Deviations may arise as a result of but not limited to: material/product – contaminated, out of specification machine/equipment –  failed calibration,  validated operating parameters violated method/procedure – approved process not followed personnel error – not appropriately trained or failing to comply with training requirements, environment – environmental monitoring (temperature/humidity/pressure), water, bioburden etc There are a number of steps to be performed when Nonconforming product is detected: 1)    Contain the Product  Affected material must be appropriately labelled and where applicable, controlled electronically immediately to prevent misuse. 2)    Investigate and Determine Root Cause  The investigation should identify the root cause. Any other potential lots affected should also be identified and contained if … Continue reading ISO 9001 / ISO 13485 clause 8.3 | ISO 22716 Cosmetics GMP clause 13 – Control of Nonconforming Product / Deviations