What the inspector wrote
Planned deviation PD-23-014 authorised the use of an alternative mixing speed for product X 'pending completion of the change control'. The planned deviation was approved by the production manager and had been extended four times over eleven months. No change control had been raised. Process validation had not been assessed for the altered parameter.
Why it was cited
The deviation system has lighter approval and no validation assessment. When a change goes through it, the validated state is altered without the controls that change control exists to apply. Eleven months of batches were made under an unassessed parameter.
Inspectors are alert to the term 'planned deviation' for this reason. Some sites have removed it from their vocabulary entirely.
What would have prevented it
- Define a planned deviation, if you keep the concept, as a one-off, time-boxed departure with QA approval and a risk assessment. Anything repeated or extended is a change.
- Set a hard limit on extensions (one, with QA approval) and require a change control to be raised as a condition of that extension.
- Have QA review all open planned deviations monthly and ask of each: why is this not a change?