Criticality Matrix






Product Performance Impact

Assessment against product claims (Labeling, Users Manual

No impact

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)

No impact

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)

Customer Satisfaction

Assessment of performance against customer expectations

Not noticeable

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.

GMP Systems

Assessment on Systems such as Compliance to Procedures, Quality Records, Release Information

No impact

No impact

Potential recall.

(i.e., labeling, packaging, integrity)

Potential recall.

(i.e., labeling, packaging, integrity).

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