英文版的依纳-舍弗勒集团 2_PPAP_Production_Part_Approval.doc

Quality Assurance Agreement with SuppliersPart 2 Production Part Approval Process1 PurposeThe Production Part Approval Process ensures that material products fulfill the customers requirements. The primary focus is the manufacturing process.As a result, the release is comprised of: Processes through process capability investigations and/or process audit Product through sample inspectionThis ensures that products which are manufactured using disciplined and efficient processes comply with the requirements that have been defined.The basic idea of this procedure is to put the supplier in a position where he can submit confirmation to the customer which states that the Production Part Approval Process has been successfully completed.2 Evaluation of the Manufacturing ProcessesThe planning, development and introduction of disciplined and efficient processes form a significant part of the activities that are involved in introducing new or modified products and/or processes.In the case of the Production Part Approval Process, the implementation of these activities is substantiated by means of documents and records, which include, for example, the System FMEA Process/Process FMEA, Process Flow diagram, Control Plan and the results of process capability investigations.The evidence is presented to the customer in accordance with the required submission stage (see Point 4). In addition to this, the customer may also carry out a process audit, e.g. in accordance with VDA 6 Part 3. This audit can take place at the suppliers premises in conjunction with the production part approval. 3 Evaluation of the Product (Sample Inspection)Samples are used to check whether the defined requirements have been fulfilled. There are various types of samples.3.1 Prototype Samples Prototype samples can originate from provisional production processes. A corresponding process is required, as described under Point 3.2 Initial samples. However, as a minimal requirement in each case, an inspection record of a marked part, a nominal-actual comparison in the drawing and information concerning material composition must be included with the sample. An initial sample inspection is always required for volume production release, irrespective of prototype sampling. 3.2 Initial SamplesInitial samples are parts, units or other production materials which have been manufactured using production materials, tooling, and processes. Subsequent volume production deliveries may only be made once the initial samples have been successfully released. 3.2.1 Submission of Initial SamplesAll initial samples must be manufactured using the same procedures and tooling that will be used for normal volume production.Initial samples must be submitted in the event of the following: New parts or products (i.e. a specific part, unit or material which has not been supplied to the customer before) Design changes which affect the drawing, specification or material of the volume product. The elimination of a deviation in a part that has already been sampled previously, i.e. the release was carried out to a stipulated time or initial samples were discarded. Or if defined by the customer in the event of the following: Use of new or modified tooling (with the exception of wear tooling) including additional or spare tooling for volume production Volume production which uses existing tooling, machinery or installations that have been overhauled or modified Volume production which uses tooling, machinery and installations that are being transferred to a different plant. Change of subcontractor for parts or services (e.g. heat treatment or coating) where these affect the customers requirements in terms of fit, shape, function, life, or production performance. Manufactured volume products if tooling for volume production has not been used for 12 months or more. Changes to products or processes concerning individual parts from volume production which are manufactured internally, or by subcontractors, and which influence the function. Changes to inspection or test methods released through sampling Introduction of new inspection or test methods (no influence on the acceptance criteria)3.2.2 Preparation of Initial Sample Inspection Reports by SuppliersPrior to supplying initial samples, the supplier must prove that all of the specified features correspond with the customers specifications. This should be proven by means of the initial sample inspection reports. Parts originating from multiple cavity tooling must be checked and recorded separately according to each mould cavity.Features which cannot be checked by the manufacturer are, by agreement, either confirmed using certification by means of specific inspection results or proven by means of inspection certificates from accredited inspection institutes. In special cases there are agreements with suppliers that they must store specific test reports acc. to DIN EN 10204 3.1 and DIN 55350-18 (alternative documentation in compliance is admissible) and make these available to the customer within 24 hours upon request.The initial sample inspection report should contain a declaration which confirms that the materials and their ingredients comply with legal requirements and the customers requirements where the environment, safety and recycling are concerned, or reference made to the documentation in a material database (e.g. IMDS). If declaration limits are exceeded, a safety information sheet is required. The inspection reports must be included with the initial samples. Unless agreed otherwise, it must be possible to allocate the actual values to the respective numbered sample part in the form of a table.The process and the form are based on the procedure described in the Production Part Approval Process, in accordance with QS 9000. This means that unless specified otherwise by the customer, five parts taken at random are checked against the customer drawing and the actual values recorded in the relevant form. Five parts per nest are to be sampled when multiple tools are used.Special processes requested by the customer must be agreed