The following is a quick list of things to do as an auditor. Using this list will help you to make sure that you are on track as you plan and conduct GMP audits.
以下是作为审计人员（内审/自检人员或外部审计人员）需要做的事项列表。使用此列表将帮助你确保在计划和进行 GMP 审计时少走弯路。
Maintain and Use a Written SOP for GMP Auditing
维护和使用书面的GMP审计SOP
Establishing a written audit procedure will help to ensure that all audits are conducted in a consistent manner, and that they meet the minimum requirements. The audit procedure is your roadmap to a successful audit. Some information you could include in an audit procedure might be the frequency of audits, the systems to checked, whether audits are announced or unannounced, and who should be included on the audit team.
建立书面审计程序将有助于确保所有审计都以一致的方式进行，并符合最低要求。审计程序是你成功审计的路线图。你可以在审计程序中包括的一些信息，例如审计的频率、要检查的系统、审计是通知还是不通知，以及审计团队中应包括哪些人。
Assure Confidentiality of Outcomes
确保结果机密
Assuring the confidentiality of the outcomes of the audit and audit reports is extremely important as an auditor fosters a good relationship with the people you will be auditing. Make sure that they know that you are not trying to embarrass them, or to catch them doing something wrong. Remind them that the purpose of your audit is to check systems to make sure that there are no lapses in quality, and that the results will not be used in a way that publicly targets individuals. In most cases, even the FDA will not be able to look at internal audit results.
确保审计和审计报告结果的机密性非常重要，因为审计人员可以与你将要审计的人员建立良好的关系。确保他们知道你不是想让他们难堪，或者抓住他们做错事。提醒他们，你审计的目的是检查系统以确保质量不会出错，并且结果不会以公开针对个人的方式使用。在大多数情况下，即使是FDA也无法查看内部审计结果。
Use Checklists As Needed
必要时，使用检查表
The checklist is a popular tool to assist the cGMP auditor in conducting a thorough, systematic and consistent audit.A checklist, however, should not be a substitute for proper planning and cooperative climate-setting prior to starting the audit. Consider the advantages of using a well-prepared checklist. It ensures that the auditor will ask most of the critical items necessary to satisfy cGMP requirements, and if properly prepared, it will assist the auditor in focusing on important issues and not becoming absorbed in small details.
检查表是帮助GMP审计人员进行彻底，系统和一致的审计的常用工具。然而，检查表不应取代开始审计之前的适当规划和合作氛围设定。考虑使用精心准备的清单的优势。它确保审计人员将询问满足cGMP要求所需的大部分关键项目，如果准备得当，它将帮助审计人员专注于重要问题，而不是沉迷于小细节。
Make Sure That All Auditors Have Proper Qualifications
确保所有审计人员都有适当的资质
GMP regulations require that employees be properly qualified (through proper training, education, and experience, or a combination thereof) to do their jobs. It should therefore be documented that auditors are able to properly conduct their duties.
GMP法规要求人员具有适当的资质（通过适当的培训，教育和经验，或两者的组合）来完成他们的工作。因此，应该记录审计人员能够正确履行其职责。
Eliminate Any Conflicts of Interest
消除任何利益冲突
Integrity is one of the most important characteristics of a good auditor, and maintaining integrity necessitates eliminating any conflicts of interest you may have. The most common conflict of interest to arise for an internal auditor is when he or she has responsibility for an area being audited. External or supplier auditors can face other types of conflicts of interest, including having a family member or friend who works for the company, owning a significant amount of stock in the company, or having previously worked there. If you find yourself in one of these positions, or facing another type of conflict of interest, you must disclose it to management, and in most cases decline to participate in the audit.
诚信是优秀审计人员最重要的特征之一，保持诚信需要消除您可能拥有的任何利益冲突。内部审计人员最常见的利益冲突是当他或她对被审计的领域有责任时。外部或供应商审计人员可能面临其他类型的利益冲突，包括家庭成员或朋友在该公司工作，拥有该公司的大量股票，或以前在那里工作过。如果你发现自己处于这些境地之一，或面临其他类型的利益冲突，应向管理层披露，并且在大多数情况下拒绝参与审计。
Address Scheduling Issues
审计计划
When considering when to schedule audits, make sure that you do a GMP audit at least once a year. Also, you will have to decide whether to do an announced or an unannounced audit. Unannounced audits are more common.
