Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Happy New Year to all the wonderful regulatory/quality professionals!!

I am trying to understand the requirements as it relates to equipment calibrations.

We are not ISO17025 certified, but we aim to comply.  Currently, we have a few pieces of equipment that we can't calibrate in house, but we can verify in house.  Are we allowed to "verify" equipment and if it meets specifications, not send for calibration?  Therefore the verification records would replace the calibration.  Or are we required to conduct an annual calibration?

Of course, if it does not meet specifications, we would send it out for calibration and conduct an out of tolerance risk assessment.

I'm not a metrologist, but am aware that, if an organization is in the medical device sector applying ISO 13485, then ISO 13485 provides that measuring equipment is to be calibrated or verified, or both, at intervals specified by the organization, or prior to use.  ISO 10012 appears to require calibration at least once, followed by verifications thereafter until such time as recalibration is appropriate.  But I too would be interested in hearing the interpretations of those more bona fide in metrology.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
ComplianceAcuity, Inc.
Ridgway, CO
United States
www.complianceacuity.com
© Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 26-Jan-2021 13:57
From: Anonymous Member
Subject: Equipment Calibration and Verification

This message was posted by a user wishing to remain anonymous

Happy New Year to all the wonderful regulatory/quality professionals!!

I am trying to understand the requirements as it relates to equipment calibrations.

We are not ISO17025 certified, but we aim to comply.  Currently, we have a few pieces of equipment that we can't calibrate in house, but we can verify in house.  Are we allowed to "verify" equipment and if it meets specifications, not send for calibration?  Therefore the verification records would replace the calibration.  Or are we required to conduct an annual calibration?

Of course, if it does not meet specifications, we would send it out for calibration and conduct an out of tolerance risk assessment.

You didn't state what you do. I infer that you are a device manufacturer. I also infer that you implement ISO 13485:2016. The specific requirement is in clause 7.6 which requires, "to ensure valid results, measuring equipment shall be calibrated or verified or both …" QSR has a similar requirement.

 

As a device manufacturer you do not need to comply with ISO/IEC 17025:2017.

 

For verification you check your IM&TE against a standard, usually internal. Some common examples are daily verification of an ESD wrist strap using a wrist strap checker, daily verification of a vernier micrometer using a gage block, etc.

 

In such a verification instance, you need to create a chain of "calibration" that leads back to, for the US, NIST. In the best case, you will have determined the uncertainty of the calibration chain.

 

As you follow the verification chain you will come to an instrument (IM&TE) that requires outside calibration. You will have determined its calibration interval, usually from the equipment manual.

 

As a device manufacturer your metrology system should follow FDA QSR and ISO 13485:2016. If you conduct internal calibration consider the ISO 10012 family.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 26-Jan-2021 13:57
From: Anonymous Member
Subject: Equipment Calibration and Verification

This message was posted by a user wishing to remain anonymous

Happy New Year to all the wonderful regulatory/quality professionals!!

I am trying to understand the requirements as it relates to equipment calibrations.

We are not ISO17025 certified, but we aim to comply.  Currently, we have a few pieces of equipment that we can't calibrate in house, but we can verify in house.  Are we allowed to "verify" equipment and if it meets specifications, not send for calibration?  Therefore the verification records would replace the calibration.  Or are we required to conduct an annual calibration?

Of course, if it does not meet specifications, we would send it out for calibration and conduct an out of tolerance risk assessment.

Hello Anon,

ISO 17025 is a standard used for accreditation (certification) though more precisely competency of testing laboratories including calibration labs.  The ISO 17025 standard can be viewed as a management system standard for testing laboratories and calibration testing organisations.  There are many requirements either by local government or by their customers where calibration facilities would need to be accredited to ISO 17025.   Unless your organisation is doing testing for external parties, this is probably not applicable to you.

Concerning your question, yes verification could be performed on instruments or equipment instead of performing a calibration.  This really depends on the type of equipment, what it is being used for, what testing or measuring is being performed of the components, sub-assemblies, or finished product.  You are not required to complete annual calibration, in fact calibration cycle depends on the type of instrument or equipment being viewed.  There is a process surrounding verification and/or calibration which needs to be clearly documented within your quality management system and specific to the devices.  It seems like you may need to have some further discussions with an expert related specifically to your measuring equipment or instruments to determine needs for verification, calibration, and the cycle period.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 26-Jan-2021 19:19
From: Dan O'Leary
Subject: Equipment Calibration and Verification

You didn't state what you do. I infer that you are a device manufacturer. I also infer that you implement ISO 13485:2016. The specific requirement is in clause 7.6 which requires, "to ensure valid results, measuring equipment shall be calibrated or verified or both …" QSR has a similar requirement.

 

As a device manufacturer you do not need to comply with ISO/IEC 17025:2017.

 

For verification you check your IM&TE against a standard, usually internal. Some common examples are daily verification of an ESD wrist strap using a wrist strap checker, daily verification of a vernier micrometer using a gage block, etc.

 

In such a verification instance, you need to create a chain of "calibration" that leads back to, for the US, NIST. In the best case, you will have determined the uncertainty of the calibration chain.

