Calibration Certificates - Do Calibration Certificates Need to be Reviewed?

Jim Wynne

Staff member
Admin
#31
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
I'm seeing this more clearly now. I looked at 21 CFR Part 820, and perhaps I can tie things together for clarity here. First, Subpart D (Document Control) says,
Each manufacturer shall establish and maintain procedures to control all documents that are required by this part...Each manufacturer shall designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part. The approval, including the date and signature of the individual(s) approving the document, shall be documented.
Note the explicit requirement for all documents required by this part to be dated and signed.
Moving on to Subpart G, §820.72, we find,
Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. The procedures shall include provisions for handling, preservation, and storage of equipment, so that its accuracy and fitness for use are maintained. These activities shall be documented.
Thus there's a clear requirement for calibration activities to be documented, and another clear requirement for all documents to be signed and dated. That seems to answer the question, no?
 
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Benjamin28

#32
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.
Yes, actually our company is a small company, the technical manager is an officer of the company and is responsible for review of calibration as one of his tasks, you make a lot of assumptions in this post.

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.
Again, this is an assumption on your part, the review is outlined in a quality document and is a specific task, we deal in data and therefore we take great care in ensuring our documentation is pristine. Nor is our boss pointy haired.

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?
If you're trying to be a lawyer here you're doing a good job, in the realm of law everything is "open to debate". Again I'd refer to our review procedure for clarification to narrow down the "debate".

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.
In a class action law suit against a corporation sure. I'm talking personal liability here. For example we had a tech once who slept through his shift while pouring 25,000 gallons of JetA fuel onto the ground, he was arrested, his boss had a lien put against his house, and the corporation had to deal with the clean-up costs/emergency worker costs. By your reasoning only the corporation would be liable? So if I always have a boss I never will be held responsible?

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.
Isn't that what I said in my post...that this is our practice, it works for us, it's easy and, since we don't have a pointy haired boss, the review is actually a useful process which doesn't require a huge commitment of time and work. So why try to contend that? I wasn't saying you personally have to do things this way, only that we do so and find it useful and easy!

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.
And what if there's a foul up? If the technician misses something, or makes a calculation error and the reviewer catches it and makes the correction prior to putting the instrument back into production use? Then you have prevented numerous measurement errors...There are a lot of what ifs in this world, I'd rather have better odds of having the data correct in the first place than worry about asking why two people missed something.


There are going to be varying viewpoints on this issue, I'm simply offering mine and you can take it or leave it. We utilize complex instruments and the calibration of those instruments is of utmost importance, because the calibration is not an automated process and is vulnerable to human error we find the review process to be beneficial. And yes, our technicians are extremely competent and we are confident in their abilities, but human error is a fact of life, reviewing their work has proven useful. If you're just calibrating micrometers by all means a review with a signature isn't going to be very useful, but if you're programming variables into a complex instrument based on calibration calculations I'd rather have a review and overcheck so I can ensure that instrument is indeed working correctly.
 

BradM

Staff member
Admin
#33
Thus there's a clear requirement for calibration activities to be documented, and another clear requirement for all documents to be signed and dated. That seems to answer the question, no?
At least for the FDA requirement, in my book, Yes. Thanks to Phil for the citations.

There have been some excellent posts on this one (both sides). I thank those for sharing their thoughts, as it makes for a great reference for others.

As stated earlier, in my world of "Brad is king for a day", all CoC should be signed/initialed by a responsible person assuring completion, accuracy, etc. Not because you're "told" to, but because it makes good sense.
 

Jim Wynne

Staff member
Admin
#34
Thanks to Phil for the citations.
Ditto.

As stated earlier, in my world of "Brad is king for a day", all CoC should be signed/initialed by a responsible person assuring completion, accuracy, etc. Not because you're "told" to, but because it makes good sense.
Define "responsible person." Does this assume that a person who drafts a calibration certificate isn't responsible? Aren't we supposed to be moving away from the idea that everyone's work should be inspected? I can understand (if not completely sympathize with) a requirement for checks and balances in things like medical devices, pharmaceuticals, and nuclear explosives, but in most instances, I think we need to trust trained and skilled people to do things correctly.
 
C

CliffK

#35
Ditto.


