21CRF820.70(g)(2) Maintenance Inspection Interval

[Logan_]

Hi,

21CRF820.70(g)(2) states “Inspection. Each manufacturer shall conduct periodic inspections in accordance with established procedures to ensure adherence to applicable equipment maintenance schedules. The inspections, including the date and individual(s) conducting the inspections, shall be documented.”

The majority of our equipment is maintained on yearly intervals however there are a few which require weekly tasks to be completed.

I was unsure if this inspection can lump multiple equipment together or if an inspections needs to be completed for individual equipment?

Is there any guidance on the frequency of the inspections based on the maintenance schedule?

 

[ScottK]

Hi,

21CRF820.70(g)(2) states “Inspection. Each manufacturer shall conduct periodic inspections in accordance with established procedures to ensure adherence to applicable equipment maintenance schedules. The inspections, including the date and individual(s) conducting the inspections, shall be documented.”

The majority of our equipment is maintained on yearly intervals however there are a few which require weekly tasks to be completed.

I was unsure if this inspection can lump multiple equipment together or if an inspections needs to be completed for individual equipment?

Is there any guidance on the frequency of the inspections based on the maintenance schedule?

Hi Logan, welcome
There is really a great deal of flexibility in this. FDA doesn't mandate frequency and will usually be happy with the equipment manufacturer's recommended schedule. Individual inspectors will have opinions but the standard is pretty open.

How you document it is up to you - just be consistent and document how you will do it and make sure the documented checks are kept in accordance with record retention procedures

If you have, say, a weekly checklist that has all machines on it where you walk the lines and check coolant levels of each machine that's fine. It's also fine if you have a weekly check list for each machine.

From a practical perspective I've always had everything separated by machine so I can easily pull all the records for a given machine and not have to sort through group records. So I might have a binder for each CNC machine in my shop where all the completed inspection forms are stored. (I've also worked with CMMS systems, which are nice)

As far as frequency this would be a combination of manufacture's recommended intervals and past experience... bring risk into the equation here and think "What's the risk to the product if I check the oil level monthly rather than weekly? What can happen if the oil goes too low? What's the likelihood that it will, base on history?"

In my experience most equipment has short term and long term things to monitor. And some equipment now has alarms that will notify you that maintenance is required - that can be factored in to eliminate periodic checks.

The most important things are: be consistent and have rationale based on risk to the product documented if schedules deviate from a manufacturer recommendation.

 

[Logan_]

Thanks for your response Scott. Am i right in assuming that the Maintenance Schedule and the Inspection are two separate records?

For example if i have a Lathe with a folder containing the Maintenance Schedule and Record which I keep with the instrument. When the daily/weekly/monthly maintenance is required it is completed and signed off.

This seems to cover 21CFR820.70(g)(1):
"Maintenance schedule. Each manufacturer shall establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met. Maintenance activities, including the date and individual(s) performing the maintenance activities,
shall be documented. "

Do I then also need a separate document where an inspection of this folder is completed to ensure the maintenance is being done? Is this what 21CFR820.70(g)(2) is referring to?

Or does the inspection form part of the maintenance record. Using my example of the Lathe. One item may be a weekly task "Inspect that lead screw is oiled" i inspect it and find it sufficient so i note this and sign off on it. This is my documented inspection. Next week i inspect it and find it insufficient and so i note it and oil the lead screw. This would be my documented inspection and maintenance.

I hope you can understand where my confusion is.

 

[ScottK]

Thanks for your response Scott. Am i right in assuming that the Maintenance Schedule and the Inspection are two separate records?

For example if i have a Lathe with a folder containing the Maintenance Schedule and Record which I keep with the instrument. When the daily/weekly/monthly maintenance is required it is completed and signed off.

This seems to cover 21CFR820.70(g)(1):
"Maintenance schedule. Each manufacturer shall establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met. Maintenance activities, including the date and individual(s) performing the maintenance activities,
shall be documented. "

Do I then also need a separate document where an inspection of this folder is completed to ensure the maintenance is being done? Is this what 21CFR820.70(g)(2) is referring to?

Or does the inspection form part of the maintenance record. Using my example of the Lathe. One item may be a weekly task "Inspect that lead screw is oiled" i inspect it and find it sufficient so i note this and sign off on it. This is my documented inspection. Next week i inspect it and find it insufficient and so i note it and oil the lead screw. This would be my documented inspection and maintenance.

I hope you can understand where my confusion is.

They can be the same document or different documents.
Whatever works best for your company.

You can make the schedule a form that is filled out as 2018 progresses and at the end of the cycle you save the record and print a new one for 2019.

Or you can have a documented annual schedule, and then write the results in a log book, which becomes your record.

If you have a maintenance work order system you'd probably go with something similar to the latter of these. Example: A procedure that outlines maintenance steps and intervals for each piece of equipment, documenting the actual work on the work order and keeping that as the record.

So as to your example... Yes. you must document the requirement and frequency somewhere. Then you must document that you did it as required. How you do that it up to your business.