The document discusses pharmaceutical quality management systems. It provides an overview of key aspects of an effective pharmaceutical quality management system including quality management, quality assurance, evaluation analysis, risk management tools, preventive action, continuous improvement, and ensuring compliance with cGMPs. It describes the six subsystems that comprise a modern pharmaceutical quality management system: quality system, production system, facilities and equipment system, laboratory controls system, materials system, and packaging and labeling system. The quality subsystem provides the foundation for the other five manufacturing subsystems.
This document provides an overview of pharmaceutical quality management. It discusses risk management in the pharmaceutical industry and the importance of a robust quality system. An effective quality system should focus on quality management, quality assurance, evaluation analysis, risk management, preventive action, and continuous improvement. It also describes the key subsystems of a modern pharmaceutical quality system: quality system, production system, facilities/equipment system, laboratory controls system, materials system, and packaging/labeling system. The document provides examples of quality management tools including check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, histograms, and others.
This document provides an overview of quality management systems and examples of tools and processes used for quality management. It discusses the key steps to building a quality management system, including defining processes, quality policy and objectives, defects, documentation, quality processes, training needs, performance measurement, and continuous improvement. Specific quality management tools described include check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, histograms, and additional related topics like quality management courses and standards.
This document discusses quality risk management process for aseptic processes. It begins by defining an aseptic process as the manipulation of sterile components in a controlled environment to produce a sterile product. Aseptic processes carry a high risk of contamination, so quality risk management is essential. The document then discusses quality risk management and its uses, including determining the scope of audits, evaluating changes, and identifying critical process parameters. Finally, the document lists several quality management tools like check sheets, control charts, Pareto charts, and histograms that can be used in quality risk management.
This document provides information and sample documents for creating a quality management system that conforms to ISO/IEC 17025 standards for laboratories. It includes videos, ebooks, and articles on quality management. Sample documents and procedures are provided for a quality manual, code of ethics, document control, continual improvement, feedback, conflict of interest, internal audits, and job hazard assessment. Related sample forms are also included to support implementation of these quality management processes. The document outlines tools and approaches for laboratories to develop a quality management system that meets ISO/IEC 17025 requirements.
The document provides information about ISO 9001 quality management systems. It discusses the history and benefits of ISO 9001 certification, which has been adopted by over 1 million organizations worldwide. The document also outlines the key requirements of ISO 9001, including customer focus, leadership, and continual improvement. Finally, it describes several common quality management tools used in ISO 9001 systems, such as check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms.
This document discusses various ways that quality management can be measured. It provides five methods for measuring customer service quality: considering supply and demand trends, asking customers directly via surveys, tracking the number of customer complaints, identifying specific weaknesses, and assessing competitors' offerings. The document also outlines several quality management tools, including check sheets, control charts, Pareto charts, and scatter plots, and provides brief descriptions of how each tool is used.
This document discusses quality management system templates and provides related resources. It describes templates that can be used to develop policies, procedures, work instructions and other documents needed for a quality management system. The templates are in Microsoft Word format and are designed to help companies comply with standards like ISO 13485 for medical devices. The templates cover key areas like product development, production, monitoring, management review and continual improvement. The document also lists six common quality management tools - check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams and histograms.
The document discusses lean quality management systems. It provides an overview of tools and strategies for lean quality management including forms, check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms. It also discusses challenges that can arise when implementing lean initiatives within an existing quality management system and provides strategies for effective "lean compliance" through prioritizing quality procedures based on compliance, efficiency, and effectiveness.
This document provides an overview of pharmaceutical quality management. It discusses risk management in the pharmaceutical industry and the importance of a robust quality system. An effective quality system should focus on quality management, quality assurance, evaluation analysis, risk management, preventive action, and continuous improvement. It also describes the key subsystems of a modern pharmaceutical quality system: quality system, production system, facilities/equipment system, laboratory controls system, materials system, and packaging/labeling system. The document provides examples of quality management tools including check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, histograms, and others.
This document provides an overview of quality management systems and examples of tools and processes used for quality management. It discusses the key steps to building a quality management system, including defining processes, quality policy and objectives, defects, documentation, quality processes, training needs, performance measurement, and continuous improvement. Specific quality management tools described include check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, histograms, and additional related topics like quality management courses and standards.
This document discusses quality risk management process for aseptic processes. It begins by defining an aseptic process as the manipulation of sterile components in a controlled environment to produce a sterile product. Aseptic processes carry a high risk of contamination, so quality risk management is essential. The document then discusses quality risk management and its uses, including determining the scope of audits, evaluating changes, and identifying critical process parameters. Finally, the document lists several quality management tools like check sheets, control charts, Pareto charts, and histograms that can be used in quality risk management.
This document provides information and sample documents for creating a quality management system that conforms to ISO/IEC 17025 standards for laboratories. It includes videos, ebooks, and articles on quality management. Sample documents and procedures are provided for a quality manual, code of ethics, document control, continual improvement, feedback, conflict of interest, internal audits, and job hazard assessment. Related sample forms are also included to support implementation of these quality management processes. The document outlines tools and approaches for laboratories to develop a quality management system that meets ISO/IEC 17025 requirements.
The document provides information about ISO 9001 quality management systems. It discusses the history and benefits of ISO 9001 certification, which has been adopted by over 1 million organizations worldwide. The document also outlines the key requirements of ISO 9001, including customer focus, leadership, and continual improvement. Finally, it describes several common quality management tools used in ISO 9001 systems, such as check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms.
This document discusses various ways that quality management can be measured. It provides five methods for measuring customer service quality: considering supply and demand trends, asking customers directly via surveys, tracking the number of customer complaints, identifying specific weaknesses, and assessing competitors' offerings. The document also outlines several quality management tools, including check sheets, control charts, Pareto charts, and scatter plots, and provides brief descriptions of how each tool is used.
This document discusses quality management system templates and provides related resources. It describes templates that can be used to develop policies, procedures, work instructions and other documents needed for a quality management system. The templates are in Microsoft Word format and are designed to help companies comply with standards like ISO 13485 for medical devices. The templates cover key areas like product development, production, monitoring, management review and continual improvement. The document also lists six common quality management tools - check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams and histograms.
