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Record Retention requirements of Calibration and Verification Service Providers

P

pangchiaboon

#1
Hi all,
Base on ISO13485 "the organization shall retain the records for a period of time at least equivalent to the lifetime of the medical device as defined by the organization, but not less than 2 years from the date of the product release by the organization or as specified by relevant regulatory requirements".

We have defined the retention period for product related records to be retained for at least 55 years, including records of outsourced process for traceability in the future.

How about records generated by external monitoring and measuring equipment calibration / verification service provider? Normally calibration / verification service provide will issue us calibration / verification cert.

1. Is it the only record that we need to retain?
2. Do we need to request calibration / verification supplier to keep their other internal records for 55 years? I think ISO 17025 does not required calibration/verification service provider to keep the records for so long.
3. What is our industrial practice?

Please advise. Thank you.
 

Stijloor

Staff member
Super Moderator
#2
Hi all,
Base on ISO13485 "the organization shall retain the records for a period of time at least equivalent to the lifetime of the medical device as defined by the organization, but not less than 2 years from the date of the product release by the organization or as specified by relevant regulatory requirements".

We have defined the retention period for product related records to be retained for at least 55 years, including records of outsourced process for traceability in the future.

How about records generated by external monitoring and measuring equipment calibration / verification service provider? Normally calibration / verification service provide will issue us calibration / verification cert.

1. Is it the only record that we need to retain?
2. Do we need to request calibration / verification supplier to keep their other internal records for 55 years? I think ISO 17025 does not required calibration/verification service provider to keep the records for so long.
3. What is our industrial practice?

Please advise. Thank you.
Can someone with this expertise help?

Thank you!!

Stijloor.
 
G

George Weiss

#3
From FDA 21CFR820:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1
Reviewing Sec. 820.72 lists Calibration records, Sec. 820.180 General requirements, the answer is clear:
All records required by this part shall be maintained for past life of device, or 2 years at least! Exceptions in red
Sec. 820.72 Inspection, measuring, and test equipment.
(a)Control of inspection, measuring, and test equipment. Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results. 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.
(b)Calibration. Calibration procedures shall include specific directions and limits for accuracy and precision. 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.
(1)Calibration standards. Calibration standards used for inspection, measuring, and test equipment shall be traceable to national or international standards. If national or international standards are not practical or available, the manufacturer shall use an independent reproducible standard. If no applicable standard exists, the manufacturer shall establish and maintain an in-house standard.
(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.
Sec. 820.180 General requirements.
All records required by this part shall be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer and to employees of FDA designated to perform inspections.Such records, including those not stored at the inspected establishment, shall be made readily available for review and copying by FDA employee(s). Such records shall be legible and shall be stored to minimize deterioration and to prevent loss. Those records stored in automated data processing systems shall be backed up.
(a)Confidentiality. Records deemed confidential by the manufacturer may be marked to aid FDA in determining whether information may be disclosed under the public information regulation in part 20 of this chapter.
(b)Record retention period. All records required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer.
(c)Exceptions. This section does not apply to the reports required by 820.20(c) Management review, 820.22 Quality audits, and supplier audit reports used to meet the requirements of 820.50(a) Evaluation of suppliers, contractors, and consultants, but does apply to procedures established under these provisions. Upon request of a designated employee of FDA, an employee in management with executive responsibility shall certify in writing that the management reviews and quality audits required under this part, and supplier audits where applicable, have been performed and documented, the dates on which they were performed, and that any required corrective action has been undertaken.
This is my prudent observation.
 
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arios

Your Mexican Amigo
#6
Check the guidance on ISO/TR 14969 :read:

There you will find an explanation regarding retention of records related to the product and the QMS
 
G

George Weiss

#7
Only the black was to be read. I was a bit silly last night. I was also assuming the 2 years + life cycle time, and not just 2 years. I amaze my self when re-reading what I wrote. I must be the same when I speak.
All help is apreciated!
 
G

George Weiss

#8
FDA Laboratory stores the QA Calibration Records for 3 years. Refer the Attachment A in the ORA Laboratory procedure.
.
I wonder if this policy would apply to a medical device, as the 21CFR820 was refering to? I also did see exemption(s) in the 21CFR820 similar to much of the QMS documents in the ORA list. I is additional documentation to go with! The best answer will appear I hope.
This article adds to the FDA pile of statements about medical device, and maintenance records retention @
http://medicaldeviceschool.com/A00008.html
 
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G

George Weiss

#9
Check the guidance on ISO/TR 14969 :read:

There you will find an explanation regarding retention of records related to the product and the QMS
I didn't see anything about the time of retention in ISO 14969? There was some descriptions. I realy like this read the book smiley face!

I reviewed another ISO 13485 QM and did see the life of the product, or 2 years minimum stated there also. I like this as the way to go!
I am sure asking a calibration provider to hold documents for 55 years is a stretch, but if this is the requirement, then everyone should be doing it.
 

Ajit Basrur

Staff member
Admin
#10
I wonder if this policy would apply to a medical device, as the 21CFR820 was refering to? I also did see exemption(s) in the 21CFR820 similar to much of the QMS documents in the ORA list. I is additional documentation to go with! The best answer will appear I hope.
Remember, the retention period that is being discussed is for Calibration Records and not for the medical device itself. If its a medical device, your answer is most appropriate.
 
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