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8/6/2019 InfOutlook-TransitionQStoTS_Part05
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S P E C I A L
R E P R I N T
…your source for the latest information on international management system standards
®
This reprint is provided with compliments of…
What Is the “Real” Deadline for Transition to TS 16949:2002?
Thr ee Mor e Key Challenges ofTr ansit ion to TS 16949:2002
By Chad Kymal andDave Watkins
Publisher’s Note: This article has beenreprinted with permission from TH E
INFORMED O UTLOOK Newsletter,
September 2002 issue.
If your organization is a supplier to
one or more of the Big Three, what
is the real deadline for transitioning
from QS-9000 to ISO Technical Specifi-
cation (TS) 16949:2002? And what if
you supply to other automotive original
equipment manufacturers (OEMs) that
have required registration to QS-9000 or
another sector-specific quality manage-ment system (QMS) requirements cata-
log that is to be replaced by ISO/TS
16949? What is the real deadline for
transitioning your organization to ISO/
TS 16949:2002, Quality management
systems—Particular requirements for the
application of ISO 9001:2000 for auto-
motive production and relevant service
part organizations?
As has already been reported,
DaimlerChrysler announced in late July
2002 that its Tier 1 suppliers worldwide
are required to transition from QS-9000
to ISO/ TS 16949:2002 by July 1, 2004,
while the Big Three released a joint
letter in early August 2002 officially
stating that the TS will replace QS-9000
on December 14, 2006 (see
“DaimlerChrysler Sets July 2004 Tier 1
Mandate”, THE OUTLOOK , August2002). The other OEMs in Europe and
some in the Asia-Pacific Rim region are
likely to issue ISO/TS 16949 deadlines
closer than the paramount 2006 dead-
line for transitioning from QS-9000.
However, our organization main-
tains that the realistic deadline should
be December 15, 2003. That is the date
when ISO 9001/2/3:1994 become
obsolete as far as accredited registration
is concerned, so automotive suppliers
that wish to retain their ISO 9001/2-
registered status (keeping in mind thatISO 9002 will no longer be an option)
must treat December 2003 as the real
deadline. Otherwise, organizations that
want to maintain an ISO 9001 registra-
tion and a QS-9000 registration would
have to go through two audits—one for
ISO 9001:2000 and one for QS-9000
conformity.
In practical terms, implementing
ISO 9001:2000 on top of QS-9000 so
as to satisfy nonautomotive and auto-
motive customers does not make sense
for several reasons. First, organizations
would find many duplicate and contra-
dictory requirements. For example,
management review is specified in both
ISO 9001:2000 and QS-9000/ISO
9001:1994, and organizations would
have to comply with two sets of dupli-
cate requirements.
Also, organizations may find that
quality planning, which is covered by
Subclause 4.2.3 in QS-9000/ISO
9001:1994 and Clause 5.4, Planning,
are almost contradictory, with one fo-
cusing on product planning and the
other focusing on business planning.Ultimately, it is possible to reconcile
QS-9000 with ISO 9001:2000 and
create a single QMS that satisfies the
requirements of both, but it is easier
said than done.
Second, it is not practical or pro-
ductive to transition twice. It would
prove much easier for a QS-9000-regis-
tered supplier to revise its QS-9000-
conforming QMS to satisfy the
requirements of ISO/TS 16949:2002
and upgrade its QS-9000 registration to
it. The supplier would thereby achievesimultaneous conformity with ISO
9001:2000, which is contained verba-
tim in the second edition of the TS.
The other option is to maintain QS-
9000-based procedures and implement
changes to satisfy ISO 9001:2000 only
to have to transition again within 2-4
years to ISO/TS 16949 when QS-9000
becomes obsolete.
Therefore, December 15, 2003, is
for all practical purposes the de facto
deadline for organizations that want to
maintain their ISO 9001 status and
meet automotive OEM contractual
requirements, since it would be confus-
ing and difficult to meet the Q S-9000
O m n e x , In c .7 3 4 -7 6 1 -4 9 4 0 ✧ w w w . o m n e x . c o m
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2 ✧ TH E I N FO RM ED O u t l o o k Reprint: September 2002
© 2002 by INFORM Web Site: HTTP:/ / WWW .INFORM INTL.CO M
and ISO 9001:2000 requirements and
then have to revamp the QMS once
again soon thereafter.