The document discusses lean quality management systems. It provides an overview of tools and strategies for lean quality management including forms, check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms. It also discusses challenges that can arise when implementing lean initiatives within an existing quality management system and provides strategies for effective "lean compliance" through prioritizing quality procedures based on compliance, efficiency, and effectiveness.
This document provides an overview of quality management service and related topics. It discusses common questions about quality management systems, how they provide structure for developing and improving processes, and why things like documenting processes and having an organization chart are important. It also outlines several common quality management tools like check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms. PDF downloads are available on additional quality management topics.
Quality Management and Statistical Process ControlMahmudul Hasan
This document discusses quality management concepts including the meaning of quality, quality assurance vs quality control, process control, and statistical process control. It defines quality as meeting customer expectations and fitness for use. Quality assurance focuses on implementing processes while quality control checks output. Process control monitors a process to ensure it behaves as expected. Statistical process control uses tools like control charts to reduce variability and identify sources of variation. The document reviews various quality measurement and process analysis tools.
This document discusses process of quality management. It provides an overview of 7 key steps in quality management: 1) identifying organizational goals, 2) identifying critical success factors, 3) identifying internal and external customers, 4) obtaining customer feedback, 5) implementing continuous improvements, 6) selecting quality management software, and 7) measuring results. It also describes several common quality management tools including check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, histograms, and others. Additional related topics on quality management are listed for further reading.
Quality management can be measured using various tools and techniques. Statistical process control charts track variations in a process and identify whether variations are due to common or special causes. Flowcharts visually map out processes to look for inefficiencies. Pareto charts identify the most common problems affecting 80% of issues. Balanced scorecards provide a holistic view of business performance across financial, customer, process, and learning/growth metrics. Employees also help identify quality issues through their direct interactions with customers.
This document provides an overview of quality management approaches and tools. It discusses Total Quality Management (TQM) which aims for customer satisfaction through continuous improvement and involving customers and employees. Six common quality management tools are then described in detail: check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms. These tools can be used to collect and analyze quality data to identify issues and improve processes. Links to additional quality management resources are also provided.
This document provides an overview of tools and resources for service quality management systems. It discusses common questions around implementing a quality management system and why documentation, processes and an organization chart are important. Key points of a quality management system include having a structured approach to developing and improving processes through deployment, control and continuous improvement. Common quality management tools are also outlined, including check sheets, control charts, Pareto charts, scatter plots and Ishikawa diagrams. Additional PDF resources on related quality management topics are listed.
This document provides information about quality management policy statements, including what they are, why companies use them, and what they typically include. A quality statement explains a company's quality management system, commitments, and approach to ensure high quality work. It is included in bids/tenders to convince buyers that the company can reliably deliver projects on time and to standard. A quality statement generally covers issues like project management approach, quality certifications, policies, staff qualifications, and experience on similar projects. Customizing the statement for each tender is important.
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.
This document provides information about and a template for a quality management system. It includes a 23 policy and procedure template that has been used successfully by training companies seeking accreditation. The template covers key areas like quality assurance, resource management, learning program development, and assessment. It is intended to help explicitly document quality processes that are often implicit. The template can be customized for a specific organization and accrediting body. Quality tools like check sheets, control charts, Pareto charts, scatter plots and histograms are also discussed.
This document provides information about quality management organizations and tools. It discusses Total Quality Management (TQM) which is a management philosophy that focuses on customer satisfaction through continuous process improvement. The document recommends implementing an integrated TQM and quality assurance/quality control approach and outlines specific steps for effective quality management including management commitment, training, use of tools like control charts, checklists and histograms.
This document discusses various quality management models including Total Quality Management. It provides details on several TQM models such as Deming Application Prize, Malcolm Baldrige Criteria for Performance Excellence, and ISO quality management standards. It also outlines six common quality management tools: check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms. The document is a reference for information on quality management models, tools, and strategies.
This document discusses various inventory control techniques used in pharmaceutical companies. It describes ABC analysis which divides inventory items into three categories based on their value and consumption. High-value items that consume most of the budget are category A and require strict control. Economic order quantity technique is used to determine optimal order quantities to minimize total costs. Perpetual inventory system continuously records receipts and issues to facilitate regular checking. Slow-moving and obsolete items are periodically reviewed. Input-output ratio analysis relates raw materials used to final outputs. Maintaining proper inventory control is important for smooth operations and maximum profitability.
This document discusses the benefits of quality management systems. It lists increased efficiency, revenue, employee morale, international recognition, fact-based decision making, supplier relationships, documentation, consistency, customer satisfaction, and improvement processes as benefits. It also provides examples of quality management tools including check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, histograms. Finally, it lists related topics to quality management systems.
This document provides an overview of operations management concepts related to forecasting, materials flow, production processes, and just-in-time systems. Specifically, it discusses forecasting methods and applications, defines materials flow and material flow management, describes different production systems including job shop, batch, and continuous production, and outlines the objectives, types of waste, tactics, and benefits of just-in-time systems.
This document discusses quality and risk management in a diagnostic imaging department. It provides details on the department's quality and risk management program, including key aspects like quality assessment and improvement committees. It also describes the quality management system implemented, focusing on continual quality improvement. Finally, it discusses some common quality management tools used, like check sheets, control charts, and Pareto charts.
This document discusses transforming supply chain management in healthcare to a value-based clinically integrated model. At the transformational level:
- Supply chain is viewed as patient-centric and products are judged on how they contribute to clinical and organizational goals.
- A multi-disciplinary medical economics team is formed with clinicians, supply chain, and finance to evaluate new technologies and standardize products based on efficacy, costs, and outcomes.
- Automation, data analysis, and physician engagement are needed to optimize contracts, reduce non-compliant spending, and minimize excess inventory which can lead to significant cost savings.
Statistical process control (SPC) is a method of quality control which uses statistical methods. SPC is applied in order to monitor and control a process. Monitoring and controlling the process ensures that it operates at its full potential. At its full potential, the process can make as much conforming product as possible with a minimum (if not an elimination) of waste (rework or scrap). SPC can be applied to any process where the "conforming product" (product meeting specifications) output can be measured. Key tools used in SPC include control charts; a focus on continuous improvement; and the design of experiments. An example of a process where SPC is applied is manufacturing lines.
