This document discusses the importance of quality management (QM) in the mining sector. QM involves proactively monitoring quality control data over time to detect trends or biases and ensure consistent results. The document provides examples of how QM can be applied across various stages, including sample collection, preparation, and chemical analysis. It emphasizes that averages alone may mask issues and QM allows for real-time assessment to close gaps. QM helps ensure sustainable and stable business decisions by maintaining consistent quality throughout the sampling and analysis process.
ANALYZING THE PROCESS CAPABILITY FOR AN AUTO MANUAL TRANSMISSION BASE PLATE M...ijmvsc
The industry today is working intensively on a goal-oriented way towards introducing regular studies in
manufacturing. The current study is part of a large overall spanning project aiming towards an increase in
productivity, i.e. more products produced per year with availability. In this paper we have analyze what
Process Capability is and how it is implemented on a current process. All the steps are listed out in an easy
to understand manner. In current scenario, specifications for products have been tightened due to
performance competition in market. Statistical tools like control charts, process capability analysis and
cause and effect diagram ensure that processes are fit for company specifications while reduce the process
variation and improve product quality characteristic. Process capability indices (PCIs) are used in the
manufacturing process to provide numerical measures on whether a process is capable of producing items
within the predetermined limits. For the analysis purpose MINITAB 16.0 is used and is found that the
process is placed exactly at the centre of the control limits. Analysis also shows that process is not
adequate. The cause and effect diagram is prepared to found out the root cause of variation in diameter of
work. In this study, a process-capability analysis was also carried out in a medium-sized company that
produces machine and spare parts.
David Lerma has over 18 years of experience as a materials manager. He has worked for several electronics and manufacturing companies, managing purchasing, inventory, logistics and supply chain. He is proficient in ERP systems like Oracle, SAP and MRP software. His objective is to successfully complete projects with dedication, continuous improvement and efficient processes while meeting objectives and ensuring customer satisfaction.
This document discusses the importance of Quality by Design (QbD) for ensuring the four As (acceptable quality, affordable medicines, availability, and accessibility) expected by regulators. It explains how QbD can help manufacturers optimize their processes to reduce waste and costs, while meeting regulatory expectations for a robust quality system. The key elements of a QbD approach include defining a Quality Target Product Profile, identifying critical quality attributes and risks, establishing a control strategy linking material attributes and process parameters to critical quality attributes, and enabling continuous improvement.
Role of quality by design (qb d) in quality assurance of pharmaceutical productNitin Patel
This document discusses the role of Quality by Design (QbD) in assuring quality of pharmaceutical products. It defines QbD and compares the traditional quality assessment system to the QbD approach. The document outlines the steps of a QbD program, including defining target quality profiles, identifying critical quality attributes and process parameters, designing the manufacturing process and establishing a control strategy. It also discusses tools used in QbD like design of experiments and risk assessment.
This document provides an overview of Quality by Design (QbD), including its background and definition. It discusses the FDA's initiative on QbD and why the QbD approach is used. Key quality guidance documents such as ICH Q8, Q8(R1), Q9, and Q10 are summarized. The document compares the current and QbD approaches to pharmaceutical development and provides an example of a QbD approach. It also describes several tools used in QbD like design space, design of experiments, quality risk management, and process analytical technology.
This document provides an overview of quality by design (QbD) principles including ICH guidelines Q8, Q9, and Q10. It discusses key QbD elements such as quality target product profiles, critical quality attributes, risk assessment, design space, design of experiments, and continual improvement. Examples are given of various statistical experimental designs that can be used including factorial, response surface, and mixture designs. The document aims to facilitate understanding of a QbD approach to pharmaceutical development and manufacturing.
The document discusses quality by design (QbD) approaches in the pharmaceutical industry. It covers:
- A brief history of quality regulation and the move toward more science-based approaches like QbD.
- Key elements of QbD including product and process understanding, design space, control strategy, and risk assessment.
- Tools used in QbD like design of experiments, multivariate statistics, failure mode and effects analysis, and neuronal networks.
- Open questions and challenges around fully implementing QbD approaches.
This document provides a summary of Jaya Shankar Sharma's career experience and qualifications. It includes details about his current role as Manager of Material and Logistics at Reliance Industries, where he has worked since 2007, managing inventory, logistics, and store operations. Previous roles included Logistics Officer at Hindustan Lever Limited from 2004-2007 and Assistant Manager of Operations at Total Logistics India Pvt. Ltd. from 2001-2004. Jaya Shankar holds an M.Sc. in Chemistry, Post Graduate Diploma in Logistics Management, M.B.A. in Marketing and Systems, and Master's Diploma in Computer Applications.
ANALYZING THE PROCESS CAPABILITY FOR AN AUTO MANUAL TRANSMISSION BASE PLATE M...ijmvsc
The industry today is working intensively on a goal-oriented way towards introducing regular studies in
manufacturing. The current study is part of a large overall spanning project aiming towards an increase in
productivity, i.e. more products produced per year with availability. In this paper we have analyze what
Process Capability is and how it is implemented on a current process. All the steps are listed out in an easy
to understand manner. In current scenario, specifications for products have been tightened due to
performance competition in market. Statistical tools like control charts, process capability analysis and
cause and effect diagram ensure that processes are fit for company specifications while reduce the process
variation and improve product quality characteristic. Process capability indices (PCIs) are used in the
manufacturing process to provide numerical measures on whether a process is capable of producing items
within the predetermined limits. For the analysis purpose MINITAB 16.0 is used and is found that the
process is placed exactly at the centre of the control limits. Analysis also shows that process is not
adequate. The cause and effect diagram is prepared to found out the root cause of variation in diameter of
work. In this study, a process-capability analysis was also carried out in a medium-sized company that
produces machine and spare parts.
David Lerma has over 18 years of experience as a materials manager. He has worked for several electronics and manufacturing companies, managing purchasing, inventory, logistics and supply chain. He is proficient in ERP systems like Oracle, SAP and MRP software. His objective is to successfully complete projects with dedication, continuous improvement and efficient processes while meeting objectives and ensuring customer satisfaction.
