4.2.3 Document Control 文件控制的理解

Keeping your QMS Current 让质量管理体系保持最新
by scott dawson

"It behooves those responsible for managing their organization’s QMS to design a document control process that is simple to use, easy to monitor and effective to prevent the use of incorrect documentation."
让那些负责管理组织质量管理体系的人制定文件控制过程是适宜的，让使用更简单，监控更容易，并且防止使用错误文件更有效。


THE IMPORTANCE OF DOCUMENT CONTROL 文件控制的重要性
A cornerstone of the quality management system (QMS) is the control of documents. While not a particularly glamorous activity, document control is an essential preventive measure ensuring that only approved, current documentation is used throughout the organization. Inadvertent use of out-of-date documents can have significant negative consequences on quality, costs and customer satisfaction.
质量管理体系的基石是文件的控制。文件控制并不是什么特别时髦的活动，而是基本的预防措施，保证只有批准了的现行文件在全组织内使用。过期文件的不经意的使用可以对质量、成本和顾客满意产生巨大的负面影响。
Because of its importance, companies often invest heavily in dedicated staff, detailed procedures and specialized software programs to keep control of their QMS and other business documents. Auditors (internal and external) also pay particular attention to document control disciplines resulting in frequent audit nonconformances (it is commonly reported that document control generates the most nonconformances in and ISO9000 QMS). It behooves those responsible for managing their organization's QMS to design a document control process that is simple to use, easy to monitor and effective to prevent the use of incorrect documentation.
这是由于文件控制的重要性，为了控制质量管理体系文件和其它业务文件，企业经常在专业人员，细化程序和专业软件方面下大力气。审核员（内部和外部）也侧重于文件控制方法，导致大量的审核不符合项的产生（有报道称文件控制有最多的不符合项）。让那些负责管理组织质量管理体系的人制定文件控制过程是适宜的，让过程使用更简单，监控更容易，并且防止使用错误文件更有效。


DESIGNING YOUR DOCUMENT CONTROL PROCESS 制定文件控制过程
Before reviewing the specific ISO9001 document control requirements, let's briefly discuss essential design criteria for an effective document control process.
在回顾ISO9001文件控制特定要求前，让我们简单讨论一下有效文件控制过程的基本制定准则。
Less is often better than more. 通常越少越好
While it may see obvious, it's easier to control a smaller number of documents than a larger number of documents. Document control starts with document design. Encourage your document authors to be concise and make their documents multi-purpose when possible. An annual documentation review to spot redundancies, documents no longer needed, and opportunities to consolidate will help keep your QMS document set lean.
很明显，控制少量文件要比控制大量文件来的容易。文件控制起始于文件的制定。鼓励文件起草者简明扼要，尽可能使文件多用途。每年一度的文件评审发现冗余，文件不再需要，和文件合并的机会，这将帮助你使质量管理体系文件集减量。
Navigation, hierarchy & structure 导航，层级和结构
Developing a layered structure for your documents helps users find what they are looking for. An ISO9001 structure typically organizes itself into 4 levels:
制定分层式的文件结构有助于读者找到他们想要的东西。ISO9001典型结构分四级：
· Policy - the company’s position or intention for its operation 方针——公司经营立场或意图
· Procedure - responsibilities and processes for how the company operates to comply with its policies 程序——为遵循这些方针，公司经营职责和过程
· Work Instruction - step-by-step instructions for a specific job or task 作业指导书——特点工作或任务按部就班的指导书
· Forms and Records - recorded information demonstrating compliance with documented requirements 表格和记录——证明符合文件化要求的记录信息
This logical arrangement clarifies the authority, scope and interrelationships of each document. Lower-level documents must agree with requirements of related higher-level documents. Higher-level documents generally reference lower-level documents for easy navigation.
这种合乎逻辑的安排清晰了每个文件的权限，范围和相互作用关系。低层级的文件必须与相关的高层级文件一致。高层级文件通常给低层级文件提高附注，以便于导航。
The mixed blessing of cross-referencing 交叉引证的优缺点
It is common for companies to add multiple references to related documents within the body of their documents. While this can help a reader quickly find additional information on a topic, the ability to maintain (update) all references to a document can be difficult. If you choose to use cross-references, be sure you have a way to comprehensively search for all instances of a specific document reference so they can be reviewed and updated if needed when a document is revised.
公司经常在文件内加入相关文件的交叉引证。这样可以帮助读者快速发现某一主题的额外信息，但是保持（更新）一个文件的所有引证是很难的。如果选择使用交叉引证方法的话，要保证你有办法全面搜索某一特定文件引证的所有地方，这样在文件修改时，如果需要，可以评审和更新这些引证。
Alternatives to intra-document referencing might include: 文件内引证的备选方案可能包括：
· Carefully designed document numbering systems 仔细设计文件编号体系
· A document master list showing parent-child relationships between documents 阐明文件之间上下级关系的文件总表
· The use of an electronic document management system that helps manage document interrelationships and provides for easy searching of document contents 使用电子文件管理系统帮助管理文件相互关系，提供方便的文件内容搜索。
Reviews & approvals 评审与批准
As a document is written, it is often helpful to solicit input from others before it is finalized. Circulating the document for review can include future users of the document, managers responsible for the activity, workers in areas affected by the activity and other interested individuals. Planning a "review cycle" into your document development procedure can help document authors improve the quality of the resulting documentation.
在起草一份文件时，通常在文件完成前得到其他人的输入很有益处。传审文件可以包括文件的未来的用户，那项活动负责经理，那项活动影响区域的工人，和其他相关人员。把“传审循环”策划到文件制定程序里可以帮助文件起草人提高最终的文件质量。
Document approvals are mandatory and must be kept as a record as well. When determining who should approve a particular document you must balance the desire for gaining buy-in and accountability by affected departments with the need for efficiency of the document control process. Often it is helpful to ask, "what value does each signature add to the document?" and limit approvals to those with direct knowledge or responsibility for the document.
文件批准（过程）是强制性的，并且必须作为记录保管的。在确定谁有权签署某一特定文件时，你必须在获得批准（认可）与涉及需要有效的文件控制过程部门之间的平衡。经常问问“每个签字对增加这个文件价值了吗？” ，并且把批准权限定在那些对文件有直接认识或责任的人，这样做是很有帮助的
Generally, the more signatures you require, the longer the approval process will take. An alternative to a long approval list would be to include more individuals in the review process, giving everyone a chance to comment on the document before it is released.
通常，你要的签字越多，批准过程就会越长。避免批准多头签字的另一个办法是将更多的人囊括到评审过程，让每个人有机会在文件发布前，对文件评头论足。

