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.
以下是作為審計人員（內審/自檢人員或外部審計人員）需要做的事項列表。使用此列表將幫助你確保在計劃和進行 GMP 審計時少走彎路。
Maintain and Use a Written SOP for GMP Auditing
維護和使用書面的GMP審計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.
建立書面審計程序將有助于確保所有審計都以一致的方式進行，并符合最低要求。審計程序是你成功審計的路線圖。你可以在審計程序中包括的一些信息，例如審計的頻率、要檢查的系統、審計是通知還是不通知，以及審計團隊中應包括哪些人。
Assure Confidentiality of Outcomes
確保結果機密
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.
確保審計和審計報告結果的機密性非常重要，因為審計人員可以與你將要審計的人員建立良好的關系。確保他們知道你不是想讓他們難堪，或者抓住他們做錯事。提醒他們，你審計的目的是檢查系統以確保質量不會出錯，并且結果不會以公開針對個人的方式使用。在大多數情況下，即使是FDA也無法查看內部審計結果。
Use Checklists As Needed
必要時，使用檢查表
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.
檢查表是幫助GMP審計人員進行徹底，系統和一致的審計的常用工具。然而，檢查表不應取代開始審計之前的適當規劃和合作氛圍設定。考慮使用精心準備的清單的優勢。它確保審計人員將詢問滿足cGMP要求所需的大部分關鍵項目，如果準備得當，它將幫助審計人員專注于重要問題，而不是沉迷于小細節。
Make Sure That All Auditors Have Proper Qualifications
確保所有審計人員都有適當的資質
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法規要求人員具有適當的資質（通過適當的培訓，教育和經驗，或兩者的組合）來完成他們的工作。因此，應該記錄審計人員能夠正確履行其職責。
Eliminate Any Conflicts of Interest
消除任何利益沖突
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.
誠信是優秀審計人員最重要的特征之一，保持誠信需要消除您可能擁有的任何利益沖突。內部審計人員最常見的利益沖突是當他或她對被審計的領域有責任時。外部或供應商審計人員可能面臨其他類型的利益沖突，包括家庭成員或朋友在該公司工作，擁有該公司的大量股票，或以前在那里工作過。如果你發現自己處于這些境地之一，或面臨其他類型的利益沖突，應向管理層披露，并且在大多數情況下拒絕參與審計。
Address Scheduling Issues
審計計劃
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.
在考慮何時安排審計時，請確保每年至少進行一次GMP審計。此外，還必須決定是提前通知還是突擊檢查。突擊檢查更為常見。
Assume a Cooperative and Non-Confrontational Manner While Auditing
在審計時采取合作和非對抗的方式
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.
內部GMP審計人員的作用是協助公司確保所有適當的質量和GMP規范得到適當滿足。因此，努力與你的審計對象建立良好的工作關系。你真的應該和你的被審計人員一起保護你的客戶，確保每個人都能保住自己的工作，確保公司保持盈利和受人尊敬。不要把審計當成抓住某人搞砸事情或讓他們難堪的機會。公司里的每個人都應有相同的目標——生產安全、純凈、有效的產品。以合作和不對抗的方式行事將幫助你實現這些目標。
Make Sure That Your Audit Report Is Completed In a Timely Manner
確保審計報告及時完成
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.
對于一些審計人員來說，起草審計報告是工作中最不喜歡的部分。這很耗時，而且似乎總有更緊急的事情你必須參加。但是，沒有及時完成審計報告的審計人員可能會危及自己的專業性。你越早將審計結果寫在紙上，它在你的腦海中就越新鮮。因此，如果立即完成，則更有可能是準確的。此外，盡快將反饋給到受檢查結果影響的人員也很重要。如果審計結果立即提出，而他們仍然記憶猶新，他們將更有可能及時采取必要的糾正措施。
In The Audit Report, Make Sure That Your Observations Are Fair, Balanced, and Use Non-inflammatory Language
在審計報告中，請確保你的檢查結果公平、平衡，并使用非煽動性的語言
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.
審計的目的是讓你的公司做得更好，而不是冒犯同事。雖然有時可能無法充分完成審計工作而不冒犯任何人，但你當然應該盡量減少負面情緒和對抗，同時不影響你工作的完整性。確保你對審計報告的觀察是公平、平衡的，并且不使用不必要的煽動性語言，將有助于你獲得被審計者的信任。
Plan Corrective Actions and Re-audits, If Necessary
如有必要，計劃糾正措施和重新審計
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.
審計的最后一步是參與糾正措施的計劃，糾正措施的時間范圍，并安排對缺陷領域的重新審計。這將確保審計缺陷的改進結果。
