PME 640

FMECA

PROCESS FAILURE MODES EFFECTS AND CRITICALITY ANALYSIS

Process: Blending

Date:

Team Number:

6 Calibrate the equipment

150

6 Train the operator

30

Improper function of Butterfly

valve Rotation speed is not
adjusted IInadequate SOP to
how to operate blender

5 Calibrate the equipment

320

Inappropriate sampling method

Inadequatee training of operator

Rewrite the SOP for

sampling method

180

Inadequate training of operator,

3 Inadequate SOP for clening
after material discharging

Provide proper training of

the staff

45

There might be chances of mix up

and product contamination

Weighing of Raw Material

Weighing machine

Variation in the quantity of the raw

material

Uncalibrated weighing machine,

5 SOP is nor availlabe for
weighing of material

Charge the materia in to the Blender

Improper traing of the operator

Waste of the material

1 Improper traing of the operator

Blending of the Raw Material using suitable

blender

Blender

Improper blending of the raw

material

Take three samplle at the end of the blending

Operator

Can not predict the quality of the

product

Discharge final blend material

None

Waste of the material

Inadequate space for

Compounding

Notifyy the vendor

Follow SOP

Weighing

Charging

Blending

Sampling

Discharrging

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Page 1 of 3

Risk is easily detectable and

mix up can be avoided by
proving enough space for
compounding
I f there is less variation in
quantity of materials due to
weighing defects then there
is less chance that this going
to effect patient life
The waste of material is not
going to effect the life of the
patient
Improper mixiing of the
material may lead to
uniuniform distribution of the
API which may affect
significantely to the patients
life
Improper sampling may
effect the quality of the
product
Untrained staff effect the
quality of the product

RPN

Inadequate space for Compounding

Description of
Risk Analysis

Detection

36

Receive the Raw Material from the supplier

Dispensing of Raw Material according to
Formulation Requirements

Current Controls

Severity

Potential Cause(s)

Occurrence

RPN

Criticality

Potential Effect(s) of
Failure

Occurrence

Potential Failure Mode

Detection

Recieving & compounding

Step Description

Severity

Process Step

9/24/2014

Provide enough space for

compounding

Krunal 10/2/2014

Keep all components

separate to avoid
mixup

36

Do proper weighing of
components

Jaynita 10/02/2014

Calibration of weighing
machine

180

Give training to Operator

Megha 10/02/2014

Provrde traning
program for Operator

30

Revallidate the equipment

Hiren10/08/2014

Calibration of weighing
machine

320

Provide traning to operator

Alpa 10/02/2014

Revise a new SOP

27

None

Jahin10/02/2014

Provrde traning
program for Operato

45

Recommended
Action

Assigned To
and Target
Date

Quantitative
Post Action

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PME 640

FMECA

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Page 2 of 3

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PME 640

FMECA

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Page 3 of 3

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