Environmental Technology Verification Coatings and
Coating Equipment Program (ETV CCEP)
Final Technology Applications Group TAGNITE -
Testing and Quality Assurance Plan (T/QAP)
July 24, 2006
Distribution Statement "A" applies
Approved for public release; distribution is unlimited
Requests for this document shall be referred to:
Office of the Assistant Secretary of the Army
for Installations and Environment
ASA (I&E) - ESOH
1235 Clark Street
Crystal Gateway 1, Suite 307
Arlington, VA 22202-3263
Contract No. W74V8H-04-D-0005
Task No. 0428
CDRL No. A004
Prepared by
National Defense Center for Environmental Excellence (NDCEE)
Submitted by
Concurrent Technologies Corporation
100 CTC Drive
Johnstown, PA 15904
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REPORT DOCUMENTATION PAGE
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3. REPORT TYPE AND DATES COVERED
Final (Sep. 2005 - Nov. 2006)
4. TITLE AND SUBTITLE
Technology Applications Group TAGNITE - Testing and Quality Assurance Plan (T/QAP); Revision No. 0
6. AUTHOR(S)
Principal Author/PMt: Robert J. Fisher, CTC
5. FUNDING NUMBERS
Contract: W74V8H-04-D-0005
Task: NDCEE Task No. 0428
1. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES)
National Defense Center for Environmental Excellence
Operated by Concurrent Technologies Corporation
100 CTC Drive
Johnstown, PA 15904
PERFORMING ORGANIZATION
REPORT NUMBER
9. SPONSORING/MONITORING AGENCY NAME(S) AND ADDRESS(ES)
NDCEE Program Office (Office of the Assistant Secretary of the Army for Installations and Environment)
1235 Clark Street, Suite 307
Arlington, VA 22202-3263
Program Manager: Dr. Chuck Lecher, NDCEE Program Manager, 703-602-5538
10. SPONSORING/MONITORING
AGENCY REPORT NUMBER
NDCEE-CR-2006-058
10 SUPPLEMENTARY NOTES
12a. DISTRIBUTION/AVAILABILITY STATEMENT
Approved for public release; distribution is unlimited.
12b. DISTRIBUTION CODE
13. ABSTRACT (Maximum 200 words)
The ETV CCEP verifies the pollution prevention and performance characteristics of coating technologies and make sthe results of the testing available to
prospective coating technology users. The objective of this particular Testing and Quality Assurance Plan (T/QAP) is to establish the performance of the Technology
Applications Group (TAG) TAGNITE magnesium anodizing process. This innovative process was developed and patented by TAG to replace other anodizing
processes and conversion coatings for magnesium alloys. The test data from this verification test will be compiled and used to develop a Verification Report, and, at the
discretion of the vendor, a Verification Statement will be developed from the data contained in the Verification Report. TAG may use the Verification Statement as a
marketing tool for the TAGNITE process, in accordance with the ETV Program requirements.
The primary purpose of this document is to establish the T/QAP for the TAGNITE magnesium anodizing process, and to establish specific data quality
requirements for the verification of this technology. The vendor claims that the TAGNITE process is capable of exceeding the performance characteristics of existing
magnesium anodizing processes while providing and environmental benefit in terms of eliminating the generation of chromates or permanganates in the waste stream.
14. SUBJECT TERMS
15. NUMBER OF PAGES
63
16. PRICE CODE
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OF REPORT
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18. SECURITY CLASSIFICATION
OF THIS PAGE
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NSN 7540-01-280-5500
Standard Form 298 Rev. 12/00
Prescribed by ANSI ST. 239-18
880922
Technology Applications Group TAGNITE® - Testing and Quality Assurance Plan (T/QAP)
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TABLE OF CONTENTS
Page
SI TO ENGLISH CONVERSIONS iv
LIST OF ABBREVIATIONS AND ACRONYMS v
1.0 INTRODUCTION 1
1.1 Purpose of the Technology Applications Group TAGNITE® - T/QAP 1
1.2 Quality Assurance for the ETV CCEP 1
1.3 Organization of the TAGNITE T/QAP 1
1.4 Formatting 2
1.5 Approval Form 2
2.0 PROJECT DESCRIPTION 3
2.1 General Overview 3
2.1.1 Off-Site Panel Preparation Phase 3
2.1.2 CrC's Environmental Coatings Laboratory 3
2.1.3 Statement of Project Objectives 4
2.2 Technical/Experimental Approach and Guidelines 4
2.2.1 Test Approach 5
2.2.2. Verification Test Objectives 6
2.2.3 Standard Test Panels 6
2.2.4 Galvanic Corrosion Coupons 6
2.2.5 Process Standards 6
2.2.6 Design of Experiment 7
2.2.7 Performance Testing 8
2.2.8 Quantitative Measurements 8
2.2.9 Participation 8
2.2.10 Critical and Non-Critical Factors 9
2.3 Schedule 11
3.0 PROJECT ORGANIZATION AND RESPONSIBILITIES 13
4.0 QUALITY ASSURANCE OBJECTIVES 16
4.1 General Objectives 16
4.2 Quantitative Quality Assurance Objectives 16
4.2.1 Accuracy 18
4.2.2 Precision 19
4.2.3 Completeness 19
4.2.4 Impact and Statistical Significance Quality Objectives 19
4.3 Qualitative QA Objectives: Comparability and Representativeness 20
4.3.1 Comparability 20
4.3.2 Representativeness 20
4.4 Other QA Objectives 20
4.5 Impact of Quality 20
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5.0 SITE SELECTION AND SAMPLING PROCEDURES 21
5.1 Site Selection 21
5.2 Sampling Procedures and Handling 21
5.3 Sample Custody, Storage and Identification 21
6.0 ANALYTICAL PROCEDURES AND CALIBRATION 23
6.1 Facility and Laboratory Testing and Calibration 23
6.1.1 Facility Testing and Calibration 23
6.1.2 Laboratory Testing and Calibration Procedures 23
6.2 Product Quality Procedures 24
6.3 Standard Operating Procedures and Calibration 24
6.4 Non-Standard Methods 25
7.0 DATA REDUCTION, VALIDATION, AND REPORTING 26
7.1 Raw Data Handling 26
7.2 Preliminary Data Package Validation 26
7.3 Final Data Validation 26
7.4 Data Reporting and Archival 26
7.4.1 Calculation of DFT Variation 26
7.4.2 Evaluation of the Technology Applications Group, Inc. TAGNITE
Magnesium Anodizing System 27
7.5 Verification Statement 27
8.0 INTERNAL QUALITY CONTROL CHECKS 28
8.1 Guide used for Internal Quality Program 28
8.2 Types of QA Checks 28
8.3 Basic QA Checks 28
8.4 Specific Checks 30
9.0 PERFORMANCE AND SYSTEM AUDITS 31
10.0 CALCULATION OF DATA QUALITY INDICATORS 32
10.1 Precision 32
10.2 Accuracy 32
10.3 Completeness 33
10.4 Project Specific Indicators 33
11.0 CORRECTIVE ACTION 34
11.1 Routine Corrective Action 34
11.2 Non-Routine Corrective Action 34
12.0 QUALITY CONTROL REPORTS TO MANAGEMENT 35
13.0 REFERENCES 36
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LIST OF TABLES
Table 1. Overall Guidelines and Procedures to be Applied to this T/QAP 5
Table 2. Test Matrix Summary 7
Table 3. Critical Control Factors 10
Table 4. Non-Critical Control Factors 10
Table 5. Critical Response Factors 11
Table 6. Estimated Schedule as of 05/05/06 12
Table 7. Summary of ETV CCEP Experience and Responsibilities 14
Table 8. Frequency and Mechanisms of Communications 15
Table 9. Responsibilities During Testing 15
Table 10. QA Objectives for Precision, Accuracy and Completeness for All Non-Critical
Control Factor Performance Analyses 17
Table 11. QA Objectives for Precision, Accuracy and Completeness for All Critical
Response Factor Performance Analyses 18
Table 12. Process Responsibilities 21
Table 13. Non-Critical Control Factor Testing and Calibration Criteria 24
Table 14. Critical Response Factor Testing and Calibration Criteria 25
Table 15. CTC Laboratory QA/QC Format Sources 28
LIST OF FIGURES
Figure 1. Project Organization Chart
LIST OF APPENDICES
A Standard Test Panels
B Galvanic Corrosion Coupons
C TAGNITE Product Specifications
D Baseline Treatments' Product Specifications
E ASTM Methods
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SI to English Conversions
Multiply SI
by factor to
SI Unit English Unit obtain English
°C °F 1.80, then add 32
L gal. (U.S.) 0.2642
m ft 3.281
kg Ibm 2.205
kPa psi 0.14504
cm in. 0.3937
mm mil (1 mil = 1/1000 in.) 39.37
m/s ft/mm 196.9
kg/L Ibm/gal. (U.S.) 8.345
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List of Abbreviations and Acronyms
ANSI American National Standards Institute
AOAC Association of Official Analytical Chemists
ASME American Society of Mechanical Engineers
ASQC American Society for Quality Control
ASTM American Society for Testing and Materials
CCEP Coatings and Coating Equipment Program
CTC Concurrent Technologies Corporation
DFT dry film thickness
EPA U.S. Environmental Protection Agency
ETF Environmental Technology Facility
ETV Environmental Technology Verification
HAP hazardous air pollutant
1C Ion Chromatography
ICP-AES Inductively Coupled Plasma-Atomic Emission Spectrometry
ID identification
ISO International Standardization Organization
NDCEE National Defense Center for Environmental Excellence
NIST National Institute for Standards and Technology
OFL Organic Finishing Lab
QA/QC quality assurance/quality control
QMP Quality Management Plan
RPD Relative Percent Difference
RSD Relative Standard Deviation
SRM Standard Reference Materials
TAG Technology Applications Group
T/QAP Testing and Quality Assurance Plan
VOC volatile organic compound
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1.0 INTRODUCTION
1.1 Purpose of the Technology Applications Group T AGNITE® - T/Q AP
The primary purpose of this document is to establish the Testing and Quality
Assurance Plan (T/QAP) for the Technology Applications Group (TAG)
TAGNITE magnesium anodizing process. The objective of this T/QAP is to
verify the performance of the TAGNITE process, which is chromate and
permanganate free. The format and guidelines for this T/QAP are established
below.
