Inspection Hosting and Behaviors檢查接待及行為規(guī)范 In order for audits and inspections to proceed efficiently, there are logistic and hosting activities an organization may identify before an inspection, including informing personnel of their roles.
為確保審計(jì)和檢查工作的高效開(kāi)展，組織可在檢查前明確相關(guān)的后勤與接待安排，并明確相關(guān)人員的職責(zé)分工。
Reception 接待
Processes should be in place to receive a regulatory inspector. This should take place at the secured main entrance to the facility. The process includes verifying the inspector’s credentials, signing into the facility, notifying management of the inspector’s arrival, and conducting a site safety orientation of the inspectorate staff. Best practice for notification includes a list of individuals and alternates to be notified and the order in which they are notified, or a call tree.
應(yīng)當(dāng)制定專門(mén)流程以妥善接待監(jiān)管檢查員。該流程應(yīng)在設(shè)施主入口處啟動(dòng)。具體流程包括：核實(shí)檢查員的資質(zhì)、在設(shè)施內(nèi)進(jìn)行登記、及時(shí)通知管理層檢查員已到訪，并對(duì)檢查員團(tuán)隊(duì)進(jìn)行現(xiàn)場(chǎng)安全簡(jiǎn)介。最佳通知實(shí)踐包括：明確列出需通知的人員及候補(bǔ)人員名單，并規(guī)定通知順序，或者采用呼叫樹(shù)的方式。
The inspector should be greeted by trained audit support personnel in as little time as possible.檢查員抵達(dá)后，應(yīng)由經(jīng)過(guò)培訓(xùn)的審計(jì)支持人員及時(shí)接待。
Rooms 房間
At a minimum one room should be secured to host the inspector. If there are multiple inspectors, it may be beneficial to secure separate rooms for each, if feasible, to avoid confusion caused by multiple conversations occurring at once.
至少應(yīng)預(yù)留一間房間供檢查員使用。如果有多個(gè)檢查員，如果可行的話，為每位檢查員預(yù)留單獨(dú)的房間可能會(huì)更有利，以避免因同時(shí)進(jìn)行的多場(chǎng)對(duì)話而造成混亂。
Inspection hosting best practice includes the use of a backroom or preparation room. The backroom supports inspection management activities such as tracking the inspector’s requests for documentation, preparing SMEs, and formulating responses to inquiries. In addition, the requested documentation is reviewed in the backroom, prior to giving it to the inspector, to ensure the request is addressed properly.
檢查接待的最佳實(shí)踐包括使用后臺(tái)或準(zhǔn)備室。后臺(tái)支持檢查管理活動(dòng)，例如跟蹤檢查員的文件需求、準(zhǔn)備SME以及制定對(duì)詢問(wèn)的回應(yīng)。此外，在將文件交給檢查員之前，會(huì)在后臺(tái)對(duì)其進(jìn)行審核，以確保正確處理了相關(guān)文件。
Personnel人員
The following roles are recommended to facilitate a successful inspection:
為確保檢查工作的順利開(kāi)展，建議配備以下崗位人員：
- Host/Escort – Typically a host or escort is designated for each inspector. This individual serves as the primary liaison with the inspector and remains with them at all times. The inspector should not to be left unescorted within the facility. The host should be familiar with both the company’s quality system and manufacturing operations so that they can field questions without the assistance of SMEs when feasible.
- 主持人/陪同人員-通常應(yīng)為每位檢查員指定一名主持人或陪同人員。該人員作為檢查員的主要聯(lián)絡(luò)人，并全程陪同其開(kāi)展工作。檢查員在設(shè)施內(nèi)部活動(dòng)期間不得無(wú)人陪同。主持人應(yīng)熟悉公司的質(zhì)量管理體系及生產(chǎn)運(yùn)營(yíng)流程，以便在必要時(shí)能夠獨(dú)立回答相關(guān)問(wèn)題，無(wú)需依賴專家支持。
- Scribe – A scribe is assigned to each inspector to record information requests, questions, and discussions. This recorded information is shared with runner and support staff. (Using an electronic system can quickly and efficiently update backroom support personnel.)
- 記錄員- 每位檢查員都配備一名記錄員，負(fù)責(zé)記錄信息請(qǐng)求、問(wèn)題和討論的內(nèi)容。這些記錄的信息會(huì)與跑腿員和支持人員共享。（使用電子系統(tǒng)可以快速高效地更新后臺(tái)支持人員的信息。）
- Tour Guide – Typically inspectors and auditors request a tour of the facility. This may be led by one person (and a scribe) with general knowledge of the facility, or a small group in which SMEs are available for the area of focus.
