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| document control and records management procedure: Organising and Controlling Current Records Andrew Griffin, Michael Roper, 1999 |
| document control and records management procedure: The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices Amiram Daniel, Ed Kimmelman, 2008-02-21 This new and expanded second edition maintains the organizational approach of the first and includes the requirements and guidance contained in the Quality System Regulation (QSReg), the ISO 13485:2003 standard, the ISO/TR 14969:2004 guidance document, and, as appropriate, a number of the FDA and Global Harmonization Task Force (GHTF) guidance documents.This second edition also addresses a number of additional topics, such as the incorporation of risk management into the medical device organization’s QMS, QMS issues related to combination products, the key process interactions within a QMS, effective presentation of and advocacy for a QMS during FDA inspections and third-party assessments, and future FDA compliance and standards activities. The organization of the guidebook is based on the order of the requirements in the QSReg. For each substantive requirement section there is: A verbatim statement of the QSReg requirement. A description of the comparable requirement in ISO 13485:2003, focusing on any additions to or differences from the requirements contained in the QSReg.Excerpts of the FDA responses to relevant comment groups contained in the Preamble to the QSReg. Excerpts from various FDA guidance documents related to quality management systems. A description of the relevant guidance contained in ISO/TR 14969:2004, focusing on any additions to or differences from the guidance in the Preamble and other FDA guidance documents, and, if useful, excerpts from relevant GHTF guidances. Authors’ notes giving guidance derived from the authors’ sixty years of regulatory compliance experience. This guidance book is meant as a resource to manufacturers of medical devices, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS. |
| document control and records management procedure: Sampling Procedures and Tables for Inspection by Attributes United States. Department of Defense, 1963 |
| document control and records management procedure: Integrated Management Systems Wayne Pardy, Terri Andrews, 2009-12-16 Today's competitive business environment poses a wide range of challenges to successful quality, safety, and environmental management systems. While many organizations create their management systems based on the requirements of their respective areas, integrating management systems provides the most effective solution to the challenges these organizations face. Integrated Management Systems: Leading Strategies and Solutions assists readers in the successful integration of their safety, quality, and environmental management systems. Using examples taken from a wide and diverse range of business situations, authors Terri Andrews and Wayne Pardy weave together a management system roadmap that can be used by any HSEQ practitioner, from the beginner to the seasoned industry professional. This book explores the many different management system options currently available, examines the requirements of the various management systems, explains the differences and similarities in the various approaches to management systems, and suggests practices and tools to help managers implement an integrated approach in order to reduce redundancies, streamline processes, and optimize resources. It includes an in-depth analysis of corporate culture and behavioral factors that affect management systems, and it employs a wide range of practical examples that any safety, quality, and environmental management practitioner can relate to. This book benefits health, safety, environmental management, and quality management practitioners and professionals, especially those who design and implement systems for the successful management of their safety and environmental performance, and for quality management requirements, customer service, and customer satisfaction. |
| document control and records management procedure: Records Management For Dummies Richardson, 2012-10-16 Here's what you should know to manage data records efficiently With proper electronic data management, your business can lower costs, improve efficiency, eliminate duplication, and be protected in the event of a lawsuit. This book provides an overview of records management solutions and implementation strategies in plain, non-technical English. Step-by-step instructions show you how to begin managing records and information and how to maintain the program once you have it established. Sample forms for inventory, scheduling, and necessary documentation are also available on the companion website. Electronic records management offers cost savings, greater efficiency, and protection in case of legal action; this book gets you started on an effective data management system This plain-English guide helps you determine what constitutes a record, shows you how to inventory records and create an efficient way to file both electronic and paper copies, and explains how to create a retention schedule Walks you through switching to electronic record-keeping, what to look for in a records management system, implementing best practices, ensuring that your system will stay current, and using the system effectively Helps you assure that the destruction of any sensitive information is conducted and documented correctly Records Management For Dummies helps your business save money and improve efficiency with effective electronic records management. |