This T/QAP establishes specific data quality requirements for all technical parties
involved in the verification of the TAGNITE process. This T/QAP follows the
format described below to facilitate independent reviews of the project plans and
test results, and to provide a standard platform of understanding for stakeholders
and participants.
1.2 Quality Assurance for the ETV CCEP
Projects conducted under the auspices of the U.S. Environmental Protection
Agency's (EPA) Environmental Technology Verification Coatings and Coating
Equipment Program (ETV CCEP) meet or exceed the requirements of the
American National Standards Institute/American Society for Quality Control
(ANSI/ASQC), Specifications and Guidelines for Quality Systems for
Environmental Data Collection and Environmental Technology Programs,
ANSI/ASQC E-4 (1994) standard (see Section 13 for reference). This T/QAP
will ensure that project results are compatible with and complementary to similar
projects. All ETV CCEP T/QAPs are adapted from this standard and the ETV
Program Quality Management Plan (QMP) (see Section 13 for reference).
T/QAPs will contain sufficient detail to ensure that measurements are appropriate
for achieving project objectives, that data quality is known, and that the data are
legally defensible and reproducible.
1.3 Organization of the TAGNITE T/QAP
This T/QAP contains the sections outlined in the ANSI/ASQC E-4 standard. As
such, this T/QAP identifies processes to be used, test and quality objectives,
measurements to be made, data quality requirements and indicators, and
procedures for the recording, reviewing and reporting of data.
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The major technical sections discussed in this T/QAP are as follows:
• Project Description
• Project Organization and Responsibilities
• Quality Assurance (QA) Objectives
• Site Selection and Sampling Procedures
• Analytical Procedures and Calibration
• Data Reduction, Validation and Reporting
• Internal Quality Control (QC) Checks
• Performance and System Audits
• Calculation of Data Quality Indicators
• Corrective Action
• Quality Control Reports to Management
• Appendices
1.4 Formatting
In addition to the technical content, this T/QAP also contains standard formatting
elements required by the ANSI/ASQC E-4 standard and Concurrent Technologies
Corporation (CTC) deliverables.
1.5 Approval Form
Key ETV CCEP personnel indicate their agreement and common understanding
of the project objectives and requirements by signing a T/QAP Approval Form for
the verification testing of the TAGNITE process. Acknowledgment by each key
person indicates commitment toward implementation of the plan.
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2.0 PROJECT DESCRIPTION
2.1 General Overview
The overall objective of the ETV CCEP is to verify pollution prevention and
performance characteristics of coating technologies and make the results of the
testing available to prospective coating technology users. The objective of this
particular T/QAP is to establish the performance of the TAGNITE magnesium
anodizing process. This innovative process was developed and patented by TAG
to replace other anodizing processes and conversion coatings for magnesium
alloys. The test data from this verification test will be compiled and used to
develop a Verification Report, and, at the discretion of the vendor, a Verification
Statement will be developed from the data contained in the Verification Report.
TAG may use the Verification Statement as a marketing tool for the TAGNITE
process, in accordance with the ETV Program requirements.
2.1.1 Off-Site Panel Preparation Phase
TAG'S facility in Grand Forks, ND, will be the location for the TAGNITE
coating application portion of this verification test. The baseline
anodizing, conversion coatings, sealers, primers, and topcoats will be
applied per the appropriate specifications either in-house at CTU's
Johnstown, PA, Environmental Technology Facility (ETF), or at an off-
site location(s) familiar with the particular treatments. Whenever an off-
site location is utilized for any portion of this test, the ETV CCEP staff
will conduct site visits, perform technical audits, and oversee all sample
preparations. The ETV CCEP staff will also measure process variables,
conduct some on-site laboratory analyses, and package the Standard Test
Panels and Galvanic Corrosion Coupons for transport to the
Environmental Coatings Laboratory in CTC's ETF. In the event other
laboratory analyses are required where a particular capability is not
present at the CTC's facilities, an outside laboratory may be obtained to
complete those analyses.
2.1.2 C7U' s Environmental Coatings Laboratory
In support of the ETV CCEP, the extensive state-of-the-art Environmental
Coatings Laboratory within CTC's ETF facility will be available to
evaluate the treated and/or coated Standard Test Panels and Galvanic
Corrosion Coupons. Laboratory facilities available for this test include a
taber abrasion unit, multiple salt spray chambers, and a direct impact unit.
The Environmental Coatings Laboratory will also conduct sample
analyses of the various raw treatment chemicals and their respective waste
streams to determine the level of chromates and other heavy metals
present, as well as pH and volumes used and/or generated.
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2.1.3 Statement of Project Objectives
The overall objective of the ETV CCEP is to verify pollution prevention
characteristics and/or performance of coatings and coating equipment
technologies, and to make the results of the verification tests available to
prospective technology users. The ETV CCEP aspires to increase the use
of more environmentally friendly technologies in products finishing in an
effort to reduce emissions.
The primary criteria for verification of TAGNITE process will be:
• Does the coating provide an environmental benefit in terms of
reduced chromate and heavy metal generation compared to
existing processes and coatings?
• Does the coating perform to an acceptable level of quality and
performance?
• Is there a reduction of solid, liquid, or hazardous waste?
Based on the best available data, as presented by an unbiased third party,
end-users will be able to determine whether the coating can provide them
with a pollution prevention benefit while meeting the finish quality
requirements of their application. This program intends to supply end-
users with the unbiased technical data to assist them in the decision-
making process.
The quantitative pollution prevention benefit in terms of reducing or
eliminating chromates and permanganates depends on a multitude of
factors; therefore, the TAGNITE process will be applied per TAG's
instructions, and the resulting verification data will be representative of
the exact conditions tested. To qualify the existence of an environmental
benefit, this program will conduct a test to qualify the chemicals used in
the process and determine if the TAGNITE process improves the
durability of magnesium alloys compared to existing technologies.
2.2 Technical/Experimental Approach and Guidelines
The following tasks are planned for this project (see estimated schedule in Section
2.3, Table 6):
. Obtain TAG's concurrence with this T/QAP.
. Obtain CTC and EPA approval of this T/QAP.
Conduct verification test of the TAGNITE process.
. Prepare and provide the draft Verification Report to EPA.
. Prepare and provide the final Verification Report to EPA.
. Prepare Verification Statement for approval and distribution.
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Table 1 describes the general guidelines and procedures that will be applied to
this T/QAP.
Table 1. Overall Guidelines and Procedures to be Applied to this T/QAP
• A detailed description of each part of the test will be given.
• Critical and non-critical factors will be listed. Non-critical factors will
remain constant throughout the testing. Critical factors will be listed as
control (process) factors or response (product quality) factors (see Section
2.2.10 below).
• This T/QAP will identify the potential testing sites.
• All testing will be under the control and close supervision of ETV CCEP
representatives to ensure the integrity of the third party testing.
• The QA portion of this T/QAP will be strictly adhered to.
