The document provides guidance on conducting a proper Root Cause Analysis (RCA) with a supplier using a Supplier Corrective Action Request (SCAR). It outlines the key elements of a SCAR, which includes 7 steps: 1) problem verification, 2) containment action, 3) failure analysis, 4) root cause analysis, 5) corrective action, 6) preventive action, and 7) effectiveness verification. Examples are provided for each step to illustrate the process. The document emphasizes that identifying the true root cause is critical and recommends tools like 5 Whys analysis and fishbone diagrams to aid in root cause analysis. It also stresses that corrective and preventive actions should correspond to the identified root cause to prevent recurrence.
This document defines the internal laboratory scope of the Heat Treat Laboratory. It outlines the technical capabilities including the measurement ranges and equipment used to measure crystal grain size, microstructure, surface and core hardness, case depth, and indirect surface hardness. It also describes the quality procedures, including compliance with ASTM standards, annual calibrations, daily master verifications, and training of personnel.
The document discusses failure mode and effects analysis (FMEA). It provides definitions and descriptions of different types of FMEAs, including design FMEA (DFMEA) which focuses on potential design failures, and process FMEA (PFMEA) which focuses on potential process failures and their causes. The document outlines the key steps in conducting a PFMEA, including developing a process flow diagram, identifying potential failure modes and their effects and causes, analyzing the risks associated with failures, and creating a process control plan to address potential failures.
This coupon test report summarizes the results of a welding qualification test. It includes details of the welding parameters, materials used, and test results. Six coupons were welded and tested for maximum load, staincile strength, and fracture location. The welder was qualified based on meeting the minimum tensile strength requirements. Additional remarks were provided on the bead, nick-break, and tensile strength tests.
This document summarizes an attribute measurement system analysis (MSA) study. It defines MSA and its requirements, describes when to use attribute studies, and outlines the procedure for conducting an attribute MSA study. The document analyzes the results of an attribute MSA study, including effectiveness, false alarm rate, and miss rate. It provides acceptability criteria for these parameters and describes concluding the study by implementing improvements or corrective actions if needed.
The document discusses the Production Part Approval Process (PPAP), including when PPAP submissions are required, the different submission levels, and the forms and documents required for each submission level. A PPAP submission is needed for new parts, design or process changes, changes in suppliers, inactive tooling, and more. The default submission level is level 3, which requires samples, supporting data, a design record, a process flow diagram, and more. Level 1 requires only a warranty, while level 2 adds limited data and samples.
Dokumen tersebut memberikan panduan untuk mendeteksi dan memperbaiki beberapa masalah umum pada TV LCD, seperti masalah pada motherboard, bekalan kuasa, layar, dan lampu latar. Beberapa perbaikan sederhana seperti mengganti bateri kawalan jauh atau lampu latar dapat dilakukan sendiri, sedangkan masalah yang lebih rumit sebaiknya dibawa ke pusat servis.
This document provides an overview of the revision process from ISO/IEC Guide 65 to ISO/IEC 17065, the new standard for product, process, and service certification bodies. It outlines the timeline of the revision from 2007 to 2012, the purpose of aligning with new CASCO requirements, and highlights key changes between the standards. These include improved definitions, separating the application and evaluation processes, more detailed surveillance and management requirements, and aligning with other conformity assessment standards like ISO/IEC 17000 and ISO/PAS 17003. Cross-references are also provided between clauses of the old and new standards.
This document defines the internal laboratory scope of the Heat Treat Laboratory. It outlines the technical capabilities including the measurement ranges and equipment used to measure crystal grain size, microstructure, surface and core hardness, case depth, and indirect surface hardness. It also describes the quality procedures, including compliance with ASTM standards, annual calibrations, daily master verifications, and training of personnel.
The document discusses failure mode and effects analysis (FMEA). It provides definitions and descriptions of different types of FMEAs, including design FMEA (DFMEA) which focuses on potential design failures, and process FMEA (PFMEA) which focuses on potential process failures and their causes. The document outlines the key steps in conducting a PFMEA, including developing a process flow diagram, identifying potential failure modes and their effects and causes, analyzing the risks associated with failures, and creating a process control plan to address potential failures.
This coupon test report summarizes the results of a welding qualification test. It includes details of the welding parameters, materials used, and test results. Six coupons were welded and tested for maximum load, staincile strength, and fracture location. The welder was qualified based on meeting the minimum tensile strength requirements. Additional remarks were provided on the bead, nick-break, and tensile strength tests.
This document summarizes an attribute measurement system analysis (MSA) study. It defines MSA and its requirements, describes when to use attribute studies, and outlines the procedure for conducting an attribute MSA study. The document analyzes the results of an attribute MSA study, including effectiveness, false alarm rate, and miss rate. It provides acceptability criteria for these parameters and describes concluding the study by implementing improvements or corrective actions if needed.
The document discusses the Production Part Approval Process (PPAP), including when PPAP submissions are required, the different submission levels, and the forms and documents required for each submission level. A PPAP submission is needed for new parts, design or process changes, changes in suppliers, inactive tooling, and more. The default submission level is level 3, which requires samples, supporting data, a design record, a process flow diagram, and more. Level 1 requires only a warranty, while level 2 adds limited data and samples.
Dokumen tersebut memberikan panduan untuk mendeteksi dan memperbaiki beberapa masalah umum pada TV LCD, seperti masalah pada motherboard, bekalan kuasa, layar, dan lampu latar. Beberapa perbaikan sederhana seperti mengganti bateri kawalan jauh atau lampu latar dapat dilakukan sendiri, sedangkan masalah yang lebih rumit sebaiknya dibawa ke pusat servis.