Our organization suggests that
suppliers that cannot complete the ISO/
TS 16949:2002 transition by December
15, 2003, should continue with QS-
9000 registration beyond the ISO
9001:2000 deadline but not upgradetheir QMSs solely to conform with ISO
9001:2000. Instead, they should let any
separate “ISO 9001/2 registration”
status lapse while they focus on imple-
menting an ISO/TS 16949:2002-con-
forming QMS and moving directly to
TS registration at some point in 2004.
True, the extended use of ISO
9001:1994’s quality system requirements
in QS-9000 does appear to give additional
time to suppliers that find the task of
transitioning to ISO/TS 16949:2002
challenging. However, as future OEM
requirements have begun to take shape,
making that transition is taking on in-
creasing importance as we continue our
series examining what we have identified
as 15 key challenges for automotive sup-
pliers that plan to transition their QMSs
from the third edition of QS-9000 to the
second edition of the TS. We have already
explored 6 of those challenges in two
previous entries in this series as indicated
in Table 1 on the next page, which sum-
marizes the 15 challenges.In this entries in the series, we will
explore Clause 5.2, Customer Focus,
“7.0,” Product Realization, and Sub-
clause 8.2.2, Internal Audit, to help you
understand and effectively meet each of
the 15 key challenges.
5.2, Customer FocusThis is the requirement of ISO
9001:2000, to which ISO/TS
16949:2002 provides no additions,
where most implementers need to start
when designing what we refer to as theirQuality/Business Management Systems
(QBMSs). Our organization is in the
process of assisting several hundred
organizations worldwide in their imple-
mentations of ISO/TS 16949:2002. In
most of these organizations, customer
expectations are taken as an implemen-
tation afterthought rather than the first
place to start.
Customer expectations influence
and impact on an organization’s strategy(including the objectives and business
plan), which is then implemented by
processes that carry the strategy out. If
the strategy correctly drives the organi-
zation and its processes are effective, the
organization will meet customer expec-
tations. Thus, there is a chain reaction
between customer expectations, strategic
objectives, the business plan and pro-
cesses designed to meet the objectives of
an organization.
Figure 1 below shows how customer
requirements, which are addressed in
Clause 5.2 in ISO/TS 16949:2002/ISO
9001:2000, are connected to other ele-
ments and activities of the QBMS that
are addressed elsewhere in ISO/TS
16949:2002. If an organization under-
stands that its management system must
start with customer requirements, it will
Reprinted with permission from
THE INFORMED OUTLOOK
September 2002 issues
THE INFORMED OUTLOOK ✧ 15913 Edgewood Drive✧Montclair, VA 22026Tel: (703) 680-1436 ✧ Fax: (703) 680-1356
E-Mail: [email protected] ✧Web Site: HTTP: WWW.INFORMINTL.COM
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…and a SPECIAL subscription offer (code OMNEX-0209)!
be able to implement a QBMS that
meets all the requirements of ISO/TS
16949 because it flows naturally from
how a business operates, that makes sense
to the employees using the system be-
cause it flows the way processes occur in
a business and that is easy to implement
because it is understandable and seen as
having value by everyone from top man-
agement to the sales reps to the produc-
tion line workers.
When determining which customer
expectations are to be met, the imple-
mentation team will need to decide
whether it is only going to look at “cus-
tomers” alone or to take an ISO
9004:2000 or Baldridge view of “inter-
ested parties”. ISO 9000:2000, Quality
management systems—Fundamentals and
vocabulary, defines an “interested party”
in 3.3.7 as a “person or group having an
interest in the performance or success of
an organization”. Thus, an organization
could consider some or all interested
parties as “customers” with expectations
to be met.
As the number of expectations grows
or varies, what would they impact? Figure
1 should lead you to understand that your
Figur e 1. Links Betw een Customer Requir ements and Pr ocesses
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organization has to set objectives around
expectations and then design processes
that can deliver these expectations. The
implementation team will look at the need
to consider the expectations of interested
parties in designing processes as additional
“work”, but some interested parties (e.g.,
community, employees, suppliers) may
play a key part in the organization’s suc-
cess. In some cases, these parties may be as
important a part as the end customer. If
parties other than customers have the
potential to influence an organization’s
success or even existence, the implementa-
tion team should include the expectations
of interested parties in developing the
QMS for the organization’s own self-
interest and survival.
