What is Risk? Have you risk assessed your business?

by | Feb 17, 2015 | Quality Systems

For every business the element of risk is all around you. From the warehouse operative operating a fork lift truck to the receptionist ascending the stairs to her desk. Every day we as human beings identify, assess and control risk with every action taken. From making a cup of coffee to driving to work. I am making am assumption that you did not burn yourself with the kettle and that you did not crash on your way to work.

 

Why is it that we do not apply the same approach to our businesses? Some would argue that they do apply a risk based approach. My next question would be show me how? This is where many would falter. Ask yourself how do you document that you have used a risk based approach?

 

Risk Assessments is the obvious answer! So how many do you need? 1? 10? 50? More . . . .

What assessment criteria do you use? Low-med-high? Green-amber-red? Or do you use a number based calculation? Severity vs likelihood?

 

Regardless of the system you choose to adopt the same principles should be applied.

Step 1) identify the hazards involved with the chosen activity

Step 2) assess the risk of the hazards, how likely is it going to happen? If it does happen how severe are the consequences? Who is the risk likely to affect?

Step 3) Control the risk of the hazards, what can you do to minimise the risk? Once minimise what can you do to ensure the residual risk is controlled?

Step 4) Evaluate the risk, have enough measures been taken to reduce the risk? If all measures are implemented what is the risk rating now?

Step 5) review and respond, if circumstances change the risk assessments will need to be reviewed, if no changes the risk assessments need to be reviewed at least annually to ensure they are still valid.

 

Do you need help evaluating the risks in your business? Do you know where to start? Do you know how to document the information correctly? We can help please contact us for more information.

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Having just completed the very informative API and Clinical Trail course (thank you Shankar) I was reminded of the traps we can fall into whereby we try to keep ourselves in our little boxes. At the MHRA symposium, I have heard several times comments such as:- “no, I’m not doing the GMP day as it’s not relevant to me” or “GDP? Oh, that doesn’t apply to us as we are manufacturers”. I am sure these comments were made well out of the earshot of MHRA personnel and on the face of it see… Read more
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