Medical device supplier quality management can be daunting for any quality group, especially when you have many suppliers in multiple geographic areas. The most significant risks to supplier quality are increased fragmentation and globalization of the clinical and commercial supply chain and an increased emphasis on cost control. Both of these risks can result in product made under non-good manufacturing practice (GMP) conditions, studies run under non-good clinical practice (GCP)/good laboratory practice (GLP) conditions, or intentionally adulterated material for the purpose of economic gain. Regulatory agencies expect the sponsor to know their responsibilities for outsourced services and ensure effective assessment of their suppliers before engaging their services. This article will help you learn how to simplify and strengthen your supplier management program.
Engaging a supplier before the quality can be assessed leads to difficulties down the road for your medical device supplier quality management program, which sometimes cannot be mitigated due to contractual agreements. A company may look good from the technical and financial perspective, but if you don’t assess quality before you sign the master services agreement, you may be setting your company up for problems that could ultimately adversely affect your product quality, product launch timelines, safety and efficacy, and company success in the industry. In evaluating contract service providers, you must also consider the cost of poor quality.
As the sponsor, you must have processes in place to assure the control of outsourced activities and quality of purchased material by qualifying your suppliers to ensure they are capable of carrying out the activity or providing material for your process. Supplier risk management is key to managing the multitude of suppliers. It drives supplier selection, the extent of oversight needed, selection of investigational sites to audit, etc. By incorporating quality risk management techniques, you can perform a risk assessment of all your suppliers to determine which are the most critical and should be audited on-site at least every two years, or annually if there are frequent problems. For medium-risk suppliers, you may alternate between on-site and remote audits. For low-risk suppliers, remote audits or questionnaires may be appropriate. Be sure to document your rationale for classifying each supplier and as in any quality decision, it’s critical to relate the risk of poor suppliers back to the product quality, including patient and user safety.
Using supplier quality agreements for critical suppliers helps define the responsibilities and communication processes for quality-related activities and fosters good communication and relationships between suppliers and sponsors. Agreeing on how issues will be handled and resolved before they arise makes navigating the details easier in the future. It provides standards for turnaround times for routine documents (i.e., batch records, reports, etc.) and notification times for deviations, regulatory inspections, and other critical activities. In addition, having a quality agreement in place assures that:
Supplier oversight and routine supplier auditing help monitor supplier performance to identify and implement any needed improvements. In addition, for effective oversight, routine review of quality metrics with your suppliers on a regular basis helps ensure their system is effective and illuminates focused areas for improvement. Metrics typically captured are performance monitoring, test, or product failures, deviations/out of specifications, stability late pulls, failures/rejects, reprocesses/rework, turnaround times, notification times, regulatory history, audit observations, environmental monitoring, etc.
Supplier quality management software can provide the tools needed to ensure proper documentation of the supplier qualification process, monitoring required assessments/audit schedules, and out-of-specification conditions or deviations from the product and/or service provided. It can automate many aspects that are time consuming when performed manually, including creating metrics and other required reports needed as part of the monitoring process.
Having adequately trained personnel and tools to provide oversight of all suppliers is also critical to the success of your medical device supplier quality management program. Effective oversight of suppliers can only be accomplished through regular communication and feedback, including opportunities for improvement from both the sponsor and the service provider. Meeting regularly with your critical suppliers along with occasional visits to their sites helps build strong, lasting relationships and contributes to your company’s success in the long term.
A strong quality culture is critical to ensure patient safety, data integrity, and high-quality products. A sponsor must know their responsibilities for managing suppliers and the risks associated with contracting work to other companies.
In short, your company’s compliance to current regulations and the assurance of a successful supplier management program hinges on three key factors:
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