&IEPA
limited States
Environmental Protection
Agency
Risk Reduction
Engineering Laboratory
Cincinnati OH 45268
Research and Development WPA/6 00/9-89/08 7 Oct. 1989
repanng
erfect
A Pocket Guide
for the Preparation of
Quality Assurance Project Plans
-------
This POCKET GUIDE has been prepared by Guy F. Slmes,
Quality Assurance Manager, EPA, Risk Reduction Engineering
Laboratory, Cincinnati, Ohio 45268. Contact him to request addi-
tional copies or suggest enhancements for future revisions.
-------
INTRODUCTION
This POCKET WIDE will help you prepare Quality Assurance
(QA) Project Plans thoroughly and easily. It summarizes guidance
found In Preparation Aids for the Development of RREL Quality
Assurance Project Plans, U.S. EPA, Risk Reduction Engineering
Laboratory, Cincinnati, Ohio 45268, October 20, 1989. This title Is
shortened to Preparation Aids... In the Pocket Guide.
RREL utilizes a four-tiered project category approach in its QA
Program in order to more effectively focus QA. Category I involves
the most stringent QA Approach, whereas Category IV represents
the least stringent. The RREL Technical Project Manager Is
responsible for assigning the category that accurately reflects the
Intended use of the data and the type of work being done. Specific
details regarding the category levels can be found In the "Table of
Contents."
Because requirements for QA Project Plans depend on the
project category, the Pocket Guide has a separate section for each
category. Each section contains short summaries of all topics
required for your QA Project Plan. At the bottom of each page Is a
reference to a specific section in Preparation Aids... where you can
find more detailed Information.
Using the Pocket Guide Isa simple four-step process:
1. Turn to the appropriate category (I, II, III, or IV) for your
project.
2. Read the summaries of each of the topics required for that
category.
3. Consult Preparation Aids... for additional Information, If
needed.
4. Then prepare your QA Project Plan, confident that you will
Include everything needed to ensure that your
measurement program meets the data quality objectives
for your project.
-------
DISCLAIMER
This material has been funded by the United States Environmental
Protection Agency. Although It has been subject to the Agency's
review, and has been approved for publication as an EPA
document, It does not necessarily reflect EPA policy.
-------
Table of Contents
CATEGORY I PROJECTS are those producing results that are au-
tonomous. These projects are of sufficient scope and substance
that their results could be used directly, without additional support,
for compliance or other litigation. Such projects are of critical
importance to Agency goals and must be able to withstand legal
challenge. Accordingly, the quality assurance requirements will be
the most rigorous and detailed in order to ensure that such goals
are met.
Section Page
Project Description 1
Project Organization and Responsibilities 2
Quality Assurance Objectives 3
Site Selection and Sampling Procedures 4
Sample Custody 6
Calibration Procedures and Frequency 7
Analytical Procedures 8
Data Reduction, Validation, and Reporting 9
Internal Quality Control Checks 10
Performance and Systems Audits 11
Preventive Maintenance 12
Calculation of Data Quality Indicators 1.3
Corrective Action 16
Quality Control Reports to Management 17
References .1.8.
Other Items 19
-------
Table of Contents
CATEGORY II PROJECTS are those producing results that com-
plement other inputs, These projects are of sufficient scope and
substance that their results could be combined with the results of
other projects of similar scope to produce narratives that would be
used for rulemaking, regulation making, or policy making. In addi-
tion, projects that do not fit this pattern, but have high visibility,
would also be included In this category.
Section Page
Project Description 20
Project Organization and Responsibilities 21
Quality Assurance Objectives 22
Site Selection and Sampling Procedures 23
Analytical Procedures and Calibration 25
Data Reduction, Validation, and Reporting 26
Internal Quality Control Checks 27
Performance and Systems Audits 28
Calculation of Data Quality Indicators 29
Corrective Action .32
Quality Control Reports to Management 33
References 34
Other Items 35
-------
Table of Contents
CATEGORY III PROJECTS are those producing results for the
purpose of evaluating and selecting basic options, or performing
feasibility studies or preliminary assessments of unexplored areas
which might lead to further work.
Section Page
Project Description 36
Quality Asurance Objectives 38
Site Selection and Sampling Procedures 39
Analytical Procedures and Calibration 41
Data Reduction, Validation, and Reporting 42
Internal Quality Control Checks 43
Performance and Systems Audits 44
Calculation of Data Quality Indicators 45
Corrective Actlon 48
Quality Control Reports to Management 49
References 50
Other Items 51
-------
Table of Cntents
CATEGORY IV PROJECTS are those producing results for the
purpose of assessing supositions.
Section Page
Project Decription 52
Quality Assurance Objectives 53
Sampling and Analytical Procedures 54
Approach to QA/QC 56
References 60
Other Items 61
-------
Category I
PROJECT DESCRIPTION
Q, How detailed should the description be?
A. A technical person unfamiliar with your project must be able to
understand what you've written.
Be sure to include:
General overview
- Statement of the decision to be made or the question
to be answered
Purpose of the study In quantitative terms
- Description of the site, facility, process, or operating
parameters to be studied
- Actual uses of the results
- Consequences of incorrect decisions or conclusions
based on these results
Experimental design features
List of all measurements, differentiating the critical
measurements (i.e., process and analytical
measurements essential to achieving project
objectives) from the non-critical measurements
Description of that portion of the environment or
physical system to which decisions or conclusions will
be applied
- Summary table covering the following for each
samplinglocation:
- Total number of samples (including primary, quality
control, and reserve)
- Type of sample (air, water, soil, etc.)
- All measurements planned for each sample
Project start-up and ending dates, including preliminary
studies and field and laboratory activities
For more information, see
"PreparationAids...," Category I, Section 1.0
-------
Category I
PROJECT ORGANIZATION AND RESPONSIBILITIES
Q, What's the most important thing to do here?
A. Name all key individuals In charge of every major activity In
your project. This applies to your subcontractors, too.
Also include:
A detailed organizational chart showing management
structure and lines of communication
Telephone numbers to facilitate communication between
project officials
Both technical and QA/QC functions
An Independent QA coordinator
Geographical locations of contractors and subcontractors
Procedures for monitoring subcontractors
Description of type, frequency, and mechanisms of
communication between contractor and subcontractors,
and among subcontractors
Description of type, frequency, and mechanisms of
communication among the contractor, the contractor's
project quality assurance officer, and the EPA project
officer
Descriptions of the relevant certifications held by the
responsible samplers, sample custodians, and analysts,
and by the prime contractor and subcontractor
organizations for the performance of their respective tasks
For more information, see
"Preparation Aids...," Category I, Section 2.0
-------
Category I
QUALITY ASSURANCE OBJECTIVES
Q, What's the most common reason for a QA Project Plan getting
a NOT APPROVED rating?
