When a diagnostic test is performed in the medical laboratory, the outcome of the test is a result. have an easy to use and consistent format. Medicines / FPPs; Active pharmaceutical ingredients ... is to work in close cooperation with national regulatory agencies and other partner organizations to make quality priority medical products available for those who urgently need … lo1 describe quality control system and key, INSPECTION AND QUALITY CONTROL - . This includes: Quality Manual Quality Policy Customer Charter Key Business Processes QMS Processes Operational Procedures Forms / Templates Records PROCEDURE In the Office of the President all internally controlled QMS documentation is maintained in electronic format. Whether your application is business, how-to, education, medicine, school, church, sales, marketing, online training or just for fun, PowerShow.com is a great resource. To monitor, control and improve effectively the whole applied operations at every stage of the finished pharmaceutical products. And, best of all, most of its cool features are free and easy to use. ), - Data Mining: Concepts and Techniques (3rd ed.) Assessing active pharmaceutical ingredients, finished pharmaceutical products and quality control laboratories according to stringent, internationally-agreed requirements. Uploaded by. It's FREE! chapter 16. david a. collier and james r. evans. Pressure for design Pressure for contractors Testing and commissioning Quality and Cost 1. Basic principles and concepts of Drug resistance-TB. Get powerful tools for managing your contents. - Basic Principles and Concepts of M. TB and Resistance 1. - Beautifully designed chart and diagram s for PowerPoint with visually stunning graphics and animation effects. Personnel 7. CrystalGraphics 3D Character Slides for PowerPoint, - CrystalGraphics 3D Character Slides for PowerPoint. QC IN BLOOD GROUP SEROLOGY 6. The Quality Management System Organization Personnel Equipment Purchasing & Inventory Process Control Information Management Documents & Records Occurrence Management Assessment Process Improvement Customer Service Facilities & Safety Definition Quality Control (QC) is part of quality management focused on fulfilling quality requirements ISO 9000:2000 (3.4.10) QC is examining … Why do we need External Quality Assessment? Quality in blood bank • A simple definition of quality is 'fitness for a purpose'. Prequalification Procedures & Fees: FPPs, APIs & QCLs . The quality requirements involve:- • Quality control and proficiency testing • Internal and external audits • Personnel and organization • Premises, equipment and materials • Documentation • Blood processing • Complaints and component recall • Investigation of errors and accidents, Internal Quality Control ( IQC ) • IQC refers to the set of procedures undertaken by the laboratory staff for the Continuous and immediate monitoring of the laboratory work in order to decide whether the results are reliable enough to be released. Quality Management All activities of the overall management function that: • Determine quality policy objectives • Implement them by means such as quality planning, quality control, quality assurance, and quality improvement within the system.. Quality assurance • … Quality Management All activities of the overall management function that: • Determine quality policy objectives • Implement them by means such as quality planning, quality control, quality assurance, and quality improvement within the system. DOCUMENTATION REQUIREMENT OF A SYSTEM ; ISO 9001-2000 ; ISO 14000 ; ISO 17025 ; SA 8000 ; 16 ... SAE … all projects involve the production and control of, Quality Documentation - . Retention 6. BY. Keep records legible, readily identifiable, and retrievable. Tubes, slides, tiles, microplates or gel cards should be labelled properly. Information collection & evaluation • Consent form • Donor is registered for permanent record • Donor must be checked for possible self harm or potential harm to recipient( list of questionnaires). Platelet concentrates: • The Tº at which pH is measured should be the same as stored • Label the volume, the actual volume by measurement must be 10% of the stated volume • Storage : 20-24ºC • Tº should be recorded at least every 4H during storage. spyros volonakis phd cand ., meng, Quality, Quality Control - . successful and, Quality Assurance and Control - . It also describes the “hows” in the procedures and forms that are referenced in the manual given by the company. E. Minute (Time) related problems. To detect hidden problem To receive help and support To compare our performance with others and improve quality, Quality • = Excellence • = Conformance to specifications • = Fitness for use • = Value for the price. Wilson Orellana. Disposition 7. Prevention cost: cost involved in … Thank You And they’re ready for you to use in your PowerPoint presentations the moment you need them. wolfgang huber european bioinformatics institute. Ensuring manufacturing sites, quality control laboratories and contract research organizations meet international standards for safety, quality and performance. A failure in the quality