Title: Preparing Quality Assurance Project Plans
1Preparing Quality Assurance Project Plans
- Presented By
- Denise L. Goddard, Chemist
- Quality Assurance Section
- Athens, Georgia
2EPA DISCLAIMER
- This Presentation is for Training Purposes Only.
3EPA - QA Documents for Preparing Quality
Assurance Project Plans
- Guidance on Systematic Planning Using the Data
Quality Objectives Process, EPA QA/G-4,
EPA/240/B-06/001 (February 2006) - Requirements for Quality Assurance Project Plans,
EPA QA/R-5, EPA/240/B-01/003 (March 2001) - Guidance for Quality Assurance Project Plans, EPA
QA/G-5, EPA/240/R-02/009 (December 2002)
4Are QAPPs Really Required??? YES!!
- Quality System Requirements Approved Quality
Assurance Project Plans (QAPPs) or equivalent
documents defined by your organizations QMP, for
all applicable projects and/or studies that will
involve environmental data collection or where
environmental decisions will be made for a
particular site. QAPP must be approved prior to
any data gathering work or activities, except
under circumstances requiring immediate action
(emergency response) to protect human health and
the environment or operations conducted under
police powers.
5Organizational Applicability??
- EPA Organizations Covered under Executive Order
5360.1, A2 The Agency-wide Quality System
requirements defined by this Order apply to all
EPA organizations, and components thereof, in
which the environmental programs conducted
involve the scope of activities described in
Section 5.a above. The authority of this Order
applies only to EPA organizations except as
addressed by Section 5.d(2) below.
6External Organizations Requirements
- Extramural Agreements Agency-wide Quality
System requirements may also apply to non-EPA
organizations. These requirements are defined in
the applicable regulations governing extramural
agreements. Agency-wide Quality System
requirements may also be invoked as part of
negotiated agreements such as memoranda of
understanding (MOUs). Non-EPA organizations that
may be subject to quality system requirements
include
7Extramural Agreements
- (a) Any organization or individual under direct
contract to EPA to furnish services or items or
perform work (i.e. contractor) under the
authority of 48 CFR 46, (including applicable
work assignments, delivery orders, and task
orders) - 40 CFR 31 Grants Cooperative Agreements with
State Local Governments - 40 CFR 35 State Local Assistance
8The Purpose of a Quality Assurance Project Plan
- As a planning document, the QAPP should contain a
detailed description of environmental data
collection activities and operations, the
problems associated with a site, the sampling and
analysis requirements, the decisions to be made,
and the necessary QA/QC activities governing this
effort.
9Issues Addressed by a QAPP
- The QAPP must provide sufficient detail such as
- The projects technical and quality objectives
these must be well defined and agreed upon by all
affected parties and stakeholders - The program-specific and site-specific
requirements (stipulated in consent decrees,
records of decision, regulations, statutes,
etc.). - The intended measurements, data generation or
data acquisition methods that are appropriate for
achieving project goals/objectives.
10Issues Addressed by a QAPP Cont
- A summary of the assessment procedures for
confirming that data of the type, quantity and
quality required and expected were obtained, and - A description of the process for evaluating the
limitations on the use of the information or data
obtained that includes identifying, documenting
and communicating the limitations to all affected
parties and stakeholders.
11Overview of Content Requirements
- To be effective, the QAPP must clearly state
- The purpose of the environmental data operation
(e.g., enforcement, research and development,
rulemaking), - The type of work to be done (e.g., pollutant
monitoring, site characterization, risk
characterization, bench level proof of concept
experiments), and - The intended use of the results (e.g., compliance
determination, selection of remedial technology,
site closure, development of environmental
regulations).
12Before We Start - Some Preliminaries
Format/Content Requirements
- Because the QAPP is a formal document it should
contain - A Title Page containing the title of the
document, the Identification of the Organization
that Prepared the QAPP, the Preparation Date and
the Version Number The document should be
Paginated - An Approval Page Containing Signature and Date
Blocks for each of the individuals/organizations
responsible for approving this document.