在考虑何时安排审计时，请确保每年至少进行一次GMP审计。此外，还必须决定是提前通知还是突击检查。突击检查更为常见。
Assume a Cooperative and Non-Confrontational Manner While Auditing
在审计时采取合作和非对抗的方式
The role of an internal GMP auditor is to assist the company by ensuring that all proper quality and GMP specifications are being properly met. Therefore, work to establish a good working relationship with those you audit. You really should be working with your auditees to protect your customers, to make sure that everyone gets to keep their job, and that the company remains profitable and respected. Do not approach an audit as an opportunity to catch someone messing up, or to embarrass them. Everyone in the company should have the same goals - making products that are safe, pure, and effective. Acting in a cooperative and non-confrontational manner will help you to achieve these goals.
内部GMP审计人员的作用是协助公司确保所有适当的质量和GMP规范得到适当满足。因此，努力与你的审计对象建立良好的工作关系。你真的应该和你的被审计人员一起保护你的客户，确保每个人都能保住自己的工作，确保公司保持盈利和受人尊敬。不要把审计当成抓住某人搞砸事情或让他们难堪的机会。公司里的每个人都应有相同的目标——生产安全、纯净、有效的产品。以合作和不对抗的方式行事将帮助你实现这些目标。
Make Sure That Your Audit Report Is Completed In a Timely Manner
确保审计报告及时完成
For some auditors, drafting the audit report is the least favorite part of the job. It is time consuming, and it can seem like there is always something more urgent to which you must attend. However, auditors who don't complete audit reports in a timely manner may jeopardize their own professionalism. The sooner you can put the results of an audit on paper, the fresher it will be in your mind. Therefore it is more likely to be accurate if it is done right away. Also, it is important to get the feedback to the people who are affected by the findings as quickly as possible. If the audit findings are presented right away, while it is still fresh in their minds, they will be more likely to take needed corrective action in a timely manner.
对于一些审计人员来说，起草审计报告是工作中最不喜欢的部分。这很耗时，而且似乎总有更紧急的事情你必须参加。但是，没有及时完成审计报告的审计人员可能会危及自己的专业性。你越早将审计结果写在纸上，它在你的脑海中就越新鲜。因此，如果立即完成，则更有可能是准确的。此外，尽快将反馈给到受检查结果影响的人员也很重要。如果审计结果立即提出，而他们仍然记忆犹新，他们将更有可能及时采取必要的纠正措施。
In The Audit Report, Make Sure That Your Observations Are Fair, Balanced, and Use Non-inflammatory Language
在审计报告中，请确保你的检查结果公平、平衡，并使用非煽动性的语言
The purpose of an audit is to make your company better at what it does, not to offend fellow co-workers. While sometimes it may be impossible to adequately do the job of an auditor and not offend anyone, you should certainly try to minimize negative feelings and confrontations without compromising the integrity of your work. Making sure that your observations on the audit report are fair, balanced, and don't use unnecessarily inflammatory language will help you to gain the trust of those being audited.
审计的目的是让你的公司做得更好，而不是冒犯同事。虽然有时可能无法充分完成审计工作而不冒犯任何人，但你当然应该尽量减少负面情绪和对抗，同时不影响你工作的完整性。确保你对审计报告的观察是公平、平衡的，并且不使用不必要的煽动性语言，将有助于你获得被审计者的信任。
Plan Corrective Actions and Re-audits, If Necessary
如有必要，计划纠正措施和重新审计
The last step of an audit is to participate in the planning of corrective action, the time frame in which it will occur, and to schedule a re-audit of deficient areas. This will ensure that improvement results from the findings of the audit.
审计的最后一步是参与纠正措施的计划，纠正措施的时间范围，并安排对缺陷领域的重新审计。这将确保审计缺陷的改进结果。