This document provides an overview of the revision process from ISO/IEC Guide 65 to ISO/IEC 17065, the new standard for product, process, and service certification bodies. It outlines the timeline of the revision from 2007 to 2012, the purpose of aligning with new CASCO requirements, and highlights key changes between the standards. These include improved definitions, separating the application and evaluation processes, more detailed surveillance and management requirements, and aligning with other conformity assessment standards like ISO/IEC 17000 and ISO/PAS 17003. Cross-references are also provided between clauses of the old and new standards.
The document discusses Failure Modes and Effects Analysis (FMEA), which is a systematic method used to evaluate processes and identify potential failures, causes, and effects. It also assesses the impact of different failures to identify parts of the process most in need of improvement. FMEA involves reviewing process steps, potential failure modes and causes, failure effects, and uses a team approach. It aims to evaluate processes proactively for failures and prevent them by correcting processes before failures occur. FMEA is useful for new processes prior to implementation and assessing changes to existing processes. It provides a structured way to identify risks in processes.
This document provides an overview of Failure Mode and Effects Analysis (FMEA). FMEA is a systematic process used to evaluate potential failures in a design, manufacturing or process and identify actions to address or prevent these failures. It involves identifying potential failure modes and ranking them based on severity, occurrence likelihood and ability to detect. Actions are then recommended to reduce the highest risk failures based on their Risk Priority Number. FMEA is intended to be preventative and identify issues before they occur.
The document introduces the Ford Motor Company FMEA Handbook which provides guidance on conducting Failure Mode and Effects Analyses (FMEAs) to identify and address potential failures in product design, manufacturing processes, and concepts. The handbook covers Design FMEAs, Process FMEAs, and Concept FMEAs and includes examples, forms, and best practices. It aims to help engineering teams at Ford and its suppliers conduct effective FMEAs to improve product quality and safety.
A DFMEA is a design tool used to systematically list potential failure modes of a design. It aims to increase design robustness by involving a team to identify failures, satisfy customers, and incorporate checkpoints and reviews with experts and customers. The process involves a DFMEA expert developing the analysis, getting senior reviews, and implementing agreed changes from customer reviews to iteratively improve the design.
This document is a reference manual for measurement systems analysis (MSA) published by the Automotive Industry Action Group (AIAG). It is copyrighted and was licensed to Magna International. The manual provides guidelines for evaluating the capability and accuracy of measurement systems used in automotive manufacturing. It describes methods for determining the stability, bias, linearity, repeatability, and reproducibility of variable measurement systems as well as methods for attribute measurement systems. The guidelines are intended to help users understand the factors that influence measurement systems and determine if their level of variation is acceptable for use.
This presentation explains recommended practice for qualification and certification of acoustic emission personnel according to ASNT SNT-TC-1A and CP-189.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive functioning. Exercise boosts blood flow and levels of neurotransmitters and endorphins which elevate and stabilize mood.
In this presentation you will learn about Error Proofing and their types which refers to the IATF:16949 clauses and some practical examples from the industry.
Design Review Based on Failure Mode (DRBFM) CourseRa'uf Tailony
The document outlines Design Review Based on Failure Mode (DRBFM), a process for proactively identifying potential failures from design changes. It discusses (1) visualizing changes between old and new designs, (2) identifying functions and change points, (3) discovering potential concerns through a change matrix, (4) conducting root cause analysis, and (5) reflecting preventative measures in design. The goal is robust design through collaborative problem finding and solving to predict risks from changes before issues occur.
The document summarizes changes made from ISO/TS 16949 to the new IATF 16949 standard. Key changes include strengthening requirements around product safety, corporate responsibility, process reviews, and risk analysis. A multi-phase revision process was used and over 1,700 stakeholder comments were received. The goal of the changes is to better address quality management system needs in the automotive industry and prevent quality problems.
The document provides an overview of failure mode and effects analysis (FMEA). It discusses the history and evolution of FMEA from its origins in the aerospace industry in the 1960s to the current AIAG VDA FMEA Handbook published in 2019. The document outlines the seven step approach of the new handbook, including planning, structure analysis, function analysis, optimization, risk analysis, failure analysis, and documentation of results. It also summarizes some of the major changes between the previous AIAG 4th edition and new handbook, such as replacing RPN with action priority and revising the rating tables.
The Seven Basic Tools of Quality is a designation given to a fixed set of graphical techniques identified as being most helpful in troubleshooting issues related to quality.They are called basic because they are suitable for people with little formal training in statistics and because they can be used to solve the vast majority of quality-related issues.
IATF 16949:2016 is an automotive quality management system standard developed by the International Automotive Task Force. It is based on ISO 9001:2015 and includes additional automotive industry requirements. Some key changes in IATF 16949:2016 compared to the previous version include expanded requirements for risk analysis, management of externally provided processes and products, and control of nonconforming outputs. The standard outlines mandatory documented processes and records required as part of an organization's quality management system.
The document provides an overview of Failure Mode and Effects Analysis (FMEA) as a tool to identify, analyze, and prevent potential product and process failures. It discusses the history and definitions of FMEA, the different types of FMEAs (system, design, process), how to conduct an FMEA including forming a team, terminology, scoring, and developing action plans to address high risks.
Luis Carrasquillo successfully completed an Exemplar Global Certified course in Quality Management System Lead Auditor (ISO 9001:2015), including ISO 13485:2003 and ISO 13485:2016. The course was presented from September 26-30, 2016 in Boston, MA. The certificate certifies that Luis Carrasquillo completed the training portion required for certification as a Lead Auditor.
