People

  • Has the operator been trained to requirements of the job and is the training matrix updated?

  • Are all personnel using all the posted Personal Protective Equipment?

  • Are containers of chemicals and wastes properly labelled?

  • Is 5s & housekeeping completed/implemented/followed?

  • Is the area free of spills/leaks/stains?

  • Is OWI contained EMS and followed?

  • Where applicable, are forms, checklists (e.g. forklift), logs (e.g. flammable cabinets), etc. properly in use?

Standardisation / Built in Quality

  • Is Error-Proofing Verification performed at prescribed frequency and was it done at the beginning of each shift?
    Ask operator to perform an error proofing verification.
    Is correspondent documentation filled out?

  • Are test “rabbits” present in the workcell where error-proofing verification is required?

  • Idling procedure compliance?

  • Has there been any quality complaints in the audited area? If “Yes” review Corrective Action

  • Is there a quality alert posted?

  • Are people trained on the alert & has it been signed off?

  • Is the work being performed to the instructions on the alert?

  • Are Inspection Instruction Sheets, Packaging & Labelling Instructions, Operator Work Instructions, Measuring Devices Instruction Sheet signed by Area Shift Supervisors and Managers?

  • Are the work instructions at the work station?

  • Are they being followed and up-to-date (also verify takt time, cycle time)?

  • Are all quality checks being performed to the Inspection requirements including product critical characteristics & documented? Are the requirements being met?

  • Has the process run sheet been verified / Safety Check Sheet / Changeover checklist?

  • Is the first off part present and tagged as per the First-off Procedure?

  • Is FIFO in place and followed at workcell?

  • Are scrap racks / bins present & parts clearly marked & defective parts marked on the scrap sheets?

  • Per Inspection sheet / Control Plan, is gauge available & does have proper calibration stickers?

  • Is there lot traceability on the part/container?

  • Do the labels at the cell / line match the parts being produced?

  • Does the packaging/labeling match the packaging/labeling instructions (photos of containers and labels in the Packaging and Labeling Instruction correspond with what is currently used)?

  • Are the operators adding their employee # on the label or part/containers?

  • Review Top RPN elements from PFMEA

  • Is the communication log ("Black/Red Book") available and completed as required?

  • Reset process followed (reset log filled out, deviation in place when required, for bypass with approval from Quality)

More

Sign-off

  • Signature

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