Faking it
I had an illegible entry in a field sheet so I used the White-Out from the manager's office to make it neater.
NOT ALLOWED. Only a single-line cross out with initials and date are allowed for correcting results.
After 5 tries the YSI calibration finally worked, so I recorded it on a new YSI log sheet and tossed the old paper with all the tries on it.
NOT ALLOWED. All data must be retained. Multiple calibrations until one passes is not allowed.
Everyone knows what happened to the samples so I don't need to leave a note in the QC Batch notes box.
NOT ALLOWED. Notes and explanations should always be entered in the QC Batch notes box with initials and date of the person leaving the note.
The recorded results don't look right, but I'll enter my approval checks and if the next reviewer has a problem with it they can let me know.
NOT ALLOWED. Saving approval checks is your signature of approval for the data.
I never worry about backing up computer files because that's the job of IT.
NOT ALLOWED. Data must be backed up according to the Quality Manual.
The water level in one E. coli bottle is below the 100mL mark, but it's close. I can still use it.
NOT ALLOWED - If the sample level is below the 100mL mark, it cannot be used and must be rejected.
I jotted down the incubator temperature on the back of the first tray so I would remember what it was when I went to enter the temperature in LIMS.
NOT ALLOWED. Times and temperatures must be entered into LIMS in real time. The tray becomes original data which must be retained.
I saw that the new employee wasn't reading any of the SOPs, just filling out the Agree to Follows, so I talked it over with my manager.
ALLOWED. Report improper laboratory practices to the manager.
I measured transparency, but forgot to write it on the field sheet. I remembered a few days later and entered the data from memory.
NOT ALLOWED. Data must be recorded at the time of measurement. (contemporaneously)
LIMS wouldn't save my data, so I took a screen shot and entered the data later after LIMS was restarted. I left a note in the QC Batch with the screen shot attached.
ALLOWED. The screen shot is the original data and must be attached.
It's almost time to leave and I still have several QC Batches to approve. I'll just enter all the approval checks without looking very carefully at the data since the next reviewer will catch any problems.
NOT ALLOWED. Saving approval checks without reviewing the data is improper laboratory practice.
Since we have good electronic scans of all the field sheets, we threw the paper copies of last month's runs away.
ALLOWED. As long as scans are good representations of the paper copy, the paper copy does not need to be preserved.
My manager never follows the procedure so I'm going to report my manager anonymously by calling 254-761-3110
NOT ALLOWED. This is Clay's phone number. The BRA hotline is 1-866-418-8048.
I noticed a typo in my Entero MPN results a couple of days after I entered it. I changed the results after my manager and the DQAO gave me permission to do so, with an explanation attached.
ALLOWED. Changes may be made with approval and justification.
LIMS is expected to be down all day, so the most recent paper worksheet versions were used to record all the data. The data will be entered into LIMS later and the worksheets attached.
ALLOWED. Original data must be retained.
I know I will set E. coli tomorrow at 2:00, so I went ahead and entered that as my set time when I created the QC batch.
NOT ALLOWED. Measurements should be entered contemporaneously, in real time, as the actions occur.
Susan in Central Files just threw out all the lab files from 2015.
ALLOWED. CRP requires data to be retained for 7 years.
My co-worker purposely doesn't follow the SOPs. He's a really good friend... He'll get caught by someone else someday.
NOT ALLOWED. Improper laboratory practice must be reported.
I didn't have a lot of time to perform an analysis, so I went back to a historical QC Batch and entered similar results.
NOT ALLOWED. This is dry-labbing, reporting results without doing the analysis is improper laboratory practice.
For turbidity calibration, the standard was running low, so I changed the formula in the Excel spreadsheet so the % recovery would always come up 100%.
NOT ALLOWED. Approved and verified worksheets must be locked and unchangeable.
When I downloaded the YSI data for the lake profile depth samples, some of the DO readings were negative numbers so I changed them to zeros.
NOT ALLOWED. Original data must not be changed without approval or justification.
The NELAP assessor is due to arrive next week, so everyone agreed we wouldn't show them data for College Station West since the anions results are always so high and there tend to be problems running the samples.
NOT ALLOWED. All data is accessible to the NELAP assessors. Hiding problems is an improper laboratory practice.
My co-worker used the ESL E. coli Dilution test method but I didn't see them do any dilutions - I don't have any proof and I may not have seen everything, but I'm very skeptical they followed the procedure. I ended up not saying anything to anyone.
NOT ALLOWED. If you have a question, ask the person or talk it over with the manager. Keeping things to yourself is probably not the right thing to do.
I didn't collect a 290mL bottle for an E. coli duplicate so I took 50mL out of the 120mL bottle for the sample and set up the duplicate with the other 50mL.
ALLOWED. The reporting limit becomes < 2 MPN. Be sure to tell Clay and DQAO and leave a description in the QC Batch notes box.
A new test was created in LIMS to calculate Enterococcus MPN, so the DQAO checked the calculations by hand to make sure the LIMS calculations and the hand calculations matched.
ALLOWED. All calculating worksheets must be verified.