The document provides an overview of quality initiatives and performance metrics at Switchgear Equipments & Electromechanical Industry and Trade Inc. It discusses their quality core values and Elimsan Way approach, which focuses on standard work, parts, production, and process assurance. Metrics are provided tracking performance of their suggestion system, supplier improvement activities, process control, and other quality programs from 2010-2012, showing improvements in areas like cost reduction, scrap reduction, productivity increases, and more.
Rcm qad life sciences validation scripts and servicesLaura DeLea
RCM offers three options for computer system validation of the QAD ERP system: 1) purchasing all validation documents and protocols, 2) a team approach utilizing both RCM and client staff, or 3) a turnkey approach using only RCM staff. RCM consultants have experience preparing validation documents, executing protocols to test requirements are met, and producing a final validation report. Services include validation project management, document preparation, installation and operation qualifications, and ensuring FDA and GMP compliance.
The document provides an overview of a training module on the qualification and validation of HVAC systems used in manufacturing facilities. It discusses key concepts like commissioning, qualification, documentation requirements, design qualification, installation qualification, operational qualification, performance qualification, monitoring programs, and maintenance. The module aims to help understanding of critical issues for HVAC systems and how their proper design, installation, and maintenance can ensure the quality of pharmaceutical products manufactured.
Beyond The Change - Using Tripwire to Promote Consistency and ROIdanielblander
This document discusses best practices for configuration management and change control. It describes a customer need to comply with regulations like SOX and PCI. The approach taken focused on developing standardized configuration baselines using Tripwire and implementing a change control process with segregated environments. This provided visibility into changes and reduced variances. It allowed testing changes in a test environment before moving to production. This improved quality and the audit process.
This document provides an overview of validation requirements for computerized systems used in manufacturing processes. It discusses validating both hardware and software, including system specifications, functional specifications, security, backups, and revalidation. The key aspects to consider include location, maintenance, inputs, outputs, limits, documentation, consistency, and functionality under worst-case conditions.
This document discusses quality management systems and how they can provide competitive advantage. It covers:
1) Quality management systems involve designing, implementing, and improving interconnected processes to effectively meet customer needs and organizational objectives.
2) Key aspects of a quality management system include system planning, design, operation, control, evaluation, and continuous improvement.
3) An organization's quality assurance and quality control departments work to ensure standards are met through requirements analysis, auditing, and corrective actions.
4) Consistent, well-defined processes are important for delivering quality products and services, and are enabled by procedures, standards, and documentation.
The document discusses the advantages of an integrated ERP solution for the pharmaceutical industry using Microsoft Dynamics AX. It summarizes that AX for Pharma 2012 is fully compliant with various regulatory requirements, enforces operating procedures and work practices, integrates key functionality like LIMS and plant maintenance, and supports a wide range of workflows to reduce costs and ensure consistency and compliance. The approach aims to significantly reduce implementation costs through a single team and minimizing customizations.
Integrated methodology for testing and quality management.Mindtree Ltd.
MindtestTM is an integrated testing methodology that meshes all the components of a testing engagement, manages the quality of testing, and delivers measurable and predictable software quality.
The document describes creating a software development lifecycle (SDLC) using the waterfall model and data flow diagram principles, with the goal of optimizing the SDLC for measurement and analysis. It instructs taking the initial SDLC and adding phases/stages to reach a second level of productivity in analysis. Requirements include creating a workflow, adding assumptions, and structuring phases to optimize the SDLC.
Rcm qad life sciences validation scripts and servicesLaura DeLea
RCM offers three options for computer system validation of the QAD ERP system: 1) purchasing all validation documents and protocols, 2) a team approach utilizing both RCM and client staff, or 3) a turnkey approach using only RCM staff. RCM consultants have experience preparing validation documents, executing protocols to test requirements are met, and producing a final validation report. Services include validation project management, document preparation, installation and operation qualifications, and ensuring FDA and GMP compliance.
The document provides an overview of a training module on the qualification and validation of HVAC systems used in manufacturing facilities. It discusses key concepts like commissioning, qualification, documentation requirements, design qualification, installation qualification, operational qualification, performance qualification, monitoring programs, and maintenance. The module aims to help understanding of critical issues for HVAC systems and how their proper design, installation, and maintenance can ensure the quality of pharmaceutical products manufactured.
Beyond The Change - Using Tripwire to Promote Consistency and ROIdanielblander
This document discusses best practices for configuration management and change control. It describes a customer need to comply with regulations like SOX and PCI. The approach taken focused on developing standardized configuration baselines using Tripwire and implementing a change control process with segregated environments. This provided visibility into changes and reduced variances. It allowed testing changes in a test environment before moving to production. This improved quality and the audit process.
This document provides an overview of validation requirements for computerized systems used in manufacturing processes. It discusses validating both hardware and software, including system specifications, functional specifications, security, backups, and revalidation. The key aspects to consider include location, maintenance, inputs, outputs, limits, documentation, consistency, and functionality under worst-case conditions.
This document discusses quality management systems and how they can provide competitive advantage. It covers:
1) Quality management systems involve designing, implementing, and improving interconnected processes to effectively meet customer needs and organizational objectives.
2) Key aspects of a quality management system include system planning, design, operation, control, evaluation, and continuous improvement.
3) An organization's quality assurance and quality control departments work to ensure standards are met through requirements analysis, auditing, and corrective actions.
4) Consistent, well-defined processes are important for delivering quality products and services, and are enabled by procedures, standards, and documentation.
The document discusses the advantages of an integrated ERP solution for the pharmaceutical industry using Microsoft Dynamics AX. It summarizes that AX for Pharma 2012 is fully compliant with various regulatory requirements, enforces operating procedures and work practices, integrates key functionality like LIMS and plant maintenance, and supports a wide range of workflows to reduce costs and ensure consistency and compliance. The approach aims to significantly reduce implementation costs through a single team and minimizing customizations.
Integrated methodology for testing and quality management.Mindtree Ltd.
MindtestTM is an integrated testing methodology that meshes all the components of a testing engagement, manages the quality of testing, and delivers measurable and predictable software quality.
The document describes creating a software development lifecycle (SDLC) using the waterfall model and data flow diagram principles, with the goal of optimizing the SDLC for measurement and analysis. It instructs taking the initial SDLC and adding phases/stages to reach a second level of productivity in analysis. Requirements include creating a workflow, adding assumptions, and structuring phases to optimize the SDLC.
The document discusses principles and approaches to cleaning validation for pharmaceutical manufacturing. It covers topics such as cleaning validation protocols and reports, personnel and equipment, use of detergents, microbiology, sampling, analytical methods, acceptable limits, and bracketing of products for validation. The objectives of cleaning validation are to demonstrate that cleaning procedures adequately remove product, detergent, and microbial residues to prevent contamination and cross-contamination. Written standard operating procedures and documentation of validation studies are required.
The document discusses several auxiliary facility programs that are important components of a GMP quality system, including pest control, cleaning programs, drawing control, engineering change control, spare parts management, lubricant control, and qualification of maintenance technicians and outside contractors. It emphasizes that written procedures and documentation are required for these programs to ensure facilities and equipment are properly maintained and calibrated.
The document discusses analytical method validation for good manufacturing practices. It covers validation of pharmacopoeial and non-pharmacopoeial methods, and characteristics that should be considered during validation including accuracy, precision, robustness, specificity, linearity, range, detection limit and quantitation limit. The objectives are to validate analytical methods to demonstrate suitability for their intended purpose and ensure results are reliable, accurate and reproducible.
The Quality Unit plays an important role in GMP maintenance according to regulations. The Quality Unit must approve preventative maintenance procedures and any changes to ensure equipment remains validated and products are of appropriate quality. Regulations require maintenance procedures describing methods, schedules, and responsibilities to be established and approved by the Quality Unit. While maintenance departments have technical expertise, Quality Unit review is still required to ensure compliance.
V-Empower Technical Competence WorkflowHannan Ahmed
This document summarizes V-Empower's technical competence and workflow. It outlines their core services including software development, reengineering, and maintenance. It describes their typical web architecture and waterfall project life cycle. It also provides details on their technical skills in technologies like .NET, Java, PHP, databases, graphics tools, and testing tools. Finally, it describes V-Empower's focus on project charter, quality, teamwork, and client communication.
This document discusses validation concepts including user requirement specification, phases of validation such as design qualification, installation qualification, operational qualification, performance qualification, and maintenance qualification. It provides definitions and guidelines for each phase. The key phases involve design qualification to define functional specifications, installation qualification to ensure proper installation, operational qualification to test functions, performance qualification to ensure consistent performance over time, and maintenance qualification to document maintenance. The overall goal of validation is to provide high assurance that a process will consistently produce quality products meeting specifications.
The document discusses Corrective and Preventive Action Plans (CAPA) used to improve organizations and address issues found through failure rates, customer complaints, and supplier definitions. CAPA helps find core issues and actions for improvement programs. Root cause analysis is used to identify the underlying cause of problems in order to implement targeted action plans. Effective CAPA systems include escalation processes, separate phases for investigation and action planning, and trend analysis to identify common issues requiring preventative improvement initiatives. Documentation of CAPA plans should include a root cause analysis, identification of corrective/preventative actions, verification of actions, implementation, and effectiveness checks.
Process validation presentation for finished goods, we will able to follow the activity in anywhere in Pharmaceuticals. Process validation is one of the main part of Quality Assurance,
Hamilton Sundstrand implemented a Process Certification program based on Six Sigma to reduce variability and control processes. Key aspects included:
1) Defining critical product characteristics and milestones for certification.
2) Developing standard work procedures and classifications to identify and select important product characteristics consistently.
3) Establishing systems like a database to track key product characteristics, collect statistical data, and report on progress.
Process Certification Implementation Presentationmdmilward
The document summarizes Hamilton Sundstrand's implementation strategy for process certification (Six Sigma) at their Windsor Locks, Connecticut facility. Key aspects included establishing a process certification council and steering committees to oversee the effort. Standard work, procedures, systems and infrastructure were developed to support data collection, analysis and reporting. Training programs were implemented to develop black belts and green belts across internal operations and supplier sites. The results were reported as reductions in cost of poor quality, variation and improvements in customer satisfaction scores and certification levels.
The document summarizes several Lean projects implemented at a manufacturing facility to improve production processes. Key outcomes included establishing standard work procedures, improving material flow through production by organizing logical work cells and implementing a Kanban system, and reducing work in progress and lead times. Other projects optimized the packaging area layout and implemented a two-bin material replenishment system between stores and production. Overall the projects significantly reduced process times, inventory, and improved productivity.
The document is a supplier quality manual that outlines Dynamatic Technologies Limited's (DTL's) quality management system requirements for suppliers. It details 21 sections covering topics such as the supplier quality management system, product and process requirements, inspection requirements, handling of non-conforming products, and continuous improvement. The overall goals are to ensure suppliers implement effective quality systems and meet DTL's quality standards.
QUALIFICATION OF MANUFACTURING EQUIPMENTSANKUSH JADHAV
it gives the information about qualification of various manufacturing equipment which is used into the pharmaceutical labs. (only for information purpose)
This document discusses the validation of water and air handling utility systems for use in pharmaceutical manufacturing. It outlines the purpose of validation, which is to demonstrate that the systems can continuously supply water and air meeting specified quality attributes. The validation process involves determining quality attributes, developing validation protocols, installation qualification, operational qualification, and performance qualification to prove the engineering design and operating procedures under all expected conditions. Change control and routine monitoring are also required to ensure the systems remain in a state of control.
The document describes Micro Memory Bank's quality management system which is compliant with ISO 9001. It establishes responsibilities and processes for quality planning, documentation, management reviews, customer focus, and continual improvement. The quality policy demonstrates management's commitment to meeting customer and regulatory requirements.
The document discusses validation and calibration of equipment used in the pharmaceutical industry. It defines validation as establishing evidence that a process will consistently produce quality products. Calibration ensures instrument readings are accurate by comparing them to standards. The FDA provides guidelines for validation. Key equipment discussed include tablet presses, dissolution apparatus, friability equipment, balances, and stability chambers. Specifications and operating parameters are provided for each.
This document outlines objectives and key concepts around production, operations management, and operations control. Specifically, it discusses defining production and productivity, strategies for improving quality and productivity, the role of operations management in selecting, designing, and controlling production systems, and tools for operations control like budgets, ratios, materials management, and break-even analysis. The overall aim is to provide insights into production, operations strategies and processes, and how operations concepts are applied in practice.
The document discusses analytical instrument qualification (AIQ) in the pharmaceutical industry. It states that AIQ involves collecting evidence that an instrument is suitable for its intended purpose. The key phases of AIQ are design qualification, installation qualification, operational qualification, and performance qualification. It also discusses the roles and responsibilities of various parties in ensuring instruments are properly qualified.
This document discusses quality costs and analyzing the cost of quality (CoQ) through a CoQ program. It defines categories of quality costs like prevention, appraisal, internal failure and external failure costs. The goal of a CoQ system and analysis is to facilitate quality efforts that lead to reducing operating costs by directing attacks on high failure costs and investing in prevention. It provides details on how to start a CoQ program, including getting management awareness, implementing a CoQ plan, identifying quality cost elements, and reporting quality costs over time on function and company-wide levels. The document promotes applying the DMAIC model and Six Sigma infrastructure to CoQ analysis and improvement projects.
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 discusses principles and approaches to cleaning validation for pharmaceutical manufacturing. It covers topics such as cleaning validation protocols and reports, personnel and equipment, use of detergents, microbiology, sampling, analytical methods, acceptable limits, and bracketing of products for validation. The objectives of cleaning validation are to demonstrate that cleaning procedures adequately remove product, detergent, and microbial residues to prevent contamination and cross-contamination. Written standard operating procedures and documentation of validation studies are required.
The document discusses several auxiliary facility programs that are important components of a GMP quality system, including pest control, cleaning programs, drawing control, engineering change control, spare parts management, lubricant control, and qualification of maintenance technicians and outside contractors. It emphasizes that written procedures and documentation are required for these programs to ensure facilities and equipment are properly maintained and calibrated.
The document discusses analytical method validation for good manufacturing practices. It covers validation of pharmacopoeial and non-pharmacopoeial methods, and characteristics that should be considered during validation including accuracy, precision, robustness, specificity, linearity, range, detection limit and quantitation limit. The objectives are to validate analytical methods to demonstrate suitability for their intended purpose and ensure results are reliable, accurate and reproducible.
The Quality Unit plays an important role in GMP maintenance according to regulations. The Quality Unit must approve preventative maintenance procedures and any changes to ensure equipment remains validated and products are of appropriate quality. Regulations require maintenance procedures describing methods, schedules, and responsibilities to be established and approved by the Quality Unit. While maintenance departments have technical expertise, Quality Unit review is still required to ensure compliance.
V-Empower Technical Competence WorkflowHannan Ahmed
This document summarizes V-Empower's technical competence and workflow. It outlines their core services including software development, reengineering, and maintenance. It describes their typical web architecture and waterfall project life cycle. It also provides details on their technical skills in technologies like .NET, Java, PHP, databases, graphics tools, and testing tools. Finally, it describes V-Empower's focus on project charter, quality, teamwork, and client communication.
This document discusses validation concepts including user requirement specification, phases of validation such as design qualification, installation qualification, operational qualification, performance qualification, and maintenance qualification. It provides definitions and guidelines for each phase. The key phases involve design qualification to define functional specifications, installation qualification to ensure proper installation, operational qualification to test functions, performance qualification to ensure consistent performance over time, and maintenance qualification to document maintenance. The overall goal of validation is to provide high assurance that a process will consistently produce quality products meeting specifications.
The document discusses Corrective and Preventive Action Plans (CAPA) used to improve organizations and address issues found through failure rates, customer complaints, and supplier definitions. CAPA helps find core issues and actions for improvement programs. Root cause analysis is used to identify the underlying cause of problems in order to implement targeted action plans. Effective CAPA systems include escalation processes, separate phases for investigation and action planning, and trend analysis to identify common issues requiring preventative improvement initiatives. Documentation of CAPA plans should include a root cause analysis, identification of corrective/preventative actions, verification of actions, implementation, and effectiveness checks.
Process validation presentation for finished goods, we will able to follow the activity in anywhere in Pharmaceuticals. Process validation is one of the main part of Quality Assurance,
Hamilton Sundstrand implemented a Process Certification program based on Six Sigma to reduce variability and control processes. Key aspects included:
1) Defining critical product characteristics and milestones for certification.
2) Developing standard work procedures and classifications to identify and select important product characteristics consistently.
3) Establishing systems like a database to track key product characteristics, collect statistical data, and report on progress.
Process Certification Implementation Presentationmdmilward
The document summarizes Hamilton Sundstrand's implementation strategy for process certification (Six Sigma) at their Windsor Locks, Connecticut facility. Key aspects included establishing a process certification council and steering committees to oversee the effort. Standard work, procedures, systems and infrastructure were developed to support data collection, analysis and reporting. Training programs were implemented to develop black belts and green belts across internal operations and supplier sites. The results were reported as reductions in cost of poor quality, variation and improvements in customer satisfaction scores and certification levels.
The document summarizes several Lean projects implemented at a manufacturing facility to improve production processes. Key outcomes included establishing standard work procedures, improving material flow through production by organizing logical work cells and implementing a Kanban system, and reducing work in progress and lead times. Other projects optimized the packaging area layout and implemented a two-bin material replenishment system between stores and production. Overall the projects significantly reduced process times, inventory, and improved productivity.
The document is a supplier quality manual that outlines Dynamatic Technologies Limited's (DTL's) quality management system requirements for suppliers. It details 21 sections covering topics such as the supplier quality management system, product and process requirements, inspection requirements, handling of non-conforming products, and continuous improvement. The overall goals are to ensure suppliers implement effective quality systems and meet DTL's quality standards.
QUALIFICATION OF MANUFACTURING EQUIPMENTSANKUSH JADHAV
it gives the information about qualification of various manufacturing equipment which is used into the pharmaceutical labs. (only for information purpose)
This document discusses the validation of water and air handling utility systems for use in pharmaceutical manufacturing. It outlines the purpose of validation, which is to demonstrate that the systems can continuously supply water and air meeting specified quality attributes. The validation process involves determining quality attributes, developing validation protocols, installation qualification, operational qualification, and performance qualification to prove the engineering design and operating procedures under all expected conditions. Change control and routine monitoring are also required to ensure the systems remain in a state of control.
The document describes Micro Memory Bank's quality management system which is compliant with ISO 9001. It establishes responsibilities and processes for quality planning, documentation, management reviews, customer focus, and continual improvement. The quality policy demonstrates management's commitment to meeting customer and regulatory requirements.
The document discusses validation and calibration of equipment used in the pharmaceutical industry. It defines validation as establishing evidence that a process will consistently produce quality products. Calibration ensures instrument readings are accurate by comparing them to standards. The FDA provides guidelines for validation. Key equipment discussed include tablet presses, dissolution apparatus, friability equipment, balances, and stability chambers. Specifications and operating parameters are provided for each.
This document outlines objectives and key concepts around production, operations management, and operations control. Specifically, it discusses defining production and productivity, strategies for improving quality and productivity, the role of operations management in selecting, designing, and controlling production systems, and tools for operations control like budgets, ratios, materials management, and break-even analysis. The overall aim is to provide insights into production, operations strategies and processes, and how operations concepts are applied in practice.
The document discusses analytical instrument qualification (AIQ) in the pharmaceutical industry. It states that AIQ involves collecting evidence that an instrument is suitable for its intended purpose. The key phases of AIQ are design qualification, installation qualification, operational qualification, and performance qualification. It also discusses the roles and responsibilities of various parties in ensuring instruments are properly qualified.
This document discusses quality costs and analyzing the cost of quality (CoQ) through a CoQ program. It defines categories of quality costs like prevention, appraisal, internal failure and external failure costs. The goal of a CoQ system and analysis is to facilitate quality efforts that lead to reducing operating costs by directing attacks on high failure costs and investing in prevention. It provides details on how to start a CoQ program, including getting management awareness, implementing a CoQ plan, identifying quality cost elements, and reporting quality costs over time on function and company-wide levels. The document promotes applying the DMAIC model and Six Sigma infrastructure to CoQ analysis and improvement projects.
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 an overview of quality management presented by the Society of Statistical Quality Control Engineers in Bhopal. It defines quality, traces the growth of quality management from craftsmen era to total quality management. It discusses measuring quality through quality indices and costs, highlighting approaches from quality gurus like Deming, Juran, Crosby, Ishikawa and Taguchi. The road ahead is described as marching towards total quality management and its key principles.
This document discusses various aspects of quality control including:
1. It defines quality as the degree to which a product meets customer needs based on factors like design, production, and inspection.
2. It describes types of inspection as preventive (finding defects before production) and corrective (finding defects after production).
3. It defines quality control as processes used to ensure uniform, acceptable product quality and analytical quality control as procedures to ensure consistent, accurate lab test results.
4. It discusses statistical quality control using parameters and statistics to analyze process variations, good manufacturing practices to ensure quality products, and quality assurance to implement quality system activities so requirements are fulfilled.
Maximizing the return on your control investment meet the experts sessions pa...Emerson Exchange
The design and commissioning of the controls associated with a continuous or batch process directly impact plant operating efficiency and production quality and throughput. In this session we review techniques that may be used to identify control opportunities to reduce production costs, minimize variations in product quality and to maximize production within the limits set by market demand. Several common application examples from the process industry will be used to illustrate how plant production rate and product quality are directly influenced by process control variation and constraints in plant operation. Starting with an assessment of control loop utilization and automatic control performance, a step by step process is outlined that may be used to identifying and addressing areas where it is possible to justified the time and material costs required to improve control performance. In particular, information will be provided on how to quickly tune single loop control of self-regulating or integrating process and to recognize when variations in control loop performance are not associated with loop tuning. An overview will be provided of tools and techniques that may be used to achieve best control performance over a wide variety of operating conditions. Also, guidance will be provided on when it is possible to justify the cost associated with the installation and commissioning of multi-loop techniques such as feedforward control, ratio and override control. The steps required to commission multi-loop control strategies will be address along with common mistakes to avoid. Also, input will be provided on how to recognize when advanced control techniques such as Fuzzy logic or MPC are needed to achieve the desired control performance. At the end of this session a drawing will be held to give away 10 copies of “Control Loop Foundation – Batch and Continuous Processes”. Many of the ideas discussed in this session are addressed in this book.
This document discusses various quality improvement principles and techniques including prevention, customer focus, process capability, process control, variation reduction, and the Pareto principle. The key points are:
1. Prevention focuses on eliminating errors by applying appropriate tools and processes to prevent defects and minimize total quality costs.
2. Customer focus means building consumer loyalty by meeting and exceeding customer requirements and differentiating products from competitors.
3. Process capability involves defining, measuring, and verifying processes to maintain balance and control through timely adjustments in response to variations.
The quality manual summarizes LLC's quality system for ensuring compliance with medical device regulations as an importer. It outlines 12 key parts of the quality system including quality policy, management responsibility, process validation, personnel training, management review, supplier quality requirements, shipping/receiving, complaint handling, corrective actions, audits, and revisions. The manual provides policies and procedures to meet FDA regulations and achieve continuous quality improvement through monitoring suppliers and processes.
This workshop examines the approach to Continued Process Verification and demonstrating that your product and process are operating in a state of control and continue to do so over the life of the product. Without any prior coordination, the theme was elaborated by the afternoon speakers once the conference itself was underway. The concept of “step up step down” for adjusting the level of product scrutiny both for process parameters monitoring and for sampling and testing quality attributes was explored and developed.
Quality Assurance is of Tremendous Importance in Pharma and Health care sector.
A brief of that is try to explain here..
A Trust of the Customer on Product is solely based on the Effective QA
Customer Satisfaction and Quality Induction_PPM .pptxMunirahAyub1
Gutor provides an induction for new employees on customer satisfaction and quality. It covers core values of customer first, quality management systems, and important eLearnings. Customer personas are introduced to represent key accounts including those in oil and gas, power, mining, and water utilities. Metrics like Customer Net Promoter Score are used to measure customer experience performance. The quality organization structure is reviewed along with tools like the IQ-Soft system for problem reporting.
This QA/QC plan provides guidelines for maintaining the quality of data from CEMS and COMS systems at a power plant. It outlines responsibilities for communication, documentation, training, quality control activities like calibration and audits, preventative maintenance, and corrective actions. The goal is to ensure emission data meets applicable regulations and permits.
This document is the quality management system manual for XYZ. It describes the quality management system which complies with ISO 9001:2008. The manual includes sections on scope, exclusions, documentation requirements, management responsibility, and other quality system processes. It provides the table of contents and outlines the organization and control of the quality management system documents.
This document discusses quality control and inspection. It defines quality as fitness for use and outlines why quality control is important to ensure consistent product quality given variability in manufacturing processes. Quality control involves planned actions to measure product characteristics against requirements. Inspections occur at various stages of production like pre-production, in-process, and final inspection to check for defects. Statistical tools like control charts and acceptance sampling are used to objectively evaluate quality.
This document provides an agenda for a supplier day meeting between Magna Donnelly and DaimlerChrysler. The agenda includes presentations on the voice of the customer from DaimlerChrysler, quality metrics and improvements at the Lowell plant, and Magna Donnelly's supply base expectations. It also includes time for questions and closing remarks. Supporting documents provide additional details on quality improvement plans, processes, and strategies being implemented at the Lowell plant to address quality issues, including fast response, control of non-conforming product, risk reduction, standardized operator training, and lessons learned.
ANALYTICAL METHOD VALIDATION -A PREDICAMENT OF SERVICE PROVIDERanezlin
This document discusses analytical method validation and outlines the challenges faced when outsourcing these services. It notes that while full validation according to ICH guidelines may not always be necessary, methods should still be scientifically sound. Some ways to reduce validation efforts discussed include adjusting the scope based on development stage, establishing method feasibility early on, and employing a risk-based approach. The responsibilities of both service providers and sponsors are examined, with the importance of alignment on quality expectations through a detailed agreement emphasized.
Quality and Inspection indicators which are in details.RajviParmar5
This document discusses quality control and inspection. It defines quality as fitness for use and outlines why quality control is important. Quality control involves verifying that products meet requirements through planned and systematic actions. Key aspects of quality control covered include pre-production inspection of materials, in-process inspection during production, and final inspection of finished products. Statistical quality control techniques like control charts and acceptance sampling are also summarized. The document emphasizes that quality control is essential throughout the production system from raw materials to final outputs.
This document discusses quality control and inspection. It defines quality as fitness for use and outlines why quality control is important. Quality control involves verifying that products meet requirements through planned and systematic actions. Key aspects of quality control covered include pre-production inspection of materials, in-process inspection during production, and final inspection of finished products. Statistical quality control techniques like control charts and acceptance sampling are also summarized. The document emphasizes that quality control is essential throughout the production system from raw materials to final outputs.
This document discusses key concepts in quality management. It defines quality according to several experts and standards, including Deming, Juran, ISO 9000. It outlines dimensions of quality, levels of quality management from organizational to process to performance. It also discusses statistical quality control tools like control charts and acceptance sampling. Finally, it provides a brief history of quality management approaches from inspection to total quality management.
Sop 820 capa procedure corrective preventive action med devConnie Dello Buono
This document outlines the corrective and preventive action (CAPA) procedure for addressing non-conformances and quality problems. It defines when a CAPA should be initiated, such as for systemic or repetitive issues. It describes assigning a CAPA owner to investigate the root cause and identify corrective actions. Effectiveness of these actions must be verified through follow-up audits. Preventive actions may also be initiated through trend analysis to address potential problems. All CAPAs require management review and sign-off for implementation and closure within 4 months. The CAPA coordinator communicates results and actions to management.
Discover timeless style with the 2022 Vintage Roman Numerals Men's Ring. Crafted from premium stainless steel, this 6mm wide ring embodies elegance and durability. Perfect as a gift, it seamlessly blends classic Roman numeral detailing with modern sophistication, making it an ideal accessory for any occasion.
https://rb.gy/usj1a2
Navigating the world of forex trading can be challenging, especially for beginners. To help you make an informed decision, we have comprehensively compared the best forex brokers in India for 2024. This article, reviewed by Top Forex Brokers Review, will cover featured award winners, the best forex brokers, featured offers, the best copy trading platforms, the best forex brokers for beginners, the best MetaTrader brokers, and recently updated reviews. We will focus on FP Markets, Black Bull, EightCap, IC Markets, and Octa.
LA HUG - Video Testimonials with Chynna Morgan - June 2024Lital Barkan
Have you ever heard that user-generated content or video testimonials can take your brand to the next level? We will explore how you can effectively use video testimonials to leverage and boost your sales, content strategy, and increase your CRM data.🤯
We will dig deeper into:
1. How to capture video testimonials that convert from your audience 🎥
2. How to leverage your testimonials to boost your sales 💲
3. How you can capture more CRM data to understand your audience better through video testimonials. 📊
Best practices for project execution and deliveryCLIVE MINCHIN
A select set of project management best practices to keep your project on-track, on-cost and aligned to scope. Many firms have don't have the necessary skills, diligence, methods and oversight of their projects; this leads to slippage, higher costs and longer timeframes. Often firms have a history of projects that simply failed to move the needle. These best practices will help your firm avoid these pitfalls but they require fortitude to apply.
Industrial Tech SW: Category Renewal and CreationChristian Dahlen
Every industrial revolution has created a new set of categories and a new set of players.
Multiple new technologies have emerged, but Samsara and C3.ai are only two companies which have gone public so far.
Manufacturing startups constitute the largest pipeline share of unicorns and IPO candidates in the SF Bay Area, and software startups dominate in Germany.
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.
Building Your Employer Brand with Social MediaLuanWise
Presented at The Global HR Summit, 6th June 2024
In this keynote, Luan Wise will provide invaluable insights to elevate your employer brand on social media platforms including LinkedIn, Facebook, Instagram, X (formerly Twitter) and TikTok. You'll learn how compelling content can authentically showcase your company culture, values, and employee experiences to support your talent acquisition and retention objectives. Additionally, you'll understand the power of employee advocacy to amplify reach and engagement – helping to position your organization as an employer of choice in today's competitive talent landscape.
Part 2 Deep Dive: Navigating the 2024 Slowdownjeffkluth1
Introduction
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.
Storytelling is an incredibly valuable tool to share data and information. To get the most impact from stories there are a number of key ingredients. These are based on science and human nature. Using these elements in a story you can deliver information impactfully, ensure action and drive change.
B2B payments are rapidly changing. Find out the 5 key questions you need to be asking yourself to be sure you are mastering B2B payments today. Learn more at www.BlueSnap.com.
Top mailing list providers in the USA.pptxJeremyPeirce1
Discover the top mailing list providers in the USA, offering targeted lists, segmentation, and analytics to optimize your marketing campaigns and drive engagement.
Anny Serafina Love - Letter of Recommendation by Kellen Harkins, MS.AnnySerafinaLove
This letter, written by Kellen Harkins, Course Director at Full Sail University, commends Anny Love's exemplary performance in the Video Sharing Platforms class. It highlights her dedication, willingness to challenge herself, and exceptional skills in production, editing, and marketing across various video platforms like YouTube, TikTok, and Instagram.
1. Switchgear Equipments &
Electromechanical Industry and Trade Inc.
QUALITY PRESENTATION
Prepared by
Quality Ass. and Env. Manager
Taner KUZU – 29/10/2010
3. ELİMSAN WAY
Standard work STANDARD QUALITY
with STANDARD WORK
Standard part STANDARD PRODUCTION
with STANDARD PART
Process Assurance INTERNAL CUSTOMER SATISFACTION
(Quality in place) with PROCESS ASSURANCE
Analysis with PDCA PERMENANT SOLUTION AGAINST PROBLEMS
with PDCA
Work with 5S LIVING and MAINTAINING in WORK DISCIPLINE
with 5S
4. Supplier monitoring & Improvement System
Receving problem
Line complain
Non-conform part report
1 sent to SUPPLIER
Corrective actions
2 followed closely
3 Regular visit to Supplier
GENCHI GENBUTSU
LINE
SATISFACTION
5. Supplier monitoring & Improvement System
Conditional acceptance Standard Deviation
SUPPLIER Not allowed Form in use
Standard part assured Standard work assured
SUPPLIER
SUPPLIER
SUPPLIER
SUPPLIER
SUPPLIER
ELİMSAN QUALITY SYSTEM
Standard part
Standard work
6. ISO-9001:208 Quality Management system
SYSTEM DOCUMENTS are CONTINOUSLY UPDATED
ALL CONTROLLED DOCUMENTS HAS EASY ACCESS FOR ALL
PRODUCT ASSURANCE HAS BEEN STANDARDIZED with INSTRUCTIONS
DOCUMENT MANAGEMENT FOLLOWED with MASTER LIST
7. SOLUTION SEEKING with PDCA
PROBLEM SOLVING APPROACH in ELİMSAN
HAS BEEN PENETRATED TO ALL FORMS in USE
APPROACH
PROBLEM ANALYSIS FORM CORRECTIVE ACTION FORM
8. 5S DISCIPLINE
5S RULES APPLIED
ALL PRODUCTION AREAS
ESPECIALLY in ALL QUALITY AREAS
MONITORING with 5S AUDIT MONTHLY
and DISPLAYED the RESULTS
10. KAIZEN (SUGGESTION) SYSTEM
EACH WORKERS INVOLVES in BETTER PRODUCTION PROCESSES
ALL KAIZENs ARE NUMBERED and
FOLLOWED with LIST
RESULTS DISPLAYS in GRAPHICS MONTHLY KAIZEN AWARDING
CEREMONY with TOP MANAGEMENT
11. WORKER ENRICHMENT SYSTEM
EACH WORKERS IMPROVES THEIR SKILLS
PER PRODUCTION PROCESSES SYSTEMATICALLY
NOT OPERATOR, CRATFSMAN
EASY WORKER BACK-UP
VISUAL WORKER MANAGEMENT
BETTER WORKER FLEXIBILITY
12. CONTINIOUS TRAINING
ALL BLUE COLLARS AS WELL AS WHITE COLLARS
ARE BEING TRAINED CONTINIOUSLY
Some trainings…
TOTAL QUALITY MANAGEMENT
5S DISCIPLINE
PROCESS IMPROVEMENT with
ISO-9001:2008 QMS
BETTER INTERNAL AUDITING
PROBLEM SOLVING METHODS
5why, pareto, fishbone, 4W1H
SOLVING APPROACH with PDCA
2013 planned trainings…
SWIFTING to LEAN PRODUCTION (TOYOTA Production System)
GOLDEN KEY - TOTAL PRODUCTIVE MAINTENANCE (TPM)
13. CORRECTIVE and PREVENTIVE ACTION SYSTEM
INTERNAL CUSTOMER
COMPLAIN
1 Corrective action request
form initiated
2 Corrective actions
followed closely with list
All countermeasures are
3 verifid by Quality Dep. and
displayed the results in graphics
INTERNAL CUSTOMER
SATISFACTION
14. LEAN MANUFACTURING
PRODUCTION UNITS DESIGN with RESPECT TO LEAN MANUFACTURING
ONE PIECE FLOW
FRONTAL FEEDING
PRODUCE with KANBAN
15. IN-PROCESS CONTROL (jikotei kanketsu)
EACH PROCESS CONFORM ITS WORK with
CONTROL FORM based on IN-PROCESS QUALITY PLANs
In-process
control form
CONTROL FORMS MOVES
with PRODUCT ALONG the LINE
16. MANAGEMENT BY TARGETS (hoshin kanri)
EACH DEPARTMENTS ASSES with ITS TARGETS
DEPARTMENT TARGETS DEFINED REGULARELY FOLLOWED
By TOP MANAGEMENT with GRAPHICS
17. LOSS MONITORING with PARETO
NON-QUALITY COST SUCH AS:
RECEIVING CONTROL
TEST CONTROL
FINAL CONTROL
CUSTOMER COMPLAINS
ALL FOLLOWED with PARETO and FOCUSED on
MOST PROBLEMATIC ISSUE FIRST for EFFECTIVE IMPROVEMENTS
RECEIVING TEST CONTROL CUSTOMER COMPLAIN
INSPECTION
18. CUSTOMER SATISFACTION SYSTEM
Customer
Complain
1 3 Actions followed by Quality
Dep. closely and displayed
Complains are entered the results in graphics
into Follow-up list
2
Every complain fill into
the form and issue
CUSTOMER
SATISFACTION
19. CUSTOMER CONVEY FOLLOW UP
Customer
Convey
1
Complain and suggestions 2 All conveys are analysed
Collected through form with report
3 Feedback to customer
CUSTOMER
SATISFACTION
20. SUSTAINABLE QUALITY
1 Based on production unit for CB and LBS ,
Samples are taken randomly and tested with QA-R&D team
Follow up list
Durability test record form
2 Results are investigated and
finalized in KAİZEN manner
Special durability test case
(Our Laboratory* has just entitled for durability
test as well from TURKAK
(*) Lightning impulse, Temperature rise test,
Partial discharge, Power frequency is already in our scope since 2008 ,
21. Switchgear Equipments &
Electromechanical Industry and Trade Inc.
IMPROVEMENTS in FIGURES’2012
Prepared by
Quality Ass. and Env. Manager
Taner KUZU – 11/08/2011
22. SUGGESTION
KAIZEN
SYSTEM
Kick off:
Suggestion system initiated at 01/08/2010
Target and current figures:
Kaizen target Accepted Kaizen Status
2010 140 301 Doubled the target
2011 220 276 Target reached
2012 190 173 Almost reached
ITEM PROFIT PICTURES
COST: 1.280 K$ profit
SCRAP: %39 scrap down in two parts
PRODUCTIVITY: 204 min. faster production
QUALITY: 135 quality kaizen implemented
WORK SAFETY: 59 kaizen implemented
WORKER HEALTH: 33 kaizen implemented
23. SUPPLIER GENCHI
IMPROVEMENT GENBUTSU
Kick off:
Supplier QUALITY SYSTEM AUDIT initiated at 10/05/2010
Target and current figures:
2010: 7
2011: 38 suppliers audited in terms of product, process, delivery assurance
and quality system with 4 pages assessment form
Monitoring the Defining the suppliers
supplier performance With full collaboration of supplier , ''To do list'' for
that should be improved improvements is summarized during the audit.
with PARETO. and planning the visit
Payback:
Reject Ratio decresed
6 times in 1 year
24. PROCESS JIKOTEI
CONTROL KANKETSU
Kick off:
Process control initiated at 01/01/2011 for all units
Target and current figures:
Decrease the product failures and improve the process quality
90 100 90 99
100100
98 98 97
96 97
95 96 96
85 94 95 85 94
93 94 93 Seri 2
81 91 91
90 Seri 2 90 90 Seri 1 90
80 89 80 88
77 88 87
86 Seri 1 85
85 75 84
75 83 82
81 80
80 80 79
70 78 70
76 75
74 65
65 69 70
70 70
60
60 57 66
63
62 55 60
55 60 57
57 50
50
DECEMBER 2010 JULY 2012
47 51
52 45 50
45 50
46
40 44
40 40
35
40 37
35 38
33
31 30
30 28 30
25 28
25 30
25 28
21 20
20 20
20 15 18
20 12
15
15 12 10
14 7 10
6
9 9 9 9 9 5 5
10 8 8 4 4 4 4
7 7 7 10 5 3 2
5 1 1 1 1 1 1 1 1 1 1 1 1
4 4
5 3 3 3 3 3 3 0 0
11
13
16
15
10
17
E7
3
6
8
E5
E8
9
1
4
E9
E6
1
2
5
P3
0
4
0 0
EL
EL
EL
EL
E2
E1
E1
EM
E1
E1
EM
EL
EL
EL
EL
EL
EL
M
M
M
M
M
K
ME2 - EL7 - EL5 - EL4 - EL6 - EL11 - EL9 - EL16 - EL10 - EL3 - EL17 - EL2 - ME15 - ME6 - ME4 - KP3 - EL13 - EL14 - EL15 - ME7 - KP6 - EM4 - ME22 - ME14 - ME11 - ME10 - EL1 - ME12 - ME8 - KP1 - ME18 - M
M
M
M
M
Final control defect that flows out from process failures
Payback:
Process failures for Metal Enclosed Switchgears decresed 8 times in 6
months.
25. PROCESS JIKOTEI
CONTROL KANKETSU
SWITCHGEAR
CIRCUIT BREAKER
26. DEFECT FREE ZERO
PRODUCT DEFECT
Kick off:
Zero Defect Product project initiated at 01/05/2010 for all units.
Target and current activities:
Produce defect free product at the level of %80 minimum.
Regular preventive activity
meetings between quality
and production team
Daily monitoring the
line performance
with GRAPHICS.
Payback:
Average defect free product ratio
increased 2 times , from %45 to %90.
Now 9 product out of 10 is DEFECT FREE
27. COST SCRAP
EFFICIENCY IMPROVEMENT
Kick off:
Since February’2010, epoxy process problems have been taken into
consideration with PDCA problem solving methodology.
Target and current activities:
2011 Second half %5 and reached after improving process and initiating one
POKA YOKE solution in the line.
POKA YOKE INITIATED
If the resistance in the mould broken,
system automatically detects
Payback:
Average 45,5 K$ scrap cost down. (Gain SF6 gases, disassambling cost, epoxy