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LAI LAI LAI OSWER 9950.4
LAI LAI LAI
LAI LAI LAI
LAI LAI LAI
LAI LAI LAI RCRA LABORATORY
5* A J5* A * ^ AUDIT INSPECTION
LAI LAI LAI
LAI LAI LAI GUIDANCE DOCUMENT
LAI LA! LAI
LAI LAI LAI (RCRA Ground-Water Monitoring Systems)
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LAI LAI LAI RCRA Enforcement Division
LAI LAI LAI Office of Waste Programs Enforcement
LAI LAI LAI u s Environmental Protection Agency
LAI LAI LAI
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LAI LA! LAI s tember 1988
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, O.C. 20460
v " ./
OFFICE Of
SOLID WASTE AND EMERGENCY RESPONSE
MEMORANDUM
SUBJECT: RCRA La boratoj^y Audit Inspection Guidance Document
FROM: J. WinfoTJ orter
Assistant Administrator
TO: Waste Management Division Directors
Environmental Services Division Directors
Regions I - X
Attached is a copy of the final RCRA Laboratory Audit
Inspection Guidance Document (LAI). The LAI is one component of
the multi-phased RCRA ground-water monitoring enforcement
process. The guidance is closely related to RCRA Ground-Water
Monitoring Operation and Maintenance Guidance (O&M) and the RCRA
Comprehensive Ground-Water Monitoring Evaluation Guidance
Document (CME). The LAI closes the loop on guidance that is
needed by enforcement officials to review the design and
operation of ground-water monitoring systems.
The development of the LAI was assisted by a workgroup
composed of both Headquarters and Regional personnel. Their
combined experience in RCRA inspections and laboratory practices
is reflected in the technical quality of this document. The LAI
was further reviewed by the Office of Enforcement and Compliance
Monitoring (OECM) and the Office of General Counsel (OGC) to
ensure its regulatory soundness.
The LAI is intended to assist RCRA inspectors in conducting
laboratory audits. The LAI provides a framework for evaluating
the reliability of tn« laboratory analysis performed by RCRA
facilities on their ground-water monitoring samples. The LAI
will generally involve a -review of the following:
owner/operator sampling and analysis plan or permit/
laboratory staffing, equipment/ and maintenance program/
Laboratory QA/QC procedures and sample tracking system,
and
Analytical methodologies used (if qualified enforcement
personnel and resources are available).
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RCRA Laboratory Audit Inspection Guide
Table of Contents
Section Page
1.0 Overview of the RCRA Laboratory Audit Inspection
1.1 Enforcement Objectives of the RCRA Laboratory Audit Inspection ... 1
1.2 Regulatory Basis for the RCRA Laboratory Audit Inspection 2
1.3 Relationship of the RCRA Laboratory Audit Inspection to Other
RCRA Inspections 4
1.4 Laboratory Quality Control Programs for Ground-Water
Analyses 6
1.5 The Laboratory Audit Inspection Process 12
2.0 Office Preparation for the RCRA Laboratory Audit Inspection 15
3.0 The Laboratory Inspection 16
4.0 Compliance Decision-Making 17
List of Figures
Figure 1. Example Laboratory, Inc. Organization Chart 9
Figure A-l. Sample Label A-22
Figure A-2. Sample Tracing Form A-24
List of Tables
Table 1. Regulatory Basis for the Laboratory Audit Inspection 3
Table 2. Quality Control Requirements and Frequency
of Application 11
Table 3. The RCRA Laboratory Audit Inspection 13
Table 4. Summary of Technical Inadequacies A-35
Appendices
Appendix ARCRA Laboratory Audit Inspection Form
Appendix BQuestions and Answers
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APPENDIX A
RCRA Laboratory Audit Inspection Form
(RCRA Ground-Water Monitoring Systems)
Part 1 Pre-Inspection Planning Guide
Part 2 Laboratory Inspection Guide
Part 3 Compliance Decision Making
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PART ONE
Pre-Inspection Planning
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PART ONE
The laboratory inspector and the enforcement official will meet and complete four
tasks. These tasks are: 1) review permitting and enforcement actions taken to date
involving the owner/operator; 2) review the owner/operator's sampling and analysis
program; 3) review the owner/operator's Laboratory QA/QC procedures; and 4)
prepare site-specific inspection instructions.
Laboratory Name:
Name of Laboratory Contact:
Phone Number: ( )
Address of Laboratory:
Name, RCRA identification number, address, phone number, and contact of owner/
operator using laboratory:
Name of inspector(s):
Date(s) of inspection:
Does the owner/operator have:
Interim Status (Go to la)
Q detection monitoring
D assessment monitoring
0 corrective action (§3008(h))
Permit Status (Go to Ib)
G detection monitoring
D compliance monitoring
corrective action
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la. Past action taken at facility (interim status)
Type Date(s)
Operation and Maintenance
Comprehensive Ground-water Monitoring Evaluation
Case Development Inspection
RCRA Facility Assessment
Compliance Evaluation Inspection
Past reviews of the laboratory (i.e., CWA, LAI, CLP, etc.)
Results of performance audit samples
Complete the following regarding the actions listed above:
Do you have a copy of completed inspection reports and/or site studies?
D Yes a No
For each, summarize deficiencies regarding the owner/operator's sampling
and analysis program (i.e., deficiencies relating to the owner/operator's ability
to generate high quality monitoring data).
Go To 2a
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Ib. Actions taken at the facility to date (permit status)
Type Date(s)
Permit Issuance
Operation and Maintenance Inspection
Comprehensive Ground-water Monitoring Evaluation
Case Development Inspection
Compliance Evaluation Inspection
RCRA Laboratory Audit Inspection
Complete the following in regard to the actions listed above:
Do you have a copy of the permit and copies of inspection reports completed
after permit issuance?
DYes D No
Summarize the deficiencies identified after permit issuance regarding the owner/
operator's sampling and analysis program?
Go To 2b
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2a. Identify enforcement actions issued to the facility in regard to interim
status violations
Action Date(s)
§3008(a) complaint/order
§3013 order
§3008(h) complaint/order
§7003 complaint/order
Referral for litigation
Complete the following regarding the actions listed above:
For each, identify if the enforcement action focused on the owner/operator's
sampling and analysis program. Summarize relevant requirements imposed
on the owner/operator.
Go To 3
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2b. Identify enforcement actions issued to the facility after the permit
issuance date
Action Date(s)
§3008(a) complaint/order
§3008(h) complaint/order
(issued prior to permit)
§3013 order
§7003 complaint/order
Referral for litigation
Permit revocation
Complete the following regarding the actions listed above:
For each, identify if the enforcement action focused on the owner/operator's
sampling and analysis program. Summarize relevant requirements imposed
on the owner/operator.
Go To 3
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3. Review and summarize the owner/operator's sampling and analysis plan.
(NOTE: Revise or add to the table if permit conditions dictate a
different requirement the owner/operator must follow.)
Does The Plan:
N'ame an individual as the Laboratory Quality Assuarance Manager and specify job
requirements relating to the position?
Include a current summary of training, experience, and job description for each
member of the laboratory staff?
Describe quality control paperwork flow and identify those who are authorized to
approve data and results?
Identify who is responsible for corrective procedures?
Describe the laboratory's system for developing or revising technical procedures and
identify those who have authorization for doing so?
Require dating chemicals upon receipt and using them on a first-in, first-out basis?
Specify use of reagent grade or high purity chemicals to prepare standards?
Require testing of chemicals used in analyses to ensure they contain no contaminants
which may interfer with analyses?
Require labeling of all reagents and solutions to indicate identity, concentration,
storage requirements, preparer's name, preparation date, and expiration date?
Require checking and recording of the conductivity of distilled/demineralized water on
a routine basis?
Specify use of reagent grade water as required by specific method?
Specify use of distilled water as required by specific method?
Require discontinuing the use of any reagents/solutions that have passed the expiration
date on the label?
Require storage of samples and/or standards containing the analyte(s) of interest in
areas other than where trace analysis is performed?
Require storage of standards separately from sample extracts?
Specify the use of analysis request sheets?
Y/N/NA
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(3. Con't) Does The Plan:
Include and mandate the use of written calibration procedures, analytical
procedures, computational procedures, quality control procedures, and operating
procedures?
Require daily instrument calibration?
Specify the use of standard curves and check samples for calibration purposes?
Specify the use of logs to record all instruments and equipment checks?