A.. Inadequate treatment of QA objectives. These QA objectives
must be defined in terms of project requirements, not in terms
of the capabilities of the test methods used. Project require-
ments, in turn, must be defined in terms of the Data Quality
Objectives (DQOs) developed specifically for the project
during the early stages of project planning. When defined in
this way, QA objectives should not only be attainable by the
chosen methods of sampling, sample preparation, and
analysis, but, more Important they should be indicative of the
minimum quality of data project management requires to draw
valid conclusions regarding the objectives of the test program
and to support specific decisions or regulatory actions.
Make sure you cover the following for each critical
measurement and each matrix:
Summary table of quantitative QA objectives
- Method detection limit
- Precision, both within and between samples
- Accuracy
Completeness (as required to achieve a specific
statistical level of confidence)
Discussion of qualitative QA objectives
- Representativeness
- Comparability
Others, as applicable
Discussion of how not meeting the QA objectives will affect
decision making and litigious actions
Discussion of how data quality indicators will affect the
legal defensibility of the data
For more information, see
"Preparation Ads...," Category I, Section 3.0
-------
Category I
SITE SELECTION AND SAMPLING PROCEDURES
Q, How important is this section?
!A. Very important, because collecting representative samples In
both time and space Is crucial to subsequent decision making
and legal defensibility of the data. Obtaining good analytical
results on non-representative samples is dangerous because
such results could lead to incorrect decisions and/or invalidate
the use of the data for support of regulatory actions.
The selection of appropriate sampling sites and sampling
strategies is predicated upon the Data Quality Objectives
(DQOs) developed specifically for the project during the early
stages of project planning. As a result, the appropriate
sampling strategy will be one that ensures attainment of the
quality of data required by the project management to draw
valid conclusions regarding the objectives of the test program
and to support specific decisions or regulatory actions.
Your QA Project Plan must describe the following:
Sampling site selection
- Scientific and regulatory objectives for sampling,
including analyte concentrations of Interest
- Statistical method or scientific rationale for choosing
sampling sites and sampling frequencies
- Extent to which the site selection will affect the validity
of the resulting data and the project objectives
Sampling site description
- Chart, map, etc., showing sampling sites
- Site-specific factors affecting sampling
- Critical process measurements
(Continued)
For more information, see
"Preparation Ads...," Category I, Section 4.0
-------
Category I
SITE SELECTION AND SAMPLING PROCEDURES (Cont.)
Sampling procedures
List of analytes and sample volumes to be collected
Sampling methods (composite, grab, etc.)
EPA-approved or other validated standard
methods-cite by reference
Non-standard or modified methods-describe fully
- Preparation and cleaning of sampling equipment,
containers, reagents, and supplies
- Calibration of equipment
Preservation, transportation, nd storage
Holding times of samples, before and after extraction,
as applicable
Whenever possible, Include standard perating
procedures (SOPs) to fulfill the above requirements.
For more inormation, see
"Prepration Aids...," Category I, Section 4.0
5
-------
Category I
SAMPLE CUSTODY
Q, fe a separate section on Sample Custody really necessary?
&. Yes. A complete description of all custody procedures, forms,
documentation, and personnel responsibilities is needed to
ensure both the scientific credibility and the legal defensibility
of data obtained for ail project samples.
You should include a SOP discussing the
following topics:
Field operations
- Names of field sample custodians
~ Records of sample acquisition data, including location,
time, sample size, and other pertinent parameters
- Records of sample preservation methods
Documentation of procedures for preparing sampling
media and reagents
~ Examples of sample labels, custody seals, and field
sample tracking forms
- Record of field chain-of-custody
- Documentation of procedures for transporting samples
from field to laboratory, including Identification; of the
individuals or organizations responsible for transport
Laboratory operations (specify for each laboratory facility,
including subcontractor facilities)
- Names of laboratory sample custodians
Forms for laboratory sample tracking
Records of laboratory chain-of-custody
- Specification of procedures for sample handling,
storage, and final disposition
- Documentation of procedures for disbursement and
transfer of samples within the laboratory and between
contractor and subcontractor laboratories
For more Information, see
"Preparation Aids...," Category I, Section 5.0
8
-------
Category I
CALIBRATION PROCEDURES AND FREQUENCY
Q, What Important information should this section include?
A. Description of the calibration procedures and frequency of
calibration for each analytical system, instrument, device, or
technique used to obtain critical measurement data..
Be sure to include the following for each critical
measurement and each method:
(Note: Use a summary table whenever possible.)
Calibration procedures
- Reference EPA-approved or other validated, standard
methods.
Describe non-standard or modified methods fully.
Append instrument-specific calibration SOPS as
needed to support the use of non-standard or modified
methods, or methods that do not Include detailed
calibrationprocedures.
- List standards, including source, traceability, and purity
checks.
Describe frequency of initial and continuing calibration
checks.
Define specific acceptance criteria for all calibration
measurements.
For more information, see
"Preparation Aids...,'Category I, Section 6.0
-------
Category I
ANALYTICAL PROCEDURES
Q, What factors are critical in selecting analytical methods?
!A.. Mehods must be appropriate for all analytes in the
specific matrix at the anticipated concentrations. They require
extensive validation to show that they meet your QA
objectives.
Include the following in your QA Project Plan:
(Note: Use a summary table whenever possible.)
EPA-approved or other validated standard methods
Reference sample preparation and analysis methods
for both critical and non-critical measurements for all
matrices.
- Cite by reference if method validation data are
appropriate for your critical measurements.
Describe your data validation plans for all critical
measurements If existing validation data are
inappropriate.
- List independent, validated, confirmatory analytical
methods for each critical measurement for which a
multi-method confirmatory approach Is applicable.
Non-standard or modified methods
Include sample preparation and analysis methods for
both critical and non-critical measurements for all
matrices.
Append pertinent method validation data for critical
measurements, If aailable.
Describe plans for conducting preliminary method
validation studies as project subtasks if pertinent
validation data are not available.
Whenever possible include detailed SOPs to fulfill the
aboverequirements.
-REMEMBER-
Only validated methods should be used for Category I Projects.
For more information, see
"PreparationAids...," Category I, Section 7.0
-------
Category I
DATA REDUCTION, VALIDATION, AND REPORTING
Q, What's the main purpose of this section?
%.. You want to collect good data. This section shows how you
plan to maintain gSod data quality throughout data reduction,
transfer, storage, retrieval, and reporting.
