What the inspector wrote
Review of maintenance work orders for the purified water system identified 14 component replacements over 18 months recorded as like-for-like. In six cases the replacement was from a different manufacturer or of a different material of construction, including a UV lamp of a different output and a pump seal of a different elastomer. No equivalence assessment was documented for any of the 14. The procedure permitted the maintenance technician to determine like-for-like status.
Why it was cited
Like-for-like is an exemption from change control, and an exemption is only defensible when its criteria are defined and its application is evidenced. A different manufacturer or material means the qualification evidence for the old component does not automatically cover the new one. Nobody checked.
Allowing the requester to decide the classification of their own change removes the independent review that change control exists to provide. Inspectors read maintenance records precisely to find this.
What would have prevented it
- Define like-for-like in the procedure as identical in form, fit, function, material and manufacturer part number, and require a documented equivalence check by engineering and QA for anything that is not.
- Route every replacement on a qualified system through a short-form change or an equivalence record; make the maintenance system unable to close a work order on a qualified system without one.
- Include maintenance records for critical utilities in internal audit scope with a specific check for uncontrolled changes.