Free Essay

Metrology and Validation

In:

Submitted By luisepe
Words 1724
Pages 7
QUALIFICATION OF RAW MATERIAL SUPPLIERS USING METROLOGY AND MEASUREMENT PRINCIPLES

Table of Contents

Abstract Introduction Statement of the problem Hypothesis Instrument specifications, Procedure and Data Collection Discussion Conclusion Bibliography

Abstract
Maxi Quality Pharmaceuticals, Inc is a worldwide manufacturing company of Transdermal Delivery Systems (TDS). The Active Product Ingredient (API) adhered to a laminate foil and coated by a plastic film creates an advanced delivery technology (Figure 1).
The active is contained in round or square patches, and the dosage is gradually released through the human skin by twenty four hours. Narrow specifications for laminated foil had been established in order to control the blending process and to guarantee the adhesion of active in the laminate. Due to the complexity of the TDS manufacturing process, there are just a few suppliers in the market constraining the availability of this raw material for Maxi Pharmaceutical, Inc. To ensure quality and product reliability the company had evaluated three different suppliers of laminated film. The application of the metrology and measurement principles on testing the thickness through Upright Gage Series 547 from Mitutoyo (Figure 2) ion for the main and ongoing supplier for this raw material.

Introduction
Qualification of Raw Materials (RM) suppliers is critical on a pharmaceutical process since product quality is straightly related to the specifications attained to the materials used. FDA has established strict regulations to be accomplished by drug manufacturers to ensure quality, efficacy and safety. Companies usually deploy significant resources to assess raw material suppliers’ chain previous to launch a new product to the market. All the materials should be approved using the Company’s Change Control Procedures and /or Supplier Approval Procedures. Selection and qualification of RM suppliers are an essential component of manufacturing process development to guarantee intermediate and finished product fulfillment the specifications (APIC, 2009).
Select reliable suppliers of high-quality product are one of the four strategic objectives of pharmaceutical procurement. Prospective suppliers should be pre-qualified, and selected suppliers should be monitored through a process which considers product quality, service reliability, delivery time and financial viability. Pre- and post-qualification procedures help to eliminate substandard supplier properly managed. (WHO, 1999)
Pre-qualification is the procedure of evaluating supplier capacity and reputation before bids are solicited for specific products. This is the preferred procedure, especially for ongoing drug procurement systems. Although substantial time is required to establish an initial list of pre-qualified suppliers, once this had been done the lowest pre-qualified tendered for each product is deemed to be qualified, which expedites adjudication and contract award. Post-qualification evaluates the suppliers after bids have been received. If there are numerous offers from unknown suppliers, there may be long delays in awarding contracts, as it will be necessary to validate suppliers’ capacity to supply good-quality products. One important aspect of quality assurance is the concept of “traceability”. The supplier must be able to trace the product to the finished product manufacturer, and then latter must be able to tracking the ingredients to their producers, all in a transparent manner.
Evaluation of the consistency of the Physical Chemistry of the material contributes to the evaluation of the manufacturability of the material in next process steps (APIC, 2009). Polyester Film Laminate is classified as a non-critical raw material in manufacturing process for adhesive patches (TDS). Giga Pharmaceutical Inc. has received a business proposal from three different suppliers: Biochem Corporation Reliable Polymer Group Inc. Advanced Laminate Technologies, LLC
Suppliers were submitted through the Vendor Management across the Life Cycle process designed by the Giga to ensure quality, safety, and effectiveness (Figure 3).
Measurements, tolerance, calibration, accuracy, precision and reliability are fundamental principles of Dimensional Metrology science they are involved in all processes. The relevance of this concepts and its applications are increased on pharmaceutical process due to the fact of customer nature and the high risk of compromise their health and safety.
This term paper aims to demonstrate through an example how this metrology science terms help to qualify a raw material vendor by measuring a critical parameter on calibrate instrument.

Statement of the problem
Use of metrology and measuring principles as qualification tools to select the best laminate raw material supplier from a reduced market of vendors.

Hypothesis
Results for thickness measurement through a calibrated Upright Gage provide consistent evidence to discern between a grade A and B raw material supplier.

Instrument specifications, Procedure and Data Collection Instrument Specifications:
Mitutoyo Upright Gage Series 547
Specifications 547-035S
Type Digital Inc/Metric
Range 0.5”
Resolution 0.00005”/0.001mm
Workpiece height 1.2”
Accuracy ±0.0001”
Measuring force 1.5N or less
Type of anvil 1.57” (DIA Steel type)
Display LCD
Scale type Absolute
Contact Point 3mm carbide flat type
Functions GO/±NG judgment. SPC data output
Next Calibration due 06/30/2011 Procedure
Principle: The average thickness of films and laminates is determined by digital thickness gauge.
Reference: Pressure Sensitive tape Council PSTC-33 (Mantelle, 2000)
Applicability: All films and laminates
Technique: Turn on the thickness gauge by pressing the ON/OFF button and zero the instrument. Raise the spindle off the base by gently pushing down on the lift lever. Ensure that the spindle is properly tightened. Insert onto the base an uncreased, unwrinkled piece of film/laminate. Lower the spindle onto the film/laminate by gently lowering the spindle using the lift lever. Record the thickness value displayed on digital readout (use the figures of magnitude stated in the material’s specification). Repeat measurement twice more on different areas of the film/laminate. (Note: 1 inch = 1000 mils). Data Collection: Sampling specialists from Maxi Pharmaceuticals coordinated with each vendor to randomly pooling one hundred fifty samples from polyester film laminate. The sample size ensures the measuring of thickness by triplicate to report the average as required by procedure G-100 (Figure 4). This grant a total of fifty samples. The data is evaluated conforming to Maxi specifications for Polyester Foil Laminate (Figure 4). In addition statistic tools support evidence for data behavior since variation from the middle is critical for manufacturing process.

Discussion
Thickness is intrinsically related to laminate properties as Tensile, Wrinkles, and Adhesion. Simultaneously, manufacturing steps as coating and drying are also impacted by any variation on thickness. This is the reason why the specifications are intentionally narrowed to minimize out of specification, deviations, fluctuation and wasting time downstream in the process (Figure 4).

Figure 5 shows the histogram for results of Thickness for fifty samples from each supplier. Although that mostly all the results meet specifications (1.92-2.19 mils) supplier A achieve more consistent values, smaller dispersion from the middle and certainly a better standard deviation value comparing the others suppliers. The data is closer to a perfect Gauss’ Bell shape for A and it is widening from B to C. This could indicate that supplier A is able to satisfy Giga requirements for raw materials. The select specification limits or tolerances can delineate the range of measurement values that will accept as “close enough” to the target value, in the sense that product are within specifications (Devore & Farnun, 2005)
The statistics analysis and x ̅ bar graph illustrated on figure 6, allows weighing the data for behavior within true limits. The majority of results for supplier A fall within specification limits since only one value are out of specifications. The trend is almost even at both side of the middle. Comparing A and B results through figure 6 and 7, respectively, are observed that the most of the values for supplier B also meet specs specification. The difference lies on the amount of values being Out of Specifications. Supplier A only has one value (2%) outside of limits while supplier B has six results (12%) and two very close to the specs. This is an indication that in spite that data would be considered acceptable mathematically and good for other purposes, for this particular objective there is not strong criteria to accept this source as the first choice. This status could change after convey the technical issues of company B and the Maxi raw material needs. Probably more samples could be request to be evaluated at the future.
The outcomes for supplier C ( Figure 8) exhibit more variation and dispersion in the results than the other suppliers in concourse. A total of eight values (16%) are out of limits and three results are very close to these values. This supplier has limited possibilities at the present to become a Maxi provider. However, a partially satisfactory conditional for approval status could be assigned to this company until corrective actions are in place.
Conclusion:
The application of the Metrology principles and methodology through the use of a calibrated Mitutoyo Upright Gage provides enough evidence to select supplier A (Biochem Cooporation) as the first choice for raw material provider. Supplier A exhibits more precise and accuracy results than supplier B and C. However, B could be considered for a mainly satisfactory status with limited approval (ongoing supplier). The narrow specifications for Polyester Film Laminate reduce the possibility to find stable suppliers. This limitation affects the increasing of TDS production at Maxi. Metrology principles and measurements helped to categorize the suppliers according to the precision and accuracy of thickness results and consequently find and alternate solutions with supplier B and C.

Figure 1. Pressure Sensitive Adhesive

Figure 2. Mitutoyo Upright Gage Series 547

Figure 3. Vendor Management Life Cycle

Figure 4. Specifications Polyester Laminate Foil

Specifications
Description
Procedure
Appearance Meet requirements G-156
Core I.D 5” ± 0.032” G-232
Roll O.D ≤ 25” G-232
Web Width 22 ± 0.125” G-351
Identification: FT-IR Compares to Standard G-104
Thickness 1.91-2.19 mils G-100

Figure 5. Histogram of Thickness Supplier A, B and C

Figure 6. Data behavior for Supplier A

Figure 7. Data behavior for Supplier B

Figure 8. Data behavior for supplier B

VIII. Bibliography

APIC. (2009). Supplier Qualification and Management Guideline. Brussels: Active Pharmaceutical Ingredients Commitee (APIC).
Devore, J., & Farnun, N. (2005). Applied Statistics for Engineers and Scientists. Belmont, CA: Brooks/Cole.
Mantelle, J. (2000). Pressure Sensitive tape Council PSTC-33. Retrieved 02 26, 2011, from http://www.pstc.org/i4a/pages/index.cfm?pageID=3533: http://www.pstc.org
WHO. (1999). Operational principles for good pharmaceutical procurement. Geneva: World Health Organization.

Similar Documents

Premium Essay

Q Pharma Sample Quality Report

...DOCUMENT TYPE DOC NO. REVISION Quality Management Policy TITLE ISSUED BY QMP-001 EFFECTIVE DATE 1.0 PAGE Q Pharma Quality System Manual rJ Boatman 16 Feb 2007 1 of 32 SUPERCEDES CSSC QSM-001 iPT QSM-001 QUALITY MANAGEMENT POLICY QUALITY SYSTEM MANUAL QMP-001 Rev. 1.0 Prepared by Date (Signed) Jeff Boatman, Director of Quality Reviewed by 01 Feb 2007 Date (Signed) Alexis Stroud, Compliance Manager Reviewed by 07 Feb 2007 Date (Signed) Raymond Roggero, iPT Business Unit Manager Reviewed by 2/7/07 Date (Signed) Robert Lorence, CSSC Business Unit Manager Approved by 9 Feb 2007 Date (Signed) Patrick Den Boer, President and CEO 16 Feb 2007 ©2007 Q Pharma Incorporated. Unauthorized reproduction or distribution prohibited. CONTROLLED DOCUMENT • VERIFY LATEST REVISION • PRINTED COPY IS UNCONTROLLED IF NOT STAMPED IN RED DOCUMENT TYPE DOC. NO. REVISION Quality Management Policy TITLE QMP-001 1.0 PAGE Quality System Manual TABLE OF CONTENTS 0. Page 2 of 32 1. 2. 3. 4. 5. 6. INTRODUCTION .........................................................................................................................4 0.1 General...............................................................................................................................4 0.2 Process Approach ................................................................................................................

Words: 10681 - Pages: 43

Free Essay

Si Units

...—————————————————————————— Bureau International des Poids et Mesures The International System of Units (SI) 8th edition 2006 —————————————————— Organisation Intergouvernementale de la Convention du Mètre 94 Note on the use of the English text To make its work more widely accessible, the International Committee for Weights and Measures has decided to publish an English version of its reports. Readers should note that the official record is always that of the French text. This must be used when an authoritative reference is required or when there is doubt about the interpretation of the text. Translations, complete or partial, of this brochure (or of its earlier editions) have been published in various languages, notably in Bulgarian, Chinese, Czech, English, German, Japanese, Korean, Portuguese, Romanian, and Spanish. The ISO and numerous countries have also published standards and guides to the use of SI units. 95 The BIPM and the Metre Convention The International Bureau of Weights and Measures (BIPM) was set up by the Metre Convention signed in Paris on 20 May 1875 by seventeen States during the final session of the diplomatic Conference of the Metre. This Convention was amended in 1921. The BIPM has its headquarters near Paris, in the grounds (43 520 m2) of the Pavillon de Breteuil (Parc de Saint-Cloud) placed at its disposal by the French Government; its upkeep is financed jointly by the Member States of the Metre Convention. The task of...

Words: 36954 - Pages: 148

Premium Essay

Total Quality Management

...TOTAL QUALITY MANAGEMENT AND SIX SIGMA Edited by Tauseef Aized Total Quality Management and Six Sigma http://dx.doi.org/10.5772/2559 Edited by Tauseef Aized Contributors Aleksandar Vujovic, Zdravko Krivokapic, Jelena Jovanovic, Svante Lifvergren, Bo Bergman, Adela-Eliza Dumitrascu, Anisor Nedelcu, Erika Alves dos Santos, Mithat Zeydan, Gülhan Toğa, Johnson Olabode Adeoti, Andrey Kostogryzov, George Nistratov, Andrey Nistratov, Vidoje Moracanin, Ching-Chow Yang, Ayon Chakraborty, Kay Chuan Tan, Graham Cartwright, John Oakland Published by InTech Janeza Trdine 9, 51000 Rijeka, Croatia Copyright © 2012 InTech All chapters are Open Access distributed under the Creative Commons Attribution 3.0 license, which allows users to download, copy and build upon published articles even for commercial purposes, as long as the author and publisher are properly credited, which ensures maximum dissemination and a wider impact of our publications. After this work has been published by InTech, authors have the right to republish it, in whole or part, in any publication of which they are the author, and to make other personal use of the work. Any republication, referencing or personal use of the work must explicitly identify the original source. Notice Statements and opinions expressed in the chapters are these of the individual contributors and not necessarily those of the editors or publisher. No responsibility is accepted for the accuracy of information contained...

Words: 105584 - Pages: 423

Free Essay

Civil Engineering 2025

...ASCE American Society of Civil Engineers THE VISION FOR CIVIL ENGINEERING IN 2025 BASED ON THE SUMMIT ON THE FUTURE OF CIVIL ENGINEERING June 21 – 22, 2006 Prepared by the Task Committee to Plan a Summit on the The Future of the Civil Engineering Profession January 5, 2007 (Final draft prepared by TC) Contents Executive Summary ...................................................... 1 2006: Status, Concerns, and Opportunities in the Civil Engineering Profession ..................................... 3 Issues and Trends ................................................. 3 New Pressures....................................................... 4 Career Appeal........................................................ 5 Future Directions.................................................... 5 Why a Summit? ............................................................. 7 The Vision for Civil Engineering .................................. 9 Vision ..................................................................... 9 Profile of the 2025 Civil Engineer......................... 10 2025: The Civil Engineer’s World............................... 13 A Sustainable World ............................................ 14 Research and Development................................. 16 Managing Risk ..................................................... 18 Master Innovators and Integrators ....................... 19 Reform in the Preparation of Engineers ............... 20 What Next?.....................

Words: 7710 - Pages: 31

Free Essay

Computer Vision

...Learning OpenCV Gary Bradski and Adrian Kaehler Beijing · Cambridge · Farnham · Köln · Sebastopol · Taipei · Tokyo Learning OpenCV by Gary Bradski and Adrian Kaehler Copyright © 2008 Gary Bradski and Adrian Kaehler. All rights reserved. Printed in the United States of America. Published by O’Reilly Media, Inc., 1005 Gravenstein Highway North, Sebastopol, CA 95472. O’Reilly books may be purchased for educational, business, or sales promotional use. Online editions are also available for most titles (safari.oreilly.com). For more information, contact our corporate/institutional sales department: (800) 998-9938 or corporate@oreilly.com. Editor: Mike Loukides Production Editor: Rachel Monaghan Production Services: Newgen Publishing and Data Services Cover Designer: Karen Montgomery Interior Designer: David Futato Illustrator: Robert Romano Printing History: September 2008: First Edition. Nutshell Handbook, the Nutshell Handbook logo, and the O’Reilly logo are registered trademarks of O’Reilly Media, Inc. Learning OpenCV, the image of a giant peacock moth, and related trade dress are trademarks of O’Reilly Media, Inc. Many of the designations used by manufacturers and sellers to distinguish their products are claimed as trademarks. Where those designations appear in this book, and O’Reilly Media, Inc. was aware of a trademark claim, the designations have been printed in caps or initial caps. While every precaution has been taken in the preparation of this...

Words: 150684 - Pages: 603

Free Essay

Engineering

...-Aa posteriori distribution a priori distribution A.C. pulse abandoned connection abbreviated address calling abend aberration abnormal end abnormal reflection abnormal termination abort sequence abort, to aborted connection absolute code absolute delay absolute error absolute error of measurement absolute instruction absolute instrument absolute pressure absolute stability of a system absolute system of electrical units absolute-value device absolutely stable system absolutely summable absorb, to absorbant absorbing state absorption cross-section absorption loss absorption modulation absorption absorption spectrum absorption trap absorptive attenuator abstract abstract symbol abstract syntax tree abstraction AC AC/DC converter accelerate, to accelerated test accelerating relay acceleration of gravity sonsal dağılım önsel dağılım almaşık akım darbesi yarıda kalan bağlantı kısa numarayla arama olağandışı sonlanma sapınç olağandışı son olağandışı yansıma olağandışı son durdurma dizisi (bitirmeden) durdurmak yarıda kalan bağlantı makina dilindeki kod, mutlak kod mutlak gecikme mutlak hata mutlak ölçüm hatası makina dilindeki komut, mutlak komut mutlak ölçü aleti mutlak basınç bir dizgenin mutlak kararlılığı elektrik birimlerinin mutlak sistemi mutlak değer aygıtı mutlak kararlı dizge mutlak toplanır soğurmak soğurgan soğurucu durum etkin soğurma alanı soğurum yitimi enerji soğurum kiplenimi soğurulma, soğurum soğurum izgesi soğurum tuzağı soğurgan zayıflatıcı 1) öz; 2) soyut soyut...

Words: 38690 - Pages: 155

Free Essay

Meteorological Instruments

...Guide to Meteorological Instruments and Methods of Observation WMO-No. 8 Guide to Meteorological Instruments and Methods of Observation WMO-No. 8 Seventh edition 2008 WMO-No. 8 © World Meteorological Organization, 2008 The right of publication in print, electronic and any other form and in any language is reserved by WMO. Short extracts from WMO publications may be reproduced without authorization, provided that the complete source is clearly indicated. Editorial correspondence and requests to publish, reproduce or translate this publication in part or in whole should be addressed to: Chairperson, Publications Board World Meteorological Organization (WMO) 7 bis, avenue de la Paix P.O. Box No. 2300 CH-1211 Geneva 2, Switzerland ISBN 978-92-63-10008-5 NOTE The designations employed in WMO publications and the presentation of material in this publication do not imply the expression of any opinion whatsoever on the part of the Secretariat of WMO concerning the legal status of any country, territory, city or area, or of its authorities, or concerning the delimitation of its frontiers or boundaries. Opinions expressed in WMO publications are those of the authors and do not necessarily reflect those of WMO. The mention of specific companies or products does not imply that they are endorsed or recommended by WMO in preference to others of a similar nature which are not mentioned or advertised. Tel.: +41 (0) 22 730 84 03 Fax: +41 (0) 22 730 80 40 E-mail: publications@wmo...

Words: 216230 - Pages: 865

Free Essay

Ingenieria Del Software

...GUÍA AL CUERPO DE CONOCIMIENTO DE LA INGENIERÍA DEL SOFTWARE VERSIÓN 2004 do r SWEBOK UN PROYECTO DEL COMITÉ DE LA PRÁCTICA PROFESIONAL DEL IEEE COMPUTER SOCIETY Bo rra BORRADOR - ESPAÑOL GUÍA AL CUERPO DE CONOCIMIENTO DE LA INGENIERÍA DEL SOFTWARE VERSIÓN 2004 do r SWEBOK Directores ejecutivos Alain Abran, École de Technologie Superieure James W. Moore, The Mitre Corp. rra Directores Pierre Bourque, École De Technologie Superieure Robert Dupuis, Universite Du Quebec A Montreal Bo Jefe de proyecto Leonard L. Tripp, Chair, Professional Practices Committee, IEEE Computer Society (2001-2003) Copyright © 2004 por The Institute of Electrical and Electronics Engineers, Inc. Todos los derechos reservados. Copyright y permisos de impresión: Este documento puede ser copiado, completo o parcialmente, de cualquier forma o para cualquier propósito, y con alteraciones, siempre que (1) dichas alteraciones son claramente indicadas como alteraciones y (2) que esta nota de copyright esté incluida sin modificación en cualquier copia. Cualquier uso o distribución de este documento está prohibido sin el consentimiento expreso de la IEEE. Use este documento bajo la condición de que asegure y mantenga fuera de toda ofensa a IEEE de cualquier y toda responsabilidad o daño a usted o su hardware o software, o terceras partes, incluyendo las cuotas de abogados, costes del juicio, y otros costes y gastos relacionados que surjan del...

Words: 99648 - Pages: 399

Free Essay

Nit-Silchar B.Tech Syllabus

...NATIONAL INSTITUTE OF TECHNOLOGY SILCHAR Bachelor of Technology Programmes amï´>r¶ JH$s g§ñWmZ, m¡Úmo{ à VO o pñ Vw dZ m dY r V ‘ ñ Syllabi and Regulations for Undergraduate PROGRAMME OF STUDY (wef 2012 entry batch) Ma {gb Course Structure for B.Tech (4years, 8 Semester Course) Civil Engineering ( to be applicable from 2012 entry batch onwards) Course No CH-1101 /PH-1101 EE-1101 MA-1101 CE-1101 HS-1101 CH-1111 /PH-1111 ME-1111 Course Name Semester-1 Chemistry/Physics Basic Electrical Engineering Mathematics-I Engineering Graphics Communication Skills Chemistry/Physics Laboratory Workshop Physical Training-I NCC/NSO/NSS L 3 3 3 1 3 0 0 0 0 13 T 1 0 1 0 0 0 0 0 0 2 1 1 1 1 0 0 0 0 4 1 1 0 0 0 0 0 0 2 0 0 0 0 P 0 0 0 3 0 2 3 2 2 8 0 0 0 0 0 2 2 2 2 0 0 0 0 0 2 2 2 6 0 0 8 2 C 8 6 8 5 6 2 3 0 0 38 8 8 8 8 6 2 0 0 40 8 8 6 6 6 2 2 2 40 6 6 8 2 Course No EC-1101 CS-1101 MA-1102 ME-1101 PH-1101/ CH-1101 CS-1111 EE-1111 PH-1111/ CH-1111 Course Name Semester-2 Basic Electronics Introduction to Computing Mathematics-II Engineering Mechanics Physics/Chemistry Computing Laboratory Electrical Science Laboratory Physics/Chemistry Laboratory Physical Training –II NCC/NSO/NSS Semester-4 Structural Analysis-I Hydraulics Environmental Engg-I Structural Design-I Managerial Economics Engg. Geology Laboratory Hydraulics Laboratory Physical Training-IV NCC/NSO/NSS Semester-6 Structural Design-II Structural Analysis-III Foundation Engineering Transportation Engineering-II Hydrology &Flood...

Words: 126345 - Pages: 506

Premium Essay

Sanitation in Ghana

...REPUBLIC OF GHANA THE BUDGET STATEMENT AND ECONOMIC POLICY of the GOVERNMENT OF GHANA for the 2015 FINANCIAL YEAR presented to PARLIAMENT on WEDNESDAY, 19TH NOVEMBER 2014 by SETH E. TERKPER Minister for Finance on the Authority of HIS EXCELLENCY PRESIDENT JOHN DRAMANI MAHAMA Theme: “Transformational Agenda: Securing the Bright Medium Term Prospects of the Economy ’’ THE 2015 BUDGET STATEMENT AND ECONOMIC POLICY ~ ii ~ Theme: “Transformational Agenda: Securing the Bright Medium Term Prospects of the Economy ’’ For copies of the Statement, please contact the Public Relations Office of the Ministry: Ministry of Finance Public Relations Office New Building, Ground Floor, Room 001/003 P. O. Box MB 40 Accra – Ghana The 2015 Budget Statement and Economic Policy of the Government of Ghana is also available on the internet at: www.mofep.gov.gh ~ iii ~ Theme: “Transformational Agenda: Securing the Bright Medium Term Prospects of the Economy ’’ ACRONYMS AND ABBREVIATIONS ABFA ACLP ADR AFCON AfDB AIDS AML AMSECs APR ATMA AVIC BACs BDS BIEPC BoG BOP bopd bps BR BRICS BSPs BVDs Annual Budget Funding Amount Ascertainment and Codification of Customary Law Project Alternative Dispute Resolution African Cup of Nations African Development Bank Acquired Immune Deficiency Syndrome Anti-Money laundering Agricultural Mechanization Services Enterprise Centres Annual Progress Report Accra-Tema Metropolitan Area Accra Visitor Information Centre Business Advisory Centres...

Words: 63016 - Pages: 253

Premium Essay

Quality

...and tools 8. Standardization 9. Problem solving 10. QC Circles 11. Statistical methods 12. Education and training Module Four: Production and sales 13. Production control 14. Process control 15. Inspection 16. Management of facilities & equipment 17. Measurement control 18. External suppliers 19. After-sales service 20. Product design and development Acknowledgements A Roadmap to Quality was prepared by the Trade Capacity-building Branch of UNIDO led by Mr. Lalith Goonatilake, Director. The overall coordination was carried out by Mr. Ouseph Padickakudi, Programme Manager, Trade Capacity-building Branch, UNIDO, who was preceded as co-ordinator by Dr. Bernardo Calzadilla-Sarmiento, then Project Manager, Quality, Standardization and Metrology Branch, UNIDO. A Roadmap to Quality has been developed with valuable assistance and support provided by Japan's Ministry of Economy, Trade and Industry as a part of its technical cooperation programme in the field of standards and conformity assessment, and by the Japanese Standards Association. All the TQM source materials were produced by the Japanese Standards Association...

Words: 107128 - Pages: 429

Premium Essay

Miss

...MODULE ONE THEORY AND CONCEPT OF ENTREPRENEURSHIP STUDIES Learning Objectives At the end of this module students should be able to;  Discuss the origin of Entrepreneurship  Define the concept “Entrepreneur”  List the roles and characteristics of an Entrepreneur  State the motivational factors of Entrepreneurship. UNIT ONE: ORIGIN AND CONCEPTS OF ENTREPRENEUR AND ENTREPRENEURSHIP Objectives: At the end of this unit students should be able to;  Compare and contrast the various definitions of Entrepreneur and Entrepreneurship.   1.2. Differentiate between Entrepreneur and Entrepreneurship. List five contributions to the study of Entrepreneurship. Introduction Businesses are any undertaking created for the purpose of creating utility. Utility is simply the satisfaction derived from consuming certain goods and services. Businesses are created by a special kind of labour which is also referred to as the entrepreneur. Entrepreneur is regarded as a special kind of labour because not all labour possesses entrepreneurial abilities which enable them to start a business from the scratch. Thus, entrepreneurship is simply the establishment of a new business or business enterprise or venture. This Unit looks at the development of the concept of entrepreneurship and the various ways in which this concept can be defined. Quick Review questions I. Businesses are not any undertaking created for the purpose of creating utility...

Words: 63960 - Pages: 256

Free Essay

Maglev

...*3963103* [3963] – 103 T.E. (Petroleum) (Semester – I) Examination, 2011 DRILLING & PRODUCTION OPERATIONS (2003 Course) Time : 3 Hours Max. Marks : 100 Instructions : 1) Question Nos. 1 and 5 are compulsory. Out of the remaining attempt 2 questions from Section I and 2 questions from Section II. 2) Answers to the two Sections should be written in separate books. 3) Neat diagrams must be drawn wherever necessary. 4) Black figures to the right indicate full marks. 5) Use of Logarithmic Tables, Slide Rule, Mollier Charts, Electronic Pocket Calculator and Steam Tables is allowed. 6) Assume suitable data, if necessary. SECTION – I 1. What are different systems on a drilling rig ? Explain any one in detail with suitable diagramme. 18 2. a) Calculate Bottom hole pressure if well depth is 2500 m and mud weight is 1.2 gm/cc. b) Calculate mud weight if mud gradient is 0.87 psi/ft. ′ c) Calculate volume bbl/meter for drill pipe O.D. = 5′ inch and I.D. = 4.276 inch. 2 2 2 10 8 8 16 d) Draw circulation system on a drilling rig. 3. a) Discuss IADC classification of a bit in details. b) Discuss different factors affecting rate of penetration in details. 4. Write short note on : i) Coring ii) Fishing tools iii) BOP iv) Directional well P.T.O. [3963] – 103 -2- *3963103* SECTION – II 5. a) Discuss different types of casings and function of the casings in brief. b) Discuss different types of well completion techniques. 6. a) Discuss primary cementation process with...

Words: 172166 - Pages: 689

Free Essay

Economic Sectors

...Twelfth Five Year Plan (2012–2017) Economic Sectors Volume II Copyright © Planning Commission (Government of India) 2013 All rights reserved. No part of this book may be reproduced or utilised in any form or by any means, electronic or mechanical, including photocopying, recording or by any information storage or retrieval system, without permission in writing from the publisher. First published in 2013 by SAGE Publications India Pvt Ltd B1/I-1 Mohan Cooperative Industrial Area Mathura Road, New Delhi 110 044, India www.sagepub.in SAGE Publications Inc 2455 Teller Road Thousand Oaks, California 91320, USA SAGE Publications Ltd 1 Oliver’s Yard, 55 City Road London EC1Y 1SP, United Kingdom SAGE Publications Asia-Pacific Pte Ltd 33 Pekin Street #02-01 Far East Square Singapore 048763 Published by Vivek Mehra for SAGE Publications India Pvt Ltd, Phototypeset in 11/13pt Minion Pro by RECTO Graphics, Delhi and printed at Saurabh Printers, New Delhi. Library of Congress Cataloging-in-Publication Data Available ISBN: 978-81-321-1131-3 (PB) The SAGE Team: Rudra Narayan, Archita Mandal, Rajib Chatterjee and Dally Verghese Twelfth Five Year Plan (2012–2017) Economic Sectors Volume II Planning Commission Government of India Thank you for choosing a SAGE product! If you have any comment, observation or feedback, I would like to personally hear from you. Please write to me at contactceo@sagepub.in —Vivek Mehra, Managing Director and CEO, SAGE Publications India Pvt...

Words: 131771 - Pages: 528

Free Essay

The Public Needs to Know

...******Created by ebook converter - www.ebook-converter.com****** ******ebook converter DEMO - www.ebook-converter.com******* ******Created by ebook converter - www.ebook-converter.com****** KOINONIA HOUSE Coeur d’Alene, Idaho 83816-0347 ******ebook converter DEMO - www.ebook-converter.com******* ******Created by ebook converter - www.ebook-converter.com****** COSMIC CODES Copyright © 1999 by Koinonia House Revised 2004 P.O. Box D Coeur d’Alene, ID 83816-0347 Web Site: http://www.khouse.org Second Printing 2004 Third Printing 2011 ISBN 978-1-57821-072-5 Design and production by Koechel Peterson & Associates, Minneapolis, Minnesota. Scripture quotations in this book are taken from the King James Version of the Bible. All rights reserved. No portion of this book may reproduced in any form without the written permission of the Publisher. Printed in the United States of America. ******ebook converter DEMO - www.ebook-converter.com******* ******Created by ebook converter - www.ebook-converter.com****** “Cosmic Codes was the authoritative resource that we relied on in the research of our PAX-TV/Discovery Channel television special Secrets of the Bible Code Revealed. It’s absolutely packed with fascinating factual information on all of the Bible-related codes.” DAVID W. BALSIGER PRODUCER, SECRETS OF THE BIBLE CODE REVEALED “Chuck Missler writes from a technological and Biblical background in this cutting-edge analysis of the hidden codes...

Words: 141008 - Pages: 565