Here are tooics to discuss:
Data reduction
Names of Individuals responsible
Summary of data reduction procedures
Summary of statistical approach for reducing data,
including units and definitions of terms
- Examples of data sheets
Description of how results on blanks will be treated in
the calculations
- Presentation of all calculations and significant
underlying assmptions
Data validation
- Names of individuals responsible
- Procedures for determining outliers and flagging data
- Identification of critical control points
Data reporting
Names of Individuals responsible
Flowchart of the data handling process, covering all
data collection, transfer, storage, recovery, and
processing steps, and including QC data for both field
and labratory
Identification of critical control points
For more information, see
"Preparation Aids...," Category I, Section 8.0
-------
Category I
INTERNAL QUALITY CONTROL CHECKS
Q» What determines which QC checks are needed?
&. The QA objectives for your project and the anticipated uses of
your results. QC checks apply to both field and laboratory
activities. List the type and number of QC checks, Including
acceptance criteria.
Here are some QC checks to consider:
(Note: Use a summary table whenever possible.)
Samples*
- Collocated, split, replicate
Spikes*
- Matrix spikes and matrix spike duplicates
- Spiked blanks
- Surrogates and Internal standards
Others
- Standard reference materials
- Blanks (field, trip, method, reagent, Instrument)
Zero and span gases
Mass tuning for mass spectral analyses
- Confirmation with second column for gas
chromatographic anlyses
Control charts
- Calibration stadards
- Proficiency testing of analysts
Independent, multi-method analyses for confirmation of
analytical results
- Independent, multi-lboratory analyses
Any additional checks required by the special needs of
your project
Identify ail stages In the sampling and analytical process
where the QC activity will occur.
For more information, see
"Preparation Aids...," Category I, Section 9.0
10
-------
Category I
PERFORMANCE AND SYSTEMS AUDITS
Q, What information is most important here?
%.. Schedule of all planned performance evaluation audits and
technical systems audits.
Be sure to include:
Schedule of all contractor- and EPA-planned audits
Personnel responsible for audits
Explanation if no audits are planned
Schedule for any Interlaboratory performance evaluation
studies
For more information, see
"Prepration Aids...," Category I, Section 10.0
ii
-------
Category I
PREVENTIVE MAINTENANCE
Q, What information needs to be included here?
ft. A brief description of the types of preventive maintenance
needed for adhering to project schedules and for achieving
completeness objectives.
Here's what to include:
(Note: These may be conveniently presented In a table)
A schedule of important preventive maintenance tasks for
critical measurement systems
A list of critical spare parts
Reference to current maintenance contracts and standard
maintenance procedures for critical measurement systems
For more information, see
"Preparation Aids...," Category I,Section 11.0
12
-------
Category I
CALCULATION OF DATA QUALITY INDICATORS
Q, What tells me if my data quality is "good enough"?
J%. Detailed planning of data assessment procedures as
summarized here, Including statistical treatment planned,
equations, units, and assessment frequency. Make sure
everything agrees with the QA objectives. You and other data
users can then make the needed comparisons.
Here's how to calculate your results:
Precision
If calculated from duplicate measurements:
RED =
- C2) x 100%
C2)/2
RPD = relative percent difference
Ci = larger of the two observed values
C2 = smaller of the two observed values
If calculated from three or more replicates, use relative
standard deviation (RSD) rather than RPD:
RSD = (s/y) x 100%
RSD = relative standard deviation
s = standard deviation
y = mean of replicate analyses
(Continued)
For more information, see
"Prearation Aids...," Category I, Section 12.0
13
-------
Category I
CALCULATION OF DATA QUALITY INDICATORS (Cont.)
Standard deviation,s, is defined as follows:
8 =
n (y . -
Z1
. _ n -
i.2
- TL
s = standard deviation
y,= measured value of the /I th replicate
y =mean of replicate measurements
n = number of replicates
Accuracy
For measurements where matrix spikes are used:
%R = 100% x
s - u
%R=percent recovery
S = measured concentration In spiked aliquot
U = measured concentration In unspiked aliquot
Csa=ual concentration of spike added
For situations where a standard reference material
(SRM) is used instead of or in addition to matrix spikes:
%R = 100% x
m
arm
(Continued)
For more information, see
"Preparation Aids...," Category I, Section 12.0
14
-------
Category I
CALCULATION OF DATA QUALITY INDICATORS (Cont.]
%R=percent recovery
Cm= measured concentration of SRM
Csrm=actual concentrion of SRM
Completeness (statistical)
Defined as follows for all measurements:
%C = 100% x ' V
n
%C = percent completeness
V = number of measurements judged valid
n = total number of measurements necessary to
achieve a specified statistical level of
confidence In decision making
Method detection
Defined as follows for all measurements:
MDL
(n-1, l-« =0.99) x S
MDL = method detection limit
S = standard deviation of the replicate analyses
*(n-1.1-a = 0.99) = Scents' t-value appropriate to a 99%
confidence level and a standard deviation
estimate with n-1 degrees of freedom
For more information, see
"Preparation Aids...," Category I, Section 12.0
15
-------
Category I
CORRECTIVE ACTION
Q, What exactly is a "corrective action "plan?
A. It's a contingency plan spelled out in IF...THEN... statements.
("IF this happens, THEN we will do the following.")
For each measurement critical to the success of
your project, discuss the following:
Trigger points
What pre-specified conditions will automatically require
corrective action?
Personnel
Who initiates, approves, implements, evaluates, and
reports corrective action?
Response
What specific procedures will you use when corrective
action is needed?
For more information, see
"Preparation Aids...," Category I, Section 13.0
16
-------
Category I
QUALITY CONTROL REPORTS TO MANAGEMENT
What is the main purpose of this section?
It helps you do several things: (1) identify the Individuals
responsible for reporting; (2) describe the form and contents of
all anticipated reports; and (3) present QC data so that
management can monitor your data quality effectively.
Here are some things to describe:
Individuals preparing and receiving reports
Type of report
Written or oral, frequency
- Interim or final (QA/QC reporting is required In Final
Reports)
Content of various reports
- Changes in QA Project Plan
Summary of QA/QC programs, training, and
accomplishments
Results of technical systems and performance
evaluationaudits
Significant QA/QC problems, recommended solutions,
and results of corrective actions
Data quality assessment in terms of precision,
accuracy, representativeness, copleteness,
comparability, and method detection limit
Discussion of whether the QA objectives were met,
and the resulting impact on technical conclusions and
regulatory actions
Limitations on use of the measurement data, and
discussion of the effects of such limitations on the legal
defensibility of the data
For more information, see
"PreparationAids...," Category I, Section 14.0
17
-------
Category I
REFERENCES
Q, Are references mandatory, and must they be placed in a
separate section?
ft. Specific references to primary methods, procedures, validation
studies, and supporting information required for the project are
mandatory, but they need not be placed in a separate
reference section. You can also cite references in the body of
the text or as footnotes. If any reference is not readily
available, attach a photocopy to your QA Project Plan.
