Office of Emergency and Remedial Response Emergency Response Division Environmental Response Branch, MS-101 United States Office of January 1992 Environmental Protection Solid Waste and Agency Emergency Response Creating SOP Documents Quality Assurance Technical Information Bulletin Purpose Standard Operating Procedures (SOPs) are intended to provide a project team with a uniform approach to routine tasks and a consistent basis for training and auditing. The objective of this bulletin is to discuss the importance of SOPs, the content of SOPs, the control of SOPs, specific SOPs which are available through the ERT, and responsibilities associated with SOPs. Reasons for Development SOPs are developed to document the specific activities that make up a routine operation and the jecom- mended sequence of those activities. In addition, the SOP can be used as a tool to train new personnel in how to properly perform an activity. SOPs can provide a basis for the development of other SOPs for similar or related activities. As routine operations are carried out, the steps outlined in the SOP should be followed. However, as activities progress, new and different practices could be discovered and implemented. Upon completion of the activity, the actual procedure followed by field and lab personnel should be docu- mented. This may lead to revision of the SOP. Another reason for developing written SOPs is that they provide criteria which allow someone who is inde- pendent of the activity being performed to verify that the activity is being performed correctly.' ERT SOPs ERT has developed detailed SOPs for approximately 45 different field analytical, sampling and technical activities. In addition, these SOPs were grouped by technical areas and have been published in seven com- pendiums: • ERT Groundwater Sampling Procedures (OSWER Directive 9360.4-06) • ERT Waste Sampling Procedures (OSWER Directive 9360.4-07) • ERT Soil Sampling and Surface Geophysics . Procedures (OSWER Directive 9360.4-02) • ERT Surface Water and Sediment Sampling Procedures (OSWER Directive 9360.4-03) • ERT Toxicity Testing Procedures (OSWER Directive 9360.4-08) • ERT Field Analytical Procedures (OSWER Directive 9360.4-04) • ERT Air Sampling Procedures (OSWER Directive 9360.4-05) Contents At a minimum, SOPs should include the sections described below. Some sections will not be relevant for certain SOPs. In such cases, indicate that the sec- tion is not applicable under the header. Do not just delete the section. Scope and Application - a description of the sample collection, analytical or other technical activities to which the SOP applies. In addition, the media/matrix, chemical compounds of interest, and concentration levels which can be obtained, shall be described, as applicable. Method Summary - a brief summary of the method. Sample Preservation, Containers, Handling and Storage - a description of the amount of sample to be collected, the sample container type, chemical preser- vation, if required, and storage requirements. ------- Interferences and Potential Problems - a description of environmental conditions, weather conditions, or non-targeted chemicals that can cause problems and/or interferences of which the user should be aware. Equipment/Apparatus - the names and model num- bers of equipment and/or instruments used in the procedure, including ancillary equipment such as power supplies, data acquisition equipment, re- corders, etc. Reagents - a list of all chemical reagents used in the procedure (i.e., cylinder gases, acids, solvents,- stand- ards, powdered reagents). In addition, a description of preparation methods of any stock solution (i.e., 10% nitric acid, etc.) should be included. Procedure - a step-by-step list of how the actual sample collection, analytical procedure or technical activity is performed. Calculations - equations/formulas for calculating results and associated units of measurement. If direct read-out, this should also be stated. Quality Assurance/Quality Control - list and frequen- cy of QA/QC samples that are to be collected and analyzed with the environmental samples (i.e., blanks, duplicates, spikes, and PE's). Acceptance criteria for each QA/QC sample should be given. In addition, other QA/QC activities such as equipment calibration, background sample collection, implementation of manufacturer's instructions, etc. should also be listed. Data Validation - indicate how data is reviewed against identification and quantitation criteria. Also indicate how data is qualified when QA/QC accep- tance criteria are exceeded (i.e., data is rejected or flagged, etc.) Health and Safety - a discussion of potential problems which may require personal protective equipment and other standard safety practices to be considered. References - a list of documents which were consulted in the development of the SOP or which may provide further information on a particular subject. Control of SOPs SOPs are controlled to ensure that procedures are understood and are in the hands of those responsible for performing the activities. Before SOPs and revisions thereto, are released, they should be reviewed to ensure that their contents are adequate and accurate, and that quality requirements are ap- propriately stated. Obsolete' or superseded SOPs must be controlled to prevent inadvertent use. In the ERT system, this control is ensured through the main- tenance of a master list of SOPs which includes the current revision level and publication date of all SOPs. In addition, the revision levels and publication dates are printed in the upper right corner of all pages of each SOP. As SOPs are revised, the revision levels and publication dates are changed to reflect this. For the compendiums, the publication date is printed on the cover sheet and title page. Submittal of SOPs SOPs may be submitted to the Removal Program QA Officer for consideration for use as an ERT SOP. The SOP must address all of the sections described above. The author will be notified of acceptance or rejection of the SOP upon review by the Removal Program QA Officer or designee. Distribution of SOPs Individual ERT SOPs are available on an as-requested basis from the Removal Program QA Officer. Com- pendiums of ERT SOPs are available through the Na- tional Technical Information Service, (703) 487-4600; the ERT Bulletin Board, (908) 906-6968; and U.S. EPA Superfund/RCRA Hotline, (800) 424-9346. Responsibilities Users - Prepare SOPs according to the content re- quirements, as well as industry standards for the respective activity. Also, perform activities in accord- ance with SOPs or document any deviations from or modifications to SOPs. Section Chiefs - Ensure the development and im- plementation of SOPs within their respective dis- ciplines. Also, identify changes needed in any existing procedure, based on new and relevant information. QA Officer - Ensures implementation of the content requirements; maintains the master list of SOPs; en- courages the development of SOPs; reviews and ap- proves SOPs. For more information, contact: Mr. William Coakley U.S. EPA, ERT Phone: (908) 906-6921 Ms. Christine Andreas Roy F. Weston, Inc./REAC Phone: (908) 632-9200 ------- |