M72-199
£ U. S.
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December 1912
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QUALITY ASSURANCE AND MONITORING
BY LAW, THE PRIMARY FUNCTION OF EPA IS TO SET AND ENFORCE ENVIRONMENTAL STANDARDS. DATA FROM
MONITORING ACTIVITIES ACROSS THE NATION PROVIDE THE BASIS FOR THAT STANDARD SETTING AND ENFORCE-
MENT. THE EPA QUALITY ASSURANCE PROGRAM HAS BEGUN OPERATION AND IS DESIGNED TO ASSURE THAT THE
MONITORING DATA PROVIDED TO EPA DECISION MAKERS IS BOTH ACCURATE AND VALID. THE ROLE OF QUALITY
ASSURANCE IN EPA MONITORING ACTIVITY IS THE SUBJECT OF THIS BRIEFING.
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QUALITY ASSURANCE AND MONITORING
SOURCE MONITORING
AMBIENT TREND
MONITORING
CASE PREPARATION
MONITORING
RESEARCH MONITORING
QUALITY
ASSURANCE
PROGRAM
TO PROVIDE
ACCURATE.
VALID DATA
FOR ESTABLISHMENT
AND ENFORCEMENT
OF ENVIRONMENTAL
STANDARDS
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THE ROLE OF QUALITY ASSURANCE IN EPA
WHILE MONITORING TO ACQUIRE DATA ON THE ENVIRONMENT IS IMPORTANT, ACQUIRING DATA BY ITSELF IS
NOT ENOUGH. IN ORDER TO ACHIEVE EPA'S GOALS IN ENVIRONMENTAL QUALITY, THE DATA USED IN RESEARCH
AND ENFORCEMENT MUST BE BOTH ACCURATE AND VALID. THIS IS WHERE THE ROLE OF QUALITY ASSURANCE
COMES INTO PLAY. THE EPA QUALITY ASSURANCE PROGRAM IS DESIGNATED TO CONTINUOUSLY IMPROVE AND
DOCUMENT THE ACCURACY AND VALIDITY OF ALL MONITORING DATA USED BY EEA.
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THE ROLE OF QUALITY ASSURANCE IN EPA
TO
IMPROVE
AND
DOCUMENT
OF ALL ENVIRONMENTAL
MONITORING DATA USED
BY EPA
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WHY HAVE EPA PROGRAMS FOR QUALITY ASSURANCE?
SOME OF THE REASONS FOR HAVING A QUALITY ASSURANCE PROGRAM ARE SELF-EVIDENT, BUT LET US REVIEW
THEM AT THIS POINT.
— FIRST, VALID AND ACCURATE DATA. ARE ASSURED
— SECOND, DATA GENERATED BY ALL PROGRAMS ARE COMPARABLE AND THE PROBLEM OF
COMPARING APPLES AND ORANGES IS AVOIDED
— THIRD, UNNECESSARY DUPLICATION CAN BE AVOIDED AND THE MOST EFFICIENT USE
OF RESOURCES IS POSSIBLE
~ FOURTH, DETAILED SPECIFICATIONS FOR SAMPLING AND ANALYSIS EQUIPMENT RESULT
IN BETTER MONITORING INSTRUMENTATION
— FIFTH, QUALITY ASSURANCE GIVES CONFIDENCE IN DATA AND ENHANCES THE OVERALL
CREDIBILITY OF THE AGENCY
ALL OF THESE CONTRIBUTE TO ONE OVERRIDING PURPOSE OF A QUALITY ASSURANCE PROGRAM:
WITH STANDARDIZATION AND QUALITY CONTROL EPA HAS BETTER INFORMATION ON WHICH TO BASE POLICY
DECISIONS FOR ENHANCEMENT OF ENVIRONMENTAL QUALITY.
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WHY HAVE AN EPA PROGRAM FOR QUALITY ASSURANCE?
VALID, ACCURATE DATA
COMPARABLE DATA
EFFICIENT RESOURCE USE
BETTER TECHNOLOGY
AVAILABLE
AGENCY CREDIBILITY
ENHANCED
RELIABLE INFORMATION
FOR SUPPORTING EPA
POLICY DECISIONS
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QUALITY ASSURANCE PROGRAM ELEMENTS
EPA'S QUALITY ASSURANCE PROGRAM COMPRISES COMPREHENSIVE, MUTUALLY REINFORCING PROGRAMS OF
STANDARDIZATION AND QUALITY CONTROL. IN THE STANDARDIZATION PROGRAM, REFERENCE METHODS ARE
DEVELOPED FOR POLLUTANTS IN EACH MEDIUM, AND GUIDELINES FOR DETERMINATION OF METHOD EQUIVALENCY
ARE ALSO DEVELOPED. IN ADDITION, GUIDELINES AND PROCEDURES ARE ISSUED FOR ALL PHASES OF
SAMPLING AND ANALYSIS. THE QUALITY CONTROL PROGRAM IS A CONTINUOUS OPERATION INVOLVING
CALIBRATION, INTERLABORATORY AND INTRALABORATORY TESTING, AND EVALUATION OF MONITORING PROGRAMS,
LABS, NETWORKS AND PERSONNEL.
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ELEMENTS OF THE QUALITY ASSURANCE PROGRAM
STANDARDIZATION
QUALITY CONTROL
QUALITY ASSURANCE
-------
LET US NOW LOOK MORE SPECIFICALLY AT THE TASKS WHICH MAKE UP THE EPA QUALITY ASSURANCE PROGRAM.
