This document summarizes a presentation on quality culture given at the 2012 CGMP Conference in Baltimore. The presentation discusses the importance of quality culture in protecting patient safety and product quality across complex pharmaceutical supply chains. It defines quality culture as an environment where everyone understands and embraces their responsibility for quality. Strong quality culture is identified as the most important indicator of an organization's ability to consistently deliver high quality products and services.
The document discusses building a quality culture in the pharmaceutical industry. It outlines six dimensions of cultural excellence: building capability, corporate culture, business continuity planning, robust quality systems, quality metrics, and communication. Implementing these dimensions can lead to a proactive quality culture and continual improvement. A strong quality culture is evidenced by consistently doing the right things even when no one is watching.
Culture is an integral part of an organization and Quality is one of the key focus of current business environment.Thus creating a need of changing existing traditional culture in to a quality culture.
This document provides an overview of ISO 9001:2015 for quality management systems. It discusses the seven quality management principles and the ten clauses of the ISO standard. The principles are customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management. The ten clauses cover the scope, leadership, planning, support, operation, performance evaluation, and improvement aspects of an effective quality management system. The document provides explanations of the key elements within each clause.
Culture of quality workshop - Qualsys Training WorkshopQualsys Ltd
Establish and nurture a culture of quality within your organisation with this quality culture training.
More tools and resources at https://quality.eqms.co.uk/culture-of-quality-toolkit
The slides contain:
- How to sustain a culture of quality
- Culture of quality and continuous improvement
- Culture of quality vision statement
Culture of Quality Can Accelerate Growth and Performance in the EnterpriseASQ
This document summarizes the findings of a global study on developing a culture of quality in enterprises. Some key findings include that 59% of respondents said their organization exhibits a quality culture, but only 5% of quality professionals rated their programs as world-class. The study identified several essentials for a quality culture, including a clearly stated vision and values supported by leadership. It also found that defining and meeting customer needs is important but challenging for quality programs to adapt globally. Most organizations plan to increase investment in quality programs to enhance their culture of quality.
Embedding a culture of quality: ISO 9001:2015 FocusQualsys Ltd
What does an organisation with a mature culture of quality look like? In this ppt presentation, Richard Green, Former Head of Technical Services at CQI, explains what a culture of quality looks like, the essential building blocks and how to achieve this.
More information can be found: http://quality.eqms.co.uk/blog/6-critical-building-blocks-of-a-quality-culture
Developing a quality culture presentation [autosaved]Yomna Motea
The document discusses techniques for creating a quality culture within an organization. It recommends providing quality goals and measurements at all levels, demonstrating leadership commitment to quality from upper management, empowering employees through self-development opportunities, inspiring action through employee participation, and recognizing and rewarding quality performance. The overall goal is to continuously reinforce the priority of quality throughout the organization.
The document discusses building a quality culture in the pharmaceutical industry. It outlines six dimensions of cultural excellence: building capability, corporate culture, business continuity planning, robust quality systems, quality metrics, and communication. Implementing these dimensions can lead to a proactive quality culture and continual improvement. A strong quality culture is evidenced by consistently doing the right things even when no one is watching.
Culture is an integral part of an organization and Quality is one of the key focus of current business environment.Thus creating a need of changing existing traditional culture in to a quality culture.
This document provides an overview of ISO 9001:2015 for quality management systems. It discusses the seven quality management principles and the ten clauses of the ISO standard. The principles are customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management. The ten clauses cover the scope, leadership, planning, support, operation, performance evaluation, and improvement aspects of an effective quality management system. The document provides explanations of the key elements within each clause.
Culture of quality workshop - Qualsys Training WorkshopQualsys Ltd
Establish and nurture a culture of quality within your organisation with this quality culture training.
More tools and resources at https://quality.eqms.co.uk/culture-of-quality-toolkit
The slides contain:
- How to sustain a culture of quality
- Culture of quality and continuous improvement
- Culture of quality vision statement
Culture of Quality Can Accelerate Growth and Performance in the EnterpriseASQ
This document summarizes the findings of a global study on developing a culture of quality in enterprises. Some key findings include that 59% of respondents said their organization exhibits a quality culture, but only 5% of quality professionals rated their programs as world-class. The study identified several essentials for a quality culture, including a clearly stated vision and values supported by leadership. It also found that defining and meeting customer needs is important but challenging for quality programs to adapt globally. Most organizations plan to increase investment in quality programs to enhance their culture of quality.
Embedding a culture of quality: ISO 9001:2015 FocusQualsys Ltd
What does an organisation with a mature culture of quality look like? In this ppt presentation, Richard Green, Former Head of Technical Services at CQI, explains what a culture of quality looks like, the essential building blocks and how to achieve this.
More information can be found: http://quality.eqms.co.uk/blog/6-critical-building-blocks-of-a-quality-culture
Developing a quality culture presentation [autosaved]Yomna Motea
The document discusses techniques for creating a quality culture within an organization. It recommends providing quality goals and measurements at all levels, demonstrating leadership commitment to quality from upper management, empowering employees through self-development opportunities, inspiring action through employee participation, and recognizing and rewarding quality performance. The overall goal is to continuously reinforce the priority of quality throughout the organization.
1) Quality culture refers to the shared beliefs, attitudes, and behaviors that characterize an organization regarding quality. It involves both technical and social systems within the organization.
2) Developing a quality culture requires motivating employees through addressing needs like safety, belonging, and self-actualization. It also means empowering employees and having leadership committed to quality goals.
