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With the advent of COVID-19 pandemic, our ComplianceQuest solutions experts have seen a surge in queries for better supply chain quality management from manufacturing companies globally. As a result, we have been creating powerful resources to share our expertise on supplier, quality and risk management with you. Recently, we released a whitepaper on the Future of Digital Supplier Quality Management. It covers the finer nuances of the future of supplier management from the quality perspective including the importance of regulatory compliance.

This blog is a short excerpt from this whitepaper.

Ensuring Regulatory Compliance in the Supply Chain

Quality leaders have to ensure regulatory compliance while catering to the fast-changing needs and the corresponding transformations in the supply chain. Let’s look at some of these regulatory requirements.

In the United States, regulations such as 21 CFR 820 for medical device firms, the Food and Drug Administration Safety and Innovation Act (FDASIA) for life science companies, and international standards such as ISO 9001:2015, require supplier qualification.

Enterprises across sectors are expected to have regular evaluation and monitoring of their suppliers as part of the quality management process. Every supplier needs to be qualified based on internal and regulatory parameters and reviewed periodically to ensure compliance. Training of existing and new suppliers is also mandated.

Let’s take a quick glance at the current regulations:

  1. FDASIA, Title VII of the Food and Drug Safety and Innovation Act, gives the FDA more authority on the pharmaceutical and medical product supply chain. This regulation relates to the reliance of US-based companies on foreign entities, foreign manufacturing locations and imported goods. Any limitation in supply chain data can hinder visibility into the medical product supply chain and make it difficult to determine the extent of US reliance on foreign manufacturers. The lack of transparency of the medical product supply chain may contribute to product shortages. This became a deep concern in the current pandemic, and several interruptions and shortages were experienced.
  2. Furthermore, regulations like ISO 9001:2015 and ISO 13485 state that:
    1. External providers shall be approved on the basis of their ability to deliver products or services in accordance with predefined requirements. The approval will be given upon an evaluation. An effective and objective evaluation considers the significant parameters regarding the purchased product.
    2. The evaluation is to be conducted on a periodic basis. The frequency of evaluation must be determined. The objective is to establish an ongoing control process over the external provider in order to foresee events that might become nonconformities or quality problems. This is done normally once a year, but there are cases of purchased products that require a more frequent control and risk management.
    3. The parameters for the evaluation should represent the ability of the supplier to deliver products or services that meet the requirements such as:
      • Quality of goods or services
      • Credibility and reliability of delivery
      • Quantities
      • Commitment to prices
      • Maintaining conditions of a standard QMS (ISO 9001, ISO 14001)
      • Parameters like willingness to solve quality problems or the ability to train personnel

Need for Automation

One of the key regulatory requirements is that the manufacturing enterprise is ultimately responsible for the quality of the product, even that of components or raw materials provided by suppliers. The manufacturer is responsible for ensuring that any non-conformance in the final product – even if the root cause of the issue was a component supplied by a third party.

The enterprise, therefore, needs an integrated framework to assess, qualify, onboard, interact and collaborate with suppliers, measure and monitor their performance, escalate issues and, when required, off-board suppliers effectively. This is not possible in a manual system, especially when you are handling several suppliers, across product lines.

A truly integrated supplier management system is therefore a critical need in today’s context. The supplier management solution that is part of your EQMS must seamlessly integrate with your company’s ERP and CRM. This will ensure enterprise-wide data visibility.

This was an excerpt. For more, sign up and get our detailed whitepaper on the Future of Digital Supplier Quality Management.

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