Identified Risks and Preventative Actions

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Process Defining the Possible Process Problem Likelihood Consequence Risk Preventative Action
Poor design of the transport equipment Equipment not equivalent to sample-type equipment fully GDP qualified Poor quality finishes (example: bad insulation) 2 4 8 (Moderate)

  1. At IQ, check that the equipment design specifications are similar to sample-type equipment fully GDP qualified.

  2. At IQ, check that the refrigeration body is sufficiently and tightly insulated and body specifications correspond to ATP standards.

  3. At IQ, Check that the refrigeration unit only uses approved refrigerant and is labelled according to refrigerant R-452A.
The refrigerated unit has been installed incorrectly on the body Installation Qualification to be conducted and checked by Thermo King authorized and trained technician.
Temperature excursions Unexplained temperature excursions 3 4 12 (Moderate) Datalogger and/or a monitoring system should be installed on the transport equipment.
Installations obstructing the discharge air flow Correctly check design specifications of the equipment at point of sales.
Transport equipment not pre-cooled before loading goods Pre-cool the transport equipment to the set -temperature before loading the products.
Products not loaded at correct temperature. Implement correct loading/unloading practices.
Settings of the refrigerated unit Incorrect settings of set points for the temperature range to be maintained 3 4 12 (Moderate) To maintain the best temperature management within the load-space in winter and summer time, Thermo King recommends operation with the following set point temperatures:

  • +20°C Set-point for temperature range +15°C to +25°C

  • +5°C Set-point for temperature range +2°C to +8°C

  • -25°C Set-point for temperature below -20°C

Environment

Process Defining the Possible Process Problem Likelihood Consequence Risk Preventative Action
Temperature Europe Expected ambient temperature in the regions can go up to extremes. 3 3 9 (Moderate) Full Qualification of sample-type equipment (temperature mapping) has been successfully performed at extreme temperatures from -25°C to +40°C.
Risk of temperature excursion due to high delta difference with inside temperature. Refrigeration capacity reserve: Thermo King equipment are designed as standard to overcome temperature met in Middle East Africa regions, with temperatures up to 55°C.
Solar radiation In summer time, the effect of solar radiation can have a negative impact on the surface temperature of the equipment. The darker the body colour, the higher temperature increase. 2 3 6 (Moderate) In DQ, recommended body to be white in colour with a max. 20% decal coverage.
Refrigeration capacity reserve: Thermo King equipment are designed as standard with reserve capacity of 75% based on ATP standards.
Door opening at non temperature controlled storage location Depending on:

  • duration of the opening

  • temperature in the carrier and outside temperature

  • switch on/off of the cooling unit during opening doors

 3 4 12 (Moderate) Minimize door opening time.
Load and unload the transport equipment at temperature controlled loading docks of storage location.
Driver training on best loading/unloading practices should be conducted. Door opening tests have been performed to enable better risk management.

Process / Operational Qualification

Process Defining the Possible Process Problem Likelihood Consequence Risk Preventative Action
Temperature sensor accuracy check Invalid temperature registration 2 4 8 (Moderate) At IQ check Process, all sensors that are used for temperature control and monitoring are to be checked. A proof of calibration check of each sensor as part of IQ Process.
Yearly calibration check of all sensors that are used for temperature control and monitoring.
Minimum sensor requirements and location should be in accordance with equipment manufacturer's recommendations.
The calibration process should be in line with the EN13486.
Breakdown / Damage of the equipment No regular maintenance of the transport equipment
Maintenance not done correctly
No use of genuine parts		 2 4 8 (Moderate) A maintenance contract with Thermo King or authorized Thermo King dealer should be in place.
If no maintenance contract, the user of the equipment should prove that he has the right schedule maintenance, repair procedures, genuine parts, breakdown risk assessment, and training in place.The user should be open to regular audits.
All replacement parts are to be from genuine manufacturer's parts.
Lack of hygiene Risk of contamination of pharmaceutical products 3 3 9 (Moderate) A Cleaning Procedure should be in place.
The internal space is easily accessible for cleaning.
The internal surfaces of the refrigeration body are corrosion-resistant and comply with hygiene regulations.
Pharmaceutical products should not be transported in a mixed load with food products.
Driver’s operating mode Transport equipment not used appropriately Lack of knowledge on how to use the refrigerated unit 3 4 12 (Moderate) Thermo King provides an Operational manual to use efficiently the transport equipment.
Conduct Training of drivers on GDP and how to use the refrigerated unit.

Parent topic: Risk Analysis Thermo King