NCD991278953_19860829_National Starch & Chemical Corp._FRBCERCLA SAPQAPP_Addendum to the Quality Assurance Project Plan-OCR

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rn INTERNATIONAL
TECHNOLOGY CORPORATION
ADDENDUM TO
QUALITY ASSURANCE PROJECT PLAN (QAPP)
Revision No.: 0
Date: 08/29/86
PROJECT TITLE: REMEDIAL INVESTIGATION/FEASIBILITY STUDY
NATIONAL STARCH AND CHEMICAL CORPORATION
CEDAR SPRINGS ROAD
SALISBURY, NORTH CAROLINA
Prepared by:
IT Corporation
Knoxville, Tennessee
August 29, 1986
(Addendum Prepared January 30, 1987)
Regional Oflice
312 Directors Drive• Knoxville. Tennessee 37923 • 615-690-321 l
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QUALITY ASSURANCE PROJECT PLAN
DISTRIBUTION LIST
Project Coordinator, NSCC -Hank Graulich
Program Manager, IT -Cliff Vaughan
Quality Assurance Officer, IT -Don Mack
Laboratory Coordinator, IT -Jack Hall
Project Coordinator, EPA -Giezelle S. Bennett (5)
Revision No: 0
Date: 08/29/86
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EXCERPTS FROM
IT ENGINEERING SERVICES QUALITY ASSURANCE MANUAL
IT SOUTHEAST REGION QUALITY ASSURANCE PROCEDURES
IT ANALYTICAL SERVICES QUALITY ASSURANCE MANUAL
NATIONAL STARCH AND CHEMICAL CORPORATION SITE
CEDAR SPRINGS ROAD
SALISBURY, NORTH CAROLINA
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TABLE OF CONTENTS
IT ENGINEERING SERVICES QUALITY ASSURANCE MANUAL
5.0 Data Acquisition
5.1 Literature/Information Survey
5.2 Field Investigation and Sampling
5.3 Sample Control
5.4 Laboratory Analysis
5.5 Equipment Calibration
11.0
11. l
11. 2
11. 3
11.4
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
9.0
Tables and Figures
Quality Assurance Audits
Audit Types
Audit Procedure
Audit Reports and Responses
Audit Closure
Figures
IT SOUTHEAST REGION QUALITY ASSURANCE PROCEDURES
SR QAP -9. 0
Purpose
Scope
Discussion
References
Definition
Responsiblities
Procedures
Documentation
Attachments
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ANALYTICAL SERVICES QUALITY ASSURANCE MANUAL
3.0 Standard Laboratory Practice
3.1 Receipt of Samples and Initiation of Testing Program
3.2 Material and Instrument Preparation
3.4 Analytical Procedures
3.4 Process Quality Control Data
3.5 Corrective Action
3.6 Data Processing and Validation
3.7 Reporting
3.8 Records Management
Figure
7.0
12.0
12.l
12.2
12.3
Preventive Maintenance
Figures
Records Management
Project Records
General Laboratory Operations
Record Control
Tables and Figures
Records
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5.0 DATA ACQUISITION
Section No. 5.0
Revision No. 0
Date: July 16, 1985
Page 1 of 45
Data is generally acquired by literature/information surveys, field investiga-
tion and sampling, and/or Laboratory analysis. Quality-related activities
associated with each method shall be performed 1n accordance with approved
written procedures, using calibrated equipment as necessary. Samples obtained
shall be properly identified and controlled to retain in situ character-
istics. All daily activities, data, data reduction, results, and variances to
procedures shall be documented. Data reduction shall be checked using the
standard IT process (Section 6.3.1).
5.1 LITERATURE/INFORMATION SURVEY
During project planning, the need to assemble pertinent information previously
developed by IT or others shall be determined. The intensity of the survey
shall be determined by the Project Manager dependent on the needs of the
project. Acquired information may include:
• Applicable federal, state, and local regulations and
rulings
• Project status
-History/background
-Future plans
-Client requirements/schedule
• Methodologies available for:
Field exploration, testing, and sampling
-Laboratory testing
-Processing and volume reduction of hazardous material
-Isolation and disposal of hazardous material
-Numerical analysis and design
• Existing data generated for a specific region or site
-Geological (surface and subsurface)
-Ground water (configuration and usage)
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-Hydrological/meteorological
-Geochemical
-Geotechnical
-Seismological
-Population distribution
Section No. 5.0
Revision No. 0
Date: July 16, 1985
Page 2 of 45
-Industrial development and practices (past, present,
and future)
-Type, volume, and extent of contamination
-Physical layout of man-made facilities
• Data generated on specific materials or chemical com-
pounds of interest
-Physical
-Chemical
-Geochemical
-Mechanical
-Thermomechanical
Toxicity/hazards and protection
• Quality of existing data. (Is the data adequate for
the needs of the project?)
• Previous or concurrent, surveys, studies, analyses, and
designs of a similar or parallel nature.
Sources for the above information may ·include:
• Government arid private regulations, standards, guide-
lines, journals, periodicals, and data compilations
• Textbooks and maps
• Reports and manuals previously issued by IT, the
client, or other organizations
• Results of presently ongoing investigations by govern-
ment and private agencies, corporations, and research
facilities
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• Personal communications
• Aerial photographs and satellite imagery
• Procurement documents issued by the client.
Section No. 5.0
Revision No. 0
Date: July 16, 1985
Page 3 of 45
Information collected shall be documented to indicate its source. Documentation
shall, as appropriate, include author or individual contacted; title; identifi-
cation of periodical or journal; standard, ·guideline, or _report number; identi-
fication of publisher or originating organization; page location; and date.
Documentation must be sufficient to allow other individuals to easily obtain or
verify the information.
llhenever possible, complete copies of articles, data compilations, maps,
reports, and photographs shall be included in the project files. If this 1s not
feasible, copies of title pages and pertinent sections shall be included with
complete source documentation. Regulations, standards, guidelines, and text-
books, which are generally not project specific, may be obtained and kept in the
office library if they are of a unique nature or will be used on several
projects.
Personal communications such as interviews, correspondence, or telephone conver-
sations shall be completely documented in the form of trip reports, meeting
notes, memorandums, and telephone records and the resulting documentation in-
cluded in the project files. Provide, as appropriate, the name. organization,
date, address, phone number, and credentials of all individuals contacted. A
request shall be made for formal written confirmation of critical data obtained
by telephone to serve as final documentation.
5.2 eIELD INVESTIGATION AND SAMPLING
This section discusses the performance and documentation of quality-related
field activities. rhese activities can include site reconnaissance, surface and
subsurface exploration, field surveys and testing, and collection of samples for
subsequent laboratory analyses.
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5.2.1 Performance
Section No. 5.0
Revision No. 0
Date: July 16, 1985
Page 4 of 45
Field investigation and sampling shall be performed in accordance with
documented and approved procedures, such as Manuals of Practice and project-
specific plans (Sections 3.2 and 3.3 discuss preparation, review, and approval
of procedures). Procedures. shall provide for performance of activities under
suitably controlled conditions which include the use of appropriate materials
and calibrated equipment, environmental conditions, and completion of any
prerequisites.
When appropriate, generic procedures shall be supplemented by project-specific
work or sampling plans. The plans may identify specific project tasks, required
equipment and materials, approved procedures for work performance, prerequisites
co be· completed prior co performance, and activity schedule. Plans shall be
sufficiently flexible co permit field necessitated changes while maintaining
desired control. Original plans, and any revisions to them, shall be reviewed
and approved by Project Group and Quality Assurance personnel as stated in
Section 3.3.l.
Field activities are the responsibility of the Project Manager and Field Super-
visor. Prior to initiating field work, the Project Manager shall discuss the
scope of work, contractual and regulatory requirements, and applicable Quality
Assurance/Quality Control procedures with assigned personnel. At the request of
the Project Manager, this may be done by Quality Assurance personnel or senior
members of the Project Staff.
Once in the field, IT field personnel are responsible for all daily Quality
Control activities. Included in chis responsibility shall be the supervision of
IT subcontractors.
Generic methods for field investigation and sampling are presented in IT Manuals
of Technical Practice associated with this Quality Assurance Manual and in vari-
ous internal technical procedures.
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5,2,2 Performance Documentation
Section No, 5.0
Revision No. 0
Date: July 16, 1985
Page 5 of 45
To provide evidence of satisfactory work performance and the basis for
subsequent activiti~s and information transmitted external to IT; data, data
reduction, and results of field investigations and sampling shall be completely
documented. Whenever possible, information shall be recorded on a standardized
form or 1n a bound field logbook, Documentation shall include a daily log of
project activities and the appropriate subsurface logs, test and survey data
forms, monitoring/sampling equipment installation records, photographs, and
field collection and sampling custody forms;
Members of the Project Staff working in field operations shall keep a daily log
of project activities. Standard IT forms such as is shown in Figure 5-1 should
be used. Each page of log books or daily activity logs shall be signed by the
person preparing the log. Items to be included in the daily log, as
appropriate, are:
• Project identification
• Field activity subject
• General work activity
• Unusual events
• Changes to plans and specifications
• Visitors on site
• Subcontractor progress or problems
• Communication with the client or others
• Weather conditions
• IT personnel on site,
Copies of the daily activity logs should be sent to the Project Manager, or a
senior member of the Project Staff, approximately on a weekly basis. After
review of the logs, they should be routed to other members of the Project
Staff as needed. If the logs are not submitted as required, it is the respon-
sibility of the Project Manager, or designee, to contact the field personnel.
As part of field activities, a photographic record should be prepared, Photo-
graphs should be in color. As examples, photographs should be t~ken of the
general site layout, geologic features, field equipment and installations,
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Revision No. 0
Date: July 16, 1985
Page 6 of 45
sampling stations, and field testing. When test pits or trenches are dug,
photographs should be taken of the subsurface profiles if possible.
Photographs are to be identified with the project number, date taken, and a
brief description. This may be done individually on the back of the photo-
graphs or in an album in which the photographs are mounted. Album photographs
must be provided with individual descriptions and dates taken.
Before photographs are taken, the client should be contacted to determine
their policy concerning photographs.
Appropriate test survey and equipment installation data forms shall also be
prepared. They shall include, as appropriate, the activity location (e.g.,
boring, test pit, depth, sampling station, elevation, and field coordinates)
and the items listed in Section 5.4.2 for laboratory test data forms. All
requested information shall be addressed. If not applicable, requested infor-
mation should be designated as such.
All field records shall be collected and maintained by the Field Supervisor
until completion of the field program or program phase, or until they are
submitted to the project central file (Section 10.2.1). During the
performance of a field program, it is recommended that a copy of the field
records be periodically made and sent to the Project.Manager. These copies
can provide adequate documentation of work activities should the originals be
destroyed, lost, or stolen.
Variances from standard approved field operational procedures and plans shall
be documented in a Variance Log (Figure 5-2) or equivalent form. It is recog-
nized that procedures such as work plans cannot be prepared which properly
foresee all conditions encountered during a field program. The Field Super-
visor shall initiate and chronologically maintain the Variance Log. All items
recorded in the Variance Log require the approval of the Project Manager and
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Revision No. 0
Date: July 16, 1985
Page 7 of 45
the appropriate Quality Assurance Officer. Approval by the Project Manager
can be initiated on a verbal basis via telephone. It is suggested, as normal
practice, that the Field Supervisor communicate via telephone with the Project
Manager at least weekly. The Variance Log shall contain: date and nature of
the variance, applicable document, and IT personnel initiating the variance.
In no case shall a subcontractor initiate a variance. If a variance is
proposed by the client, it shall be so recorded.
Formal approval of the Variance Log shall be in writing. The Project Manager
shall be provided with a copy of all entries made in the log. Upon receipt
the Project Manager shall review copies of the logs and, when in agreement,
indicate approval by signing and dating each variance. The copy shall be
forwarded to the Quality Assurance Officer for review, signing, and dating and
then returned to the Project Manager for inclusion in the project files.
Originals of the Variance Log shall be kept on site until the field work 1s
complete.
5.2.3 Verification of Data Reduction
The numerical reduction of field data shall be formally checked using the
standard IT process outlined in Section 6.3.l. Checking shall be performed
prior to the presentation of results. If it becomes necessary to present or
use unchecked results, transmittals or subsequent calculations shall be marked
"prelim_inary" until such time that the results are checked and determined to
be correct.
All data reduction and resulting tables and graphs shall be checked. This
includes computer input (see Sections 6.2.2 and 6.3.2), if reduction 1s
performed by computer. Data sheets shall be complete, with all requested
information addressed.
The verification of field data reduction is the responsibility of Project
personnel. The assignment of a checker shall be made or approved by the Field
Supervisor or the Project Manager.
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5.3 SAMPLE CONTROL
Section No. 5.0
Revision No. 0
Date: July 16, 1985
Page 8 of 45
Field personnel are responsible for the identification, preservation, packag-
ing, handling, shipping, and storage of samples obtained in the field so that
all samples can be readily' identified arid that they will retain, to the extent
possible, in situ characteristics to be determined through testing. Specific
information on sample control is presented in the ITAS Quality Assurance
Manual, IT Manuals of Practice, and various internal technical procedures.
5.3.1 Samples for Chemical Analysis
This section discusses the control of samples taken for chemical analysis.
The media to be sampled can be water, air, soil, sludge, etc. Samples
collected for traditional (nonchemical) geotechnical analysis are discussed tn
Section 5.3.2.
5.3.1.1 Identification
Samples shall be adequately marked for identification at the time of collec-
tion. Marking shall be on a tag or label attached to the sample container
(jar, bottle, bag, etc.). Sample identification shall include, as a minimum:
• Project name and number
• Unique sample number
• Sampling location (e.g., boring, ,depth or sampling
interval, and field coordinates)
• Sampling date
• Individual performing the sampling
• Preservation or conditioning employed,
An example identification label for chemical analysis samples ts shown 1n
Figure 5-3.
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Page 9 of 45
5.3.1.2 Chain-of-Custody
An overriding consideration for data resulting from chemical analyses is the
ability to demonstrate that the samples were obtained from the locations
stated and that they reached the laboratory without alteration. Evidence of
collection, shipment, laboratory receipt, and laboratory custody until dis-
posal must be documented to accomplish this. Documentation shall be
