Title 40
SECTION 1090.1375
1090.1375 Quality control procedures.
§ 1090.1375 Quality control procedures.This section specifies ongoing quality testing requirements as part of the Performance-based Measurement System specified in § 1090.1360.
(a) General provisions. You must perform testing to show that your laboratory meets specified precision and accuracy criteria as follows:
(1) The testing requirement applies for the referee procedures in § 1090.1360(d) and for alternate procedures that are qualified or approved under § 1090.1365. The testing requirements apply separately for each test instrument at each laboratory.
(2) If you fail to conduct specified testing, your test instrument is not qualified for measuring fuel parameters to demonstrate compliance with the standards and other specifications of this part until you perform this testing. Similarly, if your test instrument fails to meet the specified criteria, it is not qualified for measuring fuel parameters to demonstrate compliance with the standards and other specifications of this part until you make the necessary changes to your test instrument and perform testing to show that the test instrument again meets the specified criteria.
(3) If you perform major maintenance such as overhauling an instrument, confirm that the instrument still meets precision and accuracy criteria before you start testing again based on the procedures specified in ASTM D6299 (incorporated by reference in § 1090.95).
(4) Keep records to document your testing under this section for 5 years.
(b) Precision demonstration. Show that you meet precision criteria as follows:
(1) Meeting the precision criteria of this paragraph (b) qualifies your test instrument for performing up to 20 tests or 7 days, whichever is less. Include all tests except for testing to meet precision or accuracy requirements.
(2) Perform precision testing using the control-chart procedures in ASTM D6299. If you opt to use procedure 2A (Q-Procedure) or 2B (dynamically updated exponentially weighted moving average), validate the first run on the new QC batch by either an overlap in-control result of the old batch, or by a single execution of an accompanying standard reference material. The new QC material result would be considered validated if the single result of the standard reference material is within the established site precision (R') of the ARV of the standard reference material.
(3) Use I charts and MR charts as specified in ASTM D6299 to show that the standard deviation for the test instrument meets the precision criteria specified in § 1090.1365(b).
(c) Accuracy demonstration. For absolute fuel parameters (VCSB and non-VCSB) and for method-defined fuel parameters using non-VCSB methods, you must show that you meet accuracy criteria as specified in this paragraph (c). For method-defined VCSB procedures, you may meet accuracy requirements as specified in this paragraph (c) or by comparing your results to the accepted reference value in an inter-laboratory crosscheck program sponsored by ASTM International or another VCSB at least 3 times per year.
(1) Meeting the accuracy criteria of this paragraph (c) qualifies your test instrument for 130 days.
(2) Except as specified in paragraph (c)(3) of this section, test every instrument using a check standard meeting the specifications of ASTM D6299. Select a fuel sample with an ARV that is at or slightly below the standard that applies. If there are both average and batch standards, use the average standard. If there is no standard, select a fuel sample representing fuel that is typical for your testing.
(3) The following provisions apply for method-defined non-VCSB alternative procedures with high sensitivity to sample-specific bias:
(i) Procedures have high sensitivity if the closeness sum of squares (CSS) statistic exceeds the 95th percentile value, as specified in ASTM D6708 (incorporated by reference in § 1090.95).
(ii) Create a check standard from production fuel representing the fuel you will routinely analyze. Determine the ARV of your check standard using the protocol in ASTM D6299 at a reference installation as specified in § 1090.1370.
(iii) You must send EPA a fuel sample from every twentieth batch of gasoline or diesel fuel and identify the procedures and corresponding test results from your testing. EPA may return one of your samples to you for further testing; if this occurs, you must repeat your measurement and report your results within 180 days of receiving the fuel sample.
(4) You meet accuracy requirements under this section if the difference between your measured value for the check standard and the ARV is less than the value from the following equation:
Where:
Δmax = Maximum allowable difference. R = Reproducibility of the
referee procedure identified in § 1090.1360(d), as noted in Table 1
to paragraph (b)(3) of § 1090.1365 or in the following table:
Table 1 to Paragraph (c)(4) - Criteria for Qualifying Alternative Procedures
| Tested product | Referee procedure 1 |
Reproducibility (R) 2 |
|---|---|---|
| ULSD, 500 ppm diesel fuel, ECA marine fuel, diesel fuel additive, gasoline, gasoline regulated blendstock, and gasoline additive | ASTM D2622 | R = 0.4273 · x 0.8015 |
| Butane | ASTM D6667 | R = 0.3130 · x |
1 ASTM specifications are incorporated by reference, see § 1090.95.
2 Calculate reproducibility using the average value determined from testing. Use units as specified in § 1090.1350(c).