Define "responsible person." Does this assume that a person who drafts a calibration certificate isn't responsible? Aren't we supposed to be moving away from the idea that everyone's work should be inspected? I can understand (if not completely sympathize with) a requirement for checks and balances in things like medical devices, pharmaceuticals, and nuclear explosives, but in most instances, I think we need to trust trained and skilled people to do things correctly.
Thank you Jim for the clear explanation. This is exactly the point I was trying to make earlier.
 

BradM

Staff member
Admin
#36
Ditto.

Define "responsible person." Does this assume that a person who drafts a calibration certificate isn't responsible? Aren't we supposed to be moving away from the idea that everyone's work should be inspected? I can understand (if not completely sympathize with) a requirement for checks and balances in things like medical devices, pharmaceuticals, and nuclear explosives, but in most instances, I think we need to trust trained and skilled people to do things correctly.
Ok, good point. By stating responsible person, that does not apply that everyone else is irresponsible. It means operationally defining an individual who knows the appropriate requirements, appropriate standards to use, etc. Depending on the scope of the calibration activities, levels of requirements, etc., that may/ may not be within the realm of the person performing the calibrations.

To me, this has nothing to do with trust. If I did not trust people doing the work, I would find someone else. As I stated earlier, if you have established a process that ensures that all those potential errors cannot be made, then "no", I guess you don't have to inspect anything.

As I stated earlier, I don't think there is any slam-dunk answer for this one; just different people's experiences and realities.
 
D

Dale D. Barnes

#37
I am going to admit that I read about the first three pages then started skipping the longer replies do to time constraints. (Lean/kaizan) :cool:

I handle it this way and it seems not to bring up any problems:

Internal calibrations: Done in Gage Trak and have no signatures. The person who does the calibration is associated with it thru the software.

External calibrations: The certificates are inspected to make sure the item was not found to be out of calibration-

1. If found good then "OK" and initials are placed on top of cert. along with gage ID (because its easier to see that way when looking thru the binders)
2. Once Activated then "Activated On xx/xx/xxxx" is also wrote on cert.

Example: Activated On 11/30/2007
01-0001
OK DB

3. If found out of tolerance then we make sure that it did not affect any of production and the Quality Manager writes and signs a letter that states that product was not affected. (Just a note-this is e-mailed and I save in a folder just in case)

4. If found out of tolerance and it does affect the product well lets just say FUBAR :mg:

That is how I handle it and I may not have to but it is easy to do and I am never questioned.

Thanks
Dale
 
#38
Thanks everyone for all the comments. I never expected this many comments on this subject. I only wish that the FDA would update the regs to state this requirement, as I still feel that it's not clearly stated as a requirement and left to interpretation. Also, you have to ask if this is really value added function. Having a 2nd reviewer does not assure 100% compliance, as I'm sure most reviewers make sure that the data recorded is complete not necessarily accurate without mistakes.

The approach that I'm proposing will require the reviewer to look for a calibration done to the current revision, and they used the correct test points, along with looking for typo's. I figure this will require ~100 man hours of additional work (value added?). I guess it's "better to lose the battle in order to win the war."
 
P

Phil Fields

#39
Charles,
Have you challenged your FDA auditor to state where in the regs it requires such a review? We do in house calibration for mics and calipers only, we do not require that a review be performed (I do one every 4 to 6 month anyway).

I would not add extra work if the auditor can not define the regulation. If the auditor can not give you a good answer, you can always go up the up to the next level, the FDA Center that you use and ask for clarification.

Did you post the exact finding/observation the FDA cited you for?

Phil
 
J

Joconnell

#40
In our first surveillance audit I also received this same feedback. Verbatim the 'deviation' (or finding) states: 'Objective evidence to show review and approval of Calibration Certificates not available for all certificates sampled and test data from service provider not always present'. We have our equipment calibrated by an outside source, and the data is available per request. Initial data comes with the equipment, but subsequent calibration data is a pass/fail. Per our policy the certificates of calibration are checked into our electronic calibration system, therefore reviewed.

During the audit I challenged this, and the auditor said that they were going to check on it with some collegues. I was just curious if I had a leg to stand on or do I just accept it? BTW I am talking ISO 13485:2003, and the supplier of the calibration service has been approved. My argument was: if we approve the supplier for use, why would question that they haven't done their job? If we were questioning whether or not their calibration abilities are satisfactory, why would we have them as our approved supplier?

Thank-you in advance for any feedback!
 
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