Audit Preparation for the CCOP - Division of Cancer :审核准备CCOP分癌症
全面检查生产线的建议英语作文
全面检查生产线的建议英语作文英文回答:Comprehensive Production Line Audit.Objective: To thoroughly assess the performance and efficiency of a production line in order to identify areas for improvement and optimize overall operations.Scope: The audit will encompass all aspects of the production line, including:Equipment and machinery.Materials and inventory.Processes and workflows.Quality control measures.Workforce and training.Safety and compliance.Methodology:Data collection: Gather relevant data from various sources, such as production logs, quality reports, employee records, and equipment manuals.Site observations: Conduct on-site observations to witness the production process firsthand and identify potential bottlenecks or inefficiencies.Interviews and discussions: Engage with personnel at all levels, including operators, supervisors, managers, and engineers, to gather insights and perspectives.Analysis and evaluation: Analyze the collected data and observations to identify strengths, weaknesses, and areas for improvement.Reporting:Summary report: Provide a comprehensive overview ofthe audit findings, including key observations, recommendations, and potential cost savings.Detailed report: Present specific details of the audit, including data analysis, process mapping, and improvement suggestions.Action plan: Outline a prioritized list of recommendations and timelines for implementation.Benefits:Improved efficiency: Identify and eliminatebottlenecks and inefficiencies in the production process.Increased productivity: Optimize workflows and improve resource allocation to enhance output.Enhanced quality: Ensure that products meet qualitystandards and reduce defects.Reduced costs: Identify cost-saving opportunities through optimized operations and improved resource utilization.Increased safety: Ensure compliance with safety regulations and improve workplace conditions for employees.Timeline: The timeline for the audit will be determined based on the scope and complexity of the production line.中文回答:全面检查生产线的建议。
中国注册会计师审计准则应用指南 英语
中国注册会计师审计准则应用指南英语全文共6篇示例,供读者参考篇1The Very Important Guide for Checking NumbersHi there, kids! Today we're going to learn about a super important book called the Chinese Certified Public Accountant Auditing Standards Application Guide. That's a really long name, so let's just call it "The Number Checker's Guide" for short.This guide is like a rule book that grown-ups called auditors use when they need to check that businesses are keeping track of their money correctly. Just like you have to follow the rules in school, businesses have to follow the rules in this book when they count their dollars and cents.The Number Checker's Guide has loads of different rules and instructions. It tells the auditors exactly how they should look over all the numbers to make sure nothing is missing or wrong. That way, we can trust that the businesses are being honest about their money.Let me give you an example of how it works. Let's say you have a lemonade stand and you sell lemonade for 25 cents a cup. The Number Checker's Guide would tell the auditors how to make sure you counted up your quarters correctly at the end of the day.First, they would check that you wrote down every sale in a logbook, just like the guide says. Then they would count all the quarters in your money box and make sure the total matches the number of lemonade cups you sold according to your logbook.If the numbers don't match up, then the auditors know that there was a mistake somewhere. Either you forgot to log some sales, or maybe you miscounted your quarters. The Number Checker's Guide helps them figure out what went wrong.But it's not just about lemonade money! The Number Checker's Guide has rules for checking all kinds of numbers that businesses deal with. Like if a company orders supplies or builds a new factory, the auditors check that the costs were all recorded properly following the rules.The guide also gives instructions on how auditors should behave when they go check a business. It tells them to be honest, independent, and never take bribes or do anything shady. That'sreally important, because we need to be able to trust that the auditors aren't helping businesses cheat on their math!There are tons of different rules about all sorts of stuff like keeping documents safe, interviewing employees, checking computer programs, and more. The Number Checker's Guide is like an encyclopedia of auditing!Auditors have to study this guide really hard to learn all the rules. It's kind of like how you have to study really hard for your math tests, except their tests are way harder! After they learn it all, they can call themselves Certified Public Accountants. That's a fancy way to say they are number checking experts who follow the rules in the guide.So next time your family goes to a restaurant or buys something from a store, you can thank the auditors who use the Number Checker's Guide. Because of their hard work, we know that businesses aren't fibbing about their money. Pretty cool, huh?Learning how to check numbers properly is super important as you start to grow up. Who knows, maybe someday you'll want to get a cool job as an auditor too! But for now, you can practice by carefully counting your pennies and making sure you always follow the rules, just like the Number Checker's Guide says.篇2Title: A Fun Guide to Auditing for Kids!Hey there, kids! Have you ever wondered what auditing is all about? Well, get ready for an exciting adventure into the world of numbers and rules!Auditing is like playing detective, but instead of solving mysteries, we make sure that companies are following the right accounting rules. Think of it as a game where you have to check if everything adds up correctly.In China, we have a special set of rules called the Chinese Certified Public Accountant Auditing Standards Application Guide. These rules are like the instruction manual for auditors, telling them exactly what to do when checking a company's books.Now, let's imagine you're an auditor working for a big accounting firm. Your job is to make sure that a company's financial statements are accurate and follow all the rules. It's like being a superhero, but instead of fighting bad guys, you're fighting against mistakes and errors!First, you need to plan your audit mission. You'll decide which areas of the company you want to focus on and gather all the information you need. It's like getting your spy gear ready before going on a secret mission!Next, you'll have to assess the risks involved. Are there any areas where mistakes are more likely to happen? It's like looking for clues to find out where the trouble spots might be.Once you've identified the risks, it's time to gather evidence. You'll request documents, interview employees, and observe how the company operates. It's like collecting clues at a crime scene, but instead of fingerprints, you're looking for numbers that don't add up.As you gather evidence, you'll need to keep detailed records of everything you find. This is called documentation, and it's like keeping a secret diary of all your adventures.If you discover any errors or problems, you'll have to report them to the company. This is called issuing an audit opinion, and it's like giving the company a report card on how well they've followed the rules.But wait, there's more! After you've completed your audit, you'll need to communicate your findings to the company'smanagement and those in charge of governance. It's like having a big meeting to discuss your secret mission and how it went.Throughout the entire process, you'll need to follow the Chinese Certified Public Accountant Auditing Standards Application Guide. These rules are like your trusty guidebook, helping you navigate through the world of auditing and making sure you do everything correctly.Auditing may sound complicated, but it's really just a game of following the rules and making sure companies are playing fair. And who knows, maybe one day you'll become a superhero auditor, fighting against financial crimes and keeping the world of accounting safe!So, what do you say, kids? Are you ready to join the exciting world of auditing? Remember, with the Chinese Certified Public Accountant Auditing Standards Application Guide by your side, you'll be unstoppable!