accomplished through a chain-of-custody form that records each sample and the
individuals responsible for sample collection, shipment, and receipt.
sample LS considered 1n custody if it is:
• In a person's actual possession
• In view, after being 1n physical possession
• Locked so that no one can tamper with it, after having
been in physical custody
• In a secured area, restricted to authorized personnel.
A
l'igure 5-4 shows an example chain-of-custody form to be used by IT personnel
in collecting and shipping samples. An ITAS laboratory will not accept
samples collected by IT personnel for analysis without a correctly prepared
chain-of-custody form.
The chain-of-custody form shall be signed by each individual who has the
samples in their possession. Preparation of the chain-of-custody shall be as
follows:
• The chain-of-custody record shall be initiated in the
field by the person collecting the sample, for every
sample. Every sample shall be assigned a unique iden-
tification number that is entered on the chain-of-
custody form. Samples can be grouped for shipment 1nd
use a common form.
• If the person collecting the samples does not transport
the samples to the laboratory or deliver the sample
containers for shipment; the first Relinquished ·
By , Received By_·_ shall be completed in the
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Section No. 5.0
Revision No. 0
Date: July 16, 1985
Page 10 of 45
field. It is noted that the names of all members of
the sampling team shall be listed on the chain of
custody.
• The person transporting the samples to the laboratory
or delivering them for shipment shall sign the record
form as Relinquished By
• If the samples are shipped to the laboratory by commer-
cial carrier, the chain-of-custody form shall be sealed
in a watertight container, placed in the shipping con-
tainer, and the shipping container sealed prior to
giving it to the carrier.
• If the samples are directly transported to the labora-
tory, the chain-of-custody shall be kept in possession
of the person delivering the samples.
• For samples shipped by commercial carrier, the waybill
shall serve as an extension of the chain-of-custody
record between the final field custodian and receipt in
the laboratory.
• Upon receipt in the laboratory, the Quality Control
Coordinator, or representative, shall open the shipping
containers, compare the contents with the chain-of-
custody record, and sign and date the record. Any
discrepancies shall be noted on the chain-of-custody
form.
• If discrepancies occur, the samples in question shall
be segregated from normal sample storage and the field
personnel' immediately notified.
• The chain-of-custody form is completed after sample
disposal. Note the blanks for this purpose in Figure
5-4.
• Chain-of-custody records shall be maintained with the
records for a specific project, becoming part of the
data package.
• The following documentation may supplement the chain-
of-custody records:
-Field notebook prepared by a member of the sample
team. The field notebook shall provide supporting
information regarding sample collection.
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-Sample label on each sample
Section No. 5.0
Revision No. 0
Date: July 16, 1985
Page 11 of 4.5
-Water quality field collection report (Figure 5-5) or
corresponding soil or waste field collection report,
and request for analysis form (copies accompany the
samples) Figure 5-6.
-Photographic records (wherever practical).
Multipart chain-of-custody forms may be used so that a copy can be returned to
the individual shipping the sample after they are received at the laboratory
and after they are disposed.
5.3.1.3 Preparation, Packaging, Handling, and Shipping
Samples shall be placed in containers compatible with the intended analysis
and properly preserved. Also, control of samples must consider the time
interval between acquiring the sample and analysis (holding time) so that the
sample is representative. Table 5-1 has been provided to denote requirements
for various analytical parameters with respect to the type of container,
preservation method, and maximum holding time between collection and analy-
sis. Polyethylene or glass containers are required; and, in most cases,
samples must be cooled to four degrees Centigrade (4°C) The table also pro-
vides the recommended sample volume for a specific analysis. This table is
from the ITAS Quality Assurance Manual.
Samples to be shipped off site for chemical analysis shall be placed in ice
chests containing ''blue ice'' or a similar pack of frozen gel and packed to
prevent breakage during shipment. The ice chest shall be sealed, addressed,
identified, and placarded as appropriate.
As soon as field personnel have consigned samples to a commercial carrier,
they shall notify the laboratory by telephone of the shipment. If the samples
are transported by field personnel, the estimated time of arrival at the
laboratory should be given. Figure 5-7 contains the information that must be
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[i] Section No. 5.0
Revision No. 0
Date: July 16, 1985
Page 12 of 45
provided to the laboratory. A blank of this form will be completed at the
laboratory during the telephone conversation.
The final step in providing information to the laboratory is shown in Figure
5-6. The Request for Analysis form shall be completed by the field personnel,
or other Project personnel if appropriate, and included with the chain-of-
custody record. It is imperative that the Request for Analysis be provided so
that analytical requirements are defined and sample holding times are not
exceeded.
Transportation shall enable samples to arrive at the laboratory in time to
permit testing in accordance with established sample holding time and project
schedule. No samples shall be accepted by the receiving laboratory personnel
unless they are properly labeled and sealed.
5.3.1.4 Storage
Sample storage in the field and laboratory shall generally be in a refriger-
ated (four degrees Centigrade), secure area until required analyses are com-
pleted. Field and laboratory storage are the responsibility of the Field
Supervisor and Laboratory Manager, respectively. In general, samples shall
not be kept longer than six months beyond the completion of analysis, unless
otherwise specified.
5.3.2 Samples for Geotechnical Analysis
Following is a discussion of the control of samples (soil or rock) obtained
for geotechnical analyses.
5.3.2.1 Identification
Geotechnical samples shall be adequately marked for identification from che
time of collection and packaging through shipping and storage, ~arking shall
generally be on the sample container (corebox, undisturbed tube, jar, bag,
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Section No. 5.0
Revision No. 0
Date: July 16, 1985
Page 13 of 45
etc.); but may be applied directly to the sample, or on a tag or label at-
tached to the sample or container, depending on the type of sample and its
intended use. Sample identification shall include, as appropriate:
• Project name and number
• Unique sample number
• Sampling location (e.g., boring, test pit, depth or
sampling interval, and field. coordinates)
• Sampling date (soil samples only).
Additional information may be included in response to internal technical
procedures or at the discretion of the Field Supervisor.
5.3.2.2 Packaging, Handling, and Shipping
Packaging of geotechnical samples shall be based on the protection a sample
requires during handling, shipping, and storage. The size and material of
containers, methods of container closing or sealing, and packaging of con-
tainers for shipment shall maintain desired in situ characteristics to the
extent possible.
Samples shall be handled and shipped so that damage, loss, or unacceptable
deterioration 1s prevented. Suitable handling precautions, environmental
protection, and methods of transportation shall be employed. Transportation
shall be provided so that samples arrive at the laboratory in time to permit
testing in accordance with project schedule. Special emphasis shall be placed
on the handling and shipping of undisturbed geotechnical samples. Whenever
possible, these samples should be transported by IT personnel. Undisturbed
geotechnical samples shipped as freight shall be packed to prevent movement 1n
the package and to reduce shock, vibration, and disturbance. Specific re-
quirements for handling and storage of undisturbed samples may be developed
for individual projects.
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Page 14 of 45
Samples shipped, or hand carried, co an IT laboratory shall be accompanied by
a laboratory log sheet providing a record of the samples shipped. A typical
log sheet is shown in Figure 5-8.
5.3.2.3 Storage
Field storage of samples shall be adequate to prevent damage, loss, or unac-
ceptable deterioration. Samples shall not be subjected co excessive moisture
or large temperature variations. They shall not be allowed co freeze, if the
1n situ characteristics to be determined by testing could be affected. Indoor
storage shall be employed, where possible, to provide a controlled environ-
ment. All field storage shall be under the direction of the Field Supervisor.
Laboratory storage of samples prior to testing shall follow the above require-
ments. Storage supervision is the responsibility of the Laboratory Manager.
For the storage of samples which remain after testing, IT also maintains
storage facilities. Samples from nuclear-related projects stored in these
facilities shall be recorded on an inventory sheet with copies on file 1n the
laboratory and the storage facility, if separate from the laboratory. An
example of an inventory sheet for geotechnical samples ·is presented 1n Figure
5-9. Samples shall be stored by type and project number. The type of sample,
sample number, sampling location, dace stored, and date for sample disposal
shall be indicated.
Depending upon regulatory and client requirements, samples remaining after
testing is complete may be disposed of at the option of the Project Manager.
In general, samples shall not be kept longer than six months. As appropriate,
transferal to the client or owner may be arranged.
5.3.2.4 Chain-of-Custody for Geotechnical Samples
Section 5.3.2 is appropriate only for geotechnical samples which are not used
for chemical analyses. If chemical analysis is to be performed on the
geotechnical samples, the provisions for chain of custody cited 1n Section
5.3.1.2 shall be applied.
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Page 15 of 45
It is recommended that the chain-of-custody procedure (Section 5.3.1.2) be
imposed on geotechnical samples that will be tested'to confirm, or in some
cases establish, geotechnical parameters. The following reasons for using a
chain of custody for chemical samples are also often appropriate for
geotechnical samples:
• Demonstrating or1g1n of the samples
• Demonstrating .the samples have not been altered (or
alteration minimized) from the time of collection to
testing.
Examples of the chain-of-custody procedure being appropriate for geotechnical
samples could be:
• Obtaining undisturbed samples from a clay liner to
demonstrate that strength characteristics and perme-
ability meet specification requirements
• Collecting samples from potential borrow areas for
laboratory analyses to determine appropriate compaction
requirements to meet project objectives
• Demonstrating in situ .strength and permeability of
soils which will not be subject to site remedia~ion.
The decision to impose chain-of-custody requirements for geotechnical samples
shall be made by the Project Manager.
5.4. LABORATORY ANALYSIS
This section discusses the general performance and documentation of laboratory
chemical and geotechnical analyses. Detailed guidance for these activities ,s
presented in the appropriate laboratory Quality Assurance ~anuals.
5.4.l Performance
Quality-related laboratory operations shall be documented in approved proce-
dures (as discussed in Section 3.0). Procedures shall provide for accom-
plishment of activities under suitably controlled conditions which include the
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Revision No. 0
Date: July 16, 1985
Page 16 of 45
use of appropriate materials and calibrated equipment, suitable environmental
conditions, completion of prerequisites, and the analysis of Quality Control
samples.
When appropriate, individual procedures shall be supplemented by project-
specific project work and test plans. The plans may identify specific project
tasks, required equipment and materials, approved procedures for work
performance, prerequisites to be completed prior to performance, and activity
schedule. The plans shall be sufficiently flexible to permit change while
maintaining desired control. The original plans, and any revisions to them,
shall be reviewed by the Project Group and Quality Assurance personnel.
Approval shall be provided by project management,
A Laboratory testing program 1s the joint responsibility of the Project Mana-
ger and appropriate Laboratory Manager(s). Project personnel shall provide
the Laboratory Staff with information necessary to perform the testing pro-
gram, while the Laboratory Staff shall conduct the testing in accordance with
approved procedures. Figure 5-10 shows the progress of testing program
activities.
The scheduling and execution of a testing program 1s the responsibility of the
appropriate Laboratory Manager; however, the manager should be notified by
field personnel as to when samples will arrive for testing. As part of the
testing program, the Laboratory Manager is responsible for the completion,
checking, and organization of all laboratory data sheets and calculations and
the release of testing results to Project personnel,
5.4,2 Performance Documentation
To provide evidence of satisfactory work performance and the basis for subse-
quent activities and information transmitted external to IT; the test program
initiation, data, data reduction, and results of laboratory testing shall be
completely documented, Whenever possible, information shall be recorded on a
standardized form or a bound laboratory logbook.
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Revision No. 0
Date: July 16, 1985
Page 17 of 45
To initiate a testing program, a Laboratory Testing Record and/or Work Assign-
ment Sheet shall be prepared by project personnel and appropriate laboratory
management. An example of a geotechnical Laboratory Testing Record is pro-
vided in Figure 5-11 at the end of this section. For tests that require
unique, test-specific input parameters, a Testing Procedure Record (Figure
5-12) shall be completed.
Test data forms shall be completed during testing and the subsequent data
reduction. All requested information shall be addressed. This information
shall include, as appropriate:
• Project name and number
• Identification of test personnel
• Testing date
• Identification of calibrated equipment used (Test
Equipment List g1v1ng equipment name and unique identi-
fication number)
• Identification and description of sample(s) tested
• Test data and any subsequent data reduction
• Test results in the form of tables and curves
• Unusual conditions encountered.
If not applicable, requested information should be designated as such.
For chemical analysis the collection and evaluation of Quality Control data
(e.g., standard eval~ations and duplicate and matrix spike testing) shall be
completely documented on test data forms and the results presented in the form
of Quality Control charts for precision and accuracy.
All laboratory administrative forms, test data, computer printout, and check-
prints shall be organized and maintained by the Laboratory Managers in
accordance with the ·requirements of Section 10.0.
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Revision No. 0
Date: July 16, 1985
Page 18 of 45
Variances from standard approved laboratory operational procedures and plans
shall be documented in a Testing Procedure Record (Figure 5-12), or equivalent
form. This record is to be completed by appropriate laboratory management and
maintained with the associated testing records.
5.4.3 Verification of Data
5.4.3.1 Analysis of Quality Control Samples
For chemical analysis, Quality Control samples shall be used to demonstrate
that a laboratory is operating within prescribed requirements for precision
and accuracy (Section 8.0 of the ITAS Quality Assurance Manual.). Typical
Quality Control samples include:
• Reagent and method blanks
• Field blanks
• Check standards
• Surrogate and internal standards
• Duplicate samples
• Matrix spike samples
• Standard reference materials.
Quality Control samples shall be processed and the results statistically
