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ISO/TS 16949
Process Approach
Inter nal Auditing Training
Nui Thanh, March 20 - 2013
Course Content
Session 1 ISO/TS 16949 Background
Session 2 Introduction to Auditing
Session 3 Audit Overview
Session 4 Audit Planning
Session 5 Conduct Audit
Session 6 Reporting Audit
Session 7 Post-audit Actions
Course Objectives
To provide participants with the necessary
competency in:
Planning & conducting Internal
Audit by using the IATF Process Approach
techniques
Reporting & following up the audit findings
effectively
STRIVE FOR EXCELLENCE
BERUSAHA KE ARAH KECEMERLANGAN
ISO/TS 16949
BACKGROUND
1
What is ISO/TS 16949?
Harmonization of automotive industry
requirements.
Developed by International Automotive Task Force
(IATF) and Japan Automobile Manufacture
Association (JAMA), supported by ISO/TC 176
Established based on major industry standard
ISO 9001:2000
AVSQ (Italian) , EAQF ( French) , QS-9000(U.S)
and VDA 6.1 (German) automotive catalogs.
Recognized by major European , American and
Japanese automotive manufacturer.
ISO/TS Development
1st Edition
ISO/TS 16949:1999
2nd Edition
ISO/TS 16949:2002
(OFFICIALLY PUBLISHED
ON 25 MARCH 2002)
3rd Edition
ISO/TS 16949:2009
ISO/TS Goals
Continual improvement
Emphasis on defect prevention
Reduction of variation and waste in the
supply chain
Intention of ISO/TS 16949
■ To avoid multiple certification
■ To provide a common QMS approach in
the Automotive industry
ISO/TS Scope
Flexibility:
ISO/TS 16949 becomes the common platform, other
customer imposed requirements are easily added on.
Customer
imposed
ISO/TS16949
Customer specific
requirements
Additional
Requirements
ISO 9001
Together with
customer-specific
requirements, ISO/TS
16949 defines the
quality system
requirements for use in
the automotive supply
chain.
STRIVE FOR EXCELLENCE
BERUSAHA KE ARAH KECEMERLANGAN
Introduction
toAuditing
2
What is audit ?
A ‘check & balance’ process to ensure activities are
performed in an appropriate and effective manner.
Usually conducted on an independent basis.
Objective evidence is required.
“ 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
[...]...Type of audits 1st Party (Internal Audit) Your own Organisation Certification 3rd Party 2nd Party Subcontractor or Supplier Body Purpose of Internal Audit Assess the overall process control Ensure conformance to the Documented Quality System & Standards Evaluate the effectiveness of the key processes in achieving their objectives Investigating problems (product or process) Way of improving the... Automotive process approach auditing technique Core tools (APQP, FMEA, SPC, MSA, PPAP) Customer- specific requirements 4 STRIVE FOR EXCELLENCE BERUSAHA KE ARAH KECEMERLANGAN Audit Planning Audit Planning Prepare Annual Audit Schedule Prepare Audit Plan Prepare Checklist Types of Processes Organization Management Processes input Customer Customer Oriented Processes output Support Processes Customer... Understanding the process Usually 3 methods can be used to understand the process Before that, confirm the scope of audit area Where to start and where to end It can be presented in process outline, process flow etc Question Ask the auditee to explain their process Observe Go to the work area, and see what they have/do Check documentation Look on Manual Audit Trail Example – Incoming activities Received... 19011 Guidance on quality and environmental auditing Common Internal Audit Failure ♦ Perceive audit as waste of time ♦ Lackluster auditor selection process ♦ Lack of proper system to train auditors ♦ Inadequate process to evaluate ability to perform audit ♦ Over reliance on Quality department ♦ Poor auditor judgment leads to lack of confidence in internal audit result ♦ See auditor as fault finder or trouble... QMS What To Look For During Internal Audit 3 key aspects of a process Improvement Effectiveness Conformance Conformance What shall be done vs What is actually done Conformance is the basic principle Compare the actual activities against the audit criteria In other words, “do what have written and recorded down what you have done.” Effectiveness How do we know if a process is effective? It is... maintain ‘mountains’ of documentation? Able to follow Procedure strictly? Able to produce results? Effectiveness of a process is shown by the result it achieved with the delivered output Hence, auditors shall look at indicator / measurable metrics to tell is customer requirements are met Improvement Look for trends Compare current result against past results 3 types of internal audit Product... Types of Processes Organization Management Processes input Customer Customer Oriented Processes output Support Processes 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 Organization 0 Multiple COPs in an Organization Customer I OI OI OI OI O Interaction... the process >>Output –Trail Understanding audit criteria requirement >>Output – Trail Mapping Time Planning >>Output – Audit Plan Ensure completeness of the audit >>Output – Audit Checklist Jelly Fish Diagram Annual audit schedule Auditor Audit Preparation Process Analysis Ensure completeness Understanding audit criteria Time Planning Trail Trail Mapping Audit Plan Audit Checklist Understanding the process. .. Compare current result against past results 3 types of internal audit Product Audit Manufacturing Process Audit Quality Management System Audit QMS Audit To verify conformance to ISO/TS 16949 Standard & customer specific requirements (CSR) Manufacturing Process Audit Focuses on the Manufacturing Process within the total quality management system Product Audit Focuses on product characteristics... material Issue raw material Understanding Audit Criteria Requirement Audit Processes are required to fulfill one or more audit criteria requirements Audit criteria can include ISO/TS requirements Legal requirements Customer requirements It is essential for the auditor to understand the requirements and map to the process Definition of Terms » ‘Shall’ – mandatory requirement » ‘Notes’ – for . Supplier
1st Party
(Internal Audit)
2nd Party
3rd Party
Purpose of Internal Audit
Assess the overall process control
Ensure conformance to the Documented
Quality. key
processes in achieving their objectives
Investigating problems (product or process)
Way of improving the current QMS
What To Look For During Internal