篇3The Super Important Auditing Guide for Certified AccountantsHi there, kids! Today we're going to learn about a very important book called the Chinese Certified Public Accountants Auditing Standards Application Guide. It might sound like a mouthful, but it's a crucial set of rules that accountants need to follow when they check the books and finances of companies and organizations. Think of it as a playbook that helps accountants do their jobs properly!You know how your teachers have rules in the classroom that everyone needs to obey? Well, this guide is like that, but for accountants who work with numbers and money all day. Just like you have to raise your hand before speaking in class, accountants have to follow certain steps and guidelines when they audit (that means check) a company's financial records.Now, let's imagine you're a detective, and your job is to make sure nobody is cheating or breaking any rules when it comes to money. That's kind of what auditors (accountants who do audits) do. They look at a company's books, receipts, bank statements, and other financial documents to make sure everything adds up correctly and that no one is cooking the books (which means falsifying or changing the numbers illegally).The Auditing Standards Application Guide is like a detective's handbook that tells auditors exactly what they need to do to solve the case and catch any financial wrongdoings. It covers all sorts of important topics, like how to plan an audit, what kind of evidence they need to collect, how to test different areas of a company's finances, and how to write up their final report with their findings.One of the key things this guide emphasizes is something called "professional skepticism." That means auditors can't just take a company's word for it when they say their finances are all in order. Auditors have to be like detectives who question everything and look for any clues or red flags that something might be fishy.The guide also talks about things like auditor independence, which means auditors have to be completely unbiased and not have any conflicts of interest with the company they're auditing. It's like if a detective was best friends with the suspect they were investigating – that wouldn't be fair or objective, right?Another important part of the guide covers audit risk, which is the chance that an auditor might miss something important or make a mistake in their audit. It's like if a detective overlooked a crucial piece of evidence at a crime scene. The guide helpsauditors identify and manage these risks so they can do their jobs as thoroughly as possible.Now, you might be wondering, "Why do we need all these rules and guidelines for auditors?" Well, just like you need rules in your classroom to keep things organized and fair, these auditing standards help ensure that companies are being honest about their finances. If companies weren't audited properly, they could try to hide money or lie about their profits, which could hurt investors, employees, and even the whole economy!So, the next time you see a news story about a company getting in trouble for financial misdeeds, remember that auditors and this important guide play a huge role in catching those kinds of shenanigans. By following the Auditing Standards Application Guide, auditors can be like super-detectives who keep the financial world in check and make sure everyone is playing by the rules.And who knows, maybe one day you'll grow up to be an auditor yourself, using this guide to fight financial crime and keep companies honest. But for now, just focus on following your teacher's rules in class, and you'll be well on your way to becoming a responsible citizen!篇4The Big Book of Rules for Checking the NumbersHi there! My name is Audrey and I'm going to tell you all about the really important rules accountants have to follow when they check a company's financial records. It's kind of like a big rule book that helps them do their jobs properly. Are you ready? Let's go!First up, we have the Ethics rules. These rules remind accountants to always be honest, keep things fair, stay independent from the companies they check up on, and maintain professional behavior. It's kind of like the rules your teacher has about being a good student and treating everyone with respect. The accountants have to prove they follow these Ethics rules before they can even start their work.Next, there are the big Risk Assessment rules. This part is all about understanding the company really well before digging into the numbers. The accountants need to learn about the type of business, any risks it might face, the internal controls it has to prevent mistakes or fraud, and anything else that could affect the financial statements. It's like a detective gathering all the background information before investigating a crime scene.Then we get into the really meaty stuff - the Audit Evidence rules. These tell the accountants exactly what kinds of proof they need to collect to back up the numbers in the financial reports. Things like inspecting physical inventory, confirming balances with banks, testing calculations, and examining contracts or other legal documents. It's like showing your work on a math test so the teacher knows you didn't just guess!There are also special rules for different areas like cash, inventory, investments, revenues, expenses, and so on. The accountants have to follow the correct procedures for each section. For example, the revenue rules tell them how to make sure a company properly recorded all its sales and didn't overstate its income. It's kind of like having a playbook with specific strategies for different situations in a game.Now for the hard part - if the accountants find errors or issues, they have to communicate that based on the Communication rules. Depending on how serious it is, they might have to tell the company's audit committee, update their reports, or even quit the whole audit engagement. They have to be really careful about explaining the problems clearly.There are a lot more rules in this big book, but those are some of the key chapters. The accountants basically use it as aguide to plan their work, gather evidence, and wrap things up properly. Following the rules helps give investors and the public confidence that a company's financial statements are accurate and trustworthy.Anyway, I hope this helped explain it in a simple way. Studying can be tough, but just take it step-by-step like the auditors do. Who knows, you might end up being an awesome accountant superhero someday! Now if you'll excuse me, I need to go audit my puppy's treat stash...篇5Title: Let's Learn About Auditing Standards for Accountants in China!Hey there, kids! Have you ever wondered what it's like to be an accountant? It's a pretty cool job where you get to work with numbers and help businesses keep track of their money. But did you know that accountants in China have to follow special rules called auditing standards? These standards are like a big guidebook that tells them how to do their job properly.Imagine you're playing a game, and you need to follow certain rules to win. Well, the auditing standards are kind of like that, but for accountants. They're a set of instructions that helpaccountants make sure they're doing their job correctly and honestly.So, what are these auditing standards all about? Let me break it down for you!First of all, the auditing standards are created by a group of really smart people called the Chinese Institute of Certified Public Accountants (CICPA). They're like the bosses of all the accountants in China, and they make sure everyone is playing by the same rules.The auditing standards cover all sorts of things that accountants need to do when they're checking a company's financial records. For example, they tell accountants how to plan their work, how to gather evidence, and how to report their findings.One of the most important things the auditing standards say is that accountants have to be independent and honest. That means they can't take bribes or do anything that might make them favor one company over another. They have to be fair and impartial, just like a good referee in a sports game.Another big part of the auditing standards is about risk assessment. Accountants have to look for any risks or problemsthat could affect a company's finances. It's like being a detective and searching for clues that something might be wrong.The auditing standards also talk about how accountants should communicate with the companies they're auditing. They need to ask lots of questions and share their findings with the people in charge. That way, everyone is on the same page, and the company can make any necessary changes.But wait, there's more! The auditing standards cover all kinds of other topics, like how to use technology in auditing, how to deal with special situations like fraud or legal problems, and how to report on things like environmental issues or social responsibility.Phew, that's a lot of information, right? But don't worry; accountants don't have to memorize everything all at once. The auditing standards are like a big reference book that they can go back to whenever they need help or have questions.So, why are these auditing standards so important? Well, they help make sure that companies in China are being honest about their finances. That's really important for investors, customers, and everyone else who depends on those companies. It's like having a trustworthy referee in a game, making sure everyone plays by the rules.Isn't it cool to know that there are special guidelines in place to help accountants do their jobs properly? Next time you see an accountant, you can think about all the hard work they're doing to follow the auditing standards and keep businesses running smoothly.Who knows, maybe someday you'll even want to become an accountant yourself and learn all about these auditing standards! But for now, just remember that they're like a big rulebook that helps accountants stay honest and do their jobs the right way.