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ISO/TS 16949 Process Approach Internal Auditing

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ISO/TS 16949 Process Approach Internal Auditing © Copyright Neville-Clarke International Ltd, 2003

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Course Content • Session 1 ISO/TS 16949 Background • Session 2 Introduction to Auditing •
Course Content
• Session 1
ISO/TS 16949 Background
• Session 2
Introduction to Auditing
• Session 3
Audit Overview
• Session 4
Automotive Process Approach
• Session 5
Audit Planning
• Session 6
Conduct Audit
• Session 7
Reporting Audit
• Session 8
Post-audit Actions
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Course Objectives To provide delegates with a good understanding of: • Process-approach auditing • Audit
Course Objectives
To provide delegates with a good
understanding of:
• Process-approach auditing
• Audit skills and technique
• Planning, conducting and reporting on
an internal audit performed against
the requirements of ISO/TS 16949.
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Session 1

ISO/TS 16949 BACKGROUND

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What is ISO/TS 16949? • Harmonization of automotive industry requirements. • Developed by Automotive Task
What is ISO/TS 16949?
• Harmonization of automotive industry
requirements.
• Developed by Automotive Task Force(IATF)
and Japan Automobile Manufacturer
Association (JAMA), supported by ISO/TC
176
• Established based on major industry
standard
o ISO 9001:2000
o AVSQ (Italian), EAQF (French), QS-9000 (U.S.)
and VDA6.1 (German) automotive catalogs
• Recognized by major European, American
and Japanese automotive manufacturer.
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Copyright of the Technical Specification is held by ANFIA, CCFA/FIEV, SMMT, VDA and Daimler Chrysler, Ford Motor and General Motor.

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Goal of ISO/TS 16949 • Continual improvement • emphasis on defect prevention • Reduction of
Goal of ISO/TS 16949
• Continual improvement
• emphasis on defect prevention
• Reduction of variation and waste in
supply chain
Intention of ISO/TS 16949
• To avoid multiple certification
• To provide a common approach to
QMS in Automotive industry
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Why Do We Need ISO/TS 16949? • New market opportunities o AFTA o Global sourcing
Why Do We Need
ISO/TS 16949?
• New market opportunities
o
AFTA
o
Global sourcing trend
• International Recognition
o
Wider recognition, including Big 3, Major
European and Japanese automotive industry
o
Independent third party registration for
assessment and certification serves as good
evidence of company capability
• Customer pressure/ demand
• Discontinuance of QS-9000
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Scope of ISO/TS 16949 Flexibility: ISO/TS 16949 becomes the common platform, other customer imposed requirements
Scope of ISO/TS 16949
Flexibility:
ISO/TS 16949 becomes the common platform,
other customer imposed requirements are easily
added on.
Customer
Customer specific
imposed
requirements
Additional
requirements
ISO/TS16949
ISO 9001:2000
Coupled with
customer-specific
requirements
defines quality
system
requirements for
use in the
automotive supply
chain
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ISO/TS 16949 Vs Other Automotive Requirements ISO/TS 16949 QS-9000/ VDA 6.1/ AVSQ/ EAQF • International
ISO/TS 16949 Vs Other
Automotive Requirements
ISO/TS 16949
QS-9000/ VDA 6.1/
AVSQ/ EAQF
• International initiative
• Recognized by major
automotive manufacturer
• Regional/country
initiative
• single certification
• Only recognized by the
specific customer
• A common platform to
build QMS; can have
customer-specific
requirements as add-on
to the QMS.
• require multiple
certification if supply to
more than one customer
• Not flexible, as it is a
customer-specific
requirement.
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Session 2

Introduction to Auditing

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What is Audit? • A ‘check and balance’ process to ensure activities are performed in
What is Audit?
• A ‘check and balance’ process to
ensure activities are performed
in an appropriate manner.
• Usually conducted on an
independent basis.
• Objective evidence is required.
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Formal definition of Audit • ‘Systematic, independent and documented process for obtaining audit evidence and
Formal definition of Audit
• ‘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
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8.2.2 Internal Audit • Planned intervals; annual plan • Audit criteria, scope, frequency and methods
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
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8.2.2 Internal audit

The organization shall conduct internal audits at planned intervals to determine whether the quality management system

a) conforms to the planned arrangements (see 7.1), to the requirements of this International

Standard and to the quality management system requirements established by the

organization, and

b) is effectively implemented and maintained.

An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.

The responsibilities and requirements for planning and conducting audits, and for reporting results and

maintaining records (see 4.2.4) shall be defined in a documented procedure.

The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities shall include the verification of the actions taken and the reporting of verification results (see 8.5.2).

