Dairy Establishment Inspection Manual – Chapter 9 Good Manufacturing Practices
9.4 Inspection Procedures
This page is part of the Guidance Document Repository (GDR).
Looking for related documents?
Search for related documents in the Guidance Document Repository
This activity should be performed in conjunction with one or more other product inspection activities. Unlike an in-depth inspection, no advance notice should be given prior to a GMP inspection. GMP inspections should be scheduled so that they are conducted throughout the year. All tasks should be assessed according to the criteria on the applicable GMP worksheet and the explanations provided below, all of which are based on criteria in the DEIM. For the most part, the evaluation must be based on the actual activities occurring that day rather than on historical records. The inspector, wherever possible, should verify each task's compliance according to actual processing conditions. The tasks are to be rated as Satisfactory, Not Satisfactory, Not Applicable or Not Evaluated.
At least once per year, one of the GMP inspections will also evaluate the corrective actions taken for the unsatisfactory Category 2, 3 and 4 tasks from a satisfactory in-depth inspection (when a plant meets the criteria for Category 1, 2, 3 and 4 tasks, i.e. 100% in Category 1, ≥75% in Category 2, ≥60% in Category 3 and ≥50% in Category 4) with the results recorded on the MCAP Outstanding Task Report. In this case, because the plant rating was satisfactory, the activity is not considered a follow-up inspection but rather part of a GMP inspection, (Refer to Section 6.3.5, DEIM).
9.4.1 Completing the GMP Inspection Worksheet
Select the appropriate worksheet to use, depending on the type of establishment being inspected:
- GMP Inspection Worksheet (Appendix 9-1). This worksheet is to be used in most establishments
- GMP Inspection Worksheet (For Establishment cutting, grating and packaging cheese; blending powders; freezing pre-pasteurized mixes) (Appendix 9-2). This worksheet is to be used in establishments that do not apply any heat treatment, e.g. cheese cutting, grating and packaging; blending powders and freezing pre-pasteurized mixes.
Careful attention should be paid to the following tasks when evaluating pasteurization or other practices:
1.1Footnote * Verify that the indicating thermometer reading is greater than or equal to the minimum legal temperature and is recorded on the present chart (at a reference point).
1.2Footnote * Verify if the actual indicating thermometer reading is equal or greater to the recorded temperature and that it is recorded on the present chart.
1.3Footnote * If possible, verify that the operator does cut-in/cut-out verifications at start up and at any change in set point according to the proper procedures (observing the indicating thermometer at the actual temperature when the flow diversion device (FDD) moves to forward (cut-in) and divert positions (cut-out)). If this is not possible to observe, ask the operator how this procedure is done. Verify that this has been documented on the present chart.
1.4Footnote * The physical seal must be intact on the flow control device (FCD) (positive pump or magnetic flow meter) to ensure that the minimum hold time has been maintained. Seals must also be verified on the FDD, safety thermal limit recorder (STLR), program logic controllers (PLC), resistance temperature devices (RTD) and pressure differential controllers (PDC).
1.5Footnote * If the homogenizer has a clean-in-place (CIP) bypass line, this line must be physically disconnected during processing. To ensure that no by-pass is present during processing a proximity switch is utilized.
1.6Footnote * Batch pasteurization (including starter vats):
- verify a vat pasteurization cycle to determine if hold time is calculated and inscribed properly on chart (not to include warm-up/cool down period, time starts after the indicating thermometer reading has reached the pasteurization temperature and the airspace thermometer reaches higher required temperature, not to include filling/emptying times, etc.)
- verify that the indicating thermometer reading is greater than or equal to the minimum legal temperature and recorded at least once on the chart during the 30 minute hold at a given time or reference point indicated on the chart
- verify that the airspace thermometer reading is at least 3°C higher than the minimum legal temperature at all times during the hold and is recorded on the chart at the start of the holding period at a given time or reference point and at the end of the holding period.
1.7Footnote * Batch Pasteurization (including starter vats):
- verify that inlet and outlet piping is disconnected during pasteurization.
- verify that lid is closed during operation.
- verify that the agitator is operating during pasteurization.
1.8Footnote * Other - Thermal Processing Tasks or none:
- verify adequacy and effectiveness of other critical thermal processes as per the DEIM inspection criteria appropriate for each process.
NOTE: In the case of establishments manufacturing unpasteurized cheeses, use Appendix 9-1 when establishment is manufacturing or manufacturing and storing unpasteurized cheeses and Appendix 9-2 when an establishment is not manufacturing but storing unpasteurized cheese prior to cutting and/or packaging.
1.9 Verify that the frequency and temperature recorder pens (and third pen, if applicable) are in good working order. (i.e. must have ink and must show divert and forward flow). Both the frequency and temperature recorder pens must track the same time.
1.10 Recording Chart Information:
- verify that the recording charts are completed with the required information by reviewing a small sampling of historical charts.
1.11 Critical Process Test Procedures - verify the frequency and methodology of testing to required standards and that appropriate follow up action is done by reviewing plant records and interviewing plant personnel.
1.12 Microbiological and Composition Controls and Records - verify adequate sampling and testing to ensure regulatory requirements are being met. Appropriate follow up action is done for non-compliant product. Pick one product being produced and have a look at historical microbiological and compositional records for it. In the case of unpasteurized cheese, review records for one product to verify calibration of pH meter, acidity development rate and desired pH has been achieved within the specified timeframe determined by the establishment and that action was taken on any out of specification results.
1.13 Listeria Monitoring Program Records – Verify that sampling and testing (using proper testing methodology) of food contact surfaces (FCS) during production, non-FCS and end product is adequate. Ensure appropriate follow up action for unsatisfactory findings is done in a timely manner and the result is taken into account for trend analysis and when making changes to the frequency of monitoring. Select one product from the highest risk dairy product category and verify that the establishment's sampling of FCS/non-FCS and finished product is based on an internal risk assessment that takes into consideration product risk categories, processing conditions, equipment designs, history of compliance, volume produced etc. All positive results for Listeria monocytogenes or persistent findings of L. spp. on a FCS are communicated to CFIA.
2.1 - 2.4 During the inspection, inspectors are encouraged to spend some time observing the employees at work (their personal hygiene practices, food handling practices, movement throughout plant and allergen and manufacturing controls are in place) to better evaluate inspection tasks 2.1 to 2.4.
NOTE: Any items observed during the course of a GMP inspection that are unsatisfactory but not related to a specific DEIM task identified on the GMP worksheet, are not to be ignored and must be addressed by the plant. Record the observation as Not Satisfactory (NS) under task 2.3 of the worksheet, note the observation in the comments section of the worksheet and request corrective action from the establishment.
Record the inspection findings on the GMP inspection worksheet. All inspection tasks should be scored either: Satisfactory, Non-Satisfactory, Not Applicable or Not Evaluated. (indicate on the worksheet the reason why the task is not applicable or not evaluated). Any deficiencies must be recorded on the CFIA/ACIA 950 form which must be discussed with and signed by a plant representative and the inspector.
Corrective action dates for all non-satisfactory tasks must be agreed upon and recorded on the CFIA/ACIA 950. In some cases, rather then re-writing all the deficiencies on the CFIA/ACIA 950 form an inspector can choose to attach a copy of the GMP inspection worksheet to the CFIA/ACIA 950 form. Reference to the worksheet must be made on the CFIA/ACIA 950 form. If the worksheet is attached then corrective action dates for all non-satisfactory tasks must be agreed upon and recorded on the worksheet.
- Date modified: