This document discusses quality risk management standard operating procedures (SOPs). It provides links to additional quality management resources and outlines the contents of a quality risk management SOP, including quality risk management principles, tools like check sheets and control charts, and ensuring focus on protecting patients.
This document provides an introduction and overview of Preliminary Hazard Analysis (PHA). It discusses that PHA is usually the first attempt to identify potential hazards associated with a proposed system or process. The document outlines the key steps in conducting a PHA including establishing a team, describing the system, identifying hazards, estimating consequences and frequencies, and ranking risks. PHA provides rationale for hazard control and indicates if more detailed analyses are needed. The document also briefly discusses related analyses like Subsystem Hazard Analysis and Operating and Support Hazard Analysis that can build upon an initial PHA.
Dear All, I have prepared this presentation to get a better understanding of Statistical Process Control (SPC). This is a very informative presentation and giving information about the History of SPC, the basics of SPC, the PDCA approach, the Benefits of SPC, application of 7-QC tools for problem-solving. You can follow this technique in your day to day business working to solve the problems. Thanking you.
This document provides an overview of statistical process control (SPC). SPC uses statistical techniques to monitor processes and detect changes, helping to prevent defects and drive continuous improvement. It aims to identify problems in production as early as possible through analysis of process capability. Control charts are a key tool in SPC, monitoring the average and variation of a process over time through control limits. Being in statistical control means a process's measurements vary randomly within control limits in a predictable way. Patterns outside the limits indicate the process is out of control due to assignable causes that need correction. Benefits of SPC and control charts include reduced scrap, preventing unnecessary adjustments, and providing diagnostic information.
This document discusses statistical process control (SPC) techniques for managing quality. It covers various SPC methods including error detection, error prevention, and process control systems. The benefits of SPC include controlling processes, predicting behavior, avoiding waste, and achieving defect prevention. Key SPC tools include data collection, summarization using charts, histograms, and control charts to monitor processes and detect issues. The document also discusses process capability, measurement of variation, and using frequency distributions and histograms to analyze process capability.
Professor Yakub Aliyu Product Quality Non Conformance presentation -v1.4_11...Professor Yakub Aliyu
This document discusses corrective action and preventative action (CAPA) processes for addressing nonconforming products in a quality management system. It provides an overview of CAPA responsibilities and procedures, the 8D problem solving approach, examples of immediate and long term corrective actions, and requirements for verifying the effectiveness of CAPA measures through validation, monitoring for recurrence, and ensuring information dissemination. The goal of CAPA is to eliminate the root causes of problems in order to improve products, processes and customer satisfaction.
This document discusses quality risk management standard operating procedures (SOPs). It provides links to additional quality management resources and outlines the contents of a quality risk management SOP, including quality risk management principles, tools like check sheets and control charts, and ensuring focus on protecting patients.
This document provides an introduction and overview of Preliminary Hazard Analysis (PHA). It discusses that PHA is usually the first attempt to identify potential hazards associated with a proposed system or process. The document outlines the key steps in conducting a PHA including establishing a team, describing the system, identifying hazards, estimating consequences and frequencies, and ranking risks. PHA provides rationale for hazard control and indicates if more detailed analyses are needed. The document also briefly discusses related analyses like Subsystem Hazard Analysis and Operating and Support Hazard Analysis that can build upon an initial PHA.
Dear All, I have prepared this presentation to get a better understanding of Statistical Process Control (SPC). This is a very informative presentation and giving information about the History of SPC, the basics of SPC, the PDCA approach, the Benefits of SPC, application of 7-QC tools for problem-solving. You can follow this technique in your day to day business working to solve the problems. Thanking you.
This document provides an overview of statistical process control (SPC). SPC uses statistical techniques to monitor processes and detect changes, helping to prevent defects and drive continuous improvement. It aims to identify problems in production as early as possible through analysis of process capability. Control charts are a key tool in SPC, monitoring the average and variation of a process over time through control limits. Being in statistical control means a process's measurements vary randomly within control limits in a predictable way. Patterns outside the limits indicate the process is out of control due to assignable causes that need correction. Benefits of SPC and control charts include reduced scrap, preventing unnecessary adjustments, and providing diagnostic information.
This document discusses statistical process control (SPC) techniques for managing quality. It covers various SPC methods including error detection, error prevention, and process control systems. The benefits of SPC include controlling processes, predicting behavior, avoiding waste, and achieving defect prevention. Key SPC tools include data collection, summarization using charts, histograms, and control charts to monitor processes and detect issues. The document also discusses process capability, measurement of variation, and using frequency distributions and histograms to analyze process capability.
Professor Yakub Aliyu Product Quality Non Conformance presentation -v1.4_11...Professor Yakub Aliyu
This document discusses corrective action and preventative action (CAPA) processes for addressing nonconforming products in a quality management system. It provides an overview of CAPA responsibilities and procedures, the 8D problem solving approach, examples of immediate and long term corrective actions, and requirements for verifying the effectiveness of CAPA measures through validation, monitoring for recurrence, and ensuring information dissemination. The goal of CAPA is to eliminate the root causes of problems in order to improve products, processes and customer satisfaction.
