Summary of THE AUDIT PROCESS--principles,practice and cases
中英文版—Woolworths质量与人权验厂程序
WOOLWORTHS LIMITED 澳大利亚沃尔沃斯有限公司Quality Management andEthical Audit Program质量管理和伦理审计程序Vendor Pack供应商材料包内容What we require from you 概述 (3)1.0 Introduction to the Ethical Sourcing Policy & Audit Program关于道德采购政策&审计程序的介绍 (4)2.0 Supplier Responsibilities供应商职责 (12)3.0 Audit Process审计过程 (13)3.1 Supplier Preparation供应商准备 (14)3.2 Audit Scheduling审查时间进度表 (16)3.3 Conducting the Audit进行审计 (17)3.4 Audit Outcome审计结果 (18)4.0 Certification Bodies认证机构 (24)5.0 Confidentiality机密 (26)6.0 Appendix附件 (27)Appendix A – Critical Non-Conformances附录A -关键的不符合项 (28)Appendix B – Pre-Audit Questionnaire附录B -事先审计问卷 (29)Appendix C – Factory Checklist附录C -工厂检查表 (30)Appendix D – Additional Contacts for Approved Certification Bodies附录D其他认证机构33What we require from you 概述Below is a checklist that outlines what we require from you within 2 weeks of receiving this supplier pack:以下是一份清单概括了收到这份供应商材料包后你需要在两个星期内做的Contact detailsShould you have any concerns regarding your specific circumstances, please contact consumergoodsquality@.au or your relevant Woolworths’ business unit buying contact for further assistance.联系细节:如果您有任何关于您具体情况的问题,请联系以下邮箱:consumergoodsquality@.au 或者联系沃尔沃斯的相关业务单位来获得进一步的帮助。
实用审计英语
Introduction to auditing(审计概述)【key words and phrases】1. Audit - the objective of an audit of financial statements is to enable the CPA to express an opinion whether the financial statements are prepared, in all material respects, in accordance with an identified financial reporting framework. 审计2. CPA - Certified Public Accountant or independent CPA, the CPA is the person with final responsibility for the audit. 注册会计师3. Attestation - CPAs are engaged to issue a written communication that expresses a conclusion about the reliability of a written assertion that is the responsibility of another party. 鉴证4. Assurance - CPAs evaluate or measure a subject matter through the application of independent professional judgment to enhance the credibility of information about subject matter and thereby to improve the likelihood that the information will meet the needs of an intended use. 可信性保证5. Audit of financial statements - the CPA's performance of the necessary audit procedures to obtain sufficient appropriate audit evidence on the entity's financial statements in accordance with the requirements of the Independent Auditing Standards, and the expression of an audit opinion on the financial statements, following the CPA's acceptance of the engagement in accordance with relevant laws an regulations. 会计报表审计6. Financial statements - the annual financial statements which need to be audited by the CPA. They include the balance sheet, the profit and loss account (or the income statement), the statement of changes in financial position(or the cash flow statement), notes to the financial statements and relevant appendices. 会计报表7. Agreed-upon procedures - an CPA is engaged to vary out those procedures of an audit nature to which the CPA and the entity and any appropriate third parties have agreed and to report on factual findings. 执行商定程序8. Compilation - in a compilation engagement, the accountant is engaged to use accounting expertise as opposed to auditing expertise to collect, classify and summarize financial information. 编制9. High levels of assurance - any assurance engagement intended to provide a high, but not absolute, level of assurance. The professional accountant has obtained sufficient appropriate evidence to conclude that the subject matter conforms in all maturate respects with identified suitable criteria. 高保证水平10. Moderate levels of assurance - the professional accountant has obtained sufficient appropriate evidence to be satisfied that the subject matter is plausible in the circumstances. 中等保证水平11. Credibility 可信性、可信程度12. Reliability 可靠性、可靠程度13. Relevance 相关、相关性Introduction to CPAs(注册会计师)【key words and phrases】1. continuing professional education(CPE)-the study and research undertaken by CPAs with a view to maintaining and improving their professional competence and the standard of their professional work, and obtaining and applying relevant new knowledge, skills, laws and regulation. 职业后续教育2. A uniform CPA examination- a uniform CPA examination administered once a year by the Chinese Institute of Certified Public Accountants for state boards of accountancy to enable them to issue CPA licenses. 统一的注册会计师考试3. Professional skepticism -an attitude that includes a questioning mind and a critical assessment of audit evidence. 职业谨慎4. Objectivity - a combination of impartiality, intellectual honesty and a freedom from conflicts of interest. 客观,客观性5. Professional competence - any CPA performing independent audit work should possess professional knowledge and experience, receive appropriate professional training and possess adequate analytical capability and judgment. 专业胜任能力6. Senior/CPA-in-charge - the senior/CPA-in-charge is an individual qualified to assume responsibility for planning and conducting an audit and drafting the audit report, subject to review and approval by the manager and partner. 项目经理Audit engagement letters(审计业务约定书)【key words and phrases】1. audit engagement letter - a written agreement or contract(usually acknowledged and accepted by the client as indicated by the client's signature)that documents and confirms the CPA's acceptance of the engagement, the objective and scope of the audit, the extent of the CPA's responsibilities to the client, and the form of any reports. 业务约定书2. recurring audit - an audit performed by a continuing CPA who also performed the prior year audit. 常年审计,连续审计3. the client - the entity or individual who engages the accounting firm and signs the audit engagement letter with the accounting firm. 委托人4. the nominated CPA 被提名审计师5. change CPA 更换审计师6. the existing CPA 现任审计师7. the successor CPA - the auditors who have accepted an engagement or who have been invited to make a proposal for an engagement to replace the CPA firm that formerly served as auditors. 后任审计师8. the preceding CPA(The predecessor CPA) - the CPA firm that formerly served as CPA but has resigned from the engagement or has been notified that its services have been terminated. 前任审计师9. audit appointment 审计委托10. the agreed term 约定条款11. accept an audit engagement 接受业务委托12. the objective of the engagement 委托目的13. the scope of the audit - the review procedures deemed necessary in the circumstances to achieve the objective of the audit. 审计范围14. issue the audit report 出具审计报告15. other CPA - the CPA of another accounting firm who is responsible for performing an audit on the accounting information of one or more components of the entity 其他注册会计师16. expert - a person or firm possessing special skill or knowledge in a field other than accounting or auditing, such as an actuary. 专家17. withdraw 撤消18. an initial audit 初次审计19. the board of directors 董事会20. a change in engagement 变更约定书21. shareholder 股东22. component - the entity's division, branch, subsidiary of associated company etc. Whose accounting information is included in the financial statements as a whole, audited by the principal CPA. 组成部分Knowledge of the entity's business【key words and phrases】1. knowledge of then entity's business - a general understanding of the economic environment and the industry within which the entity operates, and a more detailed understanding of the entity's internal condition. 了解被审计单位情况2. performing an audit of financial statements 实施财务报表审计3. assess inherent and control risks 评估固有风险和控制风险4. determine the nature, timing and extent of the audit procedures 确定审计程序的性质、时间和范围5. a general knowledge of...,a preliminary knowledge of 初步了解...的情况6. a more particular knowledge of ... 进一步了解...的情况7. prior to accepting an engagement 承接业务委托前8. following acceptance of the engagement 承接业务委托后9. update and reevaluate information gathered previously 更新并重新评价以前收集的信息10. the prior year's working papers 以前年度工作底稿11. director 董事12. senior operating personnel 高级管理人员13. internal audit personnel, internal audit's —— corporation employees who design and execute audit programs to test the effectiveness and efficiency of all aspects of internal control. The primary objective of internal audit is to evaluate improve the effectiveness and efficiency of the various operating units of an organization rather than to express an opinion as to the fairness of financial statements. 内部审计人员,内部审计师14. internal audit reports 内部审计报告15. minutes of meeting 会议纪要16. material sent to shareholders or filed with regulatory authorities 寄送给股东或报送监管部门备案的资料17. interim financial reports 中期财务报告18. management policy manual 管理政策手册19. chart of accounts 会计科目表20. exercise professional judgement 作出专业判断21. business risks (of the client) ——the risk assumed by investors or creditors that is associated with the company's survival and profitability. 经营风险22. management response thereto 管理当局的对策23. appropriateness ——the measure of the quality of audit evidence and its relevance to a particular assertion and its reliability. 适当性24. accounting estimate 会计估计25. management representations ——representations provided by management to the CPA that are related to the financial statements, either unsolicited or in response to specific inquiries. 管理当局声明26. related party ——parties are considered to be related if one party has the ability to control the other party or exercise significant influence over the other party in making financial and operating decisions. 关联方27. related party transaction ——a transfer of resources or obligations between related parties, regardless of whether a price is changed. 关联交易28. going concern assumption —— under the going concern assumption, an entity is ordinarily viewed as continuing in business for the foreseeable future with neither the intention nor the necessity of liquidation, ceasing trading or seeking protection from creditors pursuant to laws or regulations. 持续经营假设Audit planning【key words and phrases】1. audit plan ——a work plan, prepared by the CPA before performing detailed audit procedures, for completing an audit engagement of annual financial statements and achieving the expected audit objectives. 审计计划2. the overall audit plan —— the overall audit plan gives guidance on the expected scope of the audit and the way to perform the audit tests. It is a comprehensive plan of what the CPA's work basically involves throughout the whole process, from the acceptance of an audit engagement to the issuance of an audit report. 总体审计计划3. the detailed audit paln ——the detailed plan is prepared based on the overall audit plan. it sets out a detailed descriptionof the approach, nature, timing and extent of the audit procedures required in implementing the overall audit plan. 具体审计计划4. efficient audit (Audit in an effective manner) ——an effective audit that is performed at the lowest possible cost. 提高审计效率5. the size of the entity 被审计单位的规模6. the complexity of the audit 审计的复杂程度7. the specific methodology and technology 具体方法和技术8. financial performance 财务业绩9. material misstatement 重大虚假陈述10. significant audit areas 重点审计领域11. accounting estimate 会计估计12. coordination 协调13. review 复核14. statutory responsibility 法定责任15. time budget ——an estimate of the time required to perform each step in the audit 时间预算Error and Fraud【key words and phrases】1. error ——error refers to an unintentional misstatements or omissions in financial statements. 错误2. fraud ——fraud refers to intentional act which results in a misrepresentation of financial statement. 舞弊3. modified or additional procedures 修改或追加审计程序4. plan and perform audit procedure 计划和实施审计程序5. adequate accounting and internal control system 适当的会计和内部控制系统6. reduce but not eliminate 减少但不能消除7. manipulation 篡改8. falsification 伪造9. alteration of records or documents 更改记录和凭证10. misapproporation of assets 侵占资产11. transaction without substance 虚假交易12. misapplication of accounting policies 滥用(误用)会计政策13. the underlying records 原始凭证14. oversight or misinterpretation 疏忽或误解15. unusual pressures 异常压力16. accounting policy alternative 会计政策变更17. unusual transactions 异常交易18. incomplete files 不完整的档案19. out of balance control accounts 账户余额不平衡20. lack of proper authorization 缺乏适当的授权21. computer information systems environment 计算机信息系统环境22. inherent limitations of audit test 审计测试的固有限制23. discuss with management 与管理当局讨论24. the remedial action 纠正措施25. seek legal advice 寻求法律咨询Noncompliance with laws and regulations【key words and phrases】1. laws and regulations —— state laws, administrative regulations, departmental rulesand local laws and regulations other than the Accounting Standards for Business Enterprises and other relevant financial and accounting laws and regulations promulgated by the State. 法律与规章2. noncompliance ——noncompliance refers to acts of omission or commissionby the entity being audited, either intentional or unintentional, which are contrary to the prevailing laws or regulations. Such acts, include transtractions entered into by, or in the name of, the entity or on its behalf by its management or employees. 违反,不遵守3. withdrawal from the engagement 报销审计约定4. board of directors 董事会5. senior management 高级管理层6. detect noncompliance laws and regulations 发现违反法律和规章的行为7. deliberate failure to record transactions 故意漏记交易8. senior management override of control 高级管理层逾越控制9. intentional misrepresentations being made to the CPA 故意对注册会计师作出错误的陈述10. written representation 管理当局声明11. the suspected noncompliance 涉嫌存在违法行为12. audit committee ——a committee of a corporation's board of that engages independent auditors, reviews audit findings monitors activities of the internal staff, and intervenes in any disputes between management and the independent auditors. Preferably, members of the audit committee are directors, that is, members of the board of directors who do not also serve as corporate officers. 审计委员会13. supervisory board 监事会14. regulatory and enforcement authorities 监管和执法部门Audit materiality【key words and phrases】1. materiality ——the seriousness of misstatements or omissions in the entity's financial statements. The degree of the seriousness may affect the judgement or decisions made by users of financial statements in certain specific circumstances. 重要性2. exceed the materiality level 超过重要性水平3. approach the materiality level 接近重要性水平4. an acceptably low level 可接受水平5. the overall financial statement level and in related account balances and transaction levels 会计报表层面和相关账户、交易层面6. misstatement or omissions 错报或漏报7. the detected but uncorrected misstatements or omissions 已发现但尚未调整的错报或漏报8. the detected and the projected misstatements or omissions 已发现的和推断的错报或漏报9. aggregate 总计、合计10. subsequent events —— both events occurring between the balance sheet date andthe date of the audit report and events occurring between the date of the audit report and the date the financial statements are issued, which have an impact on the financial statements. 期后事项11. contingencies 或有事项12. extend the scope of the substantive test 扩大实质性测试范围13. adjust the financial statements 调整会计报表14. perform additional audit procedures 实施追加的审计程序15. carry out extended or additional tests of control 实施扩大或追加的控制测试16. modify the nature, timing and extent of planned substantive procedures. 修改计划的实质性测试程序的性质、时间和范围Audit risk【key words and phrases】1. audit risk ——the risk that the CPA gives an inappropriate audit opinion when the fianncial statements are materially misstated. Audit risk has three components: inherent risk, control risk and detection risk 审计风险2. inherent risk —— the susceptibility of an account balance or class of transactions to misstatement that could be material, individually or when aggregated with misstatements in other balances or classes, assuming that there were no related internal controls. 固有风险3. control risk ——the risk that a misstatement, that could occur in an account balance or class of transactions and that could be material individually or when aggregated with misstatements in other balances or classes, will not be prevented or detected and corrected on a timely basis by the accounting and internal control systems. 控制风险4. detection risk —— the risk that an CPA's substantive procedures will not detect a misstatement that exists in an account balance or class of transactions that could be material, individually or when aggregated with misstatements in other balances or classes. 检查风险5. an acceptably low level 可接受的低水平6. inappropriate audit opinion 不适当的审计意见7. material misstatement 重大的错报8. analytical procedures risk 分析性测试风险9. substantive tests of the detail risk 实质性测试风险10. tolerable misstatement 可容忍误差11. the combined level of inherent and control risks 固有风险和控制风险的综合水平12. the acceptable level of detection risk 可接受的检查风险13. planned assessed level of control risk ——the level of control risk auditor uses in developing a preliminary audit strategy which includes an appropriate combination of tests of controls and substantive tests. 控制风险的评估水平14. small business ——a business that has a low level of turnover or of total assets, few employees and limited segregation of duties. 