 

As you follow the verification chain you will come to an instrument (IM&TE) that requires outside calibration. You will have determined its calibration interval, usually from the equipment manual.

 

As a device manufacturer your metrology system should follow FDA QSR and ISO 13485:2016. If you conduct internal calibration consider the ISO 10012 family.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States

Original Message:
Sent: 26-Jan-2021 13:57
From: Anonymous Member
Subject: Equipment Calibration and Verification

This message was posted by a user wishing to remain anonymous

Happy New Year to all the wonderful regulatory/quality professionals!!

I am trying to understand the requirements as it relates to equipment calibrations.

We are not ISO17025 certified, but we aim to comply.  Currently, we have a few pieces of equipment that we can't calibrate in house, but we can verify in house.  Are we allowed to "verify" equipment and if it meets specifications, not send for calibration?  Therefore the verification records would replace the calibration.  Or are we required to conduct an annual calibration?

Of course, if it does not meet specifications, we would send it out for calibration and conduct an out of tolerance risk assessment.

I'm confused with your question... are you performing calibrations for other companies? Are you a laboratory seeking accreditations? Or are you manufacturing products and trying to control the measurements of instruments in your QMS? Not sure why you would want to be ISO:17025 certified.... ??

Assuming that you're a device manufacturing company and trying to be 13485 compliant, you as a company can decide what/how you want to control your instruments. Whether you contract out, or perform calibrations in-house can be determined by you. You just need to show/prove that you are controlling the measuring of equipment in your QMS. 

When it comes to deciding calibrations for instruments, you need to look at the complexity of the instrument... what is it used for? Is there software involved? is it just a bloody hammer? In your QMS, you should have some kind of Master Equipment LOG (MEL). This MEL has ALL instruments on-site in a list format, showing what instruments are currently being used, what instruments are out of service, and what instruments are being repaired... stuff like that.  This MEL has a unique number (ID assigned by your company that allows you to track a specific instrument), serial number, model number, location, calibration performed, calibration interval, some kind of instrument classification (A,B, or C ect.) letting you know what equipment needs calibrations/validations/verifications ect., basically an MEL is one big list of all the equipment being used by your company.  

Through this MEL, you'll be able to set up calibration intervals.. according to NIST, a 1 year calibration interval is acceptable, however, calibration intervals SHOULD be set through the equipment manual provided by the manufacture of the instrument. Most cases, the manual will be your best friend when determining intervals. Also, just because the manual says annual calibrations are the minimal requirement, doesn't mean that's what you should do. The integrity of the instrument comes into play as well... how often is it being used, are you starting to notice discrepancies after use. You may calibrate an instrument and 3 months later it's starting to perform out-of-spec, thus needing to be recalibrated. And vice versa. You may have an instrument set up on a 3 month interval and noticed after several calibration intervals the instrument is still operating to spec, thus you could increase the interval.

If you're lucky, you might purchase an instrument and there are no instructions/manuals... in this case it would be wise to not do business with these companies, because you'll run into problems down the road.. speaking from experience. That is rare, but it does happen.

Instruments that can't be calibrated due to lack of complexity can be verified for performance. Some instruments can't be calibrated, simply because there are no tolerances associated. These instruments are considered more of a tool and non-critical and don't need to be tracked on the MEL.

Tolerance risk assessment LOL... ubber waste of time. If an instrument is out of spec and continues to stay out of spec, after calibrations/repairs, then retirement of the instrument, or a simple discard would suffice.

Hope this helps.
CHEERS!!




------------------------------
Lance Tovar
RA/QA Specialist
Roy UT
United States
------------------------------

Original Message:
Sent: 26-Jan-2021 13:57
From: Anonymous Member
Subject: Equipment Calibration and Verification

This message was posted by a user wishing to remain anonymous

Happy New Year to all the wonderful regulatory/quality professionals!!

I am trying to understand the requirements as it relates to equipment calibrations.

We are not ISO17025 certified, but we aim to comply.  Currently, we have a few pieces of equipment that we can't calibrate in house, but we can verify in house.  Are we allowed to "verify" equipment and if it meets specifications, not send for calibration?  Therefore the verification records would replace the calibration.  Or are we required to conduct an annual calibration?

Of course, if it does not meet specifications, we would send it out for calibration and conduct an out of tolerance risk assessment.

Hi Anon,

Respectfully I disagree with Mr. Tovar's statement, "Tolerance risk assessment LOL... ubber waste of time.", and believe perhaps that he misread...

An Out of Tolerance Risk Assessment is an absolutely essential piece of the calibration cycle documentation and I would strongly suggest that you not discontinue it when applicable.


------------------------------
Pamela Stogsdill
Regulatory and Quality Specialist
Oak Creek WI
United States
------------------------------

Original Message:
Sent: 28-Jan-2021 17:31
From: Lance Tovar
Subject: Equipment Calibration and Verification

I'm confused with your question... are you performing calibrations for other companies? Are you a laboratory seeking accreditations? Or are you manufacturing products and trying to control the measurements of instruments in your QMS? Not sure why you would want to be ISO:17025 certified.... ??

