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    As IA Checklist Sec7 5

    Uploaded by

    Randy Wee Aguilar
    This document is an internal audit checklist for AS9100 that addresses production and service provision requirements. It contains questions to audit control of production planning, work instructions, equipment usage, process validation, product identification and traceability, customer property, product preservation, and monitoring device calibration. The checklist ensures production and service meet AS9100 standards for accountability, work instructions, foreign object prevention, and configuration management.

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    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd

    As IA Checklist Sec7 5

    Uploaded by

    Randy Wee Aguilar
    120 views5 pages
    This document is an internal audit checklist for AS9100 that addresses production and service provision requirements. It contains questions to audit control of production planning, work instructions, equipment usage, process validation, product identification and traceability, customer property, product preservation, and monitoring device calibration. The checklist ensures production and service meet AS9100 standards for accountability, work instructions, foreign object prevention, and configuration management.

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    This document is an internal audit checklist for AS9100 that addresses production and service provision requirements. It contains questions to audit control of production planning, work instructions, equipment usage, process validation, product identification and traceability, customer property, product preservation, and monitoring device calibration. The checklist ensures production and service meet AS9100 standards for accountability, work instructions, foreign object prevention, and configuration management.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    120 views5 pages

    As IA Checklist Sec7 5

    Uploaded by

    Randy Wee Aguilar
    This document is an internal audit checklist for AS9100 that addresses production and service provision requirements. It contains questions to audit control of production planning, work instructions, equipment usage, process validation, product identification and traceability, customer property, product preservation, and monitoring device calibration. The checklist ensures production and service meet AS9100 standards for accountability, work instructions, foreign object prevention, and configuration management.

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    AS9100 Internal Audit Checklist

    7.5 Production and Service


    Provision
    7.5.1 Control of Production and
    Service Provision
    Does planning include the items
    required by the standard?
    How are production and service
    provision controlled?

    Where are product characteristics


    documented?

    When are work instructions required?


    Are they available?

    How do personnel know what


    equipment to use for a process?

    Does documentation identify what


    monitoring and measuring devices
    should be used, and when?

    Where are release, delivery and post


    delivery activities and requirements
    defined?

    Are processes carried out under


    controlled conditions required by the
    standard with regards to:

    a. Accountability

    b. Evidence of all required


    operations being completed
    c. Foreign objects
    d. Monitoring utilities and
    supplies
    e. Criteria for workmanship
    Is production carried out in
    accordance with approved data
    required by the standard?
    Are process changes approved
    properly including:
    a. Acceptance of changes by
    customers and regulators
    when required
    b. Documentation of changes
    and procedures to control of
    implementation of changes
    AS9100 Internal Audit Checklist
    c. Assessing results of changes
    Is production equipment validated
    prior to use? Is it maintained and
    inspected according to procedures?
    Are storage requirements
    established?

    If work is temporarily transferred


    outside of your facilities, is the
    process for control and validation
    defined?
    Where servicing is a specified
    requirements is it controlled as
    required by the standard, including:
    a. Collecting in-service data
    b. Actions taken when problems
    are identified
    c. Control and updating of
    documentation
    d. Approval and control of repair
    e. Control of off site work
    Additional Questions:

    7.5.2 Validation of Processes for


    Production and Service Provision
    Does your organization have any
    processes for production and service
    where the output cannot be verified
    by monitoring or measurement? Do
    you validate these processes?

    How is validation performed?

    Does it address the requirements of


    the standard, including:

    a. Criteria

    b. Qualification of equipment and


    personnel

    c. Records

    d. Revalidation

    e. Use of specific methods and


    procedures?
    AS9100 Internal Audit Checklist

    Additional Questions:

    7.5.3 Identification and Traceability


    How is product identified?

    Is identification of configuration
    maintained?
    How is measuring and monitoring
    status identified?

    Are stamps, electronic signatures or


    other acceptance media used
    controlled?
    Does your organization control and
    record the unique identification of the
    product, where traceability is
    required?

    Does your traceability system meet


    contract or regulatory requirements
    including when specified:
    a. Identification, maintained
    through the product life
    b. Tracing of batches (raw
    material, manufacturing and
    destination batches)
    c. Traceability of components of
    assemblies
    d. Sequential records of product
    production
    Additional Questions:

    7.5.4 Customer Property


    How does your organization maintain
    the customer property while it is
    under your control?

    How do you identify and safeguard


    customer property? How do you
    determine if it is suitable for use?

    If any customer property is damaged,


    lost, or unsuitable for use is it
    reported to the customer and
    AS9100 Internal Audit Checklist
    recorded?

    Additional Questions:

    7.5.5 Preservation of Product


    How do you make sure that product
    quality is maintained during
    processing and delivery?

    Does this process address the


    requirements of the standard
    including handling, packaging,
    storage and delivery?
    Does your process provide for
    requirements of specifications or
    regulations including:

    a. Cleaning

    b. Foreign objects

    c. Special handling

    d. Marking and labeling

    e. Shelf life, stock rotation


    f. Hazardous materials
    Are documents that are required (by
    the contract) to be kept with the
    product protected fro loss?
    Additional Questions:

    7.6 Control of Monitoring and


    Measuring Devices
    Is a register maintained according to
    the standard?
    Has your organization established a
    mechanism to ensure monitoring and
    measuring is performed consistent
    with requirements?

    Is equipment handled and maintained


    according to the standard
    requirements including:
    a. Calibration schedules and
    AS9100 Internal Audit Checklist
    traceable measurement
    standards
    b. Adjustments

    c. Calibration status

    d. Safeguarding

    e. Protection during handling,


    maintenance and storage
    f. Recall for calibration
    Are environmental conditions suitable
    for the tests and equipment?

    What action is taken if equipment is


    found to be out of calibration?

    Does your organization take


    appropriate action on the equipment
    and any product affected above?

    What records are maintained?

    How is software used for measuring


    and monitoring verified prior to use
    and reconfirmed as necessary?

    Additional Questions:

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