Calibration Certificates - Do Calibration Certificates Need to be Reviewed?

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CliffK

#21
How would you know the equipment was out of calibration unless you reviewed the certificates you receive back from your cal service? Do they automatically notify you if a piece of equipment if found OOT or do they just bring it back within tolerance?
Good point; however. requiring a signature, initials or other "objective evidence" of the review seems to be going a little too far in the direction of making sure all the i's are crossed and the t's are dotted.

How about another set of initials to confirm that the first party actually reviewed the documents, as opposed to just marking them?:tg:
 
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CliffK

#22
To be unusually blunt, it's not very difficult to review a cert of cal and sign the bottom to show approval and document the review. We do this for all calibrations and it works just fine for us. Would it save us much time or money to not sign these, not really...would it be unpleasant if we found out that a majority of our certs were filed with errors in the document, you betcha. To me, reviewing the cert of cal is about the same as rereading an email to check for errors before sending it out, just good practice.
All a signature proves is that somebody signed a piece of paper.

As I said before, I don't do FDA. That said, I would advise my ISO (9001 and 17025) clients to push back if an auditor asked for signatures to prove "review" of CoC's.

If it was an internal calibration, presumably the tech who did the work signed off on it.

In any system where I have influence, the tech is responsible for initiating the reaction if an instrument is out of cal.

If another party signs off, who then is responsible for the work?
 
B

Benjamin28

#23
All a signature proves is that somebody signed a piece of paper.

That statement sounds rather like something Bill Clinton would say.

A signature by an offficer of the company is a notation accepting responsibility for the task of the review, at which point the signing member can be held legally responsible for his/her actions, fraud, liability, etc. To say it doesn't prove anything is a bit naive.

Either way, it is our practice to have the technician review their work, sign to accept that the information is correct etc, it is then reviewed by their superior (signed by them) and filed. This is not an overly time consuming task and moreover it gives us certainty that our instrumentation and its associated documentation is in order, which for a laboratory is quite critical.

This is simply the way we do our calibration cert reviews here, it works well for us and isn't a difficult task.
 
A

Aaron Lupo

#24
Good point; however. requiring a signature, initials or other "objective evidence" of the review seems to be going a little too far in the direction of making sure all the i's are crossed and the t's are dotted.

How about another set of initials to confirm that the first party actually reviewed the documents, as opposed to just marking them?:tg:
Industry Standard is that the tech initials/signs and dates they did the work and it is accurate and quality (or another independent function) reviews the data and signs if any OOT conditions are found and the unit if brought back within tolerance an investigation is performed (documented) to determine if any adverse affects could have been caused. it also allows us to see if the interval needs to be changed due to drifting or stability.
 
J

Jeff Frost

#25
Well to be honest, I would not want to sign one unless I knew the information recorded was correct. This means several things:
1. Was the calibration procedure followed (i.e. using the correct test points)
2. Did the tech accept the calibration, but it was actually out of tolerance (math error)?
3. Does the accuracy statement on the calibration certifcate match the statement in the calibration procedure?
4. Is there a training record on file, and did they use the current rev of the calibration procedure?
5. Typo's (e.g. forgot to record the standards used, forgot to sign, etc)

This is a very intensive review if you wanted to do one to that level.
That’s funny, is this not something you should do to assure the certificaiton does not contain these errors.
 
C

CliffK

#26
A signature by an offficer of the company
Surely you are not claiming that officers of corporations sign cal certs, are you? An officer of a company generally has a job title containing words such as "president," "vice president," "general counsel," "treasurer," "comptroller" or, helpfully, "officer." Now perhaps someone with a title like that has at some time signed a certificate of calibration, but I sort of doubt it. It is also remotely possible that those who routinely sign CoC's have been named as officers of their corporations, but I doubt that, too.

is a notation accepting responsibility for the task of the review,
First of all, the signature proves nothing about the depth of the review or about the qualifications of the signer or about the quality of the signed-for work. At worst, it proves only that some clueless pointy-haired boss was hornswoggled into signing off.

Second, the meaning of a signature is open to debate unless the signed document clearly indicates what the signature means. Words like, "by signing here I affirm that I have assiduously reviewed the work in question and find it to be adequate. I hereby relieve the technician of all responsibility," would help to tie down the meaning. But how often do those kinds of words appear on QMS documents?

at which point the signing member can be held legally responsible for his/her actions, fraud, liability, etc. To say it doesn't prove anything is a bit naive.
I'm not a lawyer and neither are you. But I think you have this bit wrong. Corporations are persons, and they generally bear the responsibility for the actions of their employees as they relate to the business of the corporation. That's why, for example, my class-action suit payout from Toshiba came from the person known as Toshiba, not from Toshiba and the chief of Toshiba engineering. This, even though Toshiba's chief engineer was certainly head of the function, and therefore responsible for the problem that caused the lawsuit.

Either way, it is our practice to have the technician review their work, sign to accept that the information is correct etc, it is then reviewed by their superior (signed by them) and filed. This is not an overly time consuming task and moreover it gives us certainty that our instrumentation and its associated documentation is in order, which for a laboratory is quite critical.
That's YOUR practice. If it helps you sleep better at night, great. Personally I would rather rely on the knowledge, integrity and accountability of the technician doing the cal.

