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    Fmea Pos

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    Geovin Dexter Uy
    This document outlines a failure mode and effect analysis (FMEA) for the production of paracetamol oral suspension. It identifies 9 key processes in production and potential failure modes for each. For each failure mode, it evaluates the potential causes, effects, existing controls, and recommended actions. It aims to manage risks and prioritize potential failures through a risk priority number analysis. The FMEA was created on November 14, 2014 and takes effect on November 15, 2014.

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    Fmea Pos

    Uploaded by

    Geovin Dexter Uy
    449 views8 pages
    This document outlines a failure mode and effect analysis (FMEA) for the production of paracetamol oral suspension. It identifies 9 key processes in production and potential failure modes for each. For each failure mode, it evaluates the potential causes, effects, existing controls, and recommended actions. It aims to manage risks and prioritize potential failures through a risk priority number analysis. The FMEA was created on November 14, 2014 and takes effect on November 15, 2014.

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    FMEA POS

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    FMEA POS

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    This document outlines a failure mode and effect analysis (FMEA) for the production of paracetamol oral suspension. It identifies 9 key processes in production and potential failure modes for each. For each failure mode, it evaluates the potential causes, effects, existing controls, and recommended actions. It aims to manage risks and prioritize potential failures through a risk priority number analysis. The FMEA was created on November 14, 2014 and takes effect on November 15, 2014.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    449 views8 pages

    Fmea Pos

    Uploaded by

    Geovin Dexter Uy
    This document outlines a failure mode and effect analysis (FMEA) for the production of paracetamol oral suspension. It identifies 9 key processes in production and potential failure modes for each. For each failure mode, it evaluates the potential causes, effects, existing controls, and recommended actions. It aims to manage risks and prioritize potential failures through a risk priority number analysis. The FMEA was created on November 14, 2014 and takes effect on November 15, 2014.

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    Page 1 of 8

    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

    Page 2 of 8

    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

    Page 3 of 8

    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

    Page 4 of 8

    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

    Page 5 of 8

    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.

    Page 6 of 8

    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

    Page 7 of 8

    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

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