Dairy Establishment Inspection Manual – Chapter 10 Prerequisite Programs
1.10.03 - Equipment Program
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This documented program as well as its effective implementation, will help control operational conditions within an establishment allowing for environmental conditions that are favourable to the production of safe food. It serves as a prerequisite program or universal-type CCP for a HACPP based program.
Dairy establishments and importers must have a documented program in place to monitor and control all the elements in this section, and maintain the appropriate records.
This task covers equipment and components which may affect the safety of the product. This task assesses:
- The design and installation of equipment. For example, equipment is to be designed and installed to be accessible for cleaning, sanitizing, maintenance and inspection, to prevent contamination of product during operations, to prevent excessive condensation, permit proper drainage and has acceptable food contact surfaces. There must be a detailed plan showing the types and locations of equipment used in the establishment.
- The maintenance of all equipment and its components. For example, the calibration of indicating thermometers, gasket and filter replacement program, testing for all critical processes (e.g. HTST, Batch pasteurizer, APPS), etc.
- The establishment's control and use of equipment seals. There are many tasks within the critical processes (HTST, Batch pasteurizer, APPS) that require a particular device be sealed to maintain the safety of the product. There must be a program in place to monitor and control the use and replacement of these seals. Records must be kept by the establishment for the sealing of equipment, which identifies (e.g. sequential numbering system) and lists the seals used and their location, when the seals are broken, reason why the seal was broken, that the equipment is re-sealed and the person responsible. In order for an establishment to be able to identify which seal has been removed, replaced and recorded, i.e. identifiable, the seals themselves need to be coded. This is the only way for the establishment to exhibit control over the seals.
- The documented program must specify:
- protocols and methods of standardization (how it is done and what is done),
- responsible personnel (qualified and trained) (who does it),
- inspection frequencies (how often or when it is done)
- records to be kept
- parameters of acceptability/unacceptability (tolerances).
- results of monitoring and verification (both on-site and record review),
- action to be taken for deviant situations.
The monitoring and verification procedures clearly define the preventative measures taken to prevent the re-occurrence of deviations. The person responsible for verifying the program must be different from the person performing the task.
The equipment must be maintained to ensure that no physical or chemical hazard potentials result (e.g. inappropriate repairs, flaking paint and rust, excessive lubrication). Mechanical parts, lubricants, oils, etc. must not be stored in food containers. Metal detectors can be useful in detecting some physical hazards in foods. If the establishment does not have a metal detector, the inspector must assess if the establishment has control over metal hazards (e.g. inspector would look for high number of foreign object complaints that have been received, maintenance of screens/filters, employee training program to see if employees are trained to observe any equipment malfunctions, etc.).
The preventative maintenance program must be adhered to. When individual items are being assessed (e.g. storage tanks) and poor maintenance is observed and rated unsatisfactory, this task must be referenced to determine if the maintenance program requires updating.
This program must be regularly reviewed and updated as required when changes occur.
1.10.03.02 Air Quality
This task covers the air and inert gases that are added directly into the product or on the packaging; for example air used in drying, freezing, agitation (e.g. product storage tanks), and ice cream and fluid milk packaging. It covers both ambient air and compressed air sources.
Air when used for agitation, air blows, drying processes and incorporation into product (overrun) may be a vehicle that allows pathogenic organisms to enter the product. Poor quality air can also lead to product contaminated with particulate matter, condensate or oil.
Processing systems which incorporate air directly into the product, such as freezers, air blows and air agitation systems must be designed to reduce potential contamination and should be easily cleanable. All air used for processing must be filtered. Sanitary check valves should be provided as necessary to prevent product backup into air lines. Air blow and agitation equipment must be routinely checked for proper assembly and cleanliness. Most sanitary check-valves, air blows and agitation equipment are not satisfactorily cleaned by usual CIP methods and should be dismantled and manually cleaned and sanitized routinely.
The design of the compressing equipment must preclude contamination of the air with lubricant vapours and fumes. Oil-free air may be produced by one of the following methods or their equivalent:
- Use of a carbon ring piston compressor.
- Use of oil-lubricated compressor with effective provision for removal of any oil vapour by cooling the compressed air.
- Water-lubricated or non-lubricated blowers.
Oils and lubricants used are listed in the Reference Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents published by CFIA or the manufacturer has a letter of no objection from Health Canada.
The air supply must be taken from a clean space or from relatively clean outer air and pass through an air filter upstream from the compressing equipment. This filter is located and constructed so that it is easily accessible for examination. The filter should be protected from weather, drainage, water product spillage and physical damage. Filter size must be such that it is effective for the purpose it is designed. See Appendix 19 - 2 for various types of compressed air systems.
A process air system must contain appropriate filters to remove undesirable particulate matter. If this air is withdrawn from a room, the air supply to the room must be filtered. The air filters in the latter case are rated under task 1.10.01.04 Building Interior. A variety of air filters are available to the industry. Pressure differential prior and after the filter may be used as an indicator of the filter's effectiveness.
To ensure good air quality, the air filters must be cleaned appropriately. Coarse metal mesh filters are cleaned by boiling in an alcohol solution followed by a dip in special adhering oil. Oil coated, fiberglass filters are discarded after use. These filters are used in tandem; the second filter is moved up when the first becomes dirty. If a dirty second filter is observed, then the filters are not being cycled in a satisfactory manner. Common furnace type filters (usually one inch thick) are inefficient and are unsatisfactory.
1.10.03.03 Compressed Air Equipment
This task includes compressed air equipment that is used to operate valves and other equipment pneumatically. This air is not intended to be in direct contact with the product. If the air is in direct contact with the product or packaging, evaluate this under task 1.10.03.02 Air Quality.
For most purposes, the compressed air must be dry. This is achieved by passing the air under pressure through an oil-free filter and moisture trap for removal of solids and liquids. The filter and trap are located in the air pipeline downstream from the compressing equipment and air tank, if one is used. Filter size must be such that it is effective for the purpose it is designed. Air pipeline filters and moisture traps downstream from compressing equipment are not needed where the compressing equipment is of the fan or blower type (See Appendix 19 - 2).
1.10.03.04 Metal Detector
Metal detectors must be suitable for the specific product, associated hazard and the environmental conditions that the unit will operate in. If metal detectors are used, they must be designed, constructed, installed, calibrated and maintained in accordance with the equipment manufacturer's manual to ensure effective removal of metals. This may include: adjustment for product effect, selection of target metal and size and timing of the reject mechanism.
1.10.03.05 Critical Process Test Procedures
Plant management must ensure that the critical processes (e.g. HTST, Batch Pasteurizer, APPS, HHST/ESL) are tested in accordance with the Critical Process Test Procedures (Chapter 18), the appropriate Dairy Establishment Inspection Manual (DEIM) chapters, and Appendix 19 - 5 and 19 - 6 of the DEIM manual. This testing can be done by trained plant personnel or a reliable third party. The results of the testing should be recorded on the CFIA test procedures form. It will also be acceptable for the establishment or third party to use a different form to record the results of testing as long as the inspector assessing this task feels that the results can be easily interpreted, that the form has all the information present and that the test procedures are completed according to the test procedures.
The establishment must have a written procedure outlining what tests are being performed, how often, who is responsible (plant contact and third party, if used), verification procedures (record and on-site review) to verify that the requirements are being met. If the requirements are not met, appropriate action is taken by the establishment to correct the non-compliant equipment. Depending on the non-compliance, an investigation into the safety of the product may have to be done. Records are being kept to show that testing was done and corrective action was taken. All test procedure results must be reviewed on a timely basis by a member of plant management.
To adequately assess this task, records for all critical processes in the establishment must be available for review. In addition, the inspector is to observe the testing of the equipment at an appropriate frequency to assure proper procedures are being followed. The inspector will be looking to see that the testing is done according to the procedures and frequencies outlined in Chapter 18. If the testing is contracted out a list of the contractors could be maintained and scheduling could be coordinated with the establishment in order for the inspector to observe the testing. A suggested frequency of observation could be once per contractor per area.
For the critical processes, the following tasks are associated with a specified frequency of testing: 1.11.04.03, 1.11.05.01, 1.11.06.02, 1.11.06.03, 1.11.07.01, 1.11.07.03, 1.11.08.04, 1.11.09.01, 1.11.09.05, 1.011.09.06, 1.11.10.04, 1.11.11.02, 1.11.11.06, 1.11.12.03, 1.11.15.04, 1.11.16.03, 1.11.18.02, 1.11.19.02, 1.12.03.03, 1.12.04.03, 1.12.05.05, 1.14.04.03, 1.14.05.01, 1.14.05.02, 1.14.06.02, 1.14.06.03, 1.14.07.01, 1.14.07.03, 1.14.08.03, 1.14.09.04, 1.14.09.05, 1.14.10.04, 1.14.11.01, 1.14.11.03, 1.14.11.04, 1.14.11.05, 1.14.12.01, 1.14.12.04, 1.14.14.01, 1.14.14.02, 1.14.17.02, 1.17.04.03, 1.17.05.01, 1.17.05.02, 1.17.06.02, 1.17.06.03, 1.17.07.01, 1.17.07.03, 1.17.08.03, 1.17.09.01, 1.17.09.04, 1.17.10.04, 1.17.11.04, 1.17.11.05, 1.17.12.01, 1.17.12.04, 1.17.14.01, 1.17.14.02 and 1.17.17.02. When assessing the frequency of testing, each individual task should be assessed as unsatisfactory if the frequency of testing is not adhered to according to those set out in the DEIM, not just once for the overall system. The overall written program for the Critical Process Test Procedures task 1.10.03.05 should also be reviewed to see if there is a concern with the written program and maintenance schedules being followed. In some cases, depending on the scheduling by the third party testing company the timeframes may not be exactly as stated in the DEIM so there should be some flexibility allowed as to the exact timeframe (Not exceeding one month).
|1.10.03.01 General (HS=3)||(A) Documented Program
A representative sampling of the plant's historical records must be assessed.
Note: This task evaluates the presence of an Equipment Program. Individual task Inspection Criteria verify that the program is in place and is effective.
|1.10.03.02 Air Quality (HS=2)||(A) General
(B) Air Intakes
|1.10.03.03 Compressed Air Equipment (HS=3)||(A) General
|1.10.03.04 Metal Detector (HS=2)||(A) General
|1.10.03.05 Critical Process Test Procedures (HS=2)||(A) Requirements
A representative sampling of the plant=s historical records must be assessed.
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