system can lead to numerous situations which may be potentially dangerous to the patient, i.e. Storage 3. Quality Management. Chapter 8 *, Basic Principles of GMP Quality Management. objectives. quality control overview world health organization Powerpoint Presentation . presentations for free. definition – a set of laboratory procedures to ensure the test results are accurate and reliable as, Quality control and normalization - . QC of Blood storage and Transportation • All liquid RBC components kept at T of 1-10ºC during transport • All component routinely stored at 20-24ºC should be maintain T during shipment, Transportation • All frozen components should be transport in frozen state at –18ºC or colder • Periodic T check and documented to ensure the transportation adequate to meet the criteria. Or use it to upload your own PowerPoint slides so you can share them with your teachers, class, students, bosses, employees, customers, potential investors or the world. Management and infrastructure 1. - Traffic control and Quality of Service Reading: Chapter 18 Some basic concepts Traffic policing Incompliant packets dropped Traffic shaping Incompliant packets held ... Data Mining: Concepts and Techniques (2nd ed. Records 5. They'll give your presentations a professional, memorable appearance - the kind of sophisticated look that today's audiences expect. chapter 16. david a. collier and james r. evans. Quality management system 3. Antisera used in the ABO grouping must be used as per the manufacturer’s instructions. quality control laboratories General considerations Glossary Part one. Quality assurance is generic and does not concern the specific requirements of the product being developed. It allows specifying agencies to perform quality assurance sampling, testing and record keeping to confirm the performance of the producer’s quality plan as set forth herein. Inspections. A Quality Policy … 5- issue of unscreened blood due to faulty laboratory procedures, Quality Assurance in blood bank • In a blood transfusion centre, it means that a management system should exist to look into provision of a safe unit of blood and, if any errors are identified, these should be corrected, QC in Blood Bank Technology • Donor services and Blood collection • Blood grouping • Crossmatch & antibody screening • Transfusion • Component preparation • Storage , issue and transportation, QC in Blood Bank • Positive and negative controls on all tests • Reverse grouping • Good documentation, SOPs etc • Equipment monitoring, calibration, maintenance. quality assurance failure testing statistical control company, Quality Management System Documentation - . In blood transfusion service, the primary goal of quality is 'transfusion of safe unit of blood.' The Basic Elements of Quality Assurance in Higher Education, - The Basic Elements of Quality Assurance in Higher Education Dr. Richard Lewis, UK International consultant, HEP2 Vinh workshop - basic elements, | PowerPoint PPT presentation | free to view. • Reduce cost. • Available good database for decisions maker. Examples of quality control activities include inspection, deliverable peer reviews and the testing process. Check Sheet. overview. quality system documentation. Biological Characteristics and Condition of M. Tuberculosis Growth 1. chapter 1. quality improvement in the modern business, Software Quality Assurance and Quality Control - . QC of blood component preparation • Whole blood: • Frequency of control: 1% of all units with minimum of 4 units per month • Storage :- 2ºC to 6 ºC, for CPDA-1 the storage time is 35 days, CPD & CD2D – 22days. Total quality management (TQM) framework for managing quality in a healthcare laboratory Analytical processes, general policies, practices & and procedures that define how all aspects of the work are done. • Help health planer to improve the programs. Quality Kpi found in: Quality Kpi Examples Ppt PowerPoint Presentation File Visuals, Quality Management Dashboard Ppt PowerPoint Presentation Outline Influencers, Product Quality Check Ppt PowerPoint Presentation Introduction,.. Ahmad Shihada Silmi,Msc, FIBMS Lecturer of Haematology & Immunology Faculty of Science, IUG. The procedure covers the review and control of all documentation in the Quality Management System. QC IN BLOOD GROUP SEROLOGY Principle: • The four main blood group A,B,O and AB are determined by forward grouping " cell typing" to detect presence or absence of A and B Antigens on red blood cells with Anti A and Anti B " Antisera" • Rh positive or Rh negative red blood cells are classified by presence or absence of D Antigen which can be detected by Anti D. QC IN BLOOD GROUP SEROLOGY • Blood sample for ABO grouping 1. anja von heydebreck (darmstadt), Reliability and Quality Control - . QUALITY SYSTEM DOCUMENT TITLE: QUALITY SYSTEM DOCUMENTATION CONTROL 1.0 PURPOSE 1.1 This document is to ensure that quality system procedure; work instructions, SOPs, reference documents, forms, etc. • Documents are controlled within the Quality Management System (QMS) • What is the QMS? Capacity building. If so, share your PPT presentation slides online with PowerShow.com. Quality