A medical device manufacturer implemented a historian system to improve quality and reduce risk. The system provided native statistical process control functionality, allowed the creation of a plant model to aggregate data, and included notification services. This enabled more effective use of data, freed up the quality engineer's time, and enhanced patient safety. The results included cost savings of over $100,000 per manufacturing lot, greater focus on quality, quicker release of product lots, and increased confidence in the product.
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
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
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
