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

A Plan for the Transition from QS-9000 to TS 16949:2000

By Chad Kymal and Dave Watkins
Publishers Note: This article has been reprinted with permission from THE INFORMED OUTLOOK Newsletter, August 2001 issue. mains whether and when an automotive supplier should consider making the switch from the third edition of QS9000 to TS 16949:2002 (for details on this topic, see The Impact of ISO 9001:2000 on QS-9000 and ISO/TS 16949, THE OUTLOOK, May 2001). In essence, the challenge for QS9000-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 requirements of all the original equipment manufacturers (OEMs) that are additional to the TSthere 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.

hat is the future of automotive sector-specific quality management system (QMS) requirements? And what should your organization 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) 16949:2002 Quality management systemsAutomotive suppliersParticular requirements for the application of ISO 9001:2000, which indicate that TS 16949:2002 will fully align with ISO 9001:2000, Quality management systemsRequirements. Also, the International Automotive Task Force (IATF) additions to TS 16949, with only a few minor edits, have been mapped directly to ISO 9001:2000s structure. Although changes could still be made before the second edition is published as a revised ISO/TS, the latest draft we saw is the one that will circulate within ISO Technical Committee 176 for a ballot of approval. The issue re-

1. Create a Process Map and Understand Customer Requirements

Before you do anything, study your organizationfollow the product development process and interview personnel in that process. To create a process map,

you need to identify all your organizations key activities from new product ideation to research, design and development to production and all the way to the shipping 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 development 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 whether the 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 immense. The processes needed to support interested partiesowners/investors, lenders, personnel, suppliers/partners, the communitymay result in incorporating many more processes to your process map. In ISO 9004:2000, Quality management systemsGuidelines for performance improvements, Clause 5.2, Management ResponsibilityNeeds 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 expectations? (See Figure 1.) The organization 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 processes for identifying and analyzing customer expectations and needs re-

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2 4 THE INFORMED Outlook

garding your organizations capabilities (customer requirements as envisioned in Clause 5.2, Customer Focus)? Are there processes for capturing and analyzing customer expectations for product (customer requirements as envisioned in Subclause 7.2.1Determination of Requirements Related to the Product)?

Reprint: August 2001

structure behind your organizations QMS. Do you have the necessary processes documented? If so, verify whether you have documents needed by the organization to ensure the effective planning, operation, and control of its processes as required by Subclause 4.2.1(d), Documentation RequirementsGeneral. Also, determine if both the operation and control of these processes are effective per Clause 4.1(c), Quality Management SystemGeneral Requirements. Taking these steps, which involves asking questions about the existing QMS, should result in the clarification of your organizations documentation needs for satisfying customers 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 documented that are already required by QS9000 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 16949:2002s requirements, even before it is available. The changes to the automotive requirements in the draft from the first edition are minimal, so using TS 16949:1999 and ISO 9001:2000we recommend using ISO 9004:2000 as wellwill provide you with the right criteria to measure your organizations 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 16949 requires two methodologies. The first links customer expectations to objectives

2. Conduct Gap Analysis of the Existing System

Now, examine the documentation

Figure 1. The Complete Process Map

Figure 2. Customer Expectations Categories

Delivery Product Quality Service Quality Financial Stability

Ship On Time

No Rejects

Quick Quote Response

Diversify

Ship Complete

No Low Cpk

Bar-Coded Labels

Reprinted with permission from THE INFORMED OUTLOOK August 2001 issues

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Volume 6, Number 8
and then to key processes, something our organization calls the Business Operating System (BOS) process. The second institutionalizes continual improvement at the process level, which our organization calls the Process Review Methodology (PRM). 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 supplier to satisfy critical, value-added requirements of TS 16949 and improve the effectiveness of the QMS and the organizations customer satisfaction. To effectively satisfy Subclause 5.4.1, PlanningQuality Objectives, of ISO 9001:2000, the organization should use benchmarking to determine what its short- and long-term objectives should be. The organizations improvement plans or planning to meet overall objectives (per Subclause 5.4.2, Quality Management 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.

THE INFORMED Outlook

4 3

4. Implement PRM
PRM is a method of documenting and controlling QMS processes. It takes the processes in the process map and your organizations documentation and applies Process Flows (PFs), Process Failure Mode and Effects Analyses (PFMEAs) and Control Plans to ensure the documentation your organization has is effective and that its QMS processes are under control. The tools and methods used for QS-9000 compliance of production processes are used in PRM for the analysis and control of nonmanufacturing processes. An organization does not need to document every process using PFs, only those that require documentation to ensure the effective planning, operation and control of its processes or key business processes of the organization that need this kind of analysis. However, each process uses PFMEAs for documenting problems or

3. Implement BOS
The first step in implementing BOS involves identifying customer and interested-party expectations. In working with our clients, our organization uses a process by which we list, group and rate expectations using Post-It notes. Through these groupings into Customer Expectations 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 methodology is the use of alignment charts to link each expectation category to the key processes and process measurables that

Table 1. Comparison of Requirements in ISO/TS 16949:1999 vs. QS-9000

Requirement
Quality Policy, Objectives Continuous Improvement Quality Responsibility Shift Resources Management Review Supplemental Analysis and use of Company Level Data Employee Motivation, Empowerment and Satisfaction Certification Body/Registrar Notification Quality System Documentation Quality Plan Requirements Product Realization, General Computer Aided Design Special Characteristics Management of Process Design, General Management of Process Design, Process Design Input Management of Process Design, Process Design Output Management of Process Design, Process Verification Quality System Performance Design Input, Design Optimization Maintaining Process Control Requirements Corrective Action Plan Returned Product Test/Analysis Inventory Production Scheduling Process Audit Product Audit Auditor Qualification Training Effectiveness Training on the Job Servicing Agreement with Customer

ISO/TS 16949
4.1.1.2 (New) 4.1.1.4 (Partially New) 4.1.2.1.3 (Partially New) 4.1.2.2.2 (New) 4.1.3.2 (Partially New) 4.1.5 (Partially New) 4.1.6 (New) None 4.2.2.2 (New) 4.2.3.2 (New) 4.2.4.1 (Partially New) 4.2.4.6 (Partially New) 4.2.4.7 (Partially New) 4.2.4.9.1 (New) 4.2.4.9.2 (New) 4.2.4.9.3 (New) 4.2.4.9.4 (New) 4.2.8 (New) 4.4.4.2 4.9.3 4.13.1.3 (Partially New) 4.14.2.3 (Partially New) 4.15.3.2 (Partially New) 4.15.6.3 (Partially New) 4.17.2.3 (New) 4.17.2.4 (Partially New) 4.17.3 (New) 4.18.2 (Partially New) 4.18.2 (Partially New) 4.19.3 (New)

QS-9000*
None None; 4.2.5.2; 4.2.5.3 4.1.2.5; 4.1.2.1.a NOTE None 4.1.3.1 4.1.5 None 4.1.6.1 None None 4.2.3.1; 4.4.11 4.4.4.1 4.2.3.2 None None None None None None None 4.13.2.1 4.14.2.1 4.15.3.1 4.15.6.2 None 4.10.4.2 None 4.18.1 None 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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4 4 THE INFORMED Outlook

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 outcome 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 their nonmanufacturing processes.

Reprint: August 2001 5. Implement TS 16949:2002

One of the greatest challengesand benefitsof implementing TS 16949:2002 is that it will require a QS9000-registered organization to become customer-focused as well as processfocused. The other major changes between ISO 9001:1994 and ISO 9001:2000, such as customer satisfaction, continuous improvement and data analysis, are already required by QS-9000, so these transition elements are non-starters. Becoming customer-focused requires 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-functional management, matrix organizations 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 registration cannot be achieved yet and customer-specific requirements may be adjusted by the time the second edition is printed. Most important, implementing methodologies to become customerfocused and process-oriented do not require any standards to initiate the process, so you should start your organizations change to the new requirements now because they make business sense in an increasingly competitive marketplace.

Figure 3. Example of an Alignment Chart

Customer Expectations Category Strategic Goals Internal Quality 99.95% FOA Date External Quality 20 ppm Date

Product Quality

Eliminate Reworks Owner

No Incoming Inspections GM

Improve Problem Solving Ford

Result Measurables

External Quality PPM per Part

Internal Quality Rejects per 1000 pieces

Key Processes

Process Engineering

Quality Assurance

Procurement

Potential Causes

Poor Process Design

Problems Not Resolved

Poor Incoming Product

An Alternative: The Minimalist Approach

The minimalist approach is the alternative to what clearly is a commitment of resources and involves some effort by management to improve the organization: Make No Change This is the approach some organizations may take. It involves an organization making changes only to the Quality Manual (Level One) by rewriting it to
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Process Measureables

Process Capability % Cpk<1.33

Problem Solving # Recurring Problems

Material Quality Tons Rejected

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Volume 6, Number 8
include QMS scope, exclusions, and adding a process map that shows a description of the interaction between the procedures of the quality management 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-9000conforming 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 organizations 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 regulatory requirements (Clause 1.2, Scope Application) should be identified within the process map (Clause 4.1[a]). Has the organization identified all the processes 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 procedure needs to clearly show how it hands off to the program management procedure. 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 monitored, measured and analyzed, as per the requirements of Clause 4.1(e). Organizations and auditors need to be careful not to fall into the trap of the minimalist approach. In effect, no improvement will be evident in such a

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system. More important, the organization will not make any movement forward in becoming customer- or process-focused, which could be detrimental in the long-term even if the OEMs it supplies never require TS 16949:2002 registration. ### Note: Table 1 is derived from a more detailed mapping of the second edition of TS 16949 that can be viewed by visiting the authors web site (www.omnex.com).

Figure 4. The Process Review for Nonmanufacturing Processes

Documents for Control

4.1c,d,e; 4.2.1d 8.2.3

Trend Charts Check Sheet Process Flow PFMEA (8.5.1) Control Plan (8.1) Work Instructions Other

Data Analysis (8.4)

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