Quality Management

Documents & Templates

Deviations and non-Conformances

7.5

Prevent further deterioration and / or Correct the event.

Corrective Actions

The corrective action is the action necessary to recover the product / process / material / system, affected by the deviation.
7.6 Preventative Action

The preventive action is the action taken to address the root cause of the deviation and prevent reoccurrence of the event.
7.7 Trending of Deviations

Deviations must be trended to detect/predict reoccurrence problems and to monitor the effectiveness of the implementation of the corrective actions. The frequency of the trend analysis and reporting must be at least monthly.

8 PROCEDURE
8.1 Deviation occurred

After deviations has occurred discoverer (originator) takes action, where required, in order to contain the effects of the event (immediate action). The originator informs line manager or supervisor. Originator and supervisor determine if the event requires a deviation report. In doubt QA must be consulted. Discoverer (originator) records the details of the occurrence in the area logbook.
8.2 Details of Deviation Section I (attached form)

The Originator and line manager complete section I of the deviation form. All details of the occurrence must be recorded also in the area logbook. This includes the date and time that the observation was made, a description of the event (what happened, where and when). The immediate action that was taken to contain the event must also be documented. Identify all batches affected by the deviation, if applicable. Date and sign Section I (originator and line manager). QA assigns a unique deviation number added to the top of section I form (QA log file No).
8.3 QA Confirmation Section II (attached form)

QA records the date/time of the observation and a description of the non-conformance, together with any affected batch numbers (if applicable) in the log / database and confirms that in section II.

Document Type SOP

Document ID XX_WWW_ZZZ_YYYY

Version 1.0

Status Approved

Page 9/17

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