Expiration of QS-9000 • ISO (Geneva, Switzerland) has stated that QS-9000 has been extended by 3 years, and will expire on 14 December, 2006 • ISO has indicated that there is virtually no chance of additional extensions, nominally, the ISO 9000:1994 standard embedded within QS-9000 will expire 15 December, 2003.
Two Key Organizations • International Automotive Task Force • International Automotive Oversight Bureau
Purpose of the IATF • Develop consensus for international quality system requirements (automotive) • Develop policy & procedure for registration • Provide appropriate training • Serve as formal liaison
IATF Members • Authoring Organization of ISO/TS 16949 includes: • Vehicle manufacturers: BMW, DaimlerChrysler, FIAT, Ford Motor, GM, PSA, Renault, Volkswagen • Industry trade organizations: AIAG, ANFIA, FIEV, SMMT, VDA • Guest members: JAMA
IATF Oversight • ANFIA, IAOB, IATF-France, SMMT, VDA-QMC • Implementation of IATF registration scheme and rules via a common process • Witness audits • Auditor qualification training and exam • Monitor CB/auditor performance • Apply and implement IATF policy and decisions • Coordinate special projects and work teams • Develop sanctioned interpretations and recommendations for improvement • Database management
Purpose of IAOB • Implement and manage 16949 registrations • Manage and coordinate with IATF Europe • Support further global consistency • Develop and maintain central database
Which Car Manufacturers Will Accept ISO / TS 16949? • The users of - QS-9000 - US Big 3 VDA 6.1 - German AVSQ - Italian EAQF - French
Why Upgrade to TS? From the OEM subscriber’s view: • TS 2nd is based on the current ISO 9001:2000 • Includes Customer Specifics to achieve conformity • Improved control of the auditing process • Reduced audit variation • Better control of certification and its value
Why Upgrade to TS? From the supplier’s point of view: • Reciprocal recognition (one size fits all) • Vocabulary is consistent with ISO 9001:2000 • Process audit is aligned with the way the automotive business is run • Continual improvement from earlier requirements documents (e.g., TS 1st,QS-9000, EAQF, AVSQ, VDA 6.1) • Closer oversight – greater value in certification
ISO/TS 16949:2002 Addresses Significant QS-9000 issues • The Oversight process • Tighter registrar control than with QS-9000 Accreditation Body method, and higher quality auditors • International recognition of ISO/TS 16949:2002 • The Multinational OEM authoring group reduces the number of certification requirements in Europe, and therefore cost • ISO/TS 16949:2002 is based on and includes ISO 9001:2000 • ISO 9001:2000 includes strengthened management reporting, continuous improvement and customer satisfaction metrics (aligned with Q1 2002)
Eight Principles Customer focus Leadership Involvement of people Process approach System approach to management Continual Improvement Factual approach to decision making Mutually beneficial supplier relationships
Introduction The goal of this Technical Specification: • development of a quality management system • provide for continuous improvement • emphasize defect prevention • reduction of variation and waste in the supply chain
Through industry standards - ISO9001:2000 & ISO/TS16949:2002. • “The intent of this international standard is to encourage the adoption of the process approach to manage an organization.” • Process approach - “for organizations to function effectively, they have to identify and manage numerous interrelated and interacting processes. The systematic identification and management of the processes employed within an organization and particularly between such processes is referred to as process management.
How Will the Audit Change? • Process audit approach • Automotive application • Line of sight from the organization to the customer • Audit plan • Identification of key processes impacting the customer • Based on the processes as defined by the organization • Performance • Linked to common metrics for • Organization • Supplier • Oversight • Adherence to the “Rules” and Common Global Process
Continual Improvement Cycle Management Responsibility R E Q U I R E M E N T S S A T I S F A C T I O N C U S T O M E R C U S T O M E R Resource Management Measurement, Analysis & Improvement C.I. Product Realization Inputs Outputs Product
ISO / TS 16949 Scope and Applicability • Applicable to production and service part supplier sites that are providing: • Parts or materials • Heat treating, painting, plating, other finishing services • Other customer specific products • May also be applied throughout supply chain
What’s New (and Different) • Based on ISO 9001:2000 not ISO 9001:1994 • Greater focus on the customer and customer satisfaction • New focus on the “Process” approach vs. the “elemental” approach • Clarification of requirements for continual improvement
New and Different (Cont.) • Greater emphasis upon the role of top management • Measurable quality objectives • Reduced emphasis on documented procedures
New and Diff. (Cont.) • Modification in the purpose of internal audits • Use the “Deming Cycle” of Plan, Do, Check, and Act as a basic methodology • Process Conrol and improvement is expanded from product to include all activities of the organization.
