Five Best Practices for Ensuring Supplier Quality

Supply chains can become extensive and involve multiple levels of suppliers, depending on the complexity of the end product. Managing various suppliers is complicated due to the many variables involved. Any lapses in process or product quality along the supply chain can have a negative impact on the end product.

For instance, the suppliers your original equipment manufacturer (OEM) uses likely have expertise in developing parts or materials that function with multiple products. Therefore, they might not have the ability, or desire, to develop parts with the level of precision and quality you need for your specific product.

Regulated companies are expected to specify quality-related responsibilities in their contract agreements. Such agreements should include the type of events that would trigger an on-site audit. It should also include expectations for change control processes, validation processes1 and availability of documentation for risk evaluation. The following five best practices will help your organization oversee and ensure a consistent level of quality throughout your supply chain.

#1: Keep Record of ISO Certifications

Suppliers are considered an extension of your company. This means they all need to be evaluated, audited and monitored. A best practice for supplier management is to keep a record of the supplier’s International Organization for Standardization (ISO) certificate on file.

While adherence to ISO standards is voluntary, they are used throughout the world and are considered a hallmark of quality. It’s in the best interest of supplier organizations of companies in regulated industries to earn this certification and keep it current. If a supplier’s certificate is nearing expiration, request an updated certificate with the next purchase order. If the supplier fails to provide an updated certificate, your incoming inspection team can place the next shipment on hold until the updated certificate is provided.

#2: Understand Supplier’s Quality Processes

Your supplier qualification method has multiple phases, including learning about the company’s operation and quality procedures. Reviewing the supplier’s quality manual can be helpful with this part of your qualification efforts. The supplier’s quality manual reveals important information about the company’s quality processes and operational policies. For instance, you can learn:

• The supplier’s step-by-step quality procedures.
• Who is empowered/authorized to shut down production.
• Who is involved in discussing and making decisions about procedures, materials or productivity issues.
• The company’s change management processes.

Understanding how suppliers work presents opportunities to help all supplier organizations improve their capabilities and increase the quality of their output.

#3: Use Supplier Questionnaires

Supplier questionnaires can help you establish transparency across the supply chain. This is useful for creating a risk control plan and determining the specific inspection methods to employ for each supplier. The questionnaire can reveal information about:

• Raw material traceability.
• Incoming product inspection approaches — critical for preventing the use of materials that might be out-of-specification.
• The equipment and processes the supplier uses to perform final inspections.

#4: Collect Objective Data on Supplier Performance

A formalized supplier performance scorecard helps you track and evaluate supplier quality, performance and compliance. Maintaining accurate and up-to-date supplier data helps with:

• Monitoring supplier processes.
• Discovering inconsistencies and other issues with suppliers’ internal systems.
• Finding solutions to production issues before they become defects.
• Keeping your approved vendor list (AVL) comprehensive and current.

Having access to supplier data in real time allows ample time to adjust schedules and resolve issues such as a supplier corrective action request (SCAR) or a component supply shortage.

#5: Create a Supplier Matrix

Auditing suppliers involves channeling resources to oversee the efforts of specific suppliers — often in the form of an in-person audit. To help determine which suppliers to audit, develop a unique supplier matrix for each purchased part. This provides a tool for focusing on the specific processes that should be validated and the suppliers that should be audited.

As the sponsor organization, you are ultimately responsible for all quality- and compliance-related aspects of your suppliers. Applying these supplier management best practices will help your OEMs and the companies throughout the supply chain ensure a high level of quality throughout the product’s life cycle.

References

1. “Guide to Inspections of Medical Device Manufacturers,” U.S. Food and Drug Administration (FDA), Page 9, Dec. 1997. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/page-9