Jump to content

TEMPERATURE CORRECTIVE ACTION


R1R2

Recommended Posts

How do you confirm the accuracy or quality of material before use when temps are out of range?   2 scenarios:

 

1.  Reagent range temp is 2-8C.   Fridge temp increases to 10 C for 30 minutes during inventory before returning to acceptable range.

2.  Reagent range temp is 2-8C.   Fridge temp increases to 22 C for 2 hours before discovery and reagents moved to another fridge.

COM.30800

Temperature Corrective Action

 

 

There is evidence of corrective action taken if acceptable temperature ranges for temperature-dependent equipment and environmental temperatures are exceeded, including evaluation of contents of refrigerators and freezers for adverse effects.

NOTE:  If acceptable temperature ranges are exceeded, stored reagents, controls, calibrators, etc. must be checked to confirm the accuracy or quality of the material before use and records maintained. The check should follow a defined procedure.

 

Edited by R1R2
Link to comment
Share on other sites

On ‎3‎/‎14‎/‎2017 at 6:44 AM, goodchild said:

Are these materials that are often taken out of the fridge and left at room temperature for lengths of time for testing purposes? I would focus my corrective action on why it took two hours to discover.

Quality Guy,

 

Scenario 1 happens frequently after reagent inventory or after new shipments are added to the fridge.   I would imagine that a lot of labs have these types of temp issues.  Sometimes they are unavoidable.   Scenario 2 hasn't happened since we installed an electronic temp monitoring system but for hospitals that still take manual temps, this could be a possibility.   What does your policy say about checking reagents after unacceptable storage conditions?   Do you perform a visual check or do you qc all the reagents stored in the fridge or do you do something else?  Thanks for your input.

Link to comment
Share on other sites

I would change the process.  I don't see any reason to leave any refrigerator door opened for an extended period of time (over one minute)  to the extent it causes an over-temp in the storage unit.  Load the shipment into the refrigerator in batches so that it can recover between each batch.

Link to comment
Share on other sites

I agree with Dansket. Change your process.

We used to have lots of spike son our charts and documentation inventory?

We have electronic system now and everytime the temp. goes to 5C, we get a call and tech is required to check all temperatures and add comment in computer.....guess what the ref. does not alarm at all...the tech changed the process ...they closed the door early enough to the temperature does not even go to 5C!

 

Link to comment
Share on other sites

Create an account or sign in to comment

You need to be a member in order to leave a comment

Create an account

Sign up for a new account in our community. It's easy!

Register a new account

Sign in

Already have an account? Sign in here.

Sign In Now
  • Recently Browsing   0 members

    • No registered users viewing this page.
  • Advertisement

×
×
  • Create New...

Important Information

We have placed cookies on your device to help make this website better. You can adjust your cookie settings, otherwise we'll assume you're okay to continue.