Describe when an analytical system is "out of control" through the use of matrix
spikes and/or surrogates?
Require corrective procedures when an analytical system is "out of control?"
Specify the use of Class A type glassware?
Name an individual to log-in samples in the laboratory?
Describe storage requirements for incoming samples?
Specify the assignment of laboratory numbers to all incoming samples?
Require maintenance of proper temperatures for incoming samples?
Describe chain-of -custody procedures the laboratory will use?
Specify the use of a master schedule sheet or log book of all samples being
analyzed, indexed by laboratory numbers, client, date of arrival, and analysis to be
performed?
Specify the use of sample analysis request sheets?
Specify maximum holding times for samples?
Require the daily recording of temperature in cold storage areas?
Specify the use of matrix spikes (one per analytical batch per matrix, or every
cwenty samples, whichever is more frequent)?
Require the use of replicates and laboratory duplicates (one per analytical batch per
matrix, or every twenty samples, whichever is more frequent)?
Y/N/NA
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(3. Con't) Does The Plan:
Require the use of blanks (one per analytical batch per matrix, or every twenty
samples, whichever is more frequent)?
Require the use of field duplicates (one per analytical batch, or every twenty
samples, whichever is more frequent)?
Require the use of check samples (one per analytical batch, or every twenty
samples, whichever is more frequent)?
Require the use of surrogates for volatile and semi- volatile organics and pesticides
(add to every blank, standard, sample, and QC sample)?
Require the use of column check samples (absorbent chromatography and back-
extractions of organic compounds one per batch of absorbent)?
Require the use of standard curves for AA, ICP, GC, and other analytical methods?
Require GC/MS instrument performance check (initial five point calibration is to be
verified with a single point calibration once every twelve hours of instrument
operation, and if the sensitivity and linearity criteria are not met, a new five point
initial calibration must be generated)?
Require owner/operator to have a system to examine validate raw data from a
commercial laboratory?
Y/N/NA
Comments on Sampling and Analysis Plan and
Site Specific Instructions
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Comments on Sampling and Analysis Plan and
Site Specific Instructions (continued)
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SECTION ONE
OVERVIEW OF THE RCRA LABORATORY AUDIT INSPECTION
1.1 Enforcement Objectives of the RCRA Laboratory Audit Inspection
The 1989 RCRA Implementation Plan introduces the RCRA Laboratory Audit
Inspection (LAI) as a new type of inspection. The LAI reinforces EPA's
commitment to the proper implementation of the RCRA ground-water monitoring
regulations. The LAI guide complements existing ground-water monitoring
enforcement guidance documents issued by EPA, including the RCRA Ground-
Water Monitoring Technical Enforcement Guidance Document (September 1986),
the RCRA Ground-Water Monitoring Compliance Order Guide (August 1985),
and the Operation and Maintenance Inspection GuideRCRA Ground-Water
Monitoring Systems (March 1988).
The LAI guide, in essence, closes the loop on guidance that is needed by
enforcement officials to review the design and operation of RCRA ground-water
monitoring systems. It focuses on the laboratory and is designed to ensure that the
laboratories which perform ground-water analyses generate reliable analytical
data. Specifically, EPA has designed the LAI to achieve the following
enforcement objectives:
determine that the owner/operator's personnel who perform analyses on ground-
water samples are analyzing them in accordance with proper procedures; e.g.:
- in accordance with the owner/operator's 40 CFR Part 265 (interim status)
Sampling and Analysis Plan; or
- in accordance with conditions associated with the sampling and analysis
section of the owner/operator's RCRA permit: or
- in accordance with conditions associated with the sampling and analysis
section of the workplan in a Corrective Action Order,
determine that laboratories which perform analyses on RCRA ground-water
monitoring samples are capable of generating high quality analytical data:
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identify violations in regards to the owner/operator's laboratory program and/or
trigger a more thorough scrutiny of laboratory practices through the initiation of
a Case Development Inspection; and
provide a mechanism to investigate concerns over anomolies in owner/operator
ground-water data sets or concerns over the quality of data generated by
individual laboratories.
1.2 Regulatory Basis for the RCRA Laboratory Audit Inspection
The authority of EPA to require an owner/operator to implement procedures to
generate high quality analytical data for ground-water samples is firmly rooted in
regulations under 40 CFR Parts 265, 264 and 270. Table 1 lists the most pertinent
regulatory requirements related to ground-water analytical programs. These
regulations require owner/operators to implement a comprehensive program to
ensure the generation of high quality analytical data associated with ground-water
samples. RCRA 3008(a) gives EPA the authority to take enforcement action
against those owner/operators who fail to comply with these regulations.
Sections 265.92 and 264.97 are particularly important regulatory sections in
regards to ground-water sampling and analysis. Section 265.92 requires the owner/
operator (interim status) to prepare and follow a written sampling and analysis
plan. Similar provisions are to be written into RCRA permits as per the
requirements of Section 264.97. In either case, specific details as to the analytical
procedures and quality control procedures the owner/operator will follow should
be described in written form. Section 1.4 of this guidance describes the type of
quality control procedures owner/operators should have in place at their
laboratories. These quality control procedures will be the focal point for much of
the effort in the RCRA Laboratory Audit Inspection.
Part Three of the laboratory audit inspection form (Appendix A) illustrates how the
regulations in Table 1 relate to violations EPA is likely to encounter. It is
important to understand that the generation of reliable analytical data is the sole
responsibility of the owner/operator. An owner/operator cannot escape this
obligation by contracting with a commercial laboratory. Questionable
performance on the part of the commercial laboratory will always be viewed by
EPA as questionable performance on the part of the owner/operator. Where
appropriate, EPA will initiate enforcement actions against the owner/operator in
cases where the contracted commercial laboratory is generating questionable
quality data or is engaging in questionable laboratory practices.
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TABLE 1
REGULATORY BASIS FOR THE
LABORATORY AUDIT INSPECTION
§264.97(d)
"The ground-water monitoring program must include consistent sampling and analysis
procedures that are designed to ensure monitoring results that provide a reliable indication of
ground-water quality below the waste management area. At a minimum the program must
include procedures and techniques for
(1) Sample collection;
(2) Sample preservation and shipment:
(3) Analytical procedures; and
(4) Chain of custody control."
§264.97(e)
"The ground-water monitoring program must include sampling and analytical me:hods that are
appropriate for ground-water sampling and that accurately measure hazardous constituents in
ground-water samples."
§270.14(c)(6)liv)
"A description of proposed sampling analysis and statistical companson procedures to be
utilized in evaluating ground-water monitoring data." {Detection Monitoring)
§270.14(c)(7)(vi)
"A description of proposed sampling, analysis, and statistical comparison procedures to be
utilized in evaluating ground-water monitoring data." (Compliance Monitoring)
§265.92(a)
"The owner or operator must obtain and analyze samples from the installed ground-water
monitoring system. The owner or operator must develop and follow a ground-water sampling
and analysis plan.... The plan must include procedures and techniques for:
(1) Sample collection;
(2) Sample preservation and shipment;
(3) Analytical procedures; and
(4) Chain of custody control."
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13 Relationship of the Laboratory Audit Inspection
to Other RCRA Inspections
There are three types of RCRA inspections that relate to the RCRA Laboratory
Audit Inspection. They are: 1) the Comprehensive (Ground-Water) Monitoring
Evaluation (CME); 2) the Operation and Maintenance InspectionRCRA Ground-
Water Monitoring Systems (O&M); and 3) the RCRA Case Development
Inspection (CDI). Each of these inspections are cited in the FY 1989 RCRA
Implementation Plan.
EPA designed the Comprehensive Ground-Water Monitoring Evaluation (CME) to
determine whether a facility's RCRA ground-water monitoring system has been
properly designed and constructed, and is being sampled in such a manner to
provide representative ground-water samples. Some activities included in a CME
are:
evaluation of the owner/operator's hydrogeologic data and site
characterization,
review of the design of the monitoring well network,
evaluation of the construction of the monitoring wells,
review/observation of the owner/operator's sampling program,
review of chain of custody procedures, and
review of the statistical techniques used and conclusions drawn from the
detection/assessment monitoring data.