This document discusses the importance of Quality by Design (QbD) for ensuring the four As (acceptable quality, affordable medicines, availability, and accessibility) expected by regulators. It explains how QbD can help manufacturers optimize their processes to reduce waste and costs, while meeting regulatory expectations for a robust quality system. The key elements of a QbD approach include defining a Quality Target Product Profile, identifying critical quality attributes and risks, establishing a control strategy linking material attributes and process parameters to critical quality attributes, and enabling continuous improvement.
Role of quality by design (qb d) in quality assurance of pharmaceutical productNitin Patel
This document discusses the role of Quality by Design (QbD) in assuring quality of pharmaceutical products. It defines QbD and compares the traditional quality assessment system to the QbD approach. The document outlines the steps of a QbD program, including defining target quality profiles, identifying critical quality attributes and process parameters, designing the manufacturing process and establishing a control strategy. It also discusses tools used in QbD like design of experiments and risk assessment.
This document provides an overview of Quality by Design (QbD), including its background and definition. It discusses the FDA's initiative on QbD and why the QbD approach is used. Key quality guidance documents such as ICH Q8, Q8(R1), Q9, and Q10 are summarized. The document compares the current and QbD approaches to pharmaceutical development and provides an example of a QbD approach. It also describes several tools used in QbD like design space, design of experiments, quality risk management, and process analytical technology.
This document provides an overview of quality by design (QbD) principles including ICH guidelines Q8, Q9, and Q10. It discusses key QbD elements such as quality target product profiles, critical quality attributes, risk assessment, design space, design of experiments, and continual improvement. Examples are given of various statistical experimental designs that can be used including factorial, response surface, and mixture designs. The document aims to facilitate understanding of a QbD approach to pharmaceutical development and manufacturing.
The document discusses quality by design (QbD) approaches in the pharmaceutical industry. It covers:
- A brief history of quality regulation and the move toward more science-based approaches like QbD.
- Key elements of QbD including product and process understanding, design space, control strategy, and risk assessment.
- Tools used in QbD like design of experiments, multivariate statistics, failure mode and effects analysis, and neuronal networks.
- Open questions and challenges around fully implementing QbD approaches.
This document provides a summary of Jaya Shankar Sharma's career experience and qualifications. It includes details about his current role as Manager of Material and Logistics at Reliance Industries, where he has worked since 2007, managing inventory, logistics, and store operations. Previous roles included Logistics Officer at Hindustan Lever Limited from 2004-2007 and Assistant Manager of Operations at Total Logistics India Pvt. Ltd. from 2001-2004. Jaya Shankar holds an M.Sc. in Chemistry, Post Graduate Diploma in Logistics Management, M.B.A. in Marketing and Systems, and Master's Diploma in Computer Applications.
The document discusses best practices for risk assessment, which is the first step in Quality by Design (QbD). It recommends that risk assessment should focus on linking process parameters (CPP) to critical quality attributes (CQA) and how they ultimately impact the quality target product profile (QTPP). Failure Mode and Effects Analysis (FMEA) is not always the ideal tool for early development projects due to a lack of process understanding. Instead, it suggests using a simpler rating system of impact vs probability of occurrence to prioritize risks. Building these linkages from QTPP to CQA to CPP is key to developing a successful control strategy and executing QbD projects.
Quality by design for Pharmaceutical Industries: An introductionCovello Luca
In this presentation, I have attempted to provide a quick introduction into the main concepts behind Pharmaceutical Quality by Design, an approach that aims to ensure the quality of medicines by employing statistical, analytical and risk-management methodology in the design, development and manufacturing of drugs.
This document is a presentation on Quality by Design (QbD) in the pharmaceutical industry. It begins with an introduction comparing the traditional Quality by Test (QbT) approach to QbD. The presentation defines QbD and discusses ICH guidelines on QbD. It identifies key elements of QbD including Quality Target Product Profile, Critical Quality Attributes, Critical Material Attributes, Critical Process Parameters. The presentation outlines the steps for QbD implementation and importance of QbD in ensuring product quality and facilitating innovation.
This document provides an overview of Quality by Design (QbD) principles and their application in pharmaceutical development and manufacturing. It discusses key QbD concepts like critical quality attributes, design space, risk assessment and design of experiments. Statistical tools like factorial design, response surface methodology and multivariate analysis are presented as ways to characterize critical parameters, optimize processes and demonstrate robustness. The importance of a science-based and continuous improvement approach enabled by QbD is emphasized, compared to traditional pharmaceutical development methods. Regulatory expectations around QbD implementation from agencies like FDA and ICH are also reviewed.
Talk on QbD at CPhI Malaysia by Nitin Kadam.Nitin Kadam
QbD implementation faces challenges including organizational culture, scientific understanding, and regulatory perspectives. For manufacturers, it is important to understand the basics of QbD, potential benefits, and barriers. Self-assessment is needed to ensure the right mindset, priorities, and adequate resources. Case studies can provide insights into applying a systematic, knowledge-based approach to developing formulations and processes to meet quality objectives. Key aspects of a QbD-based development include defining quality targets, understanding products and processes, designing control strategies, and continually improving.
This document provides an overview of training courses offered by QbD Academy in 2017 related to quality assurance in the pharmaceutical, medical device, and biotech industries. QbD Academy offers both on-site and online training courses on various topics including auditing, quality management systems, good manufacturing practices, validation, and regulations. The training courses range from half-day to multi-day sessions and cover the objectives, content, duration, and location for each course. Contact information is also provided for QbD Academy.
Quality by Design - Presentation by Naveen PathakWPICPE
This document provides a summary of a presentation on Quality-by-Design (QbD) for biopharmaceuticals. It begins with an overview of QbD and its key principles of product and process understanding and control based on science and risk management. The presentation then discusses applying QbD concepts to coffee making as an example. Key aspects of coffee quality are identified and process parameters that impact quality are described. The presentation emphasizes using process understanding to develop a control strategy to ensure consistent quality. It also discusses integrating QbD with process validation approaches.
Key Components of Pharmaceutical QbD, an IntroductionSaurabh Arora
In the past few years, US FDA has implemented the concepts of Quality by Design (QbD) into its approval processes. FDA is insisting that quality should be built into a product with an understanding of the product and process, through development and manufacturing. QbD is a successor to the "quality by QC" (or "quality after design") approach.
