Information
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Document No.
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Process Area Audited
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Conducted on
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Audited by
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Process Owner
Material Verification
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Check VPN, thickness, width, edge bow and finish against control plan
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Check that the supplier is approved and accreditation certificate is in date
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Check that a valid material certificate exists
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Check that Goods Inwards process has been followed.
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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
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Are operators fully aware of their role within the process
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Can operators locate a hard or electronic copy of relevant instructions?
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Does the operators explanation of the process conform to instructions?
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Is the operator on training matrix for the process.
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Check correct drawing issue is used on QCIC.
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Are parts compliant to QCIC?
Tools And Gauges
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During the audit, randomly select four pieces of measuring equipment. <br>Check unique ID on equipment. <br>Is equipment logged on calibration register?<br>Is equipment in date?<br>If externally calibrated, is cert in date and UKAS traceable?<br>All calibration masters must be UKAS calibrated.
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Check the control plan to ensure gauge used is the gauge shown on MSA. <br>Check gauge for damage. <br>Confirm MSA studies are available for equipment type selected on audit. <br>
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Do studies confirm the suitability of measuring equipment for the type of measurements they are being used for?<br>
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Is the operator fully trained and competent in the use of the equipment?<br>Do they understand the colour coding calibration system?<br>Do they understand their role if they find equipment damaged or lost?
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Check tools are identified with customer ID. Check location against tool register on Efacs and Agility
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Check key spares are held for tools.
Subcontract
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Check sub contractor is on the approved supplier list and that their accreditation certificate is in date.
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Check sub contract purchase orders match and correspond with latest PPAP submission
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Is the operation classed as a "special process"? I.e. Plating, painting, heat treatment etc. <br>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
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Is the appropriate set up instruction document available?<br>Is it the latest issue?<br>
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Is the set up information stored on the database?
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Check lubrication type is correct to set up instruction.
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Are guards in order and guard cards signed off correctly?
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Are documents GMP compliant?
Labelling and Packaging
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Check packing specifications are available on Efacs.
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Check route card against information on Efacs.<br>Are all previous operations signed off?
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Check that all parts are labelled clearly and correctly with all required information.
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Check that packing process matches Efacs packing specification.
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Check stock holding area for quantity and location is correct to Efacs record.
Control of Non Conforming Material and Rework.
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Does the operator clearly identify all non conforming items?<br>Are they separated from production items?<br>Are they being recorded on the production sheet and via Tensor when booking off the job?
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Is rework being carried out in a controlled manner?<br>Is it suitably identified?<br>Has the rework method been approved by QA?<br>
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Check PPAP/layout register and ensure that customer requirements are being met.
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Is layout inspection current to annual schedule?
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Is quarantine area secure?<br>Are all quarantined parts correctly labelled?
Maintenance
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Check maintenance plan and ensure it is up to date and accurate. <br>Check key spares held for tool. <br>Check tool record on Agility.
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Check maintenance plan for two random presses are up to date.
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Pick two running tools and check that all maintenance records are available and up to date.
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Select four random tools on tool racks and ensure;<br>Locations are correct on Agility.<br>The too.s are identified with customer name and/or number.
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Is the setter able to demonstrate safe operation of the press including;<br>The first off process.<br>Last off process.<br>Check process if part fails first or last off.
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Check area for unidentified containers. Eg oil and chemical bottles with no labels etc present
Production Areas
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Ask Supervisor if all necessary tools, gauges and QCIC's available?<br>Is the correct process followed when these items are not available?
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Check random parts for identification of product including details of next operation.
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Check 5S standard in area. <br>What 5S activity is currently taking place?
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How is stock availability?<br>Is material available in line with stock records?
Quality Performance
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Is there evidence of continuous improvement activities in the area?<br>Discuss projects with area supervisor.
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Check PPM and COQ for the area.<br>Are they on target and improving?<br>If not, what actions are in place?
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Take a poorly performing part or machine.<br>What actions are in place to improve performance?
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Is all data relating to scrap, rework, PPM and COQ being recorded.
Audit Non Conformances
Audit Non Conformances
NC1
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Non Conformance Description
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Photo if Available
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Corrective Action
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Date Issued
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Responsible Person
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Closed?
NC2
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Non Conformance Description
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Photo if Available
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Corrective Action
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Date Issued
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Responsible Person
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Closed?
NC3
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Non Conformance Description
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Photo if Available
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Corrective Action
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Date Issued
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Responsible Person
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Closed?
NC4
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Non Conformance Description
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Photo if Available
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Corrective Action
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Date Issued
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Responsible Person
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Closed?
NC5
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Non Conformance Description
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Photo if Available
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Corrective Action
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Date Issued
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Responsible Person
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Closed?
