Current through Register Vol. 56, No. 24, December 18, 2024
(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.