evaluated to assess the validity of ·each data set. Precision and accuracy
Quality Control charts (Figure 5-13) shall then be developed and updated for
each analytical parameter (Section 10.0 of the ITAS Quality Assurance Manual).
5.4.3.2 Verification of Data Reduction
The numerical reduction of Laboratory data shall be verified using the stan-
dard processes outlined 1n Section 10.2.1 of the ITAS Quality Assurance Manual
for chemical analysis, and Section 6.3.1 of this Manual for geotechnicaL test-
ing. Checking shall be performed prior to the presentation of results. If is
becomes necessary to present or use unchecked results, transmittals or subse-
quent calculations shall be marked "preliminary" until such time that the
results are checked and determined to be correct.
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Revision No, 0
Date: July 16, 1985
Page 19 of 45
Data reduction (generally 20 percent of all data for chemical analysis and 100
percent for geotechnical analysis) and any resulting summaries, tables, and
graphs shall be checked. This includes computer input (Sections 6.2.2 and
6.3.2) if reduction is performed by computer. Data sheets shall be complete,
with all requested information addressed.
The verification of laboratory data reduction is the responsibility of labor-
atory personnel. The assignment or approval of checkers is the responsibility
of the appropriate Laboratory Manager.
5.5 EQUIPMENT CALIBRATION
Measuring and test equipment used in the field or IT laboratories and IT
reference equipment shall be controlled by a formal calibration program. The
program shall provide equipment of the proper type, range, accuracy, and
prec1s1on to supply data compatible with proJect requirements and desired
results. Calibration of measuring and test equipment may be performed
internally using IT reference equipment and standards, or externally by agen-
cies or manufacturers. Calibration of in-house reference equipment is, in
general, performed externally.
The responsibility for the calibration of IT laboratory and associated refer-
ence equipment rests with the Laboratory Managers. Calibration of other
equipment within the IT calibration system (Section 5.5.7) is the responsibil-
ity of the office or group maintaining that equipment. The Project Manager
and Field Supervisor are responsible for the calibration of project-specific
IT field equipment, which is not part of the calibration system, and field
equipment provided by subcontractors.
5.5.l Calibration Procedures
Documented approved procedures shall be used for calibrating measuring and
test equipment and reference equipment. Whenever possible widely accepted
procedures, such as those published by ASTM or EPA, or procedures provided by
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Revision No. 0
Date: July 16, 1985
Page 20 of 45
manufacturers shall be adopted. Where preestablished information is not
available, procedures shall be developed (Section 3.2) considering the type of
equipment, stability characteristics of the equipment, required accuracy and
precision, and the effect of error on the quantities measured. As a minimum
procedures shall include:
• Type of equipment to be calibrated
• Reference equipment and standards to be used
• Calibration method and sequential actions
• Acceptance tolerances
• Frequency of calibration
• Data recording form/format.
Calibration procedures for test equipment routinely calibrated by IT are
presented in the ITAS Quality Assurance Manual and IT Manuals of Technical
Practice.
5.5.2 Equipment Identification
Calibrated equipment shall be ·uniquely identified by using either the manufac-
turer's serial number, an IT calibration system (Section 5.5.7) identification
number, or other means. This identification, along with a label indicating
when the next calibration is due (only for equipment requiring periodic cali-
bration), shall be attached to the equipment. If this is not possible,
records traceable to the equipment shall be readily available for reference.
It is the responsibility of all personnel to verify calibration status from
the due date labels or records prior to using the equipment.
5.5.3 Calibration Frequency
Measuring and test equipment and reference equipment shall be calibrated at
prescribed intervals and/or as part of operational use. Frequency shall be
based on the type of equipment, inherent stability, manufacturer's recommenda-
tions, values given in national standards, intended use, effect of error on
the measurement process, and experience. Specific calibration frequencies are
given in the ITAS Quality Assurance Manual and IT Manuals of Practice.
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[i] Section No. 5.0
Revision No. 0
Date: July 16, 1985
Page 21 of 45
In some cases, particularly ,for field equipment, scheduled periodic calibra-
tion will not be performed because the equipment is not continuously in use.
Such equipment shall be calibrated on an "as needed" basis prior to use, and
then at the required frequencies for as long as its use continues.
5.5.4 Calibration Reference Equipment and Standards
Equipment shall be calibrated, whenever possible, using reference equipment
and standards having known relationships to nationally recognized standards
(e.g., National Bureau of Standards) or accepted values of natural physical
constants. If national standards.do not exist, the basis for the reference
standard or calibration shall be documented.
Reference equipment shall be used only for calibration and shall be stored
separately from working measuring and test equipment t.o prevent inadvertent
use. In general, reference equipment ·shall be at least four to ten times as
accurate as the equipment being calibrated.
5.5.5 Calibration Failure
Equipment that fails calibration or becomes inoperable during use shall be
removed from service and segregated to prevent inadvertent use, or shall be
tagged to indicate it is out of calibration. Such equipment shall be repaired
and satisfactorily recalibrated to the satisfaction of the Laboratory Managers
or Field Supervisors, as appropriate. Equipment that cannot be repaired shall
be replaced.
Results of activities performed using equipment that has failed recalibration
· shall be evaluated by the involved Quality Assurance personnel and the Labora-
tory Manager or Project Manager, as appropriate. If the activity results are
adversely affected, the results of the evaluation shall be documented and
appropriate personnel notified.
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Revision No. 0
Date: July 16, 1985
Page 22 of 45
Scheduled calibration of measuring and test equipment does not relieve any
personnel of the responsibility of using properly functioning equipment, If
an equipment malfunction is suspected, the device shall be tagged or removed
from service and recalibrated. If it fails recalibration, the above process
shall apply.
5,5,6 Calibration Records
Records shall be prepared and maintained for each piece of calibrated measur-
ing and test equipment and each piece of reference equipment to indicate that
established calibration·procedures have been followed. Records for equipment
used only for a specific project shall be kept in the project files. Records
for equipment controlled by the IT calibration system (Section 5.5.7) shall
generally be maintained by the Laboratory Managers (along with documentation
demonstrating the accuracy of reference standards) or the offices or groups
responsible for maintaining that equipment.
Records for periodically calibrated equipment shall include, as appropriate:
• Type and identification number of equipment
• Calibration frequency and acceptance tolerances
• Calibration dates
• Identities of individuals and organi•zat ions performing
the calibrations
• Reference equipment and standards used for each
calibration·
• Calibration data
• Certificates or statements of calibration provided by
manufacturers and external agencies, and traceable to
national standards
• Statements concerning calibration acceptance or failure
and repair of failed equipment.
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Revision No. 0
Date: July 16,
Page 23 of 45
1985
Much of the measuring and test equipment used for field geophysical
surveys or in the analytical laboratories is calibrated or checked as
part of the operational use. Fnr this equipment, records of the cali-
brations or checks shall be kept in the files of projects for which the
work was performed, or as part of the responsible group calibration
record system.
5;5,7 IT Calibration System
To provide control of measuring and test equipment and reference equip-
ment routinely used by IT, a formal calibration system is employed.
Each piece of equipment within the system shall be assigned a unique
equipment number and tagged with that number so that calibration infor~
mation pertinent to the equipment can be retrieved upon request. The
equipment shall have an individual calibration file and be calibrated
prior to use or as part of operational use.
In addition to the numbering and tagging of equipment, a recalibration
date label shall, whenever possible, be applied to each item requiring
periodic calibration. For convenience, the date labels may be made from
plastic tape used in an embossing label maker,
Calibration files for the equipment controlled by the various labora-
tories, offices, and groups shall be maintained by the appropriate
Laboratory Mangers, offices, or groups., Calibration files shall con-
tain an Equipment Calibration Record form (Figure 5-14), IT calibration
data forms and/or certificates of calibrations provided by manufacturers
and external agencies, and any Notice of Equipment Calibration Faiiure
(Figure 5-15),
For the transfer of equipment between laboratories and offices, the
calibration files should be sent with the equipment so that a continuous
updated record can be maintained. In general, recalibration of sensi-
tive equipment should be performed following the transfer.
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Revision·No. 0
Date: July 16, 1985
Page 24 of 45
Equipment which fails calibration must be repaired to the satisfaction
of the appropriate Laborator:, Manager or Field Supervisor before it 1s
reused, or it shall be removed from service. A Notice of Equipment
Calibration Failure form (Figure 5-15) shall be completed and kept in
the equipment file for items that are removed from service for failure
to satisfy calibration requirements. Failure to pass calibration shall
also be noted in the Equipment Calibration Record.
TABLE 5-1
SAMPLING AND PRESERVATION REQUIREMENTS
PARAMETER
lfaclerial Tests
• Coliform, fecal and total
• Fecal streptococci
!~1organi c Tests
• Acidity
• Alkalinity
• Amm0nia
• Biochemical Oxygen Demand
• Biochemical Oxygen
Demand (carbonaceous)
• Bromide
• Chemical Oxygen Demand
• Chloride
• Chlorine, Total Residual
• Color
• Cyanide, Total and Amenable
to Chlorination
• Fluoride
• Hardness
CONTAINER(a)
P,G
P,G
P,G
P,G
P,G
P,G
P,G
P,G
P,G
P,G
P,G
P,G
P,G
p
P,G
See footnotes at end of table.
VOLUME REQUIRED
(mL)
200
200
so
so
100
1,000
1,000
200
75
so
200
50
1,500
300
100
PRESERVATION(b)
Cool 4°C,
Cool 4°C,
Cool
Cool
4•c
4°C
Cool 4°C, H2so4 to pH <2
Cool 4°C
Cool 4°C
None required
Cool 4°C, H2so4 to pH <2
None required
None required
Cool 4°C
Cool 4°C, NaOH to pH(>~2,
0.6g ascorbic acid d
None required
HN0 3 to pH <2, H2so 4 to pH <2
MAXIMUM HfcH>ING
TIMES c
6 hours
6 hours
14 days
14 days
28 days
48 hours
48 hours
28 days
28 days
28 days
Analyze immediately
48 hours
14 day/el
28 days
6 months
Sect ion No. 5. 0
Revision No. O
nate: July 16. 1985
Page ~5 of 45
PARAMETER CONTAINER(a)
• Hydrogen Ion (pH) P,G
.• Kjeldahl and Organic Nitrogen P,G
Metals(f) ---
• Chromium VI P,G
• Mercury P,G
• Metals, Except Chromium VI P,G
and Mercury
• Nitrate P,G
• Nitrate-Nitrite P,G
• Nitrite P,G
• Oil and Grease G
• Organic Carbon P,G
• Orthophosphate P,G
• Oxygen, Dissolved Probe G bottle and top
• Phenols G
• Phosphorus (Elemental) G
• Phosphorus, Total P,G
• Residue, Total P,G
• Residue, Filterable P,G
• Residue, Nonfilterable P,G
TABLE 5-1
(Continued)
VOLUME REQUIRED
(mL)
25
500
50
100
200
100
100
50
1,000
25
50
300
500
50
50
100
100
250
. PRESERVATION(b)
None required
Cool 4°C, H2so4 to pH <2
Cool
Cool
Cool 4°C
HN0 3 to pH <2
HN0 3 to pH <2
Cool 4°C
4°c, H2so 4 to
Cool 4°C
4•c, H2so4 to
pH <2
pH <2
Cool 4°C, HCl or H2so4 to pH <2
filter immediately, cool 4°C
Cool
Cool
None required
4°c, H2so 4 to
Cool 4°C
4°c, H2so4 to
Cool 4•c
Cool 4°C
Cool 4°C
pH <2
pH <2
MAXIMUM Hf.~ING
TIMES c
Analyze immediately
28 days
24 hours
28 days
6 months
48 hours
28 days
48 hours
28 days
28 days
48 hours
Analyze immediately
28 days
48 hours
28 days
7 days
48 hours
7 days
Section No. 5.0
Revision No. O
Date: July 16, 1985
'P.:lr,P. 2h nf l1 ~
@!Ila .,. -( .. ----.....
PARAMETER
• Residue, Settleable
• Residue, Volatile
• Silica
• Specific Conductance
• Sulfate·
• Sulfide
• Sulfite-
• Surfactants
• Temperature
• Turbidity
Organic Tests(g)
• Purgeable Halocarbons
• Purgeable Aromatic
Hydrocarbons
• Acrolein and Acrylo-
nitrile
• Phenols ( j)
<,
CONTAINER(a)
P,G
P,G
p
P,G
P,G
P,G
P,G
P,G
P,G
P,G
G, Teflon-1 ined
septum
G, Teflon-1 i ned
septum
G, Teflon-Ii ned
septum
G, Teflon-lined
cap
TABLE 5-1
(Continued)
VOLUME REQUIRED
(mL)
1,000
100
50
100
100
500
50
250
1,000
100
40
40
40
1,000
PRESERVATION(b)
Cool 4'C
Cool 4°C
Cool 4°C
Cool 4'C
Cool 4'C
Cool 4'C, add zinc acetate plus
sodium hydroxide to pH >9
None required
Cool 4'C
None required
Cool 4'C
Cool 4'C, 0.008% Na 2s2o3
(d)
Cool 4'C, ~-~08% Na 2s2o3(d),
HCl to pH 2 h
Cool 4'C, 0.008\r)"2s203 (d) ,
adjust pH to 4-5 1
Cool 4'C, 0.008% Na2s2o3
(d)
MAXIMUM HfiH1ING
TIMES c
48 hours
7 days
28 days
28 days
28 days
· 7 days
Analyze immediately
48 hours
Analyze immediately
48 hours
14 days
14 days
14 days
7 days until extraction,
40 days after extraction
Section No. 5.0
Revision No. O
Date: July 16, 1985
Page 27 of 45
.. ----
PARAMETER
• Benzidines(j)
• Phthalate Esters(j)
• Nitrosamines(j,m)
• PCBs(j) acrylonitrile
• ~itroaromafi)s and
1 sophorone J ·
• Polynuclear tt~matic
Hydrocarbons J
• Haloethers(j) ·
• Chlorinated Hydrocarbon.< j)
• TCDD(j)
Pesticides
• Pesticides
CONTAINER(a)
G, Teflon-lined
cap
G, Teflon-lined
cap
G, Teflon-lined
cap
G, Teflon-lined
cap
G, Teflon-1 i ned
cap
G, Teflon-lined
cap
G, Teflon-lined
cap
c, Teflon-lined
cap
G, Teflon-lined
cap
G, Teflon-lined
cap
TABLE 5-1
(Continued)
VOLUME REQUIRED
(mL)
1,000
1,000
1,000
l, 000
1,000
1,000
1,000
1,000
1,000
1,000
PRESERVATION(b)
Cool 4°C
Cool 4°C
Cool 4°C, 0.008% Na 2s2o3 (d),
store in dark
Cool 4°C, 0.008% Na 2s2o3(d),
store in dark
Cool 4"C
Cool 4"C, pH 5-9(n)
MAXIMUM Hf,rfING
TIMl!S c
-
7 days until extraction(!)
7 days until extraction,
40 days after extraction
7 days until extraction,
40 days after extraction
7 days until extraction,
40 days after extraction
7 days until extraction,
40 days after extraction
7 d~ys until extraction,
40 days after extraction
7 days until extraction,
40 days after extraction
7 days until extraction,
40 days after extraction
7 days until extraction,
40 days after extraction
7 days until extraction,
40 days after extraction
Section No. 5.0
Revision No. O
Date: July 16, 1985
Page 28 of 45
-
PARAMETER
- - - ---
CONTAINER(a)
TABLE 5-1
(Continued)
VOLUME REQUIRED
(mL)
- -..
PRESERVATION(b) MAXIMUM Hf.~ING
TIMES c
Hadiological Tests
o Alpha, Beta, and
Radium
P,G 1,000 HN0 3 to pH <2 6 months
H~terence: This table includes the requirements of the U.S. Environmental Protection Agency, as published 1n the
Code of Federal Regulations, Vol. 49, No. 209, 40 CFR 136, October 26,. 1984, pg, 43260.
( d )
(b)
( C)
Polyethylene (P) or glass (G).
Sample preservation should be performed immediately upon sample collection. For composite chemical samples,
each aliquot should be preserved at the time of collection. When use of an automatic sampler makes it impos-
sible to preserve each aliquot, then chemical samples may be preserved by·maintaining at 4°C until compositing
and sample splitting is completed.
Samples should be analyzed as soon as possible after collection. The times listed are maximum times that
samples may be held before analysis and still be considered valid. Samples may be held for longer periods only
if permittee, or monitoring laboratory, has data on file to show that the specific types of samples under study
are stable for the longer time. Some samples may not be stable for the maximum time period given in the table.
A permittee, or monitoring laboratory, is obligated to hold the sample for a shorter period if knowledge exists
to show this is necessary to maintain sample stability.
(J)Should only be used in the presence of residual chlorine.
Section No. 5.0
Rev is iori No. O
Date: July 16, 1985
Page 29 of 45
-
(e)
( f)
--

