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disposition of defectives, fda (food and drug administration), fda requirements, iso 13485 - medical device qms, microscopes, calibration (general topics)
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  #1  
Old 5th May 2011, 08:00 AM
medicalcomp medicalcomp is offline
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Question Do basic Microscopes require Calibration per FDA and ISO 13485

We make a medical device. per FDA and ISO 13485, can anyone tell me if we need (are required) to calibrate a basic microscope? It is used to disposition product as the acceptance criteria is a visual attribute noted/or not noted at 10 x. Thank you.

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Old 5th May 2011, 08:13 AM
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Re: microscopes

I do not believe that you should worry about calibration of the microscope. You should however worry about the operators ability to set up the microscope in a correct manner - that is actually a tricky task. You may also want to get into the operators eyesight - is it OK, or do they need glasses/lenses?

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Old 5th May 2011, 08:23 AM
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Re: microscopes

Quote:
It is used to disposition product as the acceptance criteria is a visual attribute noted/or not noted at 10 x.
The answer is yes.
Whatever your "visual attribute" is that you are verifying through the microscope needs a device that if fit for use and compliant with industry standards. Operator training goes hand in hand but operator's eyesight health (is unique & different) on top of using an optical instrument that is not properly maintained will exponentionally increase variability & inconsistency in your acceptance criteria procedure.

The instrument is used to make a decision of pass vs. fail therefore it should be reliable & reproducible. If equipment is not maintained regularly & consistently, this is a big gap in your quality system & someone will easily figure it out & find it. I look at critical steps in a process, then I look at how are these steps controlled & look deeper into those steps and go even deeper until there is a clear logical description & proof that it is followed every single time during production. If I don't see evidence of it, then it is a non-conformance & I flag it.
Basic preventive maintenance & calibration services can be scheduled from an external vendor annually, you get your paper work and then your are set.

The decision is good for your quality system and the quality of your product but a business decision as well.

Good luck!

Last edited by AnaMariaVR2; 5th May 2011 at 08:47 AM.
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Old 5th May 2011, 08:34 AM
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Re: microscopes

Quote:
In Reply to Parent Post by medicalcomp View Post

We make a medical device. per FDA and ISO 13485, can anyone tell me if we need (are required) to calibrate a basic microscope? It is used to disposition product as the acceptance criteria is a visual attribute noted/or not noted at 10 x. Thank you.
I don't know about medical device requirements in this regard (there are two conflicting responses as I write this), but if the microscopic verification involves use of a reticle ( or what an old boss of mine used to call a "radical" ) in the microscope, I would think that calibration would be necessary.

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Old 5th May 2011, 08:46 AM
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Re: microscopes

What would happen if the attribute was observed at 11x...it may have passed if at the proper mag; similarly it may be missed if only at 9x mag.

you have to be able to demonstrate that you are getting 10x magnification (or if appropriate >10x) otherwise it could lead to an incorrect pass/fail of your product; which is bad news from the FDA's and other regulatory bodies point of view.

As pointed out, the biggest source of error is likely to be the operator, therefore you should have adequate training and frequent eye tests in place

Last edited by pkost; 5th May 2011 at 09:00 AM. Reason: clarification
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Thumbs up Re: microscopes

Any measuring instrument used to verify/accept product must be calibrated and records must be available to support the calibration.
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Old 5th May 2011, 09:01 AM
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Re: Do basic Microscopes require Calibration per FDA and ISO 13485

I agree that risk of it being off and acceptance at 9 x could happen. I want it calibrated. Sometimes logic isn't enough when there is push back. But, is there something in a standard I can use? -there is an interesting change of opinion when when you point out something in a standard. It simply isn't questioned (usually). I just haven't found anything.
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Old 5th May 2011, 09:07 AM
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Re: Do basic Microscopes require Calibration per FDA and ISO 13485

further to my last post:

Quote:
In Reply to Parent Post by ISO 13485

7.6 Control of monitoring and measuring devices

The organization shall determine the monitoring and measurement to be undertaken and the monitoring and
measuring devices needed to provide evidence of conformity of product to determined requirements
(see 7.2.1).

The organization shall establish documented procedures to ensure that monitoring and measurement can be
carried out and are carried out in a manner that is consistent with the monitoring and measurement
requirements.

Where necessary to ensure valid results, measuring equipment shall
a) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable
to international or national measurement standards; where no such standards exist, the basis used for
calibration or verification shall be recorded;
The key thing here and I'm sure some calibration expert will jump down my neck for this: the standard does not specify how often you have to calibrate. I would have thought that the variation in a lens and the associated magnification is going to be insignificant over quite a considerable period of time. You should therefore be able to justify a really long calibration period!

edit: the second paragraph about documented procedures is specific to 13485 and not present in 9001
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