N.J. Admin. Code § 7:18-8.4

Current through Register Vol. 56, No. 21, November 4, 2024

Section 7:18-8.4 - Requirements for quality assurance/quality control program

(a) The laboratory shall develop and keep current a quality assurance/quality control manual. The laboratory shall not perform analyses of regulatory samples without having a current quality assurance/quality control manual covering the analysis in question. In the manual, the laboratory shall describe the following:

1. The procedures that the laboratory will use in meeting the quality control requirements of this subchapter, N.J.A.C. 7:18-3 and 5, and all applicable DSAMs, including without limitation requirements pertaining to laboratory equipment and instrumentation, supplies, and the frequency with which such procedures shall be performed; and

2. The frequency with which the laboratory will perform the procedures listed pursuant to (a)1 above.

(b) The laboratory shall develop and implement a written methods manual containing a standard operating procedure (SOP) for each DSAM, in accordance with the criteria and procedures of the DSAM and this chapter. A laboratory shall not perform analyses using a DSAM unless it has developed and implemented such an SOP for the DSAM.

1. The laboratory shall update the manual to reflect any changes in the procedures practiced by the laboratory.

2. The laboratory shall keep copies of the methods manual in the immediate bench area of personnel engaged in the analysis of samples and related procedures within the Chemical Testing Categories.

3. In the manual, the laboratory shall properly designate by revision number and date the standard operating procedure (SOP) for a specified analytical method for a particular type of analysis.

4. Changes to SOPs are effective only if:

i. The change is made by the manager, supervisor or quality assurance officer of the laboratory; and

ii. The manager, supervisor or quality assurance officer makes the change in writing, signed and dated by the manager, supervisor or quality assurance officer.

(c) A laboratory performing analyze-immediately and continuous monitoring environmental measurements shall conduct the quality control checks specified in the applicable DSAMs.

N.J. Admin. Code § 7:18-8.4

Amended by 47 N.J.R. 782(a), effective 4/20/2015.