小规模企业Internal control【key words and phrases】1. accounting system ——the series of tasks and records of an entity by which transactions are processed as a means of maintaining financial records. Such systems identify, assemble, analyze, calculate, classify, record, summarize and report transactions and other events.2. internal control system ——all the policies and procedures (internal controls) adopted by the management of an entity to assist in achieving management's objective of ensuring, as far as practicable, the orderly and efficient conduct of its business, including adherence to management policies, the safeguarding of assets, the prevention and detection of fraud and error, the accuracy and completeness of the accounting records, and the timely preparation of reliable financial information.3. control environment —— the overall attitude, awareness and actions of directors and management regarding the internal control system and its importance in the entity.4. control procedures ——those policies and procedures in addition to control environment which management has established to achieve the entity's specific objectives.5. compliance test6. test of control ——tests directed toward the design or operation of a control to assess its effectiveness in preventing or detecting material misstatements of financial statement assertions.7. walk-through test ——a test of the accuracy and completeness of the CPAs' working paper description of internal control. A walk-through is performed by tracing several transactions through each step of the related transaction cycle, noting whether the sequence of procedures actually performed corresponds to that described in the audit working papers.8. management letter —— a report to management containing the written recommendations made by the CPA with respect to material internal control weaknesses identified during the audit, which may result in material misstatements or omissions in the entity's financial statements9. material weakness in internal control —— a reportable condition in which the risk that material errors or irregularities might occur and not be detected.10. risk assessment —— the identification, analysis, and management of risk relevant to the preparation of financial statements that are fairly presented.11. control activities —— the policies and procedures that help ensure that necessary actions are taken to address the risks involve in the achievement of the entity's objectives.12. information —— the information system relevant to financial reporting objectives, which includes the accounting system, consists of methods and records established to record, process, summarize, and report an entity's transactions and to maintain accountability for the related assets and liabilities.13. communication ——communication involves providing an understanding of individual roles and responsibilities pertaining to internal control over financialreporting.14. monitoring ——monitoring is a process that assesses the quality of internal control over time.15. procedures manual16. job descriptions17. flow chart —— a graphic representation of the major steps and logic of a system or a series of procedures.18. written narrative ——memoranda that describe the flow of transaction cycles, identifying the employees performing various tasks, documents prepared, records maintained, and the division of duties. Written narratives are more flexible than questionnaires, but by themselves are practical only for describing relatively small, simply systems.19. questionnaire —— questionnaires are usually designed to describe internal control in audit working papers so that "no" answers prominently identify weaknesses in internal control.20. reperformance of internal control21. computer-assisted audit techniques22. communication with management —— a CPA's enquiring or informing the entity's management of matters relevant to the audit of financial statements or discussing such matters with the entity's management.Audit evidence【key words and phrases】1. audit evidence ——the information obtained by the CPA in arriving at the conclusions on which the audit opinions is based. 审计证据21. enquiry —— enquiry consists of the CPA questioning the relevant staff in written form of orally. 询问22. confirmation ——confirmation consists of the CPA's written correspondence with third parties to corroborate information contained in the entity's accounting records. 函证23. computation ——computation consists of the CPA checking the arithmetical accuracy of the data in the entity’s source documents and accounting records, or of the CPA performing independent calculations. 计算24. analytical procedures ——analytical procedures consist of the CPA analyzing material ratios or trends, including the investigation of unusual fluctuations and their differences from the expected amounts and relevant information. 分析性程序25. vouch ——to verify the accuracy and authenticity of entries in the accounting records by examining the original source documents supporting the entries. 核对26. aged trial balance —— a listing of individual customers’accounts classified by the number of days subsequent to billing, that is, age, serves as a preliminary step in estimating the collectibles of accounts receivable. 账龄分析表27. trace —— the direction of testing is from selecting an accounting transaction( a source document) to the journal or ledger. 追查Audit sampling【key words and phrases】1.audit sampling —— the CPA’s performance of tests on certain number of sampleitems selected from the population when the CPA performs the audit procedures.The CPA then projects the characteristics of the population based on the results of the tests. 审计抽样2.error ——either control deviations, when performing tests of control, ormisstatements, when performing substantive procedures. Similarly, total error is used to mean either the rate of deviation or total misstatement. 误差3.anomalous error ——an error that arises from an isolated event that has notrecurred other than on specifically identifiable occasions and is therefore not representative of errors in the population. 偶发性误差4.expected error —— the error that the CPA expects to present in the population.预期误差5.population —— the entire set of data from which a sample is selected and aboutwhich the CPA wishes to draw conclusions. For example, all of the items in an account balance or a class of transactions constitute a population. A population may be divided into strata, or sub-populations, with each stratum being examined separately. The term population is used to include the term stratum. 总体6.sampling risk —— arises from the possibility that the CPA’s conclusion, based ona sample may be different from the conclusion reached if the entire populationwere subjected to the same audit procedures. 抽样风险7.non-sampling risk ——arises from factors that cause the CPA to reach anerroneous conclusion for any reason not related to the size of the sample. For example, most audit evidence is persuasive rather than conclusive, the CPA might use inappropriate procedures, or the CPA might misinterpret evidence and fail to recognize an error. 非抽样风险8.sampling unit ——the individual items constituting a population, for examplechecks listed on deposit slips, credit entries on bank statements, sales invoices or debtor s’ balances, or a monetary unit. 抽样单位9.statistical sampling ——any approach to sampling that has the followingcharacteristics: (1)random selection of a sample; and (2)use of probability theory to evaluate sample results, including measurement of sampling risk. 统计抽样A sampling approach that does not have characteristics (1) and (2) isconsidered non-statistical sampling. (非统计抽样)10.stratification —— the process of dividing a population into subpopulations, eachof which is a group of sampling units which have similar characteristics (often monetary) 分层11.tolerable error —— the maximum error in population that the CPA is willing toaccept. 可容忍误差12.the risk of under reliance ——because of the sample result, the CPA does notadequately rely on the internal controls which could actually be relied upon. 信赖不足风险13.the risk of over reliance —— because of the sample result, the reliance the CPAplaces on the internal controls exceeds the reliance exceeds the reliance that should actually be placed on them. 信赖过度风险14.the risk of incorrect rejection ——although the sample result supports theconclusion that an account balance is materially misstated, in fact it is not materially misstated. 误拒风险15.the risk of incorrect acceptance ——although the sample result supports theconclusion that an account balance is not materially misstated, in fact it is materially misstated. 误受风险16.the rate of deviation 偏离程度17.sample size 样本量18.required confidence level 可信赖水平19.the number of sampling units in the population 总体中样本单位的数量20.methods used 所选用的方法21.effective audit —— an audit that achieves the planned degree of effectiveness indetecting any material misstatement in the client’s financial statements. 审计效果22.efficient audit —— an effective audit that is performed at the lowest possible cost.审计效率Audit working papers【key words and phrases】1.audit working papers (documentation) ——the audit working records andmaterials prepared, or obtained, by CPA in connection with the performance of the audit. 审计工作底稿2.working trial balance ——the working trial balance links the amounts in thefinancial statements to the audit working papers. It contains columns for working paper references, the prior year’s balance, the unadjusted current-year balances, and columns for adjusting and reclassification entries. 试算平衡表3.adjusting and reclassification entries ——adjusting entries are made to correcterrors in the client’s records. Reclassification entries are made to provide proper presentation of information on the financial statements. Adjusting entries are posted in both the client’s records and the working trial balance. Reclassification entries are not posted to the client’s records. 调整和重分类分录4.audit mark —— CPAs use audit marks as a way of documenting work performed.Audit mark is typically explained or defined at the bottom of the working paper, although many firms use a standard set of audit marks. 审计标识5.indexing and cross-referencing ——this process of indexing andcross-referencing provides a trail from the financial statements to the individual working papers that a reviewer can easily follow. 索引和交叉索引6.permanent audit files —— those audit files which contain information that is notfrequently changed and is referred to cover a long period of time. They also contain information of continuing relevance to, or with a direct impact on, succeeding audits. 永久性档案7.current audit files ——those audit files, the contents of which vary frequently.They are primarily used for the audit of the current period and for reference in thenext subsequent period. 当期档案prehensive working papers —— audit working papers prepared by the CPAduring the audit planning and reporting states. They are used for planning, controlling and concluding the audit engagement as a whole and for documenting the audit opinion. 综合类工作底稿9.audit-oriented working papers ——audit working papers prepared by the CPAregarding his performance of specific audit procedures during the audit implementation stage. 业务性工作底稿10.reference working papers —— the audit working papers used merely for referencewhich are prepared by the CPA in the course of the audit. 备查类工作底稿11.the use of standardized working papers 使用标准的工作底稿12.checklists 核对用清单Audit reporting【key words and phrases】1.audit report —— the written document which expresses the CPA’s audit opinionon the entity’s annual financial statements, following the performance of the necessary audit procedures in accordance with the requirements of the Independent Auditing Standards. 审计报告2.the truthfulness of the audit report ——the requirement that the audit reportshould objectively reflect the CPA’s scope and basis of the audit, the audit procedures performed and the audit opinion that should be expressed. 审计报告的真实性3.the legitimacy of the audit report ——the requirement that the preparation andissuance of the audit report should be in accordance with the requirements of both the Law of PRC on CPA and the Independent Auditing Standards. 审计报告的合法性4.entity —— an enterprise, or an institution managed on a commercial basis, whichis responsible for the preparation and submission of financial statements and audited by the CPA. 被审计单位,客户5.addressee of the audit report ——the client of the audit engagement. The fullname of the addressee should be stated in the audit report. 审计报告的收件人6.unqualified opinion ——an unqualified opinion should be expressed when theCPA concludes that。
供应商质量管理工程师岗位职责范本
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四大会计师事务所之一尽职调查所需资料清单-中英文对照_最新修正版
Target – Project [ ]Information Request List (“IRL”) – Accounting and TaxAs of [ , ]审阅对象—项目会计及税务资料清单截止年月日The following is IRL for conducting a review of financial, certain operational and tax information of ________(the “Group”; references to “Company” or “Target” refer to any of the subsidiaries or legal entities of the Group). The “historical period” referred to herein is defined as the years ended___________, ______, and ______ (“Fiscal______, _______and ______”) and the ____ months ended _________, ______and ______ (“Interim _____ and ______”). Thus, the historical period has ____ separate periods within it. Please note that this IRL has three sections: I. Financial and Accounting; II. Tax; and III. Discussion Items.以下为对__________(以下简称“贵集团”;倘提及“贵公司”或“审阅对象”乃指贵集团之任何子公司或法定实体)进行的财务、经营及税务各方面的审阅,所需由贵公司准备的资料清单。
英文版管理当局声明书
SPECIMEN MANAGEMENT LETTER PARAGRAPHSThe management letter should normally be addressed to the most senior member of those charged with governance, as identified on A/10.Dear AddresseeManagement and governance report for the [year/period] ended [date]The purpose of this letter is to provide the [directors] with constructive observations arising from the audit process. We set out below details of any expected modifications to our audit report, details of any unadjusted misstatements in the financial statements (except any misstatements that are clearly trivial), any material weaknesses in systems we have identified during the course of our audit work and our vies about the quality of accounting practices and financial reporting procedures, and any other relevant matters.Our procedures are carried out solely for the purpose of our audit of the financial statements. Our audit does not necessarily disclose every weakness and for this reason the matters referred to below may not be the only shortcomings which may exist.We take this opportunity to remind you that:•This report has been prepared for the sole use of [firm name] and [entity name] [and its parent undertaking] [and its auditors];•It must not be disclosed to any third party without our written consent;•No responsibility is assumed by us to any other person who may chose to rely on it for his or her own purpose.Expected modifications to our reportWe do not expect to make any modifications to our audit report. However, our responsibilities with regard to the audit report extend up to the date on which it is signed and we will advise you of any changes to this position if necessary.orWe have discussed with you the potential modification of our audit report to reflect that [specify details - for instance application of the going basis for preparation of the financial statements when there are substantial doubts as to the suitability of that basis eg following wording adjusted for the particular circumstances:The applicable financial reporting framework presumes that the financial statements will be prepared on a going concern basis. However the entity has an excess of liabilities over assets at the balance sheet date [or excess of current liabilities over current assets after taking account of reclassifications when breaches of banking covenants are not remedied by the balance sheet date]. This is caused by [specify circumstances]. You continue trading because you informed us that your plans are adequate to ensure that the entity returns to profitability. In the meantime, you rely on the continuing support of your bankers. We have, as a part of our audit procedures, evaluated your assessment of the entity’s ability to continue as a going concern. We have considered the adequacy of your disclosures in the financial statements in this regard. Whilst the disclosures appear adequate in all the circumstances of the entity, we are nevertheless obliged to refer to the matter in our audit report in view of the significance of the matter to the appreciation of the financial position disclosed by the financial statements. We attach a draft for your consideration.orOther appropriate wordingUnadjusted misstatements detected by usWe have not identified misstatements or omissions from the financial statements which have not been adjusted by you.orWe have discussed with you the misstatements we identified in the financial statements but which you have declined to adjust. We attach the schedule of potential adjustments that we discussed which records the misstatements and/or omissions and the reasons you gave us for not making the adjustment. The schedule does not include matters we believe to be clearly trivial. We have asked you separately to confirm in writing the reasons you have given us for not making the adjustments to the financial statements.Qualitative aspects of accounting practices and financial reportingDuring the course of our audit, we consider the qualitative aspect of the financial reporting process, including items that have a significant impact on the relevance, reliability, comparability, understandability and significance of the information provided by the financial statements. We have discussed with you the following observations (expand as appropriate):•The appropriateness of the accounting policies to the particular circumstances of the entity;•The timing of transactions and the period in which they are recorded;•The appropriateness of accounting estimates and judgements, [for example, in relation to provisions],including the consistency of assumptions and degree of prudence reflected in the accounting records;•The potential effect on the financial statements of any uncertainties, including significant risks, and disclosures, such as pending litigation, that are required to be disclosed in the financial statements; •Material uncertainties related to events and conditions that may cast significant doubt on the entity’s ability to continue as a going concern;•The extent to which the financial statements are affected by any unusual transactions during the period and the extent to which such transactions are separately disclosed in the financial statements;•Apparent misstatements in [other information to accompany audited financial statements] or material inconsistencies between this information and the audited financial statements;•Disagreements about matters that, individually or in aggregate, could be significant to the entity’s financial statements or the auditor’s report. These communications include consideration of whether the matters have or have not been resolved and the significance of the matters.Accounting system and internal controlsDuring the course of our audit of the financial statements for the year/period ended [date] we examined the principal internal controls which the [directors] have established to enable them to ensure, as far as possible, the accuracy and reliability of the entity’s accounting records and to safeguard the entity’s assets.We have discussed these matters and we are writing formally in order to draw your attention to weakness in control which came to our notice during this examination and to suggest ways in which the system could be improved. The attached schedule provides details of our observations and recommendations. Please provide your response to each matter on the attached schedule, which should then be returned to us.Concluding remarksFinally, we take this opportunity of thanking your staff for the assistance offered to us during the course of our audit work. Their patient help and assistance was much appreciated and we trust that their co-operation has enabled us to keep your costs down.We shall be pleased to supply you with any further information that you may require.We shall be glad if you will inform us in due course the steps that you decide to take in connection with each of the above matters. If would also be of assistance if you would inform us when any changes are made in the existing systems and controls, together with details of such changes.Yours faithfullyAppropriate firm signatory。
Audit 笔记整理
