كتاب Guidance for Preparing Standard Operating Procedures (SOPs) E

TABLE OF CONTENTS PERATING PROCEDURES 1.0 INTRODUCTION 1.1 Overview A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an organization. The development and use of SOPs are an integral part of a successful quality system as it provides individuals with the information to perform a job properly, and facilitates consistency in the quality and integrity of a product or end-result. The term “SOP” may not always be appropriate and terms such as protocols, instructions, worksheets, and laboratory operating procedures may also be used. For this document “SOP” will be used. SOPs describe both technical and fundamental programmatic operational elements of an organization that would be managed under a work plan or a Quality Assurance (QA) Project Plan [EPA Requirements for QA Project Plans (QA/R-5) (EPA 2001a)], or Chapter 5 of the EPA Quality Manual for Environmental Programs, (EPA Manual 5360 A) and under an organization’s Quality Management Plan [EPA Requirements for Quality Management Plans (QA/R-2) (EPA 2001b)], or Chapter 3 of the EPA Quality Manual. This document is designed to provide guidance in the preparation and use of an SOP within a quality system. 1.2 Purpose SOPs detail the regularly recurring work processes that are to be conducted or followed within an organization. They document the way activities are to be performed to facilitate consistent conformance to technical and quality system requirements and to support data quality. They may describe, for example, fundamental programmatic actions and technical actions such as analytical processes, and processes for maintaining, calibrating, and using equipment. SOPs are intended to be specific to the organization or facility whose activities are described and assist that organization to maintain their quality control and quality assurance processes and ensure compliance with governmental regulations. If not written correctly, SOPs are of limited value. In addition, the best written SOPs will fail if they are not followed. Therefore, the use of SOPs needs to be reviewed and re-enforced by management, preferably the direct supervisor. Current copies of the SOPs also need to be readily accessible for reference in the work areas of those individuals actually performing the activity, either in hard copy or electronic format, otherwise SOPs serve little purpose. 1.3 Benefits The development and use of SOPs minimizes variation and promotes quality through consistent implementation of a process or procedure within the organization, even if there are temporary or permanent personnel changes. SOPs can indicate compliance with organizational EPA QA/G-6 1 April 2007 and governmental requirements and can be used as a part of a personnel training program, since they should provide detailed work instructions. It minimizes opportunities for miscommunication and can address safety concerns. When historical data are being evaluated for current use, SOPs can also be valuable for reconstructing project activities when no other references are available. In addition, SOPs are frequently used as checklists by inspectors when auditing procedures. Ultimately, the benefits of a valid SOP are reduced work effort, along with improved comparability, credibility, and legal defensibility. SOPs are needed even when published methods are being utilized. For example, if an SOP is written for a standard analytical method, the SOP should specify the procedures to be followed in greater detail than appear in the published method. It also should detail how, if at all, the SOP differs from the standard method and any options that this organization follows. As noted in ASTM D5172-91 (2004), Standard Guide for Documenting the Standard Operating Procedures Used for the Analysis of Water, “a significant part of the variability of results generated by different laboratories analyzing the same samples and citing the same general reference is due to differences in the way the analytical test methods and procedures are actually performed in each laboratory. These differences are often caused by the slight changes or adjustments allowed by the general reference, but that can affect the final results." Using a correct well-written SOP can minimize such differences. 1.4 Writing Styles SOPs should be written in a concise, step-by-step, easy-to-read format. The information presented should be unambiguous and not overly complicated. The active voice and present verb tense should be used. The term "you" should not be used, but implied. The document should not be wordy, redundant, or overly lengthy. Keep it simple and short. Information should be conveyed clearly and explicitly to remove any doubt as to what is required. Also, use a flow chart to illustrate the process being described. In addition, follow the style guide used by your organization, e.g., font size and margins.
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