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    PRO-CAL-01 Measuring Equipment Calibration Program

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    Chiekoi Pasaoa
    This procedure outlines the company's process for validating critical equipment, tools, and software programs prior to use. The Quality Management Representative is responsible for managing the calibration program. Equipment must undergo trial operations and inspections to prove conformance to requirements before being approved for production. Ongoing assessments and preventative maintenance help ensure continued validation.

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    © All Rights Reserved
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    PRO-CAL-01 Measuring Equipment Calibration Program

    Uploaded by

    Chiekoi Pasaoa
    198 views2 pages
    This procedure outlines the company's process for validating critical equipment, tools, and software programs prior to use. The Quality Management Representative is responsible for managing the calibration program. Equipment must undergo trial operations and inspections to prove conformance to requirements before being approved for production. Ongoing assessments and preventative maintenance help ensure continued validation.

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    This procedure outlines the company's process for validating critical equipment, tools, and software programs prior to use. The Quality Management Representative is responsible for managing the calibration program. Equipment must undergo trial operations and inspections to prove conformance to requirements before being approved for production. Ongoing assessments and preventative maintenance help ensure continued validation.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    198 views2 pages

    PRO-CAL-01 Measuring Equipment Calibration Program

    Uploaded by

    Chiekoi Pasaoa
    This procedure outlines the company's process for validating critical equipment, tools, and software programs prior to use. The Quality Management Representative is responsible for managing the calibration program. Equipment must undergo trial operations and inspections to prove conformance to requirements before being approved for production. Ongoing assessments and preventative maintenance help ensure continued validation.

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    © All Rights Reserved
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    Document Title:

    PROCEDURE: CALIBRATION PROGRAM


    Document No. : PRO-CAL-01 Revision No. : 02 Effectivity Date : 13 January 2018

    1. SUMMARY

    1.1. The purpose of this procedure is to define how the company validates critical equipment
    tools and software programs prior to use.
    1.2. The Quality Management Representative (QMR) is responsible for implementation and
    management of this procedure.
    2. REVISION AND APPROVAL

    Rev. Date Nature of Changes Approved By

    0 September 15, 2016 Original issue. Rene Pasaoa

    01 October 20, 2016 Whole document context revision Rene Pasaoa


    Change of header content and
    02 13 January 2018 Rene Pasaoa
    aligned to ISO 9001:2015 version
    3. APPLICATION AND EXEMPTIONS

    3.1. Application
    3.1.1. This procedure applies to all departments and facilities which develop and design
    production equipment, test equipment and tooling
    3.2. Exemptions
    3.2.1. Equipment solely used for supporting the facilities is exempt from this procedure;
    this includes compressors, vehicles, air handling systems, lighting, etc.
    3.2.2. All production and QA equipment, tooling and software in use for at least six months
    prior to the release of the first version of this procedure in August 5,, 2016 is to be
    considered validated by way of previous use and history, and therefore is exempted
    from this procedure, unless otherwise marked as nonconforming (see rules below).
    However, if any significant change is made to legacy equipment, tooling or software,
    this may trigger a new validation requirement if the change could affect product
    quality.
    4. VALIDATION PROCEDURES

    4.1. Equipment and Tooling


    4.1.1. In order to validate production equipment and tooling, the items shall be built or
    installed and put through at least one trial operation; this usually means producing a
    part using the item or software, and then sending the resulting part to QA In Line for
    an inspection of the dimensions created or impacted by the hardware or software in
    question; this is typically through a first piece inspection, but could also be a full
    First Article. In some cases, multiple parts may be manufactured and inspected to
    ensure validation, or multiple production runs may be required at various settings or
    over a range of criteria.
    4.1.2. If the results of QA In Line inspection show the item is not acceptable, the
    information shall be provided to the appropriate area manager and adjustments to
    the device made. Another round of production and QA In Line inspection is then
    conducted.
    4.1.3. Where appropriate, it may become necessary to work with a device’s manufacturer
    to assist in making the appropriate adjustment or repairs to get the equipment
    validated.

    Master Copy Page 1 of 2


    Document Title:
    PROCEDURE: CALIBRATION PROGRAM
    Document No. : PRO-CAL-01 Revision No. : 02 Effectivity Date : 13 January 2018

    4.1.4. Equipment failing validation may not be used, and must be marked visibly with
    appropriate signage indicating “DO NOT USE” or “AWAITING VALIDATION” or
    similar language.
    4.1.5. Equipment and tooling may be considered to have been validated unless otherwise
    marked.
    4.2. Calibration
    4.2.1. Calibration frequency of the equipment and tools is conducted annually by a third
    party calibration (ACAiSi)
    4.2.2. Calibration of similar equipment such as weighing scale, automatic screw drivers is
    calibrated internally. Only one unit shall be submitted for external calibration as
    reference.
    4.2.3. Internal calibration shall be made by QA Analyst on a quarterly basis. Record of
    calibration will be recorded on CAL-02 Calibration Record
    5. MAINTENANCE AND ONGOING VERIFICATION

    5.1. Ongoing assessments of the validity of validated equipment, tooling and programs are
    done during internal auditing (see procedure PRO-IQA-01 Internal Audit ), as well as
    ongoing inspection of parts during normal production.
    5.2. Preventive maintenance programs are in place for critical equipment, to ensure proper
    functioning of such equipment, per the procedure. PRO-PPM-01 Preventive
    Maintenance Program

    Master Copy Page 2 of 2

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