NOTE

See ISO 10011-1, ISO 10011-2 and ISO 10011-3 for guidance.

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Types of audit • 8.2.2.1 Quality management system audit The organization shall audit its quality
Types of audit
• 8.2.2.1 Quality management system audit
The organization shall audit its quality management
system to verify compliance with this Technical
Specification and any additional quality management
system requirements.
• 8.2.2.2 Manufacturing process audit
The organization shall audit each manufacturing process
to determine its effectiveness.
• 8.2.2.3 Product audit
The organization shall audit products at appropriate
stages of production and delivery to verify conformity to
all specified requirements, such as product dimensions,
functionality, packaging and labeling, at a defined
frequency.
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International Ltd, 2003 Slide No 0:14 QMS X Issue 1.0/03 There are many approaches to analyse

There are many approaches to analyse quality management system, product quality and process performance. In the context of the internal audit clause, internal audit for the organization should be independent of those having direct responsibility for the work performed. Personnel should not audit their own work.

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Purpose of Conducting Audit • Looking at the overall process • Auditing for conformity •
Purpose of Conducting Audit
• Looking at the overall
process
• Auditing for conformity
• Auditing for
effectiveness
• Approving Suppliers/
Subcontractors
• Assessing for
Certification
• Investigating problems
• Way of improving
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Key principles of auditing • Ethical conduct • Fair presentation • Due professional care •
Key principles of auditing
• Ethical conduct
• Fair presentation
• Due professional
care
• independence
• Evidence-based
approach
o Source: ISO 19011
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Common Internal Audit Failure • Perceive audit as waste of time. • Over-reliance on Quality
Common Internal Audit
Failure
• Perceive audit as
waste of time.
• Over-reliance on
Quality department
• Lackluster auditor
selection process
• Lack of proper
system to train
auditors
• Poor auditor
judgment leads to
lack of confidence
in internal audit
result.
• Inadequate process
to evaluate ability
to perform audit.
• See auditor as
fault-finder or
trouble-maker
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Audit Types 1st1st PartyParty YourYour Your ownown own OrganisationOrganisation Organisation 3rd3rd PartyParty
Audit Types
1st1st PartyParty
YourYour Your ownown own
OrganisationOrganisation Organisation
3rd3rd PartyParty
SubcontractorSubcontractor Subcontractor
2nd2nd PartyParty
oror or SupplierSupplier Supplier
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Adequacy Audit • Document Vs Standard • Look for quality management system document adequacy •
Adequacy Audit
• Document Vs
Standard
• Look for quality
management
system document
adequacy
• Also known as
Document Audit
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Compliance Audit • Practice Vs Standard • Find things on the ground/ in the field
Compliance Audit
• Practice Vs
Standard
• Find things on the
ground/ in the field
• Interview staff
doing the job
• Take samples
• Look at results of
activity
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Audit Terminology • Auditee • Audit programme • Auditor • Audit plan • Audit Team
Audit Terminology
• Auditee
• Audit programme
• Auditor
• Audit plan
• Audit Team
• audit scope
• Audit Criteria
• Audit Evidence
• Audit Findings
• Audit Conclusion
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Session 3

Audit Overview

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Typical Internal Audit Cycle 1 Planning The Audit 2 Conducting The Audit 3 Reporting The
Typical Internal Audit Cycle
1 Planning The Audit
2 Conducting The Audit
3 Reporting The Audit
4 Corrective Action & Follow up
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Planning the audit 1 Appoint audit team Define audit objective, scope and criteria Contact auditee
Planning the audit
1
Appoint audit team
Define audit objective, scope and criteria
Contact auditee
Review document
Prepare audit plan
Prepare Checklist
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Conducting the audit 2 Conduct Opening meeting Collecting & verify audit evidence Evaluate audit evidence
Conducting the audit
2
Conduct Opening meeting
Collecting & verify
audit evidence
Evaluate audit evidence
against audit criteria
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Reporting the audit 3 Auditor review meeting Review audit finding with auditee Conclusion & Report
Reporting the audit
3
Auditor review meeting
Review audit finding with auditee
Conclusion & Report Writing
Closing Meeting
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Corrective Action & Follow-up 4 Circulate Audit Report Update Audit Schedule Corrective Action (performed by
Corrective Action & Follow-up
4
Circulate Audit Report
Update Audit Schedule
Corrective Action
(performed by auditee)
Verify completed actions
Close case
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What auditors need to know • Auditors for ISO/TS 16949 are required to demonstrate competence
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
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Session 4

Automotive Process Approach

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Key Focus of ISO/TS 16949 Audit • Customer-specific requirements • Customer satisfaction • Efficient handling
Key Focus of ISO/TS 16949
Audit
• Customer-specific
requirements
• Customer
satisfaction
• Efficient handling of
customer-oriented
processes
• Operational
performance
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Less focus on paper work • 7 areas require documented procedures • Flexibility allowed for
Less focus on paper work
• 7 areas require
documented
procedures
• Flexibility allowed for
other areas.
• Shift of focus from
documentation to
results of processes.
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Model of Process Based QMS CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM CustomersCustomers
Model of Process Based QMS
CONTINUAL IMPROVEMENT OF THE
QUALITY MANAGEMENT SYSTEM
CustomersCustomers
CustomersCustomers
(and(and otherother
(and(and otherother
ManagementManagement
InterestedInterested
InterestedInterested
responsibilityresponsibility
Parties)Parties)
Parties)Parties)
ResourceResource
MeasurementMeasurement ,
CustomerCustomer
analysisanalysis
managementmanagement
,
SatisfactionSatisfaction
improvementimprovement
Input
ProductProduct
Output
CustomerCustomer
Product
realizationrealization
RequirementsRequirements
KeyKey Value adding activities
Information flow
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What is a Process? “Set of interrelated or interacting activities which transforms inputs into outputs.”
What is a Process?
“Set of interrelated or interacting
activities which transforms inputs
into outputs.”
ISO 9000, 3.4.1
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Model of a process PROCESSPROCESS Output of a process can be input to the next
Model of a process
PROCESSPROCESS
Output of a process can
be input to the next
process
INPUT
TRANSFORMATION
OUTPUT
A sequence of processes
Each process step adds value to the step before till the output
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What is Process Approach? • For an organization, there may be numerous inter-linked processes. •
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.
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Functional Vs Process Approach Customer Customer Functional Thinking Process Thinking Priority: to meet functional
Functional Vs Process
Approach
Customer
Customer
Functional Thinking
Process Thinking
Priority: to meet
functional objective
Priority: To meet
customer needs
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Customer Oriented Process • COPs are processes which start with the customer input and results
Customer Oriented Process
• COPs are processes
which start with the
customer input and
results in outputs
delivered to the
customer
• COPs are primary
processes which
interact with the
customer.
Customer
I
O
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Multiple COPs in an Organization Customer I O I O I O I O I
Multiple COPs in an
Organization
Customer
I
O
I
O
I
O
I
O
I
O
Interaction
with
customer
OrganizationOrganization Organization
Interaction of one COP with
another
• Within an organization, there are many
COPs
• Each COP interfaces with the customer
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COP Examples Request Formal Order for Quotation Order accepted Customer quotation Order Bid/ processing
COP Examples
Request
Formal
Order
for
Quotation
Order
accepted
Customer
quotation
Order
Bid/
processing
quotation
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COP Examples Customer Prototype Spec. Test request Prototype Customer Result Product Product Validation
COP Examples
Customer
Prototype
Spec.
Test
request
Prototype
Customer
Result
Product
Product
Validation
Development
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COP Examples Warranty Warranty Action Corrective, Claim accepted Request preventive Customer actions Customer
COP Examples
Warranty
Warranty
Action
Corrective,
Claim
accepted
Request
preventive
Customer
actions
Customer
Warranty
Feedback
process
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Focus on process links • How each organization perceive a process is unique and always
Focus on process links
• How each organization perceive a
process is unique and always different.
• DO NOT ‘nit-pick’ on process category.
Emphasize on the linkage of the
processes! DO NOT spend time
arguing how the process should be
categorized!
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Auditors Perspective • Each COP in detail is complex and involve many sub-processes performed by
Auditors Perspective
• Each COP in detail is complex and involve
many sub-processes performed by various
functions of the organization.
• Some of these sub-processes do NOT have
direct interface with customers.
• Depending on the nature and organization
perspective, these processes can be
classified as support and management
process.
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How COPs Are Described • Description of the COP can be found through documentation which
How COPs Are Described
• Description of the COP can be found
through documentation which tell ‘who
does what, when and where’:
o by graphics, e.g. flow charts
o by text, e.g. procedures
It does NOT matter how it is described!
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Exercise 1 Identifying COP © Neville-Clarke International Ltd, 2003 Slide No 0:45 QMS X Issue
Exercise 1
Identifying
COP
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What To Look For? • 3 aspects Improvement Effectiveness Conformance © Neville-Clarke International Ltd, 2003
What To Look For?
• 3 aspects
Improvement
Effectiveness
Conformance
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Conformance What should be done What is actually done • Conformance is the basic principle.
Conformance
What should
be done
What is
actually done
• Conformance is the basic principle.
• Compare the actual activity against
the audit criteria
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How To Determine Effectiveness • How do we know if a process is effective? o
How To Determine
Effectiveness
• How do we know if a process is
effective?
o
Ability to maintain ‘mountains’ of
documentation?
o
Able to follow procedures strictly?
o
Ability to produce results?
o
Look at inputs or outputs?
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Effectiveness of process • Effectiveness of a process is shown by the result it achieved
Effectiveness of process
• Effectiveness of a
process is shown by
the result it achieved
with the delivered
output. Hence, auditors
shall look at indicators/
measurable metrics to
tell is customer
requirements are met.
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Examples of common metrics Process metrics Delivery On Time Delivery -OTD Production Yield, utilization, cycle
Examples of common metrics
Process
metrics
Delivery
On Time Delivery -OTD
Production
Yield, utilization, cycle
time, Cpk, ppm
Inspection/ test
defect rate, pass ratio
Planning
Delay, progress vs
plan
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Improvement • Look for trends • Compare current results against past results © Neville-Clarke International
Improvement
• Look for trends
• Compare current
results against past
results
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Process Analysis • Every process has these characteristics: o Process owner(s) o Process is defined
Process Analysis
• Every process has these characteristics:
o
Process owner(s)
o
Process is defined and if appropriate,
documented
o
Process linkages/ interface of the processes
are established
o
is monitored to tell the performance and is
improved if needed
o
has records to show as evidence
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Audit by process approach How?How? (method,(method, technique)technique) WithWith Who?Who? (skill,(skill,
Audit by process approach
How?How?
(method,(method, technique)technique)
WithWith Who?Who?
(skill,(skill, training)training)
INPUT
ProcessProcess Process
OUTPUT
WhatWhat keykey criteria?criteria?
(measurement,(measurement, assessment)assessment)
WithWith What?What?
(equipment,(equipment, material)material)
Other than input, output, auditor should look at ‘who does
what’, ‘with what’, ‘how it is done’ and ‘key criteria measured’
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Audit by Process Approach A process in sequence: When auditing, look at the process from
Audit by Process Approach
A process in sequence:
When auditing, look at the process from various
angle
An output of previous process becomes the
input to the next process. Processes are inter-
link!
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Question Auditors Should Ask • Who is the process owner? • What is the purpose
Question Auditors
Should Ask
• Who is the process owner?
• What is the purpose of your process?
• What are the inputs to your process?
• What are your process outputs?
• What type of process are you working on?
• What are the important process parameters?
• What do you measure about your process?
• What do you do with these measurements?
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Summary Points • Automotive process approach audit MUST NOT be driven by a ‘clause’ or
Summary Points
• Automotive process approach audit MUST
NOT be driven by a ‘clause’ or an ’element’
driven checklist
• Purpose of checklist: an audit tool to verify
the completeness of the audit
• Audit should cover all applicable
requirements to a Customer Oriented
Process (COP) with linkages to Management
Oriented Process (MOP) & Support Oriented
Process (SOP).
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Exercise 2 Understanding Process Base Approach Auditing © Neville-Clarke International Ltd, 2003 Slide No 0:57
Exercise 2
Understanding
Process Base
Approach
Auditing
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Session 5

Audit Planning

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Planning the audit 1 Appoint audit team Define audit objective, scope and criteria Contact auditee
Planning the audit
1
Appoint audit team
Define audit objective, scope and criteria
Contact auditee
Review document
Prepare audit plan
Prepare Checklist
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Appoint Audit Team • Independent of audit area • Auditors must be trained • Has
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
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The organization should define the minimum qualification requirements for personnel responsible for

Delegate Notes

performance of internal audits, taking into account any customer-specific requirements.

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Determine Audit Objective • To investigate quality issue • To assess readiness for external audit
Determine Audit Objective
• To investigate quality issue
• To assess readiness for
external audit
• Routine ‘balance and check’
• To identify improvement
• To evaluate capability to
meet statutory, regulatory,
contractual requirements
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Audit Criteria • ISO/TS 16949 • Customer Specific requirements • Company documented Quality Management System
Audit Criteria
• ISO/TS 16949
• Customer Specific
requirements
• Company
documented Quality
Management
System
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ISO/TS 16949 Requirements • Resource management 6 • 0 Introduction 6.1 Provisions of resources •
ISO/TS 16949 Requirements
• Resource management
6
• 0
Introduction
6.1
Provisions of resources
• 1
Scope
6.2
Human Resources
• Normative reference
2
6.3
Infrastructure
• Terms and definitions
3
6.4
Work Environment
• Quality Management
System
4
• 7 Product Realization
7.1 Planning of product realization
4.1 General requirements
7.2 Customer related processes
4.2 Documentation
Requirements
7.3 Design & Development
7.4 Purchasing
• Management Responsibility
5
7.5 Production & Service provision
5.1 Management Commitment
7.6 Control of Monitoring &
Measuring devices
5.2 Customer focus
5.3 Quality Policy
• 8 Measurement, Analysis and
Improvement
5.4
Planning
8.1 General
5.5
Responsibility & Authority and
Communication
8.2 Monitoring & Measurement
• Management Review
5.6
8.3 Control of Nonconforming
Product
8.4 Analysis of Data
8.5 Improvement
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Terminology • Definition of Terms ‘Shall’ - mandatory requirement ‘Notes’ - for guidance in understanding
Terminology
• 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
Contents Page - ISO 9001 heading are normal
type face, additional requirements are in italics.
In the Technical Specification - ISO 9001
requirements are “boxed”, Sector-Specific
supplemental requirements are outside the
boxes.
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Audit Scope • “the extent and boundaries of audit” • Include: o Physical locations o
Audit Scope
• “the extent and boundaries of audit”
• Include:
o
Physical locations
o
Organizational units
o
Activities
o
processes
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ISO/TS 16949 Audit Scope • Product: all automotive products supplied to customer • Activity: design
ISO/TS 16949 Audit Scope
• Product: all automotive products supplied to
customer
• Activity: design & development, production,
installation and service.
• Applicable to any activity within the
automotive supply chain.
• Coverage: all sites & locations:
Site
location at which value-
added manufacturing
processes occur
Remote location
location that supports sites
and at which non-production
processes occur
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Contact Auditee • Auditor Contacts Department Manager • Explains the process—if required • Confirms Date
Contact Auditee
• Auditor Contacts
Department Manager
• Explains the process—if
required
• Confirms Date / Time
Audit
• Sets up Opening Meeting
• Gets information for
Audit Plan e.g. Check
which people/processes
will be available on audit
• Checks if protective
clothing needed
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Review document • Obtains representative documents, e.g. procedures, guidelines • Checks on outstanding
Review document
• Obtains
representative
documents, e.g.
procedures,
guidelines
• Checks on
outstanding
nonconformities in
previous audit
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Audit Plan o Details who looks at what and when o Should ‘follow the process’
Audit Plan
o
Details who looks at what and when
o
Should ‘follow the process’
o
Allows auditee to know what is
planned
o
Makes efficient use of time
o
Should be flexible
o
Should not restrict the audit
o
Need not be conveyed to company
if appropriate
o
Must cover all shifts
o
To cover all remote location and sites
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Audit planning should include the following activities in the following sequence:

1. Identification of processes based on quality management system documentation and any additional

Delegate Notes

information provided by the organization.

2. Analysis of processes according to the criteria

• Products and/or services provided to customer

• Risks to the customer

• Interfaces (inputs/outputs)

• Possibilities to group processes for economical and effective audit

3. Prioritization of audit activities considering

• Follow up issues of prior audits (external and internal)

• Customer complaints

• Value (add) to audited organization

4. Finalization of audit plan including sequence/process steps, timing and interview partners

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Audit Plan Content • Objectives of Audit • Audit Scope • Documents required Audit Plan
Audit Plan Content
• Objectives of Audit
• Audit Scope
• Documents required
Audit Plan
• Personnel you want
to see
Audit Plan
e.g. Key Managers,
typical cross-section
of staff
• Timetable of events
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Audit Checklist • Aide Memoire • Concise • Should follow ‘process’ • Avoid tick sheets
Audit Checklist
• Aide Memoire
• Concise
• Should follow ‘process’
• Avoid tick sheets
Check-list
• Should not take over
Audit
What?
• Separate checklist for
each area
Where?
When?
Why?
• Useful for new Auditors
How?
• Can evolve over time
Who?
• Aids time management
Checklist is a tool to verify ‘completeness’ of audit,
NOT to take over audit!
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Exercise 3 Creating Check List © Neville-Clarke International Ltd, 2003 Slide No 0:72 QMS X
Exercise 3
Creating
Check List
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Session 6