• A statistically significant number of samples will be analyzed for each
critical response factor (see Table 5). Variances (or standard deviations) of
each critical response factor will be reported for all results.
2.2.1 Test Approach
The following approach will be used in the test protocol.
• TAG and the ETV CCEP will agree on the performance
parameters to be verified;
• TAG will supply the Standard Test Panels, Galvanic
Corrosion Coupons, and related materials;
• TAG will provide the TAGNITE process capability;
• The baseline treatments, sealers, primers, and topcoats will
be applied by CTC or other qualified, independent
facilities;
• Data such as dry film thickness, abrasion resistance, salt
spray, and impact resistance will be collected, following
American Society for Testing and Materials (ASTM)
methods, or equivalent; and,
• A statistically valid test program that efficiently
accomplishes the required objectives will then be used to
analyze the data.
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2.2.2. Verification Test Objectives
The objectives of the verification test performed per this T/QAP are to
determine the environmental and performance benefits that the TAGNITE
process provides over a baseline of anodizing processes and conversion
coatings. The coated Standard Test Panels will be tested for dry film
thickness (DFT), direct impact, abrasion resistance, and salt-spray
resistance (including paint adhesion, short-term corrosion pit depth
analysis, and galvanic corrosion).
2.2.3 Standard Test Panel s
The Standard Test Panels to be used for this verification test will consist
of four magnesium alloys (ZE41 A, EV31, AZ91E, and ZK60). A
dimensioned drawing of the Standard Test Panels is shown in Appendix A
(Standard Test Panels). TAG will obtain the required materials and
provide a sufficient number of panels to CTC. The Standard Test Panels
will have the same approximate dimensions of 10.2 cm (4 in.) wide, 15.2
cm (6 in.) long, and 0.6 cm (0.25 in.) thick. The Standard Test Panels will
include a threaded hole on the top, short side, and an aluminum bolt,
which will aid in handling the panels and as a conductive connecting
point. CTC will evaluate each panel prior to treatment to ensure that the
surface profiles of the panels are similar.
2.2.4 Galvanic Corrosion Coupons
The Galvanic Corrosion Coupons will consist of two magnesium alloys
(ZE41A and EV31). A dimensioned drawing of the Galvanic Corrosion
Coupons is shown in Appendix B (Galvanic Corrosion Coupons). TAG
will obtain the required materials and provide a sufficient number of
coupons to CTC. The Galvanic Corrosion Coupons will have the same
approximate dimensions of 7.6 cm (3 in.) wide, 7.6 cm (3 in.) long, and
3.1 cm (1.25 in.) thick. The Galvanic Corrosion Coupons will include a
threaded hole in the center of the square sides. Cadmium-plated bolts,
washers, and nuts will be used to initiate the galvanic action in the salt
spray chamber. As with the Standard Test Panels, CTC will check the
surface profile of each Galvanic Corrosion Coupon prior to the test.
2.2.5 Process Standards
The Standard Test Panels and Galvanic Corrosion Coupons will be made
of multiple alloys, as listed in Table 2. The treatments will be evaluated
alone, with a sealer coating, and with a waterborne primer/topcoat system
applied over a sealer coating. The anodizing process will be the similar
for each alloy type and test combinations. Operating parameters will be
held relatively constant throughout the test.
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2.2.6 Design of Experiment
This T/QAP will be used to verify the performance of the TAGNITE
process. A mean value and variance (or standard deviation) will be
reported for each critical response factor, and default 95% confidence
limit will be applied. The statistical analyses for all response factors will
be carried out using the latest version of Minitab statistical software.
The verification test will be comprised of sixty-four (64) separate
combinations with three (3) Standard Test Panels or Galvanic Corrosion
Coupons per combination. This will enable total variation to be
determined for each response factor.
Table 2 shows the test matrix summary. The test samples are grouped
according to their finished state (e.g., treated panels only, treated panels
with sealer, treated panels with sealer, primer, and topcoat, and treated
coupons with sealer). Four magnesium treatments and four magnesium
alloys will be used. The number in parenthesis after each alloy represents
the number of samples to be created using that particular combination.
The product specifications for the four magnesium treatments can be
found in Appendix C (TAGNITE Product Specifications) and D (Baseline
Treatments' Product Specifications).
Table 2. Test Matrix Summary
Standard Test
Panels with
treatment only
Standard Test
Panels with
treatment and
sealer
Standard Test
Panels with
treatment, sealer,
primer, & topcoat
Galvanic Corrosion
Coupons with
sealer
TAGNITE
ZE41A(12)
EV31 (9)
AZ91E(3)
ZK60 (3)
ZE41A(6)
EV31(3)
AZ91E(3)
ZE41A(3)
EV31 (3)
ZE41A(3)
EV31(3)
Dow 17
ZE41A(12)
EV31 (9)
AZ91E(3)
ZK60 (3)
ZE41A(6)
EV31(3)
AZ91E(3)
ZE41A(3)
EV31 (3)
ZE41A(3)
EV31(3)
H.A.E.
ZE41A(12)
EV31 (9)
AZ91E(3)
ZK60 (3)
ZE41A(6)
EV31(3)
AZ91E(3)
ZE41A(3)
EV31 (3)
ZE41A(3)
EV31(3)
Dow 7
ZE41A(6)
EV31 (6)
AZ91E(3)
ZK60 (3)
ZE41A(3)
EV31(3)
AZ91E(3)
ZE41A(3)
EV31 (3)
ZE41A(3)
EV31(3)
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2.2.7 Performance Testing
Standard Test Panels and Galvanic Corrosion Coupons will be used to
measure the performance characteristics of each magnesium treatment.
The manufacture and final surface preparation will be the same for all
Standard Test Panels and Galvanic Corrosion Coupons, prior to testing.
The panels and coupons will be evaluated prior to testing to ensure that
the variability between samples is minimal. Non-critical control factors
will be monitored or held relatively constant for the verification test. A
comparison will be made from combination to combination.
2.2.8 Quantitative Measurements
In order to establish a basis for comparison between the magnesium
treatments, DFT will be measured on the Standard Test Panels and
Galvanic Corrosion Coupons after each treatment is applied, after each
layer of sealer, and after each layer of primer and topcoat. The uniformity
of the applied layers will be determined by measuring DFT at several
locations on each sample. There are fourteen (14) measurement sites on
the Standard Test Panels, and twelve (12) sites on each Galvanic
Corrosion Coupon. The sites will be numbered so that the recorded
measurements can be correlated to a specific site (see Appendices A and
B). The thickness measurement data will be used to evaluate the average
thickness and thickness variation across the samples.
Chemical analyses will be completed of both the process solutions and the
waste streams to determine the relative environmental impacts of each
treatment. The chemical analyses will focus on heavy metals and other
hazardous compounds, in addition to the pH during the various stages of
each process. A cursory review of the materials used to make up each
process solution will be conducted to determine whether there is a
potential for volatile organic compound (VOC) and/or hazardous air
pollutant (HAP) emissions.
2.2.9 Participation
TAG will supply the Standard Test Panels and Galvanic Corrosion
Coupons. TAG will also treat the appropriate samples with TAGNITE.
The ETV CCEP personnel will be responsible for verifying that all data
and QA requirements have been met. The ETV CCEP personnel will also
perform all laboratory analyses identified for this verification whenever
possible. Off-site facilities or laboratories may be utilized when a
particular capability is not available at CTC. However, ETV CCEP
personnel will oversee and observe all sample preparation activities.
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2.2.10 Critical and Non-Critical Factors
In a designed experiment, critical and non-critical control factors must be
identified. In this context, the term "critical" does not convey the
importance of a particular factor. (Importance can only be determined
through experimentation and characterization of the total process.)
Rather, this term displays its relationship within the design of
experiments. For the purposes of this T/QAP, the following definitions
will be used for critical control factors, non-critical control factors, and
critical response factors.
• Critical control factor - a factor that is varied in a controlled manner
within a design of experiments matrix to determine its effect on a
particular outcome of a system.
• Non-critical control factors - factors that remain relatively constant or
are randomized throughout the testing.
• Critical response factors - the measured outcomes of each combination
of critical and non-critical control factors used in the design of
experiments.
In this verification test, there are four critical control factors, the four
separate treatment processes. All other processing factors are non-critical
control factors; therefore, the multiple combinations and sample
measurements within each combination of critical control factors will be
used to determine the amount of variation expected for each critical
response factor.
Tables 3 through 5 identify the factors to be monitored during testing, as
well as their acceptance criteria (where appropriate), data quality
indicators, measurement locations, and measurement frequencies. The
values in the Total Numbers column are based on the default test
scenarios.