External audit- Def.: External audits provide assurance to shareholders that the financial statement are prepared, in all material respects, in accordance with IFRS and laws/ regulations.(Express an opinion whether F/S is true&fair)- Source: Separation of ownership and management-Appoint independent Measure performance AuditorAddsF/S credibilityShareholdersAppointManagementOwnCompany- Agent theory:Management acts as the agent. Shareholder is the principle.Management are accountable for their stewardship of the company.Auditor acts on behalf of interest of shareholder. Auditor is agent.ManageShareholder is principle.True and Fair- FS is prepared in accordance with IFRS- FS is prepared in accordance with laws and regulationsMateriality- Def.: Information is materiality if its omission or misstatement could influence the economic decisions of users taken on the basis of the financial statements.- Factor: Both the amount(quantity)and nature(quality)need to be considered.- ML: The auditor has to set his own materiality levels.The higher the anticipated risk, the lower the value of materiality will be.Calculation: 5- 10% profit before taxe.g.Reasonable assurance- No auditor can give 100%assurance. The highest level of assurance given, as in the case of statutory audit, is described as‘reasonable assurance’.- ‘Reasonable assurance’is not absolute assurance because there are inherent limitations of an audit which result in the auditor forming an opinion on evidence that is persuasive rather than conclusive.- Limitations of the audit and materiality: The assurance given by auditors is governed by the fact that auditors use judgment in deciding what audit procedures to use and what conclusions to draw, and also by the limitations of every audit.- Levels of assurance:Appointment,removal and resignation of auditors- Appointment: by shareholders ordinary resolution- Removal: by shareholders;Auditors entitle to: notice/ make written representation/ speak at shareholders’meeting - Resignation: at any time and right to speak- Advantages and disadvantages of ACAdvantagesCorporate Governance- Def.: system relationship ( shareholders & stakeholders) BS - Principles:BODChairmanCEORisk management CommitteeInternal Audit DepartmentNEDThere should be an effective body of directors.CEO & chairman should be different persons. CEO run the business and chairman run the BOD There should be a nomination committee to be responsible for appointment, remove, re-elect directors. There should be a remuneration committee to be responsible for remuneration package of directors. AC (见下)There should be a risk management committee to be responsible for controlling the risk of the entity. There should be included at least 50% NEDs in BOD. Remuneration CommitteeNomination CommitteeAudit CommitteeED-Responsibility of AC(role of AC)External auditor:令 To recommend appointment,reappointment and removal external auditor令 To approve remuneration and engagement terms of external auditor令 To implement policy on supply of non-audit services by external auditor令 To review and monitor independence and objectivity of external auditorInternal auditor:令 Where there is no internal audit function, to consider annually whether there is need for one 令 To recommend appointment of the head of internal audit department令 To monitor and review effectiveness of internal audit departmentOthers:令 To monitor financial statement令 To review i nternal controls and risk management systems令 To monitor arrangements safeguarding the privacy of whistle blowers- Advantages and disadvantages of ACAdvantages令 It will lead to increased confidence in the credibility and objectivity of financial reports.令 By specializing in the problems of financial reporting and thus, to some extent, fulfilling the directors’responsibility in this area, it will allow the executive directors to devote their attention to management.令 In cases where the interests of the company, the executive directors and the employees conflict, the audit committee might provide an impartial body for the auditors to consult. (公平的机构)令 The internal auditors will be able to report to the audit committee.(role)令 The external auditors have an independent point of reference. (role).Disadvantage令 There may be difficulty selecting sufficient NEDs with the necessary competence in auditing matters for the committee to be really effective.令 The establishment of such a formalized reporting procedure may dissuade the auditors from raising matters of judgment and limit them to report only on matters of fact.令Costs may be increased.- When considering the need for an internal audit function,the board should consider:.Any trends or current factors relevant to the company’s activities, markets or other aspects of its external environment that have increased risks..Internal factors such as organizational restructuring or changes in reporting processes or underlying information systems .Adverse trends evident from the monitoring of internal control systems..Increased incidence of unexpected occurrences.-The relationship(AC&IA).AC令 Monitor and review effectiveness of IA令 Approve appointment/ termination of appointment of Head of IA令 Review and assess annual IA work plan.IA令 Regular report on results of IA work-Limitation of AC function令 Direct access to Board chairman and AC令 Accountable to AC-Scope(IA role).Value for money audits.Information technology audits.Financial audits.Operational audits.Procurement audits-VFM audits tend to focus on three‘Es’.Economy: Buying the resources needed at the cheapest cost.Efficiency: Using the resources purchased as wisely as possible.Effectiveness: Doing the right things and meeting the organization’s objectives -Limitation of AC functionIf the internal audit function to be effective, then both they and their work need to possess certain qualities.These qualities include independence, objectivity and due skill and care.-Outsourcing internal auditAdvantages: cost low, independence, competence, expertiseDisadvantages: confidential, industry knowledge- The role of external and internal auditExternal audits provide assurance to shareholders that the financial statement are prepared, in all material respects, in accordance with IFRS and laws/ regulations.When undertaking an external audit, the auditor is carrying out a statutory duty to report as to whether the financial statements ‘present fairly’the activities of the busines s.The external audit will be conducted in accordance with the International Standards on Auditing and local law/ legislation.The purpose of the internal audit function however is to assist the Board in achieving their corporate objectivities.-Responsibilities for fraud and errorExternal auditors令 No responsibility for prevention令 Responsibility to consider the risk of material misstatement in the financial statements due to fraud and error令 Provide reasonable assurance that financial statements are free from material misstatement令 Responsibility to detect fraud and error which has a material impact on the financial statements Internal auditors令Directors responsible for prevention and detection令 Internal audit can assist directors with the prevention of fraud and error by assessing the effectiveness of internal control systems令 Existence of IA department may act as deterrent(警示作用)令 Can contribute to detection by reporting suspicions令 May be called on to investigate suspected fraud-Use of the internal auditors(others)’work by the external auditorScope of workOrganizational statusDue skill and careIndependenceTechnical competence-Matters the auditors would communicate to those charged with governanceThe auditor’s responsibilities to form and express an opinion on the FSThe fact that it is the responsibility of those charged with governance to prepare the FSAn overview of the planned scope and timing of the auditFor listed entities:令 A statement confirming their independence令 Any relationships that may impact their independence令 Safeguards that have been implemented to eliminate/ reduce threats to independence to an acceptable levelSignificant findings from the audit:令 Views on accounting policies/ estimates and FS disclosures令 Significant difficulties encountered during the audit令 Significant deficiencies in the design, implementation or effectiveness of IC令 Written representations requested by the auditor令 Other matters which are significant to the oversight of the financial reporting processProfessional ethics- The fundamental principles (independence)1. Integrity:Professional accountants should be straightforward and honest in all professional and business relationships.Integrity also implies fair dealing and truthfulness.2. Objectivity: Professional accountants should not allow bias, conflicts of interest or the undue influence of others tooverride their professional or business judgment.3. Professional competence and due care: Professional accountants should maintain professional knowledge and skill atthe level required to ensure that clients or employers receive competent professional service. They should also act diligently in accordance with applicable technical and professional standards when providing professional services.4. Confidentiality: Professional accountants must respect the confidentiality of information acquired as a result ofprofessional and business relationships. They should not disclose any such information to third parties without proper and specific authority or unless there is a legal or professional right or duty to disclose. Confidential information acquired as a result of professional and business relationships should not be used for the personal advantage of the professional accountant or third parties.Obligatory disclosure:Where required by law (terrorism, treason)By process of law (count order)Reporting to regulatorsVoluntary disclosure:In the public interestTo protect a member’s interests (to defend against legal action or to sue for fee s)Authorized by statuteTo non-governmental bodies5. Professional behavior: Professional accountants should ensure they comply with relevant laws and regulations andshould avoid any action that discredits the profession.- The engagement letter1. The objective and scope of the audit2. The auditor’s responsibility3. Management’s responsibility4. Identification of the applicable financial reporting framework for the preparation of the FS5. The fee- Threats to the fundamental principles (independence)1. Self-interest threat: Relates to the risk that a financial or other interest in a client will inappropriately influence theprofessional accountant’s judgment or behavior. ( owning shares in an audit client / receiving gifts from an audit client)2. Self-review threat:This arises where a professional accountant from the audit firm performs work for the client and thiswork must later be reviewed by the same person or another professional accountant from the same firm in order to arrive at a judgment on the subject matter. (preparing the F/S of an entity which are to be audited by your firm)3. Advocacy threat:Relates to the risk that a professional accountant promotes a client’s position to the point that theprofessional accountant’s objectivity is compromised. (acting as an advocate on behalf of an assurance client in litigation or disputes or promoting shares in a listed audit client)4. Familiarity threat:This arises where, due to a long or close relationship with a client, the professional accountantcould be too sympathetic to their interests or too accepting of their work. (if a firm has audited the same client for several years they may not question the information presented by the client as closely as in the initial years)5. Intimidation threat:Relates to the risk that the professional accountant is deterred from acting objectively because ofactual or perceived pressures, including attempts to exercise undue influence over the professional accountant. (being pressured to reduce inappropriately the extent of work performed in order to reduce the fees charged)- Threats and safeguards1. Financial interests (holding shares in a client by the firm/ a member of the assurance team/ an immediate family memberof a team member)ThreatsSelf interest threat arises as the firm or individual team member would benefit personally if the client’s financialstatements exceed market expectations.SafeguardsDisposal of shares (only option if firm holds shares)Remove individual from teamInform audit committeeIndependent partner review2. Loans and guarantees令 Clients that are banksThreatsLoans and guarantees to the firm- No threats if immaterial and on normal terms-If material,apply safeguardsLoans to members of the assurance team- Not a treat to independence if on normal commercial termsSafeguardsReview by professional accountant from outside the firm令 Clients that are not banksThreatsLoans or guarantees to/ from the firm or members of the assurance teamSafeguardsNo safeguard can reduce the threat unless the loan in immaterial to client and firm/ team member.3. Fees and pricing令 Large portionThreatsSelf interest threat arises when total fees from a client represent a large portion of the firm’s total fees. The firm may issue a favorable opinion rather than risk losing such a significant income stream.SafeguardsDiscuss with audit committeeResign from some servicesExternal quality control reviewConsult ACCA or another professional accountant on any key audit areas requiring judgmentIf the audit client is a public interest entity then there are additional ethical requirements. If the total fees from the client represent more than 15%of the total fees received by the firm for 2consecutive years then there is likely to be undue dependence on the client and the firm should put safeguards in place.令 Overdue feesThreats.These could give rise to intimidation and self interest threats. The client could use outstanding fees to pressure the firm into providing a favorable opinion. The firm may issue a favorable opinion rather than possibly losethe amounts owed.Safeguards.Discuss with audit committee.Consider resignation if overdue fees not paid令 Contingent feesThreats.The fee is dependent on the result of the work performed. This would create a self interest and advocacy threat.Safeguards.No safeguards acceptable – contingent fees are not allowed for audit services.令 LowballingThreats.An assurance engagement is won by offering a fee below the market rate. This gives rise to a self interest threat as the firm may either take shortcuts to make a reasonable recovery on the engagement or need to perform theengagement for a number of years before achieving a reasonable profit.Safeguards.Appropriate time and quality staff assigned to engagement..All applicable standards are complied with.4. Gifts and hospitabilityThreats.Acceptance of gifts from a client may create a self interest threat because the firm/ individual may feel obliged to give a favorable opinion. Acceptance of gifts may also be perceived as a bribe..Hospitality from clients may give rise to a familiarity threat.Safeguards. Gifts and hospitality should not be accepted unless the value is not material.5. Business relationship (holding an interest in a joint venture with a client/ distribution of a client’s products)Threats.Self interest threat arises as the firm would benefit from the favorable performance of the joint venture or client’s products.Safeguards.Disposal of interests unless clearly insignificant6. Personal relationshipThreats.Family or close personal relationships between assurance team members and client staff give rise to self interest, familiarity or intimidation threats.SafeguardsRemove individual from teamDiscuss with audit committeeIndependent partner review7. Employment ( member of an assurance team or partner becomes a director or employee of a client in a position to exertinfluence on the financial statements or vice versa.)令Firm to clientThreatsPrevious employment by the firm of a director or employee of a client creates self interest,familiarity and intimidation threat.SafeguardsConsider modification of an audit plan.Change members of an audit team.Independent partner review.Quality control review.For public interest entities, an audit partner should not accept a managerial position with their audit client unless > 12months have passed.令Client to firmThreatsFormer director or employee of client has joined assurance firmSafeguardsIndividual should not be assigned to audit team if the work they performed whilst employed by the client is to be evaluated in the current period as part of the current audit engagement.8. Long associationThreatsUsing the same senior staff on an engagement may create a familiarity threat and the audit may issue a favorable opinion.SafeguardsIndependent partner reviewIndependent quality control reviewRotate senior staffFor public interest entities:Key audit partner: rotate after 7yrs and do not return for 2yrs9. Actual and threatened litigationThreatsWhen litigation takes place or appears likely between the firm or member of the assurance team and the assurance client,a self interest or intimidation threat may be created.SafeguardsDisclose to the audit committeeRemoval of individual involved in litigation from the assurance teamRefuse to perform the assurance engagement10. Preparing accounting records and financial statementsThreatsSelf review threat arises if accounting assistance includes making management decisions because it is unlikely that the firm will criticize its own work and decisions.Safeguards令If the client is not a public interest entity:Accounting services should not be performed by audit team staffClient must provide all source dataClient must approve all journal entriesDiscuss non-audit services with audit committee令If the client is a public interest entity:No accounting services should be provided unless in an emergency11. Tax services (compliance, planning, assistance in resolving tax issues)ThreatsSelf review threat arises if tax computation is prepared by firm as it is unlikely to be criticized by audit staff.SafeguardsTax computation must not be prepared by audit team staffIndependent partner review to ensure tax computation is audited rigorously.12. Internal audit services令Do internal auditThreatsSelf review threat arises if audit team plan to rely on the work of the internal audit department.SafeguardsRemind client(in engagement letter) that it is their responsibility to establish, maintain and monitor a system of internal controls.Internal audit services should not be provided by audit team members.Independent partner review to ensure appropriate reliance is placed on internal audit and that its work is rigorously audited.令Make decisionThreatsA managerial threat may arise if the firm makes decisions on behalf of the client when provided the internal auditservice.SafeguardsClient is reminded that it must evaluate and determine which recommendations of the firm should be implemented.Risk assessment- Professional skepticism:Critical assessment, with a questioning mind, of the validity of evidence obtainedLateness to contradictory evidence- Risk-based approach to auditAnalyze the risk in the client’s business, transactions and systems that could lead to material misstatementDirect their testing to risky area- Audit risk- Inherent risk- Control risk- Detection risk- Business risk: result from significant conditions, events, circumstances, action or inactions that could adversely affect the entity’s ability to achieve its objectives and execute its strategies, or from the setting of inappropriate objectives and strategies.-Understanding the entity and its environmentISA315 identifying and assessing the ROMM through understanding the entity and its environment including internal controls.Perform RAP to understand the entity and its environment.Assess the ROMM at the financial statement and assertion level.-RAP-Importance of assessing risk / the need for planningHelp the auditor to fully understand the entity, which is vital for an effective audit.Focus early on the areas most likely to cause material misstatements.Any unusual transactions or balances would also be identified early, so that these could be addressed in a timely manner.Ensure that the most appropriate team is selected with more experienced staff allocated to higher risk audits and high risk balance.AssertionInventory1 、Completeness: All inventories that should have been recorded have been recorded.2 、Existence: All inventories recorded are genuine.3 、Valuation: All inventories are included at appropriate amount.4 、Right: The entity holds and controls the rights to inventories.5 、Classification: All inventories are held for sale.Sale1 、Completeness: All sales that should have been recorded have been recorded.2 、Occurrence: All sales that have been recorded have occurred.3 、Accuracy: Amounts and other data relating to recorded sales have been recorded appropriate.4 、Cut-off: Sales have been recorded in the correct accounting period.5 、Classification: All inventories are held for sale.*cut-off: around year 特殊时段的completeness & occurrence1 、y/e 容易出现调节销售和利润的情况2 、audit procedures:a. Select a sample of GDN/invoice (in the current year) and trace them to sale ledger.b. Select a sample of GDN/invoice around the y/e and trace them to sale ledger.MAP 中相关的知识点Audit risk is the risk that the auditor express an inappropriate audit opinion when the financial statements are materially misstated. Audit risk is made up of two components - the risks of material misstatement and detection risk.Risk of material misstatement is the risk that the financial statements are materially misstated prior to audit. This consists of two components- inherent risk and control risk.Reasonable assurance: 对于 500 万以上的重大错报,通过审计程序都已发现;Audit risk: FS 有 500 万以上的错报,但审计师在审计中未发现,并发表了不恰当的审计意见。
