Plan for QA/QC and Allied Activities

Let me begin with minutes of discussions with SL Sir during my first visit (Before my
joining), this is important in terms of long term objectives of AROSOL, here I am trying to
summarize whatever he talked about(all the green highlighted points in this document are
either under implementation or actions have been taken to rectify them ):
Boiler section-For long term maintenance
o
Water analysis
Hardness

Dissolved silica and gases

Mineral mixture
o
Why there is lumping?
o
Anti caking agent-which can be used without any side effect?
Process water for liquid formulations:
o
What should be its pH(ideally 5.5-6);but its showing some upward trend?
Being adjusted with Citrate?

Remedy-Backwash properly?
Purchase a conductivity meter for QC
Effect of TDS on Lactomix?
Emulsified Pinyl oil to disinfect liquid section
Nitrogen purging is not being practiced?
Mineral mixture(Both)-Composition and samples->send to SL Sir
Sharmaji(Manager Production's query)-Banana flavor-why it goes out so early?
Tyagiji's store-Refrigerator / Flooring issue
Develop agent which may kill Ticks/Mites
Discussion with KL Sir at the time of Joining
Sonali (Non-herbal part)and Chauhan(Herbal part) will take up R&D; If any assistance is
needed then SL Sir will ask me to do that.
o
Some new projects expected by SLS in future-fat emulsifier, Antibiotic
replacement etc
QA, QC with me
Export documents(already with Sonali but regularly view them for any modifications)
Vitamins or trace elements have to be added(initially in Lactomix only) in the presence of
a QC person
o
Attach Lavisha with Tyagiji to monitor weighing of trace elements/vitamins
Weighing balance with print out facility ->print outs will be given to QA/QC person
Moisture in powders(mineral mixture)-anticaking agent
Breakage of Bottles! May be due to gas formation(Lactomix-Urgent)
Stability chambers
Mastitis -How to add Sulphur in fomulation
Herbal choline ->Switzerland->Insecticide present
Issue of GM seeds
Discussions in Lab with lab-mates:
1

Crude protein analysis/assembly

We dont have testing methods of all the Finished products
Proper lead time is not defined(time usually taken to test a material)
My observations:
o
We dont have a proper documentation system, in absence of that we can't fix
accountability.
o
Most of the commands are delivered verbally which give people a room to
manipulate.
o
There is a multi-centric documentation management system; some documents are
prepared in production and products are tested in QC without knowledge of
composition; QC chemist usually analyzes it as per the existing specs which does not
support the label claim and then conflict arises. Similarly in case of labeling, there is
distant role of QC/QA; ideally there should be a separate file in QC/QA for every
label which should work as a master file before passing any label for any batch . All
such things result in flow of half baked information.
o
Ideally, first of all a master formula is fixed, according to that list of raw materials
is prepared and to maintain a uniform standard RMS(Raw Material Specifications) are
prepared but hardly we do that. This is very crucial step because on the basis of RMS
we can look for STPs(Standard Testing Procedures). In the same way FPS(Finished
Goods Specifications) are designed to test the final products, but I found several
mismatch in this system
o
Formulations are not stable. Phase separation/appearance change/viscosity
change/odor change are common phenomenon
o
Vessels in production are not properly calibrated which ultimately result in change
in g/ml or viscosity changes

Like any other growing organization we are also focused on GROWTH only, but if our
fundamentals are not strong then it would be difficult to sustain this growth. In the above
discussions I have enumerated lots of problems. No one can solve all of them at once but I have
taken this opportunity to spell out my plan to deal with them one by one.
As I mentioned, we dont have a strong documentation system and most of the problems l
found here are so I would start with it, that too with all the variants of Lactomix
First decide specifications of raw materials/finished goods

Design STPs(Standard testing protocols) for raw materials/finished goods

Develop testing protocols raw materials/finished goods

Maintain inward record for raw material

Maintain Document issuance record

Maintain tracking record of approved document

Calibration of Instrument

SOPs of all the instruments

Chemical Inventory