PHARMA DEVILS

QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSMENT & MITIGATION PLAN

FAILURE MODE EFFECT ANALYSIS FOR OF DPI
Reference Document No.: Risk Assessment No.:

Name of Facility / Equipment / Utility / System / Activity / Procedure / Unit Operation for: Production (DPI) Date of Quality Risk Assessment:

Risk with Current Recommended

Risk after control measure
control Measure Actions
Potential Potential Effect Potential Cause/
S. Item / Current Risk (if any) RPN
Failure Mode of Failure Mechanism Reference
No. Function Control Priority (S*O*D)
(Effect) of Failure S O D S O D
Number
(S*O*D)
Sampling Probability of Product Failure Procedure is not available for ➢ Cleaning is performed by trained personnel.
use of Un- & mix-up Garments cleaning ➢ Cleaning Procedure is available. SOP
cleaned chances Garments cleaning are performed by untrained ➢ Storage Cabinets are provided for storage of
garments personnel. garments. Qualification
➢ In-adequate cleaning ➢ HEPA filter is provided in garments storage protocol 4 1 4 16 NA NA NA NA NA
➢ Garments Storage Cabinets are not provided cabinets.
for Storage of Garments ➢ Garments cabinet is previously qualified
➢ Garments cabinet is not Qualified

Probability of Contamination ➢ Proper Status of Labeling is not done in each ➢ All containers of materials properly SOP
mix up of and Product container of material. identified by status label.
material after failure ➢ Material transfer procedure is not available. ➢ Staging room is provided for storage of
Sampling ➢ Container of Raw material are not segregated sampled material and kept in Container with
➢ Proper storage condition not followed. proper status label.
➢ Unskilled/Untrained person performing ➢ SOP is available for Raw material sampling.
Sampling. ➢ Demarcation already done for placing more 1 4 4 16 NA NA NA NA NA
➢ Material transfer in unsafe manner. than one batch in staging area for
1. ➢ Unclean Tools used for Sampling. segregation of batches.
➢ RLAF not clean properly and Pressure ➢ Provision for controlled storage condition is
Differential not in Limit. available.
➢ Weighing Balances are not clean. ➢ Line clearance procedure followed before
start the Sampling
Personnel Contamination ➢ Proper gowning procedure is not followed. ➢ Provision of Secondary Change Room
Safety during of raw material ➢ Safety devices are not available. before entry in dispensing Area. Gowning
Sampling and Effect on ➢ Unskilled/untrained person performing procedure are provided and followed.
Human Health Sampling. ➢ Safety devices are available i.e. PPE SOP
➢ Activity is performed by without supervision (personnel protective equipments), Gloves,
of senior person. mask, goggles, etc required safety devices
are provided. First aid facility is provided in Safety manual
1 1 4 4 NA NA NA NA NA
case of any miss happening.
➢ Untrained person is not allowed to work in
sampling area.
➢ List of Authorized personnel is displayed in
all area.
➢ All activity is performed in presence of
senior/experienced chemist.

Page 1 of 10
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSMENT & MITIGATION PLAN

FAILURE MODE EFFECT ANALYSIS FOR OF DPI
Reference Document No.: Risk Assessment No.:

Risk with Current Recommended

Risk after control measure
control Measure Actions
Potential Potential Effect Potential Cause/
S. Item / Current Risk (if any) RPN
Failure Mode of Failure Mechanism Reference
No. Function Control Priority (S*O*D)
(Effect) of Failure S O D S O D
Number
(S*O*D)
Contamination & Product Failure ➢ In adequate cleaning ➢ Proper cleaning & sanitization procedure
Sampling Cross ➢ Area not qualified. are followed. SOP
Contamination ➢ HVAC is not qualified. ➢ HVAC & area are previously qualified.
➢ Procedure for area cleaning is not available & ➢ Validation cleaning procedure is available,
followed. followed & documented.
➢ Procedure is not available for cleaning ➢ Procedure is available & followed for
schedule of area. cleaning schedule of area
➢ Validated Cleaning Procedure is not available. ➢ Pressure differential of the area is
➢ Pressure differential of area is not maintained maintained, monitored at defined frequency.
& monitored in regular intervals. ➢ Untrained/Unqualified personnel is not
➢ Untrained / Unqualified personnel are allowed allowed in the area.
in the area. ➢ All activity is performed by trained
➢ Cleaning is performed by untrained personnel. personnel.
➢ Dedicated area is not provided for Storage of ➢ Dedicated area is provided for Storage of
Cleaned sampling tools. Cleaned dispensing tools.
➢ Separate Washing Area is not provided. ➢ Separate Washing Area is provided.
4 1 4 16 NA NA NA NA NA
➢ Dedicated AHUs is not provided for all the ➢ Dedicated AHUs is provided for all the
area. store area. SOP
➢ Procedure is not available for AHU cleaning & ➢ Procedure is available for AHU cleaning &
filter cleaning filter cleaning
➢ Gowning procedure is not available & not ➢ Gowning procedure is available & followed.
followed. ➢ Unidirectional Men Material Movement /
➢ Unidirectional men material movement / Flow Flow are provided.
are not provided. ➢ Pictorial for gowning procedure are
➢ Pictorial for gowning procedure are not displayed in respective area.
displayed in respective area. ➢ Procedure is available for Line clearance of
➢ Procedure is not available for Line clearance sampling area.
of sampling area.
➢ Procedure is not available for cleaning of ➢ Procedure is available for cleaning of AHU
AHU & equipment filter & equipment filter
➢ Two different products sampled at a time.
➢ Only single product sampled at a time.

Page 2 of 10
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSMENT & MITIGATION PLAN

FAILURE MODE EFFECT ANALYSIS FOR OF DPI
Reference Document No.: Risk Assessment No.:

Risk with Current

Risk after control measure
control Measure
Potential Effect Potential Cause/ Recommended
S. Item / Potential Current Risk RPN
of Failure Mechanism Reference Actions
No. Function Failure Mode Control Priority (S*O*D)
(Effect) of Failure S O D (if any) S O D
Number
(S*O*D)
2. Dispensing Risk of Cross Material ➢ Due to dis-balancing of ➢ Magnehelic gauges are provided in the facility. Checking & SOP
Contamination & product pressure differential. logging of differential pressure is done twice in a shift for
4 1 4 16 NA NA NA NA NA
contaminated. critical areas. At the time of line clearance differential
pressure verification is also done by QA.
➢ Person carrying out the ➢ Gowning procedure is available & pictorials are displayed in SOP
dispensing activity is not all changing room. Before authorize any person to entry in
4 1 4 16 NA NA NA NA NA
following proper gowning the critical areas training is carried out on entry procedure,
procedure. gowning procedure & working procedure.
➢ Person carrying out ➢ Person suffering from any infectious disease is not allowed to SOP
dispensing activity is enter in the premises.
4 1 4 16 NA NA NA NA NA
suffering from infectious ➢ Medical checkup of persons working in critical areas is
disease. carried out on annual basis.
➢ Due to damaged material ➢ At the time of material receiving check point of container SOP
container. condition is available. At a defined frequency material
4 1 4 16 NA NA NA NA NA
condition is also verified as per procedure including
container physical conditions.
➢ Due to improper cleaning of ➢ Cleaning of all equipments& utensils is done by trained SOP
scoops & utensils used for professionals by using validated cleaning procedures. 4 1 4 16 NA NA NA NA NA
dispensing.
➢ Due to improper cleaning of ➢ As per procedure & GMP practices cleaning is done before SOP
area. the critical activity & verification of cleaning also done by 4 1 4 16 NA NA NA NA NA
QA person as per check point of line clearance.
➢ Cleaning of the area is ➢ As per procedure & GMP practices cleaning is done before SOP
running simultaneously with the critical activity. 4 1 4 16 NA NA NA NA NA
dispensing.
➢ Due to improper cleaning of ➢ Cleaning of area is done by validated & defined cleaning SOP
4 1 4 16 NA NA NA NA NA
area. procedure with the help of validated disinfectant.
➢ RLAF operation is not done ➢ Operation & cleaning procedure of RLAF is done by defined SOP
4 1 4 16 NA NA NA NA NA
properly. procedure only by trained staff.
➢ RLAF is not working ➢ Preventive maintenance of RLAF s done routinely. For SOP
properly. checking performance of RLAF viable monitoring is done on 4 1 4 16 NA NA NA NA NA
daily basis.
➢ AHU is not working properly. ➢ Preventive maintenance of AHU’s is done at defined SOP
frequency. For checking performance of AHU viable
monitoring is done on weekly basis .Performance of
4 1 4 16 NA NA NA NA NA
dispensing area AHU is also checked on annual basis by
performing air velocity, ,filter integrity, flow pattern,
Recovery ,leakage test. Temperature, RH & pressure