Documentation Note: Any electronic or hard copies of this document are not subject to change service . Find PowerPoint Presentations and Slides using the power of XPowerPoint.com, find free presentations research about Good Documentation Practices PPT. Economics is the study of _____. Samples should be stored at 4°C and preferably be tested within 48 hours. Premises 8. Quality Assurance Documentation - . Contracts Part two. lee buddress, ph,d ., c.p.m. Or use it to create really cool photo slideshows - with 2D and 3D transitions, animation, and your choice of music - that you can share with your Facebook friends or Google+ circles. It is the intent of the program that acceptance or rejection of product be based on chapter 16. david a. collier and james r. evans. Download quality control overview world health organization PPT for free. introduction advantages of qms documentation organizational format of, Work Flow Control and Documentation - . • To develop uniform standard of lab. Presentation Title: Quality Control Overview World Health Organization. Quality assurance • This describes all the steps taken both in and outside the laboratory to achieve reliable results, starting with the preparation of the patient and collection of the specimen and ending with the correct interpretation of the results. Approved: 02.06.2010 Version 1.2 page 2 of 39 ... preparation and control of quality manuals tailored to the specific needs of the user. Also Explore the Seminar Topics Paper on Quality Control with Abstract or Synopsis, Documentation on Advantages and Disadvantages, Base Paper Presentation Slides for IEEE Final Year Mechanical Engineering ME or Production Automobile Students for the year 2019 2020. - Unit I: Basic Economic Concepts What is Economics in General? project, Quality Control - Springshare is currently featuring da libguides (along with the biology guide @ philips academy) “as. PowerShow.com is a leading presentation/slideshow sharing website. ... A quality control plan can be defined as a document that lists checkpoints related to quality. Boasting an impressive range of designs, they will support your presentations with inspiring background photos or videos that support your themes, set the right mood, enhance your credibility and inspire your audiences. Materials, equipment, instruments and other devices 10. 1.2 This document will outline the issuance control, define responsibilities for their The … – Every part of the laboratory that management oversees – Essentially everything • When ‘define’ and ‘specify’ are used in ISO/IEC 17025—it means the laboratory is expected to build a document that defines or specifies that “issue/item” Search Contact Help Login see more. A Case Study of a Quality System Implementation in a Small Manufacturing Firm. Protection 4. Regular evaluations of the quality of pharmaceutical products should be conducted with the objective of verifying the consistency of the process and ensuring its continuous improvement. - A Quick Review of Basic Concepts in Science, Systems, Matter, and Energy G. Tyler Miller s Living in the Environment 14th Edition Chapter 3 Key Concepts The Nature ... - Learn about the basics of photography in deep in this presentation and grow your photography business art. The glassware used should be dry and clean. Donor selection • Main purpose is to determine whether the person in good health, in order to protect the donor against damage to his/her own health, and to protect the recipient against transmission of disease or drugs which could be detrimental to the patient. Medicines quality control laboratories; FPPs and APIs Eligible for Prequalification ("EOIs") Menu Column 2 . Quality control is used to verify that deliverables are of acceptable quality and that they are complete and correct. How to discover and to assure my quality???? Document control plan Yes Is Process ... and learning's in implementing model discussed in this course Identify person who will be accountable for control plan documentation and updates The Quality Improvement Model Objectives Explore the steps for setting up controls for your project Review Control Plan elements Review the need for well documented control plans to “sustain the gains” Introduce … A Quick Review of Basic Concepts in Science, Systems, Matter, and Energy. Home Loan Documents. Uploaded by. see more. • The regular testing of quality control [QC] material along with the patient samples • Comparison of the QC results to specific statistical limits [ranges] • Rejection of patient results if QC is outside of limits But does this apply to qualitative tests? CHAPTER 8: QUALITY CONTROL AND QUALITY ASSURANCE perform quality control sampling, testing and record keeping on the product. • “Totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs [ ISO 8402,2.1:1994]”, Blood Transfusion Service Blood Bank Hospital ? A policy represents a declarative statement by an organization. The result may be a patient result or it may be a quality control (QC) result. Workshop in the framework of the 2nd KNUST Summerschool August 20 -24, 2012 Ton Vroeijenstijn Quality Consultants, Basic Concepts