EPA designed the Operation and Maintenance (O&M) inspection to ensure that the
monitoring network is continuing to perform as designed. The O&M does not
involve a re-evaluation of the design of the system, but focuses on the field
performance of the owner/operator's staff in collecting ground-water samples, and
on the evaluation of the continued integrity of the owner/operator's monitoring
system. The inspection will confirm, for example, that the wells continue to yield
low turbidity samples, the well casings are structurally sound, and continue to
isolate the formations being monitored and that the purging and sampling
equipment are functioning properly.
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Hie Case Development Inspection (GDI) is a comprehensive effort to compile
evidence to support litigation or administrative enforcement actions against an
owner/operator or to establish the need for such actions. Case Development
Inspections are often performed on an as-needed basis in response to the results
from other RCRA inspections (e.g., LAI, O&M, CEI, CME).
The Laboratory Audit Inspection (LAI) will generally involve a review of the
following:
the owner/operator's sampling and analysis plan;
the laboratory staffing, equipment and maintenance program;
laboratory QA/QC procedures and sample tracking system; and
the analytical methodologies used (see Test Methods for Evaluating Solid
Waste (SW-846)).
It is important to note that EPA has not designed the LAI to be a certification
program. Rather, it is a tool to determine whether improper or inadequate
laboratory procedures have resulted in the generation of inaccurate ground-water
monitoring data. The purpose of the LAI is to confirm that the owner/operator is
fulfilling the responsibilities of the RCRA programnot to certify or give the
laboratory in question an EPA "seal of approval" for RCRA work.
The results of a CME or O&M inspection may prompt the enforcement program to
initiate an LAI. For example, the findings of an O&M inspection may reveal that
analytical data from split samples differs significantly. The RCRA inspector would
perform an LAI to determine whether or not laboratory error caused the
discrepancy. In some instances, laboratory results may not indicate contamination
even though such contamination is evident down-gradient from the facility. In such
a case, an LAI would be conducted to determine whether improper analytical
practices caused false negative results. Widely varying analytical results or
unsatisfactory detection limits may also indicate the need for an LAI.
EPA has designed the CME, O&M, and the LAI to form a comprehensive and
ongoing evaluation of the design and operation of RCRA ground-water monitoring
systems. The CME, O&M, and LAI form a system of checks to ensure that RCRA
ground-water monitoring systems are designed properly, are operated properly, and
produce high-quality data to support regulatory and compliance decision-making.
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The number of laboratory audit inspections to be conducted annually is left to the
discretion of authorized State and EPA enforcement officials. There are, however,
situations that should prompt an enforcement official to consider conducting a
Laboratory Audit Inspection. These situations include:
where a CME or an O&M inspection has uncovered anomalies or patterns
of concern in the owner/operator's data set;
where the enforcement official suspects the owner/operator's waste
management unit is leaking, but the monitoring data indicates no
evidence of leaks; and
where the enforcement official is concerned that an individual laboratory
is chronically generating inconsistent or questionable analytical data.
1.4 Laboratory Quality Control Programs for Ground-Water Analysis
The generation of high quality analytical data was of paramount concern to EPA
when the Agency promulgated the RCRA ground-water monitoring regulations.
The regulations specify that owner/operators must prepare and follow written plans
(interim status) in regards-to the sampling and analytical procedures they will
follow in generating ground-water monitoring data. EPA's view is that an owner/
operator's quality control (QC) program begins at the conception of the monitoring
program, continues through collection and storage of samples, includes all phases
of chemical and physical analyses and extends through the interpretation and
compilation of data results.
In order to ensure the generation of reliable monitoring data, the owner/operator
must follow standard operating procedures (SOPs) written into the sampling and
analysis plan (or in the permit for permitted facilities). The RCRA Ground-Water
Monitoring Technical Enforcement Guidance Document; Test Methods for
Evaluating Solid Wastes (SW-846, November 1986); and the Operation and
Maintenance Inspection GuideRCRA Ground-Water Monitoring Systems
describe in detail SOPs related to the collection of ground-water samples. In
addition, an adequate sampling and analysis plan should include SOPs for all
routine laboratory tasks.
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Laboratory SOPs should be comprehensive enough to establish the traceability of
standards, instrumentation, samples and environmental data; simple enough, so a
user with basic education, experience, and/or training can properly use them;
complete enough so the user can follow the directions in a stepwise manner; and
consistent with sound scientific principles and with instrument manufacturers'
instruction manuals. SOPs should also provide documentation sufficiently
complete to record the performance of all tasks and their results, explain the cause
of missing data, and demonstrate the validation of data each time they are
recorded, calculated or transcribed.
An owner/operator's sampling and analysis plan should include SOPs and quality
assurance provisions which address the following:
qualifications of the laboratory's personnel and the organizational
structure of the laboratory;
procedures for maintaining laboratory supplies and equipment;
procedures for equipment calibration;
procedures for sample handling (collection, preservation, etc.);
analytical methodologies used;
quality control procedures; and
procedures for data handling, reporting, and recordkeeping.
Although there are no regulatory minimum qualifications, the inspector should use
his discretion to determine if adequate training and experience exists in the
laboratory.
1.4.1 Qualifications of Laboratory Staff and Organizational Considerations
A laboratory should be organized to ensure the generation of reliable data.
Figure 1 is an example of a laboratory organizational chart. Suggested levels of
qualifications for the laboratory staff have been, in this case, attached to each
position. Although there are no regulatory minimum qualifications, the inspector
should use his discretion to determine if adequate training and experience exists in
the laboratory.
Every owner/operator's sampling and analysis plan should reflect organizational
decisions made by the laboratory. Specifically, the plan should:
describe the laboratory's organizational structure;
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identify a quality assurance coordinator or supervisor,
describe quality control paperwork flow and identify those who are
authorized to approve data and results;
identify those who are responsible for corrective procedures; and
describe the laboratory's system for developing or revising technical
procedures or documentsand identify those who have authority to
do so.
1.4.2 Procedures for Maintaining Laboratory Supplies and Equipment
The laboratory should document purchasing guidelines for all equipment and
reagents having an effect on data quality. Similarly, performance specifications
should be documented for all items of equipment having an effect on data quality.
Once any item which is critical to the analysis such as in-situ instrument or reagent
is received and accepted by the organization, the laboratory should retain
documentation of the type, age, and acceptance status of the item. Reagents should
be dated upon receipt in order to establish their order of use and to minimize the
possibility that the reagents will exceed their useful shelf life.
Preventive maintenance procedures should be written for each measurement
system and required support equipment. When maintenance activity is necessary,
the laboratory should document it on standard forms maintained in logbooks. A
history of the maintenance record of each system serves as an indication of the
adequacy of maintenance schedules and parts inventory.
1.4.3 Equipment Calibration
Calibration is the process of establishing the relationship of a measurement system
output to a known stimulus. In-essence, calibration is a reproductive reference
point to which all sample measurements can be correlated. The laboratory should
prepare a calibration SOP to include provisions for documentation of frequency,
conditions, standards, and records reflecting the calibration history of measurement
systems. The accuracy of the calibration standards is an important point to
consider since all data will be in reference to the standards used. The laboratory
should routinely follow a SOP for verifying the accuracy of all working standards
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Figure 1
Example Laboratory, Inc.
Organization Chart
Laboratory Director
BS Chemistry or equivalent
5 years experience
I
Laboratory Operations
Supervisor
BS Chemistry or equivalent
2 years experience
Quality Assurance
Coordinator
BS Chemistry or equivalent
3 years experience
Inorganic Analyst
BS Chemistry or
equivalent
> 2 years experience
> 6 months in specific
instrument
measurements
GC/MS Operator
BS Chemistry or equivalent
2 years experience
Completion of 40 hours of
equipment training
1 year operational
experience
Organic Analyst
BS Chemistry or
equivalent
2 years experience
6 months in specific
instrument
measurements
General Inorganic Analyst
High School Diploma
6 months OJT
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against primary grade standards. The laboratory's SOP should also specify the
corrective procedures that the laboratory will take when an analytical system is
determined to be out of control.
1.4.4 Sample Handling Procedures
Samples taken to satisfy regulatory requirements must comply with "chain-of-
custody" procedures. At a minimum, the laboratory should address sample custody
procedures in the QA/QC SOP including identification of a sample custodian,
development of a sample custody sheet and specification of sample custody
procedures.
A responsible person should be identified to act as sample custodian at the
laboratory facility. The sample custodian should be authorized to sign for
incoming field samples, obtain documents of shipment (e.g., the bill of lading
number or mail receipt), and verify that data is entered onto the sample custody
records. The laboratory should prepare a laboratory sample custody log consisting
of serially numbered standard lab-tracking report sheets and should specify
laboratory sample custody procedures for sample handling, storage and
disbursement for analysis.
