Dairy Establishment Inspection Manual – Chapter 6 - Inspection Procedures
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Adequate and thorough planning of the inspection is necessary to maximize its effectiveness.
Usually advance notice is given to the dairy plant to ensure that appropriate plant personnel are available and disruptions to production are minimized. This notice can be given in writing or verbally (if verbal, should be noted in inspector log or establishment file). Usually, a two week notice should be adequate. Longer notifications are to be minimized and used infrequently in order to standardize the notification for all plants.
Unannounced inspections may be performed if it is believed that announced visits do not reflect everyday conditions.
Seasonal rotation of a plant's annual inspection dates is necessary to reflect year-round plant conditions.
It is critical that the plant's complete file be reviewed prior to inspection to thoroughly understand its status. Reports to be reviewed include:
- Last in-depth report and all follow-up actions
- Product inspection summaries
- Environmental sampling reports
- GMP report
- Provincial product/plant reports
- Consumer complaints
This review will enable potential and real risks to be thoroughly examined during the in-depth inspection.
6.1.4 Multi Commodity Activities Program
The Dairy Plant Inspection Manual has been incorporated into the CFIA's inspection database, the Multi Commodity Activities Program (MCAP). Relevant information related to registered dairy establishments has been entered and stored in the database. Inspection worksheets and reports derived from inspections will be generated from the MCAP database.
6.1.5 Worksheet Generation
Establishment and process specific worksheets are created from the MCAP database. The pre-printed inspection worksheet will serve as the main reference during the in-depth inspection. The inspection worksheets are arranged by product section and specific activities. The inspector can easily select the appropriate worksheets for his inspection by knowing the products produced and all the activities performed in the plant. The Product section refers to the product produced or a generic area. The Activity refers to the function performed. (For example, for a Cheese manufacturing room, "cheese" is the product section and "manufacturing room" is the activity).
You will notice that some tasks, for example, storage tanks, pumps, pipelines and valves, other equipment to name a few, have the option of being rated as Health and Safety 2 or 3. The task selected in MCAP will depend on the location of the equipment, where it is being used and if it is pre-or post-pasteurization. If the equipment being assessed is pre-pasteurization you would choose the task to be rated as Health and Safety 3. If the equipment is post-pasteurization you would choose the task to be rated as Health and Safety 2. This is consistent with the definitions in section 5.1.
There is also a non-standardized products worksheet that covers non-standardized products (dairy and other). These are designed to cover the inspection of food preparation areas that may have an effect on the safety of dairy products but are not covered by traditional worksheets.
The worksheet for each activity lists the tasks to be inspected in a normal product flow sequence. The health and safety categories for each task are pre-printed on the worksheet. All tasks are to be inspected unless they do not exist and are not required.
For all establishments, there are some worksheets that are mandatory to ensure uniformity. The Prerequisite Program worksheets must be evaluated for every establishment. If critical processes are evaluated (HTST, Batch pasteurization, Thermal processing, APPS), the "Pre/Post critical processing" worksheet must be used as well. These must not be deleted by the inspector when selecting worksheets.
Each dairy plant should be subjected to an in-depth plant inspection at least once a year. This interval will provide a reasonable time for correction and commencement of intermediate and long term actions and identify any new concerns before they cause any serious problems. This activity is not conducted in establishments that are HACCP recognized. In HACCP recognized establishments inspection frequencies are dictated by the partial audit frequencies.
Since seasonal rotation of the plant's inspection dates is required, some plants may receive an in-depth only once every 18 months. This is permissible only if there are no major problems in the plant or if regular follow-ups have been done and generated positive responses.
6.2.2 Who Inspects
An inspection may consist of one or a team of two representatives (often a provincial and federal inspector) who carry out the in-depth inspection. A plant representative needs to accompany this team to provide for the dismantling of equipment and assist in record and program reviews.
As well, plant personnel are encouraged to carry out their own in-depth inspections with the inspection team and independently as required by their plant.
