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DOE-STD-1112-98
CHECKLIST FOR DOELAP SERVICE LABORATORY INDEPENDENT ASSESSMENTS
Accept
QUALITY ASSURANCE
1. A documented, approved quality assurance (QA) plan is in place, and addresses the following aspects of quality assurance:
organizational structure, management and operational responsibilities
____
instructions and procedures, including procedure validation
____
qualification and training of laboratory personnel
____
document control
____
procurement of materials
____
identification and control of material and samples (chain of custody)
____
inspection and testing of material and equipment
____
control and maintenance of calibration standards
____
corrective actions
____
review of procedures, specifications, and operating logs
____
observation of operations and evaluation of quality control data
____
quality assurance records
____
documentation of detector capabilities, detector background checks, relative bias, relative precision, and methods of
calculating results for periodic quality control determinations
____
records management including any deviation from the use of established procedures, equipment, or facilities
____
verification, validation, and documentation of computer software used for calculations
____
documentation of specific customer requirements.
____
2. Internal QA assessments on the use of written procedures are performed at least annually.
3. Procedures are reviewed at least once every two years.
4. The QA plan includes practices for ensuring staff competency.
5. The QA plan describes the training program used to prepare staff to conduct assigned tasks (procedures), and for retraining staff
when assignments or procedures are revised.
6. Equipment used to process biological samples is procured and used in conformance with the QA plan.
7. Results of the laboratory's participation in intercomparison programs or internal measurement assurance programs are consistent
with requirements defined in the QA plan.
8. Open lines of communication are maintained between technical and supervisory staff.
9. Quality control protocols for measurement systems are in place and include:
use of traceable radionuclide reference standards
____
performance checks of measurement systems
____
instrument calibration
____
intra laboratory analyses (e.g., known quantities, replicates, and blanks)
____
participation in available inter-laboratory intercomparison comparison programs
____
computational checks
____
review of procedures, specifications, and operating logs
____
observation of operations and evaluation of quality control data
____
evaluating conformance to the performance criteria of ANSI N13.30
____
evaluating conformance with internal performance criteria set by the QA plan
____
evaluating quality control data to ensure the long-term consistency of analytical results
____
verification of Lc, MDA, and/or MDC determinations
____
background counts
____
blind samples
____
measurement equipment controls such as humidity, cooling, and power fluctuation, if necessary.
____
10. Laboratory staff are familiar with and implement the documented quality control program.
11. An authorized laboratory staff member examines all daily QC results on a periodic basis, and takes timely action to correct any
deficiencies before samples and sample residuals are discarded and results are reported.
12. Quality control results are summarized on a quarterly basis.
A-5


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