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Table 3. Critical Control Factors
Critical Control
Factor
TAGNITE
Magnesium
Anodizing Process
Dow 17 Magnesium
Anodizing Process
HAE Magnesium
Anodizing Process
Dow 7 Conversion
Coating
PH
12.8-13.2
~5
-14
4.1-5.6
Operating
Temperature
4.4 -15. 5 °C
(40 - 60 °F)
>71°C
Ł>160 °F)
21-30°C
(70 - 86 °F)
Boiling
>93 °C
(>200 °F)
Bath Solution
Hydroxide
Silicate
Fluoride
Phosphate
Fluoride
Chromate
Hydroxide
Fluoride
Phosphate
Manganate
Chromate
Fluoride
Coating Thickness
Type I: 0.2 - 0.4 mil
Type I: 0.1 -0.5 mil
Type I: 0.1 -0.3 mil
30 to 45 min.a
" The Dow 7 conversion coating is applied in a very thin film thickness. The amount of material deposited is based on the duration of
the treatment process.
Table 4. Non-Critical Control Factors
Non-Critical
Factor
Products Involved in
Testing
Surface Area of
Standard Test Panels
and Galvanic
Corrosion Coupons
Surface Profile of
Standard Test Panels
and Galvanic
Corrosion Coupons
Set Points/
Acceptance
Criteria
Standard Test
Panels and
Galvanic
Corrosion
Coupons
Varies <16.1 cm2
(<2.5 in.2)
ASMEB46.1
Measurement
Location
Each Standard
Test Panel or
Galvanic
Corrosion
Coupon
CTC
CTC
Frequency
Once per
Standard Test
Panel or
Galvanic
Corrosion
Coupon
All Standard Test
Panels or
Galvanic
Corrosion
Coupons
All Standard Test
Panels or
Galvanic
Corrosion
Coupons
Total Number
for the Test
192
192
192
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Table 5. Critical Response Factors
Critical Response Factor
Measurement
Location
Frequency
Total
Number
Environmental
Chromate and Heavy Metal
Content and pH in Total Process
Process Area
Once for each process solution and
waste stream
Varies
Quality/Performance (Mandatory)
Dry Film Thickness (DFT)
Taber Abrasion, Treatment Only
Salt Spray, Treatment Only,
Scribed
(Failure or Score=7)
Salt Spray Pit Depth, Treatment
Only, Scribed (168 hours)
Salt Spray, Treatment w/ Sealer,
Scribed
(1000 hrs or Score=7)
Salt Spray, Treatment w/ Sealer,
Primer, and Topcoat, Un-Scribed
(1000 hrs or Score=7)
Direct Impact, Treatment Only
Direct Impact, Treatment w/
Sealer
Galvanic Corrosion Salt Spray w/
Sealer, Un-Scribed
(1000 hrs or Score=7)
ASTMB244
(Eddy Current)
ASTMD
4060; CS-10
ASTMB 117
ASTMB 117
ASTMB 117
ASTMB 117
ASTM D 2794
ASTMD 2794
ASTMB 117
14 points on each Standard Test
Panel (12 points on each Galvanic
Corrosion Coupon) per coating
layer
3 samples per combination, 6
combinations (ZE41A and EV3 1
with TAGNITE, Dow 17, &
H.A.E.)
3 samples per combination, 16
combinations (All four alloys and
all four treatments)
3 samples per combination, 8
combinations (ZE41A and EV3 1
with all four treatments)
3 samples per combination, 12
combinations (ZE41A, EV31, and
AZ91E with all four treatments)
3 samples per combination, 8
combinations (ZE41A and EV3 1
with all four treatments)
3 samples per combination, 3
combinations (ZE41A with
TAGNITE, Dow 17, and H.A.E.)
3 samples per combination, 3
combinations (ZE41A with
TAGNITE, Dowl7, and H.A.E.)
3 samples per combination, 8
combinations (ZE41A and EV3 1
with all four treatments)
4566
18
48
24
36
24
9
9
24
Score = 7 refers to the amount of corrosion considered to be a failure, as determined using ASTM B 117.
2.3 Schedule
ETV CCEP uses standard tools for project scheduling. Project schedules are
prepared in Microsoft Project, which is an accepted industry standard for
scheduling. Project schedules show the complete work breakdown structure of
the project, including technical work, meetings and deliverables. Table 6 shows
the estimated schedule for the verification testing of the TAGNITE process.
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Table 6. Estimated Schedule as of 07/24/06
ID
Taskl
Task 2
TaskS
Task 4
TaskS
Task 6
Name
Approval of T/QAP
Verification Testing
Complete Data Analyses
Prepare Verification Report
Approval of Verification Report
Issue Verification Statement
Duration
15d
80d
lOd
30d
90d
15d
Start Date
TBD
TBD
TBD
TBD
TBD
TBD
Finish Date
TBD
TBD
TBD
TBD
TBD
TBD
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3.0 PROJECT ORGANIZATION AND RESPONSIBILITIES
CTC employs a matrix organization, with program and line management, to perform
projects. The laboratory supports the ETV CCEP Project Manager by providing test
data. Laboratory Analysts report to the ETV CCEP Laboratory Leader. The ETV CCEP
Laboratory Leader and Organic Finishing Engineer coordinate with the ETV CCEP
Project Manager on testing schedules. The ETV CCEP Project Manager will be
responsible for preparing the T/QAPs and Verification Report and Statement for each
test.
The ETV CCEP QA Officer, who is independent of both the laboratory and the program,
is responsible for administering CTC policies developed by the Quality Committee.
These policies provide for, and ensure that quality objectives are met for each project.
The policies are applicable to laboratory testing, factory demonstration processing,
engineering decisions, and deliverables. The ETV CCEP QA Officer reports directly to
CTC senior management and is organizationally independent of the project or program
management activities.
The project organization chart, showing lines of responsibility and the specific CTC
personnel assigned to this project, is presented in Figure 1. A summary of the
responsibilities of each CTC participant, his/her applicable experience, and his/her
anticipated time dedication to the project during testing and reporting is given in Table 7.
ETV CCEP Project Manager
Robert Fisher
_L
ETV CCEP Laboratory
Leader
Lynn Summerson
ETV CCEP Organic
Finishing Leader
Stephen Kendera
Figure 1. Project Organization Chart
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Table 7. Summary of ETV CCEP Experience and Responsibilities
Key CTC Personnel and Roles
Heather Moyer —
NDCEE Program Manager
Shannon Miller - ETV CCEP
QA Officer
Rob Fisher — Staff Process
Engineer/ ETV CCEP Project
Leader
Lynn Summerson - ETV CCEP
Laboratory Leader/ Statistical
Support Staff
Stephen Kendera - ETV CCEP
Organic Finishing Leader
Responsibilities
Manages NDCEE Program
Accountable to CTC Technical Services
Manager and CTC Corporate Management
Responsible for overall project QA
Accountable to NDCEE Program Manager
Technical project support
Process design and development
Accountable to NDCEE Program
Manager
Laboratory analysis
Accountable to ETV CCEP Project
Manager
QC Analysis
Accountable to ETV CCEP Project
Manager
Applicable Experience
Project Manager
(10 years)
Quality Mgmt. /ISO 9000 (6 years)
Environmental Compliance and ISO
14000 Management Systems (6 years)
ISO Internal Auditor (5 years)
Organic Finishing Regulations
(10 years)
Organic Finishing Operations
(10 years)
Registered Professional Engineer
Industrial and Environmental
Laboratory Testing (22 years)
Organic Finishing Operations
(25 years)
Education
B.S., Chemical
Engineering
B.A.,
Communications
MS.,
Manufacturing
Systems
Engineering
B.S., Chemical
Engineering
M.S., Chemistry
B.S., Chemistry
N/A
Time
Dedication
1%
5%
60%
15%
5%
The ETV CCEP personnel specified in Table 7 are responsible for maintaining
communication with other responsible parties working on the project. The frequency and
mechanisms for communication are shown in Tables 8 and 9.
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Table 8. Frequency and Mechanisms of Communications
Initiator
NDCEE Program Manager
and/or ETV CCEP Project
Manager
ETV CCEP Project
Manager
ETV CCEP Laboratory
Leader
ETV CCEP QA Officer
EPA ETV CCEP Project
Manager
Recipient
EPA ETV CCEP Project
Manager
NDCEE Program Manager
ETV CCEP Project
Manager
NDCEE Program Manager
CTC
Mechanism
Written Report
Verbal Status Report
Written or Verbal Status
Report
Data Reports
Quality Review Report
On-Site Visit
Frequency
Monthly
Weekly
Monthly
As Generated
As Required
As Needed
Special Occurrence
Schedule or Financial
Variances
Major (will prevent
accomplishment of
verification cycle testing)
Quality Objective Deviation
Initiator
NDCEE Program Manager
or ETV CCEP Project
Manager
NDCEE Program Manager
or ETV CCEP Project
Manager
Recipient
EPA ETV CCEP Project
Manager
EPA ETV CCEP Project
Manager
Mechanism/
Frequency
Telephone Call,
Written Follow-up
Report as Necessary
Telephone Call with
Written Follow-up
Report
Table 9. Responsibilities During Testing
Position
ETV CCEP Project
Manager
ETV CCEP QA Officer
Statistical Support
Responsibility
Overall coordination of project, testing, reporting, and data reviews
Audits of verification testing operations and laboratory analyses
Coordinates interpretation of test results
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4.0 QUALITY ASSURANCE OBJECTIVES
4.1 General Objectives
The overall objectives of this ETV CCEP T/QAP are to verify the pollution
prevention benefit of the TAGNITE anodizing process and the quality and
performance of the resultant finish. These objectives will be met by controlling
and monitoring the critical and non-critical factors, which are the specific QA
objectives for this T/QAP. Tables 3 and 4 list the critical and non-critical factors,
respectively.
The analytical methods that will be used for this evaluation are adapted from
ASTM Standards, or industrial standard equivalent. The QA objectives of the
program and the capabilities of these test methods for product and process
inspection and evaluation are synonymous because the methods were designed
specifically for evaluation of the anodizing process properties under investigation.
The methods will be used as published, or as supplied, without deviations. The
specific methods to be used for this project are attached to this document in
Appendix E (ASTM Methods/
4.2 Quantitative Quality Assurance Objectives
Quality assurance parameters such as precision, accuracy, and completeness, are
presented in Tables 10 and 11. Table 10 presents the manufacturers' stated
capabilities of the equipment used to measure non-critical control factors. The
precision and accuracy parameters listed are relative to the true value to which the
equipment measures. Table 11 presents the precision and accuracy parameters for
the measurement equipment for the critical response factors. Precision and
accuracy are determined using duplicate analysis and known standards and/or
spikes and must fall within the values found in the specific methods expressed.
The statistical support staff, ETV CCEP QA Officer, and laboratory personnel
will coordinate efforts to calculate and interpret the test results.
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Table 10. QA Objectives for Precision, Accuracy and Completeness for All Non-Critical
Control Factor Performance Analyses
Measurement
Products Involved in Testing
(Standard Test Panels and
Galvanic Corrosion Coupons)
Surface Area of Products
Surface Profile of Products
Method
Visual
Ruler
ASMEB46.1
Units
N/A
cm2
(ft2)
Ra
Precision
N/A
±0.025
(±0.0036)
±20%
Accuracy
N/A
±0.025
(±0.0036)
±3%
Completeness
100%
100%
100%
Ra is defined as the arithmetic average deviation from the center line of the surface.
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Table 11. QA Objectives for Precision, Accuracy and Completeness for All Critical Response
Factor Performance Analyses
Measurement"
Chromate or Heavy Metal
Content and pH
DFT - Eddy Current
Taber Abrasion
Salt Spray, Un-Coated,
Scribed
(Failure or Score=7)
Salt Spray Pit Depth, Un-
Coated, Scribed (168
hours)
Salt Spray, Sealer,
Scribed
(1000 hrs or Score=7)
Salt Spray, Sealer,
Primer/Topcoat, Un-
Scribed
(1000 hrs or Score=7)
Direct Impact, Un-Coated
Direct Impact, Sealer
Galvanic Corrosion Salt
Spray,
Sealer, Un-Scribed
(1000 hrs or Score=7)
Method
EPA Methods
200.7 and 218.6
ASTM B 244
(Eddy Current)
ASTM D 4060
ASTM B 117
ASTM B 117
ASTM B 117
ASTM B 117
ASTM D 2794
(Direct & Reverse)
ASTM D 2794
(Direct & Reverse)
ASTM B 117
Units
ug/L
mils0
g
Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail
Pass/Fail
Precision
±20%
20% RPD
0.025d
All Pass
or All Fail
All Pass
or All Fail
All Pass
or All Fail
All Pass
or All Fail
All Pass
or All Fail
All Pass
or All Fail
All Pass
or All Fail
Accuracy1"
±10%
10% True
Thickness
Not reported
in ASTM D
4060
N/A
N/A
N/A
N/A
Ranges listed
in ASTM D
2794
Ranges listed
in ASTM D
2794
N/A
Completeness
90%
90%
90%
90%
90%
90%
90%
90%
90%
90%
a Score = 7 refers to the amount of corrosion considered to be a failure, as determined using ASTM B 117.
b Accuracy is presented as percent recovery of a standard, unless otherwise noted.
cl mil = 0.001 inch
d Precision is expressed as the maximum allowable difference for low abrasion resistant coatings at 1000 cycles.
N/A = Not Applicable
RPD - relative percent difference
4.2.1 Accuracy
Standard reference materials, traceable to national sources such as the
National Institute for Standards and Technology (NIST) for instrument
calibration and periodic calibration verification, will be procured and
utilized where such materials are available and applicable to this project.
For reference calibration materials with certified values, acceptable
accuracy for calibration verification will be within the specific guidelines
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provided in the method if verification limits are given. Otherwise, 80-120
percent of the true reference values will be used (see Tables 10 and 11).
Reference materials will be evaluated using the same methods as for the
actual test specimens. Calculations for precision, accuracy, etc. are
contained in Section 10.0.
4.2.2 Precision
The experimental approach of this T/QAP specifies the exact number of
Standard Test Panels to be coated. The analysis of replicate Standard Test
Panels and Galvanic Corrosion Coupons for all tests at each of the
experimental conditions will occur by design. The degree of precision
will be assessed based on the agreement of all replicates within a property
analysis group.
4.2.3 Completeness
The laboratory strives for at least 90 percent completeness. Completeness
is defined as the number of valid determinations expressed as a percentage
of the total number of analyses conducted, by analysis type. Samples,
which are invalidated due to uncorrectable errors and cannot be re-
analyzed, will be considered incomplete.
4.2.4 Impact and Statistical Significance Quality Objectives
All laboratory analyses will meet the accuracy, precision, and
completeness requirements specified in Tables 10 and 11. The precision
will also be checked on Standard Test Panel or Galvanic Corrosion
Coupon replicates to determine whether a nonconformance exists. If any
non-conformance from T/QAP QA objectives occurs, the cause of the
deviation will be determined by checking calculations, verifying the
testing and measuring equipment, and performing reanalysis. If an error
in analysis is discovered, reanalysis of a new batch for a given trial will be
considered, and the impact to overall project objectives will be
determined. If the deviation persists despite all corrective action steps, the
data will be flagged as not meeting the specific quality criteria and a
written discussion will be generated.
If all analytical conditions are within control limits and instrument and/or
measurement system accuracy checks are valid, the nature of any
nonconformance may be beyond the control of the laboratory. If, given
that laboratory quality control data are within specification and any
nonconforming results occur, the results will be interpreted as the inability
of the particular technology to produce parts meeting the performance
criteria at the given set of experimental conditions.
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4.3 Qualitative QA Objectives: Comparability and Representativeness
4.3.1 Comparability
The TAGNITE coating process will be used per TAG's recommendations
or conditions otherwise established in agreement with TAG. The data will
be comparable from the standpoint that other testing programs could
reproduce similar results using a specific T/QAP. The Magnesium
anodizing process and environmental performance will be evaluated using
EPA, ASTM and other nationally or industry-wide accepted testing
procedures. Process performance parameters and cost data will be
generated and evaluated according to standard best engineering practices.
Standard Test Panels and Galvanic Corrosion Coupons used in these tests
will be compared to the performance data obtained from the baseline tests
and to other applicable end-user and industry specifications, such as
anticipated corrosion resistance. The specifications will be used to verify
the performance of the TAGNITE coating. Additional assurance of
comparability comes from the routine use of precision and accuracy
indicators as described above, the use of standardized and accepted
methods, and the traceability of reference materials.
4.3.2 Representativeness
The limiting factor to representativeness is the availability of a large
sample population. Experimental designs will be constructed such that
projects will have either sufficiently large sample populations per trial or
otherwise statistically significant fractional populations. The tests will be
conducted at the paint and equipment supplier-recommended operating
conditions. If the test data meets the quantitative QA criteria (precision,
accuracy, and completeness), the measurements of the tested samples will
be considered representative of the technologies under evaluation and will
be used to interpret the outcomes relative to the specific project objectives.
4.4 Other QA Objectives
No other QA objectives have been identified as part of this evaluation.