13Some Preliminaries Format and Content
Requirements
- A Distribution List Containing the Names,
Mailing Addresses, Phone Numbers, and Email
Addresses for each of the individuals and
organizations requiring copies of the approved
QAPP. - Table of Contents For Text, Tables, Figures,
Maps Appendices. If there are numerous Tables,
Figures Maps Place these items in the
Appendix to reduce breakup of the text.
14Some Cautionary Tips!!!
- Some Cautions
- Avoid using generic language that does not
provide the required information or level of
detail required. - For projects requiring the generation of chemical
or biological data, make sure that you produce a
list of contaminants of concern or identify the
biological parameters of interest. - Make sure the approved QAPP is distributed to
project personnel, laboratory staff and if you
are using CLP, identify the COCs in project log
(unless there are numerous contaminants).
15Lets Start - Components of a QAPP
- A QAPP is composed of approximately 25 elements
that are grouped into four classes or categories
as follows - Class A Project Management
- Class B Measurement/Data Acquisition
- Class C Assessment/Oversight
- Class D Data Validation/Data Usability
16Class A Topics - Overview
- The elements in this group address
- Project Management
- Project History/Site History
- Goals Objectives of the Project
- Project Outputs
17Class A Topics
- The following topics must be addressed as part of
the Class A components/elements - A1 Title/Approval Page
- A2 Table of Contents
- A3 Distribution List
- A4 Project/Task Description
- A5 Problem Definition/Background Info
- A6 Project/Task Description
- A7 Quality Objectives Criteria DQOs/DQIs
- A8 - Documents Records
18A4 Project/Task Organization
- The following information is required
- Identify the individuals/organizations that will
participate in the project/study discuss their
roles/responsibilities identify the principal
data users, decision makers, QA Manager,
stakeholders and end data users. - QA Manager should be iidentified in the QAPP
this individual should be independent of data
collection operations, should have direct access
to senior management, have overall authority over
data collection activities when non-conformance
with the QAPP is encountered. - An organizational chart depicting the lines of
communication and authorities between senior
management, the QAM and project personnel
should also include principal and end data users,
decision makers, stakeholders, contractors and
any subcontractors.
19Organizational Chart 1
Senior Management
Laboratory Analysis
Field Sampling Staff
Data Validation
20Organizational Chart 2
Senior Management
Laboratory Analysis
Data Validation Data Quality Assessment
Field Sampling Staff
QA Manager
21Organizational Chart 3
Senior Management
QA Manager
Data Validation Data Quality Assessment
Laboratory Analysis
Field Sampling Staff
22Organizational Chart 4
Senior Management
QA Manager
Project Management
Laboratory Analysis
Field Sampling Staff
Data Validation Data Quality Assessment
23Organizational Chart 5
QA Manager
Senior Management
Project Manager
Decision Makers
Laboratory Analysis
Field Sampling Staff
Data Validation Data Quality Assessment
Organic Analysis
Inorganic Analysis
John WU DQA
Linda Good D. Val.
Joe Smo
Jane Doe
24A5 Problem Definition/Background
- Summarize the problem to be solved
- The decision to be made
- Or outcome to be achieved
- Include background/historical information
- Include scientific and regulatory perspectives
25A6 Project/Task Description
- Summarize all work to be done
- Specify all measurements that must be taken
identify which measurements are critical or
non-critical - critical measurements will be used
to make site decisions non-critical
measurements wont be used during the decision
making process - Provide a list of all of the equipment required
- Identify any products that will be produced
- Provide Maps, Charts, Figures Tables
26A7 Quality Objectives Criteria
- Describe the quality goals/objectives for the
project provide the performance criteria for
achieving these goals/objectives, etc. - Provide the project-specific data quality
objectives (both qualitative and quantitative)
and the specific data quality indicators
(precision, bias, sensitivity, comparability,
completeness and representativeness) relevant to
the project/study.
27Brief Overview of the Systematic Planning Process
- Data Quality Objectives Process
- Step 1 State the Problem
- Step 2 Identify the Goals of the Study
- Step 3 Identify the information inputs
- Step 4 Define the Boundaries of the Study
- Step 5 Develop the Analytical Approach
- Step 6 Specify Performance or Acceptance
Criteria - Step 7 Develop the Plan for Obtaining Data
28Additional Thoughts on the DQO Process
- Include any and all assumptions concerning site
contamination, contaminant pathways, remedial
techniques, clean-up design, monitoring
strategies, etc., as part of the DQO process. - Identify any suspected potential departures from
assumptions in support of the DQO process.