Our organization has developed a
template that relates customer expecta-
tions to organizational processes, strategicobjectives and process control methods.
This table can be used to align customer
expectations with an organization’s
QBMS activities, and we recommend
that our clients adapt this table to their
operations and include it as part of their
Quality Manuals. Table 2 on the next
page provides an excerpt of what this
table would look like if completed for a
hypothetical organization.
Some in the automotive sector have
noted that QS-9000 already mentions
customer expectations in Subclause
4.1.4, Business Plan, where it states,
“Methods to determine current and
future customer expectations shall be in
place.” However, this requirement is
buried in the overall requirements. We
know of no supplier that implemented
or audited for customer expectations in
conforming to QS-9000. So, where in
ISO/TS 16949:2002 is there a require-
ment regarding “customer expecta-
tions”? Furthermore, where does it ask
for objectives to be aligned to expecta-tions and for processes to be aligned to
strategy?
If you study Clause 5.2, Customer
Focus, what it really is saying is, “Your
organization needs to understand and be
capable of satisfying customer require-
ments.” Indeed, throughout ISO/TS
16949:2002/ISO 9001:2000 are re-
quirements that the organization “meet
customer requirements”. ISO
9000:2000 defines “requirement” in
3.1.2 as a “need or expectation that is
stated, generally implied or obligatory”.Thus, 5.2 requires your organization to
understand and be capable of satisfying
customer needs and expectations.
If you then look at Subclause 5.4.1,
Quality Objectives, you will find that
the TS adds to ISO 9001:2000 a NOTE
that states,
Quality objectives should address
customer expectations and be achiev-
able within a defined time period.
Table 1. The 15 Key ISO/TS 16949 :2002 Tr ansit ionChallenges for QS-900 0-Regist er ed Or ganizat ions
Clause/ Subclause Influenced by Challenges
4.1, Quality Management ISO 9001:2000 Requirements for process map (orSystem—General equivalent), process management,Requirements* customer-oriented processes, support
processes and process characteristics
5.2, Management ISO 9001:2000 Decision on customers vs. interestedResponsibility— parties. Need for process to gather “needsCustomer Focus and expectations” of customer/interested
parties
5.4.1, Planning—Quality ISO 9001:2000 & Deployed Objectives addressing customer
Objectives† TS 16949:1999 expectations
5.5.3, Internal ISO 9001:2000 Creation of internal communicationCommunication processes suitable to organization
5.6, Management ISO 9001:2000 & Revision of previous management reviewReview† TS 16949:1999 process. TS adds additional items to be
reviewed
6.1, Resource ISO 9001:2000 Establishment of a resource allocat ionManagement—Provision processof Resources
6.2, Human Resources ISO 9001:2000 & Provision of job competency, on-the-job(particularly 6.2.2.3 and TS 16949:1999 training and employee motivation and6.2.2.4) empowerment
7, Product Realization ISO 9001:2000 Documents for “effective control” of allprocesses in process map
7.1.4, Change Control New (actually Minor change for most suppliersFord’s Q1 2002)
7.3, Design and New Inclusion of design and development of Development* processes, not just product (note required
development and use of FMEAs)
7.4, Purchasing* New Inclusion of service suppliers in coverageand use of supplier monitoring indicators.ISO 9001:2000 registration of suppliers
8.2.1, Monitoring and ISO 9001:2000 Customer rating for quality and deliveryMeasurement—Customer insufficient; monitoring of “customerSatisfaction† perceptions” of quality. Importance of
customer satisfaction—supplementalrequirements, including delivered partquality and schedule performance to IATF
8.2.2, Internal Audit TS 16949:1999 Manufacturing process and productaudits and audits based on COPS andprocess approach
8.2.3, Monitoring and ISO 9001:2000 & Process studies on manufacturing processes.Measurement of Processes TS 16949:1999 Measurement of all processes in process map
8.4, Analysis of Data ISO 9001:2000 Increased scope from QS-9000
*Clauses/Subclauses examined in the third article in series (November 2001).†Clauses/Subclauses examined in the fifth article in series (July 2002).