Statistical Process Control Training Online - Tonex TrainingBryan Len
It’s all about key concepts behind SPC or statistical process control, a statistically-based family of tools used to monitor, control, and improve processes.
All the attendees of Tonex statistical process control training will learn about the details of SPC, control charting, other procedures and tools to apply them in their projects.
Learn about :
Statistical process control (SPC) terminology & key principals
Learn how SPC integrates into the total quality system
Variation in manufacturing processes such as patterns
Learn about data collection, control charts
Techniques and tools to implement statistical process control
Recognize the fundamentals of process sampling strategy
Differentiate methods and tools to implement and assess SPC
Select and use recommended SPC practices
Course designed for:
Production Engineers, quality managers,
Operators, project managers,
Product process control, analysts,
Quality process, improvement associates
Other people engaged with SPC process
Course Topics :
What is Statistical process control (SPC)?
Introduction to Process Variation
Control Charts
7-QC Tools & 7-SUPP Tools
The Relationship Between Statistical Quality Control and Statistical Process Control
Statistical process control (SPC) Workshop
Want to learn more ?
Visit tonex.com for statistical process control training detail.
Statistical Process Control Training Online - Tonex Training
https://www.tonex.com/training-courses/statistical-process-control-training-spc-training/
This document provides an introduction to statistical process control (SPC). It defines SPC as a strategy that uses statistical techniques to evaluate processes, identify variability, and find opportunities for improvement. The goal of SPC is to make high-quality products the first time by reducing variability, rather than reworking defective products. It focuses on monitoring process behavior rather than just final product quality. SPC distinguishes between common cause variability that is always present and special cause variability that can be addressed to improve the process. It emphasizes identifying and addressing special causes first before adjusting process means. Control charts are used to monitor processes and determine if they are in control or need adjustment.
This document discusses quality management manual templates and tools. It provides links to additional quality management resources and outlines what is included in the quality management manual template. The template contains 10 procedures, 26 forms and records, audit checklists, process maps and guidance. It also describes six common quality management tools: check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams and histograms. These tools can be used to collect and analyze quality data.
OHSAS 18001 provides a framework for an occupational health and safety management system (OH&S-MS) that is designed to be compatible with ISO 14001. It contains 17 elements that address establishing an OH&S policy, identifying hazards and risks, implementing controls, training employees, monitoring performance, investigating incidents, and conducting management reviews. The standard is designed to help organizations improve their health and safety performance and comply with applicable legal requirements through a systematic process of planning, implementing, reviewing and improving OH&S practices.
This document summarizes the key requirements of ISO 9001:2008 for quality management systems. It outlines the main sections including quality management system, management responsibility, resource management, product realization processes, and measurement, analysis and improvement. For each section, it lists the main requirements and considerations organizations must address to comply with the ISO 9001 standard.
This document provides an overview of quality management service and related topics. It discusses common questions about quality management systems, how they provide structure for developing and improving processes, and why things like documenting processes and having an organization chart are important. It also outlines several common quality management tools like check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms. PDF downloads are available on additional quality management topics.
Quality Management and Statistical Process ControlMahmudul Hasan
This document discusses quality management concepts including the meaning of quality, quality assurance vs quality control, process control, and statistical process control. It defines quality as meeting customer expectations and fitness for use. Quality assurance focuses on implementing processes while quality control checks output. Process control monitors a process to ensure it behaves as expected. Statistical process control uses tools like control charts to reduce variability and identify sources of variation. The document reviews various quality measurement and process analysis tools.
This document discusses process of quality management. It provides an overview of 7 key steps in quality management: 1) identifying organizational goals, 2) identifying critical success factors, 3) identifying internal and external customers, 4) obtaining customer feedback, 5) implementing continuous improvements, 6) selecting quality management software, and 7) measuring results. It also describes several common quality management tools including check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, histograms, and others. Additional related topics on quality management are listed for further reading.
Quality management can be measured using various tools and techniques. Statistical process control charts track variations in a process and identify whether variations are due to common or special causes. Flowcharts visually map out processes to look for inefficiencies. Pareto charts identify the most common problems affecting 80% of issues. Balanced scorecards provide a holistic view of business performance across financial, customer, process, and learning/growth metrics. Employees also help identify quality issues through their direct interactions with customers.
This document provides an overview of quality management approaches and tools. It discusses Total Quality Management (TQM) which aims for customer satisfaction through continuous improvement and involving customers and employees. Six common quality management tools are then described in detail: check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms. These tools can be used to collect and analyze quality data to identify issues and improve processes. Links to additional quality management resources are also provided.
This document provides an overview of tools and resources for service quality management systems. It discusses common questions around implementing a quality management system and why documentation, processes and an organization chart are important. Key points of a quality management system include having a structured approach to developing and improving processes through deployment, control and continuous improvement. Common quality management tools are also outlined, including check sheets, control charts, Pareto charts, scatter plots and Ishikawa diagrams. Additional PDF resources on related quality management topics are listed.
This document provides information about quality management policy statements, including what they are, why companies use them, and what they typically include. A quality statement explains a company's quality management system, commitments, and approach to ensure high quality work. It is included in bids/tenders to convince buyers that the company can reliably deliver projects on time and to standard. A quality statement generally covers issues like project management approach, quality certifications, policies, staff qualifications, and experience on similar projects. Customizing the statement for each tender is important.
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.
This document provides information about and a template for a quality management system. It includes a 23 policy and procedure template that has been used successfully by training companies seeking accreditation. The template covers key areas like quality assurance, resource management, learning program development, and assessment. It is intended to help explicitly document quality processes that are often implicit. The template can be customized for a specific organization and accrediting body. Quality tools like check sheets, control charts, Pareto charts, scatter plots and histograms are also discussed.
This document provides information about quality management organizations and tools. It discusses Total Quality Management (TQM) which is a management philosophy that focuses on customer satisfaction through continuous process improvement. The document recommends implementing an integrated TQM and quality assurance/quality control approach and outlines specific steps for effective quality management including management commitment, training, use of tools like control charts, checklists and histograms.
This document discusses various quality management models including Total Quality Management. It provides details on several TQM models such as Deming Application Prize, Malcolm Baldrige Criteria for Performance Excellence, and ISO quality management standards. It also outlines six common quality management tools: check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms. The document is a reference for information on quality management models, tools, and strategies.
This document discusses various inventory control techniques used in pharmaceutical companies. It describes ABC analysis which divides inventory items into three categories based on their value and consumption. High-value items that consume most of the budget are category A and require strict control. Economic order quantity technique is used to determine optimal order quantities to minimize total costs. Perpetual inventory system continuously records receipts and issues to facilitate regular checking. Slow-moving and obsolete items are periodically reviewed. Input-output ratio analysis relates raw materials used to final outputs. Maintaining proper inventory control is important for smooth operations and maximum profitability.
This document discusses the benefits of quality management systems. It lists increased efficiency, revenue, employee morale, international recognition, fact-based decision making, supplier relationships, documentation, consistency, customer satisfaction, and improvement processes as benefits. It also provides examples of quality management tools including check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, histograms. Finally, it lists related topics to quality management systems.
This document provides an overview of operations management concepts related to forecasting, materials flow, production processes, and just-in-time systems. Specifically, it discusses forecasting methods and applications, defines materials flow and material flow management, describes different production systems including job shop, batch, and continuous production, and outlines the objectives, types of waste, tactics, and benefits of just-in-time systems.
This document discusses quality and risk management in a diagnostic imaging department. It provides details on the department's quality and risk management program, including key aspects like quality assessment and improvement committees. It also describes the quality management system implemented, focusing on continual quality improvement. Finally, it discusses some common quality management tools used, like check sheets, control charts, and Pareto charts.
This document discusses transforming supply chain management in healthcare to a value-based clinically integrated model. At the transformational level:
- Supply chain is viewed as patient-centric and products are judged on how they contribute to clinical and organizational goals.
- A multi-disciplinary medical economics team is formed with clinicians, supply chain, and finance to evaluate new technologies and standardize products based on efficacy, costs, and outcomes.
- Automation, data analysis, and physician engagement are needed to optimize contracts, reduce non-compliant spending, and minimize excess inventory which can lead to significant cost savings.
Statistical process control (SPC) is a method of quality control which uses statistical methods. SPC is applied in order to monitor and control a process. Monitoring and controlling the process ensures that it operates at its full potential. At its full potential, the process can make as much conforming product as possible with a minimum (if not an elimination) of waste (rework or scrap). SPC can be applied to any process where the "conforming product" (product meeting specifications) output can be measured. Key tools used in SPC include control charts; a focus on continuous improvement; and the design of experiments. An example of a process where SPC is applied is manufacturing lines.
Statistical Process Control Training Online - Tonex TrainingBryan Len
It’s all about key concepts behind SPC or statistical process control, a statistically-based family of tools used to monitor, control, and improve processes.
All the attendees of Tonex statistical process control training will learn about the details of SPC, control charting, other procedures and tools to apply them in their projects.
Learn about :
Statistical process control (SPC) terminology & key principals
Learn how SPC integrates into the total quality system
Variation in manufacturing processes such as patterns
Learn about data collection, control charts
Techniques and tools to implement statistical process control
Recognize the fundamentals of process sampling strategy
Differentiate methods and tools to implement and assess SPC
Select and use recommended SPC practices
Course designed for:
Production Engineers, quality managers,
Operators, project managers,
Product process control, analysts,
Quality process, improvement associates
Other people engaged with SPC process
Course Topics :
What is Statistical process control (SPC)?
Introduction to Process Variation
Control Charts
7-QC Tools & 7-SUPP Tools
The Relationship Between Statistical Quality Control and Statistical Process Control
Statistical process control (SPC) Workshop
Want to learn more ?
Visit tonex.com for statistical process control training detail.
Statistical Process Control Training Online - Tonex Training
https://www.tonex.com/training-courses/statistical-process-control-training-spc-training/
This document provides an introduction to statistical process control (SPC). It defines SPC as a strategy that uses statistical techniques to evaluate processes, identify variability, and find opportunities for improvement. The goal of SPC is to make high-quality products the first time by reducing variability, rather than reworking defective products. It focuses on monitoring process behavior rather than just final product quality. SPC distinguishes between common cause variability that is always present and special cause variability that can be addressed to improve the process. It emphasizes identifying and addressing special causes first before adjusting process means. Control charts are used to monitor processes and determine if they are in control or need adjustment.
This document discusses quality management manual templates and tools. It provides links to additional quality management resources and outlines what is included in the quality management manual template. The template contains 10 procedures, 26 forms and records, audit checklists, process maps and guidance. It also describes six common quality management tools: check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams and histograms. These tools can be used to collect and analyze quality data.
OHSAS 18001 provides a framework for an occupational health and safety management system (OH&S-MS) that is designed to be compatible with ISO 14001. It contains 17 elements that address establishing an OH&S policy, identifying hazards and risks, implementing controls, training employees, monitoring performance, investigating incidents, and conducting management reviews. The standard is designed to help organizations improve their health and safety performance and comply with applicable legal requirements through a systematic process of planning, implementing, reviewing and improving OH&S practices.
This document summarizes the key requirements of ISO 9001:2008 for quality management systems. It outlines the main sections including quality management system, management responsibility, resource management, product realization processes, and measurement, analysis and improvement. For each section, it lists the main requirements and considerations organizations must address to comply with the ISO 9001 standard.
The document discusses ISO 9001, a quality management standard. It describes ISO 9001's requirements and benefits, including improved customer satisfaction, staff motivation, and continual improvement. A quality management system based on ISO 9001 provides a framework for organizations to monitor and improve performance. Certification involves an external audit to verify an organization's quality management system meets ISO 9001's requirements.
ISO 9001:2015 Overview: Revisions & Impact - Part 1DQS Inc.
This document provides an overview of changes to ISO 9001:2015 from previous versions. It outlines the structure of the new standard and notable changes including removal of the quality manual and management representative requirements. The presentation reviews sections 0.1 to 0.4 of the standard which provide context on the process approach, risk-based thinking, and plan-do-check-act cycle. It also outlines UL DQS's transition plan and training programs to help clients implement the new standard.
Iso 9001 2008 awareness training-slidesumar farooq
This document outlines an ISO 9001:2008 awareness training covering the following topics:
- An 8-hour training course structure including tutorials and discussions
- Understanding concepts of quality management systems and the historic evolution of quality
- Understanding the requirements of the ISO 9001:2008 quality management standard
- Explaining key terms like quality assurance, quality control, and quality management systems
- Discussing the eight quality management principles and how they relate to continual improvement
ISO 9001-2015 Revision Training PresentationDQS Inc.
ISO 9001 is a great tool that is used for managing an organization and implementing continuous improvement. More than one million organizations worldwide are certified to ISO 9001 in order to help ensure that good quality products and services are provided to customers.
Get an in-depth overview of the upcoming changes to ISO 9001:2015, including:
- Revision timing and roll out
- Details on structure change
- In-depth review of changes including risk assessment
- Transitioning from ISO 9001:2008 to ISO 9001:2015 timing and requirements
- and more.
The new ISO 9001:2015 committee draft is published and distributed. There are changes which affect organizations who applied this standard. As it is among most famous ISO standards, follow up the changes would be critical and it is time to consider changes which might affect organizations' management systems.
This document provides an overview of knowledge management. It defines data, information, and knowledge and describes explicit and tacit knowledge. It discusses the history of knowledge management from the 1970s to present. It also outlines several common knowledge management models and describes the typical stages in the knowledge management life cycle including information mapping, storage, retrieval, use, and auditing. Finally, it discusses some key terms used in knowledge management.
Quality management system in pharmaceutical industryselinasimpson2401
The document discusses quality management systems in the pharmaceutical industry. It provides an overview of the key components of an effective quality management system, including quality management, quality assurance, evaluation analysis, quality risk management tools, preventive action, and risk management. It describes how a quality management system should function as the central hub connecting six subsystems: quality system, production system, facilities and equipment system, laboratory controls system, materials system, and packaging and labeling system. The document also lists and provides brief descriptions of several common quality management tools used in pharmaceutical quality systems, such as check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms.
The document discusses the FDA quality management system and how MasterControl software can help companies achieve and maintain FDA compliance. It provides an overview of MasterControl's quality management system suite and how it allows companies to build customized quality management systems, ensure alignment with business operations, and facilitate adherence to FDA quality standards, cGMP, and ISO standards. The document also lists and briefly describes several quality management tools, including check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms.
This document discusses retail service quality management. It provides an overview of quality management tools that can be used for retail service quality management including check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms. It also discusses MetricStream quality management software solutions that can help retailers manage quality across their supply chains and operations. Key benefits of these solutions include standardizing processes, automating quality processes, providing visibility across operations, and facilitating risk management.
This document provides an overview of 10 quality management tools that can help setup a quality management strategy to improve quality and processes. It describes tools such as the Six Sigma management guide, Six Sigma template, total quality management guide, quality management presentation, quality manager job description, and equipment maintenance log. It also summarizes common quality management tools like check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms. Additional PDF downloads on related quality management topics are listed.
This document discusses quality management issues and provides resources on the topic. It begins by outlining common quality management issues organizations may face and provides questions to help assess an organization's quality management processes. It then discusses specific issues in more depth, including nurturing a quality culture, assessing metrics, integrating disparate quality systems, handling increasing data volumes, and closing the quality loop. The document also introduces several quality management tools, such as check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms. It concludes by listing additional quality management topics.
This document provides an overview of quality management systems definitions for different industries including pharmaceutical, medical device, and MasterControl's definition. It discusses key regulations like 21 CFR Part 211 that inform quality management system definitions. The document also lists several quality management tools including check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms. Finally, it provides additional related topics to quality management systems.
This document discusses different approaches to structuring quality management within an organization. It describes centralized, decentralized, and hybrid models. A centralized model places quality management under a corporate team, while a decentralized model gives business units more autonomy. A hybrid model balances centralized and decentralized approaches. The document also lists some common quality management tools, including check sheets, control charts, Pareto charts, and scatter plots.
This document provides an overview of effective quality management systems. It discusses the benefits of implementing an automated quality management system, such as saving time and improving profitability. It also compares building your own system versus buying a pre-existing system from companies like MasterControl. Finally, it outlines several quality management tools, including check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, histograms, and others. The document provides examples and definitions for how to use these various quality management tools.
This document provides an overview of quality management systems (QMS) and discusses some common questions that arise about implementing a QMS. It explains that a QMS provides a structured system for developing and improving processes through documentation, organization charts, and continuous improvement. Key benefits include optimized processes, consistency, reduced defects, and compliance. The document also summarizes several common quality management tools, including check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms.
This document discusses approaches to quality management, including three popular approaches: empowering teams, using Pareto charts, and following ISO quality procedures. It provides details on each approach, such as empowering employees and celebrating successes to create an environment focused on quality over costs or speed. Pareto charts can identify the most important problems contributing to 80% of defects. ISO procedures standardize processes to ensure consistency. The document recommends combining approaches to suit a company's needs and culture.
This document provides an overview of quality management including definitions, principles, and common tools. It defines total quality management as a customer-focused, systematically strategic approach to continual improvement that involves all employees. Common quality management tools are then described, including check sheets to collect data, control charts to monitor processes, Pareto charts to identify key factors, and scatter plots to illustrate correlations between variables. Various online resources for additional quality management information are also listed.
This document provides an overview of quality management including definitions, tools, and other related topics. It defines total quality management as involving all employees in continual improvement to meet customer needs. Key aspects include being customer-focused, using a strategic approach, fact-based decision making, and continual improvement. Common quality management tools are then described in detail, such as check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, histograms. Other related quality management topics are also listed for reference.
This document provides an overview of quality management systems and how to build one. It discusses 10 steps to build a quality management system, including defining processes, quality policy, objectives, defects, documents/records, quality processes, training needs, using the system, measuring performance, and taking action to improve. It also lists and describes several common quality management tools, such as check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms. Finally, it lists additional topics related to quality management systems.