This document provides an overview of Quality by Design (QbD), a systematic approach to pharmaceutical development and manufacturing that emphasizes product and process understanding. It discusses key QbD concepts like critical quality attributes, design space, and control strategy. The document also outlines some advantages of QbD like improved quality, flexibility, and reduced regulatory oversight. Finally, it examines implications of QbD for various technical roles, including new skills needed and a shift towards more predictive and science-based approaches.
Talk on QbD by Nitin Kadam at International Conference on Novel Formulation S...Nitin Kadam
This document provides an overview of quality by design (QbD) principles for pharmaceutical product and formulation development. It defines key QbD elements like quality target product profile, critical quality attributes, critical material attributes, and critical process parameters. It outlines a systematic approach to QbD-based development that involves identifying these elements, conducting risk assessments, design of experiments for optimization, defining a design space and control strategy. The document concludes with describing a case study example of using this QbD approach to optimize a tablet formulation through statistical experimental design and process verification.
The document discusses key concepts in Quality by Design (QbD) for pharmaceutical product development including establishing a Quality Target Product Profile, identifying Critical Quality Attributes and linking them to Critical Material Attributes and Critical Process Parameters through Design of Experiments. It provides examples of establishing a design space for a tablet formulation through a multifactorial study of variables affecting dissolution and for a blending process through assessment of process parameters. The importance of developing a control strategy based on the design space to ensure final product quality is also highlighted.
The document provides an overview of analytical quality by design (AQbD) and a case study on optimizing an HPLC method for quantification of an unknown impurity in a drug product. Key aspects included:
- Defining the analytical target profile (ATP) and critical quality attributes (CQA) for the method
- Conducting a qualitative risk assessment to identify critical method parameters using a prioritization matrix
- Performing a quantitative risk assessment using FMECA to calculate risk priority numbers and identify high, medium, and low risk factors
- Selecting experimental factors (column temperature, particle size, etc.), response variables (resolution, retention time), and constant factors for the design of experiments study.
The document provides an overview of lean production principles and the system kaizen process for continuous improvement. It describes the Plan-Do-Check-Act cycle and how to document an improvement project using the A3 report format. The A3 report guides teams through defining the current condition, target condition, implementation plan, key performance indicators, and approval process. The goal is to standardize improvements to sustain gains over time on the path towards an ideal lean system with continuous flow and zero waste.
This document discusses process capability analysis, which relates a production process's variability to customer specifications to determine if the process is capable of meeting requirements. It defines key terms like critical-to-quality characteristics, control charts, process capability indices Cp and Cpk. Cp measures a process's potential capability if centered on target, while Cpk considers deviation of the mean. For a process to be capable, its natural variation (control limits) must be narrower than specifications. If Cpk=1 the process is barely capable, and if Cpk<1 the process is incapable and requires improvement. Process capability analysis assumes an in-control, stable production process.
This document discusses statistical quality control (SQC) and its use in manufacturing and services. It describes how SQC uses statistical sampling and control charts to monitor processes and identify issues. Historically, quality control began with judgment inspections but SQC provided improvements by reducing inspection needs and providing feedback to prevent nonconformities. The document also provides examples of how Toyota and Ritz Carlton hotels successfully used SQC to improve quality.
Analysis and Reduction of Production Waste in the Process of Production of Fr...IRJET Journal
This document analyzes production waste in a beverage industry using value stream mapping and the Pareto principle. It identifies various wastes like transit leakages, in-house leakages, and production line wastes. A current state value stream map is created to analyze value-added and non-value added times. Pareto analysis shows that 53 defects come from filling and 34 from labeling, accounting for over 70% of total defects. Recommendations are made to reduce wastes, improve process cycle efficiency from 12.18% to 25.16%, and reduce lead time from 11 hours 46 minutes to 5 hours 49 minutes through implementing techniques like just-in-time.
This document outlines the course content for a statistical quality control course. It covers 5 chapters: 1) Introduction to statistical quality control, 2) Methods of statistical process control and capability analysis, 3) Other statistical process monitoring and control techniques, 4) Acceptance sampling, and 5) Reliability and life testing. Key topics include the history of statistical quality control, uses of SQC, quality improvement, modeling process quality, control charts, process capability indices, cumulative sum control charts, and acceptance sampling concepts. The document provides an overview of the concepts, methods, and techniques that will be covered in the statistical quality control course.
The document discusses the FDA's 2011 guidance on a lifecycle approach to process validation. It begins by explaining the differences between the 1987 guidance and the 2011 guidance, which focuses on three stages: process design, process qualification, and continued process verification. The document then goes into detail about each stage, explaining the goals and key activities of each stage. It provides details on what should be included in process qualification protocols, execution of process qualification, and ongoing activities in continued process verification.
This project aims to improve labor productivity at a manufacturing line by 30% from 0.14 hours/unit to 0.1 hours/unit. Process improvements including value stream mapping, layout changes with a "birdcage" shape, and jig/fixture improvements were implemented. This resulted in a headcount reduction from 50 to 32 people, meeting the goal of a 30% productivity improvement.
This document discusses Quality by Design (QbD), a systematic approach to pharmaceutical development that emphasizes product and process understanding based on sound science and quality risk management. It outlines the key elements of QbD including quality target product profiles, critical quality attributes, critical material attributes, critical process parameters, design space, control strategy, and product lifecycle management. Risk assessment tools and process analytical technology are also described as important tools that can be utilized in a QbD approach.
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.
The document discusses best practices for risk assessment, which is the first step in Quality by Design (QbD). It recommends that risk assessment should focus on linking process parameters (CPP) to critical quality attributes (CQA) and how they ultimately impact the quality target product profile (QTPP). Failure Mode and Effects Analysis (FMEA) is not always the ideal tool for early development projects due to a lack of process understanding. Instead, it suggests using a simpler rating system of impact vs probability of occurrence to prioritize risks. Building these linkages from QTPP to CQA to CPP is key to developing a successful control strategy and executing QbD projects.
Quality by design for Pharmaceutical Industries: An introductionCovello Luca
In this presentation, I have attempted to provide a quick introduction into the main concepts behind Pharmaceutical Quality by Design, an approach that aims to ensure the quality of medicines by employing statistical, analytical and risk-management methodology in the design, development and manufacturing of drugs.
