12
Quality Assurance Plan
Under the U.S. Department of Transportation workplace testing program (see 49 CFR,
Part 40), transportation employers are required to test employees working in certain
safety sensitive positions for alcohol under certain conditions. The DOT workplace
testing program requires that breath test instrument manufacturers provide employers
or Breath Alcohol Technicians with this Quality Assurance Plan, which together with the
operation instructions provided with the
Mark V
, will assist in assuring that breath
testers are calibrated to the required degree of accuracy.
QAP:
1. Allowed Calibration Units: Any wet bath simulator listed on the NHTSA
Conforming Products List of Calibration Units for Breath Alcohol Tests. When
calibration or re-calibration (not an accuracy check) is needed the simulator
should be used with a certified 0.080% BAC solution, following the operating
manual provided by the wet bath simulator manufacturer. Alternatively, a dry gas
standard of 0.080% that has been approved by NHTSA may also be used.
2. External Calibration Check Interval: Calibration Checks (Accuracy Checks) should
be performed monthly; after positive test results; or if the unit fails to air blank to
0.000 after 2 attempts, and after repair. There is no limitation on the number of
tests that may be conducted between calibration checks, providing the monthly
checks are completed.
3. External Calibration Check Tolerance: +/- 0.005 or +/- 5% at or above 0.100.
4. Intervals for Periodic Inspection: Self-diagnostics and visual inspection by the
operator before every use. Routine maintenance and service recommended
every 2 years. Calibration should be performed when 2 consecutive calibration
(accuracy) checks fail (out of tolerance).
5. Events which require instrument be taken out of service: Self-diagnostics failure
or indication by error code. The power supply is not providing necessary power
to the Mark V. The Mark V does not display “BLOW” within 2 minutes of power
up.
6. For other information regarding quality assurance unique to this instrument, see
the Mark V Calibration Software Manual as set forth in the Mark V Operating
Manual.
Follow the operating instructions provided by the manufacturer for proper
procedure to use dry gas for calibration checks.
Instruments indicating any of the above ERRORS should be returned to PAS Systems
International, Inc. for repair. Please call PAS Systems International, Inc. Technical
Service Team to describe the problem & for more information on sending the unit in for
service. Please have the serial number of the unit.
This QAP is subject to change and should neither be considered a final
requirement nor a contractual term in any agreement to purchase the MARK V.