4.5 Impact of Quality
Due to the highly controllable nature of the Standard Test Panel and Galvanic
Corrosion Coupon evaluation methods and predictability of factors affecting the
quality of the laboratory testing of panels or coupons, the quality control of
Standard Test Panel and Galvanic Corrosion Coupon qualifications is expected to
fall within acceptable levels. Comparison of response factors will be checked for
run-to-run process variations. Deviation from quantitative and qualitative QA
objectives is not expected.
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5.0 SITE SELECTION AND SAMPLING PROCEDURES
5.1 Site Selection
TAG's facility in Grand Forks, ND, will be utilized to apply the TAGNITE
treatment to the appropriate samples. Samples will be evaluated before and after
treatment. ETV CCEP staff will oversee all phases of the treatment process.
Application of the remaining three treatment processes, the sealer, and the
primer/topcoat system are anticipated to occur at CTC's ETF in Johnstown, PA.
Evaluation of the performance characteristics for each treatment will be
performed in the ETF Environmental Coatings Laboratory. In the event that the
necessary equipment is either not available at CTC, other facilities may be
utilized to complete the sample preparation or testing.
5.2 Sampling Procedures and Handling
Standard Test Panels and Galvanic Corrosion Coupons will be used in this
project. They will be pre-labeled by stamping their ID (identification) number on
one side. The experimental design will prepare 192 samples during the
verification test. ETV CCEP staff will process the samples according to a pre-
planned sequence of stages, which includes those identified in Table 12.
Table 12. Process Responsibilities
Procedure
Provide the Requisite Number and Type of Samples
Inspection of All Samples
Numbering of Samples
Apply TAGNITE to Samples
Apply Remaining Treatments to Samples
Apply Appropriate Coatings to Samples
Evaluate the Treated/Coated Samples
Conduct Laboratory Testing
TAG
X
X
ETV CCEP
Staff
X
X
X
X
X
X
A laboratory analyst will process the Standard Test Panels and the Galvanic
Corrosion Coupons through the ETF Environmental Coatings Laboratory login
prior to performing the required analyses.
5.3 Sample Custody, Storage and Identification
The Standard Test Panels and Galvanic Corrosion Coupons will be given unique
laboratory ID numbers and logged into the laboratory record sheets. The analyst
delivering the samples will complete a custody log indicating the sampling point
IDs, sample material IDs, quantity of samples, time, date, and analyst's initials.
The samples will remain in the custody of CTC, unless a change of custody form
has been completed. The change of custody form should include a signature from
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CTC, the sample ID number, the date of custody transfer, and the signature of the
individual to whom custody was transferred.
Laboratory analyses may only begin after each sample is logged into the
laboratory record sheets. The laboratory's sample custodian will verify this
information. Both personnel will sign the custody log to indicate transfer of the
samples from the coating processing area to the laboratory analysis area. The
laboratory sample custodian will log the samples into a bound record book; store
the samples under appropriate conditions (ambient room temperature and
humidity); and create a work order for the various laboratory departments to
initiate testing. The product evaluation tests also will be noted on the laboratory
record sheet. Testing will begin within several days of receiving the samples.
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6.0 ANALYTICAL PROCEDURES AND CALIBRATION
6.1 Facility and Laboratory Testing and Calibration
CTC shall maintain a record of calibrations and certifications for all applicable
equipment. A calibration check will be made of the testing and measuring
equipment prior to and after the verification test.
6.1.1 Facility Testing and Calibration
Calibration procedures within the ETF organic finishing line and
environmental coatings laboratory will follow the applicable standards or
manufacturer's recommendations. Certified solutions and reference
materials traceable to NIST shall be obtained as appropriate to ensure the
proper equipment calibration. Where a suitable source of material does
not exist, a secondary standard is prepared and a true value obtained by
measurement against a technical-grade NIST-traceable standard.
6.1.2 Laboratory Testing and Calibration Procedures
The analytical methods performed at CTC are adapted from standard
ASTM, MIL-SPEC, EPA, Association of Official Analytical Chemists
(AOAC) and/or industry protocols for similar manufacturing operations.
Initial calibration and periodic calibration verification are performed to
insure that an instrument is operating sufficiently to meet sensitivity and
selectivity requirements. At a minimum, all equipment are calibrated
before use and are verified during use and/or immediately after each
sample batch. Standard solutions are purchased from reputable chemical
supply houses in neat and diluted forms. Where certified and traceable to
NIST reference materials and solutions are available, the laboratory
purchases these for calibration and standardization. Data from all
equipment calibrations and chemical standard certificates from vendors
are stored in laboratory files and are readily retrievable. No samples are
reported in which the full calibration curve, or the periodic calibration
check standards, is outside method performance standards. As needed,
equipment will be sent off-site for calibration or certification.
The listing of ASTM Methods used in this verification can be found in
Appendix E. All equipment, used for these analyses, is calibrated
according to Tables 13 and 14.
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6.2 Product Quality Procedures
Each apparatus that will be used to assess the quality of a treatment on a panel or
coupon is set up and maintained according to the published reference method's
instructions. Actual sample analysis will take place only after setup is verified
per the reference method and the equipment manufacturer's instructions. As
available, samples of known materials with established product qualities are used
to verify that a system is functioning properly. For example, traceable thickness
standards are used to calibrate the DFT instrument. Applicable ASTM methods
are listed in Appendix E.
6.3 Standard Operating Procedures and Calibration
Tables 13 and 14 summarize the methods and calibration criteria that will be used
for the evaluation of the coatings. Each analysis shall be performed per the
applicable published methods.
Table 13. Non-Critical Control Factor Testing and Calibration Criteria
Non-Critical
Factor
Products
Involved in
Testing (Standard
Test Panels and
Galvanic
Corrosion
Coupons)
Surface Area of
Standard Test
Panels and
Galvanic
Corrosion
Coupons
Surface Profile of
Standard Test
Panels and
Galvanic
Corrosion
Coupons
Method
Visual
Ruler
ASMEB46.1
Method
Type
N/A
Ruler
Stylus
Calibration
Procedure
N/A
Inspect for damage,
replace if necessary
Inspect for damage,
replace if necessary
Calibration
Frequency
N/A
With each use
With each use
Calibration
Accept. Criteria
N/A
Lack of damage
Lack of damage
N/A = Not Applicable
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Table 14. Critical Response Factor Testing and Calibration Criteria
Critical
Measurement
Chromate and
Heavy Metal
Content and pH
DFT
Taber Abrasion
Salt Spray, Un-
Coated, Scribed
Salt Spray Pit
Depth, Un-Coated,
Scribed
Salt Spray, Sealer,
Scribed
Salt Spray, Sealer,
Primer/Topcoat,
Un-Scribed
Direct Impact, Un-
Coated
Direct Impact,
Sealer
Galvanic Corrosion
Salt Spray,
Sealer, Un-Scribed
Method
Number
EPA Methods
200.7 and
218.6
ASTMB244
ASTM D 4060
ASTMB117
ASTM Bl 17
ASTM Bl 17
ASTM Bl 17
ASTM D 2794
(Direct &
Reverse)
ASTM D 2794
(Direct &
Reverse)
ASTM Bl 17
Method
Type
ICP-AES
and 1C
Eddy
Current
N/A
Visual
Visual
Visual
Visual
Visual
Visual
Visual
Calibration
Procedure
Comparison to
standard blanks or
check solutions
Comparison to
NIST-traceable
standard per ASTM
method
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Calibration
Frequency
Verify calibration
after every ten
samples
Verify calibration
after every three
samples
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Calibration
Accept. Criteria
90-110%
90-110%
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
a Listing of test methods to be used is provided in Appendix E.
a (2) As a percent recovery of a standard.
ICP-AES stands for Inductively Coupled Plasma-Atomic Emission Spectrometry
1C = Ion Chromatography
N/A = Not Applicable
6.4 Non-Standard Methods
CTC does not anticipate using any non-standard methods for this verification.
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7.0 DATA REDUCTION, VALIDATION, AND REPORTING
7.1 Raw Data Handling
Raw data will be gathered by ETV CCEP staff and recorded onto bench or
laboratory data sheets. This data will undergo validation by the ETV CCEP
Laboratory Leader and the ETV CCEP Project Manager.
7.2 Preliminary Data Package Validation
The generating analyst will assemble a preliminary data package for each
analysis. This package will contain the QC and raw data results, calculations,
electronic printouts, conclusions and laboratory sample tracking information. The
ETV CCEP Laboratory Leader will review the entire package and may also check
sample and storage logs, standard logs, calibration logs, and other files, as
necessary, to insure that tracking, sample treatments and calculations are correct.
