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QAManualTemplate - PDF Part 3

The document discusses procedures for when a laboratory fails a proficiency test or identifies issues with split sample analysis. It requires the laboratory to conduct an investigation, outline a corrective action plan, and complete actions in a timely manner. It also provides instructions and an example for how the laboratory should report analytical results, including ensuring data is free from errors through validation and review, applying data qualifiers, and following the procedure required by the regulating agency.

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waichui403
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© © All Rights Reserved
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0% found this document useful (0 votes)
25 views

QAManualTemplate - PDF Part 3

The document discusses procedures for when a laboratory fails a proficiency test or identifies issues with split sample analysis. It requires the laboratory to conduct an investigation, outline a corrective action plan, and complete actions in a timely manner. It also provides instructions and an example for how the laboratory should report analytical results, including ensuring data is free from errors through validation and review, applying data qualifiers, and following the procedure required by the regulating agency.

Uploaded by

waichui403
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 8

Document No.

: Effective Date:

Revision No.: Page 17 of 35

If the laboratory fails a PT study, an investigation of the cause is conducted. When problems are identified, a
corrective action plan is outlined on the corrective action form and actions are completed in a timely manner.

18.3 Split Sampling (Duplicate)


The laboratory collects a duplicate sample and submits the duplicate to a subcontract laboratory for confirmation
analysis [on a quarterly, semi-annual, annual basis] to ensure the results reported are accurate. When problems are
identified, a corrective action plan is outlined on the corrective action form and actions are completed in a timely
manner.

19.0 Reporting the Results

Instructions: This section should contain a description of the laboratory's procedures for
reporting analytical results. This description should describe the procedures to ensure that data
are free from errors.

Example:

19.1 Procedures to Ensure Reported Data are Free from Errors

Data Validation:
The analyst performing the analysis verifies all data. The data review is to include the following items:

▪ Calibration of the instrumentation. (Confirm the calibration criteria are met.)


▪ Quality control data. (Confirm QC meets the acceptance criteria.)
▪ Calculations. (Check for calculation errors.)
▪ Documentation. (Check worksheets, logbooks and printouts for accuracy and completeness.)

Before final reporting is done, data are validated by the [Define the responsible staff person] to verify that all quality
control measures are reviewed and evaluated and to ensure the reported data are free from transcription and
calculation errors. [When a second person is not available for data review before report release, describe the
schedule for data review of an analyst’s work.]

19.2 Procedures for Data Qualifiers


Data qualifiers are added to all data not meeting collection, analytical, or internal QC acceptance criteria.

19.3 Procedures for Reporting Analytical Results


[Describe the procedure DEQ requires your laboratory/facility to use to report the results of analytical testing.]
Document No.: Effective Date:

Revision No.: Page 18 of 35

20.0 Glossary
[Remove any that do not apply]

"Acceptance criteria" means specified limits placed on characteristics of an item, process, or


service defined in requirement documents.

"Accuracy" means the degree of agreement between an observed value and an accepted
reference value. Accuracy includes a combination of random error (precision) and systematic
error (bias) components that are due to sampling and analytical operations. Accuracy is an
indicator of data quality.

"Aliquot" means a portion of a sample taken for analysis.

"Analyst" or "laboratory technician" means the designated individual who performs the "hands-
on" analytical methods and associated techniques and who is the one responsible for applying
required laboratory practices and other pertinent quality controls to meet the required level of
quality. (NELAC)

"Analyte" means the substance or physical property to be determined in samples examined.

"Analytical method" means a technical procedure for providing analysis of a sample, defined by
a body such as the Environmental Protection Agency or the American Society for Testing and
Materials, which may not include the sample preparation method.

"Audit" means a systematic evaluation to determine the conformance to quantitative and


qualitative specifications of some operational function or activity.

"Batch" means environmental samples that are prepared together or analyzed together or both
with the same process and personnel, using the same lot or lots of reagents. "Analytical batch"
means a batch composed of prepared environmental samples (extracts, digestates or
concentrates) that are analyzed together as a group. An analytical batch can include prepared
samples originating from various environmental matrices and can exceed 20 samples.
"Preparation batch" means a batch composed of one to 20 environmental samples of the same
matrix that meets the criteria in this definition for "batch" and with a maximum time between the
start of processing of the first and last sample in the batch to be 24 hours.