The document discusses risk based quality management in clinical trials. It summarizes the EMA Reflection Paper on Risk Based Quality Management, which encourages a more systematic, prioritized, risk-based approach to quality management. The paper endorses the use of central statistical monitoring to identify risks and ensure data integrity. Several quality management tools are also described, including check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, histograms. Other related topics like quality management systems and standards are listed for further reading.
Risk management in pharmaceutical IndustryMahesh shinde
This document provides an overview of risk management in the pharmaceutical industry. It discusses the objectives, scope, definitions, and tools used in risk management. The key tools covered include Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA), Hazard Analysis and Critical Control Points (HACCP), and Preliminary Hazard Analysis (PHA). The goal of risk management is to identify potential risks, evaluate their likelihood and impact, and develop control measures to mitigate risks and ensure product quality and safety.
Project Quality Management involves creating policies and procedures to ensure a project meets the customer's needs. It includes three key processes:
1) Plan Quality - Define what quality means for the project and how it will be ensured. This includes developing a quality management plan.
2) Perform Quality Assurance - Check that the project is following the quality standards, including performing quality audits.
3) Perform Quality Control - Verify the project is meeting the quality standards by inspecting deliverables and performing tests. Quality control uses various tools like control charts, checklists, and sampling to measure and control quality.
A CAPA (Corrective and Preventive Action plan) is written to address problems identified in clinical research studies. It outlines the root cause of the problem, corrective actions taken to resolve the issue, and preventive measures to avoid future occurrences. The CAPA should be authored by the responsible party, focus on solutions rather than blame, and include a root cause analysis, corrective actions, and preventive actions. It follows a specific template that provides the issue, analyses, resolutions and plans for evaluation. The completed CAPA is submitted to the IRB and site monitors to document handling of issues.
Test Planning and Test Estimation TechniquesMurageppa-QA
In this Quality Assurance Training session, you will learn about Types of Testing , Test Strategy and Planning, and Test Estimation Techniques. Topic covered in this session are:
• Test Planning,
• Test Estimation Techniques
For more information, about this quality assurance training, visit this link: https://www.mindsmapped.com/courses/quality-assurance/software-testing-training-with-hands-on-project-on-e-commerce-application/
This document provides information and sample documents for creating a quality management system that conforms to ISO/IEC 17025 standards for laboratories. It includes videos, ebooks, and articles on quality management. Sample documents and procedures are provided for a quality manual, code of ethics, document control, continual improvement, feedback, conflict of interest, internal audits, and job hazard assessment. Related sample forms are also included to support implementation of these quality management processes. The document outlines tools and approaches for laboratories to develop a quality management system that meets ISO/IEC 17025 requirements.
1) This document discusses Statistical Process Control (SPC), which uses statistical methods to monitor and control processes to ensure they operate at full potential. SPC aims to maximize conforming product output while minimizing waste.
2) Key aspects of SPC include understanding variation in processes, distinguishing between common and special causes of variation, using statistical tools like control charts to monitor processes and detect issues, and taking action to control processes and continually improve quality.
3) The document outlines the basic elements of a process control system, including gathering performance information, taking action on processes and outputs, and using feedback to maintain stability and reduce variation. It emphasizes prevention over detection to avoid waste.
The document provides guidance on quality risk management as outlined in ICH Q9. It defines key terms related to risk management such as harm, hazard, risk, severity, and quality risk management. It also outlines the basic quality risk management process which includes risk identification, analysis, evaluation, control, reduction, acceptance, communication and review. The process is meant to help assess risks to quality in a systematic way and facilitate risk-based decision making. It emphasizes basing decisions on scientific knowledge and linking risks to potential harm for patients.
The document discusses project quality management. It defines quality and project quality management, which ensures projects satisfy needs. Quality is planned through quality planning and quality standards. Quality assurance evaluates performance while quality control monitors results. Tools like control charts, Pareto charts and sampling are used. Statistical concepts like six sigma and ISO standards help manage quality.
Risk Based Testing: Deferring the Right Bugsindus329
QA InfoTech is a professional Quality Assurance and Software Testing service provider with qualified Testing Experts who are committed to provide creative QA / Testing solutions to challenging technical projects.
This document provides an introduction to statistical process control (SPC). It defines SPC as a strategy that uses statistical techniques to evaluate processes, identify variability, and find opportunities for improvement. The goal of SPC is to make high-quality products the first time by reducing variability, rather than reworking defective products. It focuses on monitoring process behavior rather than just final product quality. SPC distinguishes between common cause variability that is always present and special cause variability that can be addressed to improve the process. It emphasizes identifying and addressing special causes first before adjusting process means. Control charts are used to monitor processes and determine if they are in control or need adjustment.
ICH Guideline Q9 - Quality Risk Managementmuna_ali
A presentation of the ICH guideline Q9 (Quality Risk Management). It discusses the basic risk management procedure, list of recognized risk management tools and its role in pharmaceutical industry.