audit_report
TRAINING MATERIALTHE AUDIT REPORTINTRODUCTIONThe audit report is the written document presented to the principal, authorizer or other statutory recipients by the auditors or audit institution responsible for fulfilling an audit assignment.It is an integrated reflection of the audit work and its results and an important way to exhibit audit achievements. As the subjects of audit, types of audit assignments and recipients of reports differ, audit reports also differ in nature, contents, binding force and methods of preparation. The audit report referred to herein is the audit report that is prepared by the audit team and submitted to the audit institution in the conduct of government audits. It is a written document that the audit team presents to its dispatching audit institution at the completion of field audit about the fulfillment of audit tasks and achievement of audit results.The Role of the Audit ReportAs a summary of audit work and its achievements, the audit report is of great significance to the audit institution, the audited body and other users of the report. The audit report is the essential basis for the top management of the audit institution to learn about the conduct of audit, make relevant judgment and handle audit issues. According to the Audit Law, after auditing the audit items, auditors should submit their audit report to the audit institution within the prescribed time limit explaining audit work and results, evaluating audit items and putting forward audit recommendations. Consequently, the audit institution can use the report to understand work done by the audit team, including timing, scope and methods of audit, basic situation and business operation/results of the audited body and problems discovered in the course of audit.The audit report is the foundation for audit opinions and decisions. After the audit team completes the audit assignment, the audit institution needs to evaluate the truthfulness, compliance and effectiveness of the audit items, produce its audit opinion, and make its audit decision on punitive measures (such measures are to be imposed on the audited body against its irregular actions of revenues and expenditures that are discovered in audit). Only by relying on the audit report presented by the audit team can the audit institution understand the economic activities of the auditedbody or project, learn about the latter’s compliance with relevant laws and regulations and then evaluate the audit items and mete out appropriate penalties or punishments. The audit report is an important source for the audit institution to prepare audit information for the government’s macroscopic decision making. By summarizing, integrating and analyzing information provided by each individual audit report from the perspective of macroscopic operation and management, the audit institution can play its role in promoting and strengthening macroscopic management within a certain scope by providing the government and relevant organizations with factual, analytical and suggestive audit informationThe audit report is an important reference for the audited body to improve its management. In the audit report, auditors evaluate the financial position, profitability and liquidity of the audited body, evaluate and analyze causes for errors in financial activities and defects in internal control, disclose existing problems and shortcomings and put forward recommendations for reference of competent authorities. Such information and comments provided by the auditors are of great reference value for the audited body to improve its internal control and management.CONTENTS OF THE AUDIT REPORTAs a type of documentation employed in the audit institution, the audit report possesses all the basic elements of an official document, including title, major recipient, subjects of report, signature by the audit team leader, date of reporting, etc. ∙The title of the audit report should include the name of the audited body, major contents and timing of the audit items.∙Major recipient of the audit report usually refers to the audit institution that dispatches the audit team to do the audit assignment.∙Subjects of report are main component of the audit report reflecting the audit work and its results.∙Signature of the audit team leader means that the team leader assumes responsibility for the truthfulness and lawfulness of the contents reported by his team.∙Date of reporting refers to the date when field audit is completed.To be more specific, the audit report includes the following aspects:Explanation of audit tasksThe audit report should provide a concise explanation about the relevant audit tasks. Such an explanation covers the following∙Audit basis;∙Name of the audit subject, i.e., name of the audited body or project;∙Scope and contents of audit, i.e., time limit, audit scope and specific audit items; ∙Audit approaches adopted in the audit;∙Areas requiring sampling or extended audit;∙Explanation about the handling of material issues;∙Cooperation and assistance provided by the audited body.Explanation of these aspects can help users of the audit report to gain a basic understanding of the nature and tasks of the audit assignment.Explanation about accounting and auditing responsibilitiesThe audit report should clarify the accounting responsibility of the audited body and auditing responsibility of the auditors so that the users can understand and use the report correctly. It is the responsibility of the audited body to ensure that accounting information is true, complete and lawful while responsibility of the auditors is to express opinions as to the truthfulness, compliance and effectiveness of revenues and expenditures of the audited body.Basic information about the audited bodyThe audit report should briefly explain the basic situation of the audited body so that the report users can gain an understanding of the latter. Such explanation covers the following∙Business nature, management system, evolution, organizational set-up, business scope and scale of the audited body;∙Financial affiliation and accounting system of the audited body;∙Major economic indicators of the fiscal year under audit;∙Material issues related to audit items;∙Changes of business and legal context in which the audited body operates;∙Impact of state macroscopic economic situ ation on the audited body’s revenues and expenditures.The conduct of the auditThe conduct of audit covers two aspects:∙Information about the audit including work done by the audit team, audit procedure and methods adopted by the audit team, adjustments made to the audit programs and fulfillment of audit tasks.∙Confirmation of facts related to audit items after the completion of audit such as disclosure of revenues and expenditures of the audited body.Audit evaluationAudit evaluation covers∙Evaluation of truthfulness, compliance and effectiveness of the audited items;∙Evaluation of internal control related to the audited body’s revenues and expenditures;∙Evaluation of the audited body’s accountability.Audit findingsDisclosure of problems existing in audit items is an important component of the audit report and a concrete reflection of audit achievements. Audit findings refer to irregular actions of revenues and expenditures that are committed by the audited body and discovered by the auditors in the course of audit. In the report, auditors should explain such findings, covering the following aspects:∙Details about revenues and expenditures that are in violation of relevant state laws and regulations;∙Causes for such irregularities;∙Details of provisions that have been violated;∙Impacts or consequences of the irregularities.Audit opinions and recommendationsFor the above-mentioned audit findings, the audit report should put forward corresponding audit opinions or recommendations. Audit opinions mentioned herein refer to opinions on imposing penalties and punishments on the audited body against its irregular actions of revenues and expenditures that have violated relevant laws andregulations to the point of being liable to such punitive measures. Where the audited body falls behind standards in its business activities and is weak in management, the auditors should put forward recommendations for improvement. For audit findings that go beyond the mandate of the audit institution and should be subject to punitive measures imposed by other relevant organizations, the audit report should produce recommendations that such relevant organizations should mete out the appropriate penalties or punishments.PROCEDURE FOR PREPARING, REVIEWING AND FINALIZING THE AUDIT REPORTThe audit report is usually prepared according to the following steps:∙Sorting out and analyzing audit working papersAudit working papers are historical records about the auditors’ audit work and the direct basis for preparing the audit report. However, as each working paper is prepared for an individual item, the information contained in such papers ispiecemeal thereby unable to give a comprehensive reflection of the entire audit assignment. Therefore, prior to the preparation of the audit report, auditors should sum up, sort out, classify and analyze various audit working papers. Such work mainly cover the following aspects:o To examine whether the audit tasks as laid down in the audit program have been fulfilled with corresponding working papers providing supportinginformation;o To sort out all audit findings, and then classify and summarize according to their different nature;o To review whether facts about audit findings are clear with sufficient and appropriate corresponding audit evidence;o To analyze audit items within the audit scope and judge whether the facts are clarified, whether relevant audit evidence has been obtained andwhether audit conclusions are correctly drawn.∙Screening audit information to select audit evidenceAs a government audit report should give a separate disclosure of audit findings, it is necessary for auditors to select the key information related to problems found in audit before they prepare the report in accordance with the audit objectives and thenature of audit findings. Afterward, they should classify and sort out the selected information.First, auditors should classify audit findings into different types according to their different nature and arrange them in order of amounts or according to the degree of seriousness.Secondly, the selection of audit evidence should be able to support the disclosed problems.Evidence should be chosen according to the principles of sufficiency, relevance, objectivity and lawfulness.∙Outlining and drafting the audit reportAfter summarizing and sorting out the audit findings, the audit team can discuss the outline of the audit report focusing on the following:o Whether the outline has a clear theme and reasonable structure;o Whether the outline lists clear subjects and reflects major issues to be resolved by the report;o Whether the outline contains clear facts, sufficient evidence and correct conclusions for the problems listed and whether further investigation isneeded for collection of evidence.After determining the outline, auditors can draft the audit report, discuss andrevise the draft within the audit team and ask the audit team leader to reviewand approve the draft, thereby forming the exposure draft of the audit report. ∙Soliciting opinions from the audited body and revising the audit report Before submitting the audit report to the audit institution, the audit team should solicit opinions from the audited body as to whether facts acknowledged by the audit team are correct, whether the right laws and regulations are applied, whether the audit evaluation is objective, whether audit opinions and recommendations are reasonable and effective.The audited body should present its written comments to the audit team or audit institution 10 days within its receipt of the audit report. Where the audited body fails to do so within the prescribed time limit, it is regarded that the audited body has no objection to the audit report. Upon receipt of comments from the audited body, however, the audit team should study them in an earnest manner.For disagreements with the audit report due to obscure facts and insufficientevidence, the audit team should make further verification and supplementation.Where the audited body holds that the audit report makes inappropriate reference to laws and regulations, necessary adjustments should be made. For the audited body’s disagreement with the audit team’s evaluation, audit opinions andrecommendations, auditors should adopt the audited body’s reasonable comments.The audit team should also explain its reasons for not adopting certain writtencomments made by the audited body.In conclusion, the audit team should produce an explanation on the audited body’s feedback on the exposure draft and submit it to the audit institution together with the report itself for review and approval.Reviewing the audit reportAfter receiving the audit report submitted by the audit team, the audit institution should ask full-time reviewers or organization to review the report and produce review opinions.Examining and approving the audit report by the audit institutionAfter the reviewing process, the audit institution will examine and approve the audit report. For audit reports on ordinary audit items, competent members of the top management of the audit institution can carry out this job while audit panel meetings will examine and approve reports on material items. In this process, the audit institution focuses on the following:∙Whether facts related to the audit items are clear and whether audit evidence is solid;∙Whether the audited body gives right comments on the audit report and whether the review organizations or reviewers produce correct review opinions;∙Whether audit evaluation is appropriate;∙Whether judgmental opinions and recommendations for punitive measures concerning irregular actions are correct, lawful and appropriate.REQUIREMENTS FOR A QUALITY REPORTTo ensure that the audit report is of high quality and plays an effective role, auditors should meet the following requirements in preparing the report:∙Clear facts and true dataFacts listed in the audit report should be clear while data should be accurate, true and reliable. Origins and causal relations should be clarified. These will enable the audit institution to carry out correct evaluation and draw correct conclusion of the audit items and the report users to gain a correct understanding of the report. ∙Complete contents and clear prioritiesThe audit report must contain complete contents so as to give a complete andaccurate reflection of the audit results and make correct evaluation of thetruthfulness, compliance and effectiveness of the audited body’s revenues and expenditures within a certain period. To begin with, the report must be complete in its basic elements. Secondly, details of the report should be able to reflect the actual situation of the audited body. Meanwhile, the audit report should focus on priorities.∙Clear arrangement of ideas and reasonable structureTo promote its readability and enable the users to make correct judgments and decisions, the audit report should arrange ideas in a clear and reasonable structure.Clear arrangement of ideas means summarization of the contents and arrangement in a logical way. Each paragraph should focus on a single main idea whileinterrelated to other paragraphs. Issues of the same type should be stated in the same paragraph or section instead of scattered among several paragraphs.Similarly, the same paragraph should not attempt to explain several differentissues.Reasonable structure means that the framework of the report should meet standard requirements with reasonable arrangements of major and minor issues. In general, major issues are stated first followed by minor ones. When stating an issue, facts should be given first, followed by the judgement on their nature, production of recommendations for punitive measure. In other words, the actual situation is put forward at the beginning, followed by evaluation, opinions and recommendations. ∙Sufficient evidence and correct judgmentThe audit report should be based on facts using evidence to prove such facts.Relevant laws and regulations should be regarded as the criteria for judgement.Evidence used in the report must be reliable and sufficient to support the audit opinions. To make judgments on the nature of the audit items, auditors mustgrasp the fundamental features of the items and refer to appropriate laws andregulations. If using references, they should quote the relevant legal article in addition to the name and reference number of the document so that theirevaluation and recommendations can be more convincing.∙Concise wording and accurate expressionThe audit report is an official document of the audit institution. Therefore, reports should be concise and correct in wording and conform to the format of auditdocumentation. Sticking to the principle of making clear explanations forconcerned issues, auditors should use qualitative, quantitative, judgmental and reflective words in preparing the audit report. In short, the report should use plain words to help the users understand. Obscurity and exaggeration should be strictly avoided.∙Compliance with principles and adherence to factsCompliance with principles means that the audit report should make fairevaluation of the truthfulness, compliance and effectiveness of audit itemsaccording to relevant laws and regulations. A firm attitude should be maintained in this process. To be more specific, auditors should make their judgment of the nature of audit findings and produce their recommendations for punitive measures strictly on the basis of facts and with the use of legal criteria. They should neither withdraw in the face of contradictions nor avoid heavier responsibilities to assume lighter tasks.Adherence to facts means that the audit report should disclose the true situation and problems of the audited body without overstatement or understatement. Audit evaluation should be appropriate, i.e., pointing out shortcomings while affirming achievements. For problems existing in the audited body, the audit report should analyze their causal relations and the larger context in a fair and objective manner instead of imposing punitive measures in simplistic ways.。
