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  • Document No - AU-001-T

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Antibiotic

Determination of CCP’s WW Excellence 2.8, BRC 2.8, CFMSR V2 1.13, Export Control Orders Milk 2005 – Division II 3.1-3.9, Approved Arrangements section 20

  • For each hazard that requires control, control points shall be reviewed to identify those that are critical.

  • Has each identified critical step in the HACCP plan been assessed with the decision tree in HA-003 HACCP Procedure?<br>

  • Has this been documented in the HACCP Study.

Critical Limits WW Excellence 2.8, BRC 2.8, CFMSR V2 1.14, Export Control Orders Milk 2005 – Division II 3.1-3.9 , Approved Arrangements section 20, AS 1766.3.11 Penicillin, Food Standards Code 1.4.2 – MRL’s schedule 1

  • Critical limits must be defined and documented in the HACCP Audit Table and Flow Chart.<br>Charm (Quick Screen) : Negative (-400 or less) on the Rosa reader / EZ reader<br>Copan / Delvo (CCP): Negative (<0.0015ug/L Benzyl G Penicillin) <br>

  • Do HACCP plans reference HA-004 HACCP - Critical Control Point Validation, AS 1766.3.11 Penicillin and Food Standards Code 1.4.2 – MRL’s schedule 1 as justification of limits?

  • Are these limits clearly displayed on the HACCP plans and associated log sheets?

Monitoring Plan WW Excellence 2.10, BRC 2.10, CFMSR V2 1.15, 1.16, Export Control Orders Milk 2005 – Division II 3.1-3.9, Approved Arrangements section 20

  • Is the Audit Table written in a way so any loss of control can be detected? <br>

  • Does the Audit Table contain details of how the measurement is to occur, frequency required, acceptable limits and persons responsible?

  • Do records associated with the monitoring of CCP’s include the date, time, result of measurement and signed off by a person responsible?

  • Is there Supervisor review and sign off?

Corrective Actions WW Excellence 2.11, BRC 2.11, CFMSR V2 1.17, Export Control Orders Milk 2005 – Division II 3.1-3.9, Approved Arrangements section 20,

  • The corrective action taken when a CCP deviates from the critical limits must be detailed and documented in the Audit Table by the HACCP team.

  • In the event of a Copan / Delvo positive, (CCP failure), does the site follow QF-09 Antibiotic Testing?<br><br>

  • Does this include notification to the State Regulatory Authority?

  • A MYOSH notification must be raised for every positive Copan / Delvo test. This will include a risk assessment, root cause analysis and corrective actions?<br>Review any PIRs raised following a positive AB Test result.<br>

  • Has Milk Supply followed up with the Supplier identified as being the cause of the positive antibiotic.

Verification WW Excellence 2.11, BRC 2.11, CFMSR V2 1.19, Export Control Orders Milk 2005 – Division II 3.1-3.9 , Approved Arrangements section 20

  • HACCP plans must be verified to confirm effectiveness.<br>Site verification activities occurring around antibiotic testing?<br>• Daily calibration checks on the Rosa reader (MK-04-04-A Rosa Reader Daily Calibration)<br>• Weekly calibration checks on the EZ reader<br>• Supervisor review / sign off of Charm log sheets daily<br>• Monthly downloading of Rosa Reader / EZ Charm results and review<br>

  • In the verification activity around antibiotics, every Myosh notification raised for a positive Copan result has been closed out as complete?

CCP Training WW Excellence 13.10, BRC 7.1.2, CFMSR V2 1.18, Export Control Orders Milk 2005 – Division II 3.1-3.9, Approved Arrangements section 20

  • Site personnel responsible for monitoring CCP’s must have an understanding of food safety issues related to their task. <br>Does the site training plan cover HACCP and CCP monitoring (antibiotic) methods?<br>MK-01-04 Charm MRL Test Method<br>MK-04-04-A Rosa Reader Daily Calibration<br>MK-04-04-T Charm MRL Training Notes<br>QC-363 Antibiotics Charm EZ Reader<br>QC-363-T Antibiotics Charm EZ Reader Training Notes<br>QB-078 Delvo / Copan Test Method<br>QB-078-T Antibiotics – Copan / Delvo<br>QF-09 Antibiotic Testing (Actions & Notification of Test results)<br>QF-09-T Antibiotic Testing Training Assessment<br>Is there a record of initial training for all personnel conducting tests using these methods and has refresher training occurred in the last 12 months?<br>

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