The document discusses corrective and preventive actions (CAPA) for recurring problems. It explains that CAPA is a structured process required by ISO 9001 to investigate nonconformities, determine appropriate corrections and actions, and measure effectiveness. The CAPA process involves defining the problem, investigating the root cause, developing solutions, verifying the solutions address the root cause, and checking effectiveness. Root cause analysis tools discussed include 5 whys, cause-and-effect diagrams, IS/IS NOT analysis, and the 8D (eight disciplines) approach. The document emphasizes finding facts over fault to properly solve problems.
A risk-based CAPA process is a common goal of medical device manufacturers, but until recently “risk-based” was not clearly defined.
The biggest fundamental change in both ISO 9001:2015 and ISO 13485:2016 is an emphasis on risk-based process management.
The CAPA process is the heart of your quality system and one of the most important processes. Therefore, this presentation gives you a whole new set of tools for managing your CAPA process using risk-based approach
A risk-based CAPA process is more than prioritization.
This presentation includes:
-An outline of the CAPA process and proposed risk management activities
-Various risk control options that can be integrated with corrective actions
-How to reconcile conflicts between the definitions for risk in ISO 9001:2015 and ISO 13485:2016
-And more...
Watch the presentation here: https://www.greenlight.guru/webinar/risk-based-capa-process
Statistical process control (SPC) is a method of quality control which uses statistical methods. SPC is applied in order to monitor and control a process. Monitoring and controlling the process ensures that it operates at its full potential. At its full potential, the process can make as much conforming product as possible with a minimum (if not an elimination) of waste (rework or scrap). SPC can be applied to any process where the "conforming product" (product meeting specifications) output can be measured. Key tools used in SPC include control charts; a focus on continuous improvement; and the design of experiments. An example of a process where SPC is applied is manufacturing lines.
Statistical process control (SPC) is a method of quality control that monitors processes by identifying correctable variations from the target mean. SPC was pioneered by Dr. Walter Shewhart and involves setting upper and lower control limits based on the target mean and standard deviation to determine when a process is out of statistical control. SPC uses variable and attribute control charts to monitor processes over time and identify abnormal variations that require investigation and correction.
The document discusses risk-based approaches in GMP (Good Manufacturing Practices) project life cycles. It describes how to identify GMP projects, the benefits of a risk-based approach, and the typical structure and implementation of a GMP project life cycle. The life cycle includes phases for project origination, initiation, planning and design, execution and control, and close-out. It provides examples of tools and documents used in each phase, as well as who is responsible for key tasks and when they should be performed to successfully implement a risk-based GMP project life cycle. An interactive exercise is proposed to help apply the concepts.
Seminário Aese - Implementar um processo de LSSPedrodosSantos
O documento descreve um seminário sobre Lean Six Sigma que inclui:
1) Uma agenda detalhada para os dois dias do seminário cobrindo conceitos, ferramentas e casos práticos de LSS.
2) Os dez fatores críticos para o sucesso da implementação de LSS, incluindo compromisso da gestão e seleção de projetos com valor.
3) Um processo detalhado para a implementação de LSS numa organização, desde a definição da estratégia até à celebração dos resultados.
The document discusses risk based quality management in clinical trials. It summarizes the EMA Reflection Paper on Risk Based Quality Management, which encourages a more systematic, prioritized, risk-based approach to quality management. The paper endorses the use of central statistical monitoring to identify risks and ensure data integrity. Several quality management tools are also described, including check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, histograms. Other related topics like quality management systems and standards are listed for further reading.
Risk management in pharmaceutical IndustryMahesh shinde
This document provides an overview of risk management in the pharmaceutical industry. It discusses the objectives, scope, definitions, and tools used in risk management. The key tools covered include Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA), Hazard Analysis and Critical Control Points (HACCP), and Preliminary Hazard Analysis (PHA). The goal of risk management is to identify potential risks, evaluate their likelihood and impact, and develop control measures to mitigate risks and ensure product quality and safety.
Project Quality Management involves creating policies and procedures to ensure a project meets the customer's needs. It includes three key processes:
1) Plan Quality - Define what quality means for the project and how it will be ensured. This includes developing a quality management plan.
2) Perform Quality Assurance - Check that the project is following the quality standards, including performing quality audits.
3) Perform Quality Control - Verify the project is meeting the quality standards by inspecting deliverables and performing tests. Quality control uses various tools like control charts, checklists, and sampling to measure and control quality.
A CAPA (Corrective and Preventive Action plan) is written to address problems identified in clinical research studies. It outlines the root cause of the problem, corrective actions taken to resolve the issue, and preventive measures to avoid future occurrences. The CAPA should be authored by the responsible party, focus on solutions rather than blame, and include a root cause analysis, corrective actions, and preventive actions. It follows a specific template that provides the issue, analyses, resolutions and plans for evaluation. The completed CAPA is submitted to the IRB and site monitors to document handling of issues.