Page 3 of 10
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSMENT & MITIGATION PLAN

FAILURE MODE EFFECT ANALYSIS FOR OF DPI
Reference Document No.: Risk Assessment No.:

Risk with Current

Risk after control measure
control Measure
Potential Effect Potential Cause/ Recommended
S. Item / Potential Current Risk RPN
of Failure Mechanism Reference Actions
No. Function Failure Mode Control Priority (S*O*D)
(Effect) of Failure S O D (if any) S O D
Number
(S*O*D)
differential is monitored twice in a day.
➢ Person performing dispensing ➢ Before dedicating any person for any activity training related SOP
is not properly trained. to the activity is given & after evaluating training
4 1 4 16 NA NA NA NA NA
authorization is given by QA Head to start working related to
Dispensing Risk of Cross Material the activity on regular basis.
Contamination & product ➢ Use of un-cleaned gowns. ➢ Cleaning of gowns is done on daily basis. At exit change SOP
contaminated. room bin for used garments (washable+ Disposal) is kept to
put used garments.
4 1 4 16 NA NA NA NA NA
➢ Washable garments from used bin are transferred to washing
area whereas disposable gowns are disposed by housekeeping
professionals.
➢ Pass box used for material ➢ Preventive maintenance of pass box is done on quarterly SOP
transfer from storage area to basis.
4 1 4 16 NA NA NA NA NA
dispensing area is not
working properly.
➢ Person is not performing ➢ Training for entry & exit procedure is given to each SOP
sanitization of hands individual intended for the area. Training evaluation is also
4 1 4 16 NA NA NA NA NA
properly. done. Hand sanitization procedure with pictorial is also
available in identified change rooms.
➢ Cleaning of area is not done ➢ Cleaning procedure is available Disinfectant used for SOP
properly. cleaning of area are also validated. Persons dedicated for 4 1 4 16 NA NA NA NA NA
cleaning are also trained.
➢ Improper cleaning of RLAF. ➢ Cleaning procedure of dispensing booth is available & SOP
cleaning of booth is done on daily basis or after every 4 1 4 16 NA NA NA NA NA
dispensing by trained persons.
➢ Improper cleaning of Pass ➢ Cleaning procedure of pass box is available & cleaning of SOP
4 1 4 16 NA NA NA NA NA
Box. pass box is done on daily basis by trained persons.
➢ RLAF is not working ➢ RLAF working is checked by viable monitoring on daily Qualification
properly. basis. After every 06 moth qualification of RLAF is also Protocol
checked. Preventive maintenance schedule of RLAF is also
4 1 4 16 NA NA NA NA NA
available.
➢ Mehnehalic gauge pressure reading monitoring performs on
daily basis.
➢ Use of torned or unclean ➢ Before dispensing cleaning & integrity of containers is SOP
dispensing containers. checked by the store person & QA person also. In case of
4 1 4 16 NA NA NA NA NA
dispensing in polybags double poly bag is used to dispense
material.
➢ Untrained staff. ➢ Before authorize to any person to carry out dispensing SOP 4 1 4 16 NA NA NA NA NA
Dispensing procedure not activity training is carried out related to the all activities at
followed. the time of dispensing. After training person is evaluated by 4 1 4 16 NA NA NA NA NA

