SAMPLE COMPANY Page 1 of 2 SOP # 05-2 Revision: 0 Prepared by: _ Effective Date: Approved by: _ Title: WORK INSTRUCTIONS (ASSEMBLY MANUALS) Policy: As part of the company's quality assurance system and to assure consistent, quality production within established specification criteria, detailed assembly manuals and/or work instructions will be prepared for each product manufactured by the company. These manuals will be utilized for personnel training and as an ongoing reference source. Purpose: This procedure outlines the typical formats and content for preparation of assembly manuals. Scope: This procedure applies to the manufacturing and assembly of all products. Procedures: 1.0 Preparation of Assembly Manuals 1.1 As part of the product documentation, the Master Product Record contains when appropriate specific written procedures for construction or fabrication of the device or sub- assembly components. These procedures should cover, as appropriate: - Who is assigned to perform the task; - What activity or task is to be performed; - When and Where the task is to be performed; and - How to perform the task including What tools, materials, etc., to use. A written procedure may not be necessary when: - the activity is very simple; - the activity is relatively simple and models are used as aids; - straightforward quantitative rather than qualitative standards determine acceptability; and - the operation is performed by personnel highly skilled relative to the task being performed. Often training and work experience alone combined with drawings, photographs, and models can be valid substitutes for written procedures. For example, machinists can fabricate components and finished devices using dimensional drawings for guidance instead of written procedures. WORK INSTRUCTIONS (ASSEMBLY MANUALS) Page 2 of 2 2.0 Models or Samples 2.1 Documentation may be supported by production aids such as labeled photographs, video tapes, slides, sample sub- assemblies, or sample finished products. All of these perform master record functions and therefore must be current, correct and approved for the intended operation. The most commonly used aids are models and samples. There are two conditions that should be satisfied in order to use these aids. First, a written specification for the sample must be contained in the master product record. This specification should be the same as the specification for the assembly or finished product to be manufactured and is subject to formal change-control procedures. Even though a model is available, the specification is needed for present and future product development and for production control purposes. Second, the sample must: - adequately reflect the master product record specification; - be identified as an approved acceptable sample, which means it should meet the company required workmanship standards; and - when appropriate, contain a drawing number, revision level, and control number (lot, serial, batch, etc.). A card/tag may be used to identify and help control the use of samples of assemblies or finished products. Such tags should usually be covered by a clear plastic laminate and attached to the model or sample. As samples and other aids such as photographs are subject to normal wear and tear in a production environment, such aids should be adequately protected by a suitable means such as being located in a protected area, or covered by a protective container to maintain their integrity. Samples and other aids should be inspected periodically to insure their continued conformance to written specifications.