Florian Czaszewicz, Industry Solutions Consultant, Pilgrim Quality Solutions
Last week, I had the opportunity to explore the Life Sciences Supplier Qualification and Control Framework along with Nicky Dodsworth of Premier Research, Dr. Benjamin del Tito of the Biologics Consulting Group, Peggy J. Barry of Synergy Consulting, and The Knowledge Group. In today’s post, we’ll review key takeaways from Pilgrim’s portion of the webinar. If you’d like to view the entire webinar, you can watch the on-demand version of Life Sciences Supplier and Contractor Qualification and Control Framework Explored here.
The Supplier Market Canvas
To frame this question, I asked my 16-year old daughter to paint my vision of the supplier market on a canvas. Our perspective on what constitutes the “supply chain” may vary considerably depending on where we sit, the type of organization we are a part of, the activities/projects, products/services, resources, and information we manage or are responsible for.
Within the context of drug development, BioPharma companies look to acquire multiple external components to support their strategies and programs. This could be compared to entering a broad farmers’ market looking at products and services that resemble each other and not knowing how the individual ingredients will affect the final result.
Purchasing at a market stall without making a thorough assessment is similar to making uninformed supplier and contractor choices. A poor assessment could ruin the entire production altogether with potential disastrous collateral effects. These could include higher internal and external costs due to waste and rework, retesting, failure analysis, customer complaints or recalls, fines, jeopardizing clinical trials, or damage to the organization’s reputation. Every supplier can have an impact on the entire demand chain and make the process stop. As sourcing practices grow to satisfy global business imperatives, risk due to supplier contracting activities also multiplies.
Responsibilities and Obligations for Supplier Qualification Process and Control
Even though individual supplier quality practices can vary considerably, the responsibilities and obligations surrounding and pertaining to outsourcing are clear, are not new, and only reinforce the principle that,
“The pharmaceutical company is ultimately responsible to ensure processes are in place to assure the control of outsourced activities and quality of purchased materials.”
Additional international directives and guidelines enunciate similar duties. FDA 21 CFR 200.10, 820.50, Eudralex Volume 4 Chapter 7, ISO 13485:2016, CGMP, PIC/S Guidance, or EU-GMP Chapters, and previous ICH Q versions.
Beyond regulations, contract givers also have a moral obligation to satisfy these protecting rules, realizing the serious impact or consequences poor quality outsourced activities could cause to the safety of the patient and to their own business.
If organizations are not fulfilling their obligations of control against their suppliers, the statistical curve reflecting the number of supplier-related FDA 483 citations will continue to get higher.
SmartSolve Supplier Quality Management
Assess, monitor, and improve supplier quality.
The Traditional Supplier Control Framework
A traditional approach to supplier and contractor lifecycle management comprises several different phases:
- Initial Vendor Assessment
- Supplier Qualification Audits
- Contractual and Legal Agreements
- Periodic Reviews or Surveillance Audits
- Supplier Requalification
- Supplier Performance Monitoring
While each of these lifecycle steps present their own challenges, supplier performance monitoring can present significant challenges considering the high number of suppliers Life Sciences organizations are utilizing, the global nature of the supply chain, and limited internal audit resources.
Traditional approaches may work well for the early-stage efforts of the supplier qualification, evaluation, and selection process if the “predicate rules” are followed, but later stages, such as supplier performance monitoring, must be supported by well-defined processes, tools, and methods.
Reading the Signals Early On
Due to the breadth of the supply chain, it is literally impossible to audit all suppliers on an ongoing basis. Supplier and contractor management activities must follow risk-based principles to be effective.
Organizations should look for ways to dynamically capture and immediately assess the essential facts and details from quality records such as complaints, investigations, out-of-specification results, nonconformances, deviations, CAPAs, calibration events, requirements certification statuses, and more.
This also means that Risk Management must be embedded into Supplier Quality Management activities to detect, estimate, or even predict potential areas of concern. The use of an automated, global supplier quality platform becomes essential to capture, measure, and analyze all of this data.
Use a Palette of Supplier Quality Tools to View the Whole Picture
Pilgrim SmartSolve® Supplier Quality Management integrates and aggregates key supplier qualification and quality data to generate accurate supplier ratings or scorecards based on the results of audit findings, deviations, corrective actions, or incoming inspections. These events are all cross-referenced for full traceability and transparency.
These real-time snapshots of supplier quality can also retrieve any issue details or data elements, and map them to Quality Metrics. This is where the full meaning and practical expression of supplier performance monitoring and risk management occurs.
Quality Intelligence through visualizations, predictive analytics, queries, dynamic reports, and dashboards will empower users to perform data discovery to uncover trends, patterns and data outliers, adding significant value to the traditional monitoring methods, and helping gather knowledge and trigger appropriate, risk-based actions.
The supplier qualification and control framework is an essential process that Life Sciences organizations must not miss, lose, or misplace if they want all parts of their Enterprise Quality puzzle to be complete. Effective supplier and contractor management will drive safety, compliance, risk management, and quality throughout your product lifecycle.