The Process Approach to Internal Auditing

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The Process Approach to Internal Auditing
WHO! WHEN! HOW!
April 1, 2009
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GOALS 1. To standardize the process of
completing Internal Audits within the
organization. 2. To verify that personnel are
complying to Company ISO / TS Quality
requirements. 3. To identify non value
activities ( wastes) within a process for
reduction or removal to improve the overall
effectiveness
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The Audit Schedule All System Processes
relating to the Core Processes will be audited
annually. Mfg Audits will be audited monthly,
covering all operating shifts.
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WHO Qualified Internal auditors will audit
internally thru the calendar year as per the
audit schedule.
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• To be a Qualified Internal Auditor, you must have
  
• External Certified ISO / TS Internal Auditing
  Training or Internal Training

THE Training Matrix identifies Qualified Internal
Auditors
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• Qualifying a New Internal Auditor
• Review the ISO and TS Awareness Power Point
  presentations to get an understanding of the
  ISO/TS Quality System principles.
• Complete a Test - gt80 passing Grade
• Assist with 2 Audits with a qualified auditor.
• Complete an Internal Audit while being reviewed
  by a Qualified Auditor.
• Qualified Auditor will approve certification of
  new auditor.
• A certificate is issued to new qualified
  internal auditors

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The Process Approach
When taking the process approach, youre not just
verifying that all the steps of the process are
being followed. You are looking at the complete
process for effectiveness efficiency. Verify
the process recognizes the inputs ( Materials
Manpower Equipment Supplies other processes )
and outputs ( the intent of the process ).
Verify the process and/or owner is aware of the
company objectives with targeted goals and that
the process is maintaining these targets. If the
objectives are below target, actions should
documented or a recovery plan to meet these
objective targets.
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The Process Approach
Evaluating the process for effectiveness and
efficiency with recommendations on how to
improve. Looking to identify the non value
activities that may be eliminated or reduced.
Focus on the value, what the Customer pays
for. Identify current concerns, are they being
addressed. Is they Process being monitored
and/or measured? Are there objectives goals ?
Does the process meet those goals? Challenge
the Process - Look for factual evidence that the
process works, is effective. Follow the process
to identify areas for improvement.
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The Process Approach
Verify the process outputs interact with another
processes inputs. Communication a key metric
to an effective process. Verify that personnel
are aware of their responsibilities and their
tasks are being completed. Interviewing
personnel associated with the process to get
their input on how to improve the process.
Process knowledge and how personnel responsible
may affect the outcome ( outputs ) of this
process.
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• AUDIT PREPERATION
• Contact the Process Owner to schedule the audit.
• Make a copy of the process Control Plan or Work
  Instructions to reference during the audit
• Print a copy of the appropriate checklist

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• AUDIT PREPERATION
• Review the Process to identify the requirements
• List the evidence you will be reviewing

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DURING THE AUDIT Use the Checklist as a reminder
to what questions need to be asked? We have 2
checklists 1 for auditing the Mfg Processes 1
for auditing the System Processes
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DURING THE AUDIT 1. Write on the checklist or
on the documented Process or Control Plan the
evidence you have reviewed. Focus on looking
for non compliance concerns or opportunities for
improvement
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• DURING THE AUDIT
• Focus on
• Non value activities
• The 8 Wastes

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AFTER THE AUDIT Submit all audit documentation
to the Corrective Action Team
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AFTER THE AUDIT The CA Team will schedule a
meeting to review the completed audit with the
auditor auditee(s) The audit report will be
created for management to review
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AFTER THE AUDIT The CA Team will identify
concerns or OFIs ( Opportunities for
Improvement ) that require corrective action
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The CA Team, along with the audiles will discuss
the Concerns OFIs The CA Team will support
with identifying root cause corrective action
preventive action implementation target dates (
ECD)
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Documenting concerns on a Internal Audit
Log Documenting a concern or OFI, along with
root cause analysis corrective action
preventative action ECD
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CARs will be created and issued to the
responsible personnel. This form will reference
the concerns and actions that are required to be
taken
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For concerns requiring Corrective Action ( CAR )
, a sequenced control number will be issued for
traceability
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Multiple CARs or OFIs to be issued to the same
responsible person from the audit will be
documented on the one form. 3 Concerns noted on
this report
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Once the corrective action has been implemented,
a member of the CA Team will verify. Verifying
documents that were revised along with the
improvements made to the processes Once verified
to be implemented and effective, the CAR will be
closed.
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The Internal Audit Log is a live document that is
continually revised
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The Audit Log will be issued monthly for
Management to review
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Record Retention
Internal Audit documentation
shall be retained
For 3 Years