This document provides an overview of quality management systems definitions for pharmaceutical and medical device industries. It discusses key FDA regulations like 21 CFR Part 211 and guidance documents that inform quality management systems definitions. These definitions generally cover establishing a quality control unit and documenting quality processes around areas like document control, training, auditing, corrective actions and risk management. The document also lists several quality management tools commonly used, such as check sheets, control charts, Pareto charts, scatter plots and Ishikawa diagrams.
This document discusses quality management and provides resources on the topic. It introduces total quality management as involving all employees in continual improvement to meet customer needs. It also lists and describes six common quality management tools: check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms. Additional quality management topics and materials are referenced.
The document discusses product quality management systems. It provides an overview of quality management tools and strategies that can be used, including check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, histograms, and more. It also discusses quality management challenges and solutions for different consumer product industries like food and beverage, personal care, tobacco, and how an enterprise quality management software system can help automate processes and ensure compliance.
This document discusses the benefits of implementing a quality management system that is compliant with ISO 9001 standards. It lists several key benefits, including increased efficiency, revenue, and employee morale through more structured and consistent processes. Other benefits mentioned are achieving international recognition, more factual decision making, improved supplier relationships, effective documentation, and consistency across all company processes. The document also provides information on common quality management tools like check sheets, control charts, Pareto charts, and scatter plots that can be used as part of a quality management system.
The document discusses definitions and components of quality management systems according to various standards and regulations. It provides definitions for quality management systems in the pharmaceutical and medical device industries according to FDA regulations and ISO standards. It also summarizes MasterControl's quality management system definition and lists common quality management tools including check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms. Finally, it lists additional topics related to ISO quality management system definitions.
This document discusses the advantages of implementing a quality management system (QMS) such as ISO 9001. It lists several key advantages in 3 points:
1) Achieving international recognition and consistency of processes within the organization.
2) Boosting employee morale and ensuring customer satisfaction through consistent and efficient processes.
3) Improving processes based on documented facts and ensuring a factual approach to decision making with well-structured documentation.
This document discusses the importance of quality management for organizations. It explains that quality management ensures high quality products and services by eliminating defects and incorporating continuous improvements. This leads to increased customer satisfaction and loyalty, as well as higher revenues and productivity for the organization. The document also provides an overview of several common quality management tools, including check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, histograms, and others. It emphasizes that quality management is essential for businesses to deliver superior products and exceed customer expectations.
Similar to Pharmaceutical quality management system (20)
The document discusses quality management system audit checklists. It provides examples of advantages and disadvantages of using audit checklists. Some key advantages are that checklists promote planning, ensure consistency, and act as memory aids. Some disadvantages are that checklists can be seen as intimidating and focus too narrowly. The document also describes several quality management tools, including check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms. It provides examples of how each tool is used.
The document discusses information about a quality management office, including forms, tools, and strategies for quality management. It provides links to additional quality management resources and discusses the goals and roles of a quality management office, including organizing quality assurance, training engineers, conducting testing at all stages of product development, and advising customers. Quality management tools discussed include check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms. Other related quality management topics are also listed.
The document discusses quality management in the imaging sciences. It provides information on quality management forms, tools, and strategies. It also lists additional resources on quality management including free eBooks, forms, templates, key performance indicators, job descriptions, and interview questions. The document then discusses the contents of a book on quality management in the imaging sciences, which covers quality management procedures and evaluation forms for various imaging modalities. It also lists features of the book like learning objectives, regulations, practice exams, and online resources. Finally, the document describes several quality management tools: check sheets, control charts, Pareto charts, scatter plots, and Ishikawa diagrams.
This document provides an overview of quality management tools and concepts. It discusses six common quality management tools: check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms. It also discusses key quality management concepts like quality management, quality assurance, quality control, and good laboratory practice (GLP). The document is intended to help improve quality performance in a laboratory setting.
Post graduate diploma in food safety and quality managementselinasimpson1701
This document provides information about a post graduate diploma in food safety and quality management. It discusses the job duties and requirements to become a food safety and quality manager. Common requirements from job postings include a bachelor's degree in food science, 2+ years of experience in food manufacturing, HACCP certification, and strong communication and problem solving skills. The document also outlines the step-by-step process to become a manager, including gaining relevant work experience through internships and becoming familiar with food safety regulations and guidelines like HACCP. Finally, it discusses various quality management tools used in food safety like check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, histograms, and more.
This document discusses objectives of quality management. It provides an overview of quality management objectives, tools, and strategies. Specifically, it outlines 10 objectives of quality management including understanding customer needs, promoting leadership and teamwork, training people, efficient resource use, continuous improvement, accurate information, supplier relationships, and compliance. It then describes 6 common quality management tools - check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms. The tools help identify sources of variation and determine if processes are in statistical control.
The document provides information about management quality systems including definitions of common quality management tools such as check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms. It also lists certification requirements and grades for quality management system auditors as well as additional online resources related to quality management systems, courses, tools, standards, and strategies. The management quality system focuses on regularly assessing performance through competent auditing to ensure maximum effectiveness.
This document provides an overview of global quality management. It discusses key responsibilities of a Global Quality Management System Manager including ensuring compliance with quality standards like ISO 9001, managing quality projects, maintaining documentation, and performing audits. Several quality management tools are also outlined such as check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, histograms. Links to additional quality management resources are provided.
This document discusses Philip Crosby's 14 steps for quality management. It provides details on each of the 14 steps, including establishing management commitment to quality, creating quality teams, measuring processes, calculating quality costs, raising quality awareness, taking corrective actions, monitoring progress, training supervisors, holding zero defects days, encouraging quality goals, encouraging employee communication, recognizing participation efforts, creating quality councils, and continuously improving. It also discusses Crosby's definitions of quality and characteristics of successful organizations. Finally, it provides information on several quality management tools including check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, histograms.
This document discusses clinical quality management. It provides an overview of common tools used in clinical quality management like check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, histograms. It also discusses challenges in clinical quality management like multiple measures for the same condition across different quality initiatives and periodically changing measure definitions. Additional resources on clinical quality management topics are provided.