10
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DESCRIPTION OF PROGRAM
11
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OVERVIEW OF THE FUNCTIONS REQUIRED FOR QUALITY ASSURANCE
THE OVERALL QUALITY ASSURANCE PROGRAM COMPRISES TWO MAIN ELEMENTS: STANDARDIZATION AND
QUALITY CONTROL. TO SIMPLIFY THE EXPLANATION OF PROGRAM FUNCTIONS, EACH OF THESE TWO MAIN
ELEMENTS CAN BE THOUGHT OF AS INCLUDING THE GENERAL TASKS SHOWN. THE STANDARDIZATION TASKS
INCLUDE (1) TESTING AND EVALUATION OF METHODS TO DEVELOP A REFERENCE METHOD FOR POLLUTANTS
IN EACH MEDIUM; (2) DEVELOPING AND ISSUING GUIDELINES TO DETERMINE EQUIVALENCY OF ALTERNATE
METHODS; AND (3) DEVELOPING AND ISSUING GUIDELINES AND PROCEDURES TO BE USED FOR ENVIRONMENTAL
MONITORING.
THE OTHER ELEMENT OF QUALITY ASSURANCE — QUALITY CONTROL ~ INCLUDES (1) QUALITY CONTROL WITHIN
LABORATORIES; (2) QUALITY CONTROL AMONG LABORATORIES; (3) A PROGRAM OF REGULAR EVALUATION OF ALL
MONITORING ACTIVITIES; AND (4) ROUTINE CALIBRATION OF MONITORING INSTRUMENTS EMPLOYING STANDARD
REFERENCE MATERIALS AND SAMPLES (SRMs AND SRSs).
STANDARDIZATION AND QUALITY CONTROL, OF COURSE, ARE CLEARLY RELATED. FOR EXAMPLE, INTERLABORATORY
TESTING IS USED BOTH TO DEVELOP REFERENCE METHODS (STANDARDIZATION) AND TO EVALUATE LABORATORY
PERFORMANCE (QUALITY CONTROL).
12
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OVERVIEW OF THE FUNCTIONS REQUIRED FOR QUALITY ASSURANCE
INTRALAB
QUALITY
CONTROL
INTERLAB
QUALITY
CONTROL
PROMULGATE
EQUIVALENCY
GUIDELINES
DEVELOP
REFERENCE
METHODS
ISSUE
MONITORING
PROCEDURES
CALIBRATION
MATERIALS
EVALUATION
PROGRAM
QUALITY
ASSURANCE
QUALITY CONTROL
STANDARDIZATION
(VALID, ACCURATE
DATA)
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OPERATING THE QUALITY ASSURANCE PROGRAM
1. STANDARDIZATION
REFERENCE METHODS WILL BE DEVELOPED THROUGH AN INTENSIVE PROGRAM OF HIGH QUALITY SCIENTIFIC
LABORATORY AND FIELD PROCEDURES, INVOLVING COLLABORATIVE INVESTIGATION AND TESTING BY MANY
ORGANIZATIONS. ON THE ORDER OF 1000 PRINCIPAL MEDIUM-POLLUTANT COMBINATIONS ARE TENTATIVELY
IDENTIFIED AS REQUIRING REFERENCE METHODS.
PROCEDURES ARE BEING CAREFULLY DEVELOPED TO DETERMINE THE EQUIVALENCY OF METHODS USED OR
PROPOSED BY ANY MONITORING PROGRAM TO THE REFERENCE METHOD.
MANUALS ARE BEING PREPARED FOR THE PRINCIPAL MONITORING ROUTINES, AND THEY WILL BE WIDELY
DISSEMINATED TO ENCOURAGE UNIFORMITY IN THE OPERATION OF MONITORING PROGRAMS, THEREBY PRODUCING
COMPARABLE DATA FROM DIFFERENT SOURCES.
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OPERATING THE QUALITY ASSURANCE PROGRAM
1. STANDARDIZATION
D DEVELOP AND PUBLISH
REFERENCE METHODS
INTENSIVE SCIENTIFIC LAB AND FIELD WORK
ABOUT 1000 MAIN
POLLUTANT-MEDIUM
COMBINATIONS
PROMULGATE EQUIVALENCY
GUIDELINES
HOW TO DETERMINE WHETHER ANY METHOD
IS EQUIVALENT TO THE REFERENCE METHOD
D DEVELOP AND ISSUE MONITORING
GUIDELINES AND PROCEDURES
15
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OPERATING THE QUALITY ASSURANCE PROGRAM
2. QUALITY CONTROL
ADEQUATE AND RESPONSIVE SUPPLY SYSTEMS ARE BEING DEVELOPED TO INSURE THAT EVERY LABORATORY AND
STATION HAS AVAILABLE THE SRMs AND SRSs REQUIRED TO CALIBRATE ITS INSTRUMENTS. THIS WILL
INCLUDE ACTUAL PRODUCTION, TESTING AND CERTIFICATION OF THE CALIBRATION MATERIALS.
PROCEDURES ARE BEING DEVELOPED AND DISSEMINATED FOR EACH LABORATORY AND STATION TO USE IN INSURING
THE VALIDITY AND ACCURACY OF ITS OWN DATA.
PROGRAMS ARE BEING DESIGNED AND OPERATED FOR THE COMPARISON OF DATA FROM LABORATORY TO LABORATORY
TO CONTINUOUSLY VERIFY THE SUITABILITY OF METHODS FOR USE UNDER VARYING CIRCUMSTANCES, AND TO
INSURE THE COMPARABILITY OF DATA FROM DIFFERENT LABORATORIES.
PROGRAMS ARE BEING DEVELOPED AND IMPLEMENTED TO EVALUATE THE PERFORMANCE OF LABORATORIES AND
STATIONS BY INDEPENDENT PROCEDURES. EVALUATION OF EPA LABORATORIES WILL BE AUTHORITATIVE AND
COMPULSORY; EVALUATION OF OUTSIDE INSTALLATIONS WILL BE PERFORMED AS A SERVICE TO THEM BY EPA.