The ETV CCEP Laboratory Leader will hand-check at least 10% of the data
calculations. The data reports will be reviewed for clarity and accuracy of
transcription. After the package has been peer reviewed in this manner, a
preliminary data report will be prepared. The entire package and final laboratory
report will be submitted to the ETV CCEP Project Manager.
7.3 Final Data Validation
The ETV CCEP Project Manager shall be ultimately responsible for all final data
released from this project. The ETV CCEP Project Manager will review the final
results for adequacy to project QA objectives. If the manager suspects an
anomaly or non-concurrence with expected or historical performance values, with
project QA objectives, or with method specific QA requirements of the laboratory
procedures, he will initiate a second review of the raw data and query the
generating analyst at CTC and the ETV CCEP Laboratory Leader about the non-
conformance. Also, he will request specific corrective action. If suspicion about
data validity still exists after internal review of laboratory records, the ETV CCEP
Project Manager may authorize a re-analysis. If sufficient sample is not available
for re-testing, a re-sampling will occur. If the sampling window has passed, or re-
sampling is not possible, the ETV CCEP Project Manager will flag the data as
suspect and notify the EPA ETV CCEP Project Manager.
7.4 Data Reporting and Archival
7.4.1 Calculation of DFT Variation
The DFT gauge has a stated accuracy of 0.1 mils. Since the calculated
DFT variation is intended for use as quality assurance measures only in
this phase of testing, it is not listed as a Critical Response Factor. Once
DFT measurements have been made at several locations on each product
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(see Appendices A and B), DFT variation will be determined as a function
of actual deviations from the average thickness and the standard deviation.
7.4.2 Evaluation of the Technology Applications Group, Inc. TAGNITE
Magnesium Anodizing System
The CTC Environmental Laboratory will retain the data packages at least
10 years.
The ETV CCEP Project Manager or the NDCEE Program Manager will
forward the results and conclusions to EPA in their regular reports for
final EPA approval of the test data. This information will be used to
prepare the Verification Report, which will be published by the ETV
CCEP. The ETV CCEP project team, TAG, EPA ETV CCEP Project
Manager, EPA ETV CCEP QA Manager, EPA technical peer reviewers,
and the EPA technical editor will review the Verification Report. The
EPA and the NDCEE will then approve the revised document prior to it
being published.
7.5 Verification Statement
CTC will also prepare a Verification Statement from the information contained in
the Verification Report. After receiving the results and conclusions from the ETV
CCEP Project Manager or the NDCEE Program Manager, the EPA will approve
the Verification Report and Verification Statement. Only after agreement by
TAG, will the Verification Statement be disseminated.
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8.0 INTERNAL QUALITY CONTROL CHECKS
8.1 Guide used for Internal Quality Program
CTC has established an ISO 9001 operating program for its laboratories and the
Demonstration Factory within the ETF. The laboratory is currently establishing a
formal quality control program for its specific operations. The format for
laboratory QA/QC is being adapted from several sources, as listed in Table 15.
Table 15. CTC Laboratory QA/QC Format Sources
Document
General Requirements for the
Competence of Calibration and Testing
Laboratories
Critical Elements for Laboratories
Chapter One, Quality Control
Requirements of 100-300 Series of
Methods
Handbook of Quality Assurance for the
Analytical Chemistry Laboratory, 2nd
Edition
Reference Source
ISO Guide 25, ISO Quality Programs
Pennsylvania Department of
Environmental Protection
SW-846, EPA Test Methods
EPA Test Methods
James P. Dux
8.2 Types of QA Checks
The ETF laboratory at CTC shall follow published methodologies, wherever
possible, for testing protocols. Laboratory methods shall be adapted from Federal
specifications, military specifications, ASTM test methods, and supplier
instructions. The ETF laboratory adheres to the QA/QC requirements specified in
these documents. Each CTC facility that uses standard test products implements
its own level of QA/QC. CTU's laboratory within the ETF will perform the
testing and QA/QC verification as outlined in Tables 10 and 11 (Precision,
Accuracy, Completeness) and Tables 13 and 14 (Calibration); therefore, these
tables should be referred to for the method-specific QA/QC that will be
performed.
8.3 Basic QA Checks
During each test, laboratory staff will complete an internal process QA checklist
to ensure that the appropriate parts, standard test products, samples, and operating
conditions are used. The laboratory also monitors its reagent-deionized water to
ensure it meets purity levels consistent with analytical methodologies. The filters
are replaced quarterly before failures are encountered. When failures do occur,
samples are not processed until the filters are replaced. Blank levels must not
exceed minimum detection levels for a given parameter to be considered valid for
use.
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Thermometers are checked against NIST-certified thermometers at two
temperatures. The laboratory checks and records the temperatures of sample
storage areas, ovens, hot plate operations, and certain liquid baths using
thermometers.
Balances are calibrated by an outside organization using standards traceable to
NIST. CTC also performs in-house, periodic verifications with ASTM Class 1
weights. The ETF laboratory maintains records of the verification activities and
calibration certificates. The laboratory analyst also checks the balances prior to
use with ASTM Class 1 weights.
Reagents purchased directly by the laboratory are American Chemical Society
grade or better. Reagents, dated on receipt and when first opened, are not used
beyond their certified expiration dates.
Laboratory waste is segregated according to chemical classifications in labeled
containers to avoid cross-contamination of samples.
Worksheets will be used to record the various data required by this project. Each
worksheet will contain the name of the process with which it is associated, as well
as blanks for the date, the name of the staff member immediately responsible for
carrying out the measurements, and the associated data.
At the end of each experiment, or at the end of the workday, all worksheets for
that date will be collected, double-checked for completeness, and filed into a
dated folder. These data will be entered into a computer for analysis.
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8.4 Specific Checks
CTC laboratory personnel will also check any referenced materials and equipment
as available and specified by the referenced methodology and/or the project-
specific QA/QC objectives. CTC laboratory records will be maintained with the
sample data packages and/or in centralized files, as appropriate. To insure
comparability, the CTC laboratory will carefully control process conditions and
perform product evaluation tests consistently for each specimen. The specific QA
checks listed in Tables 10, 11, 13, and 14 provide the necessary data to determine
if process control and product testing objectives are being met. ASTM, Federal,
and Military methods that are accepted in industry for product evaluations, and
supplier-endorsed methods for process control, are used for all critical
measurements, thus satisfying the QA objective. A listing of the ASTM methods
that will be used for this T/QAP is included in Appendix E.
The ETV CCEP QA Officer, who is independent of the ETV CCEP project
management, will perform QA audits of the testing and laboratory analyses to
supplement CTC's QC checks. These audits will check that processes are
completed as per the approved written documentation, both internal and external.
The QA audits will also check that the laboratory data is handled properly.
The calibration checks generally consist of calibrating the equipment (if
applicable), checking the calibration against a secondary standard, analyzing
samples, rechecking the calibration, analyzing more samples, etc. The calibration
is also checked against the secondary standard at the completion of an analysis
series. If, at any time, the equipment falls out of calibration, all samples analyzed
since the last good calibration check will be re-analyzed after the equipment is re-
calibrated.
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9.0 PERFORMANCE AND SYSTEM AUDITS
CTC has developed a system of internal and external audits to monitor both program and
project performance. These include monthly managers' meetings and reports, financial
statements, EPA reviews and stakeholders' meetings, and In-Progress Reviews. The ETF
laboratory also analyzes performance evaluation samples to maintain Pennsylvania
Department of Environmental Protection Certification.
ISO Internal Audits
CTC has established its quality system based on ISO 9000 and 14000 and has
implemented a system of ISO internal audits. This information will be used for internal
purposes.
On-Site Visits
The EPA Project Manager may visit CTC for an on-site visit during the execution of this
project. All project, process, quality assurance, and laboratory testing information will be
available for review.
EPA Audits
The EPA may periodically audit CTC during this project. All project, process, quality
assurance, and laboratory testing information will be made available per the EPA's
auditing procedures.
Technical Systems Audits
A listing of all equipment used, laboratory measuring and testing devices and procedures,
a copy of the currently approved ETV QMP, and the currently approved ETV CCEP
QMP will be given to the ETV CCEP QA Officer for this project. The QA Officer will
conduct an initial audit, and additional audits thereafter according to the ETV CCEP
QMP, of demonstration and testing activities. The results of this activity will be
forwarded to EPA in reports from the NDCEE Program Manager or the ETV CCEP
Project Manager.
Audits of Data Quality
Peer review in the laboratory constitutes a process whereby two analysts review raw data
generated at the bench level. After data are reduced, they undergo review by ETV CCEP
laboratory management. For this T/QAP, the ETV CCEP QA Officer will spot-check
10% of the project data by performing a total review from raw to final results. This
activity is performed in addition to the routine ETV CCEP review of all data. Records
will be kept to show which data have been reviewed in this manner.
