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PPAP Fourth Edition

Production_Part Approval Process - Four Edition - LIvro com processo de aprovação, para do processo de produção.

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0% found this document useful (0 votes)
156 views69 pages

PPAP Fourth Edition

Production_Part Approval Process - Four Edition - LIvro com processo de aprovação, para do processo de produção.

Uploaded by

LeonardoVianna
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Production Part Approval Process Vs Fourth Edition dco ay el | PPAP Process Flowchart Example ~ CUSTOMER | eon =] — ee oe rmgome || Summa races autem l ‘i | Required of PAP Requirements, | Team ] Regdrs qe L | Ld 7 Cs _| neste |||} [ae || | emt | | ‘Supper ities coon . pees << site || | emprapes ||| Ne Notes 1 Rates shown wl not aay be present Ee 2. Records shown may be in various med and in various storage locations, CUSTOMER — Record of Approved Pow Receipt and Approval of ‘suomited PSI Volited Process [PSO Run ate] _— t Customer nites d TABLE OF CONTENTS INTRODUCTION, Purpose Applicability Approach ‘SECTION 1 -GENERAI 1.1 Submission of PPAP. SECTION 2~PPAP PROCESS REQUIREMENTS. 2.1 Significant Production Run. 2.2 PPAP Requirements. 22.1 Design Record... 2.22. Autoried Enginecing Change documents 223, Customer Engineering Approval 2.24 ‘Design Failure Mode and Effects Analysis (Design FMEA) 22.8 Process Flow Diagrams) 22.6 Process Falare Mode and Effects Analysis (Process FMEA), 22.7 Control Plan... ‘a 22,8. Measurement System Anysis Side. 22.9 Dimensional Results. 22.10 Records of Material / Performance Test Results 2.2.11. Initial Process Studies. oo so mth 2.2.12 Qualified Laboratory Doctimentation a! 10 2.2.13 “Appearance Approval Report (AAR) sens 1 22.14 Sample Production Pans 2.2.15 Master Sample 22.16 Checking Aids 22.17 Customer-Specific Requirements 2.2.18 Part Submission Warrant (PSW) ‘SECTION 3- CUSTOMER NOTIFICATION AND SUBMISSION REQUIREMENTS 1B 3.1 Customer Notification. o ee 3.2 Submission to Customer. lS SECTION 4 SUBMISSION TO CUSTOMER - LEVELS OF EVIDENCE... 7 4.1, Submission Levels. 7 SECTION 5-PART SUBMISSION STATUS. sel 5.1. General. . . 7 19 5.2. Customer PPAP Status 9 52.1 APPIOVEE nnn 219 522 Interim Approval. iii 523 Rejected non ini - SECTION 6- RECORD RETENTION APPENDICIES APPENDIX A — COMPLETION OF THE PART SUBMISSION WARRANT (PSW) APPENDIX B ~ COMPLETION OF THE APPEARANCE APPROVAL REPORT. ‘APPENDIX C— PRODUCTION PART APPROVAL, DIMENSIONAL. RESULTS. APPENDIX D~PRODUCTION PART APPROVAL, MATERIAL TEST RESULTS. APPENDIX E —PRODUCTION PART APPROVAL, PERFORMANCE TEST RESULTS, APPENDIX F — BULK MATERIAL - SPECIFIC REQUIREMENTS APPENDIX G~ TIRES - SPECIFIC REQUIREMENTS APPENDIX H— TRUCK INDUSTRY - SPECIFIC REQUIREMENTS. ST GLOSSARY. INTRODUCTION Purpose Production Part Approval Process (PPAP) defines generic requirements for production part approval, including production and bulk materials (see Glossary). The purpose of PPAP is to determine if all customer engineering design record and specification requirements are properly understood by the ‘organization and that the manufacturing process has the potential to produce product consistently meeting ‘these requirements during an actuel production nun at the quoted production rate. Applicability PPAP shall apply to internal and external organization sites (see Glossary) supplying production parts, service parts, production materials, or bulk materials. For bulk materials, PPAP is not required unless specified by the authorized customer representative. An organization supplying standard catalog production or service parts shall comply with PPAP unless formally waived by the authorized customer representative. NOTE 1: Sce customer-specific requirements for additional information, All questions about PPAP should be addressed to the authorized customer representative NOTE 2: A customercan formally waive PPAP requirements for an organization. Such waivers can only ‘be issued by an authorized customer representative NOTE 3: An organization or supplier requesting 8 waiver of a PPAP requirement should contact the authorized customer representative. The organization or supplier should obtain documentation of waivers from the authorized customer representative. NOTE 4: Cotalog parts (e.g., bolts) are identified and/or ordered by fumetional specifications or by recognized industry standards. ‘The word “shall” indicates mandatory requirements. The word “should” indicates a recommendation, Paragraphs marked “NOTE” are for guidance in understanding or clarifying the associated requirement. The word “should” appearing in a NOTE is for guidance only. terms and definitions given in ISO/TS 16949 and the PPAP Glossary ) SECTION 1 —- GENERAL 1.4_Submission of PPAP The organization shall obtain approval (see 5.2.1) from the authorized customer representative for: 1. anew part or product (e.g., a specific part, material, or color not previously supplied to the specific customer), 2. correction of a discrepancy on a previously submitted part, 3. product modified by an engineering change to design records, specifications, or materials. 4, any situation required by Section 3. NOTE: If there is any question concerning the need for production part approval, contact the authorized ‘customer representative. SECTION 2 — PPAP PROCESS REQUIREMENTS 2.4 Significant Production Run For production parts, product for PPAP shall be taken from significant production run. This significant production run shall be from one hour to eight hours of production, and with the specific production quantity to total a minimum of 300 consecutive parts, unless otherwise specified by the authorized customer representative. This significant production run shall be conducted at the production site, at the production rate (see Glossary) using the production tooling, production gaging, production process, production materials, and production operators. Parts from each unique production process, e.g., duplicate assembly line and/or work cell, each position of a multiple cavity die, mold, tool or pattem, shall be measured and representative pars tested For bulk materials: No specific number of “parts” is required. The submitted sample shall be taken in a manner as to assure that it represents “steady-state” operation of the process. NOTE: For bulk material, production histories of current products may often be used to estimate the initial ‘process capability or performance of new and similar products. In cases where no production history of a similar bulk material product or technology exists, a containment plan may be put into effect until sufficient production has demonstrated capability or performance, unless otherwise specified by the customer. 2.2__PPAP Requirements ‘The organization shall meet all specified PPAP requirements listed below (2.2.1 through 2.2.18). The organization shall also meet all customer-specific PPAP requirements. Production parts shall meet all customer engineering design record and specification requirements including safety and regulatory requirements), Bulk Material PPAP requirements are defined by a completed Bulk Material Requirements Checklist (see Appendix F). If any part specifications cannot be met, the organization shall document their problem-solving efforts and shall contact the authorized customer representative for concurrence in determination of appropriate corrective action. NOTE: _ Items or records from 2.2.1 through 2.2.18 may not necessarily apply to every customer part number from every organization, For example, some parts do not have appearance requirements, others do not have color requirements, and plastic parts may have polymeric part marking requirements. In order 10 determine with certainty which items must be included, consult the design record, eg,, part print, the relevant Engineering documents or specifications, and your authorized customer representative. 2.2.1 Design Record ‘The organization shall have the design record for the saleable produc/part, including design records for components or details of the saleable product/part. Where the design record is in electronic format, ¢.g., CADICAM math data, the organization shall produce a hard copy (e-g., pictorial, geometric dimensioning & tolerancing [GD&T] sheets, drawing) to identify measurements taken. NOTE 1: For any saleable product, part or component, there will only be one design record, regardless of who has design-responsibility. The design record may reference other documents making them part of the design record. NOTE 2: A single design record can represent multiple part or assembly configurations, eg, @ sub-frame assembly with various hole configurations for different applications NOTE 3: For paris identified as black box (see Glossary), the design record specifies the interface and performance requirements NOTE 4: For parts identified as catalog parts, the design record may consist only of @ functional specification or a reference to a recognized industry standard. NOTE 5: For bulk materials, the design record may include identification of raw materials, formulations, processing steps and parameters, and final product specifications or acceptance criteria. If dimensional results do not apply, then CAD/CAM requirements are also not applicable. 2.2.1.1 Reporting of Part Material Composition ‘The organization shall provide evidence that the Material/Substance Composition reporting that is required by the customer has been completed for the part and that the reported data complies with all customer-specific requirements NOTE: This materials reporting may be entered into the IMDS (Intemational Materials Data System) or other customer-specified system/method. IMDS is available through hitp:/www-mésystem.com/index jsp. 2.2.1.2. Marking of Polymeric Parts Where applicable, the organization shall identify polymeric parts with the ISO symbols such as specified in ISO 11469, “Plastics ~ Generic Identification and marking of plastic products” and/or ISO 1629, “Rubber and lattices — Nomenclature.” The following weight criteria shall determine if the marking requirement is applicable: ‘+ Plastic parts weighing at least 100g (using ISO 11469/1043-1) ‘* Elastomeric parts weighing at least 200g (using ISO 11469/1629) NOTE: Nomenclature and abbreviation references to support the use of ISO 11469 are contained in ISO 1043-1 for basie polymers and in ISO 1043-2 for fillers and reinforcements 2.2.2 Authorized Engineering Change documents ‘The organization shall have any authorized engineering change documents for those changes not yet recorded in the design record but incorporated in the product, part or tooling. 2.2.3. Customer Engineering Approval Where specified by the customer, the organization shall have evidence of customer engineering approval. NOTE: For bulk materials, this requirement is satisfied by a signed ‘Engineering Approval’ line item on the Bulk Material Requirements Checklist (see Appendix F) and/or inclusion on a customer maintained list of approved materials. 2.24. Design Failure Mode and Effects Analysis (Design FMEA) if the organization is product design-responsible The product design-responsible organization shall develop a Design FMEA in accordance with, and compliant to, customer-specified requirements (e.g., Potential Failure Mode and Effects Analysis reference manual). NOTE 1: A single Design FMEA may be applied to a family of similar parts or materials NOTE 2: For bulk materials, see Appendix F. 2.2.5 Process Flow ‘The organization shall have a process flow diagram in an organization-specified format that clearly describes the production process steps and sequence, as appropriate, and meets the specified customer needs, requirements and expectations (e.g., Advanced Product Quality Planning and Control Plan reference manual). For bulk materials, an equivalent to a Process Flow Diagram is a Process Flow Description. igram(s) NOTE: Process flow diagrams for ‘families’ of similar parts are acceptable if the new parts have been reviewed for commonality by the organization. 2.2.6 Process Failure Mode and Effects Analysis (Process FMEA) ‘The organization shall develop a Process FMEA in accordance with, and compliant to, customer-specified requirements, (e.g., Potential Failure Mode and Effects Analysis reference manual). NOTE 1: A single Process FMEA may be applied to a process manufacturing a family of similar parts or ‘materials if reviewed for commonality by the organization, NOTE 2: For bulk materials, see Appendix F. 2.2.7 Control Plan ‘The organization shall have a Control Plan that defines all methods used for process control and complies with customer-specified requirements (¢.g., Advanced Product Quality Planning and Control Plan reference manual), NOTE 1: Control Plans for “families” of parts are acceptable if the new parts have been reviewed for ‘commonality by the orgenization, NOTE 2: Control Plan approval may be required by certain customers, 2.2.8 Measurement System Analysis Studies ‘The organization shall have applicable Measurement System Analysis studies, e.g., gage R&R, bias, linearity, stability, for all new or modified gages, measurement, and test equipment. (sce the ‘Measurement Systems Analysis reference manual). NOTE 1: Gage R&R acceptability criteria are defined in the Measurement Systems Analysis reference manual NOTE 2: For bulk materials, Measurement System Analysis may not apply. Customer agreement should be obtained on actual requirements 2.2.9 “Dimensional Results ‘The organization shall provide evidence thet dimensional verifications required by the design record and the Control Plan have been completed and results indicate compliance with specified requirements. The organization shall have dimensional results for each unique manufacturing process, eg., cells or production lines and all cavities, molds, patterns or dies (see 2.2.18). The organization shall record, with the actual results: all dimensions (except reference dimensions), characteristics, and specifications as noted on the design record and Control Plan. ‘The organization shall indicate the date of the design record, change level, and any authorized engineering change document not yet incorporated in the design record to which the part was made. The organization shall record the change level, drawing date, organization name and part number on all auxiliary documents (e.g., supplementary layout results sheets, sketches, tracings, cross sections, CMM inspection point results, geometric dimensioning and tolerancing sheets, or other auxiliary drawings used in conjunction with the part drawing). Copies of these auxiliary materials shall accompany the dimensional results according to the Retention/Submission Requirements Table. A tracing shall be included when an optical comparator is necessary for inspection ‘The organization shall identify one of the parts measured as the master sample (see 2.2.15). NOTE 1: The Dimensional Results form in Appendix C, a pictorial, geometric dimensioning & tolerancing [GD&T] sheets, or a checked print where the results are legibly writen on a part drawing including cross- sections, tracings, or sketches as applicable may be utilized for this purpose. NOTE 2: Dimensional results typically do not apply to bulk materials. 