Your Best Recall is the One You Never Have to DoSparta Systems
This document discusses product recalls and the importance of managing quality across the supply chain. It notes that recalls have significantly increased since 2006 and about half are due to issues with suppliers or contract manufacturers. Recalls can cost companies between $10-90 million on average. The document then provides an example of the peanut corporation of America recall that cost over $1 billion. It emphasizes that identifying issues earlier in the supply chain reduces costs according to Deming's 1-10-100 rule. The rest of the document discusses how companies can implement strategies like HACCP and supplier relationship management to proactively monitor quality and ensure compliance across the extended supply chain using a quality management system.
There are many concerns when facing quality management within organizations and big companies. There are always high risks in the supply chain. Furthermore, there are risks with internal infrastructure and the value chains (from distribution to retail to the consumer).
Organizations in highly regulated industries continue to face pressure to maintain the highest level of quality in every facet of their operations, while at the same time reducing costs and maintaining margins. This presentation from Sparta Systems describes what Enterprise Quality Management Systems (EQMS) can do for these organizations.
Understanding Enterprise Quality Management Systems (EQMS)Sparta Systems
The quality software landscape has progressed to become enterprise-level solutions, whose integrated systems enable organizations to implement automated quality processes tailored to align with each of their specific products and business practices. This presentation from Sparta Systems explains the concept of Enterprise Quality Management Systems (EQMS).
This document analyzes FDA warning letters issued between 2007 and June 2014. It finds that warning letters increased 78% from 2007 to 2013, with pharmaceutical/biotech, medical devices, and food/beverage industries receiving 95.72% of letters. Recent decreases in letters are likely due to reduced FDA funding and inspection freezes. The document predicts letters will rise in 2015 with a proposed FDA budget increase.
Cloud Technology and Its Implication for Quality ServicesSparta Systems
Cloud computing occurs when a program is run on many computers at the same time, referring to a server connected through the internet. This presentation from Sparta Systems describes how cloud technology can be an integral part of the Enterprise Quality Management Systems (EQMS).
Implementing a quality management system (QMS) provides regulatory benefits, improves market positioning, and enables continuous improvement. Regulatory bodies in the EU and US recognize QMS standards like ISO 13485 for medical devices. A QMS also increases customer satisfaction, reduces costs, and strengthens competitiveness. Continuous improvement, including preventative action, is a key benefit but also often underutilized aspect of a QMS. While establishing a QMS requires time and money for training and certification, the long-term advantages make it worthwhile for companies.
Course Objectives:
How does industry use Metrics?
FDA Challenges and Requirements and Use of Quality Metrics
Complexities of Implementation (Industry Feedback)
What does it all mean?
Key in Risk identification – systematic use of information to identify potential sources of harm (hazards)
referring to the risk question or problem description.
Enables the detection of potential problems as early as possible to plan corrective and preventive
actions
Provides indication that controls are losing effectiveness Important in achieving problem resolution and problem prevention
Another important concept of modern quality systems is the use of trending to examine processes as a whole.
Driving wrong behaviors and unintended consequence
• Establishing excessive or overly complex metrics
Comparing data that is not consistently defined or comparison of single data values
Using metrics as a quality “surrogate”
Your Best Recall is the One You Never Have to DoSparta Systems
This document discusses product recalls and the importance of managing quality across the supply chain. It notes that recalls have significantly increased since 2006 and about half are due to issues with suppliers or contract manufacturers. Recalls can cost companies between $10-90 million on average. The document then provides an example of the peanut corporation of America recall that cost over $1 billion. It emphasizes that identifying issues earlier in the supply chain reduces costs according to Deming's 1-10-100 rule. The rest of the document discusses how companies can implement strategies like HACCP and supplier relationship management to proactively monitor quality and ensure compliance across the extended supply chain using a quality management system.
There are many concerns when facing quality management within organizations and big companies. There are always high risks in the supply chain. Furthermore, there are risks with internal infrastructure and the value chains (from distribution to retail to the consumer).
Organizations in highly regulated industries continue to face pressure to maintain the highest level of quality in every facet of their operations, while at the same time reducing costs and maintaining margins. This presentation from Sparta Systems describes what Enterprise Quality Management Systems (EQMS) can do for these organizations.
Understanding Enterprise Quality Management Systems (EQMS)Sparta Systems
The quality software landscape has progressed to become enterprise-level solutions, whose integrated systems enable organizations to implement automated quality processes tailored to align with each of their specific products and business practices. This presentation from Sparta Systems explains the concept of Enterprise Quality Management Systems (EQMS).
This document analyzes FDA warning letters issued between 2007 and June 2014. It finds that warning letters increased 78% from 2007 to 2013, with pharmaceutical/biotech, medical devices, and food/beverage industries receiving 95.72% of letters. Recent decreases in letters are likely due to reduced FDA funding and inspection freezes. The document predicts letters will rise in 2015 with a proposed FDA budget increase.
Cloud Technology and Its Implication for Quality ServicesSparta Systems
Cloud computing occurs when a program is run on many computers at the same time, referring to a server connected through the internet. This presentation from Sparta Systems describes how cloud technology can be an integral part of the Enterprise Quality Management Systems (EQMS).