Wherever you put the references, make sure they
include the following information:
Author
Title
Source, date, edition
Volume, page, year
Document number
For more information, see
"Preparation Aids...," Category I, Section 15.0
-------
Category I
OTHER ITEMS
Q, What else is needed?
y\.. Before you begin to write a Category I QA Project Plan, Data
Quality Objectives (DQOs) must be developed for the project.
A definitive discussion of the DQO development process is
given In "Preparation Aids,..," Category I, Appendix A. After
you have written the QA Project Plan, you need a technical
editor to ensure that your document Is ready to be submitted
for review.
Make sure vour document has the followina items:
A signed QA Project Plan approval form
Title page, table of contents, and distribution list, Including
subcontractors when applicable
EPA-approved document control format, as shown below,
in the upper right-hand corner of each page:
Section No.: 5.0
Revision: 0
Date: June 22, 1987
Page: I of 6
A good, clear, writing style with correct grammar and
spelling
Inclusion of all appendices, attachments, and figures cited
-REMEMBER-
Your QA Project Plan explains YOUR reguirements to
the sampling team, analytical laboratory, management,
and all other interested parties. Make sure it is well
organized and complete to do this critical job
effectively.
19
-------
Category II
PROJECT DESCRIPTION
Q, How detailed should the description be?
%.. A technical person unfamiliar with your project must be able to
understand what you've written.
Be sure to include:
General overview
Statement of the decision to be made or the question
to be answered
- Purpose of the study in quantitative terms
Description of the site, facility, process, or operating
parameters to be studied
- Anticipated uses of the results
Consequences of Incorrect decisions or conclusions
based on these results
Experimental design features
- List of ail measurements, differentiating the critical
measurement (i.e., process and analytical
measurements essential to achieving project
objectives) from the non-critical measurements
Description of that portion of the environment or
physical system to which decisions or conclusions will
be applied
Summary table covering the following for each
sampling location
Total number of samples (including primary, quality
control, andreserve)
- Type of sample (air, water, soil, etc.)
All measurements planned for each sample
Project start-up and ending dates, including preliminary
studies and field and laboratory activities
For more information, see
"Preparation Aids...," Category II, Section 1.0
20
-------
Category II
PROJECT ORGANIZATION AND RESPONSIBILITIES
Q, What's the most Important thing to do here?
fl. Name all key Individuals in charge of every major activity in
your project. This applies to your subcontractors, too.
Also include:
A detailed organizational chart showing management
structure and lines of communication
Telephone numbers to facilitate communication between
project officials
Both technical and QA/QC functions
An independent QA coordinator
Geographical locations of contractors and subcontractors
Procedures for monitoring subcontractors
Description of type, frequency, and mechanisms of com-
munication between contractor and subcontractors, and
amongsubcontractors
Description of type, frequency, and mechanisms of com-
munication among the contractor, the contractor's project
quality assurance officer, and the EPA project officer
For more information, see
"PreparationAids...," Category II, Section 2.0
-------
Category
QUALITY ASSURANCE OBJECTIVES
Qj What's the most common reason for a QA Project P/an getting
a NOT APPROVED rating?
!A. Inadequate treatment of QA objectives. These QA objectives
must be defined In terms of project requirements, not In terms
of the capabilities of the test methods used.
Make sure you cover the following for each critical
measurement and each matrix:
Summary table of quantitative QA objectives
Method detection limit
- Precision, both within and between samples
- Accuracy
Completeness (as required to achieve a specific,
statistical level of confidence)
Discussion of qualitative QA objectives
- Representativeness
- Comparability
- Others, as applicable
Discussion of how not meeting the QA objectives will affect
decision making
For more information, see
"PreparationAids...," Category II, Section 3.0
-------
Category
SITE SELECTION AND SAMPLING PROCEDURES
Q, How important is this section?
5\. Very important, because collecting representative samples in
both time and space is crucial to subsequent decision making.
Obtaining good analytical results on non-representative
samples is dangerous because such results could lead to
incorrect decisions.
Your QA Project Plan must describe the following:
Sampling site selection
Scientific and regulatory objectives for sampling,
including analyte concentrations of interest
Statistical method or scientific rationale for choosing
sampling sites and sampling frequencies
Extent to which the site selection will affect the validity
of the resulting data and the project objectives
Sampling site description
- Chart, map, etc., showing sampling sites
- Site-specific factors affecting sampling
- Critical process measurements
(Continued)
For more information, see
"PreparationAids...," Category II, Section 4.0
23
-------
Category II
SITE SELECTION AND SAMPLING PROCEDURES (Cont.)
Sampling procedures
- List of analytes and sample volumes to be collected
Sampling methods (composite, grab, etc.)
EPA-approved or other validated standard
methods-cite by reference
Non-standard or modified methods-describe fully
Preparation and cleaning of sampling equipment,
containers, reagents, and supplies
Calibration of equipment
Preservation, transportation, and storage
- Holding times of samples, before and after extraction,
as applicable
Whenever possible, include standard operating
procedures (SOPs) to fulfill the above requirements
Sample custody concerns
Names of sample custodians
- Records of sample acquisition data
Records of sample preservation methods
Examples of labels and custody seals
Forms for field and lab tracking
- Records of field and lab chain-of-custody
- Procedures for transferring samples from field to lab,
within lab, and among contractor and subcontractors
- Whenever possible, include SOPS to fulfill the above
requirements
For more information, see
"Preparation Aids...," Category II, Section 4.0
24
-------
Category II
ANALYTICAL PROCEDURES AND CALIBRATION
Q, What factors are critical in selecting analytical methods?
A. The methods must be appropriate for all analytes in the
specific matrix at the anticipated concentrations. They require
extensive validation to show that they meet your QA
objectives.
Include the followfna in vour QA Project Plan:
(Note: Use a summary table whenever possible.)
EPA-approved or other validated, standard methods
Reference sample preparation and analysis methods
for both critical and non-critical measurements for all
matrices to be studied.
Cite by reference if method validation data are
appropriate for your critical measurements.
Describe your data validation plans for all critical
measurements if existing validation data are
inappropriate.
Non-standard or modified methods
Include sample preparation and analysis methods for
all measurements for ail matrices.
Describe data validation plans for all critical
measurements.
Whenever possible, include SOPs to fulfill the above
requirements.
Calibration procedures
Reference EPA-approved or standard methods.
Describe non-standard or modified methods fully.
List standards, Including source, traceability, and purify
checks.
Describe frequency of calibration checks.
