With manufacturing and supply chain processes becoming more complex, critical aspects of a product are being outsourced to external global suppliers or product parts have become commodity purchases. It has become imperative that the quality of these products also meet regulatory requirements. Of course, regulatory compliance and quality metrics, ideally, must not delay time to market. A well-designed Supplier Quality Agreement plays a crucial role in ensuring this compliance. In our recent whitepaper, we take an in-depth look at SQAs.
This blog is a short excerpt from this whitepaper.
Apart from being a regulatory requirement, SQAs are legally binding documents that can serve as critical evidence during a lawsuit or litigation. They also remove any ambiguity regarding what is expected of the supplier.
Therefore, organizations must establish a robust supplier quality management program to help quality and SCM leaders ensure that the established requirements are met. Additionally, any changes proposed by the suppliers are required to be properly reviewed and approved by the quality leader.
The SQA must cover key clauses related to the following:
- Critical suppliers
- Contract warehouses
- Original equipment manufacturers (for any redesign of equipment)
- Label/IFU suppliers
- Contract laboratories
- Calibration service providers
- Critical outsourced providers
- Translation service providers
- Sister facilities (they will also be treated as independent contractors)
The only way to ensure adherence to the Supplier Quality Agreement: A robust EQMS
In an organization, SQA may be initiated by any function. While the compliance and quality functions may be responsible for review and ensuring conformance, the SQA can be signed between any department and their suppliers. Therefore, it is essential that everybody knows the SOP and follows it for creating and maintaining SQAs.
The process of identifying, onboarding suppliers, assessing their risk level, creating specific quality agreements unique to each supplier, review and revision is complex, requiring time and effort. An EQMS like the one from ComplianceQuest makes managing SQA-related workflows or processes easier. Of course, it also makes it easy for the head of quality to have a finger on the pulse of all supplier-related regulatory compliance requirements.
Some of the key features of the Supplier Management module in the CQ EQMS that can help manage the SQA workflow effortlessly include:
- Supplier Ratings and Scorecards
- Onboarding and change management
- Corrective action requests
- Deviation request
- Document exchange
- Incoming inspections and CoA
- Production Part Approval Process
Being built on the Salesforce.com platform, the ComplianceQuest supplier solution automates the supplier management workflow and integrates with enterprise solutions such as ERP and CRM to provide end-to-end visibility. Being aligned to ISO and other key regulatory standards across geographies, helps revise documents based on any new regulatory changes. The ComplianceQuest Supplier Management solution also integrates with other EQMS workflows including CAPA, change management, risk management, document management and training.
If you would like to automate your supplier quality agreement program workflow, contact us here: https://www.compliancequest.com/contact-us
For a detailed read on Supplier Quality Agreements, get our detailed whitepaper, Supplier Quality Agreements for Supply Chain Risk Mitigation and Compliance
This whitepaper has been created based on a Webinar by Bob Mehta, Principal Consultant at GMP ISO Expert Services.