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10.0 CALCULATION OF DATA QUALITY INDICATORS
10.1 Precision
Duplicates will be performed on separate, as well as on the same sample source,
depending on the method being employed. In addition, the final result for a given
test may be the arithmetic mean of several determinations on the product or
matrix. In this case, duplicate precision calculations will be performed on the
means. The following calculations will be used to assess the precision between
duplicate measurements.
Relative Percent Difference (RPD) = [(Cl - C2) x 100%] / [(Cl + C2) / 2]
where: Cl = larger of the two observations
C2 = smaller of the two observations
Relative Standard Deviation (RSD) = (s/y) x 100%
where: s = standard deviation
y = mean of replicates.
10.2 Accuracy
Accuracy will be determined as percent recovery of a check standard, check
sample or matrix spike.
For matrix spikes and synthetic check samples:
Percent Recovery (%R) = 100% x [(S - U)/T]
where: S = observed concentration in spiked sample
U = observed concentration in un-spiked sample
T = true value of spike added to sample.
For standard reference materials (srm) used as calibration checks:
%R=100%x(Cm/CSrm)
where: Cm = observed concentration of reference material
Csrm = theoretical value of srm.
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10.3 Completeness
Percent Completeness (%C) = 100% x (V/T)
where: V = number of determinations judged valid
T = total number of determinations for a given method type.
10.4 Project Specific Indicators
Process control limit: range specified by supplier for a given process parameter.
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11.0 CORRECTIVE ACTION
11.1 Routine Corrective Action
Routine corrective action will be undertaken in the event that a parameter in
Tables 10, 11, 13, or 14, is outside the prescribed limits specified in these tables,
or when a process parameter is beyond specified control limits. Examples of non-
conformances include invalid calibration data, inadvertent failure to perform
method-specific QA tests, process control data outside specified control limits,
and failed precision and/or accuracy indicators. Such non-conformances will be
documented on a standard laboratory form. Corrective action involves taking any
necessary steps to restore a measuring system to proper working order and
summarizing the corrective action and results of subsequent system verifications
on a standard form. Some non-conformances will be detected during analysis or
sample processing, and can be rectified in real time at the bench level. Others
may be detected following completion of processing trial and/or sample analyses.
Typically, these types of nonconformances will be detected at the ETV CCEP
laboratory management level of data review. In all cases of nonconformance, the
ETV CCEP Project Manager will consider repeating the sample analysis as one
method of corrective action. If insufficient sample is available, or the holding
time has been exceeded, complete reprocessing may be ordered to generate new
samples. Reprocessing will only be performed if the ETV CCEP Project Manager
determines that the nonconformance will jeopardize the integrity of the
conclusions to be drawn from the data. In all cases, a nonconformance will be
rectified before sample processing and analysis continues. If corrective action
does not restore the production or analytical system causing a deviation from the
ETV CCEP QMP, CTC will contact the EPA ETV CCEP Project Manager. In
cases of routine nonconformance, EPA will be notified in the NDCEE Program
Manager's or ETV CCEP Project Manager's regular report to the EPA ETV
CCEP Project Manager. A complete discussion will accompany each
nonconformance.
11.2 Non-Routine Corrective Action
While not anticipated, internal audits by the ETV CCEP QA Officer, or onsite
visits by the EPA ETV CCEP Project Manager, may identify nonconformances of
the requirements stated in the ETV CCEP QMP. In the event that
nonconformances are detected by bodies outside the ETF laboratory
organizational unit, as for routine nonconformances, these problems will be
rectified and documented prior to processing or analyzing further samples or
specimens.
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12.0 QUALITY CONTROL REPORTS TO MANAGEMENT
As shown in Table 7 (Summary of ETV CCEP Experience and Responsibilities), the
ETV CCEP QA Officer is independent of the ETV CCEP project management team. It is
the responsibility of the ETV CCEP QA Officer to monitor ETV CCEP verification tests
for adherence to project specific QMPs and T/QAPs. The ETV CCEP QA Officer will
audit the operation records, laboratory records, and laboratory data reports and provide a
written report of his findings to the ETV CCEP Project Manager and to the ETV CCEP
laboratory management. The ETV CCEP Project Manager will insure that these reports
are included in his report to EPA. The ETV CCEP laboratory management will be
responsible for achieving closure on items addressed in the report. Specific items to be
addressed and discussed in the QA report include the following:
• General assessment of data quality in terms of general QA objectives in
Section 4.1
• Specific assessment of data quality in terms of quantitative and qualitative
indicators listed in Section 4.2 and 4.3
• Listing and summary of all non-conformances and/or deviations from the
ETV CCEP T/QAP
Impact of non-conformances on data quality
Listing and summary of corrective actions
Results of internal/external QA audits
Closure of open items from last report or communications with EPA in
current reporting period
Deviations or changes in the ETV CCEP QMP
Limitations on conclusions, use of the data
Planned QA activities, open items for next reporting period.
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13.0 REFERENCES
The following documents are referenced in this T/QAP:
American Society for Quality Control. American National Standard Specifications and
Guidelines for Quality Systems for Environmental Data Collection and Environmental
Technology Programs. ANSI/ASQC E4-1994, E4. American Society for Quality, 1994.
ETV Program QMP
Environmental Technology Verification Program Quality and Management Plan,
EPA/600/R-03/021, Cincinnati OH: U. S. Environmental Protection Agency, 2002.
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Section No. A
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APPENDIX A
Standard Test Panels
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Page A2
-114 in.
i j
6 in.
4 in.
(0,0)
DFT Measurement Sites on the Standard Test Panels
Dl
D2
(3,1)
D3
(2,2)
D4
(2,3)
D5
(2,4)
D6
(1,5)
D7
(3,5)
D8
(3,1)
D9
(1,1)
D10
(2,2)
Dll
(2,3)
D12
(2,4)
D13
(3,5)
D14
(1,5)
Side A
SideB
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Section No. B
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APPENDIX B
Galvanic Corrosion Coupons
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Section No. B
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11/4 in.'
3 in.
3 in.
(0,0)
DFT Measurement Sites on the Galvanic Corrosion Coupons
Dl
(1,1)
D2
(2,1)
D3
(1,2)
D4
(2,2)
D10
(2,1)
D9
(1,1)
D12
(2,2)
Dll
(1,2)
Side A
SideB
Note: Sites D5, D6, D7, and D8 are located in the center of each of the
four edges.
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Section No. C
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APPENDIX C
TAGNITE Product Specifications
Please contact:
Technology Applications Group
810 48th Street South
Grand Forks, ND 58201
(701)746-1818
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APPENDIX D
Baseline Treatments Product Specifications
Please contact SAE International at www.sae.org for the following
Aerospace Material Specifications:
AMS2476C
AMS2479D
AMS2475F
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APPENDIX E
ASTM Methods
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ASTM Methods
ASME B46.1 — Surface Texture (Surface Roughness, Waviness, and Lay)
[Referenced/Supplemental Methods: ASME Y14.36M, ASME D89.6.2,
and ASME Y14.5M]
ASTM B 117 -- Standard Test Method of Salt Spray (Fog) Testing
[Referenced/Supplemental Methods: ASTM B 368, ASTM D 1193, ASTM
D 1654, ASTM D 609, ASTM E 691, ASTM E 70, and ASTM G 85]
ASTM B 244 — Measurement of Thickness of Anodic Coatings on Aluminum and of Other
Nonconductive Coatings on Nonmagnetic Basis Meals with Eddy-Current
Instruments [Referenced/Supplemental Methods: ASTM B 499]
ASTM D 2794 -- Standard Test Method for Resistance of Organic Coatings to the Effects of
Rapid Deformation (Impact) [Referenced/Supplemental Methods: ASTM
D 609, ASTM D 823, and ASTM D 1186]
ASTM D 4060 — Standard Test Method for Abrasion Resistance of Organic Coatings by the
TaberAbraser [Referenced/Supplemental Methods: ASTM D 823, ASTM
D 968, ASTM D 1005, ASTM D 1186, ASTM D 1400, ASTM D 2240, and
ISO 7784-2}
EPA Method 200.7
EPA Method 218.6
Determination of Metals and Trace in Water and Wastes by
Inductively Couple Plasma-Atomic Emission Spectrometry
[Referenced/Supplemental Methods: ASTMD 1193]
Determination of Dissolved Hexavalent Chromium in Drinking
Water, Groundwater, and Industrial Wastewater Effluents by Ion
Chromatography [Referenced/Supplemental Methods: EPA Method
1636, EPA Method 1669, EPA Method 200.2, and ASTM D 1193]
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