2.2.10 Records of Material / Performance Test Results The organization shall have records of material and/or performance test results for tests specified on the design record or Control Plan. 2.2.10.1 Material Test Results ‘The organization shall perform tests for all parts and product materials when chemical, physical, or ‘metallurgical requirements are specified by the design record or Control Plan, Material test results shall indicate and include: ‘© the design record change level of the parts tested; © any authorized engineering change documents that have not yet been incorporated in the design record; * the number, date, and change level of the specifications to which the part was tested; * the date on which the testing took place; © the quantity tested: the actual results; ‘© the material supplier's name and, when required by the customer, the customer-assigned supplier/vendor code. NOTE: Material test sesults may be presented in any convenient format. An example is shown in ‘Appendix D. For products with customer-developed material specifications and a customer-approved supplier list, the organization shall procure materials and/or services (c.g., painting, plating, heat-treating, welding) from suppliers on that list. 2.2.,10.2 Performance Test Results ‘The organization shall perform tests for all pert(s) or product material(s) when performance or functional requirements are specified by the design record or Control Plan, Performance test results shall indicate and include: «the design record change level of the parts tested; * any authorized engineering change documents that have not yet been incorporated in the design record; the number, date, and change level of the specifications to which the part was tested; the date on which the testing took place; the quantity tested; the actual results NOTE: Performance test results may be presented in any convenient format. An example is shown in “Appendix E. 2.2.11 Initial Process Studies 22111 General The level of initial process capability or performance shall be determined to be acceptable prior to submission for all Special Characteristics designated by the customer or organization, The organization shall oblain customer concurrence on the index for estimating initial process capability prior to submission. ‘The organization shall perform measurement system analysis to understand how measurement error affects the study measurements. (see 2.2.8) NOTE 1: Where no special characteristics have been identified, the customer reserves the right to require demonstration of initial process capability on other characteristics. NOTE 2: The purpose of this requirement is to determine if the production process is likely to produce product that will meet the customer's requirements. ‘The initial process study is focused on variables not attribute date. Assembly errors, test failures, surface defects are examples of attribute data, which is important to understand, but is not covered in this initial study. To understand the performance of characteristics monitored by attribute data will require more data collected over time. Unless approved by the authorized customer representative, atribute data are not acceptable for PPAP submissions. NOTE 3: Cok and Pye are described below. Other methods more appropriate for certain processes or products may be substituted with prior approval from an authorized customer representative NOTE 4: Ini 1 process studies are short-term and will not predict the effects of time and variation in people, materials, methods, equipment, measurement systems, and environment. Even for these short-term studies, itis important to collect and analyze the data in the order produced using control charts NOTE 5: For those characteristics that can be studied using X-bar and R charts, a short-term study should be based on 2 minimum of 25 subgroups containing at least 100 readings from consecutive parts of the significant production run (see 2.1). The initial process study data requirements may be replaced by longer- term historical data from the same or similar processes, with customer concurrence. For certain processes, alternative analytical tools such as individual and moving range charts may be appropriate and permitted with prior approval from an authorized customer representative. 2211.2 Quality Indices Initial process studies shall be summarized with capability or performance indices, if applicable. NOTE 1: The initial process study results are dependent on the purpose of the study, method of data acquisition, sampling, amount of data, demonstration of statistical control, etc. See the Statistical Process Control reference manual for additional information in understanding the basic principles of statistical stability and process measures (indices). For guidance on items listed below, contact the authorized ‘customer representative Ga - The capability index for a stable process. The estimate of sigma is based on within subgroup variation (R-barld2 or S-bar/c4). Cy isan indicator of process capability based on process variation within ach subgroup of set of data. C,, does not include the effect of process variability between the subgroups. Gz is an indicator of how good @ process could be if all process variation between subgroups was to be eliminated, Therefore, use of Cyx alone may be an incomplete indicator of process performance. For more information, see the Statistical Process Control reference manual Pyz~ The performance index. The estimate of sigma is based on total variation (all of individual sample dota using the standard deviation {root mean square equation], “s"). Pax is an indicator of process performance based on process variation throughout the full set of data. Unlike Cy, Py isnot limited to the variation within subgroups. However, P,x cannot isolate within subgroup variation from between subgroup variation. When calculated from the same data set, Cpt and Py. can be compared to analyze the sources of process variation. For more information, see the Statistical Process Control reference manual. Initial Process Studies. The purpose of the initial process study is to understand the process variation, not just to achieve a specific index value. When historical data are available or enough initial data exist to plot 4 control chart (at least 100 individual samples), Cyy can be calculated when the process is stable. Otherwise, for processes with known and predictable special causes and output meeting specifications, Pa. should be used. When not enough data are available (< 100 samples) or there are unknown sources of variation, contact the authorized customer representative to develop a suitable plan. NOTE 2: For Initial Process Studies involving more than one process stream, additional appropriate statistical methods or approaches may be required. NOTE 3: For bulk material, the organization should obtain customer agreement regarding the appropriate techniques for initial process studies, if required, in order to determine an effective estimate of capability 22.113 Acceptance Criteria for Initial Study ‘The organization shall use the following as acceptance criteria for evaluating initial process study results for processes that appear stable. Results: Interpretation Index > 1.67 ‘The process currently meets the acceptance criteria. 1.33 < Index < 1.67 ‘The process may be acceptable, Contact the authorized customer representative for a review of the study results. Index < 1.33 ‘The process does not currently meet the acceptance criteria, Contact the authorized customer representative for a review of the study results NOTE 1: Meeting the initial process study capability acceptance criteria is one of a number of customer requirements thet leads to an approved PPAP submission NOTE 2: See 2.2.1.1 and 2.2.11.2. 2.2.11.4 Unstable Processes Depending on the nature of the instability, an unstable process may not meet customer requirements, The organization shall identify, evaluate and, wherever possible, eliminate special causes of variation prior to PPAP submission. The organization shall notify the authorized customer representative of any unstable processes that exist and shall submit a corrective action plan to the customer prior to any submission. NOTE: For bulk materials, for processes with known and predictable special causes and output meeting specifications, corrective action plans may not be required by the customer. 