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Ranvijay Akela

The Production Part Approval Process (PPAP) document provides information about NCR's PPAP requirements for suppliers. It describes what a Production Warrant is and when one is required. A Production Warrant confirms that production parts meet all specifications and requirements. It must be submitted before shipping parts to NCR. The document outlines the information required on the warrant, including part numbers, engineering changes, submission level, and a supplier declaration that the parts were produced to requirements.

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Production Part Approval Process (PPAP)
2NCR Confidential 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 with input from the Big 3 - Ford, Chrysler, and GM •AIAG’s 4th edition effective June 1, 2006 is the most recent version •PPAP has now spread to many different industries beyond automotive
3NCR Confidential Purpose of PPAP •Provide evidence that all customer engineering design record and specification requirements are properly 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 PPAP manages change and ensures product conformance!
4NCR Confidential When is PPAP Required? New part Engineering change(s) Tooling: transfer, replacement, 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 PPAP is required with any significant change to product or process!
5NCR Confidential Benefits of PPAP Submissions •Helps to maintain design integrity •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 satisfaction
6NCR Confidential Production Run •PPAP data must be submitted from a productionproduction run using:: Production equipment and tooling Production employees Production rate Production process All data reflects the actual production process to be used at start-up!
7NCR Confidential Run @ Rate •The purpose of a Run @ RateRun @ Rate is to verify the supplier’s manufacturing process is capable of producing components that meet NCR’s quality requirements, at quoted tooling capacity, for a specified period of time •Verification of the Run @ Rate will be at the Supplier Quality Engineer’s (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 components 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
8NCR Confidential Official PPAP Requirements 1. Design Records 2. Authorized Engineering Change Documents 3. Customer Engineering Approval, if required 4. Design Failure Modes and Effects Analysis (DFMEA) applied in special situations 5. Process Flow Diagram 6. Process Failure Modes and Effects Analysis (PFMEA) 7. Control Plan 8. Measurement Systems Analysis (MSA) 9. Dimensional Results 10. Records of Material / Performance Test Results 11. Initial Process Studies 12. Qualified Laboratory Documentation 13. Appearance Approval Report (AAR) 14. Sample Production Parts 15. Master Sample 16. Checking Aids 17. Customer-Specific Requirements 18. Part Submission Warrant (PSW) Now, let’s take a closer look at NCR’s requirements
9NCR Confidential NCR’s PPAP Requirements 1. Design Records 2.2. Authorized Engineering Change DocumentsAuthorized Engineering Change Documents 3.3. Customer Engineering Approval, if requiredCustomer Engineering Approval, if required 4. Design Failure Modes and Effects Analysis (DFMEA) applied in special situations 5.5. Process Flow DiagramProcess Flow Diagram 6.6. Process Failure Modes and Effects Analysis (PFMEA)Process Failure Modes and Effects Analysis (PFMEA) 7.7. Control PlanControl Plan 8.8. Measurement Systems Analysis (MSA)Measurement Systems Analysis (MSA) 9.9. Dimensional ResultsDimensional Results 10.10. Records of Material / Performance Test ResultsRecords of Material / Performance Test Results 11. Initial Process Studies 12.12. Qualified Laboratory DocumentationQualified Laboratory Documentation 13.13. Appearance Approval Report (AAR)Appearance Approval Report (AAR) 14.14. Sample Production PartsSample Production Parts 15. Master Sample 16. Checking Aids 17. Customer-Specific Requirements 18.18. Part Submission Warrant (PSW) – NCR calls this the “Production Warrant”Part Submission Warrant (PSW) – NCR calls this the “Production Warrant” Supplier shall submit these 12 items and retain a copy of records at appropriate locations
10NCR Confidential 1.1. Design RecordsDesign Records 2. Authorized Engineering Change Documents 3. Customer Engineering Approval, if required 4.4. Design Failure Modes and Effects Analysis (DFMEA)Design Failure Modes and Effects Analysis (DFMEA) applied in special situationsapplied in special situations 5. Process Flow Diagram 6. Process Failure Modes and Effects Analysis (PFMEA) 7. Control Plan 8. Measurement Systems Analysis (MSA) 9. Dimensional Results 10. Records of Material / Performance Test Results 11.11. Initial Process StudiesInitial Process Studies 12. Qualified Laboratory Documentation 13. Appearance Approval Report (AAR) 14. Sample Production Parts 15.15. Master SampleMaster Sample 16.16. Checking AidsChecking Aids 17.17. Customer-Specific RequirementsCustomer-Specific Requirements 18. Part Submission Warrant (PSW) – NCR calls this the “Production Warrant” Supplier shall retain these 6 items at appropriate locations, and make readily available upon request NCR’s PPAP Requirements
11NCR Confidential Level 1 Production Warrant and Appearance Approval Report (if applicable) submitted to NCR Level 2 Production Warrant, product samples, and dimensional results submitted to NCR Level 3 Production Warrant, product samples, and complete supporting data submitted to NCR Level 4 Production Warrant and other requirements as defined by NCR Level 5 Production Warrant, product samples and complete supporting data (a review will be conducted at the supplier's manufacturing location) PPAP Submission Levels
12NCR Confidential Requirement Level 1 Level 2 Level 3 Level 4 Level 5 1. Design Records of Saleable Product R R R * R a. For proprietary components/details R R R * R b. For all other components/details R R R * R 2. Engineering Change Documents, if any R S S * S 3. Customer Engineering approval, if required R S S * S 4. Design FMEA R R R * R 5. Process Flow Diagrams R R S * S 6. Process FMEA R R S * S 7. Dimensional Results S S S * S 8. Material, Performance, Test Results R S S * S 9. Initial Process Study R R R * R 10. Measurement System Analysis Studies R R S * S 11. Qualified Laboratory Documentation R R S * S 12. Control Plan R R S * S 13. Part Submission Warrant (PSW) S S S * S 14. Appearance Approval Report, (AAR) if applicable S S S * S 15. Bulk Material Requirements Checklist (for bulk material only) R R R * R 16. Sample Product R S S * S 17. Master Sample R R R * R 18. Checking Aids R R R * R 19. Records of compliance with Customer-Specific Requirements (DVP&R) R R R * R Submission Level PPAP Levels for Submission & Retention S = The supplier shall submit to NCR and retain a copy of records or documentation items at appropriate locations. R = The supplier shall retain at appropriate locations and make readily available to NCR upon request. * = The supplier shall retain at appropriate locations, and submit to NCR upon request. NCR will identify what is needed for submission. PLEASE CONTACT YOUR SUPPLIER QUALITY ENGINEER WITH ANY QUESTIONS . PPAP Submission Level Table S = Supplier shall submit to NCR & retain a copy of records or documentation items at appropriate locations R = Supplier shall retain at appropriate locations and make readily available to NCR upon request * = Supplier shall retain at appropriate locations, and submit to NCR upon request. NCR will identify what is needed for submission.
13NCR Confidential Definition of Risk •High Risk Parts associated with multiple critical features, complex design, or high end technology that is not yet established in the general manufacturing environment Supplier’s 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 Supplier’s quality system and quality performance are acceptable
14NCR Confidential Submission Level Requirements •New PartsNew Parts Level 2 is required for Low Risk Parts Level 3 is required for Medium and High Risk Parts •Part ChangesPart Changes Level 3 is required for Parts produced at a new or additional location Supplier Quality Excellence will define the level required for all other changes NCR reserves the right to redefine the submission level required
15NCR Confidential 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 requirements, based on the production lot from which it was taken and/or accompanying documentation Production quantities may not be shipped before NCR Approval
16NCR Confidential Electronic Submission Requirements •NCR requires that all PPAPs be submitted electronically •Use of paper submission must have prior approval by the 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 requires all submissions to be electronic
17NCR Confidential NCR PPAP Playbook •What is the NCR PPAP Playbook? An Excel spreadsheet containing templates of the documents suppliers are required to submit to NCR •Why 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
18NCR Confidential PRODUCTION WARRANTPRODUCTION WARRANT
19NCR Confidential Production Warrant Now, let’s take a closer look 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 Used to : • document part approval • provide key information • declare that the parts meet specification Objective or Purpose When to Use It • Prior to shipping production parts Part Name NCR Part Number Shown on Drawing no. Supplier Part Number Engineering Drawing Change Level Dated Additional Engineering Changes Dated Safety and/or Government Regulation Yes No Purchase order No. Weight (kg) Checking Aid No. Engineering Change Level Dated SUPPLIER MANUFACTURING INFORMATION NCR SUBMITTAL INFORMATION Supplier Name Supplier Code NCR Location Street Address Buyer Buyer Code City Model Name / Number Note: Does this part contain any restricted or reportable substances? Yes No Are parts identified with appropriate UL/CE/ISO marking codes if applicable? Yes No REASON FOR SUBMISSION Initial Submission Change to Optional Construction or Material Engineering Change(s) Sub-Supplier or Material Source Change Tooling: Transfer, Replacement, Refurbishment, or additional Change in Part processing Correction of Discrepancy Parts Produced at New or Additional Location Tooling Inactive > than 1 year Other - please specify REQUESTED SUBMISSION LEVEL (Check one based on NCR requirements) Level 1 - Production Warrant and Appearance Approval Report (if applicable) submitted to NCR Level 2 - Production Warrant, product samples, and dimensional results submitted to NCR Level 3 - Production Warrant, product samples, and complete supporting data submitted to NCR Level 4 - Production Warrant and other requirements as defined by NCR Level 5 - Production Warrant, product samples, and complete supporting data reviewed at supplier's manufacturing location SUBMISSION RESULTS The results for dimensional measurements material and functional tests appearance criteria statistical process package These results meet all drawing and specification requirements: Yes No (If "No" - Explanation Required) Mold / Cavity / Production Process: DECLARATION I affirm that the samples represented by this warrant are representative of our parts, which were made by a process that meets all of NCR's Production Part Approval Process requirements. I further affirm that these samples were produced at the production rate of _____ pieces / _____ hours. I also certify that documented evidence of such compliance is on file and available for review. I have noted any deviations from this declaration below. EXPLANATION/COMMENTS: Supplier Authorized Signature Date Print Name Title Email Phone No. PPAP Warrant Disposition: Approved Rejected Other ____________________________________________________ NCR Signature _____ Date Print Name NCR Tracking Number (optional) Production Warrant CountryPostal CodeRegion FOR CUSTOMER USE ONLY (IF APPLICABLE)
20NCR Confidential Production Warrant Part Name NCR Part Number Shown on Drawing no. Supplier Part Number Engineering Drawing Change Level Dated Additional Engineering Changes Dated Safety and/or Government Regulation Yes No Purchase order No. Weight (kg) Checking Aid No. Engineering Change Level Dated SUPPLIER MANUFACTURING INFORMATION NCR SUBMITTAL INFORMATION Supplier Name Supplier Code NCR Location Street Address Buyer Buyer Code City Model Name / Number Note: Does this part contain any restricted or reportable substances? Yes No Are parts identified with appropriate UL/CE/ISO marking codes if applicable? Yes No Production Warrant CountryPostal CodeRegion Part Name / NCR Part Number Engineering released finished end item part name and number Safety and/or Government Regulation “Yes” if so indicated by the Design Record, otherwise “No” Engineering Change Level & Date Show the change level and date of the Design Record Additional Engineering Changes List all authorized Engineering changes not yet incorporated in the design record but which are incorporated in the part Shown on Drawing Number The design record that specifies the customer part number being submitted Checking Aid Number, Change Level, & Date Enter if requested by the customer Purchase Order Number Enter this number as found on the contract / purchase order Supplier Part Number Part number defined by the supplier, if any
21NCR Confidential Production Warrant Part Name NCR Part Number Shown on Drawing no. Supplier Part Number Engineering Drawing Change Level Dated Additional Engineering Changes Dated Safety and/or Government Regulation Yes No Purchase order No. Weight (kg) Checking Aid No. Engineering Change Level Dated SUPPLIER MANUFACTURING INFORMATION NCR SUBMITTAL INFORMATION Supplier Name Supplier Code NCR Location Street Address Buyer Buyer Code City Model Name / Number Note: Does this part contain any restricted or reportable substances? Yes No Are parts identified with appropriate UL/CE/ISO marking codes if applicable? Yes No Production Warrant CountryPostal CodeRegion NCR Location Show the location where parts will be shipped toBuyer / Buyer Code Enter the buyer’s name and code Restricted Substances Enter “Yes” or “No” Model Name / Number Enter the model name and number Parts Identified with Appropriate Marking Codes ULUL = Underwriters Laboratories safety standards CECE = Conformite Europeenne (European Conformity) – Certifies that a product has met European consumer Safety, health, or environmental requirements ISO = International Organization for Standardization Enter “Yes” or “No” Supplier Manufacturing Information Show the name and code assigned to the manufacturing site on the purchase order / contract
22NCR Confidential Production Warrant REASON FOR SUBMISSION Initial Submission Change to Optional Construction or Material Engineering Change(s) Sub-Supplier or Material Source Change Tooling: Transfer, Replacement, Refurbishment, or additional Change in Part processing Correction of Discrepancy Parts Produced at New or Additional Location Tooling Inactive > than 1 year Other - please specify REQUESTED SUBMISSION LEVEL (Check one based on NCR requirements) Level 1 - Production Warrant and Appearance Approval Report (if applicable) submitted to NCR Level 2 - Production Warrant, product samples, and dimensional results submitted to NCR Level 3 - Production Warrant, product samples, and complete supporting data submitted to NCR Level 4 - Production Warrant and other requirements as defined by NCR Level 5 - Production Warrant, product samples, and complete supporting data reviewed at supplier's manufacturing location SUBMISSION RESULTS The results for dimensional measurements material and functional tests appearance criteria statistical process package These results meet all drawing and specification requirements: Yes No (If "No" - Explanation Required) Mold / Cavity / Production Process: Reason For Submission Check the appropriate box(es) Requested Submission Level Identify the submission level requested by NCR Submission Results Check the appropriate boxes Mold / Cavity / Production Process If production parts will be produced from more than one mold, cavity, tool, die, pattern, or production process, the supplier shall complete a dimensional evaluation on one part from each. The specific molds, lines, etc. shall then be identified here.
23NCR Confidential Production Warrant DECLARATION I affirm that the samples represented by this warrant are representative of our parts, which were made by a process that meets all of NCR's Production Part Approval Process requirements. I further affirm that these samples were produced at the production rate of _____ pieces / _____ hours. I also certify that documented evidence of such compliance is on file and available for review. I have noted any deviations from this declaration below. EXPLANATION/COMMENTS: Supplier Authorized Signature Date Print Name Title Email Phone No. PPAP Warrant Disposition: Approved Rejected Other ____________________________________________________ NCR Signature _____ Date Print Name NCR Tracking Number (optional) FOR NCR USE ONLY The approved Production Warrant officially warrants the parts ready for production Declaration Enter the number of pieces manufactured during the significant production run and the time (in hours) taken for the significant production run Explanation / Comments Provide any explanatory comments on the submission results or any deviations from the Declaration. Attach additional information as appropriate. Supplier Authorized Signature A responsible supplier official, after verifying that the results show conformance to all NCR requirements and that all required documentation is available, shall approve the declaration For NCR Use Only To be completed by appropriate NCR Supplier Quality Engineer Declaration Affirmation that the samples represented by the warrant are representative and were made by a process that meets NCR’s PPAP requirements PPAP Warrant Disposition Approved, Rejected, OtherNCR Signature Signed by NCR Supplier Quality Engineer
24NCR Confidential Reviewers Checklist Must be completely 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
25NCR Confidential AUTHORIZED ENGINEERINGAUTHORIZED ENGINEERING CHANGE DOCUMENTSCHANGE DOCUMENTS
26NCR Confidential Authorized Engineering Change Documents The supplier shall provide authorized change documents for 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
27NCR Confidential PROCESS FLOW DIAGRAMPROCESS FLOW DIAGRAM
28NCR Confidential Process Flow Diagram What is It? • A visual diagram of the entire process from receiving through shipping, including outside processes and services To help people “see” the real process. Process maps can be used to understand the following characteristics of a process: • Set-by-step process linkage • Offline activities (measurement, inspection, handling) • Rework, scrap Objective or Purpose When to Use It • To understand how a process is done • Prior to completing the PFMEA Operator Get Traveler and Nest from Holding Shelf (26) Operator Prints Cut Tags (27) Operator Load Machine with Blanket (28) Operator Download Cutting Infomation (2s to 2m) (29) Operator Program Command "Ready to Cut" (30) Operator Observe Cutting Operation for Errors (32) Cutting Error? (33) Operator Separate Cutting Tags (31) Operator Cutting Operation Complete (34) Large or Small Plies or Test Coupons? (35) Operator Tag while Laying on the Cutting Table (39) Operator Remove Small Plies from the Cutting Table (36) Operator Move to Kitting Table (37) Small Plies Large Piies And Coupons Operator Remove Plies from the Cutting Table (40) Operator Tag Small Plies (38) Operator Move Plies to Kitting Table (41) Yes Evaluate for Corrective Action Operator Stamp Traveler (43) Traveler Complete? (42) Yes No No Project Idea Fill Out Master Form with Initial Information Is Hard Savings > $??? Does the Project Involve Only Your Group? Does the Project Involve >3 Depts. outside Eng? Does the Project Involve >2 Groups in Eng? Do you have BB/GB to Assist/Work the project? Prefer to work this project within your area? 6 Sigma Project Department or Group Project Yes No Yes No Yes No No No Yes Yes Yes No Enter Remaining Information on Master Form Master Form Will Generate Contract Finance Approval and Signature Other Required Signatures: Segment CEO Champion Process Owner BB or GB 6 Sigma Assigns Project Number Get WO Assigned Begin/Work Project Follow DMAIC or DFSS process Monitor Progress through Power Steering and Monthly Financial Reviews Complete Project (Has to be fully Documented Finance Approval and Signature Other Required Signatures: Champion: Dir T&E Process Owner Project Owner Dept BB or MBB Enter Remaining Information on Master Form Master Form Will Generate Contract Finance Approval and Signature Other Required Signatures: Champion: Process Owner Project Owner Dept GB/BB/MBB Group Assigns Project Number Get DLN Assigned Monitor Progress through Bi- Weekly Updates and Monthly Reviews Begin/Work Project Follow DMAIC or DFSS process Complete Project (Has to be fully Documented) Finance Approval and Signature Other Required Signatures: Champion: Dir T&E Process Owner Project Owner Dept BB or MBB Complete all Documentation including a (1) Page Close- out Sheet Close Project Complete all Documentation including a (1) Page Close- out Sheet Final Project Review Close Project Final Project Review 6 Sigma Project High Level Process Map Department/Group Project High Level Process Map
29NCR Confidential Process Flow Diagrams Date: ECL: Prepared By: STEP Fabrication Move Store Inspect Operation Description Item# Item# Control Methods 1 2 3 4 5 6 7 8 9 10 11 12 PROCESS FLOW DIAGRAM Part Description: Part Number: Product and Process Characteristics The process flow diagram utilizes these symbols to clearly identify each step in the process
30NCR Confidential Process Flow Diagram - Example : 484 -0100264 : : : : : Deburring & Cleaning Despatch T T Arul Incoming Inspection - INSPECTION- PROCESS- SUPPLIER END OPERATION CNC Sliding Machining Final Isnpection APPROVED BY & DATE V Raja Pre delivery Inspection PREPARED BY & DATE Oiling, Packing & Preservation Pre shipment audit - PATROL INSPECTION Layout Inspection - MOVEMENT - STORAGE LEO PROCESS FLOW DIAGRAM Rev. No. / Date1 of 1 O / 10.08.09Part Name : Page Shaft Pressure Paddle F/QA/05/0 PFD/NCR/0264Part No. Customer Name NCR Doc. No. **RM receiving Insp. report Inspection as per RIQP If Rejected Return to supplier ** Inspection as per Opertion layout Not ok , Rejected If rework possible Rework Scrap 100% Re-inspection Next operation Not ok OkNote : Tags to be provided for OK, Rework, Inspection & Rejection 05 10 3040 Pre shipment audit report 60 Self Inspection Report Layout Inspection Report 5070 20 Final Inspection register Patrol Insp. report Not ok , Rejected 15
31NCR Confidential Star Exercise •Divide into teams •Distribute supplies −Paper for Stars −Instructions for making Stars −Scissors •Using the instructions handed out in class, make 10 Shuriken Stars •This exercise will prepare your team to complete future exercises 45 Minutes
32NCR Confidential 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 Operation layout If rework possible Rework 100% Inspection Scrap Next Operation Not OK OK Patrol Insp Report
33NCR Confidential 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 raw material  Part manufacturing  Offline inspections and checks  Assembly  Shipping Process Flow Diagrams
34NCR Confidential PROCESS FMEAPROCESS FMEA
35NCR Confidential Process FMEA (PFMEA) When to Use It • After completion of the process flow diagram. • Prior to tooling for production Failure Mode and Effects Analysis (Design FMEA) F M EA N um be r: P a ge o f Sys te m / C o m po ne nt: P repa re d by: F M EA D a te (O rig.) (R ev .) C o re T ea m : ActionsTaken S e v O c c u r D e t e c R. P. N. D es ign R e s po ns ibility: Action Results O c c u r Current Design Controls Prevention Current Design Controls Detection D e t e c R. P. N. Recommended Action(s) Responsibility & Target Completion Date Potential Cause(s)/ Mechanism(s) of Failure Item / Process Function Potential Failure Mode Potential Effect(s) of Failure S e v What is It? • A tool used to identify and prioritize risk areas and their mitigation plans. The PFMEA should be completed using a cross-functional team! IMPORTANT! Objective or Purpose • Identifies potential failure modes, causes, and effects. Inputs come from the process flow diagram. • Identifies key inputs which positively or negatively affect quality, reliability and safety of a product or process.
36NCR Confidential 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
37NCR Confidential Process FMEA (PFMEA) Print # Rev. FMEA Number Item: Process Responsibility: Prepared by: Model Year(s)/Vehicle(s) Key Date Date (Orig.) Team: Date (Rev.) Actions Taken Sev Occ Det R.P.N. Occur Current Process Controls Process Step Potential Failure Mode Potential Effect(s) of Failure Sev POTENTIAL (PROCESS FMEA) Action Results Detec R.P.N. Recommended Actions Responsibility & Target Date FAILURE MODE AND EFFECTS ANALYSIS Class Potential Cause(s)/ Mechanism(s) of Failure This is included in the PPAP Playbook!
38NCR Confidential Spray head clogged: - Viscosity too high - Temp too low - Pressure too low 5 Variables check for film thickness; Visual check for coverage; Test spray at start-up and after idle periods and preventative maintenance program to clean heads 5 175 Detec R.P.N. Class Potential Cause(s)/ Mechanism(s) of Failure Occur Current Process Controls Process Step Potential Failure Mode Potential Effect(s) of Failure Sev 280Allows integrity breach of inner door panel Corroded interior lower door panels Deteriorated life of door leading to: - Unsatisfactory appearance due to rust through paint over time - Impaired function of interior door hardware Insufficient wax coverage over specified surface Op 70: Manual application of wax inside door panel 7 Manually inserted spray head not inserter far enough Variables check for film thickness; Visual check for coverage 58 TIPS • There should be at least one failure mode for each input. Using the completed Process Flow Diagram, enter the process step. Failure Modes For each Process Input, determine the ways in which the input can go wrong. PFMEA - Step 1
39NCR Confidential Spray head clogged: - Viscosity too high - Temp too low - Pressure too low 5 Variables check for film thickness; Visual check for coverage; Test spray at start-up and after idle periods and preventative maintenance program to clean heads 5 175 Detec R.P.N. Class Potential Cause(s)/ Mechanism(s) of Failure Occur Current Process Controls Process Step Potential Failure Mode Potential Effect(s) of Failure Sev 280Allows integrity breach of inner door panel Corroded interior lower door panels Deteriorated life of door leading to: - Unsatisfactory appearance due to rust through paint over time - Impaired function of interior door hardware Insufficient wax coverage over specified surface Op 70: Manual application of wax inside door panel 7 Manually inserted spray head not inserter far enough Variables check for film thickness; Visual check for coverage 58 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. Potential Failure Effects For each Failure Mode, determine what effect the specific failure could have on the process output. PFMEA - Step 2
40NCR Confidential Spray head clogged: - Viscosity too high - Temp too low - Pressure too low 5 Variables check for film thickness; Visual check for coverage; Test spray at start-up and after idle periods and preventative maintenance program to clean heads 5 175 280Allows integrity breach of inner door panel Corroded interior lower door panels Deteriorated life of door leading to: - Unsatisfactory appearance due to rust through paint over time - Impaired function of interior door hardware Insufficient wax coverage over specified surface Op 70: Manual application of wax inside door panel 7 Manually inserted spray head not inserted far enough Variables check for film thickness; Visual check for coverage 58 Occur Current Process Controls Process Step Potential Failure Mode Potential Effect(s) of Failure Sev Detec R.P.N. Class Potential Cause(s)/ Mechanism(s) of Failure TIPS • There should be at least one potential cause for each failure mode. Potential Causes For each Failure Mode, determine the possible cause of the failure. PFMEA - Step 3
41NCR Confidential Spray head clogged: - Viscosity too high - Temp too low - Pressure too low 5 Variables check for film thickness; Visual check for coverage; Test spray at start-up and after idle periods and preventative maintenance program to clean heads 5 175 Detec R.P.N. Class Potential Cause(s)/ Mechanism(s) of Failure Occur Current Process Controls Process Step Potential Failure Mode Potential Effect(s) of Failure Sev 280Allows integrity breach of inner door panel Corroded interior lower door panels Deteriorated life of door leading to: - Unsatisfactory appearance due to rust through paint over time - Impaired function of interior door hardware Insufficient wax coverage over specified surface Op 70: Manual application of wax inside door panel 7 Manually inserted spray head not inserter far enough Variables check for film thickness; Visual check for coverage 58 TIPS • 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.” Current Controls For each potential cause, list the current method used for preventing or detecting failure. PFMEA - Step 4
42NCR Confidential Spray head clogged: - Viscosity too high - Temp too low - Pressure too low 5 Variables check for film thickness; Visual check for coverage; Test spray at start-up and after idle periods and preventative maintenance program to clean heads 5 175 Detec R.P.N. Class Potential Cause(s)/ Mechanism(s) of Failure Occur Current Process Controls Process Step Potential Failure Mode Potential Effect(s) of Failure Sev 280Allows integrity breach of inner door panel Corroded interior lower door panels Deteriorated life of door leading to: - Unsatisfactory appearance due to rust through paint over time - Impaired function of interior door hardware Insufficient wax coverage over specified surface Op 70: Manual application of wax inside door panel 7 Manually inserted spray head not inserter far enough Variables check for film thickness; Visual check for coverage 58 Assign Severity, Occurrence, and Detection ratings Assign Severity (How serious is the effect if it fails?) Assign Occurrence (How likely is the cause to occur?) Assign Detection (How easily can the cause or failure mode be detected?) Severity, Occurrence and Detection rating details on next slide PFMEA - Step 5
43NCR Confidential PFMEA - Definition of Terms SeveritySeverity (of Effect) - severity of the effect on the Customer and other stakeholders (Higher Value = Higher Severity) OccurrenceOccurrence (of Cause) - frequency with which a given Cause occurs and creates Failure Mode. ((Higher Value = Higher Probability of Occurrence)) DetectionDetection (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)) Caution: Notice the scale difference for DetectionDetection!
44NCR Confidential High 10 Low 1 Rating Severity Occurrence Detection* Hazardous without warning Very high and almost inevitable Cannot detect or detection with very low probability Loss of primary function High repeated failures Remote or low chance of detection Loss of secondary function Moderate failures Low detection probability Minor defect Occasional failures Moderate detection probability No effect Failure unlikely Almost certain detection *If No Controls Exist, Detection = 10 Create a rating system that makes sense for the defects you are trying to prevent. An Example of Rating Definitions
45NCR Confidential Spray head clogged: - Viscosity too high - Temp too low - Pressure too low 5 Variables check for film thickness; Visual check for coverage; Test spray at start-up and after idle periods and preventative maintenance program to clean heads 5 175 Detec R.P.N. Class Potential Cause(s)/ Mechanism(s) of Failure Occur Current Process Controls Process Step Potential Failure Mode Potential Effect(s) of Failure Sev 280Allows integrity breach of inner door panel Corroded interior lower door panels Deteriorated life of door leading to: - Unsatisfactory appearance due to rust through paint over time - Impaired function of interior door hardware Insufficient wax coverage over specified surface Op 70: Manual application of wax inside door panel 7 Manually inserted spray head not inserter far enough Variables check for film thickness; Visual check for coverage 58 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 calculated risk. • Regardless of RPN, high SeveritySeverity scores (9 or 10) should be given special attention. Calculate the Risk Priority Number RPNRPN = Severity x Occurrence x Detection PFMEA - Step 6
46NCR Confidential • 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 team select a “cut-off” RPN for the next steps. RPN Thresholds • When using an RPN threshold, DO NOT forget to address high SeveritySeverity scores Others 490 150759 35070502530 250 30015 32222444468910 53333777710131517 100959288858275686255453217 60 50 40 30 20 10 0 100 80 60 40 20 0 Defect Count Percent Cum % Percent Count Pareto Chart for RPN Pareto Chart ?How many items should be the focus of the next steps? Sort by RPN to determine the most significant failure modes Analyzing the PFMEA
47NCR Confidential PFMEA – Remediation Guidelines SeveritySeverity – can only be improved by a design change to the product or process OccurrenceOccurrence – can only be reduced by a change which removes or controls a cause. Examples are redundancy, substituting a more reliable component or function or mistake-proofing. DetectionDetection – can be reduced by improving detection. Examples are mistake-proofing, simplification and statistically sound monitoring. In general, reducing the Occurrence is preferable to improving the Detection In general, reducing the Occurrence is preferable to improving the Detection
48NCR Confidential Actions Taken Sev Occ Det R.P.N. Add positive depth stop to sprayer Mfg. Eng. By 5/10/10 Stop added, sprayer checked on-line Automate spraying Mfg. Eng. By 5/25/10 Rejected due to complexity of different doors on the same line 175 Use DOE on viscosity vs. temp vs. pressure Mfg. Eng. By 5/31/10 Temp and press limits were determined and limit controls have been installed - Control charts show process is in control Cpk = 1.85 7 1 5 35 Action Results R.P.N. Recommended Actions Responsibility & Target Date Process Step Potential Failure Mode Potential Effect(s) of Failure 280Allows integrity breach of inner door panel Corroded interior lower door panels Deteriorated life of door leading to: - Unsatisfactory appearance due to rust through paint over time - Impaired function of interior door hardware Insufficient wax coverage over specified surface Op 70: Manual application of wax inside door panel 7 2 5 70 • Determine Actions Recommended to reduce High RPNs For the high RPN numbers, determine the recommended actions. FMEA – Step 7
49NCR Confidential Actions Taken Sev Occ Det R.P.N. Add positive depth stop to sprayer Mfg. Eng. By 5/10/10 Stop added, sprayer checked on-line Automate spraying Mfg. Eng. By 5/25/10 Rejected due to complexity of different doors on the same line 175 Use DOE on viscosity vs. temp vs. pressure Mfg. Eng. By 5/31/10 Temp and press limits were determined and limit controls have been installed - Control charts show process is in control Cpk = 1.85 7 1 5 35 Action Results R.P.N. Recommended Actions Responsibility & Target Date Process Step Potential Failure Mode Potential Effect(s) of Failure 280Allows integrity breach of inner door panel Corroded interior lower door panels Deteriorated life of door leading to: - Unsatisfactory appearance due to rust through paint over time - Impaired function of interior door hardware Insufficient wax coverage over specified surface Op 70: Manual application of wax inside door panel 7 2 5 70 • 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). Resp (responsibility) Assign a specific person who will be responsible for recommended actions. Actions Taken As actions are identified and completed, document in the “Actions Taken” column. FMEA – Steps 8 and 9 SEV, OCC, DET, RPN As actions are complete reassess Severity, Occurrence, and Detection and recalculate RPN.
50NCR Confidential 1. For each Process Input, determine the ways in which the Process Step can go wrong (these are Failure Modes). 2. For each Failure Mode associated with the inputs, determine Effects on the outputs. 3. Identify potential Causes of each Failure Mode. 4. List the Current Controls for each Cause. 5. Assign Severity, Occurrence and Detection ratings after creating a ratings key appropriate for your project. 6. Calculate RPN. 7. Determine Recommended Actions to reduce High RPNs. 8. Take appropriate Actions and Document. 9. Recalculate RPNs. 10. Revisit steps 7 and 8 until all the significant RPNs have been addressed. Summary Steps To Complete a FMEA
51NCR Confidential PFMEA Exercise 30 Minutes Instructions •Open the PPAP 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. Use the file PPAP Training Templates.xls
52NCR Confidential • Collaborative Effort: Do not try alone, use a group • Very laborious: Time consuming process. Take necessary breaks. • Action 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)
53NCR Confidential Reviewers Checklist Verify there is a system for prioritizing risk of failure such 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)
54NCR Confidential CONTROL PLANCONTROL PLAN
55NCR Confidential Control Plan A document that describes how to control the critical inputs to continue to meet customer expectations of the output. What is It? Objective or Purpose • Primary reference source for minimizing process and product variation. • Description of how teams should react to out-of-control situations. Since processes are expected to be continuously updated and improved, the control plan is a living document! NOTE When to Use It • Implementation of new process • Following a process change
56NCR Confidential Process Steps Process Steps New/Revised Process Steps New/Revised Process Steps Project Idea Fill Out Master Form with Initial Information IsHard Savings > $??? Doesthe Project Involve OnlyYour Group? Doesthe Project Involve >3 Depts. outsideEng? Doesthe Project Involve >2Groups in Eng? Do you have BB/GB to Assist/Workthe project? Prefer to work this project within your area? 6 Sigma Project Department or Group Project Yes No Yes No Yes No No No Yes Yes Yes No Enter Remaining Information on Master Form Master Form Will Generate Contract Finance Approval and Signature Other Required Signatures: Segment CEO Champion Process Owner BB or GB 6 Sigma Assigns Project Number Get WO Assigned Begin/Work Project Follow DMAIC or DFSS process Monitor Progress through Power Steering and Monthly Financial Reviews Complete Project (Hasto befully Documented Finance Approval and Signature Other Required Signatures: Champion: Dir T&E Process Owner Project Owner Dept BB or MBB Enter Remaining Information on Master Form Master Form Will Generate Contract Finance Approval and Signature Other Required Signatures: Champion: ProcessOwner Project Owner Dept GB/BB/MBB Group Assigns Project Number Get DLN Assigned Monitor Progress through Bi- Weekly Updates and Monthly Reviews Begin/Work Project Follow DMAIC or DFSS process Complete Project (Has to be fully Documented) Finance Approval and Signature Other Required Signatures: Champion: Dir T&E Process Owner Project Owner Dept BB or MBB Completeall Documentation including a (1) PageClose- out Sheet Close Project Complete all Documentation including a (1) Page Close- out Sheet Final Project Review Close Project Final Project Review 6 Sigma Project High Level Process Map Department/Group Project High Level Process Map Process FlowchartProcess Flowchart N ew /R evised Process Steps N ew /R evised Process Steps Process Steps Process Steps Process Step Key Process Input Potential Failure Mode Potential Failure Effects S E V Potential Causes O C C Current Controls D E T R P N E O C Actions Recommended Resp. Ac Receive Payment Checks Delay internal mail AR balance does not go down 7 Inadequate staffing in mail room 7 None 10 490 Investigate mail room staffing and associated processes G. Lee Added clerk. schedu Identify Customer Wire Transfer reference line Information not supplied AR balance is past due 10 Customer or bank did not include name and/or account info on wire transfer 5 Acct identifies problem when trying to apply payment 5 250 Poka-Yoke wire transer process N. Peart Contac establi transfe 2112) Identify Invoice Checks Incorrect invoice supplied Invoice shows outstanding (AR balance does go down) 5 Customer error 5 Customer might catch it when reviewing the next statement 10 250 Provide payment stub with statement for each invoice A. Lifeson Revise include with ea Identify Invoice Checks Invoice number not supplied Invoice shows outstanding (AR balance does go down) 5 Customer error 10 Acct identifies problem when trying to apply payment 5 250 Provide payment stub with statement for each invoice S. Hagar Revise include with ea Process Step Key Process Input Potential Failure Mode Potential Failure Effects S E V Potential Causes O C C Current Controls D E T R P N E O C Actions Recommended Resp. Actions Receive Payment Checks Delay internal mail AR balance does not go down 7 Inadequate staffing in mail room 7 None 10 490 Investigate mail room staffing and associated processes G. Lee Added anoth clerk. Adjus schedule. Identify Customer Wire Transfer reference line Information not supplied AR balance is past due 10 Customer or bank did not include name and/or account info on wire transfer 5 Acct identifies problem when trying to apply payment 5 250 Poka-Yoke wire transer process N. Peart Contacted b established w transfer proc 2112) Identify Invoice Checks Incorrect invoice supplied Invoice shows outstanding (AR balance does go down) 5 Customer error 5 Customer might catch it when reviewing the next statement 10 250 Provide payment stub with statement for each invoice A. Lifeson Revised stat include paym with each inv Identify Invoice Checks Invoice number not supplied Invoice shows outstanding (AR balance does go down) 5 Customer error 10 Acct identifies problem when trying to apply payment 5 250 Provide payment stub with statement for each invoice S. Hagar Revised stat include paym with each inv Process FMEAProcess FMEA Risk Prioritized Process Steps Risk Prioritized Process Steps Im proved Controls Im proved Controls Control PlanControl Plan Tool Interaction Control Plan
57NCR Confidential Control Plan Number Key Contact/Phone Date:(Org.) Date (Rev.) Part Number/Latest Change Level Core Team Customer Engineering Approval/Date (If Req'd.) Part Name/Description Supplier/Plant Approval/Date Customer Quality Approval/Date(If Req'd.) Supplier/Plant Supplier Code Other Approval/Date (If Req'd.) Other Approval/Date (If Req'd.) Size Freq. CONTROL PLAN Part/Process Number Process Name/Operation Description Machine, Device, Jig, Tools, for MFG. Characteristics Special Char. Class No. Product Process Methods Sample Product/Process Specification/ Tolerance Evaluation /Measure ment Technique Control Method Prototype Pre-Launch Production Reaction Plan NCR’s Control Plan This is included in the PPAP Playbook!
58NCR Confidential Control Plan Number Key Contact/Phone Date:(Org.) Date (Rev.) Part Number/Latest Change Level Core Team Customer Engineering Approval/Date (If Req'd.) Part Name/Description Supplier/Plant Approval/Date Customer Quality Approval/Date(If Req'd.) Supplier/Plant Supplier Code Other Approval/Date (If Req'd.) Other Approval/Date (If Req'd.) Size Freq. CONTROL PLAN Part/Process Number Process Name/Operation Description Machine, Device, Jig, Tools, for MFG. Characteristics Special Char. Class No. Product Process Methods Sample Product/Process Specification/ Tolerance Evaluation /Measure ment Technique Control Method Prototype Pre-Launch Production Reaction Plan Control Plan 3 Distinct Phases 1. Prototype – a description of the dimensional measurements and material and performance tests that will occur during Prototype build. 3 Distinct Phases 3 Distinct Phases 2. Pre-Launch – a description of the dimensional measurements and material and performance tests that will occur after Prototype and before full Production. 3 Distinct Phases 3. Production – a comprehensive documentation of product/process characteristics, process controls, tests, and measurement systems that will occur during mass production
59NCR Confidential Control Plan Number Key Contact/Phone Date:(Org.) Date (Rev.) Part Number/Latest Change Level Core Team Customer Engineering Approval/Date (If Req'd.) Part Name/Description Supplier/Plant Approval/Date Customer Quality Approval/Date(If Req'd.) Supplier/Plant Supplier Code Other Approval/Date (If Req'd.) Other Approval/Date (If Req'd.) Size Freq. CONTROL PLAN Part/Process Number Process Name/Operation Description Machine, Device, Jig, Tools, for MFG. Characteristics Special Char. Class No. Product Process Methods Sample Product/Process Specification/ Tolerance Evaluation /Measure ment Technique Control Method Prototype Pre-Launch Production Reaction Plan Control Plan Administrative Section Identifies part number and description, supplier, required approval signatures, and dates. Administrative Section
60NCR Confidential Control Plan Number Key Contact/Phone Date:(Org.) Date (Rev.) Part Number/Latest Change Level Core Team Customer Engineering Approval/Date (If Req'd.) Part Name/Description Supplier/Plant Approval/Date Customer Quality Approval/Date(If Req'd.) Supplier/Plant Supplier Code Other Approval/Date (If Req'd.) Other Approval/Date (If Req'd.) Size Freq. CONTROL PLAN Part/Process Number Process Name/Operation Description Machine, Device, Jig, Tools, for MFG. Characteristics Special Char. Class No. Product Process Methods Sample Product/Process Specification/ Tolerance Evaluation /Measure ment Technique Control Method Prototype Pre-Launch Production Reaction Plan Control Plan Part/Process Use this area to define part/process number and description. Machine/Tools List the machine, device, jig, or tools that will be used in the manufacturing process Characteristics Define the characteristics of the product or process Process, Machine/Tools, Characteristics
61NCR Confidential Control Plan Number Key Contact/Phone Date:(Org.) Date (Rev.) Part Number/Latest Change Level Core Team Customer Engineering Approval/Date (If Req'd.) Part Name/Description Supplier/Plant Approval/Date Customer Quality Approval/Date(If Req'd.) Supplier/Plant Supplier Code Other Approval/Date (If Req'd.) Other Approval/Date (If Req'd.) Size Freq. CONTROL PLAN Part/Process Number Process Name/Operation Description Machine, Device, Jig, Tools, for MFG. Characteristics Special Char. Class No. Product Process Methods Sample Product/Process Specification/ Tolerance Evaluation /Measure ment Technique Control Method Prototype Pre-Launch Production Reaction Plan Control Plan Specifications/Tolerance Use this area to define upper/lower spec limits for each control element. Measurement Technique For each line in the control plan, list the measurement procedure that will be used (may list R&R Gage Plan or Poka- Yoke). Sample Size What is the size of the sample you should gather data from? Frequency Define the frequency for which the measurement will be taken. Specifications, Measurement, Sample Size & Frequency
62NCR Confidential Control Plan Number Key Contact/Phone Date:(Org.) Date (Rev.) Part Number/Latest Change Level Core Team Customer Engineering Approval/Date (If Req'd.) Part Name/Description Supplier/Plant Approval/Date Customer Quality Approval/Date(If Req'd.) Supplier/Plant Supplier Code Other Approval/Date (If Req'd.) Other Approval/Date (If Req'd.) Size Freq. CONTROL PLAN Part/Process Number Process Name/Operation Description Machine, Device, Jig, Tools, for MFG. Characteristics Special Char. Class No. Product Process Methods Sample Product/Process Specification/ Tolerance Evaluation /Measure ment Technique Control Method Prototype Pre-Launch Production Reaction Plan Control Plan Control Method Method that will be used to control the process Reaction Plan Actions to be taken if controls fail Control Method, Reaction Plan
63NCR Confidential Control Plan Audit Plans •Audit plans should be included in the control plan as a separate line. •Auditing is an important tool for 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 based on balancing level of risk (FMEA) and cost.
64NCR Confidential Control Plan – Example Control Plan Number Key Contact/Phone Date:(Org.) Date (Rev.) 002 T. Smith / 313-555-5555 11/29/2009 2/20/2010 Part Number/Latest Change Level Core Team Customer Engineering Approval/Date (If Req'd.) 54321231 / D Erin Hope, Alan Burt, Ken Light Part Name/Description Supplier/Plant Approval/Date Customer Quality Approval/Date(If Req'd.) Electronic Circuit Board Supplier/Plant Supplier Code Other Approval/Date (If Req'd.) Other Approval/Date (If Req'd.) ACR Control 439412 Size Freq. 2 Soldering Connections Wave solder machine Wave solder height 2.0 +/- .25 mc Sensor continuity check 100% Continuous Automated inspection (error proofing) Adjust and retest Flux concen - tration Standard #302B Test sampling lab environment 1 pc 4 hours x-MR chart Segregate and retest Prototype Pre-Launch Production Reaction Plan Sample Product/Process Specification/ Tolerance Evaluation / Measurement Technique Control Method CONTROL PLAN Part / Process Number Process Name / Operation Description Machine, Device, Jig, Tools, for MFG. Characteristics Special Char. Class No. Product Process Methods 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 solder 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 concentration level. 3 Distinct Phases Production Part/Process Soldering Connections Machine/Tools Wave solder machine Characteristics Product = Wave solder height Process = Flux concentration Specifications/Tolerance Product = 2.0 +/- 0.25 mc Process = Standard #302B Measurement Technique Product = Sensor continuity check Process = Test sampling lab environment Sample Size Product = 100% Process = 1 pc Frequency Product = Continuous Process = 4 hours Control Method Product = Automated inspection Process = x-MR chart Reaction Plan Product = Adjust and retest Process = Segregate and retest
65NCR Confidential 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 potential solutions with your teams. Control Plan Exercise 20 Minutes Use the file PPAP Training Templates.xls
66NCR Confidential 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 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. Reviewer’s Checklist
67NCR Confidential MEASUREMENT SYSTEMMEASUREMENT SYSTEM ANALYSIS (MSA)ANALYSIS (MSA)
68NCR Confidential Measurement System Analysis (MSA) An MSA is a statistical tool used to determine if a measurement system is capable of precise measurement. What is It? Objective or Purpose • To determine how much error is in the measurement due to the measurement process itself. • Quantifies the variability added by the measurement system. • Applicable to attribute data and variable data. When to Use It • On the critical inputs and outputs prior to collecting data for analysis. • For any new or modified process in order to ensure the quality of the data. Measurement System Analysis is an analysis of the measurement process, not an analysis of the people!! IMPORTANT! Who Should be Involved Everyone that measures and makes decisions about these measurements should be involved in the MSA.
