I n c r e a s e d

Q u a l i t y C o n t r o l P r o p o s a l
Prepared for: Sarah Atzet Ph.D., Chief Operating Officer
Prepared by: Kevin Blanco, Aseptic Filler

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Date: September 4 , 2016
Proposal #1
CC: Elisa Stone, English 2100 Professor

Increased Quality Control Proposal

Objective

Quality control has been an on-going issue at Sentrx Animal Care. The purpose of
this proposal is to present a solution that will increase quality control. Finding a cost
effective way to increase quality control is important for the sake of the company. In
recent months we have produced a number of quarantined animal products due to
low quality, which has resulted in a loss of money. The company has also failed
many TSB (Tryptic Soy Broth) tests, which has resulted in the company being
unable to earn new medicine certifications. The solution presented in this proposal
with allow Sentrx to continue revolutionizing veterinary care, and continue moving
forward in an efficient manner.

Current Situation

Sentrx Animal Care has been unable to pass TSB tests in the recent months to earn
new medicine certifications. A possible cause of being unable to pass these tests is
the cleanliness of the aseptic fillers while they are filling the TSB solution into
bottles. Another possible cause is the cleanliness of the equipment the aseptic fillers
use while filling the TSB solution. Along with being unable to pass TSB testing in the
recent months, the company suffers from the occasional quarantined lot of animal
medicine, resulting in lost money. The cause of these occasional quarantined lots
can also be a result of the cleanliness of aseptic fillers and the equipment they use to
fill the animal medicine. Some action needs to be taken so the company can pass the
TSB testing and earn new certifications as well as eliminate the occasional
quarantined lot of animal medicine that is costing the company money. The
proposed solution shall increase quality control and allow the company to move
forward.

Solution

In order to increase quality control, the company must do a number of things.
The aseptic fillers are currently only required to autoclave the Scilogex
product pump, pump accessories, and the liter bottles used in the filling
process. Autoclaving this equipment in the Sentrx facility ensures the
equipment is sterilized. However, the aseptic fillers are not required to
sterilize their own lab coat, facemask, booties, arm sleeves, hair cap, and
gloves because these items are bought sterilized. If the company starts
sterilizing all of the equipment the aseptic fillers use in its own facility, it will

eliminate the possibility of using unsterilized equipment in the clean room

environment. The company buys already sterilized equipment from a
variety of outlet companies, but how can sterilization be guaranteed when
those companies are shipping out millions of units every year. If Sentrx
starts sterilizing its own equipment, it will eliminate the risk of
contamination during production or shipping with another outlet company.
Along with the new sterilized equipment, the company must produce a new
SOP (Standard Operating Procedure) for the aseptic fillers. A new SOP that
increases the cleanliness of the fillers while they are in the clean room
environment.
Lastly, the aseptic fillers must receive new training for working in the clean
room environment. This training will include new methods for preparing for
work in the clean room.

Project Plan

1. Sentrx must began by taking lab coats, facemasks, booties, arm sleeves, hair
caps, and gloves to be used by the aseptic fillers and autoclave them in their
own facility to ensure sterilization. The sterilizing of this equipment should
take place at the beginning of every week, preparing enough equipment to fill
with for the entirely of that week.
2. Create a new SOP for the aseptic fillers to follow that includes new rules as
well as cleanliness methods.
Washing hands with soap and warm water for at least 60 seconds in
the clean room preparation area.
Clearing outside clothing of any loose items and debris
Not allowing any unapproved outside items into the clean room, such
as cell phones, IPods, books, etc.
Ensuring new and sterilized equipment is being used every time the
clean room is entered.
3. Train the aseptic fillers on the new SOP and ensure they understand the
significance of the new rules and cleanliness methods.

Cost & Benefits

The beauty of this solution is it will cost next to nothing to perform. Sentrx already
spends money to obtain the equipment needed to work in the clean room, that
equipment being lab coats, facemasks, booties, arm sleeves, hair caps, and gloves.
With that being said, the only extra step necessary in this proposed solution is
autoclaving that equipment in Sentrxs own facility. Being that the company already
has an autoclaving unit, the only cost to the company would be the increased usage
of that unit. The autoclaving unit at Sentrx runs on water and electricity, so the

company will only see a small increase on the water and electricity bill every month.
Considering this solution hasnt been performed yet, theres no saying the amount of
increase each bill will receive. Considering the autoclaving unit will only be ran 1
more time every week than usual, the costs should be minimal. This solution only
requires running the autoclaving unit once a week (every Monday), thats four times
a month, so the water and electricity should see an increase of no more than $30
dollars a month combined. As for the increased usage of the autoclaving unit, the
unit is already used 3 to 4 times a day, increasing that use by 1 every Monday, will
not damage the unit in any way. The small increase of utilities will be more than
worth it for the company of Sentrx. This solution will allow the company to pass TSB
testing and earn new medicine certifications, which will in the future make the
company money. This solution will also put a stop to the occasional quarantine lot of
animal medicine, which will save the company upwards to $10,000 dollars every
time a lot doesnt come back quarantined.

Conclusion

The main point of this proposal is to provide a solution to increase quality control.
Increasing quality control through new equipment sterilizing methods, a new SOP
that introduces new rules and cleanliness methods for aseptic fillers, and new
training for the aseptic fillers. These are all effective methods of increasing quality
control at minimal cost, not to mention these changes will save Sentrx money down
the road as well as allow Sentrx to move forward in the world of medicine. Thank
you for your time and consideration in reading this proposal and I hope Sentrx
continues to thrive in Animal Care.