Supplier Resource

Supplier Quality

Message from our Quality Leadership

Hello, I’m Peter Shearstone, Vice President of Global Quality Assurance & Regulatory Affairs. Thermo Fisher is the world leader in serving science, enabling our customers to make the world healthier, cleaner and safer.

As an organization we highly value integrity, intensity, innovation, and involvement not only from our colleagues but from those that support our business with best in quality products and services.

We are global company that continually looks for qualified suppliers that enable our products to consistently fulfill our customer requirements. That means that Thermo Fisher is looking for those who are industry leaders with integrity, those with innovation embedded in their processes, and those who are focused on delivering products and services that are right the first time. We value supplier partnerships to support our strategic goals, ensure continued growth, and customer satisfaction.

Our products range from providing health solutions, like COVID-19 testing, to helping battery manufactures keep our environment clean. 
 

Scientists, educators, students, public safety employees and patients are just some of the people that depend on our instruments and products being reliable, accurate, and predictable. In turn, we depend on you, our suppliers, to provide the parts and services we need to help them find the right answers to some of our world’s toughest questions.
 

Therefore, we invite you to join us as a select supplier and engage in helping us make the world healthier, cleaner, and safer.

Vision and Values of Supplier Quality

The Supplier Quality vision of Thermo Fisher is to strategically align ourselves with a supply base that enables us to provide products/services that make the world healthier, cleaner and safer. Partnering with strategic suppliers will allow us to foster a repeatable process of continuous improvement and process controls.

Here is how our Quality and Sourcing teams are incorporating our 4i core values with each strategic supplier partnership:

Integrity

• Honor commitments
• Treat others with dignity and respect
• Communicate openly and encourage candid feedback
• Be accountable for successes and failures
• Be a role model for our values

Intensity

• Drive to "win/win"
• Focus on the desired result
• Work with speed, passion and a can-do attitude
• Win with dignity, lose with renewed commitment
• Hold ourselves to a higher standard

Innovation

• Demonstrate a passion for discovery and learning
• Raise the bar, push the standard
• Recognize opportunities and take risks
• Practice continuous improvement
• Learn from the best practices

Involvement

• Team up with our strategic suppliers to win together
• Listen actively; communicate completely
• Be a rold model in everything you do
• Think and act globally,
• Seek out challenges

Our Quality Policy

We fulfill our Mission to enable our customers to make the world healthier, cleaner and safer by continuously improving the quality of our products and services and by ensuring global regulatory compliance.

Quality for our customers means they can rely on our products and services to consistently meet their specifications and requirements.

Quality for our colleagues means we take personal ownership to ensure our work meets customer requirements and is error-free from design through use.

Quality for regulatory authorities means that we operate at the highest ethical standards and meet of exceed all applicable regulatory requirements.

Quality for our company means we drive a continous improvement culture that is enabled by Practical Process Improvement (PPI) and our company's Quality System.

Key Message

Quality is a key part of fulfilling Thermo Fisher Scientific's Mission. Our Customers rely on out products and services to consistently meet their expectations - we need to get them right the first time. And regulatory authorities require us to operate at the highest ethical standards and meet or exceed all requirements. That's why our colleagues take personal ownership for the quality of the work they do each day. And we don't let ourselves becoms complacent; we continuously improve Quality by using our PPI Business System. Our companywide Quality Policy reinforces our promise to focus on quality for our key stakeholders: Customer, Colleagues, Regulatory Authortities and our Company.

Quality System Requirements

It is expected that suppliers to Thermo Fisher Scientific will maintain an internal Quality Manual that documents their internal Quality System.  Suppliers should be able to demonstrate that they have Management Reviews of their Quality System and are compliant with an applicable Quality Management Standard.

Suppliers must comply with all applicable quality standards and agency requirements as specified by their respective industry, country of manufacture or Thermo Fisher Scientific.  The supplier may be required to support validations for materials in our products, where applicable and required by business unit.

Team of colleagues standing by white board reading sticky notes

From time to time, suppliers may by audited by Thermo Fisher Scientific representatives.  Such audits may include reviews of the suppliers’ Quality System and compliance to their processes and procedures, as well as compliance to all applicable requirements that may be delineated in any contracts or agreements that are in effect between the supplier and Thermo Fisher Scientific.

 

All local/national/international standards must be complied with in the areas of human rights, health, safety, environmental, and Corporate Social Responsibility (CSR) governance as well as the Thermo Fisher Scientific Code of Conduct available on our website.

Regulated Products

Products supplied to Thermo Fisher are required to comply with all relevant requirements/regulations of country, federal, state and local environmental regulations. 
 

Regulations that restrict the use of certain products include, but are not limited to, the Medical Device Directive, the RoHS Directive, the REACH Regulation, Conflict Minerals, Waste Electrical and Electronic Equipment (WEEE), Global Harmonization System (GHS) and rules concerning materials safety and materials of animal origin. This may be achieved by policies/procedures for restricting or controlling materials, and/or by implementing collection and waste reduction programs. 


Suppliers shall have knowledge of, and inform Thermo Fisher of, restricted and regulated products that are used to manufacture, process, or package products. Additional information will be provided by the supplier, when requested by Thermo Fisher, to ensure compliance to these requirements.

Performance Monitoring

Thermo Fisher continuously monitors its suppliers using various methods. Audits, risk assessments, nonconformance identification, CAPA and SCAR processes, and scorecards are just a few examples. When improvement plans do not reach the expected results, the supplier is required to allow Thermo Fisher to perform an audit or inspection at the supplier’s facilities/processes.

Audits

Supplier audits may be performed to assess conformance to established external standards and regulations (e.g., ISO, FDA), assessment of production processes, assessment of technical competencies with the use of specific part drawings or service requirements. Based on the scope of the audit the results can be shared throughout the Thermo Fisher organization in order to minimize supplier audit interruptions.

Audit intervals will vary across the organization and are based on the criticality of the supplier’s product/service, performance history, and risk. Each business unit or site will determine the appropriate audit interval.

Nonconforming Product/Service

Thermo Fisher has established different methods to deal with nonconformities to make sure the effect is contained in the most effective way. Due to the vast variety of products, customers we serve, and the standards we must comply with, divisions will have different levels of requirements and approvals.  We expect our suppliers to keep in close contact with the Thermo Fisher supplier quality engineer or procurement representative to address nonconformities as soon as they become known.

As general rule, when the supplier becomes aware of having material, product/services due for delivery to Thermo Fisher, which deviate from agreed product/process specifications and do not affect form, fit and function; they are expected to inform Thermo Fisher before delivery.  If this approach is not followed, the delivery will be treated as a standard complaint.

Corrective and Preventive Action

When nonconformities arise (which the supplier is not aware of in advance), a standard approach will be used by Thermo Fisher to communicate with its suppliers. If there is sufficient risk to the supplied product or service, a formal request for corrective action in the form of Supplier Corrective Action Request (SCAR) will be given to suppliers. The supplier is expected to utilize their Corrective and Preventive Action tools noted below, to restore the product/service to required quality performance, to prevent future failures, and remove the root cause.

Suppliers are expected to apply a robust problem-solving method which incorporates the internationally known 8 Disciplines (8D) or will otherwise cover the following steps as a minimum:

        • Define and describe the problem

        • Contain the problem (immediate Containment Action)

        • Root Cause Analysis

        • Implement and record the Corrective Action

        • Define and Plan Preventative Action

Here too, divisions, business units or sites will have different levels of requirements and approvals. Our suppliers are expected to keep in close contact with the Thermo Fisher Supplier Quality Engineer (SQE) or Procurement representatives, to be properly and timely informed. Expected timelines of response and implementation of corrective action are determined by each division, business unit and site.  

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