29A8 Special Training/Certifications
- Identify and describe any specialized training
(including QA training) needed by project
personnel required to successfully complete the
project or task. - Discuss how such training will be provided
discuss who is responsible for obtaining internal
training for staff. - Discuss where training documentation will be
maintained. - Specify whether professional certifications,
accreditations or licenses are required for staff
to perform their designated tasks/duties.
30A9 Documents Records
- Describe the process and responsibilities for
ensuring the appropriate project personnel have
the most current approved version of the QAPP,
including version control, updates, distribution
and disposition. - Itemize the information required in project
documents, records and reports. The type of
information required for analytical data reports
must be specified for both hard-copy and
electronic formats. Data deliverables can and do
include raw data, data from other sources such as
computer databases, literature searches, field
logs, sample preparation logs, analysis logs,
instrument printouts, model inputs and outputs
files, and the results of calibrations and QA
checks.
31A9 Documents Records
- Specify whether status/progress reports and final
reports are required. - Specify or reference all applicable requirements
for the final disposition of records/documents,
including location and retention time. - Identify the individuals who are responsible for
preparing project documents, records and reports
also identify who within EPA will receive this
information.
32Class B Topics - Overview
- Discuss all aspects of data collection and
generation - Describe sampling design and provide rationale
for your approach - Specify the analytical measurements both field
and fixed laboratory - Describe sample handling and chain-of-custody
requirements - Specify QA/QC samples with acceptance criteria
33Class B Topics
- B1 Sampling Process Design
- B2 Sampling Methods
- B3 Sample Handling Custody
- B4 Analytical Methods
- B5 Quality Control
- B6 Instrument/Equipment Testing, Inspection
Maintenance - B7 Instrument/Equipment Calibration Frequency
- B8 - Inspection/Acceptance of Supplies
Consumables - B9 Non-Direct Measurements
- B10 Data Management
34B1 Sampling Process Design Experimental Design
- Describe the experimental data generation or data
collection design for the project, including as
appropriate - The types numbers of samples required
- The design of the sampling network
- The sampling locations, frequency of collection
at each location and sample matrices - The measurement parameters of interest, and
- The rationale for the sampling design chosen.
35Sampling Designs Should be Consistent with your
Conceptual Models!!
- Evaluate your underlying assumptions -whether
they are conscious or unconscious - Use a statistical tool or sampling tool such as
Visual Sample Plan to test your sampling design. - Use historical data if available to determine the
actual distribution of contaminants.
36B1 Sampling Designs
- Directed Sampling Designs
- Judgmental Sampling
- Probability Sampling Designs
- Simple Random
- Systematic/Grid
- Stratified
- Composite
- Adaptive
- Collaborative ( Double)
- Hot Spot
37Judgmental Sampling Design - Pros
- Judgmental sampling is the subjective selection
of sampling locations in space time by an
individual analyst or expert. - Consistent with intuitive feeling
- Easy to direct, easy to do
- May be cost effective if the conceptual site
model for the project is correct - Great if you know absolutely everything there is
to know about the site and your conceptual site
model is absolutely correct.
38Judgmental Sampling Design - Cons
- Inference from sample to population questionable
- Use of incorrect conceptual model can lead to
incorrect decisions can be a disaster. - Not suitable for estimating underlying population
parameters (e.g., mean) with specified confidence
Cannot use statistics to evaluate distribution
of data with any degree of confidence with this
sampling design this is no underlying assumption
that the data are normally distributed. - Not suitable for testing hypothesis about
underlying populations with specified decision
error rates
39Simple Random Sampling - Pros
- Simple in concept and provides proper
(theoretical support) data for statistical data
analysis representative sampling locations are
chosen using the theory of random chance
probabilities - Protects against bias in estimating parameters
(e.g., means) and testing hypothesis - Is the basic building block of more complicated
(and efficient) sampling designs.