This document is a presentation on Quality by Design (QbD) in the pharmaceutical industry. It begins with an introduction comparing the traditional Quality by Test (QbT) approach to QbD. The presentation defines QbD and discusses ICH guidelines on QbD. It identifies key elements of QbD including Quality Target Product Profile, Critical Quality Attributes, Critical Material Attributes, Critical Process Parameters. The presentation outlines the steps for QbD implementation and importance of QbD in ensuring product quality and facilitating innovation.
This document provides an overview of Quality by Design (QbD) principles and their application in pharmaceutical development and manufacturing. It discusses key QbD concepts like critical quality attributes, design space, risk assessment and design of experiments. Statistical tools like factorial design, response surface methodology and multivariate analysis are presented as ways to characterize critical parameters, optimize processes and demonstrate robustness. The importance of a science-based and continuous improvement approach enabled by QbD is emphasized, compared to traditional pharmaceutical development methods. Regulatory expectations around QbD implementation from agencies like FDA and ICH are also reviewed.
Talk on QbD at CPhI Malaysia by Nitin Kadam.Nitin Kadam
QbD implementation faces challenges including organizational culture, scientific understanding, and regulatory perspectives. For manufacturers, it is important to understand the basics of QbD, potential benefits, and barriers. Self-assessment is needed to ensure the right mindset, priorities, and adequate resources. Case studies can provide insights into applying a systematic, knowledge-based approach to developing formulations and processes to meet quality objectives. Key aspects of a QbD-based development include defining quality targets, understanding products and processes, designing control strategies, and continually improving.
This document provides an overview of training courses offered by QbD Academy in 2017 related to quality assurance in the pharmaceutical, medical device, and biotech industries. QbD Academy offers both on-site and online training courses on various topics including auditing, quality management systems, good manufacturing practices, validation, and regulations. The training courses range from half-day to multi-day sessions and cover the objectives, content, duration, and location for each course. Contact information is also provided for QbD Academy.
Quality by Design - Presentation by Naveen PathakWPICPE
This document provides a summary of a presentation on Quality-by-Design (QbD) for biopharmaceuticals. It begins with an overview of QbD and its key principles of product and process understanding and control based on science and risk management. The presentation then discusses applying QbD concepts to coffee making as an example. Key aspects of coffee quality are identified and process parameters that impact quality are described. The presentation emphasizes using process understanding to develop a control strategy to ensure consistent quality. It also discusses integrating QbD with process validation approaches.
Key Components of Pharmaceutical QbD, an IntroductionSaurabh Arora
In the past few years, US FDA has implemented the concepts of Quality by Design (QbD) into its approval processes. FDA is insisting that quality should be built into a product with an understanding of the product and process, through development and manufacturing. QbD is a successor to the "quality by QC" (or "quality after design") approach.
This document provides an overview of Quality by Design (QbD), a systematic approach to pharmaceutical development and manufacturing that emphasizes product and process understanding. It discusses key QbD concepts like critical quality attributes, design space, and control strategy. The document also outlines some advantages of QbD like improved quality, flexibility, and reduced regulatory oversight. Finally, it examines implications of QbD for various technical roles, including new skills needed and a shift towards more predictive and science-based approaches.
Talk on QbD by Nitin Kadam at International Conference on Novel Formulation S...Nitin Kadam
This document provides an overview of quality by design (QbD) principles for pharmaceutical product and formulation development. It defines key QbD elements like quality target product profile, critical quality attributes, critical material attributes, and critical process parameters. It outlines a systematic approach to QbD-based development that involves identifying these elements, conducting risk assessments, design of experiments for optimization, defining a design space and control strategy. The document concludes with describing a case study example of using this QbD approach to optimize a tablet formulation through statistical experimental design and process verification.
The document discusses key concepts in Quality by Design (QbD) for pharmaceutical product development including establishing a Quality Target Product Profile, identifying Critical Quality Attributes and linking them to Critical Material Attributes and Critical Process Parameters through Design of Experiments. It provides examples of establishing a design space for a tablet formulation through a multifactorial study of variables affecting dissolution and for a blending process through assessment of process parameters. The importance of developing a control strategy based on the design space to ensure final product quality is also highlighted.
The document provides an overview of analytical quality by design (AQbD) and a case study on optimizing an HPLC method for quantification of an unknown impurity in a drug product. Key aspects included:
- Defining the analytical target profile (ATP) and critical quality attributes (CQA) for the method
- Conducting a qualitative risk assessment to identify critical method parameters using a prioritization matrix
- Performing a quantitative risk assessment using FMECA to calculate risk priority numbers and identify high, medium, and low risk factors
- Selecting experimental factors (column temperature, particle size, etc.), response variables (resolution, retention time), and constant factors for the design of experiments study.
The document provides an overview of lean production principles and the system kaizen process for continuous improvement. It describes the Plan-Do-Check-Act cycle and how to document an improvement project using the A3 report format. The A3 report guides teams through defining the current condition, target condition, implementation plan, key performance indicators, and approval process. The goal is to standardize improvements to sustain gains over time on the path towards an ideal lean system with continuous flow and zero waste.
This document discusses process capability analysis, which relates a production process's variability to customer specifications to determine if the process is capable of meeting requirements. It defines key terms like critical-to-quality characteristics, control charts, process capability indices Cp and Cpk. Cp measures a process's potential capability if centered on target, while Cpk considers deviation of the mean. For a process to be capable, its natural variation (control limits) must be narrower than specifications. If Cpk=1 the process is barely capable, and if Cpk<1 the process is incapable and requires improvement. Process capability analysis assumes an in-control, stable production process.
This document discusses statistical quality control (SQC) and its use in manufacturing and services. It describes how SQC uses statistical sampling and control charts to monitor processes and identify issues. Historically, quality control began with judgment inspections but SQC provided improvements by reducing inspection needs and providing feedback to prevent nonconformities. The document also provides examples of how Toyota and Ritz Carlton hotels successfully used SQC to improve quality.
Analysis and Reduction of Production Waste in the Process of Production of Fr...IRJET Journal
This document analyzes production waste in a beverage industry using value stream mapping and the Pareto principle. It identifies various wastes like transit leakages, in-house leakages, and production line wastes. A current state value stream map is created to analyze value-added and non-value added times. Pareto analysis shows that 53 defects come from filling and 34 from labeling, accounting for over 70% of total defects. Recommendations are made to reduce wastes, improve process cycle efficiency from 12.18% to 25.16%, and reduce lead time from 11 hours 46 minutes to 5 hours 49 minutes through implementing techniques like just-in-time.