-
--

-
-

-
-
TABLE 5-1
(Continued)
-

-
---

-
-
Maximum holding time is 24 hours when sulfide is present. Optionally, all samples may be tested with lead
acetate paper before pH adjustment to determine if sulfide is present.
Samples should be filtered immediately on site before adding preservative for dissolved salts.
(g)Cuidance applies to samples to be analyzed by CC, LC, or GC/MS for specific compounds.
(h) Sample receiving no pH adjustment must be analyzed within seven days of sampling.
(i) · · · 'f l . ·11 l f . . .
The pH adjustment 1s not required 1 aero e1n w1 not be measured. Samp es or acrole1n rece1v1ng no pH
adjustment must be analyzed within three days of sampling.
-
( j ) When the extractable analytes of concern fall within a single chemical category, the specified preservative and
maximum holding times should be observed for optimum safeguard of sample integrity. When the analytes of
concern fall within two or more chemical categories, the sample may be preserved by cooling to 4°C, reducing
residual chlorine with 0.008% sodium thiosulfate, storing in the dark, and adjusting the pH to six to nine;
samples preserved in this manner may be held for seven days before extraction and 40 days after extraction.
Exceptions to the optional preservation and holding time· procedure are noted in footnote (d) (re the re-
quirement for thiosulfate reduction of residual chlorine) and footnotes {k) and (1) (re the analysis of
benzidine).
(k) . . .
If l,2-d1phenylhydraz1ne is likely to be present, adjust the pH of the sample to 4.0±0.2 to prevent rearrange-
ment to benzidine.
( I ) Extracts may be stored up to seven days before analysis if storage is conducted under an inert (oxidant-free)
atmosphere.
(m) . . ror the analysis of diphenylnitrosam1ne, add 0.008% Na 2s2o3-and adjust pH to seven to ten with NaOH within 24
hours of sampling.
(n\he pH adjustment may be performed upon receipt at the laboratory and may be omitted if the samples are ex-
tacted within 72 hours of collection. For the analysis of aldrin add 0.008% Na 2s2o3• -"' co
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IT CODOL\TION
FIGURE 5-1
FIELD ACTIVITY DAILY LOG
§ DATE
► NO. .,
~ SHEET OF
PROJECT NAME I PROJECT NO.
FIELD ACTIVITY SUBJECT:
.
DESCRIPTION ON DAILY ACTIVITIES AND EVENTS:
Section 5 .. 0
Revision No. 0
Date: July 16, 1985
Page 31 of 45
VISITORS ON SITE: CHANGES FROM PLANS AND SPECIFICATIONS, AND
OTHER SPECIAL ORDERS AND IMPORTANT DECISIONS.
WEATHER CONDITIONS: IMPORTANT TELEPHONE CALLS:
JT PERSONNEL OH BITE:
(FIELD ENGINEER) DATE
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Figure 5-2
IT CORPORATION
Southeast Region
Knoxville, Tennessee
VARIAN CZ LOG ·
Office / / Field / /
Page __ of __
Section No. 5.0
Revision No. 0
Dati: July 16, 1985
Page 32 of 45
Project _______________________________ _
eject No.
Variance Initiated Applicable I AO"Oroved
Date 'By Document Descriotion of Variance P~/Date IOAO/Date
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Project Name Project No.
Sample Location
Boring/Well No.
Collector's Name Date
Sample Type: __ Ground Water __ Surface Water
__ Soil __ Sludge/Waste
Parameters reservative
Bottle of Filteted Nonfillered
FIGURE 5-3
EXAMPLE SAMPLE LABEL
Section No. 5.0
Revision No. 0
Date:· July 16, 1985
Page 33 of 45
- --

-

-

-

-
-

-

-

-
-

-

-
-

-

-

-
l!!!!!!I rn INTERNATIONAL
TECHNOLOGY
CORPORATION
Figure 5-4
CHAIN-OF-CUSTODY RECORD
R/A Control No. ______ _
CIC Control No. Q 2 5 5 j 9
PROJECT NAME/NUMBER LAB DESTINATION
SAMPLE TEAM MEMBERS----------------CARRIER/WAYBILL NO. ________________ _
Sample Sample Date and Time Sample Container Condition on Receipt Disposal
Number Location and Description Collected Type Type (Name and Date) Record No.
'
Special Instructions:---------------------------------------------------
Possible Sample Hazards:-------------------------------------------------
SIGNATURES: (Name, Company, Date and Time)
1. Relinquished By: ____________________ _
Received By: ______________________ _
2. Relinquished By: ____________________ _
Received By:
WHITE -To accompany samples
YELLOW -Field copy
3. Relinquished By: ____________ _
Received by: ______________ _
4. Relinquished By: _____________ _
Received By: _______________ _
""Clo~ en
(l) fl) !ti ('t)
OQr-t<:n
Ctl(tll-'•M" •• co .....
I.,.) I-'• 0 ~ c..... 0::,
c:: " 0 .-Z
t-ti'<Z:O 0 • ..,. .....
V, °' V,
00
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PROJECT NAME
FIELD ACTIVITY SUBJECT:
Figure 5-5
FIELD ACTIVITY DAILY LOG
Section No. 5.0
Revision No. 0
Date: July 16, 1985
Page 35 of 45
I PROJECT NO.
DESCRIPTION ON DAILY ACTIVITIES AND EVENTS:
VISITORS ON SITE: CHANGES FROM PLANS AND SPECIFICATIONS, AND
OTHER SPECIAL ORDERS AND IMPORTANT DECISIONS.
WEATHER CONDITIONS: IMPORTANT TELEPHONE CALLS:
IT PERSONNEL ON 61TE:
!FIELD ENGINEER( DATE •
-m rMNA""AL-TECHNOLOGY
CORPORATION ---111!1'8ur-6 --
REQUEST FOR ANALYSIS -

-
'ffl Co~No."' J ~ 3 111!!!1
CIC Control No. ______ _
'
PROJECT NAME
PROJECT NUMBER
PROJECT MANAGER
BILL TO
PURC~ASE OP.DER NO.
DATE SAMPLES SHIPPED
LAB DESTINATION
LABORATORY CONTACT
SEND LAB REPORT TO
DATE REPORT REQUIRED
PROJECT CONTACT
PROJECT CONTACT PHONE NO.
Sample No. Sample Type Sample Volume Preservative Requested Testing Program
TURNAROUND TIME REQUIRED: (Rush must be approved by the Project Manager.)
Normal ___ _ Rush ___ _ (Subject to rush surcharge)
POSSIBLE HAZARD IDENTIFICATION: ( Please indicate if sample(s) are hazardous materials and/or suspected to contain high levels of hazardous substances)
Nonhazard __ _ Flammable __ _ Skin Irritant __ _ Highly Toxic __ _
SAMPLE DISPOSAL: (Please indicate disposition of sample following analysis. lab will charge for packing, shipping. and disposal.)
Return to Client __ _ Disposal by Lab __ _
FOR LAB USE ONLY Received By ______________ _ Date/Time _________ _
WHITE -Original, to accompany samples
YELLOW -Field copy
Special Instructions
t-c o ~ en Ill CU n> n> Other _______ OQ rt <: o
(Pleue Specify) l'Dltlt-'•n-•• Ol t-'• w t-'• 0
O" c.... 0 ;:I
C: " 0 ,_. Z H'l'< zo 0 • -I' .....
V, "' V,
00
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Date of Shipment:
SHIPMENT INFORMATION
(Field to Lab by Telephone)
---------
Laboratory Destination: ____________ _
Section No. 5.0
Revision No. o
Date: July 16, 1985
Page 37 of 45
Laboratory Project Contact:_~~-..--------------,-,=-c,--,------,,--,--~ (Name) (Telephone Number)
Number Containers Shipped: ---------
Mode of Shipment: --------------
Shipment Number(s): ____________ _
Time of Shipment: _____________ _
Date/Time of Shipping Information Transmitted to Lab: ___________ _
Individual Contacting Lab: _________________________ _
Individual in Lab Receiving Information: __________________ _
NOTE: PROVIDE THIS INFORMATION TO RECEIVING
LABORATORY AS SOON AS POSSIBLE AFTER
SAMPLES ARE SHIPPED.
FIGURE 5-7
SAMPLE SHIPPING INFORMATION
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FIGURE 5-8
Section No. 5.0
Revis ion No. 0
Date: July 16, 1985
Page 38 of 45
LABORATORY LOG SHEET
PROJECT NAME-----------------------
PROJECT NO. _____________________ _
PROJECT ENGINEER ---------------------
DATE __________ _
SAMPLE NO.
► w DATE 15 ► a:: SAMPLE BORING OR m m 8 DEPTH DATE "' J i.:f a:: C) OR MAY BE Oz TEST PIT NO. w <( <( LOCATION RECEIVED DISCARDED ...1-::c ::c :,,::
11,1<!1 U) U) .., m u -Z = :N 0 1&.W ..., a::
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STORAGE FACILITY INVENTORY
Section No. 5.0
Revision No. 0
Date: July 16, 1985
Page 39 of 45
PROJECT NAME ________________ LOGGED BY _________ _
PROJECT NO. DATE ____________ _
STORAGE LOCATION __________________________ _
SAMPLE NUMBER
BORING w DEPTH
OR a: DATE DISPOSAL w 0
TEST PIT aJ u OR STORED DATE REMARKS
::) ..: LOCATION
NO. I-a: (!) u
= <t <t 0 .., -, aJ a:
~----
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FUNCTIONS
MATERIAL
PROCUREMENT & CONTROL
CALIBRATION
PREVENTIVE
MAINTENANCE
CORRECTIVE
ACTION
QC
UNACCEPTABLE
LABORATORY
FUNCTIONS
COLLECTION AND
RECEIPT
OF
SAMPLES
AND
INITIATION
OF
TESTING
PROGRAM
ANALYTICAL
PROCEDURES
PROCESS
DA~~*
QC
ACCEPTABLE
DATA
PROCESSING &
VALIDATION
REPORTING
RECORDS
MANAGEMENT
*chemical analysis only.
FIGURE 5-10
LABORATORY ANALYSIS FLOW CHART
Section No; 5.0
Revivision No. O
Date: July 16, 1985
Page 40 of 45
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Section No. 5.0
Revision No. 0
·•-LABORATORY TESTING RECORD
Date: July 16, 1985
Page 41 of 45
PROJECT NAME _______________ _
PROJECT NO. _________________ _
PROJECT ENGINEER _______________ _
z BORING OR TEST PIT NO.
Q SAMPLE NO . ... I FROM <t DEPTH u I TO 0 ..J
t 3 TUBE
2 TUBE ...
"' JAR
It BAG
::; ROCK CORE
<t CJ)
ID
VISUAL CLASSIFICATION
PLASTICITY INDEX
SIEVE ANALYSIS
<Ji HYDROMETER ANALYSIS
CJ) SPECIFIC GRAVITY <t d
CJ) UNIT WEIGHT !;; RELATIVE DENSITY "' ... PROCTOR (STANDARD)
,-. PROCTOR (MODIFIED). ... HARVARD MINIATURE iii z PERMEABILITY
~
UNCONFINED COMPRESSION
CJ) QUICK TRI AXIAL ... CONS. CJ) DRAINED TRIAXIAL
"' CONS. UNDRAINED TRIAXIAL ...
CONS. UNDRAINED TRIAXIAL WITH PP
:,: DIRECT SHEAR ... "' DIRECT SIMPLE SHEAR ·z
"' VANE SHEAR 0: ... FALL CONE PEN ET RA Tl ON
CJ)
'd RESONANT COLUMN
::;
<t CYCLIC TRIAXIAL
z ,-. TORSIONAL SIMPLE SHEAR
0
CONSOLIDATION
CJ) CONSTANT DIAMETER TRIAXIAL 0: "' -:,: ... 0
AMOUNT SAVED
0 TO BE TESTED ~ TEST COMPLETED
DATE RECEIVE...._ ______ _
DATE COMPLETED ______ _
REMARKS
....
■ UNABLE TO RUN
SIGNED•--=,-.=~===~----PROJECT ENGINEER
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FIGURE 5-12
TESTING PROCEDURE RECORD*
Section No. 5.0
Revision No. 0
Date: July 16, 1985
Page 42 of 45
PROJECT NAME_;__ _____________________ _
PROJECT NO.------------------------
LABORATORY TEST _____________________ _
SPECIMEN ________________________ _
INSTRUCTIONS• -----------------------
DATE _________ SIGNED _______________ _
• THIS RECORD IS TO BE COMPLETED BY THE RESPONSIBLE PROJECT PERSONNEL OR
THE LABORATORY MANAGER TO DENOTE ALL VARIABLE QUANTITIES OR VARIANCES
FltOM STANDARD PRACTICE FOR A LABORATORY TEST.
---··--

-

-

-

-

-
-· -

-

-

-

-

-

-

-
-
% R + 3SR 125.--.:::..:.:....:.-=..:::!!. _______________ ~-----------~-,
•
115 _!o_R + ~Sft ____________________ . ----------------
>-105
a:: w > 0
(.)
•
•
•
• • w 0/o R a::95 .:::_.:.:_ _________________________________ ~
1--z •
w • • • (.) a::
~ 85
•
• •
75 % R -2SR -----------------------------------------

-
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SAMPLES SPIKED
PARAMETER---------
FIGURE 5-13
EXAMPLE ACCURACY QUALITY CONTROL CHART
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FIGURE 5-14
Section No. 5.0
Revision No. 0
Date: July 16,
Page 44 of 45
•
LABORATORY
EQUIPMENT CALIBRATION RECORD
1985
EQUIPMENT NUMBER _____________________ _
EQUIPMENT NAME _______________________ _
REQUIRED CALIBRATION PERIOD'~----------------
DATE CALIBRATION DATE CALIBRATION CALIBRATION PERFORMED CALI BRAT ION PERFORMED
PERFORMED BY PERFORMED BY
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FIGURE 5-15
NOTICE OF EQUIPMENT
CALIBRATION FAILURE
Section No. 5.0
Revision No. 0
Date: July 16, 1985
Page 45 of 45
EQUIPMENT NUMBER _______________ _
EQUIPMENT NAME ________________ _
REASON FOR FAILURE TO PASS CALIBRATION _____ _
WAS EQUIPMENT REPAIRED OR REPLACED ? _____ _
IF REPAIRED , WAS THE CORRECTIVE ACTION ADEQUATE_
Signed __________ _
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11.0 QUALITY ASSURANCE AUDITS
Section No. 11.0
Revision No. 0
Date: July 16, 1985
Page 1 of 13
To verify compliance with IT and project-specific Quality Assurance/Quality
Control requirements, Quality Assurance personnel shall perform planned and
documented audits of project-specific activities and nonspecific (generic)
laboratory and office technical activities. These audits shall consist, as
appropriate, of an evaluation of Quality Assurance/Quality Control procedures
and the effectiveness of their implementation, an evaluation of work areas and
activities, and a review of activity documentation. Audits shall be performed
in accordance with written checklists by trained Quality Assurance personnel
and, as appropriate, technical specialists. They shall be conducted to the
level of detail necessary for the activity audited. Audit results shall be
formally documented and sent to management of the activity audited for review.
Audits may be both scheduled and nonscheduled and can include, but not be
limited to, the following areas:
• Subcontractor capabilities and performance
• Field operations and records
• Laboratory testing and records
• Equipment calibration and records
• Identification and control of samples
• Numerical analyses and designs
• Computer program documentation and verification
• Transmittal of information external to IT
• Record control and retention.
11.1 AUDIT TYPES
Two major categories of Quality Assurance audits will be performed: project-
specific audits, generally performed by the Quality Assurance Officers as-
signed to IT offices, and generic audits of office and laboratory technical
activities, performed by the Corporate Director, Quality Assurance, the ITAS
Quality Assurance Manager, or members of the Corporate Quality Assurance
Croup.
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11.l.l Project-Specific Audits
Section No. 11.0
Revision No. 0
Date: July 16, 1985
Page 2 of 13
Several different types of project-specific audits may be conducted based on
the needs of a project. The audits may be performed on IT activities (inter-
nal) or subcontractors to IT (external). Types of audits include:
• Field operations (internal)
• In-process project and report (internal)
• Project file (internal)
• Prequalification of subcontractors (external)
• Source (subcontractor) activities (external).
As indicated above, project-specific audits shall generally be conducted by
the Quality Assurance Officers. Members of the Corporate Quality Assurance
Group, however, may also perform or assist in the auditing. The determination
of whether a project will require specific audits shall be based on the
definition of project quality level (Section 4.2) and the scope of work.
Project-specific audits shall be conducted in accordance· with the requirements
of Sections 11.2 through 11.4.
11.1.1.1 Field Operations Audits
A field operations audit involves an on-site visit by Quality Assurance per-
sonnel. Consultants, who are technically competent in the operations to be
audited and independent of the subject project, may also participate as part
of the audit team for the purpose of providing technical expertise. Items to
be examined may, as appropriate, include the availability and implementation
of approved work procedures, sampling, protocols, and specifications;
calibration and operation of equipment; labeling, packaging, storage, and
shipping of samples; performance documentation and checking; subcontractor
performance; and nonconformance documentation. At the request of the
auditors, subcontractor calibration records and personal resumes shall be
furnished.
The scheduling of field operations audits will depend upon the Project Manager
notifying Quality Assurance personnel that a field operation is to commence.
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Revision No. 0
Date: July 16, 1985
Page 3 of 13
It is preferable that the Quality Assurance personnel be notified prior to
beginning work so the initial field audit can be scheduled in the early stages
of on-site activity. The scheduling of the audit should be such that the
resolution of corrective action will not adversely affect the project schedule
nor impact a significant portion of the field work. The field operations
audit schedule will be dependent upon the extent and complexity of the field
operations. At least one audit should be conducted, with succeeding audits at
least every six months. This frequency may be adjusted by the Corporate
Director, Quality Assurance.
11.1,1.2 In-Process Project and Report Audits
Both in-process project and report audits consist of a review of pertinent
project material. In process audits are performed during the course of work
and·usually concentrate on one specific task, such as design. Report audits
consider all work performed that is to be reported. ·For a report audit, items
examined may, as appropriate, include the documentation and verification of
field and laboratory data and results; performance, documentation, and
verification of analyses and designs; documentation and verification of
computer programs; preparation and verification of drawings, logs, and tables;
content, consistency, and conclusions of the transmittal or report; compliance
with IT, regulatory, and client project requirements; and maintenance and
filing of project records,
The records of field operations shall be ceviewed to verify that field-related
activities were performed in accordance with appropriate project procedures.
Items reviewed shall include, but not be limited to, the calibration records
of field equipment; field activity logs; photographs; and data, sample collec-
tion and custody forms, waste inventories, logs, and checkprints resulting
from the field operations.
The auditing of laboratory results shall include, but not be limited to, the
originals and checking of .laboratory data sheets and Quality Cantrel testing,
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Revision No. 0
Oate: July 16, 1985
Page 4 of 13
originals and checkprints of data presentations prepared by the Laboratory
Staff, laboratory test scheduling records ·for the project, and test equipment
lists.
Auditing of analyses and designs shall include a complete review of calcula-
tions, computer input, sketches, charts, tables, and their associated check-
prints that were prepared by the Project Group. These items shall be reviewed
to verify conformance to project requirements.
The report preparation process shall be audited to verify that:
• The report correctly and accurately presents the
results obtained by the project work
• Information presented in the report is substantiated by
project work
• Tables and figures presented in the report are prepared
and checked according to IT requirements
• The report satisfies the scope of work, IT and client
requirements, and any pertinent regulatory requirements.
If peer review is undertaken for a report,_ the audit and peer review will
jointly review these items. The audit shall also, as appropriate, review the
maintenance and control of project documents to verify that applicable
procedures have been implemented.
Report audits shall be performed prior to issuance of the final transmittal or
report. The issuance of a final report shall be postponed if Quality Assur-
ance personnel determine that the work does not meet requirements. If che
project schedule demands issuance of a transmittal or report prior to audit,
it may be issued 11 preliminary11 or "draft," or the client may be formally
notified that an internal audit is in progress and that the submittal will be
.considered final only after completion of the audit process. The burden of
scheduling the time needed for Quality Assurance personnel to perform a report
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Revision No. 0
Date: July 16, 1985
Page 5 of 13
audit rests with the Project Group, The Project Group shall notify Quality
Assurance personnel sufficiently in advance to allow the audit to be performed
and requests for corrective action satisfied,
11.1,1.3 Project ~ile Audits
In general, the maintenance and control of project records shall be reviewed
as part of in-process project or report audits, However, for individual
projects having long periods of inactivity (greater than six months) or at the
request of clients, the various areas designated for record storage may be
separately audited.
The primary concern of a file audit is that project material, such as
correspondence, memorandums, telexes, field and laboratory data, computer
output, calculations, drawings, checkprints, and reports, is properly main-
tained in the record filing systems. Records shall be identified and main-
tained in a controlled manner that will provide their retrievability
throughout the course of, and after, the project,
11.1.1.4 Prequalification Audits
If required by project requirements, Quality Assurance personnel shall perform
a prequalification audit of potential subcontractors prior to bid award or the
beginning of work, The purpose of these audits will be to determine if
subcontractors are qualified to perform the desired work, Items to be covered
may, as appropriate, include the qualifications of personnel, condition and
calibration of equipment, documentatio~ procedures, and the subconcractor 1 s
Quality Assurance/Quality Control Program. During the course of the prequali-
fication audit, any instrumentation that is to be supplied by the subcontrac-
tor shall be inspected and approved for use.
11.1,1,5 Source Audits
To verify subcontractor conformance to procurement requiremen~s, source audits
shall be conducted; as appropriate, during the course of a project. Items
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Revision No. 0
Date: July 16, 1985
Page 6 of 13
reviewed may include the effectiveness of the subcontractor's Quality Assur-
ance/Quality Control Program, implementation of work procedures, calibration
and operation of equipment, performance documentation and checking, qualifica-
tions of personnel, and maintenance of records.
11.l.2 Generic Audits
Nonproject-specific (generic) audits shall.be performed by the Corporate
Director, Quality Assurance, members of the Corporate Quality Assurance Group,
the ITAS Quality Assurance Manager, and, as appropriate, Quality Assurance
Officers, to provide an overview of implementation of the IT Quality Assurance
Program in the various laboratories and offices.
11.l.2.l Laboratory Audits
Laboratorf audits will be conducted by the Corporate Director, Quality
Assurance _and the ITAS Quality Assurance Manager. The primary responsibility
for these audits rests with the ITAS Quality Assurance Manager. These audits
will usually be generic, rather than project specific. Each corporate
permanent laboratory (analytical or geotechnical) shall be formally audited
once every six months. Audits of the analytical laboratories shall follow the
requirements of the ITAS Quality Assurance Manual, Section 14.2. Items ex-
amined by the audit team may, as appropriate, include the availability and
implementation of approved labor~tory procedures, equipment calibration and
records, control and storage of samples, Quality Control sample program, per-
formance documentation and checking, and nonconformance documentation.
During the course of the semiannual audits, the audit team should be cognizant
of recurring nonconformances in laboratory operation. or trends which will
affect quality. Recurring nonconformances and trends should be addressed 1n
the audit report. Correction of such items may require a review of the
adequacy of the laboratory Quality Assurance Program.
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11.1.2.2 Office Operations Audits
Section No. 11.0
Revision No. 0
Date: July 16, 1985
Page 7 of 13
Each office providing engineering services shall be audited annually by the
Corporate Quality Assurance Group. Primary responsibility rests with the
Corporate Director, Quality Assurance for performance of the audits. Audits
of office operation shall follow the requirements of Sections 11.2 through
11.4 of this Manual. Items examined may, as appropriate, include the
availability and implementation of approved work procedures, performance
documentation and checking, control and retention of records, and activities
of the Quality Assurance Officer.
At the beginning of each audit, the audit team shall meet with the Operations
Manager, or designee, to discuss the scope of the audit. The Quality Assur-
ance Officer should be available to the audit team throughout the audit.
Following audit completion, the team shall meet with the Operations Manager to
discuss the results and the means for satisfying any required corrective
action. The Operations Manager is responsible for responding to the post
audit report.
11.2 AUDIT PROCEDURE
Auditing shall be initiated and conducted, as appropriate, 1n accordance with
the following procedure.
An individual audit plan (e.g., Figure 11-1) shall be developed by the appro-
priate Quality Assurance personnel to provide a basis for each audit. This
plan shall identify the audit scope, activities to be audited, audit
personnel, external organizations to be notified, any applicable documents,
and schedule. The plan shall be consistent with the project or audit scope,
schedule, and requirements.
The audit team shall be selected based on the activities to be audited and the
level of activity technology and complexity. Member selection shall consider
technical expertise and experience in auditing. Most audits will be performed
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Section No. 11.0
Revision No. 0
Date: July 16, 1985
Page 8 of 13
using only Quality Assurance personnel; however, technical specialists may
also be used as necessary. All auditors shall be independent of the activi-
ties audited.
A Lead Auditor*, approved by the Corporate Director, Quality Assurance, shall
serve as team leader, Lead Auditor responsibilities shall include the selec-
tion and preparation of the team, coordinating the audit process, communica-
tions with the group or organization being audited, participation in the
audit, coordinating the preparation and issuance of audit reports, and evalu-
ating audit responses.
Checklists shall be prepared by the audit team and used to conduct all
audits. They shall be developed so that necessary items are reviewed and to
document the results of the audit. An example of an audit checklist is pre-
sented in Figure 11-2.
IT groups or external organizations shall be notified of a schedul~d audit
prior to performance. For external organizations, notification should be in
writing.
Each audit shall cover the items necessary to verify proper control of the
activities reviewed. During an audit and upon its completion, the audit team
will discuss the findings with the group or organization audited and specify
corrective actions to be initiated. Minor administrative findings which can
be resolved to the satisfaction of the audit team during the audit are not
required to be documented as items requ1r1ng corrective actions. All findings
that are not resolved during the course of the audit and all findings affect-
ing quality, regardless of when they are resolved, shall be noted on the audit
checklists.
* ror nuclear projects, Lead Auditors shall be certified in accordance with
the requirements of ANSI NQA-1, Supplement 2S-3, and Appendix 2A-3 (Section
4.3.3).
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11.3 AUDIT REPORTS AND RESPONSES
Section No. 11.0
Revision No. 0
Date: July 16, 1985
Page 9 of 13
After completion of an audit, the audit team shall prepare and submit a post-
audit report to the following individuals:
• For project-specific audits the Quality Assurance
Review Committee (Section 2.1)
• For generic laboratory audits, the Vice President
Analytical Services, Laboratory Manager, Corporate
Director of Quality Assurance (if other than the Lead
Auditor), ITAS Qualey Assurance Manager (if other than
the Lead Auditor), and Quality Control Coordinator
• For generic office operations audits, the Senior Vice
President Engineering, Nuclear and Remediation
Services; Operations Manager; Corporate Director,
Quality Assurance (if other than the Lead Auditor), and
appropriate Quality Assurance Officer.
If applicable, appropriate management of any external organization audited
shall also receive a copy of the post-audit report. This report shall serve
to notify management of audit results. The report may also be sent to indivi-
duals contacted during the audit and the members of the audit team.
The audit report shall be prepared as soon as possible (maximum 30 days) after
the audit and contain, as appropriate:
• Date(s) and location of the audit
• Identification of audit participants
• Identification of activities audited
• Audit results
• Description of items requiring correccive action and,
if possible, the means for correction
• Due date for completion of corrective actions and/or
audit response
• Means for audit response (in writing).
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Audit results shall include findings and observations.
Section No. 11.0
Revision No. 0
Date: July 16, 1985
Page 10 of 13
Findings are items
which require corrective action. Observations are nonrequired recommendations
made by the audit team to the group audited. Such recommendations are in-
tended to improve project quality.
The report shall be signed, as a minimum, by the Lead Auditor. Checklists
need not be included with the post-audit report.
If corrective action 1s requested in the post-audit report, the corrective
action shall be undertaken and completed on schedule unless sufficient evi-
dence can be provided to the Quality Assurance Review Committee to demonstrate
that action is unnecessary. If required, the Corporate Director, Quality
Assurance, is empowered to stop work on a project pending resolution.
The group or organization audited shall respond in writing to the audit
