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QUALITY ASSURANCE PROJECT PLAN (QAPP) TEMPLATE U.S. Environmental Protection Agency Great Lakes National Program Office 77 W. Jackson Boulevard Chicago, Illinois 60604‐3511 Instructions:This QAPP template was prepared based on EPA Requirements for Quality Assurance Project Plans(EPA QA/R‐5), EPA/240/B‐01/003, March 2001 (http://www.epa.gov/quality/qs‐docs/r5‐final.pdf)
It contains an outline of the QAPP elements based on the EPA QA/R‐5, with an abridged descriptionof the discussion that should be included within each section (included in redline text). Thistemplate was created as a tool to assist in development of QAPPs. Users of this QAPP templatemust consult the EPA QA/R‐5 or the more general Guidance for Quality Assurance Project Plans(EPA QA/G‐5), EPA/240/R‐02/009, December 2002 (http://www.epa.gov/quality/qs‐docs/g5‐final.pdf) as appropriate to obtain additional details and guidance for development of a QAPP
Acknowledgements:This QAPP template was prepared by CSC, under EPA contract number EP‐W‐06‐046, with thedirection of Louis Blume, Quality Manager of EPA Great Lakes National Program Office andWork Assignment Manager
DRAFT QUALITY ASSURANCE PROJECT PLANTitle of Project (or portion of project addressed by this QAPP) Prepared for: Contract/WA/Grant No./Project Identifier Prepared by: Project Identifier Version Date Page 2 SECTION A – PROJECT MANAGEMENT A.1 Title of Plan and Approval Quality Assurance Project Plan Prepared by: Date:, Project Manager / Principal Investigator Date:, Quality Assurance Manager (or equivalent) Date: Date: Project Identifier Version Date Page 3 A.2 Table of Contents SECTION A – PROJECT MANAGEMENT ..........................................................................................................2 A.1 Title of Plan and Approval......................................................................................................................2 A.2 Table of Contents ...................................................................................................................................3 A.3 Distribution List....................................................................................................................................5 A.4 Project/Task Organization ...................................................................................................................5 A.5 Problem Definition/Background..........................................................................................................6 A.6 Project/Task Description .....................................................................................................................6 A.7 Quality Objectives & Criteria .................................................................................................................6 A.8 Special Training/Certification ..............................................................................................................7 A.9 Documents and Records......................................................................................................................7SECTION B – DATA GENERATION & AQCUISITION...........................................................................................8 B.1 Sampling Process Design (Experimental Design).................................................................................8 B.2 Sampling Methods ...............................................................................................................................8 B.3 Sampling Handling & Custody..............................................................................................................9 B.4 Analytical Methods ..............................................................................................................................9 B.5 Quality Control.....................................................................................................................................9 B.6 Instrument/Equipment Testing, Inspection, and Maintenance ........................................................10 B.7 Instrument/Equipment Calibration and Frequency ..........................................................................10 B.8 Inspection/Acceptance of Supplies & Consumables .........................................................................11 B.9 Data Acquisition Requirements for Non‐Direct Measurements .......................................................11 B.10 Data Management ..........................................................................................................................11SECTION C – ASSESSMENT AND OVERSIGHT .................................................................................................12 C.1 Assessments and Response Actions ..................................................................................................12 Project Identifier Version Date Page 4 C.2 Reports to Management ...................................................................................................................12SECTION D – DATA VALIDATION AND USABILITY ........................................................................................13 D.1 Data Review, Verification, and Validation ........................................................................................13 D.2 Verification and Validation Methods ................................................................................................13 D.3 Reconciliation with User Requirements ............................................................................................13List of TablesList of Figures Project Identifier Version Date Page 5 A.3 Distribution List List the individuals and their organizations who need copies of the approved QA Project Plan and any subsequent revisions, including all persons responsible for implementation (e.g., project managers), the QA managers, and representatives of all groups involved
Name, Agency/Company, Title, other contact information as needed A.4 Project/Task Organization Identify the individuals or organizations participating in the project and discuss their specific roles and responsibilities. Include the principal data users, the decision makers, the project QA manager, and all persons responsible for implementation. Project QA manager position must indicate independence from unit colleting/using data
Table A.1 Roles & ResponsibilitiesIndividual(s) Assigned Responsible for: Authorized to:Name Responsibility Action Responsibility Action Provide a concise organization chart showing the relationships and the lines of communication among all project participants. The organization chart must also identify any subcontractor relationships relevant to environmental data operations, including laboratories providing analytical services
Figure A.1 Organization Chart A.5 Problem Definition/BackgroundState the specific problem to be solved, decision to be made, or outcome to be achieved
Include sufficient background information to provide a historical, scientific, and regulatoryperspective for this particular project