3) Maintaining awareness of quality involves planning communication strategies, implementing programs, reviewing success, and sustaining momentum over time including with new employees.
How to change Quality Culture in an organization.By.Dr.Mahboob ali khan Phd Healthcare consultant
Start the change process with people who have disproportionate influence in the organization. Look for ways to get people to experience the harsh realities that makechange necessary. Look for ways to redistribute resources toward “hot spots” – activities that require few resources but result in large change.
This Slideshare presentation is a partial preview of the full business document. To view and download the full document, please go here:
http://flevy.com/browse/business-document/total-quality-process-tqp-349
Many quality improvement programs fail because they were not managed as a total process. Total Quality Process (TQP) teaches you how to approach quality or any change initiative as a company-wide effort. You will learn how to make a commitment, plan and begin to implement systems for managing quality that integrates all the people, processes/systems and continuous improvement initiatives together.
Based on Philip Crosby's methodology, what this presentation guide will focus is not a new quality control system, but a company-wide approach to total quality. A process for total quality must comprise Quality Management and Quality Improvement. The Total Quality Process (TQP) introduced in this presentation is based on Five Quality Principles and establishes Four Key Activities for Quality Management. TQP is designed to involve every employee in your company in quality improvement efforts.
NO. OF SLIDES = 83
LEARNING OBJECTIVES
1. Explain the Principles of Quality
2. Describe the TQP framework ("House of Quality")
3. Define the Four Key Activities for managing quality
4. Explain the need for a culture change, starting at the top
5. Demonstrate a personal commitment to total quality
6. Explain the TQP implementation infrastructure
7. Describe how to put the systems for TQP into motion
8. Identify ways to sustain TQP activities
9. Understand a manager's role in quality improvement
This presentation was given by Jack Moran from the Public Health Foundation at the 2011 NPHPSP Annual Training on Assessing and Building a Culture of Quality Improvement in Your Agency
Building Quality Culture in Agile Software Development discusses how to build a quality culture in agile transformations. It outlines how organizational culture and leadership influence quality and how agile transformations impact processes, teams, and governance. The document recommends strategic initiatives to transform culture such as establishing a quality vision, clear communication, process improvements, empowering teams, continuous delivery, quality analytics, and training. The key takeaways are that building quality culture requires leadership, communication, empowering people, process improvements, technology enablement, and analytics.
This document introduces seven quality management principles (QMPs) that ISO 9000, ISO 9001, and related standards are based on. The seven QMPs are customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management. For each principle, the document provides a statement, rationale, key benefits, and examples of actions organizations can take to apply each principle.
This document introduces the seven quality management principles (QMPs) that ISO 9000, ISO 9001, and related quality management standards are based upon. The seven QMPs are customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management. For each principle, the document provides a statement, rationale, key benefits, and examples of actions organizations can take to apply that principle.
This document provides an overview of ISO 9001 and quality management systems. It discusses ISO 9001 as a standard that sets requirements for quality management systems to help organizations continually monitor and improve quality, meet customer requirements, and enhance profitability. It describes why companies achieve ISO 9001 certification, how the standard can be utilized, key quality management principles, and the benefits of adopting practices like customer focus, leadership, employee engagement, a process approach, and continual improvement.
The document discusses the seven principles of quality management: customer focus, leadership, people engagement, process approach, continual improvement, decision making, and relationship management. It explains that quality management aims to meet and exceed customer requirements through an interrelated process that empowers people, analyzes data, and manages relationships to continually improve performance and satisfy customers. Effective use of these principles can help organizations enhance their capabilities and achieve quality objectives.
This document provides an overview of ISO standards and quality management systems. It discusses that ISO develops international standards to ensure products and services are safe, reliable and of good quality. The main ISO standards discussed are ISO 9000 for quality management systems and ISO 9001 which defines the requirements for a quality assurance system. It also summarizes the seven quality management principles of ISO 9000 which are customer focus, leadership, engagement, process approach, improvement, evidence-based decisions and relationship management. The benefits of establishing a quality management system and adhering to these principles are also highlighted.
roducing quality work (the first time) means quality is built into the processes for producing products or providing services, and continual improvement measures are taken to ensure the processes work every time. Employees are empowered to make decisions to improve a process and are provided with continual training to develop their skills.
Scott A. Slonaker is a supply chain manager with over 18 years of experience in inventory management, distribution, warehousing, logistics, and operations management. He most recently worked as the manager of a waste management facility in Canton, OH where he improved safety practices and efficiency rates. Prior to that, he worked as the distribution/warehouse/transportation manager for a food grade and non-food grade distribution center, and as a global supply chain manager for the US Air Force.
This document discusses quality management. It defines quality as exceeding customer expectations and doing what a product or service is intended to do. The main components of quality management are planning, control, assurance, and improvement. Key principles of quality management include understanding customer needs, meeting requirements, striving to exceed expectations, and having a system approach focused on continual improvement and factual decision making. Quality in organizations aims to achieve long term success through customer satisfaction and benefits for all members of the organization and society.
The document outlines 7 management principles: 1) Customer Focus, 2) Leadership, 3) Engagement of People, 4) Process Approach, 5) Improvement, 6) Evidence-Based Decision Making, and 7) Relationship Management. For each principle, it provides a definition, some key benefits, and possible actions organizations can take to implement that principle. It also includes an introduction about the author's background and qualifications.
