Calibration Certificates - Do Calibration Certificates Need to be Reviewed?

#1
I get audited several times a year, either internally or externally by the FDA, BSI, KEMA, etc. Recently, the FDA said that our calibration certificates need to be reviewed and signed. There is nothing in any regulation that states calibration certificates need to be reviewed 100%. I do perform a 10% monthly sample of each technician. I look for the following:
1. Following written calibration procedure for the instrument
2. Does the tech have a training record on file for the instrument he calibrated
3. Is the calibration certificate filled out correctly?
Any issues discovered are communicated directly to the technician, and I also use it as a training tool in my quarterly staff meetings with all the calibration staff. The main purpose of the record review is to assess the quality of work the technician is performing to, and also use it as a merit tool at the end of the year. The goal is to have less than 5% of paperwork related errors, and no leeway on following procedures.

So my question is: are there any docs that state this as a requirement for calibration records?

Thoughts?
 
Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Hi Charles,

I did a Google search and found the government requirement for you: 21 C.F.R. § 820.72(a)

Do a Google search of 21 C.F.R. § 820.72(a) and you might find the same interesting list of warning letters as I did. I hope it helps.
 
J

Jeff Frost

#3
If your organization is ISO 9001:2000 or the medical device equivalent you are required by the standard under clause 7.4.3 (ISO 9001) to verify the purchased product. ISO 9000:2005 defines a product as also being a service so in this case you are verifying the calibration certifications issued by a service provider. These verifications are to assure that the services procured from the calibration service meet your contractual requirements, those imposed by the customer and of course the requirements contained in clause 7.4 and 7.6 of the standard and that you aware of and have taken action related to M&MDs found to be nonconforming inclusive of product recall when warranted.

In other words they are looking for objective evidence you have reviewed the certifications and accepted the calibration results before using the M&MD.
 

Jim Wynne

Staff member
Admin
#4
Hi Charles,

I did a Google search and found the government requirement for you: 21 C.F.R. § 820.72(a)

Do a Google search of 21 C.F.R. § 820.72(a) and you might find the same interesting list of warning letters as I did. I hope it helps.
Here is the text of the relevant bit about calibration records:
(2) Calibration records. The equipment identification, calibration dates, the individual performing each calibration, and the next calibration date shall be documented. These records shall be displayed on or near each piece of equipment or shall be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment.
So there's nothing there about records having to be signed by anyone. I did the suggested Google search and encountered a few warning letters that did address deficiencies in calibration systems, but nothing about certificates not being signed.

I think the best advice is to ask the person who made the finding to provide the documentary basis for it. "Where's the shall?" in other words.
 
C

CliffK

#5
Is this about internal calibration or calibration performed by vendors?

Don't know about FDA/CFR, but ISO 17025 contains verbiage about approval of results. Perhaps you have run into something similar?

The best advice has already been given, of course: ask the originator of the finding to show you the shall.

I get audited several times a year, either internally or externally by the FDA, BSI, KEMA, etc. Recently, the FDA said that our calibration certificates need to be reviewed and signed. There is nothing in any regulation that states calibration certificates need to be reviewed 100%. I do perform a 10% monthly sample of each technician. I look for the following:
1. Following written calibration procedure for the instrument
2. Does the tech have a training record on file for the instrument he calibrated
3. Is the calibration certificate filled out correctly?
Any issues discovered are communicated directly to the technician, and I also use it as a training tool in my quarterly staff meetings with all the calibration staff. The main purpose of the record review is to assess the quality of work the technician is performing to, and also use it as a merit tool at the end of the year. The goal is to have less than 5% of paperwork related errors, and no leeway on following procedures.

So my question is: are there any docs that state this as a requirement for calibration records?

Thoughts?
 
M

Mr Niceguy

#6
Here is the text of the relevant bit about calibration records:

Quote:
(2) Calibration records. The equipment identification, calibration dates, the individual performing each calibration, and the next calibration date shall be documented. These records shall be displayed on or near each piece of equipment or shall be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment.
On the other hand I looked at this part under 21 CFR 820.72 (b)

"When accuracy and precision limits are not met, there shall be provisions for
remedial action to reestablish the limits and to evaluate whether there was
any adverse effect on the device’s quality. These activities shall be documented."

Although I am not affected by 21 CFR and I have not seen this before, I do recognise this principle in ISO 17025 clause 5.5.2. We have had a non-conformity from our AB by not documenting that an external calibration met our stated requirements. We do this by confirming (and signing/dating) on the certificate that it complies with a requirement/limit etc. documented in a procedure.

I think our AB was trying to stop the following scenario: Certificate arrives in post; technician takes one look, seems to be Ok, puts away in drawer, forgets it and does nothing.
 
Last edited by a moderator:

BradM

Staff member
Admin
#7
Interesting question. I do know that all calibration certificates (within my experience with FDA) are reviewed, and cannot go without being reviewed. However, to state the requirement for that is out of my realm.

I do think that calibration certificates (CoC) are considered raw data, and I do believe there are requirements for reviewing raw data. Also, CoC need to be reviewed for impact.

I certainly did not give you any meat for your hunger:). However, maybe there is some solace in the fact that my reality is unlike yours.
 

Jim Wynne

Staff member
Admin
#8
On the other hand I looked at this part under 21 CFR 820.72 (b)

"When accuracy and precision limits are not met, there shall be provisions for
remedial action to reestablish the limits and to evaluate whether there was
any adverse effect on the device’s quality. These activities shall be documented."

