Product Quality Risk Assessment
Department
Product Name:
Subject : Materials (Raw Materials / Packing Materials)
Sl.
No.
Parameters to be checked
Stores (Raw Materials & Packing Materials)
1
a
b
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d
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g
Whether approved vendor list is available and
followed?
Whether materials purchased as per vendor list?
Whether the material stored as per its required storage
conditions.
Whether materials are segregated / stored and handled
safely.
Is there a proper identification / location for each
materials stored?
Whether the status of the material is clearly identified
and labeled?
Is there proper segregation of materials as Quarantine /
Approved & Rejected?
Are all safety instructions followed for materials?
Whether materials are stored securely?
j
k
2
a
b
c
d
Is there counterfeiting control system available while
material is under transfer?
Whether the material storage conditions are maintained
through out its processing stage?
Raw Materials Dispensing
Whether the sampling of Raw materials is carried out
strictly as per SOP?
Whether line clearance procedure is followed for
product to product change over strictly to avoid
cross contamination?
Whether FEFO / FIFO system is followed for raw
materials and raw materials to be dispensed?
Whether Raw materials taken for dispensing is checked
for approval / retest / use before date status
before dispensing?
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Observation
Remarks
Sl.
No.
e
f
g
h
i
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k
Parameters to be checked
Observation
Remarks
Whether the Weighing Balances used for dispensing is
checked for calibration status / calibrated before
dispensing activity.
Whether the dispensing is carried out under clean
environment / under dispensing booth?
Whether the employees follow secondary dress
discipline and handle dispensing with personal
protective equipments like, gloves / mask etc.,?
Whether dedicated scoops are being used for active raw
materials to be dispensed?
Whether a single material taken for dispensing at a
time?
Whether the dispensed material is sealed and labeled
with proper dispensing label?
Whether the dispensed materials are stored safely with
authorized handling and control?
Packing Materials Dispensing
3
a
b
c
d
e
g
h
Whether the Printed Packing materials are stored with
proper segregation securely?
Whether the sampling of Packing materials is carried
out strictly as per SOP?
Whether the line clearance procedure is followed for
printed packing material dispensing?
Whether FIFO system is followed for packing
materials?
Whether Packing materials taken for dispensing are
checked for approval status before dispensing?
Whether a single material is taken for dispensing at a
time? Whether the Printed Packing materials
are dispensed under authorized person one by
one to avoid mix-ups?
Whether the dispensed material is labeled with proper
dispensing label?
Whether the dispensed materials are stored safely with
authorized handling and control?
Assessment Done By:
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Checked By:
Approved By:
Department
Product Name:
Subject : Personnel (Working Employees)
Sl.
No.
Parameters to be checked
Observation
Remarks
Whether employees are subjected to Pre-employment
medical checkup before appointment?
Whether employees are subjected to medical checkup
b
periodically there after?
a
Whether employees are trained for their specific job?
Whether the employees are provided with safety
apparels for their specific job?
Whether the employees are assessed for competency?
Whether the employee-to-employee (designationwise) reporting procedure is followed?
Whether there is a proper communication between
g
employee and reporting boss and also between
shifts?
Is First Aid facility provided to the working personnel
h
and are they trained?
f
Assessment Done By:
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Checked By:
Approved By:
Department
Product Name:
Subject : Equipments
Sl.
No.
a
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s
Parameters to be checked
Observation
Remarks
Are Equipments master list available for all
departments?
Are Equipments coded?
Are Equipments supplied with safety features?
Are Equipments of GMP model with product contact
parts made up of SS316?
Are Equipments contact parts are tested for SS316?
Are Equipments earthed?
Are the electrical lines / wirings of all Equipments
concealed and safe for operation?
Are Equipments provided with safety doors (or) machine
guards, emergency off switch etc.,?
Are Equipments cleaned as per schedule?
Are Equipments subjected to cleaning verification during
product to product changeover?
Are all Equipments in use labeled with the adequate
status label?
Are safety instructions for operation of Equipments
included in SOPs?
Is equipments master calibration list available?
Are equipments calibrated as per schedule and reports
available?
Are equipments qualified for Design, Installation,
Operation and Performance (DQ, IQ, OQ & PQ)?
Is equipments planned preventive maintenance schedule
available?
Is preventive maintenance carried out for all critical
equipments and reports available?
Are filters of AHU units cleaned as per schedule and
reports available?
Are equipments free from noise and noise level is with in
the noise control limits?
