United States Region 10 Alaska
Environmental Protection 1200 Sixth Avenue Idaho
Agency Seattle WA 98101 Oregon
^ Washington
14 February 1991 Version
GUIDANCE ON PREPARATION OF
LABORATORY QUALITY ASSURANCE PLANS
This document is designed to provide guidance on the
preparation of laboratory quality assurance plans. A laboratory QA
plan needs to include some of the elements from both QAMS-004
Interim Guidance for the Preparation of QA Program Plans (1) and
QAMS-005 Interim Guidance for the Preparation of QA Project Plans
(2) plus some additional topics. It is expected that laboratories
that prepare a QA plan following this guidance will produce a plan
that will cover all their operations and therefore would not
produce "project specific" laboratory QA plans unless required. It
is assumed that most laboratories operate at some specified level,
i.e., parameter specific quantitation limits for a majority of
their work. The laboratory may do work on specific projects that
may require lower quantitation limits or tighter precision or
accuracy goals than the lab's normal operating basis; only in these
cases would project specific QA plans be required for those
parameters that are not covered by normal laboratory operations.
The laboratory QA plan is designed to be written to cover a single
lab operating at a single location.
This guidance document is designed to be generic in nature so
that all types of labs may follow it. This would include analytical
chemistry labs, geotechnical service labs and other lab facilities.
It is designed to include a statement of QA policy, organizational
structure, facility layout and equipment, personnel qualifications,
and QA/QC.
The minimum elements of the lab QA plan would include:
1. Title Page
2. Table of Contents
3. Quality Assurance Policy Statement
4. Corporate Ethics Policy on Waste, Fraud, and Abuse
5. Quality Assurance Management
6. Administrative Organization
7. Personnel Qualifications
8. Facility Description and Capital Equipment
9. Preventive Maintenance
10. Corrective Action
11. Laboratory Evaluation and Audits
12. Quality Assurance Reports to Management
13. Lab Documentation and Forms
14. Sub-Contracting of Services
15. Standard Operating Procedures
The content expected in each section is briefly described
below. The lab QA plan will be prepared in document control format.
This will consist of revision, date and page number on each page of
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the document.
1. Title Page
The title page will include the name and address of the lab,
and dated signature approval lines for the company's management,
lab director, QA director and other chief officers. A separate
dated signature page may be used if necessary. The lab QA plan will
be signed by the chief officers to concur with the contents of the
lab QA plan and to show their commitment to provide the resources
necessary to ensure proper quality operation of the lab facility.
A suggested title page format is shown in Figure 1.
2. Table of Contents
The table of contents will address each of the following
elements:
Introduction - optional.
A serial listing of all the elements for a laboratory QA plan.
A listing of any appendices which are required to augment the
laboratory QA plan, it is suggested that all operational
Standard Operating Procedures (SOPs) be included as appendices
and organized in some manner that is convenient for the
laboratory to distribute.
3. Quality Assurance Policy Statement
The policy statement in this section should describe the QA
goals of the laboratory and describe, in general terms, the
laboratory's commitment to ensure data are of known and documented
quality.
The policy statement reflects management's commitment to QA
throughout the data generating and processing operations. All
reported data must be accompanied by a calculation of precision and
accuracy. Where appropriate, a statement on the completeness,
representativeness and comparability is to be included.
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Laboratory Quality Assurance Plan
For
Laboratory Name
Street Address
City, State ZIP Code
Phone Number
Revision
Date
Approvals:
Name:
Title:
Signature:
Name:
Title:
Signature:
Name:
Title:
Signature:
Date:
Date:
Date :
Figure 1 - Example Title Page
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4- Corporate Ethics Policy on Waste. Fraud, and Abuse
A statement on/or the laboratory's policy on improper
manipulation, falsification of data, or deviations from contractual
requirements shall be included. The policy shall state how the
laboratory will handle such activities and any punitive measures
the lab will take towards employees engaging in such activities.
