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QUALITY ASSURANCEPROJECT 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 aQA
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 environmentaldata?
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 documentedmanagement system which has a system
in place for ensuring the quality of its workprocess, products and services.
The QMP describes the policies,
objectives, principles, organizationalauthority, responsibilities, accountability,and implementation plan of theorganization
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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 forEnvironmental Data Collection and
Environmental Technology Programs
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Extramural Regulations QADocumentation
48 CFR 46 Quality Management Plan (or
equivalent) and a QA Project Plan (or
equivalent)
40 CFR 30 Quality Management Plan and a QAProject 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
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What is a QA Project Plan?
A document that describes the technical
and quality activities of an environmental
data operations project that should beimplemented 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 (generatingor using).
Non-EPA organizations which receive EPA
funds need to satisfy those requirements
defined in the Code of Federal
Regulations.
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ProblemIdentification
Proposal
Plan
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QA Project Planning andQA 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)
QA
Project Plan
Standard
Operating
Procedures
Conduct Study/
Experiment
Technical
Assessments
Data Verification
& Validation
Data Quality
Assessment
Planning Implementation Assessment
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Four Main Topics:
A. Project Management 9
elements
B. Data Generation/Acquisition 10elements
C. Assessment and Oversight 2
elementsD. Data Validation and Usability 3
elements
24
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References
Existing Documentation can beReferenced 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 environmentaldata 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 theintended 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 dataacquisition 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 withrevisions, 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 theproject'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
implementedas 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 changebeing 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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Project #/Name ___________
Revision No. ___________Date ___________Page ____ of ____
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List key personnel of all organizations who
need a copy of the approved QA Project
Plan and revisions
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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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Describe the underlying issue that led to
this project, including background/
historical information indicating the needfor this study.
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Summarize work to be performed, products
to be produced, and the schedule for
implementation
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Time
People
Materials
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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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Precision
Accuracy/Bias
Representativeness
Comparability
Completeness
Sensitivity
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Representati eness
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Representativeness
Comparability
Completeness
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Relative Positions of
MDLs and CC Consequence
MDL CC Non-Detects and Detects
Useable
MDL CC Possibility of False Positives
and False Negatives
CC MDL Non-Detects Not Useable
Detects Useable
Possibility of False Negatives
lower concentr at ion higher
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0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - MDL
C
O
NC
E
N
T
R
A
T
I
O
N
SAMPLES
------------------------------------------------ Action Level?
------------------------------------------------- Action Level?
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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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Describe process to ensure project
personnel have most current Plan
Itemize information/records to be includedin 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 datacollection
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 datacollection
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 contaminationlevels, 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 datacollection
design for the project:
measurement parameters of interest,
rationale for the sampling design,
sampling locations and frequencies,
types and numbers of samples needed, an
sources of variability
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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
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 MaterialsMatrix 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 instrumentationrequiring 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 Suppliesand 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 anylimitations,
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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C. Assessment and Oversight
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Assessment Types Readiness Reviews
Technical System Audits
Surveillance
Performance Evaluations/Proficiency Testin
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1. Assessments and ResponseActions Describe each assessment needed,
including
frequency and type, information expected,
andcriteria for success
Identify potential assessors and theirauthority
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, andValidation
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,
identifyingany 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 UserRequirements
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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Summary
I C i i C id f
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Important Criteria to Consider forQuality 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.
I C i i C id f
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Important Criteria to Consider forQuality 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
theparticipants 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
Wh i h l f h i
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What is the value of having anapproved QA Project Plan?
D i th Ri ht Thi th Ri ht W
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Doing the Right Things the Right Waythe First Time!