1.4.5 Laboratory Quality Control
The quality control procedures the laboratory uses should be described in its SOPs.
The purpose of laboratory QC is to indicate the quality of the data as it is being
produced. Indications of the data quality are often looked at in terms of accuracy,
precision, and detection limit of the analyses.
Accuracy may be thought of as a measurement indicating the closeness of an
individual measurement, or an average of a number of measurements to the true
value. Accuracy is generally represented as percent recovery. Precision is defined
as a measure of reproducibility among individual measurements of the same
property under similar conditions. Instrument and overall method precision are
often represented as coefficient of variation, standard deviation, and relative
standard deviation. Precise and accurate results are obtained by instituting a QC
program which demands that the degree of variability of all operating parameters
be kept within specified limits.
Table 2 contains analytical QC requirements and their frequency of application
that are typical of a laboratory QC program. The QC provisions contained in
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TABLE 2
QUALITY CONTROL REQUIREMENTS AND FREQUENCY OF APPLICATION
QC Parameter
Freqency
Comments
Matrix spikes
1 per analytical batch per matrix or
every 20 samples, whichever is more
frequent
Replicates &
laboratory dupli-
cates
1 per analytical batch per matrix or
every 20 samples, whichever is more
frequent
Replicate samples are separate atiquots
taken from the same sample container in
the laboratory and analyzed independently.
Analysis of two replicates indicates the
existence of gross errors. In cases where
aliquoting is impossible (i.e., volatiles)
duplicate samples must be taken for
replicate analysis
Blanks
(field, trip, equip-
ment)
1 per analytical batch per matrix or
every 20 samples, whichever is more
frequent
Field duplicates
1 per analytical batch per matrix or
every 20 samples, whichever is more
frequent
Field duplicate samples are two
separate samples taken from the
same sampling point in the field
(i.e., in separate containers and
analyzed independently)
Check sample
1 per analtyical batch or every 20
samples, whichever is more frequent
Surrogates
Add to every blank, standard, sample,
and QC sample
Only for volatile and semi-volatile
organics and pesticides
Column check
sample
1 per batch of adsorbent
Applies to absorbent
chromatography and back
extractions of organic compounds
Column check
sample blank
1 per batch of adsorbent
Applies to adsorbent
chromatography and back
extractions of organic compounds
Standard curves
Refer to specific method for necessary
periodic calibration
Applies to AA, ICP and GC
Methods
GC/MS instrument
performance
criteria
Initial 5 point calibration is to be verified with
a single point calibration once every 12 hours
of instrument operation and if the sensitivity
and linearity critera are not met, a new 5 point
initial calibration must be generated
Performed to meet tuning criteria of the
instrument as specified in the GC/MS
methods. Organic analytes shall be
checked with 4-bromofluorobenzene (BFB
for determination of volatiles and with
decafluorotriphenylphophine (BFTPP) for
determination semivolaules
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Table 2 will help to ensure that generated data is of known accuracy and precision.
If accuracy and precision fall outside of specified limits, corrective procedures
should be taken.
1.4.6 Data Handling, Reporting, and Recordkeeping
Data handling, reporting, and recordkeeping procedures should be included in a
laboratory's SOR Data handling and reporting includes all procedures used to
record data on standard forms and in laboratory notebooks. The reporting format
for different types of bench data should be described and forms provided.
Notebooks should be bound with numbered pages and contents should be
specified.
Laboratory recordkeeping makes possible the reexamination of a set of data at a
future time if various aspects of the analysis are called into question. Data
validation procedures, defined ideally as a set of computerized and manual checks
applied at various appropriate levels of the measurement process, should be in
written form and clearly defined for all measurement systems. Criteria for data
validation must be documented and include limits on:
operation parameters such as GC conditions;
calibration data;
special checks unique to each measurement, e.g., successive
values/averages;
statistical tests, e.g., outliers; and
manual checks such as hand calculations.
Data validation activities (GC operating conditions, analytical precision, etc.)
should be recorded on standard forms in a logbook.
1.5 The RCRA Laboratory Audit Inspection Process
Developing enforcement cases relating to the RCRA Laboratory Audit Inspection
requires the participation of a variety of persons, including the laboratory inspector
(analytical chemist or equivalent); the enforcement official and enforcement
counsel. Table 3 illustrates the generic process Regions and States should follow
in conducting a laboratory audit inspection. It is important to note that Table 3
does not represent a prescribed set of activities states and regions must follow. The
states and regions may, in fact, use variants of the generic process in Table 3.
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TABLE 3
THE RCRA LABORATORY AUDIT INSPECTION
STEP
WHO
WHAT
1
Office
Preparation
for the
Laboratory
Inspection
Enforcement
Official
Laboratory
Inspector
Review sampling
and analysis plan
Review enforcement
and permitting
actions
Prepare laboratory
specific Inspection
Instructions
2
Laboratory
Inspection
Laboratory Inspector
(Analytical Chemist)
3
Post-inspection
Debriefing
Enforcement
Official
Laboratory Inspector
Fill out generic
checklist
Carry out special
Instructions
Review analytical
technique In detail
(optional)
Review Inspection
report and
Inspector's
observations
Make decision:
no action; or
- Initiate CDI; or
go to step 4
4
Enforcement
Action
Enforcement Official
Enforcement Counsel
Issue complaint for
violations
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In Step 1, the laboratory inspector and the enforcement official will meet. The
purpose of their meeting is to plan out the laboratory portion of the laboratory audit
inspection. They will review the owner/operator's sampling and analysis plan,
review enforcement and permitting actions taken to date at the facility and prepare
a list of laboratory-specific observations the inspector should make. After
completion of Step 1, the inspector will be prepared to inspect the owner/operator's
laboratory.
In Step 2, the inspector will visit the laboratory. The laboratory inspector will
complete the laboratory audit inspection checklist and carry out any special
instructions generated during Step 1.
In Step 3, the laboratory inspector and the enforcement official will meet again.
They will review the laboratory audit inspection checklist and discuss the
inspector's observations. The enforcement official will make a decision to pursue
one of the following actions:
issue a complaint; or
initiate a Case Development Inspection; or
take no further action.
If enforcement action is warranted, the enforcement official will meet with
counsel. They will prepare and issue a complaint to the owner/operator for
violations detected during the laboratory audit inspection.
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SECTION TWO
OFFICE PREPARATION FOR THE LABORATORY INSPECTION
The laboratory inspector and the enforcement official will work together in
preparation for the laboratory inspection. There are four tasks the laboratory
inspector and the enforcement official must complete prior to the inspection. They
are:
1. review and summarize the enforcement and permitting actions taken to
date regarding the owner/operator's laboratory program;
2. review and summarize the owner/operator's sampling and analysis plan
(or permit conditions);
3. review the owner/operator's laboratory QA/QC procedures; and
4. prepare laboratory-specific inspection objectives.
The laboratory inspector and the enforcement official will use Part One of the
RCRA Laboratory Audit Inspection Form (RCRA Ground-Water Monitoring
Systems) to guide them through the tasks listed above. The form has been
constructed so that when the laboratory inspector and enforcement official
complete it, they will know:
the laboratory procedures and techniques the owner/operator
uses to ensure the generation of reliable monitoring data;
and
the existence and nature of any prior or on-going permitting
or enforcement action which may affect the laboratory
inspection.
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SECTION THREE
THE LABORATORY INSPECTION
The laboratory inspector will complete a number of tasks during the inspection.
The tasks are:
1. review the qualifications of the laboratory's personnel and the
organizational structure of the laboratory;
2. review the laboratory's procedures for maintaining supplies
and equipment;
3. review calibration procedures at the laboratory;
4. review sample handling procedures at the laboratory;
5. review the laboratory's quality control program;
6. review the laboratory's procedures for data handling,
reporting and recordkeeping; and
7. review analytical procedures used, and evaluate their
appropriateness (optional task).
The laboratory inspector will use Part Two of the RCRA Laboratory Audit
Inspection Form (RCRA Ground-Water Monitoring Systems) to guide him/her
through the tasks listed above. The form has been constructed so that when the
laboratory inspector completes it, the inspector will have:
assessed whether the laboratory departed from written
sampling and analysis procedures in the owner/operator's
sampling and analysis plan (interim status) or in the owner/
operator's RCRA permit (permit status); and
identified deficiencies in the owner/operator's laboratory
analysis program.
