Assignment Scenario

You work in Divisional Operational Excellence for a biopharma company. You are comparing performance between the HPLC testing lab in the US and in Ireland. The output in the Irish plant is less as it$$s only a start$-$up$.$

You are working the QC testing lab. You are in the measure$/$analyse phase looking at outputs and performance in the lab focusing primarily on HPLC testing.

Process Overview

A broad overview of the process is that samples are dropped each morning into your lab from $3$ different departments $($paperwork dropped into an $$in$$ tray$)$: incoming raw materials, upstream processing, and downstream processing. Analysts start testing what they can as soon as they start their shift. There is usually a backlog of testing based on the number of samples and tester you have. You have $3$ HPLCs in the lab and $3$ analysts. Currently no one is assigned to any particular type of testing. Each analyst is cross$-$trained. Once they do the testing they ensure the results are entered into the paperwork documentation as a well as ensuring that the results have processed electronically on LIMS $($Laboratory integrated management system$).$ They leave the paperwork in an $$out$$ tray and that$$s it$.($Note if they were in the middle of testing and someone from one of the $3$ test departments came along and asked them to prioritise a particular sample for testing, they would do so accordingly in order to keep production schedules running.

Data Review

You look at the number of tests performed in the HPLC lab over a $14-$day period

US Lab: $15,19,24,6,8,14,22,19,12,14,13,16,19,4$

Irish Lab: $6,7,5,3,14,15,16,15,4,20,13,15,7,5,$

You looked at data to see the number of invalid results each day across both labs over a $27$ day period.

$2,4,7,6,3,9,7,1,17$

$1,4,7,9,12,11,6,12,24$

$2,3,5,7,12,7,6,5,23$

Further analysis gets you to investigate the reasons for the invalids. You review the Lab Invalids over a $2$yr period to see what were the assignable cause.

You see a high incidence on invalid test results that require repeat testing. As part of measure phase you investigate the occurrence of reasons for the invalid results

Controls out of range low $85$

Controls out of range high $105$

Paperwork not completed in advance of testing started $120$

Incorrect HPLC settings $44$

Incorrect column used for testing $20$

Buffers out of date $40$

Preventative maintenance not completed: $20$

System no calibrated prior to running the test: $14$

Level sense errors $22$

No assignable cause: $28$

You also notice that there is a larger incidence of invalids on Fridays!

$1.$ Show how you would evaluate the data above using Quality Tools and problem solve the above information to identify potential root cause and see what areas you should focus on first?

$2.$ Based on the information you have on the process and the data analysis you have completed compile it in the form of an A$3$ report. As part of the A$3$ report you should utilise a $1-2$ of the $$old quality tools$$ and any other tool that I may have introduced you to in the course $($hint: keep it simple!$).$

$3.$ You will have $2$ files to submit, One excel file show any analysis of the raw data and an A$3$ report $($use different tabs in the Spreadsheet for this$).$ There will also be a dropbox for you to submit your meeting minutes as proof you met in some virtual way $($Skype etc.$)$ for the assignment.