Helpful Hints for QAPP Writers
THE SUGGESTIONS IDENTIFIED HERE ARE ONLY PROVIDED AS EXAMPLES AND NOT INTENDED TO INDICATE SPECIFIC LANGUAGE THAT MUST BE USED.
To many first-time writers, the preparation of a Quality Assurance Project Plan (QAPP) can seem an intimidating task. These helpful hints are intended to be used as an additional tool to help guide the preparer through the process. These hints and suggestions have been compiled by the Region 7 Quality Assurance Office (RQAO) and are meant to: 1) help the first-time writer avoid common errors; 2) offer suggestions on how to correct these errors when they are made; and 3) provide helpful hints as additional guidance Although these hints are targeted toward the novice, experienced QAPP writers may also find the information useful. These helpful hints compliment the requirements found in "EPA Requirements for Quality Assurance Project Plans for Environmental Data Operations," EPA QA/R-5 and "Guidance for Quality Assurance Project Plans," EPA QA/G-5. The information is not intended to be a replacement or substitution for Agency QAPP requirements and will only be valuable when used in conjunction with R-5 and G-5. Many of the suggestions are geared towards QAPPs written for Region 7 and may not apply to QAPPs prepared for other regions. Use of References: There are occasions when the required QAPP information is adequately addressed in a separate document. To avoid duplication of effort, the appropriate QAPP section can reference the applicable document. However, the reference must be complete. Error: The following statement appears at the beginning of the QAPP: "Additional information is contained in the Statement of Work (SOW)." No further details are provided regarding the SOW. Correction: Each section of the QAPP that is addressed by a separate document should include a specific reference. For example, "The background information is addressed in section 1.1, page 3 of the SOW. See attachment A." A copy of the SOW is included as an attachment to the QAPP. Copies of referenced documents (or at least the applicable portions) should be included as an attachment to the QAPP when the referenced document(s) is not readily available to reviewers. Referenced documents that are readily available to reviewers (e.g., Region 7 standard operating procedures, EPA methods) do not need to be included as attachments. Use of Templates and Model QAPPs: Sometimes a preparer will use a previously written QAPP or a model QAPP as a template but will not verify that all changes are made. Error: A QAPP uses a previously prepared QAPP as a template and includes the following statement, "Percent moisture will be determined on groundwater samples by gas chromatography." Correction: Percent moisture is not a measurement performed for aqueous samples and is not determined by gas chromatography; this statement is a result of a carryover from a template. To avoid these types of errors, a third party (e.g., peer review) is asked to read the QAPP to identify inconsistencies before the QAPP is submitted to EPA. Identification of Non-applicable Elements: Not every QAPP element will apply to every project. It is important to clearly indicate any QAPP element that does not apply to a particular project. Error: The QAPP element entitled "Sample Handling and Custody Requirements" is omitted from a QAPP with no additional information provided. Correction: The heading "Sample Handling and Custody Requirements" appears on the QAPP's table of contents and in the text. Under this heading in the text, the QAPP includes the following statement, "Because the project only involves water quality measurements taken directly in the field, no sample handling or chain-of-custody requirements apply." Format and Content of QAPPs Helpful Hint: Although the content of a QAPP is more important than the actual format, QAPPs that do not comply with the R-5 format could potentially prolong the review process by causing a greater effort on the part of a reviewer to ensure all critical issues are adequately addressed. Helpful Hint: A QAPP is the blueprint for a project and should be written in enough detail to allow someone with a minimum technical background to read and understand the QAPP and to repeat the project. The QAPP needs to answer these six basic questions: who, what, when where, why, and how. Be sure the QAPP reflects what will actually happen and not make assumptions about what reviewers want to read. Distribution List Error: Individuals on the Distribution List are not included in the Project/Task Organization section. Correction: Individuals or organizations receiving a copy of the QAPP only for informational purposes or as a courtesy are so identified on the Distribution List. All individuals with an active role in the project are included on both the Distribution List and in the Project/Task Organization. Project/Task Organization Helpful Hint: Make the organizational chart an appendix or attachment to the QAPP rather than incorporating it into the text of the document. The organizational chart can then be easily revised and replaced if personnel changes occur