流程一词是西方带到中国的,下面的一段文章写了一个标准的流程所应具备的基本要素。 Company name and pagination. The company name and pagination (e.g., "page 3 of 7") must appear on every page of the document. These procedures can appear in submission documents; therefore, it should always be apparent which company is responsible for the document. Title. The title should be descriptive. Because a procedure describes how to do something, the title should use directive language to declare what is being done to what. An SOP titled "Water for Injection Still" is not descriptive of the procedure's content; a more appropriate title would be, "Operation of Water for Injection Still." Identification and control. Procedures must be uniquely identified. This identification supports accountability and traceability of the document throughout the facility and over time as it changes. the accountability and traceability of procedures are based on assigning them identification numbers or codes and control numbers or codes (e.g., revision or edition numbers). Purpose. the purpose or objective of a procedure should restate and expand a well-written title. Scope. The scope should provide limits to the use of the procedure. Are there certain samples that are appropriate to test by this method? Do these operations apply only to certain equipment or to certain departments? Is there a limit to the capacity, volume, or throughput of the procedure? State to what areas this procedure does and does not apply. Responsibility. Who is responsible for performing the work described? Who is responsible for reporting the work? Are there special training or certification requirements? As discussed below, this section defines the procedure's audience, i.e., who will be qualified to perform the work described. It will set the stage for the amount of detail in the document that follows. Procedure. Describe the procedure in a step-by-step, chronological manner. Use active verbs and direct statements. Calculations / data handling / documentation requirements. Describe how the raw data are managed and reported. Provide examples of calculations, when appropriate. |