- 導(dǎo)覽員-通常檢查員和審計(jì)員會(huì)要求參觀設(shè)施。這可能由一位對(duì)設(shè)施有大致了解的人（以及一位記錄員）帶領(lǐng)，或者由一個(gè)小組帶領(lǐng)，小組中要有該關(guān)注領(lǐng)域的SME。
- Runner and Support Staff – Runners and support staff obtain documents requested by the inspector from the backroom to allow the scribe and host to continue working with the inspector without interruption or delay.
文件傳遞員與支持人員—文件傳遞員和支持人員從后臺(tái)準(zhǔn)備室獲取檢查官所需的文件，確保記錄員（scribe）和主接待人（host）能夠無(wú)干擾、無(wú)延誤地繼續(xù)協(xié)助檢查官開(kāi)展工作。
- SME – Ideally SMEs are on hand in the backroom. If this is not possible, SMEs are readily available to answer questions and explain processes when needed. SMEs are typically the process owners of the subject to which they will speak.
- SME - 在理想狀態(tài)下，SME應(yīng)隨時(shí)在后臺(tái)待命。若無(wú)法實(shí)現(xiàn)此要求，SME也應(yīng)具備即時(shí)回應(yīng)問(wèn)題并闡釋流程的能力。SME通常是其負(fù)責(zé)主題的流程負(fù)責(zé)人。
- Backroom Lead – This lead manages the activities of the backroom and ensures document requests and SME availability are met in a timely manner.
-后臺(tái)負(fù)責(zé)人 - 該主管負(fù)責(zé)管理后臺(tái)的活動(dòng)，并確保及時(shí)滿足文檔請(qǐng)求和SME的可用性。
- Interpreter – If necessary, an interpreter/translator should be brought in to help in translating requests from the inspectorate staff.
-口譯員-如有必要，應(yīng)請(qǐng)口譯員/筆譯員協(xié)助翻譯檢查人員的要求。
Inspection Interaction檢查互動(dòng)
An inspection is a formal process and should be treated as such. The inspector should be addressed andconversed with in a professional and respectful manner. Questions should be answered truthfully without embellishment. If there is uncertainty for an answer, site personnel are advised to not speculate; it is acceptable to take notes on the request and follow-up with an answer later. If it is not clear what the inspector is requesting, discuss the question for clarification.
檢查是一項(xiàng)正式程序，應(yīng)當(dāng)予以重視。應(yīng)以專業(yè)和尊重的方式與檢查員交談。應(yīng)如實(shí)回答問(wèn)題，不做任何修飾。如果對(duì)答案不確定，建議現(xiàn)場(chǎng)人員不要推測(cè)；可以接受的做法是：記錄下該請(qǐng)求，并在后續(xù)提供答復(fù)。如果檢查官的要求不明確，應(yīng)進(jìn)行討論以尋求澄清。
7.2 Opportunities for Improvement 改善機(jī)會(huì)
An early part of a regulatory inspection is usually a tour of the facility, often a specific portion of the facility that could be the focus of the audit. Having available an up-to-date blueprint of the facility, including the layout of the CU, helps to identify the route for the tour.
監(jiān)管檢查的早期階段通常是參觀設(shè)施，有時(shí)是設(shè)施中的特定部分，該部分可能是審核的重點(diǎn)。擁有設(shè)施的最新圖紙，包括CU的布局，有助于確定參觀路線。
The first thing a regulatory inspector or site auditor sees when entering a manufacturing or manufacturing support area is its general physical condition and upkeep. After that, specific areas become apparent, such as wetness; hose handling; equipment and piping design, condition, and tagging; pest control efforts; and the competence and knowledge of the tour guides.
當(dāng)監(jiān)管檢查官或現(xiàn)場(chǎng)審計(jì)員進(jìn)入生產(chǎn)或生產(chǎn)支持區(qū)域時(shí)，首先看到的是其整體物理狀況和維護(hù)狀況。隨后，會(huì)注意到具體方面，例如：潮濕；軟管管理；設(shè)備與管道的設(shè)計(jì)、狀況和標(biāo)識(shí)；蟲(chóng)害防治措施；以及導(dǎo)覽負(fù)責(zé)人的專業(yè)能力與知識(shí)水平。
First impressions are important and can set the tone for the audit and where the auditor directs his/her focus thereafter. An unkempt facility implies a disregard for GMP and sensitizes the auditor to look for other poor manufacturing processes or poor GMP attitudes that could directly affect product quality. It should be remembered that anything out of the ordinary, or not as clean as possible, may raise questions from the auditor. If the answers do not alleviate the inspector’s concerns, the focus of the audit may become intent on finding deficiencies. Having a wellmaintained facility that meets a stringent level of cleanliness helps to show that the facility is committed to meeting GMPs.