药物临床试验英文缩写
药物临床试验英文缩写缩略语英文全称中文全称ADE Adverse Drug Event 药物不良事件ADR Adverse Drug Reaction 药物不良反应AE Adverse Event 不良事件AI Assistant Investigator 助理研究者BMI Body Mass Index 体质指数CI Co-investigator 合作研究者COI Coordinating Investigator 协调研究者CRC Clinical Research Coordinator 临床研究协调者CRF Case Report Form 病历报告表CRO Contract Research Organization 合同研究组织CSA Clinical Study Application 临床研究申请CTA Clinical Trial Application 临床试验申请CTX Clinical Trial Exemption 临床试验免责CTP Clinical Trial Protocol 临床试验方案CTR Clinical Trial Report 临床试验报告DSMB Data Safety and monitoring Board 数据安全及监控委员会EDC Electronic Data Capture 电子数据采集系统EDP Electronic Data Processing 电子数据处理系统FDA Food and Drug Administration 美国食品与药品管理局FR Final Report 总结报告GCP Good Clinical Practice 药物临床试验质量管理规范GCP Good Laboratory Practice 药物非临床试验质量管理规范GMP Good Manufacturing Practice 药品生产质量管理规范IB Investigator’s Brochure 研究者手册IC Informed Consent 知情同意ICF Informed Consent Form 知情同意书ICH International Conference on国际协调会议HarmonizationIDM Independent Data Monitoring 独立数据监察IDMC Independent Data Monitoring Committee 独立数据监察委员会IEC Independent Ethics Committee 独立伦理委员会IND Investigational New Drug 新药临床研究IRB Institutional Review Board 机构审查委员会IVD In Vitro Diagnostic 体外诊断IVRS Interactive Voice Response System 互动语音应答系统MA Marketing Approval/Authorization 上市许可证MCA Medicines Control Agency 英国药品监督局MHW Ministry of Health and Welfare 日本卫生福利部NDA New Drug Application 新药申请NEC New Drug Entity 新化学实体缩略语英文全称中文全称NIH National Institutes of Health 国家卫生研究所(美国)PI Principal Investigator 主要研究者PL Product License 产品许可证PMA Pre-market Approval (Application) 上市前许可(申请)PSI Statisticians in the Pharmaceutical制药业统计学家协会IndustryQA Quality Assurance 质量保证QC Quality Control 质量控制RA Regulatory Authorities 监督管理部门SA Site Assessment 现场评估SAE Serious Adverse Event 严重不良事件SAP Statistical Analysis Plan 统计分析计划SAR Serious Adverse Reaction 严重不良反应SD Source Data/Document 原始数据/文件SD Subject Diary 受试者日记SFDA State Food and Drug Administration 国家食品药品监督管理局SDV Source Data Verification 原始数据核准SEL Subject Enrollment Log 受试者入选表SI Sub-investigator 助理研究者SI Sponsor-Investigator 申办研究者SIC Subject Identification Code 受试者识别代码SOP Standard Operating Procedure 标准操作规程SPL Study Personnel List 研究人员名单SSL Subject Screening Log 受试者筛选表T&R Test and Reference Product 受试和参比试剂UAE Unexpected Adverse Event 预料外不良事件WHO World Health Organization 世界卫生组织WHO-ICDRA WHO International Conference ofWHO国际药品管理当局会议Drug Regulatory Authorities药物临床试验英文缩写英文全称中文全称Accuracy准确度Active control, AC阳性对照活性对照Adverse drug reaction, ADR药物不良反应Adverse event, AE不良事件Adverse medical events不良医学事件Adverse reaction药物不良反应Alb白蛋白ALD(Approximate Lethal Dose)近似致死剂量ALP碱性磷酸酶Alpha spending function消耗函数ALT丙氨酸氨基转换酶Analysis sets统计分析的数据集Approval批准Assistant investigator助理研究者AST天门冬酸氨基转换酶ATR衰减全反射法AUCss稳态血药浓度-时间曲线下面积Audit稽查Audit or inspection稽查/视察Audit report稽查报告Auditor稽查员Bias偏性偏倚Bioequivalence生物等效应Blank control空白对照Blind codes编制盲底Blind review盲态审核Blind review盲态检查Blinding method盲法Blinding/masking盲法/设盲Block层Block size每段的长度Carryover effect延滞效应Case history病历Case report form/ case record form CRF病例报告表病例记录表Categorical variable分类变量Cav平均浓度CD圆二色谱CL清除率Clinical equivalence临床等效应Clinical study临床研究Clinical study report临床试验的总结报告Clinical trial临床试验Clinical trial application CTA临床试验申请Clinical trial exemption CTX临床试验免责Clinical trial protocol CTP临床试验方案Clinical trial/ study report临床试验报告Cmax峰浓度Co-investigator 合作研究者Comparison对照Compliance依从性Composite variable复合变量Computer-assisted trial design CATD计算机辅助试验设计Confidence interval可信区间Confidence level置信水平Consistency test一致性检验Contract research organization CRO合同研究组织Contract/ agreement协议/合同Control group对照组Coordinating committee协调委员会Crea肌酐CRF(case report form)病例报告表Crossover design交叉设计Cross-over Study交叉研究Css稳浓度Cure痊愈Data management数据管理Database建立数据库Descriptive statistical analysis描述性统计分析DF波动系统Dichotomies二分类Diviation偏差Documentation记录/文件Dose-reaction relation剂量-反应关系Double dummy双模拟Double dummy technique双盲双模拟技术Drop out脱落DSC 差示扫描热量计Effectiveness疗效Electronic data capture EDC电子数据采集系统Electronic data processing EDP电子数据处理系统Emergency envelope应急信件End point终点Endpoint Criteria终点指标Endpoint criteria/ measurement终点指标Equivalence等效性Essential Documentation必需文件Ethics committee伦理委员会Excellent显效Exclusion criteria排除标准Factorial design析因设计Failure无效失败Final point终点Fixed-dose procedure固定剂量法Forced titration强制滴定Full analysis set全分析集GC-FTIR气相色谱-傅利叶红外联用GC-MS气相色谱-质谱联用Generic drug通用名药Global assessment variable全局评价变量GLU血糖Good clinical practice, GCP药物临床试验质量管理规范Good manufacture practice, GMP药品生产质量管理规范药物非临床研究质量管理规范Good non-clinical laboratory practice,GLPGroup sequential design成组序贯设计Health economic evaluation, HEV健康经济学评价Hypothesis test假设检验Hypothesis testing假设检验Improvement好转Inclusion Criteria入选表准Inclusion criteria 入选标准Independent ethics committee IEC独立伦理委员会Information consent form ICF知情同意书Information Gathering信息收集Informed consent IC知情同意Initial meeting启动会议Inspection检察/视察Institution inspection机构检查Institution review board, IBR机构审查委员会Intention-to –treat ITT意向性分析(-统计学)Interactive voice response system IVRS互动式语音应答系统Interim analysis期中分析International Conference of Harmonization ICH 人用药品注册技术要求国际技术协调会国际协调会议Investigational Product试验药物Investigator研究者Investigator’s brochure, IB研究者手册Last observation carry forward, LOCF最接近一次观察的结转LC-MS液相色谱-质谱联用LD50板数致死剂量LOCF, Last observation carry forward最近一次观察的结转Logic check逻辑检查LOQ (Limit of Quantization)定量限Lost of follow up失访Marketing approval/ authorization上市许可证Matched pair匹配配对Missing value缺失值Mixed effect model混合效应模式Monitor监察员Monitoring监查Monitoring Plan监察计划Monitoring Report监察报告MRT平均滞留时间MS质谱MS-MS质谱-质谱联用MTD(Maximum Tolerated Dose)最大耐受剂量Multi-center Trial多中心试验New chemical entity NCE新化学实体New drug application NDA新药申请NMR核磁共振谱Non-clinical Study非临床研究Non-inferiority非劣效性Non-parametric statistics非参数统计方法Obedience依从性ODR旋光光谱Open-label非盲Optional titration随意滴定Original medical record原始医疗记录Outcome结果Outcome Assessment结果评价Outcome assessment结果指标评价Outcome measurement结果指标Outlier离群值Parallel group design平行组设计Parameter estimation参数估计Parametric statistics参数统计方法Patient file病人档案Patient history病历Per protocol PP符合方案集Placebo安慰剂Placebo control安慰剂对照Polytomies多分类Power检验效能Precision精密度Preclinical study临床前研究Primary endpoint主要终点Primary variable主要变量Principle investigator PI主要研究者Product license PL产品许可证Protocol试验方案Protocol Amendments修正案Quality assurance QA质量保证Quality assurance unit QAU质量保证部门Quality control QC质量控制Query list query form应用疑问表Randomization随机Range check范围检查Rating scale量表Reference Product参比制剂Regulatory authorities RA监督管理部门Replication可重复RSD日内和日间相对标准差Run in准备期Safety evaluation安全性评价Safety set安全性评价的数据集Sample size样本量样本大小Scale of ordered categorical ratings有序分类指标Secondary variable次要变量Sequence 试验次序Serious adverse event SAE严重不良事件Serious adverse reaction SAR严重不良反应Seriousness严重性Severity严重程度Severity严重程度Significant level检验水准Simple Randomization简单随机Single blinding单盲Site audit 试验机构稽查SOP试验室的标准操作规程Source data SD原始数据Source data verification SDV原始数据核准Source document SD原始文件Specificity特异性Sponsor申办者Sponsor-investigator申办研究者Standard curve标准曲线Standard operating procedure SOP标准操作规程Statistic统计量Statistical analysis plan统计分析计划Statistical model统计模型Statistical tables统计分析表Stratified分层Study Audit研究稽查Study audit研究稽查Study Site研究中心Subgroup亚组Sub-investigator助理研究者Subject受试者Subject受试者Subject diary受试者日记Subject Enrollment受试者入选Subject enrollment log受试者入选表Subject identification code SIC受试者识别代码Subject Identification Code List受试者识别代码表Subject Recruitment受试者招募Subject screening log受试者筛选表Superiority 检验Survival analysis生存分析SXRD单晶X-射线衍射System audit系统稽查System Audit 系统稽查T1/2消除半衰期Target variable目标变量T-BIL总胆红素T-CHO总胆固醇Test Product受试制剂TG热重分析TLC、HPLC制备色谱Tmax峰时间TP总蛋白Transformation变量变换Treatment group试验组Trial error试验误差Trial Initial Meeting 试验启动会议Trial Master File试验总档案Trial objective试验目的Trial site试验场所Triple blinding三盲Two one-side test双单侧检验Un-blinding 揭盲Unexpected adverse event UAE预料外不良事件UV-VIS紫外-可见吸收光谱Variability变异Variable变量Visual analogy scale直观类比打分法Visual check人工检查Vulnerable subject弱势受试者Wash-out洗脱Washout period洗脱期实验室检查英文缩写英文全称中文全称血常规WBC white blood cell count白细胞计数GR% granulocyte中性粒细胞百分比LY% lymphocyte 淋巴细胞百分比MID% 中值细胞百分比EOS% eosimophil 嗜酸性粒细胞百分比AL% allergy lymphocyte 变异淋巴细胞百分比ST% 中性杆状粒细胞百分比RBC red blood cell 红细胞计数HGB hemoglobin 血红蛋白HCT hematocrit 红细胞比积红细胞比积MCV mean corpusular volume平均红细胞体积MCH mean corpusular hemoglobin平均红细胞血红蛋白含量MCHC mean corpusular hemoglobin平均红细胞血红蛋白浓度concerntration红细胞分布宽度变异RDW red blood cell volume distributionwidthPLT/BPC platelet count/blood platelet血小板计数countMPV mean platelet volume 平均血小板体积PCT plateletocrit 血小板比积PDW platelet distribution width 血小板分布宽度尿便常规PH acidity 酸碱度NIT nitrite 亚硝酸盐GLU glucose尿糖SG specific gravity 比重PRO protein 尿蛋白BLD blood 隐血BIL bilirubin 尿胆红素URO urobilinogen 尿胆原WBC white blood cell 白细胞addish计数 addish count 艾迪氏计数/HP high power objective 每高倍视野/LP low power objective 每低倍视野OB occult blood test 大便隐血试验体液常规CSF cerebrospinal 脑积夜Pandy pandy 庞氏试验生化检验TB total bilirubin 总胆红素DB direct bilirubin 直接胆红素TP total protein 总蛋白ALB albumin 白蛋白GLOB globulin 球蛋白UREA urea 尿素CREA creatinine 肌肝UA uric acid 尿酸GLU glucose 血糖ALT alanine amiotransferase 丙氨酸氨基转移酶AST aspartate aminotransferase 门冬氨酸氨基转移酶GGT γ-glutamyl transpeptadase谷氨酰转肽酶CK creatine kinase 肌酸肌酶CK-MB creatine kinase-MB 肌酸肌酶同工酶LDH lactate dehydrogenase 乳酸脱氢酶α-HBD α-hydroxybutyric dehydrogenaseα-羟丁酸脱氢酶AMY serum amylase血淀粉酶TG triglyceride 肝油三脂CHOL cholesterol 胆固醇高密度脂蛋白HDL-c high-density lipoproteincholesterolLDL-c low-density lipoprotein低密度脂蛋白cholesterolVLDL very low-density lipoprotein 极低密度脂蛋白Ca serum calcium 钙Mg serum magnesium 镁IP inorganic phosphate 无机磷ALP alkaline phosphatase 碱性磷酸酶TBA total biliary acid 总胆汁酸ASO antistreptolysin 抗链球菌溶血素O a-AG a-acid glycoprotein a-酸性糖蛋白CRP C-reactive protein C反应蛋白RF rheumatoid factor 类风湿因子MTP mili-total protein 微量蛋白IgG immunoglobin G 免疫球蛋白G IgA immunoglobin A 免疫球蛋白 A IgM immunoglobin M 免疫球蛋白M C3 complement C3 补体C3C4 complement C4 补体C4cTNT troponin T 肌钙蛋白T MYOG myoglobin肌红蛋白电解质Na sodium 钠K kalium 钾Cl chloride 氯Ga calcium钙Mg magnesium镁乙肝标志物HBV hepatitis B virus 乙肝病毒HBsAg hepatitis B surface antigen 乙肝表面抗原乙肝表面抗体HBsAb antibody to hepatitis surfaceantigenHBcAg hepatitis B core antigen 乙肝核心抗原乙肝核心抗体HBcAb antibody to hepatitis B coreantigenHBeAg hepatitis B e-antigen 乙肝e抗原HBeAb antibody to hepatitis B e-antigen乙肝e抗体ELISA enzymelinked immunosorbentassy酶联免疫吸附试验HAV hepatitis A virus 甲肝病毒HCV hepatitis C virus 丙肝病毒输血免疫全套HBV hepatitis B virus 乙型肝炎病毒HCV hepatitis C virus 丙型肝炎病毒TP treponema pallidum 梅毒螺旋体HIV human immunodeficiency virus 人类免疫缺陷病毒如有侵权请联系告知删除,感谢你们的配合!。
四种审计意见(英文版)
审计报告意见类型有以下四种:无保留意见、保留意见、否定意见和无法表示意见(原为拒绝表示意见)。
下面对这四种意见作了简要解释。
AUDIT REPORTINGAudit Reports are categorized into four categories. Each type is briefly described as follows:UNQUALIFIED OPINION(无保留意见)An unqualified opinion states that the financial statements are presented fairly in conformity with GAAP. However, in some instances, the standard unqualified report may be modified without affecting the unqualified opinion issued on the financial statements.QUALIFIED OPINION. (保留意见)A qualified opinion is issued when the financial statements present the entity's financial position, results of operations, and cash flows in conformity with GAAP except for the matter of the qualification. Qualified opinions are issued, in some cases, when: (1) a scope limitation, or (2) a departure from GAAP exists.ADVERSE OPINION. (否定意见)When issuing an adverse opinion, the auditor concludes that the financial statements do not present the entity's financial position, results of operations, and cash flows in conformity with GAAP. This type of opinion is only issued when the financial statements contain very material departures from GAAP.DISCLAIMER OF OPINION.(无法表示意见)A disclaimer of opinion is issued when the auditor is unable to form an opinion on an entity's financial statements. A disclaimer may be issued in cases when: (1) the auditor is not independent with respect to the entity under audit, (2) a material scope limitation exists, or (3) a significant uncertainty exists.SAS No. 58 suggests seven principal reasons why an independent auditor my depart from the wording of the standard report. These are:1. Limitations on the scope of the auditor's examination.2. Division of responsibility.3. Lack of conformity with GAAP.4. A departure from an accounting principle set by the body designated to establish such principles.5. Lack of consistency.6. Uncertainties.7. Emphasizing a matter.AUDPORT: Expert System EvaluationThis knowledged-based system uses the criteria contained in Statement on Auditing Standards No. 58 to determine the type of audit opinion that should be rendered by anexternal auditor after conducting a financial audit under generally accepted auditing standards (GAAS). Assessment of the educational impact of the Audport expert system is described in a paper by L. Murphy Smith and R. Stephen McDuffie, "Impact of an Audit Reporting Expert System on Learning Performance: A Teaching Note" (forthcoming in Accounting Education). This Web-based HTM (hypertext m arkup language) approach was developed by Professors Smith and McDuffie, with assistance from Ms. Jennifer Calhoun.Answer the questions that appear on the screen by clicking on the correct answer. Based upon your answers, the criteria contained in SAS No. 58 will be evaluated. As each criterion is evaluated you will be provided with information on the screen either that a particular type of audit opinion should be rendered by the auditor or that additional evaluation is necessary.If the type of audit opinion to be rendered has been determined, you have completed the evaluation and can then quit the consultation. If additional evaluation is necessary to determine the type of audit opinion to render, this will be indicated to you and you will need to continue the consultation. The system only considers one audit problem for each consultation. However, many potential problems can be evaluated by the system.Two sets of terms are important when using this system, material versus pervasive and significant versus severe. Pervasive is of more concern than material, and severe is of more concern than significant. For example, a departure from generally accepted accounting principles that is not immaterial and is not justified either has a material affect on the financial statements or a pervasive affect on the financial statements, but not both. Depending on the situation, either a qualified opinion or an adverse opinion will be rendered.Significant and severe are used in describing a circumstance-imposed scope limitation. One or the other terms can be used to describe a situation but both terms can not be used to describe the sam e situation.A list of the questions that make up the AUDPORT Web-based expert system are available for you to review under 'AUDPORT questions' below. At any time during the consultation you may quit the consultation and return to the AUDPORT homepage.。
ACCA P7必考Group Auditing集团报表审计七步走
P7必考Group Auditing集团报表审计七步走译者:集团审计是P7必考的必选题目,而且考的内容都比较重量级,比如:业务风险(BR),重大错报风险(RMM), 对一两个财务事项的审计程序,初次审计考虑事项,职业道德和专业话题等。
本文是对一篇最近的考官文章(原版英文6页)的改编翻译,并梳理成七个步骤,看起来一目了然(为了更直观表达部分简化处理)。
这是篇比较全面讲集团审计的文章,值得好好理解。
本文内容主要属于ISA600范畴,Special Considerations – Audits of Group FSs (Incl. the Work of Component Auditors。
1接单Acceptance of Engagement考虑5个问题:1)Skill; 2) Restriction; 3)Components; 4) TWO opinions; 5) No reference1)事务所是否有必需的专业能力Professional skills:Audit partner each year formally assesses whether it is appropriate to act as group auditor. 合伙人每年评估事务所是否有执行该集团审计的专业能力,否则辞职;2)客户(母公司)管理层是否有意限制提供信息Restriction placed by Parent company mgt on info:Resign or disclaim opinion if resignation is not legally possible. 如果是,就辞职或拒绝发表意见;3)子公司审计师协调Component auditor: Group auditor must form their own concurring opinion on any judgmental areas; review 3P’s files, understand work done, reason for the work & conclusions from that evidence. 集团审计师必须(和子公司审计师)在需要判断的领域形成一致意见。
FM 对自动喷淋系统要求
Байду номын сангаасClass Number 1630
November 2013
©2013 FM Approvals LLC. All rights reserved
Foreword
The FM Approvals certification mark is intended to verify that the products and services described will meet FM Approvals’ stated conditions of performance, safety and quality useful to the ends of property conservation. The purpose of Approval Standards is to present the criteria for FM Approval of various types of products and services, as guidance for FM Approvals personnel, manufacturers, users and authorities having jurisdiction. Products submitted for certification by FM Approvals shall demonstrate that they meet the intent of the Approval Standard, and that quality control in manufacturing shall ensure a consistently uniform and reliable product. Approval Standards strive to be performance-oriented. They are intended to facilitate technological development. For examining equipment, materials and services, Approval Standards: • • must be useful to the ends of property conservation by preventing, limiting or not causing damage under the conditions stated by the Approval listing; and must be readily identifiable.