Implementing a quality management system (QMS) provides regulatory benefits, improves market positioning, and enables continuous improvement. Regulatory bodies in the EU and US recognize QMS standards like ISO 13485 for medical devices. A QMS also increases customer satisfaction, reduces costs, and strengthens competitiveness. Continuous improvement, including preventative action, is a key benefit but also often underutilized aspect of a QMS. While establishing a QMS requires time and money for training and certification, the long-term advantages make it worthwhile for companies.
Course Objectives:
How does industry use Metrics?
FDA Challenges and Requirements and Use of Quality Metrics
Complexities of Implementation (Industry Feedback)
What does it all mean?
Key in Risk identification – systematic use of information to identify potential sources of harm (hazards)
referring to the risk question or problem description.
Enables the detection of potential problems as early as possible to plan corrective and preventive
actions
Provides indication that controls are losing effectiveness Important in achieving problem resolution and problem prevention
Another important concept of modern quality systems is the use of trending to examine processes as a whole.
Driving wrong behaviors and unintended consequence
• Establishing excessive or overly complex metrics
Comparing data that is not consistently defined or comparison of single data values
Using metrics as a quality “surrogate”
Performance metrics are an essential element of the management review process.
Quality metrics may include elements such as customer satisfaction, supplier performance, manufacturing defects, complaints, cycle times and many other internal or external processes.
This presentation provides a framework for establishing right quality indicators for evaluating the performance of the quality system.
TrackWise is an enterprise quality management system that defines, tracks, manages and reports on critical quality and compliance processes. It centralizes these processes into a single, integrated system to help organizations gain efficiencies and achieve compliance. TrackWise provides secure, web-based access and flexibility to meet changing needs, with scalability for global use. It is used by hundreds of customers globally across regulated industries like pharmaceuticals and medical devices.
This document discusses vendor quality management. It provides an overview of common quality issues attributed to vendors in the biopharmaceutical industry, including poor change control, quality problems, and unmet promises. The document also shares quality management tools that can help address vendor issues, such as check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms. Additional related topics on vendor quality management are listed for further reference.
Quality Metrics are used to monitor the overall quality of pharmaceutical products and helps to improve product quality and implementing the culture in manufacturing facility.
the various factors that expose a global supply chain to risk. also known as the vulnerability of global supply chains to risks. case study's from KFC, YAHOO, APPLE, INTEL, NIKE companies to learn how this affected them.
The document is a group presentation on supply chain vulnerability. It discusses various causes of supply chain vulnerability including risks within the supply chain from lack of visibility and inaccurate forecasts as well as external risks from natural disasters, terrorism, and industrial action. Specific factors are also examined like globalized supply chains, outsourcing, and reduction in the supplier base. The presentation concludes by outlining approaches to supply chain risk management including identifying risks, analyzing their potential impact, and designing appropriate responses to reduce prevention and mitigate consequences.
The document discusses the need for medical device manufacturers to comply with ISO 13485:2003 quality standards. It notes that situations like Medtronic paying $268 million to settle lawsuits over faulty defibrillator leads emphasize the importance of standards to ensure quality and manage risk. ISO 13485:2003 provides requirements for a quality management system to consistently meet customer and regulatory requirements. It shifts the focus from end-of-production quality inspection to quality control throughout the production process. Following the standard helps manufacturers realize better quality, cost-effectiveness and time to market for their medical devices.
A vendor audit is performed for a company that aims to attain an objective assessment of its contractors' or vendors' compliance to the terms, conditions, and intent of the contracts and/or agreements between two entities.
This document provides an overview of quality management review including definitions, purposes, and tools. It discusses that quality management reviews are conducted regularly according to ISO 9001 standards to evaluate the quality management system. The review assesses adequacy, suitability, and effectiveness of the system. Several quality management tools are also introduced, including check sheets, control charts, Pareto charts, scatter plots, and Ishikawa diagrams.
The document discusses moving quality inspections earlier in the production process to reduce costs. It presents a model showing the distribution of quality costs throughout production, from development to after sales. The goal is to shift from a reactive, trust-based quality system to a proactive, fact-based one by building quality into decision making, supplier qualifications, and development processes. A five-level quality system maturity model ranges from local and random inspections to an intelligent system that integrates quality across the business through data-driven decision making, supplier audits, and clear quality performance goals.
The document discusses quality issues in global supply chains. It explains that quality is impacted by both suppliers and customers, and that moving from transactional to relationship-based supply behaviors can improve quality performance. The document also notes that counterfeiting is a growing problem and that effective quality management can help address it. Finally, it recommends that organizations first assess their own supply chain management processes and then develop a supply quality strategy to prioritize quality initiatives.
Maetrics: The ROI of Good Quality & ComplianceGeneris
The document discusses investing in quality and compliance programs to justify costs. It outlines how to quantify direct and indirect quality costs, examines the FDA's increasing focus on medical devices, and explores the impacts of non-compliance. Proactive quality systems can reduce costs compared to reactive systems. Good investments include dedicated CAPA resources, risk management programs, quality metrics, and harmonizing quality systems during acquisitions.
Intertek provides strategic support across the entire supply chain through testing, inspection, auditing, and certification services. They have a global network with over 35,000 employees in more than 100 countries. Their services help clients innovate while complying with regulations, focus on core business by mitigating risks, and make decisions based on data. Case studies show how they have helped clients with regulatory compliance, material selection, sustainability assessments, and developing partnerships with suppliers.