Test Planning and Test Estimation TechniquesMurageppa-QA
In this Quality Assurance Training session, you will learn about Types of Testing , Test Strategy and Planning, and Test Estimation Techniques. Topic covered in this session are:
• Test Planning,
• Test Estimation Techniques
For more information, about this quality assurance training, visit this link: https://www.mindsmapped.com/courses/quality-assurance/software-testing-training-with-hands-on-project-on-e-commerce-application/
This document provides information and sample documents for creating a quality management system that conforms to ISO/IEC 17025 standards for laboratories. It includes videos, ebooks, and articles on quality management. Sample documents and procedures are provided for a quality manual, code of ethics, document control, continual improvement, feedback, conflict of interest, internal audits, and job hazard assessment. Related sample forms are also included to support implementation of these quality management processes. The document outlines tools and approaches for laboratories to develop a quality management system that meets ISO/IEC 17025 requirements.
1) This document discusses Statistical Process Control (SPC), which uses statistical methods to monitor and control processes to ensure they operate at full potential. SPC aims to maximize conforming product output while minimizing waste.
2) Key aspects of SPC include understanding variation in processes, distinguishing between common and special causes of variation, using statistical tools like control charts to monitor processes and detect issues, and taking action to control processes and continually improve quality.
3) The document outlines the basic elements of a process control system, including gathering performance information, taking action on processes and outputs, and using feedback to maintain stability and reduce variation. It emphasizes prevention over detection to avoid waste.
The document provides guidance on quality risk management as outlined in ICH Q9. It defines key terms related to risk management such as harm, hazard, risk, severity, and quality risk management. It also outlines the basic quality risk management process which includes risk identification, analysis, evaluation, control, reduction, acceptance, communication and review. The process is meant to help assess risks to quality in a systematic way and facilitate risk-based decision making. It emphasizes basing decisions on scientific knowledge and linking risks to potential harm for patients.
The document discusses project quality management. It defines quality and project quality management, which ensures projects satisfy needs. Quality is planned through quality planning and quality standards. Quality assurance evaluates performance while quality control monitors results. Tools like control charts, Pareto charts and sampling are used. Statistical concepts like six sigma and ISO standards help manage quality.
Risk Based Testing: Deferring the Right Bugsindus329
QA InfoTech is a professional Quality Assurance and Software Testing service provider with qualified Testing Experts who are committed to provide creative QA / Testing solutions to challenging technical projects.
This document provides an introduction to statistical process control (SPC). It defines SPC as a strategy that uses statistical techniques to evaluate processes, identify variability, and find opportunities for improvement. The goal of SPC is to make high-quality products the first time by reducing variability, rather than reworking defective products. It focuses on monitoring process behavior rather than just final product quality. SPC distinguishes between common cause variability that is always present and special cause variability that can be addressed to improve the process. It emphasizes identifying and addressing special causes first before adjusting process means. Control charts are used to monitor processes and determine if they are in control or need adjustment.
ICH Guideline Q9 - Quality Risk Managementmuna_ali
A presentation of the ICH guideline Q9 (Quality Risk Management). It discusses the basic risk management procedure, list of recognized risk management tools and its role in pharmaceutical industry.
The document discusses corrective and preventive actions (CAPA) for recurring problems. It explains that CAPA is a structured process required by ISO 9001 to investigate nonconformities, determine appropriate corrections and actions, and measure effectiveness. The CAPA process involves defining the problem, investigating the root cause, developing solutions, verifying the solutions address the root cause, and checking effectiveness. Root cause analysis tools discussed include 5 whys, cause-and-effect diagrams, IS/IS NOT analysis, and the 8D (eight disciplines) approach. The document emphasizes finding facts over fault to properly solve problems.
A risk-based CAPA process is a common goal of medical device manufacturers, but until recently “risk-based” was not clearly defined.
The biggest fundamental change in both ISO 9001:2015 and ISO 13485:2016 is an emphasis on risk-based process management.
The CAPA process is the heart of your quality system and one of the most important processes. Therefore, this presentation gives you a whole new set of tools for managing your CAPA process using risk-based approach
A risk-based CAPA process is more than prioritization.
This presentation includes:
-An outline of the CAPA process and proposed risk management activities
-Various risk control options that can be integrated with corrective actions
-How to reconcile conflicts between the definitions for risk in ISO 9001:2015 and ISO 13485:2016
-And more...
Watch the presentation here: https://www.greenlight.guru/webinar/risk-based-capa-process
Statistical process control (SPC) is a method of quality control which uses statistical methods. SPC is applied in order to monitor and control a process. Monitoring and controlling the process ensures that it operates at its full potential. At its full potential, the process can make as much conforming product as possible with a minimum (if not an elimination) of waste (rework or scrap). SPC can be applied to any process where the "conforming product" (product meeting specifications) output can be measured. Key tools used in SPC include control charts; a focus on continuous improvement; and the design of experiments. An example of a process where SPC is applied is manufacturing lines.
