How do you develop and maintain supplier quality documentation and records?

Sometimes suppliers cannot make the parts to the specification. There needs to be a robust process to review the exceptions and approve/decline the request. The exceptions that are approved should be connected to the specification and quality data. I have seen parts approved on deviation, sit in nonconforming material areas for weeks, causing production delays. I have seen the flip side where unapproved parts were released to production and a major field modification was required to correct the issue.

To develop and maintain supplier quality documentation, I establish a standardized system ensuring consistency and compliance with regulatory requirements. I create and update supplier quality agreements, audit reports, and CAPA records, ensuring they are accurate, complete, and easily accessible in a controlled document management system. Regular reviews ensure records stay current with evolving standards. I also implement version control and ensure all supplier documentation is audit-ready, traceable, and supports continuous improvement through clear corrective actions, performance tracking, and compliance verification.

At the ASQ conference in 2019, I had the opportunity to present the supplier quality journey on behalf of my employer at the time. Originally, we integrated the supplier quality processes into our quality management system, with a supplier-facing portal. After several years, we used the data to compute a risk score using a machine learning model. When the risk score was statistically significant compared to their peers, an engagement initiative was launched, to identify proactive areas of improvement. The result was a 30% improvement in supplier defects for those suppliers.

Developing and maintaining supplier quality documentation and records is crucial for ensuring that your suppliers meet the required standards and contribute to the overall quality of your products or services. Here is a general guide on how to approach this process: 1. Define Requirements 2. Supplier Qualification 3. Documentation System 4. Supplier Agreements and Contracts 5. Communication and Training 6. Audit and Inspection 7. Quality Control Plans 8. Performance Monitoring 9. Issue Resolution 10. Record Keeping: 11. Continuous Improvement 12. Regulatory Compliance

Examples of supplier quality documentation and records: Supplier Qualification Records: Records of how you choose suppliers Inputs to Supplier before Manufacturing: Give suppliers all the details Drg, QAP, Delivery schedule First Part Inspection Report: Inspection of very first part of project. Supplier Performance Tracker : Keeping track of supplier quality and delivery performance. Non-Conformance Documentation: All NCR to be documented Corrective Action Implementation and Tracking Documents: Preparing action plan by using methodologies like 8D. Timely Monitoring Data and Training/Education to Supplier: Give suppliers feedback on how they're doing and provide training as per project requirement id required.

Examples of supplier quality documentation and records: Supplier quality manual: This document should describe the supplier's quality management system and how it meets your requirements. Supplier quality plan: This document should describe how the supplier will meet your specific quality requirements for a particular product or service. Supplier performance reviews: These reviews should assess the supplier's performance in terms of quality, delivery, and cost. Supplier audits: These audits should verify that the supplier is meeting your quality requirements. Corrective action plans: These plans should describe how the supplier will address any quality problems that have been identified.

Developing and maintaining supplier quality documentation involves creating a systematic record-keeping process for supplier qualifications, certifications, and performance metrics. This includes maintaining updated records of supplier audits, quality control processes, any corrective actions taken. Regular communication with suppliers ensures timely documentation submission. Periodic audits verify ongoing adherence to quality standards. This systematic approach enhances transparency and traceability in the supply chain. For instance, an automotive manufacturer may maintain records of supplier certifications for materials, while a pharmaceutical company would meticulously document supplier compliance with Good Manufacturing Practices (GMP).

For developing and maintaining supplier quality documentation and records key steps are: 1.Define & communicate your quality standards & requirements including specifications and any regulatory compliance standards. 2. Implement a robust document control system to manage supplier-related documents. This includes revision control, and a process for document review and approval. 3.Develop supplier evaluation and approval process based on their quality performance, capabilities, and compliance with your requirements. 4.Communicate effectively with suppliers to address any quality concerns or issues promptly.