Assessment Done By:
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Checked By:
Approved By:
Department
Product Name:
Subject : Facilities
Sl.
No.
a
b
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d
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Parameters to be checked
Observation
Remarks
Is Approved site master plan available and updated?
Is Approved site layout drawing for all the floors
available and updated?
Is Site construction / area qualification done and
protocol / reports available?
Are all the critical manufacturing areas supplied with
dedicated Air Handling Units?
Are Material and Men movements clearly defined for
all the critical manufacturing operations?
Are required utilities connected in all the areas and are
working condition satisfactory?
Are equipments utilities are colour coded / labeled and
flow direction is indicated?
Are utilities lines leak proof and is leakage observed in
any section?
Is floor / wall / ceiling integrity (including painting
structure) maintained for all sections in critical
manufacturing areas?
Is there proper lightening system for all sections and
lux level for the same is within the limits?
Are doors of all critical operations in working condition
and door discipline maintained?
Is building maintenance work carried out on regular
basis?
Is Non-routine work to return to routine work
procedure followed during building
maintenance work and reported?
Are all the departments provided with fire fighting
equipments and can be accepted for safe
operations?
Are all the floors provided with emergency evacuation
doors with escape route directions?
Are fire alarm system provided for all critical
operations?
Whether the tamper proof system is available in
manufacturing / packing of products to avoid
any misuse (or) mischief?
Assessment Done By:
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Checked By:
Approved By:
Department
Product Name:
Subject : Environment Control
Sl.
No.
a
b
c
d
e
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o
Parameters to be checked
Observation
Remarks
Is cleaning and disinfection schedule available for all
critical operations?
Is cleaning and disinfection carried out for all sections
as per schedule?
Is disinfection validation carried out for all
disinfectants used in site and reports available?
Are the critical manufacturing areas clean and suitable
for hygienic operations?
Is temperature controlled / monitored and reported for
all critical manufacturing operations?
Is humidity controlled / monitored and reported for all
critical manufacturing operations?
Is pressure differential for critical manufacturing
operations controlled / monitored and reported?
Is pest control schedule available in the site?
Is pest control carried out outside the premises and
away from critical operations?
Is pest control carried out as per the schedule and
reported?
Is there any possibility for cross contamination with
respect to adjacent area operations?
Is there any possibility for cross contamination with
respect to Men movements?
Is there any possibility for cross contamination with
respect to Material movements?
Is microbiological monitoring of air carried out on
routine basis and are trend results satisfactory?
Is microbiological monitoring of water carried out on
routine basis and are trend results satisfactory?
Assessment Done By:
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Checked By:
Approved By:
Department
Product Name:
Subject : Method and Procedures
Sl.
No.
a
b
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Parameters to be checked
Is SOP for SOP available and followed?
Are SOPs available for all critical operations?
Are SOPs distributed by QA and displayed for all
operations?
Are SOPs reviewed?
Is Approved Master validation plan available and updated?
Is current version Approved product master formula record
available and followed?
Is master formula record and site batch record (BMR/BPR)
matching and verified?
Are current Raw material and Packing material
specification for the product available / followed?
Are current version of intermediate / finished product
specifications available and followed?
Is the current version of Artwork copy and printed packing
material instructions available for the product?
Are PPI, Artwork, specification of raw materials and
finished products regulatory complied?
Are current version of product quality standards and
method of analysis available?
Is product process validation carried out and are compiled
reports available?
Is air supplied by AHUs to various sections validated and
validation reports available?
Is water supplied by RO Plant to various sections validated
and validation reports available?
Is compressed air supplied by compressor to various
sections validated and validation reports available?
Is product analytical method validation carried out and
reports available?
Is change control system followed for all change in process
/ facility / equipment and documents and are reports
available?
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Observation
Remarks
Sl.
No.
s
t
u
v
y
z
Parameters to be checked
Observation
Remarks
Is change control register maintained and any change
control raised in documentation reflected in Batch
Record?
Is deviation control system followed for deviations in
product processing and are they documented?
Is QA inprocess control in place for checks on all critical
quality parameters of the product?
Is intermediate / finished products tested by QC and
reported / approved before finished products
release?
Is finished product release procedure followed? Are batch
records / QC reports reviewed before product
release?
Is record room for retention of documents available and
provided with pest control monitoring and free from
fire hazards?
Is record room arranged with documents product wise,
batch no. wise and year wise in an orderly manner?
And are documents easily traceable?
Is documents retention period and destruction after
retention time followed?
Assessment Done By:
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Checked By:
Approved By:
