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by Radley M. Smith
Just as automotive suppliers are coming to terms with the Third Edition of QS-9000, along comes a new document with a rather mysterious title: ISO/TS 16949--Quality Systems Automotive Suppliers--Particular Requirements for the Application of ISO 9001:1994. It raises a number of questions in the minds of those working in the industry: What exactly is this document? How will it affect my duties as a quality professional responsible for the quality management system (QMS) of an automotive supplier? And perhaps most important, what's the urgency--do I have until tomorrow to understand this new arrival, or must I drop what I'm doing and listen up?
To answer the first question, ISO/TS 16949 harmonizes the supplier quality requirements of the U.S. Big Three (QS-9000, Third Edition) and French, German and Italian automakers. (Of the European requirements, perhaps the most familiar in the United States is the German VDA 6.1, to which Volkswagen has required North American suppliers to its Mexican operations to be registered.) The goal was to create a single document and a single third-party registration that the European automakers and the U.S. Big Three would accept. Although the registration process is still under development, there is a definite possibility that the goal will be fulfilled this year.
A key point to understand is that in many (if not all) cases, the participating automakers' customer-specific requirements will be assessed as part of the ISO/TS 16949 registration. There are preliminary indications that each company's registration certificate will list the customers whose requirements that company has met.
Each company considering registration to ISO/TS 16949 should obtain the document (available from the Automotive Industry Action Group at (248) 358-3003) as quickly as possible, because a close reading of ISO/TS 16949 will be necessary to determine the extent of needed revisions. However, the following element-by-element summary explains the direction and extent of the changes.
 4.1--Management responsibility: A number of additions to this element are clearly intended to focus suppliers' attention on continuous quality improvement. Suppliers must establish goals, objectives and measurements to develop their quality policies. Continuous improvement in quality, service, cost and technology must be covered in the quality policy. Quality-responsible personnel's authority to stop production is no longer a "note" or suggestion, as in QS-9000, but a requirement. All production shifts must be staffed with personnel responsible for quality. The management review requirement is expanded to include the "performance (of the QMS) over time as an essential part of the continuous improvement process." Evaluation of the cost of poor quality was a parenthetical note in QS-9000, but is a specific requirement of ISO/TS 16949. Suppliers must develop a process for motivating employees to achieve quality objectives and providing employees at all levels with "quality awareness." Customer experience with the supplier's product must be communicated in a timely manner. Finally, the "due care for product safety" requirement from QS-9000 has been expanded to minimize risks to employees, customers and the environment.
4.2--Quality system: The term "product realization" is introduced to cover the entire process of designing, planning and delivering products that meet customer requirements. A requirement for a project manager and a project team is introduced. The modifying phrase "If a project management approach is used" suggests that this approach is preferred, if not actually required. Continuing to expand the project management concept, ISO/TS 16949 requires that a method be established for measuring the product-realization process against appropriate mileposts, with appropriate analysis and management review. The factors to be measured include quality, risks, costs and lead times. Process capability studies must be conducted on all new processes. Results for the capability studies must be used to establish requirements for production equipment where applicable. Inclusion of all special characteristics on control plans, although always implicit, is now explicitly required. ISO/TS 16949 also has a requirement for procedures on developing and verifying the product-realization process--perhaps one of the murkier requirements of the document. Detailed procedural requirements for process design inputs and outputs have been added, including a verification of the inputs vs. the outputs. The use of the "customer-recognized product approval process" (e.g., production part approval process [PPAP]) is mandated rather than recommended as in QS-9000, although General Motors has had a customer-specific requirement for subsupplier PPAP for some time. Additionally, when the customer so requires, special verification methods for new products must be implemented.
4.3--Contract review: Suppliers must have a formal process for identifying cost elements and employ this process in the preparation of price quotations for new products.
4.4--Design control: The requirement for skill qualifications of the supplier's design team is now a "shall" rather than a "should." Suppliers must have access to research and development to support product innovation. Analysis of competitive products is identified as one alternative source of input for the design process. For design changes, the impact on the customer's assembly operations is added to the factors that the supplier must consider for each change.