篇6The Awesome Auditing Adventure GuideHi there, awesome auditing adventurers! Are you ready to learn all about the super cool world of auditing? Get ready to put on your detective hats and explore the exciting rules that accountants follow when checking a company's books.First up, let's talk about what auditing actually means. You see, companies have to keep track of all their money coming in and going out - things like sales, expenses, payments to workers, and so on. Auditors are like financial detectives who make sure the numbers add up properly and that everything is on theup-and-up.In China, there are special standards that auditors have to follow to do their jobs right. These are called the Chinese Certified Public Accountant Auditing Standards. They act like a guidebook filled with important rules and steps that auditors need to take when auditing a company. It's kind of like how adventurers need to follow a treasure map to find the loot!The first big rule is about being independent and honest. Auditors have to be like fair judges - they can't take sides or be influenced by anyone. Their job is to look at the evidence and financial records objectively without any bias. It's like being an umpire at a baseball game - you call it like you see it, no favors for anyone!Next up is having the right professional skills and knowledge. Auditors need to be total math whizzes who understand all the accounting rules backward and forward. They also have to stay up-to-date on the latest auditing procedures. Companies' finances can get super complex, so auditors have to be financial experts!Planning is another crucial part of the auditing process. Just like how you'd plan a trip to the beach - packing your swimsuit, grabbing some snacks, etc. - auditors need to properly plan out their work. They figure out what areas to focus on, whatdocuments they need to look at, what risks to watch out for, and how to gather all the evidence they need. Skipping this planning stage would be like going to the beach without sunscreen - you're gonna get burned!During the actual audit work, auditors have to gather lots and lots of evidence to back up their conclusions. They pore over financial statements, accounting records, contracts, invoices, and more. It's like being a detective, gathering clues and piecing together the whole picture. Auditors have to be superdetail-oriented to catch anything fishy.Communicating is key too. Auditors share important findings with the company they're auditing and discuss any issues that come up. They have to be clear educators to explain complex accounting standards in simple terms. At the end, they provide their official auditing report and opinion on whether the company's financial records are accurate.All along the way, auditors have to create and keep incredibly thorough documentation on everything they did, found, and concluded. These audit working papers act like a trail of breadcrumbs, allowing anyone to re-trace the auditor's steps. It's how they demonstrate they followed all the auditing rules to a T.Finally, the auditing standards require auditors to continue improving through quality control reviews. Their work gets evaluated by more experienced auditors to see if they missed anything or if there are areas they can learn from. It's like getting coaching advice after a big game to up your skills for next time.Phew, that's a lot to take in! Auditing is a seriously important job with tons of complicated standards and procedures to follow. By adhering to guidelines like these, auditors promote transparency and keep the financial world in order.So thanks for joining me on this auditing adventure! I know it was a long and complex trail to navigate, but I hope you walked away with a basic understanding of these essential accounting rules. Stay curious, study hard, and who knows - you may become a top-notch auditing detective yourself one day! The corporate world needs honest auditing experts to keep things in check. Why not let that be your awesome future job?。
会计英语审计流程中的七个环节英语
会计英语审计流程中的七个环节英语Auditing is an essential process in the field of accounting to ensure the accuracy and reliability of financial information. 审计是会计领域中的一个重要过程,用来确保财务信息的准确性和可靠性。
It involves a series of steps or stages that auditors follow to evaluate a company's financial statements and internal controls. 这涉及审计人员遵循的一系列步骤或阶段,以评估公司的财务报表和内部控制。
The seven key stages in the auditing process include planning, preliminary review, control testing, substantive procedures, final review, audit report, and follow-up. 审计过程中的七个关键阶段包括计划、初步审查、控制测试、实质性程序、最终审查、审计报告和后续。
Each stage plays a crucial role in ensuring the integrity of the financial information and providing valuable insights to stakeholders. 每个阶段在确保财务信息的完整性和为利益相关者提供有价值见解方面发挥着至关重要的作用。
During the planning stage, auditors gather information about the company's operations, risks, and internal controls to develop anaudit plan. 在计划阶段,审计人员收集有关公司运营、风险和内部控制的信息,制定审计计划。
国际审计准则 ISA320
INTERNATIONAL STANDARD ON AUDITING 320AUDIT MATERIALITY(Effective for audits of financial statements for periodsbeginning on or after December 15, 2004)∗CONTENTSParagraph Introduction ...................................................................................................1-3 Materiality ..................................................................................................... 4-8 The Relationship between Materiality and Audit Risk ..................................9-11 Evaluating the Effect of Misstatements .........................................................12-16 Communication of Errors (17)International Standard on Auditing (ISA) 320, “Audit Materiality” should be read inthe context of the “P reface to the International Standards on Quality Control, Auditing, Review, Other Assurance and Related Services,” which sets out the application and authority of ISAs.∗ISA 240, “The Auditor’s Responsibility to Consider Fraud in an Audit of Financial Statements,” ISA 315, “Understanding the Entity and Its Environment and Assessing the Risks of Material Misstatement,”ISA 330, “The Auditor’s Procedures in Response to Assessed Risks,” and ISA 500, “Audit Evidence”gave rise to conforming amendments to ISA 320. The conforming amendments are effective for audits offinancial statements for periods beginning on or after December 15, 2004 and have been incorporated inthe text of ISA 320.ISA 320393AUDIT MATERIALITYIntroduction1.The purpose of this International Standard on Auditing (ISA) is to establishstandards and provide guidance on the concept of materiality and itsrelationship with audit risk.2.The auditor should consider materiality and its relationship with auditrisk when conducting an audit.3.“Materiality” is defined in the International Accounting Standards Board’s“Framework for the Preparation and Presentation of Financial Statements” inthe following terms:Information is material if its omission or misstatement couldinfluence the economic decisions of users taken on the basis of thefinancial statements. Materiality depends on the size of the item orerror judged in the particular circumstances of its omission ormisstatement. Thus, materiality provides a threshold or cut-off pointrather than being a primary qualitative characteristic w hichinformation must have if it is to be useful.Materiality4.The objective of an audit of financial statements is to enable the auditor toexpress an opinion whether the financial statements are prepared, in allmaterial respects, in accordance with an applicable financial reportingframework. The assessment of what is material is a matter of professionaljudgment.5.In designing the audit plan, the auditor establishes an acceptable materialitylevel so as to detect quantitatively material misstatements. However, both theamount (quantity) and nature (quality) of misstatements need to be considered.Examples of qualitative misstatements would be the inadequate or improperdescription of an accounting policy when it is likely that a user of the financialstatements would be misled by the description, and failure to disclose thebreach of regulatory requirements when it is likely that the consequentimposition of regulatory restrictions will significantly impair operatingcapability.6.The auditor needs to consider the possibility of misstatements of relativelysmall amounts that, cumulatively, could have a material effect on the financialstatements. For example, an error in a month end procedure could be anindication of a potential material misstatement if that error is repeated eachmonth.7.The auditor considers materiality at both the overall financial statement leveland in relation to classes of transactions, account balances, and disclosures.Materiality may be influenced by considerations such as legal and regulatoryrequirements and considerations relating to classes of transactions, account ISA 320 394AUDIT MATERIALITYISA 320 395balances, and disclosures and their relationships . This process may result in different materiality levels depending on the aspect of the financial statements being considered.8.Materiality should be considered by the auditor when:(a)Determining the nature, timing and extent of audit procedures;and(b)Evaluating the effect of misstatements.The Relationship Between Materiality and Audit Risk9.When planning the audit, the auditor considers what would make the financialstatements materially misstated. The auditor’s understanding of the entity and its environment establishes a frame of reference within which the auditor plans the audit and exercises professional judgment about assessing the risks of material misstatement of the financial statements and responding to those risks throughout the audit. It also assists the auditor to establish materiality and in evaluating whether the judgment about