Informed Outlook - 3rd TS article--web version

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					                       Transitioning from QS-9000 to ISO/TS-16949,
                         Second Edition – The Biggest Challenges

The Final Draft International Standard (FDIS) of the ISO/TS16949:2002 is now
available. Though the circulation is limited to a small circle, it is a sign that it will be
soon released to the larger public. What is still missing is the Customer Specific
document (GM, Ford and Daimler) accompanying the ISO/TS 16949:2002 standard.

The ISO/TS 16949:2002 will be voted on in December, 2002 and released in March of
2002. Rumors have it that GM, Ford and Daimler Chrysler will require their first tier
suppliers to become ISO/TS-16949 certified. Also, QS-9000 is expected to be extended
to 2005. Suppliers who are not first tier and who do not want the ISO certification could
technically stay QS-9000 certified. In other words, as we stated in the first article in this
series, QS-9000 will not get upgraded from ISO 9001:1994 to ISO 9001:2000. Also, per
ISO/TC 176 all ISO 9001:1994-registered companies including sector specific ones such
as QS-9000 will have to upgrade to ISO 9001:2000 by December, 2003.

Most QS-9000-registered suppliers will be transitioning to ISO/TS 16949:2002. One,
because their customers require them to and second because they would like them to
transition to the ISO 9001:2000 standard. As we stated in the second article published in
the Informed Outlook August 2001, ISO/TS-16949:2002 is more influenced by the ISO
9001:2000 Standard than any new automotive-based change. For the most part, the
ISO/TS 16949 First Edition has been faithfully mapped into the ISO 9001:2000 to create
ISO/TS 16949:2002.

The biggest challenge for QS-9000 registered companies is the customer focus and
process focus represented by this technical specification. In a nutshell, the table below
represents this change in detail. This article and the next will discuss the most significant
changes facing organizations transitioning from QS-9000 to ISO/TS-16949:2002. These
changes are 4.1 General Requirements, 5.2 Customer Focus, 5.6 Management Review,
6.2 Human Resource, 7.3 Design and Development, 7.4 Purchasing and 8.2.3 Monitoring
and Measurement of Processes. This article will address 4.1 Customer Requirements, 7.3
Design and Development and 7.4 Purchasing.

The Biggest Challenge for QS-9000 Organizations In a Nutshell
Element                    Influenced by               Comment
4.1 General Requirements   ISO 9001:2000               Requirements for Process
                                                       Map (or equivalent) and
                                                       Process management
5.2 Customer Focus         ISO 9001:2000               Decision on customers
                                                       versus interested parties.
                                                       Need for
                                                       customer/interested parties
                                                       “needs and expectations”
                                                       gathering process
5.4.1 Quality Objectives       ISO 9001:2000 and              Deployed Objectives
                               TS16949:1999                   addressing customer
5.5.3 Internal                 ISO 9001:2000
5.6 Management Review          ISO 9001:2000 and              Nothing like the old
                               TS16949:1999                   management review. TS
                                                              requirements add additional
                                                              items to review
6.1 Provision of Resources     ISO 9001:2000                  Need a resource allocation
6.2 Human Resource,            ISO 9001:2000 and TS           Requirements for job Training on the Job,   16949:1999                     competency, on the job
and Employee                                          training, and employee
Motivation and                                                motivation and
Empowerment                                                   empowerment
7.0 Product Realization        ISO 9001:2000                  Documents for “effective
                                                              control” of all processes in
                                                              process map
7.1.4 Change Control           New (actually Q-101)           Trivial addition for most
7.3 Design and                 New                            Scope includes processes.
Development                                                   Note requirements for the
                                                              new FMEA document
7.4 Purchasing                 New                            Scope includes Service
                                                              Suppliers and deadline for
                                                              ISO 9001:2000 registration
                                                              for all suppliers
8.2.1 Customer Satisfaction    ISO 9001:2000                  Customer rating for quality
                                                              and delivery is not enough.
                                                              ISO requires “customer
                                                              perception” of satisfaction
                                                              see ISO 9000:2000
8.2.2 Internal Audits          TS-16949:1999                  Process and Product audits
8.2.3 Monitoring and           ISO 9001:2000 and TS           Process studies for
Measurement of Processes       16949:1999                     manufacturing processes
                                                              and measurement of all
                                                              processes in process map
                                                              (also see 4.1 e, and f)
8.4 Analysis of Data           ISO 9001:2000                  Increased scope from QS-

See the second article of this series, which had a detailed table that contrasted QS-9000
and ISO/TS 16949:1999 (First Edition).
4.1 General Requirements
This requirement in ISO 9001:2000 and ISO/TS-16949:2002 requires organizations to go
beyond QS-9000. They have to identify the processes within their hierarchical
organizational structure. The organizational structure and the chain of command follow
Fredrick Winslow Taylor’s theory of “specialization”. It is what we call in the automotive
industry – organizational silos or Chimney’s. (See picture).