Page 4 of 10
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSMENT & MITIGATION PLAN

FAILURE MODE EFFECT ANALYSIS FOR OF DPI
Reference Document No.: Risk Assessment No.:

Risk with Current

Risk after control measure
control Measure
Potential Effect Potential Cause/ Recommended
S. Item / Potential Current Risk RPN
of Failure Mechanism Reference Actions
No. Function Failure Mode Control Priority (S*O*D)
(Effect) of Failure S O D (if any) S O D
Number
(S*O*D)
QA head & after satisfactory observation he/she is authorized
to carry out dispensing activity.
➢ Washing area for utensils is ➢ In the designed facility washing area is kept separately from Facility Layout
4 1 4 16 NA NA NA NA NA
not separate. the processed area.
Risk of Mix Risk to patient & ➢ Wrong material may get ➢ Only trained person are authorized to carry out dispensing. SOP
ups product safety & dispensed. Men & material movement is kept different. Proper labeling
4 1 4 16 NA NA NA NA NA
efficacy. system is followed. At one time only one product dispensing
is allowed to avoid mix ups
Dispensing Risk to product & ➢ Wrong labeling ➢ Proper labeling system is available & followed by trained SOP
4 1 4 16 NA NA NA NA NA
patient safety. persons.QA also checks labeling of the material.
Risk to product & ➢ Proper labeling system is available & followed by trained SOP
➢ Wrong material dispensing 4 1 4 16 NA NA NA NA NA
patient safety. persons.QA also checks labeling of the material.
Risk to product & Quantity of material wrongly ➢ Proper labeling system is available & followed by trained SOP
4 1 4 16 NA NA NA NA NA
patient safety. taken. persons.QA also checks labeling of the material.
Risk to person Loss of material ➢ Due to spillage of material ➢ Spill kit, safety devices are available & persons are properly SOP
Safety. & exposure of trained for its use.
4 1 4 16 NA NA NA NA NA
material directly
with person.
Person Health & ➢ Due to unavailability of
4 1 4 16 NA NA NA NA NA
life. safety devices.
Mixing of Chances of ➢ Due to presence of various ➢ After dispensing dispensed material for single product is SOP
dispensed mixing, material & product in the packed in a large polybag & after that polybag is tied up with
material. contamination & same area. a cable tie .Proper labeling system is followed & in staging
cross area single batch material is stored on a single pellet with
contamination. proper labeling.
➢ At the time of material receiving production person in
presence of QA verify the qty. of material against master 4 1 4 16 NA NA NA NA NA
formula & label pasted on the material.
➢ Verification of material qty. is done with the help of
calibrated balance & balance calibration is done by
production person familiar with the procedure. QA verify the
calibration status of balance with the help of label pasted on
it
3. Washing & Risk of product Product may get ➢ Sterilizer is not working ➢ Sterilizer working & performance is checked on six month Respective
Sterilizatio contamination contaminated & properly. frequency & also preventive maintenance has been Protocol
n of & patient contamination performed on every 03 month basis.
Containers. safety. may harm to 4 1 4 16 NA NA NA NA NA
patient health.
Due to product
contamination
Page 5 of 10
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSMENT & MITIGATION PLAN

FAILURE MODE EFFECT ANALYSIS FOR OF DPI
Reference Document No.: Risk Assessment No.:

Risk with Current

Risk after control measure
control Measure
Potential Effect Potential Cause/ Recommended
S. Item / Potential Current Risk RPN
of Failure Mechanism Reference Actions
No. Function Failure Mode Control Priority (S*O*D)
(Effect) of Failure S O D (if any) S O D
Number
(S*O*D)
death & adverse
reactions may
also happens.