Quality Management Principles Become CEO Management Practices!Phi Jack
The document discusses the eight quality management principles (QMP) outlined in ISO standards: customer focus, leadership, involvement of people, process approach, systematic approach to management, continual improvement, factual approach to decision-making, and mutually beneficial supplier relationships. It provides details on how each principle can be applied and benefits organizations by improving performance, productivity, efficiency and customer satisfaction. Implementing the eight principles requires leadership, vision, communication and planning to establish them as a management system.
Leadership has been defined by various authors in varied ways. Such as,
Leadership has been described as the “process of social influence in which one person can enlist the aid and support of others in the accomplishment of a common task”.[Chemers MM 2002]
This document provides an overview of several quality management principles and methodologies, including:
- Lean manufacturing, which aims to eliminate waste and improve efficiency. Key aspects are flow, value streams, and eliminating muda (waste).
- The seven types of waste in lean manufacturing: overproduction, queues, transportation, inventory, motion, overprocessing, and defects.
- Just-in-time manufacturing, which supplies customers with exactly what they want when they want it by pulling supplies through the system as needed.
- Six Sigma, which identifies and removes defects from processes to improve quality using a DMAIC methodology of define, measure, analyze, improve, and control.
- Total quality management, which takes
This document summarizes a full day workshop on quality culture for success. It discusses the importance of quality culture in ensuring product quality and safety. Quality culture is defined as an environment where everyone understands the importance of product quality and patient safety. It is the single most important indicator for delivering quality drugs. However, quality culture does not happen by accident - it must be intentionally created through relevant processes, controls, and behaviors that are understood and followed. The document provides examples of how quality culture can be measured and discusses the criticality of quality culture and how to maintain it despite pressures to reduce costs. It outlines potential symptoms and actions if an organization lacks a strong quality culture.
IGPA Building a Culture of Quality Ajaz Hussain_5 Sept 2015_Rferences minAjaz Hussain
Improving Confidence in Quality of Medicines . We make two products – medicine and evidence (documents) but many forget this and do not pay attention to documentation.
Level of attention to documentation is a “canary in a coal mine”
Breaches are irrational –”System 1 thinking” and cognitive biases.
Culture of Quality is familiar to all of us – a framework proposed
Quality Metrics – great idea – very much needed; but we are not yet ready for an FDA Guidance.
We must first address our collective blind spots; be confident that process validation truly ensures complexity is sufficiently reduced and that outcomes are predictable.
1. The document discusses the importance of creating and maintaining a culture of quality in pharmaceutical manufacturing. It outlines several key aspects of a quality culture, including a focus on continuous improvement, willingness to identify and address issues, and an understanding that quality is everyone's responsibility.
2. Maintaining a quality culture requires leadership commitment to reinforce the right behaviors and decision making. Quality culture can deteriorate quickly if management loses focus on it or faces pressures like cost reductions. Early indicators of issues need to be addressed immediately.
3. The document provides examples of metrics that can help measure quality culture, such as the number of reported deviations, complaints, and process failures. A strong quality culture helps ensure product quality is not compromised
1) Quality culture refers to the shared beliefs, attitudes, and behaviors that characterize an organization regarding quality. It involves both technical and social systems within the organization.
2) Developing a quality culture requires motivating employees through addressing needs like safety, belonging, and self-actualization. It also means empowering employees and having leadership committed to quality goals.
3) Maintaining awareness of quality involves planning communication strategies, implementing programs, reviewing success, and sustaining momentum over time including with new employees.
How to change Quality Culture in an organization.By.Dr.Mahboob ali khan Phd Healthcare consultant
Start the change process with people who have disproportionate influence in the organization. Look for ways to get people to experience the harsh realities that makechange necessary. Look for ways to redistribute resources toward “hot spots” – activities that require few resources but result in large change.
This Slideshare presentation is a partial preview of the full business document. To view and download the full document, please go here:
http://flevy.com/browse/business-document/total-quality-process-tqp-349
Many quality improvement programs fail because they were not managed as a total process. Total Quality Process (TQP) teaches you how to approach quality or any change initiative as a company-wide effort. You will learn how to make a commitment, plan and begin to implement systems for managing quality that integrates all the people, processes/systems and continuous improvement initiatives together.
Based on Philip Crosby's methodology, what this presentation guide will focus is not a new quality control system, but a company-wide approach to total quality. A process for total quality must comprise Quality Management and Quality Improvement. The Total Quality Process (TQP) introduced in this presentation is based on Five Quality Principles and establishes Four Key Activities for Quality Management. TQP is designed to involve every employee in your company in quality improvement efforts.
NO. OF SLIDES = 83
LEARNING OBJECTIVES
1. Explain the Principles of Quality
2. Describe the TQP framework ("House of Quality")
3. Define the Four Key Activities for managing quality
4. Explain the need for a culture change, starting at the top
5. Demonstrate a personal commitment to total quality
6. Explain the TQP implementation infrastructure
7. Describe how to put the systems for TQP into motion
8. Identify ways to sustain TQP activities
9. Understand a manager's role in quality improvement
This presentation was given by Jack Moran from the Public Health Foundation at the 2011 NPHPSP Annual Training on Assessing and Building a Culture of Quality Improvement in Your Agency
Building Quality Culture in Agile Software Development discusses how to build a quality culture in agile transformations. It outlines how organizational culture and leadership influence quality and how agile transformations impact processes, teams, and governance. The document recommends strategic initiatives to transform culture such as establishing a quality vision, clear communication, process improvements, empowering teams, continuous delivery, quality analytics, and training. The key takeaways are that building quality culture requires leadership, communication, empowering people, process improvements, technology enablement, and analytics.
