Elements of an Approved Arrangement

The outcome of this element is to ensure your establishment and all processing equipment are running smoothly through an effective preventive maintenance program, with minimum interruptions to production. Your program must also consider sudden breakdowns or faults and describe the reactive maintenance controls in place when an unexpected breakdown occurs.

Your procedure should include how maintenance activities are raised, prioritised, allocated, completed and how post maintenance checks are completed to ensure the equipment is suitable for production use. Staff responsible for verification activities must be trained and competent.

Your procedure must include controls to prevent contamination during breakdowns and maintenance activities. For example, your procedures must clearly state what occurs if equipment is faulty and may need to be removed.  Some items may need to be tagged out if they cannot be moved from their point of use.  Equipment should be isolated to ensure it is not brought back into use until any maintenance has been completed and equipment and area is cleaned and approved for use. 

After any maintenance works, procedures must identify what clearance checks are to be performed before equipment is reintroduced and the production line is able to be re-started. This may involve re-cleaning equipment and re-inspection by an authorised person.

Any equipment which is no longer in use should be clearly identified or removed to reduce any potential source of contamination or accidental use.

When documenting and reviewing your Maintenance procedure, you should consider the following points:

• Have you scheduled your preventative maintenance checks appropriately to meet requirements and manufacturer specifications?
• Is each piece of equipment or any relevant machinery which has undergone any form of maintenance, whether it is planned maintenance or after a breakdown, reported and recorded?
• Do records include all maintenance conducted, whether preventive or breakdown issues?
• Do records include a description of the issue, the date the maintenance was identified and when the maintenance was conducted and the date the issue was resolved? 
• Do you clearly outline your Maintenance program or system in your procedures (for example, use of a MEX system). Does the procedure explain how maintenance requests are generated and recorded? 
• Are your maintenance personnel aware of food safety risks whilst they perform their jobs and are there documented controls in place to minimise these risks?
• Are sub-contractors suitably qualified to conduct maintenance?  Are they included on your Approved suppliers list?   
• How will you identify and escalate any maintenance issues that cannot be resolved immediately or in a short timeframe, to ensure that they do not present a contamination risk? You need to keep records of these decisions and justifications. 
• Are temporary repairs acceptable?  If they are, is there a procedure documenting this? How do you manage such temporary repairs to ensure they are permanently rectified in the future and do not present a product contamination risk?

Your procedures should include links back to your corrective action and internal audit programs.  

Calibration

Your site must ensure that all key measuring devices used at your registered establishment are accurately calibrated.

Procedures must define how the equipment is to be calibrated. This includes procedures or work instructions for how internal calibrations are performed and who is responsible for organising calibrations which are to be performed by an approved external service provider and how these are conducted with minimal interruption to the site.

You will need to clearly define what instruments require calibration. The location and type of equipment to be calibrated must be identified. It may be helpful to include a site map. Your procedure must include a schedule covering all calibration checks, including a list of all equipment, the frequency of calibration, who is responsible, what the acceptance criteria or accuracy tolerance is for each piece of equipment. Your tolerances must meet legislative requirements where applicable. The calibration document must clearly identify the equipment using its unique identification number, allowing each calibration document to be tracked to its corresponding equipment.

You must clearly define who is responsible for calibrating and if any specific qualifications or training are required to competently complete the task.  

Your procedures also need to explain what to do in the event that equipment is not operating within the required tolerances or if calibration is not effective at correcting a deviation outside of acceptable tolerances. If any equipment is not within the defined criteria, any corrective action taken must be documented. Any equipment which is out of calibration must be controlled to ensure it is not inadvertently used.

When documenting your Calibration procedures you should consider the following:

• Is an up-to-date list of equipment available for all items which require calibration?
• Do you have a calibration schedule which clearly defines what needs to be calibrated, and the frequency of the calibration? What will you do if calibrations are missed or overdue?
• Are all equipment identifiable using a unique ID for traceability purposes?
• Are work instructions or procedures available and detail how internal verification checks are performed for all key measuring equipment?
• Do you review calibration reports issued by external providers and take action if there are any failures or concerns?
• Where verification activities indicate a piece of equipment is out of calibration, do you have procedures to ensure the equipment is tagged and controlled to prevent inadvertent use, until it is calibrated? Have you described what must be done if equipment cannot be accurately calibrated?
• Have you clearly defined the tolerance limits for each type of equipment in your procedures? Do the limits comply with the relevant legislation?
• Are your calibration methods compared with a known standard? (for example, an Australian Standard method)? 
• Are sub-contractors suitably qualified to conduct calibrations?  Are they included on your Approved suppliers list?  Are they aware of food safety requirements?
• Do you verify that your equipment is designed and capable of monitoring accurately at the required monitoring limit? For example, if what you need to weigh is 100g, you would need to ensure your scale is designed and capable of weighing at a range of 0g and 200g accurately per NMI requirements.
• Do you verify and calibrate your equipment is near its operating range? (For example, if your product temperature measured is at 70°C to 80°C, you must verify and calibrate your thermometers above and below the monitoring temperature, to ensure equipment is operating properly at the monitoring range.