This document provides an overview of process failure mode and effects analysis (PFMEA). It discusses the steps to conduct a PFMEA, including identifying critical process steps and their potential failure modes, effects, causes, controls, and risk priority numbers. The goals of a PFMEA are to proactively identify potential process failures, prioritize issues based on risk, and determine actions to reduce failures and improve process quality, reliability, and customer satisfaction. Conducting a thorough PFMEA requires a cross-functional team approach.
The RCCA PPT is an excellent training tool to implement into your functional group or business.
It basically forces you to peel the onion on a failure as far back until you’ve reached the root cause whereas in some cases it could be several.
It incorporates the 5 whys and the problem solving technique.
Effective CAPA Implementation in a Management System - Praneet SurtiPraneet Surti
The document discusses the Corrective Action and Preventive Action (CAPA) process. It defines CAPA as a structured way to investigate non-conformities, determine appropriate corrections and actions, and measure their effectiveness. It outlines the key steps in the CAPA process including defining the problem, investigating the root cause, determining corrective and preventive actions, implementing solutions, and measuring effectiveness. The document emphasizes that the goal of CAPA is to eliminate causes of issues in order to prevent recurrence and notes that a mature CAPA system can help continuously improve products, services, and compliance.
The document discusses Failure Modes and Effects Analysis (FMEA), which is a systematic method used to evaluate processes and identify potential failures, causes, and effects. It also assesses the impact of different failures to identify parts of the process most in need of improvement. FMEA involves reviewing process steps, potential failure modes and causes, failure effects, and uses a team approach. It aims to evaluate processes proactively for failures and prevent them by correcting processes before failures occur. FMEA is useful for new processes prior to implementation and assessing changes to existing processes. It provides a structured way to identify risks in processes.
This document provides an overview of Failure Mode and Effects Analysis (FMEA). FMEA is a systematic process used to evaluate potential failures in a design, manufacturing or process and identify actions to address or prevent these failures. It involves identifying potential failure modes and ranking them based on severity, occurrence likelihood and ability to detect. Actions are then recommended to reduce the highest risk failures based on their Risk Priority Number. FMEA is intended to be preventative and identify issues before they occur.
The document introduces the Ford Motor Company FMEA Handbook which provides guidance on conducting Failure Mode and Effects Analyses (FMEAs) to identify and address potential failures in product design, manufacturing processes, and concepts. The handbook covers Design FMEAs, Process FMEAs, and Concept FMEAs and includes examples, forms, and best practices. It aims to help engineering teams at Ford and its suppliers conduct effective FMEAs to improve product quality and safety.
A DFMEA is a design tool used to systematically list potential failure modes of a design. It aims to increase design robustness by involving a team to identify failures, satisfy customers, and incorporate checkpoints and reviews with experts and customers. The process involves a DFMEA expert developing the analysis, getting senior reviews, and implementing agreed changes from customer reviews to iteratively improve the design.
This document is a reference manual for measurement systems analysis (MSA) published by the Automotive Industry Action Group (AIAG). It is copyrighted and was licensed to Magna International. The manual provides guidelines for evaluating the capability and accuracy of measurement systems used in automotive manufacturing. It describes methods for determining the stability, bias, linearity, repeatability, and reproducibility of variable measurement systems as well as methods for attribute measurement systems. The guidelines are intended to help users understand the factors that influence measurement systems and determine if their level of variation is acceptable for use.
This presentation explains recommended practice for qualification and certification of acoustic emission personnel according to ASNT SNT-TC-1A and CP-189.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive functioning. Exercise boosts blood flow and levels of neurotransmitters and endorphins which elevate and stabilize mood.
In this presentation you will learn about Error Proofing and their types which refers to the IATF:16949 clauses and some practical examples from the industry.
Design Review Based on Failure Mode (DRBFM) CourseRa'uf Tailony
The document outlines Design Review Based on Failure Mode (DRBFM), a process for proactively identifying potential failures from design changes. It discusses (1) visualizing changes between old and new designs, (2) identifying functions and change points, (3) discovering potential concerns through a change matrix, (4) conducting root cause analysis, and (5) reflecting preventative measures in design. The goal is robust design through collaborative problem finding and solving to predict risks from changes before issues occur.
The document summarizes changes made from ISO/TS 16949 to the new IATF 16949 standard. Key changes include strengthening requirements around product safety, corporate responsibility, process reviews, and risk analysis. A multi-phase revision process was used and over 1,700 stakeholder comments were received. The goal of the changes is to better address quality management system needs in the automotive industry and prevent quality problems.
The document provides an overview of failure mode and effects analysis (FMEA). It discusses the history and evolution of FMEA from its origins in the aerospace industry in the 1960s to the current AIAG VDA FMEA Handbook published in 2019. The document outlines the seven step approach of the new handbook, including planning, structure analysis, function analysis, optimization, risk analysis, failure analysis, and documentation of results. It also summarizes some of the major changes between the previous AIAG 4th edition and new handbook, such as replacing RPN with action priority and revising the rating tables.
The Seven Basic Tools of Quality is a designation given to a fixed set of graphical techniques identified as being most helpful in troubleshooting issues related to quality.They are called basic because they are suitable for people with little formal training in statistics and because they can be used to solve the vast majority of quality-related issues.