                                            Process Focus
      • Process vs. Function Matrix
                                                                K ey M eas ura bl es

                                                        G e n e ra l M a n a g e m e n t

                P u r c h a s in g     H um an                  O p e r a t io n s         A c c o u n ti n g       S ales
                                     R e s o u rc e s

                                                            P ro ce ss               V ar iat ion           O u tpu ts

      Introduction - 4                                              © 2001 OMNEX, Inc.                                       4

Products are “realized” by processes. ISO/TS 16949:2002 would force QS-9000
registered organizations to identify the “product realization” processes and the “support”
processes. These processes provide for the product and are responsible for satisfying the

Two ISO 9001:19944 paradigms need to be discarded at this stage. One is that the
organization can scope out processes not required by the elements of ISO/TS
16949:2002. 1.2 Application in ISO 9001:2000 and ISO/TS 16949:2002 is careful to
point out that only processes that do not “affect the organization’s ability or responsibility
to provide product that meets customer and applicable regulatory requirements” can be
scoped out. “Requirements” are defined as “need and expectation”. In other words, an
organizational entity or a process can only be scoped out if it does not affect customer
expectations. Now, it is questionable if organizations can scope out R&D Centers or
Sales offices. Furthermore, ISO/TS 16949 has defined 7.3 Design and Development as
product and process design. No organizations implementing ISO/TS 16949:2002 can
exclude 7.3 Design and Development from process design.
Two, ISO 9001:2000 and ISO/TS 16949 clearly state that the organization needs to
maintain control of the outsourced processes that “affect product conformity.”
Organizations will need to include outsourced processes in their process map including
heat treating or plating or any component of an assembly manufactured by a supplier.

Organizations need to go beyond the elements of ISO/TS 16949:2002 when creating the
process map. Telltale signs to auditors are process maps that only include elements
related to the standard. Inherently, a “process focus” is different from a “departmental”
focus. Worse yet is the compliance-driven approach of many companies who
implemented QS-9000 with procedures solely based upon elements of the standard.

Omnex recommends that organizations study four types of processes for inclusion in the
process map – ISO/TS 16949 Processes, Product Realization Processes, Support
Processes and Business Processes. ISO/TS 16949 processes inherently fulfill the
requirements of the standard. The Product Realization Processes include product ideation,
research & development, marketing input, design & development all the way through to
delivery of product and post delivery services. The Support Processes aid the overall
organization –these include operations like training, purchasing, and document control.
The Business Processes are those processes that differentiate you from your competitor
and those that help fulfill “customer needs and expectations.” The Business Processes are
the most important processes for the success of a business. Of course, there is overlap in
the four types of processes. In fact a picture of the relationship between the four types of
processes is shown in the attached figure.

By definition, Product Realization and Support Processes are exclusive. In other words, a
process can either be a support process or a product realization process. ISO and Business
Processes can be both product realization or support processes.

After studying the different processes, the organization can create a process map that
“identifies the processes” in the organization. The process map also can show the
“sequence and interaction” of these processes. The figure of a process map was included
in the first series article of this series in May 2001 volume of the Informed Outlook.

7.3 Design and Development
The most significant change in 7.3 Design and Development is the exclusion of APQP
and second most significant change is the inclusion of process design. The exclusion of
APQP was on purpose. The APQP process will become a customer-specific document for
GM, Ford and Daimler Chrysler. The inclusion of process design by the IATF is indeed
significant. QS-9000-compliant organizations will need to carefully study the
requirements of 7.3 for process design and make the necessary changes to their APQP
process. The difficult challenge comes when the organization actually has to implement
these changes. In some QS-9000 organizations, the process-engineering group is only one
or two people.

When QS-9000 was released during late 1994, the payback to design-responsible
organizations was a systematic design process. Many organizations went from chaotic
product design to systematic design development. With ISO/TS 16949:2002 one of the
paybacks will be a systematic manufacturing process design process.

What are the challenges for process design? Organizations will need to carefully create a
design and development plan that includes all the phases of process design including –
Manufacturing Process Design Input, Manufacturing Process Design Output, Design and
Development Reviews, Monitoring of Process Design, Design and Development
Verification and then Validation of the Manufacturing Process.

Organizations can decide whether to include Machine FMEA as a verification process
and/or to include Machine Run off as a validation process. One of the opportunities is to
build Mean Time to Repair (MTTR) and Mean Time to Failure (MTBF) into the process
design. The other opportunity is to build in the entire methodology of Reliability and
Maintainability (R&M). Leading edge organizations are already practicing this.
Organizations interested in the up-front involvement of their tooling and equipment
suppliers can look to the QS-9000/TE supplement requirements. They are guidelines and
methodologies for machine FMEA, Machine Run off, Reliability, Maintainability, MTTR
and MTBF for the entire life cycle of the manufacturing process.

