Supplier SQM Participation

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What is SQM?

• Stands for Supplier Quality Managment– Formally referred to as SPACE and SPICE

• Is a system in which data can be uploaded and valuated against the specific product requirements. To provide instant feedback to the supplier prior to release of the product and identify opportunities in the process

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Why SQM?

• Understand and control product variation in a real time manner so we can provide the most reliable and robust products to end users, the Doctors and most importantly the Patients that we serve.

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Key Benefits

• Medtronic is looking at SQM implementation at our key suppliers as an opportunity to improve collaboration.

• With improved collaboration, issues are identified and addressed prior to shipment of any material.

– Ensuring product shipped to Medtronic using Supplier measurement data, allows for the following:

• Confidence that material shipped to Medtronic meets Lot Acceptance requirements

• Reduced returned discrepant material for quality issues

• Reduction in sCAPA documentation and supplier resources supporting sCAPA activities

• Real time data analysis will improve process efficiency and enhance communication.

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Key Benefits

• Industry and regulatory pressures demand that we improve the team dynamics between supplier and Medtronic to work together to identify, monitor, and control risk.

• The opportunities of risk manifest in many ways, but the key customer concern is in the form of variation, stability and capability of the process.

• SQM facilitates cooperation between Medtronic and our key suppliers to:

– Increase the understanding of product and process requirements– Monitor and interpret process/ product variation– Establish reasonable control actions to reduce product variability

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Supplier Owned Quality

• Active project to eliminate receiving inspection at Medtronic

• We want to drive the ownership of the quality of our supplied products back to our suppliers

• We will be using SQM as the mechanism to monitor our supplier quality

– Each manufacturer shall establish and maintain procedures for acceptance of incoming product. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. (21 CFR Part 11 Part 820.80(b))

• We don’t want to be in the business of double checking our suppliers quality

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Expectations

• Ownership• Compliance• Data Integrity

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Expectations - Ownership

• Integration– SQM should be integrated into existing training and documentation as part of your

quality system. – The SQM upload process should be part of product acceptance activities.

• Communication– Think collaboration, how can we do this together.

• Product Quality– You are responsible to ensure that all requirements are met per specifications and

purchase order as necessary and is not limited to only the parameters being submitted through SQM.

– Ship authorization is determine by successful notification within SQM and must occur prior to product shipment.

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Expectations - Compliance

• Traceability– It is important that lot traceability be maintained

• This is done by ensuring that the lot or batch identification matches between the certification of compliance (CoC), SupplierLotID in SQM and shipped product.

• 21 CFR Part 11– As it applies to SQM, part 11 compliance has to do with record

integrity and management of user IDs and passwords

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Expectations - Data Integrity

• Ensure data is complete and accurate and that it successfully loads into the system without failure– i.e. Product meets specification limits, k-Value calculation,

Control limits, capability requirements.

• Violation reaction plan – If data fails, follow internal quality system to determine why it

failed and how to fix it….

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Expectations

• Supplier is responsible to ensure that all requirements are met per specifications and purchase order as necessary and is not limited to only the parameters being submitted through SPICE.

• Critical evaluation of measurement techniques• Acceptable MSAs of 30% SV/Tolerance or less

for features used for lot acceptance.

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Process Control

• k-Value (Variable data only)– Helps to ensure that you are meeting and/or exceeding a

certain capability level– To identify variation in the process– Indicate that the process has drifted

• To drive proactive activities before product begins to fail

– Provides assurance that product is not outside specification

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Process Control

• Control Limits – Provides notification early on that the process has shifted.– Creates an opportunity to react to prior to the failure of parts.

• cpk– Medtronic is moving to 1.67 cpk requirement for the

development of new components. • 1.00 cpk is equivalent to 2700 ppm defect

• 1.33 cpk is equivalent to 64 ppm defect

• 1.67 cpk is equivalent to .5 ppm defect

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Questions?

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Backup Slides

K-VALUE EXPLANATION

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K-value Explanation

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Graphical Explanation