Daryl Oldham, Product Marketing Manager, Pilgrim Quality Solutions, an IQVIA company
Do you have the proper processes in place to evaluate, monitor, track, and rate your suppliers? How confident are you that you can rely on your suppliers, or even that you are protected from issues your suppliers encounter at any of their locations?
As global outsourcing activities increase, manufacturers should be placing additional emphasis on the control/oversight of their suppliers, and paying attention to potential risks. Poor cost of quality results in rework, waste, delays in product approval, resource inefficiencies, corrections and removals, enforcement actions, etc., which impact the bottom line.
“When securing an agreement with third-party suppliers, it is critical to identify the positives and negatives, and to properly assess the associated risk of contracting with them,” according to Phil Johnson, Senior Director of Quality and Compliance Services for IQVIA.
How, then, can you strengthen your quality management in the supply chain to ensure your organization’s success in today’s highly complex supplier ecosystem?
Last week, Pilgrim Quality Solutions presented the first in a four-part webinar series taking an in-depth look at Supplier Quality Management (SQM) for the pharmaceutical and medical device industries. During this webinar, Johnson laid out the business drivers shaping the requirements of supplier quality management and the importance of Quality in the evaluation, monitoring, and approval of suppliers.
SQM Driver: Business Considerations
“It’s alarming to still see manufacturers begin receiving product and services from supplier without conducting effective due diligence on the supplier and without securing a formal agreement,” Johnson said.
As a result of this negligence, consequently, outsourcing all too often still results in an increased number of quality issues from product nonconformances, to product recalls and regulatory action. In some cases, simple product changes, within even a minor component from a supplier, can lead to major finished product recalls.
It is important to take a coordinated business approach, both internally and with suppliers. During the webinar, Johnson addresses the importance of assessing the status of their various supplier’s internal quality controls, and monitoring intelligence on the changing global requirements as they relate to Original Equipment Manufacturers (OEMs) and Own Brand Labelers (OBLs).
SQM Driver: Regulatory Considerations
The webinar then provided a brief look at some of the regulatory drivers shaping supplier quality management, including ICH 10 guidance for Pharmaceuticals, the Quality System Requirement (QSR) 21 CFR Part 820 for Medical Devices, the Medical Device Single Audit Program (MDSAP), and ISO 13485:2016.
Johnson described the 2016 updates to the ISO regulation, citing its risk-based approach to the entire Quality Management System, including medical device suppliers of components and services. Under these requirements, simply relying on the basis that the supplier has ISO certification, is not an acceptable practice. Regulators expect legal manufacturers to impose levels of supplier controls that reflect the risk associated with the product or service being provided.
In Parts 2 and 3 of the webinar series, Johnson will take an even more in-depth look at the regulatory landscape driving the need for Supplier Management controls for Medical Devices (Part 2) and Pharmaceuticals (Part 3) respectively.
Best Practices for Supplier Management
More than other quality processes, optimizing supplier quality processes gives you room to differentiate from competitors and get ahead of the industry. But optimization does not happen without regard for potential risks inherent within complex supply chains nor the ever-evolving regulatory requirements.
Johnson outlined best practices for satisfying the supplier quality management requirements being shaped by complex business environments. He presented best practices that emphasized the importance of:
- Implementing supplier controls during the design phase
- Increasing supplier QA resources
- Business and product risks based on the criticality of materials and services
- Including quality in developing agreements with suppliers
- Reviewing how suppliers assess and control the quality of their sub-suppliers
The first webinar concluded with a look at current data and real-world examples from the FDA’s website of organizations that would have benefited from following best practices, and particularly, from having more stringent controls around their supply chain. This included statistics that indicated the majority of pharmaceutical and medical device recalls are due to defects at the supplier.
SmartSolve® Supplier Quality Management
Pilgrim Quality Solutions is ready to alleviate the headaches that come with supplier quality management in the life sciences. With an eco-system of modules that contribute to supplier quality management, Pilgrim is empowering organizations to evaluate, track, report on, and rate suppliers to tackle the business and regulatory challenges presented by a complex supply chain.
Quality In, Quality Out
Exploring Pharmaceutical and Medical Device Supplier Quality Management (Part 1 of 4).