16
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OPERATING THE QUALITY ASSURANCE PROGRAM
2. QUALITY CONTROL
D CALIBRATION MATERIALS
MAINTAIN EXTENSIVE INVENTORY
AND SUPPLY SYSTEM
D INTRALABORATORY QUALITY CONTROL
D INTERLABORATORY QUALITY CONTROL
D EVALUATION
17
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NOW THAT THE FUNCTIONS OF THE EPA QUALITY ASSURANCE PROGRAM HAVE BEEN EXPLAINED, THE QUESTION
BECOMES, "WHO IS GOING TO DO IT?"
18
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ORGANIZATION OF PROGRAM
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QUALITY ASSURANCE ORGANIZATIONAL RESPONSIBILITIES
BECAUSE THE PROGRAM IS EPA-WIDE AND WILL ALSO TAKE IN STATES AND EXTERNAL ORGANIZATIONS ON A
VOLUNTARY BASIS, VIRTUALLY EVERY OFFICE INVOLVED WITH MONITORING AND THE USE OF MONITORING DATA
WILL HAVE SOME INPUTS. THE QUALITY ASSURANCE DIVISION IN THE OFFICE OF MONITORING AND THE QUALITY
ASSURANCE GROUPS IN THE NERCs WILL DEVOTE FULL TIME TO DEVELOPING THE PROGRAM AND SERVING THE
OPERATING UNITS. THEY WILL DEVELOP THE STANDARDIZATION PROTOCOLS AND PROVIDE TECHNICAL ASSISTANCE
FOR IMPLEMENTATION. WHILE THE QUALITY ASSURANCE DIVISION AND THE NERCs ARE EXPECTED TO PERFORM
THE BULK OF EPA'S STANDARDIZATION ACTIVITY, ANY MONITORING GROUP CAN PARTICIPATE IN STANDARDIZATION
BY FOLLOWING THE GUIDELINES PROVIDED. IN THE AREA OF QUALITY CONTROL, THE QUALITY ASSURANCE
DIVISION AND THE NERC QUALITY CONTROL GROUPS WILL HAVE THE DUAL ROLE OF PROVIDING SERVICES AND
CONDUCTING EVALUATIONS. SERVICES WILL INCLUDE PROVIDING QUALITY CONTROL TOOLS AND ASSISTANCE
TO ALL MONITORING PROGRAMS, WITH THE INDIVIDUAL PROGRAMS RESPONSIBLE FOR CONDUCTING QUALITY
CONTROL IN THEIR AREAS OF RESPONSIBILITY. EVALUATION INCLUDES EXTERNAL CHECKS OF ALL MONITORING
PROGRAMS TO ENSURE THAT ACCURATE, VALID DATA ARE BEING GENERATED. THE INTRA-AGENCY QUALITY
ASSURANCE COORDINATING COMMITTEE, A BOARD MADE UP OF REPRESENTATIVES FROM ALL PROGRAM OFFICES
AND THE REGIONS, PROVIDES THE MECHANISM FOR COORDINATION OF PROGRAMS.
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QUALITY ASSURANCE ORGANIZATIONAL RESPONSIBILITIES
PROGRAM OFFICE
LABORATORIES
REGIONAL
SURVEILLANCE
DIVISIONS
I] U U
QA. DIVISION,
OFFICE OF MONITORING
QA, GROUPS AT
NERCS
EXTERNAL GROUPS
(STATES, UNIVERSITIES,
INDUSTRY, ETC.)
NERCs AND
NFICs
.INTRA-AGENCY QUALITY
ASSURANCE
COORDINATING
COMMITTEE
21
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IT MAY BE HELPFUL AT THIS POINT TO SHOW AN EXAMPLE OF HOW THE QUALITY ASSURANCE PROGRAM
ACTUALLY OPERATES, FROM REFERENCE METHOD DEVELOPMENT TO QUALITY CONTROL IN THE FIELD.
22
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EXAMPLE OF QUALITY ASSURANCE IN OPERATION
23
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AN EXAMPLE OF HOW A REFERENCE METHOD IS ESTABLISHED
ANY MONITORING PROGRAM CAN DESIGNATE A CANDIDATE METHOD OR CAN ASK THE OFFICE OF MONITORING
TO STANDARDIZE A METHOD TO FILL A SPECIFIC NEED. WHEN A METHOD HAS BEEN THOROUGHLY TESTED BY
THE USER OR BY A LABORATORY DESIGNATED BY THE OFFICE OF MONITORING, AND HAS PASSED THE TESTS OF
PRECISION, ACCURACY, AND UTILITY, IT BECOMES A TENTATIVE METHOD. THE TENTATIVE METHOD IS THEN
SUBJECTED TO COLLABORATIVE TESTING BY LABORATORIES OFFERING A VARIETY OF OPERATING CONDITIONS.
THE INTRA-AGENCY COMMITTEE THEN EVALUATES THE TEST RESULTS TO DETERMINE TI1AT THE STANDARDIZATION
PROTOCOL HAS BEEN FOLLOWED AND THAT THE TEST RESULTS DEMONSTRATE THE PRECISION, ACCURACY AND
UTILITY OF THE METHOD. ON THE COliMITTEE'S RECOMMENDATION, THE ADMINISTRATOR TliEN ESTABLISHES IT
AS AN EPA REFERENCE METHOD.
