2. 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.
4. Purpose of the IATF
Develop consensus for international quality
system requirements (automotive)
Develop policy & procedure for registration
Provide appropriate training
Serve as formal liaison
5. 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
6. 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
7. Purpose of IAOB
Implement and manage 16949 registrations
Manage and coordinate with IATF Europe
Support further global consistency
Develop and maintain central database
8. Which Car Manufacturers Will
Accept ISO / TS 16949?
The users of -
QS-9000 - US Big 3
VDA 6.1 - German
AVSQ - Italian
EAQF - French
9. 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
10. 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
11. 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)
13. 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
14. “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.
15. 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
17. 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
18. 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
19. New and Different (Cont.)
Greater emphasis upon the role of top
management
Measurable quality objectives
Reduced emphasis on documented
procedures
20. 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.
21. ISO 9001 Supply Chain Terms
C u s to m e r
O r g a n iz a t io n
S U P P L I E R Was
Subcontractor
in QS-9000
Was
Supplier in
QS-9000
22. 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
24. Permissible Exclusions
ISO / 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
25. 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
26. 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)
27. 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)
28. 1 2 3 4
Functional Goals
A FUNCTIONAL
ORGANIZATION
WITH PROCESS
OVERLAYS…
Management of Processes
Process 2
1
2
3
4
Process 1
Process 3
Process 4
Processgoals
29. • 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:
30. The Process Approach
InputsInputs OutputsOutputsProcessProcess
ObjectivesObjectives
ResultsResults
RisksRisks
PurposePurpose
• Stakeholder Wants & Needs
• Specifications
• Schedule/Timing
• Market Data
• Industry Trends
• Economic Conditions
• Products
• Information
31. Process Mapping
Forms and Form Instructions
Supporting Instructions
Program Planning &
Launch
Manufacturing
Marshall Key Processes
Shipping
LRP/OP
Manufacturing
Roadmap
Information
Management
Corrective
Action
Internal 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
DFM
Supplier
Management
Non-conforming
Material
Laboratory Records Retention
Component Quality
Customer Support 5S Audit
32. 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
33. 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)
34. 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
35. 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
36. 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
37. Process Mapping
Identify support to your processes (TS16949 section
4.2.2.c)
• Human Resources
• Training
• Purchasing
• Finance
• Quality Assurance
• Etc.
38. 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
39. 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
40. 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.
41. 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?
42. P ro c e s s O bje c tiv e : S uppo rt P ro c e s s e s :
Configuration M anagement
M anufacturing
Program M anagement
Purchasing
Inputs O utputs R ule s / R e s po ns ibilitie s
(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 M gt., M anufacturing.
(1) Sales Department.
(2 ) Sales Department.
Document No./ Release No.
345643/ERD 2345
P ro c e s s
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.
P ro c e s s M e a s ura ble s :P ro c e s s R is ks :
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,
M ail
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 Check
No
(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
43. Document No. Revision
MPM0078 A
P ro c e s s O bje c tiv e : S uppo rt P ro c e s s e s :
M aterial M anagement
Document Control
Non-Conforming M aterial
Inputs O utputs R ule s /R e s po ns ibilitie s / C o mm e nts
1. S hipping ins truc tio ns .
2. G o v e rnm e nt R e gula tio ns
3. C us to me r R e quire me nts
6. Customer requirements not met. 6. Finished Goods Accuracy
4. Customer not notified (no ASN) 4. Customer Quality
5. No invoice or not correct. 5. Finished Goods Inventory
G o v e rning D o c ume nts
P ro c e s s M e a s ura ble s :
3. Premium Freight.
1. S hipping A s s o c ia te
P ro c e s s
Process Nam: Back to Marshall Key Processes
Marshall 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.
P ro c e s s R is ks :
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
M anufacturing
Assemble/Verify
Shipment
Invoice
Customer
Warehouse
Storage
Ship Product
44. Document No. Revision
MPM0079 A
P ro c e s s O bje c tiv e : S uppo rt P ro c e s s e s :
M aterials M anagement
Document Control
Non-Conforming M aterial
Inputs O utputs R ule s / R e s po ns ibilitie s / C o m m e nts
1. S hipping A s s o c ia te
2. S hipping C le rk
1. C us to m e r P a c ka ging S pe c ific a tio ns
2. D e liv e ry No te
3. H o nda D e lta S ys te m
4. D C X S M A R T S ys te m
5. F o rd D D L
6. M M O G
4. Customer not notified (no ASN)
5. Dropped parts.
4. Customer Quality
5. Finished Goods Inventory
P ro c e s s R is ks :
1. On-line system goes down and customer orders are missed.
2. The wrong quantities are shipped. 2. On-time delevery performance report (external)
P ro c e s s
Process Nam: Back to Marshall Key Processes
Assemble / 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.
P ro c e s s M e a s ura ble s :
3. Premium Freight.
6. Finished Goods Accuracy
G o v e rning D o c um e nts
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
M anufacturing 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
No
Is the box
damaged or
dropped?
No
Warehouse
Nonconformance
Yes
45. 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.
<number>
Here’s the main players of IATF! IATF has 13 voting members. OEM car makers include: BMW, DaimlerChrysler, FIAT, Ford Motor, General Motors, Renault, PSA(PeugeotCitroen), Volkswagen….
National Trade assoc. include: AIAG (North America), ANFIA(ITALY), FIEV(FRANCE), SMMT(UK), and VDA(GER).
<number>
Oversight – 5 regional offices covering the global automotive scheme. READ MAIN Bullets.
-Oversight through a common process approach has operations management and implementation responsibility of ISO/TS 16949.
<number>
From the OEM perspective. In addition to the revised req’ts doc., only certain CBs have been selected to participate in this program. And as mentioned earlier auditor qualification has been strengthened. As a result there is better control and audit variation should be reduced. /OEM's have customer-specific requirements, either written or in the purchase agreement, which, if applicable become part of the basis for the audit along with TS requirements. These Customer Specifics are as essential requirements as the standards catalog itself. In addition, some of the issues the IATF also needed to address included: poor-performing suppliers still certified, suppliers having on-going open findings existing over extended periods of time and still certified / lack of evidence of supplier organization improvement over time.
<number>
Organizations should understand that if they become certified, they could be acceptable suppliers to any OEM participating in the ISO/TS 16949, IATF recognized scheme. Organizations should understand that a special auditor qualification program exists, and they have every right to demand to see valid credentials. After all, it's their money.
Consistent with ISO 9001:2000, the documentation requirements are less prescriptive.
As mentioned previously in the discussion of “Scope”, organizations should also recognize that there are some QS-9000 certified companies who do not meet the scope definition of ISO/TS 16949, despite what a CB or auditors might tell them.
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Are there implementation strategies?
What is the strategic direction of the IATF and OEM’s who subscribe to this document and participate in recognition?
These are some of the general issues we will also address.
Note we will use the term “supplier” in generic terms not in the strict definition of ISO 9001:2000, (i.e.“organization”, which is the site seeking compliance or certification)
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The process approach means an audit focusing on the
Customer-Oriented-Processes within the organization, and also on the support processes that feed them, whether on-site or not. Process inputs and outputs should be defined by the organization, as part of their system description. /Without this information, an audit cannot be planned properly. /The automotive business is about product realization and market distribution. ISO/TS is focused on quality system capability for achieving product realization goals with the customer - Performance is critical!!!!
Organizations should also understand that they have every right (as a matter of fact, it's their job) to ensure that the auditors have a plan and present clear, well written findings. If they don't, the organization should challenge the audit team, and if not resolved advise OVERSIGHT!