Corona Virus impact on Supplier Audits and Received Parts

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#1
Aside from the difficulty in traveling I was curious if people have added CV as a risk? For example, we receive a plastic part from our supplier that is patient contacting. It is also handled by our production staff. With plastic sustaining CV for up to 7 days, it creates a risk for our production employees. Has anyone implemented specific controls with their suppliers to mitigate CV Spread?
 
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John Broomfield

Staff member
Super Moderator
#2
Aside from the difficulty in traveling I was curious if people have added CV as a risk? For example, we receive a plastic part from our supplier that is patient contacting. It is also handled by our production staff. With plastic sustaining CV for up to 7 days, it creates a risk for our production employees. Has anyone implemented specific controls with their suppliers to mitigate CV Spread?
Ed,

South Korea seems to have benefited most from its 17 years dealing with SARS coronavirus. Here is an English language paper on the subject from 2010: Effects of Air Temperature and Relative Humidity on Coronavirus Survival on Surfaces

Your Korean suppliers may be able to recommend the disinfection measures they use for outgoing goods (and for receiving them).

You may still find that you need to conduct your own study by taking swabs and having them tested for infectious amounts of virus. Naturally, for this you would engage the sampling team in assessing and treating the risks of infection.

As you say bits of the virus may survive for a long time: Study reveals how long COVID-19 remains infectious on cardboard, metal and plastic: People may acquire coronavirus through air and by touching contaminated surfaces

...but it remains unclear how infectious the bits of CV are.

Meanwhile, quarantining incoming items for at least 24 hours unless you have more reliable criteria seems sensible.

Stay well,

John
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#5
Thanks. I have added interim controls on our Quality Planning. For the interim controls, we are holding material for 7 calendar days before use.
 
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