IATF 16949:2016 is an automotive quality management system standard developed by the International Automotive Task Force. It is based on ISO 9001:2015 and includes additional automotive industry requirements. Some key changes in IATF 16949:2016 compared to the previous version include expanded requirements for risk analysis, management of externally provided processes and products, and control of nonconforming outputs. The standard outlines mandatory documented processes and records required as part of an organization's quality management system.
The document provides an overview of Failure Mode and Effects Analysis (FMEA) as a tool to identify, analyze, and prevent potential product and process failures. It discusses the history and definitions of FMEA, the different types of FMEAs (system, design, process), how to conduct an FMEA including forming a team, terminology, scoring, and developing action plans to address high risks.
Luis Carrasquillo successfully completed an Exemplar Global Certified course in Quality Management System Lead Auditor (ISO 9001:2015), including ISO 13485:2003 and ISO 13485:2016. The course was presented from September 26-30, 2016 in Boston, MA. The certificate certifies that Luis Carrasquillo completed the training portion required for certification as a Lead Auditor.
This document provides an overview of process failure mode and effects analysis (PFMEA). It discusses the steps to conduct a PFMEA, including identifying critical process steps and their potential failure modes, effects, causes, controls, and risk priority numbers. The goals of a PFMEA are to proactively identify potential process failures, prioritize issues based on risk, and determine actions to reduce failures and improve process quality, reliability, and customer satisfaction. Conducting a thorough PFMEA requires a cross-functional team approach.
The RCCA PPT is an excellent training tool to implement into your functional group or business.
It basically forces you to peel the onion on a failure as far back until you’ve reached the root cause whereas in some cases it could be several.
It incorporates the 5 whys and the problem solving technique.
Effective CAPA Implementation in a Management System - Praneet SurtiPraneet Surti
The document discusses the Corrective Action and Preventive Action (CAPA) process. It defines CAPA as a structured way to investigate non-conformities, determine appropriate corrections and actions, and measure their effectiveness. It outlines the key steps in the CAPA process including defining the problem, investigating the root cause, determining corrective and preventive actions, implementing solutions, and measuring effectiveness. The document emphasizes that the goal of CAPA is to eliminate causes of issues in order to prevent recurrence and notes that a mature CAPA system can help continuously improve products, services, and compliance.
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.
Case study dre using 7 qc tools for problem solvingAB
This case study examines the use of 7 quality control tools to improve defect removal efficiency. The current scenario showed high numbers of defects reported across various phases. Analysis identified issues like unstructured internal testing, poor third party testing, and late defect detection. The root causes were determined to be a lack of unit testing, missing review documents, and incomplete requirements. Solutions developed included new testing and review flowcharts, check sheets, and contractual obligations for third parties. Monitoring charts showed defect rates decreased after implementing the solutions. Further control is needed to continually improve efficiency towards a new goal.
The document provides information on root cause analysis tools and methods. It discusses what root cause analysis is, the cause mapping method of root cause analysis, and the basic steps of cause mapping which include defining the issue, analyzing causes, and preventing negative impacts. The document also covers the DMAIC process for process improvement, which includes the phases of define, measure, analyze, improve, and control. It provides examples of various root cause analysis tools that can be used such as fishbone diagrams, brainstorming, data collection plans, FMEAs, Pareto charts, and DPMO calculators.
This document provides an overview of the 8D methodology for problem solving. It begins with a brief history of the 8D methodology, noting it was originally developed by the US Department of Defense. It then describes each of the 8 steps in the 8D process: 1) Establishing a team; 2) Describing the problem; 3) Implementing containment actions; 4) Identifying the root cause; 5) Implementing corrective actions; 6) Validating corrective actions; 7) Implementing actions to prevent recurrence; and 8) Verifying actions and congratulating the team. For each step, examples are provided of the types of actions that could be taken. The document emphasizes the importance of properly identifying the root
1) The document provides an overview of quality problem solving tools including the 8D (Eight Disciplines) problem solving method, 5 Whys process, and Ishikawa (fishbone) diagram.
2) The 8D method is an 8-step team-based problem solving approach that focuses on containing, correcting, and preventing recurrence of problems. The steps include establishing a team, describing the problem, implementing containment actions, identifying root causes, and validating corrective actions.
3) The 5 Whys process involves repeatedly asking "Why?" to get to the root cause of a problem. It helps identify not only why the defect occurred but also why it was not detected.
4) The Ish
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.
This document describes a project using the 8D methodology to solve defects occurring during the assembly process of light commercial vehicles at a Tata Motors plant. The 8D methodology involves 8 disciplines: forming a team, defining the problem, developing interim containment actions, determining the root cause, developing permanent corrective actions, implementing and validating corrective actions, taking preventative measures, and congratulating the team. The project team used tools like Ishikawa diagrams, 5 whys analysis, and corrective action plans to solve 10 different problems. The outcomes of the project helped reduce defects and move the plant toward achieving World Class Quality Level 2.
1. The document discusses the Measure phase of the DMAIC process for Six Sigma innovation projects.
2. Key aspects of the Measure phase include selecting Critical to Quality characteristics, defining performance standards and specifications, establishing a data collection plan, and validating measurement systems.
3. Tools discussed that are useful for the Measure phase include process mapping, fishbone diagrams, Pareto analysis, and Failure Mode and Effects Analysis (FMEA). FMEA involves identifying failure modes, causes, and effects to determine appropriate actions.
