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Signatures–What’sin a Name?

簽名的含義是什么？

Q. In arecent audit, we were asked about the meaning of the signatures on ourcontrolled documents. Our reply was that it clearly states that the signatoriesare either authors, reviewers, or approvers. The auditor considered ourresponse insufficient, pointing out that we often have up to 10 reviewers.Though the names and titles of these are given, their review responsibilitiesare not defined or described. We are unclear how to make the meaning of the signaturesmore precise.

問(wèn)：在最近的一次審計(jì)中，我們被問(wèn)及受控文件上簽名的含義。我們的答復(fù)是，它明確指出，簽名者是作者、審核人，或批準(zhǔn)人。檢查官認(rèn)為我們的答復(fù)不夠充分，指出我們往往有多達(dá)10個(gè)審核人員。雖然給出了這人的名字和職位，但沒(méi)有定義或描述其審核責(zé)任。我們不清楚如何使簽名的含義更加精確。

A. The regulations do not provide much detail with regards to your question. For example, the European Union guidelines (1) require, “Documents containing instructions should be approved, signed, and dated by appropriate and authorised persons.” The US regulations are a little bit more specific in21 Code of Federal Regulations (CFR) Part 11 (2) regarding the signing of electronicrecords and state, “This information must include the printed name of thesigner, the date and time when the signature was executed, and the meaning [emphasis added] (such as review,approval, responsibility, and authorship) associated with the signature.”

回答：法規(guī)沒(méi)有提供你所述問(wèn)題的細(xì)節(jié)。例如，歐盟指南（1）要求，"指令類文件應(yīng)由適當(dāng)和授權(quán)的人員批準(zhǔn)和簽名/日期。美國(guó) 21 CFR） Part 11 （2）關(guān)于電子記錄則略為具體，并聲明，"應(yīng)包含簽名者的打印名稱、簽名日期和時(shí)間，以及與簽名相關(guān)的的含義（如審核、批準(zhǔn)、負(fù)責(zé)人或作者） [強(qiáng)調(diào)]。

The question is whether the meaning of the signatures in your documents isclear enough and unambiguous. Let us look at an example, such as a cleaningstandard operating procedure (SOP) for manufacturing equipment. An author, mostlikely a member of the operations team, prepares the document. There will beseveral reviewers, possibly including manufacturing, engineering, validation,quality unit, regulatory affairs, and health and safety. These reviewers willeach have a different perspective from which they perform their review.

問(wèn)題是，文件簽名的含義是否足夠清晰和明確。讓我們看一個(gè)例子，例如生產(chǎn)設(shè)備的清潔標(biāo)準(zhǔn)操作程序（SOP）。作者（很可能是操作班組的成員）正在準(zhǔn)備文件。將會(huì)有幾位審核人員，可能包括生產(chǎn)、工程、驗(yàn)證、質(zhì)量部門、注冊(cè)部門以及健康和安全。這些審核人各自有不同的視角來(lái)執(zhí)行審核。

One could argue that the role and the associated job description definesufficiently what a reviewer has to do. In theory, yes; but in practice this isoften not the case. Therefore, companies typically apply one of two approaches:either define the controlled documents review and approval responsibilities ina document (e.g., the SOP for SOPs) or add the meaning to each signature in thesignature list.

有人可能會(huì)爭(zhēng)辯說(shuō)，角色和相關(guān)的工作描述足以界定審核人需要做什么。從理論上講，是的；但在實(shí)踐中，情況往往并非如此。因此，公司通常采用兩種方法之一：在文件中定義受控文件審核和批準(zhǔn)職責(zé)（例如，SOP以概之），或者在簽名表中添加每個(gè)簽名的含義。

Table I is an example of such a review responsibilities matrix.

表1是此類審核責(zé)任矩陣的示例。

If we apply this to the cleaning SOP example, we would expect:

如果我們將其應(yīng)用于清潔SOP 中，我們期望：

The operators to check if theinstructions can actually be performed (technical feasibility)

操作人員檢查該規(guī)程是否可實(shí)際執(zhí)行（技術(shù)可行性）

Managers in manufacturing to check the functionalcorrectness of the cleaning procedures (e.g., cross-referencecleaning validation reports) and to verify that the instructions are clear andlogical

生產(chǎn)經(jīng)理檢查清潔程序的功能正確性（例如，交叉引用清潔驗(yàn)證報(bào)告），并確認(rèn)該規(guī)程是否清晰且合乎邏輯

The validation team to verify that thecleaning procedures are in concurrence with previously executed cleaningvalidations

驗(yàn)證組確認(rèn)清潔程序是否與所執(zhí)行的清潔驗(yàn)證一致

The quality unit to ensure that thedocument uses the correct template and format, that the procedure meetsregulatory requirements, and that any related change controls oraudit/inspection commitments have been met

質(zhì)量部門確保文件使用正確的模板和格式、該程序符合法規(guī)要求以及任何相關(guān)變更控制或?qū)彶?檢查已完成

The regulatory affairsdepartment to confirm that the procedure is in concurrence with themanufacturing licenses

法規(guī)注冊(cè)部門確認(rèn)程序與生產(chǎn)許可一致

The health and safety executive to checkthat all required safety precautions are applied, for example, where flammableor corrosive solvents are used.

健康和安全經(jīng)理檢查是否采取了所有必需的安全預(yù)防措施，例如使用易燃或腐蝕性溶劑的地方。

In summary, it is good industry practice to clarify the precise remit foreach of the reviewers of a controlled document, rather than just apply thegeneral term of ‘reviewer.’ 

總之，良好的行業(yè)做法是明確受控文件的每個(gè)審核人員的確切職責(zé)，而不僅僅是應(yīng)用"審核人"這一詞。

And finally: are you still sure you need up to 10 reviewers?

最后：你還確定需要多達(dá) 10 個(gè)審核人嗎？