The document discusses key topics related to managing supply chains, including definitions, trends, best practices, and risks. It provides definitions of supply chain management and logistics management. It outlines trends changing supply chains such as globalization, technology advances, and sustainability issues. Leading practices discussed include focusing on cash flow, visibility, and strategic supplier/customer relationships. Risks covered involve disruptions, regulatory changes, and factors within and outside a company's control.
This document provides guidance on developing a green chemicals procurement strategy. It outlines the drivers for green chemicals procurement including government regulations, consumer demands, and business benefits. The benefits of green chemicals procurement are increased brand value, reduced costs, competitive advantage, product innovation, and increased productivity. An effective strategy involves evaluating current practices, identifying green alternatives, gaining management support, developing goals and procedures, and ongoing assessment of key performance indicators. The goal is to choose suppliers and products that minimize environmental impacts across the product lifecycle.
Innovation in the Supply Chain (Distribution)rahulgulrajani
Rahul Gulrajani studied the Indian pharmaceutical supply chain to identify issues and recommend improvements. Key findings included inefficiencies across the supply chain from manufacturers to pharmacies. Recommendations focused on establishing performance indicators and implementing electronic ordering/invoicing to increase transparency, reduce errors and manual work, and optimize inventory management through data sharing between stakeholders. Adopting technologies like RFID and blockchain was suggested to improve security and traceability.
Claims leakage presentation with narrationMark Rayner
This is our presentation on Claims Leakage audits that we perform for insurers. Please visit our website if you'd like more information or to see the presentation with narration. Please feel free to contact me if you'd like to discuss or comment. Mark Rayner.
"Quality Metrics" not only helpful US FDA, moreover helpful for all pharmaceutical industries.
Quality metrics are helpful for Chairman, MD, CEO & higher management to evaluate & know the firm performance (*Indirectly different department employees performance & productivity).
The primary responsibility of the post-close supply chain transition team is to achieve and maintain uninterrupted upstream supply and an excellent downstream customer experience while delivering the projected savings from the combined company. This presentation provides guidance on ways to identify, assess and avoid or minimize opportunities for supply chain disruption immediately after closing, as well as best practices for successful supply chain consolidation and integration.
Sql bits creating a meta data driven ssis solution with bimlMarco Schreuder
This document discusses creating a meta data driven SSIS solution using BIML. BIML allows describing an SSIS solution as XML that can then be used to automatically generate packages. The solution involves storing meta data in a database that describes packages, connections, and columns. BIML scripts are used to generate SSIS packages from this meta data to perform ETL processes based on the flexible meta data model. Logging and configurations are also implemented using the meta data to make the packages dynamic and traceable. Dimension loading and fact table loading packages are generated along with a master package to orchestrate the entire process.
Performance metrics are an essential element of the management review process.
Quality metrics may include elements such as customer satisfaction, supplier performance, manufacturing defects, complaints, cycle times and many other internal or external processes.
This presentation provides a framework for establishing right quality indicators for evaluating the performance of the quality system.
TrackWise is an enterprise quality management system that defines, tracks, manages and reports on critical quality and compliance processes. It centralizes these processes into a single, integrated system to help organizations gain efficiencies and achieve compliance. TrackWise provides secure, web-based access and flexibility to meet changing needs, with scalability for global use. It is used by hundreds of customers globally across regulated industries like pharmaceuticals and medical devices.
This document discusses vendor quality management. It provides an overview of common quality issues attributed to vendors in the biopharmaceutical industry, including poor change control, quality problems, and unmet promises. The document also shares quality management tools that can help address vendor issues, such as check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms. Additional related topics on vendor quality management are listed for further reference.
Quality Metrics are used to monitor the overall quality of pharmaceutical products and helps to improve product quality and implementing the culture in manufacturing facility.
the various factors that expose a global supply chain to risk. also known as the vulnerability of global supply chains to risks. case study's from KFC, YAHOO, APPLE, INTEL, NIKE companies to learn how this affected them.
The document is a group presentation on supply chain vulnerability. It discusses various causes of supply chain vulnerability including risks within the supply chain from lack of visibility and inaccurate forecasts as well as external risks from natural disasters, terrorism, and industrial action. Specific factors are also examined like globalized supply chains, outsourcing, and reduction in the supplier base. The presentation concludes by outlining approaches to supply chain risk management including identifying risks, analyzing their potential impact, and designing appropriate responses to reduce prevention and mitigate consequences.
The document discusses the need for medical device manufacturers to comply with ISO 13485:2003 quality standards. It notes that situations like Medtronic paying $268 million to settle lawsuits over faulty defibrillator leads emphasize the importance of standards to ensure quality and manage risk. ISO 13485:2003 provides requirements for a quality management system to consistently meet customer and regulatory requirements. It shifts the focus from end-of-production quality inspection to quality control throughout the production process. Following the standard helps manufacturers realize better quality, cost-effectiveness and time to market for their medical devices.
A vendor audit is performed for a company that aims to attain an objective assessment of its contractors' or vendors' compliance to the terms, conditions, and intent of the contracts and/or agreements between two entities.
This document provides an overview of quality management review including definitions, purposes, and tools. It discusses that quality management reviews are conducted regularly according to ISO 9001 standards to evaluate the quality management system. The review assesses adequacy, suitability, and effectiveness of the system. Several quality management tools are also introduced, including check sheets, control charts, Pareto charts, scatter plots, and Ishikawa diagrams.
