Mid Year Review Justification 2013

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    Ensure release of F & N (Powder) shipment products in time.

    The shipment products are released within 2 working days for normal and 7 working days withexternal lab testing. Deviations will be managed with min impact on business. (% released willbe derived from MySap.)

    100% release: >120%; 99% release: 120%; 98% release: 100%; 97% release: 90%

    To ensure release of F & N products without any QC error.

    External customer complaints (CC) due to QC error (b) errors identified internally due to QCmistake.

    0.015% CC: 80%

    - Total batches received in 2012: 2,203 from March August 2013 (FG Powder).a. 100% were released after compliance with product specification without delay.b. Deviations were managed accordingly with minimum impact on business.

    i. 54 batches were internally rejected due to failure in product quality.ii. 44 batches were restricted and recommended to salvage the concerned

    batches.

    (a) Ensure that all products shipped from Singapore meet the specificationand/or in compliance with accepted specific food safety requirements(including 1st time production).

    (b)Manage product spec & customer Questionnaires of powder products withno error.

    (a) Error/deviations from accepted specific food safety requirements in release of product.(b) Error in product specs issued and completed the questionnaireNo error: 120%; 1 error: 100%; 2 error: 90%; 3 error: 80%

    Ensure that there is no major / minor nonconformance (NC) related to QC inexternal audits by external agencies and customers.

    No major/minor NC: 120%; 1 major/minor NC: 100%; 2 major/minor NC: 80%; 3 major/minorNC: 60%

    Product Revision / QC setting for new code creation to be completed in time All QC settig need to be completed in a day / All PR need to completed within 2 days

    1 / No delay: >120%, 2 delays: 120%, 3 delays: 100%, 4 delays: 80%,

    Manage GLP & lab safety

    A) Manage GLP activities in time (B) No accident in lab

    - Zero accident.- Strict compliance with GLP.

    c. Customer complaint initial investigation reports were sent out to relevant

    departments within 24 hours.d. Proper documentation of non-conformance reports (71 NC reports) were in place.

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    e. Reviewed 72 QC SOPs and WIsf. Assigned analytical instrument (T90 salt analyser) was maintained accordingly to

    avoid downtime in the QC operations.i. Verification was done quarterly on the instrument to ensure correct,

    repeatable and reproducible results.g. Calibration of instrument parts (burets) to ensure functionality was managed

    accordingly in coordination with the supplier.h. Maintenance of the instrument was managed accordingly in coordination with the

    supplier.

    Manage internal rejections as per local SOP/work instructions.

    All internal rejection reports/emails need to be raised within 2 working days with proper reasoningand follow up on closing of all NCs within stipulated time line

    1 delay: >120%, 2 delays: 120%, 3 delays: 100%, 4 delays: 80%,

    - 7164 non-conformance reports were issued as of August 2013i. No delays in the issuance of NC for the rejected and restricted powder

    products. ii. 90% NCs for the rejected and restricted powder products were closed.