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How Can You Move From QS-9000 to TS 16949:2002?

A Plan for the Tr ansit ion fr omQS-9000 to TS 16949:2000

By Chad Kymal andDave Watkins

Publisher’s Note: This article has beenreprinted with permission from TH E

INFORMED OUTLOOK Newsletter,

August 2001 issue.

What is the future of automo-

tive sector-specific quality

management system (QMS)

requirements? And what should your orga-

nization do to plan for a transition you

should seriously consider making in 2002?

We had the opportunity to see recent

drafts of the second edition of ISO/

Technical Specification (TS) 16949:2002Quality management systems—Automotive

suppliers—Particular requirements for the

application of ISO 9001:2000, which

indicate that TS 16949:2002 will fully

align with ISO 9001:2000, Quality man-

agement systems—Requirements. Also, the

International Automotive Task Force

(IATF) additions to TS 16949, with only

a few minor edits, have been mapped

directly to ISO 9001:2000’s structure.

Although changes could still be

made before the second edition is pub-

lished as a revised ISO/TS, the latest

draft we saw is the one that will circulatewithin ISO Technical Committee 176

for a ballot of approval. The issue re-

mains whether and when an automotive

supplier should consider making the

switch from the third edition of QS-

9000 to TS 16949:2002 (for details onthis topic, see “The Impact of ISO

9001:2000 on QS-9000 and ISO/TS

16949”, THE OUTLOOK , May 2001).

In essence, the challenge for QS-

9000-registered companies will be to

implement within their organizations

methodologies to help them become

“customer- and process-focused”. The

key question then is: What steps should

QS-9000-registered companies take to

implement TS 16949:2002?

While it would be inappropriate

now to discuss the details of the latest

draft until all the pieces of the TS

16949:2002 equation are known—

especially the customer-specific require-

ments of all the original equipment

manufacturers (OEMs) that are addi-

tional to the TS—there are 5 steps your

organization can take, plus an alternative

approach, to use ISO 9001:2000 and TS

16949:1999 to be ready for the future.

1. Create a Process Map andUnderstand Customer Requirements

Before you do anything, study your

organization—follow the product devel-opment process and interview personnel

in that process. To create a process map,

you need to identify all your organization’s

key activities from new product ideation

to research, design and development to

production and all the way to the ship-

ping and delivery procedures. To make

sure the process map you end up with is

useful to your organization, identify all

the support processes that affect the devel-

opment and delivery of your product, as

shown in Figure 1 on page 4.

Next, try to make an initial cut of

who your “customers” are. Decide whetherthe QMS you are going to create will

support only customers for your product or

will satisfy the requirements of all the

“interested parties” or your organization.

The implications of this decision are im-

mense. The processes needed to support

“interested parties”—owners/investors,

lenders, personnel, suppliers/partners, the

community—may result in incorporating

many more processes to your process map.

In ISO 9004:2000, Quality management

systems—Guidelines for performance im-

provements, Clause 5.2, ManagementResponsibility—Needs and Expectations of

Interested Parties, contains useful guidance

and recommendations on this topic.

It is important to understand each

need and expectation of your customers

and/or interested parties. It will help

answer the question: What process or

set of processes will satisfy these expec-

tations? (See Figure 1.) The organiza-

tion may find that it actually needs to

create new processes.

Lastly, check to see whether the

process map includes every ISO

9001:2000 process. Do you have pro-

cesses for identifying and analyzing

customer expectations and needs re-

O m n e x , In c .7 3 4 -7 6 1 -4 9 4 0 4 w w w . o m n e x . c o m



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garding your organization’s capabilities

(customer requirements as envisioned in

Clause 5.2, Customer Focus)? Are there

processes for capturing and analyzing

customer expectations for product (cus-

tomer requirements as envisioned in

Subclause 7.2.1—Determination of

Requirements Related to the Product)?