Statistical process control (SPC) is a method of quality control that monitors processes by identifying correctable variations from the target mean. SPC was pioneered by Dr. Walter Shewhart and involves setting upper and lower control limits based on the target mean and standard deviation to determine when a process is out of statistical control. SPC uses variable and attribute control charts to monitor processes over time and identify abnormal variations that require investigation and correction.
The document discusses risk-based approaches in GMP (Good Manufacturing Practices) project life cycles. It describes how to identify GMP projects, the benefits of a risk-based approach, and the typical structure and implementation of a GMP project life cycle. The life cycle includes phases for project origination, initiation, planning and design, execution and control, and close-out. It provides examples of tools and documents used in each phase, as well as who is responsible for key tasks and when they should be performed to successfully implement a risk-based GMP project life cycle. An interactive exercise is proposed to help apply the concepts.
Seminário Aese - Implementar um processo de LSSPedrodosSantos
O documento descreve um seminário sobre Lean Six Sigma que inclui:
1) Uma agenda detalhada para os dois dias do seminário cobrindo conceitos, ferramentas e casos práticos de LSS.
2) Os dez fatores críticos para o sucesso da implementação de LSS, incluindo compromisso da gestão e seleção de projetos com valor.
3) Um processo detalhado para a implementação de LSS numa organização, desde a definição da estratégia até à celebração dos resultados.
Este documento fornece informações sobre os serviços de consultoria da Profitability Engineers. A empresa especializa-se em melhorar a eficácia e eficiência de seus clientes através de metodologias como Lean, Six Sigma, planejamento estratégico e sistemas de gestão da qualidade. A Profitability Engineers tem uma equipe experiente e qualificada que já ajudou vários clientes em diferentes setores a obter resultados mensuráveis e poupanças.
O documento apresenta a agenda de uma sessão sobre Six Sigma e PAT (Processo Analítico Total). A sessão inclui uma introdução ao Six Sigma, destacando sua importância para aumentar a qualidade, reduzir custos e melhorar a competitividade das empresas. Também discute como medir a capacidade de processos usando o conceito de sigma e como o Six Sigma visa atingir níveis extremamente baixos de defeitos.
Seminário Aese - Definição das ferramentas do LSSPedrodosSantos
Definição das Ferramentas do Lean Six Sigma fornece um resumo das principais ferramentas utilizadas nas fases do processo DMAIC (Definir, Medir, Analisar, Implementar, Controlar), incluindo SIPOC, CTQs, Diagrama de Pareto, Run Chart e Value Stream Map. O documento descreve como estas ferramentas ajudam a identificar problemas, medir performance, analisar causas e desenvolver soluções para melhorar processos.
Tablets are solid dosage forms made by compressing powders or granules, with or without coatings. They contain active ingredients and excipients. Uncoated tablets dissolve normally while coated tablets may be film-coated, sugar-coated, or enteric-coated to modify release. Modified-release tablets are designed to alter the rate or location of active ingredient release in the gastrointestinal tract, such as sustained-release or delayed-release tablets. Tablets are produced via direct compression of a powder blend or by granulation of powders followed by compression. Excipients like fillers, binders, and disintegrants are selected based on their properties to improve the powder blend or granules and produce tablets with the desired
Trailer Estadistica avanzada, aplicada a la industria farmacéuticaFernando Tazón Alvarez
Trailer del Curso de Formación Especializada sobre Estadistica Avanzada, aplicada a la industria farmacéutica, realizado en Barcelona el 27 de Octubre de 2014
Final year project report on Value stream mapping and SmedUmar Yazdani
The document describes a project conducted by students at Dawood University of Engineering and Technology to reduce lead time at Printech Packages using value stream mapping. The objectives were to reduce lead time, improve productivity, determine the value stream, identify wastes and causes, and create a roadmap for a lean production line. Data was collected on three popular products at Printech and current and future state maps were developed to identify waste and opportunities. Recommendations were made to optimize the production process and reduce lead time.
Seminário Aese - Conceitos teóricos do LSSPedrodosSantos
O documento descreve um seminário sobre Lean Six Sigma que ocorrerá em dois dias. A agenda inclui conceitos teóricos, definição de ferramentas, trabalhos de grupo, discussões de casos e implementação de processos Lean Six Sigma. O documento também explica os princípios e benefícios da metodologia Lean Six Sigma de melhoria contínua.
O documento discute os conceitos de Kanban e Seis Sigma. Kanban é um sistema de cartões que gerencia o fluxo de produção e materiais em sistemas pull. Seis Sigma busca melhorar a qualidade e lucratividade reduzindo defeitos. Ambos apoiam fábricas lean na produção correta de produtos no prazo e quantidade corretos para reduzir custos.
O documento discute a importância da produtividade e da educação para o crescimento econômico brasileiro. Também apresenta a certificação Lean Six Sigma como uma solução para qualificar profissionais de forma a distância e mobilizada, utilizando ferramentas de tecnologia. A oportunidade é oferecer um programa de certificação online com conteúdos internacionalmente reconhecidos.
