Ensuring Supply Availability Begins With Robust Supplier Quality Management

In recent years, the pharma industry has gone through major challenges and is witness to disruptive trends that have impacted the ways of working and approach to supply chain processes. More than ever, the industry has experienced firsthand rampant supply chain breakdowns – from delayed shipments to outright unavailability of materials, manufacturing equipment, and finished products, which have caused grave threats to medicine availability.

A key component of the quality management system is supplier quality management. The experiences and events in the height of COVID-19 highlighted the pivotal role supplier quality management plays in ensuring that materials and products needed for manufacturing, warehousing, and lastmile delivery are available on time, in the right quantity, and in quality.

The following are key components of robust supplier quality management:

Risk Management

An organization's risk assessment has now transcended beyond identifying the risks within the organization's processes; rather, risk assessment goes steps further to include the review of the suppliers. The sourcing footprint is established – the source of supply, which includes the capacity and capability of the supplier to provide materials and products that are within specification, storage of supply, regulatory changes, and trade barriers, among others. Foremost to the assessment is determining whether the supplier's product and service impacts the quality of products of the organization. After that, the supplier's capacity, location, and supply network are evaluated to establish any potential risk to the organization's continuity of operations. The outcome of these assessments is used to classify the supplier as to whether Class A, Class B, or Class C, depending on the degree of impact. The level of management and surveillance of the supplier can then be planned commensurate to the level of risk.

Quality Partnership

The relationship between the organization and its suppliers should be one of partnership. In this partnership, the parties ee to commit, communicate, and collaborate. Commit to delivering quality products and services. Communicate openly between both parties, providing each other timely information that is critical in ensuring any disruption in supply is addressed. For instance, organizations should communicate in a timely manner any changes in requirements, giving the supplier enough time to plan and act. The supplier, on the other hand, should inform the organization at the earlier stages of any issue or concern that will potentially disrupt supply. Collaborate to uphold continuous and consistent quality supply. The organization should provide relevant information and training to the supplier to ensure there is alignment in expectations. The supplier should be willing to act on improvement areas to ensure requirements and expectations are met.

Established Performance Metrics and Monitoring

There has to be an agreed performance metric by which the supplier is to be measured. This is periodically reviewed to be able to identify any areas for improvement. If an early sign of concern is detected, both parties should work together to address the cause of the issue. On an annual basis, the supplier performance is reviewed. The review includes performance in the agreed metrics, audit performance, and promptness in addressing any finding and subsequent implementation of CAPA. The status of the supplier is then determined as to whether the approved status is retained, the supplier should be placed under probation pending rectification of issues, or the supplier is discontinued. Technology can be leveraged to digitalize the performance metrics system for a more rapid feedback mechanism, and eventually, data analysis can be performed and utilized for predictive and prescriptive analytics.

Supplier quality management builds the foundation of quality throughout the value chain. Organization–supplier interaction is no longer a buying exercise; both parties should work hand-in-hand to be able to ensure continuity of supply that is compliant with both quality and regulatory requirements. A well-established supplier quality management is key to achieving this objective.