ISO/TS 16949:2002
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 3VDA 6.1 - GermanAVSQ - ItalianEAQF - 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 PrinciplesCustomer 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
“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.
Through industry standards - ISO9001:2000 & ISO/TS16949:2002.
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
ManagementResponsibility
ResourceManagement
Product Realization
Measurement, Analysis
& Improvement
Inputs Product
CUSTOMER
Outputs
REQUIREMENTS
CUSTOMER
SATISFACTION
C.I.
Continual Improvement Cycle
Scope and Applicability
ISO / TS 16949
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
C ustom er
O rgan iza tion
S U P PL IE R 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
Permissible ExclusionsISO / TS 16949
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
Mandatory Procedures
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
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
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
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
QS-9000(Procedure Based)
TS-16949:2002(Process Based)
1 2 3 4
Functional Goals
A FUNCTIONAL ORGANIZATIONWITH PROCESS OVERLAYS…
Management of Processes
Process 2
1
2
3
4
Process 1
Process 3
Process 4 Proc
ess
goal
s
• 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.
Recognizes:
The Process Approach
Inputs OutputsProcess
Objectives
Results
Risks
Purpose
• Stakeholder Wants & Needs • Specifications• Schedule/Timing• Market Data• Industry Trends• Economic Conditions
• Products • Information
Process Mapping
Forms and Form Instructions
Supporting Instructions
Program Planning & Launch
Manufacturing
Marshall Key Processes
Shipping
LRP/OPManufacturing
RoadmapInformation
ManagementCorrective
ActionInternal Auditing Preventive Action
Document Control
Business Processes
Management Review / Continuous
Improvement
Quality Objectives
CQR/CQA
Support Processes
Asset Management Human Resource Management
Materials Management Capacity Planning Purchasing
DFMSupplier
Management
Non-conforming Material
Laboratory Records Retention
Component Quality
Customer Support 5S Audit
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 processesYou 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
Process Mapping
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
Identify suppliers to your process (internal and external) (TS 16949 section 4.2.2.c)
• What are their inputs to your processOther processesLaborMaterial Ideas InformationEnvironmentProcedures, 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
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?
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?
Process Objective: Support P rocesses:
Configuration ManagementManufacturingProgram ManagementPurchasing
Inputs Outputs Rules/Responsibilities
(5) If parts are required, parts may be ordered by Engineering, Sales or supplied internally from a TRW manufacturing facility.(6) Prototypes built in accordance to build checklist, drawings & specifications.
(7) Engineering to coordinate deviation or customer concurrence.
(8) Quality Assurance performs & documents inspections using inspection standards or prototype control plans, depending upon the specific customer requirements.
(9) Quality Assurance coordinates any required deviations using the specific customer forms.
(10) Quality Assurance documents results using the specific customer paperwork and maintains copies for future reference. Paperwork may be sent with the prototype parts or forwarded to the customer via mail or fax depending upon specific customer requirements.
(11) Shipping Department packas parts and coordinates develivery. Sales isrwponsbile for alerting shipping in advace if expidated develiry will be require3d.
(12) Finance Department coordinates billing and collection. Sales Department may assist in overdue collection through direct customer contact.
(3) Team usually can consists of Engineering, Quality, Sales, Program Mgt., Manufacturing.
(1) Sales Department.
(2) Sales Department.
Document No./ Release No.
345643/ERD 2345
Process
Process Name / Level:
Prototype Process - Farmington Hills (Level 2)
Build and deliver on-time, prototype parts that meet
customer design & performance requirements.
1. On-time delivery.
(4) Sales Department.
Process Measurables:Process Risks:
1. M issed delivery date to the customer.2. Parts do not meet customer requirements in quality or performance. 2. Prototype rejections by the customer.
Customer Order
(1) Receive Customer P.O., EDI, Phone, Fax,
Prototype Parts
Order Issues ? No
Yes
Drawings
(2) Enter order into SAP System
(3) Review Order Requirements with Prototype Team
Specifications
(4) Resolve with Customer
Revised P.O.
Req'd?Yes (5) Components
Inventory CheckNo
(6) Build Prototypes
Functionally Test Prototypes
Prototype Paperwork
(7) Resolve with the
Customer
Test Issues ?
(8) Quality Inspection
No
Quality Issues ?
No
(11) Packing & Shipping
(10) Complete Prototype Paperwork
(9) Resolve with the
Customer
(12) Issue Billing to Customer
Customer Invoice
Components
Yes
Yes
Document No. Revision
MPM0078 AProcess Objective: Support Processes:
Material ManagementDocument ControlNon-Conforming Material
Inputs Outputs Rules/Responsibilities/Comments
1. Shipping instructions.2. Government Regulations3. Customer Requirements
6. Customer requirements not met. 6. Finished Goods Accuracy
4. Customer not notified (no ASN) 4. Customer Quality5. No invoice or not correct. 5. Finished Goods Inventory
Governing Documents
Process Measurables:
3. P remium Freight.
1. Shipping Associate
Process
Process Nam: Back to Marshall Key ProcessesMarshall Shipping Process
Ship quality product per customer requirements.
1. On-time delivery performance report (internal).
3. The shipment is not on time to the customer schedule.
Process Risks:
1. On-line system goes down and customer orders are missed.2. The wrong quantities are shipped. 2. On-time delevery performance report (external)
Report and Move to
Finished Goods
Pull Signal to Manufacturing
Assemble/Verify Shipment
Invoice Customer
Warehouse Storage
Ship Product
Document No. Revision
MPM0079 AProcess Objective: Support Processes:
Materials ManagementDocument ControlNon-Conforming Material
Inputs Outputs Rules/Responsibilities/Comments
1. Shipping Associate2. Shipping Clerk
1. Customer Packaging Specifications2. Delivery Note3. Honda Delta System4. DCX SMART System5. Ford DDL6. MMOG
4. Customer not notified (no ASN)5. Dropped parts.
4. Customer Quality5. Finished Goods Inventory
Process Risks:
1. On-line system goes down and customer orders are missed.2. The wrong quantities are shipped. 2. On-time delevery performance report (external)
Process
Process Nam: Back to Marshall Key ProcessesAssemble / Verify Shipment
Ship quality product per customer requirements.
1. On-time delivery performance report (internal).
3. The shipment is not on time to the customer schedule.
Process Measurables:
3. P remium Freight.
6. Finished Goods Accuracy
Governing Documents
Delivery Note from Customer
Service
Place on truck
Review Pick List
Is all stock available?
Shipment Configuration
Stored Finished Goods
Assemble order per customer
directives
Consult SAP inventory screen.
Contact Manufacturing or Customer Service
Pull Order
Is stock in the correct quantity?
Reference on-hand inventory screen when picking shipment
Is container within the two week window
of stock
Is another box required?
Identify out of rotation or missing box and forward to inventory analyst. (2)
Yes
No
Yes No
No
Yes
Yes
NoIs the box
damaged or dropped?
No
Warehouse Nonconformance
Yes
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.
Questions?
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