It does not apply to lab-scale, pilot, or pre-productino processes. However, particular management of some KCs might be required using other methods than those described in the standard, during these phases of a program, when required by the customer or deemed appropriate by the organization (e.g., Engineering department requirement).
The variation control process begins with product definition, typically an engineering drawing or specification which identifies KCs, and leads to a variation management program for those KCs. This process may also be used for producer-identified KCs.
Producers and their subcontractors shall be responsible for flow down of the requirements of the applicable revision of this standard to subcontractors, who produce design characteristics, and for ensuring tht KCs conform to customer requirements.






