hmlange Posted December 19, 2017 Share Posted December 19, 2017 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! Link to comment Share on other sites More sharing options...
SMILLER Posted December 20, 2017 Share Posted December 20, 2017 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 John C. Staley 1 Link to comment Share on other sites More sharing options...
KKidd Posted December 20, 2017 Share Posted December 20, 2017 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. John C. Staley, SMILLER and AuntiS 2 1 Link to comment Share on other sites More sharing options...
Malcolm Needs ☆ Posted December 20, 2017 Share Posted December 20, 2017 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. TreeMoss, AuntiS, Eagle Eye and 4 others 5 2 Link to comment Share on other sites More sharing options...
exlimey Posted December 20, 2017 Share Posted December 20, 2017 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). Malcolm Needs, John C. Staley and SMILLER 3 Link to comment Share on other sites More sharing options...
exlimey Posted December 20, 2017 Share Posted December 20, 2017 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....... NicolePCanada, AMcCord, John C. Staley and 1 other 4 Link to comment Share on other sites More sharing options...
Malcolm Needs ☆ Posted December 20, 2017 Share Posted December 20, 2017 33 minutes ago, exlimey said: I'm sure you sent them a card....... Two, each one showing a picture of a finger! exlimey, AMcCord, NicolePCanada and 2 others 1 4 Link to comment Share on other sites More sharing options...
John C. Staley Posted December 21, 2017 Share Posted December 21, 2017 Smoke and mirrors. Never under estimate the value of smoke and mirrors! exlimey, Malcolm Needs and Baby Banker 2 1 Link to comment Share on other sites More sharing options...
Eagle Eye Posted January 2, 2018 Share Posted January 2, 2018 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! Link to comment Share on other sites More sharing options...
AMcCord Posted January 4, 2018 Share Posted January 4, 2018 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. John C. Staley and AuntiS 2 Link to comment Share on other sites More sharing options...
hmlange Posted January 9, 2018 Author Share Posted January 9, 2018 Thank you all so much for your input! Link to comment Share on other sites More sharing options...
Recommended Posts
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 accountSign in
Already have an account? Sign in here.
Sign In Now