The 12 Steps to Franchise Ownership
2015-CIRP新生调查问卷
21. At this institution, which course placement tests have you taken in the following subject areas:
YN English YN Reading YN Mathematics YN Writing
22. Please mark the sex of your parent(s) or
5 or less ` 11-50 ` 101-500 ` 6-10 ` 51-100 ` Over 500 `
7. What was your average grade in high school? (Mark one)
A or A+ ` B `
C`
A– ` B– `
D`
B+ ` C+ `
8. What were your scores on the SAT I and/or ACT?
13. To how many colleges other than this one did you apply for admission this year?
None 1 ` 4 `
7-8 `
` 2` 5`
9-10 `
3 ` 6 ` 11 or more `
14. Were you accepted by your first choice
Both alive and living with each other......... ` Both alive, divorced or living apart............. ` One or both deceased............................... `
特许经营联营店指南 (英译本) A Franchising Guide (English Version)
Ways Franchisors Can Develop the Potential of Their Franchisees
• Provide mentoring that supersedes routing training. • Keep operating manuals up-to-date. • Keep product, services, and business systems up-to-date. • Solicit input from franchisees to reinforce their importance in the larger franchise system. • Encourage franchisees to develop a franchise association. • Maintain the franchise system’s integrity.
Steps to Franchising a Business
Qualities for Look for in Prospective Franchisees
• Good work ethic. • Ability to follow instructions. • Ability to operate with minimal supervision. • Team oriented. • Experience in the industry in which the franchise competes. • Adequate financial resources and good credit history. • Ability to make suggestions without becoming upset if the suggestions are not adopted. • Represents the franchisor in a positive manner.
知识产权中英双语协议
知识产权中英双语协议Knowledge Property Rights Bilingual Agreement (知识产权中英双语协议)1. IntroductionThis Agreement outlines the terms and conditions governing the protection and usage of intellectual property rights (IPR) in both China and English-speaking countries. It aims to establish a mutual understanding and cooperation between the parties involved.2. Definitions2.1 Intellectual Property Rights (IPR)Refers to the legal rights protecting the creations of the mind, such as inventions, patents, trademarks, designs, copyrights, and trade secrets.2.2 PartiesRefers to the entities or individuals entering into this agreement.3. Scope of AgreementThis Agreement applies to all IPR-related matters, including but not limited to patents, trademarks, copyrights, and trade secrets, owned or licensed by the parties involved.4. Maintenance and Protection of IPR4.1 RegistrationThe Parties shall adhere to the relevant registration procedures and requirements in their respective jurisdictions to obtain legal protection for their IPR.4.2 Notice of InfringementIn the event of any suspected IPR infringement, the Parties shall promptly notify each other in writing and provide all necessary evidence.4.3 Cooperation in EnforcementThe Parties agree to cooperate and provide assistance to each other in enforcing and defending their respective IPR. This includes sharing information, joining litigation or administrative proceedings, and taking appropriate legal actions against infringers.5. Licensing and Transfer of IPR5.1 LicensingThe Parties may grant each other licenses to use their IPR within the agreed scope and terms. Any licensing agreement should be detailed in writing and mutually agreed upon.5.2 TransferThe transfer of IPR ownership between the Parties shall be dealt with separately and in accordance with the relevant laws and regulations of their respective jurisdictions.6. Dispute ResolutionAny disputes arising from the interpretation, implementation, or termination of this Agreement shall be settled amicably through negotiations. If no resolution can be reached, the dispute shall be submitted to the relevant courts or arbitration institutions as agreed upon by the Parties.7. Confidentiality7.1 Information SharingIn the course of cooperation under this Agreement, the Parties may share confidential information. Both Parties agree to safeguard and protect such information, not disclosing it to any third party without prior consent.7.2 Non-Disclosure Agreement (NDA)If necessary, the Parties may enter into a separate NDA to further protect confidential information shared during the collaboration.8. Term and Termination8.1 TermThis Agreement shall commence on the effective date and remain in force for a specified period, unless otherwise terminated earlier under the provisions of this Agreement.8.2 TerminationEither Party may terminate this Agreement in writing if the other Party fails to comply with its obligations or breaches any provision of this Agreement.9. Governing Law and JurisdictionThis Agreement shall be governed by and construed in accordance with the laws of the jurisdiction agreed upon by the Parties. Any disputes arising from this Agreement shall be subject to the exclusive jurisdiction of the agreed-upon courts.10. Miscellaneous10.1 Entire AgreementThis Agreement represents the entire understanding and agreement between the Parties concerning IPR cooperation and supersedes all prior agreements, whether oral or written.10.2 Amendment and WaiverAny modification or waiver of this Agreement must be made in writing and signed by both Parties.ConclusionThis Knowledge Property Rights Bilingual Agreement serves to protect and regulate the IPR of the Parties involved. By establishing clear terms and procedures, it promotes collaboration and cooperation, ensuring the effective enforcement and usage of intellectual property rights in both Chinese and English-speaking jurisdictions.。
海外并购争议解决之ICSID仲裁_必要而_奢侈的消费_
2014年3月Journal of Liaoning University （Philosophy and Social Sciences ）Mar.2014收稿日期：2013-04-09作者简介：曾莉，女，四川自贡人，甘肃政法学院法学院讲师，中国政法大学国际法学院博士生。
研究方向：国际经济法。
王传丽，女，北京人，中国政法大学国际法学院教授，博士生导师。
研究方向：国际经济法。
基金项目：本论文是国务院侨办“华侨投资法律问题研究”项目的阶段性研究成果。
海外并购争议解决之ＩＣＳＩＤ仲裁———必要而“奢侈的消费”曾莉１，２王传丽２（１．甘肃政法学院法学院，甘肃兰州７３００７０；２．中国政法大学国际法学院，北京１０００８８）摘要：随着我国经济实力的增强，我国作为世界资本输入大国的同时，也逐渐成为世界资本输出大国。
而在诸多对外投资活动中，海外并购地位突出，尤其是在金融危机之后，海外并购活动异常活跃。
在海外并购出现争议时，协商、调解、调停、国内司法途径等都是重要的争端解决方式，此外，ＩＣＳＩＤ仲裁也是重要的争议解决途径。
对我国而言，不断增加的海外并购也可能带来更多的争议，例如我国平安就其在比利时的并购争议向ＩＣＳＩＤ申请仲裁就是一例。
但是，近年来ＩＣＳＩＤ仲裁面临了诸多的挑战。
本文认为，尽管国际社会对ＩＣＳＩＤ仲裁有诸多质疑，但是这一制度对解决海外并购争议仍是必不可少的。
但是，在真正利用这一制度解决争议时，该制度审理耗时长、费用高、执行难等特点却也使其成为“奢侈的消费”。
关键词：海外并购；国际投资；争端解决；ＩＣＳＩＤ仲裁中图分类号：F832.48文献标识码：A 文章编号：1002-3291（2014）02-0044-09一、引言自2007年金融危机以来，全球经济陷入衰退，至今仍未完全复苏，各国贸易摩擦激增，全球贸易自由化受到极大挑战。
然而，一边是全球贸易领域一片萧索，另一边却是国际对外投资如火如荼，尤其是海外并购活动异常活跃。
季卫东 法律程序的意义
法律程序的意义季卫东目录:一、序言:作为制度化基石的程序二、现代程序的概念与特征1. 对于恣意的限制2. 理性选择的保证3. "作茧自缚"的效应4. 反思性整合三、现代程序的结构与功能1. 基本的构成因素2. 类型分析3. 功能要件四、程序与现代社会1. 程序与资本主义市场经济的兴起2. 程序与言论自由3. 程序与民主4. 程序与权威五、中国法律程序的缺陷1. 传统程序与现实问题2. 变动期的非程序化倾向及其批判3. 与程序有关的法律形式上的弱点六、结语∶程序建设的程序1. 程序与正统性问题2. 中国法制的程序化3. 程序再铸的若干设想权利法案的大多数规定都是程序性条款. 这一事实决不是无意义的.正是程序决定了法治与恣意的人治之间的基本区别.--威廉姆.道格拉斯(1)夫听讼者,或从其情,或从其辞. 辞不可从,必断以情.其大法也三焉,治必以宽,宽之之术归于察,察之之术归于义.--<孔丛子.刑论>一、序言:作为制度化基石的程序英国，１６８７年，牛顿发现万有引力法则，其结果导致了以力学为基础的产业革命。
两年后，议会颁布《权利法案》和信教自由令，限制王权、规定王权继承程序、确立立法的至高无上性。
与产业发展相配合的组织和制度也陆续完备起来，例如，英格兰银行成立于１６９４年，又过了四年，股票交易所在伦敦创设。
而在中国，１６８７这一年，孟子庙落成于邹县，主张民贵君轻的“亚圣”被置于治道的守护神的地位。
也是两年后，《大清会典》完成，重新认可强化君权的非常申诉（“登闻鼓”）之制。
与宫廷体面相配合的大规模土木工程也不一而足，例如，１６９５年，金碧辉煌的紫禁城太和殿甫告竣工，不久又开始营造极尽奢华的圆明园。
至１７０９年宁波、绍兴等地的商船贩米活动才终于得到官府的许可，不言而喻，在这种情形下工商业发展的组织、制度条件当然极其匮乏。
一个多世纪之后，中英第一次鸦片战争爆发。
其结果是我国惨败，被迫签订丧权辱国的南京条约。
ICH-Q7英文版
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH H ARMONISED T RIPARTITE G UIDELINEG OOD M ANUFACTURING P RACTICE G UIDE FORA CTIVE P HARMACEUTICAL I NGREDIENTSRecommended for Adoptionat Step 4 of the ICH Processon 10 November 2000by the ICH Steering CommitteeThis Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.G OOD M ANUFACTURING P RACTICE G UIDE FORA CTIVE P HARMACEUTICAL I NGREDIENTSICH Harmonised Tripartite GuidelineHaving reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 10 November 2000, this guideline is recommended foradoption to the three regulatory parties to ICHTABLE OF CONTENTS1. INTRODUCTION (1)1.1 Objective (1)1.2 Regulatory Applicability (1)1.3 Scope (1)2. QUALITY MANAGEMENT (4)2.1 Principles (4)2.2 Responsibilities of the Quality Unit(s) (4)2.3 Responsibility for Production Activities (5)2.4 Internal Audits (Self Inspection) (5)2.5 Product Quality Review (6)3. PERSONNEL (6)3.1 Personnel Qualifications (6)3.2 Personnel Hygiene (6)3.3 Consultants (7)4. BUILDINGS AND FACILITIES (7)4.1 Design and Construction (7)4.2 Utilities (8)4.3 Water (8)4.4 Containment (9)4.5 Lighting (9)4.6 Sewage and Refuse (9)4.7 Sanitation and Maintenance (9)5. PROCESS EQUIPMENT (9)5.1 Design and Construction (9)5.2 Equipment Maintenance and Cleaning (10)5.3 Calibration (11)5.4 Computerized Systems (11)Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients6. DOCUMENTATION AND RECORDS (12)6.1 Documentation System and Specifications (12)6.2 Equipment Cleaning and Use Record (13)6.3 Records of Raw Materials, Intermediates, API Labelling andPackaging Materials (13)6.4 Master Production Instructions(Master Production and Control Records) (13)6.5 Batch Production Records (Batch Production and Control Records).. 146.6 Laboratory Control Records (15)6.7 Batch Production Record Review (15)7. MATERIALS MANAGEMENT (16)7.1 General Controls (16)7.2 Receipt and Quarantine (16)7.3 Sampling and Testing of Incoming Production Materials (17)7.4 Storage (17)7.5 Re-evaluation (18)8. PRODUCTION AND IN-PROCESS CONTROLS (18)8.1 Production Operations (18)8.2 Time Limits (19)8.3 In-process Sampling and Controls (19)8.4 Blending Batches of Intermediates or APIs (19)8.5 Contamination Control (20)9. PACKAGING AND IDENTIFICATION LABELLING OF APIsAND INTERMEDIATES (20)9.1 General (20)9.2 Packaging Materials (21)9.3 Label Issuance and Control (21)9.4 Packaging and Labelling Operations (21)10. STORAGE AND DISTRIBUTION (22)10.1 Warehousing Procedures (22)10.2 Distribution Procedures (22)11. LABORATORY CONTROLS (23)11.1 General Controls (23)11.2 Testing of Intermediates and APIs (24)11.3 Validation of Analytical Procedures (24)11.4 Certificates of Analysis (24)Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients11.5 Stability Monitoring of APIs (25)11.6 Expiry and Retest Dating (25)11.7 Reserve/Retention Samples (25)12. VALIDATION (26)12.1 Validation Policy (26)12.2 Validation Documentation (26)12.3 Qualification (27)12.4 Approaches to Process Validation (27)12.5 Process Validation Program (28)12.6 Periodic Review of Validated Systems (28)12.7 Cleaning Validation (28)12.8 Validation of Analytical Methods (29)13. CHANGE CONTROL (29)14. REJECTION AND RE-USE OF MATERIALS (30)14.1 Rejection (30)14.2 Reprocessing (30)14.3 Reworking (31)14.4 Recovery of Materials and Solvents (31)14.5 Returns (31)15. COMPLAINTS AND RECALLS (32)16. CONTRACT MANUFACTURERS (INCLUDING LABORATORIES). 3217. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS,AND RELABELLERS (33)17.1 Applicability (33)17.2 Traceability of Distributed APIs and Intermediates (33)17.3 Quality Management (33)17.4 Repackaging, Relabelling and Holding of APIs and Intermediates (33)17.5 Stability (34)17.6 Transfer of Information (34)17.7 Handling of Complaints and Recalls (34)17.8 Handling of Returns (34)18. SPECIFIC GUIDANCE FOR APIs MANUFACTURED BY CELLCULTURE/FERMENTATION (35)18.1 General (35)18.2 Cell Bank Maintenance and Recordkeeping (36)18.3 Cell Culture/Fermentation (36)Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients18.4 Harvesting, Isolation, and Purification (37)18.5 Viral Removal/Inactivation Steps (37)19. APIs FOR USE IN CLINICAL TRIALS (38)19.1 General (38)19.2 Quality (38)19.3 Equipment and Facilities (38)19.4 Control of Raw Materials (39)19.5 Production (39)19.6 Validation (39)19.7 Changes (39)19.8 Laboratory Controls (39)19.9 Documentation (39)20. GLOSSARY (40)G OOD M ANUFACTURING P RACTICE G UIDE FORA CTIVE P HARMACEUTICAL I NGREDIENTS1. INTRODUCTION1.1 ObjectiveThis document (Guide) is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess.In this Guide “manufacturing” is defined to include all operations of receipt of materials, production, packaging, repackaging, labelling, relabelling, quality control, release, storage and distribution of APIs and the related controls. In this Guide the term “should” indicates recommendations that are expected to apply unless shown to be inapplicable or replaced by an alternative demonstrated to provide at least an equivalent level of quality assurance. For the purposes of this Guide, the terms “current good manufacturing practices” and “good manufacturing practices” are equivalent.The Guide as a whole does not cover safety aspects for the personnel engaged in the manufacture, nor aspects of protection of the environment. These controls are inherent responsibilities of the manufacturer and are governed by national laws.This Guide is not intended to define registration/filing requirements or modify pharmacopoeial requirements. This Guide does not affect the ability of the responsible regulatory agency to establish specific registration/filing requirements regarding APIs within the context of marketing/manufacturing authorizations or drug applications. All commitments in registration/filing documents must be met.1.2 Regulatory ApplicabilityWithin the world community, materials may vary as to the legal classification as an API. When a material is classified as an API in the region or country in which it is manufactured or used in a drug product, it should be manufactured according to this Guide.1.3 ScopeThis Guide applies to the manufacture of APIs for use in human drug (medicinal) products. It applies to the manufacture of sterile APIs only up to the point immediately prior to the APIs being rendered sterile. The sterilization and aseptic processing of sterile APIs are not covered by this guidance, but should be performed in accordance with GMP guidelines for drug (medicinal) products as defined by local authorities.This Guide covers APIs that are manufactured by chemical synthesis, extraction, cell culture/fermentation, by recovery from natural sources, or by any combination of these processes. Specific guidance for APIs manufactured by cell culture/fermentation is described in Section 18.Good Manufacturing Practice Guide for Active Pharmaceutical IngredientsThis Guide excludes all vaccines, whole cells, whole blood and plasma, blood and plasma derivatives (plasma fractionation), and gene therapy APIs. However, it does include APIs that are produced using blood or plasma as raw materials. Note that cell substrates (mammalian, plant, insect or microbial cells, tissue or animal sources including transgenic animals) and early process steps may be subject to GMP but are not covered by this Guide. In addition, the Guide does not apply to medical gases, bulk-packaged drug (medicinal) products, and manufacturing/control aspects specific to radiopharmaceuticals.Section 19 contains guidance that only applies to the manufacture of APIs used in the production of drug (medicinal) products specifically for clinical trials (investigational medicinal products).An “API Starting Material” is a raw material, intermediate, or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API. An API Starting Material can be an article of commerce, a material purchased from one or more suppliers under contract or commercial agreement, or produced in-house. API Starting Materials normally have defined chemical properties and structure.The company should designate and document the rationale for the point at which production of the API begins. For synthetic processes, this is known as the point at which "API Starting Materials" are entered into the process. For other processes (e.g. fermentation, extraction, purification, etc), this rationale should be established on a case-by-case basis. Table 1 gives guidance on the point at which the API Starting Material is normally introduced into the process.From this point on, appropriate GMP as defined in this Guide should be applied to these intermediate and/or API manufacturing steps. This would include the validation of critical process steps determined to impact the quality of the API. However, it should be noted that the fact that a company chooses to validate a process step does not necessarily define that step as critical.The guidance in this document would normally be applied to the steps shown in gray in Table 1. It does not imply that all steps shown should be completed. The stringency of GMP in API manufacturing should increase as the process proceeds from early API steps to final steps, purification, and packaging. Physical processing of APIs, such as granulation, coating or physical manipulation of particle size (e.g. milling, micronizing), should be conducted at least to the standards of this Guide.This GMP Guide does not apply to steps prior to the introduction of the defined "API Starting Material".Good Manufacturing Practice Guide for Active Pharmaceutical IngredientsTable 1: Application of this Guide to API ManufacturingType ofManufacturingApplication of this Guide to steps (shown in grey) used in this type ofmanufacturing ChemicalManufacturing Production of the APIStartingMaterialIntroduction of the API Starting Material into process Production of Intermediate(s) Isolation and purification Physical processing, and packaging API derived from animal sources Collection oforgan, fluid, ortissue Cutting, mixing, and/or initialprocessingIntroduction of the API Starting Material into process Isolation and purification Physical processing, and packaging API extracted from plant sources Collection of plants Cutting andinitialextraction(s) Introduction of the API StartingMaterial intoprocessIsolation and purification Physical processing, and packaging Herbal extracts used as API Collection of plants Cutting and initial extraction Further extraction Physicalprocessing,andpackagingAPI consisting of comminuted or powdered herbs Collection of plants and/or cultivation and harvesting Cutting/ comminuting Physicalprocessing,andpackagingBiotechnology: fermentation/ cell culture Establishment of master cell bank and working cell bank Maintenance of working cell bank Cell culture and/or fermentation Isolation and purification Physicalprocessing,andpackaging“Classical” Fermentation to produce an API Establishment of cell bank Maintenance of the cell bank Introduction of the cells into fermentation Isolation and purificationPhysicalprocessing,andpackagingGood Manufacturing Practice Guide for Active Pharmaceutical Ingredients2. QUALITY MANAGEMENT2.1 Principles2.10 Quality should be the responsibility of all persons involved in manufacturing.2.11 Each manufacturer should establish, document, and implement an effectivesystem for managing quality that involves the active participation of management and appropriate manufacturing personnel.2.12 The system for managing quality should encompass the organisational structure,procedures, processes and resources, as well as activities necessary to ensure confidence that the API will meet its intended specifications for quality and purity. All quality related activities should be defined and documented.2.13 There should be a quality unit(s) that is independent of production and thatfulfills both quality assurance (QA) and quality control (QC) responsibilities. This can be in the form of separate QA and QC units or a single individual or group, depending upon the size and structure of the organization.2.14 The persons authorised to release intermediates and APIs should be specified. 