| document control and records management procedure: Engineering Document Control, Correspondence and Information Management (Includes Software Selection Guide) for All Huw R Grossmith, 2023-01-27 The book is the Who, What, When, Where, How and, very importantly, Why of Engineering Document Control with related metadata management and includes a comprehensive software guide, and free Access based DC software tool (time limited) with examples and drills etc. |
| document control and records management procedure: Digital Forensics Processing and Procedures David Lilburn Watson, Andrew Jones, 2013-08-30 This is the first digital forensics book that covers the complete lifecycle of digital evidence and the chain of custody. This comprehensive handbook includes international procedures, best practices, compliance, and a companion web site with downloadable forms. Written by world-renowned digital forensics experts, this book is a must for any digital forensics lab. It provides anyone who handles digital evidence with a guide to proper procedure throughout the chain of custody--from incident response through analysis in the lab. - A step-by-step guide to designing, building and using a digital forensics lab - A comprehensive guide for all roles in a digital forensics laboratory - Based on international standards and certifications |
| document control and records management procedure: Handbook of Standards and Guidelines in Ergonomics and Human Factors Waldemar Karwowski, 2005-12-16 A comprehensive review of international and national standards and guidelines, this handbook consists of 32 chapters divided into nine sections that cover standardization efforts, anthropometry and working postures, designing manual material, human-computer interaction, occupational health and safety, legal protection, military human factor standar |
| document control and records management procedure: Public Sector Records Management Kelvin Smith, 2016-04-15 Records management has undergone significant change in recent years, owing to the introduction of freedom of information legislation as well as the development of e-government and e-business and the need to manage records effectively in both the private and public sector. There are very few purely practical texts for records managers and this book aims to fill that gap. The author has spent his entire career in public sector records management and has contributed to records management standards for governments around the world. The text is wholly practical and written at an accessible level. Although the author discusses legislation and examples from the UK, the book is relevant to public sector records management at an international level. It will be essential reading for professionals in record management posts as well as anyone who is responsible for record keeping as part of their operational duties. |
| document control and records management procedure: International Environmental Risk Management Robert A. Woellner, John Voorhees, Christopher L. Bell, 2020-08-13 Based on the first edition with extensive analysis of practical applications of environmental risk management and compliance management systems, this second edition of International Environmental Risk Management reflects updates made in the understanding and application of risk management best practices and makes available a frame of reference and systematic approach to environmental and social governance (ESG). It provides a pathway for readers to implement environmental management strategies that can be integrated with core operations and other risk management efforts, including supporting sustainability and corporate social responsibility initiatives associated with climate change, the circular economy or supply chain conditions, as well as enterprise risk management; anti-bribery, and other compliance management systems. This book provides in-depth discussions of ways to use global environmental management standards. New features in this edition: Combines EMS standards with discussion of specific principles, other authors’ research, and guidelines on management practices. Provides guidelines on how to prepare for, anticipate, and resolve environmental issues. Includes easily understandable information for all readers and is not simply aimed toward individuals who are knowledgeable about this topic. Provides in-depth discussions on using global environmental management standards to manage risk and promote resilience, as well as legal strategies and voluntary initiatives that companies can utilize to minimize risk. Accounts for the substantive revisions in ISO 14001:2015. As a growing and rapidly changing field, it is necessary to address new issues, guidelines, and regulations to assist businesses, academia, students, consultants, lawyers, and environmental managers with a pragmatic resolution to environmental risk management issues. This second edition gives a broad and detailed analysis of the changes made to international standards and practices and serves as an excellent guide to managing environmental risk. |
| document control and records management procedure: Guidelines for Process Safety Documentation CCPS (Center for Chemical Process Safety), 2010-09-09 The process industry has developed integrated process safety management programs to reduce or eliminate incidents and major consequences, such as injury, loss of life, property damage, environmental harm, and business interruption. Good documentation practices are a crucial part of retaining past knowledge and experience, and avoiding relearning old lessons. Following an introduction, which offers examples of how proper documentation might have prevented major explosions and serious incidents, the 21 sections in this book clearly present aims, goals, and methodology in all areas of documentation. The text contains examples of dozens of needed forms, lists of relevant industry organizations, sources for software, references, OSHA regulations, sample plans, and more. |
