Moving towards supplier-owned quality

Transcription

1 Moving towards supplier-owned quality Lisa Bobich, PhD Sourcing Continuity, Medtronic, Inc. Outline Background Customer incoming inspection Transition to supplier-only inspection Raising the bar Conclusion

2 Background Supplier Quality Management system System for Process Intelligence and Capability Excellence (SPICE). SQM utilizes supplier data electronically transmitted to the customer via an internet portal or Secure File Transfer Protocol port. Outline Background Customer incoming inspection Transition to supplier-only inspection Raising the bar Conclusion

3 Incoming Customer inspection IP Inspection Procedure Benefits of Customer inspection Understanding of measurement method to application/use Procedures are known Calibration standards Measurement error acceptability Definition of reject or mishandling

4 Benefits of Supplier inspection Eliminate redundant inspections Reduce costs Resources Inspection parts (scrap or repackage) Inventory (shorter dock to floor) Reduce incoming inspection bottlenecks Inspection alignment (agreement on discrepant material) Benefits of Supplier inspection Provide real time feedback prior to release of product Pre-determine lot acceptance & give shipment authorization upon successful data upload Drive understanding of product variation and opportunities to control the variation Possible additional benefits: Better measurement capability at supplier Use larger sample sizes

5 Outline Background Customer incoming inspection Transition to supplier-only inspection Raising the bar Conclusion 3a b

6 Select components & gain buy-in Evaluate candidates for SQM Type of features Risk of features Discuss feasibility with supplier Needed resources Changes to supply agreement Types of Data Attribute: categorical or pass/fail Variables: measurement data Variables data can be treated as attribute data if the measurements are evaluated only as pass (within specification) or fail (out of specification)

7 Infrastructure to receive supplier data Obtain/distribute database software to upload/store data Assist with setup of system at supplier Ensure validity of supplier measurements Attribute Agreement & Gage R&R Correlation between supplier & customer Check data is within specification

8 On-going activities Ensure supplier agreements are upheld Upload before shipment Procedures for upload failures Customer monitors component performance Legacy target: 1.33 Ppk or defect rate of 64 ppm; Current target: 1.67 Ppk or 0.5 ppm On-going activities Supplier monitors component performance

9 Outline Background Customer incoming inspection Transition to supplier-only inspection Raising the bar K factors Control limits Conclusion Increasing levels of quality

10 Transition to Variables Sampling Plans Assume normal distribution For non-normal, consider variables plan as a screen and accept failing lots to attribute plan Acceptance limits K factor Accepting lots with good Cpk LSL + kσ X USL kσ Control limits Accepting lots that are in control and with good Cpk T+3 σ / n X T-3 σ / n, where T is target K factors Customer and Supplier continuously monitor performance of key parameters Customer accepts data based on K factor: LSL + kσ X USL kσ Supplier benefit: Reduce sample size

11 Control limits Only supplier continuously monitors performance of key parameters Customer accepts based on control limits: T+3 σ / n X T-3 σ / n, where T is (USL+LSL)/2 Supplier benefits: Early warning of changes in process specification limit control limit control limit specification limit Conclusion Transition to supplier-only inspection has multiple benefits for both the customer and supplier, including: Reduction in costs and inventory, Measurement systems alignment between customer and supplier, and Understanding and reducing process variation

12 QUESTIONS??