Supplier qualification beyond the completed questionnaire
A supplier questionnaire can provide useful information about an organisation's systems and capabilities. Its value depends on how that information is evaluated against the material or service being supplied and the consequences of a failure.
The assessment should begin with the intended use. A calibration provider, a single-use assembly manufacturer and a contract testing laboratory present different risks and require different evidence. A common questionnaire may support initial screening, but further assessment needs to reflect the activity.
For a single-use assembly, relevant considerations may include manufacturing controls, configuration, sterilisation, integrity and notification of changes. For a laboratory, the focus may include method suitability, sample handling, data governance, investigation practices and access to the underlying records.
The strength of an answer also needs consideration. A statement that a procedure exists provides limited assurance about how effectively it is implemented. Supporting records, discussions with responsible personnel and, where justified, an audit can help establish whether the stated controls operate in practice.
In my view, the qualification decision should explain why the available evidence is sufficient for the proposed use, identify limitations and set out any conditions of approval. Where evidence remains incomplete, the associated uncertainty should be visible to the person authorising the decision.
The commercial arrangements need to support the quality expectations. Responsibilities for change notification, deviations, subcontracting, record access and escalation should be agreed where relevant, rather than discovered during an incident.
Approval is also the start of an ongoing relationship. Delivery performance, complaints, deviations, audit findings and changes can provide information that affects the original assessment. The approach to periodic review should reflect the supplier's significance and experience of its performance.
A completed questionnaire demonstrates that information has been collected. A meaningful qualification record explains how that information supports confidence in a specific supply or service.
That distinction becomes important when the supplier's output directly influences a manufacturing or batch disposition decision.
Background and scope
EU GMP Part I, Chapter 5, section 5.27 onwards, and Chapter 7, particularly sections 7.4 to 7.8. The evidence required depends on the supply or outsourced activity.