69NCR Confidential – AttributeAttribute Data Examples:  Count, Pass/fail, yes/no, red/green/yellow, timekeeping buckets – VariableVariable Data Examples:  Physical measurement (length, width, area, …)  Physical conditions (temperature, pressure…)  Physical properties (strength, load, strain…)  Continuous or non-ending Attribute and Variable MSA Unless approved by an NCR SQE, attribute data is not acceptable for PPAP submission Unless approved by an NCR SQE, attribute data is not acceptable for PPAP submission
70NCR Confidential Measurement System Analysis (MSA) Process Variation Process Variation Measuremen t System Variation Measuremen t System Variation Observed Variation Observed Variation The observed variation in process output measurements is not simply the variation in the process itself; it is the variation in the process plus the variation in measurement that results from an inadequate measurement system. Conducting an MSA reduces the likelihood of passing a bad part or rejecting a good part
71NCR Confidential Measurement System Analysis (MSA) Process Variation Process Variation Measuremen t System Variation Measuremen t System Variation Observed Variation Observed Variation The output of the process measured by: • Cycle time • Dimensional data • Number of defects and others Observed Variation
72NCR Confidential Observed Variation Observed Variation Process Variation Process Variation Measuremen t System Variation Measuremen t System Variation ReproducibilityReproducibility Precision (Variability) Precision (Variability) LinearityLinearity BiasBias StabilityStability ResolutionResolution RepeatabilityRepeatability Accuracy (Central Location) Accuracy (Central Location) Observed Variation Calibration addresses accuracy Measurement System Analysis (MSA)
73NCR Confidential Observed Variation Observed Variation Observed Variation Process Variation Process Variation Measuremen t System Variation Measuremen t System Variation Precision (Variability) Precision (Variability) LinearityLinearity BiasBias StabilityStability ResolutionResolution RepeatabilityRepeatability ReproducibilityReproducibility Accuracy (Central Location) Accuracy (Central Location) Calibration Addresses Accuracy Let’s take a closer look at Precision Measurement System Analysis (MSA)
74NCR Confidential Measurement System Analysis (MSA) Error in Resolution The inability to detect small changes. Possible Cause Wrong measurement device selected - divisions on scale not fine enough to detect changes. Resolution
75NCR Confidential Measurement System Analysis (MSA) Error in Repeatability The inability to get the same answer from repeated measurements made of the same item under absolutely identical conditions. Possible Cause Lack of standard operating procedures (SOP), lack of training, measuring system variablilty. Repeatability Equipment VariationEquipment Variation
76NCR Confidential Measurement System Analysis (MSA) Error in Reproducibility The inability to get the same answer from repeated measurements made under various conditions from different inspectors. Possible Cause Lack of SOP, lack of training. Reproducibility Appraiser VariationAppraiser Variation
77NCR Confidential Variable MSA – Gage R&R Study •Gage R&R is the combined estimate of measurement system RepeatabilityRepeatability and ReproducibilityReproducibility •Typically, a 3-person study is performed Each person randomly measures 10 marked parts per trial Each person can perform up to 3 trials •There are 3 key indicators EVEV or Equipment Variation AVAV or Appraiser Variation Overall % GRR% GRR
78NCR Confidential Variable MSA – NCR’s Gage R&R Form This spreadsheet is designed for up to three operators, three trials, and ten samples. Enter data ONLY in gray shaded cells. Upper specification limit Lower specification limit Number of samples Data Sample # 1 2 3 Range 1 2 3 Range 1 2 3 Range 1 0.000 0.000 0.000 2 0.000 0.000 0.000 3 0.000 0.000 0.000 4 0.000 0.000 0.000 5 0.000 0.000 0.000 6 0.000 0.000 0.000 7 0.000 0.000 0.000 8 0.000 0.000 0.000 9 0.000 0.000 0.000 10 0.000 0.000 0.000 Range average 0.000 0.000 0.000 Sample average #DIV/0! #DIV/0! #DIV/0! Average range 0.000 #N/A X-bar range #DIV/0! #DIV/0! #N/A #N/A Note: any ranges beyond this limit may be the result of assignable causes. Identify and correct. Discard values and recompute statistics. Do not modify this table Trials D4 K1 K2 2 3.27 4.56 3.65 3 2.58 3.05 2.7 Gage Repeatability and Reproducibility Repeatability and Reproducibility (R&R) Control limit for individual ranges #N/A #DIV/0! #N/A Reproducibility (AV) Tolerance analysis Number of operators Number of trials Operator 1 Operator 2 Operator 3 Repeatability (EV) Trial Trial Trial Included in PPAP Playbook! Automatically calculates EV, AV, and % GRR!
79NCR Confidential 1. Select 10 items that represent the full range of long-term process variation. 2. Identify the appraisers. 3. If appropriate, calibrate the gage or verify that the last calibration date is valid. 4. Open the Gage R&R worksheet in the PPAP Playbook to record data. 5. Have each appraiser assess each part 3 times (trials – first in order, second in reverse order, third random). 6. Input data into the Gage R&R worksheet. 7. Enter the number of operators, trials, samples and specification limits 8. Analyze data in the Gage R&R worksheet. 9. Assess MSA trust level. 10. Take actions for improvement if necessary. Variable MSA – Gage R&R Steps Step 1 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Step 9 Step 10Step 2
80NCR Confidential Steps 1 and 2: Variable MSA - Gage R&R Select 10 items that represent the full range of long-term process variation. Step 1 Identify the appraisers. – Should use individuals that actually do the process being tested. – Can also include other appraisers (supervisors, etc.). – Should have a minimum of 3 appraisers. Step 2
81NCR Confidential Steps 3 and 4: Variable MSA – Gage R&R If appropriate, calibrate the gage or verify that the last calibration date is valid. Step 3 Open the Gage R&R worksheet in the PPAP Playbook to record the data Step 4
82NCR Confidential Step 5: Variable MSA – Gage R&R Step 5 Have each appraiser assess each item 3 times. – Each appraiser has to work independently. – Items should be evaluated in random order. – After each appraiser completes the first evaluation of all items – repeat the process at least 2 more times. – Do not let the appraisers see any of the data during the test !!
83NCR Confidential Steps 6 and 7: Variable MSA – Gage R&R Input data into the Gage R&R worksheet Enter the number of operators, trials, samples and specification limits Step 6 Step 7
84NCR Confidential Steps 8 and 9: Variable MSA – Gage R&R Assess MSA Trust Level. – Red:Red: > 30% (fail) – Yellow:Yellow: 10-30% (marginal) – Green:Green: < 10% (pass) Step 9 Step 8 Analyze data in the Gage R&R worksheet % Tolerance* 10% 30%
85NCR Confidential Step 10: Variable MSA – Gage R&R If the Measurement System needs improvement: – Brainstorm with the team for improvement solutions. – Determine best “practical solution” (may require some experimentation). – Pilot the best solution (PDSA) – Implement best solution – train employees. – Re-run the study to verify the improvement. Step 10
86NCR Confidential MSA Parameters » (3) Operators » (3) Trials » (10) Samples Problem Statement • The sulfuric acid concentration in process tank 8 is measured at least once per day • Additions/deletions of chemicals and decisions to shut down the process are dependent on these results. • Based on current data, we need to do an MSA. A Gage R&R was conducted in order to validate the process. MSA Process Variable MSA – Gage R&R Example
87NCR Confidential This spreadsheet is designed for up to three operators, three trials, and ten samples. Enter data ONLY in gray shaded cells. 3 Upper specification limit 27 3 Lower specification limit 22 Number of samples 10 Data Sample # 1 2 3 Range 1 2 3 Range 1 2 3 Range 1 25.250 25.540 25.390 0.290 25.390 25.390 25.390 0.000 25.680 26.330 26.520 0.840 2 25.420 25.540 24.960 0.580 25.540 25.520 25.470 0.070 26.380 26.130 25.960 0.420 3 22.370 22.370 22.670 0.300 22.220 22.180 22.220 0.040 22.670 22.810 22.670 0.140 4 24.960 25.250 25.110 0.290 25.110 25.680 25.920 0.810 25.680 26.200 25.540 0.660 5 25.540 25.540 25.820 0.280 25.540 25.680 25.680 0.140 25.730 25.960 25.890 0.230 6 24.610 25.110 24.820 0.500 24.960 26.700 25.110 1.740 25.390 25.540 25.960 0.570 7 24.440 24.260 24.110 0.330 25.250 25.540 25.420 0.290 25.250 25.830 25.390 0.580 8 26.100 26.800 26.100 0.700 25.540 25.540 25.820 0.280 25.110 25.680 25.920 0.810 9 25.390 25.390 25.390 0.000 26.380 26.660 26.220 0.440 25.250 25.540 25.390 0.290 10 25.680 25.820 25.540 0.280 23.900 25.250 25.110 1.350 24.200 23.870 22.960 1.240 Range average 0.355 0.516 0.578 Sample average 25.043 25.211 25.248 Average range 0.483 1.4732 X-bar range 0.205 0.4827 1.5502 1.2461 Note: any ranges beyond this limit may be the result of assignable causes. Identify and correct. Discard values and recompute statistics. Operator 1 Operator 2 Operator 3 Repeatability (EV) Trial Trial Trial Gage Repeatability and Reproducibility Repeatability and Reproducibility (R&R) Control limit for individual ranges 29.46% 9.65% 31.00% Reproducibility (AV) Tolerance analysis Number of operators Number of trials Selected 10 samples to be measured Chose 3 operators to be appraisers Had each appraiser measure each sample 3 times Results calculated automatically Entered the number of operators, trials, and samples Entered upper and lower specification limits Variable MSA – Gage R&R Example
88NCR Confidential Variable MSA – Gage R&R Example This spreadsheet is designed for up to three operators, three trials, and ten samples. Enter data ONLY in gray shaded cells. 3 Upper specification limit 27 3 Lower specification limit 22 Number of samples 10 Data Sample # 1 2 3 Range 1 2 3 Range 1 2 3 Range 1 25.250 25.540 25.390 0.290 25.390 25.390 25.390 0.000 25.680 26.330 26.520 0.840 2 25.420 25.540 24.960 0.580 25.540 25.520 25.470 0.070 26.380 26.130 25.960 0.420 3 22.370 22.370 22.670 0.300 22.220 22.180 22.220 0.040 22.670 22.810 22.670 0.140 4 24.960 25.250 25.110 0.290 25.110 25.680 25.920 0.810 25.680 26.200 25.540 0.660 5 25.540 25.540 25.820 0.280 25.540 25.680 25.680 0.140 25.730 25.960 25.890 0.230 6 24.610 25.110 24.820 0.500 24.960 26.700 25.110 1.740 25.390 25.540 25.960 0.570 7 24.440 24.260 24.110 0.330 25.250 25.540 25.420 0.290 25.250 25.830 25.390 0.580 8 26.100 26.800 26.100 0.700 25.540 25.540 25.820 0.280 25.110 25.680 25.920 0.810 9 25.390 25.390 25.390 0.000 26.380 26.660 26.220 0.440 25.250 25.540 25.390 0.290 10 25.680 25.820 25.540 0.280 23.900 25.250 25.110 1.350 24.200 23.870 22.960 1.240 Range average 0.355 0.516 0.578 Sample average 25.043 25.211 25.248 Average range 0.483 1.4732 X-bar range 0.205 0.4827 1.5502 1.2461 Note: any ranges beyond this limit may be the result of assignable causes. Identify and correct. Discard values and recompute statistics. Operator 1 Operator 2 Operator 3 Repeatability (EV) Trial Trial Trial Gage Repeatability and Reproducibility Repeatability and Reproducibility (R&R) Control limit for individual ranges 29.46% 9.65% 31.00% Reproducibility (AV) Tolerance analysis Number of operators Number of trials Repeatability = (EV) Equipment Variation Repeatability = (EV) Equipment VariationReproducibility = (AV) Appraiser Variation Reproducibility = (AV) Appraiser VariationRepeatability & Reproducibility = R&R Repeatability & Reproducibility = R&R % Tolerance* 10% 30% % Tolerance is > 30% MSA fails!
89NCR Confidential •Divide into teams •Distribute stars (10 per team), measurement devices (1 per team), and markers (1 per team). •Number the stars from 1-10. •Mark the 2 points to be measured on each star (see diagram on next page) •Determine and document the measurement process. •Be sure everyone has a clear understanding of the process. •Determine roles. −(3) inspectors, (1) data recorder, (1) customer Gage R&R Exercise - Setup Instructions
90NCR Confidential Gage R&R Exercise - Dimensional Information Dimension Each star will be measured as shown. Mark the 2 points to be measured
91NCR Confidential 1. All inspectors need to wait outside the room when it is not their turn to evaluate the stars. 2. Open the PPAP Training Templates.xls file, then select the Gage R&R worksheet to record the data. 3. Round 1 Have the 1st inspector come in the room and measure all 10 stars in order. Data collector record the data in the Gage R&R worksheet. » Do not give any additional information to the inspector 1. Repeat Step 3 with the 2nd inspector 2. Repeat Step 3 with the 3rd inspector 6. Round 2 Change the inspection to reverse order and repeat. 7. Round 3 Change the inspection to random order and repeat. Gage R&R Exercise – Inspection Instructions Use the file PPAP Training Templates.xls
92NCR Confidential Gage R&R Exercise - Analysis Instructions 1. Complete the top section of the Gage R&R worksheet − Enter the number of operators, trials, and samples − Enter the upper and lower specification limit 2. Assess MSA Trust Level. – Red: > 30% (fail) – Yellow: 10-30% (marginal) – Green: < 10% (pass) 3. Interpret results - are improvements required? 45 Minutes % Tolerance* 10% 30% Use the file PPAP Training Templates.xls
93NCR Confidential Important: An MSA is an analysis of the process, not an analysis of the people. If an MSA fails, the process failed. A Variable MSA provides more analysis capability than an Attribute MSA. For this and other reasons, always use variable data if possible. The involvement of people is the key to success. Involve the people that actually work the process Involve the supervision Involve the suppliers and customers of the process An MSA primarily addresses precision with limited accuracy information. Tips and Lessons Learned
94NCR Confidential MSA If the gage/inspection affects quality, then conduct a Gage R&R Make sure the study is recent - less than 1 year Compare the control plan gages against the Gage R&Rs If you question that gage, then −Question the technique and part sampling −Ask for additional studies Reviewer’s Checklist
95NCR Confidential DIMENSIONAL RESULTSDIMENSIONAL RESULTS
96NCR Confidential Dimensional Results Evidence that dimensional verifications have been completed and results indicate compliance with specified requirements. What is It? Objective or Purpose • To show conformance to the customer part print on dimensions and all other noted requirements. When to Use It • For each unique manufacturing process (e.g., cells or production lines and all molds, patters, or dies Date: Supplier Name: Date Code: Part Number: Facility Location: Inspected By: Revision: Supplier Code: Verified By: Print zone or spec note Nominal Value Tol + Tol - Sample 1 Sample 2 Sample 3 Sample 4 Sample 5 Cp Cpk Pass/Fail #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! List Gage R&R value: Name and ID of gage(s) used for measurement: Cpk less than 1.33 will require action for improvement The number of non-critical data points required for part qualification is 5. The non-critical data points must be taken from the same 35-piece sample as the critical data points. Five parts from a production run must be shipped to NCR for verification of form, fit, and function. The same 5 parts will be used to verify both critical and non-critical dimensions. The supplier must clearly identify which of the 35 parts are being shipped. Non-critical dimensional results for the 5 parts being shipped must be entered below. Critical dimensional results must be entered into the "FAI Critical Dimensions" worksheet. The supplier should make every effort to ship 5 parts that represent both the low and high ends of the specifications for the non-critical dimensions. FAI Non-Critical Dimensions
97NCR Confidential Date: Part Number: Revision: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! List Gage R&R value: Name and ID of gage(s) used for measurement: Tol -Tol + Nominal Value Print zone or spec note Cpk Pass/Fail Cpk less than 1.67 will require action for improvement Sample Cp The number of critical data points required for part qualification is 35. These data points must be taken from a 35-piece sample. Five parts from a production run must be shipped to NCR for verification of form, fit, and function. The same 5 parts will be used to verify both critical and non-critical dimensions. The supplier must clearly identify which of the 35 parts are being shipped. Critical dimensional results for the 5 parts being shipped must be entered below. Non-critical dimensional results must be entered into the "FAI Non-Critical Dimensions" worksheet. The supplier should make every effort to ship 5 parts that represent both the low and high ends of the specifications for the non-critical dimensions. FAI Critical Dimensions Supplier Name: Facility Location: Supplier Code: Date Code: Inspected By: Verified By: NCR Dimensional Report (Critical) Requires 35 data pointsRequires 35 data points CpkCpk must be greater than or equal to 1.671.67 This is included in the PPAP Playbook! Automatically Calculates Cpk!The number of critical data points required for part qualification is 35. These data points must be taken from a 35-piece sample. Five parts from a production run must be shipped to NCR for verification of form, fit, and function. The same 5 parts will be used to verify both critical and non-critical dimensions. The supplier must clearly identify which of the 35 parts are being shipped. Critical dimensional results for the 5 parts being shipped must be entered below. Non-critical dimensional results must be entered into the "FAI Non-Critical Dimensions" worksheet. The supplier should make every effort to ship 5 parts that represent both the low and high ends of the specifications for the non-critical dimensions.
98NCR Confidential Date: Supplier Name: Date Code: Part Number: Facility Location: Inspected By: Revision: Supplier Code: Verified By: Print zone or spec note Nominal Value Tol + Tol - Sample 1 Sample 2 Sample 3 Sample 4 Sample 5 Cp Cpk Pass/Fail #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! List Gage R&R value: Name and ID of gage(s) used for measurement: Cpk less than 1.33 will require action for improvement The number of non-critical data points required for part qualification is 5. The non-critical data points must be taken from the same 35-piece sample as the critical data points. Five parts from a production run must be shipped to NCR for verification of form, fit, and function. The same 5 parts will be used to verify both critical and non-critical dimensions. The supplier must clearly identify which of the 35 parts are being shipped. Non-critical dimensional results for the 5 parts being shipped must be entered below. Critical dimensional results must be entered into the "FAI Critical Dimensions" worksheet. The supplier should make every effort to ship 5 parts that represent both the low and high ends of the specifications for the non-critical dimensions. FAI Non-Critical Dimensions NCR Dimensional Report (Non-Critical) CpkCpk must be greater than or equal to 1.331.33 Requires 5 data pointsRequires 5 data points This is included in the PPAP Playbook! Automatically Calculates Cpk! The number of non-critical data points required for part qualification is 5. The non-critical data points must be taken from the same 35-piece sample as the critical data points. Five parts from a production run must be shipped to NCR for verification of form, fit, and function. The same 5 parts will be used to verify both critical and non-critical dimensions. The supplier must clearly identify which of the 35 parts are being shipped. Non-critical dimensional results for the 5 parts being shipped must be entered below. Critical dimensional results must be entered into the "FAI Critical Dimensions" worksheet. The supplier should make every effort to ship 5 parts that represent both the low and high ends of the specifications for the non-critical dimensions.
99NCR Confidential Acceptance Criteria Critical Non-Critical Decision Red (Bad) <1.33 <1.00 Yellow (OK) 1.33-1.67 1.00-1.33 Green (Good) >1.67 >1.33 Acceptance criteria for critical vs. non-critical characteristics CpkCpk must be greater than or equal to 1.67 for1.67 for criticalcritical processesprocesses CpkCpk must be greater than or equal to 1.33 for1.33 for non-criticalnon-critical processesprocesses
100NCR Confidential Date: Supplier Name: Date Code: Part Number: Facility Location: Inspected By: Revision: Supplier Code: Verified By: Print zone or spec note Nominal Value Tol + Tol - Sample 1 Sample 2 Sample 3 Sample 4 Sample 5 Cp Cpk Pass/Fail 35 0.50 0.50 34.86 34.78 34.88 34.86 34.82 4.167 2.833 Pass 76 0.50 0.50 75.96 76.08 75.92 75.93 76.09 2.017 2.001 Pass 3 0.50 0.50 3.175 3.18 3.156 3.168 3.178 17.118 11.250 Pass 3 0.50 0.50 3.18 3.156 3.178 3.175 3.18 16.406 10.703 Pass 3 0.50 0.50 3.18 3.175 3.174 3.18 3.156 16.836 11.011 Pass 3 0.50 0.50 3.156 3.18 3.173 3.175 3.18 16.862 11.034 Pass Cpk less than 1.33 will require action for improvement The number of non-critical data points required for part qualification is 5. The non-critical data points must be taken from the same 35-piece sample as the critical data points. Five parts from a production run must be shipped to NCR for verification of form, fit, and function. The same 5 parts will be used to verify both critical and non-critical dimensions. The supplier must clearly identify which of the 35 parts are being shipped. Non-critical dimensional results for the 5 parts being shipped must be entered below. Critical dimensional results must be entered into the "FAI Critical Dimensions" worksheet. The supplier should make every effort to ship 5 parts that represent both the low and high ends of the specifications for the non-critical dimensions. FAI Non-Critical Dimensions NCR Dimensional Report Example Nominal ValueTolerance Sample Data Cp & Cpk Calculations Pass / Fail CpkCpk > 1.33 for all1.33 for all non-criticalnon-critical dimensions = Pass!dimensions = Pass!
101NCR Confidential Dimensional Results Thirty-five critical data points & 5 non-critical data points are required for part qualification Critical and non-critical data points must be taken from the same 35- piece sample Five parts from a production run must be shipped to NCR for verification of form, fit, and function The same 5 parts will be used to verify both critical and non-critical dimensions Supplier must clearly identify which of the 35 parts are being shipped Supplier should make every effort to ship 5 parts that represent both the low and high ends of the specifications for non-critical dimensions Capability must be greater than 1.67 for critical dimensions and greater than 1.33 for non-critical dimensions Reviewer’s Checklist
102NCR Confidential RECORDS OFRECORDS OF MATERIAL /MATERIAL / PERFORMANCE TESTPERFORMANCE TEST RESULTSRESULTS
103NCR Confidential Records of Material/Performance Test Results Material Test ResultsMaterial Test Results The supplier shall perform tests for all parts and product materials when chemical, physical, or metallurgical requirements are specified by the design record or Control Plan  For products with NCR-developed material specifications and/or an NCR-approved supplier list, the supplier shall procure materials and/or services from suppliers on that list Performance Test ResultsPerformance Test Results The supplier shall perform tests for all parts or product materials when performance or functional requirements are specified by the design record or Control Plan
104NCR Confidential Material Results Part Number Type of Test OK Not OK Title Date Name of LaboratoryLaboratory Revision Level Production Part Approval - Material Results Signature Supplier Part Name Supplier Test ResultsMaterial Spec. No./Date/Specification Outside laboratory In-house testing Material Results shall include:  The name of the laboratory that conducted the test  The type of test that was conducted  The number, date, and specification to which the part was tested  The actual test results
105NCR Confidential Module Test Results Part Number Laboratory Type of Test Parameters Tested OK Not OK Title DateSignature Test description Supplier Test Results Production Part Approval - Module Test Results Supplier Part NameName of Laboratory Revision Level In-house testing Outside laboratory Module Test Results shall include:  The name of the laboratory that conducted the test  The type of test that was conducted  A description of the test  The parameters tested  The actual test results
106NCR Confidential INITIAL PROCESS STUDYINITIAL PROCESS STUDY
107NCR Confidential Requirement Level 1 Level 2 Level 3 Level 4 Level 5 1. Design Records of Saleable Product R R R * R a. For proprietary components/details R R R * R b. For all other components/details R R R * R 2. Engineering Change Documents, if any R S S * S 3. Customer Engineering approval, if required R S S * S 4. Design FMEA R R R * R 5. Process Flow Diagrams R R S * S 6. Process FMEA R R S * S 7. Dimensional Results S S S * S 8. Material, Performance, Test Results R S S * S 9. Initial Process Study R R R * R 10. Measurement System Analysis Studies R R S * S 11. Qualified Laboratory Documentation R R S * S 12. Control Plan R R S * S 13. Part Submission Warrant (PSW) S S S * S 14. Appearance Approval Report, (AAR) if applicable S S S * S 15. Bulk Material Requirements Checklist (for bulk material only) R R R * R 16. Sample Product R S S * S 17. Master Sample R R R * R 18. Checking Aids R R R * R 19. Records of compliance with Customer-Specific Requirements (DVP&R) R R R * R Submission Level PPAP Levels for Submission & Retention S = The supplier shall submit to designated customer product approval activities and retain a copy of records or documentation items at appropriate locations, including manufacturing R = The supplier shall retain at appropriate locations, including manufacturing, and make readily available to the customer representative upon request * = The supplier shall retain at appropriate locations, and submit to customer upon request. The customer will identify what is needed for submission base on changes and conditions PLEASE CONTACT YOUR SUPPLIER QUALITY ENGINEER WITH ANY QUESTIONS . Initial Process Study Even though Initial Process Study is coded as an “R” on the PPAP Submission Level Table, we felt it was important to provide a brief overview during training R = Supplier shall retain at appropriate locations, including manufacturing and make readily available to the customer representative upon request
108NCR Confidential Capability Analysis When to Use It 1. To establish baseline capability. 2. To validate process improvements. What is It? A set of tools used to understand process capability. Objective or Purpose • To evaluate the performance of your process as compared to specification limits. • To determine if the production process is likely to produce product that will meet customer requirements Initial Process Study
109NCR Confidential Steps for Determining Process Capability Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 1. Decide on the product or process characteristic to be assessed 2. Validate the specification limits 3. Validate the measurement system 4. Collect data 5. Assess data characteristics 6. Assess process stability 7. Calculate process capability
110NCR Confidential Step 1: Which Characteristic Decide on the product or process characteristic to be assessed.  Required for all critical characteristics  If no critical characteristics exist, NCR reserves the right to require demonstration of initial process capability on other characteristics Step 1
111NCR Confidential Step 2: Specification Limits Validate the specification limits by talking to: – Customers, suppliers, controlling agencies Why is validation of the specification limits important? – They may not represent what the customer truly desires/needs. – May contain “guard banding” as a result of past problems or measurement error. – They may be based on previous designs and no longer be valid. Step 2
112NCR Confidential Step 3: Measurement System Validate the measurement system through the appropriate MSA Why is validation of the Measurement System important? – If there is significant error in your measurement system, then decisions are influenced by the error not just the measurements themselves. Step 3
113NCR Confidential Step 4: Data Collection When collecting data, consider the following: –Short term data »Free of special causes »Collected across a narrow inference space i.e. one shift, one machine, one operator, etc.. –Long term data »Subjected to the effects of both random and special cause variation »Collected across a broad inference space i.e. multiple shifts, machines, operators, etc. Step 4
114NCR Confidential Step 4: Data Collection When collecting data, consider the following: – Rational sub-grouping »A group of units produced under the same set of conditions »Mean to represent a “snapshot” of the process »Must be taken close together in time, but still be independent of each other »Use subgroups to separate the 2 types of variation in a process:  Within subgroup: The variation among measurements within subgroups; also known as common cause variation  Between subgroup: variation between subgroups that may be caused by specific identifiable factors, or special causes »To improve process quality, every effort should be made to eliminate between subgroup variation and reduce within subgroup variation Step 4 Example: A die cut machine produces 100 plastic parts per hour. The quality engineer measures 5 randomly selected parts at the beginning of every hour. Each sample of 5 parts is a subgroup.
115NCR Confidential Step 5: Data Characteristics Examine the shape of your data. – Is it what you would expect? If not, investigate. Mfg Hours Frequency 2422201816 25 20 15 10 5 0 Mean 19.98 StDev 1.713 N 100 Histogram of Mfg Hour s Mfg Hours Frequency 222018161412108 20 15 10 5 0 Mean 14.87 StDev 3.088 N 100 Histogram of Mfg Hour s Mfg Hours Frequency 75604530150-15 20 15 10 5 0 Mean 20.19 StDev 18.87 N 100 Histogram of Mfg Hours Normal Data Bimodal Data Skewed Data The shape of your data is important for determining which type of Capability Analysis applies. Step 5 Assess data characteristics
116NCR Confidential Step 6: Process Stability Process is stable and in control Process is not stable and therefore not in control Control Chart Examples Step 6 Capability is only valid when the process being studied is stable! Assess process stability in order to understand how your process behaves over time. Control charts are the recommended tool.
117NCR Confidential Step 7: Process Capability Calculate the appropriate statistical metrics in order to determine how the “Voice of the Process” compares to the “Voice of the Customer.” Specification Limits Specification Limits Process is capable Process is not capable Step 7 Capability Metrics: PPM, DPMO, Cp, Cpk, Pp, & Ppk ; Sigma Levels (Z Scores) If you were driving a truck, and the dotted lines were the construction barriers, what would be happening in each situation?
118NCR Confidential Focus on Variable Data The initial process study should be focused on variablevariable, not attribute data Assembly errors, test failures, and 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 an authorized NCR representative, attributeattribute data are not acceptable for PPAP submissiondata are not acceptable for PPAP submission Focus on variablevariable data
119NCR Confidential Capability Indices Capability Index Formula What it shows Cp Relates short term (within subgroup) standard deviation to tolerance Sometimes called “Entitlement,” meaning it is the best the current process can do, if centered Cpk Relates short term mean & short term (within subgroup) standard deviation to tolerance Only tells you about the nearest spec limit; doesn’t tell anything about the other side PP Relates long term (overall) standard deviation to tolerance Ppk Relates mean & long term (overall) standard deviation to tolerance Only tells you about the nearest spec limit; doesn’t tell anything about the other side (USL – LSL) 6*sshort-term (USL – LSL) 6*slong-term Min{(USL – X), (X – LSL)} 3*sshort-term 3*slong-term Min{(USL – X), (X – LSL)} Cp/Cpk are used to estimateestimate potential process capabilityapability Pp/Ppk are used to measuremeasure actual process performanceerformance
120NCR Confidential Capability Indices - Cpk CpkCpk predicts capabilitypredicts capability Based on short term within subgroup variation Does not include the effect of process variability between subgroups Cpk should be used whenCpk should be used when: −Developing new parts −Revising specifications on a part −Materials, processes, manufacturing location, or equipment have significantly changed −Material suppliers have changed (include certificate of analysis)
121NCR Confidential Capability Indices - Ppk PpkPpk indicatesindicates past performancepast performance Based on long term total variation Unlike Cpk, Ppk is not limited to variation within subgroups However, Ppk cannot isolate within subgroup variation from between subgroup variation When calculated from the same data set, Cpk and Ppk can be compared to analyze the sources of process variation Ppk should be used whenPpk should be used when: –The supplier is new to NCR, but has already been manufacturing a part –The supplier is existing, but has produced a number of nonconforming parts
122NCR Confidential Difference between Cp & Cpk CpCp – determines capability of producing to specification CpkCpk – same as Cp, but also measures how centered the process is It is important to look at both! Cp > 1.67 Cpk > 1.67 Capable, Centered LSL USL LSL USL Capable, Not Centered Not Capable, Centered Not Capable, Not Centered LSL USL LSL USL Cp < 1.00 Cpk < 0Cpk < 1.00 Cp < 1.00 Cpk < 1.00 Cp > 1.67
123NCR Confidential Acceptance Criteria Critical Non-Critical Decision Red (Bad) <1.33 <1.00 Yellow (OK) 1.33-1.67 1.00-1.33 Green (Good) >1.67 >1.33 Acceptance criteria for critical vs. non-critical characteristics CpkCpk must be greater than or equal to 1.67 for1.67 for criticalcritical processesprocesses CpkCpk must be greater than or equal to 1.33 for1.33 for non-criticalnon-critical processesprocesses
124NCR Confidential Initial Process Study Ensure that the results are acceptable, and that the process is stable and capable of producing a quality part PPAPs should only be approved if the capability is greater than 1.67 for critical dimensions and greater than 1.33 for non-critical dimensions More information about capability is available in the Appendix at the end of this presentation Reviewer’s Checklist
125NCR Confidential QUALIFIED LABORATORYQUALIFIED LABORATORY DOCUMENTATIONDOCUMENTATION
126NCR Confidential Qualified Laboratory Documentation •Inspection and testing for PPAP shall be performed by a qualified laboratory as defined by NCR requirements (e.g., an accredited laboratory). •The qualified laboratory (internal or external to the supplier) shall have a laboratory scope and documentation showing that the laboratory is qualified for the type of measurements or tests conducted When an external laboratory is used, the supplier 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(s) of the tests, and the standards used to run the tests shall be identified.
127NCR Confidential APPEARANCE APPROVALAPPEARANCE APPROVAL REPORTREPORT
128NCR Confidential Appearance Approval Report When to Use It • Prior to tooling for production What is It? • A report completed by the supplier containing appearance and color criteria Typically only applies for parts with color, grain, or surface appearance requirements IMPORTANT! Objective or Purpose • To demonstrate that the part has met the appearance requirements on the design record Color Suffix Master Number Master Date Material Type Material Source Color Shipping Suffix Part Disposition DL* Da* Db* DE CMC Red Yel Grn Blu Light Dark Gray CleanHigh Low High Low Appearance Approval Report Appearance Evaluation Color Evaluation Comments: Supplier Signature Phone No. Date Customer Representative Signature Date Chroma Metallic Brilliance Gloss Approved to Texture Customer Representative signature and Date Pre-Texture Evaluation Correct and Proceed Correct and Resubmit Supplier Code Other Supplier Name Manufacturing Location Application Part Name Buyer E/C Level Date Part Number Drawing Number Reason for Submission Tristimulus Data Hue Value Supplier Sourcing and Texture Information Part Submission Warrant Pre Texture Special Sample First Production Shipment Re-Submission Engineering Change
129NCR Confidential Appearance Approval Report Appearance Approval Report Appearance Evaluation Approved to Texture Customer Representative signature and Date Pre-Texture Evaluation Correct and Proceed Correct and Resubmit Supplier Code Other Supplier Name Manufacturing Location Application Part Name Buyer E/C Level Date Part Number Drawing Number Reason for Submission Supplier Sourcing and Texture Information Part Submission Warrant Pre Texture Special Sample First Production Shipment Re-Submission Engineering Change Administrative Section Supplier Sourcing & Texture Information List all first surface tools, graining Source(s), grain type(s), and grain and Gloss masters used to check part Pre-Texture Evaluation To be completed by SQE
130NCR Confidential Appearance Approval Report Color Suffix Master Number Master Date Material Type Material Source Color Shipping Suffix Part Disposition DL* Da* Db* DE CMC Red Yel Grn Blu Light Dark Gray CleanHigh Low High Low Color Evaluation Comments: Supplier Signature Phone No. Date Customer Representative Signature Date Chroma Metallic Brilliance GlossTristimulus Data Hue Value Color Suffix Alphanumeric or numeric color identification Tristimulus Data List numerical (colorimeter) data of submission part as compared to the customer- authorized master Master Number Enter alphanumeric master identification Master Date Enter the date on which the master was approved Material Type Identify first surface finish and substrate (e.g. paint / ABS) Material Source Identify first surface and substrate suppliers Hue, Value, Chroma, Gloss, and Metallic Brilliance Visual assessment by NCR Color Shipping Suffix Color part number suffix or color number Part Disposition To be determined by NCR (approved or rejected)
131NCR Confidential SAMPLE PRODUCTIONSAMPLE PRODUCTION PARTSPARTS
132NCR Confidential Sample Production Parts Actual samples that reflect the parts documented in the PPAP. What is It? Objective or Purpose • Confirm cosmetic or functional part approval. When to Use It • Sample parts should be delivered WITH the PPAP submission
133NCR Confidential Sample Production Parts •The sample parts provided should be the same parts measured for the dimensional results •Default quantity for all submissions is 3 parts unless otherwise requested
134NCR Confidential Sample Production Parts Sample production parts MUST be properly identified –Include the following information on the part label: • Date parts were packed • NCR part number • Quantity • Serial number • Supplier part number (optional) • Part description • Country of origin • Indication of RoHS compliance • Approval markings (UL, CE, etc.) where applicable See NCR part label examples on the next slide
135NCR Confidential Part Label Example
136NCR Confidential PPAP Summary •The Production Part Approval Process is an extensive approval process for new or changed designs or processes •It is very formalized, so it inevitably causes some administrative work •Later changes to the product or process can beLater changes to the product or process can be expensive and time-consuming!expensive and time-consuming!
137NCR Confidential APPENDIX –APPENDIX – CAPABILITYCAPABILITY
138NCR Confidential Process Capability Tool Selection Map Process Capability can be determined for all types of data. However, selecting the correct method is critical. Process Capability Data Type? Defect or Defective Attribute Binomial Process Capability Poisson Process Capability Defective Defect Normal Data? Variable Capability Analysis for Normal Data Yes Rational Sub-groups? Resulting data Normal? No Apply Central Limit Theorem Yes Use Minitab's "Individual Distribution Identification" function No Non-normal Distribution Identified? Use Non-Normal Capability: Select Identified Distribution Yes Transform the data using Box- Cox Transformation Is reason for Non-Normality understood? Yes Determine reasons for Non-Normality No No Is transformed data Normal? Capability Analysis for Normal Data (using subgroups) Yes Capability Analysis for Normal Data (using Box-Cox Transformation) Yes Contact your MBBNo No
139NCR Confidential Capability – Non-NormalCapability – Non-Normal Distribution IdentificationDistribution Identification Central Limit TheoremCentral Limit Theorem Box – Cox TransformationBox – Cox Transformation Capability - NormalCapability - Normal Index of Capability Examples (Using Minitab) Capability – NormalCapability – Normal
140NCR Confidential Normal Capability Example Activity Using the data in a Minitab file Capability Example.MTW determine the capability of the PO process in terms of the time is required to process the POs. Time to Process one individual PO Use the file Capability Example.MTW
141NCR Confidential QWhich Capability Analysis applies? Yes ANormal ??? Normal Capability Example Is the data attribute or variable? Is the data normal? Does sub-grouping apply?
142NCR Confidential Normal Capability Analysis in Minitab 1. Open the worksheet Capability Example.MTW. 2. Choose Stat > Quality Tools > Capability Analysis > Normal. 3. Click in the [Single Column] field. 4. Double click [Time to Process] in the column on the left. 5. Click in the [Subgroup Size] field.6. Depending on subgroup information either: a. Enter 1 if the subgroup size is 1. b. Double click Indiv Dates_1 in the column on the left. c. Since the subgroup size is constant (n=5) the number 5 could be typed in the subgroup size field. Use the file Capability Example MTW
143NCR Confidential Normal Capability Analysis in Minitab 7. Type 20 in Lower Spec. 8. Type 40 in Upper Spec. 9. Select [Options] button. 10.Add target value (if applicable). 11.Under Display select a. Parts per million or Percents b. Capability Stats or Benchmark Z 7. Add Title if desired. 8. Click [OK]. 9. Click [OK].
144NCR Confidential 484236302418 LSL USL Process Data Sample N 200 StDev (Within) 7.46329 StDev (Ov erall) 7.54439 LSL 20.00000 Target * USL 40.00000 Sample Mean 30.72100 Potential (Within) Capability CCpk 0.45 Ov erall Capability Pp 0.44 PPL 0.47 PPU 0.41 Ppk Cp 0.41 Cpm * 0.45 CPL 0.48 CPU 0.41 Cpk 0.41 Observ ed Performance %  <  LSL 7.50 %  >  USL 10.00 %  Total 17.50 Exp. Within Performance %  <  LSL 7.54 %  >  USL 10.69 %  Total 18.23 Exp. Ov erall Performance %  <  LSL 7.77 %  >  USL 10.94 %  Total 18.70 Within Overall Process Capability of Time to Process (subgroup of 1) Normal Capability Analysis Results Sample Mean StDev (Within): Represents short term data. StDev (Overall): Represents long term data, includes shift and drift between subgroups. Voice of the Customer Voice of the Process
145NCR Confidential 484236302418 LSL USL Process Data Sample N 200 StDev (Within) 7.46329 StDev (Ov erall) 7.54439 LSL 20.00000 Target * USL 40.00000 Sample Mean 30.72100 Potential (Within) Capability CCpk 0.45 Ov erall Capability Pp 0.44 PPL 0.47 PPU 0.41 Ppk Cp 0.41 Cpm * 0.45 CPL 0.48 CPU 0.41 Cpk 0.41 Observ ed Performance %  <  LSL 7.50 %  >  USL 10.00 %  Total 17.50 Exp. Within Performance %  <  LSL 7.54 %  >  USL 10.69 %  Total 18.23 Exp. Ov erall Performance %  <  LSL 7.77 %  >  USL 10.94 %  Total 18.70 Within Overall Process Capability of Time to Process (subgroup of 1) Normal Capability Analysis Results Observed Performance: Represents the sample data. Exp Within Performance: Based on StDev(Within) and represents short term process capability. Capability indices: Based on short term data. Exp Overall Performance: Based on StDev (Overall) and represents long term process capability. Capability indices: Based on long term data.
146NCR Confidential Non-Normal Capability – Distribution Identification Exercise Using the data (Time_2) in a Minitab file Capability Example.MTW determine the capability of the PO process in terms of the time that is required to process the POs. Time to Process one individual PO Use the file Capability Example. MTW
147NCR Confidential A QWhich Capability Analysis applies? No Non-normal Try Individual Distribution Identification Yes ??? Non-Normal Capability – Distribution Identification • Is the data attribute or variable? • Is the data normal? • Are the reasons for non-normality understood? • Can the data be described by another distribution?
148NCR Confidential Individual Distribution Identification in Minitab 1. Open the worksheet Capability Example.MTW. 2. Choose Stat > Quality Tools > Individual Distribution Identification. 3. Click in the [Single Column] field. 4. Double click Time_2 in the column on the left. 5. Choose [Use all distributions]. 6. Click [OK]. Use the file Capability Example. MTW
149NCR Confidential Individual Distribution Identification in Minitab
150NCR Confidential 1. Open the worksheet Capability Example.MTW. 2. Choose Stat > Quality Tools > Capability Analysis > Nonnormal. 3. Click in the [Single Column] field. 4. Double click Time_2 in the column on the left. 5. Select [Fit data with Distribution]. 6. Using pulldown menu select [3- parameter Weibull]. 7. Type 20 in [Lower Spec]. 8. Type 40 in [Upper Spec]. Using Individual Distribution Identification Use the file Capability Example. MTW
151NCR Confidential 9. Select [Options] button. 10. Add target value (if applicable). 11. Under Display select 1. Capability Stats 2. Benchmark Z 12. Add Title if desired. 13. Click [OK]. 14. Click [OK]. Using Individual Distribution Identification
152NCR Confidential Sample Mean Voice of the Customer Voice of the Process Observed Performance: Represents the sample data Exp Overall Performance: Represents long term process capability Overall Capability: Benchmark Z or Capability indices - based on long term data Using Individual Distribution Identification
153NCR Confidential Non-Normal Capability – Central Limit Theorem Activity Using the data (Time_3 and Time 3 sub) in a Minitab file Capability Example.MTW determine the capability of the PO process in terms of the time is required to process the POs. Average time to process five POs per day Time to process one individual PO Use the file Capability Example. MTW
154NCR Confidential A QWhich Capability Analysis applies? No Non-normal Try sub-grouping the data Yes Yes No ??? • Is the data attribute or variable? • Is the data normal? • Are the reasons for non-normality understood? • Can the data be described by another distribution? • Can the data be sub-grouped? • Is the sub-grouped data normal? Non-Normal Capability – Central Limit Theorem
155NCR Confidential 1. Open the worksheet Capability Example.MTW. 2. Choose Stat > Quality Tools > Capability Analysis > Normal. 3. Click in the [Single Column] field. 4. Double click Time_3 in the column on the left. 5. Click in the [Subgroup Size] field – Double click Individ Dates_3 in the column on the left. 6. Type 20 in [Lower Spec]. 7. Type 40 in [Upper Spec]. The sub-groups have to make logical sense, such as by day, by shift, by machine… Important! Check sub-group data Time_3 sub for normality. If the data is not normal then this method cannot be used! Caution! Use the file Capability Example. MTW Using Central Limit Theorem Sub-Grouping
156NCR Confidential 8. Select [Options] button. 9. Add target value (if applicable). 10. Under Display select 1. Parts per million or Percents 2. Capability Stats or Benchmark Z 11. Add Title if desired. 12. Click [OK]. 13. Click [OK]. Using Central Limit Theorem Sub-Grouping
157NCR Confidential 5045403530252015 LSL USL LSL 20 Target * USL 40 Sample Mean 31.262 Sample N 200 StDev (Within) 7.55396 StDev (Ov erall) 8.3748 Process Data Cp 0.44 CPL 0.50 CPU 0.39 Cpk 0.39 Pp 0.40 PPL 0.45 PPU 0.35 Ppk 0.35 Cpm * Ov erall Capability Potential (Within) Capability PPM < LSL 85000.00 PPM > USL 175000.00 PPM Total 260000.00 Observ ed Performance PPM < LSL 67997.38 PPM > USL 123688.49 PPM Total 191685.87 Exp. Within Performance PPM < LSL 89353.21 PPM > USL 148388.88 PPM Total 237742.09 Exp. Ov erall Performance Within Overall Process Capability of Time_ 3 Sample Mean StDev (Within): Represents short term data StDev (Overall): Represents long term data, includes shift and drift between subgroups Voice of the Customer Voice of the Process Using Central Limit Theorem Sub-Grouping
158NCR Confidential 5045403530252015 LSL USL LSL 20 Target * USL 40 Sample Mean 31.262 Sample N 200 StDev (Within) 7.55396 StDev (Ov erall) 8.3748 Process Data Cp 0.44 CPL 0.50 CPU 0.39 Cpk 0.39 Pp 0.40 PPL 0.45 PPU 0.35 Ppk 0.35 Cpm * Ov erall Capability Potential (Within) Capability PPM < LSL 85000.00 PPM > USL 175000.00 PPM Total 260000.00 Observ ed Performance PPM < LSL 67997.38 PPM > USL 123688.49 PPM Total 191685.87 Exp. Within Performance PPM < LSL 89353.21 PPM > USL 148388.88 PPM Total 237742.09 Exp. Ov erall Performance Within Overall Process Capability of Time_ 3 Observed Performance: Represents the sample data. Exp Within: Performance: Based on StDev(Within) and represents short term process capability Capability indices: Based on short term data. Exp Overall: Performance: Based on StDev(Overall) and represents long term process capability. Capability indices: Based on long term data. Using Central Limit Theorem Sub-Grouping
159NCR Confidential Non-Normal Capability – Box-Cox Transformation Activity Using the data (Time_4) in a Minitab file Capability Example.MTW determine the capability of the PO process in terms of the time is required to process the POs. Time to Process one individual PO
160NCR Confidential A QWhich Capability Analysis applies? No Non-normal Try Box-Cox transformation Yes No No ??? Non-Normal Capability – Box-Cox Transformation • Is the data attribute or variable? • Is the data normal? • Are the reasons for non-normality understood? • Can the data be described by another distribution? • Can the data be sub-grouped? • Can data be transformed?
161NCR Confidential Box-Cox Transformation 1. Open the worksheet Capability Example.MTW 2. Choose Stat > Control Charts > Box- Cox Transformation 3. Choose [All Observations …in one column] from pull down menu 4. Click in Large Box 5. Double click [Time_4] in the column on the left 6. Click in the [Subgroup Size] field – enter 1 7. Select [Options] radio button 8. Select [Optimal Lambda] 9. Enter column for Stored Data 10. Click [OK] 11. Click [OK]
162NCR Confidential Box-Cox Transformation Results QIs the transformed data normal? Transformed Data Lambda Values
163NCR Confidential 1. Open the worksheet Capability Example.MTW 2. Choose Stat > Quality Tools > Capability Analysis > Normal 3. Click in the [Single Column] field 4. Double click Time_4 in the column on the left  Use the original data, not the transformed data. 1. Click in the [Subgroup Size] field – enter 1 (the data is already sub-grouped) 2. Type 20 in Lower Spec 3. Type 40 in Upper Spec Using Box-Cox Transformation Check transformed data for normality. If the data is not normal then this method cannot be used! Caution! Use the file Capability Example. MTW
164NCR Confidential 1. Select [Box-Cox] radio button 2. Select [Box-Cox power transformation] 3. Select [Use Optional lambda] 4. Click OK 5. Select [Options] radio button 6. Add target value (if applicable) 7. Under Display select a. Parts per million or Percents b. Capability Stats or Benchmark Z 8. Add Title if desired 9. Click [OK] 10. Click [OK] Using Box-Cox Transformation
165NCR Confidential Transformed Sample Data Transformed Voice of the Process Transformed Voice of the Customer Original Sample Data Calculated Lambda Original Distribution Using Box-Cox Transformation
166NCR Confidential Observed Performance: Represents the sample data Exp Within Performance: Based on StDev (Within) and represents short term process capability. Capability indices: Based on short term data Exp Overall Performance: Based on StDev (Overall) and represents long term process capability. Capability indices: Based on long term data. Using Box-Cox Transformation

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Ppap training-presentation

  • 1. Production Part Approval Process (PPAP)
  • 2. 2NCR Confidential 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 with input from the Big 3 - Ford, Chrysler, and GM •AIAG’s 4th edition effective June 1, 2006 is the most recent version •PPAP has now spread to many different industries beyond automotive
  • 3. 3NCR Confidential Purpose of PPAP •Provide evidence that all customer engineering design record and specification requirements are properly 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 PPAP manages change and ensures product conformance!
  • 4. 4NCR Confidential When is PPAP Required? New part Engineering change(s) Tooling: transfer, replacement, 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 PPAP is required with any significant change to product or process!
  • 5. 5NCR Confidential Benefits of PPAP Submissions •Helps to maintain design integrity •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 satisfaction
  • 6. 6NCR Confidential Production Run •PPAP data must be submitted from a productionproduction run using:: Production equipment and tooling Production employees Production rate Production process All data reflects the actual production process to be used at start-up!
  • 7. 7NCR Confidential Run @ Rate •The purpose of a Run @ RateRun @ Rate is to verify the supplier’s manufacturing process is capable of producing components that meet NCR’s quality requirements, at quoted tooling capacity, for a specified period of time •Verification of the Run @ Rate will be at the Supplier Quality Engineer’s (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 components 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
  • 8. 8NCR Confidential Official PPAP Requirements 1. Design Records 2. Authorized Engineering Change Documents 3. Customer Engineering Approval, if required 4. Design Failure Modes and Effects Analysis (DFMEA) applied in special situations 5. Process Flow Diagram 6. Process Failure Modes and Effects Analysis (PFMEA) 7. Control Plan 8. Measurement Systems Analysis (MSA) 9. Dimensional Results 10. Records of Material / Performance Test Results 11. Initial Process Studies 12. Qualified Laboratory Documentation 13. Appearance Approval Report (AAR) 14. Sample Production Parts 15. Master Sample 16. Checking Aids 17. Customer-Specific Requirements 18. Part Submission Warrant (PSW) Now, let’s take a closer look at NCR’s requirements
  • 9. 9NCR Confidential NCR’s PPAP Requirements 1. Design Records 2.2. Authorized Engineering Change DocumentsAuthorized Engineering Change Documents 3.3. Customer Engineering Approval, if requiredCustomer Engineering Approval, if required 4. Design Failure Modes and Effects Analysis (DFMEA) applied in special situations 5.5. Process Flow DiagramProcess Flow Diagram 6.6. Process Failure Modes and Effects Analysis (PFMEA)Process Failure Modes and Effects Analysis (PFMEA) 7.7. Control PlanControl Plan 8.8. Measurement Systems Analysis (MSA)Measurement Systems Analysis (MSA) 9.9. Dimensional ResultsDimensional Results 10.10. Records of Material / Performance Test ResultsRecords of Material / Performance Test Results 11. Initial Process Studies 12.12. Qualified Laboratory DocumentationQualified Laboratory Documentation 13.13. Appearance Approval Report (AAR)Appearance Approval Report (AAR) 14.14. Sample Production PartsSample Production Parts 15. Master Sample 16. Checking Aids 17. Customer-Specific Requirements 18.18. Part Submission Warrant (PSW) – NCR calls this the “Production Warrant”Part Submission Warrant (PSW) – NCR calls this the “Production Warrant” Supplier shall submit these 12 items and retain a copy of records at appropriate locations
  • 10. 10NCR Confidential 1.1. Design RecordsDesign Records 2. Authorized Engineering Change Documents 3. Customer Engineering Approval, if required 4.4. Design Failure Modes and Effects Analysis (DFMEA)Design Failure Modes and Effects Analysis (DFMEA) applied in special situationsapplied in special situations 5. Process Flow Diagram 6. Process Failure Modes and Effects Analysis (PFMEA) 7. Control Plan 8. Measurement Systems Analysis (MSA) 9. Dimensional Results 10. Records of Material / Performance Test Results 11.11. Initial Process StudiesInitial Process Studies 12. Qualified Laboratory Documentation 13. Appearance Approval Report (AAR) 14. Sample Production Parts 15.15. Master SampleMaster Sample 16.16. Checking AidsChecking Aids 17.17. Customer-Specific RequirementsCustomer-Specific Requirements 18. Part Submission Warrant (PSW) – NCR calls this the “Production Warrant” Supplier shall retain these 6 items at appropriate locations, and make readily available upon request NCR’s PPAP Requirements
  • 11. 11NCR Confidential Level 1 Production Warrant and Appearance Approval Report (if applicable) submitted to NCR Level 2 Production Warrant, product samples, and dimensional results submitted to NCR Level 3 Production Warrant, product samples, and complete supporting data submitted to NCR Level 4 Production Warrant and other requirements as defined by NCR Level 5 Production Warrant, product samples and complete supporting data (a review will be conducted at the supplier's manufacturing location) PPAP Submission Levels
  • 12. 12NCR Confidential Requirement Level 1 Level 2 Level 3 Level 4 Level 5 1. Design Records of Saleable Product R R R * R a. For proprietary components/details R R R * R b. For all other components/details R R R * R 2. Engineering Change Documents, if any R S S * S 3. Customer Engineering approval, if required R S S * S 4. Design FMEA R R R * R 5. Process Flow Diagrams R R S * S 6. Process FMEA R R S * S 7. Dimensional Results S S S * S 8. Material, Performance, Test Results R S S * S 9. Initial Process Study R R R * R 10. Measurement System Analysis Studies R R S * S 11. Qualified Laboratory Documentation R R S * S 12. Control Plan R R S * S 13. Part Submission Warrant (PSW) S S S * S 14. Appearance Approval Report, (AAR) if applicable S S S * S 15. Bulk Material Requirements Checklist (for bulk material only) R R R * R 16. Sample Product R S S * S 17. Master Sample R R R * R 18. Checking Aids R R R * R 19. Records of compliance with Customer-Specific Requirements (DVP&R) R R R * R Submission Level PPAP Levels for Submission & Retention S = The supplier shall submit to NCR and retain a copy of records or documentation items at appropriate locations. R = The supplier shall retain at appropriate locations and make readily available to NCR upon request. * = The supplier shall retain at appropriate locations, and submit to NCR upon request. NCR will identify what is needed for submission. PLEASE CONTACT YOUR SUPPLIER QUALITY ENGINEER WITH ANY QUESTIONS . PPAP Submission Level Table S = Supplier shall submit to NCR & retain a copy of records or documentation items at appropriate locations R = Supplier shall retain at appropriate locations and make readily available to NCR upon request * = Supplier shall retain at appropriate locations, and submit to NCR upon request. NCR will identify what is needed for submission.
  • 13. 13NCR Confidential Definition of Risk •High Risk Parts associated with multiple critical features, complex design, or high end technology that is not yet established in the general manufacturing environment Supplier’s 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 Supplier’s quality system and quality performance are acceptable
  • 14. 14NCR Confidential Submission Level Requirements •New PartsNew Parts Level 2 is required for Low Risk Parts Level 3 is required for Medium and High Risk Parts •Part ChangesPart Changes Level 3 is required for Parts produced at a new or additional location Supplier Quality Excellence will define the level required for all other changes NCR reserves the right to redefine the submission level required
  • 15. 15NCR Confidential 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 requirements, based on the production lot from which it was taken and/or accompanying documentation Production quantities may not be shipped before NCR Approval
  • 16. 16NCR Confidential Electronic Submission Requirements •NCR requires that all PPAPs be submitted electronically •Use of paper submission must have prior approval by the 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 requires all submissions to be electronic
  • 17. 17NCR Confidential NCR PPAP Playbook •What is the NCR PPAP Playbook? An Excel spreadsheet containing templates of the documents suppliers are required to submit to NCR •Why 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
  • 19. 19NCR Confidential Production Warrant Now, let’s take a closer look 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 Used to : • document part approval • provide key information • declare that the parts meet specification Objective or Purpose When to Use It • Prior to shipping production parts Part Name NCR Part Number Shown on Drawing no. Supplier Part Number Engineering Drawing Change Level Dated Additional Engineering Changes Dated Safety and/or Government Regulation Yes No Purchase order No. Weight (kg) Checking Aid No. Engineering Change Level Dated SUPPLIER MANUFACTURING INFORMATION NCR SUBMITTAL INFORMATION Supplier Name Supplier Code NCR Location Street Address Buyer Buyer Code City Model Name / Number Note: Does this part contain any restricted or reportable substances? Yes No Are parts identified with appropriate UL/CE/ISO marking codes if applicable? Yes No REASON FOR SUBMISSION Initial Submission Change to Optional Construction or Material Engineering Change(s) Sub-Supplier or Material Source Change Tooling: Transfer, Replacement, Refurbishment, or additional Change in Part processing Correction of Discrepancy Parts Produced at New or Additional Location Tooling Inactive > than 1 year Other - please specify REQUESTED SUBMISSION LEVEL (Check one based on NCR requirements) Level 1 - Production Warrant and Appearance Approval Report (if applicable) submitted to NCR Level 2 - Production Warrant, product samples, and dimensional results submitted to NCR Level 3 - Production Warrant, product samples, and complete supporting data submitted to NCR Level 4 - Production Warrant and other requirements as defined by NCR Level 5 - Production Warrant, product samples, and complete supporting data reviewed at supplier's manufacturing location SUBMISSION RESULTS The results for dimensional measurements material and functional tests appearance criteria statistical process package These results meet all drawing and specification requirements: Yes No (If "No" - Explanation Required) Mold / Cavity / Production Process: DECLARATION I affirm that the samples represented by this warrant are representative of our parts, which were made by a process that meets all of NCR's Production Part Approval Process requirements. I further affirm that these samples were produced at the production rate of _____ pieces / _____ hours. I also certify that documented evidence of such compliance is on file and available for review. I have noted any deviations from this declaration below. EXPLANATION/COMMENTS: Supplier Authorized Signature Date Print Name Title Email Phone No. PPAP Warrant Disposition: Approved Rejected Other ____________________________________________________ NCR Signature _____ Date Print Name NCR Tracking Number (optional) Production Warrant CountryPostal CodeRegion FOR CUSTOMER USE ONLY (IF APPLICABLE)
  • 20. 20NCR Confidential Production Warrant Part Name NCR Part Number Shown on Drawing no. Supplier Part Number Engineering Drawing Change Level Dated Additional Engineering Changes Dated Safety and/or Government Regulation Yes No Purchase order No. Weight (kg) Checking Aid No. Engineering Change Level Dated SUPPLIER MANUFACTURING INFORMATION NCR SUBMITTAL INFORMATION Supplier Name Supplier Code NCR Location Street Address Buyer Buyer Code City Model Name / Number Note: Does this part contain any restricted or reportable substances? Yes No Are parts identified with appropriate UL/CE/ISO marking codes if applicable? Yes No Production Warrant CountryPostal CodeRegion Part Name / NCR Part Number Engineering released finished end item part name and number Safety and/or Government Regulation “Yes” if so indicated by the Design Record, otherwise “No” Engineering Change Level & Date Show the change level and date of the Design Record Additional Engineering Changes List all authorized Engineering changes not yet incorporated in the design record but which are incorporated in the part Shown on Drawing Number The design record that specifies the customer part number being submitted Checking Aid Number, Change Level, & Date Enter if requested by the customer Purchase Order Number Enter this number as found on the contract / purchase order Supplier Part Number Part number defined by the supplier, if any
  • 21. 21NCR Confidential Production Warrant Part Name NCR Part Number Shown on Drawing no. Supplier Part Number Engineering Drawing Change Level Dated Additional Engineering Changes Dated Safety and/or Government Regulation Yes No Purchase order No. Weight (kg) Checking Aid No. Engineering Change Level Dated SUPPLIER MANUFACTURING INFORMATION NCR SUBMITTAL INFORMATION Supplier Name Supplier Code NCR Location Street Address Buyer Buyer Code City Model Name / Number Note: Does this part contain any restricted or reportable substances? Yes No Are parts identified with appropriate UL/CE/ISO marking codes if applicable? Yes No Production Warrant CountryPostal CodeRegion NCR Location Show the location where parts will be shipped toBuyer / Buyer Code Enter the buyer’s name and code Restricted Substances Enter “Yes” or “No” Model Name / Number Enter the model name and number Parts Identified with Appropriate Marking Codes ULUL = Underwriters Laboratories safety standards CECE = Conformite Europeenne (European Conformity) – Certifies that a product has met European consumer Safety, health, or environmental requirements ISO = International Organization for Standardization Enter “Yes” or “No” Supplier Manufacturing Information Show the name and code assigned to the manufacturing site on the purchase order / contract
  • 22. 22NCR Confidential Production Warrant REASON FOR SUBMISSION Initial Submission Change to Optional Construction or Material Engineering Change(s) Sub-Supplier or Material Source Change Tooling: Transfer, Replacement, Refurbishment, or additional Change in Part processing Correction of Discrepancy Parts Produced at New or Additional Location Tooling Inactive > than 1 year Other - please specify REQUESTED SUBMISSION LEVEL (Check one based on NCR requirements) Level 1 - Production Warrant and Appearance Approval Report (if applicable) submitted to NCR Level 2 - Production Warrant, product samples, and dimensional results submitted to NCR Level 3 - Production Warrant, product samples, and complete supporting data submitted to NCR Level 4 - Production Warrant and other requirements as defined by NCR Level 5 - Production Warrant, product samples, and complete supporting data reviewed at supplier's manufacturing location SUBMISSION RESULTS The results for dimensional measurements material and functional tests appearance criteria statistical process package These results meet all drawing and specification requirements: Yes No (If "No" - Explanation Required) Mold / Cavity / Production Process: Reason For Submission Check the appropriate box(es) Requested Submission Level Identify the submission level requested by NCR Submission Results Check the appropriate boxes Mold / Cavity / Production Process If production parts will be produced from more than one mold, cavity, tool, die, pattern, or production process, the supplier shall complete a dimensional evaluation on one part from each. The specific molds, lines, etc. shall then be identified here.
  • 23. 23NCR Confidential Production Warrant DECLARATION I affirm that the samples represented by this warrant are representative of our parts, which were made by a process that meets all of NCR's Production Part Approval Process requirements. I further affirm that these samples were produced at the production rate of _____ pieces / _____ hours. I also certify that documented evidence of such compliance is on file and available for review. I have noted any deviations from this declaration below. EXPLANATION/COMMENTS: Supplier Authorized Signature Date Print Name Title Email Phone No. PPAP Warrant Disposition: Approved Rejected Other ____________________________________________________ NCR Signature _____ Date Print Name NCR Tracking Number (optional) FOR NCR USE ONLY The approved Production Warrant officially warrants the parts ready for production Declaration Enter the number of pieces manufactured during the significant production run and the time (in hours) taken for the significant production run Explanation / Comments Provide any explanatory comments on the submission results or any deviations from the Declaration. Attach additional information as appropriate. Supplier Authorized Signature A responsible supplier official, after verifying that the results show conformance to all NCR requirements and that all required documentation is available, shall approve the declaration For NCR Use Only To be completed by appropriate NCR Supplier Quality Engineer Declaration Affirmation that the samples represented by the warrant are representative and were made by a process that meets NCR’s PPAP requirements PPAP Warrant Disposition Approved, Rejected, OtherNCR Signature Signed by NCR Supplier Quality Engineer
  • 24. 24NCR Confidential Reviewers Checklist Must be completely 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
  • 25. 25NCR Confidential AUTHORIZED ENGINEERINGAUTHORIZED ENGINEERING CHANGE DOCUMENTSCHANGE DOCUMENTS
  • 26. 26NCR Confidential Authorized Engineering Change Documents The supplier shall provide authorized change documents for 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
  • 27. 27NCR Confidential PROCESS FLOW DIAGRAMPROCESS FLOW DIAGRAM
  • 28. 28NCR Confidential Process Flow Diagram What is It? • A visual diagram of the entire process from receiving through shipping, including outside processes and services To help people “see” the real process. Process maps can be used to understand the following characteristics of a process: • Set-by-step process linkage • Offline activities (measurement, inspection, handling) • Rework, scrap Objective or Purpose When to Use It • To understand how a process is done • Prior to completing the PFMEA Operator Get Traveler and Nest from Holding Shelf (26) Operator Prints Cut Tags (27) Operator Load Machine with Blanket (28) Operator Download Cutting Infomation (2s to 2m) (29) Operator Program Command "Ready to Cut" (30) Operator Observe Cutting Operation for Errors (32) Cutting Error? (33) Operator Separate Cutting Tags (31) Operator Cutting Operation Complete (34) Large or Small Plies or Test Coupons? (35) Operator Tag while Laying on the Cutting Table (39) Operator Remove Small Plies from the Cutting Table (36) Operator Move to Kitting Table (37) Small Plies Large Piies And Coupons Operator Remove Plies from the Cutting Table (40) Operator Tag Small Plies (38) Operator Move Plies to Kitting Table (41) Yes Evaluate for Corrective Action Operator Stamp Traveler (43) Traveler Complete? (42) Yes No No Project Idea Fill Out Master Form with Initial Information Is Hard Savings > $??? Does the Project Involve Only Your Group? Does the Project Involve >3 Depts. outside Eng? Does the Project Involve >2 Groups in Eng? Do you have BB/GB to Assist/Work the project? Prefer to work this project within your area? 6 Sigma Project Department or Group Project Yes No Yes No Yes No No No Yes Yes Yes No Enter Remaining Information on Master Form Master Form Will Generate Contract Finance Approval and Signature Other Required Signatures: Segment CEO Champion Process Owner BB or GB 6 Sigma Assigns Project Number Get WO Assigned Begin/Work Project Follow DMAIC or DFSS process Monitor Progress through Power Steering and Monthly Financial Reviews Complete Project (Has to be fully Documented Finance Approval and Signature Other Required Signatures: Champion: Dir T&E Process Owner Project Owner Dept BB or MBB Enter Remaining Information on Master Form Master Form Will Generate Contract Finance Approval and Signature Other Required Signatures: Champion: Process Owner Project Owner Dept GB/BB/MBB Group Assigns Project Number Get DLN Assigned Monitor Progress through Bi- Weekly Updates and Monthly Reviews Begin/Work Project Follow DMAIC or DFSS process Complete Project (Has to be fully Documented) Finance Approval and Signature Other Required Signatures: Champion: Dir T&E Process Owner Project Owner Dept BB or MBB Complete all Documentation including a (1) Page Close- out Sheet Close Project Complete all Documentation including a (1) Page Close- out Sheet Final Project Review Close Project Final Project Review 6 Sigma Project High Level Process Map Department/Group Project High Level Process Map
  • 29. 29NCR Confidential Process Flow Diagrams Date: ECL: Prepared By: STEP Fabrication Move Store Inspect Operation Description Item# Item# Control Methods 1 2 3 4 5 6 7 8 9 10 11 12 PROCESS FLOW DIAGRAM Part Description: Part Number: Product and Process Characteristics The process flow diagram utilizes these symbols to clearly identify each step in the process
  • 30. 30NCR Confidential Process Flow Diagram - Example : 484 -0100264 : : : : : Deburring & Cleaning Despatch T T Arul Incoming Inspection - INSPECTION- PROCESS- SUPPLIER END OPERATION CNC Sliding Machining Final Isnpection APPROVED BY & DATE V Raja Pre delivery Inspection PREPARED BY & DATE Oiling, Packing & Preservation Pre shipment audit - PATROL INSPECTION Layout Inspection - MOVEMENT - STORAGE LEO PROCESS FLOW DIAGRAM Rev. No. / Date1 of 1 O / 10.08.09Part Name : Page Shaft Pressure Paddle F/QA/05/0 PFD/NCR/0264Part No. Customer Name NCR Doc. No. **RM receiving Insp. report Inspection as per RIQP If Rejected Return to supplier ** Inspection as per Opertion layout Not ok , Rejected If rework possible Rework Scrap 100% Re-inspection Next operation Not ok OkNote : Tags to be provided for OK, Rework, Inspection & Rejection 05 10 3040 Pre shipment audit report 60 Self Inspection Report Layout Inspection Report 5070 20 Final Inspection register Patrol Insp. report Not ok , Rejected 15
  • 31. 31NCR Confidential Star Exercise •Divide into teams •Distribute supplies −Paper for Stars −Instructions for making Stars −Scissors •Using the instructions handed out in class, make 10 Shuriken Stars •This exercise will prepare your team to complete future exercises 45 Minutes
  • 32. 32NCR Confidential 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 Operation layout If rework possible Rework 100% Inspection Scrap Next Operation Not OK OK Patrol Insp Report
  • 33. 33NCR Confidential 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 raw material  Part manufacturing  Offline inspections and checks  Assembly  Shipping Process Flow Diagrams
  • 35. 35NCR Confidential Process FMEA (PFMEA) When to Use It • After completion of the process flow diagram. • Prior to tooling for production Failure Mode and Effects Analysis (Design FMEA) F M EA N um be r: P a ge o f Sys te m / C o m po ne nt: P repa re d by: F M EA D a te (O rig.) (R ev .) C o re T ea m : ActionsTaken S e v O c c u r D e t e c R. P. N. D es ign R e s po ns ibility: Action Results O c c u r Current Design Controls Prevention Current Design Controls Detection D e t e c R. P. N. Recommended Action(s) Responsibility & Target Completion Date Potential Cause(s)/ Mechanism(s) of Failure Item / Process Function Potential Failure Mode Potential Effect(s) of Failure S e v What is It? • A tool used to identify and prioritize risk areas and their mitigation plans. The PFMEA should be completed using a cross-functional team! IMPORTANT! Objective or Purpose • Identifies potential failure modes, causes, and effects. Inputs come from the process flow diagram. • Identifies key inputs which positively or negatively affect quality, reliability and safety of a product or process.
  • 36. 36NCR Confidential 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
  • 37. 37NCR Confidential Process FMEA (PFMEA) Print # Rev. FMEA Number Item: Process Responsibility: Prepared by: Model Year(s)/Vehicle(s) Key Date Date (Orig.) Team: Date (Rev.) Actions Taken Sev Occ Det R.P.N. Occur Current Process Controls Process Step Potential Failure Mode Potential Effect(s) of Failure Sev POTENTIAL (PROCESS FMEA) Action Results Detec R.P.N. Recommended Actions Responsibility & Target Date FAILURE MODE AND EFFECTS ANALYSIS Class Potential Cause(s)/ Mechanism(s) of Failure This is included in the PPAP Playbook!
  • 38. 38NCR Confidential Spray head clogged: - Viscosity too high - Temp too low - Pressure too low 5 Variables check for film thickness; Visual check for coverage; Test spray at start-up and after idle periods and preventative maintenance program to clean heads 5 175 Detec R.P.N. Class Potential Cause(s)/ Mechanism(s) of Failure Occur Current Process Controls Process Step Potential Failure Mode Potential Effect(s) of Failure Sev 280Allows integrity breach of inner door panel Corroded interior lower door panels Deteriorated life of door leading to: - Unsatisfactory appearance due to rust through paint over time - Impaired function of interior door hardware Insufficient wax coverage over specified surface Op 70: Manual application of wax inside door panel 7 Manually inserted spray head not inserter far enough Variables check for film thickness; Visual check for coverage 58 TIPS • There should be at least one failure mode for each input. Using the completed Process Flow Diagram, enter the process step. Failure Modes For each Process Input, determine the ways in which the input can go wrong. PFMEA - Step 1
  • 39. 39NCR Confidential Spray head clogged: - Viscosity too high - Temp too low - Pressure too low 5 Variables check for film thickness; Visual check for coverage; Test spray at start-up and after idle periods and preventative maintenance program to clean heads 5 175 Detec R.P.N. Class Potential Cause(s)/ Mechanism(s) of Failure Occur Current Process Controls Process Step Potential Failure Mode Potential Effect(s) of Failure Sev 280Allows integrity breach of inner door panel Corroded interior lower door panels Deteriorated life of door leading to: - Unsatisfactory appearance due to rust through paint over time - Impaired function of interior door hardware Insufficient wax coverage over specified surface Op 70: Manual application of wax inside door panel 7 Manually inserted spray head not inserter far enough Variables check for film thickness; Visual check for coverage 58 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. Potential Failure Effects For each Failure Mode, determine what effect the specific failure could have on the process output. PFMEA - Step 2
  • 40. 40NCR Confidential Spray head clogged: - Viscosity too high - Temp too low - Pressure too low 5 Variables check for film thickness; Visual check for coverage; Test spray at start-up and after idle periods and preventative maintenance program to clean heads 5 175 280Allows integrity breach of inner door panel Corroded interior lower door panels Deteriorated life of door leading to: - Unsatisfactory appearance due to rust through paint over time - Impaired function of interior door hardware Insufficient wax coverage over specified surface Op 70: Manual application of wax inside door panel 7 Manually inserted spray head not inserted far enough Variables check for film thickness; Visual check for coverage 58 Occur Current Process Controls Process Step Potential Failure Mode Potential Effect(s) of Failure Sev Detec R.P.N. Class Potential Cause(s)/ Mechanism(s) of Failure TIPS • There should be at least one potential cause for each failure mode. Potential Causes For each Failure Mode, determine the possible cause of the failure. PFMEA - Step 3
  • 41. 41NCR Confidential Spray head clogged: - Viscosity too high - Temp too low - Pressure too low 5 Variables check for film thickness; Visual check for coverage; Test spray at start-up and after idle periods and preventative maintenance program to clean heads 5 175 Detec R.P.N. Class Potential Cause(s)/ Mechanism(s) of Failure Occur Current Process Controls Process Step Potential Failure Mode Potential Effect(s) of Failure Sev 280Allows integrity breach of inner door panel Corroded interior lower door panels Deteriorated life of door leading to: - Unsatisfactory appearance due to rust through paint over time - Impaired function of interior door hardware Insufficient wax coverage over specified surface Op 70: Manual application of wax inside door panel 7 Manually inserted spray head not inserter far enough Variables check for film thickness; Visual check for coverage 58 TIPS • 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.” Current Controls For each potential cause, list the current method used for preventing or detecting failure. PFMEA - Step 4
  • 42. 42NCR Confidential Spray head clogged: - Viscosity too high - Temp too low - Pressure too low 5 Variables check for film thickness; Visual check for coverage; Test spray at start-up and after idle periods and preventative maintenance program to clean heads 5 175 Detec R.P.N. Class Potential Cause(s)/ Mechanism(s) of Failure Occur Current Process Controls Process Step Potential Failure Mode Potential Effect(s) of Failure Sev 280Allows integrity breach of inner door panel Corroded interior lower door panels Deteriorated life of door leading to: - Unsatisfactory appearance due to rust through paint over time - Impaired function of interior door hardware Insufficient wax coverage over specified surface Op 70: Manual application of wax inside door panel 7 Manually inserted spray head not inserter far enough Variables check for film thickness; Visual check for coverage 58 Assign Severity, Occurrence, and Detection ratings Assign Severity (How serious is the effect if it fails?) Assign Occurrence (How likely is the cause to occur?) Assign Detection (How easily can the cause or failure mode be detected?) Severity, Occurrence and Detection rating details on next slide PFMEA - Step 5
  • 43. 43NCR Confidential PFMEA - Definition of Terms SeveritySeverity (of Effect) - severity of the effect on the Customer and other stakeholders (Higher Value = Higher Severity) OccurrenceOccurrence (of Cause) - frequency with which a given Cause occurs and creates Failure Mode. ((Higher Value = Higher Probability of Occurrence)) DetectionDetection (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)) Caution: Notice the scale difference for DetectionDetection!
  • 44. 44NCR Confidential High 10 Low 1 Rating Severity Occurrence Detection* Hazardous without warning Very high and almost inevitable Cannot detect or detection with very low probability Loss of primary function High repeated failures Remote or low chance of detection Loss of secondary function Moderate failures Low detection probability Minor defect Occasional failures Moderate detection probability No effect Failure unlikely Almost certain detection *If No Controls Exist, Detection = 10 Create a rating system that makes sense for the defects you are trying to prevent. An Example of Rating Definitions
  • 45. 45NCR Confidential Spray head clogged: - Viscosity too high - Temp too low - Pressure too low 5 Variables check for film thickness; Visual check for coverage; Test spray at start-up and after idle periods and preventative maintenance program to clean heads 5 175 Detec R.P.N. Class Potential Cause(s)/ Mechanism(s) of Failure Occur Current Process Controls Process Step Potential Failure Mode Potential Effect(s) of Failure Sev 280Allows integrity breach of inner door panel Corroded interior lower door panels Deteriorated life of door leading to: - Unsatisfactory appearance due to rust through paint over time - Impaired function of interior door hardware Insufficient wax coverage over specified surface Op 70: Manual application of wax inside door panel 7 Manually inserted spray head not inserter far enough Variables check for film thickness; Visual check for coverage 58 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 calculated risk. • Regardless of RPN, high SeveritySeverity scores (9 or 10) should be given special attention. Calculate the Risk Priority Number RPNRPN = Severity x Occurrence x Detection PFMEA - Step 6
  • 46. 46NCR Confidential • 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 team select a “cut-off” RPN for the next steps. RPN Thresholds • When using an RPN threshold, DO NOT forget to address high SeveritySeverity scores Others 490 150759 35070502530 250 30015 32222444468910 53333777710131517 100959288858275686255453217 60 50 40 30 20 10 0 100 80 60 40 20 0 Defect Count Percent Cum % Percent Count Pareto Chart for RPN Pareto Chart ?How many items should be the focus of the next steps? Sort by RPN to determine the most significant failure modes Analyzing the PFMEA
  • 47. 47NCR Confidential PFMEA – Remediation Guidelines SeveritySeverity – can only be improved by a design change to the product or process OccurrenceOccurrence – can only be reduced by a change which removes or controls a cause. Examples are redundancy, substituting a more reliable component or function or mistake-proofing. DetectionDetection – can be reduced by improving detection. Examples are mistake-proofing, simplification and statistically sound monitoring. In general, reducing the Occurrence is preferable to improving the Detection In general, reducing the Occurrence is preferable to improving the Detection
  • 48. 48NCR Confidential Actions Taken Sev Occ Det R.P.N. Add positive depth stop to sprayer Mfg. Eng. By 5/10/10 Stop added, sprayer checked on-line Automate spraying Mfg. Eng. By 5/25/10 Rejected due to complexity of different doors on the same line 175 Use DOE on viscosity vs. temp vs. pressure Mfg. Eng. By 5/31/10 Temp and press limits were determined and limit controls have been installed - Control charts show process is in control Cpk = 1.85 7 1 5 35 Action Results R.P.N. Recommended Actions Responsibility & Target Date Process Step Potential Failure Mode Potential Effect(s) of Failure 280Allows integrity breach of inner door panel Corroded interior lower door panels Deteriorated life of door leading to: - Unsatisfactory appearance due to rust through paint over time - Impaired function of interior door hardware Insufficient wax coverage over specified surface Op 70: Manual application of wax inside door panel 7 2 5 70 • Determine Actions Recommended to reduce High RPNs For the high RPN numbers, determine the recommended actions. FMEA – Step 7
  • 49. 49NCR Confidential Actions Taken Sev Occ Det R.P.N. Add positive depth stop to sprayer Mfg. Eng. By 5/10/10 Stop added, sprayer checked on-line Automate spraying Mfg. Eng. By 5/25/10 Rejected due to complexity of different doors on the same line 175 Use DOE on viscosity vs. temp vs. pressure Mfg. Eng. By 5/31/10 Temp and press limits were determined and limit controls have been installed - Control charts show process is in control Cpk = 1.85 7 1 5 35 Action Results R.P.N. Recommended Actions Responsibility & Target Date Process Step Potential Failure Mode Potential Effect(s) of Failure 280Allows integrity breach of inner door panel Corroded interior lower door panels Deteriorated life of door leading to: - Unsatisfactory appearance due to rust through paint over time - Impaired function of interior door hardware Insufficient wax coverage over specified surface Op 70: Manual application of wax inside door panel 7 2 5 70 • 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). Resp (responsibility) Assign a specific person who will be responsible for recommended actions. Actions Taken As actions are identified and completed, document in the “Actions Taken” column. FMEA – Steps 8 and 9 SEV, OCC, DET, RPN As actions are complete reassess Severity, Occurrence, and Detection and recalculate RPN.
  • 50. 50NCR Confidential 1. For each Process Input, determine the ways in which the Process Step can go wrong (these are Failure Modes). 2. For each Failure Mode associated with the inputs, determine Effects on the outputs. 3. Identify potential Causes of each Failure Mode. 4. List the Current Controls for each Cause. 5. Assign Severity, Occurrence and Detection ratings after creating a ratings key appropriate for your project. 6. Calculate RPN. 7. Determine Recommended Actions to reduce High RPNs. 8. Take appropriate Actions and Document. 9. Recalculate RPNs. 10. Revisit steps 7 and 8 until all the significant RPNs have been addressed. Summary Steps To Complete a FMEA
  • 51. 51NCR Confidential PFMEA Exercise 30 Minutes Instructions •Open the PPAP 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. Use the file PPAP Training Templates.xls
  • 52. 52NCR Confidential • Collaborative Effort: Do not try alone, use a group • Very laborious: Time consuming process. Take necessary breaks. • Action 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)
  • 53. 53NCR Confidential Reviewers Checklist Verify there is a system for prioritizing risk of failure such 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)
  • 55. 55NCR Confidential Control Plan A document that describes how to control the critical inputs to continue to meet customer expectations of the output. What is It? Objective or Purpose • Primary reference source for minimizing process and product variation. • Description of how teams should react to out-of-control situations. Since processes are expected to be continuously updated and improved, the control plan is a living document! NOTE When to Use It • Implementation of new process • Following a process change
  • 56. 56NCR Confidential Process Steps Process Steps New/Revised Process Steps New/Revised Process Steps Project Idea Fill Out Master Form with Initial Information IsHard Savings > $??? Doesthe Project Involve OnlyYour Group? Doesthe Project Involve >3 Depts. outsideEng? Doesthe Project Involve >2Groups in Eng? Do you have BB/GB to Assist/Workthe project? Prefer to work this project within your area? 6 Sigma Project Department or Group Project Yes No Yes No Yes No No No Yes Yes Yes No Enter Remaining Information on Master Form Master Form Will Generate Contract Finance Approval and Signature Other Required Signatures: Segment CEO Champion Process Owner BB or GB 6 Sigma Assigns Project Number Get WO Assigned Begin/Work Project Follow DMAIC or DFSS process Monitor Progress through Power Steering and Monthly Financial Reviews Complete Project (Hasto befully Documented Finance Approval and Signature Other Required Signatures: Champion: Dir T&E Process Owner Project Owner Dept BB or MBB Enter Remaining Information on Master Form Master Form Will Generate Contract Finance Approval and Signature Other Required Signatures: Champion: ProcessOwner Project Owner Dept GB/BB/MBB Group Assigns Project Number Get DLN Assigned Monitor Progress through Bi- Weekly Updates and Monthly Reviews Begin/Work Project Follow DMAIC or DFSS process Complete Project (Has to be fully Documented) Finance Approval and Signature Other Required Signatures: Champion: Dir T&E Process Owner Project Owner Dept BB or MBB Completeall Documentation including a (1) PageClose- out Sheet Close Project Complete all Documentation including a (1) Page Close- out Sheet Final Project Review Close Project Final Project Review 6 Sigma Project High Level Process Map Department/Group Project High Level Process Map Process FlowchartProcess Flowchart N ew /R evised Process Steps N ew /R evised Process Steps Process Steps Process Steps Process Step Key Process Input Potential Failure Mode Potential Failure Effects S E V Potential Causes O C C Current Controls D E T R P N E O C Actions Recommended Resp. Ac Receive Payment Checks Delay internal mail AR balance does not go down 7 Inadequate staffing in mail room 7 None 10 490 Investigate mail room staffing and associated processes G. Lee Added clerk. schedu Identify Customer Wire Transfer reference line Information not supplied AR balance is past due 10 Customer or bank did not include name and/or account info on wire transfer 5 Acct identifies problem when trying to apply payment 5 250 Poka-Yoke wire transer process N. Peart Contac establi transfe 2112) Identify Invoice Checks Incorrect invoice supplied Invoice shows outstanding (AR balance does go down) 5 Customer error 5 Customer might catch it when reviewing the next statement 10 250 Provide payment stub with statement for each invoice A. Lifeson Revise include with ea Identify Invoice Checks Invoice number not supplied Invoice shows outstanding (AR balance does go down) 5 Customer error 10 Acct identifies problem when trying to apply payment 5 250 Provide payment stub with statement for each invoice S. Hagar Revise include with ea Process Step Key Process Input Potential Failure Mode Potential Failure Effects S E V Potential Causes O C C Current Controls D E T R P N E O C Actions Recommended Resp. Actions Receive Payment Checks Delay internal mail AR balance does not go down 7 Inadequate staffing in mail room 7 None 10 490 Investigate mail room staffing and associated processes G. Lee Added anoth clerk. Adjus schedule. Identify Customer Wire Transfer reference line Information not supplied AR balance is past due 10 Customer or bank did not include name and/or account info on wire transfer 5 Acct identifies problem when trying to apply payment 5 250 Poka-Yoke wire transer process N. Peart Contacted b established w transfer proc 2112) Identify Invoice Checks Incorrect invoice supplied Invoice shows outstanding (AR balance does go down) 5 Customer error 5 Customer might catch it when reviewing the next statement 10 250 Provide payment stub with statement for each invoice A. Lifeson Revised stat include paym with each inv Identify Invoice Checks Invoice number not supplied Invoice shows outstanding (AR balance does go down) 5 Customer error 10 Acct identifies problem when trying to apply payment 5 250 Provide payment stub with statement for each invoice S. Hagar Revised stat include paym with each inv Process FMEAProcess FMEA Risk Prioritized Process Steps Risk Prioritized Process Steps Im proved Controls Im proved Controls Control PlanControl Plan Tool Interaction Control Plan
  • 57. 57NCR Confidential Control Plan Number Key Contact/Phone Date:(Org.) Date (Rev.) Part Number/Latest Change Level Core Team Customer Engineering Approval/Date (If Req'd.) Part Name/Description Supplier/Plant Approval/Date Customer Quality Approval/Date(If Req'd.) Supplier/Plant Supplier Code Other Approval/Date (If Req'd.) Other Approval/Date (If Req'd.) Size Freq. CONTROL PLAN Part/Process Number Process Name/Operation Description Machine, Device, Jig, Tools, for MFG. Characteristics Special Char. Class No. Product Process Methods Sample Product/Process Specification/ Tolerance Evaluation /Measure ment Technique Control Method Prototype Pre-Launch Production Reaction Plan NCR’s Control Plan This is included in the PPAP Playbook!
  • 58. 58NCR Confidential Control Plan Number Key Contact/Phone Date:(Org.) Date (Rev.) Part Number/Latest Change Level Core Team Customer Engineering Approval/Date (If Req'd.) Part Name/Description Supplier/Plant Approval/Date Customer Quality Approval/Date(If Req'd.) Supplier/Plant Supplier Code Other Approval/Date (If Req'd.) Other Approval/Date (If Req'd.) Size Freq. CONTROL PLAN Part/Process Number Process Name/Operation Description Machine, Device, Jig, Tools, for MFG. Characteristics Special Char. Class No. Product Process Methods Sample Product/Process Specification/ Tolerance Evaluation /Measure ment Technique Control Method Prototype Pre-Launch Production Reaction Plan Control Plan 3 Distinct Phases 1. Prototype – a description of the dimensional measurements and material and performance tests that will occur during Prototype build. 3 Distinct Phases 3 Distinct Phases 2. Pre-Launch – a description of the dimensional measurements and material and performance tests that will occur after Prototype and before full Production. 3 Distinct Phases 3. Production – a comprehensive documentation of product/process characteristics, process controls, tests, and measurement systems that will occur during mass production
  • 59. 59NCR Confidential Control Plan Number Key Contact/Phone Date:(Org.) Date (Rev.) Part Number/Latest Change Level Core Team Customer Engineering Approval/Date (If Req'd.) Part Name/Description Supplier/Plant Approval/Date Customer Quality Approval/Date(If Req'd.) Supplier/Plant Supplier Code Other Approval/Date (If Req'd.) Other Approval/Date (If Req'd.) Size Freq. CONTROL PLAN Part/Process Number Process Name/Operation Description Machine, Device, Jig, Tools, for MFG. Characteristics Special Char. Class No. Product Process Methods Sample Product/Process Specification/ Tolerance Evaluation /Measure ment Technique Control Method Prototype Pre-Launch Production Reaction Plan Control Plan Administrative Section Identifies part number and description, supplier, required approval signatures, and dates. Administrative Section
  • 60. 60NCR Confidential Control Plan Number Key Contact/Phone Date:(Org.) Date (Rev.) Part Number/Latest Change Level Core Team Customer Engineering Approval/Date (If Req'd.) Part Name/Description Supplier/Plant Approval/Date Customer Quality Approval/Date(If Req'd.) Supplier/Plant Supplier Code Other Approval/Date (If Req'd.) Other Approval/Date (If Req'd.) Size Freq. CONTROL PLAN Part/Process Number Process Name/Operation Description Machine, Device, Jig, Tools, for MFG. Characteristics Special Char. Class No. Product Process Methods Sample Product/Process Specification/ Tolerance Evaluation /Measure ment Technique Control Method Prototype Pre-Launch Production Reaction Plan Control Plan Part/Process Use this area to define part/process number and description. Machine/Tools List the machine, device, jig, or tools that will be used in the manufacturing process Characteristics Define the characteristics of the product or process Process, Machine/Tools, Characteristics
  • 61. 61NCR Confidential Control Plan Number Key Contact/Phone Date:(Org.) Date (Rev.) Part Number/Latest Change Level Core Team Customer Engineering Approval/Date (If Req'd.) Part Name/Description Supplier/Plant Approval/Date Customer Quality Approval/Date(If Req'd.) Supplier/Plant Supplier Code Other Approval/Date (If Req'd.) Other Approval/Date (If Req'd.) Size Freq. CONTROL PLAN Part/Process Number Process Name/Operation Description Machine, Device, Jig, Tools, for MFG. Characteristics Special Char. Class No. Product Process Methods Sample Product/Process Specification/ Tolerance Evaluation /Measure ment Technique Control Method Prototype Pre-Launch Production Reaction Plan Control Plan Specifications/Tolerance Use this area to define upper/lower spec limits for each control element. Measurement Technique For each line in the control plan, list the measurement procedure that will be used (may list R&R Gage Plan or Poka- Yoke). Sample Size What is the size of the sample you should gather data from? Frequency Define the frequency for which the measurement will be taken. Specifications, Measurement, Sample Size & Frequency
  • 62. 62NCR Confidential Control Plan Number Key Contact/Phone Date:(Org.) Date (Rev.) Part Number/Latest Change Level Core Team Customer Engineering Approval/Date (If Req'd.) Part Name/Description Supplier/Plant Approval/Date Customer Quality Approval/Date(If Req'd.) Supplier/Plant Supplier Code Other Approval/Date (If Req'd.) Other Approval/Date (If Req'd.) Size Freq. CONTROL PLAN Part/Process Number Process Name/Operation Description Machine, Device, Jig, Tools, for MFG. Characteristics Special Char. Class No. Product Process Methods Sample Product/Process Specification/ Tolerance Evaluation /Measure ment Technique Control Method Prototype Pre-Launch Production Reaction Plan Control Plan Control Method Method that will be used to control the process Reaction Plan Actions to be taken if controls fail Control Method, Reaction Plan
  • 63. 63NCR Confidential Control Plan Audit Plans •Audit plans should be included in the control plan as a separate line. •Auditing is an important tool for 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 based on balancing level of risk (FMEA) and cost.
  • 64. 64NCR Confidential Control Plan – Example Control Plan Number Key Contact/Phone Date:(Org.) Date (Rev.) 002 T. Smith / 313-555-5555 11/29/2009 2/20/2010 Part Number/Latest Change Level Core Team Customer Engineering Approval/Date (If Req'd.) 54321231 / D Erin Hope, Alan Burt, Ken Light Part Name/Description Supplier/Plant Approval/Date Customer Quality Approval/Date(If Req'd.) Electronic Circuit Board Supplier/Plant Supplier Code Other Approval/Date (If Req'd.) Other Approval/Date (If Req'd.) ACR Control 439412 Size Freq. 2 Soldering Connections Wave solder machine Wave solder height 2.0 +/- .25 mc Sensor continuity check 100% Continuous Automated inspection (error proofing) Adjust and retest Flux concen - tration Standard #302B Test sampling lab environment 1 pc 4 hours x-MR chart Segregate and retest Prototype Pre-Launch Production Reaction Plan Sample Product/Process Specification/ Tolerance Evaluation / Measurement Technique Control Method CONTROL PLAN Part / Process Number Process Name / Operation Description Machine, Device, Jig, Tools, for MFG. Characteristics Special Char. Class No. Product Process Methods 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 solder 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 concentration level. 3 Distinct Phases Production Part/Process Soldering Connections Machine/Tools Wave solder machine Characteristics Product = Wave solder height Process = Flux concentration Specifications/Tolerance Product = 2.0 +/- 0.25 mc Process = Standard #302B Measurement Technique Product = Sensor continuity check Process = Test sampling lab environment Sample Size Product = 100% Process = 1 pc Frequency Product = Continuous Process = 4 hours Control Method Product = Automated inspection Process = x-MR chart Reaction Plan Product = Adjust and retest Process = Segregate and retest
  • 65. 65NCR Confidential 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 potential solutions with your teams. Control Plan Exercise 20 Minutes Use the file PPAP Training Templates.xls
  • 66. 66NCR Confidential 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 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. Reviewer’s Checklist
  • 67. 67NCR Confidential MEASUREMENT SYSTEMMEASUREMENT SYSTEM ANALYSIS (MSA)ANALYSIS (MSA)
  • 68. 68NCR Confidential Measurement System Analysis (MSA) An MSA is a statistical tool used to determine if a measurement system is capable of precise measurement. What is It? Objective or Purpose • To determine how much error is in the measurement due to the measurement process itself. • Quantifies the variability added by the measurement system. • Applicable to attribute data and variable data. When to Use It • On the critical inputs and outputs prior to collecting data for analysis. • For any new or modified process in order to ensure the quality of the data. Measurement System Analysis is an analysis of the measurement process, not an analysis of the people!! IMPORTANT! Who Should be Involved Everyone that measures and makes decisions about these measurements should be involved in the MSA.
  • 69. 69NCR Confidential – AttributeAttribute Data Examples:  Count, Pass/fail, yes/no, red/green/yellow, timekeeping buckets – VariableVariable Data Examples:  Physical measurement (length, width, area, …)  Physical conditions (temperature, pressure…)  Physical properties (strength, load, strain…)  Continuous or non-ending Attribute and Variable MSA Unless approved by an NCR SQE, attribute data is not acceptable for PPAP submission Unless approved by an NCR SQE, attribute data is not acceptable for PPAP submission
  • 70. 70NCR Confidential Measurement System Analysis (MSA) Process Variation Process Variation Measuremen t System Variation Measuremen t System Variation Observed Variation Observed Variation The observed variation in process output measurements is not simply the variation in the process itself; it is the variation in the process plus the variation in measurement that results from an inadequate measurement system. Conducting an MSA reduces the likelihood of passing a bad part or rejecting a good part
  • 71. 71NCR Confidential Measurement System Analysis (MSA) Process Variation Process Variation Measuremen t System Variation Measuremen t System Variation Observed Variation Observed Variation The output of the process measured by: • Cycle time • Dimensional data • Number of defects and others Observed Variation
  • 74. 74NCR Confidential Measurement System Analysis (MSA) Error in Resolution The inability to detect small changes. Possible Cause Wrong measurement device selected - divisions on scale not fine enough to detect changes. Resolution
  • 75. 75NCR Confidential Measurement System Analysis (MSA) Error in Repeatability The inability to get the same answer from repeated measurements made of the same item under absolutely identical conditions. Possible Cause Lack of standard operating procedures (SOP), lack of training, measuring system variablilty. Repeatability Equipment VariationEquipment Variation
  • 76. 76NCR Confidential Measurement System Analysis (MSA) Error in Reproducibility The inability to get the same answer from repeated measurements made under various conditions from different inspectors. Possible Cause Lack of SOP, lack of training. Reproducibility Appraiser VariationAppraiser Variation
  • 77. 77NCR Confidential Variable MSA – Gage R&R Study •Gage R&R is the combined estimate of measurement system RepeatabilityRepeatability and ReproducibilityReproducibility •Typically, a 3-person study is performed Each person randomly measures 10 marked parts per trial Each person can perform up to 3 trials •There are 3 key indicators EVEV or Equipment Variation AVAV or Appraiser Variation Overall % GRR% GRR
  • 78. 78NCR Confidential Variable MSA – NCR’s Gage R&R Form This spreadsheet is designed for up to three operators, three trials, and ten samples. Enter data ONLY in gray shaded cells. Upper specification limit Lower specification limit Number of samples Data Sample # 1 2 3 Range 1 2 3 Range 1 2 3 Range 1 0.000 0.000 0.000 2 0.000 0.000 0.000 3 0.000 0.000 0.000 4 0.000 0.000 0.000 5 0.000 0.000 0.000 6 0.000 0.000 0.000 7 0.000 0.000 0.000 8 0.000 0.000 0.000 9 0.000 0.000 0.000 10 0.000 0.000 0.000 Range average 0.000 0.000 0.000 Sample average #DIV/0! #DIV/0! #DIV/0! Average range 0.000 #N/A X-bar range #DIV/0! #DIV/0! #N/A #N/A Note: any ranges beyond this limit may be the result of assignable causes. Identify and correct. Discard values and recompute statistics. Do not modify this table Trials D4 K1 K2 2 3.27 4.56 3.65 3 2.58 3.05 2.7 Gage Repeatability and Reproducibility Repeatability and Reproducibility (R&R) Control limit for individual ranges #N/A #DIV/0! #N/A Reproducibility (AV) Tolerance analysis Number of operators Number of trials Operator 1 Operator 2 Operator 3 Repeatability (EV) Trial Trial Trial Included in PPAP Playbook! Automatically calculates EV, AV, and % GRR!
  • 79. 79NCR Confidential 1. Select 10 items that represent the full range of long-term process variation. 2. Identify the appraisers. 3. If appropriate, calibrate the gage or verify that the last calibration date is valid. 4. Open the Gage R&R worksheet in the PPAP Playbook to record data. 5. Have each appraiser assess each part 3 times (trials – first in order, second in reverse order, third random). 6. Input data into the Gage R&R worksheet. 7. Enter the number of operators, trials, samples and specification limits 8. Analyze data in the Gage R&R worksheet. 9. Assess MSA trust level. 10. Take actions for improvement if necessary. Variable MSA – Gage R&R Steps Step 1 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Step 9 Step 10Step 2
  • 80. 80NCR Confidential Steps 1 and 2: Variable MSA - Gage R&R Select 10 items that represent the full range of long-term process variation. Step 1 Identify the appraisers. – Should use individuals that actually do the process being tested. – Can also include other appraisers (supervisors, etc.). – Should have a minimum of 3 appraisers. Step 2
  • 81. 81NCR Confidential Steps 3 and 4: Variable MSA – Gage R&R If appropriate, calibrate the gage or verify that the last calibration date is valid. Step 3 Open the Gage R&R worksheet in the PPAP Playbook to record the data Step 4
  • 82. 82NCR Confidential Step 5: Variable MSA – Gage R&R Step 5 Have each appraiser assess each item 3 times. – Each appraiser has to work independently. – Items should be evaluated in random order. – After each appraiser completes the first evaluation of all items – repeat the process at least 2 more times. – Do not let the appraisers see any of the data during the test !!
  • 83. 83NCR Confidential Steps 6 and 7: Variable MSA – Gage R&R Input data into the Gage R&R worksheet Enter the number of operators, trials, samples and specification limits Step 6 Step 7
  • 84. 84NCR Confidential Steps 8 and 9: Variable MSA – Gage R&R Assess MSA Trust Level. – Red:Red: > 30% (fail) – Yellow:Yellow: 10-30% (marginal) – Green:Green: < 10% (pass) Step 9 Step 8 Analyze data in the Gage R&R worksheet % Tolerance* 10% 30%
  • 85. 85NCR Confidential Step 10: Variable MSA – Gage R&R If the Measurement System needs improvement: – Brainstorm with the team for improvement solutions. – Determine best “practical solution” (may require some experimentation). – Pilot the best solution (PDSA) – Implement best solution – train employees. – Re-run the study to verify the improvement. Step 10
  • 86. 86NCR Confidential MSA Parameters » (3) Operators » (3) Trials » (10) Samples Problem Statement • The sulfuric acid concentration in process tank 8 is measured at least once per day • Additions/deletions of chemicals and decisions to shut down the process are dependent on these results. • Based on current data, we need to do an MSA. A Gage R&R was conducted in order to validate the process. MSA Process Variable MSA – Gage R&R Example
  • 87. 87NCR Confidential This spreadsheet is designed for up to three operators, three trials, and ten samples. Enter data ONLY in gray shaded cells. 3 Upper specification limit 27 3 Lower specification limit 22 Number of samples 10 Data Sample # 1 2 3 Range 1 2 3 Range 1 2 3 Range 1 25.250 25.540 25.390 0.290 25.390 25.390 25.390 0.000 25.680 26.330 26.520 0.840 2 25.420 25.540 24.960 0.580 25.540 25.520 25.470 0.070 26.380 26.130 25.960 0.420 3 22.370 22.370 22.670 0.300 22.220 22.180 22.220 0.040 22.670 22.810 22.670 0.140 4 24.960 25.250 25.110 0.290 25.110 25.680 25.920 0.810 25.680 26.200 25.540 0.660 5 25.540 25.540 25.820 0.280 25.540 25.680 25.680 0.140 25.730 25.960 25.890 0.230 6 24.610 25.110 24.820 0.500 24.960 26.700 25.110 1.740 25.390 25.540 25.960 0.570 7 24.440 24.260 24.110 0.330 25.250 25.540 25.420 0.290 25.250 25.830 25.390 0.580 8 26.100 26.800 26.100 0.700 25.540 25.540 25.820 0.280 25.110 25.680 25.920 0.810 9 25.390 25.390 25.390 0.000 26.380 26.660 26.220 0.440 25.250 25.540 25.390 0.290 10 25.680 25.820 25.540 0.280 23.900 25.250 25.110 1.350 24.200 23.870 22.960 1.240 Range average 0.355 0.516 0.578 Sample average 25.043 25.211 25.248 Average range 0.483 1.4732 X-bar range 0.205 0.4827 1.5502 1.2461 Note: any ranges beyond this limit may be the result of assignable causes. Identify and correct. Discard values and recompute statistics. Operator 1 Operator 2 Operator 3 Repeatability (EV) Trial Trial Trial Gage Repeatability and Reproducibility Repeatability and Reproducibility (R&R) Control limit for individual ranges 29.46% 9.65% 31.00% Reproducibility (AV) Tolerance analysis Number of operators Number of trials Selected 10 samples to be measured Chose 3 operators to be appraisers Had each appraiser measure each sample 3 times Results calculated automatically Entered the number of operators, trials, and samples Entered upper and lower specification limits Variable MSA – Gage R&R Example
  • 88. 88NCR Confidential Variable MSA – Gage R&R Example This spreadsheet is designed for up to three operators, three trials, and ten samples. Enter data ONLY in gray shaded cells. 3 Upper specification limit 27 3 Lower specification limit 22 Number of samples 10 Data Sample # 1 2 3 Range 1 2 3 Range 1 2 3 Range 1 25.250 25.540 25.390 0.290 25.390 25.390 25.390 0.000 25.680 26.330 26.520 0.840 2 25.420 25.540 24.960 0.580 25.540 25.520 25.470 0.070 26.380 26.130 25.960 0.420 3 22.370 22.370 22.670 0.300 22.220 22.180 22.220 0.040 22.670 22.810 22.670 0.140 4 24.960 25.250 25.110 0.290 25.110 25.680 25.920 0.810 25.680 26.200 25.540 0.660 5 25.540 25.540 25.820 0.280 25.540 25.680 25.680 0.140 25.730 25.960 25.890 0.230 6 24.610 25.110 24.820 0.500 24.960 26.700 25.110 1.740 25.390 25.540 25.960 0.570 7 24.440 24.260 24.110 0.330 25.250 25.540 25.420 0.290 25.250 25.830 25.390 0.580 8 26.100 26.800 26.100 0.700 25.540 25.540 25.820 0.280 25.110 25.680 25.920 0.810 9 25.390 25.390 25.390 0.000 26.380 26.660 26.220 0.440 25.250 25.540 25.390 0.290 10 25.680 25.820 25.540 0.280 23.900 25.250 25.110 1.350 24.200 23.870 22.960 1.240 Range average 0.355 0.516 0.578 Sample average 25.043 25.211 25.248 Average range 0.483 1.4732 X-bar range 0.205 0.4827 1.5502 1.2461 Note: any ranges beyond this limit may be the result of assignable causes. Identify and correct. Discard values and recompute statistics. Operator 1 Operator 2 Operator 3 Repeatability (EV) Trial Trial Trial Gage Repeatability and Reproducibility Repeatability and Reproducibility (R&R) Control limit for individual ranges 29.46% 9.65% 31.00% Reproducibility (AV) Tolerance analysis Number of operators Number of trials Repeatability = (EV) Equipment Variation Repeatability = (EV) Equipment VariationReproducibility = (AV) Appraiser Variation Reproducibility = (AV) Appraiser VariationRepeatability & Reproducibility = R&R Repeatability & Reproducibility = R&R % Tolerance* 10% 30% % Tolerance is > 30% MSA fails!
  • 89. 89NCR Confidential •Divide into teams •Distribute stars (10 per team), measurement devices (1 per team), and markers (1 per team). •Number the stars from 1-10. •Mark the 2 points to be measured on each star (see diagram on next page) •Determine and document the measurement process. •Be sure everyone has a clear understanding of the process. •Determine roles. −(3) inspectors, (1) data recorder, (1) customer Gage R&R Exercise - Setup Instructions
  • 90. 90NCR Confidential Gage R&R Exercise - Dimensional Information Dimension Each star will be measured as shown. Mark the 2 points to be measured
  • 91. 91NCR Confidential 1. All inspectors need to wait outside the room when it is not their turn to evaluate the stars. 2. Open the PPAP Training Templates.xls file, then select the Gage R&R worksheet to record the data. 3. Round 1 Have the 1st inspector come in the room and measure all 10 stars in order. Data collector record the data in the Gage R&R worksheet. » Do not give any additional information to the inspector 1. Repeat Step 3 with the 2nd inspector 2. Repeat Step 3 with the 3rd inspector 6. Round 2 Change the inspection to reverse order and repeat. 7. Round 3 Change the inspection to random order and repeat. Gage R&R Exercise – Inspection Instructions Use the file PPAP Training Templates.xls
  • 92. 92NCR Confidential Gage R&R Exercise - Analysis Instructions 1. Complete the top section of the Gage R&R worksheet − Enter the number of operators, trials, and samples − Enter the upper and lower specification limit 2. Assess MSA Trust Level. – Red: > 30% (fail) – Yellow: 10-30% (marginal) – Green: < 10% (pass) 3. Interpret results - are improvements required? 45 Minutes % Tolerance* 10% 30% Use the file PPAP Training Templates.xls
  • 93. 93NCR Confidential Important: An MSA is an analysis of the process, not an analysis of the people. If an MSA fails, the process failed. A Variable MSA provides more analysis capability than an Attribute MSA. For this and other reasons, always use variable data if possible. The involvement of people is the key to success. Involve the people that actually work the process Involve the supervision Involve the suppliers and customers of the process An MSA primarily addresses precision with limited accuracy information. Tips and Lessons Learned
  • 94. 94NCR Confidential MSA If the gage/inspection affects quality, then conduct a Gage R&R Make sure the study is recent - less than 1 year Compare the control plan gages against the Gage R&Rs If you question that gage, then −Question the technique and part sampling −Ask for additional studies Reviewer’s Checklist
  • 96. 96NCR Confidential Dimensional Results Evidence that dimensional verifications have been completed and results indicate compliance with specified requirements. What is It? Objective or Purpose • To show conformance to the customer part print on dimensions and all other noted requirements. When to Use It • For each unique manufacturing process (e.g., cells or production lines and all molds, patters, or dies Date: Supplier Name: Date Code: Part Number: Facility Location: Inspected By: Revision: Supplier Code: Verified By: Print zone or spec note Nominal Value Tol + Tol - Sample 1 Sample 2 Sample 3 Sample 4 Sample 5 Cp Cpk Pass/Fail #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! List Gage R&R value: Name and ID of gage(s) used for measurement: Cpk less than 1.33 will require action for improvement The number of non-critical data points required for part qualification is 5. The non-critical data points must be taken from the same 35-piece sample as the critical data points. Five parts from a production run must be shipped to NCR for verification of form, fit, and function. The same 5 parts will be used to verify both critical and non-critical dimensions. The supplier must clearly identify which of the 35 parts are being shipped. Non-critical dimensional results for the 5 parts being shipped must be entered below. Critical dimensional results must be entered into the "FAI Critical Dimensions" worksheet. The supplier should make every effort to ship 5 parts that represent both the low and high ends of the specifications for the non-critical dimensions. FAI Non-Critical Dimensions
  • 97. 97NCR Confidential Date: Part Number: Revision: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! List Gage R&R value: Name and ID of gage(s) used for measurement: Tol -Tol + Nominal Value Print zone or spec note Cpk Pass/Fail Cpk less than 1.67 will require action for improvement Sample Cp The number of critical data points required for part qualification is 35. These data points must be taken from a 35-piece sample. Five parts from a production run must be shipped to NCR for verification of form, fit, and function. The same 5 parts will be used to verify both critical and non-critical dimensions. The supplier must clearly identify which of the 35 parts are being shipped. Critical dimensional results for the 5 parts being shipped must be entered below. Non-critical dimensional results must be entered into the "FAI Non-Critical Dimensions" worksheet. The supplier should make every effort to ship 5 parts that represent both the low and high ends of the specifications for the non-critical dimensions. FAI Critical Dimensions Supplier Name: Facility Location: Supplier Code: Date Code: Inspected By: Verified By: NCR Dimensional Report (Critical) Requires 35 data pointsRequires 35 data points CpkCpk must be greater than or equal to 1.671.67 This is included in the PPAP Playbook! Automatically Calculates Cpk!The number of critical data points required for part qualification is 35. These data points must be taken from a 35-piece sample. Five parts from a production run must be shipped to NCR for verification of form, fit, and function. The same 5 parts will be used to verify both critical and non-critical dimensions. The supplier must clearly identify which of the 35 parts are being shipped. Critical dimensional results for the 5 parts being shipped must be entered below. Non-critical dimensional results must be entered into the "FAI Non-Critical Dimensions" worksheet. The supplier should make every effort to ship 5 parts that represent both the low and high ends of the specifications for the non-critical dimensions.
  • 98. 98NCR Confidential Date: Supplier Name: Date Code: Part Number: Facility Location: Inspected By: Revision: Supplier Code: Verified By: Print zone or spec note Nominal Value Tol + Tol - Sample 1 Sample 2 Sample 3 Sample 4 Sample 5 Cp Cpk Pass/Fail #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! List Gage R&R value: Name and ID of gage(s) used for measurement: Cpk less than 1.33 will require action for improvement The number of non-critical data points required for part qualification is 5. The non-critical data points must be taken from the same 35-piece sample as the critical data points. Five parts from a production run must be shipped to NCR for verification of form, fit, and function. The same 5 parts will be used to verify both critical and non-critical dimensions. The supplier must clearly identify which of the 35 parts are being shipped. Non-critical dimensional results for the 5 parts being shipped must be entered below. Critical dimensional results must be entered into the "FAI Critical Dimensions" worksheet. The supplier should make every effort to ship 5 parts that represent both the low and high ends of the specifications for the non-critical dimensions. FAI Non-Critical Dimensions NCR Dimensional Report (Non-Critical) CpkCpk must be greater than or equal to 1.331.33 Requires 5 data pointsRequires 5 data points This is included in the PPAP Playbook! Automatically Calculates Cpk! The number of non-critical data points required for part qualification is 5. The non-critical data points must be taken from the same 35-piece sample as the critical data points. Five parts from a production run must be shipped to NCR for verification of form, fit, and function. The same 5 parts will be used to verify both critical and non-critical dimensions. The supplier must clearly identify which of the 35 parts are being shipped. Non-critical dimensional results for the 5 parts being shipped must be entered below. Critical dimensional results must be entered into the "FAI Critical Dimensions" worksheet. The supplier should make every effort to ship 5 parts that represent both the low and high ends of the specifications for the non-critical dimensions.
  • 99. 99NCR Confidential Acceptance Criteria Critical Non-Critical Decision Red (Bad) <1.33 <1.00 Yellow (OK) 1.33-1.67 1.00-1.33 Green (Good) >1.67 >1.33 Acceptance criteria for critical vs. non-critical characteristics CpkCpk must be greater than or equal to 1.67 for1.67 for criticalcritical processesprocesses CpkCpk must be greater than or equal to 1.33 for1.33 for non-criticalnon-critical processesprocesses
  • 100. 100NCR Confidential Date: Supplier Name: Date Code: Part Number: Facility Location: Inspected By: Revision: Supplier Code: Verified By: Print zone or spec note Nominal Value Tol + Tol - Sample 1 Sample 2 Sample 3 Sample 4 Sample 5 Cp Cpk Pass/Fail 35 0.50 0.50 34.86 34.78 34.88 34.86 34.82 4.167 2.833 Pass 76 0.50 0.50 75.96 76.08 75.92 75.93 76.09 2.017 2.001 Pass 3 0.50 0.50 3.175 3.18 3.156 3.168 3.178 17.118 11.250 Pass 3 0.50 0.50 3.18 3.156 3.178 3.175 3.18 16.406 10.703 Pass 3 0.50 0.50 3.18 3.175 3.174 3.18 3.156 16.836 11.011 Pass 3 0.50 0.50 3.156 3.18 3.173 3.175 3.18 16.862 11.034 Pass Cpk less than 1.33 will require action for improvement The number of non-critical data points required for part qualification is 5. The non-critical data points must be taken from the same 35-piece sample as the critical data points. Five parts from a production run must be shipped to NCR for verification of form, fit, and function. The same 5 parts will be used to verify both critical and non-critical dimensions. The supplier must clearly identify which of the 35 parts are being shipped. Non-critical dimensional results for the 5 parts being shipped must be entered below. Critical dimensional results must be entered into the "FAI Critical Dimensions" worksheet. The supplier should make every effort to ship 5 parts that represent both the low and high ends of the specifications for the non-critical dimensions. FAI Non-Critical Dimensions NCR Dimensional Report Example Nominal ValueTolerance Sample Data Cp & Cpk Calculations Pass / Fail CpkCpk > 1.33 for all1.33 for all non-criticalnon-critical dimensions = Pass!dimensions = Pass!
  • 101. 101NCR Confidential Dimensional Results Thirty-five critical data points & 5 non-critical data points are required for part qualification Critical and non-critical data points must be taken from the same 35- piece sample Five parts from a production run must be shipped to NCR for verification of form, fit, and function The same 5 parts will be used to verify both critical and non-critical dimensions Supplier must clearly identify which of the 35 parts are being shipped Supplier should make every effort to ship 5 parts that represent both the low and high ends of the specifications for non-critical dimensions Capability must be greater than 1.67 for critical dimensions and greater than 1.33 for non-critical dimensions Reviewer’s Checklist
  • 102. 102NCR Confidential RECORDS OFRECORDS OF MATERIAL /MATERIAL / PERFORMANCE TESTPERFORMANCE TEST RESULTSRESULTS
  • 103. 103NCR Confidential Records of Material/Performance Test Results Material Test ResultsMaterial Test Results The supplier shall perform tests for all parts and product materials when chemical, physical, or metallurgical requirements are specified by the design record or Control Plan  For products with NCR-developed material specifications and/or an NCR-approved supplier list, the supplier shall procure materials and/or services from suppliers on that list Performance Test ResultsPerformance Test Results The supplier shall perform tests for all parts or product materials when performance or functional requirements are specified by the design record or Control Plan
  • 104. 104NCR Confidential Material Results Part Number Type of Test OK Not OK Title Date Name of LaboratoryLaboratory Revision Level Production Part Approval - Material Results Signature Supplier Part Name Supplier Test ResultsMaterial Spec. No./Date/Specification Outside laboratory In-house testing Material Results shall include:  The name of the laboratory that conducted the test  The type of test that was conducted  The number, date, and specification to which the part was tested  The actual test results
  • 105. 105NCR Confidential Module Test Results Part Number Laboratory Type of Test Parameters Tested OK Not OK Title DateSignature Test description Supplier Test Results Production Part Approval - Module Test Results Supplier Part NameName of Laboratory Revision Level In-house testing Outside laboratory Module Test Results shall include:  The name of the laboratory that conducted the test  The type of test that was conducted  A description of the test  The parameters tested  The actual test results
  • 106. 106NCR Confidential INITIAL PROCESS STUDYINITIAL PROCESS STUDY
  • 107. 107NCR Confidential Requirement Level 1 Level 2 Level 3 Level 4 Level 5 1. Design Records of Saleable Product R R R * R a. For proprietary components/details R R R * R b. For all other components/details R R R * R 2. Engineering Change Documents, if any R S S * S 3. Customer Engineering approval, if required R S S * S 4. Design FMEA R R R * R 5. Process Flow Diagrams R R S * S 6. Process FMEA R R S * S 7. Dimensional Results S S S * S 8. Material, Performance, Test Results R S S * S 9. Initial Process Study R R R * R 10. Measurement System Analysis Studies R R S * S 11. Qualified Laboratory Documentation R R S * S 12. Control Plan R R S * S 13. Part Submission Warrant (PSW) S S S * S 14. Appearance Approval Report, (AAR) if applicable S S S * S 15. Bulk Material Requirements Checklist (for bulk material only) R R R * R 16. Sample Product R S S * S 17. Master Sample R R R * R 18. Checking Aids R R R * R 19. Records of compliance with Customer-Specific Requirements (DVP&R) R R R * R Submission Level PPAP Levels for Submission & Retention S = The supplier shall submit to designated customer product approval activities and retain a copy of records or documentation items at appropriate locations, including manufacturing R = The supplier shall retain at appropriate locations, including manufacturing, and make readily available to the customer representative upon request * = The supplier shall retain at appropriate locations, and submit to customer upon request. The customer will identify what is needed for submission base on changes and conditions PLEASE CONTACT YOUR SUPPLIER QUALITY ENGINEER WITH ANY QUESTIONS . Initial Process Study Even though Initial Process Study is coded as an “R” on the PPAP Submission Level Table, we felt it was important to provide a brief overview during training R = Supplier shall retain at appropriate locations, including manufacturing and make readily available to the customer representative upon request
  • 108. 108NCR Confidential Capability Analysis When to Use It 1. To establish baseline capability. 2. To validate process improvements. What is It? A set of tools used to understand process capability. Objective or Purpose • To evaluate the performance of your process as compared to specification limits. • To determine if the production process is likely to produce product that will meet customer requirements Initial Process Study
  • 109. 109NCR Confidential Steps for Determining Process Capability Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 1. Decide on the product or process characteristic to be assessed 2. Validate the specification limits 3. Validate the measurement system 4. Collect data 5. Assess data characteristics 6. Assess process stability 7. Calculate process capability
  • 110. 110NCR Confidential Step 1: Which Characteristic Decide on the product or process characteristic to be assessed.  Required for all critical characteristics  If no critical characteristics exist, NCR reserves the right to require demonstration of initial process capability on other characteristics Step 1
  • 111. 111NCR Confidential Step 2: Specification Limits Validate the specification limits by talking to: – Customers, suppliers, controlling agencies Why is validation of the specification limits important? – They may not represent what the customer truly desires/needs. – May contain “guard banding” as a result of past problems or measurement error. – They may be based on previous designs and no longer be valid. Step 2
  • 112. 112NCR Confidential Step 3: Measurement System Validate the measurement system through the appropriate MSA Why is validation of the Measurement System important? – If there is significant error in your measurement system, then decisions are influenced by the error not just the measurements themselves. Step 3
  • 113. 113NCR Confidential Step 4: Data Collection When collecting data, consider the following: –Short term data »Free of special causes »Collected across a narrow inference space i.e. one shift, one machine, one operator, etc.. –Long term data »Subjected to the effects of both random and special cause variation »Collected across a broad inference space i.e. multiple shifts, machines, operators, etc. Step 4
  • 114. 114NCR Confidential Step 4: Data Collection When collecting data, consider the following: – Rational sub-grouping »A group of units produced under the same set of conditions »Mean to represent a “snapshot” of the process »Must be taken close together in time, but still be independent of each other »Use subgroups to separate the 2 types of variation in a process:  Within subgroup: The variation among measurements within subgroups; also known as common cause variation  Between subgroup: variation between subgroups that may be caused by specific identifiable factors, or special causes »To improve process quality, every effort should be made to eliminate between subgroup variation and reduce within subgroup variation Step 4 Example: A die cut machine produces 100 plastic parts per hour. The quality engineer measures 5 randomly selected parts at the beginning of every hour. Each sample of 5 parts is a subgroup.
  • 115. 115NCR Confidential Step 5: Data Characteristics Examine the shape of your data. – Is it what you would expect? If not, investigate. Mfg Hours Frequency 2422201816 25 20 15 10 5 0 Mean 19.98 StDev 1.713 N 100 Histogram of Mfg Hour s Mfg Hours Frequency 222018161412108 20 15 10 5 0 Mean 14.87 StDev 3.088 N 100 Histogram of Mfg Hour s Mfg Hours Frequency 75604530150-15 20 15 10 5 0 Mean 20.19 StDev 18.87 N 100 Histogram of Mfg Hours Normal Data Bimodal Data Skewed Data The shape of your data is important for determining which type of Capability Analysis applies. Step 5 Assess data characteristics
  • 116. 116NCR Confidential Step 6: Process Stability Process is stable and in control Process is not stable and therefore not in control Control Chart Examples Step 6 Capability is only valid when the process being studied is stable! Assess process stability in order to understand how your process behaves over time. Control charts are the recommended tool.
  • 117. 117NCR Confidential Step 7: Process Capability Calculate the appropriate statistical metrics in order to determine how the “Voice of the Process” compares to the “Voice of the Customer.” Specification Limits Specification Limits Process is capable Process is not capable Step 7 Capability Metrics: PPM, DPMO, Cp, Cpk, Pp, & Ppk ; Sigma Levels (Z Scores) If you were driving a truck, and the dotted lines were the construction barriers, what would be happening in each situation?
  • 118. 118NCR Confidential Focus on Variable Data The initial process study should be focused on variablevariable, not attribute data Assembly errors, test failures, and 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 an authorized NCR representative, attributeattribute data are not acceptable for PPAP submissiondata are not acceptable for PPAP submission Focus on variablevariable data
  • 119. 119NCR Confidential Capability Indices Capability Index Formula What it shows Cp Relates short term (within subgroup) standard deviation to tolerance Sometimes called “Entitlement,” meaning it is the best the current process can do, if centered Cpk Relates short term mean & short term (within subgroup) standard deviation to tolerance Only tells you about the nearest spec limit; doesn’t tell anything about the other side PP Relates long term (overall) standard deviation to tolerance Ppk Relates mean & long term (overall) standard deviation to tolerance Only tells you about the nearest spec limit; doesn’t tell anything about the other side (USL – LSL) 6*sshort-term (USL – LSL) 6*slong-term Min{(USL – X), (X – LSL)} 3*sshort-term 3*slong-term Min{(USL – X), (X – LSL)} Cp/Cpk are used to estimateestimate potential process capabilityapability Pp/Ppk are used to measuremeasure actual process performanceerformance
  • 120. 120NCR Confidential Capability Indices - Cpk CpkCpk predicts capabilitypredicts capability Based on short term within subgroup variation Does not include the effect of process variability between subgroups Cpk should be used whenCpk should be used when: −Developing new parts −Revising specifications on a part −Materials, processes, manufacturing location, or equipment have significantly changed −Material suppliers have changed (include certificate of analysis)
  • 121. 121NCR Confidential Capability Indices - Ppk PpkPpk indicatesindicates past performancepast performance Based on long term total variation Unlike Cpk, Ppk is not limited to variation within subgroups However, Ppk cannot isolate within subgroup variation from between subgroup variation When calculated from the same data set, Cpk and Ppk can be compared to analyze the sources of process variation Ppk should be used whenPpk should be used when: –The supplier is new to NCR, but has already been manufacturing a part –The supplier is existing, but has produced a number of nonconforming parts
  • 122. 122NCR Confidential Difference between Cp & Cpk CpCp – determines capability of producing to specification CpkCpk – same as Cp, but also measures how centered the process is It is important to look at both! Cp > 1.67 Cpk > 1.67 Capable, Centered LSL USL LSL USL Capable, Not Centered Not Capable, Centered Not Capable, Not Centered LSL USL LSL USL Cp < 1.00 Cpk < 0Cpk < 1.00 Cp < 1.00 Cpk < 1.00 Cp > 1.67
  • 123. 123NCR Confidential Acceptance Criteria Critical Non-Critical Decision Red (Bad) <1.33 <1.00 Yellow (OK) 1.33-1.67 1.00-1.33 Green (Good) >1.67 >1.33 Acceptance criteria for critical vs. non-critical characteristics CpkCpk must be greater than or equal to 1.67 for1.67 for criticalcritical processesprocesses CpkCpk must be greater than or equal to 1.33 for1.33 for non-criticalnon-critical processesprocesses
  • 124. 124NCR Confidential Initial Process Study Ensure that the results are acceptable, and that the process is stable and capable of producing a quality part PPAPs should only be approved if the capability is greater than 1.67 for critical dimensions and greater than 1.33 for non-critical dimensions More information about capability is available in the Appendix at the end of this presentation Reviewer’s Checklist
  • 125. 125NCR Confidential QUALIFIED LABORATORYQUALIFIED LABORATORY DOCUMENTATIONDOCUMENTATION
  • 126. 126NCR Confidential Qualified Laboratory Documentation •Inspection and testing for PPAP shall be performed by a qualified laboratory as defined by NCR requirements (e.g., an accredited laboratory). •The qualified laboratory (internal or external to the supplier) shall have a laboratory scope and documentation showing that the laboratory is qualified for the type of measurements or tests conducted When an external laboratory is used, the supplier 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(s) of the tests, and the standards used to run the tests shall be identified.
  • 128. 128NCR Confidential Appearance Approval Report When to Use It • Prior to tooling for production What is It? • A report completed by the supplier containing appearance and color criteria Typically only applies for parts with color, grain, or surface appearance requirements IMPORTANT! Objective or Purpose • To demonstrate that the part has met the appearance requirements on the design record Color Suffix Master Number Master Date Material Type Material Source Color Shipping Suffix Part Disposition DL* Da* Db* DE CMC Red Yel Grn Blu Light Dark Gray CleanHigh Low High Low Appearance Approval Report Appearance Evaluation Color Evaluation Comments: Supplier Signature Phone No. Date Customer Representative Signature Date Chroma Metallic Brilliance Gloss Approved to Texture Customer Representative signature and Date Pre-Texture Evaluation Correct and Proceed Correct and Resubmit Supplier Code Other Supplier Name Manufacturing Location Application Part Name Buyer E/C Level Date Part Number Drawing Number Reason for Submission Tristimulus Data Hue Value Supplier Sourcing and Texture Information Part Submission Warrant Pre Texture Special Sample First Production Shipment Re-Submission Engineering Change
  • 129. 129NCR Confidential Appearance Approval Report Appearance Approval Report Appearance Evaluation Approved to Texture Customer Representative signature and Date Pre-Texture Evaluation Correct and Proceed Correct and Resubmit Supplier Code Other Supplier Name Manufacturing Location Application Part Name Buyer E/C Level Date Part Number Drawing Number Reason for Submission Supplier Sourcing and Texture Information Part Submission Warrant Pre Texture Special Sample First Production Shipment Re-Submission Engineering Change Administrative Section Supplier Sourcing & Texture Information List all first surface tools, graining Source(s), grain type(s), and grain and Gloss masters used to check part Pre-Texture Evaluation To be completed by SQE
  • 130. 130NCR Confidential Appearance Approval Report Color Suffix Master Number Master Date Material Type Material Source Color Shipping Suffix Part Disposition DL* Da* Db* DE CMC Red Yel Grn Blu Light Dark Gray CleanHigh Low High Low Color Evaluation Comments: Supplier Signature Phone No. Date Customer Representative Signature Date Chroma Metallic Brilliance GlossTristimulus Data Hue Value Color Suffix Alphanumeric or numeric color identification Tristimulus Data List numerical (colorimeter) data of submission part as compared to the customer- authorized master Master Number Enter alphanumeric master identification Master Date Enter the date on which the master was approved Material Type Identify first surface finish and substrate (e.g. paint / ABS) Material Source Identify first surface and substrate suppliers Hue, Value, Chroma, Gloss, and Metallic Brilliance Visual assessment by NCR Color Shipping Suffix Color part number suffix or color number Part Disposition To be determined by NCR (approved or rejected)
  • 132. 132NCR Confidential Sample Production Parts Actual samples that reflect the parts documented in the PPAP. What is It? Objective or Purpose • Confirm cosmetic or functional part approval. When to Use It • Sample parts should be delivered WITH the PPAP submission
  • 133. 133NCR Confidential Sample Production Parts •The sample parts provided should be the same parts measured for the dimensional results •Default quantity for all submissions is 3 parts unless otherwise requested
  • 134. 134NCR Confidential Sample Production Parts Sample production parts MUST be properly identified –Include the following information on the part label: • Date parts were packed • NCR part number • Quantity • Serial number • Supplier part number (optional) • Part description • Country of origin • Indication of RoHS compliance • Approval markings (UL, CE, etc.) where applicable See NCR part label examples on the next slide
  • 136. 136NCR Confidential PPAP Summary •The Production Part Approval Process is an extensive approval process for new or changed designs or processes •It is very formalized, so it inevitably causes some administrative work •Later changes to the product or process can beLater changes to the product or process can be expensive and time-consuming!expensive and time-consuming!
  • 137. 137NCR Confidential APPENDIX –APPENDIX – CAPABILITYCAPABILITY
  • 138. 138NCR Confidential Process Capability Tool Selection Map Process Capability can be determined for all types of data. However, selecting the correct method is critical. Process Capability Data Type? Defect or Defective Attribute Binomial Process Capability Poisson Process Capability Defective Defect Normal Data? Variable Capability Analysis for Normal Data Yes Rational Sub-groups? Resulting data Normal? No Apply Central Limit Theorem Yes Use Minitab's "Individual Distribution Identification" function No Non-normal Distribution Identified? Use Non-Normal Capability: Select Identified Distribution Yes Transform the data using Box- Cox Transformation Is reason for Non-Normality understood? Yes Determine reasons for Non-Normality No No Is transformed data Normal? Capability Analysis for Normal Data (using subgroups) Yes Capability Analysis for Normal Data (using Box-Cox Transformation) Yes Contact your MBBNo No
  • 139. 139NCR Confidential Capability – Non-NormalCapability – Non-Normal Distribution IdentificationDistribution Identification Central Limit TheoremCentral Limit Theorem Box – Cox TransformationBox – Cox Transformation Capability - NormalCapability - Normal Index of Capability Examples (Using Minitab) Capability – NormalCapability – Normal
  • 140. 140NCR Confidential Normal Capability Example Activity Using the data in a Minitab file Capability Example.MTW determine the capability of the PO process in terms of the time is required to process the POs. Time to Process one individual PO Use the file Capability Example.MTW
  • 141. 141NCR Confidential QWhich Capability Analysis applies? Yes ANormal ??? Normal Capability Example Is the data attribute or variable? Is the data normal? Does sub-grouping apply?
  • 142. 142NCR Confidential Normal Capability Analysis in Minitab 1. Open the worksheet Capability Example.MTW. 2. Choose Stat > Quality Tools > Capability Analysis > Normal. 3. Click in the [Single Column] field. 4. Double click [Time to Process] in the column on the left. 5. Click in the [Subgroup Size] field.6. Depending on subgroup information either: a. Enter 1 if the subgroup size is 1. b. Double click Indiv Dates_1 in the column on the left. c. Since the subgroup size is constant (n=5) the number 5 could be typed in the subgroup size field. Use the file Capability Example MTW
  • 143. 143NCR Confidential Normal Capability Analysis in Minitab 7. Type 20 in Lower Spec. 8. Type 40 in Upper Spec. 9. Select [Options] button. 10.Add target value (if applicable). 11.Under Display select a. Parts per million or Percents b. Capability Stats or Benchmark Z 7. Add Title if desired. 8. Click [OK]. 9. Click [OK].
  • 144. 144NCR Confidential 484236302418 LSL USL Process Data Sample N 200 StDev (Within) 7.46329 StDev (Ov erall) 7.54439 LSL 20.00000 Target * USL 40.00000 Sample Mean 30.72100 Potential (Within) Capability CCpk 0.45 Ov erall Capability Pp 0.44 PPL 0.47 PPU 0.41 Ppk Cp 0.41 Cpm * 0.45 CPL 0.48 CPU 0.41 Cpk 0.41 Observ ed Performance %  <  LSL 7.50 %  >  USL 10.00 %  Total 17.50 Exp. Within Performance %  <  LSL 7.54 %  >  USL 10.69 %  Total 18.23 Exp. Ov erall Performance %  <  LSL 7.77 %  >  USL 10.94 %  Total 18.70 Within Overall Process Capability of Time to Process (subgroup of 1) Normal Capability Analysis Results Sample Mean StDev (Within): Represents short term data. StDev (Overall): Represents long term data, includes shift and drift between subgroups. Voice of the Customer Voice of the Process
  • 145. 145NCR Confidential 484236302418 LSL USL Process Data Sample N 200 StDev (Within) 7.46329 StDev (Ov erall) 7.54439 LSL 20.00000 Target * USL 40.00000 Sample Mean 30.72100 Potential (Within) Capability CCpk 0.45 Ov erall Capability Pp 0.44 PPL 0.47 PPU 0.41 Ppk Cp 0.41 Cpm * 0.45 CPL 0.48 CPU 0.41 Cpk 0.41 Observ ed Performance %  <  LSL 7.50 %  >  USL 10.00 %  Total 17.50 Exp. Within Performance %  <  LSL 7.54 %  >  USL 10.69 %  Total 18.23 Exp. Ov erall Performance %  <  LSL 7.77 %  >  USL 10.94 %  Total 18.70 Within Overall Process Capability of Time to Process (subgroup of 1) Normal Capability Analysis Results Observed Performance: Represents the sample data. Exp Within Performance: Based on StDev(Within) and represents short term process capability. Capability indices: Based on short term data. Exp Overall Performance: Based on StDev (Overall) and represents long term process capability. Capability indices: Based on long term data.
  • 146. 146NCR Confidential Non-Normal Capability – Distribution Identification Exercise Using the data (Time_2) in a Minitab file Capability Example.MTW determine the capability of the PO process in terms of the time that is required to process the POs. Time to Process one individual PO Use the file Capability Example. MTW
  • 147. 147NCR Confidential A QWhich Capability Analysis applies? No Non-normal Try Individual Distribution Identification Yes ??? Non-Normal Capability – Distribution Identification • Is the data attribute or variable? • Is the data normal? • Are the reasons for non-normality understood? • Can the data be described by another distribution?
  • 148. 148NCR Confidential Individual Distribution Identification in Minitab 1. Open the worksheet Capability Example.MTW. 2. Choose Stat > Quality Tools > Individual Distribution Identification. 3. Click in the [Single Column] field. 4. Double click Time_2 in the column on the left. 5. Choose [Use all distributions]. 6. Click [OK]. Use the file Capability Example. MTW
  • 149. 149NCR Confidential Individual Distribution Identification in Minitab
  • 150. 150NCR Confidential 1. Open the worksheet Capability Example.MTW. 2. Choose Stat > Quality Tools > Capability Analysis > Nonnormal. 3. Click in the [Single Column] field. 4. Double click Time_2 in the column on the left. 5. Select [Fit data with Distribution]. 6. Using pulldown menu select [3- parameter Weibull]. 7. Type 20 in [Lower Spec]. 8. Type 40 in [Upper Spec]. Using Individual Distribution Identification Use the file Capability Example. MTW
  • 151. 151NCR Confidential 9. Select [Options] button. 10. Add target value (if applicable). 11. Under Display select 1. Capability Stats 2. Benchmark Z 12. Add Title if desired. 13. Click [OK]. 14. Click [OK]. Using Individual Distribution Identification
  • 152. 152NCR Confidential Sample Mean Voice of the Customer Voice of the Process Observed Performance: Represents the sample data Exp Overall Performance: Represents long term process capability Overall Capability: Benchmark Z or Capability indices - based on long term data Using Individual Distribution Identification
  • 153. 153NCR Confidential Non-Normal Capability – Central Limit Theorem Activity Using the data (Time_3 and Time 3 sub) in a Minitab file Capability Example.MTW determine the capability of the PO process in terms of the time is required to process the POs. Average time to process five POs per day Time to process one individual PO Use the file Capability Example. MTW
  • 154. 154NCR Confidential A QWhich Capability Analysis applies? No Non-normal Try sub-grouping the data Yes Yes No ??? • Is the data attribute or variable? • Is the data normal? • Are the reasons for non-normality understood? • Can the data be described by another distribution? • Can the data be sub-grouped? • Is the sub-grouped data normal? Non-Normal Capability – Central Limit Theorem
  • 155. 155NCR Confidential 1. Open the worksheet Capability Example.MTW. 2. Choose Stat > Quality Tools > Capability Analysis > Normal. 3. Click in the [Single Column] field. 4. Double click Time_3 in the column on the left. 5. Click in the [Subgroup Size] field – Double click Individ Dates_3 in the column on the left. 6. Type 20 in [Lower Spec]. 7. Type 40 in [Upper Spec]. The sub-groups have to make logical sense, such as by day, by shift, by machine… Important! Check sub-group data Time_3 sub for normality. If the data is not normal then this method cannot be used! Caution! Use the file Capability Example. MTW Using Central Limit Theorem Sub-Grouping
  • 156. 156NCR Confidential 8. Select [Options] button. 9. Add target value (if applicable). 10. Under Display select 1. Parts per million or Percents 2. Capability Stats or Benchmark Z 11. Add Title if desired. 12. Click [OK]. 13. Click [OK]. Using Central Limit Theorem Sub-Grouping
  • 157. 157NCR Confidential 5045403530252015 LSL USL LSL 20 Target * USL 40 Sample Mean 31.262 Sample N 200 StDev (Within) 7.55396 StDev (Ov erall) 8.3748 Process Data Cp 0.44 CPL 0.50 CPU 0.39 Cpk 0.39 Pp 0.40 PPL 0.45 PPU 0.35 Ppk 0.35 Cpm * Ov erall Capability Potential (Within) Capability PPM < LSL 85000.00 PPM > USL 175000.00 PPM Total 260000.00 Observ ed Performance PPM < LSL 67997.38 PPM > USL 123688.49 PPM Total 191685.87 Exp. Within Performance PPM < LSL 89353.21 PPM > USL 148388.88 PPM Total 237742.09 Exp. Ov erall Performance Within Overall Process Capability of Time_ 3 Sample Mean StDev (Within): Represents short term data StDev (Overall): Represents long term data, includes shift and drift between subgroups Voice of the Customer Voice of the Process Using Central Limit Theorem Sub-Grouping
  • 158. 158NCR Confidential 5045403530252015 LSL USL LSL 20 Target * USL 40 Sample Mean 31.262 Sample N 200 StDev (Within) 7.55396 StDev (Ov erall) 8.3748 Process Data Cp 0.44 CPL 0.50 CPU 0.39 Cpk 0.39 Pp 0.40 PPL 0.45 PPU 0.35 Ppk 0.35 Cpm * Ov erall Capability Potential (Within) Capability PPM < LSL 85000.00 PPM > USL 175000.00 PPM Total 260000.00 Observ ed Performance PPM < LSL 67997.38 PPM > USL 123688.49 PPM Total 191685.87 Exp. Within Performance PPM < LSL 89353.21 PPM > USL 148388.88 PPM Total 237742.09 Exp. Ov erall Performance Within Overall Process Capability of Time_ 3 Observed Performance: Represents the sample data. Exp Within: Performance: Based on StDev(Within) and represents short term process capability Capability indices: Based on short term data. Exp Overall: Performance: Based on StDev(Overall) and represents long term process capability. Capability indices: Based on long term data. Using Central Limit Theorem Sub-Grouping
  • 159. 159NCR Confidential Non-Normal Capability – Box-Cox Transformation Activity Using the data (Time_4) in a Minitab file Capability Example.MTW determine the capability of the PO process in terms of the time is required to process the POs. Time to Process one individual PO
  • 160. 160NCR Confidential A QWhich Capability Analysis applies? No Non-normal Try Box-Cox transformation Yes No No ??? Non-Normal Capability – Box-Cox Transformation • Is the data attribute or variable? • Is the data normal? • Are the reasons for non-normality understood? • Can the data be described by another distribution? • Can the data be sub-grouped? • Can data be transformed?
  • 161. 161NCR Confidential Box-Cox Transformation 1. Open the worksheet Capability Example.MTW 2. Choose Stat > Control Charts > Box- Cox Transformation 3. Choose [All Observations …in one column] from pull down menu 4. Click in Large Box 5. Double click [Time_4] in the column on the left 6. Click in the [Subgroup Size] field – enter 1 7. Select [Options] radio button 8. Select [Optimal Lambda] 9. Enter column for Stored Data 10. Click [OK] 11. Click [OK]
  • 162. 162NCR Confidential Box-Cox Transformation Results QIs the transformed data normal? Transformed Data Lambda Values
  • 163. 163NCR Confidential 1. Open the worksheet Capability Example.MTW 2. Choose Stat > Quality Tools > Capability Analysis > Normal 3. Click in the [Single Column] field 4. Double click Time_4 in the column on the left  Use the original data, not the transformed data. 1. Click in the [Subgroup Size] field – enter 1 (the data is already sub-grouped) 2. Type 20 in Lower Spec 3. Type 40 in Upper Spec Using Box-Cox Transformation Check transformed data for normality. If the data is not normal then this method cannot be used! Caution! Use the file Capability Example. MTW
  • 164. 164NCR Confidential 1. Select [Box-Cox] radio button 2. Select [Box-Cox power transformation] 3. Select [Use Optional lambda] 4. Click OK 5. Select [Options] radio button 6. Add target value (if applicable) 7. Under Display select a. Parts per million or Percents b. Capability Stats or Benchmark Z 8. Add Title if desired 9. Click [OK] 10. Click [OK] Using Box-Cox Transformation
  • 165. 165NCR Confidential Transformed Sample Data Transformed Voice of the Process Transformed Voice of the Customer Original Sample Data Calculated Lambda Original Distribution Using Box-Cox Transformation
  • 166. 166NCR Confidential Observed Performance: Represents the sample data Exp Within Performance: Based on StDev (Within) and represents short term process capability. Capability indices: Based on short term data Exp Overall Performance: Based on StDev (Overall) and represents long term process capability. Capability indices: Based on long term data. Using Box-Cox Transformation