Elements and Performance Criteria
- Gather evidence to determine advisability of product recall
- Information and/or inputs from production, regulators or customers are monitored to ensure conformance with specifications.
- Non-conformance is analysed and a risk assessment conducted to determine source of problem and potential outcome.
- Non-conformance of a scale to warrant recall action is reported to appropriate personnel/agencies.
- Decision to recall product is taken in a timely manner.
- Protocol for engaging the media during the recall is developed and agreed between the relevant parties.
- Manage recall process and associated record keeping
- Protocol for acceptance of recalled product is developed and agreed between the relevant parties.
- The need for, and level of, isolation of returned product is communicated to all personnel.
- Accurate records of current stocks and returned product are maintained throughout recall period.
- Records are stored according to third-party requirements.
- Oversee re-introduction, disposal and/or destruction of recalled product
- Conduct post-recall review