Guide to Internal

Auditing

IATF 16949:2016
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Introduction: Why are you here?

• To learn more about IATF 16949.

• To be able to evaluate your own area and
make improvements.
• To understand the audit process.
• To be able to participate in the audit process.

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Why participate in internal audits?
• The internal audit program is the most
powerful tool available for building,
maintaining and improving your quality
system.
• You can be a part of it.

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Reactions of auditors after
their first audit
• “Its great to see other parts of the system, I
had no idea there was so much to it.”

• “I thought I would hate this but I really liked

getting to see what other people are doing.
I learned a lot about the rest of the
company.”

• “I have to go change a few things in my area

now.”
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A Guide to Internal Auditing

• Types of Audits.
• Why Audit?
• Who Can Audit?
• Performing an Internal Audit
– Planning
– Opening Meeting
– Techniques
– Tools
– Closing Meeting

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Types of Audits

There are three kinds of audits that can be

conducted in your organization:
1. First party audit or an Internal audit that is the
topic of this presentation.
2. Second party audit, carried out by a customer or
a customer’s representative, usually to ensure that
you comply with contractual requirements.
3. Third party audit, carried out by a Registrar,
usually to certify that your quality management
system is in compliance to IATF 16949.
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Why Audit?

Why are internal audits so important?

•Sometimes a QMS slips over time and needs to be
checked/audited to be sure that everyone is
following the procedures and instructions.
•Conditions can change and the auditors will identify
departures from the planned arrangements that may
in fact be improvements over the existing methods.
•Improvements can be identified and related
procedures or instructions upgraded, accepted and
approved by the responsible parties.
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Why Audit?

ISO Standards follow Plan-Do-Check-Act:

• Plan - Establish the objectives and processes
needed to deliver the QMS results.
• Do - Implement the QMS processes.
• Check - Check the processes against the policy,
objectives, targets, regulations, and report on the
results. (Auditing)
• Act - Take actions to improve the QMS.

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Why Audit?

The Internal Audit process is one of the most important

Requirements in an ISO-Based standard.
ISO Standards require that audit procedures be
established, implemented, and maintained.
• IATF 16949:2016 Par. 9.2
• ISO 9001:2015 Par. 9.2
• AS 9100 Rev D Par. 9.2
• ISO 13485:2016 Par. 8.2.4
Failure to perform Internal audits becomes a
significant “Road-Block to Registration”. 9
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Why Audit?

Internal auditing is one of the most challenging

requirements of IATF 16949:2016.

Audit are necessary and need to be done to take

advantage of the possible benefits.

.. Audits are the Key to Improvement ..

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Why Audit?

Internal auditing is one of the most challenging

requirements of IATF 16949.

IATF 16949 further designates internal audits as:

•Quality Management System Audit

•Manufacturing Process Audit
•Product Audit

.. In all cases -- Audits are the Key to Improvement ..

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Why Audit?

Quality Management System Audit.

•QMS processes are required to be audited over each 3-

year calendar period, using the process approach to verify
compliance with the IATF QMS Standard.

•Integrated with the audits, customer-specific QMS

requirements are sampled for effective implementation.

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Why Audit?

Manufacturing Process Audit.

•The processes are audited over each 3-year period for
effectiveness and efficiency using customer-specific
required approaches for audits.
•When not defined by the customer, the approach to be
used is determined by your company.
•Within the audit plan, each manufacturing process is
audited on all shifts, and includes sampling of the shift
handover.
•The audit includes an audit of the implementation of the
process risk analysis such as PFMEA, control plan, and
associated documents. 13
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Why Audit?

Product Audit.

•Product audits are required to be conducted using

customer-specific required approaches at appropriate
stages of production and delivery to verify conformity to
specified requirements.

•When not defined by the customer, your company

defines the approach to be used.

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Who Can Audit?

• Auditors typically represent the people employed by the

organization and must be objective and dedicated to
this important task.
• The standard, at par 9.2 c requires that “selection of
auditors shall ensure objectivity and impartiality of
the audit process” ~or~ Auditors cannot audit their
own work.
• There are important techniques that they must be aware
of when they prepare for and perform the audits.
• Internal auditors must become familiar with the auditing
process.
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Performing an Internal Audit
»Overview
Internal Auditor training covers:
•The purpose and scope for auditing the QMS to the International
Standard.
•The requirements for planning and scheduling internal audits.
•The practices followed during the internal audit including opening and
closing meetings.
•How to conduct the process based audit while considering.
-What are the processes and What to audit.
-How to use audit trails and How to establish linkages.
•How to interview and what to look for when asking questions.
•Reporting on the internal audit and follow-up activities.
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Performing an Internal Audit
»Overview (Cont’d)
An internal audit on your complete QMS is required
before the registration audit is conducted and it is
done to:

1. Help train employees in the requirements of the

QMS.
2. Ensure that the activities required by the QMS are
implemented and are effective.
3. Demonstrate the requirements for internal auditing is
being implemented.
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Performing an Internal Audit
» Planning
Planning for internal audits is very important.

Top management in organizations usually prepare an

annual internal audit schedule during the Management
Review.

The schedule is the authority for the internal audit team to

plan their work and perform the audits as planned.
We will prepare a flow chart of the internal audit process.
.. on the next slides ..

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Performing an Internal Audit
» Planning (Cont’d)
Annual Annual schedule approved by top management.
schedule

Audit Plan Prepare questions for the activities to be audited. Obtain

relevant documents to be used.

Notify
auditee Agree to an itinerary that meets the needs of the auditee and
the auditor.
Meeting with
Opening meeting with auditee representatives to set the
auditee
stage for the audit.
Conduct Collect evidence and answers to questions or checklist items.
The Audit

Review Ensure audit evidence is correct. Discuss the non conformances

findings found with auditee to eliminate misunderstandings.

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Performing an Internal Audit
» Planning (Cont’d)
Flow chart cont’d

Closing Discuss audit findings and establish a plan

meeting to correct the observed non conformances.

Prepare NCRs -
Corrective Summarize audit findings, make audit records
Audit report
action reports and describe the non conformances in
as needed corrective-preventive action reports.

Audit
Verify the completion and effectiveness of
follow-up
action taken as a result of audit findings.

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Performing an Internal Audit
»Techniques
More about audits and auditing techniques.
•Auditees must be made comfortable during interviews and
there are techniques that are used by auditors to make it
easier.
•Experienced auditors learn to read body language and
other non verbal clues.
•The auditor will question the auditee, listen to the
answers, and anticipate the answer to the question.
•It is necessary to listen critically, analyze the answer,
record the information and at the same time prepare the
next question. 21
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Performing an Internal Audit
»Techniques (Cont’d)
The tools used are:
Questioning, Observing, Listening

•Care should be taken when collecting evidence to ensure

that questions are non-threatening and designed to elicit
accurate responses.

•It may be necessary to ask the same question with more

than one interviewee, to calm auditees who may feel
defensive during an interview, and to uncover underlying
objective facts to support statements made during
interviews.
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Performing an Internal Audit
»Techniques (Cont’d)
What sort of questions are asked?

There are two types of audit questioning:

1. System audits where the auditor confirms that the
procedures and instructions are understood and
implemented.
2. Process-based audits where the auditor follows
processes from the beginning to the end and considers
the output of a process as the input for a next process
to confirm that all requirements and records are in
place.
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Performing an Internal Audit
»Tools
What are typical questions of an audit?

Requirement Status Observations or comments

Is the quality policy posted and understood Okay Policy posted on bulletin board.
by employees? Paraphrased by Pat Martin

Do employees have the quality documents
they need for their jobs?
List the names of employees and what
documents they use.
Okay Procedure for document control
found on work station in mixing
area.
Joe Smith, Mary Perkins use the
latest versions of documents

Confirm employees are qualified for the job Okay Workers are well organized and
they do. know what to do.
Check personnel records. Personnel department have all
records

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Performing an Internal Audit
»Closing Meeting
Welcome to the closing meeting.
The audit team have completed their review of the audit
findings and have prepared Corrective-Preventive Action
reports (aka NCRs).

Internal audits are usually less formal during the closing

meeting than registration audits.

The meeting attendees should concur with the audit

findings and set a date for corrective action.

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Performing an Internal Audit
»Closing Meeting
Welcome to the closing meeting.
•Disagreements with audit findings can be discussed.
•However, audit findings are supported with documented
evidence, so there is not too much room for disagreement.
•Internal auditors are not required to provide or approve
what corrective actions are indicated for each observation.
•The auditors will plan to follow up on the observations
after the agreed date and when the correction taken is
acceptable, will close out the report.

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Internal Audits: Conclusion

The Internal Audit process is one of the most

important in IATF 16949 or any ISO based standard.
Conduct internal audits to determine if the QMS:
• Conforms to planned arrangements for quality
management .. this includes both the
requirements of the ISO standard and your own
operational requirements.
• Has been properly implemented and is
maintained.
• Provide information on results of audits to the
management group. 27
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Internal Audits: Next Steps

The Internal Audit process is one of the most

important in IATF 16949 or any ISO based standard.

With this brief presentation we have introduced the

internal auditor training.
Additional information will follow and training details
outlined in PPT-Section 5 – Conduction the audit with
follow up & corrective action.
Visit the 16949Store.com for information on training
and other implementation products.
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Questions?

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