2. Conduct Gap Analysis of theExisting System

Now, examine the documentation

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structure behind your organization’s

QMS. Do you have the necessary pro-

cesses documented? If so, verify whether

you have “documents needed by the orga-

nization to ensure the effective planning,

operation, and control of its processes” as

required by Subclause 4.2.1(d), Docu-

mentation Requirements—General.

Also, determine if “both the opera-tion and control of these processes are

effective” per Clause 4.1(c), Quality

Management System—General Require-

ments. Taking these steps, which in-

volves asking questions about the

existing QMS, should result in the

clarification of your organization’s docu-

mentation needs for satisfying custom-

ers and/or interested parties.

ISO 9001:2000 does not restrict an

organization from documenting any

process that is part of its QMS, but it

does require six procedures to be docu-mented that are already required by QS-

9000 and TS 16949:1999. Ultimately,

the IATF has retained documentation

requirements in TS 16949:2002 beyond

those required by ISO 9001:2000.

Once you have taken the steps

above, it is now time to conduct an audit

or gap analysis to prepare for revision of

your QS-9000-registered quality system

to conform with TS 16949:2002’s re-

quirements, even before it is available.

The changes to the automotive require-

ments in the draft from the first edition

are minimal, so using TS 16949:1999

and ISO 9001:2000—we recommend

using ISO 9004:2000 as well—will pro-

vide you with the right criteria to mea-

sure your organization’s QMS against.

The greatest adjustment will be

from QS-9000 to TS 16949, so Table 1

on page 5 lays out the key differences

between TS 16949 and QS-9000 to

show you where you need to focus.

Once the gaps have been identified,

your organization should develop a

timing plan for implementing TS

16949:2002. Implementing TS 16949requires two methodologies. The first

links customer expectations to objectives

DeliveryProductQuality

ServiceQuality

FinancialStability

Ship

On Time

No

Rejects

Quick

QuoteResponse

Diversify

Ship

Complete

No Low

Cpk

Bar-Coded

Labels

Figur e 2. Customer Expect at ions Categor ies

Figur e 1. The Complete Pr ocess Map



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and then to key processes, something

our organization calls the Business Op-

erating System (BOS) process. The

second institutionalizes continual im-

provement at the process level, which

our organization calls the Process Re-

view Methodology (PRM).

3. Implement BOSThe first step in implementing BOS

involves identifying customer and inter-

ested-party expectations. In working with

our clients, our organization uses a pro-

cess by which we list, group and rate

expectations using Post-It notes. Through

these groupings into Customer Expecta-

tions Categories, we are able to better

align the customers’ or interested parties’

expectations with processes and metrics,

as demonstrated in Figure 2 at left.

Another key step in this methodol-

ogy is the use of alignment charts to link each expectation category to the key

processes and process measurables that

need to be measured and monitored to

satisfy the requirements of Clause 4.1(e)

and Subclause 8.2.3, Monitoring and

Measurement of Processes, of ISO

9001:2000. Figure 3 on page 6 provides

an example of an alignment chart that

would be used by an automotive sup-

plier to satisfy critical, value-added

requirements of TS 16949 and improvethe effectiveness of the QMS and the

organization’s customer satisfaction.

To effectively satisfy Subclause 5.4.1,

Planning—Quality Objectives, of ISO

9001:2000, the organization should use

benchmarking to determine what its

short- and long-term objectives should

be. The organization’s improvement

plans or planning to meet overall objec-

tives (per Subclause 5.4.2, Quality Man-

agement System Planning) are thereby

accomplished by using BOS. With BOS,

the organization will be on its way to

achieving both enterprise improvement

and breakthrough process improvement.

4. Implement PRMPRM is a method of documenting

and controlling QMS processes. It takes

the processes in the process map and

your organization’s documentation and

applies Process Flows (PFs), Process

Failure Mode and Effects Analyses

(PFMEAs) and Control Plans to ensure

the documentation your organizationhas is effective and that its QMS pro-

cesses are under control.

The tools and methods used for

QS-9000 compliance of production

processes are used in PRM for the analy-

sis and control of nonmanufacturing

processes. An organization does not

need to document every process using

PFs, only those that require documenta-

tion to “ensure the effective planning,

operation and control of its processes”

or key business processes of the organi-

zation that need this kind of analysis.

However, each process uses

PFMEAs for documenting problems or

Table 1. Compar ison of Requir ements in ISO/TS 16949:1999 vs. QS-9000Requirement ISO/TS 16949 QS-9000*

Quality Policy, Objectives 4.1.1.2 (New)† None

Continuous Improvement 4.1.1.4 (Partially New)† None; 4.2.5.2; 4.2.5.3

Quality Responsibility 4.1.2.1.3 (Partially New) 4.1.2.5;4.1.2.1.a NOTE

Shift Resources 4.1.2.2.2 (New) None

Management Review – Supplemental 4.1.3.2 (Partially New) 4.1.3.1

Analysis and use of Company Level Data 4.1.5 (Partially New) 4.1.5

Employee Motivation, Empowerment and Satisfaction 4.1.6 (New) None

Certification Body/Registrar Notification None 4.1.6.1

Quality System Documentation 4.2.2.2 (New) None

Quality Plan Requirements 4.2.3.2 (New) None

Product Realization, General 4.2.4.1 (Partially New) 4.2.3.1; 4.4.11

Computer Aided Design 4.2.4.6 (Partially New) 4.4.4.1

Special Characteristics 4.2.4.7 (Partially New) 4.2.3.2

Management of Process Design, General 4.2.4.9.1 (New) None

Management of Process Design, Process Design Input 4.2.4.9.2 (New) None

Management of Process Design, Process Design Output 4.2.4.9.3 (New) None

Management of Process Design, Process Verification 4.2.4.9.4 (New) None

Quality System Performance 4.2.8 (New) None

Design Input, Design Optimization 4.4.4.2 None

Maintaining Process Control Requirements 4.9.3 None

Corrective Action Plan 4.13.1.3 (Partially New) 4.13.2.1Returned Product Test/Analysis 4.14.2.3 (Partially New) 4.14.2.1

Inventory 4.15.3.2 (Partially New) 4.15.3.1

Production Scheduling 4.15.6.3 (Partially New) 4.15.6.2

Process Audit 4.17.2.3 (New) None

Product Audit 4.17.2.4 (Partially New) 4.10.4.2

Auditor Qualification 4.17.3 (New) None

Training Effectiveness 4.18.2 (Partially New) 4.18.1

Training on the Job 4.18.2 (Partially New) None

Servicing Agreement with Customer 4.19.3 (New) None

*Some of the additions to QS-9000 are IASG Sanctioned Interpretations.

†“New” identifies new requirements in TS 16949:1999; “Partially New” indicates that both documents share the same requirements to some degree.



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“failure modes” and then recommended

actions to be taken. In this manner,

small improvements at the process level

can be identified and documented, as

required by Clause 4.1(f) and Subclause

8.2.3. A Control Plan is used at the

process level for planning the types of

controls required to ensure the outputs

of the process meet the intended out-come of the process. This document

links the BOS process measurables and

the PRM approach.

Our organization has been using

these tools since 1995 in

nonmanufacturing settings with great

success. QS-9000-registered clients with

which we have worked are using PRM

as displayed in Figure 4 on page 7 to

document, control and improve theirnonmanufacturing processes.

5. Implement TS 16949:2002One of the greatest challenges—and

benefits—of implementing TS

16949:2002 is that it will require a QS-

9000-registered organization to become

customer-focused as well as process-

focused. The other major changes be-

tween ISO 9001:1994 and ISO

9001:2000, such as customer satisfaction,continuous improvement and data analy-

sis, are already required by QS-9000, so

these transition elements are non-starters.

Becoming customer-focused re-

quires an organization to implement a

methodology like the BOS process,

while becoming process-focused requires

a process map and an implementation

process like PRM. However, it also

requires an organizational culture

change. The application of cross-func-

tional management, matrix organiza-

tions and process-based organizational

requirements may be considered but are

not required by TS 16949:1999, nor

will they be in the second edition.

Organizations are encouraged to

understand and learn more about ISO

9001:2000, which will require more

adjustment and cultural change for most

organizations than TS 16949. What is

also clear is that organizations need not

wait until 2002 to in effect implement

TS 16949:2002, even though registra-

tion cannot be achieved yet and cus-

tomer-specific requirements may be

adjusted by the time the second editionis printed. Most important, implement-

ing methodologies to become customer-

focused and process-oriented do not

require any standards to initiate the

process, so you should start your

organization’s change to the new re-

quirements now because they make

business sense in an increasingly com-

petitive marketplace.

An Alternative: The MinimalistApproach

The minimalist approach is thealternative to what clearly is a commit-

ment of resources and involves some

effort by management to improve the

organization:

Make No Change

This is the approach some organiza-

tions may take. It involves an organiza-

tion making changes only to the Quality

Manual (Level One) by rewriting it to

Figur e 3. Example of an Alignment Char t

ProcessEngineering

QualityAssurance

ProcurementKeyProcesses

PoorProcess

Design

ProblemsNot

Resolved

PoorIncoming

Product

Potential

Causes

Eliminate

Reworks

Owner

ProductQuality

External

Quality20 ppm

Date

Internal

Quality99.95%

FOA Date

ResultMeasurables

ProcessMeasureables

Customer ExpectationsCategory Strategic Goals

No Incoming

Inspections

GM

Improve

ProblemSolving

Ford

External

Quality

PPM per Part

InternalQuality

Rejects per1000 pieces

ProcessCapability

% Cpk<1.33

Problem

Solving

# Recurring

Problems

Material

Quality

Tons

Rejected



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include Q MS scope, exclusions, and

adding a process map that shows “a

description of the interaction between

the procedures of the quality manage-

ment system.” This process map would

also reference the procedures in the

Procedures Manual (Level Two).

No new procedures would need to

be added since typically a QS-9000-conforming system will already have

documentation for the six procedures as

required by ISO 9001:2000.

If the minimalist approach is taken,

an organization will need to consider

the following:

● Is its documentation written around

the organization’s processes? In other

words, its Procedures manual must not

be written to the elements of QS-9000,

but around its business processes.

● All the processes required to meet

“customer and applicable regulatoryrequirements” (Clause 1.2, Scope—

Application) should be identified within

the process map (Clause 4.1[a]). Has

the organization identified all the pro-

cesses it needs to satisfy all customer and

regulatory needs and expectations?

● If the process map shows that the

“contract review” process flows into the

“program management” process in

APQP, then the contract review proce-

dure needs to clearly show how it hands

off to the program management proce-

dure. The inputs and outputs between

the two processes need to be carefully

defined. This type of linkage should be

evident between all processes linked in

the process map.

● Each process, including training

and management review, is being moni-

tored, measured and analyzed, as per the

requirements of Clause 4.1(e).

Organizations and auditors need tobe careful not to fall into the trap of the

minimalist approach. In effect, no im-

provement will be evident in such a

system. More important, the organiza-

tion will not make any movement for-

ward in becoming customer- or

process-focused, which could be detri-

mental in the long-term even if the

OEMs it supplies never require TS

16949:2002 registration. ###

Note:Table 1 is derived from a moredetailed mapping of the second edition of

TS 16949 that can be viewed by visiting

the authors’ web site (www.omnex.com).

Figur e 4. The Pr ocess Review for

Nonmanufact ur ing Pr ocesses

ProcessFlow

PFMEA(8.5.1)

TrendCharts

CheckSheet

WorkInstructions

Other…

Documentsfor Control4.1c,d,e; 4.2.1d

8.2.3

Data Analysis (8.4)

ControlPlan (8.1)