This document outlines the course content for a statistical quality control course. It covers 5 chapters: 1) Introduction to statistical quality control, 2) Methods of statistical process control and capability analysis, 3) Other statistical process monitoring and control techniques, 4) Acceptance sampling, and 5) Reliability and life testing. Key topics include the history of statistical quality control, uses of SQC, quality improvement, modeling process quality, control charts, process capability indices, cumulative sum control charts, and acceptance sampling concepts. The document provides an overview of the concepts, methods, and techniques that will be covered in the statistical quality control course.
The document discusses the FDA's 2011 guidance on a lifecycle approach to process validation. It begins by explaining the differences between the 1987 guidance and the 2011 guidance, which focuses on three stages: process design, process qualification, and continued process verification. The document then goes into detail about each stage, explaining the goals and key activities of each stage. It provides details on what should be included in process qualification protocols, execution of process qualification, and ongoing activities in continued process verification.
This project aims to improve labor productivity at a manufacturing line by 30% from 0.14 hours/unit to 0.1 hours/unit. Process improvements including value stream mapping, layout changes with a "birdcage" shape, and jig/fixture improvements were implemented. This resulted in a headcount reduction from 50 to 32 people, meeting the goal of a 30% productivity improvement.
This document discusses Quality by Design (QbD), a systematic approach to pharmaceutical development that emphasizes product and process understanding based on sound science and quality risk management. It outlines the key elements of QbD including quality target product profiles, critical quality attributes, critical material attributes, critical process parameters, design space, control strategy, and product lifecycle management. Risk assessment tools and process analytical technology are also described as important tools that can be utilized in a QbD approach.
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 provides an overview of process validation according to FDA guidance. It defines process validation as collecting data from process design through commercial production to establish that a process is capable of consistently delivering quality products. The guidance outlines a lifecycle approach with three stages: process design, process qualification, and continued process verification. Process design defines the commercial process based on development knowledge. Process qualification evaluates the design and determines if the process is reproducible. Continued process verification ensures the process remains controlled during routine production. Critical quality attributes and critical process parameters are identified, and control strategies are established.
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 discusses quantifying the total benefits of improved quality control, which can be double what is typically calculated. It presents a method to account for both tangible benefits from improving average product quality and intangible benefits from reducing quality variations. Reducing variations alone is usually seen as necessary but producing no real financial benefit. However, modeling the economic penalties when products violate specifications allows defining intangible benefits equal to those from improving averages. The document provides examples and diagrams to illustrate how fluctuations in product quality relate to specifications and how statistical process control can reduce variations while moving averages closer to specifications, doubling the quantified benefits.
This document discusses process capability analysis. It introduces process capability, why it is studied, and how it is measured through graphs and calculations of metrics like Cp. Process capability determines if a process meets specifications and can help reduce variability. The principles of process capability are explained, such as predicting variability. Methods like analytical calculations and process capability ratios are covered. Advantages include process improvement, while disadvantages are that it is best for large companies. Control charts can also be used to monitor processes.
The document summarizes the author's experience leading a project to achieve Green Belt certification in Lean Six Sigma. It details how the author analyzed issues with a new rice pellet supplier's process using statistical tools. This identified that inconsistent moisture levels and extruder conditions were causing quality problems. Working with the supplier, the author defined critical process controls and helped improve stability. Repeated trials then showed the new supplier's process met requirements and quality targets.
This document discusses process validation and summarizes the key changes between the 1987 FDA guidance and the 2011 revised guidance. It outlines a three stage process validation approach: Stage 1 involves process design and understanding; Stage 2 is process qualification where batches are produced to demonstrate the process is capable of consistent commercial manufacturing; and Stage 3 is continued process verification to ensure the process remains in control during routine production. The revised guidance emphasizes a more holistic and risk-based approach across the product lifecycle compared to the previous terminal approach focused on a set number of validation batches.
John Q Public completed a Six Sigma project from January 2006 to March 2006 to reduce quality defects in the XXX process at Never Fail Inc. The process was producing over 20% defects, resulting in customer complaints, inconsistent delivery, and increased costs. The goal was to reduce defects to under 0.5% while achieving 99% on-time delivery. As black belt, John created project documents, led a team through analysis tools including process mapping, DOE, and capability studies to identify and optimize significant factors. This reduced defects and improved customer satisfaction. The project saved $250,000 annually in material and labor costs by reducing scrap and improving capacity for on-time delivery. Bruce Almighty, Operations Director at Never Fail Inc., verified
This document provides guidance on identifying critical quality attributes (CQAs), critical material attributes (CMAs), and critical process parameters (CPPs) using a Quality by Design (QbD) approach. It outlines approaches to define the quality target product profile, identify CQAs based on impact to safety and efficacy, and use prior knowledge and risk assessment to identify potentially high risk material and process variables. Experimental design is recommended to determine criticality based on a variable's impact on a CQA. Control strategies should control CMAs and CPPs within studied ranges. The document also provides illustrative examples of applying these approaches to drug products.
- Covance implemented Six Sigma in 2005 to improve process efficiency and quality while reducing costs and time for clinical trials.
- A Six Sigma green belt project reduced medical writing narrative work time by creating a SAS program to automate standard header creation, achieving the goal of reducing time by 50%.
- Ongoing Six Sigma projects aim to further reduce times for tasks like writing clinical study reports and quality checking tables and figures.
- Six Sigma provides a measurable way to improve processes by reducing variability between the actual process performance and customer requirements.
Jetpharma implemented Quality by Design (QbD) for their micronization processes to improve process understanding and control. They conducted a case study analyzing how the micronization process influences particle size distribution (PSD), a critical quality attribute. The study identified critical process parameters, performed a design of experiments, and developed a predictive model to define a design space relating PSD to operating conditions. Testing validated the model and provided samples for customers to evaluate formulation impact. The QbD approach improved process knowledge and control.