This document introduces seven quality management principles (QMPs) that ISO 9000, ISO 9001, and related standards are based on. The seven QMPs are customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management. For each principle, the document provides a statement, rationale, key benefits, and examples of actions organizations can take to apply each principle.
This document introduces the seven quality management principles (QMPs) that ISO 9000, ISO 9001, and related quality management standards are based upon. The seven QMPs are customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management. For each principle, the document provides a statement, rationale, key benefits, and examples of actions organizations can take to apply that principle.
This document provides an overview of ISO 9001 and quality management systems. It discusses ISO 9001 as a standard that sets requirements for quality management systems to help organizations continually monitor and improve quality, meet customer requirements, and enhance profitability. It describes why companies achieve ISO 9001 certification, how the standard can be utilized, key quality management principles, and the benefits of adopting practices like customer focus, leadership, employee engagement, a process approach, and continual improvement.
The document discusses the seven principles of quality management: customer focus, leadership, people engagement, process approach, continual improvement, decision making, and relationship management. It explains that quality management aims to meet and exceed customer requirements through an interrelated process that empowers people, analyzes data, and manages relationships to continually improve performance and satisfy customers. Effective use of these principles can help organizations enhance their capabilities and achieve quality objectives.
This document provides an overview of ISO standards and quality management systems. It discusses that ISO develops international standards to ensure products and services are safe, reliable and of good quality. The main ISO standards discussed are ISO 9000 for quality management systems and ISO 9001 which defines the requirements for a quality assurance system. It also summarizes the seven quality management principles of ISO 9000 which are customer focus, leadership, engagement, process approach, improvement, evidence-based decisions and relationship management. The benefits of establishing a quality management system and adhering to these principles are also highlighted.
roducing quality work (the first time) means quality is built into the processes for producing products or providing services, and continual improvement measures are taken to ensure the processes work every time. Employees are empowered to make decisions to improve a process and are provided with continual training to develop their skills.
Scott A. Slonaker is a supply chain manager with over 18 years of experience in inventory management, distribution, warehousing, logistics, and operations management. He most recently worked as the manager of a waste management facility in Canton, OH where he improved safety practices and efficiency rates. Prior to that, he worked as the distribution/warehouse/transportation manager for a food grade and non-food grade distribution center, and as a global supply chain manager for the US Air Force.
This document discusses quality management. It defines quality as exceeding customer expectations and doing what a product or service is intended to do. The main components of quality management are planning, control, assurance, and improvement. Key principles of quality management include understanding customer needs, meeting requirements, striving to exceed expectations, and having a system approach focused on continual improvement and factual decision making. Quality in organizations aims to achieve long term success through customer satisfaction and benefits for all members of the organization and society.
The document outlines 7 management principles: 1) Customer Focus, 2) Leadership, 3) Engagement of People, 4) Process Approach, 5) Improvement, 6) Evidence-Based Decision Making, and 7) Relationship Management. For each principle, it provides a definition, some key benefits, and possible actions organizations can take to implement that principle. It also includes an introduction about the author's background and qualifications.
Quality Management Principles Become CEO Management Practices!Phi Jack
The document discusses the eight quality management principles (QMP) outlined in ISO standards: customer focus, leadership, involvement of people, process approach, systematic approach to management, continual improvement, factual approach to decision-making, and mutually beneficial supplier relationships. It provides details on how each principle can be applied and benefits organizations by improving performance, productivity, efficiency and customer satisfaction. Implementing the eight principles requires leadership, vision, communication and planning to establish them as a management system.
Leadership has been defined by various authors in varied ways. Such as,
Leadership has been described as the “process of social influence in which one person can enlist the aid and support of others in the accomplishment of a common task”.[Chemers MM 2002]
This document provides an overview of several quality management principles and methodologies, including:
- Lean manufacturing, which aims to eliminate waste and improve efficiency. Key aspects are flow, value streams, and eliminating muda (waste).
- The seven types of waste in lean manufacturing: overproduction, queues, transportation, inventory, motion, overprocessing, and defects.
- Just-in-time manufacturing, which supplies customers with exactly what they want when they want it by pulling supplies through the system as needed.
- Six Sigma, which identifies and removes defects from processes to improve quality using a DMAIC methodology of define, measure, analyze, improve, and control.
- Total quality management, which takes
This document summarizes a full day workshop on quality culture for success. It discusses the importance of quality culture in ensuring product quality and safety. Quality culture is defined as an environment where everyone understands the importance of product quality and patient safety. It is the single most important indicator for delivering quality drugs. However, quality culture does not happen by accident - it must be intentionally created through relevant processes, controls, and behaviors that are understood and followed. The document provides examples of how quality culture can be measured and discusses the criticality of quality culture and how to maintain it despite pressures to reduce costs. It outlines potential symptoms and actions if an organization lacks a strong quality culture.
IGPA Building a Culture of Quality Ajaz Hussain_5 Sept 2015_Rferences minAjaz Hussain
Improving Confidence in Quality of Medicines . We make two products – medicine and evidence (documents) but many forget this and do not pay attention to documentation.
Level of attention to documentation is a “canary in a coal mine”
Breaches are irrational –”System 1 thinking” and cognitive biases.
Culture of Quality is familiar to all of us – a framework proposed
Quality Metrics – great idea – very much needed; but we are not yet ready for an FDA Guidance.
We must first address our collective blind spots; be confident that process validation truly ensures complexity is sufficiently reduced and that outcomes are predictable.