Conducting Audit

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Conducting the audit 2 Conduct Opening meeting Collecting & verify audit evidence Evaluate audit evidence
Conducting the audit
2
Conduct Opening meeting
Collecting & verify
audit evidence
Evaluate audit evidence
against audit criteria
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Opening meeting • Courtesy to talk to Manager first • Shows openness • Auditor can
Opening meeting
• Courtesy to talk to
Manager first
• Shows openness
• Auditor can
– Explain process
– Set expectations
– Confirm plan
– Answer questions
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Opening meeting Agenda 1. Introduction 2. Purpose and scope 3. Plan for the day 4.Explanation
Opening meeting Agenda
1. Introduction
2. Purpose and scope
3. Plan for the day
4.Explanation of ‘Value
added process’
5.Confirm authorized
person to acknowledge
audit report
7.Reporting method
8.Any questions
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Collecting & verifying information • Methods include: Question o Interview (Ask them what they do)
Collecting & verifying
information
• Methods include:
Question
o
Interview
(Ask them what they do)
o
Observe activities
o
Review documents
• ‘Audit Triangle’
Observe
Check
(See what they actually do)
(What the procedure says they should do)
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Where to look for information? • Observe activities and the surrounding work environment • Examine
Where to look for
information?
• Observe activities and
the surrounding work
environment
• Examine records
o Inspection/test reports,
meeting minutes, result
of measurement
• Ask for documents
o Objectives, procedures,
plans, instructions,
specification, drawing
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Sampling • Sampling cannot be statistically significant • Select examples, such as: o a purchase
Sampling
• Sampling cannot be
statistically significant
• Select examples, such
as:
o
a purchase order
o
a part number
• Follow the Audit Trail,
using the example to
provide you with
evidence of
conformance to the
Standard
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Key points for Interview • Who do we audit? o The person responsible for the
Key points for Interview
• Who do we audit?
o The person
responsible for the
activity to be audited
• How to begin?
o Ask the auditee to
explain/ describe the
activity
• When?
o Normal working
hours
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Asking Question – Filter Funnel • Open questions o Encourage Auditee to talk freely o
Asking Question –
Filter Funnel
• Open questions
o
Encourage Auditee to talk
freely
o
Use What, Where, When,
Why, How and Who?
• Probing questions
o Follow-up or focusing on
more precise detail
• Closed questions
o Used where you want a
clear ‘Yes’ or ‘No’ answer
& Don’t forget the Please
‘Show Me’.
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Feasibility Relations of Core tools Review Contract 7.2 Review 6.0 7.3 7.3 APQP APQP APQP
Feasibility
Relations of Core tools
Review
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
APQP
7.3
7.5.2
7.2
7.1
Phase 5
FMEA
MSA
SPC
Mass
Production
7.5
8.0
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How to Audit Core tools? • Select a few products as ‘audit samples’ • Use
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.
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Auditing Customer Specific Requirement Feasibility Review • Customer Specific Requirements are identified at the
Auditing Customer
Specific Requirement
Feasibility
Review
• Customer Specific
Requirements are identified
at the beginning of new
contract/ planning
Product
Contract
Incorporated
Process
Review
Product Related
Requirements
design
Special
Regulatory
Characteristic
APQP
Quality
Phase 1
Business
System Related
Incorporated
Requirements
Process
Planning
Delivery
Communication
PAP
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Put people at ease • Find best place for interview • Reason for interview &
Put people at ease
• Find best place for interview
• Reason for interview & note
taking should be explained
• Smile when appropriate
• Avoid barriers, e.g. across
table
• Keep at same physical level as
Auditee
• Be assertive
• Don't infringe 'personal space'
• Be open in speech and manner
• Use humour - but only if
appropriate
• Be calm, cool and objective
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Interview process 1.Identify individual to be audited 2. Introduce yourself 3.Explain why you are there
Interview process
1.Identify individual to be
audited
2. Introduce yourself
3.Explain why you are there &
‘break the ice’
4.Ask open question(s)
5.Ask the detailed questions
6.Do ‘show me please’
7.Check facts and make notes
8. Thank Auditee
9. Identify next Auditee on trail
drawing
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Taking Notes • Record – Suspected nonconformities – Observations – Info’ to be provided later
Taking Notes
• Record
– Suspected
nonconformities
– Observations
– Info’ to be provided
later
– Items to be followed
up
– Improvement ideas
– (Positive evidence of
conformance)
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Evaluate Audit evidence Audit Criteria Audit Evidence Audit Finding • ‘Weigh’ Evidence against criteria to
Evaluate Audit evidence
Audit Criteria
Audit Evidence
Audit Finding
• ‘Weigh’ Evidence against criteria to obtain
Audit Finding
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Exercise 4 Classifying Document vs Record © Neville-Clarke International Ltd, 2003 Slide No 0:89 QMS
Exercise 4
Classifying
Document vs
Record
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Session 7

Reporting Audit

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Reporting the audit 3 Auditor review meeting Review audit finding with auditee Conclusion & Report
Reporting the audit
3
Auditor review
meeting
Review audit finding with auditee
Conclusion & Report Writing
Closing Meeting
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Auditor Review Meeting • When? o Before final audit conclusion o At suitable time during
Auditor Review Meeting
• When?
o
Before final audit conclusion
o
At suitable time during audit to
review findings
• To utilize team experience in
evaluating audit findings
• To avoid making wrong audit
conclusions
• Purpose: To review audit
findings in a collective
manner
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Audit Report • A formal, factual and agreed record of Audit including nonconformities, observations, corrective
Audit Report
• A formal, factual
and agreed record
of Audit including
nonconformities,
observations,
corrective action,
timescales,
conclusions,
recommendations.
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Audit Report Should include • Identification of client and audited organization • Identification of audit
Audit Report Should include
• Identification of client
and audited
organization
• Identification of audit
team
• Audit objectives, scope
and plan
• Summary of audit
process
• Audit criteria
• Statement
confidentiality
• Date & place of audit
• Report distribution
• Audit findings
• Evidence objectives of
audit achieved
• Identification of
auditees
• Agreed action plans
o Source: ISO 19011
• Unresolved
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Typical Audit Report Content Opportunity Conclusion NonConformity For Statement Improvement (NCR) (OFI) ©
Typical Audit Report Content
Opportunity
Conclusion
NonConformity
For
Statement
Improvement
(NCR)
(OFI)
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Nonconformities should • Be factual/objective • Be clear and concise • Give clause number of
Nonconformities should
• Be factual/objective
• Be clear and concise
• Give clause number of Quality Standard/Company
document
• Be locatable by other Auditors
• Define the exact instance – Objective Evidence
• Be given a unique identifier
• Be categorised (e.g. minor/major)
• Be accepted/signed by authorized personnel
representing auditee
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Minor Nonconformity • A failure in some part of the organization’s documented QMS relative to
Minor Nonconformity
• A failure in some part of the
organization’s documented
QMS relative to ISO/TS 16949,
or
• A single observed lapse of
following one item of a
company’s QMS.
Does NOT results in:
• reduced ability to assure
control of process or products
& failure of the QMS.
o Source: Rules for achieving IATF
recognition
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Major Nonconformity • Absence, or total breakdown, of a system to meet a requirement of
Major Nonconformity
• Absence, or total breakdown, of a
system to meet a requirement of
ISO/TS 16949. A number of minor
nonconformities against one
requirement which can represent a
total system breakdown can be
considered a major nonconformity.
• Probable shipment of nonconforming
products causing failure or materially
reduce the usability of the products
or services for the intended purpose.
MAJOR
• Reduced ability to assure control of
process or products & failure of the
QMS.
o Source: Rules for achieving IATF
recognition
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Opportunity For Improvement • Statements outside scope of the Audit which may be useful, e.g:
Opportunity For
Improvement
• Statements outside
scope of the Audit
which may be
useful, e.g:
o
Moving towards a
nonconformity
o
Risks identified but
no problems yet
OFI
o
If allowed,
recommendations
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Writing Nonconformity Statements Nonconformity Statement should be concise, informative and CLEAR! • 3 elements of
Writing Nonconformity
Statements
Nonconformity Statement should be concise,
informative and CLEAR!
• 3 elements of a good audit
statements:
• Explain the statement of fact/
problem
• Record the objective evidence: quote
references, including part numbers,
document numbers, equipment
numbers, location, etc
• The reason why it is a
nonconformity, quote requirements
in ISO/TS 16949 and/or relevant
procedure
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Example 1 • Document revision status is not clearly indicated in visual inspection specification AQ
Example 1
• Document revision status is not clearly indicated
in visual inspection specification AQ 535 located in
dept 16, used for product inspection purpose. This
is contrary to ISO/TS 16949 clause 4.2.3 (c) and
procedure QA-P-03.
Can you identify the:
o
Statement of fact & evidence?
o
Location, making it easy to be found?
o
Requirements violated?
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Example 2 • Nonconforming parts push rods, part no. AA589 located in department 12 has
Example 2
• Nonconforming parts push rods, part no.
AA589 located in department 12 has no tag
or label as identification and the supervisor
of the area has no knowledge of the
problem. Nonconforming parts are not
adequately identified. This is contrary to
ISO/TS 16949 clause 8.3 and procedure
QP-125
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Example 3 • Jonathan Clarke of warehouse department had received fork lift truck driver training
Example 3
• Jonathan Clarke of warehouse department
had received fork lift truck driver training in
march 2002 but this had not been indicated
in the training records held in the human
resource department. Training records are
not always maintained for operators. This is
contrary to ISO/TS 16949 clause 6.2.2 and
procedure HR-P-387
“Can you tell what’s wrong with this report?”
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Example 3 • Jonathan Clarke of warehouse department had received fork lift truck driver training
Example 3
• Jonathan Clarke of warehouse department
had received fork lift truck driver training in
march 2002 but this had not been indicated
in the training records held in the human
resource department. Training records are
not always maintained for operators. This is
contrary to ISO/TS 16949 clause 6.2.2 and
procedure HR-P-387
Audit system, NOT individual!
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Audit Report ‘No’s! • Should not contain: o Individuals names in nonconformities o Confidential information
Audit Report ‘No’s!
• Should not contain:
o
Individuals names in
nonconformities
o
Confidential
information
o
Subjective
statements
o
Emotive statements
o
Information not
raised previously
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Closing Meeting • Balanced summary can be presented • Manager gets direct feedback • Queries
Closing Meeting
• Balanced summary
can be presented
• Manager gets direct
feedback
• Queries can be
resolved
• Manager can ‘buy in’
to findings
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Closing Meeting Agenda 1. Thanks for co- operation, etc. 2. Summary of good points 3.
Closing Meeting Agenda
1. Thanks for co-
operation, etc.
2. Summary of good
points
3. Nonconformities /
findings
4. Observations and
advice
5. Corrective action
6. Report details
7. What happens next
8. Questions & Answer
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Exercise 5 Writing Audit Report © Neville-Clarke International Ltd, 2003 Slide No 0:108 QMS X
Exercise 5
Writing Audit
Report
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Exercise 6 Classifying Findings © Neville-Clarke International Ltd, 2003 Slide No 0:109 QMS X Issue
Exercise 6
Classifying
Findings
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Session 8

