What supplier-management requirements are typically included in SOPs?

• A. A phone directory of approved suppliers.
• B. A simple supplier list with no criteria.
• C. Audits and acceptance testing are optional for suppliers.
• D. Approved supplier lists, qualification criteria, supplier audits/assessments, acceptance testing, and change notifications.

Answer: (D)

Supplier management in SOPs relies on establishing controlled, repeatable processes to ensure any supplier and material used meets quality and regulatory expectations. A robust SOP will specify an approved supplier list to ensure only recognized sources are used, define qualification criteria so suppliers are evaluated on relevant factors like quality systems, capability, and performance, require supplier audits or assessments to verify ongoing conformance, mandate acceptance testing to confirm incoming materials meet specifications before use, and include change notifications to manage any changes in suppliers, processes, or materials so impact is assessed and documented. This comprehensive approach provides traceability, ensures quality, and reduces risk. A phone directory alone lacks controls, a simple list with no criteria misses important oversight, and making audits or acceptance testing optional undermines essential risk management.