"Blank" means a sample that has not been exposed to the analyzed sample stream in order to
monitor contamination during sampling, transport, storage or analysis. The blank is subjected to
the usual analytical and measurement process to establish a zero baseline or background value
and is sometimes used to adjust or correct routine analytical results. Blanks include the following
types:

1. Field blank. A blank prepared in the field by filling a clean container with pure deionized
water and appropriate preservative, if any, for the specific sampling activity being
undertaken.

2. Method blank. A sample of a matrix similar to the batch of associated samples (when
available) that is free from the analytes of interest and is processed simultaneously with
and under the same conditions as samples through all steps of the analytical procedures,
Document No.: Effective Date:

Revision No.: Page 19 of 35

and in which no target analytes or interferences are present at concentrations that impact
the analytical results for sample analyses.

"Calibration" means to determine, by measurement or comparison with a standard, the correct


value of each scale reading on a meter, instrument or other device. The levels of the applied
calibration standard should bracket the range of planned or expected sample measurements.

"Calibration curve" means the graphical relationship between the known values, such as
concentrations, of a series of calibration standards and their instrument response.

"Calibration standard" means a substance or reference material used to calibrate an instrument.

"Certified reference material" means a reference material one or more of whose property values
are certified by a technically valid procedure, accompanied by or traceable to a certificate or other
documentation that is issued by a certifying body.

"Commercial environmental laboratory" means an environmental laboratory where environmental


analysis is performed for another person.

"Corrective action" means the action taken to eliminate the causes of an existing nonconformity,
defect or other undesirable situation in order to prevent recurrence.

“DEQ” or “ODEQ” means the Oregon Department of Environmental Quality.

"Demonstration of capability" means the procedure to establish the ability of the analyst to
generate data of acceptable accuracy and precision.

"Detection limit" means the lowest concentration or amount of the target analyte that can be
determined to be different from zero by a single measurement at a stated degree of confidence.

"Document control" means the act of ensuring that documents, and revisions to the documents,
are proposed, reviewed for accuracy, approved for release by authorized personnel, distributed
properly and controlled to ensure use of the correct version at the location where the prescribed
activity is performed. (AQSC)

"Environmental laboratory" or "laboratory" means a facility or a defined area within a facility


where environmental analysis is performed. A structure built solely to shelter field personnel and
equipment from inclement weather shall not be considered an environmental laboratory.

"Facility" means something that is built or installed to serve a particular function.

"Field testing and measurement" means any of the following:

1. Any test for parameters under 40 CFR Part 136 for which the holding time indicated
for the sample requires immediate analysis; or

2. Any test defined as a field test in federal regulation.


Document No.: Effective Date:

Revision No.: Page 20 of 35

The following is a limited list of currently recognized field tests or measures that is not intended
to be inclusive: continuous emissions monitoring; on-line monitoring; flow monitoring; tests for
pH, residual chlorine, temperature and dissolved oxygen; and field analysis for soil gas.

"Finding" means an inspection conclusion that identifies a condition having a significant effect
on an item or activity. An inspection finding is normally a deficiency and is normally
accompanied by specific examples of the observed condition.

"Holding time (or maximum allowable holding time)" means the maximum time that a sample
may be held prior to analysis and still be considered valid or not compromised.

"Internal standard" means a known amount of standard added to a test portion of a sample as a
reference for evaluating and controlling the precision and bias of the applied analytical method.
(NELAC)

"International System of Units (SI)" means the coherent system of units adopted and
recommended by the General Conference on Weights and Measures.

"Laboratory control sample" or "LCS" means a sample matrix, free from the analytes of interest,
spiked with verified known amounts of analytes or a material containing known and verified
amounts of analytes. It is generally used to establish intra-laboratory or analyst specific
precision and bias or to assess the performance of all or a portion of the measurement system.
"Laboratory control sample" or "LCS" may also be named laboratory fortified blank, spiked
blank, or QC check sample.

"Laboratory duplicate" means aliquots of a sample taken from the same container under
laboratory conditions and processed and analyzed independently. (NELAC)

"Laboratory manager" means the person who has overall responsibility for the technical
operation of the environmental laboratory and who exercises actual day-to-day supervision of
laboratory operation for the appropriate fields of testing and reporting of results. The title of this
person may include but is not limited to laboratory director, technical director, laboratory
supervisor or laboratory manager.

"Legal entity" means an entity, other than a natural person, who has sufficient existence in legal
contemplation that it can function legally, be sued or sue and make decisions through agents as
in the case of corporations.

"Limit of detection" or "LOD" means an estimate of the minimum amount of a substance that an
analytical process can reliably detect. An LOD is analyte and matrix specific and may be
laboratory dependent.

"Limit of quantitation" or "LOQ" means the minimum levels, concentrations, or quantities of a


target variable (e.g., target analyte) that can be reported with a specified degree of confidence.

"Matrix" means the component or substrate that may contain the analyte of interest.
Document No.: Effective Date:

Revision No.: Page 21 of 35

a. Drinking water. Any aqueous sample that has been designated a potable or
potential potable water source.

b. Non-potable water. Any aqueous sample that has not been designated a potable
or potential potable water source. Includes surface water, groundwater, effluents,
water treatment chemicals, and TCLP or other extracts.

c. Saline/estuarine. Any aqueous sample from an ocean or estuary, or other salt


water source.

c. Solid and chemical materials. Includes soils, sediments, sludges, products and
byproducts of an industrial process that results in a matrix not previously defined.

d. Biological tissue. Any sample of a biological origin such as fish tissue, shellfish, or
plant material. Such samples shall be grouped according to origins.

e. Air and emissions. Whole gas or vapor samples including those contained in
flexible or rigid wall containers and the extracted concentrated analytes of interest
from a gas or vapor that are collected with a sorbent tube, impinger solution, filter or
other device.

d. Nonaqueous liquid. Any organic liquid with less than 15% settleable solids.

f. Solids. Includes soils, sediments, sludges and other matrices with more than 15%
settleable solids.

g. Chemical waste. A product or by-product of an industrial process that results in a


matrix not previously defined.

h. Air and emissions. Whole gas or vapor samples including those contained in
flexible or rigid wall containers and the extracted concentrated analytes of interest
from a gas or vapor that are collected with a sorbent tube, impinger solution, filter or
other device.

"Matrix spike (spiked sample or fortified sample)" means a sample prepared by adding a known
mass of target analyte to a specified amount of matrix sample for which an independent
estimate of target analyte concentration is available. Matrix spikes are used, for example, to
determine the effect of the matrix on a method's recovery efficiency.

"Matrix spike duplicate (spiked sample or fortified sample duplicate)" means a second replicate
matrix spike prepared in the laboratory and analyzed to obtain a measure of the precision of the
recovery for each analyte.

"Method detection limit" means one way to establish a limit of detection, defined as the
minimum concentration of a substance (an analyte) that can be measured and reported with 99
percent confidence that the analyte concentration is greater than zero and is determined from
analysis of a sample in a given matrix containing the analyte. (NELAC)
Document No.: Effective Date:

Revision No.: Page 22 of 35

"National Environmental Laboratory Accreditation Conference (NELAC)" means a voluntary


organization of state and federal environmental officials and interest groups with the primary
purpose to establish mutually acceptable standards for accrediting environmental laboratories.
A subset of NELAP.

"National Environmental Laboratory Accreditation Program (NELAP)" means the overall


National Environmental Laboratory Accreditation Program of which NELAC is a part.

"National Institute of Standards and Technology" or "NIST" means an agency of the U.S.
Department of Commerce's Technology Administration that is working with EPA, states,
NELAC, and other public and commercial entities to establish a system under which private
sector companies and interested states can be certified by NIST to provide NIST-traceable
proficiency testing (PT) samples.

"Negative control" means measures taken to ensure that a test, its components, or the
environment do not cause undesired effects, or produce incorrect test results.

"Noncommercial environmental laboratory" means either of the following:

1. An environmental laboratory where environmental analysis is performed solely for the


owner of the laboratory.

2. An environmental laboratory where the only performance of environmental analysis


for another person is one of the following:

a. Environmental analysis performed by an environmental laboratory owned by a


local government for an owner of a small wastewater treatment system treating
domestic sewage at a flow rate of less than or equal to 1,000 gallons per day.

b. Environmental analysis performed by an environmental laboratory operated by a


corporation as part of a general contract issued by a local government to operate
and maintain a wastewater treatment system or a waterworks.

c. Environmental analysis performed by an environmental laboratory owned by a


corporation as part of the prequalification process or to confirm the identity or
characteristics of material supplied by a potential or existing customer or generator
as required by a hazardous waste management permit under DEQ rules.

d. Environmental analysis performed by an environmental laboratory owned by a


Publicly Owned Treatment Works (POTW) for an industrial source of wastewater
under a permit issued by the POTW to the industrial source as part of the
requirements of a pretreatment program.

e. Environmental analysis performed by an environmental laboratory owned by a


county authority for any municipality within the county's geographic jurisdiction when
the environmental analysis pertains solely to the purpose for which the authority was
created.
Document No.: Effective Date:

Revision No.: Page 23 of 35

f. Environmental analysis performed by an environmental laboratory owned by an


authority or a sanitation district for any participating local government of the authority
or sanitation district when the environmental analysis pertains solely to the purpose
for which the authority or sanitation district was created.