The document discusses moving quality inspections earlier in the production process to reduce costs. It presents a model showing the distribution of quality costs throughout production, from development to after sales. The goal is to shift from a reactive, trust-based quality system to a proactive, fact-based one by building quality into decision making, supplier qualifications, and development processes. A five-level quality system maturity model ranges from local and random inspections to an intelligent system that integrates quality across the business through data-driven decision making, supplier audits, and clear quality performance goals.
The document discusses quality issues in global supply chains. It explains that quality is impacted by both suppliers and customers, and that moving from transactional to relationship-based supply behaviors can improve quality performance. The document also notes that counterfeiting is a growing problem and that effective quality management can help address it. Finally, it recommends that organizations first assess their own supply chain management processes and then develop a supply quality strategy to prioritize quality initiatives.
Maetrics: The ROI of Good Quality & ComplianceGeneris
The document discusses investing in quality and compliance programs to justify costs. It outlines how to quantify direct and indirect quality costs, examines the FDA's increasing focus on medical devices, and explores the impacts of non-compliance. Proactive quality systems can reduce costs compared to reactive systems. Good investments include dedicated CAPA resources, risk management programs, quality metrics, and harmonizing quality systems during acquisitions.
Intertek provides strategic support across the entire supply chain through testing, inspection, auditing, and certification services. They have a global network with over 35,000 employees in more than 100 countries. Their services help clients innovate while complying with regulations, focus on core business by mitigating risks, and make decisions based on data. Case studies show how they have helped clients with regulatory compliance, material selection, sustainability assessments, and developing partnerships with suppliers.
The document discusses key topics related to managing supply chains, including definitions, trends, best practices, and risks. It provides definitions of supply chain management and logistics management. It outlines trends changing supply chains such as globalization, technology advances, and sustainability issues. Leading practices discussed include focusing on cash flow, visibility, and strategic supplier/customer relationships. Risks covered involve disruptions, regulatory changes, and factors within and outside a company's control.
This document provides guidance on developing a green chemicals procurement strategy. It outlines the drivers for green chemicals procurement including government regulations, consumer demands, and business benefits. The benefits of green chemicals procurement are increased brand value, reduced costs, competitive advantage, product innovation, and increased productivity. An effective strategy involves evaluating current practices, identifying green alternatives, gaining management support, developing goals and procedures, and ongoing assessment of key performance indicators. The goal is to choose suppliers and products that minimize environmental impacts across the product lifecycle.
Innovation in the Supply Chain (Distribution)rahulgulrajani
Rahul Gulrajani studied the Indian pharmaceutical supply chain to identify issues and recommend improvements. Key findings included inefficiencies across the supply chain from manufacturers to pharmacies. Recommendations focused on establishing performance indicators and implementing electronic ordering/invoicing to increase transparency, reduce errors and manual work, and optimize inventory management through data sharing between stakeholders. Adopting technologies like RFID and blockchain was suggested to improve security and traceability.
Claims leakage presentation with narrationMark Rayner
This is our presentation on Claims Leakage audits that we perform for insurers. Please visit our website if you'd like more information or to see the presentation with narration. Please feel free to contact me if you'd like to discuss or comment. Mark Rayner.
"Quality Metrics" not only helpful US FDA, moreover helpful for all pharmaceutical industries.
Quality metrics are helpful for Chairman, MD, CEO & higher management to evaluate & know the firm performance (*Indirectly different department employees performance & productivity).
The primary responsibility of the post-close supply chain transition team is to achieve and maintain uninterrupted upstream supply and an excellent downstream customer experience while delivering the projected savings from the combined company. This presentation provides guidance on ways to identify, assess and avoid or minimize opportunities for supply chain disruption immediately after closing, as well as best practices for successful supply chain consolidation and integration.
Sql bits creating a meta data driven ssis solution with bimlMarco Schreuder
This document discusses creating a meta data driven SSIS solution using BIML. BIML allows describing an SSIS solution as XML that can then be used to automatically generate packages. The solution involves storing meta data in a database that describes packages, connections, and columns. BIML scripts are used to generate SSIS packages from this meta data to perform ETL processes based on the flexible meta data model. Logging and configurations are also implemented using the meta data to make the packages dynamic and traceable. Dimension loading and fact table loading packages are generated along with a master package to orchestrate the entire process.
Lean supply chain management is challenging because so much happens outside the four walls. Time compression and inventory velocity are important in achieving end-to-end inventory speed. The benefits include higher inventory turns, less working capital, less cash burn, better cash flow, improved revenue yield maximization, and less write downs.
Inventory begins upstream where suppliers are and should flow.
FDA Requirements for Supplier Management: A Primer from EduQuestEduQuest, Inc.
FDA requirements for supplier management are outlined by EduQuest president Martin Browning, who also provides practical advice for avoiding common mistakes companies make in managing relationships with third-party vendors, suppliers and auditors.
The document discusses root cause analysis (RCA), including its definition, benefits, techniques, and process. RCA helps identify the underlying cause of problems rather than just addressing symptoms. It can prevent future issues and improve communication. Techniques discussed include brainstorming, the 5 whys, fishbone diagrams, and failure mode and effects analysis. The RCA process involves defining the problem, analyzing possible causes, verifying solutions, implementing corrective and preventive actions, and follow-up.
The document discusses best practices for improving quality in the supply chain. It identifies four key quality risks in the supply chain: ineffective material controls, inefficient material flows and logistics routes, other sources of waste like rework and over inspection, and ineffective communication with suppliers. It then proposes four best practices: formalizing lean thinking and waste elimination programs, investing in supply chain visibility tools, establishing common KPIs and accountability, and implementing an enterprise quality management system. The conclusion states that extending quality management practices into the supply chain can provide benefits like early issue identification, improved traceability and accountability, and increased profitability by mitigating financial risks.
This document discusses corrective action and root cause analysis processes. It provides an overview of nonconformances, the corrective action process which involves 4 steps - problem identification, short term remedy, root cause analysis, and implementation of corrective actions. Root cause analysis tools like fishbone diagrams, 5 whys, and flowcharts are presented. The importance of determining and addressing the underlying root cause is emphasized to prevent future nonconformances.
NexJ CDM Overview: Better Understand Customers with NexJ Customer Data Manage...NexJ Systems Inc.
NexJ Customer Data Management (CDM) is uniquely designed to define and deliver meaningful information to cost-effectively increase business agility, resiliency, and operational efficiency.
Ecommerce In Sri Lanka: Building An Experience That Customers Will LoveAdnan Issadeen
Slides for talk given at Colombo UX Conference 2015.
This talk centered around how we in Sri Lanka should approach ecommerce and what we should and shouldn't be doing.
Classic Rock Coffee Co. (CRCC) is a coffee shop franchise concept founded in 2013 that combines specialty coffee with a classic rock music atmosphere. CRCC sources high quality coffee beans from regions around the world and roasts them within 14 days of serving to ensure optimal flavor. The company operates corporate and franchised locations across the United States and internationally, with the goal of providing customers an alternative to typical laid back coffee shops.
This was a live webinar produced by Limelight Networks in conjunction with the American Marketing Association. The webinar offered listeners 7 ways to help them more easily incorporate video into their marketing strategies. Below is a walk-through of the slides, the slides (from slideshare.com), and Q&A pulled from the webinar itself.
From Prep to racing, see how managing your business is a lot like driving a racecar.
Check fuel, tire pressure, electrical, etc.
Test brakes, transmission, steering, etc.
Warm up the engine
Review plan of attack
Team review of plan, roles, responsibilities, and goals (metrics)
Play position strategy
Know when to draft and when to pass
Anticipate turns – start high, move to low and tight
Anticipate obstacles
Watch the gauges – frequent fast reads
Drive with “field awareness”
Avoid desperate moves – leave that to the rookies
This webinar discusses inbound solutions for US fund managers looking to operate in Europe, specifically through the UK. It provides an overview of the UK regulatory environment and authorization process, which can take 6-9 months to complete. Regulatory hosting offers an alternative approach, allowing firms to start operations immediately while an experienced firm like Mirabella handles ongoing compliance and reporting requirements. Attendees learn about the various activities that require Financial Conduct Authority regulation and support services available from UK Trade & Investment and Cordium to navigate setup and ongoing operations in the UK.
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.
- The document discusses managing sustainability data for businesses, which has become complex due to data from various sources. It provides an overview of sustainability reporting trends and drivers for tracking this data.
- Key challenges with using spreadsheets are discussed, such as reconciliation between years and generating real-time reports. Enterprise software is presented as an alternative, with features like automatic reporting and data validation.
- Case studies are presented on how companies like Stonyfield Farms and Seventh Generation developed sustainability metrics and programs to track performance and identify areas for improvement. Developing a business case for automation is recommended to gain management approval.
The document discusses key aspects of developing successful supplier relationships and performance management. It identifies building trust, shared vision, communication, commitment, and metrics as important ingredients. It provides examples of supplier performance metrics in areas like cost, quality, delivery, responsiveness, environment, and business. The document also discusses supplier evaluation, certification, and development to improve performance over time through setting criteria and targets.
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
Quality assurance and quality control play important roles in the pharmaceutical industry to ensure product safety and efficacy. Quality assurance focuses on preventing defects through process improvement and monitoring, while quality control identifies defects through testing of raw materials, in-process materials and finished products. Both functions are necessary to consistently deliver high quality products that do not compromise consumer health. Key responsibilities of quality assurance include overseeing quality systems, monitoring validation activities and investigating issues like deviations. Quality control responsibilities involve testing, method validation, complaint investigation and stability studies. Together quality assurance and quality control form a quality culture from design through manufacturing and distribution.
Dr. Liliana Casal-Wardle presented on navigating supply chain constraints. She discussed the increasing complexity of global supply chains and challenges presented by the COVID-19 pandemic, natural disasters, and changes in the workforce and transportation. She emphasized the importance of supplier approval programs, monitoring supplier performance, and being prepared for emergency sourcing situations. Dr. Casal-Wardle also provided tools for managing supply chain risks, such as databases for ingredient sourcing and tracking supplier audit results, recalls, and complaints. She stressed the critical role of food safety culture and continuous improvement programs across the supply chain.
