Key Process Audit Checklist
What machines, equipment, software, and Record answers and notes on blank turtle
materials are used to do this process? diagrams or audit checklist or note page Who is involved with this process?
(Departments and job functions)
Are there adequate resources? List people audited and verify training and
competency records: What training and skills are required?
Is the equipment maintained and
supported? Verify records against the jobs you saw them Any special skills, certifications or training
performing needs?
Are there gauges that require calibration?
What records of training exist?
What is the Process being audited?
What Outputs come out of this process?
What Inputs are required to do this Observe all aspects of the process
process? Are these good and correct? being done. Ask questions about how What gets delivered to internal and external
the process gets done by the people customers
What comes from internal and external
doing the process. What current records and historical
customers? Include CSR.
evidence can you see to prove effectiveness
of the process?
Who is the Process Owner?
What measurement or performance Are records adequate per plan?
indicators exist? What monitoring or What role, responsibility and
measuring is there? authority?
What procedures or work instructions exist
How is the performance and trends? What for this process?
Collect documents looked at, it’s number and
goals are there? revision date. Verify against master documents. Get copies of all appropriate
Any customer feedback? How effective is Any obsolete documents in use? documentation and review.
the process? Are all documents used for production controlled? Do the people clearly demonstrate that
Are employees and management aware of they can do their jobs per the documented
Are documents populated and signed as procedures and work instructions?
negative trends and is anything being done?
required?
What other Processes does this one link to or interact with? What examples can be followed into other processes?
Follow audit trails from this process into other processes to assure the linkage, sequence and interaction are working as intended.
What are the applicable ISO/TS 16949 clauses that affect this process?
Make sure the audit checklist asks appropriate questions from these TS clauses as they relate to the key process being audited.
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Audit Checklists for Support and
Management Processes
• Please note that checklists for support and management
processes will be more “old school” checklists that use
questions following the specific clause of the ISO
standard (possible examples of support and
management processes are: management review,
internal audits, HR/training, corrective action, preventive
action, document control, record control).
• Additional questions should be added to review
document control, records, training, etc., but expect
more traditional checklists that follow the ISO clause and
requirements.
• The Key Process Audit Checklist is not applicable for
support and management processes.
Sample Internal Audit Checklist Using The Process Audit Approach For Production/Manufacturing
Process Audited: Manufacturing Process Date: Location:
People Interviewed (Shift): Auditors:
Clause Question or Statement Audit Notes of Objective Evidence Finding
or Doc / Opp.
8.2 What is monitored, measured and reported for
this production process?
Select a process and look at the performance
data. Copy the data or record a summary here.
8.2 Are there any negative trends or bad performance
8.4 against goals?
8.5 If yes, what is being done for continual
improvement?
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PO Box 2580, Columbus, OH 43086 614-794-7404 www.simpleque.com
Sample Internal Audit Checklist Using The Process Audit Approach For Production/Manufacturing
Process Audited: Manufacturing Process Date: Location:
People Interviewed (Shift):
Clause Question or Statement Audit Notes of Objective Evidence Finding
or Doc / Opp.
8.2 Are there any customer problems, scorecards,
7.2 negative feedback or high reject rates?
Is there any specific part number or customer that
should be used for audit samples due to poor
performance?
5.5 Are appropriate employees aware of any recent
customer problems?
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PO Box 2580, Columbus, OH 43086 614-794-7404 www.simpleque.com
Sample Internal Audit Checklist Using The Process Audit Approach For Production/Manufacturing
Process Audited: Manufacturing Process Date: Location:
People Interviewed (Shift):
Clause Question or Statement Audit Notes of Objective Evidence Finding
or Doc / Opp.
7.5 Get a copy of the work instructions for the
production process or part number being
observed and audited.
Watch and see if the work instruction matches
exactly what is being done in production.
Get a copy of the traveler and routers. Are
they being followed?
Note any discrepancies between
documentation.
6.2 Has the operator been trained on the job you
are observing them perform? What records
exist for the training?
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PO Box 2580, Columbus, OH 43086 614-794-7404 www.simpleque.com
Sample Internal Audit Checklist Using The Process Audit Approach For Production/Manufacturing
Process Audited: Manufacturing Process Date: Location:
People Interviewed (Shift):
Clause Question or Statement Audit Notes of Objective Evidence Finding
or Doc / Opp.
4.2 Are all necessary documents available in
production? Work order, checklists, visual cards,
routers, etc.
List all the documents and their revision levels.
Are all the documents the most recent version?
4.2 Look at records from the last time this part was
run. Can the records be found?
Were production records properly filled out and
completed? Evaluate records from multiple shifts.