Process design has been elevated to the same importance as product design. Now both
design and process have the same type of expectations for inputs, outputs, verification
and validation. Tools such as DFMEA, special characteristics, Design Verification Plan
and Report (DVP&R) on the product design side and the tools such as process flow,
PFMEA, Control Plans on the process design side need to be linked. This is the
“effectiveness in practice” or the results that can be derived from implementing good
product and process design practices.

Another requirement closely aligned with 7.3 Design and Development (process) is Monitoring and Measurement of Manufacturing Process. requires that all
new processes be statistically studied as compared to PPAP which requires processes
with only special characteristics are studied. Many organizations will implement this
requirement as the last step of the Process Design and Development process.

The change in scope of 7.3 Design and Development toward including process design is
an addition that will require both new documentation and then subsequent
implementation. If implemented properly, this new requirement will result in profits for

7.4 Purchasing
The purchasing requirements have not changed very much. Organizations will need to
continue following their purchase order process (7.4.2 Purchasing Information), Supplier
Development ( Supplier Quality Management System Development) process, and
Receiving Inspection process (7.4.3 Verification of Purchased Product). What has
changed is the scope of supplier development and the new deadline imposed for supplier
development. A note on the bottom of 7.4.1 Purchasing process carefully defines
purchased products as including “all products and services that affect customer
requirements.” Organizations will be required to carefully study their supplier lists and
add in all suppliers that affect customer needs and expectations. (Note “requirement” is
defined in ISO 9001:2000 as a “need or expectation”.)

A series of three notes in the bottom of Supplier Quality Management System
development requires that suppliers of products and services that affect customer
requirements comply with ISO 9001:2000 by Dec. 15, 2003. This, of course, is the first
step of the ultimate goal of driving the manufacturing supply base to ISO/TS 16949,
Second Edition.

This requirement is causing concern among QS-9000-registered organizations. Many QS-
9000-registered organizations do not feel that they have the clout to impose standards on
their supply base. Omnex has seen the effects of standards on supply bases since Q-101
and Targets for Excellence. Organizations are encouraged to move forward as follows:

1) Determine your product and service supply base (i.e. add to your key supplier lists).
2) Determine the criteria and deadlines for supplier development requirements,
   including ISO 9001:2000, by Dec. 15, 2001 and TS-16949, Second Edition
3) Announce the requirements and criteria to your supply base.
4) Have evidence that you are trying to comply with the intent of the standard.

Typically organizations mention all the exceptions as reasons why they cannot implement
supplier development – ie. suppliers who are unwilling, small or strategic. Omnex’s
suggestion is to formulate your strategies around 95% of your supply base and not the
exceptions. Both your customer and auditor will understand the odd exceptions.

This article covers three of the seven significant challenges facing QS-9000 registered
organizations transitioning to ISO/TS 16949, second edition. There is a lot of work ahead
for companies with only approximately two years remaining. Organizations need to make
their plans to transition to ISO/TS 16949, Second Edition today.

How much work your organization has depends on the quality of your QS-9000
registration. The remaining four requirements and more on the case study will be covered
in greater detail in the next article.

Case Study of an International Tier One Supplier
A registrar that was not on the IAOB list audited this organization. At the end of the
registrar’s contract for QS-9000, this company decided to change registrars to one of the
registrars included on the IAOB list.

The organization had thought that it could very easily transition to both ISO 9001:2000
and ISO TS 16949. In fact, they had already been working for over five years on meeting
excellence standards.

The assumption audit included a transition from ISO 9001:1994 and QS-9000:1994 to
ISO 9001:2000 and ISO/TS 16949:1999. The audit was a wake up call. The company
ended up with several majors – including one that required them to align with a “site”
since they were technically a “remote location”. This company has a design center, sales,
purchasing and some senior management located in the US.

Some of the nonconformances resulted from the lack of preparation of the auditors. In
fact, they had not completed a document review prior to the onsite audit. The other non-
conformances were there because the organization was not prepared for both ISO
9001:2000 and TS-16949:1999.

This company has a few special circumstances. Ten to fifteen product lines are located in
the US. Several of the Business Units that the product line reports to are located in
Europe. What then is the definition of “top management”?

After the poor showing on the audit, this organization contacted Omnex. We collectively
decided that it did not make sense for them to pursue ISO 9001:2000 and ISO/TS
16949:1999, but that they should instead pursue ISO 9001:2000 and ISO/TS 16949:2002,
which had just become available in final draft form.

The implementation is in its infancy. The scoping of the implementation is the first
challenge. Then the requirements of the ISO TS 16949 and ISO 9001:2000, especially
management review, linkage of processes, and purchasing, are other significant issues.
This case study will be expanded in the future issues of Informed Outlook.