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SECTION FOUR
COMPLIANCE DECISION MAKING
The laboratory inspector and the enforcement official will meet after the inspection
and review parts one and two of the RCRA Laboratory Audit Inspection Form
(RCRA Ground-Water Monitoring Systems). With the inspector's help, the
enforcement official will use Part Three of the form to identify violations in the
owner/operator's laboratory program. After completing this task, the enforcement
official will choose one of the following options.
1. By virtue of the evidence collected by the laboratory inspector, there
are sufficient grounds to take enforcement action: work with
enforcement counsel to develop and initiate an enforcement action.
Or
2. By virtue of the evidence collected by the laboratory inspector, there
may be sufficient grounds to pursue an enforcement action, however,
additional or more detailed information is required: initiate a Case
Development Inspection. Or
3. The laboratory inspection has not uncovered significant compliance
problems at the laboratory: do not pursue additional enforcement
action.
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PART TWO
Laboratory Inspection
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After working through PART ONE, the enforcement official and the laboratory
inspector should know:
the laboratory procedures and techniques the owner/operator uses to
ensure the generation of reliable analytical data; and
the existence and nature of any prior or on-going permitting or
enforcement action which may affect the laboratory inspection.
PART TWO
The inspector will complete a number of tasks during the laboratory inspection. The
tasks are:
1) review the qualifications of the laboratory's personnel and the
organizational structure of the laboratory;
2) review the laboratory's procedures for maintaining supplies and
equipment;
3) review calibration procedures at the laboratory;
4) review sampling handling procedures at the laboratory;
5) review the laboratory's quality control program;
6) review the laboratory's procedures for data handling, reporting, and
record-keeping; and
7) review analytical procedures used and evaluate their appropriateness
(optional task).
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1. Review the qualifications of the laboratory's personnel
and the organizational structure of the laboratory
Has an individual been appointed as Quality Assurance Manager who:
1) ensures adherence to QA requirements for sampling?
2) ensures that all test and measuring equipment are properly calibrated?
3) monitors logging in of samples?
4) approves project plans, specific analyses, and final reports?
5) maintains a copy of the master schedule sheet?
6) maintains separate copies of all methods performed by the laboratory?
7) maintains written and signed records of periodic inspections?
8) maintains all Quality Assurance records in one location?
Are qualified individuals employed to perform the required analyses?
Are qualified individuals authorized to approve data and results?
Y/N/NA
NOTES
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2. Review the procedures for maintaining laboratory's supplies and
equipment
Does the laboratory have sufficient facilities and adequate laboratory instruments to
perform required analyses?
Is the solvent storage area properly vented and appropriate for the retention of
possible laboratory contamination?
Are analytical and sample storage areas isolated from all atmospheric sources of
solvent?
Are chemicals dated upon receipt and used in a first-in, first-out basis?
Are reagent grade or high purity chemicals used to prepare standards?
Are chemicals being used in analyses tested to ensure that they contain no
contaminants which may interfere with the analyses?
Are all reagents and solutions labeled to indicate identity, concentration, storage
requirements, preparer's name, preparation date, and expiration date?
Does the laboratory have a source of distilled/demineralized water?
Is the conductivity of distilled/demineralized water routinely checked and recorded?
Is reagent grade water used for organic methods?
Is distilled water used for inorganic methods?
Are any reagents or solutions being used that have passed the expiration date on the
label?
To avoid contamination, are samples and/or standards containing the analyte(s) of
interest stored or used in areas other than where trace analysis is performed:
Are standards stored separately from sample extracts?
Are the chemical handling areas either a stainless steel bench or an impervious
material covered with absorbent materials?
Are contamination free areas provided for trace level or organic analytical work?
Are exhaust hoods provided to allow contamination-free work with volatile materials
(i.e., venting for preparation, extraction, and analysis)?
Y/N/NA
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2. Review the laboratory's procedures for maintaining laboratory
supplies and equipment (cont.)
Are adequate routinely needed in-house replacement parts available? (note: this is to
ensure that the analytical equipment is not inoperable during a critical period)
Is there a service record logbook maintained for each analytical instrument?
Are instruments properly vented and/or appropriate traps in place as required?
Are chemical waste disposal policies/procedures well-defined and followed by the
laboratory?
Y/N/NA
NOTES
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3. Review calibration procedures at the laboratory
Are initial and daily instrument calibration procedures specified in QA/QC program?
Are these procedures used in daily laboratory analysis as specified in the QA/QC
program?
Are standard curves and check samples used covering the analytical range of interest
for calibrating analytical instruments to ensure that calibration accurately encompass
the range of environmental samples?
Is there a calibration log maintained of all instrument and equipment checks (i.e.,
date, analyst, calibration adjustment, etc., if any)?
Are lab personnel assigned to perform the calibration procedures?
If accuracy and precision of matrix spikes and/or surrogates fall outside of specific
limits, is the analytical system deemed "out of control?"
Does the laboratory stop analysis when an analytical system is deemed "out of
control" and implement corrective procedures?
Are corrective procedures clearly defined and documented?
Is an individual assigned the responsibility of initiating corrective procedures if the
individual deems it necessary?
Does the laboratory require prompt notification of errors in reporting data or "loss"
of a sample and a prompt request for resampling from the same point?
Is the glassware used Class A type or calibrated to ensure that the amount marked
on the glassware coincides with the amount delivered?
Is the glassware periodically checked to ensure calibration is correct?
Is the glassware cleaned correctly after each use to ensure that there will be no
contamination with the next use?
Is the analytical balance located away from drafts and areas subject to rapid
temperature change?
Has the balance been calibrated and checked within one year by a certified
1 technician?
Y/N/NA
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NOTES
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4. Review sampling handling procedures at the laboratory
Is an individual appointed to log in incoming samples?
Does this individual know the sampling requirements (i.e. type of container,
preservation, storage container, etc.) for each analysis or have that material
available?
If no individual(s) is appointed, are the individuals logging in samples aware of the
sampling requirements for each analysis?
Does this individual know the storage process for storage of incoming samples?
Is a sample label affixed to each container?
Do sample labels contain complete information in order to identify the sample and
ensure that it has been sampled in the correct manner (i.e. facility name, station
number, date sampled, time sampled, type of analysis requested, preservation used,
signature of sampler, etc.)? (See Figure A-l.)
Are samples collected in the type of container specified for each analysis?
Are samples preserved as required and/or cooled to 4°C?
Do samples which are shipped to the laboratory arrive at the correct temperature to
ensure that the sample has remained in a preserved state?
Are volatile samples received with no air bubbles?
Are transport blanks, field blanks, and field duplications used as required?
If so, are they identified as such?
If used, are spiked samples identified?
Is a chain of custody filled out and kept on file?
Does the information on the sample tag and chain of custody match?
Are laboratory numbers assigned to all incoming samples (including QC samples)?
Does the laboratory maintain a master schedule sheet or logbook of all samples being
analyzed, indexed by laboratory number, client, date of arrival, and analysis to be
performed?
Y/N/NA
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FIGURE A-l
SAMPLE LABEL (EXAMPLE)
FIELD SECTION
Name of Facility:
Address:
Telephone:
Collector's Name:
Collector's Telephone:
Date Sampled: Time Sampled:
Sample No.:
LABORATORY SECTION
Received by:
Date Received:
Analysis Required:
Preservation Used:
Storage Area:
Special Handling Required:
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4. Review sampling handling procedures at the laboratory (cont.)
Is the laboratory number written on the sample label, the master schedule sheet, and
any documents related to that sample?
Are completed sample analysis request sheets available for each sample?
Does each sample have a separate analysis request sheet for each analysis or group
of analyses (i.e. organic, inorganic, etc.) to be performed? (Note: this is to ensure
that each analyst who must perform an analysis on that sample will have a request
sheet)
After all analyses have been completed, are all request sheets attached together
with all appropriate summary sheets for each analyses?
Are all samples analyzed within correct amount of time?
Are samples maintained at correct temperature until time of analysis?
Are adequate facilities provided for storage of incoming samples, including
cold storage?
Are volatile samples stored separately from non or semi-volatile samples?
Is the temperature of the cold storage recorded daily in a logbook?
