1 Challenge #5: A manufacturing facility has recently seen an increase in bioburden counts, particularly for Gram negative bacteria which is of specific concern.

Sign in and click on "Tracking & Trending" to investigate.

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2 Click on "Customer Dashboard."

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3 Click on "1206 Samples Identified" to view all samples in tabulated form.

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4 Click on the "Options" icon to filter dates, Sample Source, and Gram reaction.

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5 Scroll down to select the desired inputs.

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6 Select 02Jun2016 for the start date.

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7 Select "Personnel - Gowning" and "Personnel Gowning" in the "Sample Source Type" filter.

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8 Select "Negative" in the "Gram Reaction" filter.

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9 Click on "OK" to display results.

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10 Review the "Operators." A CAPA was issued in order to prevent contamination events from occurring. One of the action items was re-training personnel on gowning practices, which was carried out on 02Jun2016. Were the operators adequately trained?

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11 Conclusion: Operator "CAD" should probably be re-trained on gowning.


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