This document provides a summary of a training presentation on CAPA (corrective and preventive action). The training covers 5 learning segments: 1) CAPA general information, 2) identification of the problem, 3) evaluation, investigation and analysis of the problem, 4) development of an action plan, and 5) implementation and follow-up of the action plan. Segment 1 defines CAPA and the difference between corrective and preventive actions. It also discusses the objectives, regulations and importance of the CAPA process. Segment 2 covers reporting the source and details of a problem and determining supporting evidence. The training is intended to provide an overview of the full CAPA process.
PFMEA, Risk Reduction and Effectiveness – Advance (AIAG FMEA #4 Edition)
Is your FMEA performing for you?
This is advance level of PFMEA, Have basic understanding fo Core IATF Tools before refering to this presentation.
Eliminating Critical Quality Defects at a Component ManufacturerAnirban Mazumdar
Valcon helped a plastic component manufacturer address quality defects that were impacting profitability and customer satisfaction. Valcon conducted a study of the manufacturing processes and quality systems, identifying issues with defect generation, inspection, and performance monitoring. They implemented process validation trials to optimize parameters, improved inspection methods, and created a quality index to track aggregate performance. These changes helped reduce defects from 6% to 2% within weeks, achieving zero defects for some critical issues, and improved relationships with customers.
This document summarizes an 8D report from a supplier to address a problem where concession labels were missing from packaging. It involved the following key steps:
1. An immediate containment action of rechecking all stored parts to identify the scope of the problem and holding further deliveries.
2. Forming a team to define the problem of missing concession labels and develop a containment action of rechecking all stored parts.
3. Identifying the root causes as misunderstanding of packaging standards, lack of inspector oversight, and packer not taking packaging seriously.
4. Implementing corrective actions such as establishing a process to track concessions, training on packaging standards, and assigning oversight of information updates.
This document provides an overview of root cause analysis (RCA). RCA is a process used to investigate events that impact safety, quality, reliability and production. It involves collecting data, identifying causal factors, determining root causes, and generating recommendations. Root causes are underlying issues that management can control and for which effective recommendations can be made to prevent recurrence. The document outlines the four major steps of RCA and provides examples of using RCA to improve software processes, support agile development, and address issues with third party integrations.
Corrective and Preventive Action (CAPA) systems are important tools for addressing issues and preventing recurrences. However, CAPAs require careful planning and execution to be effective. Common pitfalls include opening CAPAs without stakeholder buy-in, failing to thoroughly investigate root causes, and establishing unrealistic timelines. Keys to success are gaining management support, using root cause analysis tools, defining specific action items, conducting effectiveness checks, and maintaining thorough documentation. The FDA scrutinizes CAPA systems and may issue observations for deficiencies.
Test beyond the obvious- Root Cause AnalysisPractiTest
Kevin Wilkes - Senior Test Consultant at QualiTest and Richard Morgan - UK Delivery Manager at QualiTest, Co-present "Test beyond the obvious- Root Cause Analysis" at OnlineTestConf.com
Operating Excellence is built on Corrective & Preventive ActionsAtanu Dhar
This document provides an overview of Corrective Action Preventive Action (CAPA) and how to implement an effective CAPA process. It defines CAPA and explains the difference between corrective and preventative actions. It outlines the benefits of a mature CAPA system, including increased quality, reduced costs from problems, and improved customer satisfaction. The document then discusses various tools that can be used in the CAPA process, including root cause analysis techniques like 5 Whys, fishbone diagrams, and Pareto charts to identify causes and prioritize actions. Examples are provided for how to apply these tools to analyze specific business processes.
# 3 PPT - Expose Your Hidden Problems Using Visual ManagementRhonda Kovera
The document discusses using visual management and standard work to drive continuous improvement. It provides examples of how establishing a standard, monitoring for variances from the standard, and problem-solving the variances can create workflow. Specific visual management tools are presented, such as fishbone diagrams, andon lights, accountability boards, and standard work documents, that can be used to establish standards, identify problems, and drive improvements. The overall message is that visual management and standard work are important Lean techniques for exposing problems and waste, and driving continuous process improvement.
Six Sigma is a data-driven approach and methodology for process improvement originally developed by Motorola. It aims to reduce defects and variation in manufacturing and business processes. The document discusses the history and key aspects of Six Sigma such as the DMAIC approach, tools used in each phase like process mapping, root cause analysis, and improvement techniques like 5S, poka-yoke, and FMEA. Implementing Six Sigma through the DMAIC approach can help organizations optimize processes and improve quality, productivity, and customer satisfaction.
From Teacher to OnlyFans: Brianna Coppage's Story at 28get joys
At 28, Brianna Coppage left her teaching career to become an OnlyFans content creator. This bold move into digital entrepreneurship allowed her to harness her creativity and build a new identity. Brianna's experience highlights the intersection of technology and personal branding in today's economy.
The Future of Independent Filmmaking Trends and Job OpportunitiesLetsFAME
The landscape of independent filmmaking is evolving at an unprecedented pace. Technological advancements, changing consumer preferences, and new distribution models are reshaping the industry, creating new opportunities and challenges for filmmakers and film industry jobs. This article explores the future of independent filmmaking, highlighting key trends and emerging job opportunities.
Orpah Winfrey Dwayne Johnson: Titans of Influence and Inspirationgreendigital
Introduction
In the realm of entertainment, few names resonate as Orpah Winfrey Dwayne Johnson. Both figures have carved unique paths in the industry. achieving unparalleled success and becoming iconic symbols of perseverance, resilience, and inspiration. This article delves into the lives, careers. and enduring legacies of Orpah Winfrey Dwayne Johnson. exploring how their journeys intersect and what we can learn from their remarkable stories.
