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Medical Device Manufacturer Improves Quality with Data Historian
- 1. PUBLICPUBLIC Copyright © 2018 Rockwell Automation, Inc. All Rights Reserved. 2018 Rockwell Automation TechED™ Event #ROKTechED Kimball Electronics Medical Device Manufacturer Improves Quality, Cuts Risk with Historian Sean Hennette – Kimball Electronics – Plant Engineer Brad Downen – Stone Technologies – MES Project Manager June 2018
- 3. 3Copyright © 2018 Rockwell Automation, Inc. All Rights Reserved. 2018 Rockwell Automation TechED™ Event #ROKTechEDPUBLIC A G E N D A 3 Introduction Problem Solution Results
- 4. KimballElectronicsConfidentialLasting relationships. Global success. INDIANAPOLIS Introduction
- 5. KimballElectronicsConfidentialLasting relationships. Global success. INDIANAPOLIS Problem • CFR 21 Part 820.20 – Management Responsibility Subpart B—Quality System Requirements § 820.20 Management responsibility. (a) Quality policy. Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization. (b) Organization. Each manufacturer shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part. (1) Responsibility and authority. Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks. (2) Resources. Each manufacturer shall provide adequate resources, including the assignment of trained personnel, for management, performance of work, and assessment activities, including internal quality audits, to meet the requirements of this part. (3) Management representative. Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for: (i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and (ii) Reporting on the performance of the quality system to management with executive responsibility for review. (c) Management review. Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer’s established quality policy and objectives. The dates and results of quality system reviews shall be documented. (d) Quality planning. Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met. (e) Quality system procedures. Each manufacturer shall establish quality system procedures and instructions. An outline of the structure of the documentation used in the quality system shall be established where appropriate. Quality Policy, Planning & System Procedures MUST BE SAFE AS POSSIBLE
- 6. KimballElectronicsConfidentialLasting relationships. Global success. INDIANAPOLIS Problem • In Addition……. • Better understanding Now What??? • 0 PPM Goal • Utilize Data Better • Enhancing Patience Safety • Free up time for Quality Engineer • Continuous Improvement
- 7. KimballElectronicsConfidentialLasting relationships. Global success. INDIANAPOLIS Solution Starting Point…
- 8. KimballElectronicsConfidentialLasting relationships. Global success. INDIANAPOLIS Solution • Phase 1 - Requirements (URS) • Audit existing • What is needed and not needed • Define what will be added • Include Champions • Quality • Engineering • IT • Phase II – Design Specifications • Design a Plant Model • Compliments Future • Allow Aggregation • Vendor Selection based on User/Functional Requirements and Design Specs
- 9. KimballElectronicsConfidentialLasting relationships. Global success. INDIANAPOLIS Solution Benefits: • Native SQC Functionality • Plant Model Structure • Notification Services
- 10. KimballElectronicsConfidentialLasting relationships. Global success. INDIANAPOLIS Solution Plant Model
- 11. KimballElectronicsConfidentialLasting relationships. Global success. INDIANAPOLIS Solution Element Properties
- 12. KimballElectronicsConfidentialLasting relationships. Global success. INDIANAPOLIS Solution Test Stand Results
- 13. KimballElectronicsConfidentialLasting relationships. Global success. INDIANAPOLIS Solution Test Stand Results
- 14. KimballElectronicsConfidentialLasting relationships. Global success. INDIANAPOLIS Solution SQC Configuration With Notifications
- 15. KimballElectronicsConfidentialLasting relationships. Global success. INDIANAPOLIS Solution SQC Triggered Notifications
- 16. KimballElectronicsConfidentialLasting relationships. Global success. INDIANAPOLIS Solution SQC Review
- 17. KimballElectronicsConfidentialLasting relationships. Global success. INDIANAPOLIS Solution SQC Review
- 18. KimballElectronicsConfidentialLasting relationships. Global success. INDIANAPOLIS Solution Utilizing Data / Understanding Manufacturing processes
- 19. KimballElectronicsConfidentialLasting relationships. Global success. INDIANAPOLIS Results Notifications Understanding Saving Time
