QUALITY ASSURANCE PROJECT PLANS

Overview

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Course Schedule

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Course Objectives
After this training, you will be able to:

Discuss what information is required in a QA Project Plan

Describe your role and responsibility in the QA Project Plan development, review, and approval process
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What is meant by environmental data?

Information that describes environmental processes, locations or conditions, and health effects or consequences. It can be: Collected directly from measurements (primary data) Produced from models, or Compiled from other sources (existing or secondary data)

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What is a Quality System?

A structured and documented management system which has a system in place for ensuring the quality of its work process, products and services.
The QMP describes the policies, objectives, principles, organizational authority, responsibilities, accountability, and implementation plan of the organization
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Where can I find this information?

INTERNAL EPA Order 5360.1 A2 (the Order) EPA Order 5360 A1(the Quality Manual)
ANSI/ASQC E-4-1994 Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs
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Extramural Regulations QA Documentation

48 CFR 46 Quality Management Plan (or equivalent) and a QA Project Plan (or equivalent) Quality Management Plan and a QA Project Plan

40 CFR 30

40 CFR 31

Quality System must conform to the American National Standard (ANSI/ASQC-E-4, 1994). Submit a Quality Manual and a QA Project Plan Comply with 40 CFR 31
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40 CFR 35

What is a QA Project Plan?

A document that describes the technical and quality activities of an environmental data operations project that should be implemented to ensure that the results of the work performed will satisfy the data users needs.

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Why should I write a QA Project Plan?

QA Project Plans are prepared for all EPA projects and tasks involving environmental data operations (generating or using). Non-EPA organizations which receive EPA funds need to satisfy those requirements defined in the Code of Federal Regulations.
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Problem Identification

Proposal

Plan
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QA Project Planning and QA Project Plan Preparation

A Team Effort

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Project/QA Project Plan Development

Scope Assemble a team Systematically plan Write the Plan Submit the Plan for review and approval Once approved, distribute the plan Start work, following the plan Revise when needed, get approval, then re-distribute the plan
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Systematic Planning (e.g., DQO Process)

Conduct Study/ Experiment

Data Verification & Validation

QA Project Plan

Standard Operating Procedures

Technical Assessments

Data Quality Assessment

Assessment
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Planning

Implementation

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Four Main Topics:

A. Project Management 9 elements B. Data Generation/Acquisition 10 elements C. Assessment and Oversight 2 elements D. Data Validation and Usability 3 elements 24
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References

Existing Documentation can be Referenced and/or Attached!

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Different Types of QA Project Plans

Task-Specific QA Project Plans: those projects for which the environmental data operation is task, site or project specific.

Generic or Programmatic QA Project Plans: those projects for environmental data operations conducted at multiple locations and/or over a long period of time.
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Level of Detail the Graded Approach

The level of detail in each QA Project Plan will vary according to the nature of the work being performed and the intended use of the data.
high road

low road

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QA Project Plan Review

For EPA projects, the Project Manager and QA Manager, or designee, review the QA Project Plan.

For extramural projects, the funded organization reviews the plan, as well as the EPA organization.
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Review to ensure that:

The plan is accurate and complete, Sufficient data will be collected using appropriate measurement and data acquisition methods, Planned assessment procedures will be adequate to evaluate the project, and There is a process to identify any limitations on the data use.

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Reviewers should:
Be timely in their review, Be consistent in their review, Have a process established to deal with revisions, and Have expertise in technical areas and recognize where they need advice.

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QA Project Plan Approval

Is the responsibility of the EPA Project Manager and QA Manager, and

Indicates that the QA Project Plan is accurate and complete, and that it provides sufficient detail to identify the project's technical and quality objectives.

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Conditional Approval
May be given in situations where the project may be started while "non-critical deficiencies" are being resolved.

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QA Project Plan Implementation

Data collection may not be started until the QA Project Plan has been reviewed, approved and signed.

The QA Project Plan should be implemented as approved.

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Revisions - After Approval

When changes are needed, the QA Project Plan should be revised and re-approved by the approving official(s) prior to the change being made.

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Regular Reviews
QA Project Plans for multi-year projects should be reviewed annually and revised when necessary.

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Reflection

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A. Project Management

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1. Title & Approval Sheet

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2. Table of Contents

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Document Control Notation

Project #/Name Revision No. Date Page

___________ ___________ ___________ ____ of ____

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3. Distribution List
List key personnel of all organizations who need a copy of the approved QA Project Plan and revisions

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4. Project/Task Organization

Identify individuals and state their roles and responsibilities in the project

Attach an organizational chart and indicate lines of communication (include data users and subcontractors)

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5. Problem Definition/Background
Describe the underlying issue that led to this project, including background/ historical information indicating the need for this study.