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Early Life and Backgrounds
Orpah Winfrey: From Humble Beginnings to Media Mogul
Orpah Winfrey, often known as Oprah due to a misspelling on her birth certificate. was born on January 29, 1954, in Kosciusko, Mississippi. Raised in poverty by her grandmother, Winfrey's early life was marked by hardship and adversity. Despite these challenges. she demonstrated a keen intellect and an early talent for public speaking.
Winfrey's journey to success began with a scholarship to Tennessee State University. where she studied communication. Her first job in media was as a co-anchor for the local evening news in Nashville. This role paved the way for her eventual transition to talk show hosting. where she found her true calling.
Dwayne Johnson: From Wrestling Royalty to Hollywood Superstar
Dwayne Johnson, also known by his ring name "The Rock," was born on May 2, 1972, in Hayward, California. He comes from a family of professional wrestlers, with both his father, Rocky Johnson. and his grandfather, Peter Maivia, being notable figures in the wrestling world. Johnson's early life was spent moving between New Zealand and the United States. experiencing a variety of cultural influences.
Before entering the world of professional wrestling. Johnson had aspirations of becoming a professional football player. He played college football at the University of Miami. where he was part of a national championship team. But, injuries curtailed his football career, leading him to follow in his family's footsteps and enter the wrestling ring.
Career Milestones
Orpah Winfrey: The Queen of All Media
Winfrey's career breakthrough came in 1986 when she launched "The Oprah Winfrey Show." The show became a cultural phenomenon. drawing millions of viewers daily and earning many awards. Winfrey's empathetic and candid interviewing style resonated with audiences. helping her tackle diverse and often challenging topics.
Beyond her talk show, Winfrey expanded her empire to include the creation of Harpo Productions. a multimedia production company. She also launched "O, The Oprah Magazine" and OWN: Oprah Winfrey Network, further solidifying her status as a media mogul.
Dwayne Johnson: From The Ring to The Big Screen
Dwayne Johnson's wrestling career took off in the late 1990s. when he became one of the most charismatic and popular figures in WWE. His larger-than-life persona and catchphrases endeared him to fans. making him a household name. But, Johnson had ambitions beyond the wrestling ring.
In the early 20
The Unbelievable Tale of Dwayne Johnson Kidnapping: A Riveting Sagagreendigital
Introduction
The notion of Dwayne Johnson kidnapping seems straight out of a Hollywood thriller. Dwayne "The Rock" Johnson, known for his larger-than-life persona, immense popularity. and action-packed filmography, is the last person anyone would envision being a victim of kidnapping. Yet, the bizarre and riveting tale of such an incident, filled with twists and turns. has captured the imagination of many. In this article, we delve into the intricate details of this astonishing event. exploring every aspect, from the dramatic rescue operation to the aftermath and the lessons learned.
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The Origins of the Dwayne Johnson Kidnapping Saga
Dwayne Johnson: A Brief Background
Before discussing the specifics of the kidnapping. it is crucial to understand who Dwayne Johnson is and why his kidnapping would be so significant. Born May 2, 1972, Dwayne Douglas Johnson is an American actor, producer, businessman. and former professional wrestler. Known by his ring name, "The Rock," he gained fame in the World Wrestling Federation (WWF, now WWE) before transitioning to a successful career in Hollywood.
Johnson's filmography includes blockbuster hits such as "The Fast and the Furious" series, "Jumanji," "Moana," and "San Andreas." His charismatic personality, impressive physique. and action-star status have made him a beloved figure worldwide. Thus, the news of his kidnapping would send shockwaves across the globe.
Setting the Scene: The Day of the Kidnapping
The incident of Dwayne Johnson's kidnapping began on an ordinary day. Johnson was filming his latest high-octane action film set to break box office records. The location was a remote yet scenic area. chosen for its rugged terrain and breathtaking vistas. perfect for the film's climactic scenes.
But, beneath the veneer of normalcy, a sinister plot was unfolding. Unbeknownst to Johnson and his team, a group of criminals had planned his abduction. hoping to leverage his celebrity status for a hefty ransom. The stage was set for an event that would soon dominate worldwide headlines and social media feeds.
The Abduction: Unfolding the Dwayne Johnson Kidnapping
The Moment of Capture
On the day of the kidnapping, everything seemed to be proceeding as usual on set. Johnson and his co-stars and crew were engrossed in shooting a particularly demanding scene. As the day wore on, the production team took a short break. providing the kidnappers with the perfect opportunity to strike.
The abduction was executed with military precision. A group of masked men, armed and organized, infiltrated the set. They created chaos, taking advantage of the confusion to isolate Johnson. Johnson was outnumbered and caught off guard despite his formidable strength and fighting skills. The kidnappers overpowered him, bundled him into a waiting vehicle. and sped away, leaving everyone on set in a state of shock and disbelief.
The Immediate Aftermath
The immediate aftermath of the Dwayne Johnson kidnappin
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Leonardo DiCaprio House: Malibu Beachfront Retreat
A Prime Location
His Malibu beachfront house is one of the most famous properties in Leonardo DiCaprio's real estate portfolio. Situated in the exclusive Carbon Beach. also known as "Billionaire's Beach," this property boasts stunning ocean views and private beach access. The "Leonardo DiCaprio house" in Malibu is a testament to the actor's love for the sea and his penchant for luxurious living.
Architectural Highlights
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Leonardo DiCaprio is a well-known environmental activist. whose Malibu house reflects his commitment to sustainability. The property incorporates solar panels, energy-efficient appliances, and sustainable building materials. The landscaping around the house is also designed to be water-efficient. featuring drought-resistant plants and intelligent irrigation systems.
Leonardo DiCaprio House: Hollywood Hills Hideaway
Privacy and Seclusion
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2. Page
Objective
To provide guidance to carry out proper Root Cause Analysis
(RCA) with suitable quality tools
To ensure responded SCAR able to meet Keysight expectation
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3. Page
Introduction
Supplier Corrective Action Request (SCAR) is a systematic
approach to request investigation of a problem that already
happened and request root cause analysis and resolution from
supplier to prevent recurrence.
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5. Page
Step 1: Problem Verification
Problem verification is the first step of problem investigation. There are 3
main activities:
a) Verify the problem
b) Collect information
c) Describe the problem
To describe the problem specifically, (5W2H) terms (who, what, where,
when, why, how, and how many) would help. Example please refer to next
slide.
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6. Page
Step 1: Problem Verification
Example:
Probe (Part No.) is found out of specification at Keysight on date X. Total quantity X pcs
The output current is X when the frequency is X KHz. (specification is ±X )
The defective part date code is X. This is the first case reported from customer.
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5W2H Questions to ask Answer should be provided
Who Who first observed?
Who is affected?
- Location of defect found
What What type of problem?
What has the problem?
What is happening?
- Failure reported
- Part No./ Model
- Detail description of failure
Why Why it is a problem?
- Detail description on the failure and
verification done
- Date code of defective part
Where Where was the problem observed/ occur?
When When the problem first noticed?
How much/many How much/ many involved? - Quantity affected
How often What is the trend? Has the problem occurred
previously?
- Failure history
What? What happen? When?
What type of problem?
Where?
What? How often?
How much?
7. Page
Step 2: Containment Action
Containment action is to limit a problem extent while continue normal
operation until the root cause is defined and permanent corrective
action is implemented
The containment area should cover:
Production
Finished goods
Customer (Keysight)
Incoming material
Warehouse Storage
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Notes: Affected date code/ serial number should be clearly identified and stated.
8. Page
Step 2: Containment Action
Activities:
Stoppage of production or shipment
Segregation goods on pass or fail
Additional visual control
Informing customer about the problem
Informing operators about the problem
Check on similar product or processes if there is similar risk
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Example:
100% screening is done for below area:
Supplier’s production (xx pcs), warehouse inventory (xx pcs)
Keysight inventory including production (xx pcs), warehouse (xx pcs),
Results: xx pcs out of total xx pcs is found with similar reject. The reject rate is xx%.
Confirmed the affected date code is x. Rejected part is sent back for further FA.
9. Page
Step 3: Failure Analysis
Failure analysis (FA) is the process of collecting and analyzing data
to determine the cause of a failure.
Failure Analysis can be carry out by various methods including visual
inspection, electrical testing and physical testing.
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10. Page
Step 3: Failure Analysis
Examples:
Visual Inspection
Bare eye inspection
Optical microscope
X-ray microscope
Electrical Testing
Voltage measurement data
Resistance measurement
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Physical Testing
Drop test
Bending test
Pull test
11. Page
Step 4: Root Cause
Root cause identification is the most important step. The problem will be
solved only if the corrective action implemented is addressing the real root
cause accurately.
Root Cause Analysis (RCA) is a systematic approach to identify the actual
root causes of a problem. Below are the tools frequently used in RCA.
5 Whys Analysis
Fishbone Diagram (Cause and Effect Diagram)
Notes:
The RCA should identify root cause for both
Occurrence (Why it occur?)
Detection (Why it can’t be detect?)
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12. Page
Step 4: Root Cause
This is a continuous question-asking technique used to explore the cause-and-
effect relationships underlying a particular problem.
General Flow
i. Define the problem.
ii. Ask Why the problem happen and write down the answer
iii. Validate the answer is it the real root cause
iv. If no, Repeat step 3 until problem’s root cause is identified.
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5 Whys Analysis Tools
13. Page
Step 4: Root Cause
.
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Example of 5 Whys Analysis Tools
Answer: Wrong part was pull from the inventory
Answer: The part was mislabeled
Answer: Our supplier mislabeled the part before
ship to the warehouse
Answer: Operator at supplier site took the other
label and placed at the product
Answer: Many labels with different order was
printed at the same location everyday so it is
easy to cause mislabeled
Retrain the stock picker- almost no benefit.
The real cause is come from mislabel from supplier
Perform inspection on inventory- minimum benefit
Apply to on hand inventory only
Contain the problem by sorting out the mislabel part
-very limited long term benefit
Conduct training for operator – limited long term
benefit
Mistake proof printing label process or application –
highly effective
Why 1: Why wrong part shipped to customer?
Why 2
Why 3
Why 4
Why 5
Addressing
the true
root cause ?
14. Page
Step 4: Root Cause
A fishbone diagram is a visualization tool for categorizing the potential causes of a
problem in order to identify its root causes.
General Flow:
i. Define the problem
ii. Identify the key causes
iii. Brainstorm the causes
iv. Validate the identified root cause causes.
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Fishbone Diagram (Cause and Effect Diagram)
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Example of Fishbone Diagram (Cause and Effect Diagram)
Machine
Material Method
Man
Not update
Not available
Lack of
understanding
Not enough
responsibility
Machine
wearing
Material
defective
Not capable
Not approved
by vendor
Wrong
specification
No
maintenance
No proper
communication
Too
Complicated
Too heavy
Lack of
resources
WI not structural
used
Perception no
need
No standard
work
No agreement
with supplier
No inspection
Operator hand
dirty/oily
No attend training
Quality
Problem
EffectCause
Step 4: Root Cause
1. Identify potential root cause
16. Page
Step 4: Root Cause
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Example of Fishbone Diagram (Cause and Effect Diagram)
Category Root cause Validation / investigations Findings
True /
false
Man Hand dirty /oily
Operator’s hand are
dirty.