materiality remains appropriate as the audit progresses. The auditor’s assessment of materiality, related to classes of transactions, account balances, and disclosures, helps the auditor decide such questions as what items to examine and whether to use sampling and substantive analytical procedures. This enables the auditor to select audit procedures that, in combination, can be expected to reduce audit risk to an acceptably low level.10.There is an inverse relationship between materiality and the level of audit risk,that is, the higher the materiality level, the lower the audit risk and vice versa. The auditor takes the inverse relationship between materiality and audit risk into account when determining the nature, timing and extent of audit procedures. For example, if, after planning for specific audit procedures, the auditor determines that the acceptable materiality level is lower, audit risk is increased. The auditor would compensate for this by either:(a)Reducing the assessed risk of material misstatement, where this ispossible, and supporting the reduced level by carrying out extended oradditional tests of control; or(b)Reducing detection risk by modifying the nature, timing and extent ofplanned substantive procedures.Materiality and Audit Risk in Evaluating Audit Evidence11.The auditor’s assessment of materiality and audit risk may be different at thetime of initially planning the engagement from at the time of evaluating the results of audit procedures. This could be because of a change in circumstances or because of a change in the auditor’s knowledge as a result of performing audit procedures. For example, if audit procedures are performed prior toAUDIT MATERIALITYperiod end, the auditor will anticipate the results of operations and the financialposition. If actual results of operations and financial position are substantiallydifferent, the assessment of materiality and audit risk may also change.Additionally, the auditor may, in planning the audit work, intentionally set theacceptable materiality level at a lower level than is intended to be used toevaluate the results of the audit. This may be done to reduce the likelihood ofundiscovered misstatements and to provide the auditor with a margin of safetywhen evaluating the effect of misstatements discovered during the audit.Evaluating the Effect of Misstatements12.In evaluating whether the financial statements are prepared, in allmaterial respects, in accordance with an applicable financial reportingframework, the aud itor should assess whether the aggregate ofuncorrected misstatements that have been identified during the audit ismaterial.13.The aggregate of uncorrected misstatements comprises:(a)Specific misstatements identified by the auditor including the net effectof uncorrected misstatements identified during the audit of previousperiods; and(b)The auditor’s best estimate of other misstatements which cannot bespecifically identified (i.e., projected errors).14.The auditor needs to consider whether the aggregate of uncorrectedmisstatements is material. If the auditor concludes that the misstatements maybe material, the auditor needs to consider reducing audit risk by extendingaudit procedures or requesting management to adjust the financial statements.In any event, management may want to adjust the financial statements for themisstatements identified.15.If management refuses to adjust the financial statements and the results ofextended audit procedures do not enable the auditor to conclude that theaggregate of uncorrected misstatements is not material, the auditor shouldconsid er the appropriate mod ification to the aud itor’s report inaccordance with ISA 701, “Modifications to the Independent Auditor’sReport.”16.If the aggregate of the uncorrected misstatements that the auditor has identifiedapproaches the materiality level, the auditor would consider whether it is likelythat undetected misstatements, when taken with aggregate uncorrectedmisstatements could exceed materiality level. Thus, as aggregate uncorrectedmisstatements approach the materiality level the auditor would considerreducing audit risk by performing additional audit procedures or by requestingmanagement to adjust the financial statements for identified misstatements. ISA 320 396AUDIT MATERIALITYISA 320 397 Communication of Errors17.If the auditor has identified a material misstatement resulting from error,the auditor should communicate the misstatement to the appropriate level of management on a timely basis, and consider the need to report it to those charge d with governance in accor d ance with ISA 260 “Communication of Au d it Matters with Those Charge d with Governance.”Public Sector Perspective1.In assessing materiality, the public sector auditor must, in addition toexercising professional judgment, consider any legislation or regulation which may impact that assessment. In the public sector, materiality is also based on the “context and nature” of an item and includes, for example, sensitivity as well as value. Sensitivity covers a variety of matters such as compliance with authorities, legislative concern or public interest.。
审计五要素 英语作文
审计五要素英语作文Audit Five Elements。
Audit is an important process for companies to ensure that their financial statements are accurate and reliable. There are five key elements of an audit that must be considered in order to ensure that the audit is effective and efficient. These five elements are: risk assessment, internal control, substantive testing, audit evidence, and reporting.Risk Assessment。
Risk assessment is the first step in the audit process. The auditor must identify and assess the risks that may affect the accuracy and reliability of the financial statements. This includes identifying the risks of material misstatement, such as fraud or error, and determining the likelihood and potential impact of these risks.Internal Control。
Internal control is the second element of the audit process. The auditor must evaluate the company's internal control system to determine whether it is effective in preventing and detecting material misstatements. This includes assessing the design and implementation ofinternal controls, as well as testing their effectiveness.Substantive Testing。
2019-Audit Preparation for the CCOP - Division of Cancer :审核准备CCOP分癌症-文档资料
3. 4.
5.
Drug inventory monthly. Filing and checking packing slips against receivables and what was ordered. Ordering drug and drug disposing. Logging in and out of drug to CRAs/nurses. Responsible for tracking satellite site DARFs.
Regulatory Preparation continued
Submit new information to IRBs right away. (Check Cooperative Group websites at least monthly) Audit your IRB information from Cooperative Groups for open and closed to accrual protocols at least every two months. Permanently close trials should be audited prior to closure. Audit satellite sites at least every two months for their submissions to IRB.
Attend PRIMER, if possible, to gain perspective what is expected of IRBs
Data Management preparation
Start off tabbing shadow charts for audit when the chart is initially being put together. Color code tabs:
ready for audit审计准备
不要回答其他部门的问题
Do not answer questions that do not pertain to your dep.
用程序进行回答,避免矛盾
Use the SOP to avoid conflicting answers.
Review your procedures beforehand Provide a general response where possible Avoid going into detail, wait for the question There is a balance – don’t frustrate the Investigator
Please transfer all the related document to Document center before inspection
审计室AUDIT ROOM
• Escort: CY
Place: Motilium meeting room
CY
backup: LXF • Scriber--WX (v)
记住他手持可以挥舞的大棒叫许可证… ….
Remember he has a large club called a license, under his 我想我们都同意我的建议是合理的 control……. I'm sure we agree that
my proposal is reasonable
适当时表明此类事件很少发生If appropriate, indicate
应避免的用语
Phrases to Avoid
说实在的…… ‘To be honest.…’
我认为是这样发生的……
如何准备审计 中英版(“审核员”文档)共8张
D不o要n’给t re审co计rd员Thin特ifno权rkm。bateiofnooren iynofourmtaallakr,ead.o not be rash, take your time. Audit N otice先审想核本后卷说须,知不用焦急。
不要说 “但是有关机构的某某通知我们这样做可以,或有些地方就是这样做的〞 Do not make over-promises. 不要做过分的承诺
Do not criticize people or blame other departments in front of the auditor !
一定要确保桌应面该整洁坚〔持清场安,静最好,不不要放要文制件〕造话题
分开时关掉电脑及显示器
3 What YouDSohonuldotNOaTnDsower
questions
not
asked.
Don’t
makes!
他不该做的事不要回答没有问的东西。不要本人发明问题!
Continue working
不要让审核员打断消费/任务。
Do not give the auditor any privilege. It’s not the way to show your respect. 不要给审计员特权。这不是表现他对审核员尊重的方式。
• If the question is outside of your area of expertise or job function, state that to the Auditor. If you don’t know the answer, say so. Don’t be afraid of a “it is out of my job scope, it is better to let “some department 〞 answer that〞.
Audit Preparation for the CCOP - Division of Cancer :审核准备CCOP分癌症
Make sure information and wording of letters is correct.
Make sure that all SAEs submitted are listed in the acknowledgement letter.
Color code tabs:
Source documentation for eligibility criteria Chemotherapy cycles that include all supporting data
for those cycles
Progress notes Labs Tests Chemotherapy administration records SAE source documentation
Regulatory Preparation continued
Submit new information to IRBs right away. (Check Cooperative Group websites at least monthly)
Audit your IRB information from Cooperative Groups for open and closed to accrual protocols at least every two months. Permanently close trials should be audited prior to closure.
