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Key Process Audit Checklist

Record answers and notes on blank turtle diagrams or audit checklist or note page

What risks were identified to the process? Where are they found? How important are they? Are they listed? What was done to deal with the risks? (Action?) What records exist when actions are required, and how do we see actions were completed?

are required, and how do we see actions were completed? What machines, equipment, software, and materials

What machines, equipment, software, and materials are used to do this process? Are there adequate resources? Is the equipment maintained and supported? Are there gauges that require calibration?

Who is involved with this process? List auditees (Departments/functions) What training and skills are required? Any special skills, certifications or training needs? What records of training exist? Did people interviewed have records?

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?

effectiveness of the process? Are records adequate per plan? What procedures or work instructions exist for

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?

jobs per the documented procedures and work instructions? What Inputs are required to do this process?

What Inputs are required to do this process? Are these good and correct? What comes from internal and external customers? Any legal or regulatory requirements?

Are these good and correct? What comes from internal and external customers? Any legal or regulatory
Are these good and correct? What comes from internal and external customers? Any legal or regulatory
Are these good and correct? What comes from internal and external customers? Any legal or regulatory

What is the Process being audited? Observe all aspects of the process being done. Ask questions about how the process gets done by the

people doing the process. Who is the Process Owner? What role, responsibility and authority?

the process gets done by the people doing the process. Who is the Process Owner? What
the process gets done by the people doing the process. Who is the Process Owner? What
the Process Owner? What role, responsibility and authority? Collect documents looked at, it’s number and revision
the Process Owner? What role, responsibility and authority? Collect documents looked at, it’s number and revision

Collect documents looked at, it’s number and revision date. Verify against master documents.

Any obsolete documents in use?

Are all documents used for production controlled?

in use? Are all documents used for production controlled? What measurement or performance indicators exist? What

What measurement or performance indicators exist? What monitoring or measuring is there? How is the performance and trends? What goals are there? Any customer feedback? How effective is the process? Are employees and management aware of negative trends and is anything being done?

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 IATF 16949 clauses that affect this process? Make sure the audit checklist asks appropriate questions from the IATF clauses as they relate to the key process being audited.

the audit checklist asks appropriate questions from the IATF clauses as they relate to the key

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 IATF clause and requirements.

The Key Process Audit Checklist is not applicable for support and management processes.

IATF clause and requirements. • The Key Process Audit Checklist is not applicable for support and

Sample Internal Audit Checklist Using The Process Audit Approach For Production/Manufacturing

Process Audited: _Manufacturing Process

People Interviewed:

Date:

Location:

Clause

Question or Statement

Audit Notes of Objective Evidence

Finding

or Doc

\Opp

9.1

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.

   

9.1.1.1

P-F-D, PFMEA, Control Plan Measurement techniques Sampling plans Acceptance criteria Records of actual measurement values and /or test results Reaction plan and escalation process when acceptance criteria are not met

6.2.2.1

Are there any negative trends or bad performance against goals?

If yes, what is being done?

are not met 6.2.2.1 Are there any negative trends or bad performance against goals? If yes,

Sample Internal Audit Checklist Using The Process Audit Approach For Production/Manufacturing

Process Audited: _Manufacturing Process

People Interviewed:

Date:

Location:

Clause

Question or Statement

Audit Notes of Objective Evidence

Finding

or Doc

\Opp

9.1.2.1

Are there any customer problems, scorecards, 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?

   

Are personnel performing specific assigned

7.2.1

tasks qualified, as required with particular

&

attention to the satisfaction to the customer

7.3.1

requirements? Are appropriate employees aware of any recent customer problems?

Are special characteristics identified and cascaded throughout all documents -

8.3.3.3

drawings, FMEA, control plan, standard work instruction, router, traveler, etc. at the point of manufacture?

Are personnel aware of these special characteristics & know what they mean?

etc. at the point of manufacture? Are personnel aware of these special characteristics & know what

Sample Internal Audit Checklist Using The Process Audit Approach For Production/Manufacturing

Process Audited: _Manufacturing Process

People Interviewed:

Date:

Location:

Clause

Question or Statement

Audit Notes of Objective Evidence

Finding

or Doc

\Opp

8.5.1.2

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.

7.2

Has the operator been trained on the job you are

7.2.1

observing them perform? What records exist for

7.2.2

the training?

been trained on the job you are 7.2.1 observing them perform? What records exist for 7.2.2

Sample Internal Audit Checklist Using The Process Audit Approach For Production/Manufacturing

Process Audited: _Manufacturing Process

People Interviewed:

Date:

Location:

Clause

Question or Statement

Audit Notes of Objective Evidence

Finding

or Doc

\Opp

7.5

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?

7.5

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.