Prediction of Electrical Energy Efficiency Using Information on Consumer's Ac...PriyankaKilaniya
Energy efficiency has been important since the latter part of the last century. The main object of this survey is to determine the energy efficiency knowledge among consumers. Two separate districts in Bangladesh are selected to conduct the survey on households and showrooms about the energy and seller also. The survey uses the data to find some regression equations from which it is easy to predict energy efficiency knowledge. The data is analyzed and calculated based on five important criteria. The initial target was to find some factors that help predict a person's energy efficiency knowledge. From the survey, it is found that the energy efficiency awareness among the people of our country is very low. Relationships between household energy use behaviors are estimated using a unique dataset of about 40 households and 20 showrooms in Bangladesh's Chapainawabganj and Bagerhat districts. Knowledge of energy consumption and energy efficiency technology options is found to be associated with household use of energy conservation practices. Household characteristics also influence household energy use behavior. Younger household cohorts are more likely to adopt energy-efficient technologies and energy conservation practices and place primary importance on energy saving for environmental reasons. Education also influences attitudes toward energy conservation in Bangladesh. Low-education households indicate they primarily save electricity for the environment while high-education households indicate they are motivated by environmental concerns.
Generative AI Use cases applications solutions and implementation.pdfmahaffeycheryld
Generative AI solutions encompass a range of capabilities from content creation to complex problem-solving across industries. Implementing generative AI involves identifying specific business needs, developing tailored AI models using techniques like GANs and VAEs, and integrating these models into existing workflows. Data quality and continuous model refinement are crucial for effective implementation. Businesses must also consider ethical implications and ensure transparency in AI decision-making. Generative AI's implementation aims to enhance efficiency, creativity, and innovation by leveraging autonomous generation and sophisticated learning algorithms to meet diverse business challenges.
https://www.leewayhertz.com/generative-ai-use-cases-and-applications/
Accident detection system project report.pdfKamal Acharya
The Rapid growth of technology and infrastructure has made our lives easier. The
advent of technology has also increased the traffic hazards and the road accidents take place
frequently which causes huge loss of life and property because of the poor emergency facilities.
Many lives could have been saved if emergency service could get accident information and
reach in time. Our project will provide an optimum solution to this draw back. A piezo electric
sensor can be used as a crash or rollover detector of the vehicle during and after a crash. With
signals from a piezo electric sensor, a severe accident can be recognized. According to this
project when a vehicle meets with an accident immediately piezo electric sensor will detect the
signal or if a car rolls over. Then with the help of GSM module and GPS module, the location
will be sent to the emergency contact. Then after conforming the location necessary action will
be taken. If the person meets with a small accident or if there is no serious threat to anyone’s
life, then the alert message can be terminated by the driver by a switch provided in order to
avoid wasting the valuable time of the medical rescue team.
Digital Twins Computer Networking Paper Presentation.pptxaryanpankaj78
A Digital Twin in computer networking is a virtual representation of a physical network, used to simulate, analyze, and optimize network performance and reliability. It leverages real-time data to enhance network management, predict issues, and improve decision-making processes.
Open Channel Flow: fluid flow with a free surfaceIndrajeet sahu
Open Channel Flow: This topic focuses on fluid flow with a free surface, such as in rivers, canals, and drainage ditches. Key concepts include the classification of flow types (steady vs. unsteady, uniform vs. non-uniform), hydraulic radius, flow resistance, Manning's equation, critical flow conditions, and energy and momentum principles. It also covers flow measurement techniques, gradually varied flow analysis, and the design of open channels. Understanding these principles is vital for effective water resource management and engineering applications.
DEEP LEARNING FOR SMART GRID INTRUSION DETECTION: A HYBRID CNN-LSTM-BASED MODELijaia
As digital technology becomes more deeply embedded in power systems, protecting the communication
networks of Smart Grids (SG) has emerged as a critical concern. Distributed Network Protocol 3 (DNP3)
represents a multi-tiered application layer protocol extensively utilized in Supervisory Control and Data
Acquisition (SCADA)-based smart grids to facilitate real-time data gathering and control functionalities.
Robust Intrusion Detection Systems (IDS) are necessary for early threat detection and mitigation because
of the interconnection of these networks, which makes them vulnerable to a variety of cyberattacks. To
solve this issue, this paper develops a hybrid Deep Learning (DL) model specifically designed for intrusion
detection in smart grids. The proposed approach is a combination of the Convolutional Neural Network
(CNN) and the Long-Short-Term Memory algorithms (LSTM). We employed a recent intrusion detection
dataset (DNP3), which focuses on unauthorized commands and Denial of Service (DoS) cyberattacks, to
train and test our model. The results of our experiments show that our CNN-LSTM method is much better
at finding smart grid intrusions than other deep learning algorithms used for classification. In addition,
our proposed approach improves accuracy, precision, recall, and F1 score, achieving a high detection
accuracy rate of 99.50%.
Optimizing Gradle Builds - Gradle DPE Tour Berlin 2024Sinan KOZAK
Sinan from the Delivery Hero mobile infrastructure engineering team shares a deep dive into performance acceleration with Gradle build cache optimizations. Sinan shares their journey into solving complex build-cache problems that affect Gradle builds. By understanding the challenges and solutions found in our journey, we aim to demonstrate the possibilities for faster builds. The case study reveals how overlapping outputs and cache misconfigurations led to significant increases in build times, especially as the project scaled up with numerous modules using Paparazzi tests. The journey from diagnosing to defeating cache issues offers invaluable lessons on maintaining cache integrity without sacrificing functionality.
1. Quality Management (QM): The
heart of the QAQC process
Juan V. Salazar Jaime
Gerente Técnico Lab Perú Minerals
Juan.salazar@labperuminerals.org
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MAY-2020 1
SALAZAR JAIME JUAN VICENTE
Ingeniero Químico
CIP N°158987
E-MAIL: jumavi1211@gmail.com
juan.salazarj@cip.org.pe
Ing. Químico con 16 años de experiencia en minería y otros rubros con posgrado en Ingeniería de la
calidad y Gestión Ambiental, con especialización en Sistemas de gestión ISO/IEC 17025, ISO 9001
,ISO 14001, ISO 45001 en la Pontificia Universidad Católica del Perú (PUCP) ,Universidad Agraria
la Molina (UNALM) y la Universidad Nacional Mayor de San Marcos (UNMSM). Experto Técnico
inscrito en el instituto Nacional de la Calidad (INACAL), Consultor, auditor, y capacitador con
sólidos conocimientos en la normativa vigente: Ley 29783, D.S.005- 2012-TR, R.M. N° 312-2011-
MINSA y sus modificatorias, D.S. 024-2016-EM y su modificatoria D.S 023-2017-EM, D.S 043-2007-
EM, G050, RM 111-2013-MEM/DM).
