ISO13485:2016 Measurement System - Methods

H

henry1970

#1
Hello, I was asked to add the measurement device (instrument type) in the form where quality folks enter the result for measuring the part dimension. In addition, I must provide the calibration identification of its device or using the serial number. Knowing that the gage(s) can breakdown and replacing the same gage type is needed, is that mean I have to revise the document each time I replace the same gage type because it has different serial number? I thank you in advance for providing the recommendation.
 
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C

cal guy

#2
When you say "revise the document each time" are you asking if you need to record the Calibration ID or serial number for the gage being used? If so, the answer would be yes. The reason for this is to provide traceability of which gage was used to measure the part dimension.
 

QAengineer13

Quite Involved in Discussions
#3
Hello, I was asked to add the measurement device (instrument type) in the form where quality folks enter the result for measuring the part dimension. In addition, I must provide the calibration identification of its device or using the serial number. Knowing that the gage(s) can breakdown and replacing the same gage type is needed, is that mean I have to revise the document each time I replace the same gage type because it has different serial number? I thank you in advance for providing the recommendation.
Hi Henry,

Please refer to ISO 13485:2016 Clause 7.6 Control of monitoring and measuring equipment which states " As necessary to ensure valid results, measuring equipment shall:
a) be calibrated or verified or both......
b) be adjusted or re-adjusted in order to determine calibration status;
c)have identification in order to determine its calibration status;
d) be safeguard from adjustments....
e) be protected....
Records of the results of calibrtation and verification shall be maintained".

SO the answer is "YES" to add the instrument type, Calibration Identification and Serial Number .

Reg this question of yours :
"I have to revise the document each time I replace the same gage type because it has different serial number? "

In general the best and a pragmatic approach would be to have a Quality form (QF) or template for capturing the Inspection Test equipment details and this QF will serve as a record for each variant of the Instrument type, Model number along with its serial number. To make it clearer imagine the below as a form something like this should exist for each unique inspection test equipment model number, Serial number.


Inspection test equipment No.: ITE 123

Instrument Type: Multimeter Instrument Model No: ABC 1234

Serial Number: 45627 Calibration interval: 12 months

S.no Calibrated by Next calibration date Attach the report of calibration

1.
2.
3.
 

Mark Meer

Trusted Information Resource
#4
Hello, I was asked to add the measurement device (instrument type) in the form where quality folks enter the result for measuring the part dimension. In addition, I must provide the calibration identification of its device or using the serial number. Knowing that the gage(s) can breakdown and replacing the same gage type is needed, is that mean I have to revise the document each time I replace the same gage type because it has different serial number? I thank you in advance for providing the recommendation.
Nooo! Don't hard-code this information into the form! This will be a doc-control nightmare because, as you correctly point out, the form itself will have to be revised every time the equipment is updated.

Better approach is to make use of references.
- The form (record) references a particular piece of equipment by ID. This is entered manually, and is the only equipment information (aside from the measurements taken) that need be on the form.
- The ID traces to an equipment record where the serial number, and calibration schedule is maintained
- The equipment record traces to (or has attached) records of calibration activities.

This way, the only thing people filling in the form have to record is the ID of the equipment they are using, and you won't have to update the form if the equipment is recalibrated, or even if you approve a different equipment altogether that makes the same measurement.


:topic:
Additional suggestion (if you don't do already): Label all equipment with its ID (use something simple e.g. "C1234" so identifying on forms is simple - less chance of transcription error), and next calibration due date. This way, technicians can:
- quickly and easily record the equipment they are using on a form; and
- verify that the equipment they are using is within calibration due date
 

QAengineer13

Quite Involved in Discussions
#5
Thanks Mark, yes you have summarized it clearly that's exactly what I meant that the Record with the details about the instrument will be Hand written only the FIELD Type /ATTRIBUTE for Model No., Serial no. will be on the template form with a an empty box next to it which will be hand written with details , I have also attached the form for reference so it clear this time.
 

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