22115 Processes One-Sided Specifications or Non-Normal Distributions ‘The organization shall determine with the authorized customer representative alternative acceptance criteria for processes with one-sided specifications or non-normal distributions. NOTE: The above mentioned acceptance criteria (2.2.11.3) assume normality and a two-sided specification (target in the center). When this is not true, using this analysis may result in unreliable information. These alternate acceptance criteria could require a different type of index or some method of transformation of the data. The focus should be on understanding the reasons for the non-normality (e.g, is it stable over time?) and managing variation. Refer to the Statistical Process Control reference manual for further guidance. 2.2.1.6 Actions To Be Taken When Acceptance Criteria Are Not Satisfied The organization shall contact the authorized customer representative if the acceptance criteria (2.2.1.3) cannot be attained by the required PPAP submission date. ‘The organization shall submit to the authorized customer representative for approval a corrective action plan and a modified Control Plan normally providing for 100% inspection. Variation reduction efforts shall continue until the acceptance criteria are met, or until customer approval is received, NOTE 1: 100% inspection methodologies are subject to review and concurrence by the customer. NOTE 2: For bulk materials, 100% inspection means an evaluation of a sample(s) of product from a continuous process or homogeneous batch which is representative of the entire production run. 2.2.12 Qualified Laboratory Documentation Inspection and testing for PPAP shall be performed by a qualified laboratory as defined by customer Tequirements (e.g., an accredited laboratory). The qualified laboratory (intemal or extemal to the organization) shall have a laboratory scope and documentation showing that the laboratory is qualified for the type of measurements or tests conducted. When an externa/commercial laboratory is used, the organization shall submit the test results on the laboratory letterhead or the normal laboratory report format. The name of the laboratory that performed the tests, the date (8) of the tests, and the standards used to run the tests shall be identified. 2.2.13 Appearance Approval Report (AAR) A separate Appearance Approval Report (AAR) shall be completed for each part or series of parts if the product/part has appearance requirements on the design record, Upon satisfactory completion of all required criteria, the organization shall record the required information on the AAR. ‘The completed AAR and representative production products/parts shall be submitted to the location specified by the customer to receive disposition. AARs (complete with part disposition and authorized customer representative signature) shall then accompany the PSW at the time of final submission based upon the submission level requested. See customer-specific requirements for any additional requirements, NOTE 1: AAR typically applies only for parts with color, grain, or surface appearance requirements. NOTE 2: Certain customers may not require entries in all AAR fields. See Appendix B or customer- specifies for detailed instructions on completing the AAR. 2.2.14 Sample Production Parts The organization shall provide sample product as specified by the customer. 2.2.15 Master Sample ‘The organization shall retain a master sample for the same period as the production part approval records, or a) until a new master sample is produced for the same customer part number for customer approval, or b) where @ master sample is required by the design record, Control Plan or inspection criteria, as a reference or standard. The master sample shall be identified as such, and shall show the customer approval date on the sample. ‘The organization shall retain a master sample for each position of a multiple cavity die, mold, tool or pattern, or production process unless otherwise specified by the customer. NOTE 1: When part size, sheer volume of parts, etc. makes storage of a master sample difficult, the sample retention requirements may be modified or waived in writing by the authorized customer representative. The purpose of the master sample is to assist in defining the production standard, especially ‘where data is ambiguous or in insufficient detail to fully replicate the part to its original approved state. NOTE 2: Many bulk material properties are by their nature time dependent, and if a master sample is required, it may consist of the manufacturing record, test results, and certificate of analysis of key ingredients, for the approved submission sample. (see Appendix F). 10 2.2.16 Checking Aids If requested by the customer, the organization shall submit with the PPAP submission any part-specific assembly or component checking aid. The organization shall certify that all aspects of the checking aid agree with part dimensional requirements. The organization shall document all released engineering design changes that have becn incorporated in the checking aid at the time of submission. The organization shall provide for preventive ‘maintenance of any checking aids for the life of the part (see Glossary - “Active Part”). ‘Measurement system analysis studies, ¢.g., gage R & R, accuracy, bias, linearity, stability studies, shall be conducted in compliance with customer requirements. (see 2.2.8 and the Measurement Systems Analysis reference manual) NOTE 1: Checking aids can include fixtures, variable and attribute gages, models, templates, mylars specific to the product being submitted ‘NOTE 2: Checking aids, etc. typically do not apply to Bulk Materials. If checking aids are used for bulk tmaterials, the organization should contact the authorized customer representative regarding this requirement. 2.2.17 Customer-Specific Requirements The organization shall have records of compliance to all applicable customer-specifie requirements. For ‘bulk materials, applicable customer-specific requirements shall be documented on the Bulk Material Requirements Checklist. 2.2.18 Part Submission Warrant (PSW) Upon completion of all PPAP requirements, the organization shall complete the Part Submission Warrant (PSW), A separate PSW shall be completed for each customer part number unless otherwise agreed to by the authorized customer representative. If production parts will be produced from more than one cavity, mold, tool, die, pattem, or production process, e.g., line or cell, the organization shall complete a dimensional evaluation (see 2.2.9) on one part from each. The specific cavities, molds, line, etc., shall then be identified in the “Mold/Cavity/Production Process” line on a PSW, or in a PSW attachment, ‘The organization shall verify that all of the measurement and test results show conformance with customer requirements and that all required documentation is available and, for Level 2, 3, and 4, is included in the submission as appropriate. A responsible official of the organization shall approve the PSW and provide contact information. NOTE 1: One warrant per customer part number ean be used to summarize many changes providing that the changes are adequately documented, and the submission is in compliance with customer program timing requirement. NOTE 2: PSWs may be submitted electronically in compliance with customer requirements, 2.2.8.1 Part Weight (Mass) The organization shall record on the PSW the part weight of the part as shipped, measured and expressed in kilograms to four decimal places (0.0000) unless otherwise specified by the customer. The weight shall not include shipping protectors, assembly aides, or packaging materials. To determine part weight, the organization shall individually weigh ten randomly selected parts, calculate and report the average weight. At least one part shall be measured from each cavity, tool, line or process to be used in product realization. NOTE: This weight is used for vehicle weight analysis only and does not affect the approval process Where there is no production or service requirement for at least ten parts, the organization should use the required number for calculation of the average part weight. For bulk materials, the part weight field is not applicable. SECTION 3 — CUSTOMER NOTIFICATION AND SUBMISSION REQUIREMENTS 3.4 Customer Notification ‘The organization shall notify the authorized customer representative of any planned changes to the design, process, or site. Examples are indicated in the table below (see Table 3.1) NOTE: Organizations are responsible to notify the authorized customer representative of all changes to the part design and/or the manufacturing process. Upon notification and approval of the proposed change by the authorized customer representative, and after change implementation, PPAP submission is required unless otherwise specified. Table 3.1 Examples of changes requiring notification Clarifications I. Use of other construction or material than was used in the previously approved part or product For example, other construction as documented on a deviation (permit) or included as a note on the design record and not covered by an engineering change as described in Table 3.2, #3. 2. Production from new or modified tools, (except perishable tools), dies, molds patterns, ete. including additional or replacement tooling This requirement only applies to tools, which due to their unique form or function, can be expected to influence the integrity of the final product. It is not meant to describe standard tools (new ot repaired), such as standard measuring devives drivers (manual or power), etc. 3. Production following upgrade or rearrangement of existing tooling or equipment. 4, Production from tooling and equipment transferred to a different plant site or from an additional plant ste. 5. Change of supplier for parts, non= equivalent materials, or services (e.g, heat- treating, plating). Upgrade means the reconstruction and/or ‘modification of a tool or machine or to increase the capacity, performance, or change its existing function. This is not meant to be confused with noninal maintenance, repair or replacement of parts, etc., for which no change in performance is to be expected and post repair verification methods have been established. Rearrangement is defined as activity that changes the sequence of product/process flow from that documented in the process flow diagram (including the addition of a new process). Minor adjustments of production equipment may be required to meet safety requirements such as, installation of protective covers, elimination of potential ESD risks, ete. Production process tooling and or equipment transferred between buildings or facilities at one or more sites. “The organization is responsible for approval of supplier provided material and services. 6, Product produced after the tooling has | For product that has been produced afier tooling, been inactive for volume production for _| has been inactive for twelve months or more: twelve months or more. Notification is required when the part has had no change in active purchase order and the existing tooling has been inactive for volume production for twelve months or more. The only exception is when the part has low volume, e.g., service or specialty vehicles. However a customer may specify certain PPAP requirements for service parts. 7.Produet and process changes related to | Any changes, including changes at the suppliers to components of the production product the organization and their suppliers, that affect manufactured internally or manufactured by | customer requirements, eg. fit, form, function, suppliers. performance, durability. 8. Change in tes¥inspection method ~ new | For change in test method, the organization should technique (no effect on acceptance criteria) | have evidence that the new method has ‘measurement capability equivalent to the old method. ‘Additionally, for bulk materials: ‘These changes would normally be expected to have an effect on the performance of the product. 9, New source of raw material from new or existing supplier. 10. Change in product appearance attributes 3.2. Submission to Customer ) ‘The organization shall submit for PPAP approval prior to the first production shipment in the following situations unless the authorized customer representative has waived this requirement (see Table 3.2). NOTE: In the situations described below, prior notification to, or communication with, the authorized | customer representative is assumed ‘The organization shall review and update, as necessary, all applicable items in the PPAP file to reflect the production process, regardless of whether or not the customer requests a formal submission, The PPAP file shall contain the name of the authorized customer representative granting the waiver and the date. Table 3.2 Requirement Clarifications T. A new part or product (ic. a specific part, material, or color not previously supplied to the customer) ‘Submission is required for a new product (initial release) or a previously approved product that has a new or revised product/part number (e.g., suffix) assigned to it. A new part/product or material added to a family may use appropriate PPAP documentation from a previously approved part within the same product family. 2, Correction of a discrepancy on a previously submitted part Submission is required to correct any discrepancies on a previously submitted part ‘A “discrepancy” can be related to: ‘© The product performance against the customer requirements Dimensional or capability issues Supplier issues © Approval ofa part replacing an interim approval © Testing, including material, performance, or engineering validation issues 3. Engineering change to design records, specifications, or materials for production product/part numbers(s). Submission is required on any engineering change to the production produet/part design record, specifications or materials. ‘Additionally, for Bulk Materials: 4, Process technology new to the organization, not previously used for this product. 16 SECTION 4 — SUBMISSION TO CUSTOMER - LEVELS OF EVIDENCE 44 mmission | ‘The organization shall submit the items and/or records specified in the level identified below in Table 4.1 Table 4.1 Level 1 Warrant only (and for designated appearance items, an Appearance Approval Report) submitted to the customer. Level 2 Warrant with product samples and limited supporting data submitted to the customer. Level 3 Warrant with product samples and complete supporting dats 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 reviewed at the organization’s manufacturing location, See Retention/Submission Requirements Table 4.2 for exact retention/submission requirements for each submission level. ‘The organization shall use level 3 as the default level for all submissions unless otherwise specified by the authorized customer representative ‘The mi jum submission requirement for bulk materials is the PSW and the Bulk Materials Checklist. For Bulk Material PPAP submissions, check “Other” in the Reason for Submission Section on the PSW form and specify “Bulk Material.” This indicates that the "Bulk Material Requirements Checklist" was used to packet specify the PPAP requirements for the bulk material and shall be included in the submission NOTE 1: The authorized customer representative may identify a submission level, different from the default level, that is to be used with each organization, or organization and customer part number combination. Different customer locations may assign different submission levels to the same organization ‘manufacturing location. NOTE 2: lll of the forms referenced in this document may be replaced by computer-generated facsimiles. Acceptability of these facsimiles is to be confirmed with the authorized customer representative prior to the first submission, Retention/Submission Requirements Table 4.2 (Normative) (NOTE: Table 4.2 lists submission and retention requirements. Mandatory and applicable ‘requirements for a PPAP record are defined tn the PPAP manual and by the customer.) ‘Submission Level Requiremey Levell Level2 Leveli Leveld Level 5 1 Design Record R 8 s . R ~ for proprietary components/details R R R . R + forall other components/detals R s s . R 2 Engineering Change Documents, if any R s s . R 3 (Customer Engineering approval, if required R R s . R 4 Design FMEA R R s # R 5. Process Flow Diagrams R R s * R 6 Process FMEA, R R s . R 1 Control Plan R R s . R 8. Measurement System Analysis Studies R R s * R 9. Dimensional Results R s s * R 10. Material, Performance Test Results R s s . R 11. Initial Process Studies R R s . R 12, Qualified Laboratory Documentation R s 8 * R 13, Appearance Approval Report (AAR), 8 s 8 , R if applicable 14. Sample Product R s s . R 15. Master Sample R R R . R 16, Checking Aids R R R . R 17. Records of Compliance R R s . R With Customer-Specific Requirements 18. Part Suhmission Warrant (PSW) s s s s R Bulk Material Checklist (sce 4.1 above) 8 s s R 'S = The onganization shall submit tothe customer and rein a copy of records or documentation items at appropriste locations. R = The organization shall retain st appropriate locations and make available tothe customer upon request. ‘+ = The onpanization shall retain at appropriate locations and submit tothe customer upon request, SECTION 5 — PART SUBMISSION STATUS 5.1 General Upon approval of the submission, the organization shall assure that future production continues to meet all customer requirements. NOTE: For those organizations that have been clsssified as “self certifying” (PPAP submission level 1) bby a specific customer, submission of the required organization-approved documentation will be considered 8 customer approval unless the organization is advised otherwise. 5.2. Customer PPAP Status 5.2.1 Approved Approved indicates that the part or material, including all sub-components, meets all customer requirements. The organization is therefore authorized to ship production quantities of the product, subject to releases from the customer scheduling activity. 52.2 Interim Approval Interim Approval permits shipment of material for production requirements on a limited time or piece quantity basis. Interim Approval will only be granted when the organization has: ‘+ clearly defined the non-compliances preventing approval; and, ‘+ prepared an action plan agreed upon by the customer. PPAP re-submission is required to obtain a status of “approved.” Note 1: The organization is responsible for implementing containment actions to ensure that only acceptable material is being shipped to the customer. Note 2: Parts witha status of “interim Approval” are not to be considered “Approved.” Material covered by an interim approval that fails to meet the agreed-upon action plan, either by the expiration date or the shipment of the authorized quantity, will be rejected. No additional shipments are authorized unless an extension of the interim approval is granted. For bulk materials, the organization shall use the “Bulk Material Interim Approval” form, or its equivalent (see Appendix F) 523° Rejected Rejected means that the PPAP submission does not meet customer requirements, based on the production lot from which it was taken and/or accompanying documentation. In such cases, the submission and/or Process, as appropriate, shall be corrected to meet customer requirements. The submission shall be approved before production quantities may be shipped. 20 SECTION 6 —- RECORD RETENTION PPAP records (see 2.2), regardless of submission level, shall be maintained for the length of time that the part is active (see Glossary) plus one calendar year. The organization shall ensure that the appropriate PPAP records from a superseded part PPAP file are included, or referenced in the new part PPAP file. NOTE: An example of an appropriate documentirecord that should be carried forward from the old file to the new part file would be a material certification from a raw material supplier for a new part that represents only a dimensional change from the old part number. This should be identified by conducting a PPAP “gap analysis” between the old and new part numbers. Appendix A — Completion of the Part Submission Warrant (PSW) PART INFORMATION 1 Part Name and 2s, Customer Part Number: Engineering released finished end item part name and number, 2 Org, Part Number: Partnumber defined by the organizatia, ian. ‘Shown on Drawing Number: The design record that specifies the customer pat aumber being submited. Engineering Change Level & Date: Show the change level and ete of the design record. Additional Engineering Changes & Date: Lis al authorized engnesring changes nt yet incorporated inthe design record but ‘which are incerporated nthe pare Safety andr Government Regulation 6 “Yes” is indicted by the design record, eerwise “No.” 1 ‘Purchase Order Number: Enter this umber as found on the eonteepurshase onder. 5 ‘Weight: Enter the actil weight in kilograns to four desimal places unless otherwise specified bythe customer. 10, Checking Ald Number, Change Level ané Date: Ifrequsted bythe customer, coer the checking aid aumbs, is change level and date, ORGANIZATION MANUFACTURING INFORMATION Hl, Organization Name & Supplier/Vendor Code: Show the name and code assigned tothe manfistring ste an the purchase cxdeicontract. 12. _‘Street Address, Region, Postal Code, Couatry: Show the complete aes ofthe location were the product was manufactured For “Revion,” ene tte, county, province, (CUSTOMER SUBMITTAL INFORMATION 13. Customer NamelDivision: Show the corporate mime and division or operations group. 14. Bayer’Buyer Code: Enter the buyer's nam and code, Application: Enter the model year, vehicle name, engine, transmission, es MATERIALS REPORTING 16 Substances of Concern: Enter“Yes,"*No," ar a/a TMSIOther Customer Format: Circle cther“IMDS" of “Other Customer Format” es appropriate, If submited via IMDS include “Module ID, Version #, and Creation Dae. IF submited via eter customer fortut, rer the date estomer confirmation Was received, Polymeric Pars Wentifeation: Enc “Yes:"No," of REASON FOR SUBMISSION 18 —_Chack:he appropriate box(es). For blk atria, in adon to checking the sppeoprise box, check “Other” an write “Bulle Materia” in the 5 ‘SUBMISSION LEVEL, provide. 19, SUBMISSION LEVEL: Tien the submision level requested by the eustomer. ‘SUBMISSION RESULTS 20, Check the appropriate boxes for dimensional, material tests, perfomance tess, appearance evasion, and staistical dat 21, Check the appropiate box. Ho,” enter the explanation in “comments” blow 22. Moldv\CavitiesProduetion Processes: Forinstretion, se 22.18 DECLARATION 25. Emterthe number of pies manicured ung the signin! production ra 24 ——_Emterth ime (in hous) taken forthe significant production rn. 25. EXPLANATION/COMMENTS: Provide say explanatory comments on the Suhission Rests or any deviations fom the Declaration, tach additonal information at appropriate 26 CUSTOMER TOOL TAGGING/NUMBERING: Are customerownedtols identified in accord with ISO/TS 16949 and any sustomer specific requirement, answer "Yes" or"No,” May not be applicable to OEM intra supplier 27 ORGANIZATION AUTHORIZED SIGNATURE: A responsible organization oficial, after verifying thatthe results show conformance wo all customer requirements snd that all required documentation i vais, shall sprove the deleration and provide Tite, Phone Number, Fax Number, and E-mall address FOR CUSTOMER USE ONLY Lesve blank, 2 paniencemsiex > EQ Part Submission Warrant Part Name: i Cust. Pan number Sova on Downs No ean rat tr @ ST ei enna oT ‘aly andor Govormgn Reouston req] Wo Puctase Ore Ho. — ‘Weight g) Lee caesar comes Feu ppeoicrme becaiin a een ay" @ —— im bas @ @ a — — ' ® = eae FomaiGose ——Camey—picton | [ers comm stmeensenen(D 1 Cie Coa Submited by MOS or ater customer format: Kapiti ©) le He. Dak REASON FOR SUBMSSION Check at last one) Gg) [Ey ital vemieion [change 1 Optional Construction or Material || Eetreneten est Eiscepror natal Soucs ange || Ey oe: eter Rescenet, Retain or ao Eloseren pon eee i] certon ot cy [poe Pras ot Asan! Laon I Tears nace =n yu Eloter soos cosy pacueareo unas eve enero @) eee RS Sines vot clacton tem as hopes pct pat aed car 15) v2 ~ Vor in poco ened pr a nid cor TE) eats ~ vars oan pec mgs an cong ppg nei! emma {By lnet «Wart ante mirenas a rye Te eres reo pcacteanln en conte pring ta ved penn manda nn, ‘mmmaspca resus) Typ resuts tor C] aimensional measurements [] material and functional wsts [_] appearance citeria[] stalstical process package een nents Choe 80 wen @) {Mea Cnay rotten Process @ RI cn mene rn iment pen 1 emer eae once re nye rane fenestrae ea, | Smaimocomazs ai | (9 ee |aerccmnernersmicaae? Ow Ow Sppanon peterees topamn gp iro none re we || Ea FOR CUSTOMER USE ONLY UF APPLICABLE] sPBAP Warrant Dupostion{] Approved C]Rojectes Cotmr Bustomer Signatwe ty Pent Name Cust Taching Number (options) “Ea CFG-1001 DanttenCrrasiex E> Part Submission Warrant an Name as (cust. Pat Number Siow on Drang Nog. rt pr Engicoring Cnange eve ag ‘ronal Enginerng Changes, ts hiiy andor Goverment Reguaion (Ives) No Purchase Orser No lt ‘cocking Ae No, Checking Aid Engnooing Change Lael Dated ORGANIZATION MANUFACTURING INFORMATION ‘CUSTOMER SUBMITTAL. INFORMATION in Ne apse Sa Breat Adare ~— Sieayor Code & a Tamia Oamsy enon MATERIALS. REPORTING Hib estomervaquied Substances of Concom informationbeenresetes? —C] ves C1No C1 ni Submited by IMDS of ober customer tomes, —____ ‘hire pans eros win appepate 150 mating codes? Cvs One O na [REASON FOR SUBMISSION (Check st least one) [iy Tata Subesson {Coange © Optonl Conseucton or Matera Engineering Crengets) (steerer nates! Souce Change “oing arse. Racor, Reuter of sso [DJerangs in Pan rocesing [ Gonecton f Dsczopancy [P}Pare Prasiced a asstona! Lesion [El Footing inscive> man 1 yesr Clotter~ please eooety teow STED SUBMISSION LEVEL (Check one) pe SS Level 1 ~ Warrant only end fr desgnaed anpesrance tems, an Appaaance Approvd Rept submited to custome El teva 2 ~ warrant win product sates and ied supporting dat submited to estan Br Love a — waren wth product samples ar compete supeorng daa stmt to custome. [By teve «— waren and cer requirements a dtned by cose [Ey tve 5 — waren wn proaut samples and compli supcorng data eviowad at organizations manufacturing ection. SUBMISSION RESULTS | aps ipsus tx Cl mensional measurements] mate and uncional ests 7] appearance erteia Cl siaistal process pactape “Toa resus meet at design record requrorents:]¥es [1] NO. (4-NO'~ explanation Raquted) Mois Cast /Proceson Process DECLARATION si et he samples rapeseed yi warren re rpeasntsve of our ps which wave mage by proses at mesa Producten Pan ‘Aproral Process Manca Sn Eauon Roquements, furan ia bea aunes were produced Me producton ale /-—now, [So cen at documented evdence of such eomptanen on fe at avae fr oven | hae noted any Seiaon om bs Gearon bon EXPLANATION/COMMENTS: le each Customer Too prope epged and mumoered? Elves CINe OD wa Oiganizaton Authorzed Signstre bate Pt Name Prone no FAX No. Tie Emel TOR CUSTOMER USE ONLY GF APPLICABLE) PPAP Warrant Dispesten: [Approved CJAelected [Joiner Gelomer Soneire 2 fit Name am Tang Nap) ‘BR CFG-100T Appendix B — Completion of the Appearance Approval Report 1. Customer part number: Engineering released customer part number. Drawing Number: Use the number of the drawing on which the partis shown if different from the part number - Application: Enter the model year(s) and vehicle or other program on which the partis used. Part Name: Use the finished part name on the part drawing. Buyer Code: Enter the code for specific buyer of part. /7. BIC Level & Date: Engineering change level and E/C date for this submission. Organization Name: Organization responsible for submission (include supplier if applicable). Manufacturing Location: Location where part was manufactured or assembled 0. Supplier/Vendor Code: Customer-assigned code for organization location where the part was manufactured or assembled, 11, Reason for Submission: Check box(es) explaining the reason for this submission. 12. Organization Sourcing & Texture Information: List all first surface tools, graining source(s), grain type(s), and grain and gloss masters used to check part. 13. Pre-Texture Evaluation: To be completed by authorized customer representative (not used by GM). 14, Color Suffix: Use alphanumeric or numeric color identification. 15, Tristimulus Data: List numerical (colorimeter) data of submission part as compared to the customer-authorized master. 16. Master Number: Enter alphanumeric master identification (not used by Ford). 17, Master Date: Enter the date on which the master was approved 18, Material Type: Identify first surface finish and substrate (¢.g., paint/ABS), 19. Material Source: Identify first surface and substrate suppliers. Example: Redspot/Dow. 20. Color Evaluation, Hue, Value, Chroma, Gloss and Metallic Brilliance: Visual assessment by customer. 21. Color Shipping Suffix: Color part number suffix or color number. 22, Part Disposition: To be determined by customer (approved or rejected). 23. Comments: General comments by the organization or customer (optional), 24. Organization Signature, Phone No. & Date: Organization certification that the document information is accurate and meets all requirements specified. 25. Authorized Customer Representative Signature & Date: Authorized Customer Representative approval signature, 26 TTI Lie || lapeuarhd CE es gical JORGANIZATION [HANUFACTURING [SUPPLIER VENOOR he lccanon ©) cone © [REASON FOR/,,) L) PART SUBMISSION WARRANT __L] SPECIAL SAMPLE TT RE-SUBMISSION foTHEs suamission 1715 pre Texture 5 inst PRODUCTION SHIPMENT _[]_ ENGINEERING CHANGE APPEARANCE EVALUATION ORGANIZATION souRcING ano TEXTURE WeorNarion (2) a CORRECT AND PROOEED CoRREST AND esubut FePROVEDTO erosrooucou (OLOR EVALUATION at e © aT 0 TEAL] Coxon Com] _rasnawGs vara _|nsTén| waren aatERin ste we vse Tourou | cioss bruascdsnmenc part suren{ Sr [ox [or [oe fonelwuwsen| ate | Tre | source ws [ve [cor [ar [usr] oro] nse] cow Pass on | sure [osrosmon @ [eouments —— JonsauzaTion Gay [PHONE NO, [AUTHORIZED CUSTOWER [sionaTURE JREPRESENTATIVE SIGNATURE arch Mert CFG-1002 => FY APPEARANCE APPROVAL REPORT PART loRAWiNG [APPLICATION NUWOER INuMoeR VEHICLES) PART fauveR EC LEVEL [pate NAME Joooe SUPPLIER MANUFACTURING ISUPP-IERT VENDOR NAME LOCATION Joooe REASON FOR __L] PART SUBMISSION WARRANT TD SPECIAL SAMPLE TT RESUBMISSION loTHER lsuawission _O) PRE TEXTURE: G_nrst pronuction svipvent __C]_ ENGINEERING CHANGE, APPEARANCE EVALUATION ORGANIZATION SOURCING AND TEXTURE INFORMATION. ‘CORRECT AND. PROCEED ‘CORRECT AND RESUBMIT B ‘APPROVED TO |eToHTOOLEDM COLOR EVALUATION WETALIG] COLOR JcoLoR|_TRistimu.us paTA | asTeR| WASTER |MATERIAL MATERIAL HUE vatue_| crown | toss [pRLLANCESHIPPING| — PART surrx| L"[ oa [or [oe[omcuumaer| oare | type | source mo [wm [ow] au [uom|oun)ourfacinl man] vow wan [sow] surstx | pisposrmon! (COMMENTS: [ORGANTZATION [PHONENO. PuTHORZED CUSTONER [SIGNATURE JREPRESENTATIVE SIGNATURE March ert CFG-1002 JON / SPECIFICATION] CFG-1003 Appendix C — Production Part Approval, Dimensional Production Part Approval Dimensional Test Results PART ROWBER: parr NaWe: DESIGN RECORD CHANGE LEVEL: ENGINEERING CHANGE DOCUMENTS: ums | oare |resreo| RESULTS (DATA) ‘Blanket statements of conformance are unacceptable for any test resus, SERATURE HE DATE 30 ix D — Production Part Approval, Material Test Production Part Approv: Material Test Results «@ HH arriowe Peston aecono cranse ve fa o ASO RATORT ED SUPPLIERVENOOR CODE go Sgt sen aCe ste ce .NO.1 REV /OATE umirs | pare |resteo| TEST RESULTS (DATA) [Blanket statements of conformance are unaccoplable for any test results orcaa TE TE TSE ix E — Production Part Approval, Performance ults Production Part Approval Performance Test Results "ART NONGER °ART NAME: {ESIGN RECORD CHANGE LEVEL: NGINEERING CHANGE DOCUMENTS. cove: a IYFIED SUPPLIERIVENOOR CODE: inde Supple) Cuter assigned cose EST RESULTS ERT "TEST CONDITIONS. STON REV DATE. UMTS are |resteo] Blanket statements of conformance are unacceptable for any test results. SG THLE Tae CFG-1005 plying bulk materials shall comply with the requirements in this Appendix or use relarification of PPAP. The requirements in this Appendix are minimums and may be responsible for applying PPAP to their suppliers of ingredients wl ited special characteristics. P-approval of a bulk material exists, evidence of that approval is sufficient as the PPAP revels in the supply chain. ié-material include, but are not limited to: adhesives and sealants (solders, elastomers); s, polishes, additives, treatments, colors/pigments, solvents); coatings (top coats, phosphates, surface treatments); engine coolants (antifreeze); fabrics; film and film jus and non-ferrous metals (bulk sieel, aluminum, coils, ingots); foundry (sand/silica, jal, other minerals/ores); fuels and fuel components; glass and glass components; “greases, etc.); monomers, pre-polymers and polymers (rubbers, plastics, resins and their { performance fluids (transmission, power steering, brake, refrigerant). I, the PPAP elements required are defined by the Bulk Materials Requirements, ‘customer-specific requirements shall be documented on the Bulk Materials Requirements Ik Materials Requirements Checklist as follows: ‘Required / Target Date: For each item listed in the checklist either enter a target date for completion of the element or enter “NR” for Not Required. “Primary Responsibility - Customer: Identify by name or function the individual who will feview and approve the element. tary Responsibility - Organization: Identify by name or function the individual who will smpble and assure the completeness of the element to be reviewed. rents / Conditions: Identify any qualifying information or references to attached iments that provide specific information regarding the element. For example, this may include specific formats to be used for the Design Matrix or acceptable tolerances for Measurement System Analysis (MSA) studies, “Approved by: Enter the initials of the authorized customer representative who has reviewed and accepted the element. Plan agreed to by: Identify the individuals (and their functions) who made and agreed upon the project plan, Bulk Materials Requirements Checklist Project: — € Required /_ | Primary Responsibility ‘Target Date | Cusomer | Organization | Product Design and Development Verification ‘Design Matrix | Design FMEA. ‘Special Product Characteristics Design Records Prototype Control Plan ‘Appearance Approval Report Master Sample Test Results aR Dimensional Results zea) ‘Checking Aids omni Engineering Approval I ores este | F | Process Design and Development Verification Process Flow Diagrams Process FMEA | Special Process Characteristics re-launch Control Plan : Production Control Plan “Measurement System Analysis Interim Approval Product and Process Validation M tint ous Tnitial Process Studies Part Submission Warrant Elements to be completed as needed Y wmnd « ‘Customer Plant Connection vane Customer-Specific Requirements — Change Documentation 7 ‘Supplier Considerations a Plan Agreed to by: Name / Function ‘Company / Title / Date E ign Matrix F.4.1 Introduction Organizations supplying bulk material generally deal with the chemistry and functionality of the product being designed. Use of these suggestions will arrive at the same end point of a completed Design FMEA, but with greater applicability to bulk materials. For bulk materials, a Design Matrix, when required, shall be prepared prior to developing the Design FMEA. The Design Matrix determines the complex interactions of formula ingredients, ingredient characteristics, product characteristics, process constraints, and conditions for customer use. High impact items can then be effectively analyzed in the Design FMEA. F.4.2 Design Matrix — Elaboration This matrix correlates customer expectations with the product design items. Construct the Design Matrix referring to the example which will follow: 1. Along the horizontal axis, list the Functions (Desired Attributes/Potential Failure Modes). 2. Along the vertical axis, list the design items as Potential Causes (Category/Characteristies) Formula Ingredients Ingredient Characteristics, Product Characteristics Process Constraints Conditions for Use (customer process constraints) For each design item, enter the current robust threshold range levels and units. 4. Correlate the potential causes to the potential failure modes using @ number, letter, or symbol representing the impact or strength of the relationship. Ask what would happen if a potential cause item is allowed to go under or over its robust minimum or maximum, respectively. 5. Afier completion of the rankings in the Design Matrix, review the category/characteristies for a preliminary assessment of Special Characteristics. Designate any Special Characteristics in column 1 6. The high negative impact potential causes are transferred to the Design FMEA for analysis 37 viNaWNOWIANA (e200W SuN Ws TWANSLOd) SaiNGRLLV GawISIO- NOWONNS i j | Tas wee SOUSISLOVEVHO i i vasooaive | Fy i ill MlavEe300ud| BONVNUORIaG| Sasnvo WUNaLOg 11009 oes Tea weoeing MAC NoEROGRTD Pape FId VX LNIVd OIMAN39 - XINLVW NOISSG A 2.4) F.5.1 Effects of Failure and Severity Rankings The following two steps provide an alternative method for identifying the Potential Effects of Failure and assigning a Severity Ranking, List Effects of Failure © Consumer Effects - General terms identifying the loss experienced by the ultimate user of the product (e.g., the vehicle buyer) ‘* Customer Effects - General terms identifying the loss experienced by the intermediate user of your product (e.g., the vehicle manufacturer). Assign a Severity Ranking to each Effect ‘© See the Severity Definition and Evaluation Criteria in the Potential Failure Mode and Effects Analysis reference manual ‘© The goal for cach of the items that multiply to arrive at the Risk Priority Number is to differentiate between the items in that category. The following figure provides a guideline for severity rankings. If your situation only uses a small portion of the scale then develop ‘your own scale to improve the differentiation. If your situation is greater than two tiers back from the final consumer, then the guideline figure should be adjusted to reflect the effects that will be felt by your customer's customer. Effects of Failure and Severity Ranking Table Stakeholder Effects of Failure Severity ‘Consumer (Owner Safety Problem a (c.g. vehicle buyer) “Major Owner Dissatisfaction (Loss of Owner Loyalty) ‘Moderate Owner Dissatisfaction (Inconvenience) Minor Owner Diss Customer Plant Safety Problem (ea, vehicle = 7 manufacturer) Eosaiie east [Line Stoppsze Warranty Costs Serap Regulatory Pemlly Moderate Rework (e.g, < 20% or moderate repal Plan Dissatisfeton Minor Rework (eg, <10% or imple repai) suction (Annoyance) F.5.2 Potential Cause(s)/Mechanisms of Failure and Design Matrix From the Design Matrix (if used), list the high negative impact characteristics as the Potential Causes/Mechanisms of Failure which are associated with Potential Failure Modes. Mechanisms are generally described as over or under a certain threshold. These thresholds define the boundaries of the product approval and subsequent requirements for change notification. 39

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