N.J. Admin. Code § 7:18-6.6 - 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 all applicable DSAMs, including but not limited to requirements pertaining to laboratory equipment, instrumentation and supplies; 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 radon/radon progeny-in-air 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.

5. The laboratory shall make manufacturers' instruction manuals and any applicable regulations readily available to laboratory personnel at all times. Textbooks may be used to supplement written instructions, but shall not be used in lieu thereof.

(c) A laboratory performing radiochemical testing shall conduct the quality control checks specified in the applicable DSAMs, and take the additional measures listed in (c)1 through 6 below. The laboratory shall maintain permanent records of preventive maintenance, periodic inspection, testing, and calibration for the proper operation of radiation instruments and remedial actions taken in response to detected defects. The laboratory shall maintain daily quality control performance charts and performance records for each instrument.

1. The laboratory shall calibrate each radon/radon progeny-in-air measurement device and technique before putting it into service. The laboratory shall recalibrate each such device and technique at least once every 12 months, and after any repair or modification;

2. For radon/radon progeny-in-air analysis, the laboratory shall record and maintain all information specified by the authorized measurement protocols and methods described in the DSAM and this subchapter;

3. Each day, the laboratory shall perform 10 percent duplicate analyses to verify internal environmental laboratory precision;

4. Before beginning a series of specific analyses, the laboratory shall measure a counting standard and a background standard. Thereafter, the laboratory shall make repeat measurements of the counting standard and background standard after every 20 samples have been measured;

5. During each day in which the laboratory performs fewer than 20 specific analyses, the laboratory shall measure one counting standard and background sample; and

6. The laboratory shall keep all radiochemical instruments in good repair. The laboratory shall maintain factory service contracts for such instruments, or employ an electronics technician qualified to repair and maintain such instruments.

Notes

N.J. Admin. Code § 7:18-6.6