Material Verification

  • Check VPN, thickness, width, edge bow and finish against control plan

  • Check that the supplier is approved and accreditation certificate is in date

  • Check that a valid material certificate exists

  • Check that Goods Inwards process has been followed.

  • Check how materials are recorded on Efacs and released for production. Check that Efacs location and physical location of material match

QCIC's and Training

  • Are operators fully aware of their role within the process

  • Can operators locate a hard or electronic copy of relevant instructions?

  • Does the operators explanation of the process conform to instructions?

  • Is the operator on training matrix for the process.

  • Check correct drawing issue is used on QCIC.

  • Are parts compliant to QCIC?

Tools And Gauges

  • During the audit, randomly select four pieces of measuring equipment.
    Check unique ID on equipment.
    Is equipment logged on calibration register?
    Is equipment in date?
    If externally calibrated, is cert in date and UKAS traceable?
    All calibration masters must be UKAS calibrated.

  • Check the control plan to ensure gauge used is the gauge shown on MSA.
    Check gauge for damage.
    Confirm MSA studies are available for equipment type selected on audit.

  • Do studies confirm the suitability of measuring equipment for the type of measurements they are being used for?

  • Is the operator fully trained and competent in the use of the equipment?
    Do they understand the colour coding calibration system?
    Do they understand their role if they find equipment damaged or lost?

  • Check tools are identified with customer ID. Check location against tool register on Efacs and Agility

  • Check key spares are held for tools.

Subcontract

  • Check sub contractor is on the approved supplier list and that their accreditation certificate is in date.

  • Check sub contract purchase orders match and correspond with latest PPAP submission

  • Is the operation classed as a "special process"? I.e. Plating, painting, heat treatment etc.
    If so check there is a CQI document established with the supplier. Check it is less than one year old and approved.

Set Up Instructions

  • Is the appropriate set up instruction document available?
    Is it the latest issue?

  • Is the set up information stored on the database?

  • Check lubrication type is correct to set up instruction.

  • Are guards in order and guard cards signed off correctly?

  • Are documents GMP compliant?

Labelling and Packaging

  • Check packing specifications are available on Efacs.

  • Check route card against information on Efacs.
    Are all previous operations signed off?

  • Check that all parts are labelled clearly and correctly with all required information.

  • Check that packing process matches Efacs packing specification.

  • Check stock holding area for quantity and location is correct to Efacs record.

Control of Non Conforming Material and Rework.

  • Does the operator clearly identify all non conforming items?
    Are they separated from production items?
    Are they being recorded on the production sheet and via Tensor when booking off the job?

  • Is rework being carried out in a controlled manner?
    Is it suitably identified?
    Has the rework method been approved by QA?

  • Check PPAP/layout register and ensure that customer requirements are being met.

  • Is layout inspection current to annual schedule?

  • Is quarantine area secure?
    Are all quarantined parts correctly labelled?

Maintenance

  • Check maintenance plan and ensure it is up to date and accurate.
    Check key spares held for tool.
    Check tool record on Agility.

  • Check maintenance plan for two random presses are up to date.

  • Pick two running tools and check that all maintenance records are available and up to date.

  • Select four random tools on tool racks and ensure;
    Locations are correct on Agility.
    The too.s are identified with customer name and/or number.

  • Is the setter able to demonstrate safe operation of the press including;
    The first off process.
    Last off process.
    Check process if part fails first or last off.

  • Check area for unidentified containers. Eg oil and chemical bottles with no labels etc present

Production Areas

  • Ask Supervisor if all necessary tools, gauges and QCIC's available?
    Is the correct process followed when these items are not available?

  • Check random parts for identification of product including details of next operation.

  • Check 5S standard in area.
    What 5S activity is currently taking place?

  • How is stock availability?
    Is material available in line with stock records?

Quality Performance

  • Is there evidence of continuous improvement activities in the area?
    Discuss projects with area supervisor.

  • Check PPM and COQ for the area.
    Are they on target and improving?
    If not, what actions are in place?

  • Take a poorly performing part or machine.
    What actions are in place to improve performance?

  • Is all data relating to scrap, rework, PPM and COQ being recorded.

Audit Non Conformances

Audit Non Conformances

NC1

  • Non Conformance Description

  • Photo if Available

  • Corrective Action

  • Date Issued

  • Responsible Person

  • Closed?

NC2

  • Non Conformance Description

  • Photo if Available

  • Corrective Action

  • Date Issued

  • Responsible Person

  • Closed?

NC3

  • Non Conformance Description

  • Photo if Available

  • Corrective Action

  • Date Issued

  • Responsible Person

  • Closed?

NC4

  • Non Conformance Description

  • Photo if Available

  • Corrective Action

  • Date Issued

  • Responsible Person

  • Closed?

NC5

  • Non Conformance Description

  • Photo if Available

  • Corrective Action

  • Date Issued

  • Responsible Person

  • Closed?

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