Dairy Establishment Inspection Manual – Chapter 9 Good Manufacturing Practices
9.7 Non-Satisfactory Inspections
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Actions to be taken for non-satisfactory inspections will be based on the severity of the findings and/or level of responsibility taken by the plant. The impact of the deficiency must be evaluated to determine if product safety has been compromised and what actions, if any, the establishment has taken to determine that the product is safe. For the following two scenarios, it is important that the inspector inform the appropriate Program Specialist in order to jointly determine the action to be taken.
- Critical health & safety implications - This could be due to the non-satisfactory evaluation of any pasteurization tasks, any other Category 1 or 2 tasks, or the occurrence of direct product contamination. If any of these tasks are non-satisfactory, immediate action must be taken to isolate affected product manufactured during the occurrence of the problem.
- If the establishment has not demonstrated to the inspector that the product is under control or safe, it should be detained. Laboratory analysis (phosphatase and/or microbiological analysis) of the affected lots may be done to determine the product's safety.
- If product has been distributed, the inspector should immediately contact the appropriate Program Specialist with the relevant details to determine if a product recall may be necessary as per the recall protocol.
- In addition to controlling the affected product, the establishment must also take the appropriate measures (e.g. training, reviewing written procedures) to prevent the problem from re-occurring.
- The establishment is to provide a response letter outlining their intended plan of action and the measures taken to prevent the problem from re-occurring, which is to be received no later than 3 weeks from the inspection date.
- Lack of plant responsibility -This is indicated by repetitive inaction by the plant either to formulate an action plan or to carry out any corrective actions.
- A meeting should be set up with the appropriate responsible plant management to thoroughly explain the deficiencies and why they must be corrected. The meeting should end with a mutually agreed upon action plan being developed and commitment for its implementation.
- If subsequent GMP inspections do not indicate satisfactory corrective action and it is felt that compliance will not be forthcoming, the procedures to cancel or suspend registration may be initiated. (Section 10.1 or 10.2 (2) of the DPR).
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