In Module 5 you will write your first publish of an investigation, then after you

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In Module 5 you will write your first publish of an investigation,
then after you get feedback from me, you will write a final publish.
BACKGROUND
For this Investigation assignment,
consider the collagen media exchange scenario for which you’re publishing a
final revision of the procedure.
There has been a deviation in the collagen media exchange process.
On a given day (make up a recent date), a team of three operators had to
change the media in 1000 collagen roller bottles. The normative rate
of media exchange (full process of aspirate and fill) for a single
roller bottle is about 30 seconds. On this day, the team processed all
1000 roller bottles and finalized all the documentation (batch records)
related to the work.
This media exchange process takes place every three days. When the
team returned to this set of 1000 roller bottles three days later to
process them, they found that the final 350
roller bottles had been under filled by about 100mL (target = 400mL).
Make sure to write out a clear incident description/background in your
own words. You cannot conduct an investigation with a poorly written
incident description/background.
THE INVESTIGATION
For this assignment, you will conduct an investigation as detailed in this Investigation SOP
. You will notice at the end of that SOP there is a format for your investigation report. You will use that exact format for this assignment using this template file.
For part 3.0 Investigation Summary of
the investigation report, you must note possible roots causes under
each of the main process inputs of Man, Machine, Methods, Materials, and
Environment. There must be at least one under each and a total of ten possible
root causes. You can be creative in thinking through these possible
failures related to each of the five major process inputs, but you must have 10.
For the Product Impact section,
you should respond to the best of your ability. Generally speaking, the
product impact statements either support keeping the affected the
materials or dispositioning them for waste if you feel the deviation
would have a significant impact on the quality. Again, I’m not testing
your technical ability here. Be creative in filling out this section,
but decide whether to keep, or throw away the material and back up your
decision with some sort of logical explanation.
From part 3.0, you will pick one root cause to explore in sections 5.0 Root Cause and 6.0 Recommended Corrective Action Plan. Pretend that investigative findings revealed the true root cause.
Based on what that root cause is, determine what the immediate fix is
and what can be done to prevent it from happening in the future. Again,
you should apply creativity liberally in this section to work through
the response. The goal is to have complete responses for all the
sections of the Investigation Report.
You can see that I’ve given you a lot of leeway in this assignment.
Use logic, but creativity in your investigation is acceptable. Remember
to follow the rules for writing that we have learned over the last 6
weeks. The idea is to let you freely explore all the things that could
go wrong, how you might possibly find out if it was in fact one of those
possibilities, and what you would do to fix and prevent this from
happening again. The ultimate goal in this is to recognize that it’s a
significant event when things don’t turn out the way we expect and, more
importantly, the way we said they
would turn out. Companies are obligated to work through this
investigation to tighten up their processes so they can consistently
produce a safe and effective product.
I am expecting that you will have about three pages of
single-spaced work (about 900 words) as part of this assignment. You
might find yourself going over this (not by much!) but it should be
difficult to fully document the investigation with much less than three
pages.
Common mistakes:
Not using the template
Not filling out the header
Writing a muddy/unclear incident description
Lacking 10 possible root causes
Not zeroing in on a true cause
Not deciding whether to keep or dispose of the materials
Not giving enough detail for any of the above- remember, this should be around 900 words
Typos- Don’t forget to come back to your work and proofread!
You must write in your own words. Do not copy from my text, or from a peer. Plagiarism will result in a score of zero.
Rubric
Investigation Assignment First publish
Investigation Assignment First publish
Criteria
Ratings
Pts
This criterion is linked to a Learning Outcome
Correct Template Used
5
pts
Full Marks
Utilized provided template
0
pts
No Marks
Provided template not used.
5 pts
This criterion is linked to a Learning Outcome
Template Header
5
pts
Full Marks
Header was filled out completely
2.5
pts
Partial Credit
Missing information
0
pts
No Marks
Header not filled out
5 pts
This criterion is linked to a Learning Outcome
Incident Description & Background
10
pts
Full Marks
Incident description is clear and concise while providing key details. Background provides clear understanding of process.
7
pts
Partial Credit
Incident
description is lacking a key detail, such as the number of bottles
underfilled or the volume that they were underfilled. Background
provides basic understanding of process.
3.5
pts
Partial Credit
Incident description lacks several details, and/or background does not have key process information.
0
pts
No Marks
10 pts
This criterion is linked to a Learning Outcome
Investigation Summary
10
pts
Full Marks
Summarizes key findings of investigation providing at least 10 root causes addressing the main categories of a fishbone diagram.
7
pts
Partial Credit
Provides only 6-10 root causes, OR only addresses some of the fishbone diagram categories
3.5
pts
Partial Credit
Provides 5 or less root causes.
0
pts
No Marks
10 pts
This criterion is linked to a Learning Outcome
Product Impact
5
pts
Full Marks
Provided decision on whether to keep or discard materials
0
pts
No Marks
Product disposition (keep or destroy) not included
5 pts
This criterion is linked to a Learning Outcome
Root Causes & Corrective Action Plan
10
pts
Full Marks
Focused
in on one root cause from the options listed in the Investigation
Summary, AND provided corrective action plan specific for that root
cause.
7
pts
Partial Credit
The
selected root cause was not clearly described, OR the corrective action
plan was not specifically tied to the selected root cause.
3.5
pts
Partial Credit
The
selected root cause was not clearly described, AND the corrective
action plan was not specifically tied to the selected root cause.
0
pts
No Marks
10 pts
This criterion is linked to a Learning Outcome
Spelling/Grammar
5
pts
Full Marks
Mostly free of spelling and grammar errors
2.5
pts
Partial Credit
Several spelling and grammar errors that do not interfere with basic communication
0
pts
No Marks
Spelling and grammar errors cause confusion in reader
5 pts
Total Points:
50

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