GQ_2_010_NPD_Gate_4_ Launch_03NO09,0

1.0 Purpose and ScopeThe purpose of Gate 4 in Kohler Company’s New Pr oduct Development Process is toassure that the manufacturing process is ready and capable for full production and thesystems to support production of the product are in place.2.0 Responsibility2.1 Senior Management of each Business unit or Functional Location is responsiblefor identifying the function or individual responsible for the deliverables.2.2 Senior Management of each Business unit or Functional Location is responsible todefine a cross-functional team (including, but not limited to marketing, designengineering, manufacturing, and quality) to review and approve the design to passthis gate. Approval is by consensus with each team member having “veto”authority with the intent to have a balanced approach towards quality, cost, anddelivery.3.0 Procedure3.1 Global Requirements Gate 4 Scope3.1.1 Pilot RunThe pilot run is the trial run of product using tooling and processes intendedfor final production. This run will be used to analyze the capability of themanufacturing process to produce quality product at the volume needed tomeet the projected customer demand. At this point the product design andmanufacturing processes are “frozen.” Any changes to design orproduction processes may require additional retest and/or reverification.3.1.2 Manufacturing Readiness ReviewThe Manufacturing Readiness Review is a review of all the systems neededto produce quality product meeting all key characteristic requirements at theprojected volume. This review verifies the entire system satisfies thecustomer requirements including but not limited to performance, packaging,and installation. During this review the outputs from the deliverables forGate 4 will be analyzed to assure that all systems are ready.3.1.3 Reliability/Quality TestingThe Reliability/Quality Testing is performed on samples produced from thePilot Run. The testing is performed per the Reliability/Quality Test Planapproved in Gate 2. The results of this testing are reviewed and signed offby a cross-functional team.3.1.4 Launch PlanAt Launch all systems are in place and ready for full production. A ramp upplan is in place that will meet the projected demand for the product. Gate 4has been signed off by the Approval Authority.3.2 Global Requirements Gate 4 Deliverables3.2.1 Marketing Business ReleaseThe Marketing and Sales team has reviewed and approved all of thesystems and tools need to effectively roll the product out to the customer.The customer base has been notified of the availability of the product.Examples of the tools and systems are:•Business System (SAP or appropriate system) loaded or configured for new product•Published pricing i.e. Price Lists•Promotional Literature•Order Entry Training3.2.2 Intellectual Property FinalizedTo avoid infringements, research was performed on patents andtrademarks. Applications for new patents or trademarks have beensubmitted.3.2.3 Operations CertificationThe manufacturing process is ready for production. A Pilot Run of theprocess has been performed and any corrective actions resulting from thePilot Run have been implemented. All elements of Operations Certification(GQ-4-001) are fully completed. All open issues have been identified,corrective action taken, and effectiveness of the corrective actions verified.Some key elements of Operations Certification which should be completedinclude, but are not limited to:•Prints are available to manufacturing and are finalized with keycharacteristics fully identified with the intent to immediately releasefollowing approval of this Gate.•High PFMEA RPNs have corrective actions completed and RPNs are revised to reflect verified corrective actions•Capability studies for all key characteristics have been completed with additional actions and/or controls taken to address any poorCpk/capability characteristics identified.•Control plan which provides sufficient controls for all keycharacteristics verified via capability studies and verification testing.Control plan addresses all manufacturing value streams, includingrework and repair loops.•SOP’s are updated for product/process and applicable training has been completed3.2.4 Supply Chain FinalizedSupplier selection for purchased parts is finalized. The suppliers have been audited and approved as appropriate. Sample parts have been submittedand the Production Part Approval Process (PPAP) is complete and fullyverified to consistently provide product, components, and/or raw materialswhich delivers all key characteristics. Production parts have been ordered and will be ready for the Pilot Run. The following items have been finalized with the suppliers:•Non-Disclosure Agreement•Piece Part Price•Supplier Agreement•Lead Times•Delivery commitment3.2.5 Inventory Build PlanThe ramp up schedule leading to full production is complete. The schedule includes the build up of inventory to meet projected demand.3.2.6 Reliability/Quality DataReliability testing is complete and the results have been analyzed. Anyfailures have been documented, corrective actions implemented, andeffectiveness of corrective actions verified by retesting. A cross functionalteam has reviewed and signed of the Reliability Test Report. The capability of manufacturing processes producing critical features of the product havebeen calculated from product produced from the pilot run.3.2.7 Service PlanThe Service Plan is intended to prepare the organization to support the customer if they have questions or issues with the new product. This includes but isnot limited to:•Troubleshooting guidelines•Aftermarket service parts and instructions•Installation instructions / service manuals•Customer service or call center phone scripts•Field /Distributor /Sales/ Customer training•Warranty Policy3.2.8 Financial ReviewActual expenditures and financial assumptions are compared to the ACT and a decision is made whether to proceed or halt development of the project.3.2.9 Open Issues and ActionsActions taken to address issues from previous Gates have been completedand effectiveness verified. All actions defined required to be completedduring this process step are intended to have been completed. However,any open and pending actions which impact customers are fullydocumented in a Corrective Action tracking system for follow up to ensuretimely completion.4.0 Related Procedures and ProcessesGQ-1-005 Quality RecordsGQ-2-002 Kohler NPD ProcessGQ-4-001 Operations Certification5.0 Forms and Documents•ACT•Supplier Survey•GQ-4-0001-F Operations Certification Checklist Form6.0 Quality RecordsBusiness unit and or Functional Location must define who, where, how, and retention length for records required for the approval of this gate in accordance with GQ-1-005. The records must include: • Supplier Audit Reports • PPAP documentation • Reliability Test Report • Process Capability Report• Operations Certification7.0 Definitions▪ ACT – Authorized corporate transaction▪ KQMS – Kohler Quality Management System ▪ PPAP –Production Part Approval Process。