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Table 2. Customer Expect ations Alignment Wit h Or ganizat ional Act ivi t ies
Activity Key Processes/ Customer Target Specification Control/ Monitoring
COPs Expectation Measurable Reference Method
Manufacturing and Order processing Short cycle time Cycle-time 20 days Monthly operations
Logistics in production review
Manufacturing and Manufacturing On-time delivery % OTD 100% Weekly operations
Logistics process (OTD) meeting
So, there is an explicit intent in
ISO/TS 16949:2002 that expectations
and objectives be aligned. Furthermore,
Subclause 5.4.2, Quality Management
System Planning, requires top manage-
ment to ensure that
a) the planning of the [QMS] is
carried out in order to meet the
requirements given in 4.1, as well
as the quality objectives,… .
The planning then needs not only
to address how the objectives are going
to be met, but to ensure that processes
in the process map are implemented.
To understand the linkage between
5.2 and Section 7, Product Realization
(processes in the organization planned
in Clause 4.1, Quality Management
System—General Requirements, and
5.4.2), you need only to study the QMS
process model. Customer requirements
are an input into an organization’s pro-
cesses (i.e., product realization and
support processes), which translate these
inputs into product (which is an out-
put). There is thereby a linkage between
what customers want as determined per
5.2, the objectives set by the organiza-
tion per 5.4.1 and the processes per-
formed per Section 7.
The only way organizations can
ensure that they are “capable of satisfy-
ing requirements” is to t ranslate a cus-
tomer requirement into a processrequirement for the organization. This
expectation needs to be translated to a
process measurable, as shown in Table 2,
and then measured and improved as
required by Clause 4.1d), e) and f).
“7.0”, Product Realization
(Organizational Processes)The product realization processes
and support processes in Section 7 need
to deliver the “product” to the customer.
Section 7 includes not only six clauses
that specify processes that run the range
of an organization’s production cycle
(i.e., from 7.1, Planning of Production
Realization, to 7.6, Control of Monitor-
ing and Measuring Devices), it also
includes all the processes in the process
map as required by Clause 4.1. Indeed,
earlier versions of Table 1 in this series
labeled this challenge as “7.0” because itis almost as if a separate clause existed
here on process mapping.
Although the TS does not require
the use of process maps or flows, the
only practical way to ensure that all
processes that are needed are included in
the QMS is through the use of process
mapping and process flows. And process
mapping will be most critical to effec-
tively meeting the requirements of Sec-
tion 7. Indeed, we believe process
mapping and process flows are the big-
gest differences between QS-9000 and
ISO/TS 16949:2002.
In QS-9000, organizations were
only required to implement procedures
that met all the requirements specified
in the “shalls” and “shoulds”. In ISO/TS
16949:2002, the organization needs to
“identify the processes needed [and]
determine the sequence and interaction
of these processes” (4.1a and b). And the
processes need to fulfill all the require-
ments of the customer, as discussed
above. Processes that start with a cus-tomer input and result in an output that
goes back to the customer are known as
“Customer Oriented Processes” or
COPs, as described in “More Challenges
of QS-9000 to TS 16949:2002 Transi-
tion” (THE OUTLOOK , July 2002).
An organization must have pro-
cesses that fulfill the “shalls” of ISO/TS
16949:2002. For example, it needs
processes for management review (5.6)
and control of measuring and monitor-
ing devices (7.6) as well as product
realization processes (e.g., research and
development, support processes such as
hiring and customer-oriented processes
such as warranty). In other words, the
implementation team needs to carefully
study what processes are required by the
organization to fulfill organizational
needs as well as the needs of customers/
interested parties.When it comes to documentation,
ISO 9001:2000 requires less, with only
six procedures specified as needing to be
documented, although most organiza-
tions will maintain much of the docu-
mentation they had before if they found
it necessary to ensure processes are con-
ducted consistently and effectively or
found it value-adding to their opera-
tions. These reasons will in fact be one
and the same in many instances. Unlike
ISO 9001:2000 but like QS-9000, ISO/
TS 16949:2002 requires all the pro-
cesses required to fulfill organizational
and customer/interested party needs to
be documented.
Note that you will not find the need
to document some of these processes in
the requirements contained in the TS,
but the International Automotive Task
Force (IATF), which drafted ISO/TS
16949:2002, has conveyed this require-
ment in the content of mandatory train-
ing courses for registrars and their
auditors and in ISO/TS 16949:2002rollout meetings. The training requires
auditors to analyze the following process
characteristics for each process:
1. A process owner exists
2. The process is defined
3. The process is documented
4. Process linkages are established
5. The process is monitored and
improved
6. Records are maintained.
The best way to satisfy 1, 2 and 4
above and thereby satisfy trained audi-
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Summat ion of IATF Comment s on Regis t r arAuditing and Gaps Found in PilotAuditing ISO/TS 16949:2002—Key Approach Differences as Viewed by the IATF:
● Process Approach to Audit❍ Customer Oriented Processes. These processes start with cus-
tomer requirements and then end with output. The input and out-
put need to be checked against each other to see if the output
satisfies the input. The IATF wants all the COPs identified in theorganization.