Define acceptance criteria for all calibration
measurements.
For more information, see
"PreparationAids...," Category li, Section 5.0
25
-------
Category II
DATA REDUCTION, VALIDATION, AND REPORTING
Q, What's the main purpose of this section?
ft.. You want to collect good data. This section shows how you
plan to maintain good data quality throughout data reduction,
transfer, storage, retrieval, and reporting.
Here are topics to discuss:
Data reduction
- Names of individuals responsible
Summary of data reduction procedures
Summary of statistical approach for reducing data,
including units and definitions of terms
- Examples of data sheets
- Description of how results on blanks will be treated in
the calculations
Data validation
- Names of individuals responsible
- Procedures for determining outliers and flagging data
- identification of critical control points
Data reporting
- Names of individuals responsible
Flowchart of the data handling process, covering all
data collection, transfer, storage, recovery, and
processing steps, and including QC data for both field
andlaboratory
- Identification of critical control points
For more information, see
"PreparationAids...," Category II, Section 6.0
26
-------
Category II
INTERNAL QUALITY CONTROL CHECKS
Q, What determines which QC checks are needed?
A. The QA objectives for your project and the anticipated uses of
your results. QC checks apply to both field and laboratory
activities. List the type and number of QC checks, including
acceptancecriteria.
Here are some QC checks to consider:
(Note: Use a summary table whenever possible.)
Samples*
- Collocated, split, replicate
Spikes*
Matrix spikes and matrix spike duplicates
-Spiked blanks
Surrogates and Internal standards
Others
- Standard reference materials
Blanks (field, trip, method, reagent, Instrument)
Zero and span gases
- Mass tuning for mass spectral analyses
Confirmation with second column for gas
chromatographic analyses
- Control charts
Calibration standards
- Proficiency testing of analysts
- Any additional checks required by the special needs of
your project
* Identify all stages In the sampling and analytical process
where the QC activity will occur.
For more Information, see
'Preparation Aids...," Category II, Section 7.0
27
-------
Category
PERFORMANCE AND SYSTEMS AUDITS
Q, What information is most important here?
%.. A schedule of all planned performance evaluation audits and
technical systems audits.
Be sure to include:
Schedule of all contractor- and EPA-planned audits
Personnel responsible for audits
Explanation if no audits are planned
Schedule for any interlaboratory performance evaluation
studies
For more information, see
"Preparation Aids...," Category II, Section 8.0
28
-------
Category II
CALCULATION OF DATA QUALITY INDICATORS
Q, What tells me if my data quality is "good enough"?
A. Detailed planning of data assessment procedures as
summarized here, Including statistical treatment planned,
equations, units, and assessment frequency. Make sure
everything agrees with the QA objectives. You and other data
users can then make the needed comparisons.
Here s now to calculate your results:
Precision
If calculated from duplicate measurements:
RPD =
(C-L - C2) x 100%
C2)/2
RPD = relative percent difference
Ci = larger of the two observed values
C2 = smaller of the two observed values
If calculated from three or more replicates, use relative
standard deviation (RSD) rather than RPD:
RSD = (s/y) xlOO%
RSD = relative standard deviation
s = standard deviation
y = mean of replicate analyses
(Continued)
For more information, see
"Preparation Aids...," Category II, Section 9.0
29
-------
Category
CALCULATION OF DATA QUALITY INDICATORS (Cont.)
Standard deviation, s, is defined as follows:
B =
n
z
1=1
- y)2
n - 1
s = standard deviation
y,= measured value of the / th replicate
y =mean of replicate measurements
n = number of replicates
Accuracy
- For measurements where matrix spikes are used:
%R = 100% x
I
S - U
sa
I
%R = percent recovery
S = measured concentration In spiked aliquot
U = measured concentration in unspiked aliquot
Csa = actual concentration of spike added
For situations where a standard reference material
(SRM) is used Instead of or in addition to matrix spikes:
%R = 100% x
m
srm
(Continued)
For more information, see
"Preparation Aids...," Category II, Section 9.0
30
-------
Category II
CALCULATION OF DATA QUALITY INDICATORS (Cont.)
%R = percent recovery
Cm = measured concentration of SRM
Csrm = actual concentration of SRM
Completeness (statistical)
Defined as follows for all measurements:
%C = 100% x
n
%C = percent completeness
V = number of measurements judged valid
n = total number of measurements necessary to
achieve a specified statistical level of
confidence In decision making
Method detection limit
Defined as follows for all measurements:
MDL=t _ _
MDL.= method detection limit
S = standard deviation of the replicate analyses
l(n-1,1-a = 0.99) =Students' t-value appropriate to a 99%
confidence level and a standard deviation
estimate with n-1 degrees of freedom
For more information, see
"PreparationAids...," Category II, Section 9.0
-------
Category
CORRECTIVE ACTION
Q, What exactly Is a "corrective action"plan?
A. It's a contingency plan spelled out in IF...THEN... statements.
("IF this happens, THEN we will do the following.")
For each measurement critical to the success of
your project, discuss the following:
What pre-specified conditions will automatically require
correctiveaction?
Personnel
Who initiates, approves, Implements, evaluates, and
reports correctiveaction?
Response
What specific procedures will you use when corrective
action Is needed?
For more information, see
"PreparationAids...," Category II, Section 10.0
32
-------
Category
QUALITY CONTROL REPORTS TO MANAGEMENT
Q, What is the main purpose of this section?
%.. It helps you do several things: (1) identify the individuals
responsible for reporting; (2) describe the form and contents of
all anticipated reports; and (3) present QC data so that
management can monitor your data quality effectively.
Here are some things to describe:
Individuals preparing and receiving reports
Type of report
- Written or oral, frequency
- Interim or final (QA/QC reporting is required in Final
Reports)
Content of various reports
- Changes in QA Project Plan
Summary of QAIQC programs, training, and
accomplishments
- Results of technical systems and performance
evaluation audits
Significant QA/QC problems, recommended solutions,
and results of corrective actions
- Data quality assessment in terms of precision,
accuracy, representativeness completeness,
comparability, and method detection limit
Discussion of whether the QA objectives were met,
and the resulting impact on decision making
Limitations on use of the measurement data
For more information, see
"Preparation Aids...," Category II, Section 11.0
33
-------
Category II
REFERENCES
Q, Are references mandatory,and must they be placed in a
separate section?
&. No to both questions. You can also cite references in the
body of the text or as footnotes. If any reference Is not readily
available, attach a photocopy to your QA Project Plan.
Wherever you put the references, make sure they
include the following information:
Author
Title
Source, date, edition
Volume, page, year
Document number
For more information, see
"PreparationAids...," Category II, Section 12.0
34
-------
Category
OTHER ITEMS
Q, What else Is needed?
