Basic Training Project Plan Samples

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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
 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
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
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Where can I find this information?
  • 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
48 CFR 46   Quality Management Plan (or
            equivalent) and a QA Project Plan (or
40 CFR 30   Quality Management Plan and a QA
            Project Plan
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
40 CFR 35   Comply with 40 CFR 31            7
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
user’s 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
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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      Conduct Study/    Data Verification
(e.g., DQO Process)       Experiment        & Validation

      QA               Standard
                                    Technical    Data Quality
  Project Plan        Operating
                                   Assessments   Assessment

    Planning             Implementation             Assessment

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 Four Main Topics:
A. Project Management              9
B. Data Generation/Acquisition 10
C. Assessment and Oversight        2
D. Data Validation and Usability 3
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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
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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
 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
  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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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

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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

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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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          Impact of Detection Limit and
           Contaminant Concentration

Relative Positions of
MDLs and CC                        Consequence

   MDL           CC                Non-Detects and Detects

          MDL CC                   Possibility of False Positives
                                   and False Negatives

                CC        MDL      Non-Detects Not Useable
                                   Detects Useable
                                   Possibility of False Negatives
  lower   concentration   higher

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Detection Limits/Sensitivity

O   ------------------------------------------------ Action Level?
N   - - - - - - - - - - - - - - - - - - - - - - - - - - - - MDL
T   ------------------------------------------------- Action Level?
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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
 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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B. Data Generation and Acquisition

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1. Sampling Process Design
   (Experimental Design)
Describe the data generation or data
design for the project:

measurement parameters of interest,
  indicating those critical and those
  to the study

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1. Sampling Process Design
   (Experimental Design)
Describe the data generation or data
design for the project:

   measurement parameters of interest,
   rationale for the sampling design

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Sampling Design Testing &
   - is the sampling matrix homogenous or
  - do you care about average contamination
levels, hot spots, or the proportion of site
  - do you want composites samples or
  - 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
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
 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
   and who is responsible
 Detail how samples are to be transported

 so maximum holding time conditions are
 Indicate sample identification scheme
 and      chain of custody specifications
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4. Analytical Methods
  Identify all analytical methods and
   needed for both field and lab
 List method performance standards, such
   MDL, Precision, Accuracy, PQL, %

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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
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
   to be performed, and how documented
 Identify how deficiencies will be resolved,
   effectiveness determined and documented
 Identify who will do it          qapp   54
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
   and/or standards to be used
 Identify how deficiencies will be resolved
 Indicate how records will be maintained
   traceable to the instrument      qapp   55
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
  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
   retrieval on electronic media
 Discuss methods and equipment for
   detecting/correcting errors, and
   data loss                          qapp   58
10. Data Management (continued)
   Describe procedures to demonstrate
    acceptability of hardware/software

 Identify how applicable information
  management specifications are met (for
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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
 Describe each assessment needed,
  frequency and type, information expected,
  criteria for success

Identify potential assessors and their

   Discuss how and to who findings will be
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2. Reports to Management
 Identify frequency and distribution of
  QA status reports

   Identify preparer and recipients of these

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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
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,
   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          qapp
3. Reconciliation with User
  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
 Describe how limitations in data use will
 be      reported

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Important Criteria to Consider for
Quality Assured Data
Anything that compromises data
 representativeness compromises data

Make room for independent checks along
  way, and use them.

Use methods that have been well
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Important Criteria to Consider for
Quality Assured Data (continued)
 Most important: figure out what you need
     know, and how well you need to know it.

 Then, plan how to get it, including all of
   participants in the planning process.

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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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Description: Basic Training Project Plan Samples document sample