Quality Assurance Project Plan Qapp

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Quality assurance project plan qapp

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Summary

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 description
of the discussion that should be included within each section (included in redline text). This
template was created as a tool to assist in development of QAPPs. Users of this QAPP template
must 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 the
direction of Louis Blume, Quality Manager of EPA Great Lakes National Program Office and
Work Assignment Manager

DRAFT
QUALITY ASSURANCE PROJECT PLAN
Title 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......................................................................................................................7
SECTION 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 ..........................................................................................................................11
SECTION C – ASSESSMENT AND OVERSIGHT .................................................................................................12
C.1 Assessments and Response Actions ..................................................................................................12
Project Identifier
Version
Date
Page 4
C.2 Reports to Management ...................................................................................................................12
SECTION 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 ............................................................................................13
List of Tables

List 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 & Responsibilities
Individual(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/Background
State 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 regulatory
perspective 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 Description
Provide a summary of all work to be performed, products to be produced, and the schedule for
implementation. 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 how
the 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 & Criteria
Discuss the quality objectives for the project and the performance criteria to achieve those
objectives. EPA requires the use of a systematic planning process to define these quality
objectives 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/Certification
Identify and describe any specialized training or certifications needed by personnel in order to
successfully complete the project or task. Discuss how such training will be provided and how
the necessary skills will be assured and documented


A.9 Documents and Records
Describe the process and responsibilities for ensuring the appropriate project personnel have the
most 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 and
specify the reporting format for hard copy and any electronic forms. Records can include raw
data, data from other sources such as data bases or literature, field logs, sample preparation and
analysis logs, instrument printouts, model input and output files, and results of calibration and
QC checks

Identify any other records and documents applicable to the project that will be produced, such as
audit reports, interim progress reports, and final reports. Specify the level of detail of the field
sampling, laboratory analysis, literature or data base data collection, or modeling documents or
records needed to provide a complete description of any difficulties encountered

Specify or reference all applicable requirements for the final disposition of records and
documents, 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 as
appropriate:
 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 Methods
Describe 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 & Custody
Describe 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 Methods
Identify 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 Control
Identify QC activities needed for each sampling, analysis, or measurement technique. For each
required QC activity, list the associated method or procedure, acceptance criteria, and corrective
action. State or reference the required control limits for each QC activity and corrective action
required when control limits are exceeded and how the effectiveness of the corrective action
shall 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 Maintenance
Describe how inspections and acceptance testing of instruments, equipment, and their
components affecting quality will be performed and documented to assure their intended use as
specified

Describe how deficiencies are to be resolved, when re-inspection will be performed, and how the
effectiveness 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, to
ensure availability and satisfactory performance of the systems. Note availability & location of
spare parts


B.7 Instrument/Equipment Calibration and Frequency
Identify all tools, gauges, instruments, and other sampling, measuring, and test equipment used
for data generation or collection activities affecting quality that must be controlled and
calibrated

Describe or reference how calibration will be conducted using certified equipment and/or
standards with known valid relationships to nationally recognized performance standards. If no
such 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 & Consumables
State acceptance criteria for supplies and consumables and describe how they will be inspected
for use in the project. Note responsible individuals


B.9 Data Acquisition Requirements for Non‐Direct Measurements
Identify type of data needed from non-measurement sources (e.g., computer data bases and
literature files), along with acceptance criteria for their use. Define intended use and describe
any limitations of such data


B.10 Data Management
Describe data management process from generation to final use or storage. Describe standard
record keeping & data storage and retrieval requirements. Provide examples of any forms or
checklists 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 applicable
information resource management requirements, including EPA specific requirements, are
satisfied


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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Frequently Asked Questions

What is qapp in project management?

he Quality Assurance Project Plan, or QAPP, is a written document that outlines the procedures a monitoring project will use to ensure that the samples participants collect and analyze, the data they store and manage, and the reports they write are of high enough quality to meet project needs.

What is a quality assurance project plan?

The quality assurance project plan, or QAPP, is a document that outlines the procedures that those who conduct a monitoring project will take to ensure that the data they collect and analyze meets project requirements. It is an invaluable planning and operating tool that outlines the project’s methods of data collection, storage and analysis.

Do i need to submit my qapp for epa approval?

he purpose of this chapter is to discuss the steps a volunteer monitoring might take in preparing a quality assurance project plan(QAPP). If your plan does not need to be approved by EPA (that is, youare not receiving EPA grant or contract money to conduct your monitoring), youneed not submit your QAPP for EPAapproval.

What is the uniform federal policy for quality assurance project plans?

The Uniform Federal Policy for Quality Assurance Project Plans (EPA 505/B-04/900A) is another document you may wish to reference. This document is the result of collaboration between federal agencies (EPA, DoD, and DOE) to standardize QAPP requirements and definitions.