1. The document discusses the importance of creating and maintaining a culture of quality in pharmaceutical manufacturing. It outlines several key aspects of a quality culture, including a focus on continuous improvement, willingness to identify and address issues, and an understanding that quality is everyone's responsibility.
2. Maintaining a quality culture requires leadership commitment to reinforce the right behaviors and decision making. Quality culture can deteriorate quickly if management loses focus on it or faces pressures like cost reductions. Early indicators of issues need to be addressed immediately.
3. The document provides examples of metrics that can help measure quality culture, such as the number of reported deviations, complaints, and process failures. A strong quality culture helps ensure product quality is not compromised
This document discusses key concepts in quality management. It defines quality as meeting customer satisfaction through both product features and freedom from deficiencies. Total quality management (TQM) is described as an organization-wide effort to improve quality. Several quality gurus who contributed to the field are discussed, including Deming, Juran, and Crosby. The summary emphasizes the importance of continuous improvement, customer focus, and preventing defects to reduce costs.
Quality management concepts include defining quality as customer satisfaction and fitness for use. Total quality management (TQM) is an organization-wide effort to improve quality. Key elements of TQM are leadership, employee involvement, continuous improvement, and customer focus. Implementing TQM requires integrating its principles into daily operations through strategic planning, communication, and process management tools like statistical process control.
Quality management involves defining quality, understanding customers and products, and implementing total quality management. Quality is defined as meeting customer requirements through both product design and conformance to specifications. Total quality management is an organization-wide effort to improve quality through elements like leadership, employee involvement, continuous improvement, and customer focus. Implementing TQM requires integrating its principles into daily operations through strategic planning, communication, and process management techniques like statistical process control.
The document discusses key concepts in quality management including definitions of quality, total quality management (TQM), customers, products, and how customer satisfaction is achieved. It also discusses reasons why quality has become a priority, different perspectives on quality, levels of quality in organizations, views of quality in services, historical philosophies of quality, and influential quality gurus such as Deming, Juran, and Shewhart and their philosophies and contributions to quality management.
This document discusses concepts related to total quality management. It defines quality as customer satisfaction and fitness for use. Total quality management is described as a comprehensive, organization-wide effort to improve quality. Key concepts covered include defining customers, products, and how customer satisfaction is achieved through product features and freedom from deficiencies. Reasons for the increased focus on quality like competition and changing customer demands are provided. Different perspectives on quality are outlined. The document also discusses quality gurus like Deming, Juran, Feigenbaum and their philosophies. It covers topics like costs of quality, elements of TQM implementation, and process management tools.
Total Quality Management is a comprehensive, organization-wide effort to improve quality. It focuses on customer satisfaction by preventing defects and reducing variation. Key elements of TQM include leadership, employee involvement, continuous improvement, and customer focus. Implementing TQM requires integrating its principles into day-to-day operations through communication, teamwork, training, and statistical process control.
Getting Started with GFSI (For Manufacturers)TraceGains
If you have any questions or comments, please send them to connect@tracegains.com. We look forward to hearing from you.
Meeting Description:
Being compliant with a Global Food Safety Initiative (GFSI) recognized scheme can be a business accelerator, but is also often viewed as a daunting task. It doesn’t need to be.
Join our webinar to learn about the impetus for creating the GFSI, its benefits, and basic steps to get you going on the process to becoming compliant.
Karil Kochenderfer, GFSI’s North American representative, will start with an overview of the Global Food Safety Initiative and its benefits.
John Kukoly, Director of BRC in the Americas, will then give a general overview of what is required to begin the compliancy process with any GFSI-compliant scheme relevant to food manufacturers and ingredient processors.
Topics to be addressed:
-Why certification to a GFSI scheme matters to you
-Considerations in choosing a scheme
-The audit process explained
-Best practices for successful implementation
-Poor practices to avoid
-Key areas to focus on in planning and implementation
The webinar will conclude with both Karil and John taking questions from the audience.
About the Global Food Safety Initiative:
The Global Food Safety Initiative is a business-driven initiative for the continuous improvement of food safety management systems to ensure confidence in the delivery of safe food to consumers worldwide. GFSI provides a platform for collaboration between some of the world's leading food safety experts from retailer, manufacturer and food service companies, service providers associated with the food supply chain, international organizations, academia and government.
Total quality management (TQM) is a management approach that seeks to continuously improve processes and products. It focuses on preventing mistakes by identifying causes and implementing changes. The key elements of TQM include focusing on customers, analyzing processes, working in quality teams, and using data to identify problems and solutions. TQM has advantages like increased innovation, productivity, customer satisfaction and profitability when implemented successfully in an organization. In the pharmaceutical industry, TQM and quality by design (QBD) help ensure consistent, safe and effective drug products by building quality into every stage of product and process design based on scientific understanding and risk management.
GOOD MANUFACTURING PROCESS Provides a high level assurance that medicines are manufactured in a way that ensures their safety, efficacy and quality
Medicines are manufactured to comply with their marketing authorization
Quality is built in
Testing is part of GMP, but alone does not provide a good level of quality assurance
Understanding and implementing quality management system in medical laboratoriesPathKind Labs
QMS is essential to run a good laboratory, but the various requirements pose a big challenge. Once you understand the reason for these requirements compliance may be easier.
This document provides an introduction to quality and total quality management. It defines key terms like quality, explains different perspectives on quality, and discusses the differences between traditional views of quality and total quality management. The total quality management approach focuses on customer satisfaction, continuous improvement, employee empowerment and involvement across all parts of an organization. Implementing a total quality management culture requires organizational changes and can help improve productivity, quality and profitability if done successfully.
