Title Page
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Audit Title
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Site
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Conducted on
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Audit Conducted by
- Paula Lansdowne (Level 1)
- Susan Allbury (Level 1)
- Monika Kita (Level 1)
- Joan Waters (Level 1)
- Steve Reeve (Level 1)
- Tim West (Level 1)
- Fraser Nash (Level 1)
- Richard Butler (Level 1)
- Lindsay Gallie (Level 1)
- Aron Bantin (Level 1)
- Richard Wicks (Level 1)
- Brendon Nesbitt (Level 1)
- Ian Davidson (Level 1)
- Jeremy McCurrach (Level 1)
- Leif Neilsen (Level 1)
- Chris Brown (Level 1)
- David Lamerton (Level 1)
- Crispin Merritt (Level 2)
- Steve Lightfoot (Level 2)
- Denzil Searle (Level 2)
- Claire Forsyth (Level 2)
- Helen Norton (Level 2)
- Amy Bishop (Level 2)
- Donna McGovern (Level 2)
- Chris Chrigwin (Level 2)
- Dustn Rhodes (Level 2)
- Rob Thompson (Level 3)
- Lis Goulder (Level 3)
- John Mitchell (Level 3)
- Wendy Hassan (Level 3)
- Paul Tutt (Level 3)
- Mark Estes (Level 3)
- Mike Alway (Level 3)
- Andy Paulley (Level 3)
- Arjen Barnhoorn (Level 4)
- David Festa (Level 4)
- Marc Gelnett (Level 4)
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Select auditor title from drop down list
- Cell Lead
- Supervisor
- Manager
- Quality Engineer
- Engineer
- Director
- Vice-President
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Location
Process to be audited
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Enter the Time the audit started
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Select the Process Category to be audited
- Inspection (Goods In)
- Picking
- Assembly
- Labeling
- Packing
- Receiving
- Purchasing
- Put Away
- Production Order
- QC Check
- Shipping
- Testing
- Molding
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Select 2 Receiving 'tickets'
Receiving Ticket
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Record Supplier Name
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Record Purchase Order Number
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Record Line Item Number
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Record Part number
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Record Revision of part
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Review procedure being used for receiving. (If hard copy, is it stamped with control status); Is the procedure available with the correct revision number?
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Did receiving operative follow steps in procedure QP-125 to receive product?
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Review Navision: Information entered into Nav appropriately?
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Was the shipment checked for damaged boxes
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Was the correct quantity received and recorded in Navision
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Review Navision record, Was a “put-away” list generated?
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Review paperwork received with the shipment, was all required paperwork received (delivery note / Certificate of Conformance etc)?
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Select 3 Inspections Records
Inspection Record
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Record Purchase Order Number
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Record Part number
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Record Revision of part number
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Review IQC Criteria, verify Inspection Record captures same criteria
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Is IQC Record Complete?
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Review Measurements - are they within tolerances?
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Select 2 pick lists
Work Orders
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Does the employee know the Quality Policy or where it can be located?<br>
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Have the correct parts been picked for the work order?
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Are the parts in the correct inventory location designated in Navision?
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Is the Warehouse Employee trained to the current revision of the SOP?
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Select 1 assembly station to audit
Assembly Process
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Assembly station ID (ie station number, process)
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Assembler Employee ID (number, name, etc)
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Review Work Instruction being followed, is it the current revision?
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Was a line clearance performed prior to starting work (verify from complete)?
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If quality alert in place, is the operator aware of the quality alert?
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Follow process steps on Work Instruction, is the operator following the steps of the Work Instruction?
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Are chemicals/glues at the workstation properly identified (part number and expiration)?
IMTE
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Gauge ID
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Is the IMTE (Inspection Measuring Test Equipment) properly identified with Gauge ID and Due Date?
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IS the gauge in good working order?
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Label Review: Select 3 stations where labels are being applied
Label Application Process
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Record the Station ID where labeling is being performed
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Record Work Order Number
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Record Label Part Number
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Record Label Revision
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Compare the label to the BOM, Is the label the current part number and revision?
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Is a Copy of the label added to the DHR?
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Does the label match the product being packed?
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Select 2 work orders where products are being packed into shipping carton
Packing Process
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Record the Station ID where packing is being performed
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Record Work Order Number
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Are the products being packed per the Work Instruction?
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Has the proper paperwork been generated that goes with the shipment (i.e. sterilization documentation)?
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Are the boxes free from dents, tears, or other signs of wear?
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Select 2 Orders that have been QC checked
QC Check Process
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ID of product (inc serial number)
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ID of employee (number / name etc)
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Product ID of checked component(s)
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Testing / accessory sheets checked (as applicable)
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Serial numbers checked (on product, paperwork and packaging)
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Signature(s) complete
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Any quality alerts in place?
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Is the operator / qc inspector aware of the quality alert?
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Select 2 items that have been tested
Testing Process
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ID of product (inc serial number)
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Assembler Employee ID (number, name, etc)
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Record Testing Instruction number
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Record Testing Instruction revision number
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Are all labels correct (including on product packaging)?
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Review records, is everything within tolerances?
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Signatures complete?
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Select 2 Production Orders
Production Order Process
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Record Production Order Number
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Order picked correctly (including label requirements)?
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Signatures and dates recorded correctly as required?
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Does the employee know the Quality Policy or where it can be located?
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Select 2 Purchase Orders
Purchasing Process
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Record Supplier Name
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Record Purchase Order Number
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Record part number
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Is the correct procedure being followed?
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Information added to Nav as required (per work instruction / procedure)?
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Sign-off / permissions approved?
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Select 2 Shipments to check
Shipping Process
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Does the employee know the Quality Policy or where it can be located?
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Record Shipping Number
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Correct parts being shipped
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Condition of Shipping products (Great / Fair / Poor)
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Shipment sealed correctly
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All additional label accessories added (“tip and tell” / “shockwatch” labels added)
Signature Page
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Add signature