And what if there's a foul up? If there's only one signature on the cert, you only have one problem: how did it happen? If there are two signatures, you have two problems: how did it happen; and, how did the reviewer miss it.

It all comes down to the old question about who watches the watchers. How many layers of lookers-over-the-shoulder do you need? Are you really sure just one is enough?

Now I understand that ISO 17025 requires review of test and calibration results. That's why, in my 17025 work, I make darn sure that the system documentation indicates that the technicians doing the work are competent to review their results and have the responsibility and authority to do so. Then I work with the client to make darn sure that the technicians are, in fact, so competent.
 

BradM

Staff member
Admin
#27
Great comments today on this one. It seems there has become a moderately passionate disagreement on this one. Passion is excellent, as long as we keep it towards the topic, and not each other!:D

Here is what I see so far (please feel free to edit):

1. The original question is do calibration certificates (CoC) need to be reviewed?
2. And if "yes", what are they being reviewed for?
3. Is there a regulatory requirement for reviewing CoC?
4. Do CoC need to be signed?

In my years of being involved with calibration, there have always been reviews of the CoC. Either a supervisor of a cal lab (internal calibration) or a customer. I think that is a good approach to keep for a few reasons.

#1, you need to review what you paid for. Certificates are meaningless if you cannot extract some value from it. You may need to determine if you calibration interval is too long, too short, etc.

#2, people who generate calibration certificates are not perfect. There will be math mistakes, typos, errors, training issues, etc. Depending on your situation and regulatory exposure, that can range from no big deal to big deal.

#3 Calibration information is observational data; an experiment of sorts. All observational/ experimental data I've seen has always been reviewed/ signed by someone. Your scenario may be different.

If I understand the OP as a supervisor of a lab doing FDA work, I cannot imagine being OK without reviewing the documentation. There are just too many things that need to be checked on there. If you have other processes that eliminates such errors, then I guess you would not have to review. But I would rather catch an error than my internal customer, which is not as bad as the internal auditor, that saves us from the external auditor, who hopefully has assured a proper process that the FDA auditor does not find it! :)

Now, leaping into having to sign/initial the CoC is another matter. I might think it's good to make some mark on the CoC, equipment log, database entry, something to show that "yes, someone acknowledges the review, and that it is legit".
 
P

Phil Fields

#28
Great comments today on this one. It seems there has become a moderately passionate disagreement on this one. Passion is excellent, as long as we keep it towards the topic, and not each other!:D

Here is what I see so far (please feel free to edit):

1. The original question is do calibration certificates (CoC) need to be reviewed?
2. And if "yes", what are they being reviewed for?
3. Is there a regulatory requirement for reviewing CoC?
4. Do CoC need to be signed?

In my years of being involved with calibration, there have always been reviews of the CoC. Either a supervisor of a cal lab (internal calibration) or a customer. I think that is a good approach to keep for a few reasons.

#1, you need to review what you paid for. Certificates are meaningless if you cannot extract some value from it. You may need to determine if you calibration interval is too long, too short, etc.

#2, people who generate calibration certificates are not perfect. There will be math mistakes, typos, errors, training issues, etc. Depending on your situation and regulatory exposure, that can range from no big deal to big deal.

#3 Calibration information is observational data; an experiment of sorts. All observational/ experimental data I've seen has always been reviewed/ signed by someone. Your scenario may be different.

If I understand the OP as a supervisor of a lab doing FDA work, I cannot imagine being OK without reviewing the documentation. There are just too many things that need to be checked on there. If you have other processes that eliminates such errors, then I guess you would not have to review. But I would rather catch an error than my internal customer, which is not as bad as the internal auditor, that saves us from the external auditor, who hopefully has assured a proper process that the FDA auditor does not find it! :)

Now, leaping into having to sign/initial the CoC is another matter. I might think it's good to make some mark on the CoC, equipment log, database entry, something to show that "yes, someone acknowledges the review, and that it is legit".
The point of signing and dating a docuement, in the FDA's view, if a record is not signed and dated, then it did not happen. Several week ago I attend a AMMI training seminar for 21 CFR PArt 820 Quality System Regulations. The message was very clear by the FDA that records needed to be signed and dated.
 

Jim Wynne

Staff member
Admin
#29
The message was very clear by the FDA that records needed to be signed and dated.
Did they tell you where the written requirements say that? Have we established that there's a documented requirement for signatures on calibration certificates? I know this is the government we're dealing with here, and I have no experience in this area, but it seems to me that unless there's an explicit "shall," all bets are off.

Speaking of government and signatures, I know someone who, while in the service, had a desk job for a time that required him to review documents and then initial them. One day he got one back from some higher-up with a note attached to it that said, "You were not authorized to review this document. Erase your initials, and initial your erasure." :frust:
 
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Phil Fields

#30
Jim,
This is cited in 21 CFR Part 820, section 820.40 Document Controls.
• 820.40(a) document approval and distribution states: The approval, including date and signature of individual(s) approving the document.
• 820.40(b) document changes states: the signature of the approving individual(s), the approval date, and when the change became effective

Phil
 
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