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Key Process Audit Checklist

What machines, equipment,


software, and materials are used to
do this process?

Record answers and notes on blank turtle diagrams


or audit checklist or note page

Are there adequate resources?

List people audited and verify training and


competency records:

Is the equipment maintained and


supported?

Verify records against the jobs you saw them


performing

Are there gauges that require


calibration?
What Inputs are required to do this
process? Are these good and
correct?

Observe all aspects of the process


being done. Ask questions about
how the process gets done by the
people doing the process.

What role, responsibility and


authority?

How is the performance and trends?

Any customer feedback?


How effective is the process?
Are employees and management
aware of negative trends and is
anything being done?

Any special skills, certifications or


training needs?

What is the Process being audited?

Who is the Process Owner?

What goals are there?

What training and skills are required?

What records of training exist?

What comes from internal and


external customers? Include CSR.
What measurement or performance
indicators exist? What monitoring or
measuring is there?

Who is involved with this process?


(Departments and job functions)

Collect documents looked at, its number and


revision date. Verify against master documents.
Any obsolete documents in use?
Are all documents used for production controlled?
Are documents populated and signed as
required?

What Outputs come out of this


process?
What gets delivered to internal and
external customers
What current records and historical
evidence can you see to prove
effectiveness of the process?
Are records adequate per plan?
What procedures or work instructions
exist for this process?
Get copies of all appropriate
documentation and review.
Do the people clearly demonstrate
that they can do their jobs per the
documented procedures and work
instructions?

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.
2010 simpleQuE Inc. All Rights Reserved

PO Box 2580, Columbus, OH 43086


www.simpleque.com

614-794-7404

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
or Doc
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
8.4

Are there any negative trends or bad performance


against goals?

8.5

If yes, what is being done for continual


improvement?

Audit Notes of Objective Evidence

Finding
/ Opp.

1
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
or Doc
8.2
Are there any customer problems, scorecards,
7.2
negative feedback or high reject rates?

Audit Notes of Objective Evidence

Finding
/ Opp.

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?

2
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
or Doc
7.5
Get a copy of the work instructions for the
production process or part number being
observed and audited.

Audit Notes of Objective Evidence

Finding
/ Opp.

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?

3
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
or Doc
4.2
Are all necessary documents available in
production? Work order, checklists, visual cards,
routers, etc.

Audit Notes of Objective Evidence

Finding
/ Opp.

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.

4
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
or Doc
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?

Audit Notes of Objective Evidence

Finding
/ Opp.

5
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
or Doc
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?

Audit Notes of Objective Evidence

Finding
/ Opp.

6
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
or Doc
7.5
Evaluate preventive maintenance records for
the machines being observed or audited.

Audit Notes of Objective Evidence

Finding
/ Opp.

What preventive maintenance was supposed


to have been completed?

What preventive maintenance has been


completed?

4.2

Are preventive maintenance records complete?

7
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
or Doc
7.1
Are there any deviations or exceptions in the
8.3
production process?

Audit Notes of Objective Evidence

Finding
/ Opp.

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?

8
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
or Doc
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?

Audit Notes of Objective Evidence

Finding
/ Opp.

9
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
or Doc
8.1
Were there any targets for productivity and
8.2
effectiveness?
8.4
What is OEE versus the goal?

Audit Notes of Objective Evidence

Finding
/ Opp.

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
5.5

Are operators aware of bad performance or


negative trends?

8.5

Is anything being done to make improvements in


areas that arent performing as planned?

10
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
or Doc
6.1
Observe the work environment and
equipment.
Are there adequate resources (space,
equipment, and people) to do the job as
planned?

6.3
6.4

Audit Notes of Objective Evidence

Finding
/ Opp.

Is the work environment appropriate, clean


and safe?

11
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
or Doc

Audit Notes of Objective Evidence

Finding
/ Opp.

Add your own supplemental questions:

12
PO Box 2580, Columbus, OH 43086

614-794-7404

www.simpleque.com

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