H\.. A technical editor to ensure that your document Is ready to be
submitted for review.
Make sure your document has the following itemr
A signed QA Project Plan approval form
Title page, table of contents, and distribution list, including
subcontractors when applicable
EPA-approved document control format as shown below,
in the upper right-hand comer of each page:
Section No.: 5.0
Revision:
Date: June 22, 1987
Page: 1 of6
A good, clear, writing style with correct grammar and
spelling
Inclusion of all appendices, attachments, and figures cited
-REMEMBER-
Your QA Project Plan explains YOUR requirements to
the sampling team, analytical laboratory,
management, and all other Interested parties. Make
sure it is well organized and complete to do this
critical job effectively.
35
-------
Category
PROJECT DESCRIPTION
Q, How detailed should the description be?
&. A technical person unfamiliar with your project must be able to
understand what you've written.
Be sure to include:
General overview
- Statement of the decision to be made or the question
to be answered
- Description of the site, facility, process, or operating
parameters to be studied
- Anticipated uses of the results
- Consequences of incorrect decisions or conclusions
based on these results
Experimental design features
List of ail measurements, differentiating the critical
measurements (i.e., process and analytical
measurements essential to achieving project
objectives) from the non-critical measurements
Summary table covering the following for each
sampling location:
- Total number of samples (including primary, quality
control, and reserve)
- Type of sample (air, water, soil, etc.)
- All measurements planned for each sample
Project start-up and ending dates, including preliminary
studies and field and laboratory activities
(Continued)
For more information, see
'Preparation Aids...," Category III, Section 1.0
36
-------
Category III
PROJECT DESCRIPTION (Cont.)
Project responsibilities
Identification of all key technical and QA/QC personnel
of contractor and subcontractors
Designation of an independent QA/QC coordinator
Communication procedures
Procedures for monitoring subcontractors
Communicating within and across project areas of
responsibility
- Reporting to EPA
For more information, see
"PreparationAids...," Category III, Section 1.0
37
-------
Category III
QUALITY ASSURANCE OBJECTIVES
What's the most common reason for a QA Project Plan getting
a NOT APPROVED rating?
Inadequate treatment of QA objectives. These QA objectives
must be defined In terms of project requirements, not In terms
of the capabilities of the test methods used.
Make sure you cover the following for each critical
measurement and each matrix:
Summary table of quantitative QA objectives
- Method detection limit
Precision, both within and between samples
- Accuracy
- Completeness
Discussion of qualitative QA objectives
- Representativeness
- Comparability
- Others, as applicable
Discussion of how not meeting the QA objectives will affect
decision making
For more Information, see
"PreparationAids...," Category III, Section 2.0
38
-------
Category III
SITE SELECTION AND SAMPLING PROCEDURES
Q, How important is his section?
%.. Very important, because collecting representative samples In
both time and space is crucial to subsequent decision making.
Obtaining good analytical results on non-representative
samples Is dangerous because such results could lead to
incorrectdecisions.
Your QA Project Plan must describe the following:
Sampling site selection
- Scientific objectives for sampling, including analyte
concentrations of interest
- Statistical method or scientific rationale for choosing
sampling sites and/or process sampling points, and
samplingfrequencies
- Extent to which the site selection and/or process
sampling points will affect the validity of the resulting
data and the project objectives
Sampling site description
- Chart, map, process diagram, etc., showing sampling
sites
Critical process measurements.
(Continued)
For more information, see
"PreparationAids...," Category III, Section 3.0
39
-------
Category
SITE SELECTION AND SAMPLING PROCEDURES (Cont.)
Sampling procedures
- List of analytes and sample volumes to be collected
- Sampling methods (composite, grab, etc.)
EPA-approved or other validated standard
methods-cite by reference
Non-standard or modified methods-describe fully
- Preparation and cleaning of sampling equipment,
containers, reagents, and supplies
- Calibration of equipment
- Preservation, transportation, and storage
- Holding times of samples, before and after extraction,
asapplicable
- Whenever possible, Include standard operating
procedures (SOPs) to fulfill the above requirements.
Sample custody concerns
- Names of sample custodians
- Procedures for transferring samples from field to lab,
within lab, and among contractor and subcontractors
- Whenever possible, Include SOPS to fulfill the above
requirements
For more Information, see
"PreparationAids...," Category III, Section 3.0
40
-------
Category III
ANALYTICAL PROCEDURES AND CALIBRATION
Q, What factors are critical In selecting analytical methods?
A. The methods must be appropriate for all analytes In the
specific matrix at the anticipated concentrations. They require
validation to show that they meet your QA objectives.
Include tho following in your QA Project Plan:
(Note: Use a summary table whenever possible.)
EPA-approved or other validated, standard methods
- Reference sample preparation and analysis methods
for both critical and non-critical measurements for all
matrices to be studied.
- Cite by reference If method validation data are
appropriate for your critical measurements.
Describe your data validation plans for all critical
measurements If existing validation data are
Inappropriate.
Non-standard or modified methods
Include sample preparation and analysis methods for
all measurements for all matrices to be studied.
- Describe data validation plans for all critical
measurements.
Whenever possible, include SOPS to fulfill the above
requirements.
Calibration procedures
Reference EPA-approved or standard methods.
Describe non-standard or modified methods fully.
- List standards, including source, traceability, and purity
checks.
Describe frequency of calibration checks.
Define acceptance criteria for all calibration
measurements.
For more information, see
"Preparation Aids...," Category III, Section 4.0
41
-------
Category
DATA REDUCTION, VALIDATION, AND REPORTING
Q, What's the main purpose of this section?
A. You want to collect good data. This section shows how you
plan to maintain good data quality throughout data reduction,
transfer, storage, retrieval, and reporting.
Here are topics to discuss:
Data reduction
- Names of individuals responsible
Summary of data reduction procedures
Summary of statistical approach for reducing data,
including units and definitions of terms
Examples of data sheets
Description of how results on blanks will be treated In
the calculations
Data validation
Names of Individuals responsible
- Procedures for determining outliers and flagging data
Data reporting
Names of individuals responsible
Flowchart of the data handling process, covering all
data collection, transfer, storage, recovery, and
processing steps, and Including QC data for both field
andlaboratory
For more Information, see
'Preparation Aids...; Category III, Section 5.0
42
-------
Category III
INTERNAL QUALITY CONTROL CHECKS
Q, What determines which QC checks are needed?
A. The QA objectives for your project and the anticipated uses of
your results. QC checks apply to both field and laboratory
activities. State the type and number of QC checks, including
acceptancecriteria.
Here are some QC checks to consider:
(Note: Use a summary table whenever possible.)