| document control and records management procedure: IT Audit, Control, and Security Robert R. Moeller, 2010-11-02 When it comes to computer security, the role of auditors today has never been more crucial. Auditors must ensure that all computers, in particular those dealing with e-business, are secure. The only source for information on the combined areas of computer audit, control, and security, the IT Audit, Control, and Security describes the types of internal controls, security, and integrity procedures that management must build into its automated systems. This very timely book provides auditors with the guidance they need to ensure that their systems are secure from both internal and external threats. |
| document control and records management procedure: Quality by Delitala (QbD) Volume 1: The Quality Manual Michael A. delitala, What is quality and how do you instill it? Quality by Delitala answers this question in an easy to understand, lucid, and pragmatic way. Michael A. Delitala takes his 29 years of experience at big pharma and small pharma and distills his knowledge and experience into this book providing a practical, hands-on approach to The Quality Manual. |
| document control and records management procedure: Quality Management System Handbook for Product Development Companies Vivek Nanda, 2005-01-27 Quality Management System Handbook for Product Development Companies describes a systematic approach for quality management and continuous improvement via a formal management system. The approach centers on a high-level process for defining a QMS from essential prerequisites to improvement mechanisms. The book outlines the five major QMS |
| document control and records management procedure: The AMA Handbook of Project Management Paul C. Dinsmore, Jeannette Cabanis-Brewin, 2014-06-12 A must-read for any project management professional or student. Projects are the life blood of any organization. Revised to reflect the latest changes to A Guide to the Project Management Body of Knowledge (PMBOK(R)) and the Project Management Professional Exam(R), the fourth edition of The AMA Handbook of Project Management provides readers with a clear overview of a complex discipline. Covering everything from individual projects to programs and strategic alignment, it addresses: Project initiation and planning Communication and interpersonal skills Scheduling, budgeting and meeting business objectives Managing political and resource issues Implementing a PMO Measuring value and competencies. The book compiles essays and advice from the field's top professionals and features new chapters on stakeholder management, agile project management, program management, project governance, knowledge management, and more. Updated with fresh examples, case studies and solutions to specific project management dilemmas, it remains an essential reference to the critical concepts and theories all project managers must master. |
| document control and records management procedure: Mastering and Managing the FDA Maze Gordon Harnack, 2014-07-18 The number of FDA regulations and the agency’s increased expectations is staggering and their content tedious, creating a regulated industry need for compliance insight and appropriate detail. This book is the reference needed to successfully navigate through the FDA maze! The target audiences for this desk reference include: Regulatory professionals, who know their responsibility to keep their firm’s employees trained and competent on FDA device regulations and who need a preliminary desk reference that can be used throughout their enterprise to help train and ensure compliance Neophytes, who know nothing about FDA but need a resource that provides both broad and specific information in sufficient detail to be useful Beginners, who know a little about FDA, need to know more, and need a reference tool to help them be more effective and productive on the job Intermediates, who knows enough about FDA to know they need to know more and who need a reference tool that provides them with both more basics and executable detail Busy managers, who need to know regulatory requirements and FDA expectations in order to manage compliance in their specific activity Busy executives (CEOs, COOs, and operations managers, whom FDA holds responsible for all regulatory compliance), who also need a desk reference with specific information to quickly assess regulatory compliance, identify potential noncompliance, and review corrective, preventive, and compliance actions |
| document control and records management procedure: Quality Management in Oil and Gas Projects Abdul Razzak Rumane, 2021-02-24 This book provides the tools and techniques, management principles, procedures, concepts, and methods to ensure the successful completion of an oil and gas project while also ensuring the proper design, procurement, and construction for making the project most qualitative, competitive, and economical for safer operational optimized performance. It discusses quality during design, FEED, detailed engineering, selection of project teams, procurement procedure of EPC contract, managing quality during mobilization, procurement, execution, planning, scheduling, monitoring, control, quality, and testing to achieve the desired results for an oil and gas project. This book provides all the related information to professional practitioners, designers, consultants, contractors, quality managers, project managers, construction managers, and academics/instructors involved in oil and gas projects and related industries. Features Provides information on the various quality tools used to manage construction projects from inception to handover Discusses the life cycle phases, developed on systems engineering approach, and how it is divided into manageable activity/element/components segments to manage and control the project Includes a wide range of tools, techniques, principles, and procedures used to address quality management Covers quality management systems and development of quality management systems manuals Discusses quality and risk management, and health, safety, and environmental management during the design and construction process |
| document control and records management procedure: Food and Drink - Good Manufacturing Practice Institute of Food Science and Technology, Louise Manning, 2018-10-22 The latest updated edition of the market-leading guide to Good Manufacturing Practice (GMP) in the food and drink industry This all-new, 7th edition of Food and Drink - Good Manufacturing Practice: A Guide to its Responsible Management features a wealth of new information reflecting changes in the industry and advances in science that have occurred since the publication of the last edition back in 2013. They include topics such as: Food Safety Culture, Food Crime and Food Integrity Management Systems, Food Crime Risk Assessment including vulnerability risk assessment and Threat Analysis Critical Control Point (TACCP), Security and Countermeasures, Food Toxins, Allergens and Risk Assessment, Provenance and authenticity, Electronic and digital traceability technologies, Worker Welfare Standards; Smart Packaging, Food Donation Controls and Animal Food Supply, Safety Culture; Provenance and integrity testing and Sustainability Issues. In addition to the new topics mentioned above, Food and Drink - Good Manufacturing Practice, 7th Edition offers comprehensive coverage of information in chapters on Quality Management System; Hazard Analysis Critical Control Point (HACCP); Premises and Equipment; Cleaning and Sanitation; Product Control, Testing and Inspection; Heat Preserved Foods; Frozen Foods; Foods for Catering and Vending Operations; and much more. Comprises both general guidance and food sector-specific requirements for good manufacturing practice Incorporates all the most recent developments and changes in UK and EU law Provides a readable and accessible reference for busy managers in the food industry Food and Drink - Good Manufacturing Practice: A Guide to its Responsible Management, 7th Edition is a valuable reference for anyone in a managerial or technical capacity concerned with the manufacture, storage, and distribution of food and drink. The book is also a “must –read” for the recommended reading lists for food science, food technology and food policy undergraduate and postgraduate studies. IFST - the Institute of Food Science and Technology is the leading qualifying body for food professionals in Europe and the only professional qualifying body in the UK concerned with all aspects of food science and technology. |
| document control and records management procedure: A Practical Field Guide for ISO 13485:2016 Erik V. Myhrberg, Joseph Raciti, Brandon L. Myhrberg, 2019-11-06 The purpose of this expanded field guide is to assist organizations, step-by-step, in implementing a quality management system (QMS) in conformance with ISO 13485:2016, whether from scratch or by transitioning from variations of the ISO 13485 family. In keeping with ISO 9000:2015's definition of quality as the degree to which a set of inherent characteristics fulfills requirements, Myhrberg, Raciti, and Myhrberg have identified the requirements and inherent characteristics (distinguishing features) for this expanded field guide. Within the guide, each subclause containing requirements is the focus of a two-page visual spread that consistently presents features that fulfill the requirements listed below. This guide will: Provide a user-friendly guide to ISO 13485:2016's requirements for implementation purposes -Identify the documents/documentation required, along with recommendations on what to consider retaining/adding to a QMS during ISO 13485:2016 implementation -Guide internal auditor(s) regarding what to ask to verify that a conforming and effective QMS exists -Direct management on what it must do and should consider to satisfy ISO 13485:2016's enhanced requirements, as well as on the responsibilities for top management -Depict step-by-step in flowchart form what must occur to create an effective, conforming QMS |
| document control and records management procedure: The Routledge Handbook of Language Testing Glenn Fulcher, Luke Harding, 2021-12-15 This second edition of The Routledge Handbook of Language Testing provides an updated and comprehensive account of the area of language testing and assessment. The volume brings together 35 authoritative articles, divided into ten sections, written by 51 leading specialists from around the world. There are five entirely new chapters covering the four skills: reading, writing, listening, and speaking, as well as a new entry on corpus linguistics and language testing. The remaining 30 chapters have been revised, often extensively, or entirely rewritten with new authorship teams at the helm, reflecting new generations of expertise in the field. With a dedicated section on technology in language testing, reflecting current trends in the field, the Handbook also includes an extended epilogue written by Harding and Fulcher, contemplating what has changed between the first and second editions and charting a trajectory for the field of language testing and assessment. Providing a basis for discussion, project work, and the design of both language tests themselves and related validation research, this Handbook represents an invaluable resource for students, researchers, and practitioners working in language testing and assessment and the wider field of language education. |
