SMART G/O	Tier 1 Metrics	FDA Readiness	Supplier Management	Sterilization Management
Specific	Every site has site-specific targets for Tier 1 Metrics that have been established and communicated as part of this G&O presentation. - Complaint Rate- Nonconformance Rate- CAPAs >180 days or OverdueSites are expected to consistantly meet Tier 1 performance rates. Consistently Meets = At no point does a site fail to meet a Tier 1 target for 3 consecutive months. The site will achieve the Tier 1 target for a minimum of 8 months total in the Fiscal year.	FDA & Audit Readiness is an indication that the site is proactively monitoring and preparing for FDA engagements. - Inspection Strategy is in place and practiced where appropriate. - System Owner program is updated.- Mock FDA program is adhered to according to sites current state in 3-year cycle.- Most recent Mock FDA/FDA results are 'acceptable' or Response/Remediation is appropriate and on-track.	With regards to the sites supplier management program:- Review current SOP to confirm it is compliant and represents the current practice.- AVL is up to date and compliant with procedures and current supplier base. - Critical-High risk supplier files are compmliant and up to date- Supplier monitoring/Scorecard system is active and compliant with current procedures.	Each site shall:Create a Master Sterilization List (Cycles, Products, Vendors, etc.)Must be current with the annual revalidation requirements (i.e. half-cycle revals, quarterly dose audits)Must have clear plan that is followed and compmliant to ensure bioburden and/or LAL requirements are met. Must have a compliant environmental monitoring program.
Measurable	Tier 1 Metrics are by nature a measurable goal. These metrics are reported and reviewed monthly. The sites will have monthly review meetings with Corporate Quality Leadership to monitor progress towards the following:- At no point does a site fail to meet a Tier 1 target for 3 consecutive months. - The site has achieved the Tier 1 target for a minimum of 8 months total in the Fiscal year.	Sites will:- confirm completion of training/refresher training in 2026 of the Audit Strategy- Provide an updated System Owner Roster for 2026- Corporate Quality Leadership will monitor performance against 3 year mock audit cycle.- Corporate Quality Leadership will assess whether mock inspection or responses are 'acceptable' based on the risk to the business associated with the FDA/mock FDA outcomes.	At the completion of the initiatives outline above, the site will schedule an independent internal audit of the Supplier Management Systems. The resulting internal audit report will be provided to Corporate Quality Leadership for review.	No later than the start of Q4 2026, the site must be able to produce the Master Sterilization List for their site, including confirmation of complete revalidation requirements for 2026.The site must be able to demonstrate that procedures for Biorburden and LAL testing are in place and compliant where applicable. The environmental monitoring program must show throughout the year timely performance with acceptable results.
Achievable	Tier 1 Metric targets at the site level are established by performing an analysis of YTD (or rolling 12) performance against these metrics from the previous year. A modest improvement factor is established YoY and used to set the 2026 Targets for each site. Sites that don't have an identified pathway to achieve the new metric targets should escalate to Corporate Quality Leadership.	FDA Readiness is a continuous process, many of the elements associated with this initiative have been ongoing for years. They represent updates and refreshers to existing systems and processes, but little in the way of 'new' projects. The effort required to maintain these systems should be achievable in Fiscal 2026. For sites that will conduct a mock-FDA inspection or are in the process of responding/remediating to last years mock-FDA inspection; Corporate Quality Leadership will establish the schedule of mock-inspections and review.	The procedures and processes around Supplier Management represent a scope that can reasonably be reviewed and updated within the established time period. The evaluation of Supplier Files was limited in scope to Critical and High Risk suppleirs to ensure the exercise is achievable in the year.	This initiative will be supported by the Corporate Life-Sciences team as a supplement to the site level resources that will own this initiative. Establishing a master list of sterilization cycles owned by the site might be a new requirement.All other requirements of this initiative are compliance requirements that should already be in place and do not represent additional work that must be completed to satisfy this goal.
Relevant	Tier 1 metrics are a direct measure of product conformity and our timeliness in addressing significant and systemic problems. They are a primary consideration of our customers and the patients that utilize the devices we manufacture.	FDA Inspection Readiness has shown to be a critical element of preparing sites for FDA Inspections and improving outcomes. The cycle ensures that the site is routinely being challenged on their ongoing inspection readiness.	Supplier Performance has a direct impact on Product Conformity, the monitoring of supplier performance is a Compliance requirements. This system has not been an area of focus in recent organization-history.	Management of product sterility is of primary concern for patient safety and being able to demonstrate that current procedures are active, complaint and routinely monitored is part of the sites ongoing compliance program.
Time-Bound	Tier 1 metrics are measured monthly throughout the year and overall performance will be confirmed at the conclusion of Fiscal 2026 against the targets outlined above.	This initiative has elements that carry across a 3 year cycle; however, many elements of this goal are defined to be completed within this Fiscal year.	The scope of the project was specifically chosen to be completed within 12 months, the specific initiative around review of supplier files could be expanded beyond this Fiscal Year if it were to include Low and Medium risk suppliers.	This goal is scoped for evaluation prior to the end of Fiscal 2026, beyond 2026 it will continue to be part of the sites routine activities.