Audit Manual - PIFRA审核手册- pifra
Audit of the probity and propriety of administrative decisions taken within the audited entity; and,
Attestation of financial accountability of the government administration as a whole;
Audit of financial systems and transactions, including an evaluation of compliance with applicable statutes and regulations;
District Accounts Officers(DAOs). The DAOs are responsible for the accounting functions of the districts. They have authority to pre-audit bills, issue payments, and record government transactions at the district level. They receive reports from the drawing and disbursing officers and bank scrolls from the State Bank of Pakistan/National Bank ofPakistan. They report district and provincial transactions to the Accountant General responsible for the province in which their districts are located. They also report federal transactions to the AGPR.
IAA Glossary 国际精算师协会术语
Glossary名词解释汇总A B C D E F G H I K L M N O P Q R S T U AAccountant-in-charge or field seniorA professional staff member with responsibilityto the audit Engagement Partner and auditmanager for the audit engagement. 项目现场负责人就审计项目对审计项目合伙人及审计经理负责的专业人员。
Accounting estimateAn approximation of the amount of an item ofaccounting information in the absence of a precise means of measurement. 会计估计在缺乏精确的方法来计量某项会计信息时采用的约数。
Accounting policiesPrinciples, bases, conventions, rules, andprocedures adopted by management to prepareand present financial statements. 会计政策管理当局在编制及披露会计报表时所采用的原则、基础、惯例、规则及程序。
Accounting processThe records and procedures, including application systems and controls, that an entity uses toinitiate, record, process, summarize, and reporttransactions and maintain accountability forassets. 会计处理过程实体的各种记录与程序,包括会计系统和控制。
audit_report
KPMG – BARENTS GROUP LLC 2001 NOVEMBER ADB CNAO AUDIT STANDARDS PROJECT TRAINING MATERIALTHE AUDIT REPORTINTRODUCTIONThe audit report is the written document presented to the principal, authorizer or other statutory recipients by the auditors or audit institution responsible for fulfilling an audit assignment.It is an integrated reflection of the audit work and its results and an important way to exhibit audit achievements. As the subjects of audit, types of audit assignments and recipients of reports differ, audit reports also differ in nature, contents, binding force and methods of preparation. The audit report referred to herein is the audit report that is prepared by the audit team and submitted to the audit institution in the conduct of government audits. It is a written document that the audit team presents to its dispatching audit institution at the completion of field audit about the fulfillment of audit tasks and achievement of audit results.The Role of the Audit ReportAs a summary of audit work and its achievements, the audit report is of great significance to the audit institution, the audited body and other users of the report. The audit report is the essential basis for the top management of the audit institution to learn about the conduct of audit, make relevant judgment and handle audit issues. According to the Audit Law, after auditing the audit items, auditors should submit their audit report to the audit institution within the prescribed time limit explaining audit work and results, evaluating audit items and putting forward audit recommendations. Consequently, the audit institution can use the report to understand work done by the audit team, including timing, scope and methods of audit, basic situation and business operation/results of the audited body and problems discovered in the course of audit.The audit report is the foundation for audit opinions and decisions. After the audit team completes the audit assignment, the audit institution needs to evaluate the truthfulness, compliance and effectiveness of the audit items, produce its audit opinion, and make its audit decision on punitive measures (such measures are to be imposed on the audited body against its irregular actions of revenues and expenditures that are discovered in audit). Only by relying on the audit report presented by the audit team can the audit institution understand the economic activities of the auditedKPMG – BARENTS GROUP LLC 2001 NOVEMBER ADB CNAO AUDIT STANDARDS PROJECT body or project, learn about the latter’s compliance with relevant laws and regulations and then evaluate the audit items and mete out appropriate penalties or punishments. The audit report is an important source for the audit institution to prepare audit information for the government’s macroscopic decision making. By summarizing, integrating and analyzing information provided by each individual audit report from the perspective of macroscopic operation and management, the audit institution can play its role in promoting and strengthening macroscopic management within a certain scope by providing the government and relevant organizations with factual, analytical and suggestive audit informationThe audit report is an important reference for the audited body to improve its management. In the audit report, auditors evaluate the financial position, profitability and liquidity of the audited body, evaluate and analyze causes for errors in financial activities and defects in internal control, disclose existing problems and shortcomings and put forward recommendations for reference of competent authorities. Such information and comments provided by the auditors are of great reference value for the audited body to improve its internal control and management.CONTENTS OF THE AUDIT REPORTAs a type of documentation employed in the audit institution, the audit report possesses all the basic elements of an official document, including title, major recipient, subjects of report, signature by the audit team leader, date of reporting, etc. ∙The title of the audit report should include the name of the audited body, major contents and timing of the audit items.∙Major recipient of the audit report usually refers to the audit institution that dispatches the audit team to do the audit assignment.∙Subjects of report are main component of the audit report reflecting the audit work and its results.∙Signature of the audit team leader means that the team leader assumes responsibility for the truthfulness and lawfulness of the contents reported by his team.∙Date of reporting refers to the date when field audit is completed.To be more specific, the audit report includes the following aspects:KPMG – BARENTS GROUP LLC 2001 NOVEMBER ADB CNAO AUDIT STANDARDS PROJECT Explanation of audit tasksThe audit report should provide a concise explanation about the relevant audit tasks. Such an explanation covers the following∙Audit basis;∙Name of the audit subject, i.e., name of the audited body or project;∙Scope and contents of audit, i.e., time limit, audit scope and specific audit items;∙Audit approaches adopted in the audit;∙Areas requiring sampling or extended audit;∙Explanation about the handling of material issues;∙Cooperation and assistance provided by the audited body.Explanation of these aspects can help users of the audit report to gain a basic understanding of the nature and tasks of the audit assignment.Explanation about accounting and auditing responsibilitiesThe audit report should clarify the accounting responsibility of the audited body and auditing responsibility of the auditors so that the users can understand and use the report correctly. It is the responsibility of the audited body to ensure that accounting information is true, complete and lawful while responsibility of the auditors is to express opinions as to the truthfulness, compliance and effectiveness of revenues and expenditures of the audited body.Basic information about the audited bodyThe audit report should briefly explain the basic situation of the audited body so that the report users can gain an understanding of the latter. Such explanation covers the following∙Business nature, management system, evolution, organizational set-up, business scope and scale of the audited body;∙Financial affiliation and accounting system of the audited body;∙Major economic indicators of the fiscal year under audit;∙Material issues related to audit items;∙Changes of business and legal context in which the audited body operates;∙Impact of state macroscopic economic situation on the audited body’s revenues and expenditures.KPMG – BARENTS GROUP LLC 2001 NOVEMBER ADB CNAO AUDIT STANDARDS PROJECTThe conduct of the auditThe conduct of audit covers two aspects:∙Information about the audit including work done by the audit team, audit procedure and methods adopted by the audit team, adjustments made to the audit programs and fulfillment of audit tasks.∙Confirmation of facts related to audit items after the completion of audit such as disclosure of revenues and expenditures of the audited body.Audit evaluationAudit evaluation covers∙Evaluation of truthfulness, compliance and effectiveness of the audited items;∙Evaluation of internal control related to the audited body’s revenues and expenditures;∙Evaluation of the audited body’s accountability.Audit findingsDisclosure of problems existing in audit items is an important component of the audit report and a concrete reflection of audit achievements. Audit findings refer to irregular actions of revenues and expenditures that are committed by the audited body and discovered by the auditors in the course of audit. In the report, auditors should explain such findings, covering the following aspects:∙Details about revenues and expenditures that are in violation of relevant state laws and regulations;∙Causes for such irregularities;∙Details of provisions that have been violated;∙Impacts or consequences of the irregularities.Audit opinions and recommendationsFor the above-mentioned audit findings, the audit report should put forward corresponding audit opinions or recommendations. Audit opinions mentioned herein refer to opinions on imposing penalties and punishments on the audited body against its irregular actions of revenues and expenditures that have violated relevant laws andKPMG – BARENTS GROUP LLC 2001 NOVEMBER ADB CNAO AUDIT STANDARDS PROJECT regulations to the point of being liable to such punitive measures. Where the audited body falls behind standards in its business activities and is weak in management, the auditors should put forward recommendations for improvement. For audit findings that go beyond the mandate of the audit institution and should be subject to punitive measures imposed by other relevant organizations, the audit report should produce recommendations that such relevant organizations should mete out the appropriate penalties or punishments.PROCEDURE FOR PREPARING, REVIEWING AND FINALIZING THE AUDIT REPORTThe audit report is usually prepared according to the following steps:∙Sorting out and analyzing audit working papersAudit working papers are historical records about the auditors’ audit work and the direct basis for preparing the audit report. However, as each working paper is prepared for an individual item, the information contained in such papers ispiecemeal thereby unable to give a comprehensive reflection of the entire audit assignment. Therefore, prior to the preparation of the audit report, auditors should sum up, sort out, classify and analyze various audit working papers. Such work mainly cover the following aspects:o To examine whether the audit tasks as laid down in the audit program have been fulfilled with corresponding working papers providing supportinginformation;o To sort out all audit findings, and then classify and summarize according to their different nature;o To review whether facts about audit findings are clear with sufficient and appropriate corresponding audit evidence;o To analyze audit items within the audit scope and judge whether the facts are clarified, whether relevant audit evidence has been obtained andwhether audit conclusions are correctly drawn.∙Screening audit information to select audit evidenceAs a government audit report should give a separate disclosure of audit findings, it is necessary for auditors to select the key information related to problems found in audit before they prepare the report in accordance with the audit objectives and theKPMG – BARENTS GROUP LLC 2001 NOVEMBER ADB CNAO AUDIT STANDARDS PROJECT nature of audit findings. Afterward, they should classify and sort out the selected information.First, auditors should classify audit findings into different types according to their different nature and arrange them in order of amounts or according to the degree of seriousness.Secondly, the selection of audit evidence should be able to support the disclosed problems.Evidence should be chosen according to the principles of sufficiency, relevance, objectivity and lawfulness.∙Outlining and drafting the audit reportAfter summarizing and sorting out the audit findings, the audit team can discuss the outline of the audit report focusing on the following:o Whether the outline has a clear theme and reasonable structure;o Whether the outline lists clear subjects and reflects major issues to be resolved by the report;o Whether the outline contains clear facts, sufficient evidence and correct conclusions for the problems listed and whether further investigation isneeded for collection of evidence.After determining the outline, auditors can draft the audit report, discuss andrevise the draft within the audit team and ask the audit team leader to reviewand approve the draft, thereby forming the exposure draft of the audit report.∙Soliciting opinions from the audited body and revising the audit report Before submitting the audit report to the audit institution, the audit team should solicit opinions from the audited body as to whether facts acknowledged by the audit team are correct, whether the right laws and regulations are applied, whether the audit evaluation is objective, whether audit opinions and recommendations are reasonable and effective.The audited body should present its written comments to the audit team or audit institution 10 days within its receipt of the audit report. Where the audited body fails to do so within the prescribed time limit, it is regarded that the audited body has no objection to the audit report. Upon receipt of comments from the audited body, however, the audit team should study them in an earnest manner.For disagreements with the audit report due to obscure facts and insufficientKPMG – BARENTS GROUP LLC 2001 NOVEMBER ADB CNAO AUDIT STANDARDS PROJECT evidence, the audit team should make further verification and supplementation.Where the audited body holds that the audit report makes inappropriate reference to laws and regulations, necessary adjustments should be made. For the audited body’s disagreement with the audit team’s evaluation, audit opinions andrecommendations, auditors should adopt the audited body’s reasonable comments.The audit team should also explain its reasons for not adopting certain writtencomments made by the audited body.In conclusion, the audit team should produce an explanation on the audited body’s feedback on the exposure draft and submit it to the audit institution together with the report itself for review and approval.Reviewing the audit reportAfter receiving the audit report submitted by the audit team, the audit institution should ask full-time reviewers or organization to review the report and produce review opinions.Examining and approving the audit report by the audit institutionAfter the reviewing process, the audit institution will examine and approve the audit report. For audit reports on ordinary audit items, competent members of the top management of the audit institution can carry out this job while audit panel meetings will examine and approve reports on material items. In this process, the audit institution focuses on the following:∙Whether facts related to the audit items are clear and whether audit evidence is solid;∙Whether the audited body gives right comments on the audit report and whether the review organizations or reviewers produce correct review opinions;∙Whether audit evaluation is appropriate;∙Whether judgmental opinions and recommendations for punitive measures concerning irregular actions are correct, lawful and appropriate.REQUIREMENTS FOR A QUALITY REPORTTo ensure that the audit report is of high quality and plays an effective role, auditors should meet the following requirements in preparing the report:KPMG – BARENTS GROUP LLC 2001 NOVEMBER ADB CNAO AUDIT STANDARDS PROJECT ∙Clear facts and true dataFacts listed in the audit report should be clear while data should be accurate, true and reliable. Origins and causal relations should be clarified. These will enable the audit institution to carry out correct evaluation and draw correct conclusion of the audit items and the report users to gain a correct understanding of the report.∙Complete contents and clear prioritiesThe audit report must contain complete contents so as to give a complete andaccurate reflection of the audit results and make correct evaluation of thetruthfulness, compliance and effectiveness of the audited body’s revenues and expenditures within a certain period. To begin with, the report must be complete in its basic elements. Secondly, details of the report should be able to reflect the actual situation of the audited body. Meanwhile, the audit report should focus on priorities.∙Clear arrangement of ideas and reasonable structureTo promote its readability and enable the users to make correct judgments and decisions, the audit report should arrange ideas in a clear and reasonable structure.Clear arrangement of ideas means summarization of the contents and arrangement in a logical way. Each paragraph should focus on a single main idea whileinterrelated to other paragraphs. Issues of the same type should be stated in the same paragraph or section instead of scattered among several paragraphs.Similarly, the same paragraph should not attempt to explain several differentissues.Reasonable structure means that the framework of the report should meet standard requirements with reasonable arrangements of major and minor issues. In general, major issues are stated first followed by minor ones. When stating an issue, facts should be given first, followed by the judgement on their nature, production of recommendations for punitive measure. In other words, the actual situation is put forward at the beginning, followed by evaluation, opinions and recommendations.