Section A: Following Work Instructions

  • A1 Does the operator have access to and appropriately utilize the instruction?

  • A2 Has the employee confirmed it is the correct document/form and correct revision?

  • A3 Has the employee followed the instructions as written, including performing only the operations in the instructions and in the correct sequence? If not, document all deviations.

  • A4 Has the employee appropriately recorded results and done so as process steps are completed? If not, document all deviations.

  • A5 If required, has the employee appropriately performed and recorded line clearance activities?

  • A6 If the employee encountered problems during the process did they stop and request support as appropriate?

Section B: Equipment and Materials

  • B1 Based on your observation, are the equipment used in the process calibrated?

  • B2 Is the employee aware of and verifying equipment calibration?

  • B3 Has the employee appropriately recorded the equipment and calibration information if required?

  • B4 If an equipment is due for calibration, how is it communicated?

  • B5 Is there any equipment that requires preventive maintenance? If so and if it is part of the employee’s job function, is the employee aware of the preventive maintenance and what actions to take?

  • B6 Based on your observation, are chemicals (e.g. IPA, Acetone, Adhesive, etc.) labelled appropriately (e.g. full name, expiration date, etc. per QOP-00019)?

  • B7 If required, has the employee confirmed the expiration date on materials used and properly recorded?

  • B8 As applicable, has the employee properly recorded materials and components used, including lot/serial numbers and other required information?

Section C: Gowning, ESD and Safety Requirements

  • C1 Has the employee appropriately gowned for the job (including wearing a smock/gown, gloves, hairnet, etc.) as required?

  • C2 Has the employee made use of appropriate protective gear and practices as required?

  • C3 Is the employee utilizing appropriate ESD precautions and have they performed ESD checks as required?

Section D: Training

  • D1 Verify training records of the auditee and/or technician doing the work, are they complete and timely?

  • D2 Based on your observation, is the technician adequately trained to carry out the job?

Summary and Additional Commentary

Sign Off

  • Auditee(s)

  • Auditor(s)

  • QA Review and Approval

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