Inspectors must not allow accompanying plant personnel to rush the inspection or lead them away from problem areas or items.
6.2.3 Where to Inspect
All parts of the plant used for the preparation of dairy products, as well as employee welfare areas and non-processing areas related to these operations are to be inspected.
6.2.4 How to Inspect
Arrival at Plant
Prior to announcing their arrival at the plant, the inspection team must park in an appropriate area and ensure that their clothing and comportment is appropriate (no jewellery, items in pockets, gum chewing, etc.)
To demonstrate courtesy and professionalism, the inspection team head should:
- Ask for the plant manager or person in charge and introduce the team members
- Explain what the team will do
- Inform management that the results will be discussed once the inspection has been completed and arrange for a tentative time to meet and discuss the results
To facilitate the best order of inspection, the inspection team and plant management should formulate an inspection schedule. Both industry and government will be able to minimize inspection disruptions. The CFIA overtime policy should be consulted when industry requires that scheduling of the inspection or portions of the inspection occur beyond the working hours (normal or adapted) of the inspector. The need for overtime should be discussed with plant management and the inspector's supervisor prior to the inspection.
Every effort must be made by the inspection team to minimize cross contamination risks. The inspection team should commence their inspection in the microbiologically cleanest areas and end up in the worst (e.g. start at cheese packaging and end in raw receiving or plant exterior). As well, the inspectors must utilize handwashing/sanitizing facilities and any other plant facilities as frequently as possible.
All efforts must be made to assess the tasks in their operational condition prior to their dismantled condition in order to reflect true working conditions. If this is not feasible, the task may be assessed in the reverse order.
Tasks are to be rated after assessing both their operating and dismantled conditions, if applicable. All efforts are to be made to see the applicable tasks in both operating and dismantled conditions.
The operating assessment will focus on plant practices and equipment and room conditions. Contamination risks must be minimized. Particular attention should be given to, for example:
- Personnel movement, hygiene and health
- Usage of ingredients, packaging materials, etc.
- Cleaning procedures
- Handling of garbage
- Equipment leaks
The dismantled assessment considers the task's mechanical design, construction and condition as well as its cleanliness.
Following the assessment, the inspector notes on the worksheet whether the task is satisfactory or unsatisfactory based on the inspection criteria. If unsatisfactory, the observation (or reason for the "unsatisfactory" rating) is noted. It is important that the inspector only states what has been observed, rather then indicating how to correct (e.g. "pump not clean" rather than "clean the pump").
Thoroughness of Inspection
To provide a thorough assessment of the plant, it is important that the maximum number of different tasks be inspected. The plant schedule must take this into consideration; as well, the inspection team must be prepared to accept unusual working hours.
For tasks that are difficult to clean or infrequently cleaned (e.g. dryer), it is preferable that the plant clean and dismantle the equipment at the time of inspection. If this cannot be done, the inspection team must educate the plant to inform them of the time of the equipment's cleaning and/or maintenance. An inspector must go and inspect this task and document the findings. At the time of inspection, this documentation as well as the plant's own records will be used to determine the task's rating.
If the equipment is not inspected in the dismantled state during the inspection it should not be rated at the time of inspection but noted on the inspection report. This equipment must be seen in the dismantled condition during or before the next in-depth inspection.
For tasks that are allowed to be rated for quantity, it is not necessary to look at 100% of the items in their dismantled condition. The inspection team must emphasize and assess plant management's record keeping and determine the number of multiple items to evaluate depending on their findings from the dismantled equipment assessment and the plant's level of responsibility indicated by their records. It is important that the tasks that are assessed are thoroughly examined.
When assessing multiple items, for example in the case of pumps, tanks, drain tables, etc. the required number of lines can be added to the worksheet to coincide with the number of items which have been inspected and scored. Pipelines and valves would not be scored individually but grouped together and assessed on one line as either satisfactory or unsatisfactory.
6.3 Post Inspection
The post inspection procedures are important to ensure that the appropriate message is conveyed to plant management.
