How to write laboratory \"Work Instructions\"

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The most commonly used work instruction documents in laboratories are detailed written descriptions, such as guidelines for random market inspections, rules for comprehensive inspections, sampling procedures, instructions for sample preparation, and operating procedures for instruments and equipment. Today, I’ve compiled guidelines for writing work instruction manuals, covering structure, format, content, and precautions. Let’s take a look together. 01 Structure, format, and content of work instruction sheets. Work instruction sheets can be standards, specifications, guidelines, or they can include charts, pictures, models, videos, etc ； Structurally, it can adopt a standard format or a non-standard format. The structure and format of work instructions generally should not be standardized to a single pattern, but to avoid confusion and uncertainty, within an organization it is possible to specify distinct structures and formats for different types of work instructions, in order to maintain consistency in their format or structure. Regardless of the format or combination used, the sequence in which the content of the work instruction is presented should correspond to the sequence of the work activities, accurately reflecting the requirements and related actions. The structure, format, and level of detail of the work instruction should be suitable for the needs of the personnel using it within the organization. These elements are determined by the complexity of the processes being described, the methods used, the amount of time and depth required for training prior to implementation, as well as the technical skills, expertise, and qualifications of those who will carry out the tasks. A work instruction should include the following elements: 1. Title and cover page. The work instruction must have a clear title that specifies the name of the process it describes; generally, it can be structured as “Name of the work activity + Work instruction” or “Name of the work activity + Work procedures/standards”. If a cover is provided, the number, drafter, reviewer, approver, approval date, and revision status should be indicated on it; if there is no cover, these details should be written below the title. 2. Purpose and Scope: The work instruction should first specify the scope of operations for which it is applicable and those for which it is not applicable; it should also briefly outline the purpose of its creation or the objectives to be achieved through its implementation, that is, why this work instruction was developed and what goals are to be attained by creating it. 3. Task content and requirements: The task content and requirements constitute the core of the work instruction sheet, and should reflect in a specific and accurate manner the tasks to be carried out, the relevant requirements, as well as the associated activities. At the same time, the order in which the content of the work instructions is presented should correspond to the order of the work activities. If necessary, diagrams or tables can be used to facilitate understanding. The text of the work instructions should be easy to understand; it is necessary to use quantitative information as much as possible and rely on data in order to ensure that the workers have a single, correct understanding, thereby enabling control over process quality after implementation. 02 Precautions for preparing work instructions 1. The design and preparation of work instructions shall comply with the provisions of the organization’s Quality Manual; the procedures specified in these work instructions should be appropriate for the actual conditions of the organization, including considerations related to the environment, testing instruments and equipment, and the scope of testing. 2. An activity can have only one procedure and only one interpretation; therefore, a task can have only one set of instructions. Furthermore, invalid versions of the work instructions cannot be used. 3. Once the work instruction is approved for implementation, it must be followed carefully; if modifications are necessary, they must be carried out in accordance with the procedures specified in the Quality Manual. 03 Several misconceptions in the process of preparing work instructions 1. Using the operating procedures for instruments and equipment as substitutes for work instructions. The instruments and equipment we use these days are becoming increasingly advanced, with more and more functions, yet when conducting a particular experiment, we may only need to utilize a subset of those functions. As operating procedures, only some main test methods can be specified. Therefore, the instrument operation methods for each test should be outlined in the work instructions. 2. Replacing work instructions with product standards or testing method standards – these standards usually only specify the principles for using certain instruments, such as the operating environment, testing errors, measurement ranges, and testing speeds; they may not specify exactly which instruments should be used. This requires selecting instruments and equipment that meet the standard requirements, based on the specific conditions of the unit, in the work instructions. This situation is often encountered in product standards or testing method standards, where for the same testing item, more than one testing method is specified. The work instruction should specify which method to use based on the specific conditions of the unit. 3. Any replacement of instruments and equipment, as well as any revisions or updates to standards and specifications, requires changes to the operating instructions. In accordance with the provisions of the “Review Criteria”, operating instructions must possess the characteristics of legality, uniqueness, and applicability. Replacement of instruments and equipment, as well as revisions to standards and specifications, may render the corresponding work instructions obsolete; therefore, these instructions must be revised to ensure their applicability. 4. It is incorrect to prepare operation manuals for every method and instrument; operation manuals are only necessary when there is a risk of misunderstanding the method or causing improper use of the equipment. For example, no operation manual is needed for using a hammer.