40Simple Random Sampling - Cons
- Ignores available information that could be used
to develop more cost-effective sampling designs - Not as effective as other designs for delineating
patterns of contamination or finding hot spots - Difficult to find randomly selected sampling
locations - Tends to demand large numbers of samples
41Systematic (Grid) Sampling
- Systematic (grid) sampling consists of collecting
samples according to a specified pattern at
regular intervals in space or time within a grid
pattern - Square or rectangular grid patterns over space
- Equal-interval sampling along a straight line
42Systematic Sampling - Pros
- Easy to explain and implement and provides
uniform coverage of site or project - Good for estimating boundaries, trends, or
patterns of contamination over space or time. - May yield more precise estimates of population
parameters than other sampling designs - Required for statistical data analysis to
estimate trends and spatial patterns
43Systematic Sampling - Cons
- Systematic sampling can cause estimated means to
be biased if the sampling grid pattern lines up
with any pattern of contamination. - More information is needed (than for simple
random sampling) about the population to estimate
the variance of the estimated mean.
44Stratified Sampling
- The target population is divided meaningfully
into contiguous sub-populations called strata - Sampling locations are selected independently
within each strata using some sampling design
45Stratified Sampling - Pros
- Dramatically reduces the variability present in
the population and hence improves precision - Enables estimates of individual areas to be made
- Assists in providing good coverage of the project
- Allows for increased samples from policy or
project sensitive areas
46Stratified Sampling - Cons
- Requires advanced knowledge in order to divide
the study area into roughly homogeneous strata
before sampling - The number of samples to be taken in each stratum
must be determined - If strata boundaries are inaccurate, what appears
to be outlier data can appear due to being in the
wrong strata
47Composite Sampling
- Many individual (grab) samples are combined and
thoroughly mixed to make a homogeneous whole. - At random, sub-samples (composite samples) are
made and sent to the laboratory for analysis. - The physical size of composite samples are the
same size as those obtained at random.
48Composite Sampling - Pros
- Allows for estimating the mean concentration with
the same precision at a lower cost - Provides better coverage of the study site
without increasing the number of chemical
analyses - Allows for a more representative sample from a
basic area of sample support (sampling unit). - Can be used in combination with other sampling
designs.
49Composite Sampling - Cons
- Information on individual samples used to form
composite samples is lost in compositing - Potential for loss of contaminants (volatiles)
during the mixing and handling phase - Potential for reactions and interactions among
analytes during compositing - Need to make decision on how many grab samples to
be composited and how many composite samples to
send for analysis
50WHY IS YOUR SAMPLING DESIGN IMPORTANT!!
- UNCERTAINTY!!!
- UNCERTAINTY!!!
- UNCERTAINTY!!!
-
- Due to the Variability Between Analytical Results
Within a Given Data Set??? - OR
- Due to Sampling Issues???
51And The Correct Answer Is
- BOTH!!!
- ANYTHING ELSE??? You bet, in addition to how you
collected the samples is the important issue of
WHERE you collected your samples and this relates
back to your sampling design and the assumptions
you made concerning site conditions which in turn
directed the development of your conceptual site
model these issues could have greatly increased
your uncertainty and may lead to a wrong
decision. A wrong sampling design and a flawed
conceptual site model will lead to DECISION ERROR.
52Bottom Line!!
- It is understandable that analytical studies,
with their sophisticated instrumentation and high
cost, are often perceived as the dominant element
in a site characterization project/study. Yet,
despite that sophistication and high cost,
analytical data generated under a scientifically
defective or unsound sampling design will have
limited utility.
53The Best Result
- Data Set Distribution Normality
54Normal Distributions the Central Limit Theorem
- The normal distribution is one which appears in a
variety of statistical applications. One reason
for this is the central limit theorem. This
theorem tells us that sums of random variables
are approximately normally distributed if the
number of observations is large. For example, if
we toss a coin, the total number of heads
approaches normality if we toss the coin a lot of
times. Even when a distribution may not be
exactly normal, it may still be convenient to
assume that a normal distribution is a good
approximation. In this case, many statistical
procedures, such as the t-test can still be used.
55Ranked Set Sampling A Combination of Statistics
Expert Judgment
- A sampling design where expert judgment is used
in combination with simple random sampling - Simple random sampling is used to create a large
number of potential samples. The expert then
ranks these potential samples and selects which
to send for analysis.
56Ranked Set Sampling Pros Cons
- Pros
- Better representativeness through using experts
- Better precision than random sampling
- Same simple formulae to use
- Cons
- Increased cost of the expert ranking samples
- Difficult quantifying exact improvement
- Need to find best variable to do the ranking on
- ..but the pros definitely outweigh the cons
57B2 Sampling Methods
- Describe the procedures for collecting samples
provide SOPs - Specify sampling methods and equipment
- Provide sample container, volume, preservation,
and holding time requirements - Describe the decontamination procedures
- Provide a list of sampling equipment
- Describe performance requirements for sampling
methods - Identify the location of support facilities
- Identify the individuals who are responsible for
implementing corrective actions during field
sampling activities
58B3 Sample Handling Custody
- Describe the requirements for sample handling
custody in the field, laboratory, and during
transport, taking into your holding time
requirements. - Include sample handling requirements for
packaging, transporting and storing the collected
samples. - Provide examples of sample labels, custody forms,
sample custody logs and custody seal.
59B4 Analytical Methods
- Identify the analytical methods, instruments,
equipment required. - Discuss how laboratory staff are to sub-sample
the collected environmental sample. - Identify the contaminants of concern and specify
the extraction, digestion and analytical method
for each contaminant - Specify the laboratory decontamination and waste
disposal procedures - Identify the individuals who are responsible for
implementing corrective actions when problems are
encountered during extraction, digestion or
analysis of the samples. - Specify the detection limit requirements for each
contaminant. - Provide the regulatory standard(s) (action
limits, ARARs, MCLs, water quality standards,
etc.).
60B5 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.
61B5 Quality Control Samples
- Specify the type and frequency of quality control
sample collection or QC activity - Blanks
- Spikes (MS/MSDs)
- Duplicates
- Standard Reference Materials
- Rinsates/Equipment Blanks
- Second Column Confirmation
62B5 Quality Control Samples
- Specify the acceptance criteria for spike
recoveries and the precision requirements. - Specify the frequency of QC sample collection and
analysis.
63B6 Testing, Inspection Maintenance
- Identify the instruments/equipment requiring
testing, inspection maintenance during data
collection operations (both field and fixed
laboratory). - Provide the testing, inspection and maintenance
procedures identify the individuals who are
responsible for these tasks. - Specify the frequency of instrument equipment
testing, inspection maintenance. - Discuss the corrective actions necessary when
instruments equipment no longer function as
required. - Identify the location of spare parts for
repairing items.
64B7 Calibration Frequency
- Identify all tools, gauges, instruments and other
sampling, measuring and test equipment used for
data generation or collection activities
affecting the quality that must be controlled
and, at specific periods, calibrated to maintain
performance within specified limits.
65B7 Calibration Frequency
- Identify the instruments/equipment requiring
calibration. - Describe the calibration procedures and identify
the standards used during calibration. - Specify the frequency of calibration and specify
the acceptance criteria for calibrations (for all
instruments/equipment). - Identify the individuals who are responsible for
calibrating instruments/equipment. - Identify the individuals who are responsible for
performing calibrations.
66B8 Supplies Consumables
- Identify the supplies consumables that are used
during field data collection operations - Supplies consumables would include calibration
solutions/standards, calibration gases, reagents,
tubing hoses, de-ionized water, potable water,
electronic storage media (data loggers), etc. - Specify the acceptance and rejection criteria for
each item. - Identify the individuals who will inspect
supplies consumables to ensure that they meet
the relevant acceptance criteria.
67B9 Non-Direct Measurements
- Identify any types of data needed for project
implementation or decision making that are
obtained from non-measurement sources such as
computer data bases, programs, literature
searches, surveying data and historical
data/data-bases, modeling, etc. - Describe the intended use of this data, and
define the acceptance criteria for the use of
such data in the project and specify any
limitations and restrictions in the use of the
data.
68B10 Data Management
- Describe the project data management process,
tracing the path of the data from their
generation to their final use or storage (e.g.,
the field, the office and/or the laboratory). - Describe or reference the standard record-keeping
procedures, document control system, and the
approach used for data storage and retrieval on
electronic media. - Discuss the control mechanism for detecting and
correcting errors and for preventing loss of data
during data reduction, data reporting, and data
entry to forms, reports and databases. Provide
examples of any forms or checklists to be used.
69B10 Data Management
- Identify and describe all data handling equipment
and procedures used to - Process
- Compile
- And analyze data
- Including computer hardware
- Computer software
- Software configurations
- Include secondary data sources
70B10 Data Management
- Describe the procedures that will be followed to
demonstrate acceptability of the hardware and
software configuration required, and describe the
process for assuring that applicable information
resource management requirements are satisfied. - Discuss how your organization will comply with
EPA data management requirements as specified in
EPA Order 2180.1 or newly issued data standards.
71Class C Topics - Overview
- The topics in this group address the activities
for assessing the effectiveness of project
implementation and associated QA/QC activities.
The purpose of assessment is to ensure that the
QAPP is implemented as prescribed.
72Class C Topics
- C1 Assessment Response Actions
- C2 Reports to Management
73C1 Assessments Response Actions
- Describe each assessment to be used in the
project including the frequency and type. - Assessments include, but are not limited to,
surveillance, management systems reviews,
readiness reviews, technical systems audits,
performance evaluations, audits of data quality
and data quality assessments. - Discuss the information expected and the success
criteria (i.e., goals, performance objectives,
acceptance criteria specifications, etc.).
74C1 Assessments Response Actions
- List the approximate schedule of assessment
activities. - For any planned self assessments (utilizing
personnel from within the project groups)
identify potential participants and their exact
relationship within the project organization. - For independent assessments, identify the
organization and the person(s) that shall perform
the assessments if this information is available. - Describe how and to whom the results of each
assessment shall be reported. - Discuss how corrective actions will be
implemented, documented, tracked and verified for
closure.
75C2 Reports to Management
- Identify the frequency and distribution of
reports issued to inform management (EPA or
otherwise) of the project status, or to inform
them of the results of performance evaluations
and systems audits, data quality assessments, and
significant data quality issues. - Identify the preparer and the recipients of the
reports and any specific actions recipients are
expected to take as a result of the reports.
76Class D Topics - Overview
- The topics in this group address the QA
activities that occur after the data collection
phase of the project is completed.
Implementation of these elements determines
whether or not the data conform to the specified
criteria, thus satisfying the project objectives.
77Class D Topics
- D1 Data Review, Verification Validation
- D2 Verification Validation Methods
- D3 Reconciliation with User Requirements
78D1 Data Review, Verification Validation
- Specify the criteria used to review and validate
the data that is provide the acceptance and
rejection criteria by which the data will be
assessed to determine the quality of this
information. - Provide a list of the data qualifier flags or
qualifiers along with their respective
definitions.
79D2 Verification Validation Methods
- Describe the process to be used for verifying and
validating the data, including the
chain-of-custody for data throughout the life of
the project or task. - Discuss how issues shall be resolved and the
authorities for resolving such issues within the
organization. - Describe how the results of data verification
validation are conveyed to end data users,
decision makers and stakeholder. - Precisely define and interpret how validation
issues differ from verification issues for this
project. - Provide examples of any forms or checklists to be
used and, identify any project-specific
calculation required.
80D2 Reconciliation with User Requirements
- Describe how the results obtained from the
project or task will be reconciled with the
requirements defined by the data user or decision
maker. - Outline the proposed methods to evaluate the data
and determine those possible anomalies or
departures from assumptions that were established
in the planning phase of data collection. - Describe how reconciliation with user
requirements will be documented, issues will be
resolved, and how limitations on the use of the
data will be documented, communicated and
reported to decision makers and stakeholders.
81Reference Page Appendices
- Reference Page Contains a list of the
references cited in the QAPP. - Appendices Contains any relevant materials and
documents that will support the QAPP.
82QAS Contacts
- Marilyn Maycock, Chief
- (706) 355-8553
- maycock.marilyn_at_epa.gov
- Denise Goddard, Chemist
- (706) 355-8568
- goddard.denise_at_epa.gov
83QAS Contacts
- Charlie Appleby, Chemist
- (706) 355-8555
- appleby.charlie_at_epa.gov
- Ray Terhune, Chemist
- (706) 355-8557
- Terhune.ray_at_epa.gov