Attend Cooperative Groups audit preparation classes.
the gcp audit for pk study -回复
the gcp audit for pk study -回复The GCP Audit for PK StudyIntroduction:Good Clinical Practice (GCP) audits play a vital role in ensuring the quality and integrity of clinical trials. In this article, we will delve into the details of conducting a GCP audit specifically for a pharmacokinetic (PK) study. We will provide a step-by-step guide on how to prepare for and conduct the audit, highlighting the key areas of focus and the importance of adherence to GCP regulations.Step 1: Preparing for the AuditBefore conducting a GCP audit for a PK study, it is essential to familiarize yourself with the study protocol, relevant regulatory guidelines, and GCP requirements. This knowledge will help you understand the key elements of the study and ensure compliance during the audit. Additionally, it is crucial to review the investigator's brochure, case report forms, and any other relevant study documentation.Step 2: Defining Audit Objectives and ScopeDuring this step, you must clearly define the objectives and scope of the audit. The objectives may include verifying the accuracy and completeness of data collection, assessing compliance with the study protocol, or ensuring the adequate monitoring of adverse events. The scope should specify the specific aspects of the study that will be examined during the audit, such as informed consent procedures, study drug handling, and PK sample collection processes.Step 3: Selection of Audit TeamThe audit team should consist of individuals with expertise in GCP requirements and PK studies. It is essential to select team members who have a comprehensive understanding of study protocols, SOPs, data management, and statistical analysis. The team should include an experienced auditor who will lead the audit process and be responsible for coordinating and documenting the findings.Step 4: Conducting the AuditThe audit can be divided into different phases, each focusing on specific aspects of the PK study. The key areas to cover during the audit include:a. Investigator Compliance: Verify that the investigator has the necessary qualifications, training, and resources to conduct the study. Review the investigator's site file, training records, licenses, and certifications.b. Informed Consent Process: Assess the adequacy and consistency of the informed consent process. Verify that participants were fully informed about the study, its objectives, potential risks, and benefits, and that their written consent was obtained.c. Study Drug Handling: Review how the study drug was stored, dispensed, accounted for, and returned. Verify that appropriate procedures were followed to ensure the drug's integrity and accountability.d. Data Management and Monitoring: Scrutinize the data management processes, including data collection, accuracy, and integrity. Assess whether the study was adequately monitored, and any deviations or discrepancies were appropriately documented and resolved.e. PK Sample Collection: Evaluate the procedures for collecting,handling, and storing PK study samples. Confirm that the processes followed GCP regulations and study protocols. Ensure proper labeling and documentation of samples.f. Adverse Event Reporting: Verify the protocol compliance regarding adverse event reporting. Assess whether adverse events were promptly and accurately recorded, monitored, and reported as per regulatory requirements.Step 5: Documenting Audit FindingsDuring the audit, the findings and observations should be meticulously documented. Clearly note any deficiencies ornon-compliance with GCP regulations. It is imperative to provide evidence-based documentation for each finding to support your conclusions and recommendations. Incomplete or missing documentation, deviations from the protocol, or inadequate training can be reported as critical findings.Step 6: Reporting and Follow-upOnce the audit is completed and the findings are documented, generate a comprehensive audit report. The report should outline the objectives, scope, methodologies used, and a summary of thefindings with supporting evidence. Include recommendations for corrective actions to address any identified deficiencies. Ensure the report is shared with relevant stakeholders promptly.Conclusion:Conducting a GCP audit for a PK study requires meticulous planning, expertise, and adherence to GCP regulations and study protocols. By following the step-by-step guide outlined above, auditors can ensure a comprehensive assessment of the study's quality and compliance. The audit findings and recommendations serve as valuable tools for improving the conduct, integrity, and reliability of pharmacokinetic studies.。
欧洲药品GMP检查指南及附件(中英文)
GUIDE TO GOOD MANUFACTURINGPRACTICE FOR MEDICINAL PRODUCTS药品GMP检查指南.PIC/S July 2004Reproduction prohibited for commercial purposes.Reproduction for internal use is authorised,provided that the source is acknowledged.Editor: PIC/S SecretariatP.O. Box 5695CH-1211 Geneva 11e-mail: daniel.brunner@web site: :// 1 July 2004 PE 009-2TABLE OF CONTENT目录INTRODUCTION介绍 (1)CHAPTER 1 QUALITY MANAGEMENT 质量管理 (4)PRINCIPLE 原则 (4)QUALITY ASSURANCE 质量保证 (4)GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS (GMP) 药品GMP (6)QUALITY CONTROL 质量控制 (7)CHAPTER 2 PERSONNEL 人员 (10)PRINCIPLE 原则 (10)GENERAL 通则 (10)KEY PERSONNEL 关键人员 (10)TRAINING 培训 (13)PERSONAL HYGIENE 个人卫生 (14)CHAPTER 3 PREMISES AND EQUIPMENT 厂房和设备 (16)PRINCIPLE 原则 (16)PREMISES General总则 (16)Production Area 生产区域 (17)Storage Areas 储存区域 (19)Quality Control Areas 质量控制区域 (20)Ancillary Areas 辅助区域 (20)EQUIPMENT 设备 (21)CHAPTER 4 DOCUMENTATION 文件 (23)PRINCIPLE 原则 (23)GENERAL 总则 (23)DOCUMENTS REQUIRED 必需的文件 (25)MANUFACTURING FORMULA AND PROCESSING INSTRUCTIONS 生产方法和加工指示 (27)PACKAGING INSTRUCTIONS 包装指示 (28)BA TCH PROCESSING RECORDS 批加工记录 (29)BA TCH PACKAGING RECORDS 批包装记录 (30)PROCEDURES AND RECORDS 程序和记录 (32)CHAPTER 5 PRODUCTION 生产 (36)PRINCIPLE 原则 (36)GENERAL 通则 (36)PREVENTION OF CROSS-CONTAMINATION IN PRODUCTION 生产过程中防止交叉污染 (38)V ALIDATION 验证 (39)STARTING MA TERIALS 起始物料 (40)PROCESSING OPERA TIONS - INTERMEDIATE AND BULK PRODUCTS 加工操作:中间体和散装产品 (42)PACKAGING MATERIALS 包装材料 (42)PACKAGING OPERATIONS 包装操作 (43)FINISHED PRODUCTS 最终成品 (45)REJECTED, RECOVERED AND RETURNED MATERIALS 拒绝的,回收的和退回的物料46CHAPTER 6 QUALITY CONTROL 质量控制 (48)PRINCIPLE 原则 (48)GENERAL 通则 (48)GOOD QUALITY CONTROL LABORATORY PRACTICE 优良质量控制实验室实践 (49)DOCUMENTATION 文件 (49)SAMPLING 取样 (50)TESTING 检测 (52)CHAPTER 7 CONTRACT MANUFACTURE AND ANAL YSIS 合同加工和分析 (55)PRINCIPLE 原则 (55)GENERAL 通则 (55)THE CONTRACT GIVER 合同提供人 (55)THE CONTRACT ACCEPTOR 合同接受人 (56)THE CONTRACT 合同 (57)CHAPTER 8 COMPLAINTS AND PRODUCT RECALL 抱怨和产品召回 (59)PRINCIPLE 原则 (59)COMPLAINTS 抱怨 (59)RECALLS 召回 (60)CHAPTER 9 SELF INSPECTION 自检 (61)PRINCIPLE 原则 (61)ANNEX 1 MANUFACTURE OF STERILE MEDICINAL PRODUCTS无菌药品的生产 (63)PRINCIPLE (63)GENERAL (63)BLOW/FILL/SEAL TECHNOLOGY (67)TERMINALL Y STERILISED PRODUCTS (67)ASEPTIC PREPARA TION (68)PERSONNEL (68)PREMISES (70)EQUIPMENT (71)SANITATION (71)PROCESSING (71)STERILISATION (73)STERILISATION BY HEA T (74)MOIST HEAT (75)DRY HEAT (75)STERILISATION BY RADIATION (75)STERILISATION WITH ETHYLENE OXIDE (76)FILTRATION OF MEDICINAL PRODUCTS WHICH CANNOT BE STERILISED IN THEIR FINAL CONTAINER (77)FINISHING OF STERILE PRODUCTS (77)QUALITY CONTROL (78)ANNEX 2 MANUFACTURE OF BIOLOGICAL MEDICINAL PRODUCTS FOR HUMAN USE人用生物药品的生产 (79)SCOPE (79)PRINCIPLE (79)PERSONNEL (80)PREMISES AND EQUIPMENT (81)ANIMAL QUARTERS AND CARE (82)DOCUMENTATION (82)PRODUCTION (83)QUALITY CONTROL (84)ANNEX 3 MANUFACTURE OF RADIOPHARMACEUTICALS 放射性药品的生产 (85)PRINCIPLE (85)PERSONNEL (85)PREMISES AND EQUIPMENT (85)PRODUCTION (86)QUALITY CONTROL (86)DISTRIBUTION AND RECALLS (86)ANNEX 4 MANUFACTURE OF VETERINARY MEDICINAL PRODUCTS OTHER THAN IMMUNOLOGICALS MANUFACTURE OF PREMIXES FOR MEDICATED FEEDING STUFFS 除为预混合加药饲料原料生产的免疫产品以外的,兽药产品的生产 (87)THE MANUFACTURE OF ECTOPARASITICIDES (88)THE MANUFACTURE OF VETERINARY MEDICINAL PRODUCTS CONTAINING PENICILLINS (88)RETENTION OF SAMPLES (point 1.4. viii and point 6.14.) (88)STERILE VETERINARY MEDICINAL PRODUCTS (88)ANNEX 5 MANUFACTURE OF IMMUNOLOGICAL VETERINARY MEDICAL PRODUCTS免疫兽药产品的生产 (89)PRINCIPLE (89)PERSONNEL (89)PREMISES (90)EQUIPMENT (93)ANIMALS AND ANIMAL HOUSES (94)DISINFECTION - WASTE DISPOSAL (94)PRODUCTION (95)STARTING MA TERIALS (95)QUALITY CONTROL (98)ANNEX 6 MANUFACTURE OF MEDICINAL GASES药用气体的生产 (99)1. PRINCIPLE (99)2. PERSONNEL (99)3. PREMISES AND EQUIPMENT (99)4. DOCUMENTA TION (100)5. PRODUCTION (101)6. QUALITY CONTROL (104)7. STORAGE AND RELEASE (105)ANNEX 7 MANUFACTURE OF HERBAL MEDICINAL PRODUCTS草药产品的生产 (108)PRINCIPLE (108)PREMISES (108)DOCUMENTATION (108)SAMPLING (109)QUALITY CONTROL (110)ANNEX 8 SAMPLING OF STARTING AND PACKAGING MA TERIALS起始物料和包装材料的取样 (111)PRINCIPLE (111)PERSONNEL (111)STARTING MA TERIALS (111)PACKAGING MATERIAL (112)ANNEX 9 MANUFACTURE OF LIQUIDS, CREAMS AND OINTMENTS流体,霜体和膏体药品的生产 (113)PRINCIPLE (113)PRODUCTION (113)ANNEX 10 MANUFACTURE OF PRESSURISED METERED DOSE AEROSOL PREPARATIONS FOR INHALATION吸入式剂量仪的气雾剂的生产 (115)PRINCIPLE (115)GENERAL (115)PREMISES AND EQUIPMENT (115)PRODUCTION AND QUALITY CONTROL (116)ANNEX 11 COMPUTERISED SYSTEMS 计算机化系统 (117)PRINCIPLE (117)PERSONNEL (117)V ALIDATION (117)ANNEX 12 USE OF IONISING RADIATION IN THE MANUFACTURE OF MEDICINAL PRODUCTS使用离子放射生产药品 (120)INTRODUCTION (120)RESPONSIBILITIES (120)DOSIMETRY (121)V ALIDATION OF THE PROCESS (121)COMMISSIONING OF THE PLANT (122)PREMISES (124)PROCESSING (124)DOCUMENTATION (126)MICROBIOLOGICAL MONITORING (126)ANNEX 13 MANUFACTURE OF INVESTIGA TIONAL MEDICINAL PRODUCTS观察期药品的生产 (127)PRINCIPLE (127)GLOSSARY (128)QUALITY MANAGEMENT (130)PERSONNEL (130)PREMISES AND EQUIPMENT (130)DOCUMENT A TION (131)PRODUCTION (132)QUALITY CONTROL (136)RELEASE OF BATCHES (137)SHIPPING (139)COMPLAINTS (139)RECALLS AND RETURNS (139)DESTRUCTION (140)ANNEX 14 MANUFACTURE OF PRODUCTS DERIVED FROM HUMAN BLOOD OR HUMAN PLASMA生产自人类血液或人体组织分离的产品 (143)PRINCIPLE (143)GLOSSARY (144)QUALITY MANAGEMENT (144)PREMISES AND EQUIPMENT (145)BLOOD AND PLASMA COLLECTION (145)TRACEABILITY AND POST COLLECTION MEASURES (146)PRODUCTION AND QUALITY CONTROL (147)RETENTION OF SAMPLES (148)DISPOSAL OF REJECTED BLOOD, PLASMA OR INTERMEDIATES (148)ANNEX 15 QUALIFICATION AND V ALIDATION 确认和验证 (149)PRINCIPLE (149)PLANNING FOR V ALIDATION (149)DOCUMENTATION (150)QUALIFICATION (150)PROCESS V ALIDATION (151)CLEANING VALIDATION (153)CHANGE CONTROL (154)REV ALIDATION (154)GLOSSARY (154)[ANNEX 16] [QUALIFIED PERSON AND BA TCH RELEASE]*经授权的人员和批放行 (157)ANNEX 17 PARAMETRIC RELEASE参数放行 (158)1. PRINCIPLE (158)2. PARAMETRIC RELEASE (158)3. PARAMETRIC RELEASE FOR STERILE PRODUCTS (158)4. GLOSSARY (160)[ANNEX 18] [GMP GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS] 17原料药GMP 指南 (161)GLOSSARY术语表 (162)GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS药品GMP指南INTRODUCTION介绍为进一步消除药品贸易壁垒,促进许可证的一致性,以及确保整个欧洲在研发,生产和控制药品中保持高标准的质量保证,根据药品检查协会(PIC)同意,药品检查使用一致的GMP原则,和药品检查合作计划表中的欧洲药品GMP及其附录。
audit作业流程
audit作业流程英文回答:The audit process involves several steps to ensure the accuracy and reliability of financial statements. It begins with planning, where the auditor gathers information about the client's business and identifies potential risks. This step is crucial as it helps in determining the scope and objectives of the audit.Once the planning is complete, the auditor moves on to the fieldwork phase. This is where the auditor performs tests and gathers evidence to support their findings. They may conduct interviews, review documents, and perform analytical procedures to assess the client's internal controls and detect any potential errors or fraud.After completing the fieldwork, the auditor analyzes the information gathered and forms their opinion. This is done during the reporting phase, where the auditor preparesan audit report that summarizes their findings. The report includes the auditor's opinion on whether the financial statements are presented fairly and in accordance with the relevant accounting standards.Finally, the auditor communicates their findings to the client and other stakeholders. This is an important step as it allows the auditor to discuss any significant issues or recommendations for improvement. The client may also have the opportunity to respond to the audit findings and provide additional information if necessary.Overall, the audit process is designed to provide assurance to stakeholders that the financial statements are reliable and accurate. It involves careful planning, thorough fieldwork, analysis of findings, and clear communication of results.中文回答:审计作业流程包括几个步骤,以确保财务报表的准确性和可靠性。
Audit Preparation Checklist审核准备点检清单
Receiving Inspection 进料检验•COCs for resin on drawing for parts audited塑胶粒子的COC是否有产品图纸上的相关要求•Tagging of incoming material procedure 所有的物料要按程序文件规定要求贴上标签•Procedure for controlling expiration date of material过期物料的管控程序、记录•Resin Storage KANBAN board up to date 显示原材料储存情况的看板需要及时更新Chemical Warehouse 化学品仓•KANBAN Board up to date, not blocked 看板更新,安全通道不能堵塞•Safety supplies- masks, boots, gloved, goggles安全物品—口罩、酸碱鞋、手套、护目镜•Roll up door closed卷砸门必须关闭•Temperature humidity chart up to date 温湿度记录表必须是最新的•Material stored neatly物料的储存保持整洁•No out of date chemicals不能有过期的化学品Molding 注塑•Resin bags in taped foot-print area胶料袋子要放在地面胶带区分的指定区域•Resin fill logs complete胶料添加记录表必须是完整的……•Resin bins covered烤料筒必须盖好•FAI complete首件报告、首件板完整•Parameter checks complete完整的参数检查•No out of spec parameters不能有参数超出管控范围•Preventive maintenance logs complete保持定期维护保护记录的完整性•Good 5S at work station工作区保持良好的5S.•No unauthorized parameter changes未经过受控的参数表不能更改使用。
Audit Prepration for the CCOP - Division of Cancer :审核准备CCOP分癌症
Regulatory Preparation
Keep Current – start audit preparation with the initiation of a new clinical trial Organize clinical trial regulatory books by:
IRB (if you use multiple IRBs) Cooperative Groups Protocol numbers Tab and color code for: Initial Approval Updates, Amendments SAEs Continuing Reviews
Attend Cooperative Groups audit preparation classes.
Drug Accountability If you do not have a pharmacist
If possible have one CRA responsible for:
1. 2.
Regulatory continued
Look for activity since you last audited.
Document date you audited last.
Review letters from IRB immediately
Make sure information and wording of letters is correct. Make sure that all SAEs submitted are listed in the acknowledgement letter.
Audit Procedure - 公司内部审计流程(英文)