This document provides information about certified quality management systems including definitions, benefits, and common tools. It defines an ISO 9001 quality management system as a systematic, process-driven approach to managing a business to meet customer needs and deliver consistent quality. Benefits listed include increased profits, customer satisfaction, and staff motivation. Five common quality management tools are then described - check sheets, control charts, Pareto charts, scatter plots, and Ishikawa diagrams. Each tool is defined and its purpose explained.
This document provides an overview of business quality management including definitions, strategies, and tools. It discusses the Business Quality Management program which teaches skills for implementing organizational change and quality improvement. Several common quality management tools are defined, including check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms. These tools can be used to collect and analyze quality data to improve processes. Additional related topics like quality management systems and standards are also listed.
1. Pharmaceutical quality management system
In this file, you can ref useful information about pharmaceutical quality management system
such as pharmaceutical quality management systemforms, tools for pharmaceutical quality
management system, pharmaceutical quality management systemstrategies … If you need more
assistant for pharmaceutical quality management system, please leave your comment at the end
of file.
Other useful material for pharmaceutical quality management system:
• qualitymanagement123.com/23-free-ebooks-for-quality-management
• qualitymanagement123.com/185-free-quality-management-forms
• qualitymanagement123.com/free-98-ISO-9001-templates-and-forms
• qualitymanagement123.com/top-84-quality-management-KPIs
• qualitymanagement123.com/top-18-quality-management-job-descriptions
• qualitymanagement123.com/86-quality-management-interview-questions-and-answers
I. Contents of pharmaceutical quality management system
==================
Risk taking is an important part of any business endeavor. Entrepreneurs and investors take risks
every time they fund a start-up. Business executives take risks every day as they make decisions
about which products, services, ideas and people to advance within an organization. Risk taking
can be enormously profitable. But in the pharmaceutical industry, excessive risk taking can have
devastating results; product delays, recalls, and enforcement actions by the Food and Drug
Administration (FDA) have led to the demise of many small- to mid-size pharmaceutical
manufacturers. Most importantly, consumer safety can be compromised by excessive risk taking.
In the pharmaceutical industry, risk must be tempered by caution. And the mechanism for
tempering risk is a robust pharmaceutical quality system based on the latest FDA guidance.
Quality cannot be an afterthought. Implementing an effective quality system involves up-front
costs. An effective quality system should be in place at the earliest stages of product research and
development. While the pursuit of quality can be a costly line item on a financial statement or
business plan, failure to implement an effective quality system can have even more costly effects
on the bottom line.
Based on the latest guidance from the FDA, an effective pharmaceutical quality system should
help ensure compliance with cGMPs by focusing on:
Quality management
Quality assurance
Evaluation analysis and quality risk management tools
2. Preventive action
Risk management
Continuous improvement
This latest guidance does not replace previous FDA regulations, which require every
pharmaceutical quality system to include Standard Operating Practices (SOPs), adequate
personnel and training systems, and an adequate system for recordkeeping. The new guidance is
simply aimed at addressing advances in manufacturing technologies, quality systems and risk
management approaches that have been developed since 1978. The latest guidance is also aimed
at harmonizing the cGMPs with other widely used quality management systems, including the
FDA’s own medical device quality system regulations. Developing a modern, quality system
approach can provide the necessary framework for implementing continuous improvement and
risk management efforts in the drug manufacturing process.
While a culture of quality should permeate the entire organization, management plays a very
important role in the successful functioning, design, implementation and management of a
modern quality system. Not only should management align the quality system plan with the
company’s strategic plan, it must demonstrate strong support for quality systems. It’s essential
for senior leaders of pharmaceutical manufacturers to encourage internal communication about
quality issues and support the production, quality and manufacturing activities needed to produce
quality products.
But what does a modern pharmaceutical quality system look like? Imagine the hub and spokes of
a wheel. The quality system itself is at the center (the hub), but it is connected to five other
manufacturing systems (the spokes). When you include the quality system as a subsystem at the
center of it all, the six subsystems of a modern pharmaceutical quality system are the:
Quality System
Production System
Facilities and Equipment System
Laboratory Controls System
Materials System
Packaging and Labeling System
The quality subsystem at the center provides the foundation for the five manufacturing
subsystems and helps them achieve compliance. Each subsystem has an impact on the others and
they all have to work together to consistently produce a quality product. But it’s important to
understand that none of the individual subsystems equate to a functional group in an organization
or manufacturing facility. For example, the Materials System does not simply apply to
warehouse personnel. This subsystem includes the warehouse personnel who receive, store and
3. handle components and raw materials and distribute final products, but it also includes the
purchasers who buy components from qualified vendors, the manufacturing workers who request
and receive components and transfer final products to the warehouse, the quality assurance
specialists responsible for component and lot release, and the quality control employees who
sample and test components and products.
In the coming months we will take a closer look at each of these subsystems in the hopes it will
help you develop and maintain a strong overall quality system in your organization. In the end,
firms with strong quality systems will be more likely to meet and exceed cGMPs while also
enjoying many other advantages, including improved product and process understanding for
better decision making; continuous improvement; the ability to manage change to prevent
unintended consequences; minimized product variability; enhanced test method accuracy;
reduced costs due to fewer investigations, deviations and rejections; minimized product loss and
costs associated with scrap, disposal, rework and recalls; reduced downtime with more reliable
equipment and fewer repair interruptions; and decreased labor costs associated with automation
of manufacturing processes.
==================
III. Quality management tools
1. Check sheet
The check sheet is a form (document) used to collect data
in real time at the location where the data is generated.
The data it captures can be quantitative or qualitative.
When the information is quantitative, the check sheet is
sometimes called a tally sheet.
The defining characteristic of a check sheet is that data
are recorded by making marks ("checks") on it. A typical
check sheet is divided into regions, and marks made in
different regions have different significance. Data are
read by observing the location and number of marks on
the sheet.