Con entrenamientos en Metrología Química en diferentes Institutos Nacionales de Metrología de la
región, como el CENAM de México, INMETRO de Brasil, INM de Colombia, INTI de Argentina, entre
otros. Ha participado como expositor en los Simposios de Metrología en el Perú.
Diseño , implementación ,ejecución y puesta en marcha de Laboratorio Químicos y metalúrgicos
Manejo y Gestión de costos y presupuestos ( SAP), dirección de personal, gestión y planificación de
materiales, control de Insumos y bienes fiscalizados (IQBF),mantenimiento y calibración de equipos
,Evaluación y manejo de datos estadísticos (Minitab, SPSS, Statgraphics), Implementador de
sistemas de gestión de información para laboratorios LIMS( Sample Manager, CCCLAS , Labware,
Global System ,Sapphire,Acme), Diseño, Implementación y puesta en marcha de laboratorios de
ensayos, experiencia de análisis en las diferentes técnicas como: AAS, ICP, IR, FIRE ASSAY,FRX ,
DRX, VOLUMETRIA, GRAV,ION SELECTIVO.
.
2. Quality Management (QM): The
heart of the QAQC process
Juan V. Salazar Jaime
Gerente Técnico Lab Perú Minerals
Juan.salazar@labperuminerals.org
-------------------------------------------------------------------------------------------------------------
MAY-2020 2
Introduction
Business decisions are often driven by data, and for that reason data quality and reliability is paramount. In the
mining sector, investments in exploration, infrastructure construction, mining operations, ore processing,
transportation and port require multi-million dollar capital and operating budgets. The different phases of project
evolution are based on samples, usually a few grams that represent large tonnages. This was the observation that
led Pierre Gy to develop his Sampling Theory and later led researchers such as Dominique Bongarcon and Francis
Pitard, among others, to promote, convince, quantify and demonstrate to executives and mining professionals the
risks to which businesses expose themselves when compromising sample quality in a misguided attempt to reduce
costs.
In this context, quality assurance programs have been developed to establish Quality Assurance & Quality Control
(QAQC) parameters that monitor correct execution of sampling protocols and control each stage of the "sample
cycle ": sample collection, preparation (comminution) and analytical method. QAQC reports commonly include
statistical-numerical results that quantify performance of QAQC controls (field duplicates, preparation duplicates,
blanks, standards, etc.). Graphics such as scatter plots, QQ plots, histograms, and cumulative frequencies are
used to graphically represent the results. Statistical values including relative difference, absolute difference,
relative variance, averages, AMPD, T-test, and Z-scores are used to quantitatively express the relationship
between duplicate pairs... however, is an effective quality program just a statistical exercise? The following
discussion considers this question in the context of a quality program standard as outlined by the JORC code,
trying to highlight the call to return to the basics during this era of new technological applications and advanced
statistical analysis.
The case for proactivity
This paper aims to highlight the concept of "Quality Management" (QM) as the precursor of corrective actions
closing gaps determined by trend analysis (by ranges time and/or grades) with the aim of proactively determining
control performance deviation and thus proactively rectify the source of deviation.
There is sometimes confusion among those accountable for quality assurance, and even among auditors, that if
individual data points fall within a predetermined acceptance limit then they are necessarily acceptable and
therefore suitable for informing operational and investment decisions. A similar situation is that tabular summary of
statistics is enough to demonstrate acceptability of quality control outcomes. However, what is stated with respect
to QM is that sometimes results found within the acceptance limits can indeed be internally biased, or show
material deviations over a period of time, thereby impacting operational performance. An unstable process which
happens to plot within arbitrary acceptance limits is nevertheless an unstable process. Thus true process control
requires something more.
3. Quality Management (QM): The
heart of the QAQC process
Juan V. Salazar Jaime
Gerente Técnico Lab Perú Minerals
Juan.salazar@labperuminerals.org
-------------------------------------------------------------------------------------------------------------
MAY-2020 3
QM refers to the proactive detection of these "anomalous tendencies"; that is, the trend over time/grade of a given
statistic. QM includes also the process by which these trends are understood, communicated and rectified. Some
businesses refer to this process as “continuous improvement” or the “Plan, Do, Check, Act” cycle.
This proactive approach in the mining industry can have material impact on financial outcomes through sequence
optimization, contract negotiation, and management of plant and processing infrastructure.
Below are examples of how QM can be implemented through the mining value chain, using a proactive approach
as guided by JORC Table 1, and how results are typically presented in QAQC report or audits.
1) Sample Collection
JORC Table 1 provides guidance that drilling campaigns shall deploy measures to maximize sample recovery and
representivity. A typical example for an RC drilling campaign would be actual sample weights measured against a
theoretical “ideal” drilling recovery, as a function of material density, rod length and diameter, and aperture size of
the sample shoot. Where duplicate samples are collected, it is expected that they will have similar, if not identical
sample weights. This is an indication that the rig set-up, sampling devices and drilling/sample collection process
are operating according to design.
Results are commonly presented as in Figure 1, where a scatter plot shows the distribution of the results between
duplicates. In this example, the scatter plot shows differences in weight outside expected thresholds, between 10 to
30kg; and potentially a small bias towards to sample A being heavier than sample B..
Figure 1. RC Field Duplicates performance: (A) Scatter plot comparing duplicates sample weight.
4. Quality Management (QM): The
heart of the QAQC process
Juan V. Salazar Jaime
Gerente Técnico Lab Perú Minerals
Juan.salazar@labperuminerals.org
-------------------------------------------------------------------------------------------------------------
MAY-2020 4
There are several questions this graph fails to answer: Why are A samples systematically larger than B samples?
Is this the consequence of a particular drill rig? A particular sampling device? When was the bias first introduced?
Is the bias random or sustained for a period of time? What was done to fix it?
Figure 2, presents an example on how QM practices can proactively improve sample collection by monitoring rig
performance in a different way, whilst still comparing the weight of duplicate samples:
This graph can be interpreted as follows: During the first 2 weeks of drilling in February, weight differences in rig 1
were not performing within accepted thresholds (Relative Difference + 20%). A conversation with the drill crew and
drilling company supervisor is conducted in the field to explain to the driller the importance of drilling on geological
models, to understand the sources of this poor performance, develop an action plan to improve the sample
collection process and obtain their commitment to increase the quality of the samples.