Are temperature excursions noted and are appropriate actions taken when required?
If reused, are sample containers cleaned properly?
Are the possession and handling of samples traceable from the time and date of
collection to time and date of analysis and reporting?
Demonstrate by tracing three samples available in the laboratory. Summarize by
completing Figure A-2 (next page).
Y/N/NA
NOTES
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FIGURE A-2
Sample Tracing Form
Are the possession and handling of samples traceable from the time and date of
collection to time and date of reporting?
Demonstrate by tracing three samples available in the laboratory: (Optional)
Sample I.D. Information
Sample Number
Facility Name
Facility Address
Sample Location
Date Sampled
Time Sampled
Recipient at Lab
Date Received
Laboratory Number
Analyses Requested
Storage Procedure(s)
Date of Analysis
Analyst(s) I.D.
Method(s) Used
Date Results Reported
NQTES^
Sample A
Sample B
Sample C
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5. Review the laboratory's quality control program
Is one matrix spike used for every analytical batch or every twenty samples,
whichever is most frequent?
Are accuracy results of matrix spikes and surrogates measured for each method to
indicate the closeness of an individual measurement?
Are precision results of sample replicates measured for each method to indicate
reproducibility among individual measurements of the same property under similar
conditions?
Are the precision and accuracy results used to determine the control limits in which
all operating parameters will be held?
Are matrix spikes and surrogates analyzed to establish that the analytical
measurement system is functioning properly with the desired sensitivity?
Are these precision and accuracy results organized in the form of quality control
charts?
Are quality control charts or tabulation of mean and standard deviation or equivilent
used to document validity of data on an as-run basis?
Are matrix spikes and surrogates analyzed compared to control charts on an as-run
basis to determine if the analysis is "in control?"
Are check samples used, one per analytical batch or every 20 samples, whichever is
more frequent?
Is one blank used per analytical batch or every 20 samples, whichever is more
frequent, to ensure that there are no contaminants which may interfere with the
analysis?
Is one field duplicate used per analytical batch or every 20 samples, whichever is
more frequent?
Are true duplicates prepared and analyzed per analytical batch or every 20 samples,
whichever is more frequent (not reinjection or reanalysis of same set of standards/
samples)?
Y/N/NA
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5. Review the laboratory's quality control program (cont.)
Quality Control for Organic Analysis
Is the analytical system calibrated each day according to the requirements of the
method?
Y/N/NA
Are these calibration standards analyzed, compared to control charts on an as-run
basis to determine if the run is "in control?"
Is a surrogate spike added to every blank, standard, sample, and QA sample?
Are column checks samples and column check sample blanks used for each batch of
absorbent?
Are field blanks, transport blanks, and laboratory blanks used as needed, to ensure
the water contains no contaminants which may interfere with analysis?
-__ M _ .^_ «_ ^ I - "^ -^ I ^ -^ _ ^ -^_ ^_ ..«. .
Are laboratory method blanks extracted and analyzed with the same procedures used
to extract and analyze samples?
Are "true" duplicates prepared and analyzed for five percent of ail samples (not
reinjection of same set of samples)?
Quality Control for Inorganic Analysis
Is the precision of the system demonstrated by the analysis of replicate laboratory
control standards each time the analytical system undergoes a major modification or
prolonged period of inactivity?
Are a minimum of three calibration standards covering the concentration range of the
samples analyzed in order to prepare a standard calibration curve?
Of these standards analyzed, is at least one at or below the MCL?
For each day on which analyses are performed, is the standard calibration curve
verified by use of at least a laboratory method blank and one standard curve?
Is the daily check within plus or minus ten percent of the original curve?
Are laboratory method blanks used as required?
«^ I «^~ - I ^ ^ ^^ " ^^ ^ ^ ^ « <^_ ^ i^M -M~ -
Is the standard calibration curve verified by running an additional standard within
the range of the standard curve every 20 samples?
-^ ^ ^ ^ ^ .^^ ^ *« ^« ^ «^ . «^ «.. ^ -^ .^_ <^_ _ «« «. _» ^_ ^_ ^^ .
Is this check within ten percent of the original curve?
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6. Review procedures for data handling, reporting and recordkeeping
Are computerized and/or manual checks applied at various appropriate levels of the
measurement process to ensure data validation?
Is the criteria for data validation documented and are limits on operational parameters,
calibration data, special checks, statistical tests, and manual checks included?
Does the laboratory have procedures for data handling and reporting, including the
recording of data on standard forms and in laboratory notebooks?
If so, is the reporting format for different types of bench data described and the
forms provided?
Are sample calculations avaOable for inspection?
Are bound notebooks used for all laboratory activities?
Is raw data being archived and documented properly?
Are records readily available for review?
Are records maintained for a minimum of three years?
Y/N/NA
NOTES
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7. Review analytical procedures and evaluate their appropriateness
(optional task)
In certain cases, the inspector may wish to evaluate specific analytical procedures used
in the laboratory as part of the inspection effort. *The purpose of this evaluation is to
judge how faithful the laboratory's personnel are to analytical procedures as described
in such references as Test Methods for Evaluating Solid Wastes (SW-846, November
1986). Due fo the complexity and number of analytical procedures used to analyze
ground-water samples, the inspector will need to construct checklists specific to
procedures of interest. A procedure-specific checklist should allow the inspector to follow
procedures on a step-by-step basis in the laboratory and detect departures from
acceptable methodology. Areas of interest which could be factored into a checklist are as
follows:
volume of sample processed (e.g.: digested, distilled, extracted, etc.);
thoroughness of extraction (e.g.: digested to near dryness, use of and volume of correct
acids, oxidizers, other modifiers, etc.);
thoroughness of extraction (e.g.: number of times extracted, vigorousness of each
extraction, use of and volume of correct solvent, etc.);
frequency of sample preservation checks (e.g.: spot-checking sample pH and
temperature conditions upon receipt at laboratory.);
storage of samples in custody of laboratory awaiting analysis (e.g.: refrigeration at
4°C);
holding times of samples prior to analysis (e.g.: comparison of laboratory records of
date and time analyzed vs. date and time sampled with acceptable holding times.);
adequacy of standards preparation procedures (e.g.: actual preparation of stock,
intermediate and working standards, dilution techniques, shelf life, etc.);
instrumentation set-up techniques (e.g.: signal optimization, tuning, peaking, etc.);
sample introduction techniques (e.g.: 'solvent-flush injection vs. a direct or straight
injection, micro-pipettes usage, single vs. multiple injections, etc.); and
quantification techniques (e.g.: peak area of sample vs. area of standard, peak height of
sample vs. height of standard, linearity over concentration, etc.).
* It is important to note that most LAIs will probably not include an intensive review of analytical procedures. Reviews of
this type should always be conducted by an experienced analytical chemist
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NOTES
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PART THREE
Compliance Decision Making
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PART THREE
The laboratory inspector and the enforcement official will meet after the laboratory
inspection and review Parts One and Two of the inspection form. The enforcement
official and the laboratory inspector will identify evidence of violations in the owner/
operator's analytical program. After completion of this exercise, the enforcement
official will take one of the following actions:
Take enforcement action in conjunction with enforcement counsel for
violations uncovered by the laboratory inspector; OR
Initiate a Case Development Inspection to gather additional information;
OR
Take no follow-up action (no evidence of significant material violations).
It is important to note that many owner/operators choose to contract with commercial
laboratories to perform ground-water analyses on their behalf. Questionable
performance on the part of the commercial laboratory will be viewed by EPA as
questionable performance on the part of the owner/operator. EPA will initiate
enforcement actions against the owner/operator in cases where the commercial
laboratory is generating questionable quality data or engaging in questionable
laboratory practices.
It is also important to note that an individual laboratory may, in fact, conduct ground-
water analysis for a number of owner/operators. The enforcement official should
consider initiating as many enforcement cases as necessary when a laboratory is
found deficient. In other words, the enforcement official should attempt to identify all
owner/operators who use the services of the laboratory and, if warranted take
concurrent enforcement actions against them. The enforcement official should,
however, be aware that commercial laboratories may handle samples from other
owner/operators according to separate and different operating procedures as dictated
in an owner/operator's contract with that laboratory. The Operation and Maintenance
Inspection GuideRCRA Ground-Water Monitoring Systems (March 1988) provided
for the collection of laboratory information from owner/operators in the course of
O&M inspections (see page B-15). The enforcement official may use this information
to help make decisions on initiating concurrent enforcement actions in the wake of a
laboratory audit inspection.
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1. Use Table 4 to summarize technical inadequacies uncovered by the laboratory
inspector.
2. Choose one of the following options:
D By virtue of evidence collected by the laboratory inspector, there are
sufficient grounds to take enforcement action. Work with enforcement
counsel to develop and initiate an enforcement action. OR
G By virtue of evidence collected by the laboratory inspector, there may
be sufficient grounds to pursue an enforcement action, however,
additional or more detailed information is required. Initiate a Case
Development Inspection. OR
n The laboratory inspection has not uncovered significant compliance
problems at the laboratory. Do not pursue additional enforcement action.
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APPENDIX A
TABLE 4
SUMMARY OF TECHNICAL INADEQUACIES
This table illustrates examples of technical inadequacies which may constitute
regulatory noncompliance on the part of the owner/operator. The enforcement official
should apply this table on a case-specific basis in determining if an enforcement action
is warranted. Table 1 lists the regulations which provide enforcement officials with the
authority to conduct the LAI. Regulatory objectives inherent in these regulations are
listed below along with examples of technical inadequacies which may prevent an
owner/operator from satisfying the regulatory objectives.
Note: The owner I operator may choose to use a commercial laboratory. The ownertoperator is
responsible for the conduct of that laboratory. This checklist was constructed with that concept in
mind. Thus, the terms "owner!operator" and "laboratory" are used interchangeably in this checklist.
OIO refers to owner!operator.
Regulatory
Objectives
Examples of Technical Inadequacies
Which May Constitute Violations
1. Owner/operator (O/O)
should follow specified
procedures in analyzing
ground-water samples.
Failure of O/O to follow written sampling and
analysis plan for analyzing ground-water
samples (interim status).
Failure of O/O to follow permit conditions
related to analysis of ground-water
samples (permit status).
2. The O/O's laboratory
should employ
qualified staff to
manage and carry
out laboratory
responsibility.
Failure of O/O to develop Quality Assurance
procedures which include:
1) ensuring adherence to Quality Assurance
requirements for sampling;
2) ensuring that all test measuring equipment
are properly calibrated;
3) monitoring logging in of samples;
4) approving project plans, specific analyses,
and final reports;
5) maintaining a copy of the master schedule
sheet;
6) maintaining separate copies of all methods
performed by the laboratory;
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Regulatory
Objectives
Examples of Technical Inadequacies
That May Constitute Violations
The O/O's laboratory
should employ
qualified staff to
manage and carry
out laboratory
responsibility.
(Continued.)
7) maintaining written and signed records of periodic
inspections; and
8) maintains all Quality Assurance records in one
location.
Failure of O/O to authorize qualified individuals to
approve data and results.
Failure of O/O to prepare a current summary of
training, experience and job description for each
member of the laboratory staff.
3. The O/O*s laboratory
should have suitable
equipment for
conducting analyses.
The O/O's laboratory
should have suitable
procedures in place to
ensure the quality of
materials used in
laboratory analyses.
Failure of O/O to supply sufficient facilities and
adequate laboratory instruments to perform
required analyses.
Failure of O/O to properly vent solvent storage area
as appropriate for the retention of possible
laboratory contamination.
Failure of 0/0 to have analytical and sample storage
areas isolated from all atmospheric sources of
solvent.
Failure of O/O to date chemicals upon receipt and
use on a first-in, first-out basis.
Failure of O/O to use reagent grade or high purity
chemicals to prepare standards.
Failure of O/O to test chemicals being used in
analyses to ensure that they contain no
contaminants which may interfere with analyses.
Failure of O/O to label all reagents and solutions to
indicate identity, concentration, storage
requirements, preparer's name, preparation date,
and expiration date.
Failure of O/O to have a source of distilled/
demineralized water.
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Regulatory
Objectives
Examples of Technical Inadequacies
That May Constitute Violations
3. The O/O's laboratory
should have suitable
equipment for
conducting analyses.
The O/O's laboratory
should have suitable
procedures in place to
ensure the quality of
materials used in
laboratory analyses.
(Continued.)
Failure of O/O to routinely check and record the
conductivity of distilled/demineralized water.
Failure of O/O to use reagent grade water for organic
methods.
Failure of O/O to use distilled water for inorganic
methods.
Failure of O/O to discontinue using any reagents and/
or solutions that have passed the expiration date on
the label.
Failure of O/O to use a service contract or internal
protocol for maintaining instruments.
Failure of O/O to use internal protocol to
manufacturer's specifications.
Failure of O/O to have available extensive in-house
replacement parts.
Failure of O/O to maintain a service record logbook
for each analytical instrument.
Failure of O/O to properly vent and/or have traps in
place for instruments.
Failure of O/O to define and follow chemical waste
disposal policies/procedures.
Failure of O/O to dispose of chemical waste in the
proper area.
The O/O's laboratory
should use suitable
calibration and
analytical
procedures.
Failure of O/O to store or use samples and/or
standards containing the analyte(s) of interest in
areas other than where trace analysis is performed.
Failure of O/O to store standards separately from
sample extracts.
OSWER 9950.4
OWPE
A-37
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Regulatory
Objectives
Examples of Technical inadequacies
Thai May Constitute Violations
4. The 0/O's laboratory
should use suitable
calibration and
analytical
procedures.
(Continued.)
Failure of O/O to have in chemical handling areas
either a stainless steel bench or an impervious
material covered with absorbent materials.
Failure of O/O to provide contamination-free areas
for trace level or organic analytical work.
Failure of O/O to provide exhaust hoods to allow
contamination-free work with volatile materials.
Failure of O/O to periodically check and record the
air flow of the hoods.
Failure of O/O to make available manufacturer's
operating manuals to the operator.
1 Failure of the O/O to implement required or
appropriate analytical methodology such that data
is so inaccurate or imprecise as to preclude its use.
1 Failure of O/O to make available to the analyst all
methods in approved written format.
Failure of O/O to make available to the analyst
calibration procedures, analytical procedures,
computational procedures, quality control
procedures, and operating procedures.
Failure of O/O to make available reference material
for each analysis to help analysts investigate
problems.
Failure of analyst to have schedule for all analyses
they perform.
Failure of analyst to have an analysis request sheet
(if no schedule is available) for each sample they
must perform an analysis on.
Failure of O/O to specify initial and daily instrument
calibration procedures in QA/QC program.
OSWER 9950.4
OWPE
A-J8
-------
Regulatory
Objectives
Examples of Technical Inadequacies
That May Constitute Violations
4. The O/O's laboratory
should use suitable
calibration and
analytical
procedures.
(Continued.)
Failure of O/O to use above specified procedures in
daily laboratory analysis.
Failure of O/O to use standard curves and check
samples covering the analytical range of interest
for calibrating analytical instruments to ensure that
calibration accurately encompass the range of
environmental samples.
Failure of O/O to maintain a log of all instruments
and equipment checks.
Failure of O/O to assign lab personnel to perform the
calibration procedures.
Failure of O/O to deem an analytical system "out of
control" when accuracy and precision of matrix
spikes and/or surrogates fall outside specific limits.
Failure of O/O to stop an analysis and implement
corrective procedures when an analytical system is
deemed "out of control."
Failure of O/O to clearly define corrective
procedures.
Failure of O/O to assign individuals to the
responsibility of initiating corrective procedures if
the individual deems necessary.
Failure of O/O to document "out of control" situations
and corrective procedures used in getting a system
back in control.
Failure of O/O to notify about errors in reporting data
or loss" of a sample and failure to request
resampling from same point.
Failure of O/O to use Class A type glassware or
calibrate to ensure that the amount marked on the
glassware coincides with the amount delivered.
OSWER 9950.4
OWPE
A-39
-------
Regulatory
Objectives
Examples of Technical Inadequacies
That May Constitute Violations
4. The O/O's laboratory
should use suitable
calibration and
analytical
procedures.
(Continued.)
Failure of O/O to check glassware to ensure
calibration is correct.
Failure of O/O to correctly clean glassware after each
use to ensure that there will be no contamination
with the next use.
Failure of O/O to locate analytical balance away from
drafts and areas subject to rapid temperature
change.
Failure of O/O to calibrate and check analytical
balance at least once per year by a certified
technician.
The O/O and the
O/O's laboratory
should use proper
sample handling
procedures.