O documento discute as razões para mapear processos e as etapas para criar um mapa de processo. As razões incluem garantir que toda a equipe conheça o processo real, identificar atividades que agregam valor e remover as demais, e identificar fatores que afetam o processo. As etapas para criar um mapa de processo são estabelecer uma equipe, definir o escopo e nível de detalhe, coletar dados no local, criar o mapa, identificar atividades valiosas e não valiosas, confirmar no local, e identificar
O documento discute a metodologia DMAIC para projetos Six Sigma. O processo DMAIC inclui as fases Define, Measure, Analyze, Improve e Control. A fase Define envolve definir o problema, objetivos e métricas. A fase Measure envolve medição e análise de dados para determinar variáveis críticas. A fase Analyze usa ferramentas estatísticas para identificar causas-raiz do problema.
INTEGRANDO A ESTRATÉGIA DE PRODUÇÃO COM A TEORIA DAS RESTRIÇÕES, LEAN MANUFAC...Diego Pacheco
Os resultados da pesquisa publicada nessa dissertação de mestrado strictu sensu contribuem para preencher as seguintes lacunas existentes no campo da Gestão de Operações:
a) é a primeira pesquisa brasileira ao discutir em profundidade as divergências e convergêncas entre A TEORIA DAS RESTRIÇÕES, LEAN MANUFACTURING E SEIS SIGMA;
b) é a primeira pesquisa brasileira a investigar as relações entre as Dimensões Competitivas com a contribuição das abordagens da TEORIA DAS RESTRIÇÕES, LEAN MANUFACTURING E SEIS SIGMA;
c) é a primeira pesquisa brasileira a propor um modelo integrado de Estratégia de Produção estabelecendo um link entre as Dimensões Competitivas valorizadas pelo mercado na Gestão de Operações com as melhores práticas e ferramentas da TEORIA DAS RESTRIÇÕES, LEAN MANUFACTURING E SEIS SIGMA;
A discussão resultante dos esforços dessa pesquisa que levam a questionar um novo paradigma e uma possível teoria na Gestão de Operações é corroborada pelo delineamento de pesquisa adotado que permeia uma série abordagens quali e quantitativas, entre si e integradas, à luz do Design Research. Ademais, obviamente tais provocações carecem de sucessivas validações empíricas sob a lógica de validações e refutações.
----Por isso, é incentivado que pesquisas sejam realizadas por estudantes de mestrado e doutorado para aplicar e validar o modelo proposto, contribuindo assim para o avanço da área e a competitividade das empresas do Brasil.
Esperou-se assim contribuir com o avanço do tema da Estratégia de Operações no campo acadêmico e na prática, dentro do contexto nacional e internacional.
Saudações, Prof. Diego Pacheco (profdajp@gmail.com)
This document outlines the tools and activities used in the Measure phase of a Lean Six Sigma DMAIC project. It includes reviewing project documents, validating measurements, collecting baseline data, analyzing process capability, and identifying quick wins. Tools mentioned include value stream mapping, data collection planning, basic statistics, process capability analysis, control charts, and cause-and-effect diagrams. The document provides guidance on documenting measurements, operational definitions, measurement systems analysis, and documenting quick wins.
O documento fornece informações sobre três unidades hospitalares, incluindo o número de leitos e colaboradores em cada unidade. A unidade Itaim tem 334 leitos e 1.984 colaboradores, a unidade Morumbi tem 176 leitos e 1.022 colaboradores, e a unidade Anália Franco tem 279 leitos e 947 colaboradores.
The document summarizes the Analyze phase of a Lean Six Sigma project. It lists the tools and activities used in Analyze such as value stream mapping, root cause analysis, hypothesis testing, and prioritizing sources of waste. Graphs and examples are provided to illustrate how some of the tools are applied. The next steps outlined are to identify root causes, confirm the relationship between causes and outputs, estimate the impact of causes, and prioritize the root causes to address in the Improve phase.
The document outlines key concepts in quality management including defining quality, the costs of quality, international quality standards like ISO 9000 and ISO 14000, total quality management, continuous improvement, six sigma, employee empowerment, benchmarking, just-in-time, and the seven tools of TQM. It also discusses quality inspection, attributes versus variables, and applying TQM principles to the service industry.
The document provides an overview of various quality management concepts and tools including:
- Total Quality Management (TQM) which aims to design high quality products and ensure consistent production.
- Six Sigma which seeks to reduce process variation and eliminate defects through tools like DMAIC (Define, Measure, Analyze, Improve, Control).
- ISO 9000 standards for quality management systems which many companies adopt for global competitiveness.
- Various analytical tools used in quality improvement like control charts, flow diagrams and cause-and-effect diagrams.
FMEA (Failure Mode and Effects Analysis) and FMECA (Failure Modes, Effects and Criticality Analysis) are methodologies used to identify potential failures, assess risk, and prioritize corrective actions. They involve identifying items, functions, failures, effects, causes, controls, and recommended actions. Risk is evaluated using Risk Priority Numbers for FMEA or a Criticality Analysis for FMECA. The results are used to improve design, increase reliability, and reduce costs.
