Laboratory Audits
Laboratory audits are a good thing. Most laboratory managers fear them. Why? Is it because they are hiding something, or are they just too busy? I suspect it is a combination of both. In the daily grind and rush to get samples out and invoiced quality assurance measures tend to get lax. Don’t get me wrong. The Quality Control is still there just not properly recorded. The problem comes when after things slow down and going back to record everything is overlooked and forgotten.
Managers should encourage audits, however, to keep employees on their toes. Paid audits, or internal audits from QC officers should be looked forward to as ways to prevent significant deficiencies when EPA knocks on the door. Auditors should concentrate more on record keeping and performance data than on comparing lab SOPs with the SOP, or on checking the age of non-critical reagents. Make sure the methods are being done right, and that proper QA and QC is happening.
QC practices are too broad to discuss here, but generally if an instrument is involved it needs to be calibrated. Verify calibration, calibration verifications, MDL determination, Reporting Limit calculations, determination of linearity, demonstration of analyst capability, and records of all of it. Make sure spiked samples are analyzed and that they are not bench spikes if there is an extraction or digestion involved. Make sure MDLs are calculated on digested or extracted samples when applicable.
Be especially wary of records of analytical balance calibration, incubator and oven temperatures, autoclave efficiency, bacteria sterility and controls, pipet calibrations, etc. A good guide on things to watch is the Manual for the Certification of Drinking Water Laboratories, or NELAC Chapter 5.
Don’t fear the audit, prepare for it. Forcing employees to maintain paperwork and never allowing it to be put off is the best way to make sure it will always be there. Last, but not least, establish a good laboratory wide filing system that is consistent in all departments. Review records before they are filed against a checklist of required contents for the file.
William Lipps
http://www.oico.com
(979) 690-1375 ext. 230
wlipps@oico.com
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Tags: assurance, audit, auditors, control, EPA, laboratory, Managers, Quality, records, SOP
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