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PO Box 2580, Columbus, OH 43086 614-794-7404 www.simpleque.com
Sample Internal Audit Checklist Using The Process Audit Approach For Production/Manufacturing
Process Audited: Manufacturing Process Date: Location:
People Interviewed (Shift):
Clause Question or Statement Audit Notes of Objective Evidence Finding
or Doc / Opp.
7.5 Look at raw material being used.
Is there adequate identification and
traceability to a lot (if required)?
7.5 Is purchased part lot traceability information
being carried forward to production records?
8.3 Is any scrap properly handled and identified?
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PO Box 2580, Columbus, OH 43086 614-794-7404 www.simpleque.com
Sample Internal Audit Checklist Using The Process Audit Approach For Production/Manufacturing
Process Audited: Manufacturing Process Date: Location:
People Interviewed (Shift):
Clause Question or Statement Audit Notes of Objective Evidence Finding
or Doc / Opp.
8.3 Are there any examples of nonconforming
product or rework?
8.3 Is this material properly identified?
8.3 Is the procedure for nonconforming or rework
material being followed?
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PO Box 2580, Columbus, OH 43086 614-794-7404 www.simpleque.com
Sample Internal Audit Checklist Using The Process Audit Approach For Production/Manufacturing
Process Audited: Manufacturing Process Date: Location:
People Interviewed (Shift):
Clause Question or Statement Audit Notes of Objective Evidence Finding
or Doc / Opp.
7.5 Evaluate preventive maintenance records for
the machines being observed or audited.
What preventive maintenance was supposed
to have been completed?
What preventive maintenance has been
completed?
4.2 Are preventive maintenance records complete?
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PO Box 2580, Columbus, OH 43086 614-794-7404 www.simpleque.com
Sample Internal Audit Checklist Using The Process Audit Approach For Production/Manufacturing
Process Audited: Manufacturing Process Date: Location:
People Interviewed (Shift):
Clause Question or Statement Audit Notes of Objective Evidence Finding
or Doc / Opp.
7.1 Are there any deviations or exceptions in the
8.3 production process?
Is the deviation process and procedure being
followed?
How long is the deviation for, or for how many
parts?
When did the deviation start? When is it
supposed to end? Is the deviation still open?
8.3 Is the customer involved and have they approved
the deviation, if appropriate?
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PO Box 2580, Columbus, OH 43086 614-794-7404 www.simpleque.com
Sample Internal Audit Checklist Using The Process Audit Approach For Production/Manufacturing
Process Audited: Manufacturing Process Date: Location:
People Interviewed (Shift):
Clause Question or Statement Audit Notes of Objective Evidence Finding
or Doc / Opp.
7.6 Record information from any measurement
gauges or test equipment.
7.6 Check to see that gauge calibrations are up to
date and that calibration records are
maintained.
8.2 Are measurement records complete for any
inspections that are supposed to be recorded?
8.2 Are any measurements out of spec? If yes, what
was done? Is this per procedure?
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PO Box 2580, Columbus, OH 43086 614-794-7404 www.simpleque.com
Sample Internal Audit Checklist Using The Process Audit Approach For Production/Manufacturing
Process Audited: Manufacturing Process Date: Location:
People Interviewed (Shift):
Clause Question or Statement Audit Notes of Objective Evidence Finding
or Doc / Opp.
8.1 Were there any targets for productivity and
8.2 effectiveness?
8.4
What is OEE versus the goal?
What is scrap versus the goal?
What is PPM versus the goal?
What is process capability versus the goal?
What is the standard time or rates versus the
goal?
6.2 Are operators aware of bad performance or
5.5 negative trends?
8.5 Is anything being done to make improvements in
areas that aren’t performing as planned?
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PO Box 2580, Columbus, OH 43086 614-794-7404 www.simpleque.com
Sample Internal Audit Checklist Using The Process Audit Approach For Production/Manufacturing
Process Audited: Manufacturing Process Date: Location:
People Interviewed (Shift):
Clause Question or Statement Audit Notes of Objective Evidence Finding
or Doc / Opp.
6.1 Observe the work environment and
equipment.
Are there adequate resources (space,
equipment, and people) to do the job as
planned?
6.3 Is the work environment appropriate, clean
6.4 and safe?
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PO Box 2580, Columbus, OH 43086 614-794-7404 www.simpleque.com
Sample Internal Audit Checklist Using The Process Audit Approach For Production/Manufacturing
Process Audited: Manufacturing Process Date: Location:
People Interviewed (Shift):
Clause Question or Statement Audit Notes of Objective Evidence Finding
or Doc / Opp.
Add your own supplemental questions:
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PO Box 2580, Columbus, OH 43086 614-794-7404 www.simpleque.com
