Dairy Establishment Inspection Manual – Chapter 9 Good Manufacturing Practices

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9.1 Objective of Activity

To ensure that good manufacturing practices (GMP) affecting health and safety concerns are being met in registered establishments.

9.2 Scope

This activity is conducted by Canadian Food Inspection Agency (CFIA) inspectors to assess good manufacturing practices at registered dairy establishments under actual processing conditions. At least once per year a GMP inspection activity also includes the monitoring of the unsatisfactory Category 2, 3 and 4 tasks following a satisfactory in-depth inspection.

9.3 Required Equipment/References

9.4 Inspection Procedures

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:

  1. GMP Inspection Worksheet (Appendix 9-1). This worksheet is to be used in most establishments
    OR
  2. 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.

9.5 Overall GMP Assessment

An inspection will be considered non-satisfactory under the following conditions:

GMP Inspection Worksheet (Appendix 9-1):

  1. If an establishment receives one non-satisfactory rating in the inspection tasks identified with an asterisk (Footnote *), (i.e. 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8) or
  2. If an establishment receives three or more non-satisfactory ratings in the inspection tasks without an asterisk (Footnote *), (i.e. 1.9, 1.10, 1.11, 1.12, 1.13, 2.1, 2.2, 2.3, 2.4)

GMP Inspection Worksheet (For Establishment cutting, grating and packaging cheese; blending powders; freezing pre-pasteurized mixes) (Appendix 9-2):

  1. If an establishment receives one non-satisfactory rating in the inspection tasks identified with an asterisk (*), (i.e. 1.8) or
  2. If an establishment receives two or more non-satisfactory ratings in the inspection tasks without an asterisk (*), (i.e., 1.12, 1.13, 2.1, 2.2, 2.3, 2.4)

The overall GMP assessment is to be noted on the CFIA/ACIA 950. Actions to be taken will depend on the overall GMP assessment.

9.6 Satisfactory Inspections

Even if the GMP inspection is assessed as satisfactory the outstanding issues will still need to be noted on the CFIA/ACIA 950 form with agreed upon corrective action dates for all non-satisfactory tasks. As is the case with the indepth inspection the plant is required to submit corrective action dates even though the inspection may be considered satisfactory. The follow up to the correction would then be done on a subsequent GMP inspection. If the inspector so chooses he or she may want to request the establishment to respond in a letter outlining their intended plan of action which should be received no later than 3 weeks from the inspection date.

9.7 Non-Satisfactory Inspections

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.

  1. 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.
  2. 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).

Appendix 9.1 GMP Inspection Worksheet

Establishment
Reg. No.
Inspector
Contact
Date

S = Satisfactory; NS = Not Satisfactory; NA = Not Applicable (indicate why); NE = Not Evaluated (indicate why)

1.0 Food Safety Controls
Inspection Task S/NS/NA/NR Inspection Task S/NS/NA/NR
1.1Footnote *Indicating thermometer reading ≥ minimum legal temperature and recorded on chart at a reference point.
DEIM 1.11.02.01&.1.11.02.02 (HTST); 1.12.01.01 &1.12.01.02 (Batch); 14.02.04 (APPS); 1.17.02.04 (HHST/ESL)
1.2Footnote * Actual indicating thermometer reading ≥ recording thermometer temp. & recorded on present chart.
DEIM 1.11.02.02 (HTST); 1.12.01.02 (Batch)
1.14.02.04 (APPS); 1.17.02.04 (HHST/ESL)
1.3Footnote * Cut-in/cut-out verifications done properly at start up and recorded.
DEIM 1.11.02.02 & 1.11.11.03 (HTST);
1.14.11.01 (APPS); 1.17.11.01 (HHST/ESL)
1.4Footnote * Seal intact on FCD, FDD, RTD, STLR, PDC, PLC
DEIM 1.11.06.02, 1.11.09.07, 11.11.07, 1.11.11.08, 1.11.12.04, (HTST);
1.14.06.02, 1.14.09.06, 1.14.10.05, 1.14.11.06, 1.14.11.07, 1.14.12.05 (APPS);
1.17.06.02, 1.17.09.06, 1.17.10.05, 1.17.11.06, 1.17.11.07, 1.17.12.05 (HHST/ESL)
1.5Footnote * No FCD bypass during hold. If the homogenizer is used as the FCD, there is no by-pass around the homogenizer during processing. A proximity switch is used so FDD will not operate in forward flow.
DEIM 1.11.06.03 (HTST);
1.14.06.03 (APPS); 1.17.06.03 (HHST/ESL)
1.6Footnote * Batch pasteurization (including starter vats):
  • accurate hold time recorded
  • time & temp. ≥ minimum legal rqmts.
  • airspace thermometer ≥ 3°C than minimum legal temperature
DEIM 1.12.01.01, 1.12.01.02, 1.12.01.03, 1.12.02.04 (Batch)
1.7Footnote * Batch pasteurization (including starter vats)
  • continuous agitation
  • inlet and outlet lines disconnected
  • lids closed
DEIM 1.12.02.01, 1.12.02.02, 1.12.02.03 (Batch)
1.8Footnote * Other - Thermal Processing or no thermal processing
DEIM 1.13.02.02 - .04, 1.13.03.01 - .02, 1.13.07.01, 1.13.09.03, 1.13.10.01 - .02, 1.13.11.01 - .05, 1.13.12.01-04, 1.13.14.01 (Retort);
DEIM 1.13.18.01, 1.13.18.02, 1.13.18.03 (Coil Vat);
DEIM 1.13.19.01, 1.13.19.02, 1.13.19.03 (Formulation and Verification); - 60 day storage, records and labelling – production date for unpasteurized cheeses. DEIM 1.10.07.02 (E)
1.9 Frequency and temperature recording pens track the same time & all pens are functional.
DEIM 1.11.11.04 (HTST);
1.12.05.02 (Batch);
1.14.11.03 (APPS); 1.17.11.03 (HHST/ESL)
1.10 STLR & MBTS Records/Charts completed with required information.
DEIM 1.11.02.02 (HTST);
1.12.01.02 (Batch);
1.14.02.04 (APPS); 1.17.02.04 (HHST/ESL)
1.11 Critical Process Test Procedures
  • frequency of testing
  • tests performed are in accordance with the Critical Process Test Procedures
  • records are kept
  • results reviewed in a timely manner by plant management
  • appropriate corrective action taken
DEIM 1.10.03.05;
Chapter 19, Appendix 19 - 6
1.12 Microbiological and Composition Control and Records - review sampling of records for one product.
DEIM 1.10.07.03, 1.10.07.04
  • Slow vat records and calibration of pH meter for unpasteurized cheese
DEIM 1.10.03.01, 1.15.0.3204
1.13 Listeria Monitoring Program Records
  • review Listeria monitoring program records for highest risk product category (one prdt.)
  • assess frequency, sampling, methodology, follow up actions and notification.
DEIM 1.10.07.03

Table Notes

Footnote *

Pasteurization and critical process tasks must be satisfactory. All product from non-satisfactory lots must be controlled through detention and/or product recall.

Return to footnote * referrer

S = Satisfactory; NS = Not Satisfactory; NA = Not Applicable (indicate why); NE = Not Evaluated (indicate why)

2.0 Hygienic Practices
Inspection Task S/NS/NA/NR Inspection Task S/NS/NA/NR
2.1 Sanitary handling of product, ingredients & packaging material
DEIM 1.10.02.03, 1.10.02.05, 1.10.02.06;
1.10.04.02 (C), 1.10.04.04;
1.10.07.02
2.2 Well controlled movement of personnel & equipment between areas
DEIM 1.10.04.02 (B)
2.3 Absence of cross contamination
  • allergen and manufacturing controls DEIM 1.10.07.02
  • pests DEIM 1.10.01.04 (C), (D); 1.10.05.04
  • returned products DEIM 1.10.02.05 (D), (E)
  • garbage DEIM 1.10.01.05
  • structure DEIM 1.10.01.03, 1.10.01.04
  • non food chemicals DEIM 1.10.02.08
2.4 Appropriate clothing, grooming and health condition of personnel. Usage of hand washing and sanitizing stations as required
DEIM 1.10.01.06 (A);
1.10.04.03 (A), (B)
FCD
Flow Control Device
FDD
Flow Diversion Device
RTD
Resistance Temperature Device
STLR
Safety Thermal Limit Recorder
PDC
Pressure Differential Controller
PLC
Programmable Logic Controller
MBTS
Metre Based Timing System
APPS
Aseptic Processing and Packaging System
HHST/ESL
Higher Heat Shorter Time Processing and Extended Shelf-Life Dairy Products

Observations/Comments:

Appendix 9.2 GMP Inspection Worksheet (For Establishment Cutting, grating and packaging cheese; Blending powders; Freezing pre-pasteurized mixes)

Establishment
Reg. No.
Inspector
Contact
Date

S = Satisfactory; NS = Not Satisfactory; NA = Not Applicable (indicate why); NE = Not Evaluated (indicate why)

1.0 Food Safety Controls
Inspection Task S/NS/NA/NR Inspection Task S/NS/NA/NR
1.8Footnote * Other thermal processing or none Controls for the Storage and Labelling of Non – Pasteurized Cheese:  60 day storage, records and labelling – production date.
DEIM 1.10.07.02 (E)
  • to be used only if the cheese cutting and/or packaging establishment is storing unpasteurized cheese
1.12 Microbiological and Composition Control and Records – review sampling records for one product
DEIM 1.10.07.03, 1.10.07.04
1.13 Listeria Monitoring Program Records.
  • review Listeria monitoring program records for highest risk product category (one prdt.)
  • assess frequency, sampling, methodology, follow up actions and notification.
DEIM 1.10.07.03

Table Note

Footnote *

Pasteurization and critical process tasks must be satisfactory. All product from non-satisfactory lots must be controlled through detention and/or product recall.

Return to footnote * referrer

S = Satisfactory; NS = Not Satisfactory; NA = Not Applicable (indicate why); NE = Not Evaluated (indicate why)

2.0 Hygienic Practices
Inspection Task S/NS/NA/NR Inspection Task S/NS/NA/NR
2.1 Sanitary handling of product, ingredients & packaging material
DEIM 1.10.02.03, 1.10.02.05, 1.10.02.06;
1.10.04.02 (C), 1.10.04.04;
1.10.07.02
2.2 Well controlled movement of personnel & equipment between areas
DEIM 1.10.04.02 (B)
2.3 Absence of cross contamination
  • allergen and manufacturing controls DEIM 1.10.07.02
  • pests DEIM 1.10.01.04 (C), (D); 1.10.05.04
  • returned products DEIM 1.10.02.05 (D), (E)
  • garbage DEIM 1.10.01.05
  • structure DEIM 1.10.01.03, 1.10.01.04
  • non food chemicals DEIM 1.10.02.08
2.4 Appropriate clothing, grooming and health condition of personnel. Usage of hand washing and sanitizing stations as required
DEIM 1.10.01.06 (A);
1.10.04.03 (A), (B)

Observations/Comments:

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