1、Production Part Approval Process (PPAP),What is PPAP?,Production Part Approval Process Standard used to formally reduce risks prior to product or service release, in a team oriented manner using well established tools and techniques Initially developed by AIAG (Auto Industry Action Group) in 1993 wi
2、th input from the Big 3 - Ford, Chrysler, and GM AIAGs 4th edition effective June 1, 2006 is the most recent version PPAP has now spread to many different industries beyond automotive,Purpose of PPAP,Provide evidence that all customer engineering design record and specification requirements are prop
3、erly understood by the organization To demonstrate that the manufacturing process has the potential to produce product that consistently meets all requirements during an actual production run at the quoted production rate,When is PPAP Required?,New part Engineering change(s) Tooling: transfer, repla
4、cement, refurbishment, or additional Correction of discrepancy Tooling inactive one year Change to optional construction or material Sub-supplier or material source change Change in part processing Parts produced at a new or additional location,Benefits of PPAP Submissions,Helps to maintain design i
5、ntegrity Identifies issues early for resolution Reduces warranty charges and prevents cost of poor quality Assists with managing supplier changes Prevents use of unapproved and nonconforming parts Identifies suppliers that need more development Improves the overall quality of the product & customer
6、satisfaction,Production Run,PPAP data must be submitted from a production run using: Production equipment and tooling Production employees Production rate Production process,Run Rate,The purpose of a Run Rate is to verify the suppliers manufacturing process is capable of producing components that me
7、et NCRs quality requirements, at quoted tooling capacity, for a specified period of time Verification of the Run Rate will be at the Supplier Quality Engineers (SQE) discretion. The supplier will be notified of the need to perform a Run Rate as early in the process as possible. The number of compone
8、nts to be produced during the Run Rate should be sufficient to demonstrate process capability and will be predetermined by the SQE and the supplier. Factors such as product complexity, shelf life, storage, cost and single shift vs. multiple shift operations will be taken into consideration,Official
9、PPAP Requirements,Design Records Authorized Engineering Change Documents Customer Engineering Approval, if required Design Failure Modes and Effects Analysis (DFMEA) applied in special situations Process Flow Diagram Process Failure Modes and Effects Analysis (PFMEA) Control Plan Measurement Systems
10、 Analysis (MSA) Dimensional Results Records of Material / Performance Test Results Initial Process Studies Qualified Laboratory Documentation Appearance Approval Report (AAR) Sample Production Parts Master Sample Checking Aids Customer-Specific Requirements Part Submission Warrant (PSW),Now, lets ta
11、ke a closer look at NCRs requirements,NCRs PPAP Requirements,Design Records Authorized Engineering Change Documents Customer Engineering Approval, if required Design Failure Modes and Effects Analysis (DFMEA) applied in special situations Process Flow Diagram Process Failure Modes and Effects Analys
12、is (PFMEA) Control Plan Measurement Systems Analysis (MSA) Dimensional Results Records of Material / Performance Test Results Initial Process Studies Qualified Laboratory Documentation Appearance Approval Report (AAR) Sample Production Parts Master Sample Checking Aids Customer-Specific Requirements
13、 Part Submission Warrant (PSW) NCR calls this the “Production Warrant”,Design Records Authorized Engineering Change Documents Customer Engineering Approval, if required Design Failure Modes and Effects Analysis (DFMEA) applied in special situations Process Flow Diagram Process Failure Modes and Effe
14、cts Analysis (PFMEA) Control Plan Measurement Systems Analysis (MSA) Dimensional Results Records of Material / Performance Test Results Initial Process Studies Qualified Laboratory Documentation Appearance Approval Report (AAR) Sample Production Parts Master Sample Checking Aids Customer-Specific Re
15、quirements Part Submission Warrant (PSW) NCR calls this the “Production Warrant”,NCRs PPAP Requirements,PPAP Submission Levels,PPAP Submission Level Table,Definition of Risk,High Risk Parts associated with multiple critical features, complex design, or high end technology that is not yet established
16、 in the general manufacturing environment Suppliers quality system and/or quality performance is not to NCR satisfaction Medium Risk Parts that have at least one critical feature Low Risk Parts that have no critical features and can be manufactured by any manufacturer in the commodity category Suppl
17、iers quality system and quality performance are acceptable,Submission Level Requirements,New Parts Level 2 is required for Low Risk Parts Level 3 is required for Medium and High Risk PartsPart Changes Level 3 is required for Parts produced at a new or additional location Supplier Quality Excellence
18、will define the level required for all other changes,PPAP Status,Approved The part meets all NCR requirements Supplier is authorized to ship production quantities of the part Interim Approval Permits shipment of part on a limited time or piece quantity basis Rejected The part does not meet NCR requi
19、rements, based on the production lot from which it was taken and/or accompanying documentation,Production quantities may not be shipped before NCR Approval,Electronic Submission Requirements,NCR requires that all PPAPs be submitted electronically Use of paper submission must have prior approval by t
20、he SQE Submission must be received on or prior to the PPAP due date Review and Approval Process: NCR will attempt to review and provide feedback within 2 business days,NCR PPAP Playbook,What is the NCR PPAP Playbook? An Excel spreadsheet containing templates of the documents suppliers are required t
21、o submit to NCRWhy use the PPAP Playbook? Simplifies the process for suppliers by serving as a “checklist” of what needs to be submitted to NCR Reduces the number of files to manage Enables the SQE to quickly see if anything is missing,Show PPAP Playbook,Production Warrant,Now, lets take a closer lo
22、ok,What is It? Document required for all newly tooled or revised products in which the supplier confirms that inspections and tests on production parts show conformance to NCR requirements,Production Warrant,Production Warrant,Production Warrant,Production Warrant,Reviewers Checklist Must be complet
23、ely filled out Must be signed by the supplier P/N must match the PO Submitted at the correct revision level Submitted at the correct submission level Specify the reason for submission,Production Warrant,Authorized Engineering Change Documents,The supplier shall provide authorized change documents fo
24、r those changes not yet recorded in the design record, but incorporated in the product, part or tooling, such as: ECNs (must be approved, not pending) Specifications Feasibility studies Supplier change requests Sub-assembly drawings Life or reliability testing requirements,Process Flow Diagram,What
25、is It? A visual diagram of the entire process from receiving through shipping, including outside processes and services,Process Flow Diagrams,Process Flow Diagram - Example,Star Exercise,Divide into teams Distribute supplies Paper for Stars Instructions for making Stars Scissors Using the instructio
26、ns handed out in class, make 10 Shuriken Stars This exercise will prepare your team to complete future exercises,45 Minutes,Process Flow Diagram Star Exercise,05,Incoming Inspection,10,Paper Folding,15,Cutting,20,Star Folding,25,35,Tucking,30,Final Inspection,Packing,40,Shipping,Inspection as per Op
27、eration layout,If rework possible,Rework,100% Inspection,Scrap,Next Operation,Not OK,OK,Patrol Insp Report,Reviewers Checklist Process Flow must identify each step in the process Should include abnormal handling processes Scrap Rework Process Flow must include all phases of the process Receiving of
28、raw material Part manufacturing Offline inspections and checks Assembly Shipping,Process Flow Diagrams,Process FMEA (PFMEA),When to Use It After completion of the process flow diagram. Prior to tooling for production,What is It? A tool used to identify and prioritize risk areas and their mitigation
29、plans.,The PFMEA should be completed using a cross-functional team!,IMPORTANT!,FMEA Origin,Created by NASA following Apollo 1 mission failure Allows us to take a proactive approach to what can go wrong in a process and manage our risks better,Process FMEA (PFMEA),TIPS There should be at least one fa
30、ilure mode for each input.,PFMEA - Step 1,TIPS There should be at least one failure effect for each failure mode. Effects should be specific, clear, and leave no doubt to the uninformed reviewer.,PFMEA - Step 2,TIPS There should be at least one potential cause for each failure mode.,PFMEA - Step 3,T
31、IPS This step in the FMEA begins to identify initial shortcomings or gaps in the current control plan. If a procedure exists, enter the document number. If no current control exists, list as “none.”,PFMEA - Step 4,Assign Severity, Occurrence, and Detection ratings,Severity, Occurrence and Detection
32、rating details on next slide,PFMEA - Step 5,PFMEA - Definition of Terms,Severity (of Effect) - severity of the effect on the Customer and other stakeholders (Higher Value = Higher Severity) Occurrence (of Cause) - frequency with which a given Cause occurs and creates Failure Mode. (Higher Value = Hi
33、gher Probability of Occurrence) Detection (Capability of Current Controls) - ability of current control scheme to detect the cause before creating the failure mode and/or the failure mode before suffering the effect (Higher Value = Lower Ability to Detect),High 10,Low 1,Rating,*If No Controls Exist,
34、 Detection = 10,Create a rating system that makes sense for the defects you are trying to prevent.,An Example of Rating Definitions,TIPS The RPN is used to prioritize the most critical risks identified in the first half of the FMEA. High RPNs (125 or above) are flags to take effort to reduce the cal
35、culated risk. Regardless of RPN, high Severity scores (9 or 10) should be given special attention.,PFMEA - Step 6,Once the RPN Numbers are determined, they can be used to prioritize the most significant failure modes. Sort the FMEA by the RPN numbers. Graphical and statistical tools can help the tea
36、m select a “cut-off” RPN for the next steps.,RPN ThresholdsWhen using an RPN threshold, DO NOT forget to address high Severity scores,Pareto Chart,Analyzing the PFMEA,PFMEA Remediation Guidelines,Severity can only be improved by a design change to the product or process Occurrence can only be reduce
37、d by a change which removes or controls a cause. Examples are redundancy, substituting a more reliable component or function or mistake-proofing. Detection can be reduced by improving detection. Examples are mistake-proofing, simplification and statistically sound monitoring.,Determine Actions Recom
38、mended to reduce High RPNs,FMEA Step 7,Now recalculate your RPNs based on mitigation plans.,TIPS: Continue updating the actions taken and resulting RPNs until all risks are at an acceptable level (below 125).,FMEA Steps 8 and 9,For each Process Input, determine the ways in which the Process Step can
39、 go wrong (these are Failure Modes). For each Failure Mode associated with the inputs, determine Effects on the outputs. Identify potential Causes of each Failure Mode. List the Current Controls for each Cause. Assign Severity, Occurrence and Detection ratings after creating a ratings key appropriat
40、e for your project. Calculate RPN. Determine Recommended Actions to reduce High RPNs. Take appropriate Actions and Document. Recalculate RPNs. Revisit steps 7 and 8 until all the significant RPNs have been addressed.,Summary Steps To Complete a FMEA,PFMEA Exercise,30 Minutes,InstructionsOpen the PPA
41、P Training Templates.xls file, then select the PFMEA worksheet. Using process steps 20 and 25 from the completed Star Process Flow Diagram handout, complete 2 rows of the PFMEA.,Collaborative Effort: Do not try alone, use a group Very laborious: Time consuming process. Take necessary breaks. Action
42、items are required for completion Train team ahead of time by explaining scoring criteria Proper preparation is needed for meetings Summarize often: FMEA is a living document,Tips and Lessons Learned,Process FMEA (PFMEA),Reviewers Checklist Verify there is a system for prioritizing risk of failure s
43、uch as RPN numbers of 125 or above Make sure that high RPN process concerns are carried over into the control plan Make sure that all critical failure modes are addressed Safety Form, fit, function Material concerns,Process FMEA (PFMEA),Control Plan,Since processes are expected to be continuously up
44、dated and improved, the control plan is a living document!,NOTE,Process Steps,New/Revised Process Steps,New/Revised Process Steps,Process Steps,Risk Prioritized Process Steps,Improved Controls,Tool Interaction,Control Plan,NCRs Control Plan,Control Plan,3 Distinct Phases,Control Plan,Administrative
45、Section,Control Plan,Process, Machine/Tools, Characteristics,Control Plan,Specifications, Measurement, Sample Size & Frequency,Control Plan,Control Method, Reaction Plan,Control Plan,Audit Plans,Audit plans should be included in the control plan as a separate line. Auditing is an important tool for
46、control. Process auditing should be a key element of the quality system of a business. Audits generally cover: Effectiveness of controls Control plan (say) vs. what is actually done (do) Audits should be objective (done by internal or external third parties if possible). Audit frequencies should be
47、based on balancing level of risk (FMEA) and cost.,Control Plan Example,A supplier manufactures a circuit board with electronic components soldered on the board. Properly soldered connections are the major product characteristics. Two major process characteristics for the wave solder machine are sold
48、er level and flux concentration. An automated feeder controls the solder level by sensing the level of solder and feeding in additional solder as the level is reduced. This characteristic is measured 100% by checking electrically for continuity. The flux must be sampled and tested for the concentrat
49、ion level.,Instructions Open the PPAP Training Templates.xls file, then select the Control Plan worksheet. Using the completed Star Process Flow Diagram (process steps 20 and 25) and the completed PFMEA, complete 2 rows of the Control Plan. Document potential problems that might be encountered and p
50、otential solutions with your teams.,Control Plan Exercise,20 Minutes,Control Plan,Use process flow diagram and PFMEA to build the control plan; keep them aligned Controls must be used to be effective. Keep it simple. Ensure that the control plan is in the document control system of the business Good
51、 control plans address: All testing requirements - dimensional, material, and performance All product and process characteristics at every step throughout the process The control method should be based on an effective analysis of the process Such as SPC, Error Proofing, Inspection, Sampling Plan Control plans should reference other documentation Specifications, tooling, etc.,