The document discusses quality management concepts including Taguchi concepts, quality robustness, quality loss functions, and the seven tools of total quality management (TQM). It explains that Taguchi concepts aim to improve product and process design through experimental design methods. The seven tools of TQM are described as check sheets, scatter diagrams, cause-and-effect diagrams, Pareto charts, flowcharts, histograms, and statistical process control charts. Inspection methods and determining when and where to inspect are also summarized.
The document discusses the key activities and purposes of the Measure Phase in Six Sigma. These include mapping processes in detail to understand problems, conducting a Failure Modes and Effects Analysis to study possible process failures, measuring the current process capability to establish a baseline, and analyzing measurement systems to ensure accurate data collection. The goal is to focus improvement efforts by gathering information on the current process performance and identifying opportunities.
Benchmarking is an improvement process where a company measures its performance against best-in-class companies to determine how they achieved high performance levels and then uses that information to improve its own performance. A Black Belt is a full-time Six Sigma project leader who is certified after extensive training and successful completion of projects under a Master Black Belt's guidance. The "Breakthrough Strategy" involves four phases - Measure, Analyze, Improve and Control - to drive data-driven Six Sigma process improvement.
K 10716 mukesh beniwal(basic quality tools in small companies)shailesh yadav
The document discusses quality tools that can be used in small companies to improve quality, decrease costs, and increase productivity. It describes seven tools: cause and effect diagrams, flow charts, check sheets, histograms, Pareto charts, control charts, and scatter diagrams. Each tool is defined, its purpose and benefits are explained, and an example is provided. The tools can help identify problems, collect and analyze data, prioritize issues, understand processes and variations, and determine relationships between factors. Using these tools is part of a six-step problem solving process to recognize, define, investigate, analyze, solve, and confirm issues.
Risk management is a systematic process of assessing, controlling, communicating, and reviewing risks associated with equipment, processes, materials, facilities, distribution, and patients. It involves identifying potential failure modes and their causes and effects, analyzing risks, and prioritizing critical risks. Tools like Failure Mode and Effects Analysis (FMEA) are commonly used to structure the risk analysis and management process. The goal is to design quality into processes and products throughout the product lifecycle to maintain quality and minimize risks.
Quality assurance involves ensuring that products and services meet customer requirements. There are various dimensions of quality for goods like performance, reliability, and aesthetics. Implementing quality helps improve a company's reputation and reduces risks. Standards like ISO 9000 provide guidelines for quality management systems. Total quality management is a philosophy that quality should be built into processes and involves all departments. Statistical process control uses tools like control charts to monitor processes and identify issues.
This document discusses various quality management concepts including total quality management, six sigma methodology, ISO 9000 standards, and methods for measuring service quality. It defines total quality management as managing all aspects of an organization to meet customer expectations. Six sigma uses statistical methods to reduce defects and variation, with a goal of less than 3.4 defects per million opportunities. Tools discussed include control charts, pareto analysis, and failure mode and effects analysis. ISO 9000 provides quality system standards and certification. Service quality is measured using models like SERVQUAL which evaluate reliability, responsiveness, and other dimensions.
A CAPA (corrective and preventative action) program is an important indicator of a company's overall compliance efforts. It is considered a "bellwether" by the FDA. An effective CAPA program follows a closed-loop process to identify, correct, and eliminate quality issues and potential problems. It analyzes multiple sources of quality data. Failing to properly establish and maintain CAPA procedures is a common violation cited by the FDA. Ensuring a strong CAPA program that satisfies regulations like ISO 13485 and 21 CFR Part 820 can help reduce compliance risks during FDA inspections.
This document provides an overview of Six Sigma, including:
- What Six Sigma is and how it originated at Motorola and GE
- The DMAIC methodology for process improvement and DMADOV for creating new processes
- How Six Sigma aims to reduce defects through statistical analysis and achieving 6 sigma capability
- Key roles in a Six Sigma organization such as Black Belts, Green Belts, and Master Black Belts
The document provides an overview of Six Sigma, including:
1) It defines Six Sigma as a methodology for continuous improvement and creating high quality products and processes using statistical tools.
2) It discusses the origins and growth of Six Sigma at Motorola and GE in the 1980s-1990s.
3) It describes the DMAIC methodology used for process improvement projects and the roles of Master Black Belts, Black Belts, and Green Belts in a Six Sigma organization.
This document discusses quality risk management (QRM) and provides an overview of key QRM principles and processes. It defines key risk management terms and describes common risk management tools. The document outlines the general QRM process, which includes risk assessment, control, communication and review. It emphasizes that the level of effort for QRM should be commensurate with the level of risk. Various risk management tools are also described, including failure mode and effects analysis, hazard analysis, hazard operability analysis, and fishbone diagrams.