OSWER 9950.4
Failure of O/O to appoint an individual to log in
incoming samples.
Failure of O/O to make individuals logging in samples
aware of sampling requirements for each analysis.
Failure of O/O to make individuals aware of the
storage process for storage of incoming samples.
Failure of O/O to affix sample labels to each
container.
Failure of O/O to have complete information on
sample labels in order to identify the sample and
ensure that it has been sampled in the correct
manner.
Failure of O/O to collect samples in the correct type
of container specified for each analysis.
Failure of 0/0 to preserve sample for preservation
when required.
OWPE
A-40
-------
Regulatory
Objectives
Examples of Technical Inadequacies
That May Constitute Violations
The O/O and the
O/O's laboratory
should use proper
sample handling
procedures.
(Continued.)
Failure of O/O to ensure that samples shipped to
the laboratory arrive at the correct temperature so
as to remain in the preserved state.
Failure of O/O to ship volatile samples with no air
bubbles.
Failure of O/O to use transport blanks, field blanks,
and field duplications as required.
Failure of O/O to identify all blanks and spiked
samples to ensure no mix-up occurs.
Failure of O/O to fill out chain-of-custody and keep
it on file.
Failure of O/O to ensure information on chain-of-
custody and sample tag match.
Failure of O/O to assign laboratory numbers to all
incoming samples.
Failure of O/O to maintain a master schedule sheet
or logbook of all samples being analyzed, indexed
by laboratory numbers, client, date of arrival, and
analysis to be performed.
Failure of O/O to write the laboratory number of a
sample on the sample label, the master schedule
sheet, and any documents related to that sample.
Failure of O/O to provide complete sample analysis
request sheet for each sample.
Failure of O/O to provide a separate analysis
request sheet for each analysis or group of
analyses.
Failure of Q/O to attach all request sheets together
with all appropriate summary sheets for each
analysis.
OSWER 9950.4
OWPE
A-41
-------
Regulatory
Objectives
Examples of Technical Inadequacies
That May Constitute Violations
The O/O and the
O/O's laboratory
should use proper
sample handling
procedures.
(Continued.)
Failure of O/O to analyze samples within a correct
amount of time.
Failure of O/O to maintain samples at correct
temperature until time of analysis.
Failure of O/O to provide adequate facilities for
storage of incoming samples.
Failure of O/O to store volatile samples separately
from non or semi-volatile samples.
Failure of O/O to record temperature of cold storage
daily in a logbook.
Failure of O/O to note temperature excursions and
take appropriate action when required.
Failure of O/O to properly clean sample containers
for reuse.
The O/O's laboratory
should have in-
place a suitable
quality control
program.
Failure of owner operator to measure accuracy
results of matrix spikes and surrogates for each
method.
Failure of O/O to measure precision results of each
matrix spikes and surrogates for each method.
Failure of O/O to use precision and accurate results
to determine the specific limits in which all
operating parameters will be kept.
Failure of O/O to analyze matrix spikes and
surrogates to establish that the instrument is
functioning properly with the desired sensitivity.
Failure of O/O to organize precision and accuracy
results in the form of quality control charts.
OSWER 9950.4
OWPE
A-42
-------
Regulatory
Objectives
Examples of Technical Inadequacies
That May Constitute Violations
6. The O/O's laboratory
should have in-
place a suitable
quality control
program.
(Continued.)
Failure of O/O to use quality control charts or
equivalent to document validity of data on an as-
run basis.
OSWER 9950.4
OWPE
A-43
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APPENDIX B
RCRA Laboratory Audit Inspection Guide
(RCRA Ground-Water Monitoring Systems)
Questions and Answers
OSWER 9950.4
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Lab Audit Guidance
Questions and Answers
1. Is the RCRA Laboratory Audit Inspection the same as a CERCLA Contract
Lab Inspection?
No. The objectives of the CERCLA Contract Lab Program and the RCRA LAI are
very different. EPA has designed the CERCLA contract lab program to ensure that
commercial laboratories which provide analytical services for EPA and the states are
consistently producing reliable quality analytical data. EPA has designed the RCRA
LAI to ensure owner/operators are meeting their regulatory responsibilities to generate
reliable quality data. The evaluation one would make of a CERCLA contract
laboratory and a RCRA commercial laboratory is, however, very similar regarding to
what the inspectors) would evaluate and how they would make decisions as to the
quality of analytical data produced by the laboratory.
2. What is the relationship between a RCRA Lab Audit Inspection, the
Comprehensive (Ground-Water) Monitoring Evaluation (CME), and the
Operation and Maintenance (O&M) Inspection?
The CME, LAI and O&M inspection all have one step in common: they all involve
the review of the owner/operator's ground-water sampling and analysis program. The
CME, however, is primarily geared toward a review of the owner/operator's ground-
water monitoring system from a design standpoint. The O&M inspection focuses on
the field implementation of the owner/operator's sampling program. The LAI focuses
on the laboratory implementation of the owner/operator's sampling and analysis
program. Collectively, they represent a comprehensive and continuous review and
analysis of the design and implementation of an owner/operator's ground-water
monitoring program.
OSWER 9950.4 OWPE
B-l
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3. Does the RCRA Laboratory Audit Inspection require an analytical chemist to
conduct the laboratory inspection?
Yes. The laboratory inspection portion of the LAI requires a qualified analytical
chemist (or equivalent). This chemist must be able to review and critically analyze
how well laboratory personnel are discharging their duties in regards to the analysis of
RCRA ground-water monitoring samples. The chemist or equivalent should also
attempt to determine the effects or biasing caused by any questionable laboratory
practices identified.
4. Does EPA have a lab certification program for those laboratories conducting
RCRA analyses?
No. EPA does not certify laboratories which conduct analyses for RCRA owner/
operators. The LAI is not a certification procedure.
5. During the course of a RCRA Laboratory Audit Inspection, the enforcement
official finds that a laboratory engages in questionable analytical procedures.
May the enforcement official assume these practices affected the analysis of
the owner/operator's samples over time?
Yes. It is reasonable to assume that questionable practices detected during a LAI are
problems which have existed prior to the LAI. The enforcement official may take
enforcement actions on the basis of problems found during an LAI.
6. If an owner/operator's facility is in EPA Region A and laboratory facilities are
in EPA Region B, what should the Regions do to ensure an efficient and
coordinated inspection effort?
Region A and Region B should consider a joint inspection effort and/or Region A
should ask Region B to conduct the inspection on behalf of Region A. Since any
potential enforcement action will be pursued against the owner/operator (Region A),
Region A enforcement officials should take the lead in issuing the complaint.
OSWER 9950.4 OWPE
B-2
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7. If a RCRA LAI ultimately results in a questioning of the veracity of analytical
procedures/practices employed by the owner/operator's laboratory, should
the enforcement official reject data collected to date by the owner/operator?
Probably. In some cases, past data may be able to be reconstructed or used to some
useful purpose. In other cases, past data may be worthless. In these cases, the
enforcement official should take an enforcement action to require the owner/operator
to collect a full set of data as quickly as possible. The enforcement official may
consider monetary penalties equal to the cost the owner/operator avoided in collecting
high quality data (i.e., penalty equals cost of re-creating past data).
8. A Laboratory Audit Inspection uncovers a laboratory which engages in poor
analytical practices. The enforcement official is concerned that the
laboratory is conducting analyses for other RCRA facilities. What should the
enforcement official do?
The enforcement official should attempt to uncover the names of other firms for
which the laboratory conducts ground-water analyses. The enforcment official may
then consider pursuing enforcement actions against all owner/operators who use the
services of the laboratory. The enforcement official should, however, be aware that
commercial laboratories may handle samples from other owner/operators according to
separate and different operating procedures as dictated in an owner/operator's contract
with that laboratory.
9. Assume that an owner/operator uses a commercial laboratory to perform
RCRA analyses of ground-water samples. The Laboratory Audit Inspection
leads an enforcement official to doubt the veracity of the analytical data
produced by the laboratory. Who is in violationthe commercial laboratory
or the owner/operator who hired them?
EPA would only take enforcement action against the owner/operator. It is the
responsibility of the owner/operator to ensure that those parties who provide services
to support a regulatory requirement are, in fact, dischaging their responsibilities in an
acceptable manner. Questionable performance by a laboratory is not an acceptable
excuse for regulatory noncompliance by the owner/operator.
OSWER 9950.4 OWPE
B-3
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