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ISO/TS 16949
Process Approach Internal Auditing
Introduction to Auditing
Systematic,
independent and
documented process
for obtaining audit
evidence and
evaluating it
objectively to
determine the
extent to which
audit criteria are
fulfilled
Source: ISO 9000: 2000
Neville-Clarke International Ltd, 2003
Slide No 0:12 QMS X Issue 1.0/03
8.2.2 Internal Audit
Planned intervals; annual plan
Audit criteria, scope, frequency and
methods shall be defined
Auditors shall not audit their own work
Documented procedure
Action are taken without undue delay
Follow up on action taken and record results
Cover all shifts
Internal auditor qualifications
Certification
3rd Party
Body
Audit Overview
Contact auditee
Review document
Prepare Checklist
Neville-Clarke International Ltd, 2003
Slide No 0:26 QMS X Issue 1.0/03
Conducting the audit
2
Closing Meeting
Corrective Action
(performed by auditee)
Close case
Neville-Clarke International Ltd, 2003
Slide No 0:29 QMS X Issue 1.0/03
What auditors need to know
Auditors for ISO/TS 16949 are
required to demonstrate
competence for:
o ISO/TS 16949 Technical Specification
o Audit methodology:
conducting opening meeting,
writing nonconformances
Conducting closing meeting
how to close out nonconformances
o Automotive process approach to audit
o Core tools (APQP, FMEA, SPC, MSA,
PPAP)
o Customer-specific requirements
Neville-Clarke International Ltd, 2003
Slide No 0:30 QMS X Issue 1.0/03
Session 4
Customer Customer
s(and Management s (and
other responsibility other
Interested Interested
Parties) Parties)
Resource Measurement , Customer
management analysis ,
Satisfaction
improvement
A sequence of processes
Each process step adds value to the step before till the output
Neville-Clarke International Ltd, 2003
Slide No 0:36 QMS X Issue 1.0/03
What is Process Approach?
For an organization, there may be
numerous inter-linked processes.
The systematic identification and
management of the various processes
and the interactions between such
processes may be referred to as
process approach to management.
Customer Prototype
Customer Spec. Test request Prototype
Result
Customer Customer
Oriented Warranty Feedback
Processes
process
Effectiveness
Conformance
Audit Planning
Contact auditee
Review document
Prepare Checklist
Neville-Clarke International Ltd, 2003
Slide No 0:61 QMS X Issue 1.0/03
Appoint Audit Team
Independent of audit
area
Auditors must be
trained
Has good sense of
judgement
Works effectively /
efficiently
Reports findings clearly
Can communicate at all
levels of Organisation
Is objective and ethical
Definition of Terms
Shall - mandatory requirement
Notes - for guidance in understanding or clarifying
the associated requirement
should in a Note is for recommendation only
such as - suggestions given are for guidance only
Conducting Audit
Observe Check
(See what they actually do) (What the procedure says they should do)
Contract
7.2 Review
6.0
7.3 7.3
APQP APQP APQP APQP
PAP
Phase 1 Phase 2 Phase 3 Phase 4
Product Process
Planning Validation
Development Development
7.3 7.5.2 APQP
7.2 7.1 Phase 5
FMEA MSA SPC Mass
Production
7.5 8.0
Neville-Clarke International Ltd, 2003
Slide No 0:84 QMS X Issue 1.0/03
How to Audit Core tools?
Select a few products as audit
samples
Use the products to run though each
phase of APQP (process approach)
Ask for the relevant documents/
records to justify if the activities in
each phase of APQP are executed to
meet customer needs.
Audit Criteria
Audit Evidence
Audit Finding
Reporting Audit
Auditor review
meeting
Closing Meeting
Opportunity
Conclusion NonConformit For
y Statement Improvemen
(NCR) t
(OFI)
Post-audit Actions
Corrective Action
(performed by auditee)
Close case
Neville-Clarke International Ltd, 2003
Slide No 0:113 QMS X Issue 1.0/03
Follow-up Action
Report circulated
Audit programme
updated
Checklists filed
Corrective action
performed
Trends fed into
management review
Corrective action
verified