Phil Johnson, Senior Principal, Quality and Compliance Services, IQVIA
As MedTech manufacturers, do you have the right business and regulatory processes in place to manage your respective supplier management responsibilities? Last week, I presented Part 2 of Pilgrim Quality Solutions’ 4-part webinar series, Quality In, Quality Out, taking an in-depth look at supplier quality management (SQM) processes for both medical device and in-vitro diagnostic medical device manufacturers. The key takeaway from the presentation? These manufacturers need to secure and maintain effective supplier agreements to manage both the regulatory and business needs of the product/material or service being provided.
During this webinar, I laid out the regulatory drivers for medical device supplier quality management and the importance of Quality in the evaluation, monitoring, and approval of suppliers. I also provided guidance for suppliers regarding how they manage their relationships with the legal manufacturers of the product. At the conclusion, I brought it all together by highlighting the prominence of SQM-related FDA 483s.
SQM Scrutiny is on the Rise
Regulatory considerations are taking center stage in the practice of supplier quality management within the Medical Device/MedTech industry. The presentation validated this point by highlighting the newer revisions to FDA, ISO, and other key documented industry requirement. In short, manufacturers must now consider these factors:
- The regulations for medical devices are well developed, and recent updates to these regulations now place increased emphasis on the requirements of taking a risk-based approach to supplier quality management.
- Product documentation must be held by legal manufacturers, and contract manufacturers are responsible for providing it as well.
- Among European manufacturers, requirements have replaced “Own Brand Labelers” with a new definition of “Virtual Manufacturer.”
- It is now necessary to have technical and quality agreements in place between the different players in the supply pyramid to ensure supplier controls are adequately implemented and observed.
- FDA enforcement within Purchasing Controls is still high on the list of annual 483 observations, with lack of procedures as the highest number. “If it is not documented, you do not do it in the eyes of the FDA.” The same tenet also applies to all other regulators.
The Supplier Pyramid
The webinar introduced the concept of the “Supplier Pyramid” which illustrates the relationship between legal manufacturer — that is, the entity that is responsible for placing the finished product on the market — and their suppliers. The legal manufacturer can be referred to in many guises: Specification Developer, Private Labeler, Own Brand Labeler, Virtual Manufacturer.
SQM Driver: The regulations and standards
Supplier quality management regulations are represented globally by three major regulations/standards:
- 21 CFR Part 820
- ISO 13485:2016
- Medical Device Single Audit Program (MDSAP)
The 2016 updates to the ISO standard require manufacturers take a risk-based approach to the entire Quality Management System, including medical device suppliers of components and services. Regulators expect legal manufacturers to impose levels of supplier controls that reflect the risk associated with the product or service being provided.
The detailed requirements of the Medical Device Single Audit Program (MDSAP) effectively summarize the process which all three regulations/standards expect for SQM:
- Defined, documented and implemented procedures to ensure purchased or otherwise supplied products conform to specified purchase requirements
- Established criteria for the selection, evaluation and re-evaluation of suppliers based on the type and significance of the product purchased and the impact of the supplied product on subsequent product realization or the quality of the finished device
- Performed the evaluation and selection of suppliers based on the capability of the supplier to meet specified requirements
- Ensured the continued capability of suppliers to provide quality products that meet specified purchase requirements through re-evaluation
- Determined and implemented an appropriate combination of controls applied to suppliers in conjunction with acceptance verification activities to ensure conformity to product and quality management system requirements, based on the impact of the supplied product on the finished device
FDA Enforcement Metrics – Form 483 observations for purchasing controls
The webinar concluded by looking at the annual FDA metrics for Form 483 Observations for medical devices. The metrics covered the last published FDA data covering the period 10/1/2016 to 9/30/2017.
This chart illustrates that the “lack or inadequate procedures” for Purchasing Controls (21CFR Part 820.50) is still a significant deficiency with medical device manufacturers. In fact, during the time period studied, 13.4% of Form 483 Observations during this period were attributed to Purchasing Controls (SQM).
While the same data extracted from ISO/Notified Body and MDSAP audit observations is not available, through IQVIA’s interactions with manufacturers to support their corrective actions plans following FDA inspections, we know that similar nonconformances for SQM are observed during ISO/NB and MDSAP audits.
SmartSolve® Supplier Management
More than other quality processes, optimizing supplier quality management 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.
While the business and regulatory requirements that impact every device manufacturer’s supplier operations are growing more stringent, Pilgrim Quality Solutions provides support for the processes integral to a compliant and successful supplier quality management program. With an eco-system of supplier quality modules, Pilgrim is empowering organizations to evaluate, track, report on, and rate suppliers to tackle the challenges presented by a complex supply chain.
In Part 3 of the Quality In, Quality Out webinar series, on September 19, 2018, I will again talk about supplier quality management, with a focus on the regulatory drivers of SQM for Pharmaceutical manufacturers.
Quality In, Quality Out
Regulatory Drivers of Supplier Quality Management in the Medical Device Industry (Part 2 of 4).