Vertical Partnership for Scale in Impact Measurement: The Case of The Sustain...Sustainable Brands
The document summarizes The Sustainability Consortium (TSC), a nonprofit organization that works with retailers, suppliers, and stakeholders to measure and improve the sustainability of consumer products. Key points:
- TSC developed standardized metrics and tools to measure sustainability impacts across complex global supply chains in a consistent way. This reduces costs and survey fatigue for retailers and suppliers.
- TSC tools aggregate data on over 19 sustainability issues and supply chain stages to identify hotspots and benchmark performance. Over 1,700 suppliers have completed surveys on the SAP Product Stewardship Network platform.
- The tools have been implemented by many large consumer brands and retailers including Walmart. Walmart uses the data to engage suppliers, set
How Can We Ensure Effective Quality Management Throughout the Supply Chain.pdfJose thomas
Effective ERP solutions UAE throughout the supply chain is critical for businesses to consistently deliver high-quality products. Businesses can ensure quality at every stage of the supply chain by establishing clear quality standards, selecting reliable suppliers, implementing robust quality control measures, enabling traceability, fostering collaboration, and embracing continuous improvement.
This document discusses best practices for supplier quality management. It outlines six key best practices: 1) Measuring and tracking the cost of poor supplier quality, 2) Implementing cost recovery from suppliers, 3) Conducting supplier audits, 4) Using supplier scorecards, 5) Implementing a closed-loop corrective action system, and 6) Engaging suppliers in quality systems. It also provides examples of common quality management tools like check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms. The document aims to help companies improve supplier quality and reduce costs.
2013 Year of Pharmaceutical Serialization - Get it RightMichael Stewart
Pharmaceutical serialization en mass will occur in 2013 due to US and es-US regulations to track products at the item level. Michael Stewart of PharmTech Inc. shares his insight into the project Management pitfalls and allows you to use his learning curve working with top 10 pharmaceutical manufacturers, contract manufacturers and virtual manufactures to get ROI and business value in addition to compliance. Turn a perceived cost into an investment.
This document outlines a six step process for selecting suppliers that ensures quality and safety:
1. Identify potential suppliers and define selection criteria through stakeholder input. Consider total cost of ownership, not just price.
2. Develop an audit program to continuously monitor suppliers' performance on quality, compliance, and critical metrics.
3. Use self-assessments and metrics to identify gaps and track suppliers' understanding of meaningful measurements.
4. Certify top suppliers by establishing criteria for sustained successful performance.
5. Develop strategic partnerships with suppliers through open communication and mutual understanding of production needs.
6. Implement a supplier quality management program to ensure high quality products for consumers through reliable supplier relationships
This document summarizes a presentation on quality metrics and culture given at Habib University in Karachi. It discusses key quality metrics like lot acceptance rate, product complaint rate, and CAPA effectiveness. It also identifies attributes of a strong quality culture like leadership emphasis, message credibility, peer involvement, and employee ownership. Finally, it stresses that quality is everyone's responsibility and a mature quality system relies on systems thinking and a culture that prioritizes quality and continuous improvement.
The document summarizes a presentation on the pharmaceutical regulatory science landscape in 2015. It discusses:
1) Changes and emerging trends in regulatory sciences, including increased globalization and harmonization efforts.
2) Quality metrics and using data to understand industry performance and identify issues.
3) Shifting business models, including more outsourcing and the need for continuous quality improvements.
4) Ensuring data integrity and addressing challenges like lack of integrity raising doubts about safety.
Purpose of the Call:
•Review the results of the Canadian MedRec Audit Month 2015
•Discuss lessons learned from the audit month – strengths and areas for improvement
•Gather ideas about how to improve the quality of MedRec at admission
“Pharmaceutical Quality Matrices in determining overall state of Quality and ...Marcep Inc.
Introduction to Quality Matrices
•What is Quality metrics
Background&Glossary
•Modernization of Regulatory Oversight of Drug Quality and Promotion of Post-Approval Improvements
•Use of Quality Metrics by FDA for Risk-Based Inspection Scheduling and Prediction of Drug Shortages
Legal authority
•Records Associated with the Process Validation Lifecycle and PQS Assessment
•Authority to Inspect Records and Request in Advance of or In Lieu of an Inspection
The Use of Quality Metrics and Effect of Non-Reporting
•How FDA Intends to Use Quality Metrics
•Effect of Non-Reporting
Group Discussion:
Implementing Trending of Quality Indices in Your Organization
The importance of the right culture and people
• Role of leadership in trending of Quality Indices
• Developing anonline data base for Quality Indices
•Analysis, interpretation and reporting of Quality Indices
The Process Flow
• Establishing the ground rules, procedures, forms and mechanismfor data collection for Quality indices
• Determining responsibilities and roles for the implementation of trending of Quality Indices
Starting the Quality Indices Management Process
•Review of Quality Indices and Gap evaluation
•Preparation of Data bases for Data acquisition
•Collection data for completeness and Accuracy
•Processing and Reporting of Quality Metrics
Day Two
Reporting of Quality data and Calculation of Quality Metrics
• Who Reports and Who May Contribute to the Report
• Quality Metrics that FDA Intends to Calculate
• What Quality Data Would Be Reported
• How to Report Quality Data to FDA
Instructions for Quality Metric Data Submission
•Worksheet for Data Tables
•Product Specific Information
•Mandatory Data •ICH Q9
•Optional Metrics
Recognizing and Understanding the Trending of Quality Indices
Working Session, I:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis on a given data. Each group will present theresults of its analysis
Working Session II:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis and propose a Quality metric by using Risk Based approach for the specific set of data. The results of the analyses willbe shared in the class.