"Owner" means any person who owns, operates, leases or controls an environmental
laboratory.

"Preservation" means refrigeration and/or reagents added at the time of sample collection, or
later, to maintain the chemical and/or biological integrity of the sample. (NELAC)

"Person" means an individual, corporation, partnership, association, company, business, trust,


joint venture or other legal entity.

"Physical," for the purposes of fee test categories, means the tests to determine the physical
properties of a sample. Tests for solids, turbidity and color are examples of physical tests.

"Positive control" means measures taken to ensure that a test or its components are working
properly and producing correct or expected results from positive test subjects.

"Precision" means the degree to which a set of observations or measurements of the same
property, obtained under similar conditions, conform to themselves. Precision is an indicator of
data quality. Precision is expressed usually as standard deviation, variance or range, in either
absolute or relative terms.

"Primary accrediting authority" means the agency or department designated at the territory,
state or federal level as the recognized authority with the responsibility and accountability for
granting NELAC accreditation to a specific laboratory for a specific field of accreditation.

"Proficiency test or testing (PT)" means evaluating a laboratory's performance under controlled
conditions relative to a given set of criteria through analysis of unknown samples provided by an
external source.

"Proficiency test (PT) field of testing" means the approach to offer proficiency testing by maxtrix,
technology/method, and analyte/analyte group.

"Proficiency test (PT) sample" means a sample, the composition of which is unknown to both
the analyst and the laboratory provided to test whether the analyst or laboratory or both can
produce analytical results within specified acceptance criteria.

"Proficiency testing (PT) program" means the aggregate of providing rigorously controlled and
standardized environmental samples to a laboratory for analysis, reporting of results, statistical
evaluation of the results and the collective demographics and results summary of all
participating laboratories.

"Program," in the context of a regulatory program, means the relevant U.S. Environmental
Protection Agency program such as the water program under the Clean Water Act (CWA), the
air program under the Clean Air Act (CAA), the waste program under the Comprehensive
Document No.: Effective Date:

Revision No.: Page 24 of 35

Environmental Response, Compensation and Liability Act (CERCLA or Superfund) or the waste
program under the Resource Conservation and Recovery Act (RCRA).

"Publicly Owned Treatment Works (POTW)" means a treatment works as defined by § 212 of
the CWA, which is owned by a state or municipality (as defined by § 502(4) of the CWA). This
definition includes any devices and systems used in the storage, treatment, recycling, and
reclamation of municipal sewage or industrial wastes of a liquid nature. It also includes sewers,
pipes, and other conveyances only if they convey wastewater to a POTW treatment plant. The
term also means the municipality as defined in § 502(4) of the CWA, which has jurisdiction over
the indirect discharges to and the discharges from such a treatment works.

"Quality assurance" means an integrated system of activities involving planning, quality control,
quality assessment, reporting and quality improvement to ensure that a product or service
meets defined standards of quality with a stated level of confidence.

"Quality assurance officer" means the person who has responsibility for the quality system and
its implementation. Where staffing is limited, the quality assurance officer may also be the
laboratory manager.

"Quality control" means the overall system of technical activities whose purpose is to measure
and control the quality of a product or service so that it meets the needs of users.

"Quality control sample" or "QC sample" means a sample used to assess the performance of all
or a portion of the measurement system. QC samples may be certified reference materials, a
quality system matrix fortified by spiking, or actual samples fortified by spiking. (NELAC)

"Quality manual" means a document stating the management policies, objectives, principles,
organizational structure and authority, responsibilities, accountability, and implementation of an
agency, organization, or laboratory, to ensure the quality of its product and the utility of its
product to its users.

"Quality system" means a structured and documented management system describing the
policies, objectives, principles, organizational authority, responsibilities, accountability, and
implementation plan of an organization for ensuring quality in its work processes, products
(items), and services. The quality system provides the framework for planning, implementing,
and assessing work performed by the organization and for carrying out required quality
assurance and quality control.

"Range" means the difference between the minimum and maximum of a set of values.

"Reference material" means a material or substance one or more properties of which are
sufficiently well established to be used for the calibration of an apparatus, the assessment of a
measurement test method, or for assigning values to materials.

"Reference standard" means a standard, generally of the highest metrological quality available
at a given location, from which measurements made at that location are derived.

"Responsible official" means one of the following, as appropriate:

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