Check sheets typically employ a heading that answers the
Five Ws:
Who filled out the check sheet
What was collected (what each check represents,
an identifying batch or lot number)
4. Where the collection took place (facility, room,
apparatus)
When the collection took place (hour, shift, day
of the week)
Why the data were collected
2. Control chart
Control charts, also known as Shewhart charts
(after Walter A. Shewhart) or process-behavior
charts, in statistical process control are tools used
to determine if a manufacturing or business
process is in a state of statistical control.
If analysis of the control chart indicates that the
process is currently under control (i.e., is stable,
with variation only coming from sources common
to the process), then no corrections or changes to
process control parameters are needed or desired.
In addition, data from the process can be used to
predict the future performance of the process. If
the chart indicates that the monitored process is
not in control, analysis of the chart can help
determine the sources of variation, as this will
result in degraded process performance.[1] A
process that is stable but operating outside of
desired (specification) limits (e.g., scrap rates
may be in statistical control but above desired
limits) needs to be improved through a deliberate
effort to understand the causes of current
performance and fundamentally improve the
process.
The control chart is one of the seven basic tools of
quality control.[3] Typically control charts are
used for time-series data, though they can be used
for data that have logical comparability (i.e. you
want to compare samples that were taken all at
the same time, or the performance of different
individuals), however the type of chart used to do
this requires consideration.
5. 3. Pareto chart
A Pareto chart, named after Vilfredo Pareto, is a type
of chart that contains both bars and a line graph, where
individual values are represented in descending order
by bars, and the cumulative total is represented by the
line.
The left vertical axis is the frequency of occurrence,
but it can alternatively represent cost or another
important unit of measure. The right vertical axis is
the cumulative percentage of the total number of
occurrences, total cost, or total of the particular unit of
measure. Because the reasons are in decreasing order,
the cumulative function is a concave function. To take
the example above, in order to lower the amount of
late arrivals by 78%, it is sufficient to solve the first
three issues.
The purpose of the Pareto chart is to highlight the
most important among a (typically large) set of
factors. In quality control, it often represents the most
common sources of defects, the highest occurring type
of defect, or the most frequent reasons for customer
complaints, and so on. Wilkinson (2006) devised an
algorithm for producing statistically based acceptance
limits (similar to confidence intervals) for each bar in
the Pareto chart.
4. Scatter plot Method
6. A scatter plot, scatterplot, or scattergraph is a type of
mathematical diagram using Cartesian coordinates to
display values for two variables for a set of data.
The data is displayed as a collection of points, each
having the value of one variable determining the position
on the horizontal axis and the value of the other variable
determining the position on the vertical axis.[2] This kind
of plot is also called a scatter chart, scattergram, scatter
diagram,[3] or scatter graph.
A scatter plot is used when a variable exists that is under
the control of the experimenter. If a parameter exists that
is systematically incremented and/or decremented by the
other, it is called the control parameter or independent
variable and is customarily plotted along the horizontal
axis. The measured or dependent variable is customarily
plotted along the vertical axis. If no dependent variable
exists, either type of variable can be plotted on either axis
and a scatter plot will illustrate only the degree of
correlation (not causation) between two variables.
A scatter plot can suggest various kinds of correlations
between variables with a certain confidence interval. For
example, weight and height, weight would be on x axis
and height would be on the y axis. Correlations may be
positive (rising), negative (falling), or null (uncorrelated).
If the pattern of dots slopes from lower left to upper right,
it suggests a positive correlation between the variables
being studied. If the pattern of dots slopes from upper left
to lower right, it suggests a negative correlation. A line of
best fit (alternatively called 'trendline') can be drawn in
order to study the correlation between the variables. An
equation for the correlation between the variables can be
determined by established best-fit procedures. For a linear
correlation, the best-fit procedure is known as linear
regression and is guaranteed to generate a correct solution
in a finite time. No universal best-fit procedure is
guaranteed to generate a correct solution for arbitrary
relationships. A scatter plot is also very useful when we
wish to see how two comparable data sets agree with each
other. In this case, an identity line, i.e., a y=x line, or an
1:1 line, is often drawn as a reference. The more the two
data sets agree, the more the scatters tend to concentrate in
the vicinity of the identity line; if the two data sets are
numerically identical, the scatters fall on the identity line
7. exactly.
5.Ishikawa diagram
Ishikawa diagrams (also called fishbone diagrams,
herringbone diagrams, cause-and-effect diagrams, or
Fishikawa) are causal diagrams created by Kaoru
Ishikawa (1968) that show the causes of a specific
event.[1][2] Common uses of the Ishikawa diagram are
product design and quality defect prevention, to identify
potential factors causing an overall effect. Each cause or
reason for imperfection is a source of variation. Causes
are usually grouped into major categories to identify these
sources of variation. The categories typically include
People: Anyone involved with the process
Methods: How the process is performed and the
specific requirements for doing it, such as policies,
procedures, rules, regulations and laws
Machines: Any equipment, computers, tools, etc.
required to accomplish the job
Materials: Raw materials, parts, pens, paper, etc.
used to produce the final product
Measurements: Data generated from the process
that are used to evaluate its quality
Environment: The conditions, such as location,
time, temperature, and culture in which the process
operates
6. Histogram method
8. A histogram is a graphical representation of the
distribution of data. It is an estimate of the probability
distribution of a continuous variable (quantitative
variable) and was first introduced by Karl Pearson.[1] To
construct a histogram, the first step is to "bin" the range of
values -- that is, divide the entire range of values into a
series of small intervals -- and then count how many
values fall into each interval. A rectangle is drawn with
height proportional to the count and width equal to the bin
size, so that rectangles abut each other. A histogram may
also be normalized displaying relative frequencies. It then
shows the proportion of cases that fall into each of several
categories, with the sum of the heights equaling 1. The
bins are usually specified as consecutive, non-overlapping
intervals of a variable. The bins (intervals) must be
adjacent, and usually equal size.[2] The rectangles of a
histogram are drawn so that they touch each other to
indicate that the original variable is continuous.[3]
III. Other topics related to Pharmaceutical quality management system (pdf
download)
quality management systems
quality management courses
quality management tools
iso 9001 quality management system
quality management process
quality management system example
quality system management
quality management techniques
quality management standards
quality management policy
quality management strategy
quality management books