Laboratory - follow up on previous deviation from 2019

[AnnaLeinfelt]

All laboratory from 2019 listed below. All have been approved but some will be discussed (marked).

• [x] LOH_01 | Lab | The pipets has not being calibrated since September 2017. The deviation IA-150 has been written, but it is missing a plan for how the calibration is done next time.

Will be discussed Assign to ALY, MD, SC MD and SC I assigned you to listen in and learn if thisdeviation is discussed. Prepare by reading deviation.

LOH_02 | Lab | Refrigerator in Library prep lab is connected to alarm system where the alarm is tricked at 15 degrees. The instructions demand store between 2-8 degrees. There is a lack of handling of the temperature interval between 8 and 15 degrees.

• [x] LOH_03 | Prep-PCR | Several reagents in the Library prep lab were missing opening date and initials. The DNA-erase reagents were expired in October 2018.

Will be discussed Assign to KBS

• [x] LOH_04 | RNA samples | Following up on MS_01 from 2018 showed that the RNA total sample list was still containing samples with missing reception date, initials and other details. Example on this is EEW50 and HRIU59 from 20180327 (according to LIMS). The sample list should be filled out with reception date, initials ect. for all samples also the samples marked “Not done under accreditation” Ursprunlig avvikelse: "För prov ELH-3058A1 gick det inte i total sample list att se vem som gjort mottagningskontrollen och provets uppmätta koncentration."

To be discussed Assign to ALY, KE

LOH_05 | 1660 | Follow up on MS_07 2018 showed that the new document 1660_02 was not implemented in the laboratory, and the 1660_01 version were still in use until 20190404. Ursprunlig avvikelse: "Det saknas en rutin som gör det möjligt att identifiera vilket PCR-instrument i ett specifikt uppdrag som används i de olika inkubationsstegen i metod TruSeq Stranded mRNA library preparation (1616:5)"

LOH_06 | 1830 | Test specification 1852 is missing e.g. reproducibility and robustness. The test specifications for methods should contain so much data and text that they can be read as individual documents.

• [x] Assign the people that are involved in the task

[keyvanelhami]

@AnnaLeinfelt @annaengstrom I have looked into sample "16107-II-1U" in LIMS and the RNA LIMS WF looks good for me. What's you opinion? If you agree, we can assign LOH_04 as done

[AnnaLeinfelt]

@AnnaLeinfelt @annaengstrom I have looked into sample "16107-II-1U" in LIMS and the RNA LIMS WF looks good for me. What's you opinion? If you agree, we can assign LOH_04 as done

@keyvanelhami It is not a matter of being done, but to be prepared if swedac wants to discuss this issue again. Great that you are up to speed! If discussed 10/6, please show RNA LIMS wf.

[AnnaLeinfelt]

@annaengstrom You are prepared if LOH_01 is discussed?

[annaengstrom]

@AnnaLeinfelt now prepared for LOH_01 :)