第一印象至關(guān)重要，它不僅為審計(jì)定下基調(diào)，還會(huì)影響審計(jì)員后續(xù)的關(guān)注方向。雜亂無(wú)序的設(shè)施往往意味著對(duì)GMP的忽視，進(jìn)而促使審計(jì)員提高警惕，積極尋找可能直接影響產(chǎn)品質(zhì)量的不良生產(chǎn)工藝或不當(dāng)?shù)腉MP態(tài)度。必須謹(jǐn)記，任何異常情況或未達(dá)到應(yīng)有清潔標(biāo)準(zhǔn)的情況，都可能引發(fā)審計(jì)員的質(zhì)疑。若答復(fù)無(wú)法有效消除檢查官的疑慮，審計(jì)的重心可能會(huì)轉(zhuǎn)向刻意查找缺陷。相反，擁有維護(hù)良好且符合嚴(yán)格清潔水平的設(shè)施，有助于展示該設(shè)施對(duì)遵守GMP規(guī)范的堅(jiān)定承諾。
7.2.1 Identifying Opportunities for Improvement 識(shí)別改進(jìn)機(jī)會(huì)
Sometimes things that an auditor may not typically see may be “normal” for facility personnel since they have lived with or accommodated non-optimal conditions for a long time. Long-term, single-employer personnel and managers are more prone to this than experienced, multiple-employer personnel. There is benefit to preparatory audits conducted by auditors familiar with regulatory expectations but unfamiliar with the facility. One such source could be third-party auditors, possibly by customers of a contract manufacturing operation. Auditors from sister sites within the company as well as consultants could also be used for auditing the facility. The intent of these audits is to identify deficient operations, designs, and other issues at the site that may have been overlooked by site personnel. The findings offer opportunities for the site to address prior to a regulatory audit, if possible, or to develop remediation plans with defined timelines.
有時(shí)候，審計(jì)員可能不會(huì)經(jīng)?？吹降那闆r，對(duì)設(shè)施人員來(lái)說(shuō)可能是“正常”的，因?yàn)樗麄冮L(zhǎng)期與非最佳狀態(tài)共存或已適應(yīng)了這些狀態(tài)。與經(jīng)驗(yàn)豐富、曾在多家雇主工作過(guò)的人員相比，長(zhǎng)期服務(wù)于單一雇主的人員和管理者更容易出現(xiàn)這種情況。由熟悉監(jiān)管期望但不熟悉該設(shè)施的審計(jì)員進(jìn)行預(yù)備性審計(jì)是有益的。此類審計(jì)員的來(lái)源可以是第三方審計(jì)員，例如合同生產(chǎn)運(yùn)營(yíng)的客戶。來(lái)自公司內(nèi)部其他工廠的審計(jì)員以及顧問(wèn)也可用于審計(jì)該設(shè)施。這些審計(jì)的目的是識(shí)別現(xiàn)場(chǎng)人員可能已忽視的、存在于該場(chǎng)地的不足的操作、設(shè)計(jì)及其他問(wèn)題。審計(jì)發(fā)現(xiàn)為該場(chǎng)地提供了機(jī)會(huì)，以便在監(jiān)管審計(jì)之前（如有可能）進(jìn)行整改，或制定帶明確時(shí)間節(jié)點(diǎn)的整改計(jì)劃。
7.2.2 Tour Guide Competence 導(dǎo)覽人員能力
The CUs tour guide should be an SME on the CU, knowledgeable not only of this process but other manufacturing processes as well. If this person is not intimately familiar with the CU system procedures (which may give a negative impression to the auditor), then they may defer an answer until after reviewing the SOP on the subject.
該CU的導(dǎo)覽員應(yīng)當(dāng)是該CU的SME，不僅對(duì)這一流程爛熟于心，對(duì)其他制造流程也應(yīng)具備一定的了解。若導(dǎo)覽員對(duì)CU系統(tǒng)程序不夠熟悉（這可能會(huì)給審計(jì)員留下不良印象），建議其先查閱相關(guān)主題的SOP，然后再進(jìn)行回答。
There is a delicate balance in the impression given to an auditor by a quick, authoritative verbal response of inaccurate information versus a tentative response deferred to an SOP for verification. If it is a tentative answer from someone who should be a knowledgeable area manager, it implies a lack of understanding of the practices they oversee.
在審計(jì)過(guò)程中，審計(jì)員對(duì)于被審計(jì)方迅速但不準(zhǔn)確的答復(fù)，與謹(jǐn)慎推遲至依據(jù)標(biāo)準(zhǔn)操作程序進(jìn)行核實(shí)后再作答的做法，能夠形成不同的印象。若一位本應(yīng)熟悉相關(guān)業(yè)務(wù)的區(qū)域經(jīng)理僅提供試探性回答，則可能表明其對(duì)所負(fù)責(zé)的業(yè)務(wù)流程缺乏深入了解。
7.2.3 SOPs and Logbooks
There should be a company policy that addresses sharing documentation with regulators that should be part of the staff’s training requirements. With respect to CU the policy should allow for sharing of all information. The regulator should be provided with copies of the requested documents, or specific pages.