6.3.1 Inspection Team Review
When the inspection is completed, the team must meet in a private place to finalize and discuss the inspection results and prioritize the action items.
6.3.2 Management Meeting
This meeting is of critical importance. The inspection team must meet with the appropriate members of plant management (those responsible or accountable to provide corrective action) as soon as possible following the completion of the inspection. The overall inspection will be reviewed; critical unsatisfactory tasks must be highlighted and the pre-assigned time frames for correction discussed. These time frames for correction can be modified if necessary but should be reasonable in terms of what can be accomplished, depending on the seriousness of the deficiency. When tasks are rated unsatisfactory as a result of being assessed against "new" or "revised" criteria longer time frames for correction and implementation of these criteria may be given if requested and agreed upon by both parties. It is important to stress to management the importance of correcting the Category 1 and 2 tasks first (as these have an immediate effect on product safety) and then work towards the correction of the Category 3 and 4 tasks.
It is important that plant management understands the inspection findings and why certain tasks are unsatisfactory and require action. As well, they must be informed that they will be required to document dates for corrective action for all their unsatisfactory tasks.
The inspection results will be entered on line into the MCAP database, resulting in the generation of reports within a reasonable time frame (preferably one week). The establishment reporting system will consist of the inspection worksheet, the Non-Satisfactory Report and the Health and Safety Rating Report.
The inspection worksheet is a working document in which the rating for each inspection task is recorded along with the description of the non-conformities found during the inspection related to that task. The Non-satisfactory report is a summary of all not satisfactory tasks for an inspection listed by Health and Safety Categories. In the event that a task receives an unsatisfactory rating as a result of being assessed against "new" or "revised" criteria this is to be noted in the comments section of the Non-satisfactory report. The Health and Safety Rating Report summarizes the non-conformities into Health and Safety Categories and provides for the overall rating. This report focuses the inspection concerns where significant health or contaminations risks may occur and provides a basis for prioritizing corrective action, reinspection and compliance activities.
An Outstanding Task Report will also be generated through MCAP which will be used for the follow-up inspection, to keep track of any unresolved tasks from the inspection.
6.3.4 Covering Letters
A covering letter must accompany the plant's inspection report. It should include:
- Summary of inspection results highlighting critical unsatisfactory tasks
- Summary of the management meeting discussion
- Request for the plant's action plan (which should be received within 3 weeks of the date on the covering letter) to correct all unsatisfactory tasks by a specified date as determined by the severity of the deficiencies. It is important that the action plan address all unsatisfactory tasks, including Health and Safety (essential to meet registration requirements) in order to get signed commitment from plant management to correct all deficiencies within the time frame for correction or other time frame agreed upon by the inspector. Once the action plan has been received it is to be reviewed by the inspector to ensure corrective action dates are as outlined in chapter 5.4 and that the corrective action is acceptable to address the deficiencies. If there are concerns with the action plan further discussion with the plant will be required
An example of a covering letter can be found in Appendix 6-I at the end of this chapter and can be generated from MCAP.
The registered establishment will receive only one copy of the in-depth inspection report. If copies are required by other interested parties within the company's organization these will have to be obtained through the registered establishment.
6.3.5 Follow-up Inspections
These inspections document if management has followed their action plan and corrected their unsatisfactory conditions.
Obviously, if a plant has deficiencies in Category 1 tasks, the follow-up will need to be scheduled within a matter of days and may even be done within the time that the in-depth inspection is being completed. Otherwise, the inspection team should determine the time frame for the follow-up depending on the implications of the unsatisfactory tasks.
Plants require a follow-up inspection if the following occurs:
- Plants receive an overall rating less than 100% in Category 1 tasks or less than 75% in Category 2 tasks or less than 60% in Category 3 tasks or less than 50% in Category 4 tasks, the time frame of which is dependent upon the due dates for the action
- If specific product activity areas fall below a 75% rating for Category 2 tasks, 60% rating for Category 3 and 50% rating for Category 4 tasks even though the overall rating is above 75%, 60% and 50% respectively, the need and time frames for follow-ups must be discussed and determined by the inspection team. A follow-up must occur at least once within the year with the results tracked through MCAP on the Outstanding Task Report. To follow-up on the deficiencies in the Category 4 tasks, where the time frames for correction are longer, the inspector can monitor and keep track of these through MCAP on the Outstanding Task Report.