Complexities of Implementation Quality Metrics
•Overcoming the pitfalls
•Benefits and Risks
General Discussion and Questions
Quality & compliance excellence in pharmaceuticalsAnvita Bharati
Quality can be defined in several ways including conformance to specifications, fitness for use, and value for price paid. It is judged based on factors like performance, reliability, and support services provided. Pharmaceutical products have higher quality standards and more regulations compared to consumer goods due to their intended use and potential risks. Ensuring compliance with various quality guidelines is important for patient safety and involves establishing quality systems, policies, procedures, documentation, and ongoing assessments like audits and corrective actions. Non-compliance can result in issues like complaints, recalls, and regulatory actions.
Supply Chains around the world are witnessing rapid transformation due to many factors including digitization and cybersecurity. Procurement Professionals as a whole seem to be behind the curve with these trends.
You will learn how the following with impact the Procurement Function:
1. Social Responsibility
2. Digitization
3. Supplier Relationship Management
4. Supply Risk Management
Managing an end to end Pharmacovigilance system from affiliates to regulatory...MyMeds&Me
MyMeds&Me CEO Dr. Andrew Rut explores how technology can help address the challenges facing Pharmacovigilance teams.
He reviews how the latest intake technology can influence end-user experience and effectiveness, as well as internal value & efficiency.
He concludes that a focus on simplifying case intake re-shapes the traditional PV system, enabling Pharma companies to reap significant process and efficiency benefits.
Similar to Webinar SQM Best Practices and Insights (20)
Takashi Kobayashi and Hironori Washizaki, "SWEBOK Guide and Future of SE Education," First International Symposium on the Future of Software Engineering (FUSE), June 3-6, 2024, Okinawa, Japan
Do you want Software for your Business? Visit Deuglo
Deuglo has top Software Developers in India. They are experts in software development and help design and create custom Software solutions.
Deuglo follows seven steps methods for delivering their services to their customers. They called it the Software development life cycle process (SDLC).
Requirement — Collecting the Requirements is the first Phase in the SSLC process.
Feasibility Study — after completing the requirement process they move to the design phase.
Design — in this phase, they start designing the software.
Coding — when designing is completed, the developers start coding for the software.
Testing — in this phase when the coding of the software is done the testing team will start testing.
Installation — after completion of testing, the application opens to the live server and launches!
Maintenance — after completing the software development, customers start using the software.
Neo4j - Product Vision and Knowledge Graphs - GraphSummit ParisNeo4j
Dr. Jesús Barrasa, Head of Solutions Architecture for EMEA, Neo4j
Découvrez les dernières innovations de Neo4j, et notamment les dernières intégrations cloud et les améliorations produits qui font de Neo4j un choix essentiel pour les développeurs qui créent des applications avec des données interconnectées et de l’IA générative.
Software Engineering, Software Consulting, Tech Lead, Spring Boot, Spring Cloud, Spring Core, Spring JDBC, Spring Transaction, Spring MVC, OpenShift Cloud Platform, Kafka, REST, SOAP, LLD & HLD.
UI5con 2024 - Boost Your Development Experience with UI5 Tooling ExtensionsPeter Muessig
The UI5 tooling is the development and build tooling of UI5. It is built in a modular and extensible way so that it can be easily extended by your needs. This session will showcase various tooling extensions which can boost your development experience by far so that you can really work offline, transpile your code in your project to use even newer versions of EcmaScript (than 2022 which is supported right now by the UI5 tooling), consume any npm package of your choice in your project, using different kind of proxies, and even stitching UI5 projects during development together to mimic your target environment.
Transform Your Communication with Cloud-Based IVR SolutionsTheSMSPoint
Discover the power of Cloud-Based IVR Solutions to streamline communication processes. Embrace scalability and cost-efficiency while enhancing customer experiences with features like automated call routing and voice recognition. Accessible from anywhere, these solutions integrate seamlessly with existing systems, providing real-time analytics for continuous improvement. Revolutionize your communication strategy today with Cloud-Based IVR Solutions. Learn more at: https://thesmspoint.com/channel/cloud-telephony
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Recording:
https://www.youtube.com/live/MSdGLG2zLy8?si=INxBHTqkwHhxV5Ta&t=0
Graspan: A Big Data System for Big Code AnalysisAftab Hussain
We built a disk-based parallel graph system, Graspan, that uses a novel edge-pair centric computation model to compute dynamic transitive closures on very large program graphs.
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These analyses were used to augment the existing checkers; these augmented checkers found 132 new NULL pointer bugs and 1308 unnecessary NULL tests in Linux 4.4.0-rc5, PostgreSQL 8.3.9, and Apache httpd 2.2.18.
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- Invited for presentation at SoCal PLS ‘16.
- Invited for poster presentation at PLDI SRC ‘16.
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Hand Rolled Applicative User ValidationCode KataPhilip Schwarz
Could you use a simple piece of Scala validation code (granted, a very simplistic one too!) that you can rewrite, now and again, to refresh your basic understanding of Applicative operators <*>, <*, *>?
The goal is not to write perfect code showcasing validation, but rather, to provide a small, rough-and ready exercise to reinforce your muscle-memory.