Parts found with finger
print mark on surface
during process
TRUE
2. Validate identified root cause
17. Page
Step 5: Corrective Action
Corrective action (CA) is to remove the root cause and prevent a
problem from ever happening again.
The corrective action should correspond to the root cause identified
earlier in order to eliminate the real root cause and prevent recurrence
of the problem.
Method such as brainstorming is recommended as it can help to select
appropriate corrective action for identified root cause.
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18. Page
Step 5: Corrective Action
Examples:
For root cause of “Why problem occur?”
Introduce additional process control
Introduce new process
For root cause of “Why not detected?”
Introduce new testing gate
Enhance previous testing coverage
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19. Page
Step 6: Preventive Action
Preventive Action are proactive and focused on a potential problem
in the future.
Corrective actions is only a temporary solution that keeps the system
running, but a permanent solution is needed to avoid similar problems
from occurring into the system again.
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20. Page
Step 6: Preventive Action
Examples:
Changing the process parameter
Changing procedure
Changing documentation or specification
Changing of process or tools
Modified or make proper jig
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21. Page
Step 7: Effectiveness Verification
After the corrective and preventive actions are implemented, the
effectiveness should be validate.
The key to verification is evidence. This evidence usually takes the
form of data, records or first-hand observations.
It is recommended the verification made by monitoring the quality of
next deliveries.
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22. Page
Step 7: Effectiveness Verification
Examples:
Product acceptance rate
Test or control results showing improvement
Engineering measurement (Dimension and appearance) according
to specification and tolerance
Suppliers deliver goods of better quality
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23. Page
Summary
In conclusion, proper RCA should be conducted in a systematic approach in
order to obtain the real root cause. Besides, effective containment, corrective
and preventive actions correspond to identified root cause should be
provided. Below shows the difference between containment, corrective and
preventive actions.
Containment Action
A “first aid” that limit a problem’s extent and establish normal operations until
the root cause is defined and permanent corrective actions is implemented
Corrective Action
Actions to remove the root cause and prevent a problem from ever happening
again. The actions are directed to an event that happened in the past.
Preventive Action
Preventive Action are proactive and oriented towards a potential problem in the
future. They improve a process or a product to remove causes for a potential
problem and prevent it and related problems from ever happening.
Keysight Restricted 23
26. Page
SCAR Response Guideline
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Process Step Criteria
Root Cause Option
Select root cause Supplier – (category)
Category including: Material, Process, Assembly, Testing & documentation
S0: Overall Summary
Summarize the problem verification, failure analysis, identified root cause and
corrective action in less than 1000 character.
S1: Problem Verification Provide clear and precise problem statement
Method and condition to duplicate and verify the problem reported. (Refer slide 6)
Status
Valid – If is supplier induced failure
Invalid –If is Electrical over stress (EOS), No trouble found (NTF), customer
application and etc.
S2: Containment Action
Select proper screening area. If no containment action please provide justification.
Screening area including: Production, finished good inventory (FGI), remaining units
with customer(Keysight) and Unit in field (Other customer). Refer Slide 8
Information needed:
a) Method: Type of screening done in respective area selected above
b) Results: Reject quantity and rate
c) Responsible person name
d) Date of the action taken
Page 26
27. PageKeysight Restricted 27
Process Step Criteria
S3: Failure Analysis
Briefly summaries the failure analysis (FA) conducted and the results (Including
visual inspection, Electrical testing and physical testing )
Attach FA report as evidence if available
S4: Root Cause
Encourage to perform RCA using proper tool such as 5 Whys analysis and
fishbone diagram but not limited to these analysis tools.
RCA should emphasize on both area:
a) why problem happen (root cause of problem happen)
b) why escapee (root cause of problem is not detected )
Summaries the RCA results and categories the real root cause in 4M’s format
(Man, Methods, Machines, Materials)
Attach RCA report as evidence.
Page 27
SCAR Response Guideline
28. PageKeysight Restricted 28
Process Step Criteria
S5: Corrective Action (CA)
List down the corrective action which is correspond to the root cause identified in S4
Provide responsible person and implementation date for each corrective action
Operator re-training/briefing is refrained from being recorded as a corrective
action
Containment action should NOT classified as corrective action.
(Please refer slide 9)
S6: Permanent Corrective
Action
Permanent Corrective Action (PA) should NOT same as corrective action.
Please refer slide 18 & 20 to differentiate between CA and PA.
List down the permanent corrective action (preventive) which is correspond to the
root cause identified in S4
Provide responsible person and implementation date for each permanent corrective
action
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SCAR Response Guideline
29. PageKeysight Restricted 29
Process Step Criteria
S7: Verify Effectiveness of
Corrective Action
Information should be provided in S7 :
Type 2
a) Monitoring plan (E.g. type of testing and monitoring area)
b) Duration of monitoring (At least 3 months)
c) Monitoring start date of the action taken
d) Responsible person name
Type 4
a) Monitoring results (Any recurrence?)
b) Evidence/ Monitoring data
(E.g. Test results, Serial Number/ Lot/Batch No. without similar reject )
c) Responsible person name
Page 29
SCAR Response Guideline