If data is generated for, or by, any department, agency, or
entity of the federal government, then the appropriate department's
Inspector General telephone numbers shall be included with
instructions to report any allegations of fraud, waste or abuse
occurring on government projects.
The laboratory shall post it's ethics policy in a prominent
place and shall include its' policy in all Standard Operating
Procedures.
5- Quality Assurance Management
The direct and ultimate responsibility for assuring data
quality rests with the line manager (e.g., CEO, lab director, etc) ,
not the quality assurance officer (QAO). In delegating QA
responsibilities/authorities, line managers usually divide their
delegations between their subordinate line managers. The QAO is
there to provide technical support and to review and approve QA
products.
This section should contain a description of the
organizational entities involved in data collection activities. An
organizational chart showing reporting lines should be provided and
those specific groups responsible for data collection or for QA/QC
activities should be identified and their inter-relationship
defined. The responsibility/authority for carrying out the QA of
each group should be described in a way which clarifies the nature
of and division of these delegations.
While it is typical for the laboratory analyst to provide the
first level of data review in the laboratory, there should be an
independent reporting channel for quality assurance/control of
data. Thus if a problem arises, corrective action may be taken
through normal administrative reporting channels. If the problem is
not addressed, then an alternative channel for problem resolution
exists outside of the normal administrative reporting/supervisory
channels.
6. Administrative Organization
This section will cover the normal administrative reporting/
responsibilities of the laboratory. It will most likely be
different than the QA Management reporting structure, but should
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show how and where QA management reports to the administrative
management structure. QA management should be able to independently
report to the administrative management.
This section will cover the duties and responsibilities of the
key section heads in the lab and will include an organizational
chart showing lines of authority and reporting responsibilities.
7. Personnel Qualifications
A brief listing of personnel should be included. This would
include name, title, degree(s), years of experience and duties.
This should be brief and detailed resumes are not expected but
could be included at the labs option.
It is expected that personnel occupying certain positions
would meet the minimal education and experience requirements stated
in the Manual for the Certification of Laboratories Analyzing
Drinking Water (3) , EPA's Contract Laboratory Program Statements of
Work for Inorganic or Organic Analyses (4,5), or in any applicable
regulatory requirements for those positions.
Qualifications have been established for work performed under
Agency contracts and Programs and are included in Appendix A of
this guidance.
8. Facility Description and Capital Equipment
This section will have a brief description of the lab facility
and layout. Key support services for proper lab operation should be
identified, i.e., deionized water supply system, ventilation
systems, working space, equipment and sample storage areas, etc.
A list of laboratory capital equipment at the site should be
included. This would include such items as; GC/MS, GCs, AAs, ICP,
etc. If the lab instruments have computer data systems then a
listing should be included giving details on the software and
revision being used for data acquisition or manipulation.
Information to be included is type of instruments (GC, GC/MS,
AA, GFAA, etc.), manufacturer and model number, date of acquisition
(year), and if applicable, software and revision used to control
instrument or data acquisition and reduction. An example format for
the capital instrument inventory is given in Figure 2.
9. Preventive Maintenance
This section should include a schedule of specific routine
maintenance to be performed on capital equipment and lab support
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Instrument Inventory
Software Date
Make Model Type /Revision Identifier Installed
Type = GC, GC/MS, ICP, GFAA, AA, etc.
Identifier = Lab specific instrument identifier where multiple instruments are involved.
Figure 2 - Example layout for an instrument inventory.
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systems. A list of critical spare parts should also be included.
10. Corrective Action
A corrective action program, which must have the capability to
deal with errors or defects at any point in the generation of data,
is an essential management tool for quality assurance/ quality
control activities.
A plausible corrective action scheme must be designed to
identify defects, tally defects, trace defects to their source,
plan and implement measures to correct identified defects, maintain
documentation of the results of the corrective process until each
defect is eliminated. This may be accomplished through the use of
corrective action forms.