Although I am not affected by 21 CFR and I have not seen this before, I do recognise this principle in ISO 17025 clause 5.5.2. We have had a non-conformity from our AB by not documenting that an external calibration met our stated requirements. We do this by confirming (and signing/dating) on the certificate that it complies with a requirement/limit etc. documented in a procedure.
It's possible to document an activity without anyone signing anything.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#9
Before going into any response to the great posts here, I'd like some points cleared up.

I read that Charles is a calibration lab supervisor. Is this lab doing calibrations for customers? The term "certificate" imples there's some kind of formal, traceable record the cal has been done--and a signed certificate is way beyond what's usually needed in internal calibration.

Are these calibration certificates the only in-house evidence validating accuracy with traceability to NIST? In such a case I suppose I'd expect a certificate too, the files of which ought to be reviewed for requirements--but not 100% of them unless their number is small.

Like Jim, I'd like to hear the "shall". Did the auditor name the requirement?
 

BradM

Staff member
Admin
#10
Thanks, Mr. Niceguy! Good stuff. Where did the below quote come from?

Quote:
(2) Calibration records. The equipment identification, calibration dates, the individual performing each calibration, and the next calibration date shall be documented. These records shall be displayed on or near each piece of equipment or shall be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment.
 
Thread starter Similar threads Forum Replies Date
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
F Nist traceable calibration certificates General Measurement Device and Calibration Topics 1
F How many signatures do we need on calibration certificates? ISO 17025 related Discussions 8
eternal_atlas Section 7.8.4 Specific requirements for calibration certificates ISO 17025 related Discussions 2
M Calibration certificates avowing accuracy beyond the uncertainty limits? Measurement Uncertainty (MU) 7
M Producing IATF 16949 compliant calibration certificates IATF 16949 - Automotive Quality Systems Standard 24
N Calibration Vs Conformity Certificates General Measurement Device and Calibration Topics 2
L Is there a Standard regarding Calibration Certificates? General Measurement Device and Calibration Topics 3
P Resolution Requirements on Calibration Certificates General Measurement Device and Calibration Topics 8
G Signature Missing from Calibration Certificates General Measurement Device and Calibration Topics 6
K Recording Weight Values on Calibration Certificates General Measurement Device and Calibration Topics 13
K Pass Thru Calibration Certificates? Out-Sourcing Calibration to 3rd Party General Measurement Device and Calibration Topics 6
R How long do I keep expired Calibration Certificates General Measurement Device and Calibration Topics 8
M Understanding Calibration Certificates General Measurement Device and Calibration Topics 2
H How to get the Calibration Due Date? Calibration Certificates Calibration Frequency (Interval) 11
S Disappointed with Calibration Source - Different versions of certificates General Measurement Device and Calibration Topics 5
K Relative Humidity Requirement on Calibration Certificates General Measurement Device and Calibration Topics 5
M Calibration Certificates - Three different programs General Measurement Device and Calibration Topics 4
J Recommendations for Calibration Certificates/Software? General Measurement Device and Calibration Topics 11
C Accuracy on calibration certificates - How to calculate the accuracy of UUT General Measurement Device and Calibration Topics 3
J 17025 Para. 5.6.2 - Calibration certificates - Measurement results - Uncertainty ISO 17025 related Discussions 6
J Calibration intervals - Expiration dates on our certificates w/out customer approval Calibration Frequency (Interval) 3
B Calibration Certificates - Does 17025 require that all 'As Found' data be recorded? ISO 17025 related Discussions 7
D Are measuring equipment manufacturer calibration certificates (certs) sufficient? QS-9000 - American Automotive Manufacturers Standard 6
K Transferring Calibration Certificates General Measurement Device and Calibration Topics 5
Marc Calibration Certificates - Contents and Uncertainty Measurement Uncertainty (MU) 2
lanley liao Question regarding the calibration of monitoring and measure equipment. Oil and Gas Industry Standards and Regulations 0
N IATF Calibration Lean in Manufacturing and Service Industries 3
T Plug Gage Calibration Calibration and Metrology Software and Hardware 1
M Load Cell Calibration using a totalizer on a flow meter General Measurement Device and Calibration Topics 0
E Calibration Records needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D Limited Range Calibration - 5000 lb Industrial floor scale General Measurement Device and Calibration Topics 3
D Calibration of Small Scales General Measurement Device and Calibration Topics 26
C How to Establish the Calibration & Measurement Capability (CMC)? ISO 17025 related Discussions 1
I IQOQ or just initial calibration required? General Measurement Device and Calibration Topics 3
B Calibration in real life ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
A Is calibration of test weight required General Measurement Device and Calibration Topics 4
S Calibration Frequency for Slip Gauge Kit used for CMM Calibration? General Measurement Device and Calibration Topics 0
S Calibration/Verification of customer fixtures IATF 16949 - Automotive Quality Systems Standard 6
Ron Rompen Calibration by manufacturer ISO 17025 related Discussions 4
Q Calibration verification records 7.1.5.2.1 IATF 16949 - Automotive Quality Systems Standard 2
B AS9100D 7.1.5.2 Calibration or Verification Method using outside cal lab AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
W Next Calibration Due Date Calibration Frequency (Interval) 5
S Where do l get calibration standards to run a calibration lab? Other ISO and International Standards and European Regulations 2
A OEM On-Site Calibration issues during Covid19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
D Calibration tolerance question using Pipettes Medical Device and FDA Regulations and Standards News 1
M Calibration Certificate Result issued by an accredited external laboratory General Measurement Device and Calibration Topics 9
G Calibration of "Master Parts" Used as Gauges Calibration Frequency (Interval) 5
R Calibration lab environmental monitoring General Measurement Device and Calibration Topics 4

Similar threads

Top Bottom