2.15 All quality related activities should be recorded at the time they are performed.2.16 Any deviation from established procedures should be documented and explained.Critical deviations should be investigated, and the investigation and its conclusions should be documented.2.17 No materials should be released or used before the satisfactory completion ofevaluation by the quality unit(s) unless there are appropriate systems in place to allow for such use (e.g. release under quarantine as described in Section 10.20 or the use of raw materials or intermediates pending completion of evaluation).2.18 Procedures should exist for notifying responsible management in a timely mannerof regulatory inspections, serious GMP deficiencies, product defects and related actions (e.g. quality related complaints, recalls, regulatory actions, etc.).2.2 Responsibilities of the Quality Unit(s)2.20 The quality unit(s) should be involved in all quality-related matters.2.21 The quality unit(s) should review and approve all appropriate quality-relateddocuments.2.22 The main responsibilities of the independent quality unit(s) should not bedelegated. These responsibilities should be described in writing and should include but not necessarily be limited to:1. Releasing or rejecting all APIs. Releasing or rejecting intermediates for useoutside the control of the manufacturing company;2. Establishing a system to release or reject raw materials, intermediates,packaging and labelling materials;3. Reviewing completed batch production and laboratory control records ofcritical process steps before release of the API for distribution;4. Making sure that critical deviations are investigated and resolved;5. Approving all specifications and master production instructions;6. Approving all procedures impacting the quality of intermediates or APIs;Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients7. Making sure that internal audits (self-inspections) are performed;8. Approving intermediate and API contract manufacturers;9. Approving changes that potentially impact intermediate or API quality;10. Reviewing and approving validation protocols and reports;11. Making sure that quality related complaints are investigated and resolved;12. Making sure that effective systems are used for maintaining and calibratingcritical equipment;13. Making sure that materials are appropriately tested and the results arereported;14. Making sure that there is stability data to support retest or expiry dates andstorage conditions on APIs and/or intermediates where appropriate; and15. Performing product quality reviews (as defined in Section 2.5).2.3 Responsibility for Production ActivitiesThe responsibility for production activities should be described in writing, and should include but not necessarily be limited to:1. Preparing, reviewing, approving and distributing the instructions for theproduction of intermediates or APIs according to written procedures;2. Producing APIs and, when appropriate, intermediates according to pre-approved instructions;3. Reviewing all production batch records and ensuring that these arecompleted and signed;4. Making sure that all production deviations are reported and evaluated andthat critical deviations are investigated and the conclusions are recorded;5. Making sure that production facilities are clean and when appropriatedisinfected;6. Making sure that the necessary calibrations are performed and recordskept;7. Making sure that the premises and equipment are maintained and recordskept;8. Making sure that validation protocols and reports are reviewed andapproved;9. Evaluating proposed changes in product, process or equipment; and10. Making sure that new and, when appropriate, modified facilities andequipment are qualified.2.4 Internal Audits (Self Inspection)2.40 In order to verify compliance with the principles of GMP for APIs, regularinternal audits should be performed in accordance with an approved schedule. 2.41 Audit findings and corrective actions should be documented and brought to theattention of responsible management of the firm. Agreed corrective actions should be completed in a timely and effective manner.2.5 Product Quality Review2.50 Regular quality reviews of APIs should be conducted with the objective ofverifying the consistency of the process. Such reviews should normally be conducted and documented annually and should include at least:− A review of critical in-process control and critical API test results;− A review of all batches that failed to meet established specification(s);− A review of all critical deviations or non-conformances and related investigations;− A review of any changes carried out to the processes or analytical methods;− A review of results of the stability monitoring program;− A review of all quality-related returns, complaints and recalls; and− A review of adequacy of corrective actions.2.51 The results of this review should be evaluated and an assessment made ofwhether corrective action or any revalidation should be undertaken. Reasons for such corrective action should be documented. Agreed corrective actions should be completed in a timely and effective manner.3. PERSONNEL3.1 Personnel Qualifications3.10 There should be an adequate number of personnel qualified by appropriateeducation, training and/or experience to perform and supervise the manufacture of intermediates and APIs.3.11 The responsibilities of all personnel engaged in the manufacture of intermediatesand APIs should be specified in writing.3.12 Training should be regularly conducted by qualified individuals and should cover,at a minimum, the particular operations that the employee performs and GMP as it relates to the employee's functions. Records of training should be maintained.Training should be periodically assessed.3.2 Personnel Hygiene3.20 Personnel should practice good sanitation and health habits.3.21 Personnel should wear clean clothing suitable for the manufacturing activity withwhich they are involved and this clothing should be changed when appropriate.Additional protective apparel, such as head, face, hand, and arm coverings, should be worn when necessary, to protect intermediates and APIs from contamination.3.22 Personnel should avoid direct contact with intermediates or APIs.3.23 Smoking, eating, drinking, chewing and the storage of food should be restricted tocertain designated areas separate from the manufacturing areas.3.24 Personnel suffering from an infectious disease or having open lesions on theexposed surface of the body should not engage in activities that could result in compromising the quality of APIs. Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions should be excluded from activities where the health condition could adversely affect the quality of the APIs until the condition is corrected orqualified medical personnel determine that the person's inclusion would not jeopardize the safety or quality of the APIs.3.3 Consultants3.30 Consultants advising on the manufacture and control of intermediates or APIsshould have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained.3.31 Records should be maintained stating the name, address, qualifications, and typeof service provided by these consultants.4. BUILDINGS AND FACILITIES4.1 Design and Construction4.10 Buildings and facilities used in the manufacture of intermediates and APIs shouldbe located, designed, and constructed to facilitate cleaning, maintenance, and operations as appropriate to the type and stage of manufacture. Facilities should also be designed to minimize potential contamination. Where microbiological specifications have been established for the intermediate or API, facilities should also be designed to limit exposure to objectionable microbiological contaminants as appropriate.4.11 Buildings and facilities should have adequate space for the orderly placement ofequipment and materials to prevent mix-ups and contamination.4.12 Where the equipment itself (e.g., closed or contained systems) provides adequateprotection of the material, such equipment can be located outdoors.4.13 The flow of materials and personnel through the building or facilities should bedesigned to prevent mix-ups or contamination.4.14 There should be defined areas or other control systems for the followingactivities:− Receipt, identification, sampling, and quarantine of incoming materials, pending release or rejection;− Quarantine before release or rejection of intermediates and APIs;− Sampling of intermediates and APIs;− Holding rejected materials before further disposition (e.g., return, reprocessing or destruction);− Storage of released materials;− Production operations;− Packaging and labelling operations; and− Laboratory operations.4.15 Adequate, clean washing and toilet facilities should be provided for personnel.These washing facilities should be equipped with hot and cold water as appropriate, soap or detergent, air driers or single service towels. The washing and toilet facilities should be separate from, but easily accessible to, manufacturing areas. Adequate facilities for showering and/or changing clothes should be provided, when appropriate.4.16 Laboratory areas/operations should normally be separated from production areas.Some laboratory areas, in particular those used for in-process controls, can be located in production areas, provided the operations of the production process do not adversely affect the accuracy of the laboratory measurements, and the laboratory and its operations do not adversely affect the production process or intermediate or API.4.2 Utilities4.20 All utilities that could impact on product quality (e.g. steam, gases, compressedair, and heating, ventilation and air conditioning) should be qualified and appropriately monitored and action should be taken when limits are exceeded.Drawings for these utility systems should be available.4.21 Adequate ventilation, air filtration and exhaust systems should be provided,where appropriate. These systems should be designed and constructed to minimise risks of contamination and cross-contamination and should include equipment for control of air pressure, microorganisms (if appropriate), dust, humidity, and temperature, as appropriate to the stage of manufacture.Particular attention should be given to areas where APIs are exposed to the environment.4.22 If air is recirculated to production areas, appropriate measures should be takento control risks of contamination and cross-contamination.4.23 Permanently installed pipework should be appropriately identified. This can beaccomplished by identifying individual lines, documentation, computer control systems, or alternative means. Pipework should be located to avoid risks of contamination of the intermediate or API.4.24 Drains should be of adequate size and should be provided with an air break or asuitable device to prevent back-siphonage, when appropriate.4.3 Water4.30 Water used in the manufacture of APIs should be demonstrated to be suitable forits intended use.4.31 Unless otherwise justified, process water should, at a minimum, meet WorldHealth Organization (WHO) guidelines for drinking (potable) water quality.4.32 If drinking (potable) water is insufficient to assure API quality, and tighterchemical and/or microbiological water quality specifications are called for, appropriate specifications for physical/chemical attributes, total microbial counts, objectionable organisms and/or endotoxins should be established.4.33 Where water used in the process is treated by the manufacturer to achieve adefined quality, the treatment process should be validated and monitored with appropriate action limits.4.34 Where the manufacturer of a non-sterile API either intends or claims that it issuitable for use in further processing to produce a sterile drug (medicinal) product, water used in the final isolation and purification steps should be monitored and controlled for total microbial counts, objectionable organisms, and endotoxins.4.4 Containment4.40 Dedicated production areas, which can include facilities, air handling equipmentand/or process equipment, should be employed in the production of highly sensitizing materials, such as penicillins or cephalosporins.4.41 Dedicated production areas should also be considered when material of aninfectious nature or high pharmacological activity or toxicity is involved (e.g., certain steroids or cytotoxic anti-cancer agents) unless validated inactivation and/or cleaning procedures are established and maintained.4.42 Appropriate measures should be established and implemented to prevent cross-contamination from personnel, materials, etc. moving from one dedicated area to another.4.43 Any production activities (including weighing, milling, or packaging) of highlytoxic non-pharmaceutical materials such as herbicides and pesticides should not be conducted using the buildings and/or equipment being used for the production of APIs. Handling and storage of these highly toxic non-pharmaceutical materials should be separate from APIs.4.5 Lighting4.50 Adequate lighting should be provided in all areas to facilitate cleaning,maintenance, and proper operations.4.6 Sewage and Refuse4.60 Sewage, refuse, and other waste (e.g., solids, liquids, or gaseous by-products frommanufacturing) in and from buildings and the immediate surrounding area should be disposed of in a safe, timely, and sanitary manner. Containers and/or pipes for waste material should be clearly identified.4.7 Sanitation and Maintenance4.70 Buildings used in the manufacture of intermediates and APIs should be properlymaintained and repaired and kept in a clean condition.4.71 Written procedures should be established assigning responsibility for sanitationand describing the cleaning schedules, methods, equipment, and materials to be used in cleaning buildings and facilities.4.72 When necessary, written procedures should also be established for the use ofsuitable rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing agents to prevent the contamination of equipment, raw materials, packaging/labelling materials, intermediates, and APIs.5. PROCESS EQUIPMENT5.1 Design and Construction5.10 Equipment used in the manufacture of intermediates and APIs should be ofappropriate design and adequate size, and suitably located for its intended use, cleaning, sanitization (where appropriate), and maintenance.5.11 Equipment should be constructed so that surfaces that contact raw materials,intermediates, or APIs do not alter the quality of the intermediates and APIs beyond the official or other established specifications.5.12 Production equipment should only be used within its qualified operating range.。
OSHA现场作业手册说明书
DIRECTIVE NUMBER: CPL 02-00-150 EFFECTIVE DATE: April 22, 2011 SUBJECT: Field Operations Manual (FOM)ABSTRACTPurpose: This instruction cancels and replaces OSHA Instruction CPL 02-00-148,Field Operations Manual (FOM), issued November 9, 2009, whichreplaced the September 26, 1994 Instruction that implemented the FieldInspection Reference Manual (FIRM). The FOM is a revision of OSHA’senforcement policies and procedures manual that provides the field officesa reference document for identifying the responsibilities associated withthe majority of their inspection duties. This Instruction also cancels OSHAInstruction FAP 01-00-003 Federal Agency Safety and Health Programs,May 17, 1996 and Chapter 13 of OSHA Instruction CPL 02-00-045,Revised Field Operations Manual, June 15, 1989.Scope: OSHA-wide.References: Title 29 Code of Federal Regulations §1903.6, Advance Notice ofInspections; 29 Code of Federal Regulations §1903.14, Policy RegardingEmployee Rescue Activities; 29 Code of Federal Regulations §1903.19,Abatement Verification; 29 Code of Federal Regulations §1904.39,Reporting Fatalities and Multiple Hospitalizations to OSHA; and Housingfor Agricultural Workers: Final Rule, Federal Register, March 4, 1980 (45FR 14180).Cancellations: OSHA Instruction CPL 02-00-148, Field Operations Manual, November9, 2009.OSHA Instruction FAP 01-00-003, Federal Agency Safety and HealthPrograms, May 17, 1996.Chapter 13 of OSHA Instruction CPL 02-00-045, Revised FieldOperations Manual, June 15, 1989.State Impact: Notice of Intent and Adoption required. See paragraph VI.Action Offices: National, Regional, and Area OfficesOriginating Office: Directorate of Enforcement Programs Contact: Directorate of Enforcement ProgramsOffice of General Industry Enforcement200 Constitution Avenue, NW, N3 119Washington, DC 20210202-693-1850By and Under the Authority ofDavid Michaels, PhD, MPHAssistant SecretaryExecutive SummaryThis instruction cancels and replaces OSHA Instruction CPL 02-00-148, Field Operations Manual (FOM), issued November 9, 2009. The one remaining part of the prior Field Operations Manual, the chapter on Disclosure, will be added at a later date. This Instruction also cancels OSHA Instruction FAP 01-00-003 Federal Agency Safety and Health Programs, May 17, 1996 and Chapter 13 of OSHA Instruction CPL 02-00-045, Revised Field Operations Manual, June 15, 1989. This Instruction constitutes OSHA’s general enforcement policies and procedures manual for use by the field offices in conducting inspections, issuing citations and proposing penalties.Significant Changes∙A new Table of Contents for the entire FOM is added.∙ A new References section for the entire FOM is added∙ A new Cancellations section for the entire FOM is added.∙Adds a Maritime Industry Sector to Section III of Chapter 10, Industry Sectors.∙Revises sections referring to the Enhanced Enforcement Program (EEP) replacing the information with the Severe Violator Enforcement Program (SVEP).∙Adds Chapter 13, Federal Agency Field Activities.∙Cancels OSHA Instruction FAP 01-00-003, Federal Agency Safety and Health Programs, May 17, 1996.DisclaimerThis manual is intended to provide instruction regarding some of the internal operations of the Occupational Safety and Health Administration (OSHA), and is solely for the benefit of the Government. No duties, rights, or benefits, substantive or procedural, are created or implied by this manual. The contents of this manual are not enforceable by any person or entity against the Department of Labor or the United States. Statements which reflect current Occupational Safety and Health Review Commission or court precedents do not necessarily indicate acquiescence with those precedents.Table of ContentsCHAPTER 1INTRODUCTIONI.PURPOSE. ........................................................................................................... 1-1 II.SCOPE. ................................................................................................................ 1-1 III.REFERENCES .................................................................................................... 1-1 IV.CANCELLATIONS............................................................................................. 1-8 V. ACTION INFORMATION ................................................................................. 1-8A.R ESPONSIBLE O FFICE.......................................................................................................................................... 1-8B.A CTION O FFICES. .................................................................................................................... 1-8C. I NFORMATION O FFICES............................................................................................................ 1-8 VI. STATE IMPACT. ................................................................................................ 1-8 VII.SIGNIFICANT CHANGES. ............................................................................... 1-9 VIII.BACKGROUND. ................................................................................................. 1-9 IX. DEFINITIONS AND TERMINOLOGY. ........................................................ 1-10A.T HE A CT................................................................................................................................................................. 1-10B. C OMPLIANCE S AFETY AND H EALTH O FFICER (CSHO). ...........................................................1-10B.H E/S HE AND H IS/H ERS ..................................................................................................................................... 1-10C.P ROFESSIONAL J UDGMENT............................................................................................................................... 1-10E. W ORKPLACE AND W ORKSITE ......................................................................................................................... 1-10CHAPTER 2PROGRAM PLANNINGI.INTRODUCTION ............................................................................................... 2-1 II.AREA OFFICE RESPONSIBILITIES. .............................................................. 2-1A.P ROVIDING A SSISTANCE TO S MALL E MPLOYERS. ...................................................................................... 2-1B.A REA O FFICE O UTREACH P ROGRAM. ............................................................................................................. 2-1C. R ESPONDING TO R EQUESTS FOR A SSISTANCE. ............................................................................................ 2-2 III. OSHA COOPERATIVE PROGRAMS OVERVIEW. ...................................... 2-2A.V OLUNTARY P ROTECTION P ROGRAM (VPP). ........................................................................... 2-2B.O NSITE C ONSULTATION P ROGRAM. ................................................................................................................ 2-2C.S TRATEGIC P ARTNERSHIPS................................................................................................................................. 2-3D.A LLIANCE P ROGRAM ........................................................................................................................................... 2-3 IV. ENFORCEMENT PROGRAM SCHEDULING. ................................................ 2-4A.G ENERAL ................................................................................................................................................................. 