Non-conformance and Deviation Report Form
v2.4
Purpose. The source record for any product, process, supplier, good manufacturing practice or safety non-conformance at any site.
1.When to use this form
Complete this form whenever a product, material, process, record or condition does not meet its specification, procedure or standard, whenever a critical control point or in process check is out of limit, and for every customer complaint and safety incident. Complete it on the shift the event is identified.
2.Immediate containment
Before completing the form, contain the problem: stop the line if required, place affected product on hold with a hold label and tell the supervisor. Record the containment actions on the form.
3.Describing the non-conformance
Describe what was found, where, when and how much product or material is affected. Record the batch or lot numbers. Describe facts, not opinions.
4.Investigation and root cause
The quality team will investigate and record the root cause using the five whys or a cause and effect analysis. The investigation section will be completed within ten working days for moderate and major events.
5.Corrective and preventive action
Each root cause must be matched with a corrective action to fix the problem and a preventive action to stop it recurring, assigned to a named person with a due date. The form will be closed only when the actions are verified as effective.