- Case 1A: results are true.
- Case 1B: results are not true.
Measured results are outside established specifications (OOS).
- Case 2A: results are true.
- Case 2B: results are not true.
Cases 1A and 2A are routinely monitored by SPC. Cases 1B and 2B originate from other uncertainties such as imperfect test method performance or poor sampling and are not readily visible by SPC. Cases 2A and 2B are obviously not desirable because the firm cannot process nor sell this product/material. Case 1B constitutes a risk primarily to patients, but also means a risk to the firm if adverse product-related reactions and/or over-/under-dosing would actually occur. Case 2B constitutes a loss solely to the firm and should also be avoided mainly for profit reasons although other problems may also arise from this situation.
Analytical method transfer