2-4B.I NSPECTION P RIORITY C RITERIA. ..................................................................................................................... 2-4C.E FFECT OF C ONTEST ............................................................................................................................................ 2-5D.E NFORCEMENT E XEMPTIONS AND L IMITATIONS. ....................................................................................... 2-6E.P REEMPTION BY A NOTHER F EDERAL A GENCY ........................................................................................... 2-6F.U NITED S TATES P OSTAL S ERVICE. .................................................................................................................. 2-7G.H OME-B ASED W ORKSITES. ................................................................................................................................ 2-8H.I NSPECTION/I NVESTIGATION T YPES. ............................................................................................................... 2-8 V.UNPROGRAMMED ACTIVITY – HAZARD EVALUATION AND INSPECTION SCHEDULING ............................................................................ 2-9 VI.PROGRAMMED INSPECTIONS. ................................................................... 2-10A.S ITE-S PECIFIC T ARGETING (SST) P ROGRAM. ............................................................................................. 2-10B.S CHEDULING FOR C ONSTRUCTION I NSPECTIONS. ..................................................................................... 2-10C.S CHEDULING FOR M ARITIME I NSPECTIONS. ............................................................................. 2-11D.S PECIAL E MPHASIS P ROGRAMS (SEP S). ................................................................................... 2-12E.N ATIONAL E MPHASIS P ROGRAMS (NEP S) ............................................................................... 2-13F.L OCAL E MPHASIS P ROGRAMS (LEP S) AND R EGIONAL E MPHASIS P ROGRAMS (REP S) ............ 2-13G.O THER S PECIAL P ROGRAMS. ............................................................................................................................ 2-13H.I NSPECTION S CHEDULING AND I NTERFACE WITH C OOPERATIVE P ROGRAM P ARTICIPANTS ....... 2-13CHAPTER 3INSPECTION PROCEDURESI.INSPECTION PREPARATION. .......................................................................... 3-1 II.INSPECTION PLANNING. .................................................................................. 3-1A.R EVIEW OF I NSPECTION H ISTORY .................................................................................................................... 3-1B.R EVIEW OF C OOPERATIVE P ROGRAM P ARTICIPATION .............................................................................. 3-1C.OSHA D ATA I NITIATIVE (ODI) D ATA R EVIEW .......................................................................................... 3-2D.S AFETY AND H EALTH I SSUES R ELATING TO CSHO S.................................................................. 3-2E.A DVANCE N OTICE. ................................................................................................................................................ 3-3F.P RE-I NSPECTION C OMPULSORY P ROCESS ...................................................................................................... 3-5G.P ERSONAL S ECURITY C LEARANCE. ................................................................................................................. 3-5H.E XPERT A SSISTANCE. ........................................................................................................................................... 3-5 III. INSPECTION SCOPE. ......................................................................................... 3-6A.C OMPREHENSIVE ................................................................................................................................................... 3-6B.P ARTIAL. ................................................................................................................................................................... 3-6 IV. CONDUCT OF INSPECTION .............................................................................. 3-6A.T IME OF I NSPECTION............................................................................................................................................. 3-6B.P RESENTING C REDENTIALS. ............................................................................................................................... 3-6C.R EFUSAL TO P ERMIT I NSPECTION AND I NTERFERENCE ............................................................................. 3-7D.E MPLOYEE P ARTICIPATION. ............................................................................................................................... 3-9E.R ELEASE FOR E NTRY ............................................................................................................................................ 3-9F.B ANKRUPT OR O UT OF B USINESS. .................................................................................................................... 3-9G.E MPLOYEE R ESPONSIBILITIES. ................................................................................................. 3-10H.S TRIKE OR L ABOR D ISPUTE ............................................................................................................................. 3-10I. V ARIANCES. .......................................................................................................................................................... 3-11 V. OPENING CONFERENCE. ................................................................................ 3-11A.G ENERAL ................................................................................................................................................................ 3-11B.R EVIEW OF A PPROPRIATION A CT E XEMPTIONS AND L IMITATION. ..................................................... 3-13C.R EVIEW S CREENING FOR P ROCESS S AFETY M ANAGEMENT (PSM) C OVERAGE............................. 3-13D.R EVIEW OF V OLUNTARY C OMPLIANCE P ROGRAMS. ................................................................................ 3-14E.D ISRUPTIVE C ONDUCT. ...................................................................................................................................... 3-15F.C LASSIFIED A REAS ............................................................................................................................................. 3-16VI. REVIEW OF RECORDS. ................................................................................... 3-16A.I NJURY AND I LLNESS R ECORDS...................................................................................................................... 3-16B.R ECORDING C RITERIA. ...................................................................................................................................... 3-18C. R ECORDKEEPING D EFICIENCIES. .................................................................................................................. 3-18 VII. WALKAROUND INSPECTION. ....................................................................... 3-19A.W ALKAROUND R EPRESENTATIVES ............................................................................................................... 3-19B.E VALUATION OF S AFETY AND H EALTH M ANAGEMENT S YSTEM. ....................................................... 3-20C.R ECORD A LL F ACTS P ERTINENT TO A V IOLATION. ................................................................................. 3-20D.T ESTIFYING IN H EARINGS ................................................................................................................................ 3-21E.T RADE S ECRETS. ................................................................................................................................................. 3-21F.C OLLECTING S AMPLES. ..................................................................................................................................... 3-22G.P HOTOGRAPHS AND V IDEOTAPES.................................................................................................................. 3-22H.V IOLATIONS OF O THER L AWS. ....................................................................................................................... 3-23I.I NTERVIEWS OF N ON-M ANAGERIAL E MPLOYEES .................................................................................... 3-23J.M ULTI-E MPLOYER W ORKSITES ..................................................................................................................... 3-27 K.A DMINISTRATIVE S UBPOENA.......................................................................................................................... 3-27 L.E MPLOYER A BATEMENT A SSISTANCE. ........................................................................................................ 3-27 VIII. CLOSING CONFERENCE. .............................................................................. 3-28A.P ARTICIPANTS. ..................................................................................................................................................... 3-28B.D ISCUSSION I TEMS. ............................................................................................................................................ 3-28C.A DVICE TO A TTENDEES .................................................................................................................................... 3-29D.P ENALTIES............................................................................................................................................................. 3-30E.F EASIBLE A DMINISTRATIVE, W ORK P RACTICE AND E NGINEERING C ONTROLS. ............................ 3-30F.R EDUCING E MPLOYEE E XPOSURE. ................................................................................................................ 3-32G.A BATEMENT V ERIFICATION. ........................................................................................................................... 3-32H.E MPLOYEE D ISCRIMINATION .......................................................................................................................... 3-33 IX. SPECIAL INSPECTION PROCEDURES. ...................................................... 3-33A.F OLLOW-UP AND M ONITORING I NSPECTIONS............................................................................................ 3-33B.C ONSTRUCTION I NSPECTIONS ......................................................................................................................... 3-34C. F EDERAL A GENCY I NSPECTIONS. ................................................................................................................. 3-35CHAPTER 4VIOLATIONSI. BASIS OF VIOLATIONS ..................................................................................... 4-1A.S TANDARDS AND R EGULATIONS. .................................................................................................................... 4-1B.E MPLOYEE E XPOSURE. ........................................................................................................................................ 4-3C.R EGULATORY R EQUIREMENTS. ........................................................................................................................ 4-6D.H AZARD C OMMUNICATION. .............................................................................................................................. 4-6E. E MPLOYER/E MPLOYEE R ESPONSIBILITIES ................................................................................................... 4-6 II. SERIOUS VIOLATIONS. .................................................................................... 4-8A.S ECTION 17(K). ......................................................................................................................... 4-8B.E STABLISHING S ERIOUS V IOLATIONS ............................................................................................................ 4-8C. F OUR S TEPS TO BE D OCUMENTED. ................................................................................................................... 4-8 III. GENERAL DUTY REQUIREMENTS ............................................................. 4-14A.E VALUATION OF G ENERAL D UTY R EQUIREMENTS ................................................................................. 4-14B.E LEMENTS OF A G ENERAL D UTY R EQUIREMENT V IOLATION.............................................................. 4-14C. U SE OF THE G ENERAL D UTY C LAUSE ........................................................................................................ 4-23D.L IMITATIONS OF U SE OF THE G ENERAL D UTY C LAUSE. ..............................................................E.C LASSIFICATION OF V IOLATIONS C ITED U NDER THE G ENERAL D UTY C LAUSE. ..................F. P ROCEDURES FOR I MPLEMENTATION OF S ECTION 5(A)(1) E NFORCEMENT ............................ 4-25 4-27 4-27IV.OTHER-THAN-SERIOUS VIOLATIONS ............................................... 4-28 V.WILLFUL VIOLATIONS. ......................................................................... 4-28A.I NTENTIONAL D ISREGARD V IOLATIONS. ..........................................................................................4-28B.P LAIN I NDIFFERENCE V IOLATIONS. ...................................................................................................4-29 VI. CRIMINAL/WILLFUL VIOLATIONS. ................................................... 4-30A.A REA D IRECTOR C OORDINATION ....................................................................................................... 4-31B.C RITERIA FOR I NVESTIGATING P OSSIBLE C RIMINAL/W ILLFUL V IOLATIONS ........................ 4-31C. W ILLFUL V IOLATIONS R ELATED TO A F ATALITY .......................................................................... 4-32 VII. REPEATED VIOLATIONS. ...................................................................... 4-32A.F EDERAL AND S TATE P LAN V IOLATIONS. ........................................................................................4-32B.I DENTICAL S TANDARDS. .......................................................................................................................4-32C.D IFFERENT S TANDARDS. .......................................................................................................................4-33D.O BTAINING I NSPECTION H ISTORY. .....................................................................................................4-33E.T IME L IMITATIONS..................................................................................................................................4-34F.R EPEATED V. F AILURE TO A BATE....................................................................................................... 4-34G. A REA D IRECTOR R ESPONSIBILITIES. .............................................................................. 4-35 VIII. DE MINIMIS CONDITIONS. ................................................................... 4-36A.C RITERIA ................................................................................................................................................... 4-36B.P ROFESSIONAL J UDGMENT. ..................................................................................................................4-37C. A REA D IRECTOR R ESPONSIBILITIES. .............................................................................. 4-37 IX. CITING IN THE ALTERNATIVE ............................................................ 4-37 X. COMBINING AND GROUPING VIOLATIONS. ................................... 4-37A.C OMBINING. ..............................................................................................................................................4-37B.G ROUPING. ................................................................................................................................................4-38C. W HEN N OT TO G ROUP OR C OMBINE. ................................................................................................4-38 XI. HEALTH STANDARD VIOLATIONS ....................................................... 4-39A.C ITATION OF V ENTILATION S TANDARDS ......................................................................................... 4-39B.V IOLATIONS OF THE N OISE S TANDARD. ...........................................................................................4-40 XII. VIOLATIONS OF THE RESPIRATORY PROTECTION STANDARD(§1910.134). ....................................................................................................... XIII. VIOLATIONS OF AIR CONTAMINANT STANDARDS (§1910.1000) ... 4-43 4-43A.R EQUIREMENTS UNDER THE STANDARD: .................................................................................................. 4-43B.C LASSIFICATION OF V IOLATIONS OF A IR C ONTAMINANT S TANDARDS. ......................................... 4-43 XIV. CITING IMPROPER PERSONAL HYGIENE PRACTICES. ................... 4-45A.I NGESTION H AZARDS. .................................................................................................................................... 4-45B.A BSORPTION H AZARDS. ................................................................................................................................ 4-46C.W IPE S AMPLING. ............................................................................................................................................. 4-46D.C ITATION P OLICY ............................................................................................................................................ 4-46 XV. BIOLOGICAL MONITORING. ...................................................................... 4-47CHAPTER 5CASE FILE PREPARATION AND DOCUMENTATIONI.INTRODUCTION ............................................................................................... 5-1 II.INSPECTION CONDUCTED, CITATIONS BEING ISSUED. .................... 5-1A.OSHA-1 ................................................................................................................................... 5-1B.OSHA-1A. ............................................................................................................................... 5-1C. OSHA-1B. ................................................................................................................................ 5-2 III.INSPECTION CONDUCTED BUT NO CITATIONS ISSUED .................... 5-5 IV.NO INSPECTION ............................................................................................... 5-5 V. HEALTH INSPECTIONS. ................................................................................. 5-6A.D OCUMENT P OTENTIAL E XPOSURE. ............................................................................................................... 5-6B.E MPLOYER’S O CCUPATIONAL S AFETY AND H EALTH S YSTEM. ............................................................. 5-6 VI. AFFIRMATIVE DEFENSES............................................................................. 5-8A.B URDEN OF P ROOF. .............................................................................................................................................. 5-8B.E XPLANATIONS. ..................................................................................................................................................... 5-8 VII. INTERVIEW STATEMENTS. ........................................................................ 5-10A.G ENERALLY. ......................................................................................................................................................... 5-10B.CSHO S SHALL OBTAIN WRITTEN STATEMENTS WHEN: .......................................................................... 5-10C.L ANGUAGE AND W ORDING OF S TATEMENT. ............................................................................................. 5-11D.R EFUSAL TO S IGN S TATEMENT ...................................................................................................................... 5-11E.V IDEO AND A UDIOTAPED S TATEMENTS. ..................................................................................................... 5-11F.A DMINISTRATIVE D EPOSITIONS. .............................................................................................5-11 VIII. PAPERWORK AND WRITTEN PROGRAM REQUIREMENTS. .......... 5-12 IX.GUIDELINES FOR CASE FILE DOCUMENTATION FOR USE WITH VIDEOTAPES AND AUDIOTAPES .............................................................. 5-12 X.CASE FILE ACTIVITY DIARY SHEET. ..................................................... 5-12 XI. CITATIONS. ..................................................................................................... 5-12A.S TATUTE OF L IMITATIONS. .............................................................................................................................. 5-13B.I SSUING C ITATIONS. ........................................................................................................................................... 5-13C.A MENDING/W ITHDRAWING C ITATIONS AND N OTIFICATION OF P ENALTIES. .................................. 5-13D.P ROCEDURES FOR A MENDING OR W ITHDRAWING C ITATIONS ............................................................ 5-14 XII. INSPECTION RECORDS. ............................................................................... 5-15A.G ENERALLY. ......................................................................................................................................................... 5-15B.R ELEASE OF I NSPECTION I NFORMATION ..................................................................................................... 5-15C. C LASSIFIED AND T RADE S ECRET I NFORMATION ...................................................................................... 5-16。
