Quality Management Systems on SlideShare by Raj Kumar Mandal.
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Quality management systems (QMS) are essential frameworks that ensure products and services meet stakeholder requirements, promoting continuous improvement and organizational success. Key concepts include total quality management (TQM), which emphasizes customer satisfaction through continuous improvement, and quality by design (QBD), which focuses on integrating quality from the start of the process. Additionally, standards like ISO 9000 and ISO 14000 provide guidelines for establishing effective QMS and environmental management systems, while certifications validate an organization's compliance with these standards.
Quality Management Systems on SlideShare by Raj Kumar Mandal.
- 1. Quality Management Systems Quality management systems are a framework of policies, procedures, and processes designed to ensure that products or services consistently meet the requirements of customers and other stakeholders. They are critical for organizations across various industries, from manufacturing and healthcare to software development and education. Implementing a robust quality management system is essential for achieving organizational success, building customer trust, and promoting continuous improvement. RM by Raj Kumar Mandal
- 2. Concept of Quality, Total Quality Management, Quality by Design (QbD) Quality is the degree to which a product or service meets the needs and expectations of its users. Total Quality Management (TQM) is a management philosophy that emphasizes continuous improvement in all aspects of an organization, aiming to achieve customer satisfaction through team effort, customer focus, and data-driven decision-making. Quality by Design (QbD) is a proactive approach to quality assurance that focuses on designing products and processes with quality built-in from the beginning, minimizing defects and rework. Quality Meeting customer needs and expectations. Total Quality Management Continuous improvement and customer satisfaction. Quality by Design Designing for quality from the start.
- 3. Six Sigma concept Six Sigma is a data-driven approach to quality management that aims to eliminate defects and reduce variation in processes. It uses a methodology known as DMAIC (Define, Measure, Analyze, Improve, Control) to identify and address root causes of defects, leading to improved efficiency, reduced costs, and increased customer satisfaction. 1 DMAIC Define, Measure, Analyze, Improve, Control 2 Reduce Variation Minimize defects and inconsistencies. 3 Data-Driven Focus on measurable results and continuous improvement.
- 4. Out of Specifications (OOS) Out of Specification (OOS) refers to a situation where a product or process fails to meet predetermined specifications or quality standards. OOS events require immediate investigation and corrective actions to identify the root cause and prevent recurrence. A comprehensive OOS investigation involves evaluating all potential factors, such as equipment calibration, raw materials, and process parameters, to determine the source of the issue. Step Description 1 Identify the OOS event 2 Investigate the root cause 3 Implement corrective actions 4 Document the investigation and actions
- 5. Change control Change controlis a formal process for managing and approving modifications to products, processes, or systems. It ensures that changes are implemented effectively and without compromising quality or safety. The change control process typically involves submitting a change request, reviewing the request, and approving or rejecting the change based on its potential impact. This structured process helps mitigate risks, maintain consistency, and improve overallquality. Change Request Initiate a change request form. Review Assess the impact of the change. Approval Authorize the change to be implemented. Implementation Implement the change according to the approved plan. Verification Confirm that the change has been implemented correctly.
- 6. Introduction to ISO 9000 series of quality systems standards The ISO 9000 series of standards provides a framework for quality management systems (QMS). It outlines the requirements for establishing, documenting, implementing, maintaining, and continually improving a QMS to consistently meet customer and regulatory requirements. These standards are internationally recognized and help organizations demonstrate their commitment to quality and customer satisfaction. ISO 9001 Requirements for a quality management system. It provides guidance on planning, implementation, documentation, and improvement of QMS. ISO 9004 Provides guidance on quality management for achieving sustained success. It focuses on improving organizational performance and achieving organizational objectives. ISO 9000 Provides fundamental principles of quality management systems, including terminology and definitions.
- 7. ISO 14000 ISO 14000 is a set of international standards that focuses on environmental management. It provides guidelines for organizations to establish, implement, maintain, and continually improve an environmental management system (EMS). The ISO 14000 series aims to minimize the environmental impact of organizations' operations and activities, promote sustainable practices, and comply with applicable environmental laws and regulations. Reduce Waste Minimize waste generation and promote resource efficiency. Protect Ecosystems Conserve biodiversity and prevent pollution of air, water, and land. Use Renewable Energy Transition to renewable energy sources to reduce carbon footprint. Promote Recycling Implement effective recycling programs to reduce waste and conserve resources.
- 8. NABL The National Accreditation BoardforTestingandCalibrationLaboratories (NABL) is anaccreditation bodyinIndiathat provides accreditation to testingandcalibration laboratories. NABLaccreditation demonstrates that alaboratory meets internationallyrecognizedstandards forcompetence andimpartiality, assuringthe reliabilityandcredibilityof test and calibration results. Accreditation byNABLenhances the credibilityandreputation of laboratories, enabling themto provide high-qualityservices andmeet the requirements of customers andstakeholders. 1 Application for Accreditation Submit an applicationto NABL foraccreditation. 2 Assessment NABL assessors evaluate the laboratory's technical competence andmanagement system. 3 Accreditation If the laboratorymeets the requirements, NABLgrants accreditation. 4 Surveillance and Reassessment NABL conducts regularsurveillance audits andreassessments to ensure continuedcompliance.
- 9. GLP Good Laboratory Practice (GLP) is a quality system that ensures the reliability and integrity of non-clinical safety studies. It provides a framework for conducting laboratory studies in a controlled environment, with standardized procedures, documented protocols, and data management systems. GLP regulations are enforced by regulatory agencies worldwide to ensure the safety and efficacy of products, especially in the pharmaceutical and chemical industries. 1 Standardized Procedures Followestablished protocols for experimental design, data collection, and analysis. 2 Documentation Maintain comprehensive records of all experimental procedures, data, and observations. 3 Quality Control Implement rigorous quality control measures to ensure accuracy and reproducibility of results. 4 Training Provide training to personnel involved in GLP studies to ensure competence and adherence to guidelines.
- 10. Quality Management & Certifications Quality management certifications demonstrate that an organization has met the requirements of a specific quality standard, such as ISO 9001, ISO 14001, or GLP. These certifications provide a third-party validation of an organization's commitment to quality and customer satisfaction, enhancing their credibility, improving their competitive advantage, and fostering continuous improvement. ISO 9001 Demonstrates a commitment to quality management systems and customer satisfaction. ISO 14001 Highlights the organization's commitment to environmental management and sustainability.