∙Sufficient evidence and correct judgmentThe audit report should be based on facts using evidence to prove such facts.Relevant laws and regulations should be regarded as the criteria for judgement.Evidence used in the report must be reliable and sufficient to support the audit opinions. To make judgments on the nature of the audit items, auditors mustKPMG – BARENTS GROUP LLC 2001 NOVEMBER ADB CNAO AUDIT STANDARDS PROJECT grasp the fundamental features of the items and refer to appropriate laws andregulations. If using references, they should quote the relevant legal article in addition to the name and reference number of the document so that theirevaluation and recommendations can be more convincing.∙Concise wording and accurate expressionThe audit report is an official document of the audit institution. Therefore, reports should be concise and correct in wording and conform to the format of auditdocumentation. Sticking to the principle of making clear explanations forconcerned issues, auditors should use qualitative, quantitative, judgmental and reflective words in preparing the audit report. In short, the report should use plain words to help the users understand. Obscurity and exaggeration should be strictly avoided.∙Compliance with principles and adherence to factsCompliance with principles means that the audit report should make fairevaluation of the truthfulness, compliance and effectiveness of audit itemsaccording to relevant laws and regulations. A firm attitude should be maintained in this process. To be more specific, auditors should make their judgment of the nature of audit findings and produce their recommendations for punitive measures strictly on the basis of facts and with the use of legal criteria. They should neither withdraw in the face of contradictions nor avoid heavier responsibilities to assume lighter tasks.Adherence to facts means that the audit report should disclose the true situation and problems of the audited body without overstatement or understatement. Audit evaluation should be appropriate, i.e., pointing out shortcomings while affirming achievements. For problems existing in the audited body, the audit report should analyze their causal relations and the larger context in a fair and objective manner instead of imposing punitive measures in simplistic ways.。
审计证据及相关案例分析
据作假了。
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案例分析作业
?郎咸平对科龙公司的“造假”分析。 ?毕马威事务所一些非常有启发性的案例研究,
有兴趣的学生可以转到 /kpmguiuccases/cases/index.html
?当时审计就被认为是验证财务报表数据与会计记 录和文件的一致性。 McKesson & Robbins 案暴露 了这种观念的局限性,美国证券交易委员会 (SEC)此后强制要求审计师突破会计资料对存 货监盘和对应收账款函证。
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一、审计证据的内容
供应商
消费者
合作联盟
客户企业
?“试验公路”实际材料使用数和建成后测量的数 额之间差异率就是估计损失率。
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案例1:印尼KDP项目审计:哈佛大学 Benjamin 教授取证方法
(2)材料价格
?地区材料价格差异; ?运输成本; ?供应商(供应承包商、建筑供应商店、卡车司机
以及采石场工人)。 ?项目使用的每种材料,如果获得 3-5个不同价格,
?审计证据的可靠性受其性质和来源的影响, 并取决于获取审计证据的具体环境。
?(1)提供证据者的独立性;
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案例1:印尼KDP项目审计
?世界银行项目组设计了“村级责任会议”为 主的确保项目资金正确使用的机制。
?项目资金分三阶段发放给每村的执行小组, 分别是 40% 、40% 和20% 。为了获得后续 资金,执行小组必须向全村“公开会议”陈 述责任报告,解释资金是如何使用的。
四大会计师事务所之一尽职调查所需资料清单中英文对照
Target – Project [ ]Information Request List (“IRL”) – Accounting and TaxAs of [ , ]审视对象—项目会计及税务资料清单截止年月日The following is IRL for conducting a review of financial, certain operational and tax information of ________(the “Group”; references to “Company” or “Target” refer to any of the subsidiaries or legal entities of the Group). The “historical period” referred to herein is defined as the years ended___________, ______, and ______ (“Fiscal______, _______and ______”) and the ____ months ended _________, ______and ______ (“Interim _____ and ______”). Thus, the historical period has ____ separate periods within it. Please note that this IRL has three sections: I. Financial and Accounting; II. Tax; and III. Discussion Items.如下为对__________(如下简称“贵集团”;倘提及“贵公司”或“审视对象”乃指贵集团之任何子公司或法定实体)进行旳财务、经营及税务各方面旳审视,所需由贵公司准备旳资料清单。
临床监察员专业术语和职位英文描述
缩略语英文全称中文全称ADE Adverse Drug Event 药物不良事件ADR Adverse Drug Reaction 药物不良反应AE Adverse Event 不良事件AI Assistant Investigator 助理研究者BMI Body Mass Index 体质指数CI Co-investigator 合作研究者COI Coordinating Investigator 协调研究者CRA Clinical Research Associate 临床监查员(临床监察员)CRC Clinical Research Coordinator 临床研究协调者CRF Case Report Form 病历报告表CRO Contract Research Organization 合同研究组织CSA Clinical Study Application 临床研究申请CTA Clinical Trial Application 临床试验申请CTX Clinical Trial Exemption 临床试验免责CTP Clinical Trial Protocol 临床试验方案CTR Clinical Trial Report 临床试验报告DSMB Data Safety and monitoring Board 数据安全及监控委员会EDC Electronic Data Capture 电子数据采集系统EDP Electronic Data Processing 电子数据处理系统FDA Food and Drug Administration 美国食品与药品管理局FR Final Report 总结报告GCP Good Clinical Practice 药物临床试验质量管理规范GLP Good Laboratory Practice 药物非临床试验质量管理规范GMP Good Manufacturing Practice 药品生产质量管理规范IB Investigator’s Brochure 研究者手册IC Informed Consent 知情同意ICF Informed Consent Form 知情同意书ICH International Conference on Harmonization 国际协调会议IDM Independent Data Monitoring 独立数据监察IDMC Independent Data Monitoring Committee 独立数据监察委员会IEC Independent Ethics Committee 独立伦理委员会IND Investigational New Drug 新药临床研究IRB Institutional Review Board 机构审查委员会IVD In Vitro Diagnostic 体外诊断IVRS Interactive Voice Response System 互动语音应答系统MA Marketing Approval/Authorization 上市许可证MCA Medicines Control Agency 英国药品监督局MHW Ministry of Health and Welfare 日本卫生福利部 NDA New Drug Application 新药申请NEC New Drug Entity 新化学实体NIH National Institutes of Health 国家卫生研究所(美国)PI Principal Investigator 主要研究者PL Product License 产品许可证PMA Pre-market Approval (Application) 上市前许可(申请)PSI Statisticians in the Pharmaceutical Industry 制药业统计学家协会QA Quality Assurance 质量保证QC Quality Control 质量控制RA Regulatory Authorities 监督管理部门SA Site Assessment 现场评估SAE Serious Adverse Event 严重不良事件SAP Statistical Analysis Plan 统计分析计划药物临床试验网受试者招募SAR Serious Adverse Reaction 严重不良反应SD Source Data/Document 原始数据/文件SD Subject Diary 受试者日记SFDA State Food and Drug Administration 国家食品药品监督管理局SDV Source Data Verification 原始数据核准SEL Subject Enrollment Log 受试者入选表SI Sub-investigator 助理研究者SI Sponsor-Investigator 申办研究者SIC Subject Identification Code 受试者识别代码SOP Standard Operating Procedure 标准操作规程SPL Study Personnel List 研究人员名单SSL Subject Screening Log 受试者筛选表T&R Test and Reference Product 受试和参比试剂UAE Unexpected Adverse Event 预料外不良事件WHO World Health Organization 世界卫生组织WHO-ICDRA WHO International Conference of Drug Regulatory Authorities WHO国际药品管理当局会议Active Control 阳性对照、活性对照Audit 稽查Audit Report 稽查报告Auditor 稽查员Blank Control 空白对照Blinding/masking 盲法/设盲Case History 病历Clinical study 临床研究Clinical Trial 临床试验Clinical Trial Report 临床试验报告Compliance 依从性Coordinating Committee 协调委员会Cross-over Study 交叉研究Double Blinding 双盲Endpoint Criteria/measurement 终点指标Essential Documentation 必需文件Exclusion Criteria 排除标准Inclusion Criteria 入选标准Information Gathering 信息收集Initial Meeting 启动会议Inspection 检察/视察 copyright Institution Inspection 机构检察Investigational Product 试验药物Investigator 研究者Monitor 监查员(监察员)Monitoring 监查(监察)Monitoring Plan 监查计划(监察计划) Monitoring Report 监查报告(监察报告) Multi-center Trial 多中心试验Non-clinical Study 非临床研究Original Medical Record 原始医疗记录Outcome Assessment 结果评价Patient File 病人档案Patient History 病历Placebo 安慰剂创始人袁旭Placebo Control 安慰剂对照Preclinical Study 临床前研究Protocol 试验方案Protocol Amendments 修正案Randomization 随机Reference Product 参比制剂Sample Size 样本量、样本大小Seriousness 严重性Severity 严重程度Single Blinding 单盲Sponsor 申办者Study Audit 研究稽查Subject 受试者Subject Enrollment 受试者入选Subject Enrollment Log 受试者入选表Subject Identification Code List 受试者识别代码表Subject Recruitment 受试者招募Study Site 研究中心Subject Screening Log 受试者筛选表System Audit 系统稽查Test Product 受试制剂Trial Initial Meeting 试验启动会议Trial Master File 试验总档案Trial Objective 试验目的Triple Blinding 三盲Wash-out 洗脱Wash-out Period 洗脱期introductionQuintiles Transnational Corp. helps improve healthcare worldwide by providing a broad range of professional services, information and partnering solution s to the pharmaceutical, biotechnology and healthcare industries. Quintiles helps its customers compress the time it takes to bring a drug from discovery through regulatory approval; accelerate the launch of products to peak sales, build effective sales forces and manage product portfolios more efficiently; and achieve strategic and financial objectives by offering tailored alternatives to traditional fee-for-service product development and commercial services agreements. Headquartered near Research Triangle Park, North Carolina, Quintiles was founded in 1982 and hasmore than 16,000 employees and offices in over 50 countries. Quintiles Medical Development (Shanghai) Co., Ltd. is a wholly owned subsidiary of Quintiles Transnational Corp. Further information, please visit our global websiteJob title:Clinical ProjectManager(临床项目经理)RESPONSIBILITIESManage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures.Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance.Serve as primary project contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to.Collect information on team performance against contract, customer expectations, and project baselines.Lead problem solving and resolution efforts to include management of risk, contingencies and issues.Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.Provide input for the development of proposals for new work and manage project budgets.Provide input to line managers of their project team members' performance relative to project tasks.Prepare and present project information at internal and external meetings. Participate in proposal development and in the bid-defense process with guidance and supervision.Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site/visits and ongoing mentoring of CRA team. REQUIRED KNOWLEDGE, SKILLS AND ABILITIESIn depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelinesGood therapeutic and protocol knowledgeStrong communication and interpersonal skills, including good command of English languageGood problem solving skillsDemonstrated ability to deliver results to the appropriate quality and timeline metricsGood teamwork skillsExcellent customer service skillsGood presentation skillsGood judgmentStrong software and computer skills, including MS Office applicationsAbility to establish and maintain effective working relationships with coworkers, managers and clientsMINIMUM REQUIRED EDUCATION AND EXPERIENCEBachelor's degree in life sciences or related field and 5 years' clinical research experience including 2 years' project management experience and experience in clinical operations; or equivalent combination of education, training and experience. Job title:Clinical Trials AssistantLocation:BeijingResponsibilitiesAssist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for accuracy and completeness.Assist CTLs with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow. Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.May perform assigned administrative tasks to support team members with clinical trial execution.All responsibilities are essential job functions unless noted as nonessential (N).Required knowledge, skills and abilitiesAwareness of knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelinesKnowledge of applicable protocol requirements as provided in company trainingComputer skills including proficiency in use of Microsoft Word, Excel and PowerPointStrong written and verbal communication skills including good command of English languageEffective time management and organizational skillsAttention to detail and accuracy in workAbility to establish and maintain effective working relationships with coworkers, managers and clients Minimum required education and experienceSchool diploma/certificate or educational equivalent; or equivalent combination of education, training and experienceJob title:Clinical research AssistantDescriptionQuintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster.If that is your passion, we have a place for you.Job Responsibilities:- Oversees the progress of a Clinical Trial, ensuring that it is conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable Regulatory requirements.- Administer protocol and related study training to assigned site.- Establish regular lines of communication with sites to manage ongoing project expectations and issues.QualificationsRequirements:- Degree in Science, with a major in Pharmacy, Biological / Life Sciences or Nursing from a recognized tertiary institution- Minimum 1 year of clinical monitoring experience in the pharmaceutical / CRO industry.- For Senior Research Associate position, minimum 3 years clinical monitoring experience, preferably with some experience in leading clinical teams in the region- Good knowledge of drug development process, clinical trial monitoring procedures, medical terminology and GCP/ICH guidelines- Excellent organizational and problem solving skills- Strong written and verbal communication skills- Ability to travel when requiredJob title:Senior Clinical Project ManagerDescriptionQuintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us tocreate more effective trials and determine outcomes faster.If that is your passion, we have a place for you.Responsibilities- Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles. Ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures. Implement continuous improvement activities for assigned projects.- Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance.- Serve as primary project contact with Sponsor to ensure communication is maintained and continuously improved and reporting schedules are adhered to.- Report on team performance against contract, customer expectations, and project baselines to management.- Lead problem solving and resolution efforts to include management of risk, contingencies and issues. Develop proactive contingency plans to mitigate clinical risk.- Identify quality issues within the study through regular review of site communications, monitoring visit reports, data flow information and quality assurance audit findings to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.- Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.- Provide input for the development of proposals for new work and project budgets.- Provide input to line managers of their project team members performance relative to project tasks. Recommend team members further professional development. Support staff development. Mentor less experienced CPMs.- Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site visits and ongoing mentoring of CRA team.- Prepare and present project information at internal and external meetings.- Participate in proposal development. May lead bid defense presentations in partnership with Business Development and Senior Clinical Project Management staff.- Define project workloads and assignments. Develop and oversee maintenance of internal databases and project plansQualifications- Bachelors degree in life sciences or related field and 7 years clinical research experience including 4 years project management experience and experience in clinical operations; or equivalent combination of education, training and experience.- In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines- In depth therapeutic and protocol knowledge- Strong communication and interpersonal skills, including good command of English language- Strong organizational and problem solving skills- Demonstrated ability to deliver results to the appropriate quality and timeline metrics- Good team leadership skills- Effective mentoring and training skills- Excellent customer service skills- Effective presentation skills- Ability to manage competing priorities- Strong software and computer skills, including MS Office applications- Ability to establish and maintain effective working relationships with coworkers, managers and clients.Job title:Manager, Clinical Operations (China - Beijing)DescriptionQuintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster.If that is your passion, we have a place for you.Job Responsibilities:- Responsible to lead and manage the project team on regional or global studies- Responsible for designing and overseeing the implementation of project specific procedures to ensure that the study goals are met- Participate in clinical operations quality or process initiatives.Qualifications- Degree in Science, with a major in Pharmacy, Biological / Life Sciences or Nursing from a recognized tertiary institution- At least 7 years of experience working on clinical trials with 3 years experience in a leadership capacity.- Advanced knowledge and ability to apply GCP/ICH and applicable regulatory guidelines- Strong leadership skills- Excellent organizational and problem solving skills- Effective time management skills and ability to manage competing priorities- Strong written and verbal communication skills- Able to travel when required临床实验助理Job Responsibilities:1、Assist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintainingclinical systems that track site compliance and performance within project timelines.2、Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for accuracy and completeness.3、Assist CTLs with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.4、Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.5、Provide administrative support to team members with clinical trial execution. Requirements:1、Awareness of knowledge of applicable clinical research regulatory requirements;i.e.,Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.2、Knowledge of applicable protocol requirements as provided in company training. Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.3、Strong written and verbal communication skills including good command of English language4、Attention to detail and accuracy in work.5、Diploma or bachelor degree;or equivalent combination of education, training and experienceCRASkills• Strong computer and internet skills including knowledge of MS-Office products such as Excel,Word• Strong regulatory knowledge including GCP• Excellent interpersonal, verbal and written communication skills• Sound problem solving skills• Ability to successfully work in a (‘virtual’) team environment• Sound presentation skills• Consultative skills• Client focused approach to work with the ability to interact professionally within a clientorganization• Ability to prioritize multiple tasks and achieve project timelines• Able to take initiative and work independently• Sense of urgency in completing assigned tasks• Able to travel a minimum of 65% on average• Holds a driving license where required• Effective time management in order to meet daily metrics or team objectives• Shows commitment to and performs consistently high quality workEducation• Educated to degree level (biological science, pharmacy or other health-related discipline preferred), equivalent nursing qualification or other equivalent experienceLanguage Skills• Competent in written and oral English.Minimum Work Experience• Previous work experience (e.g. CR Assistant, nursing, laboratory, data management) would beadvisable药品安全经理岗位职责:1、建立药物安全工作的SOP体系1)建立与药物安全有关的不良事件收集、员工和研究者培训、严重不良事件报告、定期不良事件更新报告、临床方案和报告审阅、说明书审阅、文档管理等相关SOP体系;2)进行年度SOP回顾,必要时进行更新2、管理和培训1)对药物安全专员进行工作指导、检查、培训、辅导和业务管理;2)根据需要对公司相关部门员工、研究者和CRO公司CRA进行相关SOP培训,并记录培训结果;3)与公司相关部门协调建立建全不良事件收集渠道;4)制定ACN药物安全工作的发展规划和年度计划;3、审阅临床研究方案、ICF/CRF、定期安全更新报告、临床报告和说明书1)了解国内外药品临床开发的进展及相关资料;2)参与临床试验方案的讨论,并给出有关药物安全性方面的意见和建议;3)审阅临床试验方案(包括PMS)、ICF和CRF,给出合理的意见和建议,并签字确认;4)审阅并签发药物安全专员准备的定期安全更新报告5)审阅临床试验报告和说明书的安全性内容或信息,并给出合理的意见或修改建议;4、临床试验过程中不良事件收集和严重不良事件报告1)根据CRA(CRO公司)提供的严重不良事件报告表准备英文报告,并在规定时限内向API PV报告;2)对严重不良事件进行跟踪,并及时向API PV报告;3)对于ACN发起的临床研究,DSO应将方案中有关药品安全性的内容以英文报告给API PV, 在取得临床研究报告后,将报告中药物安全性部部分的内容以英文报告给API PV.4)对于由研究者发起并得到ACN支持的研究,督促研究者及时向DSO报告研究过程中的不良事件,DSO在规定的时间内向API PV提交AE报告;5)在临床试验过程中向SFDA, 试验基地及伦理委员会报告SUSAR Case; 6)与临床开发部门和CRO公司进行良好的沟通以取得支持;5、其他1)协助注册人员准备多中心临床试验的风险控制计划;2)与API PV部门进行有效的沟通与交流;3)接受API PV或监理管机构的审计4)定期接受有关药物安全的培训,了解有关药物安全的最新动态和知识;5)完成部门经理交办的其他任务工作要求:知识技能■药理学、或临床医学相关专业学士以上学位;■与临床有关的高等知识(病理生理学、诊断、内科学、临床药理学等);■优秀的领导和沟通协调能力■计划能力,分析和解决问题能力;■良好的计算机、人际关系技能;■能够清晰、简洁、有效地通过电话和书面进行沟通;■英语口语和书写流利;工作经验■ 5年及以上药物安全相关工作经验和管理经验;■跨国制药公司工作经历;■对药品安全有关法规和指南有正确的理解;■与药品警戒领域的专家能够进行良好的沟通和联络;。
