Visual inspection qualification introduced for operators
Ergopharm has introduced formal qualification for operators performing the 100% visual inspection of filled ampoules, assessing each inspector against a controlled set of known defects.
Visual inspection is a human detection process, and human detection varies — between people, and for the same person across a shift. Treating it as a step that anybody can perform produces an inspection whose sensitivity nobody knows. Qualification measures it.
“An inspection nobody has measured has an unknown sensitivity, which is to say none.”
Each inspector is assessed against a test set containing known defects at defined severities — particulate matter, cracks, fill volume, sealing defects, cosmetic faults — mixed with acceptable units. Performance is measured on both detection and false rejection, since an inspector who rejects everything is not a good inspector either. A minimum standard must be met before working unsupervised, and requalification is scheduled.
Inspection conditions are controlled as tightly as the people: defined lighting intensity, background contrast, inspection rate and mandatory breaks, because a qualified inspector working too fast under poor light is an unqualified one.
Key facts
- Assessment
- Controlled defect test set mixed with acceptable units
- Measured
- Detection rate and false-reject rate
- Before unsupervised work
- Minimum standard must be met
- Conditions
- Defined lighting, contrast, rate and breaks