8.5.1.3

Verify job set-up i.e. 1 st pieces approval

completed? Evaluate records from multiple shifts. 8.5.1.3 Verify job set-up – i.e. 1 s t pieces

Sample Internal Audit Checklist Using The Process Audit Approach For Production/Manufacturing

Process Audited: _Manufacturing Process

People Interviewed:

Date:

Location:

Clause

Question or Statement

Audit Notes of Objective Evidence

Finding

or Doc

\Opp

8.5.2

Look at raw material being used. Is there adequate identification and traceability to a lot (if required)?

   

8.5.2

Is purchased part lot traceability information

8.5.2.1

being carried forward to production records?

8.7

Is any scrap properly handled and identified?

8.5.2.1 being carried forward to production records? 8.7 Is any scrap properly handled and identified?

Sample Internal Audit Checklist Using The Process Audit Approach For Production/Manufacturing

Process Audited: _Manufacturing Process

People Interviewed:

Date:

Location:

Clause

Question or Statement

Audit Notes of Objective Evidence

Finding

or Doc

\Opp

8.7.1.4

Are there any examples of nonconforming product or rework? Is this material properly identified?

   

Is the procedure for nonconforming or rework material being followed? Verify vs Control Plan

8.7.1.5

Is the procedure for repair material followed? Verify vs Control Plan

followed? Verify vs Control Plan 8.7.1.5 Is the procedure for repair material followed? Verify vs Control

Sample Internal Audit Checklist Using The Process Audit Approach For Production/Manufacturing

Process Audited: _Manufacturing Process

People Interviewed:

Date:

Location:

Clause

Question or Statement

Audit Notes of Objective Evidence

Finding

or Doc

\Opp

8.5.1.5

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?

Are preventive maintenance records complete?

Predictive maintenance? Review examples

8.5.1.6

Evaluate production tooling records for the equipment being observed or audited.

Review examples 8.5.1.6 Evaluate production tooling records for the equipment being observed or audited.

Sample Internal Audit Checklist Using The Process Audit Approach For Production/Manufacturing

Process Audited: _Manufacturing Process

People Interviewed:

Date:

Location:

Clause

Question or Statement

Audit Notes of Objective Evidence

Finding

or Doc

\Opp

8.5.6.1.1

Are there any deviations or exceptions in the production process?

   

Is the deviation process and procedure being followed?

8.7.1.1

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?

For

product

For product (8.7.1.1) and/ or for process (8.5.6.1) Is the customer involved and have they approved the deviation, if appropriate?

(8.7.1.1)

and/ or

for

 

process

(8.5.6.1)

and have they approved the deviation, if appropriate? (8.7.1.1) and/ or for   process (8.5.6.1)

Sample Internal Audit Checklist Using The Process Audit Approach For Production/Manufacturing

Process Audited: _Manufacturing Process

People Interviewed:

Date:

Location:

Clause

Question or Statement

Audit Notes of Objective Evidence

Finding

or Doc

\Opp

7.1.5.1

Record information from any measurement gauges or test equipment.

   

7.1.5.2

Check to see that gauge calibrations are up to date and that calibration records are maintained.

8.6

8.6.6

Are measurement records complete for any inspections that are supposed to be recorded? Verify vs control plan

8.7

Are any measurements out of spec? If yes, what was done? Is this per procedure? Verify vs Reaction plan in the Control Plan

any measurements out of spec? If yes, what was done? Is this per procedure? Verify vs

Sample Internal Audit Checklist Using The Process Audit Approach For Production/Manufacturing

Process Audited: _Manufacturing Process

People Interviewed:

Date:

Location:

Clause

Question or Statement

Audit Notes of Objective Evidence

Finding

or Doc

\Opp

9.1.3

Were there any targets for productivity and effectiveness?

   

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?

7.3.1

Are operators aware of bad performance or negative trends?

Is anything being done to make improvements in

9.1.3.1

areas that aren’t performing as planned?

trends? Is anything being done to make improvements in 9.1.3.1 areas that aren’t performing as planned?

Sample Internal Audit Checklist Using The Process Audit Approach For Production/Manufacturing

Process Audited: _Manufacturing Process

People Interviewed:

Date:

Location:

Clause

Question or Statement

Audit Notes of Objective Evidence

Finding

or Doc

\Opp

7.1.4

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

   

7.1.4

Is the work environment appropriate, clean and

&

safe?

7.1.4.1

job as planned?     7.1.4 Is the work environment appropriate, clean and & safe? 7.1.4.1

Sample Internal Audit Checklist Using The Process Audit Approach For Production/Manufacturing

Process Audited: _Manufacturing Process

People Interviewed:

Date:

Location:

Clause

Question or Statement

Audit Notes of Objective Evidence

Finding

or Doc

\Opp

 

Add your own supplemental questions:

   
Notes of Objective Evidence Finding or Doc \Opp   Add your own supplemental questions: