BALANCING INTERNAL PROCESSES AND THIRD-PARTY PROVIDERS

The biotech and pharmaceutical industries depend on both internal manufacturing and compliance processes as well as third-party suppliers. Between these intertwined parties, it's critical for companies to find a way to hold themselves and their suppliers to stringent standards for quality and compliance while driving supply chain efficiencies and profits rather than impeding them.

Companies must take a proactive approach and increase visibility into potential supplier problems by obtaining a global view of all quality issues and supplier scorecards. This has far-reaching benefits, as it 1) ensures compliance with industry regulations, good manufacturing practices (GMPs), and ISO standards; 2) eliminates high costs related to scrap, rework, and delays caused by supplier quality problems; and 3) anticipates and eliminates repeat problems by improving supplier investigation and root cause analysis processes.

CRITICAL COMPONENTS FOR SUPPLIER QUALITY MANAGEMENT

An enterprise-wide centralized process must encompass myriad quality management and compliance components, including:

• Supplier qualification: Manage qualification and approvals of new suppliers, including all necessary qualification steps, which may vary based on the supplier's risk assessment, and may include tasks such as self-assessment and onsite audit.
• Supplier audits: Handle audits based on the risk level, audit frequency, and the supplier rating or score established in a supplier's profile. When a trend in supplier quality problems is identified, companies must schedule ad-hoc supplier audits. The audit process, related audit findings, and subsequent supplier corrective and preventive actions must be managed and tracked to ensure quick and effective resolution.
• Incoming material inspections: Create inspection records when materials are received to ensure tracking of all inspection activities, including inspection type, received date, material information, quantity, inspection results, and related information.
• Approved supplier lists and scorecards: Enable the organization to maintain and monitor approved or preferred supplier lists. Approved supplier lists can be customized reports or online databases that can be reviewed and updated by qualified staff.
• Supplier nonconformance: Directly generate nonconforming material reports (NCMRs) from the inspection record or independently within the manufacturing operation when the materials are below quality control standards. Guarantee that the supplier investigations and root cause analyses are tracked through completion.
• Supplier CAPAs: Track all supplier corrective and preventive actions (CAPAs) through completion. Provide third-party suppliers with secure access to view only their specific NCMRs, and audit findings and record corresponding corrective actions.
• Supplier documentation: Maintain or link to documentation of important specifications, including inspection plans, delivery windows, and acceptance sampling for received items.

CONCLUSIONS

Managing supply quality effectively serves not only to drive compliance, but also to reduce the cost of poor quality, which, with both tangible and intangible ramifications (costs of product recalls, tarnished reputations or brand image), can ultimately be a detriment to any biotech or pharmaceutical organization. Without a stringent, holistic, and centralized supply quality management initiative that drives numerous supply chain and organizational efficiencies, companies' bottom-line objectives will be undermined, eroding any previous organizational successes.

Mike Jovanis is the vice president of product management at Sparta Systems, Holmdel, NJ, 732.203.0400, mike.jovanis@sparta-systems.com