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Quality Assurance Project Plan (QAPP)
Maintaining a respirometer that measures
a sample's oxygen usage.
Table of Contents
IntroductionIn reviewing Process to Further Reduce Pathogens and Process to Significantly Reduce Pathogens equivalency applications, the Pathogen Equivalency Committee (PEC) will verify that the results submitted in support of a process are statistically significant and were acquired taking into account appropriate quality assurance and quality control measures. (See Tip box below.) In some cases, the PEC may conduct on-site reviews.A quality assurance project plan (QAPP) should be developed before beginning testing so that the desired quality in sample collection, laboratory analysis, data validation and reporting, and documentation and record keeping is achieved and maintained. A QAPP is a written document that provides a blueprint for the entire project and each specific task to ensure that the project produces reliable data that can be used to meet the project's overall objectives and goals. TIPApplicants are now required to prepare and submit a quality assurance project plan for the PEC to review prior to conducting any research in support of their application for equivalency. Very few exceptions to this requirement will be granted. PEC review and approval of an applicant’s project plan prior to data collection will save time and money in the long run by ensuring that the proper data is collected in an appropriate manner and unnecessary data collection is eliminated. The information required in the application for equivalency recommendation is largely drawn from the QAPP requirements. The extensive overlap between the QAPP and the application is evident in the combined Completeness Checklist below that the PEC uses to evaluate both documents. For this reason, careful preparation of a QAPP will serve as a good head start on the application itself. To assist the applicant in developing such a plan, QAPP Guidelines for Applied Research Projects are provided below. This guidance document contains information on requirements for the project description and objectives, project organization, experimental approach, sampling procedures, testing and measurement protocols, Quality Assurance/Quality Control checks, data reporting, data reduction, data validation, assessments, and references.
An anaerobic digester.
Elements: Analytical Methods Common to Most QAPPs Prepared for Equivalency RecommendationsFecal Coliform (either EPA method is preferred)
Salmonella spp.
Enteric Viruses
Viable Helminth Ova
Percent Total and Volatile Solids (either method is acceptable)
Optional and Surrogate Indicator Organisms Specific methods for the analysis of optional
and surrogate indicator organisms are not mandatory unlike the organisms
used for microbial compliance monitoring of biosolids whose methods (as
listed above) are specified by 40 CFR 503.8. However, acceptable protocols
for analysis of microbial indicator organisms and specific pathogenic
microorganisms have been developed for water, wastewater, soils, foods
and other matrixes which have been incorporated into compendiums of industry
standard assays or defined as Agency approved methods. Specifically, the
references listed below identify methods which may be useful for analysis
of biosolids. Caution should be used when selecting and using methods
for alternate or surrogate indicator organisms since none of these methods
have been subject to multi-laboratory validation studies for sewage sludge
or biosolids.
Design - Goals and Objectives, Scale, and ScopeGoals and Objectives
Performing membrane filtration for microbial
enumeration.
The goals and objectives of a QAPP prepared for the purposes of supporting an equivalency application will have the same standard components. The goal of such a QAPP will be to support the equivalency of the process in question to a process to further (or significantly) reduce pathogens on a site-specific or national basis. The objectives will vary depending on the type of equivalency because the criteria for verifying efficiency differ between a process to significantly reduce pathogens and a process to further reduce pathogens. (See the Equivalency Criteria page.) However, regardless of the equivalency type, the data should be defensible in demonstrating that the process is consistently capable of pathogen reduction on par with accepted processes. 
Using a pipette to make accurate volumetric
measurements.
ScaleTypically, to receive an equivalency recommendation, laboratory work is performed to establish the boundary conditions of all key process variables, and then pilot or full-scale testing is performed to demonstrate successful scale-up. The required elements of a QAPP can be quite different depending on scale. If laboratory-scale testing is to be used, the applicant may find it easier to divide their research into two phases and carry out the work under separate QAPPs, one for the laboratory-scale work and one for the scale-up work. Planning a pilot-scale study includes some special considerations if one of its goals is to gather data for scaling up the process to a plant scale. The pilot unit should be truly representative of a full-scale operation. (See definitions of scale.) The conditions of the pilot-scale operation should be no more severe than those expected of the full-scale operation. These conditions will likely include for example, degree of mixing, nature of the flow (batch vs. flow though units and degree of short-circuiting in flow through units), vessel sizing, and proportions of the chemicals used. Any substantial departure in process parameters between the pilot-scale and the full-scale systems that has the potential to reduce the effectiveness of the process will invalidate any approvals given and will require a retest at the new condition. Scope
A-1 broth inoculation tubes from a multiple
tube fermentation analysis for fecal coliform density.
As discussed in the Basic Information web page, whether the goal is a site-specific or a national equivalency will also play a role in the overall QAPP design. For site-specific equivalencies work only needs to be performed on sludge collected from one location. For a national equivalency, however, the work must be repeated with significantly varying sludges. This would entail a combination of laboratory studies on a wide variety of sludges followed by scale-up testing using at least one sludge/location. Or if preferred, a mobile pilot-unit could be constructed and used for all testing, eliminating the need for laboratory studies. Note that the pilot unit must be a true pilot-scale of the final full-scale system for the equivalency recommendation to apply to the full-scale and not just the pilot scale. (See the pilot-scale definition for more discussion on what is considered a true pilot-scale.) Elements: Quality Assurance & Quality Control Measures
Design - Pointers on Select DetailsProper project design and sampling techniques are of utmost importance to producing a successful QAPP. Though not all-inclusive, some important points to consider when planning your QAPP include: 
Finished biosolids in a storage shelter.
ResourcesBelow are some resources to assist in the development of a successful and useful quality assurance project plan. Two example QAPPs and mock reviews of these QAPPs using the Completeness Checklist are provided. Although neither QAPP pertains to biosolids or, more specifically, the planning of a project to demonstrate Process to Further Reduce Pathogens or Process to Significantly Reduce Pathogens equivalency, the examples and mock reviews do illustrate the type of information that is required in a well-written QAPP.
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