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AN EXAMPLE OF HOW A REFERENCE METHOD IS ESTABLISHED
USER
IDENTIFIES
A NEED
SPECIFIC:
POLLUTANT
MEDIUM
CIRCUMSTANCES
UNDERTAKES
STANDARDIZATION
OF METHOD
OR
ASKS OM
TO STANDARDIZE
A METHOD
NJ
/I
USER'S LAB OR
DESIGNATED
NERC
LITERATURE
SEARCH
INTENSIVE
SCIENTIFIC
INVESTIGATIONS
THOROUGH
TESTING
TENTATIVE
METHOD
EXHAUSTIVE COLLABORATIVE TESTING
TENTATIVE
METHOD
COMPARE
RESULTS
IQACC
EPA
ADMINISTRATOR
25
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QUALITY CONTROL FUNCTIONS
ONCE THE REFERENCE METHOD IS DESIGNATED AND PUBLISHED, THE EMPHASIS OF THE QUALITY ASSURANCE
PROGRAM SHIFTS TO QUALITY CONTROL. THE NATIONAL ENVIRONMENTAL RESEARCH CENTERS (NERCs), IN
ADDITION TO CONTINUING PARTICIPATION IN THE CROSS-CHECK SAMPLE PROGRAM, WILL MAKE AVAILABLE
SRMs AND SRSs FOR TESTS, PERFORM ROUTINE FIELD CALIBRATION SPOT CHECKS, OFFER QUALITY CONTROL
TRAINING, AND INCLUDE CHECKS OF MONITORING IN THE EVALUATION PROGRAM.
26
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QUALITY CONTROL FUNCTIONS
REGIONS
STATES
LOCALS
27
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QUALITY CONTROL IS INTEGRAL TO EACH MONITORING PROGRAM
THE INDIVIDUAL MONITORING PROGRAMS AND LABORATORIES HAVE A LARGE SHARE OF THE RESPONSIBILITY
FOR QUALITY CONTROL. WHETHER OR NOT EPA HAD A FORMAL PROGRAM OF QUALITY CONTROL, VIRTUALLY NO
LABORATORY OR MONIOTRING PROGRAM WOULD OPERATE WITHOUT A SYSTEM THAT INCLUDED CALIBRATION,
CARE OF REAGENTS, PROPER SAMPLE HANDLING, ETC. IT MAY BE DIFFICULT TO ISOLATE THE ASPECTS OF
MONITORING THAT SPECIFICALLY FALL INTO THE CATEGORY OF QUALITY CONTROL, BUT PRACTICALLY EVERYONE
AT EVERY LEVEL OF A MONITORING ACTIVITY WILL SPEND A PART OF HIS EFFORTS ON QUALITY CONTROL.
SOME OF THE SPECIFIC QUALITY CONTROL ACTIVITIES INCLUDE:
• MEASURING AND CONTROLLING THE PRECISION OF PROCEDURES AND INSTRUMENTS,
• MEASURING AND CONTROLLING THE ACCURACY OF ANALYTICAL RESULTS,
• INSURING DATA OUTPUT IS COMPUTER COMPATIBLE,
• PRESENTING DATA IN PROPER FORMAT,
• DOCUMENTING PERFORMANCE OF INSTRUMENTS AND ANALYSTS,
• DOCUMENTING TRAINING NEEDS, AND
• IDENTIFYING WEAK METHODOLOGY AND CONSEQUENT RESEARCH NEEDS.
28
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QUALITY CONTROL IS INTEGRAL TO EACH MONITORING PROGRAM
SAMPLING ACCORDING
TO PROCEDURES
CONTINUAL CALIBRATION
USING SRM/SRS
ANALYZING REFERENCE
SAMPLES
ADEQUATE TRAINING
OF PERSONNEL
ALL OF THE DATA IS
VERIFIED
QUALITY CONTROL IS A ROUTINE ACTIVITY REQUIRING UP TO 15% OF MONITORING RESOURCES
29
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CONTINUOUS EVALUATION OF PERFORMANCE AND DATA
THE QUALITY CONTROL FUNCTION OF THE NERCs INCLUDES PERIODIC EVALUATION OF MONITORING ACTIVITIES
TO MAKE SURE THEY ARE OPERATING EFFECTIVELY AND RELIABLY. THIS EVALUATION TAKES TWO FORMS:
ON-SITE SPOT CHECKS OF PROCEDURES AND EQUIPMENT, AND EVALUATION OF DATA AND QUALITY CONTROL
INFORMATION ROUTINELY SUBMITTED ALONG WITH MONITORING DATA.
AMONG THE SPECIFIC POINTS CHECKED IN THESE EVALUATIONS ARE:
• SAMPLE HANDLING AND VERIFICATION METHODS,
• SPECIFICS OF THE ANALYTICAL METHODS USED,
• TYPE AND SOURCE OF SRSs AND SRMs USED,
• FREQUENCY OF USE OF CONTROLS, AND
• ADEQUACY OF PARTICIPATION IN TRAINING ACTIVITIES.
AS A RESULT OF EVALUATIONS, A BASELINE OF INFORMATION CAN BE MAINTAINED ON THE PHYSICAL
FACILITIES, EQUIPMENT, PROCEDURES AND PERSONNEL OF EACH LABORATORY AND AGENCY.
30
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CONTINUOUS EVALUATION OF PERFORMANCE AND DATA
SAMPLING
ANALYSIS
PROCEDURES
SAMPLE
PRESERVATION
CALIBRATION
PROCEDURES
ON SITE EVALUATION
DATA EVALUATION
WWK/////SW-
WEAKNESSES IDENTIFIED AND ELIMINATED
THROUGH TRAINING AND BETTER INSTRUMENTATION
31
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SUMMARY OF QUALITY ASSURANCE FUNCTIONS
IN SUMMARY, THE TWO MAIN ELEMENTS OF QUALITY ASSURANCE ARE STANDARDIZATION AND QUALITY CONTROL.
STANDARDIZATION INCLUDES ESTABLISHING REFERENCE METHODS, AND DEVELOPING GUIDELINES AND PROCEDURES
FOR MONITORING ACTIVITIES. QUALITY CONTROL INCLUDES QUALITY CONTROL OPERATIONS WITHIN LABORATORIES
AND NETWORKS AND BETWEEN LABORATORIES AND NETWORKS, AND A THOROUGH PROCESS FOR EVALUATION OF ALL
MONITORING PROGRAMS.
32
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SUMMARY OF QUALITY ASSURANCE FUNCTIONS
1. STANDARDIZATION
REFERENCE METHOD FOR
EACH POLLUTANT
SPECIFICATIONS FOR
EQUIVALENT METHODS
MONITORING GUIDELINES
AND PROCEDURES
2. QUALITY CONTROL
CALIBRATION
MATERIALS
INTRALAB
QUALITY CONTROL
INTERLAB
QUALITY CONTROL
EVALUATION
33
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QUALITY ASSURANCE, OF COURSE, IS NOT SOMETHING THAT MUST BE STARTED FROM SCRATCH. ALMOST ALL
MONITORING PROGRAMS HAVE INCLUDED AT LEAST SOME ASPECTS OF STANDARDIZATION AND QUALITY CONTROL
FOR SOME TIME. A BRIEF LOOK AT EACH MEDIUM WILL SHOW PRESENT QUALITY ASSURANCE STATUS, AND
ALSO IDENTIFY AREAS WHERE MORE QUALITY ASSURANCE EFFORT IS REQUIRED.
34
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CURRENT STATUS
35
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STATUS — AIR
STARTING WITH AIR, WE SEE THAT REFERENCE METHODS HAVE BEEN PUBLISHED FOR FOUR MAJOR POLLUTANTS
(METHODS FOR TWO ADDITIONAL METHODS ARE UNDERGOING FURTHER TESTING), AND AN EQUIVALENCY GUIDE-
LINES DOCUMENT IS ABOUT TO BE RELEASED. STILL NEEDED ARE REFERENCE METHODS FOR ABOUT 25 MORE
POLLUTANTS, QUALITY CONTROL PROGRAM GUIDELINES, STANDARD REFERENCE MATERIALS AND SAMPLES, AND AN
EVALUATION PROGRAM. THE ITEMS LISTED AS PRIORITY ARE THE MOST CRITICAL NEEDS FOR QUALITY
ASSURANCE. THE BAR GRAPH AT THE BOTTOM OF THIS AND THE FOLLOWING VU-GRAPHS SHOWS THE RESOURCES
REQUIRED TO FILL NEEDS ON AN ANNUAL BASIS. LEVEL 1 MEANS A MINIMUM PROGRAM TO MEET PRIORITY
NEEDS, WHILE OPTIMUM MEANS A LEVEL OF FUNDING WHICH WOULD RESULT IN MEETING ALL QUALITY ASSURANCE
REQUIREMENTS.
36
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QUALITY ASSURANCE STATUS
MEDIUM: AIR
ACCOMPLISHED:
NEEDED:
PRIORITIES:
• REFERENCE METHODS FOR SO2, CO OK, AND TSP
• EQUIVALENCY GUIDELINES DOCUMENT DRAFTED
• TRAINING AND TECH. AID
• REFERENCE METHODS FOR 25 MORE POLLUTANTS
• PROCEDURES FOR SOURCE AND EMISSION TESTS
• QUALITY CONTROL PROGRAM GUIDELINES
• SRM/SRS DELIVERY SYSTEM
• EVALUATION PROGRAM
• REFERENCE METHODS & SRMs FOR HAZARDOUS POLLUTANTS
• SAMPLING GUIDELINES FOR AMBIENT AND SOURCE MEAS.
• REFERENCE METHODS FOR SOURCE TESTING (CAT. II SOURCES)
• DEVELOP INTER-LABORATORY TESTING PROGRAM
FY73
$1,565,000
LEVEL 1
$2,315,000
OPTIMUM
$3,200,000
RESOURCES:
37
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STATUS — WATER
IN THE AREA OF WATER POLLUTION MONITORING, SEVERAL COMPENDIA OF METHODS ARE PUBLISHED. THERE
IS A PROGRAM OF QUALITY CONTROL WITHIN AND AMONG LABORATORIES, INCLUDING DISTRIBUTION OF SOME
STANDARD REFERENCE SAMPLES, AND A QUALITY ASSURANCE NEWSLETTER IS PUBLISHED.
STILL NEEDED IN WATER PROGRAMS ARE DESIGNATION OF OFFICIAL REFERENCE METHODS, EQUIVALENCY GUIDE-
LINES, IMPROVED SRM/SRS DISTRIBUTION, MORE TRAINING AND TECHNICAL ASSISTANCE, AND EVALUATION
PROGRAM FOR LABORATORIES AND PERSONNEL.
38
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QUALITY ASSURANCE STATUS
ACCOMPLISHED:
NEEDED:
PRIORITIES:
MEDIUM: WATER
METHODS COMPENDIA
• INTRA- AND INTER-LAB QUALITY CONTROL
• SRS DISTRIBUTION
• QUALITY ASSURANCE NEWSLETTER
• OFFICIAL REFERENCE METHODS
• EQUIVALENCY GUIDELINES
• MORE TRAINING AND TECH. AID TO REGIONS
• EVALUATION PROGRAM
• SAMPLING & SAMPLE PRESENTATION GUIDELINES
• REFERENCE METHODS FOR EFFLUENT MONITORING
• MICROBIOLOGICAL METHODS
• SRMs & SRSs FOR WASTE WATERS
RESOURCES:
FY73 LEVEL 1
$357,000 $1,069,000
OPTIMUM
$3,180,000
39
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STATUS - SOLID WASTE
IN SOLID WASTE, 18 METHODS ARE ABOUT TO BE PUBLISHED.
