Global quality

In pursuit to be world-class in supply chain, Stryker places high emphasis on supply chain resiliency. As a result, we can ensure our business continuity plans are well developed to avoid any impact on supply. With a keen focus on supply chain resiliency, and maintenance of strong partnerships with our suppliers, we can successfully deliver on our mission – to make healthcare better, together with our customers.

To ensure we are optimally prepared at all times, we take the following steps:

• We closely monitor global demand and have great insight into emerging global risks.
• We spread our manufacturing network and suppliers across the globe and leverage multiple suppliers across each commodity.
  
• We use standardized machines and processes so, if a situation warrants it, we can move products across plants and to capable manufacturing locations in other regions. We have a robust set of processes and a dedicated product transfer team to enable such transfers and qualify alternate components and materials in case of shortages.
  
• We are equipped to make products in multiple plants in cases where demand overshoots a manufacturing plant’s capacity.
  

Product testing standards: As we build processes and systems, we utilize over 150 accredited standards from organizations such as ASTM International, International Organization for Standardization (ISO) and British Standards Institution (BSI) to ensure compliance when designing, manufacturing and distributing our products. We use both internal and external accredited testing labs to support this activity.

Incoming, in-process and final inspection: Across all our manufacturing, logistics and distribution sites, we use acceptance activities that comply with the Food and Drug Administration (FDA) QSR 820.80 and ISO 13485 and all applicable quality and regulatory standards.

Process monitoring: We control and monitor our manufacturing and distribution sites utilizing preventative maintenance programs. These include integrated process monitoring systems, such as MES and environmental monitoring in our cleanrooms that comply with all relevant standards to ensure that products meet or exceed specifications.

Training is at the core of our quality culture, permeating through all levels of the organization. This begins in the recruiting process, where we hire talented employees based on a combination of education, training, skills, and experience through onboarding and continual learning and development. Each employee is aware of the relevance and importance of their activities and how they contribute to the achievement of our quality objectives.

Every employee is trained to execute their role. Our employees complete over three million formal training events each year.¹ Training areas include but are not limited to Quality Management Systems, Compliance, Product, Process, Sales and Marketing and labeling training.

Our job-specific training curriculum is designed by role, function and location and tailored to support compliant execution of daily tasks to ensure we continually follow our processes and procedures.

At Stryker, we utilize the most appropriate training delivery methods to ensure efficacy, including self-paced reading, interactive web-based training and live in-person training.

Our global manufacturing sites are accredited to appropriate regulatory certifications.

• Across all of our manufacturing sites, we are accredited to ISO13485, and all eligible Stryker locations are certified as part of the Medical Device Single Audit Program (MDSAP).²

We maintain a continual monitoring program to ensure Stryker sites implement the latest certifications.

• Throughout all applicable Stryker sites, we are engaged in a multi-year program to implement and adhere to EUMDR.

Stryker supports all external audits.

• Every year, Stryker supports over 100 external audits across our manufacturing, logistics and distribution sites to ensure adherence to all relevant standards.

All of our suppliers are assessed and qualified before they are added to our list of approved suppliers. Part of this assessment includes evaluating the category and risk of the supplier based on the products and services they will provide. Approval requirements are risk-based and may include assessment of supplier capabilities, initial audit, regulatory certifications and supplier agreements, as required.

Learn more about Supplier Diversity at Stryker

Supplier quality agreements
We have formalized quality agreements with supplier partners based on risk level. Agreements may include –

• quality and communication expectations;
• definition of roles and responsibilities;
  
• applicable standards and regulations;
  
• registration and certification requirements;
  
• acceptance of announced and unannounced audits from external regulatory bodies.
  

Change control agreements and management:
We set expectations with all product and service suppliers on communication and implementation requirements on quality-impacting changes.

Change control communication tools:
We provide our suppliers with the tools necessary to ensure proper and timely communication to Stryker regarding any quality-impacting changes that the supplier may propose.

Change review board approval and prioritization:
Stryker assesses the risk and priority of supplier-proposed changes to ensure proper resources are allocated to execute the change.

Project planning and execution:
We assess the requirements and execution needs of the change request based on the appropriate risk and level of qualification needed to ensure no unintended effects occur as a result of the change.

Process capability analysis:
Together with our suppliers, we define criticality and qualify the manufacturing process by performing a process capability analysis.

Process risk management:
We expect our suppliers to maintain risk management documents and controls that predict and prevent quality issues.

Supplier inspection:
We monitor our suppliers with qualified inspections to ensure they meet our requirements to protect Stryker and our customers from non-conforming product.

Supplier performance review:
We monitor the performance of our suppliers through data analytics and key performance indicators. The analysis informs our assessment and determines whether action is needed.

Supplier monitoring audits:
We perform process and quality system-based audits on high-risk suppliers with a regular cadence to drive improvements while also ensuring compliance, quality expectations and sub-tier supplier management. We also perform for-cause audits on suppliers identified through the supplier performance review.

Supplier quality improvement program:
We partner with suppliers who have been identified as needing additional focus to create quality improvement projects that aim to improve the supplier’s quality culture, processes and metrics.

MedAccred partnership

• We partner with Performance Review Institute’s (PRI) MedAccred, an industry-managed, consensus-driven approach to ensuring critical manufacturing process quality throughout the medical device supply chain. We leverage this accreditation as part of our supplier evaluation processes.

ISO13485 lead auditor training

• All of our supplier lead auditors are trained and certified as ISO 13845 Lead Auditors.
• We leverage our expertise to develop our suppliers through quality improvement projects, in addition to our supplier audits.
  

Internal subject matter experts

• We leverage our internal expertise to add value to our process-based supplier audits of specialized processes.

In our code of conduct, we explicitly state our commitment to accurately represent our products and services and comply with applicable regulatory and legal requirements governing our products and services marketing and sale. It is the first of our 13 corporate policies, available in 23 languages.

Our Corporate Policy 5: On-Label Product Promotion provides further guidance and direction on our commitment by making it clear that Stryker employees, contractors, consultants and other third parties acting on Stryker’s behalf may only promote Stryker products for uses consistent with the label.

Multi-layered training focused on the code of conduct, including what’s expected of employees, business partners and the company, is the subject of a broad company-wide compliance program, communications and engagement campaigns.

Stryker employees certify to the code of conduct on an annual basis and undertake yearly compliance training.

Corporate Policy #5 On Label Product Promotion is also part of the training curriculum for our Sales and Marketing job groups, as well as the below groups within Stryker:

• Clinical Affairs
• Communications
  
• Compliance
  
• Executive and General Management
  
• Human Resources
  
• Legal Affairs
  
• R&D
  
• RAQA