碎纸机外国文献
Designing and Manufacturing an Appropriate Technology Shredder in a Developing CountryJeffrey P. WeissAn Engineering Project submitted to the faculty of the School of Engineering in partial fulfillment of the requirements of the Masters of Manufacturing Systems Engineering degreeUniversity of St. ThomasSt. Paul, MinnesotaDecember 2005AbstractThe focus of this project was to redesign a simple manual shredding machine used to shred breadfruit for the Republic of Haiti. A breadfruit shredder previously designed by a student senior design team was used as the basis for this project. The objective was to apply manufacturing principles, such as Design for Manufacturing and Assembly (DFMA), to simplify and reduce the cost of this machine so that it would be more accessible to poor farmers in Haiti. Each part of the shredder was examined using the DFMA methodology to determine if it could be eliminated or redesigned to simplify it while still making a quality product that met the performance criteria. The limitations of manufacturing a product in a developing country were also taken into consideration and played a key role in the outcome of the design. The result was a design that had a reduced number of parts, was more robust, easier to clean, simpler to build in a developing country, used materials that were more commonly available, and cost less to make.Revised Tommy Breadfruit ShredderAcknowledgementsI would like to acknowledge and send my sincerest thanks to my Project Committee of Dr. Camille George, Dr. Fred Zimmerman, and Mr. John Walker. They contributed numerous ideas during both the project phase and during the writing process. This resulted in a much better product that will hopefully improve the lives of people around the world. Dr. George also spent a great deal of time correcting and critiquing the writing of someone who was unaccustomed to writing in the academic thesis style.Many other people also lent a voice to the project during the research and design review phases. This would include Karl Mueller, Bruce Humphrey, Hank Garwick, Dave Elton, John Schevenius, Gary Olmstead, Fred Hegele, Pat O'Malley, Troy Pontgras, Yvonne Ng, and Clay Solberg. These people took the time to help and offered ideas that had previously been missed, resulting in a better product.I would also like to acknowledge the contribution of Dr. Mike Hennessey at the University of St. Thomas and the work of five of his undergraduate students. Justin Jackelen, Michael Boston, Angela Wachira, Keli Lais, and Matt Ellision took on the task of turning the revised breadfruit shredder drawings into computer animated Solidworks models. This contributed greatly to the visual understanding of the project and presentation. They also provided the fabrication prints that accompany this paper.Table of ContentsChapter I: Introduction (1)The Haitian Situation (2)Breadfruit (3)The Tommy Shredder (5)The Beneficiaries (5)Project Motivation (6)Chapter II: Research and Prior Work (7)UST Senior Design Team Work (7)Literature Search (9)Compatible Technology, International (11)Institutional Libraries (15)Research and International Organizations (15)Expert Inquires (17)Chapter III: Project Proposal (18)Project Objectives (18)Alternative Methods (20)Project Constraints (21)Project Budget (23)Financial Justification (23)Chapter IV: Findings and Results (24)Redesign Process (25)Design for Manufacture and Assembly Process (25)Alternative Designs (29)Design Reviews (30)Design Modifications (33)Fabrication Lessons (38)Design Variations (40)Shredder Blade Project (41)Testing the Redesigned Shredder (45)Redesign Results (47)Schedule (50)Final Budget (51)Chapter V: Discussion and Ramifications (52)Project Dissemination (52)Implementing the Shredder in Developing Countries (53)Project Obstacles (54)Bibliography: (57)Appendices (60)Appendix 1: Revisions 1 and 2 (60)Appendix 2: Revisions 3 and 4 (61)Appendix 3: Revisions 5 and 6 (62)Appendix 4: Revision 7 and 8 (63)Appendix 5: Breadfruit Shredder Exploded Layout (64)Appendix 6: Bill of Materials – Breadfruit Shredder (65)Appendix 7: Frame Plate Fabrication (67)Appendix 8: Drive Shaft Fabrication (69)Appendix 9: Feeder Tube Fabrication (70)Appendix 10: Blade Mount Fabrication (71)Appendix 11: Shredder Press Weight Fabrication (73)Appendix 12: Shredder Assembly Instructions (74)Appendix 13: Original Project Schedule (77)Appendix 14: Revised Project Schedule (78)Appendix 15: Preliminary Sketch by John Walker (79)Appendix 16: Contributions by Karl Mueller (80)Appendix 17: Drawing #001 – Frame Plate (82)Appendix 18: Drawing #002 – Drive Shaft (83)Appendix 19: Drawing #003 – Feeder Tube (84)Appendix 20: Drawing #004 – Drive Shaft Bearing (85)Appendix 21: Drawing #005 – Handle (86)Appendix 22: Drawing #006 – Blade Mount (87)Appendix 23: Drawing #007 – Center Divider (88)Appendix 24: Drawing #008 – Center Divider Spacer Tube (89)Appendix 25: Drawing #009 – Shredder Press Weight (90)Table of FiguresFigure 1: Map of the Republic of Haiti (CIA Fact Book, 2005) (3)Figure 2: Fruit of the Breadfruit Tree () (4)Figure 3: Senior Design Team Shredder (8)Figure 4: Garwick/Elton Breadfruit Shredder (13)Figure 5: Garwick/Elton Bicycle Drive Mechanism (14)Figure 6: Original Tommy Shredder Exploded View (28)Figure 7: Handle/Drive Shaft Changes (34)Figure 8: Drive Shaft Bearing Changes (35)Figure 9: Frame Plate Changes (35)Figure 10: Center Divider Changes (36)Figure 11: Blade Mount Changes (37)Figure 12: Combined Feeder Tube Hoop and Spacer (38)Figure 13: Alignment of Bushing Supports (39)Figure 14: Wooden Bushing Variation (41)Figure 15: Shredder Blade Profile Die, Profile Punch, and Hole Template (43)Figure 16: Fabricated Blade (45)Figure 17: The Revised Tommy Shredder (48)Table of TablesTable 1: Haiti Facts (CIA Fact Book, 2005) (2)Table 2: Proposed Budget (23)Table 3: Shredder Punch Hole Test (44)Table 4: Final Budget (52)Chapter I: IntroductionThis project will focus on redesigning for manufacture a simple breadfruit shredder for the Republic of Haiti. As one of the poorest nations in the Western hemisphere, Haiti is a country that lacks a stable government, education system, manufacturing base, or infrastructure. Malnutrition is a problem to the extent that the United States Department of State estimated that the child malnutrition rate was 22 percent in 2000(). Breadfruit is a natural food resource that is underutilized because it rots quickly and is difficult to store using traditional methods. Drying breadfruit can extend its shelf life and this process is best done when the shreds are even and consistent.A simple manual shredder was developed to produce consistent shreds for the inhabitants of Haiti by a group of senior engineering students at the University of Saint Thomas (UST) in conjunction with Compatible Technology International (CTI), an international non-profit organization. The student version of the shredder was designed and tested and found to meet all of the criteria that they had established. Despite meeting the requirements, the machine had the potential to be optimized to better reflect the manufacturing capabilities available in a developing country. This paper will document the redesign process and look at the manufacturing principles that drove this process. The end result was a machine that was simpler to build with the basic machine tools that would normally be found in a developing country such as Haiti, used materials that were more commonly available, had a reduced number of parts, was more robust, was easier to clean, and had a reduced cost.The Haitian SituationHaiti is considered to be the poorest and most destitute country in the Western hemisphere (CIA Fact Book, 2005). A majority of its population lives in poverty and relies on subsistence farming for survival. It has a long history of political upheaval and unrest since it gained its independence from France in 1804. The rotation of various governments and civil wars has hindered investment in the country and led to high unemployment and dismal living conditions for its inhabitants. The education system is broken or non-existent and there has been an exodus of knowledge from the island as people flee the dire conditions and turmoil.Table 1: Haiti Facts (CIA Fact Book, 2005)Population (Estimate, 2004): 8,121,622Land Area: 27,750 sq kmAverage Life Expectancy: 53 yearsPopulation Below Poverty Line: 80%Percentage of Population in Agriculture: 66%Unemployment Rate (no formal job): 66%Average Literacy Rate: 52%Figure 1: Map of the Republic of Haiti (CIA Fact Book, 2005)Most of the original Haitian forests have been cut down for fuel and the desire to cultivate more land. The weak governments have been unable or unwilling to confront this problem and it has continued unchecked. This deforestation has resulted in massive land erosion in the mountainous country and a net loss of arable land (CIA Fact Book, 2005). Breadfruit trees are abundant throughout the island and are one of the few trees that have survived the deforestation process.BreadfruitBreadfruit is an important food source and has become a staple for the inhabitants of warmer islands in the Caribbean Sea and Pacific Ocean. It has some nutritional value anda high starch content (Adebowale, 2005). Typical ways of preparing breadfruit are grilling, roasting, adding it to soups, and mashing.Figure 2: Fruit of the Breadfruit Tree ()One of the unique properties of breadfruit is its limited shelf life. Once it ripens and comes off of the tree, it will last between one and three days ( ). The breadfruit trees of Haiti produce fruit twice a year for a three week period (six weeks per year). Much of the fruit rots on the ground because of the inability to consume it all for the short time that it is in season (Capecchi, 2005). Typical preservation methods for fruit, such as canning, can be done but these value-adding processes are not common in Haiti and will increase the price of the food. A more economical way of preserving the breadfruit needed to be developed to utilize its potential to alleviate long-term hunger on the island.The Tommy ShredderThe development of a breadfruit harvesting process was taken on by two groups of senior mechanical engineering students as their Senior Design Projects in the 2003-2004 academic year. The first team attempted to devise a solar drier to quickly dehydrate the shredded breadfruit. The drying project showed that the shredded fruit could be successfully air-dried with an optimal shred size of ½” wide (Emiliusen, Mauritzen, McGruder, and Torgerson, 2004). The dried product can be stored for up to a year.The second team worked on developing a small, economical shredder that could efficiently and quickly process the breadfruit down into shreds so that it could be dried (Anderson, Fox, Rick, and Spah, 2004). The concept and methodology for the basic shredder design was done by the senior design team as was the testing to prove out the final design and will not be repeated in this paper. The purpose of this project was to examine and simplify the design, focusing primarily on its manufacturability.The BeneficiariesThe target beneficiaries of this shredder will be women’s cooperative groups based in Haiti. CTI, whose mission is to bring appropriate technologies to help increase food supplies and storage capacities in the developing world, has been working with the Methodist Church missions in Haiti on preserving breadfruit. Dried breadfruit can be ground into flour and local CTI volunteers have created several recipes using this breadfruit flour as the bulk material. UST teamed up with CTI to develop a simple shredder that could be used to shred the breadfruit. The goal of this joint project was tocreate a shredder that was simple to use and economical to manufacture so that local versions could be bought with micro-loans managed by the Methodist Church of Haiti. CTI also planned on helping set up a program to buy the shredded/ground breadfruit and process it into a cereal for Haitian school children (Capecchi, 2004). The plan was to take a resource, preserve it and add value, and then process it to create a commercial good. The objective of this undertaking is to give the women’s co-ops a starter model shredder that would allow them to generate some income from a readily available raw material.This shredder is also capable of processing a variety of different produce. There have been inquiries into its ability to shred cassava, sweet potatoes, and red peppers. The alternative uses of the shredder will not be explored here but the final design for this project will be made readily available and has potential uses worldwide. It will also be submitted to appropriate technology journals to broaden its dissemination.Project MotivationThe author of this master’s engineering project has spent time in developing countries and realized that there are often raw materials that are not fully utilized and exploited. The people generally lack the knowledge to manufacture items in large volumes and have limited manufacturing equipment, start-up money, a reliable source of power, or an infrastructure to transport the goods (Obi, 1999). However, these people are extremely creative and will adapt what they have on hand to work in almost any situation (Humphrey, 2005). The motivation for this project was to help the people develop theirown economy and hopefully raise their standard of living. This project will not only benefit the women of Haiti, it will help the local machine shops, provide work at the processing plant, and give the children of Haiti a stable, year around diet.Chapter II: Research and Prior WorkThe research for this project consisted of searching major journals, books on manufacturing in developing countries, contacting major research libraries, and personal contacts with experts in various fields. Many avenues for help were explored to gather information to improve the final design. The research phase of this project found that the work done by the UST senior design team was one of the few to address the issue of constructing a simple shredder for manufacture and use in a developing country.UST Senior Design Team WorkThis project is based on the work previously done by a University of Saint Thomas (UST) senior engineering design team whose goal was to develop the original breadfruit shredder based on the needs of the country of Haiti and the criteria established by Compatible Technology, International (CTI). The purpose of the original project was to “find the most efficient means of mechanically shredding breadfruit to best prepare the fruit for the drying process” (Anderson et al, 2004). The team developed concepts and tested many different methods of shredding the breadfruit and the mechanical actuators that would be needed for each prototype. The concepts were evaluated and ranked and the team chose the method best suited for their needs. The ‘Tommy Shredder’ developedby the student senior design team is shown in Figure 3 and their paper can be found on the UST website at /cmgeorge/breadfruit_shredder/.Figure 3: Senior Design Team ShredderThe senior design team had originally planned on testing the shredder in its target environment of Haiti but that country was not accessible at the time due to political unrest. A prototype shredder was built and brought to the Caribbean island of St. Vincent where there was an ample supply of breadfruit and established contacts. On the island of St. Vincent, the design was field-tested using breadfruit and the results recorded. The shredder met all of the target criteria established by CTI and the design team. It produced an average shred rate of 200 pounds/hour and cost less than $100 dollars U.S. to build (Anderson et al, 2004). This shredder became the baseline for the current project.Literature SearchA literature search done using the Compendex database at the University of Minnesota found several articles that were possibly related or relevant to the design of the breadfruit shredder. These articles were retrieved and analyzed with the result being that a majority were not related or did not contain information relevant to the design of an appropriate technology machine. Many of the applicable articles are referenced throughout this paper while those with less relevance to the project are cited in this section.In ‘Functional Properties of Native, Physically and Chemically Modified Breadfruit (Artocarpus Artilis) Starch’, Adebowale, Olu-Owolabi, Olawumi, and Lawal (2005) dealt with extracting starch from breadfruit. In the ‘Rediscovery of Local Raw Materials: New Opportunities for Developing Countries’, El-Mously (1997) discussed ways that developing countries could use local, undervalued resources to reduce their dependence on foreign imports. Breadfruit would be an undervalued resource on most Caribbean islands but the article did not provide information that would be relevant to the design of a shredder or this project. In the ‘Framework for Selecting and Introducing Appropriate Production Technology in Developing Countries’, Bruun and Mefford (1996) looked at working with the culture and education of developing countries when setting up a production facility. These are issues that will not be dealt with in this paper. In the ‘Role of Materials in Developing Countries’, Villas-Boas (1990) discussed the lack of use of new, high-tech materials in developing countries due to their cost and availability. Every effort was made to design the shredder using only common materials that would typicallybe available in a poor, developing country. In the ‘Supplier Selection in Developing Countries: a Model Development’, Motwani, Youssef, Kathawala, and Futch (1999) discussed issues involving selecting or qualifying vendors to produce a product. This will be the responsibility of the organization having the shredder built, and is beyond the scope of this project.A search of the Internet using the Google – Advanced Scholar provided more papers that had some relevance. Thakur, Varma, and Goldey (2001) in the ‘Perceptions of Drudgery in Agriculture and Animal Husbandry Operations: A Gender Analysis From Haryana State, India’ discusses the fact that women in developing countries spend much more time working in agriculture than men and the tasks given to them are more monotonous and tedious. The article supports the need for a device like the breadfruit shredder that has the potential to lift them out of that situation. In ‘A Framework for Implementing Appropriate Manufacturing Systems in Developing Economies’, Obi (1999) looked for explanations on why the Industrial Revolution passed by most developing countries and explored ways that these countries can start utilizing their vast manpower resources. He discusses the need to change workers attitudes. Finally, in ‘Meeting a Pressing Need’, Hynd and Smith (2004) discuss a simple oilseed ram press as an appropriate technology device for small scale extracting of oil from seeds and nuts. They examine some of the cultural issues that were associated with implementing the oilseed ram. The insights of this article could be used as a guide for undertaking the next phase of the shredder project; implementation into the Haitian culture. They briefly talk about some of themanufacturing difficulties, such as poor quality, associated with producing goods in a developing country.The best