Internal Audit Procedure1Purpose of this procedure1.1To ensure that the contract department continually operates in accordance with the specifiedpolicies, procedures and external requirements in meeting company goals and objectives in relation to information security.2Scope2.1This procedure includes planning, execution, reporting and follow–up of CMS internal auditsand applies to all departments and business units within scope of the organization’s CMS.3Rôles and responsibilities3.1Lead Auditor (VCW, HPY)▪Prepares an Audit Plan/Notification as a basis for planning the audit and for disseminating information about the audit.▪Leads the CMS internal audit activities▪Co-ordinates the audit schedule with concerned department/section heads▪Plans the audit, prepares the working documents and briefs the audit team.▪Consolidates all audit findings and observations and prepares internal audit report.▪Reports critical non-conformities to the auditee immediately.▪Report to the auditee the audit results clearly and without delay.▪Conducts the opening and closing meeting.3.2Auditee (WWJ, XYX, PDW, HPY, ZMY, GTY,)▪Receives, considers and discusses the audit report.▪Determines, resources, drives and completes corrective actions as necessary.▪Is and remains accountable for protecting information assets.4Procedure4.1General4.1.1This audit programme shall be created that contains all scheduled and potential audits for the wholecalendar year. This shall include schedule of internal audits, audits of suppliers as appropriate.4.1.2Internal audits shall be scheduled twice a year or as the need arises.4.1.3Only competent personnel who are truly independent of the subject area shall perform audits.4.1.4An Audit Notification Memo is sent to the department/section to be audited at least three workingdays in advance of the audit.4.2Planning and Preparing the Audit4.2.1Based on the audit programme, the Lead Auditor shall prepare the respective audit plans.4.2.2The Audit Plan/Notification shall be prepared by the Lead Auditor, reviewed and approved by theISMR. It shall be communicated to the auditors and the auditees. It shall be designed to be flexible in order to permit changes based on the information gathered during the audit. The plan shall include:▪Audit objective and scope▪Department/Section and responsible individuals in charge.▪Audit team members. The number of auditors depends on the audit area size.▪Type of management system to be audited▪Date, place, time of the audit and distribution date of the audit report4.3Pre-audit meeting4.3.1One or more pre-audit meetings between the Lead Auditor and auditors shall take place not laterthan one day prior to the audit proper. Objectives are as follows:▪To ensure the availability of all the resources needed and other logistics that may be required by the auditor.▪The scope of the audit is verified from the Audit Plan4.4Opening meeting4.4.1An opening meeting, where deemed appropriate by the Lead Auditor, shall be held on the day of theaudit but before the audit proper. The following may be discussed during the opening meeting:▪The purpose and scope of the audit.▪Confirmation of the audit plan▪Clarification of other matters must be settled before the audit takes place.4.5Audit Execution4.5.1The auditors will perform the internal audit using several checklists:▪Internal Audit Checklist/Observation Form –contains specific items that are particular to the organizational unit to be audited. The assigned auditors are responsible for generating questionsusing this form.▪Systemic Requirements Checklist▪Control Requirements Checklist4.5.2Audit findings are collected through interviews, examination of documents and observation ofactivities and conditions in the areas of concern and will be written on the above-mentioned checklists.4.5.3Evidence suggesting other non-conformities should be noted if they seem significant, even though notcovered by the checklist. Other objective evidence and/or observations that may reflect positively or negatively on the information security management system shall also be listed on the space provided for on the above-mentioned checklists.4.6Audit Reporting4.6.1The auditors shall have a wash-up meeting after the audit. Agenda includes:▪Review and analysis of findings▪Consolidation of all findings including grouping and tabulation.▪Classification of findings.▪Preparation of recommendation and audit report▪Classification of findings (see section 4.6.4)▪Preparation of recommendation and audit report4.6.2The audit team shall review all of their findings whether they are to be reported as non-conformitiesor as observations. Audit finding should likewise be supported by objective evidence.4.6.3The Lead Auditor consolidates all the audit findings for the preparation of the audit report.4.6.4 Classification of findings shall be:4.6.4The Lead Auditor shall prepare a standard internal audit Report containing the following information:▪Audit Reference Number▪Date of Audit▪Department/Section Audited/Process Name▪Name of Auditee and auditors▪Statement of findings (all non conformities found)▪Reference to the information security management system and standard▪Corrective and Preventive Actions with completion date▪Follow-up actions for non conformities▪Verification of follow-up actions4.7Closing Meeting4.7.1The Lead Auditor shall preside over the closing meeting attended by the audit team and the auditees.4.7.2The auditors shall report their findings, observations and recommendations, summarising the goodpoints before discussing non-conformities supported by the audit evidence.。
会计英语审计流程中的七个环节英语
会计英语审计流程中的七个环节英语The audit process is an important part of accounting and ensures the accuracy and integrity of financial records. There are seven key stages in the audit process, each with its own significance and purpose. In this article, we will explore each of these stages in detail to provide a comprehensive understanding of the audit process in accounting.1. Engagement PlanningThe first stage of the audit process is engagement planning. This involves the auditor and the client setting the scope and objectives of the audit, as well as establishing the timeline and resources required for the audit. During this stage, the auditor gains an understanding of the client's business and the industry in which they operate. This helps the auditor to identify potential risksand areas of focus for the audit. Additionally, the auditor will assess the client's internal controls and identify any potential areas of weakness or areas for improvement.2. Risk AssessmentOnce the engagement planning is complete, the auditorwill move on to the risk assessment stage. During this stage, the auditor will identify and assess the risks associated with the client's financial statements. This involves understanding the nature of the client's business, analyzing the internal and external factors that may impact the financial statements, and identifying any potential areas of concern. The auditor will also consider the likelihood and potential impact of these risks on the financial statements.3. Testing Internal ControlsTesting internal controls is an important stage of the audit process as it allows the auditor to evaluate the effectiveness of the client's internal controls in mitigatingthe identified risks. This involves testing the design and implementation of the client's internal controls, as well as performing tests of control to assess whether the controls are operating effectively. The auditor will also consider any deficiencies or weaknesses in the client's internal controls and provide recommendations for improvement.4. Substantive TestingSubstantive testing is a critical stage of the audit process as it involves testing the financial transactions and account balances that make up the client's financial statements. This includes examining the evidence supporting the transactions and account