| document control and records management procedure: Quality Operations Procedures for Pharmaceutical, API, and Biotechnology Syed Imtiaz Haider, Erfan Syed Asif, 2012-06-06 To stay in compliance with regulations, pharmaceutical, medical, and biotech companies must create qualtiy SOPs that build in the regulatory requirements into actions and describe personal flow, internal flow, flow of information, and processing steps. Quality Operations Procedures for Pharmaceutical, API, and Biotechnology and the accompanying CD-ROM take into account all major international regulations, such as FDA, EU GMP, cGMP, GLP, PDA technical monographs, PDA technical reports, PMA concepts, journals of PDA, GCP, and industry standard ISO 9000, to be in compliance with documentation guidelines. No other resource deals exclusively with the key elements of quality control and quality assurance procedures for pharmaceutical operations and provides hands-on templates to be tailored to achieve global regulatory compliance. The book provides instant answers about what to include in critical quality assurance and quality control SOPs and how to enhance productivity. The CD-ROM contains nineteen quality control and thirty-three quality assurance SOPs designed so that users can input them into their computers and use their Microsoft Word programs to edit and print these documents. The book ensures minimization of the number of documents, helping to reduce the nightmare-like aura that surrounds an FDA audit. The SOPs exclusively refer to the documents specially required for compliance; however, specific formats are not included to ensure that the electronic templates can be easily used by pharmaceutical, bulk pharmaceutical, medical device, and biotechnology industries. The combination of text and CD-ROM presents a ready-to-use resource on the quality systems of aseptic pharmaceutical non-aseptic production and to provide general information and guidelines. They comprise a tool that can be used to develop a set of quality SOPs in order to support the road map established for the on-time successful start-up of the facility operation in compliance with the GMP requirements. |
| document control and records management procedure: Designing a World-Class Quality Management System for FDA Regulated Industries David N. Muchemu, 2008-04 This is an autobiographical treatise of an American citizen raised during a period our nation was placed on trial in the battle for the civil right of racial equality. This writing presents a candidly plain perspective of a desire and struggle for the divine right every human being is entitled to, to come to know the truth about where mankind came from and where it is going. The journey is one we all make through the space we are allowed to experience this physical realm. This work, however, presents a bold and provocative argument to support the fact that the reality of our existence as created and pro-created spirit beings is eternal. This writing chronicles the joy and sorrow from the heights and depths involved with human relationships. The author discloses his intimate and personal experience(s) with the Elohim (God) of creation before and after his spiritual rebirth/pentecost. The writer details of such experiences that would summon the response of a US president and later result with the writer being one of the first to quantify and articulate specific technological audit incentive oversights which catalyst the greed of financial gain as exposed in America's executive corporate culture, i.e. Enron, World Com and others before conception of the Sarbannes Oxley Act. The ultimate focus and culmination of this work is to praise and extol Yahweh-Elohim, our Heavenly Father, as he has visited his creatures and children one last time in the body of Henry Clifford Kinley. This work proclaims his eternal reward of a spiritual peace, joy and happiness that embodies the power to suffer opposition. The world as a whole, is ignorant of this Divine Philosophy. Kenneth Lamar Williams Copyright 2007 |
| document control and records management procedure: ISO 9001:2000 Quality Management System Design Jay J. Schlickman, 2003 The book describes the design rules required to document, implement, and demonstrate quality management system effectiveness in compliance with the latest version of the ISO 9000 International Standard. This systematic and engineering approach simplifies the many complexities in maintaining compliance with ISO standards. This hands-on guide is packed with tips and insights the author has garnered from personally designing quality management systems that integrate organizational strategy with quality management. Moreover, the book helps professionals create meaningful documentation and a user-friendly, informative quality manual that together form the core of an effective and responsive quality management system.--Jacket. |
