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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, 4C



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., 3 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).
     

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