book relating to appropriate technology equipment used in developing countries is the ‘Appropriate Technology Sourcebook’ compiled by Darrow and Saxenian (1993). It is considered ‘The Bible’ by people in the appropriate technology field, such as those at CTI (Humphreys, 2005). The book is a resource listing appropriate technology machine books and papers that are available for purchase from other sources. It does not contain any designs of its own, but it does give a brief description of the contents of the papers and designs that are available for order. A search of this book and the updated website did not reveal any designs for manual shredders or grinders(/atnetwork/atsourcebook/index).Compatible Technology, InternationalCompatible Technology, International (CTI) () is an excellent local resource for dealing with appropriate technology in developing countries and has extensive connections throughout the world. It is an organization dedicated to using simple devices to improve food production and storage in the third world. They are a stakeholder in the design and development of the original shredder. The director of CTI is Bruce Humphreys who granted an interview on issues dealing with manufacturing in developing countries (2005). Some of the key points that he brought up were:Manufacturers in developing countries do not necessarily build parts to a fabrication print. Everything is custom and will look similar to what is desired,but is not quite the same.Creativity is not rewarded in many cultures and there is a desire to continue doing things the old way.Expectations in quality and standards will probably not be met. They do not typically produce to the same quality as is expected in the U.S.There are cultural norms and practices that will be slow to change and may not be overcome. This would primarily relate to the target market of women. Womentend to not use machines, thus the design must be easy to use and relatively toolfree.These assertions by Mr. Humphrey were reinforced in other literature relating to the topic (Obi, 1999).Hank Garwick and Dave Elton are the two CTI volunteers who are most closely tied into the Haiti mission. They have made several trips to Haiti on humanitarian missions associated with both CTI and the Methodist Church. The two offered insight into the Haitian mindset, manufacturing capabilities in Haiti, and experience in shredding breadfruit. Their comments on the manufacturing capabilities in Haiti were that “we would be lucky to find someone who could read a print, and even if they can they probably won’t follow it” (Garwick, 2005).Garwick and Elton were not satisfied with the work of the UST senior design team and continued to develop the shredder after the senior design team’s project ended. They made several small modifications to the design, built a prototype, and brought it down to Haiti to be tested (Fig. 4). The Garwick/Elton version of the shredder did not work as well as intended and did not produce the desired shred rate found by the UST engineering team (Garwick, 2005). It is unclear why this was the case. Several of the better design changes that they made to their shredder were incorporated into the current shredder design. These would include the sheet metal center divider and ideas on the retainer for the shredding blade.Figure 4: Garwick/Elton Breadfruit ShredderGarwick and Elton believed strongly that the prime power for the operation of the shredder should be a leg driven bicycle type mechanism instead of the current hand powered crank. Figure 5 shows a bicycle drive assembly that they added to a shredder (Garwick, 2005). This project is focused on producing a shredder for the poorest of people in Haiti and it was felt that a bicycle type mechanism would significantly add to the cost of the machine while making it unnecessarily complex. It is expected that this shredder will only be fully utilized for several weeks a year during the breadfruit harvest and would not justify the higher cost. The current design is one such that a bicycle type drive could be added to the shredder at a later date if desired by the user.Figure 5: Garwick/Elton Bicycle Drive MechanismInstitutional LibrariesThe United States Military Academy at West Point has an extensive library relating to military manuals and papers. The U.S. military routinely performs operations in developing countries and the units typically tasked with helping the local population are the Civil Affairs units and the Special Operations Forces. These units are often involved in nation building and community development and have close contact with the people. Daniel Prichard, a research librarian at the library, was contacted about any pamphlets, articles, or papers that the library may have on a shredder or appropriate technologies in developing countries. Mr. Prichard found nothing relevant at the Academy’s library (Prichard, 2004).A search of the University of St. Thomas’s and the University of Minnesota’s library systems found no books or on-site literature that was relevant to the design of the breadfruit shredder.Research and International OrganizationsThe Hawaiian Breadfruit Institute is an organization based in Hawaii whose mission is “to promote the study and use of Breadfruit for food and reforestation”( ). It tracks and propagates the 120 known varieties of breadfruit found on the islands of the Pacific Ocean and Caribbean Sea. Dr. Diane Ragone, director of the Hawaiian Breadfruit Institute, was contacted regarding the shredding of breadfruit and the possible existence of similar devices. Dr. Ragone responded that she had not heard of any similar processing methods for breadfruit. Her primary concern for this wasthat the latex found naturally in breadfruit would ‘gum-up’ the machine and clog the shredding blade (Ragone, 2005). This issue was raised with Hank Garwick of CTI and he stated that most of the latex in breadfruit was found in the skin. The skin is removed before processing so this did not appear to be a concern for the shredder. The field tests in St. Vincent by the senior engineering student team did not report any excessive latex build up on the blades.The International Research Development Centre (IRDC) is a Canadian based organization whose purpose is ‘to build healthier, more equitable, and more prosperous societies’ (www.irdc.ca ). An e-mail was sent to IRDC explaining the project and asking about any information that they might have on shredders. The response was a link to their website which brought up nothing of value. A similar search of the United Nations Development Program (UNDP) provided no additional information ().Research was done with the United States Food and Drug Administration (FDA) to see if there were requirements or recommendations for the food industry regarding food processing equipment or the components used in them. The purpose was to find out which materials were considered “Food Grade” and suitable for food contact. The goal is to make the shredder as sanitary and safe as possible regardless of the standards that may be present in a developing country. It was found that the FDA does not keep a list of recommended materials, but has established a list of requirements that manufactures must meet in order to state that it is a material approved for food contact. The premise of therequirements are that if any of the material could ‘migrate’ to the food, it must not pose a threat to humans (FDA, 1999).Expert InquiresThe Minneapolis/St. Paul area is home to several large food producing companies such as General Mills. Food Safety personnel at General Mills were contacted to ask about standards for their food production equipment and any suggestions that would help to make the shredder more sanitary and suitable for food contact. These inquiries covered guidelines that are typical of the food processing industry. Gary Olmstead, Food Safety Instructor at General Mills stated that equipment should be durable and easy to clean (Olmstead, 2005). General Mills avoids having any pieces of equipment over the product because of the risk of parts falling into the food. Fred Hegele, also part of food safety at General Mills, was concerned about the durability of any plastics used in the equipment. He emphasized that the machine cannot have any recessed pockets or hard to clean areas. These would trap bacteria and make it unsafe and unsanitary (Hegele, 2005). John Schevenius, a former General Mills Engineer and founder of CTI, was contacted about suggestions for the shredder. Although he was familiar with the breadfruit program, he could not offer any suggestions for improvement (Schevenius, 2005).The research done here showed that there is a lack of availability of information regarding the design of an appropriate technology machine. The design methodology varies from organization to organization and no standardized process appears to have been completed and published in a major journal regarding the topic. Appropriate。
IMCA M166 (FMEA)
A BThe International MarineContractors AssociationGuidance onFailure Modes & EffectsAnalyses (FMEAs)IMCA M 166A BThe International Marine Contractors Association (IMCA) is the international trade association representing offshore, marine and underwater engineering companies.IMCA promotes improvements in quality, health, safety, environmental and technical standards through the publication of information notes, codes of practice and by other appropriate means.Members are self-regulating through the adoption of IMCA guidelines as appropriate. They commit to act as responsible members by following relevant guidelines and being willing to be audited against compliance with them by their clients.There are two core committees that relate to all members:Safety, Environment & LegislationTraining, Certification & Personnel CompetenceThe Association is organised through four distinct divisions, each covering a specific area of members’ interests: Diving, Marine, Offshore Survey, Remote Systems & ROV.There are also four regional sections which facilitate work on issues affecting members in their local geographic area – Americas Deepwater, Asia-Pacific, Europe & Africa and Middle East & India.IMCA M 166This report was prepared for IMCA, under the direction of its Marine Division Management Committee, by Wavespec./marineThe information contained herein is given for guidance only and endeavours toreflect best industry practice. For the avoidance of doubt no legal liability shall attach to any guidance and/or recommendation and/or statement herein contained.CONTENTSEXECUTIVE SUMMARY (2)INTRODUCTION: (8)CHAPTER 1: FAQS (9)What is an FMEA? (9)What are the objectives of an FMEA? (9)What does an FMEA contain? (9)Who wants an FMEA and why? (10)When is an FMEA carried out? (10)What is needed to perform an FMEA? (11)Who carries out an FMEA? (11)What standards are used for an FMEA? (11)What practical FMEA tests are required? (12)What types of unacceptable failure modes have been uncovered by FMEAs? (12)What is done when an unacceptable failure mode is identified? (12)Who decides what is an acceptable solution to the unacceptable effects of afailure mode? (13)Is it necessary to carry out a physical inspection of the equipment being analysed? (13)How often should the FMEA be updated? (13)What is a Criticality Analysis? (13)What does a formal FMEA cost? (14)CHAPTER 2: MURPHY’S LAW AND FMEAS (15)2.1Murphy’s Law (15)2.2The FMEA in the Design Process (15)2.3The FMEA Objectives (16)2.4How Did FMEAs Start? (16)CHAPTER 3: FMEA STANDARDS & THE CLASSIFICATION SOCIETIES..173.1Standards (17)3.2Classification Societies (18)CHAPTER 4: DP FMEA – HOW FAR DO WE GO? (20)4.1How Far Do We Go? (20)4.2Bottom Up or Top Down? (20)CHAPTER 5: THE FMEA PROCESS (22)5.1The Process (22)5.2Selecting the Team (22)5.3Defining the Standard (23)5.4Defining the Reporting Procedures (23)5.5Defining the Boundaries of the System to be Analysed (23)5.6Organising System Design Information (26)5.7Evaluating the Effects of each Failure Mode on the System (29)5.8Identifying Failure Detection Methods/Corrective Actions (30)5.9Recommendations (30)5.10The FMEA Report (31)5.11FMEA Documentation and Ongoing QA (32)CHAPTER 6: VESSEL AUDITS AND PRACTICAL FMEA TESTING (33)6.1Vessel Audits (33)6.2Arranging Practical FMEA Tests, Dockside/At Sea/On Full DP (33)CHAPTER 7: OPERATIONS AND MAINTENANCE (36)CHAPTER 8: ADDITIONS TO THE FMEA PROCESS (37)8.1Criticality Analysis (37)8.2Qualitative and Quantitative Risk Assessment (QRA) (38)8.3Criticality and Probability (38)8.4Fault Tree Analysis and Event Tree Analysis (39)8.5RAM (Reliability, Availability and Maintainability) (40)8.6Software for FMEA (41)8.7FMEA on Control Software (41)APPENDIX 1:DEFINITIONS OF TERMS USED IN THE FMEA PROCESS..42 APPENDIX 2:EXAMPLE OF AN FMEA WORKSHEET ANDDESCRIPTION OF THE FMEA WORKSHEET FIELDS (44)APPENDIX 3:BACKGROUND AND EXPLANATIONS OFDP CLASS 2 AND CLASS 3 (48)APPENDIX 4:TYPES OF DP FAILURE MODE UNCOVERED BY FMEAS..57 APPENDIX 5:REFERENCES (64)This document and the advice contained in it may change with developments in the industry.It is intended to review the guidance and make any necessary improvements on a regular basis.Any person with suggested improvements is invited to forward these to IMCA.EXECUTIVE SUMMARYThis Executive Summary is designed in a what, why, when, how format to allow the reader a relatively quick overview of the main issues surrounding an FMEA which are contained in the main part of the Guidance Document itself. It does not attempt to give comprehensive answers to the frequently answered questions (FAQs), which are addressed in the main document. The summary includes an FMEA Process Flow Sheet, which provides an overview of the processes involved in carrying out an FMEA. An FMEA can be applied to any item, system or process that could fail.WHATWhat is an FMEA?A systematic analysis of the systems to whatever level of detail is required todemonstrate that no single failure will cause an undesired event.What are its objectives?To identify potential design and process failures before they occur and to minimise the risk of failure by either proposing design changes or, if these cannot be formulated, proposing operational procedures. Essentially the FMEA is to:♦Identify the equipment or subsystem, mode of operation and the equipment;♦Identify potential failure modes and their causes;♦Evaluate the effects on the system of each failure mode;♦Identify measures for eliminating or reducing the risks associated with each failure mode;♦Identify trials and testing necessary to prove the conclusions; and♦Provide information to the operators and maintainers so that they understand the capabilities and limitations of the system to achieve best performance.What does it contain?The report will be structured to outline the findings that have been developed from worksheets. The findings will concentrate on the failure modes found which would have significant effects on the system and grade them into categories, e.g. catastrophic, critical, etc, down to minimal or nuisance value.An FMEA covering the complete system (which may include FMEAs of various subsystem manufacturers) should encompass those FMEAs by a review and an analysis of the interfaces between the subsystems. An FMEA should contain a practical test programme and the results from those tests.What practical tests are required?During the course of the analysis, there will be failure modes that are difficult to assess, so during the analysis a series of tests are devised to assess those failure modes in practice.What types of failure mode have been uncovered by FMEAs?Many types of failure mode have been revealed during an FMEA. Numerous examples are given later in this document.What is criticality analysis?FMECA or Failure Modes, Effects and Criticality Analysis is an extension to the FMEA process with the addition of a risk (criticality) assessment. Risk is a measurement of the combination of the consequence of a failure mode and its probability of occurrence. The results of the risk assessment can be prioritised to indicate high risk failure modes that should receive risk reduction considerations.WHYWho wants one and why do they want one?It is both common sense and responsible design practice to carry out an FMEA on an item of equipment or a system whenever it is required to work in an environment where any failure mode has the potential for a catastrophic effect on the process. The organisations and persons who want an FMEA may include:♦Classification Societies - who require an FMEA as part of the acceptance criteria for IMO Class 2 and Class 3 type DP vessels.♦Charterers - who will require an FMEA so that they can have confidence that the vessel is fit for purpose. An appropriate FMEA will give anenhanced comfort factor that the operation will be performed withoutproblem or risk.♦Owners – who require an FMEA to satisfy a charterer’s needs and to give themselves confidence in the safety and robustness of their operations.♦Operators – who require an FMEA so that procedures can be developed to mitigate the effects of any failure modes.♦Maintenance staff – who require an FMEA so that any critical areas which could give rise to a serious problem in the event of a failure can be targetedby planned maintenance techniques during periods of downtime.WHENWhen is an FMEA carried out? (new vessel/existing vessel)The FMEA should be commenced at the earliest stage that the design and development programme will allow – even to assist at a higher level in identifying potential weaknesses during the conceptual design.If the vessel is in the process of design or construction, then the detailed FMEA should run in parallel with the design process, with any FMEA testing deemed necessary being integrated into the shipyard sea trials programme. If the vessel is an existing vessel then the FMEA can be carried out at any time though the FMEA tests will require to be programmed during a convenient period of downtime.HOWHow is the FMEA Process Progressed?♦Selecting the team-Nominating the required specialists♦Defining the standard♦Defining the reporting procedures- e.g. FMEA Team → Client Focal Point → Designers →Client Focal Point → FMEA Team.♦Defining the boundaries of the system to be analysed-The benefit of block diagrams. These break the DP system down from a high system level to lower system levels to give a graphicrepresentation of how each system level interacts with another.♦Organising system design information-Drawing log-Question and Answer (“Q&A”) Punchlists-Worksheets-FMEA Report Forms-Traceability of information-Evaluating the effects on the system of each failure mode ♦Identifying failure detection methods/corrective actions♦Formulating practical FMEA tests, dockside/at sea/on full DP- A comprehensive trials programme will establish conclusively the failure effects of certain modes of failure that the desk top study hasfailed to establish. The intention is, essentially, to confirm failuremodes and not test the whole system for correct installation.♦Recommendations-Grade each into, for example, A) For Immediate Action, B) Important and C) Nice To Have. List of recommendations.♦Conclusions♦FMEA report structure-Formulation of report template.How is the FMEA presented?This document gives guidance on what form the FMEA deliverables should take.How often should the FMEA be updated?The FMEA should grow and mature with the life of the vessel. Any changes to the design of systems relevant to the DP should be analysed in line with the original FMEA and recorded as annexes to the FMEA. At suitable intervals,depending on the number of relevant design changes made, the FMEA should be formally updated.Extensions to The FMEA ProcessThe following are also briefly discussed in this document:♦Criticality Analysis♦Failure Probability Determination – Qualitative and Quantative♦Fault Tree Analysis♦Event Tree Analysis♦RAM (Reliability and Maintainability)♦Software for FMEA♦FMEA on control softwareFMEA Process FlowsheetINTRODUCTIONThis guidance document was commissioned by IMCA to highlight best practice in the use of Failure Modes and Effects Analysis (FMEA) techniques when applied to the technical systems associated with offshore vessels. An FMEA is an easy to use yet powerful pro-active engineering quality tool that assists in the identification and countering of weak points in the early design phase of products and processes. Whilst the emphasis of this document is on dynamic positioning (DP) systems, FMEA techniques can be applied to any system, whether applied to land, sea or air based equipment or systems, in which it is required that “no single failure shall cause a total failure of the system or process”.The document firstly answers frequently asked questions (FAQs) relating to FMEAs and explains the background to FMEA work and the role of FMEAs in Classification work. The depth of FMEA reporting, the procedures and the format of the final FMEA report are discussed. Finally, the additions to the FMEA process, which can compliment the analysis, are briefly explored.When progressing through this document, it should be remembered that the FMEA process itself is not sufficient to ensure a meaningful analysis. It is a tool to assist in carrying out a job. A tool in the hands of an inexperienced craftsman will not produce a good product and so it is with an FMEA. An analyst expert in the use of FMEAs and fully conversant in the architecture and operation of the system or process to be analysed, is essential to ensure a good final product.1FAQSThis opening chapter is based on FAQs, or “Frequently Asked Questions”, relating to FMEAs. Each question and answer is intended to be a brief idea of the type of question raised relating to FMEAs and, in most cases, the answer will lead the reader on to more in-depth discussion in a later Chapter. Each FAQ will be cross-referenced to sections later in the report where relevant.What is an FMEA?An FMEA is a design tool that has been around for many years and is recognised as an essential function in design from concept through to the development of every conceivable type of equipment. It is commonly defined as “a systematic process for identifying potential design and process failures before they occur, with the intent to eliminate them or minimise the risk associated with them”. FMEA procedures are based on standards in the reliability engineering industry, both military and commercial.