Product may get ➢ Washing & sterilization is not ➢ Only trained & authorized persons are allowed to work in the SOP
contaminated & done by trained operator. designated area under the supervision of trained supervisor.
contamination QA also monitors that each activity should be performed by 4 1 4 16 NA NA NA NA NA
may harm to trained persons.
patient health. ➢ Equipment is not qualified. ➢ Before starting activity qualification status of equipments Respective
Due to product also verified by QA. Qualification 4 1 4 16 NA NA NA NA NA
contamination Protocol
death & adverse ➢ Sterilization is not as per ➢ Each & every activity shall be performed as per defined Respective BMR
reactions may validated procedure. process in the batch records. Batch records are approved by
also happens 4 1 4 16 NA NA NA NA NA
QA considering all parameters & after that QA monitors that
activity should be performed as per defined procedure.
4. Filling & Risk of Risk for patient ➢ Operator not familiar with the ➢ After satisfactory evaluation of training related to aseptic SOP
Sealing Contamination, & product safety. aseptic area criticality. area & personnel qualification observations person is
Cross permitted to work in aseptic area.
Contamination ➢ Trained operators are recruited to handle the machine & they 4 1 4 16 NA NA NA NA NA
& Sterility also trained for the company equipments. Trained IPQA
failure. person remains in the aseptic area during entire process &
monitors the operation along with production supervisor.
Filling & Risk of Risk for patient ➢ Filling is done by untrained or ➢ After satisfactory evaluation of training related to aseptic SOP
Sealing Contamination, & product safety. unauthorized operator. area & personnel qualification observations person is
Cross permitted to work in aseptic area.
4 1 4 16 NA NA NA NA NA
Contamination ➢ Trained operators are recruited to handle the machine & they
& Sterility also trained for the company equipments. Trained IPQA
failure. person remains in the aseptic area during entire process &
Risk for patient ➢ Defect in sealing & bugging. monitors the operation along with production supervisor. SOP
& product safety.
4 1 4 16 NA NA NA NA NA

Risk for patient ➢ Weight Variation.

4 1 4 16 NA NA NA NA NA
& product safety.

Page 6 of 10
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSMENT & MITIGATION PLAN

FAILURE MODE EFFECT ANALYSIS FOR OF DPI
Reference Document No.: Risk Assessment No.:

Risk with Current

Risk after control measure
control Measure
Potential Effect Potential Cause/ Recommended
S. Item / Potential Current Risk RPN
of Failure Mechanism Reference Actions
No. Function Failure Mode Control Priority (S*O*D)
(Effect) of Failure S O D (if any) S O D
Number
(S*O*D)
Risk for patient ➢ Risk for sterility maintenance. ➢ Filling operation is carried out in aseptic area under Grade A Batch
& product safety. environment. Machine parts &equipments are sterilized prior Manufacturing
to operation. Hold time for sterilized equipments& Record
accessories are validated. Transfer of sterilized articles &
product is carried out under qualified mobile LAF. Sterility 4 1 4 16 NA NA NA NA NA
of the articles maintained properly. Operators are trained for
handling of sterilized articles. All machine connections are
done under grade A environment. Media fill also performed
for checking sterility confidence in the process.
5 Visual Inspection not Risk to product ➢ Inspectors are not qualified. ➢ Qualification procedure of visual inspector is available & Qualification
4 1 4 16 NA NA NA NA NA
. Inspection done accurately. safety/ Person followed properly. Protocol
Safety ➢ Light intensity of booth is not ➢ Procedure, frequency for checking of light intensity is SOP
proper for visual inspection. available. Light intensity of booth is checked at defined
4 1 4 16 NA NA NA NA NA
frequency & recorded. In case of deviation from the defined
limit replacement also done.
➢ Mixing of good & rejected ➢ Color coding of rejected & good ampoules container is kept
4 1 4 16 NA NA NA NA NA
containers. different to avoid mix up of rejected & good containers.
➢ Visual inspectors are not re- ➢ Medical checkup of visual inspectors are done on semiannual SOP
qualified at the defined basis. Medical Report 4 1 4 16 NA NA NA NA NA
frequency.
➢ Inspection booth is not ➢ Before giving line clearance QA person checks the Line Clearance
qualified qualification of visual inspectors. This check is available in SOP 4 1 4 16 NA NA NA NA NA
line clearance checks of the QA.
6. Secondary Risk of Mixing Risk to patient ➢ Wrong labeling ➢ At the time of dispensing of packing material stores labels SOP
& Tertiary Misbranding safety product the material properly this is verified by QA. At the time of
packing of &mis- labeling. safety & efficacy. material receiving production person also verifies the
Injectables material. Before starting packing activity QA verifies the NA NA NA NA NA
absence of any other product material in the packing area &
also cleaning of the area. In the beginning of the coding of
the packing material production person checks the coding
detail which is verified by the QA. During packing activity in 4 1 4 16
process checks is carried out by production & QA persons at
the defined frequency. Sample after packing is also send to
QC for identification test t avoid any misbranding or
mismatching..On the other hand, semi finished product in the
quarantine is stored with proper labels. At the time of activity
start production & QA also verify the details mentioned on
labels
7. Transfer & Breakage of Product safety ➢ Commercial loss & loss of ➢ Although transfer of finished goods from the injection SOP
4 1 4 16 NA NA NA NA NA
storage of glass will be on risk. product. facility to finished product storage area is done manually but

Page 7 of 10
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSMENT & MITIGATION PLAN

FAILURE MODE EFFECT ANALYSIS FOR OF DPI
Reference Document No.: Risk Assessment No.:

Risk with Current

Risk after control measure
control Measure
Potential Effect Potential Cause/ Recommended
S. Item / Potential Current Risk RPN
of Failure Mechanism Reference Actions
No. Function Failure Mode Control Priority (S*O*D)
(Effect) of Failure S O D (if any) S O D
Number
(S*O*D)
finished containers. this activity is performed by trained persons & under the
goods to supervision of trained supervisor.
finished Degradation of Patient safety ➢ Effect on efficacy & safety of ➢ Dedicated storage area for finished product is available in SOP
product product due to will be on risk, product. which optimum environment conditions are monitored.
store. unfavorable ➢ Environment conditions of the area are monitored twice in a
4 4 4 64 NA NA NA NA NA
environment 8 hrs. shift.
conditions. ➢ Also temp. mapping of the area is preformed on annual basis
for 3 days.
8. Dispatch of Breakage of Product safety ➢ Commercial loss & loss of ➢ Transportation conditions are maintained during SOP
finished glass will be on risk. product. transportation. For glass containers 7 ply shippers is used to 4 1 4 16 NA NA NA NA NA
goods. containers. pack the product.
Degradation of Patient safety ➢ Effect on efficacy & safety of ➢ Warning is pasted on shippers" Glass inside Handle with
product during will be on risk, product. care".
transportation
due to 4 1 4 16 NA NA NA NA NA
unfavorable
environment
conditions.
9. Batch In-complete System failure/ ➢No SOP for review of ➢SOP for review of analytical records SOP
release analytical Market analytical records ➢SOP for review batch release
records and QA Complaint ➢No SOP for batch release
4 1 4 16 NA NA NA NA NA
release
documentation