NSF International is a public health organization that has been working to promote food safety since 1944. They have over 700 auditors globally and are a leading provider of food safety audits and certification. NSF discussed the history and increasing importance of cold chain management in ensuring food safety and quality across the supply chain. Proper cold chain management requires integrated strategies including planning, policies and procedures, and management practices to control risks. Global food safety standards like GFSI are driving innovation in the food industry by requiring continuous improvement and management commitment to meet new food safety expectations.
Yaara Dromi has over 10 years of experience in quality assurance and management roles in the pharmaceutical industry. She has led quality assurance teams and ensured compliance with regulations from agencies like the FDA and EMA. Her experience includes managing clinical supplies quality assurance at Teva Pharmaceuticals and serving as GMP Group Leader and Associate at Biotechnology General.
Total Quality Management (TQM) is a management approach focused on customer satisfaction through continuous process improvement involving all employees. The document discusses the history and key concepts of TQM, including defining quality, total quality, ISO standards, the PDCA cycle, TQM principles and implementation challenges. It also provides examples of how TQM has improved efficiency in healthcare organizations. Overall, the document provides a comprehensive overview of the TQM approach for quality management.
The document discusses quality management systems for pharmaceutical products. It outlines key principles of quality management including a focus on customers, leadership, engagement of employees, a process approach, continual improvement, evidence-based decision making, and relationship management. It then describes the components of a pharmaceutical quality management system including pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation. Quality assurance and quality control are distinguished, with quality assurance representing the overall policy and quality control focused on testing.
This document provides an overview of quality management concepts, including definitions of quality, dimensions of quality for goods and services, influential quality gurus like Deming and Juran, the costs of quality, quality management systems like ISO 9000, quality awards, and South African quality organizations. It introduces foundational quality topics and lays the groundwork for exploring quality tools and techniques in subsequent sessions.
Application of biopharmaceutics classification system in formulation developm...Surang Judistprasert
The document discusses the application of the Biopharmaceutics Classification System (BCS) in formulation development. It describes the four BCS classes based on a drug's solubility and permeability properties and how these properties impact bioequivalence studies and regulatory requirements. It also discusses factors that influence the predictability of in vivo performance based on the BCS class, such as first-pass metabolism and excipient effects. Recommendations are provided for designing successful bioequivalence studies using BCS principles.
The document discusses using 7QC tools for experiment design and problem solving. It lists 7QC tools like Pareto charts, histograms, process flow diagrams, check sheets, scatter diagrams, control charts, and run charts. These tools can be applied in design of experiments (DOE) to investigate the relationship between input attributes, process parameters, and output attributes. Minitab software can be used for DOE. Results from DOE like scatter diagrams can study the effect of parameters on quality attributes. Pareto charts can identify and prioritize problems, showing that 20% of causes often create 80% of issues. The document gives an example of using these tools to analyze quality problems with ACE tablets.
This document discusses Quality by Design (QbD) and how to implement it in a practical way. It defines QbD and outlines the key steps, which include establishing a target product profile, identifying critical quality attributes, defining a design space, control strategy, validation, and lifecycle management. Design spaces can be defined using design of experiments or multivariate analysis of historical data. Tools like DOE and MVA are useful for establishing and monitoring the design space. The document provides an example target product profile and discusses how to set the profile and manufacturing process scheme based on the active pharmaceutical ingredient's properties. It also discusses using risk assessment to identify critical variables and control strategies. The overall goal is developing a robust process understanding and control
Thai version. This material was for 3rd seminar last year. I would like to introduce innovation management for our colleague and challenged them in knowledge management in our department.
The document discusses alternative materials to gelatin capsules, including starch and HPMC capsules. It describes how starch capsules are produced via injection molding and have similar fill volumes to gelatin capsules. HPMC capsules are made using the same process as gelatin capsules. The document also provides details on the manufacture and benefits of soft gelatin capsules, which combine advantages of liquid and solid dosage forms. Soft gelatin capsules offer improved content uniformity, safety, stability, and bioavailability compared to other forms.
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This PowerPoint compilation offers a comprehensive overview of 20 leading innovation management frameworks and methodologies, selected for their broad applicability across various industries and organizational contexts. These frameworks are valuable resources for a wide range of users, including business professionals, educators, and consultants.
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To download this presentation, visit:
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1. CGMP Conference
Baltimore, MD 4-5 June 2012
Culture Of Quality
Mary Oates, Vice President,
Global Quality Operations, Pfizer
Commitment to Quality
• Product quality and patient safety are of utmost
importance to all ethical participants in the
pharmaceutical supply chain
• Comprehensive systems and controls must be in
place across the supply chain to ensure that every
l th l h i t th t
product meets appropriate quality standards
• Are systems and controls enough?