Samples*
- Collocated, split, replicate
Spikes*
- Matrix spikes and matrix spike duplicates
- Spiked blanks
- Surrogates and internal standards
Others
- Standard reference materials
- Blanks (field, trip, method, reagent, Instrument)
Zero and span gases
Mass tuning for mass spectral analyses
- Confirmation with second column for gas
chromatographic analyses
- Control charts
Calibration standards
- Proficiency testing of analysts
Any additional checks required by the special needs of
your project
'Identify all stages In the sampling and analytical process
where the QC activity will occur.
For more information, see
"Preparation Aids...," Category III, Section 6.0
43
-------
Category
PERFORMANCE AND SYSTEMS AUDITS
Q, What information is most important here?
%.. A schedule of all planned performance evaluation audits and
technical systems audits.
Be sure to Include:
Schedule of all contractor-planned audits
Schedule for any interlaboratory performance evaluation
studies
For more Information see
"Preparation Aids.../Category III, Section 7.0
44
-------
Category III
CALCULATION OF DATA QUALITY INDICATORS
Q, What tells me if my data quality is "good enough"?
A. Detailed planning of data assessment procedures as
summarized here, including statistical treatment planned,
equations, units, and assessment frequency. Make sure
everything agrees with the QA objectives. You and other data
users can then make the needed comparisons.
Here's how to calculate your results:
Precision
If calculated from duplicate measurements:
RPD
- c2) x 100%
-L + C2)/2
RPD = relative percent difference
C, = larger of the two observed values
C2= smaller of the two observed values
If calculated from three or more replicates, use relative
standard deviation (RSD) rather than RPD:
RSD = (s/y) x 100%
RSD = relative standard deviation
s = standard deviation
y = mean of replicate analyses
(Continued)
For more information, see
"Preparation Aids...," Category III, Section 8.0
45
-------
Category III
CALCULATION OF DATA QUALITY INDICATORS (Cont.)
Standard deviation,s, Is defined as follows:
8 =
- 2
z
1=1
n - 1
s = standard deviation
y,= measured value of the / th replicate
9 = mean of replicate measurements
n = number of replicates
Accuracy
- For measurements where matrix spikes are used:
%R = 100% x
s - u
sa
%R = percent recovery
S = measured concentration in spiked aliquot
U = measured concentration In unspiked aliquot
Csa = actual concentration of spike added
- For situations where a standard reference material
(SRM) is used instead of or In addition to matrix spikes:
%R = 100%
m
arm
(Continued)
For more information, see
"Preparation Aids...."Category III, Section 8.0
46
-------
Category
CALCULATION OF DATA QUALITY INDICATORS (Cent.)
%R = percent recovery
Cm= measured concentration of SRM
Csrm=actual concentration of SRM
Completeness (sampling and analytical)
Defined as follows for all measurements:
%C = 100% x
%C = percent completeness
V = number of measurements judged valid
T = total number of measurements
Method detection limit
Defined as follows for all measurements:
MDL=t _
MDL = method detection limit
S = standard deviation of the replicate analyses
'(n-1 1-e» = 099) f Students' t-value appropriate to a 99%
confidence level and a standard deviation
estimate with n-1 degrees of freedom
For more information, see
"Preparation Aids...," Category III, Section 8.0
47
-------
Category
CORRECTIVE ACTION
Q, What exactly is a "corrective action "plan?
A. It's a contingency plan spelled out in IF...THEN... statements.
("IF this happens, THEN we will do the following.")
For each measurement critical to the success of
your project, discuss the following:
Trigger points
What pre-specified conditions will automatically require
correctiveaction?
Personnel
Who initiates, approves, implements, evaluates, and
reports corrective action?
Response
What specific procedures will you use when corrective
action is needed?
For more information, see
"Preparation Aids...," Category III, Section 9.0
48
-------
Category III
QUALITY CONTROL REPORTS TO MANAGEMENT
What is the main purpose of this section?
It helps you do several things: (1)identify the individuals
responsible for reporting; (2) describe the form and contents of
all anticipated reports; and (3) present QC data so that
management can monitor your data quality effectively.
Here are some thinas to describe:
Individuals preparing and receiving reports
Type of report
- Written or oral, frequency
- Interim or final (QA/QC reporting is required In Final
reports)
Content of various reports
- Changes in QA Project Plan
- Results of technical systems and performance
evaluation audits
- Significant QA/QC problems, recommended solutions,
and results of corrective actions
- Data quality assessment in terms of precision,
accuracy, representativeness.completeness,
comparability, and method detection limit
- Discussion of whether the QA objectives were met,
and the resulting impact on decision making
- Limitations on use of the measurement data
For more information, see
"Preparation Aids...," Category III, Section 10.0
49
-------
Category
REFERENCES
Q, Are references mandatory, and must they be placed in a
separatesection ?
A. No to both questions. You can also cite references in the
body of the text or as footnotes. If any reference is not readily
available, attach a photocopy to your QA Project Plan.
Wherever you put the references, make sure they
include the following information:
Author
Title
Source, date, edition
Volume, page, year
Document number
For more Information, see
'Preparation Aids...," Category III, Section 11.0
50
-------
Category
OTHER ITEMS
Q, What else is needed?
y\.. A technical editor to ensure that your document is ready to be
submitted for review.
Make sure vour document has the followma items:
A signed QA Project Plan approval form
Title page, table of contents, and distribution list, including
subcontractors when applicable
EPA-approved document control format as shown below,
in the upper right-hand comer of each page:
Section No.: 5.0
Revision: o
Date: June 22, 1987
Page: 1 of6
A good, clear writing style with correct grammar and
spelling
Inclusion of all appendices, attachments, and figures cited
~ REMEMBER~
Your QA Project Plan explains YOUR requirements to
the sampling team, analytical laboratory,
management, and all other interested parties. Make
sure it is well organized and complete to do this
critical job effectively.
-------
Category IV
PROJECT DESCRIPTION
Q, How detailed should the description be?
%.. A technical person unfamiliar with your project must be able to
understand what you've written.
General overview
- Statement of the question to be answered
- Description of the site, facility, process, or operating
parameters to be studied
- Anticipated uses of the results
- Consequences of Incorrect decisions or conclusions
based on these results
Experimental design features
- List of all measurements, differentiating the critical
measurements (I.e., process and analytical
measurements essential to achieving project
objectives) from the non-critical measurements
- Summary table covering the following for each
sampling location:
- Projected number of samples (including primary,
quality control, and reserve)
- Type of sample (air, water, soil, etc.)
