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Cool Room Risk Assessment

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pharmaceutical coolroom
Typical walk-in cool room

 

 

Risk assessments are frequently performed on Coolroom’s but from a quality perspective. What about a “cool room safety risk assessment”?

Coolrooms are an enclosed structure that maintains temperature typically between +2.0°C to +8.0°C. Coolrooms are used to maintain temperature for the storage of pharmaceutical products. The size and layout of a Coolroom will vary based on the requirements of each individual company. Cool Rooms can be fitted out with pallet racking, shelving or a mixture of both.

Coolrooms are an enclosed structure that maintains temperature typically between +2.0°C to +8.0°C. Cool rooms are used to maintain temperature for the storage of pharmaceutical products. The size and layout of a Coolroom will vary based on the requirements of each individual company. Cool Rooms can be fitted out with pallet racking, shelving or a mixture of both.

The following risk assessment is a guide only. Individual assessments should be completed in your cool room with risks that are specific to that room and your procedures. Follow the steps below to conduct a Risk Assessment.

Step 1: Identify the Hazard

  • Firstly, you must identify the possible hazards in the specified area you are assessing.
  • Include all hazards from day to day activities along with medium to long term risks.
  • Consult operators that work in the area to identify any hazards.
  • Review incident reports relating to operators in the Cool Room.

Step 2: Assess the Risk

  • Once you have identified the hazards and the possible harm it may cause, you must then assess the risk. This will identify how significant the risk is and how likely the incident is to occur. An example of how to assess the risk is to use the matrix table below.
Risk classification matrix based on probability and Impact
Risk Classification Matrix

 

Step 3: How to control the Risk (Mitigation)

  • The most important step in managing and/or eliminating the risks as reasonably practicable. Not all risks can be eliminated and therefore need to be managed appropriately to minimize the effect of the risk.
  • Some risks will be quick to address and some will take time and preparation. You will need to prioritize areas for action.
  • Use the Hierarchy of risk control figures to work through the highest level of protection and reliability to the lowest.
Cool Room Hazard analysis and Assessment

Step 4: Review Control Measures

Once the risk assessment has been completed and the control measures have been put in place, a means to review the controls must be implemented.

Controls should be reviewed frequently to ensure they are working as intended. For example, controls can be reviewed during safety meetings, staff meetings etc. Operators must be consulted. If new hazards are created from the control measures, further investigation and elimination must be conducted.

Following any updates or introduction of new legislation that may recommend or render a control measure ineffective.

Keeping Records:

Keeping records of all risk management documentation will demonstrate compliance. Maintaining records will also;

  • Demonstrate how decisions were made in controlling risks.
  • Identify any consultants used
  • Provides specific areas of training for hazards.
  • Provide proof of compliance/management of risks to regulators.
  • Capture plans for change.

Source:

CoolPac are suppliers & consultants to the pharmaceutical industry. Our chief area of expertise is “cold chain”. We manufacture passive transport shippers, sell temperature monitoring systems, conduct temperature mapping qualifications, and Operational Qualifications in our environmental test chambers.

For more information on what we do click here.

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Address: Factory 2-3, 38 Green St,
DOVETON Victoria Australia 3177

 

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