公司應(yīng)制定一項(xiàng)政策，規(guī)定與監(jiān)管機(jī)構(gòu)共享文件的要求，且該政策應(yīng)納入員工培訓(xùn)要求的一部分。關(guān)于CU，該政策應(yīng)允許共享所有信息。應(yīng)向監(jiān)管機(jī)構(gòu)提供所要求文件或特定頁(yè)面的副本。
During the tour, the auditor may ask for a copy of an SOP associated with an observed practice or operation. The auditor should be informed that a copy of the SOP will be provided after returning to the interview room (if consistent with company policy) unless they want to view it immediately. In this case, the auditor should be shown the SOP utilized by the manufacturing personnel in that area. The accuracy of any verbal response as well as the availability of that SOP in the area where it is executed will be noted by the auditor as another indication of good or poor
在參觀過(guò)程中，審計(jì)員可能會(huì)要求提供一份與所觀察操作或?qū)嵺`相關(guān)的SOP副本。應(yīng)告知審計(jì)員，在返回面談室后將提供該SOP副本（前提是符合公司政策），除非他們提出立即查看的要求。若審計(jì)員要求立即查看，則應(yīng)向其展示該區(qū)域生產(chǎn)人員所使用的SOP。任何口頭答復(fù)的準(zhǔn)確性，以及該SOP在其執(zhí)行區(qū)域的可獲取性，都將被審計(jì)員記錄，作為評(píng)估良好或不良GMP實(shí)踐的重要依據(jù)。
The procedures should be the effective versions and may be centrally located, or hanging or posted in the area where they are used. The auditor may note the revision number of the SOP, and after returning to the interview room, may ask for the effective SOP to see if it has the same revision number. If it does not, this is an indication of poor document control. Another indication of poor compliance is the use of locally posted unofficial procedures, such as hand-written notes and reminders. These are another indication of uncontrolled documentation processes.
規(guī)程應(yīng)為當(dāng)前生效版本，可集中存放，或在其實(shí)施區(qū)域懸掛或張貼。審計(jì)員可能會(huì)記錄該SOP的版本號(hào)，并在返回面談室后，要求查看當(dāng)前生效的SOP，以確認(rèn)其版本號(hào)是否一致。若版本號(hào)不符，則表明文檔控制存在缺陷。另一合規(guī)性不佳的跡象是使用本地張貼的非正式規(guī)程，如手寫(xiě)便利貼和提醒。這同樣是文檔流程失控的表現(xiàn)。
The auditor may ask to see a logbook where drain cleaning activities are recorded (which could also reveal an inaccurate verbal response of cleaning frequency). If no logbook or SOP exists for this activity, this negative impression may lead the auditor to conclude that not all manufacturing activities are described in SOPs or recorded in logbooks, and that the activity may be subject to variable execution and frequency.
審計(jì)員可能會(huì)要求查閱記錄排水口清潔活動(dòng)的日志（這也可能揭示關(guān)于清潔頻率的口頭答復(fù)存在不準(zhǔn)確之處）。若該活動(dòng)缺乏相應(yīng)的日志或標(biāo)準(zhǔn)操作程序（SOP），這種負(fù)面印象可能導(dǎo)致審計(jì)員得出以下結(jié)論：并非所有生產(chǎn)活動(dòng)都已納入SOP的描述或在日志中得以記錄，且該活動(dòng)的執(zhí)行方式和頻率可能存在較大的變動(dòng)性。
Some facilities no longer utilize paper procedures and logbooks; thus, when an auditor requests information found in electronic systems, printouts of the requested information should be provided. Such electronic documentation systems facilitate access to information, so it is less likely for documentation to be lost, misplaced, or outdated as might occur with paper documentation systems. Evidence of compliance to electronic records regulations may be requested.
部分設(shè)施不再使用紙質(zhì)規(guī)程和日志；因此，當(dāng)審計(jì)員要求查看電子系統(tǒng)中的信息時(shí)，應(yīng)提供所要求信息的打印件。此類電子文件系統(tǒng)便于信息獲取，因此，文件丟失、錯(cuò)放或過(guò)時(shí)的可能性低于紙質(zhì)文件系統(tǒng)?？赡軙?huì)被要求提供符合電子記錄法規(guī)的證據(jù)。
Regardless of how SOPs and logbooks are managed, they should be current and readily available for use by area personnel, which in turn makes the requested information readily available for an auditor or inspector.
無(wú)論SOP和日志的管理方式如何，它們都應(yīng)當(dāng)是現(xiàn)行有效的，并且便于區(qū)域人員隨時(shí)查閱。這樣一來(lái)，審計(jì)員或檢查官也能便捷地獲取所需信息。
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