Academic literature on the topic 'Standard Manufacturing Company'
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Journal articles on the topic "Standard Manufacturing Company"
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Fałat, Kamila. "The Differences Between a Standard Costing and Normal Costing Method of Manufacturing Operating Income Calculation Caused by the Implementation of a New Integrated Information System." Folia Oeconomica Stetinensia 20, no. 2 (December 1, 2020): 95–113. http://dx.doi.org/10.2478/foli-2020-0038.
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Abstract Research background: When a company changes a few separated information systems into one integrated information system there can appear the obligation of costing method change. It happens especially when the company is a part of an international manufacturing corporation. Purpose: The main goal of the paper is to compare two methods of manufacturing operating income calculation and data presentation when a company changes a costing method from normal costing to standard costing. Research methodology: In the paper for this research comparative analysis was used between two methods of manufacturing operating income calculation. In the first method manufacturing operating income is the difference between revenues from manufacturing operations and the costs of goods manufactured. In the second one manufacturing operating income is calculated as a sum of production variances, purchase price variances, currency variances and inventory adjustments. Pearson’s correlation coefficients for pairs of variables were calculated in both of the costing methods. A comparative analysis was done on the basis of a case study executed in a big international wholesaler. The company is a member of an international manufacturing corporation. Results: The same manufacturing operating incomes were obtained in both methods. The absolute values of Pearson’s correlation coefficients were similar in normal and standard costing, but they differ in directions. Novelty: In standard costing manufacturing operating income is calculated as a sum of various types of variances. They are calculated as deviations from standard costs. It enables the easier identification of impacting a company’s results factors.
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Andry, Johanes Fernandes, Gunawan Wang, Gusti Ngurah Suryantara, and Devi Yurisca Bernanda. "Assessing The COBIT Maturity Model in Manufacturing Company." International Journal of New Media Technology 5, no. 2 (March 19, 2019): 109–15. http://dx.doi.org/10.31937/ijnmt.v5i2.927.
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PT Hema Indonesia is manufacturing company established in 2001 and has continued to grow. Nowadays the company has supported business processes in various companies, such as the use of information systems. The purpose of this research is to get an overview of the performance of information systems in order to determine the extent of maturity level which is currently running, with a few aspects to consider such as effectiveness and, efficiency. Implementing IT governance, however, is a challenge to organizations. To ensure IT alignment with business goals use standard COBIT. The analytical tool used is the standard procedure COBIT issued by ISACA. In this paper the method to be used is COBIT 4.1. Coverage of Audit IT Domain are Plan Organize (PO), such as PO4, PO5, PO7 and PO8. The conclusion that can be drawn from the research that has been done is IT governance at the company has been done, although still run optimally within each IT process contained in the sub domain average on level repeatable and defined proses.
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Ahmudi, Bambang Purwanggono, and Naniek Utami Handayani. "Effectiveness analysis of ISO 9001:2015 implementation at manufacturing industry." SHS Web of Conferences 49 (2018): 01008. http://dx.doi.org/10.1051/shsconf/20184901008.
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Globalization era requires many companies to improve service quality and resource management capabilities in order to gennerate public confidence in the products and commitments offered. The quality improvement program is contained in Quality Management System (QMS). QMS is developed in ISO 9001 standart certification.ISO 9001 is a standard that contains quality management system requirements issued by the International Organization for standarization (IOS). Companies that become the obyect of research is PT Sejahtera, this company is engaged in manufacturing.the company suffered several losses in the form of withdrawal of order from customer. Besides that happened also complaint from customer will product which yield not according to standard which have been approved. This research aims to evaluate the effectiveness of ISO 9001: 2015 implementation at PT. Sejahtera. The method used is Gap Analysis. Calculations on gap analysis use checklists made based on requirements of ISO 9001: 2015.the result of calculation using checklist will show how big the effectiveness of PT. Sejahtera in implementing ISO 9001: 2015
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Karaseva, E. V. "New standard standards for issuing personal protective equipment." Upravlenie kachestvom (Quality management), no. 4 (March 18, 2024): 39–45. http://dx.doi.org/10.33920/pro-01-2404-08.
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This article examines corporate culture as a system of values, manifestations and interactions that characterize a company, which can influence employee job satisfaction. In the context of corporate culture, job satisfaction can be defined as the emotional and cognitive state of an employee, reflecting his assessment and experience of the conditions and characteristics of work. It reflects the employee's satisfaction with his job, company, colleagues and career development opportunities. Understanding the factors that influence job satisfaction is key to creating a positive work environment and improving overall employee productivity.
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Ramadhan, Angelio Pratama, Lisa Ratnasari, and Kohar Sulistyadi. "WASTE REDUCTION AT PT. X WITH LEAN MANUFACTURING APPROACH." Sustainable Environmental and Optimizing Industry Journal 5, no. 2 (October 1, 2023): 127–35. http://dx.doi.org/10.36441/seoi.v5i2.1911.
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In 2020 PT. X produces approximately 220 thousand packaging, this causes the paper raw materials used to exceed the maximum limit or exceed the insheet determined by the company. So that there is a loss to the company, both in terms of material and time. There are 3 types of waste or damaged products that are most dominantly found using lean manufacturing methods. The three most dominant wastes are excess insheet, non-standard color and excess glue. The application of lean manufacturing is expected to reduce waste in 2020 and maximize the profits obtained. In implementing lean manufacturing, it is supported by using value stream mapping methods and process activity mapping which is expected to get factors that cause waste. Waste that occurred in 2020 averaged 7.82%, greater than the standard set by the company with an average of 5%.
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Nurwita, Nurwita, and Rindi Alimah Rodhiah. "LIQUIDITY RATIO AND PROFITABILITY ANALYSIS TO MEASURE FINANCIAL PERFORMANCE IN PT. ULTRAJAYA MILK INDUSTRY & TRADING COMPANY TBK." International Journal of Economy, Education and Entrepreneurship (IJE3) 2, no. 1 (April 6, 2022): 110–19. http://dx.doi.org/10.53067/ije3.v2i1.50.
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This study aims to determine the condition of the company's financial performance PT Ulta Jaya Milk Industry & Trading Company Tbk from 2011 to 2020 using a financial ratio measuring instrument. The research method used is a descriptive quantitative method because this research relates to the object of study, namely the company, within a certain period by collecting data and information related to the company and adapting to the research objectives. The data analysis method used is ratio analysis, which describes the relationship between a certain amount and another amount. The analysis used is liquidity and profitability analysis, where the liquidity ratio aims to determine the company's ability to meet its short-term obligations. The results of research using the liquidity ratio from 2011-2020 are seen from the company's current balance in a healthy condition because the average value is 333% above the manufacturing industry standard of 200%. Judging from the Quick Ratio, the company is beneficial because the average value is 237% above the industry standard 150%. While the profitability ratio of the company's ability to generate profits during a certain period. Meanwhile, using the profitability ratio from 2011-2020 seen from the Net Profit Margin, the company is unhealthy because the average value is 13% below the manufacturing industry standard of 20%. Judging from the Return on Assets, the company suffers because the average value is 13% below the manufacturing industry standard of 30%.
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Muhammad Akrim, Zikri Habibie, and Filson Maratur Sidjabat. "Study of Manufacture Company Strategy in Implementing ISO 9001:2015 & ISO 140001." UNM Environmental Journals 2, no. 2 (April 26, 2019): 28. http://dx.doi.org/10.26858/uej.v2i2.10081.
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In early 1980’s environmental issues were increasing, several policies were made in countries as a concern to environment, even the government has the policy about environment. One of the standards used in company related to environment is ISO 14001.Beside environmental management system companies need to get an international confession stating that their products and systems are appropriate. The international standard related to the quality management that can be used is ISO 9001:2015.In this study author try to comparing manufacturing company such asPT. Apac Inti Corpora, Omron Manufacturing and LG Electronicstrategy in implementing the ISO 9001:2015 and ISO 14001:2015 certification.
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Pratama, I. Putu Agastya Harta, I. Made Sukarsa, and Gusti Agung Ayu Putri. "Reengineering of Manufacturing Business Process Utilising the Manufacturing Module of an ERP Application." Jurnal Ilmiah Merpati (Menara Penelitian Akademika Teknologi Informasi) 9, no. 3 (October 4, 2021): 263. http://dx.doi.org/10.24843/jim.2021.v09.i03.p07.
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The significant change in the consumption pattern of Indonesia’s modernising society––further intensified by the Indonesian Government’s plan to push towards the era of the Industrial Revolution 4.0, has fostered the need for manufacturing companies to create newly automated processes and make the transition to become a digitalised business entity. Enterprise Resource Planning is a software that enables the creation of integration and automation of business processes between various departments within a company, thus creating an effective business strategy. The data that has been acquired from research at a poultry processing company are then being mapped into the ERP software of Odoo V12.0, therefore creating new sets of re-engineered business processes. There are seven newly proposed reengineering business processes––in which only concentrate on the production and technical department within the particular company, by utilising the manufacturing and maintenance modules. The re-engineered business processes are assessed using the Technology Acceptance Model theory, to measure its usability and practicality, which generates the score of Likert’s interpretation above the accepted standard of 1340 and 1227, for both the manufacturing and maintenance modules respectively.
Keywords: Business Process Reengineering, Enterprise Resource Planning, Manufacturing Process, Odoo, Technology Acceptance Model.
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Mira Diantari Sadia, Ni Putu, and Agus Fredy Maradona. "Ukuran Perusahaan, Kepemilikan Institusional, Struktur Kapital dan Nilai Perusahaan Publik di Indonesia." Jurnal Manajemen Bisnis 16, no. 1 (January 18, 2019): 87. http://dx.doi.org/10.38043/jmb.v16i1.2021.
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ABSTRACT The purpose of this study was to determine the importance of the role of corporate value in the manufacturing industry of public companies in Indonesia. Specifically, this study intends to examine whether company size and ownership structure play a role in increasing the value of the company, especially through the capital structure. This study focuses on manufacturing companies in Indonesia that are listed on the Indonesia Stock Exchange (IDX). Determination of company samples in this study was carried out by purposive sampling method, with the criteria of manufacturing companies listed on the Indonesia Stock Exchange during the period of 2016, the data collection method used in this study was the method of documentation study. The data analysis method used is Path Analysis. The results of the study, the minimum value of the company size was 12.74, while the maximum value was 30.87. The average value of company size is 23.98 with a standard deviation value of 4.87. Institutional ownership variables with a minimum value of 0.87 and a maximum value of 99.38 with an average value of 59.57 and a standard deviation of 29.22. The capital structure variable with a minimum value of 10.52 and the highest is 1658.82 with an average value of 133.98 and a standard standard deviation of 19.33. In the variable value of the company it is known that the minimum value is 0.14 and the highest is 62.78 with an average value of 3.35 and a standard deviation of 20.41. Noting the value of the cut-of-value and Goodness of fit results of the model, it appears that the criteria are good so that it is feasible to be used for further testing.
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Loebbecke, Claudia, and Bernhard Thomas. "Developing and enforcing internal information systems standards: InduMaker’s Standards Management Process." International Journal of Information Systems and Project Management 4, no. 1 (February 8, 2022): 5–24. http://dx.doi.org/10.12821/ijispm040101.
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It is widely agreed that standards provide numerous benefits when available and enforced. Company-internal Information Systems (IS) management procedures and solutions, in the following coined IS ‘standards’, allow for harmonizing operations between company units, locations and even different service providers. However, many companies lack an organized process for defining and managing internal IS standards, which causes uncertainties and delays in decision making, planning, and design processes. In this case study of the globally operating InduMaker (anonymized company name), an established manufacturing supplier, we look into the company-internal management of IS standards. Theoretically grounded in the organizational and IS-focused literature on business process modelling and business process commoditization, we describe and investigate InduMaker’s newly developed Standard Management Process (SMP) for defining and managing company-internal business and IS standards, with which the multinational pursues offering clear answers to business and IT departments about existing IS standards, their degree of obligation, applicability, and scope at any time.
Dissertations / Theses on the topic "Standard Manufacturing Company"
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Poirier, Debra. "Implementation of six sigma at Company XYZ to eliminate finished good nonconformance." Online version, 2009. http://www.uwstout.edu/lib/thesis/2009/2009poirierd.pdf.
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Leng, Yue, Mohamed Mohamed, and Peter Westerberg. "The process of making a Chinese subsidiary company meeting Western standards : A case study in a Chinese manufacturing company." Thesis, Högskolan i Gävle, Avdelningen för Industriell utveckling, IT och Samhällsbyggnad, 2015. http://urn.kb.se/resolve?urn=urn:nbn:se:hig:diva-20098.
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This research is carried out by studying a Chinese factory, producing metal spare parts, and its Swedish parent company that produces binding machines. The companies recently merged together after a previous relationship as supplier and customer. To bring the companies closer together an ERP-system was implemented during the research period. The purpose of this study is to answer three research objectives: Explore what outcomes there are when a Swedish company acquires a Chinese factory related to cultural differences affecting the merging process. Investigate conditional barriers for developing the Chinese factory to meet Swedish standards regarding the relation of quality and production. Discover how efficient communication with ERP-system can help with the achievement of meeting Swedish standards for the subsidiary Chinese factory. To answer these questions, interviews with three people in management positions was constructed and carried out. A questionnaire was constructed to get the employees views on changes. Observations was made in the Chinese factory which provided some information useful to answering the research objectives and with these three methods the results could be triangulated. Literature was reviewed with connections to: culture differences, ERP-systems and quality perspective in China to construct the theoretical basis for this research. The study discovered how culture differences affected important areas such as communication, work implementation and management. The cultural differences also affected the second research question about quality and production. Other aspects as education, quality focus, and involvement from employees were also acting as a barrier for developing quality and production. The implementation of an ERP-system experienced some of the barriers mentioned above as language and culture differences but also providing effective communication. Also other benefits as a clearer view of the organization structure, manufacturing processes and the production flow. However, the ERP-system implemented also has its flaws since it is not fully adapted to the Chinese market and users’ needs. It is also a reflection on the importance of understanding and adjusting to the Chinese culture.
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Kahl, Brooke (Elaine Brooke). "Developing and implementing standard logistics solutions for Eastman Kodak Company's inbound supply chain." Thesis, Massachusetts Institute of Technology, 2006. http://hdl.handle.net/1721.1/37220.
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Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Dept. of Electrical Engineering and Computer Science; in conjunction with the Leaders for Manufacturing Program at MIT, 2006.Vita.
Includes bibliographical references (p. 80-82).
Eastman Kodak Company managed its supply chain operations at a regional level until 2002 when it created the Global Logistics group. Prior to this, there had not been much corporate focus on the inbound supply chain; in addition, Kodak lacked a standard process for the definition, selection, and implementation of inbound logistics solutions. As a result, inventory optimization occurred at a local level without insight into what was best for the corporation as a whole. This led to situations where material inventories were not managed effectively, implementations of inbound logistics methods varied widely across the corporation, and suboptimal inbound logistics solutions were created or selected. Ultimately these practices led to inefficient supply chain management and excessive inventory and operating costs for Kodak. The purpose of this thesis is to develop a set of standardized inbound logistics solutions for the company, create a decision tool that can be used to aid in the selection of the most appropriate solution, and implement this standard process across the corporation. This thesis is the result of work done during a 6.5 month LFM internship at Eastman Kodak Company in Rochester, New York.
by Brooke Kahl.
S.M.
M.B.A.
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Chiang, Shun-Chan, and 江舜展. "The Research of Consumers'' hazardous substance free standardA case study for LCD-TFT manufacturing company." Thesis, 2010. http://ndltd.ncl.edu.tw/handle/39657636904023892901.
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碩士國立中央大學
工業管理研究所碩士在職專班
98
Case Company require through customer products unleaded green one, have lead material cooperate customer is it change for the unleaded material to require TFT-LCD products 2000 years ago, is it is it have bittern green one require, designed and took on in coordination with new personnel, special project of aircraft type, Company of case, this stages to get to go on later, do not have steamed product design to carry on the products, begin the norm and have no relevant homework of bittern, in order to guarantee the material that the customer uses is designed in order to have no bittern, begin to offer to the customer Green BOM materials. Will endanger and limit the use of the material to standardize the demand in order to accord with SONY in 2004, make SONY Green Partner of Certificate, and endanger and limit the use of the material norm requiring (SS-00259) in accordance with SONY ,Endanger and limit the use of the material operating system and channel into the case company. Since 2006, the case company establishes the green full-time unit, the green products enterprise planning department in the total place of quality, begin to arrange the danger that the full-time role combines the customer and limit the use of the material norm, guarantee the case company limits the use of the material and requires to that the customer endangers, it can accord with to produce activity homework and supplier relevantly. Because the customer limits the use of the material and demands to become essential quality of TFT-LCD products to require for endangering gradually, case company will engage the third notarization unit will endanger and limit the use of the material expert in 2008, channel into QC 080000 system, implement and endanger and limit the use of the material it in the quality system. This research limits the use of the material norm to study through endangering among every customer, carry on different aspects analysis, is it produce to advise the trend in the future, for the panel factory of a company of the case and the upper reaches supplier to consult, the relevant materials technology of operation ahead of time is researched and developed, to reach the brand factory and end on the market to endanger and limit the use of the new demand the most of material, it accords with the customer and rules and regulations to sell with the sharp panel products. Limit the use of the material norm in danger through company''s panel customer of the case, carry on the different aspects and study carefully and analyse, offer the customer to endanger and limit the use of the future homework of the material norm and propose, set up and endanger and limit the use of the material norm in the case company panel oneself, guide the case company panel and the upper reaches supplier offer the restriction that should be new and substitute materials or the new corresponding material technical research to launch, fill a
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"Implementation of ISO-9000: a case study of manufacturing company." Chinese University of Hong Kong, 1995. http://library.cuhk.edu.hk/record=b5888301.
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by Tung Man Kei.Thesis (M.B.A.)--Chinese University of Hong Kong, 1995.
Includes bibliographical references (leaves 82-83).
ABSTRACT --- p.ii
TABLE OF CONTENTS --- p.iv
LIST OF TABLES AND FIGURE --- p.vi
LIST OF APPENDIXES --- p.vii
PREFACE --- p.viii
Chapter
Chapter I. --- INTRODUCTION --- p.1
Chapter II. --- ISO-9000 Standards --- p.4
Recent Development of ISO 9000 Standards --- p.6
Other Quality Standards and Awards --- p.8
Influence of ISO 9000 --- p.11
Implementation of ISO 9000 --- p.15
Chapter III. --- CASE STUDY: PART (A) JEWELLERY INDUSTRY AND ABC JEWELLERY LIMITED --- p.18
Jewellery Industry in Hong Kong --- p.18
The ABC Jewellery Limited --- p.20
Organizational Structure of ABC Jewellery Limited --- p.21
Production Department --- p.22
Stone Department --- p.24
Human Resources Department --- p.24
Quality and Technology Department --- p.25
Management Information Department --- p.26
Marketing Department --- p.26
Export Department --- p.27
Financial Situation of ABC Jewellery Limited --- p.28
Chapter IV. --- CASE STUDY: PART (B) IMPLEMENTATION OF ISO-9002 CERTIFICATE OF A MANUFACTURING COMPANY - ABC JEWELLERY LIMITED --- p.30
Quality Reform of ABC Jewellery Limited --- p.30
The MANCOM - A Reform of Management Committee --- p.32
The Implementation Plan of ISO-9000 of ABC Jewellery Limited --- p.34
Step 1： Preliminary Goals Setting and Formulation of Action Plan --- p.35
Step 2: Creation of Mission and Vision Statements --- p.37
Step 3: Formation of Quality Team --- p.37
Step 4: Education of Quality Concept --- p.38
Step 5: Preparation of Quality Manual and Work Procedures - the Business Procedures --- p.40
Step 6: Reengineering of Business System --- p.43
Step 7： Registration for ISO-9002 --- p.44
Problems faced by the Company --- p.45
Dilemma --- p.53
Chapter V. --- CASE STUDY: PART (C) LATEST SITUATION OF ABC JEWELLERY LIMITED --- p.54
Quality and Technology Department --- p.54
"""Quality In Progress"" and Other Quality Improvement Projects in the Company" --- p.55
Chapter VI. --- CONCLUSION OF THE CASE STUDY --- p.57
TABLES AND FIGURE --- p.59
APPENDIXES --- p.63
BIBLIOGRAPHY --- p.82
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Chen, Lee-jane, and 陳麗貞. "A Study of Implementing International Financial Reporting Standards on the Government-owned Enterprise – An Example on Aerospace Manufacturing Company." Thesis, 2010. http://ndltd.ncl.edu.tw/handle/36614346230471233866.
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碩士國立中山大學
企業管理學系研究所
98
Generally Accepted Accounting Principles (GAAP) is the term used to refer to the standard framework of guidelines for financial accounting that financial and accounting people must follow when they form, perceive and conduct those financial information and data. In response to the globalization era, increasing comparative among various international enterprise financial reports under same principles and terms, also to reduce the fund-raising costs while enterprise seeking for the funding in the world capital market, on May 14, 2009, Financial Supervisory Commission, Executive Yuan, R.O.C (hereafter refers to as FSCEY) announced that ROC GAAP will adopt framework and principle of International Financial Reporting Standards (hereafter refers to as IFRS) from 2013 by means of several phases, and public companies are enforced to implement IFRS from 2013. Directorate General of Budget, Accounting and Statistics, Executive Yuan, R.O.C. asked all government-owned enterprises have to keep consistency and conduct IFRS in the first stage same as public companies, in order to pass the Bill of annual budget that reviewed and ratified by The Legislative Yuan of ROC. Therefore, for all government-owned enterprises who early-adopting IFRS have to prepare and present the related financial report in year 2013 same as public companies. Government-owned enterprises are requested to provide an update of progress on its IFRS changeover plan and any changes in its plan on “footnote disclosure” of interim and year-end financial report of the financial year 2011 and 2012. The main purpose of the essay is discussing development of IFRS, US GAAP and ROC GAAP, and analyzes the case company, one of the government-owned enterprises, in this essay could face problems when implement IFRS according to FSCEY timetable. The conclusion of this essay proposes the feasible implement plan for case company reference. The findings showed, although case company could face with many uncertainty while implement IFRS, but it should have high confidence to expect success of conducting IFRS on time through early kick-off implement plan with more communication and collaboration with the upper supervisory organization in this country.
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莊月香. "The Impact of the Amendment to the Labor Standards Act, One Fixed Day Off, One Flexible Day Off, on Manufacturing Industry- A Case Study of D Factory of H Company." Thesis, 2019. http://ndltd.ncl.edu.tw/handle/y7fkz9.
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碩士大葉大學
管理學院碩士在職專班
107
Working hours and special leave of labor right were the main issues had been amended in Labor Standard Laws on January 31, 2018. The provisions of Articles 24, 32, 34, 36-38, and 86 were amended; the provisions of Article 32-1 were added. And the date of implementation is March 1st 2018. The amendments include new rules such as the calculation of overtime hours for rest days、the replacement of overtime pay、the flexibility of monthly overtime、the flexibility of holidays、the flexibility of shifts and the flexibility of special leave. At that time, the problem of Labor Standard Laws is insufficient flexibility to both parties which are employers and employees. The purpose of the amendment is to give employers great flexibility, but the elasticity for employers is the inconvenience of the other side which is employee. The amendment of Labor standard laws becomes evil for employees. The labor-management relationship is worsened by mutual suspicion. Therefore, this study takes the H company D factory as the object, and discusses the way of the labor-based law repair method, and hopes to solve the current predicament of a case. This study was conducted by interview trying to find the solution to solve the conflict that between employers and employees. And interview data were analyzed, the employees responded positively to some of the Amendment of Labor Standard Laws, including special vacations, constant benefits, and more rest periods. Negative responses included reduced salary and high pressure on life. The supervisor also said that the difficulty of scheduling due to a single break also increased management difficulties. The study found that the problem of low-paying structure has not been solved for a long time, the actual salary has not increased, the operating costs of enterprises have increased, the number of dispatched personnel has increased, and the relationship between employers and employees has deteriorated. Since the implementation of "One Fixed Day Off, One Flexible Day Off ", lack of flexibility and the result of a three-loss situation of labor, employer, and society require the government and enterprises to solve problems together in order to create a "three-win" labor environment.
Books on the topic "Standard Manufacturing Company"
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Company, Macdonald Manufacturing, ed. Price list and descriptive circular of repairs for the Decker and Standard threshers: Manufactured by Macdonald Manufacturing Company, Stratford, Ontario, Canada. [Stratford, Ont.?: s.n., 1986.
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The six sigma revolution: How General Electric and others turned process into profits. New York: John Wiley, 2001.
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P, Neuman Robert, and Cavanagh Roland R, eds. The Six Sigma way: How GE, Motorola, and other top companies are honing their performance. New York: McGraw-Hill, 2000.
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Emission testing at a structural brick manufacturing plant: Final emission test report for testing at Belden Brick Company Plant 6, Sugarcreek, OH, November 8 to 12, 1993. Research Triangle Park, N.C: U.S. Environmental Protection Agency, Office of Air and Radiation, Office of Air Quality Planning and Standards, 2001.
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Neuman, Robert P., Peter S. Pande, and Roland Cavanagh. Six Sigma Way: How to Maximize the Impact of Your Change and Improvement Efforts, Second Edition. McGraw-Hill Higher Education, 2014.
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Pande, Peter S. The six sigma way: How to maximize the impact of your change and improvement efforts. 2014.
Find full textBook chapters on the topic "Standard Manufacturing Company"
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Ocampo-Leyva, Edward, Rafael Lopez-Morales, and Alberto Flores-Perez. "Improvement Model to Optimize Packing Times in a Peruvian SME Agricultural Export Company Using Cellular Manufacturing, SMED and Standard Work." In Communications in Computer and Information Science, 43–53. Cham: Springer Nature Switzerland, 2024. http://dx.doi.org/10.1007/978-3-031-56373-7_4.
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Pei, Eujin, and Israt Kabir. "Standardisation in AM." In A Guide to Additive Manufacturing, 59–73. Cham: Springer International Publishing, 2022. http://dx.doi.org/10.1007/978-3-031-05863-9_3.
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AbstractA standard is a published document that describes a technical specification or a list of guidelines in the form of rules, definitions, methods, vocabularies, or codes of practices. Standards provide a unified source of reference for specifying or representing products. Before the industrial revolution, manufacturers from different places used to compare and copy the dimensions and specifications of components to match those of a prototype.
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Breeze, Ruth. "Chapter 9. Lessons learned?" In Manufacturing Dissent, 284–307. Amsterdam: John Benjamins Publishing Company, 2024. http://dx.doi.org/10.1075/pbns.339.09bre.
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The 2008 financial crisis severely undermined public trust in banking systems, prompting calls for widespread reform. However, irregularities continued, leading to a further succession of scandals over the following years. We should therefore ask how banks justified the catastrophe and their failure to reform. This chapter examines two large UK-based banks: Royal Bank of Scotland (RBS), and HSBC. All the “letters to shareholders” published in their Annual Reports over 15 years are examined for commonplace arguments or “topoi” offered as justifications for their failure to comply with ethical standards. Five typical recurring arguments are analysed, with a particular focus on their use in subtle manipulations of public opinion to draw attention away from the scale and impact of corporate wrongdoing.
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Iliashenko, Oksana, Victoria Iliashenko, and Alexandra Shuvalova. "Development of the Company’s IT Infrastructure in the DAMA-DMBOK Standard Implementation." In Digital Transformation on Manufacturing, Infrastructure & Service, 732–44. Cham: Springer Nature Switzerland, 2023. http://dx.doi.org/10.1007/978-3-031-32719-3_55.
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Anaya, Victor, Enrico Alberti, and Gabriele Scivoletto. "A Manufacturing Digital Twin Framework." In Artificial Intelligence in Manufacturing, 181–93. Cham: Springer Nature Switzerland, 2024. http://dx.doi.org/10.1007/978-3-031-46452-2_10.
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AbstractDigital twin technology has become a driving force in the transformation of the manufacturing industry, playing a crucial role in optimizing processes, increasing productivity, and enhancing product quality. A digital twin (DT) is a digital representation of a physical entity or process, modeled to improve decision-making in a safe and cost-efficient environment. Digital twins (DTs) cover a range of problems in different domains at different phases in the lifecycle of a product or process. DTs have gained momentum due to their seamless integration with technologies such as IoT, machine learning algorithms, and analytics solutions. DTs can have different scopes in the manufacturing domain, including process level, system level, asset level, and component level. This work presents the knowlEdge Digital Twin Framework (DTF), a toolkit that comprises a set of tools to create specific instances of DTs in the manufacturing process. This chapter explains how the DTF relates to other standards, such as ISO 23247. This chapter also presents the implementation done for a dairy company.
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Hanenkamp, Nico, and Oliver Zipse. "Sustainability in Manufacturing Transforming." In Road to Net Zero, 187–214. Cham: Springer International Publishing, 2023. http://dx.doi.org/10.1007/978-3-031-42224-9_7.
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AbstractWhile consensus often exists regarding the principles of sustainability, their implementation on the shop floor is a challenge for every manufacturing company. The three dimensions of sustainable production—social, ecological, and economic—must be considered equally when planning investments or improving operational efficiency. In doing so, the implementation reveals additional efficiency potential because the three dimensions interact positively. For example, improved working conditions address the social aspect of sustainability, but they also have a positive impact on motivation and productivity. However, sustainability in operations depends strongly on innovation and research. First, electrification technologies to generate, store, and transport electrical energy will play major roles in the factory of the future. Second, circular processes that close loops in material and energy use will increase efficiency and positively impact sustainability. Finally, innovative manufacturing and digitalization technologies provide further improvements in sustainability. Successful companies on the path to sustainability do not interpret sustainability principles as an end in themselves. These companies have a clear vision of the factory of the future in mind, characterized by sustainable manufacturing processes on the shop floor, a high degree of digitalization and the use of artificial intelligence (AI) to generate data compatible with accepted sustainability standards, and the coupling of different systems and processes.
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Redeker, Magnus, Jan Nicolas Weskamp, Bastian Rössl, and Florian Pethig. "A Digital Twin Platform for Industrie 4.0." In Data Spaces, 173–200. Cham: Springer International Publishing, 2022. http://dx.doi.org/10.1007/978-3-030-98636-0_9.
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AbstractIn an Industrie 4.0 (I4.0), rigid structures and architectures applied in manufacturing and industrial information technologies today will be replaced by highly dynamic and self-organizing networks. Today’s proprietary technical systems lead to strictly defined engineering processes and value chains. Interacting Digital Twins (DTs) are considered an enabling technology that could help increase flexibility based on semantically enriched information. Nevertheless, for interacting DTs to become a reality, their implementation should be based on open standards for information modeling and application programming interfaces like the Asset Administration Shell (AAS). Additionally, DT platforms could accelerate development and deployment of DTs and ensure their resilient operation.This chapter develops a suitable architecture for such a DT platform for I4.0 based on user stories, requirements, and a time series messaging experiment. An architecture based on microservices patterns is identified as the best fit. As an additional result, time series data should not be integrated synchronously and directly into AASs, but rather asynchronously, either via streams or time series databases. The developed DT platform for I4.0 is composed of specialized, independent, loosely coupled microservices interacting use case specifically either syn- or asynchronously. It can be structured into four layers: continuous deployment, shop-floor, data infrastructure, and business services layer. An evaluation is carried out based on the DT controlled manufacturing scenario: AAS-based DTs of products and manufacturing resources organize manufacturing by forming highly dynamic and self-organizing networks.Future work should focus on a final, complete AAS integration into the data infrastructure layer, just like it is already implemented on the shop-floor and business services layers. Since with the standardized AAS only one interface type would then be left in the DT platform for I4.0, DT interaction, adaptability, and autonomy could be improved even further. In order to become part of an I4.0 data space, the DT platform for I4.0 should support global discovery, data sovereignty, compliance, identity, and trust. For this purpose, Gaia-X Federation Services should be implemented, e.g., as cross-company connectors.
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Jawaid, A., and J. Seewig. "Discrete Filter and Non-Gaussian Noise for Fast Roughness Simulations with Gaussian Processes." In Proceedings of the 3rd Conference on Physical Modeling for Virtual Manufacturing Systems and Processes, 1–15. Cham: Springer International Publishing, 2023. http://dx.doi.org/10.1007/978-3-031-35779-4_1.
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AbstractRough surface simulations result in tight feedback loops in research procedures, such that they speed up studies for example about roughness’ impact on tribology or fluid dynamics. To model and simulate a broad spectrum of rough surfaces, Gaussian processes (GP) have been suggested recently. However, these models are limited on surfaces with small sizes since computational time-costs and memory-costs of simulations with standard procedures scale cubically and quadratically, respectively. In this paper, we apply the discrete filter approach which is a special case of GPs. We use the discrete filter with the fast Fourier transform (FFT) algorithm to efficiently sample from a high-dimensional Gaussian distribution and we compare its computational costs with the contour integral quadrature algorithm. Our experiments show that GPs benefit from FFT and allow stationary rough surfaces with sizes as large as 30, 000 × 30, 000 to be efficiently sampled. Since this approach is complementary to the GP and noise model approach, we also show simulations of rough surfaces with underlying non-Gaussian noise models that can reduce computational complexity.
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Biltgen, Jacques, Sascha Lauer, Martin-Christoph Wanner, and Wilko Flügge. "Digital Geometry Recording for Automation of the One-Off Production of Pipes." In Annals of Scientific Society for Assembly, Handling and Industrial Robotics 2022, 267–78. Cham: Springer International Publishing, 2023. http://dx.doi.org/10.1007/978-3-031-10071-0_22.
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AbstractThe manual production in pipeline construction is often related to the fact that either the capacities for automation are lacking or the production is too individual for a simple automation solution. However, automated production would increase productivity and quality, especially in metal processing. The challenge in the manufacturing process of fitting tubes is the batch sizes of one. Nevertheless, a non-time-consuming programming solution must be found to integrate a robot-based solution economically into the production chain. Offline path planning based on CAD models would be a suitable solution. To ensure that the robot-welded seams comply with the standards, there has to be consistent quality in the seam preparations. For the final quality the direct integration of the CAD flow would be important. Due to transport and limited space, it is often impossible to use sensors to scan the piping. In case of lacking technical documentation, the pipes are still measured by hand, especially when replacing or modifying pipelines.The geometry survey is done in several steps, first a rough drawing is made on the vessel, this is then converted into a technical sketch and only later transferred to a CAD programme. There can be several days between these steps and different operators. A method will now be presented to combine these steps with the support of a tablet. For this purpose, software is used on the tablet to digitise the geometries and prepare them for further offline path planning.
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Hao, Yuqiuge, and Petri Helo. "Cloud Manufacturing Towards Sustainable Management." In Sustainable Business, 676–95. IGI Global, 2020. http://dx.doi.org/10.4018/978-1-5225-9615-8.ch030.
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Nowadays, most manufacturing companies have realized the importance of collaboration between dispersed factories, different suppliers, and distributed stakeholders. Cloud computing is an evolution of the Internet; it does not just change the technology, but also enables collaborative innovation. Cloud manufacturing (CM) is another form of networked manufacturing. It provides common and standard manufacturing services by cloud logic and principle. In this chapter, a new concept is suggested based on the fundamental theory and key technologies of CM. Cloud Future Factory, which is intended to manage a matrix-type organizational structure, focuses on improving communication in lean manufacturing. This case company has dispersed production lines and business departments. Therefore, it's very necessary to introduce an efficient and dynamic information integration platform. This chapter leads to a different way of thinking for using the cloud manufacturing concept in different formations. CM is not just suitable for small and medium sized enterprises, but also fits large size companies.
Conference papers on the topic "Standard Manufacturing Company"
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Delpagoda, R. A., P. D. E. Anjana, M. K. S. Kavindi, and A. S. D. Weeraman. "A Process architecture approach for developing standard operating procedures for manufacturing organization." In International Conference on Business Research. Business Research Unit (BRU), 2023. http://dx.doi.org/10.31705/icbr.2023.7.
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To obtain any authority or certification, such as the International Organization for Standardization (ISO), an organization must have standard documentation of the activities occurring on that premises or network. Having standard operating procedures (SOP) enables the company to perform its work to a standard. This paper focuses on developing SOPs for one of the Fast-Moving Consumer Goods (FMCG) organizations in Sri Lanka. This study is expected to help obtain the ISO 9001-2015 certification, which was a problem for the concerned Company. The main topic of this research includes process identification and standard operating procedure development for production, warehouse, and procurement processes. The value-added activities are identified through the impact matrix. The process architecture approach has been used to develop the much-needed operational SOP. Using the process architecture approach is the innovative approach in this study. Data collection for the study was done by using interviews, observations, and company records. By having a good interaction between researchers and participants, it is possible to follow the qualitative methodology. This provides a deeper understanding of the subjective aspects of the research questions. After the identification of critical processes, the qualitative attributes required by them for ISO 9001 - 2015 were recognized and the SOPs related to the existing three processes were developed in this study.
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Wu, Cheng-Wei, Tung-Kuan Liu, and Po-Wen Hsueh. "Research on Optimization of Dielectric Layer Thickness Standard Deviation of Multilayer Ceramic Capacitors-An Empirical Study on Y Manufacturing Company." In 2022 25th International Conference on Mechatronics Technology (ICMT). IEEE, 2022. http://dx.doi.org/10.1109/icmt56556.2022.9997664.
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Volak, Josef, Zbynek Bunda, and Vaclav Mentl. "Comparison of P92 Steel Fatigue Test Results in Relation to Specimen Size and Manufacturing." In ASME 2013 Pressure Vessels and Piping Conference. American Society of Mechanical Engineers, 2013. http://dx.doi.org/10.1115/pvp2013-97702.
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This paper describes fatigue properties of steel P92. This material is used as a standard in the energy industry, especially for production of pipes and flange branches and distance pieces of supercritical steam turbines. This material contains (unlike material P91) up to 2% of tungsten which has positive influence on creep strength increase. Compared to the P91 material, it is possible to reduce wall thickness of the P92 pipe up to 20%. Fatigue tests were carried out on standard samples and compared with SFT samples (Small Fatigue Test). SFT samples can be gently withdrawn from energy component by SSam 2 device made by company Rolls Royce. There is no necessity for shutdown of power plant. Thanks to the existing correlations between SFT and Fatigue tests, it is possible to determine mechanical properties of material from a small amount of withdrawn material. At the same time a comparison between a traditional way of sample production and a sample production by means of waterjet cutting was carried out.
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Beal, Valter Estevão, Márcio Araujo, João Oliveira, Rafael Tobio Claro, Saulo Queiroz Figliuolo, and Flávio Silva. "Challenges on Design, Manufacturing and Supply Chain Development of a Blowout Preventer for Onshore Oil and Gas Wells in Brazil." In ASME 2017 International Mechanical Engineering Congress and Exposition. American Society of Mechanical Engineers, 2017. http://dx.doi.org/10.1115/imece2017-70052.
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Blowout Preventers, BOPs, are essential safety equipment for oil & gas industry. Nevertheless, Brazil does not have a manufacturer that can provide this equipment and the Brazilian National O&G agency regulator has been pushing for O&G explorer and producers to use a minimum of machinery from local suppliers. With this regulatory demand, a BOP was developed from scratch. International Standards have been evaluated to understand what could be adapted as no standard is applied specifically to this equipment. Analytic and numerical simulations were performed and adjusted according to local suppliers’ limitations for materials and testing. Tree prototypes were built and tested to evaluate the design and functionality of the BOPs. At the end, the design was proven to work and the prototypes are being tested for long time without presenting any problems. This project was supported by an innovation agency EMBRAPII and was developed by SENAI CIMATEC to PERBRAS Company.
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Aremu, Adebayo A., Adeniyi O. Aremu, and Oyetunde A. Adeaga. "Assessment of Critical Equipment for Preventative Maintenance of Plastic Plant." In ASME 2015 Power Conference collocated with the ASME 2015 9th International Conference on Energy Sustainability, the ASME 2015 13th International Conference on Fuel Cell Science, Engineering and Technology, and the ASME 2015 Nuclear Forum. American Society of Mechanical Engineers, 2015. http://dx.doi.org/10.1115/power2015-49139.
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With the continual demand for effective manufacturing performance, proper maintenance of production facilities and systems has become the standard of good manufacturing practice. In response, industrial plants, machines, and equipment are becoming more technically advanced, thus more complex and difficult to control and maintained. This paper is focused on a methodology for assigning relative criticality to production equipment in order to optimise a preventative maintenance program. As a case study, the authors examine equipment used in plastic production plants. Generic factors deciding the criticality were considered using a scoring system. With the use of cumulative percentage of scores, an Always Better Control (ABC) analysis was carried out and the critical equipment identified. An effective maintenance programme for the case study shows a 23%reduction of down time and also a 12.7% of equipment durability and about 96% criticality equipment factor, with optimum output. The result of this study will be significant to manufacturing company in minimizing incidences and stoppages not only on critical equipment but production facilities.
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Hothi, Harsimran, and Fatemeh Davoudi Kakhki. "Developing a Quality Control System for Biotechnological Device Inspection Improvement." In 14th International Conference on Applied Human Factors and Ergonomics (AHFE 2023). AHFE International, 2023. http://dx.doi.org/10.54941/ahfe1003048.
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Incoming quality control (IQC) is integral to quality management system of manufacturing industries. IQC plays a significant role in ensuring delivery of high standard products to the target customers and, in turn, affects the company’s reputation and their competitiveness in the industry. Presenting a case from a biotechnology company, the purpose of this research is to develop a quality control system for inspection improvement of a biotechnological device. During the COVID-19 pandemic, the IQC Department encountered inconsistencies with output rate when providing inspected parts to the Manufacturing Department: an issue that could be mitigated with a documented process that addresses the prevalent issues that plague the current unestablished IQC system. This study utilized the Lean Six Sigma Methodology to achieve improvement for the IQC Department practice for enhanced performance by identifying root causes of inconsistencies, and creating a systematic documented process for IQC department. Upon successful analysis and implementation of the new IQC inspecting system, the non-value-added time decreased by over fifty percent. While this project is the first stepping stone in improving the IQC Department, its significant results emphasizes the integral contribution of quality control and Six Sigma practices in creating a continuous improvement system which ensures consistent high-quality instruments are being produced for the customers.
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Fantaccione, Luca, Angela Serra, Giulio Buia, Pietro Bartocci, Sergio Gandini, and Francesco Fantozzi. "Effects on Sustainability by Redesign of a 1° Stage Gas Turbine Nozzle Ring From Investment Casting to Additive Manufacturing: A Life Cycle Environmental Impact Comparison." In ASME Turbo Expo 2022: Turbomachinery Technical Conference and Exposition. American Society of Mechanical Engineers, 2022. http://dx.doi.org/10.1115/gt2022-78256.
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Abstract Energy companies are committing to protect the environment and reducing their product carbon footprint. To accomplish these objectives, they need to establish their baseline, including the life cycle emissions of key products and services. The life cycle emissions assessment will help to support customers and suppliers, many of which have set their own carbon footprint reduction targets, in finding opportunities to reduce their own environmental impact. The purpose of this study is to compare the environmental impact of two manufacturing processes, namely Additive Manufacturing (AM) and Investment Casting (IC), for the production of a 1° stage gas turbine nozzle ring in order to determine which method is the most sustainable on the Life Cycle. AM technologies brought to the world new design possibilities which become very useful for those items whose production rate decreases due to a drop in demand or a suspended production. In this case study, which considers a serviced Gas Turbine, the production volume is very low compared to the standard production of a gas turbine. For this reason, AM revealed to be a key strategy for the investigated product for environmental, cost and lead time sustainability. The LCA is conducted under Cradle-to-Gate boundaries, hence it investigates every energy/material input and output from the raw materials extractions, to the production of the good at the gate of the company ready for shipping. Raw material extraction, powder atomization, machining, finishing, and coating phases are included into the analysis. The choice of the manufacturing strategy requires different materials and different suppliers are involved into the manufacturing chain, which means also differences in transportation and sources for electricity production.
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Campbell, Michael M. "Software Tools to Support Advanced Design Techniques and Processes." In ASME 2008 9th Biennial Conference on Engineering Systems Design and Analysis. ASMEDC, 2008. http://dx.doi.org/10.1115/esda2008-59063.
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Collaboration between engineering and manufacturing can significantly reduce product costs, and increase product quality. The definition, capture and re-use of standard design features, with their associated proven manufacturing processes in the design stage can significantly reduce manufacturing cost and time to market. Today, 3D models are becoming the central repository for more and more of the critical information which is necessary throughout the Product Development Process. Significant process improvements are possible when organizations embrace the idea of a model-centric design approach, where not only geometry and attributes are captured in the 3D CAD model, but also other data relevant downstream data such as GD&T, 3D annotations, and now even manufacturing process information. The strategies for actually machining and producing designs are important assets for companies. Now, existing manufacturing process knowledge can be capture by the manufacturing engineer using XML based template, and through the use of new CAD technology, this knowledge can be attach to design features. The design feature geometry and attributes (along with the embedded process knowledge) can then be made available to the broader organization, through catalogs of company standard design features such as holes, pocket, step, groove, flange, .. etc. During the engineering activities, as the design model evolves, the design engineer is able to re-use these standard features, creating a 3D model that not only includes the geometric definition of the product, but also the validated, proven process by which that geometry can best be produced. Downstream, once the design is handed off to manufacturing, the manufacturing or process engineer has access to tools that will allow him to extract the process information from the 3D model and define rules to automate the creation of the machining process plan for this model. Specific fixtures required for the different steps of the process can be easily developed using the in-process 3D model, which is generated automatically based on stock removal. Multiple scenarios, based on varying machining resources, production quantity and cycle time, can be analyzed, allowing the process engineer to develop and optimized process plan. This model-centric approach, which leverages product and process data re-use, improves product quality and reduces manufacturing process planning and production time. Typical savings are realized in tool design, increased production throughput and savings due to improved process quality from using validated processes prior to production.
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C´atic´, Amer, and Petter Andersson. "Manufacturing Experience in a Design Context Enabled by a Service Oriented PLM Architecture." In ASME 2008 International Design Engineering Technical Conferences and Computers and Information in Engineering Conference. ASMEDC, 2008. http://dx.doi.org/10.1115/detc2008-49858.
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An increased competition on the product development market pushes the industry to continually improve product quality and reduce product cost. There is also a trend towards considering a products life cycle aspects including environmental sustainability. The manufacturing process is a major cost driver in the product life cycle; hence, there are many initiatives to improve manufacturability and reduce production cost. Learning from earlier projects is essential to avoid recurrence of problems and is generally realized through use of concurrent engineering and design for manufacturing (DFM). Other research provides general DFM principles which state detailed guidelines for how different geometries combined with different manufacturing processes affect component quality and cost. The real competitive edge lies however in the development and application of company specific DFM principles that are based on manufacturing experiences. To do so requires an overview of and access to the collected manufacturing experiences. The aim of this paper is to point out key enablers for efficient reuse of manufacturing experience, which is considered to contribute to lower product cost and higher product quality. A study performed at an automotive and at an aerospace engine manufacturer pointed out the apparent need and lack of reuse of manufacturing experiences in product development. Applications supporting reuse of manufacturing experience through embedded DFM knowledge in designer’s CAD system were found in the literature. The issue of integrating these applications with the enterprise environment, in order to capitalize on existing sources of manufacturing experience, is addressed with a proposed solution applying a service oriented PLM architecture. In addition, a graphical user interface visualizing the manufacturing experience in a combined product and process context was developed. The validation of these proposed and developed solutions was done through interviews and workshops. The conclusions are that visualization of manufacturing experiences in a combined product and process context provides improved understanding of how the experiences relate to each process history and that a key enabler for integration of information in heterogeneous environments is the use of standard service oriented architectures and neutral formats.
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Inui, Masatomo, Tong Zhang, and Nobuyuki Umezu. "Milling Simulation-Based Method to Evaluate Manufacturability of Machine Parts." In ASME 2020 International Design Engineering Technical Conferences and Computers and Information in Engineering Conference. American Society of Mechanical Engineers, 2020. http://dx.doi.org/10.1115/detc2020-22124.
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Abstract The designers of mechanical products are generally not experts in machining. Therefore, they often design parts with inherent machining difficulties. Although various design for manufacturability tools have been developed to avoid such problems, their use in practice remains limited due to their lack of versatility. We develop a novel piece of software that can automatically detect difficult-to-machine shapes in a part. Using this software, the designer can determine which shapes are difficult to produce using conventional cutting by themselves, and can modify the shape on the spot. In the Internet-based part manufacturing business, the same software can be used to check whether the given part can be produced using the standard milling operations predetermined in a company. Our system is based on “milling simulation”. It detects any shapes that cannot be produced using the prepared cutting tools by executing the milling simulations with the tools, and then visualizing shapes that remain unmachined after all simulations. In this study, the acceleration of the processing is realized using graphics processing unit technology, and it is possible to extract difficult-to-machine shapes in several minutes using a standard PC.
Reports on the topic "Standard Manufacturing Company"
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Lubowa, Nasser, Zita Ekeocha, Stephen Robert Byrn, and Kari L. Clase. Pharmaceutical Industry in Uganda: A Review of the Common GMP Non-conformances during Regulatory Inspections. Purdue University, December 2021. http://dx.doi.org/10.5703/1288284317442.
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The prevalence of substandard medicines in Africa is high but not well documented. Low and Middle-Income Countries (LMICs) are likely to face considerable challenges with substandard medications. Africa faces inadequate drug regulatory practices, and in general, compliance with Good Manufacturing Practices (GMP) in most of the pharmaceutical industries is lacking. The majority of pharmaceutical manufacturers in developing countries are often overwhelmed by the GMP requirements and therefore are unable to operate in line with internationally acceptable standards. Non-conformances observed during regulatory inspections provide the status of the compliance to GMP requirements. The study aimed to identify the GMP non-conformances during regulatory inspections and gaps in the production of pharmaceuticals locally manufactured in Uganda by review of the available 50 GMP reports of 21 local pharmaceutical companies in Uganda from 2016. The binary logistic generalized estimating equations (GEE) model was applied to estimate the association between odds of a company failing to comply with the GMP requirements and non-conformances under each GMP inspection parameter. Analysis using dummy estimation to linear regression included determination of the relationship that existed between the selected variables (GMP inspection parameters) and the production capacity of the local pharmaceutical industry. Oral liquids, external liquid preparations, powders, creams, and ointments were the main categories of products manufactured locally. The results indicated that 86% of the non-conformances were major, 11% were minor, and 3% critical. The majority of the non-conformances were related to production (30.1%), documentation (24.5%), and quality control (17.6%). Regression results indicated that for every non-conformance under premises, equipment, and utilities, there was a 7-fold likelihood of the manufacturer failing to comply with the GMP standards (aOR=6.81, P=0.001). The results showed that major non-conformances were significantly higher in industries of small scale (B=6.77, P=0.02) and medium scale (B=8.40, P=0.04), as compared to those of large scale. This study highlights the failures in quality assurance systems and stagnated GMP improvements in these industries that need to be addressed by the manufacturers with support from the regulator. The addition of risk assessment to critical production and quality control operations and establishment of appropriate corrective and preventive actions as part of quality management systems are required to ensure that quality pharmaceuticals are manufactured locally.
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Kwesiga, Victoria, Zita Ekeocha, Stephen Robert Byrn, and Kari L. Clase. Compliance to GMP guidelines for Herbal Manufacturers in East Africa: A Position Paper. Purdue University, November 2021. http://dx.doi.org/10.5703/1288284317428.
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With the global increase in the use of traditional and complementary remedies for the prevention and treatment of illness, the quality and safety of these medicines have become a significant concern for all regulatory authorities. Herbal medicines are the most commonly used form of traditional and complementary medicines in the world and the efficacy and safety of herbal medicines, like conventional medicines, largely depends on their quality from planting to harvesting, preprocessing and final processing. Due to the inherent complexity of herbal medicines, often containing an array of active compounds, the primary processing of herbal medicines has a direct influence on their quality. Quality concerns are the reason why the medicines regulatory agencies insist that manufacturers of medicines strictly follow Good Manufacturing Practices since it is an essential tool to prevent instances of contamination, mix-ups, deviations, failures and errors. However, a strict application of GMP requirements is expensive and would drive the prices of the manufactured products up. As a result, a maturity level grading of facilities is proposed as a way of justifying the costs incurred for manufacturers desiring to reach a broader market and investing in continuous improvement. 36 Good Manufacturing Practice (GMP) inspection reports of local herbal manufacturers conducted by National Drug Authority were analyzed to establish the type and extent of deficiencies to GMP requirements for local herbal manufacturers in Uganda. The different GMP chapters and related sub-parameters constituted the variables used for the analysis of conformity to requirements. The primary outcome variable was the conclusion regarding compliance or noncompliance of the inspected local herbal manufacturing facility. GMP parameters that were frequently defaulted by local herbal manufacturers and the corresponding frequencies were identified. The Pearson Chi-square test was applied independently on each category to find the association that existed between conformity and the questions in each category. Only 22% (8) of the 30 inspected facilities were found to comply with GMP requirements, as per National Drug Authority (NDA) guidelines; while the majority of the facilities, 28 (78%), were found not to comply. Of the facilities inspected, 25 were undergoing GMP inspection for the first time. A total of 1,236 deficiency observations were made in the 36 inspection reports reviewed for the study. The mean for all deficiencies was 34.3, and the standard deviation was 15.829. 91.5% of the facilities did not have mechanisms for a record of market complaints; 80.9% did not meet documentation requirements; 78.9% did not have quality control measures in place, and 65.7% did not meet stores requirements. By encouraging a culture of self/voluntary improvement through the introduction of listing of manufacturers based on a maturity level grading, the National Drug Authority will improve the Herbal Medicines sector as per the mandate of improving the herbal medicine industry. Also, increased sensitization of all relevant stakeholders regarding the requirements for GMP should be intensified.
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Salter and Weston. L51534 A Study of New Joining Processes for Pipelines. Chantilly, Virginia: Pipeline Research Council International, Inc. (PRCI), January 1987. http://dx.doi.org/10.55274/r0010083.
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Over many decades it has been accepted that the most economical way to produce a pipeline is to join together the standard lengths of pipe as quickly as possible, using a highly mobile task force of welders and other technicians, leaving tie-ins, crossings, etc. to smaller specialist crews. The work pattern which evolved almost invariably involved several crews of welders strung out along the pipelines, progress being controlled by the rate at which the leading pair could complete the weld root. The spread from this first crew to final inspection could be a considerable distance, acceptable on land but not acceptable offshore (a rapidly increasing need which reached a peak in the 1970's). This operation, involving costly lay barges, demanded even higher throughput rates to be achieved from a more compact working spread. In common with most manufacturing technologies, there was an increasing dissatisfaction with a system which relied entirely on the skill of a limited number of highly paid men who had little incentive to change their working practices. Increasingly there came reports of the development of new approaches to joining line-pipe, ranging from the mechanization of arc welding to entirely different forms of joining, for example, electron beam welding or mechanical joining. The investment in some of these developments is reported to be several million dollars. The review of present pipelining practice shows that only a handful has been put to practical use, and in the western world, probably only one, an arc welding variant, has been used to produce more than a few hundred miles of pipeline. The information available on these developments is sparse and is scattered amongst a range of companies and research agencies. A literature review and research study to collect together as much of this information as is available, assemble it into a coherent and useable form and identify those developments which show the most promise to fulfill future needs. The main body of the report, which reviews development of the welding processes has been divided into three main joining categories, Fusion Welding, Forge Welding and Mechanical Interference Joining. Within each category each process is considered separately in terms of process principles, general applications, application to pipeline welding, equipment for pipe welding, consumables, process tolerance and skill requirements, weld quality and inspection, process economics, limitations and future developments. This study and comprehensive report compares the economics of the various alternatives. For each process an estimate has been made of the procedural and development costs involved as well as personnel needs and likely production rates.