---
kind: "section"
citation: "40 C.F.R. § 136.7"
title: "40"
number: "136.7"
heading: "Quality assurance and quality control."
url: "https://uscodex.org/cfr/40/136.7"
---

# §136.7. Quality assurance and quality control.


The permittee/laboratory shall use suitable QA/QC procedures when conducting compliance analyses with any [part 136](/cfr/40/part136.md) chemical method or an alternative method specified by the permitting authority. These QA/QC procedures are generally included in the analytical method or may be part of the methods compendium for approved [Part 136](/cfr/40/part136.md) methods from a consensus organization. For example, Standard Methods contains QA/QC procedures in the [Part 1000](/cfr/40/part1000.md) section of the Standard Methods Compendium. The permittee/laboratory shall follow these QA/QC procedures, as described in the method or methods compendium. If the method lacks QA/QC procedures, the permittee/laboratory has the following options to comply with the QA/QC requirements:

- (a) Refer to and follow the QA/QC published in the “equivalent” EPA method for that parameter that has such QA/QC procedures;
- (b) Refer to the appropriate QA/QC section(s) of an approved [part 136](/cfr/40/part136.md) method from a consensus organization compendium;
- (c)
  - (1) Incorporate the following twelve quality control elements, where applicable, into the laboratory's documented standard operating procedure (SOP) for performing compliance analyses when using an approved [part 136](/cfr/40/part136.md) method when the method lacks such QA/QC procedures. One or more of the twelve QC elements may not apply to a given method and may be omitted if a written rationale is provided indicating why the element(s) is/are inappropriate for a specific method.
    - (i) Demonstration of Capability (DOC);
    - (ii) Method Detection Limit (MDL);
    - (iii) Laboratory reagent blank (LRB), also referred to as method blank (MB);
    - (iv) Laboratory fortified blank (LFB), also referred to as a spiked blank, or laboratory control sample (LCS);
    - (v) Matrix spike (MS) and matrix spike duplicate (MSD), or laboratory fortified matrix (LFM) and LFM duplicate, may be used for suspected matrix interference problems to assess precision;
    - (vi) Internal standards (for GC/MS analyses), surrogate standards (for organic analysis) or tracers (for radiochemistry);
    - (vii) Calibration (initial and continuing), also referred to as initial calibration verification (ICV) and continuing calibration verification (CCV);
    - (viii) Control charts (or other trend analyses of quality control results);
    - (ix) Corrective action (root cause analysis);
    - (x) QC acceptance criteria;
    - (xi) Definitions of preparation and analytical batches that may drive QC frequencies; and
    - (xii) **Minimum frequency for conducting all QC elements.**
  - (2) These twelve quality control elements must be clearly documented in the written standard operating procedure for each analytical method not containing QA/QC procedures, where applicable.

## Notes

### Amendments

[77 FR 29813, May 18, 2012]

### Authority

Authority: Secs. 301, 304(h), 307 and 501(a), Pub. L. 95-217, 91 Stat. 1566, et seq. (33 U.S.C. 1251, et seq. ) (the Federal Water Pollution Control Act Amendments of 1972 as amended by the Clean Water Act of 1977).

### Amendments

[77 FR 29813, May 18, 2012]