Facility and Equipment Maintenance
Facility and Equipment Maintenance
Maintenance of Equipment, Building, and Grounds
Facility Maintenance and Equipment Maintenance is imperative to ensure a safe product. Maintenance has a direct impact on your ability to control foreign material contamination, microbial contamination, chemical contamination, cleaning and sanitization, employee safety, pest infestation, and customer satisfaction.
It is common to divide maintenance into two separate programs – Facility Maintenance and Equipment Maintenance; however, this is just common practice, and all maintenance could be handled under one program or three programs, depending on your circumstances and preferences.
Regardless of how many programs you have for the various kinds of maintenance you perform, all maintenance carries with it the following considerations:
- How to implement preventive maintenance, as opposed to just reactive maintenance
- How to monitor, record, and trend maintenance activities for continual improvement
- How to prioritize maintenance tasks
- How to make safe and effective temporary repairs, while planning long-term solutions
- How to prevent contamination during maintenance activities
- How to select equipment, maintenance materials, or tools that comply with GMP requirements
- How to verify readiness for commissioning or recommissioning
Preventive Maintenance
A maintenance program is not just about keeping everything up and running. It is also about considering how maintenance impacts the product and the health and safety of consumers.
It used to be common practice that a facility would only conduct maintenance in response to an active issue. This reactive approach, however, did not usually result in continual improvement, nor did it reflect due regard for the higher risk involved in producing consumable goods, where failure can mean a significant threat to public health and safety. As I said before, maintenance has a direct impact on your ability to control things like pest infestations, microbial growth, effective cleaning and sanitization, and so forth. These in turn directly impact product quality and safety. Thus, maintenance should not be reactive, but rather, proactive; meaning that we must think ahead and identify potential issues so that we can stop them before they occur. This is not only more safe, but also more economical. The consequences for reactive maintenance, including downtime and recalls, are often more costly than the cost of preventive maintenance.
So, in the modern age, a preventive maintenance program is preferred. This means treating your facility, grounds, and equipment like you would an expensive sports car. The proud new owner of an expensive sports car would probably frequently clean and inspect the car, schedule regular maintenance and check-ups, and eagerly show off the car’s powerful engine and nice, clean leather interior to friends and neighbors. Likewise, your facility should undergo regular cleanings and inspections, scheduled preventive maintenance, and be ready for an audit by customers or regulatory bodies at any time. The idea is to show your pride in ownership and to prevent problems before they escalate into embarrassing and costly issues.
Schedules
As with most things, proactive measures are more difficult to execute than reactive measures. Preventive maintenance, therefore, needs to be well-planned and executed according to a pre-determined schedule – a Preventive Maintenance Schedule. But not only a preventive maintenance schedule, but also an Inspection Schedule to allow you to discover the unexpected before it can grow into a big surprise.
In creating your maintenance and inspection schedules, you first need to survey your equipment, building, and grounds to ensure that you identify everything requiring maintenance or inspection. Some items will require less frequent attention than others, but you should account for everything that requires any level of attention so that you can set the appropriate frequency as part of your planning.
In setting frequencies for maintenance and inspection activities, priority should be given to those items with greater risks of critical failure, and those with higher maintenance requirements for their proper function. The schedules may need to be adjusted over time based on observations made during inspection and maintenance.
Also, in creating your maintenance and inspection schedules, consistency and regularity are important. Automated notification systems and alerts are always helpful to ensure schedules are followed. Some maintenance systems will automatically issue maintenance work orders at the scheduled time as a kind of reminder to perform preventive maintenance activities. Others will use work orders only for unscheduled or corrective maintenance activities and rely instead on a preventive maintenance schedule and log as the only means for documenting preventive maintenance activities.
Work Orders
Work Orders are a useful way to document and track maintenance activities within a facility. Whenever a maintenance need arises, a work order may be created that identifies such things as: what the issue is, the priority of the repair, the deadline for the repair, what repairs were made, materials and tools used during the repair, who performed the repair, and when the repairs were completed.
Sometimes a number of work orders will arise simultaneously. Each facility should have its own method for prioritizing work orders. For instance, any issue that relates directly to the production line may take a high priority, whereas a crack in the pavement outside a loading dock may take a lower priority. Both are important and both repairs should be completed, but one will take priority over the other when time and resources are limited.
Unscheduled and Corrective Maintenance
Despite the best preventive maintenance program, unexpected breakdowns will still occur. Unexpected repairs are often called Unscheduled Maintenance or Corrective Maintenance. Typically, these repairs will be costly and must take place as soon as possible to prevent down-time on the production line.
Ideally, part of our preventive maintenance program is to anticipate possible breakdowns and have the required repair materials and tools available for such an event. However, this is not always possible or practical. Therefore, often breakdowns occur for which there is no immediate permanent solution, resulting in the need for temporary repairs.
Temporary Repairs
Temporary repairs are repairs made to keep the machines up and running until a more permanent repair can take place. Temporary repairs often equate to more risk to product, as they are not the ideal solution. A protocol should be in place for temporary repairs to prevent the temporary solution from resulting in contamination of the product. Often this protocol includes recommended materials and methods to use, as well as materials and methods to avoid, as well as a requirement that a risk assessment is performed for any unanticipated repair scenarios to ensure that contamination risks are identified and prevented. The protocol may even go so far as to require that temporary repair is not undertaken until a long-term solution is planned and scheduled. This is to prevent a temporary repair from turning into a long-term hazard. Temporary repairs should be documented just like any other repair.
It is important to record any type of temporary repair and then ensure that a more permanent fix is scheduled for the near future.
Preventing Contamination during Maintenance
Any person, whether an internal employee or an external contractor, who is assigned to perform maintenance in a facility, should be trained on how to prevent and reduce risks of contamination when performing maintenance activities. This includes knowing general best practices, as well as the specific policies, procedures, and requirements of the facility.
It is not enough to have a maintenance person who is just crafty and good at fixing things. These days it is highly recommended that maintenance staff be well-trained in various equipment repairs and that they are constantly evaluating equipment for improvement of the preventive maintenance program.
Maintenance personnel should be aware of the different zones in the facility, the product-contact surfaces in each zone, the risks to product in each zone, the cleanliness requirements in each zone, and any set protocols to prevent contamination.
Maintenance procedures and instructions should include information relative to food safety that are emphasized during every training session. Maintenance employees should be aware that there is no value in repairing a system if food safety protocols are not followed because an entire production run may have to be destroyed.
All training of maintenance personnel should be documented and kept as a record.
Designated Tools
Maintenance tools can be a source of contamination. For example, tools can have foreign material on them that can contaminate product-contact surfaces. Or tools used on one production line can carry allergenic contamination from that production line to another production line.
Therefore, it is good practice to designate tools for use only in certain production areas. When maintenance workers have designated tools available in each area, this greatly minimizes the chance that tools will be carried from one place to another in an uncontrolled manner resulting in cross-contamination.
For external contractors, it is good practice to ask them to use your tools, or to verify that their tools are cleaned and sanitized prior to beginning work.
Chemical Identification
Maintenance of equipment often includes using lubricants. Different types of lubricants are appropriate for different areas throughout the facility. It is imperative that maintenance personnel are trained on all of these substances, where they are used, and how they should be properly handled and stored. Lubricant manufacturers often provide guidance on how their lubricants can be used and whether or not they are food safe.
NSF International provides the following categories for lubricants.
H1 Lubricants – These lubricants can have incidental food contact and are also called food-grade lubricants. By incidental contact we mean that H1 lubricants are safe for human consumption only in small amounts – a very few parts per million. These products are permitted for use as lubricants and antirust agents, or as release agents on gaskets or seals of tank closures. The minimum amount required should be used to accomplish the required maintenance task. When a product is used as an anti-rust film, it should be removed by washing or wiping before putting the equipment back into service.
H2 Lubricants – These lubricants are intended for food production facilities, but not intended to have any food contact. These products are used on equipment and machine parts in locations where there is no possibility of the lubricant or lubricated part contacting edible products. H2 products must not contain even trace elements of carcinogens, mutagens, mineral acids, or intentional heavy metals such as arsenic, lead, mercury, and so forth.
H3 Lubricants – These are soluble oils that are safe for human consumption, such as corn oil, sunflower oil, soybean oil, or cottonseed oil. These lubricants are inherently biodegradable and are generally recognized as safe to be added to food or (GRAS). These oils are often used to prevent rust on hooks, trolleys, and similar equipment.
When using various grades of lubricants, make sure to clearly label containers and take any other necessary precautions to prevent mix-up or cross contamination. This can be managed as part of your chemical control program or as part of your maintenance program.
Procedures, Records, and Documentation
Every facility should have procedures in place that clearly outline both preventive and unscheduled maintenance procedures. These procedures will assist in the training of personnel. The procedures should include specifics such as how the maintenance task is to be completed, what chemicals or tools are allowed to complete the maintenance, and inspections that must be performed, and so forth.
Also, every facility should have a method for documenting all maintenance activities, usually through the use of work orders. Every maintenance activity should be well-documented and kept in a format that allows for easy review of the information. This information will be important in case of a report of contamination or a customer complaint. Also, this information is helpful to track the performance of equipment, identify trends, and improve the preventive maintenance program.
Also, every time maintenance is performed on a food-contact surface, then there should be a documented handoff to sanitation staff for inspection and approval before returning to production.
Also, every time any maintenance is completed in a production area, that area should be inspected to ensure that the work is complete and properly performed, that no tools were left behind, and, generally, that the area is clean and ready for production. A record should be kept of this inspection as well.
Sourcing and Commissioning
Generally, before purchasing any new equipment, tools, or maintenance materials, the Quality Manager reviews the specifications to ensure that GMP requirements will be met. Also, upon installation of new equipment, the quality manager generally conducts a food safety inspection before commissioning to ensure that the equipment, as installed, meets GMP requirements. An Equipment Commissioning Checklist is attached to this training for your reference.
Here are some general guidelines for what to look for in new equipment:
- A Hygienic Design and operation, and easy access for cleaning and sanitation.
- Surfaces that are non-toxic, non-absorbent, non-reactive, non-corrosive, and smooth and easily cleanable
- Surfaces that are paint-free or finished with a food-grade material
- The absence of bolts, nuts or other fasteners that may become loose and present a foreign-object hazard, or at the very least, that these items are mounted on the outside of the equipment for easy inspection and control
- Faceplates on gauges, sensors, or sight glasses that are made of a shatterproof, easily cleanable material
- Gear boxes and bearings on the equipment that are located outside the product zone, or, at the very least, if in the product zone, that are sealed or capped or equipped with a catch tray to prevent leakage of lubricants into the product
- Belts that are equipped with quick releases or other access points to enable cleaning around belt pulleys. Also, that belting material is easily cleanable, preferably without cloth backing
- Conveyers that are equipped with solid (not hollow) rollers
- Electrical and control panel doors that seal adequately and are easily opened for inspection
- Calibration that, if required, is traceable to national or international standards if available
Generally, the Quality Manager maintains a record of all food-safety approvals for equipment, materials, chemicals, lubricants, and tools that are used in the facility.