Assuming that you're a device manufacturing company and trying to be 13485 compliant, you as a company can decide what/how you want to control your instruments. Whether you contract out, or perform calibrations in-house can be determined by you. You just need to show/prove that you are controlling the measuring of equipment in your QMS.

When it comes to deciding calibrations for instruments, you need to look at the complexity of the instrument... what is it used for? Is there software involved? is it just a bloody hammer? In your QMS, you should have some kind of Master Equipment LOG (MEL). This MEL has ALL instruments on-site in a list format, showing what instruments are currently being used, what instruments are out of service, and what instruments are being repaired... stuff like that.  This MEL has a unique number (ID assigned by your company that allows you to track a specific instrument), serial number, model number, location, calibration performed, calibration interval, some kind of instrument classification (A,B, or C ect.) letting you know what equipment needs calibrations/validations/verifications ect., basically an MEL is one big list of all the equipment being used by your company.

Through this MEL, you'll be able to set up calibration intervals.. according to NIST, a 1 year calibration interval is acceptable, however, calibration intervals SHOULD be set through the equipment manual provided by the manufacture of the instrument. Most cases, the manual will be your best friend when determining intervals. Also, just because the manual says annual calibrations are the minimal requirement, doesn't mean that's what you should do. The integrity of the instrument comes into play as well... how often is it being used, are you starting to notice discrepancies after use. You may calibrate an instrument and 3 months later it's starting to perform out-of-spec, thus needing to be recalibrated. And vice versa. You may have an instrument set up on a 3 month interval and noticed after several calibration intervals the instrument is still operating to spec, thus you could increase the interval.

If you're lucky, you might purchase an instrument and there are no instructions/manuals... in this case it would be wise to not do business with these companies, because you'll run into problems down the road.. speaking from experience. That is rare, but it does happen.

Instruments that can't be calibrated due to lack of complexity can be verified for performance. Some instruments can't be calibrated, simply because there are no tolerances associated. These instruments are considered more of a tool and non-critical and don't need to be tracked on the MEL.

Tolerance risk assessment LOL... ubber waste of time. If an instrument is out of spec and continues to stay out of spec, after calibrations/repairs, then retirement of the instrument, or a simple discard would suffice.

Hope this helps.
CHEERS!!




------------------------------
Lance Tovar
RA/QA Specialist
Roy UT
United States

Original Message:
Sent: 26-Jan-2021 13:57
From: Anonymous Member
Subject: Equipment Calibration and Verification

This message was posted by a user wishing to remain anonymous

Happy New Year to all the wonderful regulatory/quality professionals!!

I am trying to understand the requirements as it relates to equipment calibrations.

We are not ISO17025 certified, but we aim to comply.  Currently, we have a few pieces of equipment that we can't calibrate in house, but we can verify in house.  Are we allowed to "verify" equipment and if it meets specifications, not send for calibration?  Therefore the verification records would replace the calibration.  Or are we required to conduct an annual calibration?

Of course, if it does not meet specifications, we would send it out for calibration and conduct an out of tolerance risk assessment.

This thread seems to have gone off track, so I would to bring it back.

First, I infer your company is not a calibration or test house, so ISO 17025 does not apply to you.

Verification implies that you check the instrument to ensure that it operates correctly. For example, you check an Ohm meter with a 50 Ohm resistor to check that the Ohm meter reads between 49.9 and 51.1 Ohms.

Calibration implies that you determine that the instrument's precision and accuracy meet the manufacturer's specification.

In verification, compare the instrument's reading with a known value. Set the known value through a calibration traceable to, in the US, NIST.

For your specific questions.
Are we allowed to "verify" equipment and if it meets specifications, not send for calibration? Yes. Typically, verification is limited to one or a few of the instrument's capabilities.

Would the verification records replace the calibration records? Yes. However, you verify the instrument for limited use only.

Are we required to conduct an annual calibration? The calibration interval needs to follow the manufacturer's recommendation. It is not necessarily annual. If you verify, then it is for a limited application. If you use the instrument more broadly, then calibrate.

If the instrument doesn't meet the verification or calibration requirement, what should we do?
Repair the instrument.

Determine any cases in which the nonconforming instrument would have classified a nonconforming product as conforming. Determine a course of action for those incorrectly classifies products.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 26-Jan-2021 13:57
From: Anonymous Member
Subject: Equipment Calibration and Verification

This message was posted by a user wishing to remain anonymous

Happy New Year to all the wonderful regulatory/quality professionals!!

I am trying to understand the requirements as it relates to equipment calibrations.

We are not ISO17025 certified, but we aim to comply.  Currently, we have a few pieces of equipment that we can't calibrate in house, but we can verify in house.  Are we allowed to "verify" equipment and if it meets specifications, not send for calibration?  Therefore the verification records would replace the calibration.  Or are we required to conduct an annual calibration?

Of course, if it does not meet specifications, we would send it out for calibration and conduct an out of tolerance risk assessment.