Clearly state problem to be resolved, decision to be made, or hypothesis to be tested Historical & background information Project Identifier Version Date Page 6 Cite applicable technical, regulatory, or program-specific quality standards, criteria, or objectives A.6 Project/Task DescriptionProvide a summary of all work to be performed, products to be produced, and the schedule forimplementation. Provide maps or tables that show or state the geographic locations of field tasks
This discussion need not be lengthy or overly detailed, but should give an overall picture of howthe project will resolve the problem or question described in A.5
List measurements to be made/data to obtain Note special personnel or equipment requirements Provide work schedule A.7 Quality Objectives & CriteriaDiscuss the quality objectives for the project and the performance criteria to achieve thoseobjectives. EPA requires the use of a systematic planning process to define these qualityobjectives and performance criteria
State project objectives and limits, both qualitatively & quantitatively State & characterize measurement quality objectives as to applicable action levels or criteria Project Identifier Version Date Page 7 A.8 Special Training/CertificationIdentify and describe any specialized training or certifications needed by personnel in order tosuccessfully complete the project or task. Discuss how such training will be provided and howthe necessary skills will be assured and documented
A.9 Documents and RecordsDescribe the process and responsibilities for ensuring the appropriate project personnel have themost current approved version of the QA Project Plan, including version control, updates,distribution, and disposition
Itemize the information and records which must be included in the data report package andspecify the reporting format for hard copy and any electronic forms. Records can include rawdata, data from other sources such as data bases or literature, field logs, sample preparation andanalysis logs, instrument printouts, model input and output files, and results of calibration andQC checks
Identify any other records and documents applicable to the project that will be produced, such asaudit reports, interim progress reports, and final reports. Specify the level of detail of the fieldsampling, laboratory analysis, literature or data base data collection, or modeling documents orrecords needed to provide a complete description of any difficulties encountered
Specify or reference all applicable requirements for the final disposition of records anddocuments, including location and length of retention period
Contract/WA/Grant # or Project Identifier Version Date Page 10 SECTION B – DATA GENERATION & AQCUISITION B.1 Sampling Process Design (Experimental Design)Describe the experimental data generation or data collection design for the project, including asappropriate: Types and number of samples required Sampling network design & rationale for design Sampling locations & frequency of sampling Sample matrices Classification of each measurement parameter as either critical or needed for information only Validation study information, for non-standard situations B.2 Sampling MethodsDescribe the sampling procedures: Identify sample collection procedures
Identify sampling methods and equipment o Sampling methods by number, date, and regulatory citation, where appropriate o Implementation requirements o Sample preservation requirements o Decontamination procedures o Any support facilities needed Describe specific performance requirements for the method
o Address what to do when a failure in the sampling or measurement system occurs o Who is responsible for corrective action o How the effectiveness of the corrective action will be determined and documented B.3 Sampling Handling & CustodyDescribe the requirements for sample handling and custody in the field, laboratory, and transport
Examples of sample labels, custody forms, and sample custody logs should be included
B.4 Analytical MethodsIdentify analytical methods to be followed (with all options) & required equipment
Specify any specific method performance criteria State requested lab turnaround time Contract/WA/Grant # or Project Identifier Version Date Page 10 Provide validation information for non-standard methods Identify procedures to follow when failures occur Identify individuals responsible for corrective action and appropriate documentation B.5 Quality ControlIdentify QC activities needed for each sampling, analysis, or measurement technique. For eachrequired QC activity, list the associated method or procedure, acceptance criteria, and correctiveaction. State or reference the required control limits for each QC activity and corrective actionrequired when control limits are exceeded and how the effectiveness of the corrective actionshall be determined and documented
Describe or reference the procedures to be used to calculate applicable statistics (e.g., precision,bias, accuracy)
B.6 Instrument/Equipment Testing, Inspection, and MaintenanceDescribe how inspections and acceptance testing of instruments, equipment, and theircomponents affecting quality will be performed and documented to assure their intended use asspecified
Describe how deficiencies are to be resolved, when re-inspection will be performed, and how theeffectiveness of the corrective action shall be determined and documented
Identify the equipment and/or systems requiring periodic maintenance and/or calibration
Describe how periodic preventative maintenance will be performed, including frequency, toensure availability and satisfactory performance of the systems. Note availability & location ofspare parts
B.7 Instrument/Equipment Calibration and FrequencyIdentify all tools, gauges, instruments, and other sampling, measuring, and test equipment usedfor data generation or collection activities affecting quality that must be controlled andcalibrated
Describe or reference how calibration will be conducted using certified equipment and/orstandards with known valid relationships to nationally recognized performance standards. If nosuch nationally recognized standards exist, document the basis for the calibration
Indicate how records of calibration will be maintained and be traceable to the equipment
Contract/WA/Grant # or Project Identifier Version Date Page 11 B.8 Inspection/Acceptance of Supplies & ConsumablesState acceptance criteria for supplies and consumables and describe how they will be inspectedfor use in the project. Note responsible individuals
B.9 Data Acquisition Requirements for Non‐Direct MeasurementsIdentify type of data needed from non-measurement sources (e.g., computer data bases andliterature files), along with acceptance criteria for their use. Define intended use and describeany limitations of such data
B.10 Data ManagementDescribe data management process from generation to final use or storage. Describe standardrecord keeping & data storage and retrieval requirements. Provide examples of any forms orchecklists to be used
Describe data handling equipment & procedures used to process, compile and analyze data (e.g.,required computer hardware & software). Describe the process for assuring that applicableinformation resource management requirements, including EPA specific requirements, aresatisfied
List the individuals and their organizations who need copies of the approved QA Project Plan and any subsequent revisions, including all persons responsible for implementation (e.g., project …
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