in writing. Process capability of main characteristics (HM) and characteristics which are especially marked in the customers drawing should be assessed on 125 parts (5 x 25 samples). The size of the production run should be agreed upon with the customer.3.2.3 Marking of Initial SamplesEach consignment of initial samples must be clearly marked Erstmuster / Initial Sample. Parts originating from multiple cavity tooling must be kept separate according to each mould cavity, and clearly marked.3.2.4 Evaluation and Release of Initial Samples for Volume Production DeliveriesFollowing submission of the initial samples and initial sample inspection reports, the customer carries out further inspections at his own discretion. On-site inspections can also be carried out by the customer at the suppliers premises.One of the following decisions is made on the basis of the initial sample inspection reports and the inspections carried out by the customer:a) Approvedb) Approved with commentsc) RejectedFunction release relating to partd) Approvede) Not necessary4 Preparation of the DocumentationThe Production Part Approval Process must be fully documented internally by the supplier. By agreeing a submission level it is possible to regulate which documentation should be submitted to the customer with the initial samples.Level 1:Warrant only (form Part Submission Warrant PSW“) submitted to the customer and, if requested for designated appearance items, an “Appearance Approval Report”.Level 2:Warrant with product samples an limited supporting data / documentation submitted to the customer.Level 3:Warrant with product samples an complete supporting data / documentation submitted to the customer.Level 4:Warrant and other requirements as defined by the customer.Level 5:Warrant with product samples and complete supporting data / documentation available for review by the customer at suppliers manufacturing location.The requirements for the particular level are given in the following matrix. The supplier shall use level 2 as the default unless specified otherwise.No.RequirementExplanation, CommentsSubmission level123451Design documentsCustomer drawing (features drawing),Design requirements, product delivery guidelines, technical delivery conditionsRRSRSRRRRR2Modification documentsDocuments on changes approved by the customer, which are not yet documented in the drawing, if available.RSSRR3Design release from the customerDesign approval from the customer, if requested in the customer drawing.RRSRR4System FMEA Product/ Design FMEAOnly applicable to suppliers with design responsibility. Document modification level and date of the System FMEA Product/Design FMEA or enclose cover sheet.RRSRR5Process flow diagramProcess flow diagram for the product or the product familyRRSRR6System FMEA Process/ Process FMEADocument modification level and date of the System FMEA Process/Process FMEA or enclose cover sheetRRSRR7Dimensional measurement resultsDimensional inspection report on all features of the customer drawing (“Production Part Approval Dimensional Report” ).RSSRR8Material inspection report and function inspection resultsEnclose material data (analysis and hardness) as 3.1 specific test report. In the Production Part Approval Material Test Results Form, reference to 3.1 specific test report is permissible. Hazardous materials should be entered into the IMDS system. In exceptional circumstances, the form Production Part Approval Material Constituents” may be used.The material analysis is to be performed on finished cast parts and agreement should be reached with the customer with respect to permissible defects.Function test only if requested in the drawing or in accordance with the design requirements (“Production Part Approval Performance Test Report”).RSSRR9Process capability investigationAlternatively, Cm/Cmk, Pp/Ppk or Cp/Cpk values should be provided as evidence for all important and critical features (usually marked in the customer drawing or defined by the supplier).RSSRR10Inspection capability investigationInspection capability investigation (e.g. R&R test or repeatability for automatic testing devices) for all of the inspection equipment defined in the control plan. Confirmation for all important and critical features in the Production Part Approval Process documentation.RRSRR11Documentation from the test laboratoryIf an external laboratory has been appointed, a certificate which specifies the scope is required. Laboratory handbook (or documentation of title and issue) for standards room and materials laboratory if requested by customer.RRSRR12Inspection planControl plan/Inspection plan as a minimum for all important and critical featuresRRSRR13Part submission confirmation Use “Part Submission Warrant PSW” SSSSR14Report for appearance-critical partse.g. co-ordinated visual defect catalogue, type of paint if requested by customer SSSRR15Checklist for raw material requirementsDroppedRRRRR16Sample parts Check five sample parts, unless specified otherwise.Parts in volume production packaging in accordance with packaging data sheet.RSSRR17Reference sample part At least one reference sample part per cavity should be stored by the supplier for a period of product life time and an additional year (minimum five years). The allocation to initial sample inspection report should be ensured by means of clear marking.RRRRR18Inspection equipment/Inspection aids Dropped (only if specifically requested)RRRRR19Further customer-specific recordsIf required in customer-specific specificationRRSRRS = supply to customer R = store and keep available for immediate access= deviant from QS 9000 standard5 Volume Production Process Evaluation (Run Rate)The supplier is solely responsible for evaluating his volume production process. In some cases, it may be necessary to check this in the customers presence. When doing this it is necessary to determine whether the actual production process can manufacture products to the required quality with the tooling and production capacity promised/offered, for a stipulated time period to be determined by the customer. whether the actual production process cor