Post-audit Actions

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Corrective Action & Follow-up 4 Circulate Audit Report Update Audit Schedule Corrective Action (performed by
Corrective Action & Follow-up
4
Circulate Audit Report
Update Audit Schedule
Corrective Action
(performed by auditee)
Verify completed actions
Close case
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Follow-up Action • Report circulated • Audit programme updated • Checklists filed • Corrective action
Follow-up Action
• Report circulated
• Audit programme
updated
• Checklists filed
• Corrective action
performed
• Trends fed into
management review
• Corrective action
verified
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Corrective Action • Department Manager defines action and timescales ACTION PLAN • Action may be
Corrective Action
• Department
Manager defines
action and
timescales
ACTION PLAN
• Action may be in
two stages:
Actions
o Fix the symptoms
o Fix the underlying
cause
Timescales
Responsibilities
• Timescales must be
realistic
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Corrective Action Vs Correction • Corrective Action • Correction o Act on nonconformity discovered o
Corrective Action Vs
Correction
• Corrective Action
• Correction
o
Act on nonconformity
discovered
o
Act on current
problem only
o
Eliminate root cause
o
DO NOT eliminate
root cause
o
Prevent recurrence
o
No guarantee that
the same event may
NOT repeat.
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Verification of Corrective Action • To look at: o Actions taken have eliminated root cause
Verification of Corrective
Action
• To look at:
o
Actions taken
have eliminated
root cause
satisfactorily
• Containment action
as quick fix
CANNOT be
acceptable!
o
Results achieved
are satisfactory.
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How To Get The Most Out Of Internal Audit • Must be a ‘no-blame’ culture
How To Get The Most Out Of
Internal Audit
• Must be a ‘no-blame’ culture
• Auditor and Auditee should work in partnership
• Encourage staff to reveal problem areas
• Both Auditor and Auditee should look for
improvements
• Audits must be seen as essential part of
business
• Positive terms can be used (e.g. ‘finding’ not
‘nonconformity’)
• ‘Findings’ or ‘nonconformities’ should be seen as
‘opportunity to improve’
• Must be adequate time and resources for
Auditee/Auditor to perform audit
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THANK YOU FOR ATTENDING THIS COURSE NEVILLE | CLARKE © Neville-Clarke International Ltd, 2003 Slide
THANK YOU FOR ATTENDING
THIS COURSE
NEVILLE | CLARKE
© Neville-Clarke International Ltd, 2003
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QMS X
Issue 1.0/03
International Ltd, 2003 Slide No 0:117 QMS X Issue 1.0/03 AMS 23 Issue 1.0/-03 Rev 1

AMS 23 Issue 1.0/-03 Rev 1 Mar04

ISO/TS 16949 Process Approach Internal Auditing © Copyright Neville-Clarke International Ltd, 2003

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