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comment_71900

Hello!

I am wondering if anyone knows of a guidance or reference regarding intervals between weekly/monthly/annual maintenance/QC tasks?

For example, weekly maintenance should be performed 7 days +/- 1 day apart. Or monthly maintenance should be performed 30 days +/- 7 days apart.

I'm looking for help avoiding gaps such as monthly maintenance being performed on Jan 1 and Feb 28.

Thanks in advance!

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  • Malcolm Needs
    Malcolm Needs

    I can understand that. In the UK, if the ever pedantic MHRA see that a test should be incubated at 37oC, they will give you a non-conformance if your incubator is at 37.1oC on the day of the insp

  • Malcolm Needs
    Malcolm Needs

    Two, each one showing a picture of a finger!

  • I'm sure you sent them a card.......

comment_71902

That system sounds pretty good to me.  I would try to do weekly every 7 days though.  If an inspector sees that  most of a particular scheduled maintenance is run on the day of the week (or month) that it is supposed to be run, I do not think they will get upset about a few that is a day or two off.  

As far as gaps, you may want to schedule monthly maintenance somewhere in the middle of the month so it looks better if you are off a day once in a while.

Scott

comment_71905

We once had weekly maintenance scheduled for Thursday.  One of our inspectors didn't like the fact that wee were so specific and said that we weren't meeting our requirements if it varied.  Now we just call it weekly.

comment_71907
1 hour ago, KKidd said:

We once had weekly maintenance scheduled for Thursday.  One of our inspectors didn't like the fact that wee were so specific and said that we weren't meeting our requirements if it varied.  Now we just call it weekly.

I can understand that.

In the UK, if the ever pedantic MHRA see that a test should be incubated at 37oC, they will give you a non-conformance if your incubator is at 37.1oC on the day of the inspection.  If, on the other hand, you say in your SOP that the test should be incubated at 37oC, +/- 2oC, they are more than happy (despite the fact that we ALWAYS run positive and negative controls with EVERY test).  As it is nearing Christmas, I will not write down my true feelings about the MHRA.

comment_71909

I agree with the sentiments above. Wiggle room is always a good idea when creating ranges for any activity/process. The art is in defining the range - certainly you don't want to be too strict that an unexpected event throws you out-of-compliance. Neither do you want ranges that are so broad that they are effectively meaningless.

For maintenance, a good idea is to have a target date and then add your wiggle factor (+/- days, weeks, months, etc).

comment_71910
1 hour ago, Malcolm Needs said:

 As it is nearing Christmas, I will not write down my true feelings about the MHRA.

I'm sure you sent them a card.......:)

comment_71911
33 minutes ago, exlimey said:

I'm sure you sent them a card.......:)

Two, each one showing a picture of a finger!

comment_71915

Smoke and mirrors.  Never under estimate the value of smoke and mirrors!  :abduction:

  • 2 weeks later...
comment_71988

Basically follow your SOP and maufacturee recommendation.

Long time back We got cited for not doing weekly every seven days...... SOmetime we were doing on Monday and then Friday which was more than 7 days so we were cited by our STAT that it is not weekly! 

comment_72010

The FDA jumped all over us when we weren't doing maintenance on exactly the same day every month, even though our SOP did give us some wiggle room. We are not longer registered with the FDA - stopped drawing autologous blood - I don't miss them...at all.

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