Despite its grandiose-sounding title, this deck consists of just three slides showing the Scala 3 code to be rewritten whenever the details of the operators begin to fade away.
The code is my rough and ready translation of a Haskell user-validation program found in a book called Finding Success (and Failure) in Haskell - Fall in love with applicative functors.
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2. The impact of poor quality
2
product recall
increase 1999-20111+135%
1 Recall Execution Effectiveness Report. Deloitte, GMA, FMI and GS1. May 2010
2 raps.org, A. Gaffney, “Number of Drug Recalls Surges at FDA, Led by Mid-Level Concerns”, August 2014
6x FDA drug recall
increase 2004-20132
3. The impact of poor quality
3
$90M
A product recall can
cost an organization
between1
$10M
1 Recall Execution Effectiveness Report. Deloitte, GMA, FMI and GS1. May 2010
52%
recalls due to
supplier/vendor
issues1
4. Let’s do the math
4
Drug recalls in 20131
1225
1 raps.org, A. Gaffney, “Number of Drug Recalls Surges at FDA, Led by Mid-Level Concerns”, August 2014
Cost per recall $10M to $90M
Cost of drug
recalls in 2013 $12B to $110B
X
5. Let’s do the math
5
Cost of drug
recalls in 2013 $12B to $110B
52% of recalls due
to suppliers/vendors $6B to $55B
1% $60M to $550MWhat if improving
supplier visibility &
quality reduced
recalls by…
5% $300M to $2.75B
6. Industry challenge:
Identifying Quality Issues Early
6
1X 10X 100X 1000X…
Issue
Resolution
Cost
Supplier
Network
Corporate
Planning & Design
Manufacturing
Facilities
Distribution
Centers
Consumers
Only 22%of companies see quality as an
integrated function of their supply chains1.
1 Gartner, S Jacobson, “Quality: The Missing Link in Your Supply Chain Strategy”, January 2015
7. Industry challenge:
Supply chain complexity
71 The Supplier Performance Measurement Benchmarking Report, Aberdeen Group, 2002
50-80%
of the total product costs
are spent on raw materials
& parts procured from
multiple suppliers across
different parts of the globe1
8. Industry challenge:
Supplier visibility
81KPMG Global Manufacturing Outlook report, 2014
Complete
visibility
Tier 1, 2 and
beyond suppliers
visibility
Limited
visibility
Limited Tier 1
supplier visibility,
but not Tier 2 &
beyond
Some
visibility
Tier 1 supplier
visibility & some
Tier 2 supplier
visibility
22%
38%40%
Only 22% of today’s manufacturers have complete visibility into their supply chain1
9. Supplier Quality Maturity Framework
Mastery of each step leads to improved visibility and quality across the supplier network
Level 1 Level 2 Level 3 Level 4 Level 5
Ad-hoc
Email
communication
Fax
communication
Manual data
capture Supplier
Scorecard
Repeatable
Supplier
Agreements
Electronic data
capture &
spreadsheets
Approved
Supplier List
Collaborative
Quality
Network
Integration
Quality
Network
Collaboration
Quality
Network
Visibility
Historical
Performance /
Automated
Scorecard
Automated
System Driven
Centralized
Supplier
Management
Metrics
and KPIs
Tier 1
Supplier
Collaboration
Predictive
Insights &
Triggered
Events
Optimized
Tier 1
Supplier
Visibility
10. Best Practices for Managing Quality In
the Supply Chain
10
Broaden supplier assessments
Enable broader visibility into the supplier network
45% of executives agree
the leading challenges to
supply chain efficiency
include supplier
performance and quality
management
- KPMG Global Manufacturing
Outlook report 2013
1
11. Establish clear measurement programs
Leverage automation tools to support measurement
& monitoring of supplier quality
Best Practices for Managing Quality In
the Supply Chain
11
2
Dynamic Supplier Scorecard
Real-Time
Consistent
Accurate
Prioritize
Schedule
Manage
Informed
Systematic
Efficient
Execute Consistent
Remediate Integrated
Measure Accurate
Decisions
Complete
Measure and Inform
Audit Management
Audit Execution
Audit Planning
Supplier Audit Checklist
12. Best Practices for Managing Quality In
the Supply Chain
12
Invest in infrastructure
Enable quality across the supply chain
through effective communication of
quality events
Cloud Computing
will play the most
important role in IT
enabling quality between
now & 2017
- Gartner, S Jacobson, “Quality: The Missing
Link in Your Supply Chain Strategy”, January 2015
3
Supplier 1
Supplier 2
Supplier 3
13. Best Practices for Managing Quality In
the Supply Chain
13
Close the quality loop with suppliers
Leverage technology to connect & integrate suppliers into quality
management processes
4
Quarantine
Quality Processes
Product Nonconformance
Notification Received
Supplier Identification
Root Cause
CAPA Plan
Effectiveness Check
Issue Identified
Notification to Supplier
SCAR
Reviewed
CAPA Approved
Action Item
Reminders
14. Extend quality management practices into
the supply chain
14
Visibility - Identify issues early before they become costly quality
incidents
Traceability - Understand the root cause and source of quality
issues in your supply chain
Accountability - Ensure supply chain partners understand issues
and resolution requirements in a timely manner
Profitability - Mitigate quality related financial risk and improve
supply chain efficiency