Process Audit Checklist 2 – Basic Production Process Checklist
Page No. _________
This checklist should be used to evaluate each workstation/activity within the overall process under review. If weaknesses or
problems are noted, either as a part of this review or as part of the pre-audit planning, then the more detailed Full Production
Process Checklist can be used to more thoroughly investigate the suspect activities. References to related sections on the Full
Production Process Checklist are provided.
Standard Requirements
Reviewer Checks
Basic Production Process Audit Questions
Have the operator walk you through/discuss the process
being performed. During the discussion, verify the
following items:
1. Is there a procedure/instruction at the
workstation? Is it current (note the rev. # for later
comparison to the master list).
(5)
2. Is the procedure being followed? Ask the operator
if the procedure is adequate. Note any deficiencies
or inadequacies.
(4)
3. Are material and parts properly identified? Can
everything be identified? How?
(9)
4. Is the inspection status for materials and parts
identified? Ask the operator how they know their
incoming product is good.
(9)
5. Are the inspections required by the Control Plan
or Inspection Plan being performed? Are they at
the right frequency? The right sample size? The
right measurement device?
(11, 12)
6. Are the measurement devices used at this
workstation calibrated? Are they being properly
handled and stored when not in use?
(14)
7. Is maintenance adequate? Are PM tasks being
accomplished as required? Are the PM’s sufficient?
Are spare parts available? Review equipment
downtime or availability performance and trends, if
poor review in detail. (13)
8. Are the operator(s) properly trained? Check
training records later. Are operators aware of the
importance of their actions to the QMS/EMS? Are
they aware of any significant environmental
aspects?

Competency
(7)
 Awareness
(7)
9. If SPC is used at this station, is it being properly
conducted? Is it effective? Review the charts for
out-of-control conditions.
(11)
11. Is nonconforming product control acceptable?
Do operators understand how to handle it?
(10)
12. Other items (list)
Basic Process Information:
Name of workstation/activity: _______________________________
Operator(s): _____________________________________________
Procedure/Instructions: _____________________ Rev: __________
Equipment Avail./Downtime Trend: _________________________
Gage/Device Type: __________________ Serial #: _____________
Control/Insp. Plan # ________________________ Rev:___________
Overall evaluation:
Conforms. No deficiencies identified.
Opportunity for improvement. Detail below.
Best Practice. Detail below. Be specific.
Nonconformity. Provide details below. Reference the specific
requirement violated.
Full Description of NC/OFI/BP (use back if necessary)