To comply with the supplement, tooling and equipment suppliers must develop and document quality systems that meet QS-9000 and/or TE Supplement requirements. These systems should include a quality policy and manual, procedures, work instructions and records. Suppliers must demonstrate not only that the documented quality systems meet all requirements, but also that they have been implemented and are effective. A documented quality system's structure and organization should be the same for QS-9000 and the TE Supplement. Both contain 20 elements in Section I, but not all the requirements are the same. Section II contains three elements, in the standard as well as the supplement, with differing requirements. Both specify customer-specific requirements in Section III; again, they are not the same. The TE Supplement also contains appendixes and a glossary, which differ from those in QS-9000. The TE Supplement is designed to improve quality, reliability, maintainability and durability of products supplied to Chrysler, Ford and General Motors. To accomplish this, suppliers must develop and implement quality management systems that provide for structured control and continuous improvement, utilizing defect prevention and reducing process variation and waste. Anticipating registration Companies that opt for third-party registration to ISO 9000 and include requirements from QS-9000 and the TE Supplement will benefit themselves on three counts: They will be demonstrating compliance to QS-9000 and the TE Supplement, realizing the benefits of compliance and setting up their facilities for third-party registration, should it become required. With this approach, it is necessary to understand the differences between the TE Supplement and QS-9000 requirements. They include: 4.1--Management Responsibility. Suppliers must commit to reliability, maintainability and durability by including these in their quality objectives. 4.2--Quality System. Suppliers must use an advanced quality planning process, embracing reliability and maintainability throughout the life-cycle process. The Reliability and Maintainability Guidelines manual must be used as a reference. Feasibility reviews are required, but a different team-feasibility review form is included in Appendix II of the TE Supplement. FMEAs and control plans are required, but the requirements are customized to the tooling and equipment business. 4.4--Design Control. Design-responsible suppliers should be qualified in additional skills such as mean time to repair, mean time between failures, fault tree analysis and life-cycle cost--all of which are defined in the Reliability and Maintainability Guidelines. An analysis of test data and projections of reliability, maintainability, durability and life-cycle cost are added requirements in the design output section. Added requirements in design verification include a focus on reliability, maintainability and durability during performance testing; using predictive reliability and maintainability techniques; and using accelerated life tests on crucial components. Suppliers are also required to maintain a design change log through each phase of the machinery build. 4.6--Purchasing. Subcontractor development must use the TE Supplement, sections I and II, as the fundamental quality system requirement. 4.8--Product Identification and Traceability. Suppliers must establish and maintain tracking systems for components and subassemblies, identifying the components to their next operation and by their job number, and cross-referencing engineering drawings and bills of materials. 4.9--Process Control. The TE Supplement changes and deletes some of the requirements added by QS-9000, including:  4.9.1--The process monitoring and operator instructions shall be adequate to document the process, and employees shall be familiar with work instructions and the objective of their job assignments.
4.9.2--Initial process studies are required, but these concentrate on qualifying the machinery and equipment under development. Requirements stipulated under 4.9.5, 4.9.6 and 4.9.7 don't apply to the TE Supplement. 4.10--Inspection and Testing. Layout and Inspection as well as Functional Testing are replaced by functional verification of equipment as described in Section II, Element I of the TE Supplement. 4.13--Control of Nonconforming Product. Requirements 4.13.3 and 4.13.4 don't apply to the TE Supplement. 4.15--Handling, Storage, Packaging, Preservation and Delivery. Supplier delivery performance is completely changed. Suppliers must establish a goal of 100-percent on-time shipments and develop timing plans to meet this goal. Critical-path scheduling is required for timing control of complex manufacturing systems. Scheduling systems must be in place to control the timing for the manufacture, test and qualification, installation and tryout of equipment. The production scheduling and shipment notification system sections of QS-9000 don't apply to the TE Supplement. 4.18--Training. The supplier shall implement a formal training program to include reliability and maintainability. 4.19--Servicing. Suppliers providing servicing under a separate contract must establish and maintain a documented procedure for communicating information regarding machine up-time, reliability, maintenance history and service concerns to manufacturing and design activities. 4.20--Statistical Techniques. Additions to Knowledge of Statistical Concepts include mean time between failures, mean time to repair, short-run SPC, and variables and attributes data control charts. Section II: Sector-specific requirements 1--Qualification runoff requirements. This section contains the most changes from QS-9000. The Production Part Approval Process doesn't apply to tooling and equipment suppliers; they are required instead to perform qualification tests to ensure that tooling and equipment are of acceptable quality, both in function and reliability. The purpose of these requirements is to: Reduce/eliminate start-up delays. Improve the quality of components. Resolve software and control problems prior to launch. Confirm cycle times. Verify reliability. Qualification runoff requirements are: At the supplier's location: 50/20 dry run (50 hours for robots, 20 hours all others) Phase 1: Preliminary evaluation Phase 2: Pp evaluation Phase 3: Ppk evaluation Reliability verification At the customer's plant: 20-hour dry run Short-term process study Long-term process study 2--Continuous Improvement. Under Techniques for Continuous Improvement (2.3), the supplier must demonstrate knowledge of the following measures: Mean time between failure Mean time to repair Life-cycle cost Reliability growth Section III: Customer-specific requirements All requirements in Section III of QS-9000 apply to the TE Supplement, with these exceptions: Chrysler-specific requirements: Third-party registration is not required. Tooling and equipment suppliers seldom will use the Lot Acceptance Sampling Table and the Product Qualification Table in QS-9000. A table is provided in the TE Supplement for process performance for initial tooling and equipment studies. Ford-specific requirements: Third-party registration is not required. Reliability and maintainability program planning requirements are described with specific requirements for: definition of failure, reliability and maintainability plan; design assurance strategies; design review; failure mode and effects analysis; reliability testing and assessment; and R&M continuous improvement activity. General Motors-specific requirements: Third-party registration is not required. Additional requirements are specified for: training, design review, failure mode and effects analysis, maintainability requirements, reliability and maintainability validation, and continuous improvement. Additional GM standards/specifications are required. Although the TE Supplement contains some new requirements, most QS-9000 requirements apply to tooling and equipment suppliers. The TE Supplement emphasizes the need for tooling and equipment suppliers to understand and practice the techniques described in the Reliability and Maintainability Guidelines. Meanwhile, it remains to be seen whether Chrysler, Ford and General Motors mandate third-party registration later this year. About the author Jerry Rogers, a former consultant with Management Resources International Inc., is quality systems manager at Cobra Patterns and Models Inc. |