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6. Project/Task Description
Summarize work to be performed, products to be produced, and the schedule for implementation

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Resource Limitations
Time People Materials

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7. Quality Objectives and Criteria

State the quality objectives for the project and the performance criteria to achieve these objectives, i.e., the quality of data needed to support your decision - Decision quality is based on data/ information quality

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Data Quality Indicators

Precision Accuracy/Bias Representativeness Comparability Completeness Sensitivity

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Representativeness Comparability Completeness

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Impact of Detection Limit and Contaminant Concentration

Relative Positions of MDLs and CC
MDL CC

Consequence
Non-Detects and Detects Useable Possibility of False Positives and False Negatives

MDL CC

CC

MDL

Non-Detects Not Useable Detects Useable Possibility of False Negatives

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lower

con cen t r a t ion

h igh er

Detection Limits/Sensitivity

C O N C E N T R A T I O N

------------------------------------------------ Action Level? - - - - - - - - - - - - - - - - - - - - - - - - - - - - MDL ------------------------------------------------- Action Level?

0
SAMPLES
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8. Special Training/Certification

Identify any special training or certifications needed by personnel to conduct project activities State how this training will be provided, assured and documented

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9. Documents and Records

Describe process to ensure project personnel have most current Plan

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9. Documents and Records

Describe process to ensure project personnel have most current Plan Itemize information/records to be included in data report package

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9. Documents and Records

Describe process to ensure project personnel have most current Plan Itemize information/records to be included in data report package Identify any other reports/documents to be produced

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9. Documents and Records

Describe process to ensure project personnel have most current Plan Itemize information/records to be included in data report package Identify any other reports/documents to be produced State specifications for final disposition of records and documents

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Group A. Project Management Recap

1. 2. 3. 4. 5. 6. 7. Title and Approval Sheet Table of Contents Distribution List Project/Task Organization Problem Definition/Background Project/Task Description Quality Objectives/Criteria for Measurement Data 8. Special Training/Certification 9. Documentation and Records
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Sample QA Project Plan

Where is more information needed?

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B. Data Generation and Acquisition

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1. Sampling Process Design (Experimental Design)

Describe the data generation or data collection design for the project:

measurement parameters of interest, indicating those critical and those secondary to the study
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1. Sampling Process Design (Experimental Design)

Describe the data generation or data collection design for the project:

measurement parameters of interest, rationale for the sampling design

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Sampling Design Testing & Estimation

- is the sampling matrix homogenous or heterogeneous? - do you care about average contamination levels, hot spots, or the proportion of site contaminated? - do you want composites samples or grabs? - are you looking for trends over time? - will there be a reference site?
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1. Sampling Process Design (Experimental Design)

Describe the data generation or data collection design for the project:

measurement parameters of interest, rationale for the sampling design, sampling locations and frequencies

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1. Sampling Process Design (Experimental Design)

Describe the data generation or data collection design for the project:

measurement parameters of interest, rationale for the sampling design, sampling locations and frequencies, types and numbers of samples needed
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1. Sampling Process Design (Experimental Design)

Describe the data generation or data collection design for the project:

measurement parameters of interest, rationale for the sampling design, sampling locations and frequencies, types and numbers of samples needed, and sources of variability
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2. Sampling Methods

Describe sample collection and preservation methods, and equipment preparation and decontamination procedures

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2. Sampling Methods
Describe sample collection and preservation methods, and equipment preparation and decontamination procedures Indicate any performance specifications

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2. Sampling Methods
Describe sample collection and preservation methods, and equipment preparation and decontamination procedures Indicate any performance specifications Identify sample equipment and support facilities needed

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2. Sampling Methods
Describe sample collection and preservation methods, and equipment preparation and decontamination procedures Indicate any performance specifications Identify sample equipment and support facilities needed Address what to do when things go wrong.

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3. Sample Handling and Custody

Describe how samples are to be handled in the field, in the lab, and during transport, and who is responsible

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3. Sample Handling and Custody

Describe how samples are to be handled in the field, in the lab, and during transport, and who is responsible Detail how samples are to be transported so maximum holding time conditions are met

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3. Sample Handling and Custody

Describe how samples are to be handled in the field, in the lab, and during transport, and who is responsible Detail how samples are to be transported so maximum holding time conditions are met Indicate sample identification scheme and chain of custody specifications

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4. Analytical Methods
Identify all analytical methods and equipment needed for both field and lab List method performance standards, such as MDL, Precision, Accuracy, PQL, % recovery

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4. Analytical Methods (continued)

Include method validation information for nonstandard methods State what to do when a failure occurs Describe sample disposal procedures Specify laboratory turnaround time
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5. Quality Control

Identify QC activities for each sampling, analysis, or measurement technique State the frequency and control limits of each QC activity, and how corrective actions will be documented Describe procedures and formulas for calculating QC statistics
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Examples of Quality Control Samples

Replicates Splits Blanks Reference Materials Matrix Spikes

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6. Instrument/Equipment Testing, Inspection, and Maintenance

Identify equipment requiring periodic maintenance, the schedule for such, and availability of critical spare parts Describe inspection and acceptance testing to be performed, and how documented Identify how deficiencies will be resolved, and effectiveness determined and documented Identify who will do it

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7. Instrument/Equipment Calibration and Frequency

Identify all equipment and instrumentation requiring calibration in field or lab Document calibration method and frequency, and test criteria and certified equipment and/or standards to be used Identify how deficiencies will be resolved Indicate how records will be maintained and traceable to the instrument

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8. Inspection/Acceptance for Supplies and Consumables

Identify all supplies that may directly or indirectly affect the quality of the project Describe the inspection and acceptance testing criteria and procedures

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9. Non-Direct Measurements

Identify data needed from computer databases, programs, literature files, and historical databases Describe the intended use of the data

Cite acceptance criteria, and any limitations, for their usage

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10. Data Management

Describe data management scheme from generation in the field to final use/storage Discuss procedures for record-keeping, document control system, and data storage/ retrieval on electronic media Discuss methods and equipment for detecting/correcting errors, and preventing data loss

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10. Data Management (continued)

Describe procedures to demonstrate acceptability of hardware/software configuration

Identify how applicable information resource management specifications are met (for EPA personnel)
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Group B. Data Generation and Acquisition: Recap

1. Sampling Process Design (Experimental Design)

2. Sampling Methods
3. Sample Handling and Custody 4. Analytical Methods

5. Quality Control
6. Instrument/Equipment Testing, Inspection/Maintenance 7. Instrument/Equipment Calibration and Frequency

8. Inspection/Acceptance for Supplies and Consumables

9. Non-Direct Measurements 10. Data Management
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Sample QAPP
Look at the sample QA Project Plan and see if all the data generation and acquisition elements have been addressed.

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C. Assessment and Oversight

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Assessment Types

Readiness Reviews Technical System Audits

Surveillance

Performance Evaluations/Proficiency Testing

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1. Assessments and Response Actions

Describe each assessment needed, including frequency and type, information expected, and criteria for success Identify potential assessors and their authority Discuss how and to who findings will be
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2. Reports to Management

Identify frequency and distribution of project QA status reports Identify preparer and recipients of these reports

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D. Data Validation and Usability

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Questions & Answers

What is the difference between data review, verification, and validation?

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1. Data Review, Verification, and Validation

Identify the project's criteria to review, verify, and validate the data

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2. Verification and Validation Methods

Describe the process to be used for both data verification and validation, identifying any calculations needed Discuss how issues will be resolved and identify the individuals responsible Discuss how these results will be conveyed to the data users

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3. Reconciliation with User Requirements

Describe how the results of the study will be evaluated to determine whether the project's objectives have been satisfied Outline proposed methods to analyze the data Describe how limitations in data use will be reported

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C. Assessment and Oversight D. Data Validation and Usability

C1. Assessments and Response Actions C2. Reports to Management D1. Data Review, Verification and Validation D2. Verification and Validation Methods D3. Reconciliation with User Requirements

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Summary

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Important Criteria to Consider for Quality Assured Data

Anything that compromises data

representativeness compromises data quality.

Make room for independent checks along

the way, and use them.

Use methods that have been well

established and/or well documented.

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Important Criteria to Consider for Quality Assured Data (continued)

Most important: figure out what you need

to know, and how well you need to know it.

Then, plan how to get it, including all of

the participants in the planning process.

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Remember
There are four basic project groups that should be discussed in a QA Project Plan. These are:

- management - data generation/acquisition - assessment/oversight - data validation and usability

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What is the value of having an approved QA Project Plan?

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Doing the Right Things the Right Way the First Time!

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