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