report. The response shall clearly state the corrective action taken or
planned. It shall, as.a minimum, be sent to tne Corporate Director, Quality
Assurance, Lead Auditor and the responsible Quality Assurance Officer. If all
corrective actions have not been completed prior to issuance of the audit
response, a scheduled date for completion should be provided. It is noted
that requests for corrective action must be addressed to the satisfaction of
the Corporate Director, Quality Assurance.
If the required response is not received by the due date set in the post audit
report, corrective action overdue notices may be sent by Quality Assurance
personnel to the same individuals receiving the post audit report and, if
applicable, appropriate management of any external organization involved. If
for any reason the corrective action should still remain unresolved, the
Corporate Director, Quality Assurance is empowered to issue a "stop work"
order to a project or subcontractor
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rn Section No, 11,0
Revision No. 0
Date: July 16, 1985
Page 11 of 13
Completion of corrective action shall be verified by the audit team through
written communication, reaudit, or other appropriate means.
11,4 AUDIT CLOSURE
After acceptance and verification of all corrective actions, an audit closure
shall be issued by the audit team to the same individuals receiving the pose-
audit report, It is emphasized that all audits must be brought to a satisfac-
tory.closure,
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IT COIIJOll.t.nO>I
PROJECT NAME
QUALITY ASSURANCE
AUDIT PLAN
DEVELOPED BY
11-----------------------1~--------Section 11. 0 -
PROJECT NO. Revision No. 0
~----------------------'---------Date: July 16, 1985 _ Page 12 of 13
DATE
AUDIT TITLE
AUDIT LOCATION AUDIT SCHEDULE
FROM
CHECKLISTS TO BE USED
GENERIC• • • • • 0
AUDIT SPECIFIC • • 0
AUDIT PERSONNEL
LEAD AUDITOR
. TO
OA STAFF _____________ _
TECHNICAL SPECIALISTS _______ _
AUDIT TYPE
PREQUALIFICATION • • • • • • • •
FIELD OPERATIONS • • • • • • • •
LA BORA TORY • • • • • • • • • •
IN-PROCESS PROJECT • • • • • • •
PROJECT ANO REPORT • • • • • • •
PROJECT FILE • • • • • • • • • •
SOURCE • • • • • • • • • • • •
OTHER • • • • • • • • • • • •
-
----.._
ACTIVITIES AND MATERIALS TO BE AUDITED
-SUBCONTRACTOR CAPABILITIES • • • • •
QA/QC PROGRAMS• • • • • • • • • •
FIELD ACTIVITIES & IN-PROCESS RECORDS • • _
IDENTIFICATION & CONTROL OF SAMPLES • • _
LABORATORY ACTIVITIES & IN-PROCESS RECORDS • _
EQUIPMENT CALIBRATION & RECORDS • • • _
PRODUCTIONACTIVITIES&IN-PROCESS RECORDS • _
IN-PROCESS NUMERICAL ANALYSES & DESIGN • _
COMPUTER PROGRAM VERIFICATION & RECORDS •
--
-COMPLETED RECORDS AND CHECKPRINTS
SUBCONTRACTOR • • • • • • • • • ~
FIELD • • • • • • • • • • • • •
LABORATORY • • • • • • • • • •
NUMERICAL ANALYSES & DESIGN • • • •
GROUP OR ORGANIZATION TO BE AUDITED
IT GROUP ____________ _
SUBCONTRACTOR
OTHER EXTERNAL ORGANIZATION
APPLICABLE DOCUMENTS
IT QA MANUALS • • • • • • • • • □
PROJECT QA PLAN • • • • • • • • 0
CONTRACT /PROCUREMENT DOCUMENT • 0
SPECIFIC/GENERIC PROCEDURES • • • 0
TRANSMITTAL OF INFORMATION TO IT • • 0
TRANSMITTAL OF INFORMATION FROM IT,
DATA & RECORDS • •
COMPUTER ANALYSES •
SAR SECTIONS • • •
LICENSE/PERMIT
APPLICATION • • •
:§ Al/ FS •• B REPORT• •
OTHER • •
RECORD CONTROL & RETENTION• ••• B
OTHER • • • • • • • • • • • •
FIGURE .11-1
.... ....
I N
rn ·-QUALITY ASSURANCE CHECKLIST
PROJECT NAME PROJECT NO. 18Y
AUDIT PARTICIPANT§
AUDIT QUESTIONS ill Jill N.A.
EQUIPMENT CALIBRATION
I. IS TEST AND CAL I RRATION F..cJIJIPHF.NT, RF.()IJIRING
CALIIIRATION AND AVAILABLE FOR IISE IN THE LAB-
ORATORY, REING FORMALLY CALIBRATED? •••••••••••••••
2. IS EACH PIECE OF TEST EQUIPMENT REQUIRING
CALIBRATI?~ ASSIGNED AND TAGGED (WHENEVER
POSSIBLE) ) WITH AH IT IDENTIFICATION NUMBER? ..
' l. IS THE IT IDENTiti~ATION NUMBER PERMANENTLY
ETCHED OR HARKED ON EACH PIECE OF TEST
EQUIPMENT, WHENEVER POSSIBLE? ...................
4. IS EACH PIECE OF IN-HOUSE CALf~'t'TION
EQUIPMENT UNIQUELY IDENTIFIED BY IT
IDENTIFICATION NUMBER OR SERIAL NUMBER? .........
5. IS EACH PIECE OF TEST AN!l CAJ.IIIRATION EOIIIP-
HENT REQIJIRING PF.RionIC CALIIIRATION TAGGED(])
WITH A CALIIIRATION DUE DATF. LAIIF.L, WHEIIEVER
POSSIIILF.? ••....•..•..•••••.••.•.•.•.••. · .......••••
( J) A MIN[HllH OF 20 PIF.C:F.S OF TEST F.OIIIPHF.NT AND 5
PIECF.S OF CALIRRATION EOIIIPHEIIT, AND THF.IR COR-
RESPONDING CALIRRATION FILES, SHALL RF. RANDOMLY
SF.LECTF.D. APPLICAIILF. F.LEHF.IITS FROH T~F.SF. SF.LF.C:-
TIONS SHALL BE USED TO DETERMINE THE ADF.OUACY OF
THIS ITEH.
AYRII
GEOTECHNICAL LABORATORY AUDIT
MANDATORY REQUIREMENTS
DATE PAIi ,
Of I I
AUDIT LOCATU!!t
REMARKS/COMMENTS
-'1j O ;:::i::, CJ)
lll'1>1'Dr'D-OQn-<n
It) rt> ..... " •• (I) ..... --.... 0 w 0 :, -'-< :,
O C Z -Hi ..... Z 0 '< 0 • --w--0'01--'-
0 --"' 0) -u, -
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IT CORPORA TI ON
Southeast Region
Knoxville, TN
Southeast Region Quality Assurance ProcedureSR QAP~9.0, Rev. 0
Qua 1, Assura
Prepared by
4-/JJ-~
PROJECT RECORDS
( (/--,-,__,' ~ oJ»:!~./~ <z:P
· Corporate D1 re<ctor / /
Quality Assurance
Effective Date July 17, 1985
D289-QA-4-1
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PROJECT RECORDS
1.0 PURPOSE
SR QAP-9.0
Revision No. O
July 17, 1985
Page 1 of 6
To identify the categories of project records required to be produced, and to
establish methods for preparing and handling them. This procedure supplements
and amplifies discussions presented in the IT Corporation Engineering Services
Quality Assurance Manual (!TES QAM).
2.0 SCOPE
This IT Corporation (IT) Southeast Region Quality Assurance Procedure (SR QAP)
describes how project records which provide evidence that work was accomplished
to the required level of quality are prepared or received, maintained,
retrieved, and stored. Record categories to which this SR QAP applies are shown
in Attachment A.
This SR QAP, except for storage requirements, applies to all records produced or
received subsequent to the effective date of this SR QAP. The storage require-
ments apply to records for all "closed" projects (i.e., those for which project
closure reports have been prepared).
Records for active projects produced before the effective date of this SR QAP
shouJd be brought into compliance with these requirements as soon as ttme and
manpower constraints permit.
3.0 DISCUSSION
Documentation of quality-related activities is the cornerstone of an effective
QA/QC program. The records that are produced provide evidence that the activi-
ties were performed to the required level of quality. These records must be
properly prepared and reviewed, carefully retained and safeguarded, and readily
made available for viewing. Review, even after the records have been placed in
long-term storage, may stem from !T's needs, those of its clients, or those of
regulatory agencies. The required records must be accurate, complete, and
readily retrievable. Further, it cannot be emphasized too strongly that IT
records are corporate ~roperty -not the property of the individual who prepared
or received them for I •
4.0 REFERENCES
IT Corporation Engineering Services Quality Assurance Manual (!TES QAM).
5.0 DEFINITIONS
Ready retrieval means retrieval of a record upon request. For records in
Central F, les this would normally be within a few minutes after the search was
initiated. For records in remote storage, 24 hours, or whatever time period has
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been established, will constitute ready retrieval.
ret ri eva l is the ability to locate the record by a
opposed to having to sort through a large quantity
find it.
SR QAP-9.0
Revision No. O
July 17, 1985
Page 2 of 6
The key factor in ready
file number or other means as
of records endeavoring to
Safeguard means to temporarily or semi-permanently store records such that:
1. They are reasonably protected from unauthorized removal,
2. Confidential records are closely controlled,
3. They are reasonably protected from damage,
4. They are readily retrievable for viewing,
5. A list of the records being stored is maintained by "file number," and
6. The identity of persons who have records "checked out" is known.
Safeguard Repository is a place or location where records are being safeguarded.
6.0 RESPONSIBILITIES
Managers-in-Charge are responsible for seeing that personnel under their super-
vision adhere to the requirements of this SR QAP •
Project Managers are. responsible for seeing that records for their project (s)
are produced or received, reviewed, and placed in a safeguard repository in
accordance with this SR QAP.
Project Personnel are responsible for turning over to the Project Manager
records they produce or receive.
Safeauard Repository Personnel are responsible for safeguarding records in
accordance with this SR QAP.
Individuals are responsible for complying with the requirements of this SR QAP
tor records that they produce, receive, review, submit to a safeguard reposi-
tory, or use.
Southeast Resion QA Officer is responsible for preparing and distributing SR
QAPs tor proJect records management, and for conducting surveillance monitoring
and audits for procedure compliance and reporting the results to management.
7.0 PROCEDURE
7.1 General
The categories of records to which this SR QAP applies are shown in Attachment A.
These records will be prepared or received as a result of correspondence between
IT and others (or internally), contractual requirements, regulatory require-
ments, legal requirements, or company policies and procedures, including docu-
mentation requirements in the !TES QAM or in SR QAPs.
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SR QAP-9.0
Revision No. O
July 17, 1985
Page 3 of 6
The records should be reviewed or checked in accordance with any requirements in
the source documents which caused them to be produced or received. Where formal
review of records specified by SR QAPs is required, the method is described in
the SR QAP. All reviews are to be documented in the manner specified, or when
not specified, in a manner appropriate for the record. As a minimum, this will
consist of the initials of the reviewer and the date reviewed placed either on
the record or on a summary statement of the record scope. Attachment Bis to be
used for the summary staterrent.
7.2 Safeguarding of Records
7.2.l Safeguard Requirements
Records maintained in a safeguard repository will be provided:
• Reasonable protection from unauthorized removal
o Protection of, and compliance with, their confidential status, when
applicable
e Reasonable protection from damage
o A means of ready ret ri eva 1
e A means of identifying persons who have records "checked out"
• A list of the repository contents by "file number"
Restricted access to the safeguard repository or locks on the containers the
records are maintained in will normally satisfy requirements for protection
from unauthorized removal.
Confidential records will be handled in accordance with this SR QAP and the
special requirements of Attachment C.
Maintaining records in an orderly manner in a protective container, such as a
steel file cabinet, will normally satisfy requirements for protection from
damage. If the container is constructed of a material other than steel, an eva-
luation will be required to ascertain if reasonable protection is provided.
Ready retrieval of records requires that the records be maintained in a systema-
tic manner. This will normally be by sequential filing of records by project
number, letter designation shown in Attachment A, and a chronological .subnumber
within each letter designation. The subnumber is assigned as the records are
filed.
Confidential records maintained in separate locked files in accordance with
Attachment C will have a file card in the nonconfidential records file noting
their location.
Records in Central Files should be stapled, or put on posts and placed in
folders, or placed in binders within the protective container, if necessary, for
added protection or enhancement of identification and retrievability. Project
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SR QAP-9.0
Revision No. 0
July 17, 1985
Page 4 of 6
Managers are responsible for necessary or desirable consolidation before sub-
mitting records to Central Files. Records for different projects within the
same container should be separated by dividers with a tab identified by the pro-
ject number. Suitable external identification of individual containers is also
required, as applicable.
Maintaining the identity of persons who have records "checked out" of the safe-
guard repository can be accomplished by placing readily visible "check-out
cards" having the name, date, and where applicable, location of the borrower on
it in the location in the container from which the record was removed. When the
record is refiled, the card is removed and the entry on the card is lined
through. Another suitable method is to maintain a log of records removed and
borrowers. The list of repository contents by file number can be shown on
Attachment D grouped by letter designation and project number and placed at the
front of the records for that project. A suitable log can also be used. The
list serves both as an index and as a complete list of contents.
7.2.2 Safeguard Repositories
The principal repository for safeguarding records will be the Central Files •
A temporary alternate repository is the Project Managers' files. Both are
required to be safeguarded. Personal files are not to have any originals or
"file" copies of project records in them. Originals and file copies are filed
only in Central Files or Project Manager's files.
Records retained by the Project Manager, after being produced or received,
should be placed in Central Files as soon as practicable, and, in any event, not
later than the date of issue of the project closure report. In most cases it
would be advantageous to the project team to have incoming records placed in
Central Files immediately, with the project manager retaining a working copy.
7.2.3 Submitting Records to Safeguard Repositories
Refer to Attachment E.
Recipients of externally-prepared records and originators of internal records
are responsible for seeing that the original (or file copy of internal records
if original has been sent to others) is placed in or routed to a safeguard repo-
sitory.
Incoming correspondence is to be copied as soon as received, marked with the
appropriate file number, and placed in Central Files. The addressee, and others
as appropriate, will be given a copy, rather than the original. In most cases
the Project Manager will need to supply the project number, particularly if work
is being performed on more than one project for a particular client.
All memos and letters typed for either external or internal distribution are to
be identified with the project number and appropriate letter designation from
Attachment A, copied and the copies placed in Central Files.
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SR QAP-9.0
Revision No. O
July 17, 1985
Page 5 of 6
All other records must be placed in the appropriate safeguards repository as
soon as practicable. The latest date for records in Project Managers' files to
be placed in Central Files is the date of issue of the project closure report.
Records which the Project Manager submits at that time should be purged by the
Project Manager of duplicates and informal notes that do not relate to the
decision-making process and/or methodology for performing the work.
All records submitted to safeguard repositories must be identified with the pro-
ject number and letter designation. Attachment For similar form, should be
used for this purpose, unless the identifier appears on the record. Project
Managers should be consulted if there is doubt as to the proper identifier.
Suggested file categories are shown in Attachments A and G.
Upon receipt, safeguard repository personnel will enter the records on
Attachment Dor a suitable log. I 7 .2 .4 Record User Requirements
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Individuals who use records are required to protect records in their possession
from damage, alteration, or loss; to comply with confidentiality and non-
disclosure requirements (see Attachment C and Section 16 of current Master
Services Agreement and applicable portions of previous agreements); to comply
with submittal and "check-out" requirements; and to keep records no longer than
necessary. Filing and retrieval of records in safeguard repositories are to be
performed by repository personnel, except in abnormal circumstances when they
are not present. Under these circumstances, retrieval will be under controlled
conditions established by the responsible manager.
7.2.5 Record Retention Requirements
Records will be retained by Central Files until other disposition has been spe-
cifically authorized in writing by the Operations Manager. Notwithstanding this
requirement, records for closed projects will be purged of all duplicates and
informal notes that do not relate to the decision-making process and/or methodo-
logy for performing the work.
Central Files personnel will be responsible for reviewing closed files and
removing duplicates. Duplicate material will be discarded unless the Project
Manager has specified other disposition.
Project Managers, or the responsible manager when a Project Manager is not
accessible, are responsible for purging informal notes from closed project
records.
8.0 DOCUMENTATION
As required by Section 7.1, the review of records for which the review method is
not described elsewhere will, as a minimum, be documented by the initials of the
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SR QAP-9.0
Revision No. O
July 17, 1985
Page 6 of 6
reviewer and the date of the review placed on the record. Attachment B may be
used where applicable.
The evaluation required by Section 7.2.1 for safeguarding records in containers
other than steel will be documented by the responsible manager or designee and
safeguarded in Central Files. This evaluation is for a particular set of
storage conditions (container type and storage room) and can be applied to all
subsequent storage after the initial evaluation so long as the storage con-
ditions do not change.
The list of safeguard repository contents required by Section 7.2.1 is to be
prepared, maintained, and safeguarded in the repository. If this list does not
serve as an index to project files, a detailed index is also required.
9.0 ATTACHMENTS
Attachment A -Project Central File Categories
Attachment B -Record Review Documentation
Attachment C -Handling Client Confidential Information
Attachment D -Project Index
Attachment E -Flowchart for Project Records
Attachment F -Suggested File Identifier
Attachment G -Suggested F.ile Letter
D289-QA-4-l to 7
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SR QAP-9.0
Re vi s i on No. 0
Attachment A
July 17, 1985