This section should cover general corrective action procedures
to be followed if lab QA/QC criteria are not met for an analysis or
project.
11. Laboratory Evaluation and Audits
Management System Reviews (MSRs) are on-site audits of an
organization used to verify the existence and to evaluate the
adequacy of internal management systems and documents necessary for
the implementation of a QA program. The primary purpose of a QA
management audit is to determine the extent to which QA is being
implemented within an organization and to recommend actions which
are necessary to correct deficiencies.
Technical System Audits (TSAs) focus on the actual quality
control and environmental data collection systems. A TSA entails an
examination of calibration records, sampling and measurement
procedures, general laboratory cleanliness, support systems,
equipment and facilities, maintenance and repair records, control
charts, etc. TSA auditors must be competent scientists who are
familiar with the particular technology and quality control
procedures.
A Performance Evaluation (PE) is the means of evaluating the
performance of laboratory technicians and the instrumentation or
analytical systems on which they work. A PE audit is accomplished
by providing PE samples containing specific pollutants (in
appropriate matrix) unknown to the technician in their
concentration and/or identity.
Data Quality Audits (DQAs) are an evaluation of the
documentation associated with data quality indicators of
measurement data to verify that the data are of known quality. The
primary purpose of this type of audit is to verify the availability
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of quantitative and qualitative indicators of data quality.
Availability of data quality indicators depends upon the proper
collection, interpretation, and reporting of information required
to characterize the quality of data.
This section will detail the types and frequency of all
performance and system audits to be performed in the laboratory on
a routine basis. Certain projects may specify more frequent audits
and if this occurs can be addressed on a project by project basis.
12. Quality Assurance Reports to Management
This section will discuss the periodic reports to be sent to
management as a result of any audits or ongoing QC sample analysis.
It should also discuss the mechanism used to follow up on any
corrective actions needed as the result of an audit or continuing
QC problems. This may be accomplished through periodic reports to
management using an established schedule of reports.
It is recommended that the Laboratory QA Plan be reviewed and
updated, if necessary, on an annual basis. This annual review may
be accomplished through the use of a Management System Review.
.13. Lab Documentation and Forms
This section should have copies of all the routinely used
forms in the lab. Document control procedures should be discussed
to explain how new forms are generated and documented and how new
forms supersede older forms.
14. Sub-Contracting of Services
Because many labs will sub-contract out services they cannot
perform on a large project, this section will discuss the general
requirements for determining when and how such sub-contracting will
be done. This should include selection of a sub-contractor,
requirements to be imposed on the sub-contractor (such as having a
QA plan), audit requirements, etc.
It should be noted that there are severe limitations on sub-
contracting of services with EPA Contract Laboratory Program
samples.
15. Standard Operating Procedures
Standard Operating Procedures (SOPs) are to be available for
all routinely used sampling or analytical laboratory methods. The
Laboratory must maintain a log of all SOPs in use and must maintain
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a file of all revisions of SOPs used in the past. A current list of
all SOPs and revision number and date must be appended to the
Laboratory QA Plan. All such methods shall be documented in detail.
Generally, simply citing a published method is not adequate for a
SOP. Published methods rarely have all the procedural details, and
those that do generally have to be modified for the applications or
facilities at hand. Suggested references for the format of SOPs are
included in the reference section of this document (6, 8) . These
SOPs shall be prepared in document control format.
As a minimum the following items should be included:
* Title Page
* Scope and Applications
* Definitions
* Procedures
* QC Limits
* Corrective action Procedures, Including Procedures for
Secondary Review of Information Being Generated
* Documentation Description and Example Forms
* Miscellaneous Notes and Precautions
* References
At times certain SOPs may not cover all the above elements,
especially administrative type SOPs. In that case some other format
and elements should be developed to properly address the purpose of
documenting the procedure covered by the SOP. SOPs shall be located
in an accessible place(s) and copies shall be available to all
personnel needing them to perform their duties.