(Refer to Chapter 2)What are the objectives of an FMEA?The fundamental purpose of an FMEA is to prove that the worst case failure in practice does not exceed that stated by the designers in the functional design specification. Where DP is concerned, the objective is to develop a fault tolerant system that can not only hold station in the face of adverse circumstances, but allows faults to be corrected as they occur, without jeopardy to the operation at hand.(Refer to Chapter 2 Section 2.3)What does an FMEA contain?The scope of the FMEA should be established at the outset. In the case of a DP vessel, it should encompass all those parts of the system involved in stationkeeping, e.g. DP control system, power generation and distribution, power management, thrusters and propulsion, DP environment and position sensors.The FMEA report itself is structured to outline the findings which have been developed from FMEA Worksheets, which are tabular forms recording the findings. The findings will concentrate on the failure modes found, which would have significant effects on the station keeping ability of the vessel and are graded into categories, e.g. catastrophic, critical, etc, down to minor or nuisance value. It should contain a practical test programme, which, in the case of a DP vessel, is carried out mainly at sea when in full DP mode, together with the test results. The FMEA will usually contain recommendations that improve the design, which need to be adequately addressed in the FMEA process. The structure of an FMEA can be found in Chapter 5, Section 5.10.An FMEA covering the complete DP system, which may include the FMEAs of various subsystem manufacturers, should encompass those FMEAs by a review and an analysis of the interfaces between those subsystems.Who wants an FMEA and why?Whenever the function of an item of equipment or system is for it to work in an environment in which any failure mode has the potential for a catastrophic effect on the process, it is common sense and responsible design practice to carry out an FMEA. Consequently, a number of people, organisations, bodies, etc., should be very interested in the findings of an FMEA. These include:♦Classification Societies, who require an FMEA as part of the acceptance criteria for IMO Class 2 and Class 3 type DP vessels. Whilst not actuallyspecifying FMEA, the US Code of Federal Regulations requires a qualitativefailure analysis technique to be applied to vital marine automation systemsand an FMEA is usually the technique applied.♦National regulatory authorities, who often require an FMEA as part of the safety case for an offshore installation or DP vessel.♦Charterers, who will require an FMEA as part of the vessel acceptance criteria so that they can have confidence that the vessel is fit for purpose. Athorough FMEA will give an enhanced comfort factor that the operation willbe performed with the minimum of disruption.♦Owners, who require an FMEA to satisfy a charterer. It is also common sense for an Owner to have a thorough FMEA carried out on his vessels as itprovides him the assurance that any risk has been minimised, if noteliminated. The FMEA should be one of the inputs to the overall “SafestOperating Mode” analysis for a DP vessel.♦Operators, who require an FMEA so that procedures can be developed to mitigate the effects of any failure modes. The FMEA will assist indevelopment of the operations manuals and training programmes.♦Maintenance staff, who require an FMEA so that any critical areas which could give rise to a serious problem in the event of a failure can be targettedby planned maintenance techniques during periods of downtime.(Refer to Chapter 3 Section 3.1, etc)When is an FMEA carried out?Ideally, the FMEA should be initiated at as early a stage in the design process as possible, and then run in parallel with the design phase. Where DP is concerned, on new builds and conversions, the vessel owner or yard typically contracts for the study near the end of the vessel construction or conversion phase with the objective of identifying any single point failures. Although well intended, this is akin to using the FMEA as the means to confirm that the horses haven’t escaped after the stable door has been bolted. It is, therefore, often toolate to do anything about identified problems without major surgery.For maximum benefit, the time to identify and eliminate or mitigate the effect of equipment failure is during the design process, not in the latter stages of vessel construction or conversion.(Refer to Chapter 2 Section 2.2)What is needed to perform an FMEA?Once the FMEA team has been selected and the scope, standard and format of the FMEA have been agreed and the administration of the documentation has been put into place, full co-operation is required from shipyard, owners, operators, vessel’s staff and any others involved in the design process. Access will be required, to all documentation relating to the DP system, i.e. DP control system, electrical systems, machinery systems, machinery control systems, and all the equipment necessary to maintain the vessel on station. All relevant information should be made available from the shipyard (if a new vessel in the process of build), from the vessel’s Owners/Operators or from the vessel itself.A physical inspection may also be necessary and access to the vessel will haveto be arranged.(Refer to Chapter 5)Who carries out an FMEA?An FMEA team should be gathered together, which includes specialists each having a discipline in each of the systems required in the design process, e.g.machinery systems, electrical systems, DP control systems and other control systems. It is also likely that access to specialist advice from naval architects and operations personnel will be required.(Refer to Chapter 5 Section 5.2)What standards are used for an FMEA?There are a number of standards to which an FMEA can be carried out. The use of standards is important so that the FMEA will be accepted by all parties interested in it.Using a common standard for an FMEA has other benefits; such as the customer gets a report to a consistent standard and the companies bidding to carry out FMEA will also benefit because they will have a level playing fieldStandards include:♦US Department of Defense MIL-STD-1629A,♦CEI/IEC812 – Analysis techniques for system reliability - Procedure for failure modes and effects analysis (FMEA)♦BSI (BS 5760-5:1991 (Reliability of systems, equipment and components.Guide to failure modes, effects and criticality analysis).♦IMO MSC Resolution 36(63) Annex 4 – Procedures for Failure Mode and Effects Analysis (Whilst this is primarily for high speed craft, it gives goodguidance on FMEA procedures).(Refer to Chapter 3 Section 3.1)What practical FMEA tests are required?During the course of the analysis, there will be failure modes that are difficult to assess. In the case of a DP system, it is by definition a dynamic system with many parts interacting with each other. When the effect of a failure mode cannot be firmly established as a result of the desktop study, an FMEA test trials programme is devised to assess the failure mode in practice.On completion of the FMEA trials programme, any recommendations that arise from the results of the trials should be assessed to ensure that the correct action is taken and that the required verification is completed to allow close out in each case. These tests together with the results will form part of the final FMEA report.The FMEA trials test programme should be developed into an Annual DP Trials Document that will be used as the ongoing acceptance criteria for DP vessels.(Refer to Chapter 6 Section 6.2)What types of unacceptable failure modes have been uncovered by FMEAs?Many types of failure mode have been revealed by an FMEA, each having different failure effects on the overall system; from ones of solely nuisance value to others that could have resulted in events of catastrophic proportion if left undetected. This is due to the searching nature of the FMEA process.Significant types of failure mode that have been revealed during FMEAs, including some failure modes revealed that could have had a major effect on a DP system, are discussed in Appendix 4.What is done when an unacceptable failure mode is identified?The FMEA administration process should contain a reporting procedure so that, as soon as a failure mode is uncovered that has the potential to result in an undesirable effect on the system, it can be notified to the client and the system designers. It should be documented on a dedicated form called an FMEA Corrective Action Report Form and forwarded to the designers with a suggestion for design correction or, if this is not possible, a suggestion to adopt operational measures to reduce the risk.(Refer to Chapter 5 Section 5.6)Who decides what is an acceptable solution to the unacceptable effects of a failure mode?The solution should be discussed with the Owner and the design team.Sometimes the charterer is included if they are party to the FMEA procedure. A charterer may put pressure on an Owner to make design changes, but, naturally, it depends on when the unacceptable failure mode is uncovered; as the later it is uncovered the more difficult it is to rectify, and hence there is more time and cost penalty.Any major change to the system would also have to be discussed with Class to determine whether or not it contravened their requirements.Is it necessary to carry out a physical inspection of the equipment being analysed?If the design of the equipment being analysed is still on paper then clearly this is not possible. However, if the equipment is being built or is already built then a physical inspection is recommended. In the case of a DP vessel, say, which is in the process of construction, there is scope for a number of visits to the vessel to audit the build progress and check the installation of equipment. In this way, it can be seen how it is being installed and how other items of equipment are located in relation to equipment under analysis, to see if a failure of one will have an impact on the other.(Refer to Chapter 6 Section 6.1)How often should the FMEA be updated?The FMEA should grow and mature with the life of the vessel. Any changes to the design of the equipment or systems, covered by the FMEA, should be analysed in line with the original FMEA and recorded as annexes to the FMEA.At suitable intervals, depending on the number of relevant design changes made, the FMEA should be formally updated.(Refer to Chapter 5 Section 5.11)What is a Criticality Analysis?An FMECA, or Failure Modes, Effects and Criticality Analysis, is an extension to the FMEA process by the addition of a criticality assessment. It is effectivelya means of estimating how often each item in the system will fail, usually byusing actual failure data gathered in the field, and then calculating how often the whole system will fail. Whilst in knowing a system will fail, say, every 10 years, it is not known when it will fail. However, the added benefit is in knowing which areas in the system are likely to be less reliable, and either the system is redesigned to increase reliability or maintenance routines can be modified to concentrate on these areas. Obviously, this extra work will drive up the cost of the overall analysis, as would other extensions to the FMEA process, such as fault tree analysis, and it is generally the sponsor of the analysis who decides whether or not it is appropriate.Risk is a measurement of the consequence of a failure mode related to its probability of occurrence (criticality). The results of the risk assessment can be prioritised to indicate high risk failure modes/ items/ systems that should receive risk reduction considerations.(Refer to Chapter 8 Section 8.1)What does a formal FMEA cost?It is difficult to put a figure on the cost of an FMEA as it would clearly depend on the complexity of the equipment or system under analysis. In the case of a new build vessel, the FMEA process can run for a considerable number of months, though not necessarily on a continuous basis, and as a result incur a significant cost. In cases where the design process is short, the FMEA may only take days or weeks. So the cost will depend on the effort necessary to produce a meaningful analysis.In the course of carrying out an FMEA, if the design is proven to be sound and no significant single point failures are found, then it would be quite natural for the ship owner or client commissioning the FMEA to ridicule it and call it a waste of money. But this should not be so. A thorough FMEA will mean that the design has undergone a rigorous analysis. The designers will get a pat on the back for catering for all eventualities, and the operator and charterer will be able to sleep peacefully in the assurance that all exposure to risk of DP failure has been minimised as far as is reasonably practicable. However, if a significant failure mode is found, then the additional cost of carrying out the FMEA is small when compared to the potential effect that that failure mode could have. It is not just the cost to the owner of a lost day’s hire or more. The cost of the FMEA could pale into insignificance when compared to the cost due to the potential for loss of life or limb and damage to installations and the environment that could result from a hidden fault. The results of a thorough FMEA can also be used to refine maintenance routines that can produce operational savings.(Refer to Chapter 4)。
国际商务英语单词
Unit1customs areavisible tradeinvisible tradegross domestic product（GDP）portfolio investmentstocksbondscertificate of depositlicensingfranchisingtrademarkpatentroyaltycopyrightlicensorlicenseefranchiserfranchiseemanagement contractvalue chaincontract manufacturingturnkey projectBOT （Build Operate Transfer） intellectual propertyUnit2national incomeGNP(Gross National Product）per capita incomePPP(purchasing power parity) consumerismincome distributionOrganization of Economic Cooperation a nd DevelopmentinfrastructureCommonwealth of Independent States staple goodscreditor countryASEANfactors of production 关税区有形贸易无形贸易国内生产总值证券投资股票债券大额存单许可经营特许经营商标专利专利使用费，许可使用费，版税 版权给予许可的人接受许可的人给予特许的人接受特许的人管理合同价值链承包生产“交钥匙”工程建设、经营、移交知识产权国民收入国民生产总值人均收入购买力平价消费，消费主义收入分布经济合作与发展组织基础设施独立国家联合体（独联体）大路货债权国东南亚国家联盟生产要素economic integrationput up barriersfree trade areatariff ratesquota restrictionsNorth American FreeTrade Agreement(NAFTA)customs unioncommon marketsovereign statepolitical entitysignatorysettlementbanknotescirculationexecutive bodyEuropean Commissioncommissionercouncil of ministersmulti-polarizationDual-Ministerial Meetingsub-committeecartedOPECin a detourterritory economics internationalizationinternational economic environment double digittechnical improvementsday-to-day runningjurisdictionaffiliateshare holdershost countriesnatural resourcesprimary commoditiesspecializationeconomies of scaleendowment of naturecapital,land and labourabsolute advantagecomparative advantagetariffs barriers 经济一体化设置障碍自由贸易区关税税率配额限制北美自由贸易协定关税同盟共同市场主权国家政治实体签字国，签字人结算纸币，钞票货币流通行政机构，执行机构 欧盟委员会委员，特派员，专员 部长理事会多极化双部长会议分委员会卡特尔，联盟石油输出国组织以迂回的方式区域性经济体国际化国际经济环境两位数字的技术进步日常管理权利，管理范围分支机构，附属机构 股东东道国自然资源初级产品专业化规模经济自然的赋予资本、土地和劳动力绝对利益比较利益关税壁垒quotacustoms unionimport dutiesexport dutiesad valorem dutiesspecific dutiescompound dutiesdrawbackmost-favoured-nation（MFN）treatment concessiontariff schedulenon-tariff barriermeans of transportinland water vesselscargo compartmentplaces of historical interest accommodationsimmigrantremittancetrade termstrading practicesamendmentpremisesdestinationroll on-roll off trafficcustoms clearancetrade fairstrunk callenquiryquotationvalidity periodoffereecounter offersales contractsales(purchase)confirmation business linecontract properconsignmentcontracting partiesforce majeurearbitrationcotton piece goodscotton yarnsarticle number 配额关税同盟进口关税出口关税从价税从量税复税，混合关税退税最惠国待遇让步税率表，税则非关税壁垒运输工具内河船只货仓古迹膳宿供应，招待设备移民汇款贸易术语；交易条件贸易惯例修正案；修正条款；修改（企业、机构等使用的）生产场所经营场址 目的地，终点滚装滚卸式运输结关商品交易会长途电话询盘，询价报价有效期收盘人还盘销售合同售货（购货）确认书业务范围，经营范围合同本身，合同正文寄售缔约方不可抗力仲裁棉布棉纱货号counter tradeterminologynet positionshyperinflationEuropean Payment Unioncompetitive devaluation photocopying machineclearing systemcompensation tradeprocessing tradeleasingagencypolicy objectivesprotectionismfinancial marketcentrally planned economiesdebtordebitfinancial standingcreditworthinessperiodic paymentscash in advancedraftbill of exchangedrawerdraweepayeeusance draft(tenor draft,term draft) documentary draftclean draftbill of ladingtitle to the goodsinsurance policydocumentary collectiondocuments against payment(D/P) documents against acceptance(D/A)go bankruptopen accountapplicantopening bankbeneficiarycorrespondent bankadvising bankconfirming bank 对销贸易；反向贸易术语实际头寸极度通货膨胀欧洲支付联盟竞争性贬值复印机清算系统，清算制度补偿贸易加工贸易租赁代理政策目标贸易保护主义金融市场中央计划经济国家债务人借方，记入借方的款财务状况资信可靠状况分阶段付款预付现金汇票汇票出票人受票人受款人远期汇票跟单汇票光票提单货物所有权保险单跟单托收付款交单承兑交单破产记账交易开证申请人（也叫opener或principal) 开证银行受益人往来行，关系行通支行保兑行unit pricepartial shipment transshipmentprice termscarrying vessel mechanismclean creditnon-trade settlement revocable credit irrevocable credit confirmed creditleading bankdouble assurancesight creditusance creditcapital turnoverface valuetransferable creditnon-transferable credit middlemannon-draft creditdeferred payment revolving credittake delivery of commissiondiscountshipping markssignaturein general termsmemos(memorandum) consignorcarriageconsigneenotify partyairway billcargo receiptthe insuredcurrencycommercial invoiceport of shipmentshipping advicenatural product provinces carriercommon carrier 单价分批装运转船价格条款，价格术语运载船只，载货船只机制光票信用证非贸易结算可撤销信用证不可撤销信用证保兑信用证主要银行双重保障即期信用证远期信用证资金周转面值可转让信用证不可转让信用证中间人无汇票信用证推迟付款循环信用证提（货）佣金折扣唛头，运输标记签字用概括性的词语，用一般性词语表达 备忘录，便笺托运人运输收货人被通知人空运提单铁路运单，货运收据被保险人货币商业发展发货港，起运港装船通知产品自然领域承运人，运载工具公共承运人contract carrierprivate carrier entrepreneurintermediate product finished productsper-unitshipperinventoryjust-in-time inventory logisticscost economiesintermediate products insurerenterprisepoolpremiumclaimclientmarginhandmaidenknown premiumrelease of fundstime lagunderwritersutmost good faithport of originbrand-newplatinumindemnitytie upcontributionpro rateFord carpercentagesubrogationnegligentforwarding charges proximate cause of the loss insurable interestthe capital tied up exchange rategold standardpar valuereserve currency 契约承运人自有承运人企业家，业主中间产品制成品每一单位托运人，发货人，货主存货，库存零库存物流节约成本，成本节约中间产品承保人企业，公司统筹的资金；共同款项保险费索赔顾客，主顾保证金起服务（或辅助）作用的事物已知的保险费腾出资金在时间上的间隔保险公司最大诚信货物原产地港口崭新的白金损失赔偿占用，冻结分摊按比例（美国）福特轿车百分比；（全部中的）所占比例：部分 代位；取代疏忽的，玩忽的交货费用导致损失的直接原因可保险权益占用的资金汇率，兑换率金本位制平价储备货币interactionclean floatdirty floatvice versaspecial drawing right BOP deficitdiscount rateidle fundsdirect quoteindirect quotebuying rateselling ratemedial ratemultilateralfinancial resources earningsspell outcriterionsubscription replenishments prerequisitepopulation-planning nutritioncornerstonecapital marketborrowing powergold tranchereservegrace periodprivate sectorequity investmentcut across sectoral lines standby arrangement investment returns beveragetunacannerybiogeneticsbiotechnology Volkswagencustomer mobility inventorytax holidayacquisition 交互作用清洁浮动肮脏浮动反过来也是这样，反之亦然特别提款权国际收支赤字贴现率邮资（汇率）直接标价（汇率）间接标价买入价卖出价中间价多边的，多国（或多方）参加的 资金收益，赢利详细说明，明确规定标准，准则捐助，认捐补充或增加的（资金）必备条件，先决条件人口计划营养基石资本市场借款权黄金份额储备金，准备金优惠期，宽限期私营经济股权投资超越部门界限备用（信贷）安排投资收益，投资回报饮料金枪鱼罐头食品厂生物遗传学生物工艺学大众汽车客户流动存货免税期并购start from scratchjoint ventureparentthe greenfield strategyinvestorsecuritiesstatuteequitiesindicesgilt-edged stocksbrokerjobbersecondary capital marketmarket floorlisted marketincome taxqualificationsstanding committeecriteriaVATshortfallpractitionerlong-term capitalprimary capital raisingoptionsaccession tobe traced back tocontroversyframeworkGeneralized System of Preferences non-discriminatepredecessorfull employmentthe most-favored nation clause trade-relatedfull-fledgedverdicttariff concessionroundinstitutional strengththresholdcounter-veiling measuresanti-dumpingnational treatment 白手起家，从零开始合资企业母公司，总公司，创始组织绿地战略投资者有价证券法令，法规，成文律（股息不定的）普通股，股票 （index的复数形式）指数金边证券经纪人，中介人，掮客股票买卖经纪人二级资本市场交易场地挂牌证券交易市场所得税资格常务委员会（criterion的复数形式）标准增值说（全称为value added tax） 亏空，不足开业者长期资本对新发行的有价证券的筹措活动 期权（合同），选购权加入追溯到争议，争论框架，机构普惠制不加区别的，非歧视的前任，原来的事物充分就业最惠国条款与贸易有关的完全合格的，名副其实的裁决，判决关税减让回合制度力量，行政力量门槛，开端反贴补措施反倾销国民待遇tariff quotafair tradeECOSOCforumterms of tradeescape clausesterritoryaction programmepreferential customs tariffsorganconferencepreferencenon-discrimination principledifferential treatment new international economic ordertransfer of technology 关税配额公平贸易联合国经济及社会理事会公开讨论的机会；论坛贸易条件免责条款，例外条款领土，领地行动纲领特惠税机构，机关（正式）会议（年会）优先（权）；优先选择（权） 无差别待遇原则差别待遇国际经济新秩序技术转让。