10. Quality Sampling of Sample cannot ➢ No SOP for Sampling ➢Sampling procedure follow at the time of Raw material SOP
Control Raw material represent the procedure of Raw Material sampling,
not in proper results/quality of ➢Unskilled/Untrained person ➢Procedure for sampling of Raw material is available.
manner Complete Batch. perform the sampling of Raw ➢Only Trained person perform the sampling of raw material.
material ➢Before the start of raw material sampling line clearance
➢Not maintain environmental procedure follow and all checks points verify at the time of line
condition clearance.
➢Pressure differential not ➢Before the environmental condition maintain QA person
maintain cannot give the permit to start the sampling.
➢In addicted procedure of
cleaning of sampling tools.
Analysis Product safety ➢Analyst not qualified ➢Analyst qualification of all analyst are done SOP
Results not in will be on risk. ➢Instrument not calibrated ➢Calibration of instrument completed as per the scheduled
Specification Patient safety ➢Analytical standards not calibration planer.
Limit will be on risk, qualified ➢Analytical standards are qualified with respect to Reference
➢Sampling not in proper standard.
Page 8 of 10
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSMENT & MITIGATION PLAN

FAILURE MODE EFFECT ANALYSIS FOR OF DPI
Reference Document No.: Risk Assessment No.:

Risk with Current

Risk after control measure
control Measure
Potential Effect Potential Cause/ Recommended
S. Item / Potential Current Risk RPN
of Failure Mechanism Reference Actions
No. Function Failure Mode Control Priority (S*O*D)
(Effect) of Failure S O D (if any) S O D
Number
(S*O*D)
manner ➢Skilled and trained person perform the sampling of material
➢Manufacturing procedure not as per the standard sampling procedure
follow as per the pre determine ➢Appropriate manufacturing procedure followed, which are
manufacturing specified in the Batch Manufacturing Record.
procedure/Process
Raw material ➢Standard test procedure not ➢STP of all Raw materials is available. SOP
not testing as followed. ➢Standard test procedure develops before the indenting of the
per standard test ➢Un approved test procedure new upcoming raw material.
procedure followed. ➢After the preparation of Standard Test Procedure and
➢Standard test procedure of Standard Test Specification QC Head Checked this STP & STS
different Raw material can be and after that QA Head approved for follow the Standard Test
followed at the time of testing Specification and Standard test Procedure.
➢Trained and Skilled Person performs the testing as per
Standard Test Specification and Standard Test Procedure.
Finished ➢Standard test procedure not ➢STP of all Finished Good Product is available. SOP
product not followed. ➢Standard test procedure develops before the indenting of the
testing as per ➢Un approved test procedure new upcoming Product.
standard test followed. ➢After the preparation of Standard Test Procedure and
procedure ➢Standard test procedure of Standard Test Specification QC Head Checked this STP & STS
different Product can be and after that QA Head approved for follow the Standard Test
followed at the time of testing Specification and Standard test Procedure.
➢Trained and Skilled Person performs the testing as per
Standard Test Specification and Standard Test Procedure.

Page 9 of 10
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSMENT & MITIGATION PLAN

FAILURE MODE EFFECT ANALYSIS FOR OF DPI
Reference Document No.: Risk Assessment No.:

Potential Failure Mode: What could go wrong?

Failure Causes: Why would the failure happen?
Failure Effects: What would be the consequences of failure?
Likelihood of Occurrence: 1–10, 10 = Very likely to occur
Likelihood of Detection: 1–10, 10 = Very unlikely to detect
Severity: 1–10, 10 = Most Severe Effect
Rating Scales:
➢ Occurrence:
1 = Not Likely, 10 = Very Likely
➢ Detection:
1 = Easy to Detect, 10 = Not easy to Detect
➢ Severity
1 = Not Severe, 10 = Very Severe
Risk Priority Number (RPN): Likelihood of Occurrence × Likelihood of Detection × Severity
Quality Risk Management Team Reviewed By Approved By
Name Department Sign & Date Plant Head (Sign & Date) Head QA (Sign & Date)

Quality Risk assessment and mitigation summary report

S. No. Proposed Control measures Responsible Person Target Date of Completion

Verification of Action Plan:

All the above agreed actions completed, Not Completed.

Remarks (if any)______________________________________________________________________________________________________________________

Verified By Approved By
QA Head QA
Sign & Date Sign & Date

Page 10 of 10