- All measurements planned for each sample
Project start-up and ending dates, Including preliminary
studies and field and laboratory activities
Project responsibilities
- Identification of all key technical and QA/QC personnel
of contractor and subcontractors
For more information, see
"Preparation Aids...," Category IV, Section 1.0
62
-------
Category IV
QUALITY ASSURANCE OBJECTIVES
Q, What's the most common reason for a QA Project Plan getting
a NOT APPROVED rating?
5\. Inadequate treatment of QA objectives for precision, accuracy,
and limits of detection needed for each critical measurement.
These QA objectives should be defined in terms of project
requirements, not in terms of the capabilities of the test
methods used.
Make sure you cover the following for each critical
measurement and each matrix:
Summary table of quantitative QA objectives
Method detection limit
- Precision
- Accuracy
Discussion of qualitative QA objectives
- Sample acceptance/rejection criteria
- Representativeness
- Comparability
- Others, as applicable
Discussion of how not meeting the QA objectives will affect
decision making
Note: Category IV projects are allowed a wide latitude in
defining the specific QA objectives and methods involved.
The important thing to remember here is that project-specific
QA objectives and methods must be established.
For more information, see
"Preparation Aids...," Category IV, Section 2.0
63
-------
Category IV
SAMPLING AND ANALYTICAL PROCEDURES
Q, What factors are critical in selecting the procedures?
&. The sampling procedures must be appropriate for the
collection of a representative sample and the analytical
methods must be appropriate for all analytes in the specific
matrix at the anticipated concentrations. Analytical methods
may be non-standard or state-of-the-art, but must be validated
to show that they meet your QA objectives.
Include the following in your QA Project Plan:
(Note: Use a summary table whenever possible.)
Sampling procedures
List of analytes and sample volumes to be collected
- Sampling methods (composite, grab, etc.)
- Preparation and cleaning of sampling equipment,
containers, reagents, and supplies
- Preservation.transportation, and storage
- Holding times of samples, before and after extraction,
as applicable
Whenever possible, include SOPs to fulfill the above
requirements.
EPA-approved or other validated standard methods
- Reference sample preparation and analysis methods
for both critical and non-critical measurements for all
matrices.
(Continued)
For more information, see
"Preparation Aids,../'Category IV, Section 3.0
54
-------
Category IV
SAMPLING AND ANALYTICAL PROCEDURES (Cont.)
Non-standard or modified methods
- Include sample preparation and analysis methods for
both critical and non-critical measurements for all
matrices.
- Describe data validation plans for all critical
measurements.
- Whenever possible, include SOPS to fulfill the above
requirements.
Calibration procedures
- Reference EPA-approved or standard methods.
- Describe non-standard or modified methods fully.
- Describe frequency of calibration checks.
- Define acceptance criteria for all calibration
measurements.
For more information, see
"Preparation Aids...," Category IV, Section 3.0
66
-------
Category IV
APPROACH TO QA/QC
Q, What is important in planning a good approach to quality
assurance and quality control for a project?
&. You want to collect good data, and you want to be able to
evaluate how good your data are. In this section, you show
how you plan to(1) maintain good data quality during the
calculation and reporting of results, (2) perform the specific
internal QC activities needed to evaluate the quality of the
data, and (3) calculate the data quality Indicators for precision,
accuracy, and method detection limit.
Here are tonics to discuss:
Calculation of results
- Summary of statistical approach for reducing data,
including units and definitions of terms
- Procedures for determining outliers and flagging data
Internal QC checks (Use a summary table if possible.
Identify the frequency and at what stage In the analytical
process each QC activity will occur.)
- Collocated, split, or replicate samples
Matrix spikes and matrix spike duplicates
Spiked blanks
Surrogates and internal standards
Standard reference materials
- Blanks (field, trip, method, reagent, instrument)
- Zero and span gases
Mass tuning for mass spectral analyses
- Control charts
Calibration standards
- Any additional checks required by the special needs
of your project
(Continued)
For more information, see
"Preparation Aids...."Category IV, Section 4.0
66
-------
Category IV
APPROACH TO QA/QC (Cont.)
Calculation of data quality indicators
- Precision
If calculated from duplicate measurements:
(C1 - C2) x 100%
RPD =
+ c2)/2
RPD = relative percent difference
C,= larger of the two observed values
C2= smaller of the two observed values
If calculated from three or more replicates, use relative
standard deviation (RSD) rather than RPD:
RSD = (s/y) x 100%
RSD = relative standard deviation
s = standard deviation
Y = mean of replicate analyses
Standard deviation,s, is defined as follows:
8 =
- 2
n (y. - y)
y
-
n - 1
(Continued)
For more information, see
"Preparation Aids.,.."Category IV, Section 4.0
57
-------
Category IV
APPROACH TO QA/QC (Cont.)
s = standard deviation
y,= measured value of the / th replicate
y =mean of replicate measurements
n = number of replicates
Accuracy
For measurements where matrix spikes are used:
%R = 100% x
s - u
sa
%R= percent recovery
S = measured concentration In spiked aliquot
U = measured concentration in unspiked aliquot
Csa = actual concentration of spike added
For situations where a standard reference material
(SRM) is used instead of or in addition to a matrix
spike:
%R =
m
arm
%R = percent recovery
Cm= measured concentration of SRM
Csrm = actual concentration of SRM
(Continued)
For more information, see
"Preparation Aids.../'Category IV, Section 4.0
68
-------
Category IV
APPROACH TO QA/QC (Cont.)
Method detection limit
Defined as follows for all measurements:
MDL = =
(n-1,1- a = 0.99)
MDL = method detection limit
S = standard deviation of the replicate analyses
- Students' t-value appropriate to a 99%
confidence level and a standard deviation
estimate with n-1 degrees of freedom
For more information, see
"Preparation Aids.../'Category IV, Section 4.0
69
-------
Category IV
REFERENCES
Q, Are references mandatory, and must they be placed in a
separate section ?
R. No to both questions. You can also cite references in the
body of the text or as footnotes. If any reference Is not readily
available, attach a photocopy to your QA Project Plan.
Wherever you put the references, make sure they
include the following information:
Author
Title
Source, date, edition
Volume, page, year
Document number
For more information, see
"Preparation Aids...."Category IV, Section 5.0
60
-------
Category IV
OTHER ITEMS
Q, What else is needed?
A. A technical editor to ensure that your document is ready to be
submitted for review.
Make sure your document has the following items:
A signed QA Project Plan approval form
Title page, table of contents, and distribution list, including
subcontractors when applicable
Inclusion of all appendices, attachments, and figures cited
-REMEMBER ~
Your QA Project Plan explains YOUR requirements to
the sampling team, analytical laboratory,
management, and all other interested parties. Make
sure it is well organized and complete to do this
critical job effectively.
81
-------
NOTES
62
------- |