This standard if for Automotive suppliers.ISO/TS 16949 harmonizes the supplier quality requirements of the U.S. Big Three (QS-9000, Third Edition) and French, German and Italian automakers.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.
Framework QS9000 to TS 16949
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.
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