If 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, then the progress of the action plans for the unsatisfactory Category 2, 3 and 4 tasks must be monitored at least once within the year, as part of a GMP inspection, with the results tracked through MCAP on the 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.
A post-inspection meeting after the follow-up inspection is required as indicated under 6.3.2 and 6.3.4. An Outstanding Task Report will be issued to the plant following the follow-up inspection. For plants that have serious problems or are uncooperative, steps towards removing registration may be considered.
A copy of the complete inspection (including the covering letter, inspection worksheet, the Non-Satisfactory Report, the Health and Safety Rating Report and the Outstanding Task Report and follow-up results) is to be kept on file in the regional inspection office or a copy of all documents can be scanned and filed electronically. If the option to scan and file the inspection is preferred ensure these are scanned into a special regional folder so as not to lose the inspection data in the system.
Covering Letter Example
Regulatory Agency Name
Address of Office
Mr. Dairy Product
Dairy Products Ltd.
123 Anywhere Street
Dear Mr. Product:
Enclosed please find the Health and Safety Rating and Non-Satisfactory reports, generated from your in-depth inspection of (Date). The Dairy Establishment Inspection Manual (January 2010 version, with minor amendments January 2012) was used to assess your establishment during this inspection. The inspection was completed jointly by (Name) of the Provincial Government and myself. During the exit interview all deficient tasks were discussed with you and your staff.
The Health and Safety report provides an overall evaluation of the compliance of your facility. An acceptable rating is given to a plant with an overall rating of 100% in Category 1, ≥75% in Category 2, ≥60% in Category 3 and ≥50% in Category 4. Numerous deficient tasks in Health and Safety Category 1 and 2 found during your inspection have resulted in an unacceptable plant rating of 60% in Category 1, 65% in Category 2, 75% in Category 3 and 80% in Category 4.
You are reminded that you may be in contravention of Sections 11 and 11.1 of the Dairy Products Regulations under the Canada Agricultural Products Act (critical deficiencies should be identified and reference made to the appropriate section of the regulations). Note: This paragraph would only appear in the letter if the inspection resulted in an unacceptable rating (less than 100% in Category 1 tasks, or less than 75% in Category 2 tasks or less than 60% in Category 3 tasks or less than 50% in Category 4 tasks). Otherwise the inspector might just note the overall rating of the inspection (For example, the inspector might say "The overall rating was 100% in Category 1, 90% in Category 2, 89% in Category 3 and 80% in Category 4").
The inspection tasks that are rated non-satisfactory are listed in the Non-Satisfactory Report. Those assessed as non-satisfactory as a result of being assessed against the new or revised criteria are noted as either "new criteria" or "revised criteria". The Non-Satisfactory Report can be used to indicate your corrective actions and dates for those tasks found non-satisfactory. The due dates for corrective actions can be found in section 5.4 of the DEIM and are as follows:
- Category 1: Action to be completed within 10 days
- Category 2: Action to be completed within 30 days
- Category 3: Action to be completed within 180 days and
- Category 4: Action to be completed within 365 days or as agreed upon at the exit meeting
Longer time frames for correction and implementation for new or revised criteria will be given if necessary as agreed upon by both parties.
Please forward your written and signed action plan to this office no later than (Date). Note: The action plan should be received no later than 3 weeks from the date on the covering letter of the report.
Copies of the plant inspection report, your action plan and follow-up inspection reports will be forwarded to (name Provincial or Federal Government).
We would like to thank you and your staff for the cooperation shown to us during this inspection. Please do not hesitate to contact me if you have any questions.
Dairy Plant Inspector
cc: Regional/Area Program Officer/Specialist (or others as appropriate)
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