FIDIC(合同条款)中英文对照(word版)国际咨询工程师联合会制
CONTENTS目录1General Provisions一般规定 (1)1.1Definitions定义 (1)1.2Interpretation解释 (7)1.3Communications通信交流 (7)1.4Law and Language法律和语言 (8)1.5Priority of Document文件优先次序 (8)1.6Contract Agreement合同协议书 (9)1.7Assignment权益转让 (9)1.8Care and Supply of Document文件的照管和提供 (9)1.9Confidentiality保密性 (10)1.10Employ er’s Use of Contractor’s Documents雇主使用承包商文件 (10)1.11Contractor’s Use of Employer’s Documents承包商使用雇主文件 (11)1.12Confidential Details保密事项 (11)1.13Compliance with Laws遵守法律 (11)1.14Joint and Several Liability共同的和各自的责任 (12)2The Employer雇主 (12)2.1Right of Access to the Site现场进入权 (13)2.2Permits, Licences or Approves许可、执照或批准 (14)2.3Employer’s personnel雇主人员 (14)2.4Employer’s Financial Arrangements雇主的资金安排 (15)2.5Employer’s Claims雇主的索赔 (15)3The Employer’s Administration雇主的管理 (16)3.1The Employer’s Representative雇主代表 (16)3.2The Employer’s personnel其他雇主人员 (16)3.3Delegated Persons受托人员 (17)3.4Instructions指示 (17)3.5Determinations确定 (18)4The Contractor承包商 (18)4.1The Contractor’s General Obligations承包商的一般义务 (18)4.2Performance security履约担保 (19)4.3Contractor’s Representative承包商代表 (20)4.4Subcontractors分包商 (21)4.5Nominated Subcontractors指定的分包商 (22)4.6Co-operation合作 (22)4.7Setting out放线 (23)4.8Safety procedures安全程序 (23)4.9Quality Assurance质量保证 (24)4.10Site Data现场数据 (24)4.11Sufficiency of the Contract Price合同价格 (25)4.12Unforeseeable Difficulties不可预见的困难 (25)4.13Rights of way and Facilities道路通行权于设施 (26)4.14Avoidance of Interference避免干扰 (26)4.15Access Route进场通路 (26)4.16Transport of Goods货物运输 (27)4.17Contractor’s Equipment承包商设备 (28)4.18Protection of the Environment环境保护 (28)4.19Electricity, Water and Gas电、水和燃气 (28)4.20Employer’s Equipment and Free-Issue Material雇主设备和免费供应的材料 (29)4.21Progress Reports进度报告 (30)4.22Security of the Site现场保安 (31)4.23Contractor’s Operations on Site承包商的现场作业 (31)4.24Fossils化石 (32)5Design设计 (33)5.1General Design Obligations设计义务一般要求 (33)5.2Contractor’s Documents承包商文件 (34)5.3Contractor’s Undertaking承包商的承诺 (35)5.4Technical Standards and Regulations技术标准和法规 (35)5.5Training培训 (36)5.6As-Built Documents竣工文件 (36)5.7Operation and Maintenance Manuals操作和维修手册 (37)5.8Design Error设计错误 (37)6Staff and Labour员工 (38)6.1Engagement of Staff and Labour员工的雇用 (38)6.2Rates of Wages and Conditions of Labour工资标准和劳动条件 (38)6.3Persons in the Service of Employer为雇主服务的人员 (38)6.4Labour Laws劳动法 (38)6.5Working Hours工作时间 (39)6.6Facilities for Staff and Labour为员工提供设施 (39)6.7Health and Safety健康和安全 (39)6.8Contractor’s Superintendence承包商的监督 (40)6.9Contractor’s Personnel承包商人员 (40)6.10Records of contractor’s Personnel and Equipment承包商人员和设备的记录 (41)6.11Disorderly Conduct无序行为 (41)7Plant, Materials and Workmanship生产设备、材料和工艺 (42)7.1Manner of Execution实施方法 (42)7.2Samples样品 (42)7.3Inspection检验 (42)7.4Testing试验 (43)7.5Rejection拒收 (44)7.6Remedial Work修补工作 (45)7.7Ownership of Plant and Materials生产设备和材料的所有权 (45)7.8Royalties土地(矿区)使用费 (46)8Commencement,Delays and Suspension开工、延误和暂停 (46)8.1Commencement of Works工程的开工 (46)8.2Time for Completion竣工时间 (47)8.3Programme进度计划 (47)8.4Extension of Time for Completion竣工时间延长 (48)8.5Delays Caused by Authorities当局造成的延误 (49)8.6Rate of Progress工程进度 (49)8.7Delay Damages误期损害赔偿费 (50)8.8Suspension of Work暂时停工 (50)8.9Consequences of Suspension暂停的后果 (51)8.10Payment for Plant and Materials in Event of Suspension暂停时对生产设备和材料的付款 (51)8.11Prolonged Suspension托长的暂停 (52)8.12Resumption of Work复工 (52)9Tests on Completion竣工试验 (52)9.1Contractor’s Obligations承包商的义务 (52)9.2Delayed Tests延误的试验 (54)9.3Retesting重新试验 (54)9.4Failure to Pass Tests on Completion未能通过竣工试验 (54)10Employer’s Taking Over雇主的接收 (55)10.1Taking Over of the Works and Sections工程和分项工程的接收 (55)10.2Taking Over of Parts of the Works部分工程的接收 (56)10.3Interference with Tests on Completion对竣工试验的干扰 (56)11Defects Liability缺陷责任 (57)11.1Completion of Outstanding Work and Remedying Defects完成扫尾工作和修补缺陷 (57)11.2Cost of Remedying Defects修补缺陷的费用 (58)11.3Extension of Defects Notification Period缺陷通知期的延长 (58)11.4Failure to Remedy Defects未能修补的缺陷 (59)11.5Removal of Defective Work移出有缺陷的工程 (60)11.6Further Tests进一步试验 (60)11.7Right of Access进入权 (60)11.8Contractor to Search承包商调查 (60)11.9Performance Certificate履约证书 (61)11.10Unfulfilled Obligations未履行的义务 (61)11.11Clearance of Site现场清理 (62)12Tests after Completion竣工后试验 (62)12.1Procedure for Tests after Completion竣工后试验的程序 (62)12.2Delayed Tests延误的试验 (63)12.3Retesting重新试验 (64)12.4Failure to Pass Tests after Completion未能通过的竣工后试验 (64)13Variations and Adjustments变更和调整 (65)13.1Right to V ary变更权 (65)13.2V alue Engineering价值工程 (66)13.3V ariation Procedure变更程序 (66)13.4Payment in Applicable Currencies以适用货币支付 (67)13.5Provisional Sums暂列金额 (67)13.6Daywork计日工作 (68)13.7Adjustments for Changes in Legislation因法律改变的调整 (69)13.8Adjustments for Changes in Cost因成本改变的调整 (69)14Contract price and Payment合同价格和支付 (70)14.1The Contract Price合同价格 (70)14.2Advance payment预付款 (70)14.3Application for Interim Payments期中付款的申请 (71)14.4Schedule of Payments付款价格表 (72)14.5Plant and Materials intended for the Works拟用于工程的生产设备和材料 (73)14.6Interim Payments期中付款 (74)14.7Timing of Payments付款的时间安排 (74)14.8Delayed Payment延误的付款 (75)14.9Payment of Retention Money保留金支付 (75)14.10Statement at Completion施工报表 (76)14.11Application for Final Payment最终付款的申请 (77)14.12Discharge结清证明 (77)14.13Final Payment最终付款 (78)14.14Cessation of Employer’s Liability雇主责任的中止 (78)14.15Currencies of Payment支付的货币 (78)15Termination by Employer由雇主终止 (79)15.1Notice to Correct通知改正 (80)15.2Termination by Employer由雇主终止 (80)15.3V aluation at Date of Termination终止日期时的估价 (82)15.4Payment after Termination终止后的付款 (82)15.5Employer’s Entitlement to Termination雇主终止的权利 (82)16Suspension and ter mination by Contracto r由承包商暂停和终止 (83)16.1Contractor’s Entitlement to Suspend Work承包商暂停工作的权利 (83)16.2Termination by Contractor由承包商终止 (84)16.3Cessation of Work and Removal of Contractor’s Equipment停止工作和承包商设备的撤离 (85)16.4Payment on Termination终止时的付款 (85)17Risk and Responsibility风险和职责 (86)17.1Indemnities保障 (86)17.2Contractor’s Care of the Works承包商对工程的照管 (87)17.3Employer’s Risks雇主的风险 (88)17.4Consequence of Employer’s Risks雇主风险的后果 (88)17.5Intellectual and Industrial Property Rights知识产权和工业产权 (89)17.6Limitation of Liability责任限度 (90)18Insurance保险 (91)18.1General Requirements for Insurances有关保险的一般要求 (91)18.2Insurance for Works and Contractor’s Equipmen t工程和承包商设备的保险 (93)18.3Insurance against Injury to Persons and Damage to Property人身伤害和财产损害险 (95)18.4Insurance for Contractor’s Personnel承包商人员的保险 (96)19Force Majeure不可抗力 (96)19.1Definition of Force Majeure不可抗力的定义 (96)19.2Notice of Force Majeure不可抗力的通知 (97)19.3Duty to Minimise Delay将延误减至最小的义务 (98)19.4Consequences of Force Majeure不可抗力的后果 (98)19.5Force Majeure Affecting Subcontractor不可抗力影响分包商 (99)19.6Optional Termination, Payment and Release自主选择终止、支付和解除 (99)19.7Release from Performance under the Law根据法律解除履约 (100)20Claims, Disputes and Arbitration索赔、争端和仲裁 (100)20.1Contractor’s Claims承包商的索赔 (100)20.2Appointment of the Dispute Adjudication Board争端裁决委员会的任命 (102)20.3Failure to Agreement Dispute Adjudication Board对争端裁决委员会未能取得一致时 (104)20.4Obtaining Dispute Adjudication Board’s Decision取得争端裁决委员会的决定 (104)20.5Amicable Settlement友好解决 (106)20.6Arbitration仲裁 (106)20.7Failure to Comply with Dispute Adjudication Board’s Decision未能遵守争端裁决委员会的决定 (107)20.8Expiry of Dispute Adjudication Board’s Appointment争端裁决委员会任命期满 (107)1General Provisions一般规定1.1Definitions定义In the Conditions of Contract (“these Conditions”), which include Particular Conditions and these General Conditions, the following words and expressions shall have the meaning stated. Words indicating persons or parties include corporation and other legal entities, except where the context requires otherwise.在合同条件（“本条件”），包括专用条件和通用条件中，下列词语和措辞应具有以下所述的含义.除上下文另有要求外，文中人员或当事各方等词语包括公司和其他合法实体.1.1.1The Contract合同1.1.1.1“Contract”means the Contract Agreement, these Conditions, theEmployer’s Requirement, the Tender, and further document (if any) which are listed in the Contract Agreement.“合同”系指合同协议书、本条件、雇主要求、投标书和合同协议书列出的其他文件（如果有）.1.1.1.2“Contract Agreement”means the contract agreement referred to inSub-Clause 1.6 [Contract Agreement], including any annexed memoranda.“合同协议书”系指第1.6款[合同协议书]中所述的合同协议书及所附各项备忘录.1.1.1.3“Employer’s requirements”means the document entitled employer’srequirements, as included in the Contract, and any additions and modifications to such document in accordance with the Contract. Such document specifies the purpose, scope, and/or design and/or other technical criteria, for the Works.“雇主要求”系指合同中包括的，题为雇主要求的文件，其中列明工程的目标、范围、和（或）设计和（或）其他技术标准，以及按合同对此项文件所作的任何补充和修改.1.1.1.4“T ender”means the Contractor’s signed offer for the Works and all otherdocuments which the Contractor submitted therewith (other than these Conditions and Employer’s Requirements, if so submitted), as included in the Contract.“投标书”系指包含在合同中的由承包商提交的为完成工程签署的报价，以及随同提交的所有其他文件（本条件和雇主要求除外，如同时提交）.1.1.1.5“Performance Guarantees”and “Schedule of payments”mean thedocuments so named (if any), as included in the Contract.“履约保证”和“付款计划表”系指合同中包括的具有上述名称的文件（如果有）.1.1.2Parties and Persons各方和人员1.1.2.1“Party” means the Employer or the Contractor, as the context requires.“当事方（或一方）”根据上下文需要，或指雇主，或指承包商。
特许经营或不特许经营外文翻译
特许经营或不特许经营外文翻译标题:To Franchise or Not to Franchise 原文:Since 1971, when the state of California enacted its own state franchise law, many rules and regulations have been established to regulate the operation and disclosure of franchising businesses. Franchising laws have been developed to curb the tide of illegal and fraudulent activities on the part of many franchisors during the 1950s and 1960s. A patchwork of legislation emerged during the early part of the 1970s which was designed to combat the alleged abuses and wrongs occurring in franchising operations. These rules and regulations were designed to require the franchisor to disclose, before the sale of the franchise, information regarding the operation of the franchise.On 21 October 1979, the Federal Trade Commission FTC established the franchise rule entitled "Disclosure Requirements and Prohibitions Concerning Franchising and Business Opportunity Ventures" FTC rule 436. This rule requires disclosure of specific activities prior to the sale of a franchise. These disclosures must be made to any prospective franchisee at the first personal meeting between the franchisor or representative and the franchisee for the purpose of discussing thefranchise sale, or ten business days prior to the execution of any franchise document or the payment of any consideration for the franchise, whichever is the earlier. This rule does not attempt to regulate the nature or substance of the franchisors/franchisee relationship; rather it requires the franchisor to make specific disclosures or provide information about franchising activities to the prospective franchisee. This rule was designed to serve two major functions:1 prevention of fraud or misrepresentation of material facts; and2 presentation of relevant facts or information to prospective franchisees The final franchising contract must be delivered to the prospective franchisee at least five days prior to the date on which the document is to be signed. The franchisor has the option of making the disclosures either according to the FTC Rule format or the Uniform Franchise Offering Circular UFOC which was developed by the North American Securities Administrators Association. These formats may not be mixed. The FTC Rule contains only 20 steps while the UFOC is a little bit longer and contains 23 steps. The FTC Rule format is accepted in only 42 states, while the UFOC format is accepted in all 50 states as well as in the province of Alberta.The substance of the disclosures required by the UFOC and FTC are similar in nature. However, franchisors generally prefer to use the UFOC format because of its acceptance in all the 50 states. The categories ofinformation in the UFOC and FTC Rule formats include, but are not limited to: information about the franchisor and any predecessors, business experience of officers and directors, litigation history, bankruptcy, description of the franchise, funds required to be paid by the franchisee, recurring fees payable to franchisor, obligations to purchase from franchisor or designated source, financing arrangements, supervision, territory and sales restrictions, trademarks, patents and copyrights, personal participation obligations, termination and renewal, statistical information concerning the number of franchises and company-owned outlets, public figure involvement, financial information concerning the franchisor, and the franchise contract As one can see from the above, there is quite a lot of information that the franchisor is required by law to divulge to the prospective franchisee. Because franchising can be subject to abuse, it is critical that such information be available to potential franchisee before he or she makes the final decision of whether to franchise or not.The question remains, however, as to what franchisors actually disclose and whether they follow the basic rules and format suggested by the FTC and UFOC. This is the question on which the present study seeks to shed light.In an effort to ascertain how franchisors use the UFOC or FTC Rule formats, a letter of enquiry was sent to 216 franchisors in seven broadindustries. A total of 101 franchisors responded, who also provided their UFOC or disclosure documents at the same time. The non respondents were randomly distributed and did not represent any particular size, group or industry.The information provided by the franchisors was classified into three categories: administrative matters, financial matters, and contractual obligations. The franchise disclosure documents contained a great deal of information about the franchisor and its administrative practices. In addition, they revealed a great deal of information about the financial obligations of the franchisee towards the franchisor as well as information about the initial start-up expenses for the franchisee. Finally, the disclosure documents also contained information about the contractual obligations of the franchisor and franchisee under the franchise agreement.Regarding litigation history, the UFOC rules required disclosure with respect to three forms of legal activity criminal, civil and administrative in which the franchisor or its officers may have been involved. This disclosure covers activities for the past ten fiscal years. It was found that 68 per cent of the companies were involved with litigation during that time period while 32 per cent were not One of the reasons why some may not have been involved in litigation was because they had not been in business very long.The rules also require the franchisor to disclose its bankruptcy history as well as its directors and officers during the past 15 fiscal years. It was found that 18 per cent of the respondent companies have been involved in some form of bankruptcy, while 82 per cent have not Another administrative requirement which many franchisors require of franchisees is the latter's actual participation in the operations of the franchise. Of those companies reporting, 33 per cent required their franchisees to participate while 67 per cent allowed for no participation or absentee ownership.When a franchisor offers financial assistance to the franchisee, such arrangements must be disclosed in the disclosure document. The majority of the respondents, 55 per cent, did not participate in providing financial support to their franchisees; however, it should be noted that 41 per cent did provide some form of financial assistance, while 4 per cent provided complete financial support to their franchisees.Furthermore, any limitation regarding the territorial or geographical areas in which a franchisee may operate must be disclosed under the law. It was found that 69 per cent of the respondents provided territorial rights or guarantees to their franchisees while 31 per cent did not. When a franchisee is granted an exclusive territory to operate, a written description of the territorial restrictions and boundaries must also be provided. The circumstances governing the maintenance of suchexclusive territorial rights, such as meeting certain sales goals, must also be stated Many franchisors require their franchisees to purchase goods or equipment from approved suppliers or specific sources. If this is the case, the franchisor is required to describe these goods or services and explain to the franchisee whether the franchisor is affiliated with any of these businesses. The study revealed that franchisees were required to purchase from approved suppliers approximately 90 per cent of the time.A franchisor must disclose the amount, method of payment, time of payment, and refund ability of the initial franchise fee that has to be paid to acquire and set up the franchise. Most initial fees are set at a fixed dollar amount by the franchisor for each franchisee. The results reported that 74 per cent of the respondent franchisors provided a specific dollar amount while 25 per cent disclosed a dollar range depending on the number and kinds of franchises to be opened. Additionally, 1 per cent provided a percentage figure rather than a dollar figure for the initial fee.Almost every franchisor requires their franchisees to pay a percentage of the latter's gross revenues back to the franchisor either on a weekly, biweekly, or monthly basis. The study reported that 81 per cent of the franchisors required a specific percentage of gross revenues to be paid for royalty fees, while 12 per cent disclosed a percentage range depending on the number of stores established and sales volume of thestores. In addition, 4 per cent disclosed that no royalty was required while 2 per cent required a fixed dollar amount for royalty fees based on a monthly charge period.Franchisors also usually require franchisees to pay specific advertising fees as a percentage of the gross revenues of the business. The study reported that 68 per cent of all franchisors required a specific percentage of such fees to be paid. In addition, 16 per cent provided a percentage range based on the number of stores and sales volume, 13 per cent disclosed no specific amount, and 2 per cent required a specific dollar amount to be paid each month to the franchisor.While some franchisors do provide leasing opportunities for franchisees, it was found in the survey that 98 per cent did not disclose leasing fees in their disclosure documents, while 2 per cent used a percentage lease fee for equipment rented from the franchisor.Some franchisors also require the payment of a transfer fee to be paid directly to the franchisor when the franchisee transfers ownership. However, it was found that 55 per cent of the respondent franchisors did not require a transfer fee to be paid, 32 per cent required a specific dollar amount, 8 per cent disclosed a dollar range depending on the number and size of stores, and 5 per cent required a percentage figure based on the sales of that particular store The franchisor is required by law to disclose estimated expenses for starting up the franchise. These expensesgenerally include items for equipment, working capital, inventory, signage, land and buildings. This is a turnkey cost and needs to be documented and estimated by the franchisor.It was found that 83 per cent of the franchisors provided a dollar range in estimating the initial start up expenses for the franchisee, while 14 per cent provided actual dollar amounts for the establishment of a franchise programme. Only 3 per cent did not provide information about the initial start up expenses.Franchisors also may provide projected earnings claims for franchisees. This may be the most sensitive area of the franchise sales programme as well as the franchise disclosure documents. Most sales representatives of franchisors are eager to provide earnings claims for franchisees. However, if the franchisor does provide an earnings claim, they must comply with either the FTC Rule or the UFOC format. Any written, visual or oral representation of financial information must be supported by disclosure information. Because of the rigid requirements established by the FTC and the UFOC, only 26 per cent of the respondents provided some form of earnings claims for the franchisees When earnings claims are provided, a separate "earnings claim document" must be furnished to each prospective franchisee. This should include all claims about actual or projected sales earnings or revenues. This information must be supported and documented by the franchisor.There are many contractual obligations which a franchisor must disclose in the franchise documents. One of these is simply the term or duration of the franchise contract. While the average marriage in the United States lasts about eight years, the average franchise agreement lasts for a much longer period. The results of this survey indicated that 78 per cent of all franchise agreements are for ten to 20 years. Additionally, 12 per cent are for five years, and 4 per cent are for three years or less.The franchisor is also required to disclose the length of the renewal term if the franchise contract is renewable. This renewal term may be for the same duration as the original contract or for any other period. The results indicated that most of these renewal contracts are for ten years 37 per cent, five years 27 per cent or 20 years.The franchisor must also disclose how a franchise may be terminated. All disclosure documents reviewed in this study indicated that the franchisor does have the right to terminate the franchise agreement. It was also found that 71 per cent of the companies allowed the franchisee to terminate the agreement at the latter's request.出处: Peng S. Chan, Robert T. Justis .To Franchise or Not to Franchise?[J]. Management Decision, 1993. 315,pp22-26标题:特许经营或不特许经营?译文:自1971年以来,当加利福尼亚州颁布了自己的特许经营的法律,很多规范制度已经建立起来用来规范特许经营业务的运作和披露。