Today’s competitive environment has, lower manufacturing cost, more productivity in less time, high-quality product, defect-free operation are required to follow to every foundryman. For the improvement of products quality, there are diff-diff quality tools used in various review papers. Here I am going to review these papers and identify the different way of uses of those tools in manufacturing industries to increase the quality of the product. There are so many defects in the manufacturing process and these defects directly affect productivity, profitability and quality level of organization. This study is aimed to review the research work made by several researchers and attempt to get a technical solution for the various defects and to improve the entire process of the manufacturing
Use the Windshield, Not the Mirror Predictive Metrics that Drive Successful ...Seapine Software
Sharon Niemi, Practice Director of SQA, talks about how the right combination of predictive and reactive metrics can help you build a measurement portfolio that improves product quality and release consistency. You’ll learn how to build a measurement system that incorporates leading and lagging indicators to improve your team’s consistency in delivering quality products on time and within budget.
The 5 core tools are recognized as standard quality tools for the automotive ...arvindsinghrathore6
The 5 core tools are recognized as standard quality tools for the automotive industry by AIAG, although they are also used in other manufacturing sectors such as aerospace, defense, medical, and pharmaceutical.
Statistical Quality Control (SQC) uses statistical techniques to control quality by inspecting, testing, and analyzing products to determine if they meet quality standards. W. Edward Deming advocated implementing SQC to reduce variation and achieve consistency, reliability, and uniformity. SQC evaluates quality of batches and controls processes using statistical methods like control charts to minimize variation and identify causes of issues so corrective actions can be taken. The goal is to have only common or random variation not due to special causes like changes in equipment or materials.
This document provides an overview of the DMAIC methodology for Six Sigma improvement projects. It describes the five phases of DMAIC - Define, Measure, Analyze, Improve, and Control. Key aspects and tools covered include identifying the problem and goals, ensuring reliable measurement, understanding sources of variation, testing solutions, implementing improvements, and sustaining gains through control plans. The overall approach provides a structured process for problem solving and continuous process improvement.
Risk management involves determining the probability and impact of process failures and mitigating risks likely to occur with severe impacts. An acceptable risk is determined by evaluating options and consequences to select the most acceptable one. Risk severity is the probability of an event multiplied by its potential negative impact. Ways to deal with risk include proactive risk management to reduce probabilities and impacts, and reactive crisis management with constrained options. The CAPA system connects to risk management by using risk assessments to prioritize CAPAs and elevate issues. An annual product review examines manufacturing, quality, and post-market records over the previous year to support management decisions.
Implicitly or explicitly all competing businesses employ a strategy to select a mix
of marketing resources. Formulating such competitive strategies fundamentally
involves recognizing relationships between elements of the marketing mix (e.g.,
price and product quality), as well as assessing competitive and market conditions
(i.e., industry structure in the language of economics).
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The global retail industry has weathered numerous storms, with the financial crisis of 2008 serving as a poignant reminder of the sector's resilience and adaptability. However, as we navigate the complex landscape of 2024, retailers face a unique set of challenges that demand innovative strategies and a fundamental shift in mindset. This white paper contrasts the impact of the 2008 recession on the retail sector with the current headwinds retailers are grappling with, while offering a comprehensive roadmap for success in this new paradigm.
Taurus Zodiac Sign: Unveiling the Traits, Dates, and Horoscope Insights of th...my Pandit
Dive into the steadfast world of the Taurus Zodiac Sign. Discover the grounded, stable, and logical nature of Taurus individuals, and explore their key personality traits, important dates, and horoscope insights. Learn how the determination and patience of the Taurus sign make them the rock-steady achievers and anchors of the zodiac.
How MJ Global Leads the Packaging Industry.pdfMJ Global
MJ Global's success in staying ahead of the curve in the packaging industry is a testament to its dedication to innovation, sustainability, and customer-centricity. By embracing technological advancements, leading in eco-friendly solutions, collaborating with industry leaders, and adapting to evolving consumer preferences, MJ Global continues to set new standards in the packaging sector.
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Structural Design Process: Step-by-Step Guide for BuildingsChandresh Chudasama
The structural design process is explained: Follow our step-by-step guide to understand building design intricacies and ensure structural integrity. Learn how to build wonderful buildings with the help of our detailed information. Learn how to create structures with durability and reliability and also gain insights on ways of managing structures.
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1. Six Sigma and Lean Tools for Validation Jan C. Crielaard, Principal, WW Validation Cordis Corporation, a Johnson and Johnson Company Pharmaceutical Technology’s Annual Conference July 23-25, 2007 - Park Hyatt at the Bellevue - Philadelphia, PA
57. Dashboard Causal driver Hierarchy Linkage / Focus Frequency of review Tactical Strategic More frequent Less frequent
58. Features of a Well-Dressed Dashboard # of Reviews LCL and UCL Average Benchmark Review iterations Time F M A J J A 2 4 6 8 10 Good Quick reference legend i.e. “Trend down=Good” Clean Data Display: Average and control limits Trend and goal Title X and Y axis Chart legend and update frequency Description This dashboard shows the number of iterations average per month. The benchmark of 2 iterations is the goal. Explanation More then 1 review means rework. Rework is waste. Waste needs to be minimalized. Action plan Descending trend is good. Ascending is bad, requires root cause analysis and preventive action. Description, Explanation and action plan