By Lisa Helmonds, Vice President of Quality and Operations, MWA Consulting, Inc., and Myrna Russell, Director of Quality and Audit Management, MWA Consulting, Inc.
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.
Assuring Quality Through Supplier Risk Management
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.
Clarifying Responsibilities With Supplier Quality Agreements
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:
- The manufacturing process stays the same.
- Changes are adequately justified.
- Deviations are properly investigated.
- Institutional knowledge is retained and remains accessible if key personnel leave the company.
Tools for Enhancing Supplier Oversight
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.
Building a Culture of Quality With Suppliers
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:
- Applying a risk-based approach to qualifying, auditing, and tracking useful metrics on the products and services provided.
- Managing suppliers effectively by using quality agreements to ensure sponsors and suppliers agree on who is responsible for each activity as well as the requisite resources.
- A reputable supplier quality management software solution capable of handling the processes involved.
About the Authors
Lisa Helmonds focuses on developing and maintaining relationships with MWA Consulting, Inc. clients, implementing training programs, and ensuring that MWA’s consulting team continues to offer the highest quality services in the industry. Lisa has over 30 years of industrial training in the areas of manufacturing and quality Assurance in the pharmaceutical and medical device industries. She has extensive GxP knowledge, has worked with several startups and large companies, and understands the challenges facing the industry. She holds a B.S. in Zoology from the University of Rhode Island and an MBA from Santa Clara University.
Myrna Russell has over 30 years of experience leading quality organizations, R&D, and manufacturing within the medical device, aerospace, and cosmetic industries. Myrna is committed to continuous improvement across platforms to ensure that MWA and its’ clients continue to meet or exceed quality and business objectives, while maintaining global regulatory requirements. Her focus is managing internal and external programs for MWA, including Client Quality System Audits and Projects. Her expertise includes growing start-ups, mid-size, and large fortune 500 companies. She credits training, coaching, mentoring employees at all levels, and communicating their value as key components to providing exceptional service to clients to maintain audit readiness, and ultimately improve the quality of their products and services to the end users and the patients.
To learn more about MWA’s capabilities please visit our Consulting Services page and contact one of our team members to discuss how we can support your goals ahead. To learn more about MWA’s capabilities please visit our Consulting Services page and contact one of our team members to discuss how we can support your goals ahead. To download a copy of the article please visit MasterControl.