Example Supply Chain Complexity
Scope
• ~ 35,000 SKU’s
• ~ 500 Sourcing Points
• ~ 175 Logistics Centers
• ~ 200 Transport providers
1
2. CGMP Conference
Baltimore, MD 4-5 June 2012
Complex Environment Presents
Risk
• Potential for adulteration, including counterfeits
• Potential for non‐GMP conditions
– Could occur at any point in the supply chain
– More common type of risk
In the News: Intentional
Adulteration
• Heparin, melamine, capsules, etc
• Must be detected and removed from the supply
chain
• Criminal activity is difficult to prevent if money can
Criminal activity is difficult to prevent if money can
be made
• Quality culture is an irrelevant concept to a criminal
Warning Letters: GMP Findings
• Inadequate control of microbiological
contamination, e.g., poor aseptic practices
• Inadequate investigation of batch failures
• Inadequate cleaning and maintenance
Inadequate cleaning and maintenance
• Inadequate complaint investigations
• Inadequate training of employees
2
3. CGMP Conference
Baltimore, MD 4-5 June 2012
Potential Explanations for a Pattern of Non‐
Compliance
• Intentional disregard of GMPs
– Should be eliminated from the supply chain
• Inconsistent understanding of requirements
necessary to protect product quality
necessary to protect product quality
– Many new participants in supply chain
– Could be educated, if willing
• Have understanding but have lost focus on the
fundamentals that protect product quality
– Quality Culture
What is Quality Culture?
• An environment in which each and every person
understands and embraces their responsibility for
protecting product quality and patient safety
• A firm can have all the SOPs, systems and controls
required but, without quality culture, product quality
and business continuity are not assured
• Cannot be externally imposed
Benefits of Quality Culture
• Protects patient safety
• Drives behaviors and ensures decision‐making is
based on what is best for product quality and patient
safety
–Employees will do the right thing at all times
–Ensures continuous improvement
• Protects the firm’s reputation and business
3
4. CGMP Conference
Baltimore, MD 4-5 June 2012
Not Just About Outsourcing
• Manufacturing, testing and distributing
pharmaceuticals requires the MAH to involve
many other firms
– Purchased items: raw materials, packaging
components, artwork and labeling, drug
substance/API, etc.
– Purchased services: contractors performing any
number of activities, transportation providers,
distributors, etc.
• A strong quality culture must be in place at
every firm, including the MAH
Unfounded Beliefs
• Quality can be tested in
– If it passes the specifications, it must be
good
• Q lit
Quality can be inspected in
b i t di
– Traditional audits, internal or by a regulator,
can demonstrate that product quality will
consistently be acceptable
• Strong controls can mitigate all risks
The Reality
• Testing, inspection and other controls are
not enough
• A strong quality culture must be in place
• A firm’s quality culture is the single most
important indicator of their ability to
routinely provide a quality service or
product
4
5. CGMP Conference
Baltimore, MD 4-5 June 2012
Compliance versus Quality Culture
• Compliance requires strong standards
that adhere to regulations, robust
systems, good training, management
oversight, etc.
• Compliance is foundational and enables
quality performance
• Quality culture is about decision‐making
and behaviors at all levels of the
organization every day
Management Responsibility
• Q10 states
– “Leadership is essential to establish and
maintain a company‐wide commitment to
quality and for the performance of the
lit d f th f f th
quality system.”
• Leadership creates and is responsible for
sustaining quality culture
Management’s Role
• Create and sustain an effective quality system
• Ensure sufficient resources are available to maintain
quality
• Know about issues and trends via a strong
Know about issues and trends via a strong
notification to management process
• Ensure that patient safety drives decisions
5
6. CGMP Conference
Baltimore, MD 4-5 June 2012
Effective Quality System: Example
• Robust deviation investigations
– Identify root cause
– Identify full scope of issue
– Implement corrective actions to prevent
Implement corrective actions to prevent
recurrence
• Serves as an indicator of the focus and
behaviors of the organization
– Number of deviations, ability to prevent
recurrence, number overdue
Sufficient Resources
• Cost pressures may result in reduced
training, maintenance, people
• The risk of such reductions must be
understood and mitigated
understood and mitigated
– Risk assessment tools can be utilized
– The assessment may indicate the risk is too
great
Sufficient Resources (continued)
• Early indicators should be in place to determine
if reductions are adversely impacting quality
– Appearance of the facility
– Overdue deviation investigations, CAPAs and change
controls
– A backlog of complaint investigations
– Overdue testing, e.g. late stability testing
• If signals indicate decreased ability to maintain
quality, corrective actions should be
implemented immediately
6
7. CGMP Conference
Baltimore, MD 4-5 June 2012
Notification to Management
• Local and global processes must ensure that
issues and trends are escalated and addressed
with patient safety driving the decision‐making
• Management must role‐model the appropriate
decision‐making behavior
• Employees must be trained in tools that enable
them to make the right quality decisions
How We Deploy Quality Across Pfizer
• Holistic, multi‐faceted
approach to product
quality and cGMP
compliance
• Requires vigilance to
ensure high quality
ensure high quality
product
• Rests on a strong
foundation of quality
culture
Pressures on Quality Culture
• Need to supply product to market
• Cost, including resource availability
• Complexity of operations, both locally and
globally
l b ll
7
8. CGMP Conference
Baltimore, MD 4-5 June 2012
Fundamental Value Proposition
Supply Cost/
Reliability Value Delivery
Quality/
Compliance
Critical to balance all three
We make difficult and tough choices...
...however, compromise to Quality/Compliance is NOT an option
Example of Quality Culture
• First commercial use of a new manufacturing facility for
a biological compound
• Significant process enhancements were made to a
product at the same time that it was introduced to the
new facility
new facility
• In the first product lot, 70 deviations occurred
• The production manager shut down manufacturing to
identify and correct root causes
• The first lot after resumption of manufacturing had 20
deviations and the current average number per lot is 5
Can Quality Culture Be Measured?