during the project. Helpful Hint: There is no specific requirement for an organization conducting an environmental data gathering project to have a person with the specific title and position of QA manager/officer. Some organizations may be too small or have limited resources to allow for this; however, an individual is needed who can perform the functions of a QA manager/officer and remain independent from those individuals and groups responsible for data generation. Project/Task Description Sometimes the project objective(s) statement is too broad. Error: "The project objective is to protect human health and the environment and to conduct a site investigation." Correction: A more specific project objective statement needs to be provided. For example, "The mean concentration of total chromium in surface soils will be measured to determine if chromium contaminated soils exist on site and if it exceeds the health-based action level established for the site." There has been some confusion in the past regarding method detection limits (MDL) and levels of interest. Error: "The levels of interest are documented in the analytical method and are adequate for this project." Correction: "The level of interest for this project for benzene is the drinking water maximum contaminant level (MCL) of 5 g/L. The laboratory's MDL for the chosen analytical method is 0.5 g/L which is adequate to meet benzene's MCL." Quality Objectives and Criteria for Measurement Data Helpful Hint: Precision, accuracy, representativeness, completeness, and comparability should be identified as data quality indicators (DQIs). Sampling Process Design The QAPP needs to provide the rationale for the chosen sampling design. The reason for selecting a sampling design over other options simply needs to be stated. Use of the phrase "best professional judgment" is not adequate. Error: "Sample locations will be chosen by the project manager based on best professional judgment." Correction: If a project will use a judgmental sampling approach, the QAPP might include a statement such as, "Soil samples will be collected at areas of stained soil, stressed vegetation, and drum storage areas where company records show a spill occurred." Use of the phrase "best professional judgment" should be avoided entirely. Sampling Methods Requirements: Helpful Hint: An effective approach for addressing the issues of sample numbers and types, sample containers, analytes of interest, holding times, and preservation techniques is to prepare a table. An example follows: Matrix # of Samples Analyte of Interest Sample Container Holding Time Preservation water 4 mercury 1L cubitainer 28 days pH<2, HNO3, 4øC Quality Control Requirements Helpful Hint: Field quality control (QC) samples are not required; however, they can provide valuable and useful information regarding sampling procedures. Field duplicates can be used to estimate the precision associated with sampling procedures. Trip blanks, field blanks, and rinsate samples can help monitor potential contamination from shipment, field conditions, and decontamination procedures, respectively. Field QC samples should always be considered when planning a project; however they should not be collected simply for the sake of QC. If, for example, a field duplicate will not provide useful information or is not needed to meet project objectives, then it is probably not worth the additional time and expense. Helpful Hint: Many times a QAPP will simply reference the control limits documented in a published method, e.g., SW-846, Method 8260, for laboratory QC samples. References to these control limits must be used with caution. Not all analytical methods include control limits, and of those that do, the control limits may be provided only as guidance and may not be appropriate for the project. Data Review, Validation, and Verification Requirements Helpful Hint: There may be some confusion regarding the evaluation of laboratory QC samples and field QC samples. Laboratory QC samples are evaluated by the analyst against the criteria defined in the lab's analytical standard operating procedure. Field QC samples are evaluated by the project manager (or other designated project personnel) against the criteria defined in the QAPP. The QAPP must describe the process to be used by the project manager when evaluating field QC (for accepting, rejecting, or qualifying data). Helpful Hint: Method-specific acceptance limit presented in SW-846 methods are single lab, single run values; using the acceptance limits published in the method is not suggested. SW-846 encourages and provides guidance for a laboratory to use in developing in-house QC limits. Section 8.7, Method 8000B provides an equation for calculating acceptance limits, i.e., ñ3 standard deviations from a mean calculated from 15-20 analyses. When SW-846 methods are proposed, the in-house acceptance limits of the laboratory should be evaluated for adequacy in meeting project objectives. Helpful Hint: The EPA's contract laboratory program (CLP) functional guidelines can only be used to validate data generated using the CLP's statements of work (SOWs).