GMP计算机化审计追踪相关知识一
审计追踪审核的法规要求Since 2011, Annex 11"Computerised Systems" of the EU GMP Guideline has demanded records of all GMP relevant changes and deletions to be implemented as a system-integrated Audit Trail: the reasons for changes and deletions must be documented. Audit Trails must be available, convertible into a generallyreadable form and checked regularly.自2011年,EU GMP指南附录11《计算机化系统》要求所有GMP 相关的修改和删除应记录作为系统完整性的审计追踪:应记录修改和删除的理由。
审计追踪应被激活,并转换成一般可读的形式,以及进行定期检查。
The PIC/S draft "Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments"from August 2016 also defines Audit Trails and provides comprehensive review requirements.PIC/S草案“受法规约束的GMP/GDP环境下数据管理和完整性良好规范”自2016年8月也定义了审计追踪,并提供了全面的审核要求。
Pharmaceutical companies should upgrade their software so that the functionality for Audit Trails is included. Through this, all events in the system can be recorded and all activities regarding the collection,evaluation, deletion and overwriting of data for the Audit Trail Review are made available.制药企业应升级其软件以包括审计追踪功能。
ACCA P7必考Group Auditing集团报表审计七步走
P7必考Group Auditing集团报表审计七步走译者:集团审计是P7必考的必选题目,而且考的内容都比较重量级,比如:业务风险(BR),重大错报风险(RMM), 对一两个财务事项的审计程序,初次审计考虑事项,职业道德和专业话题等。
本文是对一篇最近的考官文章(原版英文6页)的改编翻译,并梳理成七个步骤,看起来一目了然(为了更直观表达部分简化处理)。
这是篇比较全面讲集团审计的文章,值得好好理解。
本文内容主要属于ISA600范畴,Special Considerations – Audits of Group FSs (Incl. the Work of Component Auditors。
1接单Acceptance of Engagement考虑5个问题:1)Skill; 2) Restriction; 3)Components; 4) TWO opinions; 5) No reference1)事务所是否有必需的专业能力Professional skills:Audit partner each year formally assesses whether it is appropriate to act as group auditor. 合伙人每年评估事务所是否有执行该集团审计的专业能力,否则辞职;2)客户(母公司)管理层是否有意限制提供信息Restriction placed by Parent company mgt on info:Resign or disclaim opinion if resignation is not legally possible. 如果是,就辞职或拒绝发表意见;3)子公司审计师协调Component auditor: Group auditor must form their own concurring opinion on any judgmental areas; review 3P’s files, understand work done, reason for the work & conclusions from that evidence. 集团审计师必须(和子公司审计师)在需要判断的领域形成一致意见。
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Lecture 11 One definition of an audit of financial and other information:An audit is an investigation or a search for evidence to enable reasonable assurance to be given on the truth and fairness of financial and other information by a person or persons independent of the preparer and persons likely to gain directly from the use of the information, and the issue of a report on that information with the intention of increasing its credibility and therefore its usefulness.2 Justification of auditReliability /Reassurance/ InsuranceUncertainty/ Complexity/ Creditability /Need for Independence3 Four Parties in the Auditing environment4 Truth and fairness in accountingAuditors try to collect sufficient appropriate evidence to prove the financial statements are true and fair before giving an opinion.A major risk for auditors is that they may give an inappropriate opinion because they have failed to identify business risks and to collect the necessary evidence.5 The audito rs’ code: the fundamental principles of independent auditingAccountability/Integrity/Objectivity and Independence/Competence/Rigor/Judgment Clear, complete and effective communication /Association/providing value6 The postulate of auditing1.The primary condition for an audit is that there is a relationship of accountability or asituation of public accountability.2.The subject matter of accountability is too remote, too complex and/or of too greata significance for the discharge of the duty to be demonstrated without the process ofaudit.3. Essential distinguishing characteristics of audit are the independence of its status andits freedom from investigatory and reporting constraints.4. The subject matter of audit, for example, conduct, performance or achievement or recordof events or state of affairs or a statement of fact relating to any of these, is susceptible to verification by evidence.5. Standards of accountability,for example, conduct, performance, achievement andquality of information can be set for those who are accountable: actual conduct, etc.can be measured and compared with these standards by reference to known criteria and the process of measurement and comparison requires special skill and judgement.6. The meaning, significance and intention of financial and other statements and data,which are audited, are sufficiently clear that the credibility given thereto as a result of audit can be clearly expressed and communicated.7. An audit produces an economic or social benefit.7 The concepts of auditing: credibility, process, communication, performance8 Basic audit frameworks9Summary of principlesReliability aspect: truth and fairnessAudit is form of investigation, using a number of useful techniques.The auditor has to behave in a competent and independent manner.Audit is a search for evidence to arrive at what the auditor perceives to be the truth.An attitude of professional skepticism should be adopted.Do not assume business people are engaged in fraudulent activity.Lecture 21 Introduction - Fundamental principles of independent auditingObjectivity - impartial opinions unaffected by bias, prejudice, compromise and conflicts of interest.Independence - free from situations and relationships which would make it probable that a reasonable and informed third party would conclude that the auditors’ objectivity either is impaired or could be impaired2 Independence- by definitionThe social concept of audit is a special kind of examination by a person other than the parties involved which compares performance with expectation and reports the result; it is part of the public and private control mechanism of monitoring and securing accountability.’(Flint (1988) defines audit in broad terms)3 Mautz and Sharaf ----Two types of independenceA Close relationship which the profession of public accounting has with business– Apparent financial dependence– Existence of a confidential relationship– Strong emphasis on service to managementB The organization of the profession– Tendency towards the emergence of a limited number of firms– Lack of profession solidarity–Tendency to introduce ‘salesmanship’.4 Shockley’s concept ual model on Conflict, power of auditor and client and effect onperceived independenceFactors as having an impact on the auditor’s ability to withstand pressure:1. Provision of non-audit or non-assurance services, termed management advisory services (MAS).2. Competition in the auditing profession (competition).3. The period for which the auditor has held the position (tenure).4. Size of the audit firm (size).5. The flexibility of accounting standards (accounting flexibility).6. The degree of severity of professional sanctions and their application (professional sanctions).7. The extent of the auditor’s legal liability to third parties (legal liability).8. The fear the auditor might have of losing clientele and of losing his/her reputation (fear of losing clientele, reputation)5 Pressures affecting independence might arise from6 Potential threats to objectivity(a) Self-interest (b) Self-review(c) Advocacy (d) Familiarity(e) Intimidation7 Specific threats to integrity, objectivity and independence•Financial, business, employment and personal relationships•Long association with the audit engagement•Fees, remuneration and evaluation policies, litigation, gifts and hospitality •Non-audit (or non-assurance) services provided to audit clients8 General principles of the IFAC code(a) Integrity– straightforward and honest in all professional and business relationships.(b) Objectivity– no bias, conflict of interest or undue influence of others to override professional or business judgments.(c) Professional competence and due care – maintain professional knowledge and skill at level required to ensure client or employer receives competent professional services based on current developments in practice, legislation and techniques, and act diligently and in accordance with applicable technical and professional standards.(d) Confidentiality– respect confidentiality of information acquired as a result of professional and business relationships, and not disclose any such information to third parties without proper and specific authority, unless a legal or professional right or duty to disclose, nor use the information for personal advantage of the professional accountant or third parties.(e) Professional behavior– to comply with relevant laws and regulations and avoid any action that discredits the profession.9 Safeguards to counter threats to integrity, objectivity and independence➢Safeguards created by profession, legislation or regulation➢Educational, training and experience requirements for entry➢Continuing professional development requirements➢Corporate governance regulations➢Professional standards➢Professional/regulatory monitoring and disciplinary procedures➢External review by legally empowered third party of reports, returns, communications or information produced by a professional accountant❖Safeguards in the work environment❖Firm-wide safeguards, such as leadership of firm es tablishing ‘tone at the top’ and control environment❖Engagement specific safeguards, such as review by EQCR (not part of assurance team) of assurance work performed❖Safeguards within client’s systems and procedures10 Audit expectations gap – definition•Common element in the various definitions of the gap is that auditors are performing ina manner which is at variance with the beliefs and desires of others who are partyto or interested in the audit.11Chapter 17 Fraud and going concern1 Introduction to fraud•Fraud: ‘Intentional act by one or more individuals among management, those charged with governance, employees or third parties, involving the use of deception to obtain an unjust or illegal advantage.’ (ISA 240)•Managerial fraud or fraud by those charged with governance (TCWG):– Important in context of the financial statements– More difficult for the auditors to detect.•Fraud can involve participation of third parties.1.Reporting fraud occurred or suspected may be required by law, such as moneylaundering legislation.2.Auditors take seriously reporting of fraud because they owe a duty ofconfidentiality to their clients.3.Definition of money laundering is wide and includes a criminal offence that givesrise to some benefit.Case of Sasea Finance Limited (In liquidation) vs KPMG (2000) – an example involving fraud and auditors’ duty to report to a third party.2 Responsibility for fraud detectionISA 210 – management responsible for such internal control‘is necessary to enable the preparation of financial statements that are free from material misstatement, whether due to fraud or error’.ISA 240 – objectives of auditor:‘To identify and assess the risks of material misstatement of the financial statements due to fraud’ and ‘to obtain sufficient appropriate audit evidence regarding the assessed risks of material misstatement due to fraud, through designing and implementing appropriate responses.’Broad audit approach:1)Get management estimate of extent to which financial statements materially misstatedby fraud.2)Determine entity procedures to identify and respond to risks of fraud – tone set.3)Maintain attitude of professional skepticism during planning – possibility of fraud.4)Plan and conduct audit tests to limit possibility that material fraud goes undetected.5)Consider factors increasing possibility of fraud.Change in approach to fraud:▪Greater focus to material misstatements of financial statements.▪Acknowledging greater risk to auditor lies in failure to detect misstatements rather than failure to detect the theft of inventories or cash.▪Misappropriation of assets unlikely to be sufficiently material to distort the truth and fairness of the financial statements.▪Material misstatements in the financial statements often arise from overstatement of revenue.3 Why fraud is difficult to detect?A.Inherent limitations in audit techniques and tests, including sampling.e of deceit, collusion and other means to conceal well-planned and executed fraud(often by individuals with responsible role in company).C.Fact that auditors only required to arrive at an opinion on the financial statements(evidence in terms of persuasiveness) rather than give a guarantee.D.Limit to effectiveness of internal controls.4 Fraudulent financial reporting achieved by…1.Manipulation, falsification, suppression or alteration of accounting documents or records.2.Misrepresentation or omission of transactions or events.3.Inappropriate classification or disclosure in the accounts.4.Misapplication of accounting principles.5 Pressure to misrepresent financial performance may be high❖Poor financial performance❖Pressure from markets❖Directors wish to show growth continuing❖Company expanding by acquiring other companies, directors have incentive to show policy resulted in group continuing to be profitable❖Where company has liquidity problems and directors do not want shareholders or the markets to become aware of this6 Reporting fraud and error internallyAuditors’ procedures:1.Be aware of facts and ensure understood situation correctly.2.Discuss with management or audit committee.3.TCWG take action on reported suspicions of fraud/error.4.Document process until satisfactory resolution.5.Obtain copies of false documents, if any.Responsibilities of the directors:1.Develop appropriate control environment.2.Establish strong & effective internal controls.3.Encourage strong ethical environment.4.Establish audit committee to whom the auditors can report.5.Conduct review of effectiveness of company’s internal controls; report to shareholders.7 Consideration of law and regulationsLaw and regulations relating directly to financial statements: auditors obtain audit evidence of compliance. Companies Acts or legislation relating to particular commercial sectors.Audit procedures:–Obtain understanding of laws and regulations of industry, determine how entity ensures compliance.– Inspect correspondence with regulatory/licensing authorities.– Discuss with management if aware of non-compliance.– Consult with lawyers.– Auditor gathers sufficient appropriate audit evidence to give assurance entity has complied with law and regulations.Audit reporting:1 If uncertain about potential financial impact--ensure matter is fully disclosed in notes to the accounts and refer to it in an explanatory paragraph in their audit report.2 If disagree with management on a material non-compliance: --issue ‘except for’ or adverse opinion.3 If limitations in scope of audit work imposed by the entity:-- issue an except for opinion ora disclaimer of opinion.8 Money laundering legislationResponsibilities on accountancy firms:– Appoint money laundering reporting officer (MLRO) to receive money laundering reports from other members of firm and report to the Serious and Organized Crime Agency.–Training employees of firm on legislation requirements and how to react to potential money laundering situation and report to MLRO.–Verifying new clients’ i dentity and keeping records of evidence.– Establishing internal procedures to forestall/prevent money laundering.Potential serious impact on auditors:A.Interim guidance for auditors stresses requirements relate to performing of accountancyservices which encompass not only audit but other services also.B.Legislation can apply to activities conducted overseas, but considered an offence if conductedin the UK.Auditors might have to seek advice from their legal advisor.。