Assign topic to the user. Tracey Evans Best Answer: Jul 10, Quote 0 0. Comment as guest or Sign in. I accept the Privacy and Terms. We need to maintain technical records as evidence of documenting the valid results of our measurements during monitoring. We need to maintain records in order to traceback any issues concerning the effect of measuring equipment found to be out of tolerance that is used on a certain product in order to take appropriate action.
This is where we can review past results for validation purposes in case an issue related to the calibration or measurement process is suspected. One way to control records is to keep them for a designated period. The recommended retention period for technical records in calibration or testing is at least 4 years. Be sure that it is documented under the control of records procedure. A longer storage period for calibration records is required because some records are needed during performance review or history of data to be used during quality control.
Please do not get confused about the differences between a form and a record. Forms and records are not the same. A form is a blank document designed to guide and make a specific activity more organize and mostly much faster. While a record is a filled-up form or a form where the required data is already written in the provided space. Forms are always the best tool to use in documenting or recording your accomplished work.
Forms should always be a part of every calibration procedure. Having a form to fill up with will provide a better and faster flow of calibration execution. It is a calibration template that will guide and show you what to do next.
Just fill in the blanks. The following are a list of forms and records that we need to have while performing calibration:. In this time where technology are advancing, forms does not necessarily in a hard format or copy. Depending on the resources of the lab, forms can be in an electronic format. Just remember, all these documents must be controlled in any way possible or monitored for any changes and distribution.
Watch this topic Print this topic. Rank: Forum user. Hi All How long should we retain records for the calibration of multimeters, Clampmeters etc. Is there a statute or the should we keep the records for the equipments entire life? Many thanks in advance. Rank: Super forum user. We use SAP software and it serves as our calibration records. When I created the work instructions, I included everything above, but left out 5 since it is on a master document containing a list of calibration instruments.
We had a 3rd party audit soon afterwards and he said everything looked good. My boss got back a few weeks later and nailed me for not including 5 on each calibration record. Also, I left the instrument used field blank to be filled out by the technician at the time of calibration. My boss said the calibration instrument used field must be pre-populated first time he told me this , even though we have multiple instruments that can be used to calibrate and the technician doing the calibration would fill this out at the time of calibration.
The auditor only viewed calibration records already done, not the calibration form itself, so he didn't know the instrument field was blank. Is the specified accuracy of the instrument being calibrated required to be part of the calibration record? It is on the same master document mentioned above with the frequency of calibration. I have every intention of complying with my boss, but I would also like to verify the information he told me with a 3rd party such as yourself.
Is the frequency required on the calibration itself or just need to be documented and easily found elsewhere? You:Is the specified accuracy of the instrument being calibrated required to be part of the calibration record?
Denise: ISO requires: "The organization shall ensure that the resources provided How you document this is your choice. You: Is the frequency required on the calibration itself or just need to be documented and easily found elsewhere? Denise: ISO requires: " The location is up to the organization.
Thanks Dirk. Basically it sounds like our requirement of documenting the same information in two places is above and beyond what ISO requires. It was inferred to me that by not doing this we were going to have a CAR written against us. Since a lot of details are left up to the organization, I assume we are judged by our own standards as well as ISO standards when getting audited or re-certified.
Problem is I have not been able to find our standards in written form so I know exactly what to expect, I've had to take my boss' word for everything.
Anyway, thanks again for your response.
0コメント