Page 1 of 3
PROJECT CENTRAL FILE CATEGORIES
Category
Correspondence
"Blank"
Originals
Bids, contracts, and
specifications
Field data and checkprints
0289-QA-4-AP-l
Letter
Designation
A
B
C
D
E
Content Examples
Incoming and outgoing letters, memos,
telexes, telephone conversation records,
.etc. Subcategories will, as a minimum,
include:
"Al" -General in-house correspondence
"Al T" -All outgoing correspondence
"Al F" All incoming correspondence.
This category can be used for a project
specific need. As the system is used
within IT and a general need develops,
the category may be assigned in the
future.
Type originals for reports, regulatory submittals, applications, specifica-
tions, reports, proposals, etc.
Oversize tables should be folded and
placed in the same folder as the report
after the report has been printed.
Camera reduced copies of oversize tables
should be included_ in the body of the
report originals.
Copies of bids, proposals, contracts,
purchase orders for services, and speci-
fications; whether they are submitted by
IT to a client or subcontractor, or vice
versa.
Subsurface logs, test data forms,
calibration records, daily field logs,
sample collection forms, waste handling
and placement data, waste manifests,
inspection reports, instrument installa-
tion data, subcontract data, etc. This
includes all information generated by
the field personnel at the site, with
the exception of health and safety
records.
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Letter
Category Designation
Calculations and checkprints F
Reports from others G
IT reports H
Photographs
Miscellaneous
Laboratory data and
checkpri nts
Regulatory submittals and
licensing and permitting
applications
0289-QA-4-AP-2
J
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SR QAP-9.0
Re vi s ion No. 0
July 17, 1985
Attachment A
Page 2 of 3
Content Examples
All calculations and checkprints should
be identified on the file folder tabs by
project number, date, and subject. Each
set of calculations and checkprints
should be placed in the same folder, if
possible.
All reports received from clients or
reports by other consultants
Copies of all reports containing the
results of project activities and pre-
pared by IT except submittals filed in Ill. II
Each photograph is to be identified by
project number, date taken, and descrip-.
ti,on. Photographs should be accom-
panied by their negatives.
Only for those extreme instances when an
item cannot be placed in any other cate-
gory.
Laboratory Test data and results for
both field and office laboratories. In
general, this will include only data
prepared by laboratories external to IT.
IT laboratories will maintain the data
within the laboratory. This category
can be used for data summaries issued by
IT 1 aboratori es.
Copies of all documents, including
responses to questions, issued by
IT to regulatory agencies either on
behalf of a client or on behalf of IT.
Also included would be submittals made
by a client using information provided
by IT.
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Category
Reference material
Site monitoring records
Drawing checkprints
Confidential records
QA/QC records
-Letter
Designation
M
N
0
p
Q
SR QAP-9.0
Revision No. 0
Attachment A
July 17, 1985
Page 3 of 3
Content Examples
All reference materials such as
newspaper articles, journal articles,
etc., which pertain to a particular pro-
ject.
Site monitoring records related to
industrial hygiene such as personnel,
area, and perimeter sampling and moni-
toring that are not specified for record
maintenance with IT corporate health and
safety records.
Checkprints for drawings, figures, and
sketches.
These records will be prominently marked
"confidential" and in· addition will have
the letter "P" preceding the file iden-
tifier.
QA/QC documentation, including that
required by the ITES QAM or SR QAPs
which does not fall in any of the pre-
ceding categories.
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Project No. __________ _
File Identifier ________ _
SR QAP-9.0
Revision No. 0
Attachment B
July 17, 1985
Pagel of l
RECORD REVIEW DOCUMENTATION
This form is to be used for documenting required reviews of records when it is not
feasible or not desirable to document the review on the actual record.
Identification of Record Reviewed
Record title or subject _________________________ _
Date record was prepared _________________________ _
Record preparer or originator ______________________ _
Description of record and/or summary statement of record scope ________ _
Date reviewed _____________ _
Reviewer Review Comments or Conclusions ---------------
D289-QA-4-AP-4
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HANDLING CLIENT CONFIDENTIAL INFORMATION
SR QAP-9.0
Revision No. 0
Attachment C
July 17, 1985
Pagel of 3
All information which is transmitted to IT and is designated by the client as
being confidential will be handled according to the following procedures:
A. Custodian
The Project Manager will d~signate one individual in the project as having
prime responsibility for custodianship of confidential information. A copy
of this written designation is to be sent to Central Files for information
and filing. The responsibilities of custodianship will include:
1. Reviewing, with the Project manager, the confidential material
immediately upon receipt to determine whether the information is
required by IT; if so, it will be accepted; if not, it will imme-
diately be returned to the client.
2. Making sure that each piece of confidential information is clearly
designated "confidential."
3. Briefing IT employees who will have access to confidential informa-
tion, including Central Files personnel.
4. EstablishiQg a "need to know" with each IT employee receiving con-
fidential information.
5. Determining that each area of these procedures for confidential infor-
mation is met.
6. Executing the appropriate individual secrecy agreements with IT
employees if the client should require a specific agreement in addi-
tion to the agreement each employee has signed with IT as a condition
of employment. He will also maintain a record of all employees
signing such agreements.
B. Storage
1. Confidential material should be stored in a locked file controlled by
the custodian or Central Files personnel unless it has been released
to a cleared individual.
2. Confidential material should be under surveillance of a .cleared
employee at all times when is it out of storage and handled in the
following manner:
D289-QA-4-AP-5
a. In the presence of unauthorized persons, confidential material
will be either placed face down, or placed in a locked file
drawer.
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HANDLING CLIENT CONFIDENTIAL INFORMATION
(Continued)
SR QAP-9.0
Revision No. 0
Attachment C
July 17, 1985
Page 2 of 3
b. All material will be placed either in the cleared employee's
locked file drawer or returned to the custodian's file or the
locked file in Central Files when not in use.
C. Individual Custodianship
When confidential information is released to a cleared employee, it will be
his responsibility to maintain the confidentiality of the material by
observing the procedures set forth in this document as well as any other
prudent practices required. Client confidential information will be
treated with the same care as IT confidential information.
D. Release
E.
No cleared employee shall release orally, visually, or in writing any con-
fidential information at any IT or outside seminar or any other public
gathering unless such gathering is attended~ by authorized employees of
IT who have the "need to know." Release of tneconfidential information
outside of IT must have hrior client approval and the approval of the
Operations Manager. Bot approvals should be in writing.
Transport
1. Whenever transport of confidential information is unavoidable, the
preferred method will be for a cleared employee to hand carry the
material, both within an IT office and between locations.
2. When confidential information is carried in the possession of a
cleared employee, the material will be retained in the immediate
possession of the employee. Confidential information will not be
checked as baggage on commercial carriers.
3. Confidential material to be dispatched from IT will be wrapped in an
inner wrapper and marked as confidential. The outer wrapper will be
plain, with no such designation. It will be taken to the post office
by designated personnel and sent by registered mail or sent by
registered commercial carrier.
F. Reproduction
Reproduction of confidential material will be kept to an.absolute minimum
and will be handled in the same manner as the original confidential
material.
D289-QA-4-AP-6
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HANDLING CLIENT CONFIDENTIAL INFORMATION
(Continued)
G. IT Generated Documents
SR QAP-9.O
Revision No. O
Attachment C
July 17, 1985
Page 3 of 3
1. In cases where information is extracted from confidential documents
and incorporated into IT-generated reports, it will be the respon-
siblity of the Project Manager to evaluate the extracted material
relative to its sensitivity. Extracted materials assembled in a
manner that could be considered confidential will be treated in the
same manner as the original confidential material form the client,
including designation of IT-generated documents as confidential.
2. Generally, most extracted material will be considered nonconfidenti?.l,
but if necessary it will be classified confidential. For example,
waste records would generally be classified nonconfidential, and IT-
generated flow sheets of client's processes could be considered
confidential.
H. Retentions
At the completion of a contract, all confidential information will be
returned to the locked file in Central Files or to the custodian, who will
see that the specific contractual obligations governing such information
are met.
I. Destruction
1. IT will destroy (usually by shredding) or return any confidential
material which has been issued by a client, or any reproductions of
same, if the client wishes it so or if IT retention requirements have
been satisfied. The client should have full prior knowledge of our
intent.
2. Confi-dential material which has been generated by IT from confidential
material transmitted by a client will be retained in storage until IT
retention requirements are met. Such material will be destroyed by IT
when IT records retention requirements have been satisfied, using the
same destruction techniques as would be used for !T's own confidential
materi a 1.
D289-QA-4-AP-7
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3.0
Sect ion No . 3 . 0
Rev is ion No. 0
Date: December 20, 1984
Page I of 7 ·
STANDARD LABORATORY PRACTICE
Daily activities within an analytical laboratory are directed toward the
analysis of samples. However, there are many laboratory functions which
precede and follow analysis that are necessary to control and verify the
analysis. The functions, as a total, represent the daily implementation
of the Quality Assurance Program by the laboratory staff.
This section serves as an introduction to these functions and provides
an overview of them as the total system providing Quality Assurance
within the laboratory. Figure 3-1 presents a flow chart of functions
for laboratory analyses. The functions shown can be divided into those
which directly involve a sample, laboratory functions, and those which
are independent (in general) of specific sample analysis, auxiliary
functions.
Each function is affected by those which precede it, Therefore, it is
imperative that each function be controlled in a specified manner. It
is the purpose of the Quality Assurance Program to provide control by
specifying how functions are to be performed, and by providing "checks
and balances" to verify performance.
Each function is discussed in detail in the sections which follow
(Sections 4.0 through 13.0 as denoted in Figure 3-1). Following is a
brief discussion of the activities performed for each function and their
role in the Quality Assurance Program,
3.1 RECEIPT OF SAMPLES AND INITIATION OF TESTING PROGRAM
Upon receipt of samples in the laboratory, the following is done:
• Samples are examined for damage, checked for
proper preservatives, or preserved as required
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(I
• Chain of custody is completed
Sect ion No . 3. 0
Revis ion No. 0
Date: December 20, 1984
Page 2 of 7
• Samples are placed in the proper storage
environment
• Testing program is defined
• Determine acceptable holding times until samples
must be analyzed
• Samples are logged into the laboratory sample
stream.
3.2 MATERIAL AND INSTRUMENT PREPARATION
Concurrent with the performance of analysis are auxiliary functions
performed to provide appropriate materials to the Analysts, and verify
and maintain instrument performance.
3.2.1 Material Procurement and Control
• Specifying grades of reagents, solvents, gases,
and water used within the laboratory for specific
analyses, and verifying adequacy of these
materials before use
• Specifying material composition and volumetric
tolerance of laboratory vessels
• Controlling reagents, solvents, etc., during
storage
• Cleaning protocol for laboratory vessels.
3.2.2 Calibration
• Scheduled comparison of instrument performance
against national standards for instruments which
measure physical parameters, such as mass, time,
and temperature. This type of calibration is
independent of use in specific analyses and
projects.
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Section No. 3.0
. Revision No. 0
Date: December 20, 1984
Page 3 of 7
• Determination of instrument response to known
chemical compos it iun and concentration. Cali-
brat ion may be part of daily instrument usage to
define response for post analysis data processing
of analytical raw data, or as response checks
during or at the completion of a instrument
run. This type of calibration may be independent
of or part of the analysis for a specific
project.
3.2.3 Preventive Maintenance
• Servicing instruments on ·a scheduled basis to
maintain performance
• Maintaining a stock of instrument parts which are
known to regularly degrade because of usage
• Preparing log books so that the historical
performance of an instrument can be assessed.
3.3 ANALYTICAL PROCEDURES
The actual analysis of samples occurs during this function; however, for
the analysis to be complete, several activities must be coincident:
• Sample holding times and storage environment are
reviewed by the analyst to verify that sample
integrity has been maintained
• Analysis is performed in accordance with standard
methods adopted by ITAS or as specified by the
client. Analysis results include:
-Prescribed daily instrument calibration or
instrument tuning and documentation
Analysis of Quality Control samples and/or
standards as part of the sample stream at the
level of samples required.
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Sect ion No. 3. 0
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Date: December 20, 1984
Page 4 of 7
3,4 PROCESS QUALITY CONTROL DATA
There are four steps involved in the total verification of analytical
data:
e Computation of Quality Control sample data
• Comparison of Quality Control data with
analytical acceptance limits
• Computation of analytical results from the data
• Independent validation of analytical results.
In general, Quality Control data and analytical data are interconnected,
However, for the purposes of this discussion, the preparation of Quality
Control data and the processing and evaluation of analytical data will
be discussed separately because of the difference in quality assurance
requirements for each.
Section 3.4 discusses Quality Control data, and Section 3,6 discusses
the treatment of analytical data,
Quality Control samples results are analyzed and the QC data are
compared against stated acceptance levels for accuracy and precision.
The data are used, as appropriate, to update control charts, If the QC
data meets acceptance levels, processing of the analytical data
begins, If the QC data are unacceptable, corrective action must be
taken,
3.5 CORRECTIVE ACTION
If Quality Control ·data are unacceptable, the cause must be deter-
mined, If the cause can be resolved so that the integrity of the
analytical data are not affected or can be corrected, the processing of
the analytical data can proceed, Nonconformances which affect the
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Sect ion No • 3. 0
Revision No. 0
Date: December 20, 1984
Page 5 of 7
integrity of analytical data will require resolution by reanalysis of
the affected samples.
3.6 DATA PROCESSING AND VALIDATION
• Analytical test results are calculated by the
analyst using computational methods prescribed
for the various analytical methods
• The resulting data are validated, as required, by
an individual independent of the analysis. Vali-
dation demonstrates that the proper input
parameters (such as response factors or dilu-
tions) have been used and the mathematical
manipulation is correct.
3. 7 REPORTING
• Analytical data, and Quality Control data if
appropriate, are summarized in presentation
format
• The data are reviewed to verify the objectives of
the analysis are met
• After approval by the Laboratory Manager, the
data are issued.
3.8 RECORDS MANAGEMENT
There are two categories of records prepared within an ITAS laboratory:
• Project-specific records which are related solely
to the analysis performed for a group of samples
such as chain-of-custody and raw analytical data
• Records which demonstrate overall laboratory
operation, and are, in general, independent of
specific projects, such as the master laboratory
sample log-in book, instrument performance, and
maintenance log books and control charts.
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Revis ion No. 0
Date: December 20, 1984
Page 6 of 7
Separate files are maintained for each category of records. However,
the docwnent control system enables cross-referencing of records (such
as for instrument performance and maintenance log books) so that
implementation of the Quality Assurance Program can be demonstrated.
LEGEND
PERTINENT
SECTION
IN MANUAL
AUXILIARY
FUNCTIONS
4.0 MATERIAL
PROCUREMENT & CONTROL
6.0 CALIBRATION
7.0 PREVENTIVE
MAINTENANCE
"' :> HZ HO UH
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0
5 .o
8.0
fJ &
9.0
8.0
&
10 .o
QC
LABORATORY
FUNCTIONS
RECEIPT
OF
SAMPLES
AND
INITIATION
OF
TESTING
PROGRAM
ANALYTICAL
PROCEDURES
PROCESS
QC
DATA
QC
M UNACCEPTABLE ACCEPTABLE
~
ACTIVITY
DATA
10.0 PROCESSING &
VALIDATION
11.0 REPORTING
12 .0 RECORDS
MANAGEMENT
FIGURE 3-1
LABORATORY ANALYSIS
FLOW CHART
ACTIVITIES
• Complete chain of custody
• Sample log in
• Define tests to be performed
on specific samples
• Define QC sample requirements
• Analysis of samples
• Analysis of QA samples
• Summarize QC data
• Update control charts
• Statistical treatment of data
• Calculate analysis results
• Independent data review
• Stunmarize data
• Issue within IT or to client
• Prepare project file
• Maintain reords
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7.0
Sect ion No . 7 . 0
Rev is ion No. 0
Date: December 20, 1984
Page I of 4
PREVENTIVE MAINTENANCE
Preventive maintenance is an organized program, within ITAS labora-
tories, of actions (such as equipment cleaning, lubricating, recon-
ditioning, adjustment and/or testing) taken to maintain proper
instrument and equipment performance and to prevent instruments and
equipment from failing during use. An adequate preventive maintenance
program increases reliability of a measurement system. A preventive
maintenance program considers the following:
• Instruments, equipment, and parts thereof that
are subject to wear, deterioration, or other
change in operational characteristics without
periodic maintenance.
·• Spare parts that should be available within the
laboratory to minimize downtime.
• Frequency that maintenance is required,
The implementation of a preventive maintenance program is dependent upon
the specific instruments and equipment used with in an ITAS laboratory;
therefore, this manual does not designate specific practices for
instruments and equipment, Each ITAS laboratory shall prepare a pre-
ventive maintenance program which meets the guidelines presented in this
section, The program is considered a Laboratory Specific Attachment to
this Quality Assurance Manual.
Within a laboratory, the Operations Manager is responsible for prepara-
tion and documentation of the program. Group Leaders shall implement
the program, and the QC Coordinator shall review implementation to
verify compliance.
Each ITAS laboratory preventive maintenance program shall include the
following:
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Sect ion No. 7. 0
Revision No. 0
Date: December 20, 1984
Page 2 of 4
• A listing of the instruments and equipment that
are included in the program
• The frequency of maintenance considering manu-
facturer's recommendations and/or previous
experience with equipment. The listing and
maintenance frequency should be provided on a
schedule such as Figure 7-1. Frequency should be
stated in terms of monthly, quarterly, etc.
• For each instrument in the program provide:
- A list of spare parts maintained by the
laboratory
-External service contracts
-Items to be checked and/or serviced during
maintenance and directi_ons for performing
maintenance (if external service is not pro-
vided, or if not stated in manufacturer's in-
strument manuals).
Preventive maintenance should be documented as discussed below and the
records stored in accordance with Section 12.2 of this manual. The
master schedule (Figure 7-1) should be kept at the beginning of the
mai~tenance records. Behind the schedule, a separate file should be
maintained for each instrument. The instrument file should include:
• Spare parts list
• External service contracts
• Checklist of items to be serviced and directions
for maintenance or manufacturer's instrument
manuals
• Record of periodic maintenance.
The record of maintenance can be documented using Figure 7-2. Comments
should note any parts which were replaced, observed deterioration, etc.
INSTRUMENT/EQUIPMENT
PREVENTIVE MAINTENANCE SCHEDULE
SERIAL NUMBER MAINTENANCE
FREQUENCY
FIGURE 7-1
PREVENTIVE MAINTENANCE SCHEDULE
MAINTENANCE
REQUIRED TO BE PERFORMED BY
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INSTRUMENT ----------SER I AL NUMBER ---------MAINTENANCE FREQUENCY ____ _
MAINTENANCE PERFORMED BY
-
DATE
FIGURE 7-2
PREVENTIVE MAINTENANCE RECORD
Section 7.0
Revision No. 0
Date: December 20, 1984
Page 4 of 4
COMMENT
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Sect ion No. 12. 0
Rev is ion No. 0
Date: December 20, 1984
Page 1 of 14
12.0 RECORDS MANAGEMENT
The ITAS Quality Assurance Program has been developed to provide analyt-
ical results of known quality. To demonstrate that quality has been
achieved, each ITAS laboratory maintains a records management system
that includes documents pertinent to the analytical performance of the
laboratory.
Laboratory records are maintained in two broad categories:
• Documents which are specific to a project or a
group of samples within an ongoing project, such
as chain of custody and raw analytical data.
• Documents which demonstrate overall laboratory
operation, such as instrument log books and
control charts. These records will directly
affect the data for a specific project, but in
general their appl icab il ity is not limited to one
project.
Following is a description of the records system used within ITAS. If
it is necessary for a specific laboratory to deviate from this system,
the laboratory shall maintain a description of their system as a
Laboratory-Specific Attachment to the Quality Assurance Manual. Also,
ITAS recognizes that specific regulatory or contractual demands may
require deviation from the system described herein. In these instances,
records shall be maintained as externally required.
·12.l PROJECT RECORDS
Separate record packages are maintained for each project. Filing of
records for a specific project shall be by the unique project
identification number assigned by the laboratory for that project.
Within a project file, categories of information are filed separately.
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Section No. 12.0
Revision No. 0
Date: December 20, 1984
Page 2 of 14
Table 12.1 presents the categories used within a project file. It is
not expected that all categories will be applicable for every project.
However, in all project files, specific information will be filed in
accordance with the category designation provided. Following is a brief
discussion of each category:
Project Index
Each project file shall have an index that lists each record unit within
the project file.
Figure 12-1 presents an example of a project index page. An individual
index file page should be used for each category applicable to a
project. Within a specific category, individual files should be given a
unique file number and be 1 isted on the file index page.. For example,
if a testing program involves distinct groups of samples over a period
of time, file number Bl should contain the chain of custody from the
first group, B2 the chain of custody for the second group, etc. A brief
description of the file contents should be made. Such as for the chain
of custody records for a group of samples, the description could be the
dates the samples were collected.
A -Correspondence
All correspondence pertinent to the analytical program shall be
maintained. This includes letters to and from clients and internal
memorandums. Correspondence should be filed chronologically. Data
reports and analysis requests are maintained in· separate categories.
The correspondence file should be updated as necessary. Each item of
correspondence should not be entered in the project index. Rather, the
index should list blocks of dates, such as for file Al, the description
could be July 30, 1982 to January 10, 1983; for file AZ, the description
could be January 11, 1983 to September 17, 1983, etc.
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B -Chain of Custody
Section No. 12.0
Revision No. 0
Date: December 20, 1984
Page 3 of 14
Chain of custody records shall be maintained by the laboratory. The
chain of custody forms should be filed for groups of samples as received
and should be placed in the project file immediately after they are
signed by the Quality Control Coordinator. When the samples are
disposed of, this entry shall be made on the appropriate chain of
custody form.
C -Field Records
All field records supplied by field personnel pertinent to the analyti-
cal program shall be maintained. This could include the results of
field tests or logs of sample collection. It is the responsibility of
field personnel to provide records to the laboratory.
D -Request for Analysis
Analysis requests provided by field personnel are maintained in this
file. Also, any changes or additions to the analytical program should
be documented in this file.
E -Calibration Records
In general, calibration records are maintained with laboratory operation
records. However, if an analytical program requires calibration which
is performed solely for a project, the records shall be maintained Ln
this file. If calibration is performed as an integral part of the
analytical process; the calibration records should be maintained with.
the analytical data.
F -Analytical Data
Analytical data files should be complete for a group of samples. The
file should contain raw analytical data, processing of the data and/or
data reduction, and data validation. It should be possible to use a
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Section No. 12.0
Revision No. 0
Date: December 20, 1984
Page 4 of 14
data file to completely demonstrate that the data have been adequately
obtained, processed, and reviewed, It is recommended that data be filed
in accordance with the type of analysis performed, Suggested subcate-
gories for data are presented in Table 12.1.
G -Quality Control Samples
If Quality Control samples, such as field blanks, are processed for a
specific project, the data shall be maintained with the project file.
The results of Quality Control samples processed on a general basis are
included in the laboratory operations files, Statistical evaluation of
Quality Control sample data for a project shall also be maintained in
this file.
If Quality Control samples are processed as an integral part of a group
of samples such that the data cannot be readily separated, the Quality
Control sample data can be stored with the analytical data.
H -Data Reports
Complete copies of all reports issued by the laboratory shall be kept in
the project file, With the reports shall be the review copy checked to
verify the data. If the report provides copies of data packages which
are stored in Category F -Analytical Data, a memorandum should be
attached to the report copy stating which specific files were
included.
I -Project-Specific Requirements
If a project requires analytical procedures other than what is adopted
in the ITAS Quality Assurance Program, the requirements shall be in-
cluded in this file. Specific requirements may be due to government
regulation, specific contracts, or project need. Changes from stated
practice can be, for example, frequency of QC sample analysis, test
method, statistical data evaluation, and reporting format .
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Section No. 12.0
Revis ion No. 0
Date: December 20, 1984
Page S of 14
If it _is necessary to adopt a new analytical procedure, a procedure
different than conventionally used, or alter an existing procedure, the
method used for the project must be documented. If the analytical
procedure is developed by an ITAS laboratory as part of the analytical
program, the procedure shall be documented and included. If an existing
procedure is altered, the Analyst or Group Leader shall prepare a
memorandum to the project file stating what the changes were and the
justification for change.
J -NonconformanceS
Nonconformances and subsequent corrective actions which are specific to
a project are included in this file. The record should be in the form
of a memorandum (or copy of other records discussed in this manual) with
the nonconformance stat.ed, how it was corrected, and the approval for
the correction. A separate file for each incidence is not required, the
file should• be maintained chronologically.
K -QA Plans
If a specific Quality Assurance Plan, and rev1s1ons, are prepared for a
project, they shall be stored in this file.
L -Miscellaneous
The miscellaneous file includes all records not applicable to the pre-
vious categories. Each distinct record(s) in this file should be
entered in the project index.
12.2 GENERAL LABORATORY OPERATIONS RECORDS
General laboratory records document overall laboratory performance and
operation, These records are filed separately from project records and
will be maintained so they can be referenced to project records if
necessary. Examples of general records pertinent to project records are
·instrument log books and computer software verifications.
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Section No. 12.0
Revision No. 0
Date: December 20, 1984
Page 6 of 14
There are two types of general laboratory records:
• Documents which demonstrate laboratory
performance
• Reference documents for laboratory operations.
Records which demonstrate laboratory performance shall be filed in
categories in a manner similar to project files. Reference documents
are not indexed and their usage is not controlled.
Table 12.2 recommends the laboratory performance records to be main-
tained and the category system for their maintenance. Also shown in
this table is the manner in which the files can be correlated to project
files, if required.
12. 1.
Indexing of files should be as described in Sect ion
Many of the laboratory operations records are in daily use, such as the
Master Sample Log Book, instrument calibration logs, and control
charts. It is not intended that the records be stored daily while they
are in use. However, when individual log books, etc., are filled, they
shall be placed in the files. For a book that is in use, it should be
designated by a file index code and entered into the index. For
example, considering the Master Sample Log books, the book for the
period August 30, 1983 to April 4, 1984 is designated Al. Because it is
complete, it is stored. Book A2 starts on April 5, 1984 and is st ill in
use; therefore, the index would list A2, April 5, 1984 to
completion date would be entered when book A3 is started.
Following is a brief discussion of the categories:
Index File
The index should be maintained as discussed in Section 12.1.
The
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A -Master Sample Log Book
Section No. 12.0
Revision No. 0
Date: December 20, 1984
Page 7 of 14
The master sample log books chronologically record all samples entering
the laboratory, independent of project designation.
B -Instrument Calibration Logs
All calibration performed independent of a specific project shall be
recorded by instrument. A separate file should be maintained for each
instrument subject to calibration.
C -Instrument Maintenance Logs
Separate maintenance files should be kept for each instrument incorpo-
rated in the preventive maintenance program. The file shall include
records of maintenance performed in-house or by outside groups. Service
contracts should be included in the file for the applicable instrument.
D -Computer Software Verification
Copies of the data used to verify performance of software shall be main-
tained. For software that is periodically reverified with standard
problems, the results of the performance shall be maintained. A
separate file for each software package shall be indexed.
E -Performance Evaluation Records
Laboratory participation in Performance Evaluation Programs shall be
documented in this category. If performance standards are analyzed as
part of the overall Quality Control sample program, the results should
be included in Category G.
F -Certification Program Records
If the laboratory participates in Certification programs, such as the
AIHA program, the results shall be maintained in this category. Records
should include all correspondence, analytical data, agency results, and
certificates of performance.
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G -QC Sample Analysis
Section No. 12.0
Revis ion No. 0
Date: December 20, 1984
Page 8 of 14
This file should include the results of all QC samples inserted into the
sample stream by the QC Coordinator. It is recommended that the files
be maintained chronologically for each parameter included in the QC
program.
H -Control Charts
Control charts should be filed chronologically for each parameter.
I -Purchased Material Certificates
All information which verifies that purchased materials meet the re-
quirements of the laboratory should be maintained. Certification may be
supplied by a vendor or from in-house verification analysis. Separate
files should be kept for chemicals, gases, water, glassware, etc.
J -QC Coordinator Reports
This file includes the monthly reports prepared by the QC Coordinator.
Required signatures must be included. The file should be maintained
chronologically.
Table 12.3 lists reference documents which should be available within
the laboratory. These documents are not included 1n the laboratory
record system and should be kept where used. Reference documents shall
be revised and updated as necessary to maintain them as "currently
applicable documents. 11
12.3 RECORD CONTROL
The Laboratory Manager shall designate an individual responsible for the
records management s_ystem. Th is person shal 1:
• Initiate new project files including the project
index
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TABLE 12.1
PROJECT RECORDS
FILING CATEGORIES
Section No. 12.0
Revision No. 0
Date: December 20, 1984
Page 11 of 14
RECORD DESCRIPTION
Project Ind ex
Correspondence
Chain of Custody
Field Records
Request for Analysis
Calibration Records
Analytical Data
-GC Data
-GC/MS Data
-Metals
-General Chemistry
-Soils Chemistry
-Other
QC Samples
Data Reports
Project-Specific Requirements
Nonconformances.
QA Pl ans
Miscellaneous
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TECHNOLOGY CORPORATION
Section No. 12.0
Revision No. 0
Date: December 20, 1984
Page 12 of 14
TABLE 12.2
LABORATORY PERFORMANCE RECORDS
FILING CATEGORIES
CATEGORY
A
B
C
D
E
F
G
H
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RECORD DESCRIPTION
Index File
Master Sample Log Books
Instrunent Calibration Logs
Instrunent Maintenance Logs
Computer Software Verification
Performance Evaluation Records
Certification Program Records
QC Sample Analysis
Control Charts
Purchased Material Certificates
QC Coordinator Reports
CORRELATION TO
PROJECT FILES
By date of arrival and
sample nunber
By date, instrunent
serial nunber, and
analyst
By date and instr unent
serial nunber
By date and software
designation
By date and sample
designation
By name of program,
date, and sample
designation
By date and sample
nunber
By chemical parameter,
date, and sample
nunber
By date and parameter
By date
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TABLE 12.3
REFERENCE DOCUMENTS
• InstrtJDent Manuals
• Computer/Software Instruction Manuals
• Analytical Procedures
• QA Manual/Laboratory-Specific Attachments
Section No. 12.0
Revision No. 0
Date: December 20, 1984
Page 13 of 14
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TECHNOLOGY PROJECT IN O EX
CORPORATION
Section No. 12.0
Revision No. 0
Date: December 20, 1984
Page 14 of 14
PROJECT NUMBER' ------,------------
PROJECT NAME, ---------------
CATEGORY, __________________ _
FILE
DESIGNATION I DESCRIPTION
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