REQUIREMENTS FOR DOCUMENT CONTROL 文件控制要求
The ISO9001 standard includes specific document control requirements that will be subject to all internal and external audits (ref. 4.2.3).
ISO9001标准包括特定的文件控制要求，这对所有内外审均有制约。
Documents required by the quality management system shall be controlled.
质量管理体系所需的文件必须受控。
This includes all policies, procedures, work instructions, forms, specifications, and other company documents affecting quality or customer satisfaction.
这包括所有的方针、程序、作业指导书、表格、规范和其它邮箱质量或顾客满意的公司文件。
Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.
记录是特殊类型的文件，并根据4.2.4要求控制。
A documented procedure 文件化程序
Records often (though not exclusively) result from a form that is completed and filed. A separate ISO Explained article will cover the requirements of records in detail.
记录通常（尽管毫无例外地）由完成并填好了表格形成。另一篇ISO解释文章包含了详细的记录要求。
A documented procedure shall be established to define the controls needed
必须制定文件化程序规定所需的控制。
A document control procedure is one of six mandated procedures in the ISO9001 standard and it must include the company's processes for the following requirements:
文件控制程序是ISO9001标准中六个强制性程序之一，必须包括满足以下要求的公司过程：
a) to approve documents for adequacy prior to issue, 文件在发布前得到批准，以确保充分性
Approval signatures must be recorded prior to the release and use of the document. Approvals may be in the form of a written signature or a password-protected electronic approval record. The date of all approvals must precede the document's release date.
批准签字必须早于文件发布和使用之前。批准可以以书写签字或密码保护电子批准记录的形式。所有批准日必须早于文件发布日。
While not explicitly stated, this requirement also applies to temporary memos or postings that are used to communicate QMS or product-related requirements. Any temporary documents must be clearly identified, signed and dated. It is advisable to include an expiration date on temporary documents to ensure they are removed from use when intended.
除非另有声明，这个要求也适用于传达质量管理体系或产品相关要求的临时备忘录或墙报。必须清晰识别，签字批准和标注日期任何临时性文件。建议在临时性文件上标注失效日期，以保证需要时可以禁用。
b) to review and update as necessary and re-approve documents, 对文件进行评审，必要时更新，并再批准
All documents must be reviewed periodically and updated and re-approved if needed. This review can be tied to a company's internal audit process, management review or scheduled on some periodic (annual?) basis. A record of such reviews must be kept.
所有文件必须定期进行评审，需要时进行更新和再批准。该评审可以与内审过程、管理评审联系起来，或定期（一年？）进行。评审记录必须保留。
c) to ensure that changes and the current revision status of documents are identified, 确保文件的更改和现行修订状态得到识别
When a document is updated, a record must be kept of the change (the reasons for and nature of the change). In addition, current revision status must be maintained. This includes the current development stage (draft, review, approval, etc.) and the date or revision level (number or letter) identifying the current version of the document.
在文件更新时，记录必须保留这个改变（改变的原因和性质）。另外，现行修订状态必须保持。这包括现行开发阶段（起草、评审、批准等等）和日期或表明文件现行修订的修订级别（数字或字母）。
d) to ensure that relevant versions of applicable documents are available at points of use, 确保在使用处可获得有关版本的适用文件
The storage and access of documents must easily allow individuals to find the appropriate version of a document to use where needed. Note that older versions of a document that are still needed (e.g. specifications for an older product) may remain active if necessary, but the revision level must be made clear.
文件的储存和借取必须让使用者很容易地找到需要使用的文件合适的版本。注意旧版文件仍然需要（比如老产品的规范），如有需要，应该保持其活性，但是必须写清楚版本水平。
You should consider where designated controlled locations of your documents will be established and whether short-term reference copies of controlled documents will be permitted. Typically, the easier it is for employees to access controlled copies when needed, the fewer times they will feel the need to use an uncontrolled copy of a document. Ensuring timely and convenient access to documents is frequently the source of high costs and repeated discrepancies.
你该考虑在何处建立文件指定受控区域并且是否允许复制受控文件作为短期参考之用。一般来说，员工需要时取得受控副本越容易，他们感到要用非受控副本的次数就越少。保证文件存取的及时性和方便性经常是高成本和反复出错的源泉。
e) to ensure that documents remain legible and readily identifiable, 保证文件保持可读性和易识别
The format and storage of your documents must protect a document from being rendered unreadable due to wear or damage and that every document can be clearly identified through a title, document number or other suitable identification.
文件的版式和储存必须保护文件免受借阅因磨损或损坏而造成无法阅读，每个文件可以通过名称，编号或其它合适的识别符清晰地找到。
f) to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled, and 组织策划和运行质量管理体系时确定的所需的外来文件已经得到识别，并控制其分发，并且
Documents that do not originate within your organization, but are necessary for ensuring quality and meeting customer requirements must also be controlled. These can include customer, supplier or industry documents (including your copy of the ISO9001 standard). However, the extent of control is limited to clear identification and controlled distribution. A log or other record would suffice to track external documents.
不是产生于组织内部的文件，但又是保证质量满足顾客所必需的，也必须达到控制。这些文件包括顾客，供应商或行业文件（包括ISO9001标准副本）。但是，控制程度仅限于清晰标识和控制分发。一本记录册或其它记录足以跟踪外来文件。
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose. 防止作废文件的非预期使用，若因任何原因而保留这些作废文件时，对这些文件进行适当的标识。
Out-of-date documents or older versions of revised documents must be protected from unintentional use. This usually requires segregation or disposal of obsolete documents. Any obsolete documents that are kept for reference or other purposes must be clearly identified through markings, separate storage areas, or other means.
过期文件或旧版文件必须防止非预期使用。用来参考或其他目的的任何作废文件都必须清楚地通过记号，隔离储存区或其它方法标识。

MEASURING SUCCESS 测量成果
How can you measure the performance of your document control process? Here are some suggested metrics:
如何测量文件控制过程的绩效呢？建议以下：

1. User satisfaction – Periodically survey your employees regarding the usability of your documentation. Use the results to improve the format of your documents and training of your authors. 用户满意——定期对文件的可用性进行员工调查。利用调查结果改进文件格式并对文件起草人进行培训
2. Document errors – Track the number of document revisions due to information mistakes in your documentation. Results will often reveal weaknesses in your review and proofreading processes. 文件错误——因为文件中内容错误，跟踪文件版本的数量。调查结果常常暴露在文件评审和校对过程的缺点。
3. Up-to-date – Count the number of document revisions or audit discrepancies stemming from a document that is out-of-date. This will tell you whether your periodic document reviews or obsolete document provisions are effective. 保持最新——计算文件修订数量或来自于过期文件的审核错误。这会告诉你定期文件评审或作废文件提供是否有效。
4. Cycle time – Measure the time it takes a document to be developed or revised from initial draft to release. Work to improve the efficiency of your document control process as you would any other business process. 循环时间——测量文件从起草或修改到初稿发布所需的时间。就像其它业务过程那样。改进文件控制过程的效率
5. Cost – Consider tracking the costs associated with your documentation including developing, revising, storing, retrieving, distributing, filing, auditing, reviewing, approving, etc. Of these potential costs, document retrieval is often an expensive hidden cost generated when individuals must search endlessly for a document because of inadequate indexing, organization, storage or training. 成本——考虑跟踪与文件有关的费用，包括起草，修订，检索，分发，归档，审核，评审，批准等。在这些潜在的成本中，检索常常是昂贵的隐形成本，这是由于不适当的目录，组织，储存或培训而产生的。

Results of the performance measures of your document control process can help you determine how to drive continual improvements into your entire QMS.
文件控制过程的绩效测量结果可以帮助你决定如何在整个质量管理体系中推动持续改进。
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