- 20. KimballElectronicsConfidentialLasting relationships. Global success. INDIANAPOLIS Results $$$ - Six Figure/Lot Impact Time to Focus on Quality Quicker Release of Lots High Level of Confidence of Product Results
- 21. 22Copyright © 2018 Rockwell Automation, Inc. All Rights Reserved. 2018 Rockwell Automation TechED™ Event #ROKTechEDPUBLIC Share your Feedback Please complete a session survey on the mobile app Download the Rockwell Automation Events App Select Rockwell Automation TechED and login Click on Session Surveys or Schedule in the main menu Select the session you are attending Click on the survey tab Complete the survey and submit
- 22. www.rockwellautomation.com PUBLICPUBLIC Copyright © 2018 Rockwell Automation, Inc. All Rights Reserved. 2018 Rockwell Automation TechED™ Event #ROKTechED #ROKTechED Kimball Electronics Medical Device Manufacturer Improves Quality, Cuts Risk with Historian Thank You
Editor's Notes
- Intro Problem History Solution Results
- Origin Driven by FDA Requirement to track and trend data Looked at what data was available and what is needed to understand devices function Had Historian, but data was not being utilized Wanted to add trending Understand the Manf aspect of the process….not just release We can do predictive things on operations and assembly Goal: Be Compliant. Eliminate opportunity for quality failures Increase Patient safety and increasing our quality
- Origin Driven by FDA Requirement to track and trend data Looked at what data was available and what is needed to understand devices function Had Historian, but data was not being utilized Wanted to add trending Understand the Manf aspect of the process….not just release We can do predictive things on operations and assembly Goal: Be Compliant. Eliminate opportunity for quality failures Increase Patient safety and increasing our quality
- Action Champion of Historian (Sean). Reached out to Distributor Yes we have a system in place for the historian requirement Put in touch with Stone
- Requirements Gathering Determine what they had and what they needed to get out of it. Used previous requirements and pinpointed what they needed and didn't need Also what we needed to add Formulated to route for approval Chad- Program Manager Bryon - Quality Engineer Sean - Automation/Engineering Quality Manager - Brian Gard Break down Equipment to put in Model to assist in aggregation of equipment. Also provide future expandability Object oriented development for future and additional data. Approached it being Vendor agnostic, but would drive Rockwell spec when it made sense
- Modeling (VP vs Historian's Asset Frameworks) Historian SE with Asset Frameworks, SPC Client tools drove technical direction toward Historian SE SPC - Native functionality Event Framing VP was still in an infancy state (Eventing) Model objects needed Event actions Minimal customizing to achieve requirements
- Plant Model Base Aggregation
- Element Properties….allows growth
- Result Data
- SQC Setup
- Notifications Actions? What do they do? Leads towards investigation to determine Root Cause
- Weekly Review on KPI’s High Level review with Management Go through each point. Anything identified outside SQC Limits Action is determined and taken prior to released to customer
- Making the Data Useful/Understanding Manf Better Identifying Opener Check. No SQC Limits…but monitor lot to lot transitions Differs from Release Test Stand Data.
- Early Notifications -> Better Quality Savings: Time & Product Compliant with FDA Results Quality was greatly impacted Manually creating Exported Excel data reports Day of work for every couple of weeks Real time data & reports Production SQC Limit alerts Trigger's email notifications per limits Spec limits are defined and configured.
- Byron Had Excel before. Notifications started asking questions. Pictures to identification of issues and address We wouldn't have seen that Received 5 alerts in 5 hr times span in evening. Came in morning and recorded testing…looked at video….Exposed Needle length was fine, but debris was causing issue. Previously found out days later. Sean Alerts in realtime…we can go out and process video while still on the lot. We can either our controls system is selecting the incorrect Giving Byron back hours of his week…no longer doing a Data Dump for. Each production lot has a six figure impact, where each lot is released by the data that is now automatically generated Automation of reports leads to more quality focused activities and faster response to Realtime reporting and analysis of data allows production lots to be released soon and with a high level of confidence that all outliers have been addressed