Figure 2. Example of monitoring sample weight on duplicate samples. Quality Assurance (QA): Collect
sample weight on Duplicate samples. Quality Control (QC): Sample weight within +20% relative difference.
Quality Management (QM): Continuous monitoring of the information and actions were results are outside
expected thresholds.
Through QM, corrective actions are taken by continuously monitoring results over time. This proactive approach
can save thousands of dollars by “doing things right the first time” rather than review QAQC performance en masse
once the drilling campaign is already finished, by which time it is too late!!!
2) Sample Preparation
5. Quality Management (QM): The
heart of the QAQC process
Juan V. Salazar Jaime
Gerente Técnico Lab Perú Minerals
Juan.salazar@labperuminerals.org
-------------------------------------------------------------------------------------------------------------
MAY-2020 5
Following the same criteria as Sample Collection, the JORC Table 1 benchmark requires evidence that “quality
control procedures [are] adopted for all sub-sampling stages to maximize representivity of samples”.
Usually, Blanks and Duplicate samples and sizing tests are used as a QA tool to monitor the performance of
crushers and mills. Later, results are included on QAQC reports where the performance of crushers and mills are
summarized (for example) as shown in Figure 3.
Figure 3. Examples of how Duplicate sample performance is presented in QAQC reports.
While these graphs and summary tables are typical, this information doesn’t allow us to apply Quality Management
(QM) to monitor the information in real time and proactively improve the results.
Figure 4, shows an example where a trend analysis is performed on a time (date) and grade basis: A) The Absolute
Difference of Duplicate samples is plotted against the date the Laboratory has reported the results. The graph
doesn’t show major issues over a specific period of time, but if the data is assessed on a Grade basis as shown on
B), a trend can be interpreted as the grade of the primary sample being greater than the duplicate sample. The
action here will be to talk to the drilling company if these are field duplicates; with the team performing the core
cutting, or with the laboratory if they are crusher or pulp duplicates, to find the source of this bias, and develop an
action plan to fix and close the gap. This real-time assessment and management is the basis for a proactive
approach. It needs to be highlighted, supplementing reactive activities such as reconciliation results or
monthly/quarterly QAQC reports (if done), where the opportunity for fixing issues in near-real time is lost.
6. Quality Management (QM): The
heart of the QAQC process
Juan V. Salazar Jaime
Gerente Técnico Lab Perú Minerals
Juan.salazar@labperuminerals.org
-------------------------------------------------------------------------------------------------------------
MAY-2020 6
Figure 4. Examples of trend analysis performed on a Time and Grade basis for Duplicate samples
(applicable for field, crusher and pulp duplicates). These graphs highlight the value of performing QM on a
date and grade basis: the analysis by date doesn’t show any major issue in terms of bias and the results
look consistent, but the analysis performed on a Grade basis highlight a bias at high grades that needs to
be reviewed, understood and fixed.
3) Chemical Determination
Certified Reference Materials (CRM) are used to monitor laboratory performance, where mining companies shall
arrange preparation of their own CRMs to perform QM. It is not recommended to rely on Lab internal QAQC
processes. Changes in the lab results or consistent biases across time are best detected by an internal team
accountable for QM, in order to highlight issues with the lab, analyze the sources of deviation and consequences to
production, generate an action plan and apply lessons learned to avoid repetitive issues.
Usually statistical analysis considers “average values”, which sometimes lead to inaccurate conclusions that
assume a process is “on average” controlled or “fit for purpose”. Quality Management applies a different approach,
assessing data in real time, thereby escaping the need for averages, and keeping a business focus with the aim to
ensure consistent results supporting sustainable business decisions.
Figure 4 demonstrates the differences between an approach reliant on averages and Quality Management applied
to CRM results (QA= CRMs, QC= + 3 SD & QM= Trend analysis). Figure 4A shows 10 months performance of a
CRM. Because results have been performing mostly within 3 standard deviations, the business might infer the
process is well controlled and feel confident given the global average is close to the certified value. However,
Figure 4B shows the internal variability which the laboratory (period average) is observing over time. This lack of
consistency gives rise to operational instability, exposing the business to risks of under or over performing at
production, processing and compliance to plan results, or variable products
Such are cases where Quality Management becomes important by monitoring information in real time and
detecting changes in the performance of the Laboratory proactively, thereby ensuring consistency and
sustainability of business results.
7. Quality Management (QM): The
heart of the QAQC process
Juan V. Salazar Jaime
Gerente Técnico Lab Perú Minerals
Juan.salazar@labperuminerals.org
-------------------------------------------------------------------------------------------------------------
MAY-2020 7
Figure 4. Certified Reference Material performance showing results performing mostly within 3 expected
standard deviations. A) Global average is very close to the certified value which can be interpreted results
are considered valid. B) Period average has been included, showing the big variability on lab performance
during months.
Conclusion
This paper aims to highlight that a Quality Program is not just a statistical exercise, where global averages or
standard deviations assure sustainable and consistent QAQC results. Examples provided in this paper
demonstrate the value of Quality Management to complement routine QAQC processes and statistical analysis,
where a proactive approach and data monitoring can really ensure consistent results across time or a range of
grades, and reduce resource and operational risks.
Indirectly this paper highlights the value and necessity of having a centralized team accountable for governance
and performing quality-related activities (QAQC & QM) across Exploration and Production.
Finally, it is in vogue and companies has been pushing to be part of a new era of new technological applications
(sensors) and data analysis (machine learning, conditional simulations, etc.) trying to provide businesses real time
8. Quality Management (QM): The
heart of the QAQC process
Juan V. Salazar Jaime
Gerente Técnico Lab Perú Minerals
Juan.salazar@labperuminerals.org
-------------------------------------------------------------------------------------------------------------
MAY-2020 8
data to be used for business decisions in real time.….This paper highlights that either new technology or advanced
statistical techniques, need to be based on good quality data to calibrate and test tool’s calibrations, and quality
data needs to be incorporated into simulations or advanced statistical tools.…Quality Management becomes more
relevant to ensure that performance of future technologies will are robust...