IMPROVING QUALITY WITH IFS QUALITY MANAGEMENT IFS CUSTOMER SUMMIT 2011, CHICAGO

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IMPROVING QUALITY WITH IFS QUALITY MANAGEMENT IFS CUSTOMER SUMMIT 2011, CHICAGO

KARIN RAINESALO BUSINESS SOLUTIONS CONSULTANT karin.rainesalo@ifsworld.com IFS CUSTOMER SUMMIT 2011, CHICAGO

AGENDA IFS Quality Management Failure Mode and Effects Analysis (FMEA) Control Plans Recording Test Results (Analysis) SPC and Control Charts Capability Index Calculation Nonconforming Material Material Review Board Customer/Supplier Issues 4

QUALITY MANAGEMENT INTEGRATED, THOROUGH, EASY TO ACCESS Start quality management process during design. Integrated quality management accessible at any point in the supply chain. Test plans, sample data, MRB processes Data captured remains linked to items, lots, serials for later retrieval, as needed. For instance, to produce certificates of compliance for customers. Support of standard statistical process control charts and process capability indices. Nonconformance processing internally and externally. No duplication of data, easy retrieval lower cost, reduce risk DAY IN THE LIFE

IFS QUALITY MANAGEMENT

IFS QUALITY MANAGEMENT FAILURE MODE & EFFECTS ANALYSIS (FMEA) Design WHAT to control Process Function Failure Causes Effects Controls RPN Calculations Recommendations CONTROL PLANS HOW to control Manufacturing Purchasing Inventory SPC Charts Capability Indices where & what controls are needed how control is performed action if problem persists IFS QUALITY MANAGEMENT

FMEA

FMEA PROCEDURE Define Functions of design or process, then potential Failure Modes. For each Failure Mode, define the possible Effects and each Effect s Severity factor. Also define the possible Causes and each Cause s Occurrence factor. For each Failure/Cause combination, define the Prevention or Detection methods and each method s Detection factor. Severity x Occurrence x Detection = Risk Priority Number (RPN) Also, define Recommended Actions to take to improve RPN

FMEA FEATURES Design FMEAs are linked to Product Structures. Process FMEAs are linked to Routings. Automatic calculation of Risk Priority Numbers Printable report available. IFS Applications provides a graph of the FMEA and an indented structure of the failure modes, effects, causes, controls, and recommended actions. 10

FMEA FUNCTIONS PER PART

FMEA FAILURES AND EFFECTS 12

FMEA FAILURES AND CAUSES 13

FMEA CONTROLS PER FAILURE AND CAUSE 14

FMEA ACTIONS PER FAILURE AND CAUSE 15

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CONTROL PLANS

CONTROL PLANS CONTROL PLANS HOW to control Manufacturing Purchasing Inventory SPC Charts Capability Indices where & what controls are needed how control is performed action if problem persists

CONTROL PLANS Manufacturing Control Plans linked to Routing Revision/Alternate Purchasing Control Plans linked to Part/Supplier Inventory Control Plans linked to Part/Revision Can be scheduled Test operations defined with optional SPC Setup. All testing history retained on the control plan.

CONTROL PLANS DEFINE DATA POINTS Data point, operation, work center, test Specification Attribute or variable SPC Sample size and frequency 20

CONTROL PLANS TRIGGERS Manufacturing Control Plan Time Interval Start Shop Order Nonconforming Purchasing Control Plan At Arrival Time Scheduled Interval Scheduled Nonconforming 21

CONTROL PLANS SPC SETUP 22

CONTROL PLANS SPC SETUP 23 2009 IFS

REPORTING TEST RESULTS

IFS QUALITY MANAGEMENT TEST RESULTS CONTROL PLANS HOW to control Manufacturing Purchasing Inventory Create Analysis Print Control Plans The Testing Process Register the Results Completion 25

REPORTING TEST RESULTS Create an Analysis (sample) Manually from Shop Order Operations Dispatch List Production Schedule Purchase Receipt Inventory Control Plan Create an Analysis Automatically As scheduled on Inventory Control Plan Through Triggers Supported by Events in IFS Event Manager

REPORTING TEST RESULTS Print Test Instructions Report Results Complete Confirm Results Linked to Lot/Batch Number and/or Serial, as applicable Generate Control Chart, as needed Electronic Signature Available (FDA) 27

REPORTING TEST RESULTS DISPATCH LIST Need screen capture of Dispatch list with Inspection box enabled 28

REPORTING TEST RESULTS DISPATCH LIST Need screen capture of Dispatch list with Inspection box enabled 29

REPORTING TEST RESULTS ANALYSIS RESULTS Need screen capture of Dispatch list with Inspection box enabled For each data point record test results below. Include lot and/or serial info, as appropriate 30

REPORTING TEST RESULTS OPTIONAL SECURITY CHECKPOINT 31

TRACEABILITY Assignment of lot/batch and/or serial indicators to items raw materials, subassemblies, end items. Building of lot and/or serial structures Occurs automatically in IFS Applications as usage/consumption is reported. Identify lots used in any parent lot, serials used in any parent serial Identify where a lot or serial was used subassemblies, end items, sales orders. Be able to retrieve test data, order info, etc., for any lot or serial processed. 32 IFS QUALITY MANAGEMENT

CONTROL CHARTS

CONTROL CHARTS Variable Control Charts X-bar and R X-bar and S X and Moving Range Attribute Control Charts p np c u

CONTROL CHARTS Displays are configurable during SPC setup as part of control plan definition. Sigma limits Tolerance limits Control limits Generate Control Charts from Test Results Control Plan Out-of-control Conditions generate a pop-up window for user. Supported by Event in IFS Event Manager. 35

CONTROL CHARTS C CHART 36

CONTROL CHARTS X-BAR AND R CHART 37

CONTROL CHARTS X-BAR AND R CHART 38

PROCESS CAPABILITY ANALYSIS

CAPABILITY INDEX CALCULATION C p and C p k Calculation requirements defined on control plan Inner and Outer, depending on how spec limits are defined in control plan. Calculates corresponding ppm for each C p and C p k Can calculate for specific periods of time and graph progress.

CAPABILITY INDEX CALCULATION SUMMARY BY TEST OPERATION Control chart, data point, item Specification C p /C p k ppm Mean and C p and C p k standard Targets deviation 41

NONCONFORMING MATERIAL

NONCONFORMANCE TRACKING IFS Manufacturing Shop Order Reporting/Shop Floor Reporting Component Scrap/WIP Scrap/Finished Goods Scrap Rework IFS Purchasing Incoming Inspection Return to Vendor/Scrap IFS Quality Management Control Plans Control Charts MRB IFS Case Management

MATERIAL REVIEW BOARD NONCONFORMING MATERIAL REVIEW PROCESS MRB created Checklist response MRB in progress Inspection Shop Order creation / in process Components Operations reporting Shop Order receipt Purchase Order receipt Received parts waiting inspection Disposition Scrap Approve MRB completed Re-open Cancel Inventory part in stock Create MRB Review MRB cases by part 44 IFS QUALITY MANAGEMENT

MATERIAL REVIEW BOARD Provides a formal and controlled review process for non conforming materials Integrated with Shop Order, Purchase Receipt and Inventory processes MRB tracks: Details of non conformance and Source information Provides checklist dialogue Inspection details by serial/lot batch where appropriate Disposition details Return, reject, rework, use as it etc MRB workflow process what has been done so far History Log of updates and comments Can print MRB labels for item tagging 45

MRB DETAILS 46

MRB CHECKLIST 47

MRB INSPECTION 48

MRB DISPOSITION 49

MRB PART DETAILS 50

CASE MANAGEMENT Internal Party Queue Management Event Escalations Case / Tasks Dispatch Case/Task Assignee Solution, Resolution Knowledge Search, Templates, Category Questionnaires Handover Reference

CASE MANAGEMENT HIGHLIGHTS Configurable Organization Tasks Cases Predefined Optional wizard Time keeping Collected into Templates Task Templates linked to Call/Case Categories Links to other parts of IFS Applications Document Management, Customer Orders, RMAs, Work Orders, etc. 52 IFS CALL CENTER

CASE MANAGEMENT CONFIGURATION POSSIBILITIES Supplier Issues Customer Complaints Customer Returns Customer Requests for Service Internal Quality Issues Employee Suggestions External/Internal Audit Responses In-house Case Handling, e.g., IT Department 53

CALL CENTER SETUP FOR CASE MANAGEMENT 54 IFS CALL CENTER

CASE MANAGEMENT CREATE CASE 55

CASE MANAGEMENT WORK CASE TO RESOLUTION 56

QUALITY MANAGEMENT INTEGRATED, THOROUGH, EASY TO ACCESS Start quality management process during design. Integrated quality management accessible at any point in the supply chain. Test plans, sample data, MRB processes Case Management Data captured remains linked to items, lots, serials for later retrieval, as needed. For instance, to produce certificates of compliance for customers. Support of standard statistical process control charts and process capability indices. Nonconformance processing internally and externally. MRB Case Management No duplication of data, easy retrieval lower cost, reduce risk DAY IN THE LIFE

QUESTIONS?

THANK YOU FOR ATTENDING. STOP BY THE MEET THE EXPERTS AREA. IFS CUSTOMER SUMMIT 2011, CHICAGO

www.ifsworld.com THIS DOCUMENT MAY CONTAIN STATEMENTS OF POSSIBLE FUTURE FUNCTIONALITY FOR IFS S SOFTWARE PRODUCTS AND TECHNOLOGY. SUCH STATEMENTS OF FUTURE FUNCTIONALITY ARE FOR INFORMATION PURPOSES ONLY AND SHOULD NOT BE INTERPRETED AS ANY COMMITMENT OR REPRESENTATION. IFS AND ALL IFS PRODUCT NAMES ARE TRADEMARKS OF IFS. THE NAMES OF ACTUAL COMPANIES AND PRODUCTS MENTIONED HEREIN MAY BE THE TRADEMARKS OF THEIR RESPECTIVE OWNERS. 2011 IFS