Root cause analysis continuous assessment:

Observations from recent FDA inspections identified insufficient root cause analysis:

Using either the 5 whys method or a fishbone analysis identify the root cause of the following
scenario. Suggest changes that will stop this situation from reoccurring in the future, you should
include long term corrective actions, short term corrective actions and medium term corrective
actions in your answer as applicable.

You should give a detailed explanation of how your corrective actions will address the root cause
and prevent this issue from happening in the future. Your answer should also flag potential hurdles
for implementing corrective actions.

Teams 3-5 (no less than three no more than five)

Word count 4000± 10%

Marking

Root cause analysis 20 marks

Discussion of corrective actions 40 marks

An Assessment of how you worked as a team 30 marks (in the Appendix)

Discretion 10 marks

*Important note, you are to approach this assignment as if you were employed to prepare a report.
You should coldly and analytically assess how your team worked, outlining the challenges you faced,
how well you worked together (or not). What you would change in future assignments, your
approach, what worked well. You also should include notes on any group meetings, action items,
missed deadlines, changes in resource allocations..Etc.. FYI I hate personal vendetta’s and the blame
game, it is a sure fire way of loosing marks. Report honestly without the use of names and report the
facts. If this was your job you would not put something down on paper that was libellous. Your job is
to complete the assignment and improve how you work as a team.

Scenario 1:

An analyst presents an invalid HPLC Run to his manager. The analyst used mobile phase prepared by
his colleague to run (in this order) 1 Blank; 2 Reference Standards; 8 samples and one final
Bracketing Reference standard. The final bracketing reference standard did not inject as the vial
position was incorrect and the auto-sampler could not find the vial and in turn the HPLC went into a
system shutdown mode because of the conflict between the information entered into the software
did not match the vial position.

In his discussion with the manager, the following details emerged, the analyst is vastly experienced
and has ran this assay dozens of times in the past with only one or two out of specification results
(OOS). He did not use the pre run checklist which is a non-controlled job aid used generally by less
experienced analysts and as a training tool. The testing method (SOP) is detailed and complex and
follows a prescribed pattern i.e. purpose, scope, roles and responsibilities, list of materials, list of
reagents, standard preparation, sample preparation, assay acceptance criteria for system suitability,
assay acceptance criteria for samples. Followed by an extensive system of appendices containing
details on software, sample chromatograms, suggested run order .etc..

The analyst points out that the SOP was not at all user friendly and when using it people must flip
from page to page as it doesn’t follow a proper workflow, for example the standard preparation is
done alongside the sample preparation but is in separate sections on in the SOP section 4 and 6
respectively.