STILL NEEDED ARE DESIGNATION OF OFFICIAL REFERENCE METHODS, EQUIVALENCY GUIDELINES FOR OTHER
METHODS, QUALITY CONTROL PROGRAM GUIDELINES, A QUALITY ASSURANCE TRAINING AND TECHNICAL ASSISTANCE
PROGRAM, -AND AN EVALUATION PROGRAM.
40
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QUALITY ASSURANCE STATUS
MEDIUM: SOLID WASTE
ACCOMPLISHED: • 18 METHODS TO BE PUBLISHED
NEEDED:
PRIORITIES:
• OFFICIAL REFERENCE METHODS
• EQUIVALENCY GUIDELINES
• QUALITY CONTROL PROGRAM GUIDELINES
• TRAINING AND TECH. AID
• EVALUATION PROGRAM
• METHODS FOR LEACHATES
RESOURCES:
TO BE DETERMINED
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STATUS — PESTICIDES
PESTICIDES PROGRAMS HAVE PRODUCED A PARTIAL COMPENDIUM OF METHODS, AND A QUALITY CONTROL PROGRAM
BOTH WITHIN AND AMONG LABORATORIES (PRESENTLY LIMITED TO THE COMMUNITY STUDIES PROGRAM) IS IN
OPERATION. SRMs ARE AVAILABLE (ALTHOUGH GREATER AVAILABILITY OF STANDARD REFERENCE SAMPLES IS
NEEDED). THERE ARE ALSO PROGRAMS FOR QUALITY ASSURANCE TRAINING AND TECHNICAL ASSISTANCE.
STILL REQUIRED ARE DESIGNATION OF OFFICIAL REFERENCE METHODS, EQUIVALENCY GUIDELINES, QUALITY
CONTROL PROGRAM GUIDELINES, AND AN EVALUATION PROGRAM.
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QUALITY ASSURANCE STATUS
MEDIUM: PESTICIDES
ACCOMPLISHED:
NEEDED:
PRIORITIES:
METHODS COMPENDIUM
• INTRA- AND INTER-LAB QUALITY CONTROL
• SRM's AVAILABLE
• TRAINING AND TECH. AID
OFFICIAL REFERENCE METHODS
• EQUIVALENCY GUIDELINES
• QUALITY CONTROL PROGRAM GUIDELINES
• MORE TRAINING AND TECH. AID TO REGIONS
• EVALUATION PROGRAM
SRM CERTIFICATION
• STANDARDIZE AUTOMATED METHODS
FY73
$436,000
LEVEL 1 OPTIMUM
$538,000 $715,000
RESOURCES:
43
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STATUS - RADIATION
IN RADIATION QUALITY ASSURANCE, A COMPENDIUM OF METHODS HAS BEEN PUBLISHED, AN INTERLAB CROSS-
CHECK SAMPLE PROGRAM HAS BEEN IN OPERATION, AND THERE IS AN ACTIVE METHODS EVALUATION PROGRAM.
STILL NEEDED IN RADIATION MONITORING PROGRAMS ARE DESIGNATION OF OFFICIAL REFERENCE METHODS,
EQUIVALENCY GUIDELINES, QUALITY CONTROL PROGRAM GUIDELINES, MORE QUALITY ASSURANCE TRAINING AND
TECHNICAL ASSISTANCE, AND AN EVALUATION PROGRAM.
(THE NOISE POLLUTION PROGRAMS HAVE JUST BEGUN AND THEY WILL REQUIRE A COMPLETE QUALITY ASSURANCE
PROGRAM.)
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QUALITY ASSURANCE STATUS
MEDIUM: RADIATION
ACCOMPLISHED:
NEEDED:
PRIORITIES:
COMPENDIUM OF METHODS
• CROSS-CHECK SAMPLE PROGRAM
• METHODS EVALUATION PROGRAM
OFFICIAL REFERENCE METHODS
• EQUIVALENCY GUIDELINES
• QUALITY CONTROL PROGRAM GUIDELINES
• MORE TRAINING AND TECH. AID TO REGIONS
• EVALUATION PROGRAM
SAMPLING GUIDELINES
• REFERENCE METHODS FOR POINT SOURCE DISCHARGES
FY73
$317,000
LEVEL 1
$547,000
OPTIMUM
$730,000
RESOURCES:
45
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NOW THAT THE STATUS HAS BEEN REVIEWED, LET US LOOK AT THE SPECIFIC PROJECTS AND RESOURCES
REQUIRED TO MEET PLANNED QUALITY ASSURANCE OBJECTIVES.
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PROGRAM DEVELOPMENT
47
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STANDARDIZATION PROGRAM IMPLEMENTATION
IMPLEMENTATION OF THE QUALITY ASSURANCE PROGRAM INVOLVES A NUMBER OF SPECIFIC PROJECTS IN
STANDARDIZATION AND QUALITY CONTROL, SOME OF WHICH WILL BE SHORT-TERM, SINGLE EFFORTS AND SOME
OF WHICH WILL BE LONG-TERM, CONTINUING EFFORTS. IN STANDARDIZATION, THERE ARE FOUR MAIN PROJECTS:
(1) PROGRAM MANAGEMENT INCLUDES PLANNING AND MONITORING STANDARDIZATION ACTIVITY, AND COORDINATING
WITH ALL ORGANIZATIONS INVOLVED. (2) INTERIM PROJECTS INVOLVE SHORT-TERM TASKS TO MEET IMMEDIATE
STANDARDIZATION NEEDS, SUCH AS COMPILING COMPENDIA OF SAMPLING PROCEDURES AND ANALYTICAL METHODS
TO BE USED UNTIL REFERENCE METHODS ARE ESTABLISHED. (3) PROTOCOL DEVELOPMENT RESULTS IN ISSUANCE
OF GUIDELINES AND PROCEDURES MANUALS FOR MONITORING AND FOR DETERMINING METHOD EQUIVALENCY.
