:

  1. Overproduction: Producing more than is needed, leading to excess inventory and wasted resources.
  2. Waiting: Time spent waiting for materials, equipment, or information.
  3. Transport: Unnecessary movement of materials or products.
  4. Overprocessing: Performing more work than is necessary to meet customer requirements.
  5. Inventory: Excessive storage of materials or products, leading to increased costs and potential damage.
  6. Motion: Unnecessary movement of people or equipment.
  7. Defects: Producing products or services that do not meet customer specifications, leading to rework and waste.
  8. Untalented People: Not utilizing employees’ skills and abilities effectively, leading to wasted potential.

80/20 Rule – Pareto Principle

The 80/20 rule is a principle that states that 80% of the results or outcomes come from 20% of the causes, inputs, or efforts. It’s also known as the Pareto principle, named after the Italian economist Vilfredo Pareto.

This rule suggests that a disproportionate amount of value or significance often comes from a relatively small subset of factors. In various contexts, this could mean:

  • Business: 80% of sales come from 20% of customers.
  • Productivity: 80% of your work is accomplished during 20% of your time.
  • Quality: 80% of quality problems are caused by 20% of defects.

The 80/20 rule is often used to identify the most impactful areas for focus, optimization, or improvement. By understanding which 20% of inputs or efforts are driving the most significant results, you can allocate resources and attention more effectively.

90/385/EEC – Directive (EU) 90/385/EEC

Directive (EU) 90/385/EEC is a piece of European Union legislation that sets out safety standards for active implantable medical devices. These are devices that are intended to be fully or partially introduced into the human body through surgery or medical intervention and remain there after the procedure.

Key points of the Directive:

  • Harmonization of national laws: The Directive aims to create a uniform regulatory framework across the EU for active implantable medical devices, ensuring a high level of safety for patients.
  • Essential safety requirements: It sets out essential requirements that these devices must meet, covering areas such as design, manufacturing, sterilization, labeling, and clinical evaluation.
  • CE marking: Devices that comply with the Directive are required to bear the CE marking, indicating that they meet EU safety standards and can be freely marketed within the EU.
  • Manufacturer responsibilities: It places obligations on manufacturers, including registration, quality assurance systems, and clinical investigations.
  • Notified bodies: It establishes a system of notified bodies that assess and certify the conformity of devices to the Directive.

Importance of the Directive:

  • Patient safety: It ensures that active implantable medical devices placed on the EU market meet high safety standards, protecting patients from harm.
  • Free movement of goods: It facilitates the free movement of these devices within the EU, promoting competition and reducing trade barriers.
  • Regulatory transparency: It provides a clear and consistent regulatory framework for manufacturers and healthcare professionals.

Note: The Directive has been replaced by Regulation (EU) 2017/745, which became applicable on 26 May 2021. However, certain provisions of Directive 90/385/EEC may still be relevant in some cases, particularly for devices that were placed on the market before 26 May 2021.

93/42/EEC – Directive (EU) 93/42/EEC

Directive (EU) 93/42/EEC, also known as the Medical Devices Directive (MDD), is a European Union (EU) directive that regulates medical devices. It was adopted in 1993 and aimed to harmonize national laws on medical devices across the EU to ensure a high level of protection for human health and safety, as well as the smooth functioning of the single market.

The MDD sets out essential requirements that medical devices must meet in order to be placed on the EU market. These requirements cover various aspects of device design, manufacture, and performance, including safety, effectiveness, and traceability. The directive also establishes conformity assessment procedures that manufacturers must follow to demonstrate that their devices comply with the essential requirements.

The MDD has been replaced by Regulation (EU) 2017/745, also known as the Medical Devices Regulation (MDR), which came into full effect on 26 May 2021. The MDR introduces more stringent requirements and a more robust regulatory framework for medical devices, with the aim of further improving patient safety and public health.

93/42/EEC – Directive (EU) 93/42/EEC

The 9-Square prioritization tool is a simple yet effective matrix used to categorize tasks or ideas based on their importance and urgency. It helps individuals or teams prioritize their workload and focus on the most critical items.

Here’s how the 9-Square works:

  1. Create a 3×3 grid. Label the horizontal axis “Importance” and the vertical axis “Urgency.“
  2. List all tasks or ideas.
  3. Place each item in the appropriate square.
  • Quadrant 1 (High Importance, High Urgency): These are tasks that must be done immediately.
  • Quadrant 2 (High Importance, Low Urgency): These are important tasks that require planning and preparation.
  • Quadrant 3 (Low Importance, High Urgency): These are urgent tasks but not critical to long-term goals.
  • Quadrant 4 (Low Importance, Low Urgency): These are tasks that can be delegated or eliminated.

The 9-Square prioritization tool helps individuals and teams:

  • Focus on the most important tasks.
  • Avoid procrastination.
  • Manage time effectively.
  • Reduce stress and overwhelm.
  • Make better decisions.