4.5--Document and data control: There are no significant changes in this section.
4.6--Purchasing: Suppliers must encourage their subsuppliers to comply with ISO/TS 16949. However, there's no target date for compliance, nor is there an expectation of third-party registration for subsuppliers.
4.7--Control of customer-supplied products: There are no significant changes in this section.
4.8--Product identification and traceability: There are no significant changes in this section.
4.9--Process control: The term "process monitoring and operator instructions" has been replaced with the simpler "job instructions," which "shall" rather than "should" be accessible at the job station without disruption. These job instructions shall be derived from "appropriate sources," including the control plan and the entire product-realization process. Significant process events shall be noted on control charts.
4.10--Inspection and testing: Perhaps surprisingly, the incoming material requirements now allow the customer to waive the required control methods. Following the precedent of the Third Edition of QS-9000, requirements for internal laboratories are further strengthened. These laboratories, which include precision metrology and calibration as well as traditional laboratory functions, must now comply with ISO/IEC 17025, although third-party accreditation to that document is not required.
4.11--Control of inspection, measuring and test equipment: Methods and criteria for measurement system analysis shall conform to customer reference manuals (e.g., the Big Three Measurement Systems Analysis manual).
4.12--Inspection and test status: There are no significant changes in this section.
4.13--Control of nonconforming product: Progress on corrective action plans shall be regularly reviewed. A requirement has been added for customer notification when nonconforming material has been shipped.
4.14--Corrective and preventive action: There are no significant changes in this section.
4.15--Handling, storage, packaging, preservation and delivery: The controls implemented for nonconforming product must also be used for obsolete product. If delivery will not happen according to schedule, the supplier must notify the carrier as well as the customer of the anticipated delivery problem.
4.16--Control of quality records: The requirements for scheduling the supplier's production process have been defined in greater detail. There must be a scheduling process based on meeting the customers' requirements, such as just-in-time. The information technology must support access to production data at key production checkpoints.
4.17--Internal quality auditing: Internal audits must be performed on all shifts and must include all activities affected by ISO/TS 16949 and all relevant customer requirements. Specifically, the internal audit must include an evaluation of the effectiveness of the product-realization and production process. A product audit has been included in 4.17 that includes the "final product" audit required in QS-9000 and expands it to include all specified requirements at appropriate points in the production and delivery process. Internal auditors must meet customer-established criteria.
4.18--Training: Additions include requirements for on-the-job training for new or modified jobs affecting quality and for training on customer-specific requirements.
4.19--Servicing: If the supplier provides post-sale servicing, the effectiveness of service centers, special equipment and personnel training must be re-evaluated.
4.20--Statistical techniques: Appropriate statistical methods shall be determined during the planning process, and these methods shall be understood throughout the organization.
The sheer umber and broad implications of these additions clearly indicate that a great deal of effort will be required to migrate from a QS-9000-based QMS to one that can be registered to ISO/TS 16949. However, there's no need to drop everything for ISO/TS 16949 now; it will exist as an alternative to QS-9000 for a substantial period, perhaps 12 to 24 months. When the next edition of ISO 9001 is officially published, ISO/TS 16949 will be revised to mesh with the new ISO 9001. At that time, the countdown will begin for the possible replacement of QS-9000 with ISO/TS 16949. Nevertheless, automotive suppliers will want to prepare for ISO/TS 16949 with greater urgency than this scenario might suggest: Early evaluation of ISO/TS 16949 will allow suppliers to develop the most cost-effective ways to meet these new and revised requirements.
About the author
Radley M. Smith is the director of KPMG Quality Registrar's Automotive Division and is based in Detroit. Prior to joining KPMG, he had an extensive career with Ford Motor Co. and was the Ford representative in the original development of QS-9000. Contact him at KPMG Quality Registrar, 150 W. Jefferson, Suite 1200, Detroit, MI 48226; telephone: (313) 983-0344; fax: (313) 983-0570; e-mail: rsmith@qualitydigest.com .
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