(4) REFERENCE METHODS DEVELOPMENT IS THE MAJOR PROJECT OF STANDARDIZATION. HERE, A COMPREHENSIVE
AGENCY-WIDE PROGRAM OF SCIENTIFIC TESTING AND EVALUATION IS CARRIED OUT TO ESTABLISH THOSE ANALYTICAL
METHODS WHICH WILL BE THE REFERENCE FOR ALL DATA USED BY EPA. AT A COST OF ABOUT $100,000 PER
REFERENCE METHOD, AND WITH POTENTIALLY AS MANY AS 1,000 METHODS TO BE ESTABLISHED FOR ALL MEDIA,
THIS WILL BE THE LARGEST CONTINUING PROJECT OF STANDARDIZATION.
48
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STANDARDIZATION PROGRAM IMPLEMENTATION
INTERIM PROJECTS
PROGRAM MANAGEMENT
SAMPLING COMPENDIUM ANALYSIS COMPENDIUM
PROTOCOL DEVELOPMENT
EQUIVALENCY GUIDELINES
MONITORING GUIDELINES
REFERENCE METHOD DEVELOPMENT
AIR WATER SOLID WASTE
PESTICIDE RADIATION NOISE
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TOTAL ANNUAL RESOURCE REQUIREMENTS BY PROJECT (STANDARDIZATION)
THE ESTIMATED ANNUAL RESOURCE REQUIREMENTS FOR STANDARDIZATION ARE BROKEN OUT BY PROJECT ON
THIS TABLE. THE FIRST THREE PROJECTS SHOWN ARE FOR PROTOCOL DEVELOPMENT AND SHORT-TERM
PROJECTS. FOR REFERENCE METHOD DEVELOPMENT, ONLY TOTAL FIGURES FOR MAN YEARS AND FUNDS WERE
AVAILABLE. THE BOTTOM LINE SHOWS THE TOTAL COST OF STANDARDIZATION IN MAN YEARS AND FUNDS.
CLEARLY THE BULK OF STANDARDIZATION RESOURCES IS TARGETTED FOR DEVELOPING REFERENCE METHODS.
50
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TOTAL ANNUAL RESOURCE REQUIREMENTS BY PROJECT
(STANDARDIZATION)*
PROGRAM MANAGEMENT
INTERIM PROJECTS
GUIDELINES DEVELOPMENT
METHODS DEVELOPMENT
TOTAL
FIRST YEAR
OM
MY
2.4
2.3
1.1
$1000
86
78
38
MY
103
115
NERC
MY
4.5
1.5
$1000
135
45
$1000
3100
3481
SECOND YEAR
OM
MY
6.7
2.3
2.0
$1000
240
82
72
MY
130
144.5
NERC
MY
1.5
2.0
$1000
45
60
$1000
3900
4399
*NOT INCLUDING STANDARDIZATION CARRIED ON OUTSIDE OFFICE OF MONITORING.
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QUALITY CONTROL PROGRAM IMPLEMENTATION
THE OTHER ELEMENT OF QUALITY ASSURANCE — QUALITY CONTROL — IS COMPRISED OF THE SIX MAIN
PROJECTS SHOWN HERE. THE FIRST, ESSENTIALLY ONE-TIME, EFFORT WILL BE TO ISSUE QUALITY CONTROL
GUIDELINES MANUALS FOR ALL MONITORING ACTIVITIES TO USE IN THEIR DAY-TO-DAY ACTIVITIES.
INCLUDED WILL BE SAMPLE HANDLING PROCEDURES, TESTING PROCEDURES AND VALIDATION CHECKS. THE
CALIBRATION MATERIALS PROJECT INVOLVES PRODUCTION AND TESTING OF SRMs AND SRSs, AND ESTABLISH-
ING A SUPPLY AND DELIVERY SYSTEM FOR ALL ENVIRONMENTAL LABORATORIES. INTRALABORATORY QUALITY
CONTROL INVOLVES ACTUAL QUALITY CONTROL OPERATIONS WITHIN ALL PARTICIPATING LABORATORIES.
THE INTERLABORATORY QUALITY CONTROL PROJECT INCLUDES CROSS-CHECKING OF SAMPLES AND TESTING
AMONG LABORATORIES TO ENSURE THAT UNIFORM AND VALID RESULTS ARE BEING ACHIEVED. THE EVALUATION
PROJECT IS A MEANS OF COMPARING PROFICIENCY ON A NATIONWIDE BASIS BY ROUTINE CHECKS SO THAT
PROBLEM AREAS CAN BE IDENTIFIED AND CORRECTED. EVALUATION WILL BE COMPULSORY FOR EPA MONITORING
ACTIVITIES, AND OFFERED AS A SERVICE TO PARTICIPATING NON-EPA GROUPS. FINALLY, THE COMMUNI-
CATION AND EDUCATION PROJECT ENSURES THAT THE LATEST INFORMATION ON METHODS, TECHNIQUES, AND
INSTRUMENTS IS BROUGHT TO THE ATTENTION OF ALL USERS IN A TIMELY MANNER.
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QUALITY CONTROL PROGRAM IMPLEMENTATION
Q. C. GUIDELINES
INTERLABQ.C.
CALIBRATION
MATERIALS
EVALUATION
tNTRALAB Q. C.