ISO 9001 Supply Chain Terms Was Subcontractor in QS-9000 Was Supplier in QS-9000
Adds sector terminology Control plan Design responsible org. Error proofing Laboratory Laboratory scope Outsourcing Predictive maintenance Premium freight Remote location & “site” Special characteristics Modifies ISO terms Continual improvement Manufacturing Automotive Specific Terminology
ISO 9001 Core Sections 4.0 Quality Management System 5.0 Management Responsibility 6.0 Resource Management 7.0 Product Realization 8.0 Measurement, Analysis & Improvement
ISO / TS 16949 Permissible Exclusions • The only permitted exclusions may be in 7.3 • Where the organization is not responsible for product design and development • Permitted exclusions do NOT include manufacturing process design • Justified with details in the quality manual • Conformity should not be claimed otherwise • Only IATF will prescribe authorized exclusions for vehicle assembly plants
ISO 9001:2000 Control of Documents Control of Records Internal Audit Control of Nonconforming Product Corrective Action Preventive Action ISO/TS 16949:2002 Laboratory Field Service (i.e. Warranty) Training Mandatory Procedures
Key Differences between QS-9000 & TS16949 • TS16949 focuses on the business processes required to satisfy customer requirements (The “Process Approach”). • QS-9000 follows the 20 elements (The “Conformity Approach”) • Process audit (TS16949) vs. documentation audit (QS-9000)
Contrast between QS-9000 & TS-16949:2002 TS-16949:2002 (Process Based) QS-9000 (Procedure Based) • Processes Are: • Driven by desired output • Managed • May be completed by different departments with the same objectives • Flow to conclusion • Satisfy the stakeholders • Transform inputs into outputs • Dynamic • Procedures Are: • Driven by task completion • Issued • May be completed by different departments with different objectives • Are segmented • Satisfy the standard • Define the sequence of steps to perform a task • Static
1 2 3 4 Process 1 Process 2 1 Process 3 Process goals Process 4 2 3 4 Functional Goals Management of Processes A FUNCTIONAL ORGANIZATION WITH PROCESS OVERLAYS…
So what is the process approach to management? Recognizes: • All work is performed to achieve some objectives • The objective is achieved more efficiently when related resources and activities are managed as a process • Objectives of the organization which serve to meet its mission will be met more effectively when the organization is managed as a system of interrelated processes.
The Process Approach Purpose Objectives Risks Inputs Outputs Process • Stakeholder Wants & Needs • Specifications • Schedule/Timing • Market Data • Industry Trends • Economic Conditions • Products • Information Results
Process Mapping • How do I get started mapping???? • First map out our processes at your location at the macro level • Identify the process owner • Map out your processes at the micro level that support the processes at the macro level
Process Mapping • You will need to identify • The inputs to your processes • The outputs of your processes • And then map out the activities in between that define the processes • You might find sub processes • Identify metrics to measure the effectiveness of your processes (must tie to the process objective)
Process Mapping • Identify your customers and your process objectives/outputs (TS16949 section 4.2.2.c) • Internal (other processes) and External customers • Show interactions between the various processes
Identify your customers and your process outputs (TS16949 section 4.2.2.c) Physical products Documents Information Services Decisions On time to schedule Meet profit margins Process Mapping
Process Mapping • Identify suppliers to your process (internal and external) (TS 16949 section 4.2.2.c) • What are their inputs to your process • Other processes • Labor • Material • Ideas • Information • Environment • Procedures, Forms, Documents, Records
Process Mapping • Identify support to your processes (TS16949 section 4.2.2.c) • Human Resources • Training • Purchasing • Finance • Quality Assurance • Etc.
Process Mapping • Establish a goal against which to measure your metrics • You will need to monitor your metrics and implement corrective actions if you don’t meet your goal • Look for opportunities of continual improvement to improve your processes
Process Mapping • Identify risks to the process and the objectives • Compressed Timing • Failure to meet schedule timing • Incomplete customer requirements • Test/performance failures • Rejected approvals (appearance, PPAP) • Underestimated costs • Premium freight
Process Mapping Flow chart the process. Note: Indicating forms/records to be filled out at each step of the process can eliminate or reduce the need for procedures to document activities at each step. A well done flow chart can eliminate the need for a procedure to describe the process.
Questions to Help with Mapping • Inputs/Suppliers • Where does the information or material you work on come from? Who are your suppliers? • What do they supply? • Where do they affect the process flow? • What effect do they have on the process and on the outcome? • Process steps • What happens to each input? • What conversion activities take place? • Purpose • Why does this process exist? • What is the purpose of this process? • What is the outcome? • Outputs • What product does this process make? • What are the outputs of this process? • At what point does this process end? • Customers • Who uses the products from this process? • Who are the customers of this process?
What About the AIAG Reference Manuals? • The AIAG reference manuals (PPAP, FMEA, MSA, APQP & SPC are still viable documents. • References to these manuals will be included in DCX, Ford and GM’s respective customer specifics for TS16949. • Certification to TS16949 also includes the requirements defined in the AIAG reference manuals.