Once prepared, these SOPS would only have to be included in
QA project plans by reference, after being subjected to prior
review and approval.
This section will be quite flexible and will include all the
lab's SOPs for all its' routine operating and analytical
procedures. The following is a list of possible SOPs and should not
be considered to be all inclusive:
1. Evidentiary SOPs
1.1 Sample Identification
1.2 Chain of Custody
1.3 Sample Receiving
1.4 Sample Tracking
1.5 Laboratory Notebook Issuance and Correction
Procedures (9)
1.6 Document Numbering, Inventory and Storage
2. Sample Receipt and Storage
2.1 Sample Custody Procedure
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2.2 Sample Identification Logbooks
2.3 Refrigerator Temperature Logbooks
2.4 Extract Storage Logbooks
2.5 Security Precautions
3. Sample Preparation
3.1 Reagent Purity Check Procedures and
Documentation
3.2 Extraction Procedure
3.3 Extraction Bench Sheets
3.4 Extraction Logbook Maintenance
4. Glassware Cleaning
4.1 Organic Analysis Glassware Cleaning
4.2 Inorganic Analysis Glassware Cleaning
4.3 Sample Container Cleaning (if applicable)
5. Calibration (Balances)
5.1 Procedures
5.2 Frequency Requirements
5.3 Acceptance Criteria and Corrective Actions
5.4 Logbook Maintenance
6. Analytical Procedures (for each analytical System)
6.1 Instrument Performance Specifications
6.2 Instrumental Operating Conditions
6.3 Data Acquisition System Operation
6.4 Procedures When Automatic Quantitation
Algorithms Are Overridden
6.5 QC Required Parameters
6.6 Analytical Run/Injection Logbooks
6.7 Instrumental Error Flag Descriptions and
Resulting Corrective Actions
7. Maintenance Activities (for each Analytical System)
7.1 Preventive Maintenance Schedule and Procedures
7.2 Corrective Maintenance Determination and
Procedures
7.3 Maintenance Authorization
7.4 Maintenance Procedures should be included for
instrumentation and lab support systems, such as
distilled water, hoods, gas supplies, etc.
8. Analytical Standards
8.1 Standard Coding/Identification and Inventory
System
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8.2 Standards Preparation Logbook(s)
8.3 Standards Preparation Procedures
8.4 Procedures for Equivalency and Traceability
Analyses and Documentation
8.5 Purity Logbook (Primary Standards and Solvents)
8.6 Storage, Replacement, and Labelling Requirements
8.7 QC and Corrective Action Measures
9. Data Reduction Procedures
9.1 Data Processing Systems Operation
9.2 Outlier Identification Methods
9.3 Identification of Data Requiring Corrective
Action
9.4 Reporting Format and/or Forms for Each Operation
10. Documentation Policy/Procedures
10.1 Laboratory/Analyst's Notebook Policy, including
Review Policy
10.2 Organization and Storage Procedures for Raw Data
and Reports
10.3 Data Inventory Procedures, including Review
Policy
11. Data Validation/ Self Inspection Procedures
11.1 Data Flow and Chain of Command for Data Review
11.2 Procedures for Measuring Precision and Accuracy
11.3 Evaluation Parameters for Identifying Systematic
Errors
11.4 Procedures to Assure that Hardcopy and
Electronic Deliverables are Complete and
Compliant with Client Requirements
11.5 Procedures to Assure that Hardcopy Deliverables
are in Agreement With Electronic Deliverables
11.6 Demonstration of Internal QA Inspection
Procedures (demonstrated by supervisory sign-off
of personal notebooks, internal PE samples,
etc.)
11.7 Frequency and types of internal audits (e.g.,
random, quarterly, spot checks, perceived
trouble areas)
11.8 Demonstration of problem identification-
corrective actions and resumption of analytical
processing, Sequence resulting from internal
audit (i.e., QA feedback).
11.9 Documentation of audit reports (internal and
external), audit responses, corrective actions,
etc.
12. Data Management and Handling
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12.1 Procedures for controlling and estimating data entry
errors.
12.2 Procedures for reviewing changes for data and
deliverables and ensuring traceability of
updates.
12.3 Lifecycle management procedures for testing,
modifying, and implementing changes to existing
computing systems including hardware, software,
and documentation or installing new systems.
12.4 Database security, backup, and archival
procedures including recovery from system
failure.
12.5 System maintenance procedures and response
times.
12.6 Individual(s) responsible for system operation,
maintenance, data integrity and security.
12.7 Specifications for staff training procedures.
13. Quality Assurance and Quality Control
13.1 Frequency and types of QC samples used in
analysis methods.
13.2 Frequency and types of QC samples taken to
determine performance of lab support facilities,
i.e., deionized water supplies, etc.
13.3 Use of control charts or other data analysis
procedures to evaluate analytical method quality
control information.
13.4 Corrective action procedures to be taken when QC
information indicates a problem or deviation.
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Reference
1. EPA-600/8-83-024, Guidelines and Specifications for Preparing
Quality Assurance Program Plans, QAMS-004/80, EPA, June 1983.
2. Interim Guidelines and Specifications for Preparing Quality
Assurance Project Plans, QAMS-005/80, EPA, December 29, 1980.
3. EPA/570/9-90/008, Manual for the Certification of Laboratories
Analyzing Drinking Water: Criteria and Procedures Quality
Assurance, 3rd Ed., EPA, April 1990.
4. U.S. EPA Contract Laboratory Program Statement of Work for
Inorganic Analysis, Multi-Media Multi-Concentration, Document
Number ILM01.0.
5. U.S. EPA Contract Laboratory Program Statement of Work for
Organic Analysis, Multi-Media Multi-Concentration, Document Number
OLM01.0.
6. Dux, James P., Handbook of Quality Assurance For The Analytical
Chemistry Laboratory, Van Nostrand Reinhold Company (New York),
1986.
7. Taylor, John Keenan, Quality Assurance of Chemical Measurements,
Lewis Publishers, 1987.
8. EPA-600/4-82-057, Methods for Organic Chemical Analysis of
Municipal and Industrial Wastewater, EPA, July 1982.
9. Kanare, Howard M., Writing the Laboratory Notebook, American
Chemical Society, Washington, D.C., 1985.
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Appendix A-Personnel Qualifications
The following qualifications have been established for work
performed under Agency contracts or Programs and are recommended
for equivalent positions and work.
Inorganic Laboratory Supervisor
Education: Minimum of a Bachelor's degree in chemistry or any
scientific/engineering discipline.
Experience: Minimum of three years of laboratory experience,
including at least one year in a supervisory position.
Quality Assurance Officer
Education: Minimum of a Bachelor's degree in chemistry or any
scientific/engineering discipline.
Experience: Minimum of three years of laboratory experience,
including at least one year of applied experience with QA
principles and practices in an analytical laboratory.
Systems Manager
Education: Minimum of a Bachelor's degree with four or more
intermediate courses in programming, information management,
database management systems, or systems requirements
analysis.
Experience: Minimum of three years of experience in data or
systems management or programing including one year
experience with software being utilized for data management
and generation of deliverables.
Programmer Analyst
Education: Minimum of a Bachelor's degree with four or more
intermediate courses in programming, information management,
database management systems, or systems requirements
analysis.
Experience: Minimum of two years of experience in systems or
application programing including one year experience with
software being utilized for data management and generation of
deliverables.
ICP Spectroscopist
Education: Minimum of a Bachelor's degree in chemistry or any
scientific/engineering discipline. Specialized training in
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ICP spectroscopy.
Experience: Minimum of two years of applied experience with
ICP analysis of environmental samples.
