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)
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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
- Receiving
- Inspection (Goods In)
- Picking
- Assembly
- Labeling
- Packing
- Purchasing
- Put Away
- Production Order
- QC Check
- Shipping
- Testing
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Select 2 Receiving 'tickets'
Receiving Ticket
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Record Supplier Name
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Review Supplier Profile in Dataworks (Screen: MPO-02), or Navision: is Supplier a Direct-Active or Direct-Conditional
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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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Did receiving clerk follow steps in procedure to receive product
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IS product labeled correctly?
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Select 3 Inspections Records
Inspection Record
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Record Purchase Order #
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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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Does the employee know the Quality Policy, or where it can be located?
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Select 2 work orders
Work Orders
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Have the correct parts been picked for the work order
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Are the parts in the correct SK inventory location designated in the system
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Is the Warehouse Employee trained to the current revision of the SOP?
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Assembly Station ID (i.e. Station number, process)
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Assembler Employee ID (number, name, etc)
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Obtain Method Sheet for Station to be audited from MasterControl
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Method Sheet #
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Method Sheet Revision
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Was a line Clearance performed prior to starting work (Verify FORM completed)
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If Quality Alert in place, is the operator aware of the Quality Alert?
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Review Method Sheet being followed, is it the current revision? (verify within MasterControl)
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Follow process steps on Method Sheet, is the operator following the steps of the Method Sheet?
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Are chemicals/glues at the work station properly identified (part number and expiration)
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Gauges/Measuring Equipment requiring calibration (Select 3 gauges from Workstation)
IMTE
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Gauge ID
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Is the IMTE properly identified with Gauge ID and Due Date?
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IS the gauge in good working order?
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Record Mold ID#
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Mold Location
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Are Set Up Sheets available
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Was a First Piece Sample measured, and found to be within specification?
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Are Set up Instructions being followed
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Review the OQ Validation, is the Mold running within the validated parameters set in the Validation?
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Label Review: Select 2 stations where products are being pouched/packaged
Pouching/Packaging Process
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Record the Station ID where packaging is being performed
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Record Work Order Number
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Is the Pouch Sealer set to the correct settings per the Method Sheet?
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If a Peel Test has been complete, does the results fall within specification?
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Review packaged product, is there any product that is not properly sealed?
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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 Method Sheet?
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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?
Signature Page
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