4740.2099 Documentation Of Laboratory Personnel Training


Published: 2015

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4740.2099 DOCUMENTATION OF LABORATORY PERSONNEL TRAINING.


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A.

The laboratory must maintain current job descriptions for all personnel who manage, perform, or verify work affecting the quality of the environmental tests.


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B.

The laboratory must maintain a current table of organization showing relationships between all job classifications and responsible lines of authority associated with the procurement, analysis, reporting, and disposal of samples.


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C.

The laboratory's managing agents and owners must ensure that all laboratory staff have demonstrated capability in the activities for which they are responsible. Such demonstration must be documented. For new laboratory personnel, the demonstration of capability must be performed prior to their analysis of any sample for that field of testing. Failure to maintain records that demonstrate the capability of laboratory staff as required in this part is grounds for suspension of certification under part 4740.2050, subpart 9. In the absence of method requirements, an analyst must analyze four reagent blanks spiked at the concentration of the calibration check standard. The recoveries must meet the criteria in the laboratory's quality assurance manual.


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D.

Data produced by analysts while in the process of obtaining required training are acceptable only when reviewed and validated by an analyst or supervisor trained in such evaluations and assessments.


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E.

The laboratory's managing agents and owners must ensure that laboratory staff maintain capability to perform job functions by:

§
(1)

providing evidence that demonstrates that each employee has read, understood, and is using the approved revision of the laboratory's quality assurance manual;


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(2)

ensuring that attendance at training courses or workshops for specific equipment, analytical techniques, or laboratory procedures is documented;


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(3)

maintaining documentation of continued proficiency per analyst by at least one of the following once per year:

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(a)

acceptable results for a proficiency testing sample or other sample prepared in-house for which the concentrations of analyte are unknown to the analyst at the time of testing;


§
(b)

another demonstration of capability as described in item C;


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(c)

at least four consecutive laboratory control samples with acceptable levels of precision and accuracy; or


§
(d)

for bacteriological tests, analysis of authentic samples with results statistically indistinguishable from those obtained by another trained analyst;



§
(4)

ensuring that training files contain evidence that laboratory staff have read, understood, and agreed to perform the analysis using the approved revision of the laboratory's procedures; and


§
(5)

providing adequate supervision for all laboratory activities associated with the procurement, analysis, reporting, and disposal of samples for environmental testing from the time of collection to disposal.



§
F.

The laboratory must maintain initials and signatures of anyone analyzing or reviewing data so that the records can be traced back to an individual approving the data.