Process Auditing Worksheet

Process Name: Calibration (PROC-11)

Output: Product (Tangible) or Service (Auto Repair, Calibration Service, etc). Under “Performance Measurement”, specify how the
performance (quality) of the product or service is measured. List what records are generated with the product or service
Product /Service Performance Measure Records Generated Audit Item
• Calibrated • On-time calibration • Sticker For production processes audited, record
Equipment service indicating status measuring equipment id’s & description then:
• Accuracy of results • Calibration • Verify that sticker on equipment
records correspond to calibration status /
availability / equipment ID
accuracy • Verify that calibration records show
equipment ID, acceptable results, date
corresponding to database, correct
calibration frequency, etc.
Input / Process Activities: List applicable input elements with how they are controlled
Input Element Identification / Control Criteria Audit Item
People Quality Manager / Knowledge of • Interview the Quality Manager about their
• Qualifications?
responsibilities responsibilities. Are they consistent w/
• Any Required Training?
• Any Required Associates who run the CMM / procedure PROC-11?
Certification? Qualifications • Ask how these associates are qualified
and/or their training / certification
Materials / Information Calibration Status / Database • How does the Quality Manager use the
• Materials / components
information and previous Database to schedule calibration?
and/or information used
as input? calibration records • Ask for the masterlist of gages to be
• Suppliers or Equipment to be calibrated / calibrated. Pick a sample and verify ID’s and
subcontractors used? Masterlist serial numbers / location / status. Do they
match?
Equipment / Gage Blocks that gages are • Verify that Gage Blocks are identified as on
Measuring Devices
checked against / certification the masterlist
• Process equipment Used?
• Measuring equipment & • Verify that the Outsourced Calibration
devices to measure the Outsourced calibration / Service is certified to acceptable standard
resulting product or Certification / Supplier Evaluation (ISO 17025 or A2LA)?
service??
• Verify that the Outsourced Calibration
Service is on the Supplier Evaluation program
Methods Procedure / Document Control • Verify that PROC-11 rev. 2 and CA-01
• List of documents and
Verification Work Instructions are
references used to get the
job done (including Calibration Work Instructions / consistent against document control
external)? Document Control masterlists
• Documents accessible, • Verify that Manufacturer’s Manuals (user’s
followed?
Manufacturer’s Manuals / guides) are available for calibrating a sample
Document Control of employee-owned equipment
Environment Protection of Equipment / Storage • Verify that equipment is protected against
• Is work environment
and protection requirements damage when not in use
specified in process
documentations? • Observe that humidity and temperature
• Safety requirements? Temperature, Humidity & other limits are not violated
• Climate Control? limits / Lab
• Lighting?
• Clutter?