OEM

The original equipment manufacturer designed and built the machine, which makes its documentation the engineering evidence a risk-based qualification programme is meant to use rather than recreate. Factory acceptance testing, material certificates, instrument calibration certificates and design documentation are all work already performed by someone competent — repeating them under a new cover page consumes the effort that risk-based scoping was supposed to release.

Leveraging that evidence is a decision that must be recorded, not assumed. The question is whether the supplier’s testing covered the attribute you care about, under conditions representative of your use, with results retained and traceable — and whether the supplier’s own quality system makes those results dependable. A supplier assessment is what turns "the OEM tested it" into evidence; without one it is an assertion about a third party.

The relationship continues past handover. Recommended maintenance intervals, spare-part specifications and software support lifecycles are all inputs to keeping the system in its qualified state, and an OEM that ends support for a controller generation creates a qualification problem long before it creates an engineering one.

• —The designer and builder — distinct from a distributor or integrator.
• —Its documentation is evidence a risk-based programme leverages rather than reproduces.
• —Leverage is a recorded decision resting on a supplier assessment, not an assumption.
• —Ask whether the test covered your attribute, under your conditions, with traceable results.
• —End of software or part support becomes a qualification problem before an engineering one.

ASTM E2500-25 for leveraging supplier documentation subject to supplier assessment; ISPE Baseline Guide Vol. 5 (2nd ed., 2019); EU GMP Part I Chapter 7 (outsourced activities).