COMMUNICATIONS AND TRAINING
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TOTAL ANNUAL RESOURCE REQUIREMENTS BY PROJECT (QUALITY CONTROL)
THIS TABLE SHOWS THE QUALITY CONTROL RESOURCE NEEDS FOR THE FIRST AND SECOND YEAR OF
OPERATION. BESIDES SPECIFIC PROJECT REQUIREMENTS, THE MAN YEARS AND FUNDS ARE SHOWN DIVIDED
BETWEEN THE OFFICE OF MONITORING AND NERCs ON THE ONE HAND, AND THE REGIONS ON THE OTHER. THE
LAST LINE SHOWS THE TOTAL ANNUAL REQUIREMENTS FOR QUALITY CONTROL.
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TOTAL ANNUAL RESOURCE REQUIREMENTS BY PROJECT
(QUALITY CONTROL)
GUIDELINES
SRMS AND SRSS
INTRALABORATORY QC
INTER LABORATORY QC
FIELD EVAL. OF INSTRUMENTS
SITE AND LAB EVALUATION
CERTIFICATION
COORD. AND COMMUNICATION
TRAINING
TOTAL
FIRST YEAR
OM AND MERC
MY
5.5
9.2
2.2
15.0
8.8
3.5
1.1
2.2
4.5
52.0
$1000
703.5
593.5
57.0
700.0
336.0
164.0
44.0
87.0
125.0
2810.0
REGIONS
MY
35
15
10
10
70
$1000
700
300
200
1900
3100
SECOND YEAR
OM ANDNERC
MY
6.1
13.6
2.5
22.4
14.5
8.1
6.1
3.4
8.5
85.2
$1000
799.4
859.4
64.7
1023.5
714.7
379.4
229.4
118.8
214.7
4404.0
REGIONS
MY
50
25
10
20
105
$1000
1000
600
250
500
2350
55
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RESOURCE REQUIREMENTS PROJECTIONS
THIS CONCLUDING RESOURCES VU-GRAPH SHOWS THE ESTIMATED RESOURCE REQUIREMENTS FOR QUALITY
ASSURANCE PROJECTED FOR THE NEXT 15 YEARS. BECAUSE OF THE MANY UNCERTAINTIES OF COST
PROJECTIONS AND FUTURE LEGISLATIVE REQUIREMENTS, THE CURVES ARE ONLY APPROXIMATIONS, BUT THE
TRENDS SHOWN ARE CONSIDERED REALISTIC. THE MAJOR EFFORT OF ESTABLISHING METHODS AND DEVELOP-
ING GUIDELINES WILL PEAK OUT AFTER AN INITIAL HEAVY INVESTMENT, AND THEREAFTER QUALITY ASSURANCE
WILL CONTINUE AS A MORE ROUTINE EFFORT TO GUARANTEE VALID AND ACCURATE DATA.
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RESOURCE REQUIREMENTS TREND PROJECTION
10 i-
MILLION
DOLLARS
5 -
1975
1980
1985
57
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COSTS OF QUALITY ASSURANCE VERSUS COSTS OF NO QUALITY ASSURANCE
WE HAVE SEEN THAT AN ADEQUATE QUALITY ASSURANCE PROGRAM MUST INCLUDE INTENSIVE SCIENTIFIC WORK,
AN ORGANIZED CALIBRATION AND QUALITY CONTROL EFFORT, AND A SUBSTANTIAL TRAINING AND EVALUATION
PROGRAM. THE COST OF QUALITY CONTROL ALONE MAY BE ABOUT 10 TO 15 PERCENT OF THE COST OF THE
ENTIRE MONITORING EFFORT OF EPA.
THE COST OF NOT HAVING RELIABLE DATA FOR THE ESSENTIAL NEEDS OF EPA IS EVEN HIGHER. SUCCESSFUL
ENFORCEMENT OF ENVIRONMENTAL STANDARDS THROUGH COURT ACTION REQUIRES INCONTROVERTIBLE DATA. AN
UNDERSTANDING OF THE POLLUTION MECHANISMS FOR POLICY DECISIONS REQUIRES DATA WHICH ARE SCIENTI-
FICALLY RELATED TO PROVIDE THAT UNDERSTANDING, AS WELL AS DATA WHICH ARE ACCURATE AND VALID IN
THE FIRST PLACE. THE ENTIRE COST OF COLLECTING ANY DATA IS WASTED IF THE DATA DO NOT CONTRIBUTE
TO OPERATIONAL NEEDS OR IF THE DATA CANNOT BE RELIED ON.
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COSTS OF Q.A. VS. COSTS OF NO Q.A.
10 -15% OF MONITORING MONEY AND
MANPOWER DEVOTED TO QUALITY CONTROL
INTENSIVE
SCIENTIFIC
TESTING
EVALUATION
COSTS OF NOT HAVING RELIABLE DATA
ENFORCEMENT
CASES
LOST IN COURT
EXPENSIVELY
COLLECTED
DATA USELESS
FAULTY POLICY DECISIONS
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CONCLUSION
THROUGH COMPREHENSIVE, CLEAR PROGRAMS OF STANDARDIZATION AND QUALITY CONTROL DEVELOPED AND
IMPLEMENTED BY THE DIVISION OF QUALITY ASSURANCE AND THE NERCs, AND SUPPORTED BY ALL ORGAN-
IZATIONS ENGAGED IN ENVIRONMENTAL MONITORING, EPA WILL CONTINUALLY ENHANCE THE ACCURACY AND
VALIDITY OF ITS DATA. QUALITY ASSURANCE PROVIDES BETTER DATA, AND BETTER DATA ENABLE EPA
TO MAKE THE BEST POSSIBLE DECISIONS FOR THE ACHIEVEMENT AND MAINTENANCE OF ENVIRONMENTAL
QUALITY.
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\
QUALITY ASSURANCE > ENHANCED DATA
/
BETTER DECISIONS FOR
ENVIRONMENTAL QUALITY
61
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