| document control and records management procedure: ISO 9001:2008 for Small Businesses Ray Tricker, 2014-01-21 Small businesses face many challenges today, including the increasing demand by larger companies for ISO compliance. Compliance is a challenging task for any organisation and can often be time consuming and costly, particularly for small businesses who are unlikely to have quality assurance experts on the payroll. However, it is still possible to achieve compliance without the need for expensive consultancy or training that takes you out of the office! Ray Tricker has already guided hundreds of businesses through the challenge and this, the 5th edition of his life-saving ISO guide, has been rewritten and refined following 5 years' field use of working with the standard. The one area that an organisation (particularly a small business) always wants to know is ‘how much is it going to cost to implement and operate a QMS compliant with ISO 9001: 2008 – and is it going to be worth the trouble?!’ Due to popular demand, Edition 5 now includes a brand new chapter on the cost of implementing ISO 9001:2008. This edition provides: Relevant examples that put the concepts and requirements of the standard into a real-life context Down to earth explanations to help you determine what you need to work in compliance with and/or achieve certification to ISO 9001:2008 An example of a complete, generic, Quality Management System consisting of a Quality Manual plus a whole host of Quality Processes, Quality Procedures and Work Instructions Access to a free, software copy of this generic QMS files (available from the author) to give you a starting-point from which to develop your own documentation. ISO 9001:2008 is the most widely followed quality management standard and the rewards can be great, opening up new business opportunities, as well as bringing real improvements to your processes and outputs. |
| document control and records management procedure: Report of Apollo 204 Review Board to the Administrator United States. National Aeronautics and Space Administration. Apollo 204 Review Board, 1967 |
| document control and records management procedure: Handbook of Systems Engineering and Management Andrew P. Sage, William B. Rouse, 2014-12-31 The trusted handbook—now in a new edition This newly revised handbook presents a multifaceted view of systems engineering from process and systems management perspectives. It begins with a comprehensive introduction to the subject and provides a brief overview of the thirty-four chapters that follow. This introductory chapter is intended to serve as a field guide that indicates why, when, and how to use the material that follows in the handbook. Topical coverage includes: systems engineering life cycles and management; risk management; discovering system requirements; configuration management; cost management; total quality management; reliability, maintainability, and availability; concurrent engineering; standards in systems engineering; system architectures; systems design; systems integration; systematic measurements; human supervisory control; managing organizational and individual decision-making; systems reengineering; project planning; human systems integration; information technology and knowledge management; and more. The handbook is written and edited for systems engineers in industry and government, and to serve as a university reference handbook in systems engineering and management courses. By focusing on systems engineering processes and systems management, the editors have produced a long-lasting handbook that will make a difference in the design of systems of all types that are large in scale and/or scope. |
| document control and records management procedure: HACCP System Auditing for Food Safety Luis Couto Lorenzo, 2024-08-06 Guide to understand the fundamentals of HACCP and to planning and conducting food safety audits HACCP System Auditing for Food Safety helps readers understand the fundamentals of the HACCP concept and its importance in ensuring food safety, with guidance on how to develop auditing skills including planning, executing, and reporting on HACCP audits effectively. To aid in reader comprehension, this book incorporates many practical examples with accompanying figures and models, along with selected case studies and global practices from Europe, Canada, USA, and New Zealand to showcase international practices and standards. ISO 19011 as a standard reference is used throughout the text. Written by a seasoned industry professional with decades of hands-on experience as an official control agent, HACCP System Auditing for Food Safety includes information on: Elements of the HACCP methodology, including related concepts, adapted to the specificities of the food operator Phases of HACCP study and application of the seven principles, respecting their internal logic and how they are interrelated HACCP as a management system, starting from the commitment of the management or the company’s board of directors, with tasks and responsibilities distributed among staff Management system auditing techniques to verify performance, whether for internal audits, supplier audits, or certification purposes Providing the rational and scientific basis necessary to anticipate problems and to learn from the experiences and situations that arise in the food industry, HACCP System Auditing for Food Safety is an essential reference for various industry professionals, including technicians, quality managers, consultants, auditors, and official control agents. |
| document control and records management procedure: The ISO 14000 EMS Audit Handbook Greg Johnson, 2020-04-28 The ISO 14000 EMS Audit Handbook is an innovative and cost-effective approach for the Environmental Management System (EMS) audit to ISO 14001. The Handbook presents comprehensive strategies for conducting all phases of the EMS audit, including effective assessment processes for determining improved environmental performance. |
| document control and records management procedure: Quality and Statistics Milton J. Kowalewski, 1994 |
| document control and records management procedure: The upgrade of the Belfast to Bangor railway line Northern Ireland. Audit Office, 2007-03-22 Since 2000-01, the Department for Regional Development has provided £155 million for capital investment in the rail network in Northern Ireland. In January 2001, the Department approved a project costing £14.7 million to upgrade the Belfast to Bangor railway line, one of the busiest railway lines in Northern Ireland carrying nearly 2 million passengers a year. However, this NIAO report finds that the project experienced a number of difficulties, resulting in a very significant overspend and late delivery, with a final cost of almost £34 million, and completion in September 2002 delayed by nine months later than planned. The problems were the result of failures in several key areas, and in addition to the increased cost of the project, there is uncertainty as to whether it has delivered all of its intended benefits. The original specification of a 90 mph speed limit was reduced to 70 mph and other works on bridges and sea defences were removed from the contract to reduce costs. The report makes a number of recommendations to improve performance in relation to: economic appraisal; construction procurement and project management; records management; ex-gratia payments to staff; corporate governance; and departmental control of capital projects. |
| document control and records management procedure: Ask a Manager Alison Green, 2018-05-01 'I'm a HUGE fan of Alison Green's Ask a Manager column. This book is even better' Robert Sutton, author of The No Asshole Rule and The Asshole Survival Guide 'Ask A Manager is the book I wish I'd had in my desk drawer when I was starting out (or even, let's be honest, fifteen years in)' - Sarah Knight, New York Times bestselling author of The Life-Changing Magic of Not Giving a F*ck A witty, practical guide to navigating 200 difficult professional conversations Ten years as a workplace advice columnist has taught Alison Green that people avoid awkward conversations in the office because they don't know what to say. Thankfully, Alison does. In this incredibly helpful book, she takes on the tough discussions you may need to have during your career. You'll learn what to say when: · colleagues push their work on you - then take credit for it · you accidentally trash-talk someone in an email and hit 'reply all' · you're being micromanaged - or not being managed at all · your boss seems unhappy with your work · you got too drunk at the Christmas party With sharp, sage advice and candid letters from real-life readers, Ask a Manager will help you successfully navigate the stormy seas of office life. |
| document control and records management procedure: Quality Assurance Implementation in Research Labs Akshay Anand, 2021-08-17 This book is a comprehensive and timely compilation of strategy, methods, and implementation of a proof of concept modified quality module of Good Laboratory Practices (GLP). This text provides a historical overview of GLP and related standards of quality assurance practices in clinical testing laboratories as well as basic research settings. It specifically discusses the need and challenges in audit, documentation, and strategies for its implications in system-dependent productivity striving research laboratories. It also describes the importance of periodic training of study directors as well as the scholars for standardization in research processes. This book describes different documents required at various time points of a successful Ph.D and post-doc tenure along with faculty training besides entire lab establishments. Various other areas including academic social responsibility and quality assurance in the developing world, lab orientations, and communication, digitization in data accuracy, auditability and back traceability have also been discussed. This book will be a preferred source for principal investigators, research scholars, and industrial research centers globally. From the foreword by Ratan Tata, India “This book will be a guide for students and professionals alike in quality assurance practices related to clinical research labs. The historical research and fundamental principles make it a good tool in clinical research environments. The country has a great need for such a compilation in order to increase the application of domestic capabilities and technology” |
| document control and records management procedure: The ASQ Certified Quality Auditor Handbook Lance B. Coleman, 2020-02-01 The value of the ASQ Certified Quality Auditor Handbook, Fifth Edition, is clear. It is designed to help new auditors gain an understanding of the field and prepare for the ASQ CQA exam. In addition, experienced auditors can refer to it as a helpful reference; audit managers and quality managers can rely on it for guiding their auditing programs; and trainers and educators can use it for teaching fundamentals. This in-depth overview of quality auditing represents auditing practices for internal and external applications. It provides practical guidance for both system and process auditors as well. Many current topics have been expanded to reflect changes in auditing practices since 2012, with guidance from the recent 2017 update of ISO 19011. In addition, readers will find example audit situations, stories, and review comments to enhance their understanding of the field. Topics covered include the common elements of all types of system and process audits (quality, environmental, safety, and health): Auditing fundamentals, including types of quality audits, purpose and scope of auditing, terms and definitions, roles and responsibilities of participants, and professional conduct The audit process, from preparation and planning, to performance and reporting, to follow-up and closure Auditor competencies, including resource management, conflict resolution, communication, interviewing, and team dynamics Audit program management and business applications, including staffing, training and development, program evaluation, organizational risk management, and best practices Quality tools and techniques, including problem-solving tools, process improvement techniques, basic statistics, verification, and validation This book is an encyclopedia of all major bodies of information a new or experienced quality auditor would need. It covers both the qualitative and the quantitative, which is a strength. I can't think of a quality auditor that would not find this work helpful. Kim H. Pries, CRE, CQE, CSQE, CSSBB, CMQ/OE, CQA This handbook will be helpful to those who are new to auditing or require more in-depth knowledge of the implementation of an audit program. Boxed examples or scenarios provide some of the practical challenges encountered during auditing. Govind Ramu, ASQ Fellow, Co-Author ASQ SSGB Handbook, Author ASQ CSSYB Handbook Lance B. Coleman, Sr. has over 25 years of leadership experience in the areas of quality engineering, Lean implementation, quality, and risk management in the Medical Device, Aerospace, and other regulated industries. He has presented, trained, and consulted throughout the United States and abroad. Lance is currently a Director of Quality for IDEX Health and Science, LLC, in Oak Harbor, Washington. |
| document control and records management procedure: Records Management for Museums and Galleries Charlotte Brunskill, Sarah Demb, 2012-04-27 The systematic management of records is an important activity for 'information businesses' such as museums and galleries, but is not always recognized as a core function. Record keeping activities are often concentrated on small groups of records, and staff charged with managing them may have limited experience in the field.Records Management for Museums and Galleries offers a comprehensive overview of records management work within the heritage sector and draws on over a decade of experience in applying fundamental principles and practices to the specific circumstances of museums. It introduces readers to the institutional culture, functions, and records common to museums, and examines the legislative and regulatory environments affecting record-keeping practices. The book is comprised of eight chapters, including: a history of records keeping in the UK museum and gallery sector; the basics of records management; making a business case for records management; requirements of legislation for records management; how to conduct a records survey; strategy and action planning; how to develop a file plan, retention schedule and records management programme; and a guide to useful additional resources. - Gives practical and tested solutions to real world issues - Fills a gap in the literature as a handbook in this important sector - Provides an overview of the sector as a whole |
| document control and records management procedure: Privacy Act Issuances ... Compilation United States. Office of the Federal Register, 1984 Contains systems of records maintained on individuals by Federal agencies which were published in the Federal Register and rules of each agency concerning the procedures the agency will use in helping individuals who request information about their records. |
| document control and records management procedure: Using IBM Enterprise Records Whei-Jen Chen, Serena S Chan, Jean-Marc Costecalde, Yolanda H Yates, Harry Yessayan, IBM Redbooks, 2015-05-29 Records management helps users address evolving governance mandates to meet regulatory, legal, and fiduciary requirements. Proactive adherence to information retention policies and procedures is a critical facet of any compliance strategy. IBM® Enterprise Records helps organizations enforce centralized policy management for file plans, retention schedules, legal preservation holds, and auditing. IBM Enterprise Records enables your organization to securely capture, declare, classify, store, and dispose of electronic and physical records. In this IBM Redbooks® publication, we introduce the records management concept and provide an overview of IBM Enterprise Records. We address records management topics, including the retention schedule, file plan, records ingestion and declaration, records disposition, records hold, and Enterprise Records application programming interfaces (APIs). We also use a case study to describe step-by-step instructions to implement a sample records management solution using Enterprise Records. We provide concrete examples of how to perform tasks, such as file plan creation, records ingestion and declaration, records disposition, and records hold. This book helps you to understand the records management concept, the IBM Enterprise Records features and capabilities, and its use. |
| document control and records management procedure: Federal Register , 1976 |
| document control and records management procedure: Information and Records Management , 1974 |
| document control and records management procedure: Title List of Documents Made Publicly Available U.S. Nuclear Regulatory Commission, 1981-10 |
| document control and records management procedure: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2003: Agricultural programs United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, 2002 |
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