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Zamshed Harun's avatar

A competence held on paper and never exercised is not held, and the gap appears at the moment it is needed, by which time it cannot be rebuilt. Medicines regulation met this when manufacturing and safety monitoring moved to third parties, and its answer was not to keep the capability in-house but to inspect it: a licence holder stays personally answerable for contracted work, tested on a cycle rather than accepted on assertion. A hydrographic reserve buys surge capacity, which is the harder half to build. Whether an oversight function can still challenge what a contractor hands over is a separate question, answered by inspecting the customer.

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