海牙-维斯比规则(中英对照word版)之欧阳总创编
统一提单的若干法律规则的国际公约（1924年8月22日订于布鲁塞尔，1924年8月25日颁布，1942年8月25日实施）INTERNATIONAL CONVENTION FOR THE UNIFICATION OF CERTAIN RULES OF LAW RELATING TO BILLS OF LADING(“HAGUE RULES”), AND PROTOCOL OF SIGNATURE(Brussels, 25 August 1924)The President of the German Republic, the President of the Argentine Republic, His Majesty the King of the Belgians, the President of the Republic of Chile, the President of the Republic of Cuba, His Majesty the King of Denmark and Iceland, His Majesty the King of Spain, the Head of the Estonian State, the President of the United States of America, the President of the Republic of Finland, the President of the French Republic, His Majesty the King of the United Kingdom of Great Britain and Ireland and of the British Dominions beyond the Seas, Emperor of India, His MostSupreme Highness the Governor of the Kingdom of Hungary, His Majesty the King of Italy, His Majesty the Emperor of Japan, the President of the Latvian Republic, the President of the Republic of Mexico, His Majesty the King of Norway, Her Majesty the Queen of the Netherlands, the President of the Republic of Peru, the President of the Polish Republic, the President of the Portuguese Republic, His Majesty the King of Romania, His Majesty the King of the Serbs, Croats and Slovenes, His Majesty the King of Sweden, and the President of the Republic of Uruguay,HAVING RECOGNIZED the utility of fixing by agreement certain uniform rules of law relating to bills of lading,HAVE DECIDED to conclude a convention with this object and have appointed the following Plenipotentiaries:WHO, duly authorized thereto, have agreed as follows:第一条 Article 1本公约所用下列各词，涵义如下：In this Convention the following words are employed with the meanings set out below:(a) “承运人”包括与托运人订有运输合同的船舶所有人或租船人。
franchise案例英语作文
franchise案例英语作文【精选】It makes sense for one of the pioneers to preempt and then follow suit before they establish a monopoly. In general, imitators can be more sophisticated, perfectly legal, and have a good first mover advantage, but they can learn from the mistakes of the pioneers and take advantage of the fact that consumers like to choose, and they benefit from the fact that the market for their products is known - although in every city I visit, they obviously face deep-seated competition, and I'm looking for it I'll never bring them to the UK by signing licenses, franchises or joint ventures. I'll simply copy the best elements and do it in my own way, which is capitalism.I guess the author runs risk capital partners, a private equity firm, and risk capital partners, a British start-up Chairman of startup Britain.中文翻译：在一个先驱者建立垄断之前，让他们先发制人，然后紧随其后，这是有道理的。
我的加盟血泪故事作文
我的加盟血泪故事作文英文回答：Franchise Failure: A Cautionary Tale.The allure of franchise ownership is undeniable. The promise of a turnkey business, proven systems, and brand recognition can be incredibly tempting. However, thereality of franchise ownership is often far less rosy. My own experience with franchising is a cautionary tale, a story of broken promises, financial ruin, and shattered dreams. I am writing this account as a warning to others who may be considering the franchise path, a plea to do your due diligence and avoid the pitfalls that I fell into.My franchise journey began with high hopes and dreams.I had invested my life savings and borrowed heavily to secure my stake in a franchise. The franchisor promised me a proven business model, extensive training, and ongoing support. However, these promises proved to be empty.The training provided by the franchisor was superficial and inadequate. I was left to fumble my way through the complexities of running a business, making costly mistakes along the way. The ongoing support I was promised was nonexistent, and when I reached out for assistance, I was met with indifference and delay.As I struggled to get my business off the ground, I realized that the franchisor's financial projections were wildly optimistic. The costs of running the franchise were significantly higher than I had been led to believe, and the revenue projections were unrealistic. I found myself in a financial hole that I could not escape.Despite my best efforts, my franchise failed miserably.I lost my life savings, my borrowed money, and my dream of business ownership. The experience left me with a heavy burden of debt and a shattered sense of trust.The franchising industry is rife with unscrupulous operators who prey on unsuspecting individuals like myself.They make grand promises but deliver little in return. They take advantage of people's dreams and leave them with nothing but broken hearts and empty wallets.If you are considering purchasing a franchise, I urge you to proceed with extreme caution. Do your research thoroughly, talk to existing franchisees, and geteverything in writing. Don't fall for the glossy brochures and slick sales pitches. Remember, franchising is not a guaranteed path to success. It requires hard work, dedication, and a healthy dose of skepticism.中文回答：加盟血泪史。
特许权使用费支付流程
特许权使用费支付流程英文回答：Franchise Fee Payment Process.The franchise fee is a one-time payment that a franchisee makes to the franchisor in exchange for the right to operate a franchise. The franchise fee covers the costs of training, marketing, and other support services that the franchisor provides to the franchisee.The franchise fee payment process typically involves the following steps:1. The franchisee applies for a franchise and is approved by the franchisor.2. The franchisee and franchisor sign a franchise agreement.3. The franchisee pays the franchise fee to the franchisor.4. The franchisor provides the franchisee with training and other support services.5. The franchisee opens the franchise and begins operating the business.The franchise fee is a significant investment, and it is important for franchisees to understand the payment process before signing a franchise agreement. Franchisees should also be aware of the ongoing costs of operating a franchise, such as royalties, marketing fees, and insurance premiums.中文回答：特许权使用费支付流程。
网络知识产权转让流程
网络知识产权转让流程英文回答：Steps in Transferring Intellectual Property Rights.1. Identification of IP Rights: Determine the specific intellectual property rights that are being transferred, such as copyrights, patents, or trademarks.2. Valuation of IP Rights: Assess the value of the IP rights being transferred. This can be done through market research, appraisals, or expert opinions.3. Negotiation and Drafting of Agreement: Enter into negotiations with the transferee to establish the terms of the transfer, including the consideration, conditions, and any restrictions on use. A formal written agreement should be drafted to memorialize the terms of the transfer.4. Filing of Assignments or Changes of Ownership:Depending on the type of IP right being transferred, it may be necessary to file assignments or changes of ownership with relevant government agencies, such as the copyright office or patent office.5. Transfer of Copyright or Patent: In the case of copyrights or patents, the transfer of ownership is typically effected by assigning the rights to the transferee. This assignment should be recorded with the appropriate government agency.6. Transfer of Trademark: The transfer of ownership ofa trademark is typically effected by filing an assignment or change of ownership with the trademark office. The assignment should specify the specific mark or marks being transferred.7. Due Diligence: The transferee should conduct due diligence to ensure that the transferor has the authority to transfer the IP rights and that the IP rights are not subject to any encumbrances or restrictions.8. Legal and Tax Considerations: Seek legal and tax advice to ensure that the transfer is in compliance withall applicable laws and regulations and to determine any potential tax implications.中文回答：网络知识产权转让流程。
知识产权竞赛流程图方案
知识产权竞赛流程图方案Intellectual property rights competitions are important events that bring together people with a passion for innovation and creativity. These competitions provide an opportunity for individuals or teams to showcase their unique inventions, designs, or creative works and gain recognition for their efforts. The process of participating in an intellectual property rights competition can be both challenging and rewarding. Participants must go through various stages, from submitting an initial proposal to presenting their work to a panel of judges. It requires creativity, perseverance, and a deep understanding of intellectual property laws and regulations.知识产权竞赛是汇聚热爱创新和创造力的人们的重要活动。
这些比赛为个人或团队展示他们独特的发明、设计或创意作品提供了机会，并为他们的努力赢得认可。
参加知识产权竞赛的过程既具有挑战性又具有奖励性。
参与者必须经历从提交初始提案到向评委会展示自己的工作的各个阶段。
这需要创造力、毅力和对知识产权法律法规的深刻理解。
英文特许经营申请书模板
[Your Address][City, State, Zip Code][Email Address][Phone Number][Date][Recipient's Name][Recipient's Title][Company Name][Company Address][City, State, Zip Code]Subject: Application for Franchise OwnershipDear [Recipient's Name],I am writing to express my keen interest in acquiring a franchise with [Company Name], a renowned brand in the industry. With a strong passion for [industry], I believe that this opportunity aligns perfectly with my business acumen and personal values. I am excited to submit this application for the [specific franchise name] location in [specific location].Background:For the past [number] years, I have been actively involved in [industry], where I have honed my skills in [mention specific skills or experiences]. My professional journey has equipped me with a comprehensive understanding of the market dynamics, customer needs, and the challenges faced by businesses in this sector.Reason for Applying:1. Brand Recognition: [Company Name] has a well-established reputation and brand image that resonates with my vision for the [specificlocation]. I am confident that the brand’s strong market presence will attract a loyal customer base and enhance the success of the franchise.2. Support System: The comprehensive support provided by [Company Name] to its franchisees is a significant factor in my decision to apply. From initial training and marketing assistance to ongoing operational support, I believe that the support system will enable me to operate successfully and efficiently.3. Business Model: The business model of [Company Name] is well-suitedto the local market and has demonstrated a consistent track record of profitability. I am eager to leverage this model and adapt it to the unique characteristics of the [specific location] to maximize its potential.Franchise Experience:In the past, I have successfully managed [mention any relevant experience, such as a small business, retail, or restaurant management]. This experience has provided me with valuable insights into the operations of a business, including customer service, inventory management, and financial management.Financial Commitment:I understand that acquiring a franchise requires a significant financial investment. To demonstrate my commitment, I have attached the following documents:1. Personal Financial Statement: This statement provides a comprehensive overview of my financial situation, including assets, liabilities, and net worth.2. Business Plan: The attached business plan outlines my strategic approach to operating the [specific franchise name] location, including sales projections, marketing strategies, and financial forecasts.3. Franchise Application Fee Payment Receipt: I have already paid the application fee as per the requirements.I am fully prepared to invest [mention the amount] in the initial franchise fee and [mention the amount] in working capital. I am confident that this investment will yield a profitable venture and contribute to the continued growth and success of [Company Name].Conclusion:In conclusion, I am excited about the prospect of becoming a franchisee with [Company Name]. I am committed to upholding the brand’s values and standards, and I am confident that my experience, passion, and dedication will make me a valuable addition to the [Company Name] family.Thank you for considering my application. I look forward to the opportunity to discuss this exciting opportunity with you further. Please feel free to contact me at [Phone Number] or [Email Address] to schedule a meeting at your convenience.Sincerely,[Your Name]。
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The 12 Steps to Franchise OwnershipSo what exactly do you have to do to find the "right" franchise opportunity for you? Below are the 12 steps to franchise ownership that will help you to narrow down your search for your "ideal" franchise. These steps will give you an overview of the entire process and guide you through the stages of investigating a franchise opportunity.Basic planning is essential when purchasing any franchise business. The ability to track your progress as you move forward will help you make a business decision as opposed to an emotional one. The selection process can be demanding, even exhausting. You might convince yourself the franchise that is the easiest to buy or the one suggested by a franchise consultant or broker is really the best one, and make a quick decision with the real possibility of being stuck with an unsuitable or even fraudulent franchise and ultimately regretting your decision.The reality is that when done properly, the process of buying the right franchise will take anywhere from three to six months and may cost you several thousand dollars. While this may seem extreme given the sales hype myth that suggests you can be happily in business in as little as two weeks, the penalties for shortcutting the process are severe. There is a direct relationship between the effort you put into the process and the ultimate degree of success. Don't succumb to the emotional pressure to buy. Remember that while you may have to pay for good advice in time invested as well as real dollars, poor timing coupled with bad advice will ultimately cost you a lot more.The 12 Step To Franchise Ownership:1.Before contacting any franchisors, you should analyze your interests, abilities,strengths, and weak points, as well as your financial goals and limitations.You must be brutally honest with yourself!2.Take a good hard unemotional and objective look at the product or serviceyou would be selling as a franchisee. Analyze the market for the product inyour region and determine if you can find a viable location for the franchise in your local area.3.Determine which franchise programs might suit you best (based on yourinterest and self-analysis) and begin contacting the franchisors requesting for further information, such as brochures, DVD's, marketing and advertisingmaterials, and a UFOC.4.After you receive the information you have requested, its time to narrowdown your list of possibilities to no more than two or three companies, usinga preliminary evaluation of the franchisors, their products and services, andtheir franchise programs. Be careful not to "fall in love" with any onefranchise concept at this stage because you like the product or service or hada good experience with this franchise as a consumer.5.Check outside sources of information such as online publications includingfranchise blogs and forum, government agencies, consumer groups, etc.-formore background on the franchisors. Unfortunately, its often difficult to findnegative information or litigation on specific franchises.6.Its time to contact the companies you've singled out and indicate yourinterest to them. Submit the preliminary franchise applications to establishyourself as a serious prospect.7.Request detailed information on the financial and legal particulars of owningone of their franchises, if you haven't already received it. Ask for a list ofcurrently operating franchisees that you may speak with. Some franchisorswill send you a UFOC with your initial request and others will wait until theyreceive your application to see if you qualify.8.You MUST consult with your accountant and a qualified franchise attorney todetermine the feasibility of investing in the franchises in which you areinterested. Check franchisors' earnings claims (if they make any) and prepare profit projections for your potential business. Do not skip this step!9.This is one of the most important step of all: Speak with some of thecompanies' current and former franchisees regarding their experiences withthe franchisors. Learn all you can about the kinds of support the companiesprovide. Most people take the time to speak to a few franchisees - this is just not enough.10.Meet with the corporate staff of each of the companies you are considering.Ask any questions you might have, and give the company an opportunity tointerview you. Now its time to make your decision. Again, don't skip this step.You want to meet with these people face to face.11.Have your accountant and franchise attorney review the UFOC and thefranchise agreement that the franchisor has given you. Negotiate favorableterms, where possible, before you sign the contract.12.Final step before you commit: Whatever franchsise business you select, youwant to go in and work as an employee. Take two weeks or even 30 days ofyour life and get in there and roll up your sleeves and learn about the day today business of running this franchise. Then you will be really know if you like it and want to get into this business.If you follow these 12 steps, you should be able to make a wise decision regarding your investment in a franchise. You probably won't find a franchise that is a "perfect" match, nor do you need to. You want to find a close match. Though franchise fraud has become relatively rare since the 1979 passage of a federal law that requires all franchisors to disclose certain basic facts to potential franchisees, you can never be too careful. Don't rely solely on the information the company gives you, and verify financial data and earnings claims whenever you can. And remember; Franchise owners can be a most valuable source of information. Keep in mind also that in 15 states, there are laws governing franchises.Completing these 12 steps to franchise ownership will take some time. You should allow 2-3 months and it is important not to rush the process or pressure yourself because you may be out of work. Regardless of how attractive the franchise business appears, how great the products or services are, how enjoyable the customers seem, or how well you think you fit in, if the franchise opportunity will not deliver your desired results with a high degree of probability, it is the wrong franchise for you!。