• Quantitative tools can be developed to
evaluate quality culture
• Data should be derived primarily from
interviews of leadership, supervisors and
operators/technicians within the firm,
combined with review of supporting
documentation
• Such a tool can be used both internally
and externally
8
9. CGMP Conference
Baltimore, MD 4-5 June 2012
Example Parameters
• Management’s attitude towards compliance and their
engagement and proactive commitment to systemic
problem resolution
• Identification, trending and communication to
employees of quality metrics
• Freedom of employees to bring issues forward
Freedom of employees to bring issues forward
• Understanding by employees of tasks being executed
and how these protect product quality
• Number of deviations from procedures or expected
results
– Are there too many or too FEW?
Assessment of Potential Partners
• Due Diligence
– Quality culture of potential partners should be
specifically evaluated
• In addition to other due diligence assessments
In addition to other due diligence assessments
• Purpose is to determine if the potential partner’s
culture supports sustainable supply of high quality
products or services
Diagnosing Quality Culture
• Each element evaluated should be assessed
based on criticality and an overall conclusion
should be drawn
• Two potential outcomes
Two potential outcomes
– A few system improvements are necessary but
overall quality culture is robust
– Quality culture is lacking
9
10. CGMP Conference
Baltimore, MD 4-5 June 2012
Partner Assessment
• Output of quality culture evaluation is
part of an overall risk assessment of
potential partners
• Given all the information collected, a
decision must be made as to the
acceptability of the partner
• Could quality culture alone determine
the outcome?
Hypothetical Example
• Due diligence identified the acceptability of all
relevant systems, controls and processes
• A visit to follow up on a few outstanding
questions identified concerns about quality
culture
• Purely on this basis, the business agreement
was not pursued
• Evaluated firm’s partners later recalled product
due to quality concerns
Quality Culture at Partners
• Cannot be externally imposed nor can it be
changed in the near‐term
• Can be enhanced over time if management is
committed to the steps needed to create and
committed to the steps needed to create and
sustain it
• Should be routinely assessed through the
lifetime of a partnership
10
11. CGMP Conference
Baltimore, MD 4-5 June 2012
Contractor Quality Risk Dashboard
DYNAMIC tool for assessing
Contractor risk
Contractors evaluated every 2 months
against 10 risk elements
Provides VISUAL indication of
Focus on QUALITY & Risk History
the risk profile of our
COMPLIANCE aspects, cGMP Inspection Profile Contractor base and change
undiluted by business risks over time
Communication with Quality oversight
group
Quality of Investigation Process
COMMUNICATION tool tool Quality of Complaints
sharing information across Triggers ACTION on possible
functions Significant Deviations
risk that occur (raises the
Change Management flag)
Market Action/Stop Distribution
Quality System Oversight
Quality Culture
Real‐time assessment of risk and
initiation and follow up of mitigation
actions
Quality Culture Internally
• If the assessment indicates the quality culture
is not robust
– Management must be committed to the actions
necessary to sustain it
necessary to sustain it
• If they are not, they must be replaced
– Then the facility can begin addressing the
individual issues found in the assessment
Example Actions
• If there are too few deviation investigations
– Management must proclaim the value of deviation
investigations
– Management must help employees recognize
deviations and implement a process for effectively
d i ti di l t f ff ti l
raising them
– Management must establish a monitoring
mechanism and track and publish metrics
11
12. CGMP Conference
Baltimore, MD 4-5 June 2012
Example Actions (continued)
• If there are too few deviation investigations
– Management must celebrate an increase in
deviations and hold accountable those who do not
bring them forward
–MManagement must ensure that deviation
t t th t d i ti
investigations are performed quickly and thoroughly
– Management must ensure that holistic corrective
actions are implemented to prevent recurrence
Hypothetical Example to
Illustrate the Importance of
p
Quality Culture
Hypothetical Example
• A potential partner was evaluated via due
diligence
– Identified the need to improve quality systems
before product supply was initiated
– Quality culture was not considered a quantifiable
attribute at the time
attribute at the time
• System changes were implemented over the
course of one year
• Additional testing, person in plant and review
of all deviations, changes, etc put into place
12
13. CGMP Conference
Baltimore, MD 4-5 June 2012
Hypothetical Example (continued)
• Post‐manufacturing inspection of containers from one
product lot found a high number of a specific defect
• The supply chain partner removed the containers with
the defect and released the lot without investigation
• Previous information on this type of defect in other lots
Previous information on this type of defect in other lots
(inspection data, complaint reports, etc.) was not
reviewed
• The defect did exist in earlier released lots and, when
discovered, resulted in a Class 1 recall of all lots on the
market
Why Did This Happen?
• Failure of deviation investigation system at the partner but
more importantly
• Failure of quality culture
• Risk mitigation activities by the MAH did not prevent the issue
–C Can only react to what you know
l h k
– Every firm must have a quality culture that ensures that
the right decisions will be made by employees at all levels
of the organization at all times
Criticality of Quality Culture
• Without a strong quality culture, risks to product
quality cannot be fully mitigated
– Testing, person in plant, review of deviations, regular
audits, regulatory inspections are not enough
– Quality culture cannot be externally imposed and is not
introduced only through changes to GMP systems
– Quality culture cannot be changed in the near‐term
13
14. CGMP Conference
Baltimore, MD 4-5 June 2012
Conclusion
• Standards and systems alone are not enough
• Without a strong quality culture, risks to product quality and
patient safety cannot be fully mitigated
• Quality culture can and must be measured and, if found
lacking, improved
lacking improved
• Management bears responsibility for taking the actions
necessary for creating and sustaining a quality culture
14