ICP Operator
Education: Minimum of a Bachelor's degree in chemistry or any
scientific/engineering discipline with one year of experience
in operating or maintaining ICP instrumentation, or, in lieu
of the educational requirement, three additional years of
experience in operating and maintaining ICP instrumentation.
Atomic Absorption Operator
Education: Minimum of a Bachelor's degree in chemistry or any
scientific/engineering discipline with one year of experience
in operating or maintaining AA instrumentation, or, in lieu
of the educational requirement, three additional years of
experience in operating and maintaining AA instrumentation,
including graphite furnace, flame, and cold vapor techniques.
Inorganic Sample Preparation Specialist
Education: Minimum of a high school diploma and a college
level course in general chemistry or equivalent.
Experience: Minimum of one year of experience in sample
preparation in an analytical laboratory- If microwave
digestions are performed an additional six months of
experience with microwave digestions is required.
Classical Techniques Analysts
Education: Minimum of a Bachelor's degree in chemistry or any
scientific/engineering discipline.
Experience: Minimum of one year experience with classical
chemistry laboratory procedures, in conjunction with the
educational qualifications; or, in lieu of educational
requirement, two years of additional equivalent experience.
GC/MS Laboratory Supervisor
Education: Minimum of a Bachelor's degree in chemistry or any
scientific/engineering discipline.
Experience: Minimum of three years of laboratory experience,
including at least one year in a supervisory position.
GC/EC Laboratory Supervisor
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Education: Minimum of a Bachelor's degree in chemistry or any
scientific/engineering discipline.
Experience: Minimum of three years of laboratory experience,
including at least one year in a supervisory position.
Sample Preparation Laboratory Supervisor
Education: Minimum of a Bachelor's degree in chemistry or any
scientific/engineering discipline.
Experience: Minimum of three years of laboratory experience,
including at least one year in a supervisory position.
GC/MS Operator
Education: Minimum of a Bachelor's degree in chemistry or any
scientific/engineering discipline. Training courses in mass
spectral interpretation.
Experience: Minimum of two years of experience in mass
spectral interpretation.
GC/EC Operator
Education: Minimum of a Bachelor's degree in chemistry or any
scientific/engineering discipline.
Experience: Minimum of one year of experience in operating
and maintaining GC/EC with a Bachelor's degree or, in lieu of
the Bachelor's degree, three years of experience in operating
and maintaining the GC/EC and interpreting GC/EC data.
Pesticide Residue Analysis Expert
Education: Minimum of a Bachelor's degree in chemistry or any
scientific/engineering discipline.
Experience: Minimum of two years of experience in operating
and maintaining GC and interpreting GC chromatograms.
Extraction/Concentration Expert
Education: Minimum of a high school diploma and a college
level course in general chemistry or equivalent.
Experience: Minimum of one year of experience in sample
extraction/concentration.
Microbiology Supervisor
Education: Minimum of a Bachelor's degree in science.
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Experience: Minimum of two weeks training from a Federal
agency, state agency, or academic institution in
microbiological analysis of drinking water.
Microbiology Analyst
Education: Minimum of a high school education. Training in
microbiological analysis of drinking water, acceptable to the
state (or EPA for nonprimacy states) , plus a minimum of 30
days on-the-job training.
Experience: At least one year of bench experience in
sanitary, water, milk, or food microbiology.
Radiochemistry Supervisor
Education: Minimum of a Bachelor's degree, or its equivalent.
Experience: Minimum of five years of experience.
Radiochemistry Analyst
Education: Minimum of a Bachelor's degree in chemistry,
radiochemistry, radioisotope technology, or equivalent.
Experience: Minimum of one year of appropriate experience in
radiation measurements and radiochemical procedures.
Radiochemistry Technician
Education: Minimum of a high school diploma or its
equivalent, plus specialized training in standards and sample
preparation, instrument calibration, calculations, and data
handling.
Experience: Minimum of six months on-the-job.
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