❍ The IATF wants the process to have a clear line of sight from the
customer to the organization.● The Audit Plan should have key processes instead of just elements.The Plan needs to identify the key processes
● Performance❍ Linked to common metrics for the organization and its suppliers
(per 8.2.1.1, Customer Satisfaction—Supplemental, and 7.4.3.2,Supplier Monitoring)
● Oversight—Adherence to the ISO/TS 16949:2002 registration scheme“rules” and common global oversight body process
● An organization needs to throw away the checklist and use its proce-
dure to do the internal audit. Use the checklist to make sure your organi-zation is thorough but not as the definitive list of what the QMS must do to
conform with the TS● The IATF stressed the problem of remote locations not being able to
get certificates and to identify which sites are production or manufacturing● To obtain ISO/TS 16949:2002 certificates of registration, sites must be
automotive production and service parts suppliers● Each OEM will have a link to its web site where the customer-specificrequirements documents can be obtained.
Gaps Found During Pilot ISO/TS 16949:2002 Registrar Audits:● Control Plans were poor and not followed
● Customer specifics ignored● Registration scheme rules not followed
● Internal auditor training was poor● Records not linked to procedure● On-the-job training not addressed
● Unreported changes (production part approval process or PPAP)● Management never audited
● Interface between site and remote location not followed● PPAP does not meet requirements
● GRR (gage repeatability and reproducibility) performed by calibrationtechnicians and not production operators● Written findings did not have three elements—requirement, objective
evidence and nature of NC (nonconformance)
tors is to use process flows, which are
discussed in the fourth entry in this
series (see “What QS-9000 Registered
Suppliers Need to Prepare For”, THE
OUTLOOK , April 2002).
8.2.2, Internal AuditWith internal auditing, the biggest
difference between QS-9000 and ISO/ TS 16949:2002 is that QS-9000 does
not specify system or process audits.
Clause 4.17 of QS-9000 only requires
internal audits to be performed (in
accordance with Appendix B, Code of
Practice for Quality System Certifica-
tion Bodies/Registrars) that cover all the
elements of QS-9000. ISO/TS
16949:2002 is more specific and re-
quires system and product audits on top
of process (elemental) audits. The inter-
nal system audits need to evaluate the
processes in the organization, including
COPs and their support processes.
The product audits in ISO/TS
16949:2002 must verify conformance to
product dimensions—requirements in
the manufacturing processes—while the
process audits need to assess the manu-
facturing processes for conformity with
defined procedures and customer speci-
fications. Subclause 8.2.2 of ISO
9001:2000 is an important requirement
that can drive QBMS improvement and
has already been the topic of muchcoverage in THE OUTLOOK and will
continue to be covered in detail in fu-
ture issues.
Where do automotive suppliers
need to look to see what is actually
expected of internal auditors, the inter-
nal audits they conduct and the reports
and results from those audits? Experi-
ence has shown that third-party regis-
trar/auditor requirements tend to flow
down into the organizations being au-
dited, thereby impacting on internal
audits.While internal audits should be
conducted to verify the QMS conforms
to ISO/ TS 16949:2002 and is meeting
customer and organizational needs and
expectations and to identify opportuni-
ties for continual improvement of the
system and processes, registrar auditors
will be examining your organization’s
internal audit program to ensure it
meets the requirements of Subclause
8.2.2 and does so to the expectations of
the OEMs that subscribe to the TS.
Those OEMs, which are members
of the IATF, have issued “comments” on
registrar auditing based to a large degree
on their observations of registrar audits
of automotive suppliers for conformity
with ISO/TS 16949:2002 during an
IATF pilot registration program in
February 2002. What the IATF had to
say about the registrar audits it wit-
nessed, where there were problems and
need for improvement in auditing prac-
tices and what the key differences with
ISO/TS 16949:2002 were is worth
examining and keeping in mind as you
begin to evaluate and revise your inter-
nal audit program.