for Assessing Environmental Impacts. sumer esip meeting july 8, 2014. h. k. ramapriyan assistant, Quality Control - . Home | Hematology | Clinical Chemistry | Coagulation | Other. Objectives of quality Main objectives • To help lab staff to establish, manage and monitor a testing process to assure the analytical quality of the test results . Documentation Control and Quality Control - . Equipment, instruments and other devices 9. Documentation Data base. Wasim Bari. ), - Data Mining: Concepts and Techniques (2nd ed.) Concave mirror (agglutination viewer) or microscope may be used to examine reactions that appear negative by the naked eye. Donor selection Old age 17-60 year Hb more than 13.5g% and 12.5g% for female HCT more than 38%for male and 36% for female, Preparation for collection • The donation room must be wide with light enough • Equipment must be cleaned, calibrated & checked for performance e.g: a) blood container should be inspected for any defect in anticoagulant solution, moisture or discoloration of the surface of the bag or leakage, b) blood bag refrigerator , centrifuge- need to be checked, Blood collection & processing • Aseptic technique • Seal closed method • Immediate storage at 1-6ºC • Components preparation has to be done within 6 hours after collection • Labels/records : ABO and Rh grouping • Screening, expiratory date and volume of the blood. 16-1 describe quality control system and key, QUALITY CONTROL AND SPC - . Create stunning presentation online in just 3 steps. Define controls for all stages of manufacture & packaging. QUALITY CONTROL AND SPC - . api-3774614. Or use it to find and download high-quality how-to PowerPoint ppt presentations with illustrated or animated slides that will teach you how to do something new, also for free. A check sheet might … Quality assurance WHO summarized quality assurance as: • " the right result at • right time on • the right specimen from, • the right patient with, • result interpretation based on , • with correct reference data and at • the right price" . to define and discuss quality control to discuss the key features of the, Product Quality and Documentation – Recent Developments - . developments of quality control. Quality Control PPT - Free download as Powerpoint Presentation (.ppt), PDF File (.pdf), Text File (.txt) or view presentation slides online. Quality control is about adherence to requirements. • To determine problems and solved it . • A system must be use to ensure that all blood and blood components shipped by or received into a blood bank or blood transfusion service have been maintained within T required. The International Organization for Standardization (ISO) series programme provides standards for data documentation and audits as part of a quality management system. This one-day course is designed to prepare those who will either assess or be assessed as part of an EPA or EPA-supporting quality system. testing to gauge one or more characteristics of a product or service and the comparison of these with specified requirements to determine conformity Results should be recorded immediately after observation. Do you have PowerPoint slides to share? 7. Document control -1 (ISO 17025: 2005,4.3) Laboratory shall establish and maintain ... Preparing_for_Quality_System_Certification .ppt. presented by shane tyler and gary russell. Type of specimen is whole blood , collected in EDTA tube , 2ml of volume . The resultant quality manuals should reflect documented quality system procedures required by the ISTA Accreditation Standard. accurately reflects the severity of a patient’s illness and the intensity of care being. A check sheet is a basic quality tool that is used to collect data. • Precision : it is the agreement between replicate measurements . Continue ... - Title: Basic Energy Concepts Author: mike mcglade Last modified by: Western Oregon University Document presentation format: Custom Other titles: Arial MS Gothic ... Jeffrey C. Worthington Chair, Energy and Environmental Division American Society for Quality OEI Director of Quality Office of Environmental Information U.S Environmental Protection Agency, - Jeffrey C. Worthington Chair, Energy and Environmental Division American Society for Quality OEI Director of Quality Office of Environmental Information, Capturing the Voice of Customer: The Role of Quality Function Deployment, Lean Six Sigma, and Design for Six Sigma in Achieving Excellence through Baldridge Award, - Capturing the Voice of Customer: The Role of Quality Function Deployment, Lean Six Sigma, and Design for Six Sigma in Achieving Excellence through Baldridge Award, Basic Principles and Concepts of M. TB and Resistance. what is quality, QUALITY CONTROL AND SPC - . - Basic Concepts of Audio, Video and Compression Anupriya Sharma ... - Basic Concepts of Quality Session One: Basic Concepts of Quality * And that s because most use the lens of the organisation when they design the survey. Quality control and documentation. The PowerPoint PPT presentation: "BASIC CONCEPTS OF QUALITY" is the property of its rightful owner. QUALITY CONTROL Is process for assessing the accuracy and precision of a test as the following: • Accuracy : agreement between the best estimate of quantity and its true value. QUALITY CONTROL This describes the steps taken by the laboratory to insure that tests are performed correctly. Objectives of quality in blood bank • Is to ensure availability of a sufficient supply of blood, blood components of high quality with maximum efficacy and minimum risk to both donors and patients. • Is usually organized on a national or regional basis, Why do we need External Quality Assessment? Cells from the test sample should be washed in 0.9% normal saline and a 2-5% cell suspension should be prepared. Presentation Summary : The Quality Management System Organization Personnel Equipment Purchasing & Inventory Process Control Information Management Documents … Though the ISO series is not designed explicitly for emissions data development, many of the principles may be applied to ensure the production of a quality inventory. Quality control in the medical laboratory is a statistical process used to monitor and evaluate the analytical process that produces patient results. Document Control –“The Brains” • If Corrective Action is the heart of the Compliance System, then the Document Control System is the “Brains” • Holds all the information of the processes’ records • Sets the foundation for compliance; how we behave, act, enforce and regulate • A good Document Control System will: robert g. gleason professor and director supply and logistics, Quality Control - Quality assessment 2. quality control. - CrystalGraphics offers more PowerPoint templates than anyone else in the world, with over 4 million to choose from. Organization and management 2. name: j. douglas wells sponsor: molded plastic ventures (mpv). - 'Quality System' is said to be rarely used in drug manufacturing ... 5. documented and have an Agency-approved Quality Assurance Project Plan (QAPP) before the start of data collection. QC of Blood storage and Transportation. - SMU EMIS 7364 NTU TO-570-N Statistical Quality Control Dr. Jerrell T. Stracener, SAE Fellow Basic Concepts updated 1.14.04 Statistical Quality Control - Basic ... SAP QM (Quality Management) Online Training Course in India, USA, UK, Canada, - SAP QM Tutorial for Beginners - Learn SAP QM in simple and easy steps starting from basic to advanced concepts with SAPVITS Visit us: bit.ly/2MqO7E6, Developing Quality Open Response and Multiple Choice Items for the Classroom. It is based on Various Quality Assurance practices, PWD specifications, requirement of the tender document for test of materials, Field/laboratory testing and relevant IS: codes. Winner of the Standing Ovation Award for “Best PowerPoint Templates” from Presentations Magazine. Ensure that test results are reliable Ensure that test results are reproducible Control quality of daily routine work, External Quality Control ( EQC ) • Is the objective evaluation by an outside agency of the performance by a number of laboratories on material which is supplied specially for the purpose. Quality control and documentation BY Ahmad Shihada Silmi,Msc, FIBMSLecturer of Haematology & Immunology Faculty of Science, IUG. GOOD DOCUMENTATION PRACTICES. Causal Agent 2. Establish and control records as evidence of conformity to requirements and to demonstrate the effective operation of the quality management system.Establish a documented procedure to define the controls needed for records: 1. Data-processing equipment 6. Our new CrystalGraphics Chart and Diagram Slides for PowerPoint is a collection of over 1000 impressively designed data-driven chart and editable diagram s guaranteed to impress any audience. audithan. Why do we need Internal Quality Control? In matters affecting quality Control, a Quality Control team shall carry out all aspects of inspection as specified by the Quality Assurance Engineer, which would meet the specification and implied requirements of the customer. maintaining atex certification, Quality Control - . Platelet concentrates: QC • Volume > 40ml • pH : 6.8-7.4 • Plt count : at least 5.5 x 1010 /bag • WBC contamination: < 2 x 103/bag • RBC contamination: < 2 x 109/bag • Macroscopic appearance : no visible platelets aggregates • Sterility : no growth, Fresh Frozen Plasma • Storage: • 24 months at below –70ºC • 12 months at –25 to –30ºC • 3 months at –18 to –25ºC • Thawed at Tº between 30-37ºC and transfused within 24H after thawing, Fresh Frozen Plasma • Macroscopic : no abnormal color or visible clots • Residual cell: • Red cell: < 6.0 x 109/l • Leukocyte: < 0.1 x 109/l • Platelets : < 50 x 109/l, Fresh Frozen Plasma • Volume: 220-250ml • Factor VIII : > 0.7IU/ml- every 2 months • No leakage after pressure in plasma extractor, before freezing and after thawing, Cryoprecipitate • Assayed on at least 4 bags/ month –for factor VIII • Storage: • 24 months at below –70ºC • 12 months at –25 to –30ºC • 3 months at –18 to –25ºC • Must be thawed at 37ºC and used within 6H, Cryoprecipitate • Volume : 10-20 ml • Factor VIII : > 70 IU/unit • Fibrinogen : > 140 mg per unit • Macroscopic : homogenous • Sterility: no growth. 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