balances, as well as performing analytical procedures to assess the reasonableness and accuracy of the financial information. The auditor will also consider any potential misstatements or errors in the financial statements and assess their impact on the overall financial position of the client.5. Audit DocumentationThroughout the audit process, the auditor is required to maintain comprehensive audit documentation that supports the findings and conclusions of the audit. This includes documenting the auditor's understanding of the client's business and internal controls, the results of the risk assessment and testing, and any significant findings or issues identified during the audit. The audit documentation serves as a historical record of the audit and provides evidence of the work performed by the auditor.6. ReportingOnce the substantive testing and audit documentation are complete, the auditor will move on to the reporting stage. During this stage, the auditor will communicate the findings and conclusions of the audit to the client in the form of an audit report. The audit report includes the auditor's opinion on the fairness and accuracy of the client's financialstatements, as well as any significant issues or recommendations identified during the audit. The audit report provides valuable information to the client's stakeholders, such as investors, creditors, and regulators, about the reliability of the financial statements.7. Follow-upThe final stage of the audit process is follow-up, where the auditor will communicate any outstanding issues or recommendations to the client and ensure that they are addressed in a timely manner. This may involve discussing the audit findings with the client's management and providing guidance on implementing any recommended improvements to the client's internal controls or financial reporting processes. The auditor will also consider any changes in circumstances or events that may impact the client's financial statements and assess the need for additional audit procedures.In conclusion, the audit process in accounting involves several key stages that are critical to ensuring the accuracy and integrity of financial records. From engagement planning and risk assessment to substantive testing and reporting, each stage plays an important role in identifying and addressing potential risks and issues in the client's financial statements. By following a structured and comprehensive audit process, auditors can provide valuable assurance to the client and their stakeholders about the reliability of the financial information.。
gmp质量评审流程
gmp质量评审流程英文回答:GMP Quality Review Process involves a systematic evaluation of the manufacturing process to ensure that the product is consistently produced and controlled according to quality standards. This process includes the following steps:1. Planning: The quality review team plans the scope, objectives, and timeframe of the review.2. Preparation: The team collects and reviews relevant documentation, such as manufacturing records, quality control procedures, and specifications.3. Execution: The team conducts a thorough evaluation of the manufacturing process, including interviews with personnel, inspections of equipment and facilities, and review of documentation.4. Reporting: The team prepares a report that summarizes the findings of the review and provides recommendations for improvement.5. Follow-up: The team follows up on the implementation of the recommendations and monitors the effectiveness of the改进.中文回答:GMP质量评审流程。
战略系统审计
Share team members’ cumulative knowledge Update risk identification and assessment Consider the audit comfort gained to date, by audit assertion Answer: “Do we have enough comfort?” Answer: “What do we do next?”
Scoping Translated into Audit Strategy
Where controls over significant account balances or classes of transaction are not aligned, we will need to perform substantive tests of details.
Scoping: Risk Assessment – Key Risks
Key Risk
We identify audit risk through understanding the entity’s business objectives and related risks.
Business Risks
Scoping: Business Analysis Framework
Strategic Analysis
Understand the client’s strategic advantage
Risk Assessment
Understand the risks that threaten attainment of the client’s business objectives “The primary goal of management control is to ensure that risk monitoring and control activities are aligned properly with overall strategic objectives” p. 35 Strategic risks Process risks
出口产品产品质量审计流程
出口产品产品质量审计流程As a vital part of ensuring the quality of products before they are exported, product quality audits play a crucial role in the success of businesses. Quality audits help identify any potential issues or defects in the products, ensuring that they meet the required standards and are safe for consumers to use. 作为确保产品在出口前质量的关键环节,产品质量审计在企业的成功中扮演着至关重要的角色。
质量审计有助于发现产品中可能存在的问题或缺陷,确保产品符合要求的标准,安全供消费者使用。
One of the main reasons why product quality audits are essential is because they help companies comply with regulatory requirementsin different countries. Each country has its own set of regulations and standards that products must meet in order to be sold in that market. By conducting thorough quality audits, companies can ensure that their products meet the necessary requirements for export, avoiding any potential issues with customs or regulatory authorities. 产品质量审计至关重要的一个主要原因是,它有助于企业遵守不同国家的监管要求。
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Make sure information and wording of letters is correct.
Make sure that all SAEs submitted are listed in the acknowledgement letter.
Data Management preparation
Tab follow up information in separate color.
Write 3mo, 6 mos, annual, etc on tab
Highlight source documentation used to support information recorded on the CRFs/data management forms.
IRB (if you use multiple IRBs) Cooperative Groups Protocol numbers Tab and color code for: Initial Approval Updates, Amendments SAEs Continuing Reviews
Attend Cooperative Groups audit preparation classes.
Drug Accountability If you do not have a pharmacist
If possible have one CRA responsible for:
1. Drug inventory monthly. 2. Filing and checking packing slips against
Audit satellite sites at least every two months for their submissions to IRB.
Regulatory continu Nhomakorabead Look for activity since you last audited.
Document date you audited last.
Regulatory Preparation continued
Submit new information to IRBs right away. (Check Cooperative Group websites at least monthly)
Audit your IRB information from Cooperative Groups for open and closed to accrual protocols at least every two months. Permanently close trials should be audited prior to closure.
Audit Preparation 101 for the CCOP
Regulatory Preparation
Keep Current – start audit preparation with the initiation of a new clinical trial
Organize clinical trial regulatory books by:
Color code tabs:
Source documentation for eligibility criteria Chemotherapy cycles that include all supporting data
for those cycles
Progress notes Labs Tests Chemotherapy administration records SAE source documentation
Attend PRIMER, if possible, to gain perspective what is expected of IRBs
Data Management preparation
Start off tabbing shadow charts for audit when the chart is initially being put together.
receivables and what was ordered. 3. Ordering drug and drug disposing. 4. Logging in and out of drug to CRAs/nurses. 5. Responsible for tracking satellite site DARFs.