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FAILURE MODE AND EFFECT ANALYSIS

Supersedes: N/A
Revision Date: N/A

Document: FMEA-002
Date of Issue: 14NOV2014
Effective Date: 15NOV2014

TITLE

: FAILURE MODE AND EFFECT ANALYSIS

TOPIC

: Failure mode and effect analysis of Paracetamol Oral Suspension

REFERENCE DOCUMENT/S

FUNCTION

: To evaluate potential failure modes, factors causing these failures, effects and controls for a specific process, equipment or material

: To manage and prioritize all possible risks in a specific manufacturing operation

SCOPE

: This shall apply to the production of paracetamol oral suspension

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FAILURE MODE AND EFFECT ANALYSIS

Supersedes: N/A
Revision Date: N/A

Document: FMEA-002
Date of Issue: 14NOV2014
Effective Date: 15NOV2014

Risk Priority Number*

No.

Process

Hazards

Failure Mode

Cause/s of

Effect/s of

Failure

Failure

=OxSxD

Current Controls
O

Dissolving
NaCMC in
1

for 24 hours

Using the
1a

Action/s

Responsible

RPN

Insufficient setting
time

Addition of
enough water and
setting aside for
14 hours

112

Not using distilled

water

Clumping of
NaCMC

Using a trusted
source of distilled
water

16

Incorrect speed
setting

Heat might be
generated

Destruction of the
polymeric
structure of
NaCMC
Suspension will be
too fluid

Use of lowest
speed setting

32

Irreversible

Microorganisms
present on the
surfaces in
contact

Improper cleaning
or the use of dirty
rags

Prone to microbial
degradation

SOP on proper
cleaning
techniques

576

Irreversible

Physical

Sedimentation

Not dispersed
prior to addition

Incomplete
addition

Mixing before
addition

32

Irreversible

Chemical

Sucrose inversion

Excessive or
prolonged heating

Prone to microbial
contamination
Solution will be

Percolation
method of
preparing syrup is

448

Irreversible

Physical

hydration of Na
CMC

water and
setting aside

Person/s

Solution will be
too viscous
Clumping of
NaCMC

Incomplete

Chemical

Physical

Precipitation of
NaCMC

Lack of water

Recommended

Heidolph
mixer
Biologica
l

Measure water
accurately and start
early to ensure 24
hours setting time.
Water to be used in
the dissolution of
NaCMC should be
distilled.

QA,
Dispensing
QA,
Dispensing

QA,
Production

QA,
Maintenance

Incorporating
2
3

MCC mixture
to NaCMC
mixture
Preparing
Simple Syrup

QA
Dispensing
QA,
Dispensing

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FAILURE MODE AND EFFECT ANALYSIS

Supersedes: N/A
Revision Date: N/A

Document: FMEA-002
Date of Issue: 14NOV2014
Effective Date: 15NOV2014

Supersaturation

Biologica
l

Presence of ants
in sucrose

less viscous

used

Crystallization of
sucrose

Addition of proper
amount of water
to sugar

36

Remove sucrose
crystals with a
suitable means but
do not filter.

Improper storage
of sucrose

Contamination

Container of
sucrose is
properly
closed/sealed.

Remove ants with a

suitable means but
not by filtration.

No determination
of endpoint

Inadequate
mixing of
powders, may
affect content
uniformity

Proper trituration
procedure is
observed (should
be done in a
circular motion).

Continue
comminution while
observing proper
trituration procedure
to continue
decreasing particle
size of materials.

Sedimentation of
particles

Amount of
glycerine to be
used should fall in
the range of
acceptable
percentage
required to elicit
specific function

Sugar
concentration too
high (>85%)

Triturating
paracetamol
4

and

Physical

propylparabe

Inadequate
comminution

Dissolving
mixed
powders in
glycerin

Physical

Insufficient
wetting of
powders

Too little glycerin

20

Add glycerin in small

increments

QA,
Dispensing

QA,
Dispensing

QA,
Production

QA,
Production

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FAILURE MODE AND EFFECT ANALYSIS

Supersedes: N/A
Revision Date: N/A

Document: FMEA-002
Date of Issue: 14NOV2014
Effective Date: 15NOV2014

Adding half of
NaCMC+MCC

Adding simple
syrup

Too much glycerin

Physical

Mixture is added
all at once

Production
personnel

Clumping

Physical

Adding particles
(crystals or ants)
along with
solution

Inspection not
done

Contamination

Adding other
8

half of

Physical

NaCMC+MCC
9

Adding
colorant

Foaming,
undesirable taste
or odor

Overwetting

Mixture is added
all at once

Production
personnel

Clumping

Color too intense

Too much colorant

added

May decrease
appeal to some
customers

Too little colorant

added

Decrease
aesthetic appeal

Physical

Color too light

Amount of
glycerine to be
used should fall in
the range of
acceptable
percentage
required to elicit
specific function
Addition done
slowly and in
small portions to
assist ease in
mixing
Visually inspect
clarity of solution
Addition done
slowly and in
small portions to
assist ease in
mixing
Addition of
colorant in small
increments
Use of proper
amount of
colorant

42

Irreversible

Swirl the mixture to

facilitate dissolution
of clumped
materials.

Remove particles by
a suitable means but
do not filter.
Swirl the mixture to
facilitate dissolution
of clumped
materials.

Irreversible

QA,
Production

QA,
Production

QA,
Production

QA,
Production

QA,
Production

Addition of small
increments of predissolved colorant

QA,
Production

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FAILURE MODE AND EFFECT ANALYSIS

Supersedes: N/A
Revision Date: N/A

Document: FMEA-002
Date of Issue: 14NOV2014
Effective Date: 15NOV2014

Chemical

Color distribution
not uniform

Colorant selected
is oily or water
insoluble

Colored floccules
decrease its
aesthetic appeal

Use of water
soluble colorant

Irreversible

QA,
Production

*See appendix for the Ranking Criteria of FMEA

APPENDIX
RANKING CRITERIA FOR FMEA
Table 1. Occurrence ranking criteria.

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Document: FMEA-002
Date of Issue: 14NOV2014
Effective Date: 15NOV2014

Table 2. Severity ranking criteria.

FAILURE MODE AND EFFECT ANALYSIS

Supersedes: N/A
Revision Date: N/A

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Document: FMEA-002
Date of Issue: 14NOV2014
Effective Date: 15NOV2014

Table 3. Detection Ranking Criteria.

FAILURE MODE AND EFFECT ANALYSIS

Supersedes: N/A
Revision Date: N/A

Page 8 of 8

Document: FMEA-002
Date of Issue: 14NOV2014
Effective Date: 15NOV2014

FAILURE MODE AND EFFECT ANALYSIS

Supersedes: N/A
Revision Date: N/A