Product Performance Impact
Assessment against product claims (Labeling, Users Manual
Ancillary product impact or impact on secondary packaging (no safety or efficacy impact).
Impacts product functionality.
Causes no result to be given.
Impacts product performance.
Potential injury due to inaccurate results.
Manufacturing and Process Capability
Assessment against process requirements (i.e. yield, efficiency, process parameters, operator safety)
Impact on process efficiency. Impacts yield and throughput (i.e. increased operational cost, cycle time).
Affects secondary process parameters that impact process yield related to the quality of the product.
Directly impacts process capability that may impact the product or operator safety. (line stoppage causing severe equip damage, key process variables)
Assessment of performance against customer expectations
Potential non-technical complaint. (i.e., cosmetic, ease of use).
Potential Customer complaint. High degree of customer dissatisfaction. (e.g. Customer Technical complaint).
Definite Customer Complaint.
Assessment on Systems such as Compliance to Procedures, Quality Records, Release Information
(i.e., labeling, packaging, integrity)
(i.e., labeling, packaging, integrity).
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