In our current paper-based QMS, several of our analysts possess very handwriting, particularly when it comes to maintaining technical records. This situation raises my concerns about test traceability and repeatability. Have you experienced any instances where poor handwriting has been considered a non-compliance in ISO (9001 & 17025 etc.)? Any advice on how to improve my situation? (Knowing that I can't computerize everything overnight). Your thoughts on this matter, including any relevant regulatory requirements, would be much appreciated!
Can poor and illegible handwriting be an NC in ISO audits?
- Thread starter SeanN
- Start date
Hello SeanN,
I no longer see "legible" in 9001 - you might check 17025 for it, I don't have a copy of that in front of me. Legibility was usually applied to scribbling to make changes though.
It seems a stretch, but there is, in 9001:2015:
Overall it seems more like an OFI to me unless you have something of your own that makes it a clear requirement.
I no longer see "legible" in 9001 - you might check 17025 for it, I don't have a copy of that in front of me. Legibility was usually applied to scribbling to make changes though.
It seems a stretch, but there is, in 9001:2015:
You might also be concerned about how your customers would be concerned about records they care about not being decipherable.
Overall it seems more like an OFI to me unless you have something of your own that makes it a clear requirement.
Enghabashy
Quite Involved in Discussions
for ISO/IEC 17025:2017 ; the following requirements should be considered :
7.8.2.1 Each report shall include at least the following information, unless the laboratory has valid reasons for not doing so, thereby minimizing any possibility of misunderstanding or misuse;
7.8.8.2 Amendments to a report after issue shall be made only in the form of a further document, or data transfer, which includes the statement “Amendment to Report, serial number... [or as otherwise identified]”, or an equivalent form of wording.
If the error can affect the results & the relevant issued reports ; it could be treated as change :
7.8.8.1 When an issued report needs to be changed, amended or re-issued, any change of information shall be clearly identified and, where appropriate, the reason for the change included in the report.
7.8.8.2 Amendments to a report after issue shall be made only in the form of a further document, or data transfer, which includes the statement “Amendment to Report, serial number... [or as otherwise identified]”, or an equivalent form of wording.
Such amendments shall meet all the requirements of this document.
7.8.8.3 When it is necessary to issue a complete new report, this shall be uniquely identified and shall contain a reference to the original that it replaces.
7.8.2.1 Each report shall include at least the following information, unless the laboratory has valid reasons for not doing so, thereby minimizing any possibility of misunderstanding or misuse;
7.8.8.2 Amendments to a report after issue shall be made only in the form of a further document, or data transfer, which includes the statement “Amendment to Report, serial number... [or as otherwise identified]”, or an equivalent form of wording.
If the error can affect the results & the relevant issued reports ; it could be treated as change :
7.8.8.1 When an issued report needs to be changed, amended or re-issued, any change of information shall be clearly identified and, where appropriate, the reason for the change included in the report.
7.8.8.2 Amendments to a report after issue shall be made only in the form of a further document, or data transfer, which includes the statement “Amendment to Report, serial number... [or as otherwise identified]”, or an equivalent form of wording.
Such amendments shall meet all the requirements of this document.
7.8.8.3 When it is necessary to issue a complete new report, this shall be uniquely identified and shall contain a reference to the original that it replaces.
To the question of illegible signatures (mine is pretty bad) I know of two answers:
1. A record sheet of a specimen signature for each person who had to sign documents (I had to sign dozens of work documents a day, sometimes approaching 100).
2. A serialized stamp with a unique number issued to each QA inspector. Three stamps - pass / fail / not applicable.
1. A record sheet of a specimen signature for each person who had to sign documents (I had to sign dozens of work documents a day, sometimes approaching 100).
2. A serialized stamp with a unique number issued to each QA inspector. Three stamps - pass / fail / not applicable.
LabCat
Quality Manager
This has been a concern of mine too. We have one team member who has very poor handwriting. I have asked them to be mindful of this, to use block capitals etc. as much as possible, but I feel bad making too much of a deal of it because as adults I am not sure there is much we can do to change our writing.
I will say we have never had an NC about illegible writing (we are ISO 17025), but one assessor did make a comment when he saw an error scribbled out rather than just a strike through on a paper record.
I will say we have never had an NC about illegible writing (we are ISO 17025), but one assessor did make a comment when he saw an error scribbled out rather than just a strike through on a paper record.
This thread is posted in the ISO/IEC 17025 forum, but looking at 21 CFR 820 for medical devices, it does state in section 820.120: ..."Such records shall be legible..." referring to quality records, regardless of where they are stored. If you have external audits, this requirement could become applicable, depending on who (third-party, second-party, etc.) is performing the audit.
Enghabashy
Quite Involved in Discussions
1-it's depend upon the situation , basically if this happened in the raw data which made by handwriting ; it could be pass because the auditor also should follow the formal output
2- if it's happened in internal record which didn't affect the test results or calibration certificate ' it's ok , the output are still ok;
3- the calculations ; the estimated results , the decision of compliance or if it’s lead to ambiguous statements in the document –etc -- therefore the new issuance of report / cert. with a clear reference of the original document should be done accordingly ; it’s also critical if there’ external customer or external interested party received the output/ test results .
4-the above recurrence of the same situation in any lab. is reflecting also the ineffective review process of the lab records / documentations
5- ISO 17025 requirements maybe more tight , it’s the lab. competency ; specially in accreditation & assessment audits ; the Lab is under the assessment acc. ISO IEC 17025 & under the relevant issues of accreditation regulations also--- anyhow the judgment could be defer from one assessor to another one ; the assessor could raise many findings during the assessment but the lead assessor in the final meeting can judge ; he can delete many of them also.
2- if it's happened in internal record which didn't affect the test results or calibration certificate ' it's ok , the output are still ok;
3- the calculations ; the estimated results , the decision of compliance or if it’s lead to ambiguous statements in the document –etc -- therefore the new issuance of report / cert. with a clear reference of the original document should be done accordingly ; it’s also critical if there’ external customer or external interested party received the output/ test results .
4-the above recurrence of the same situation in any lab. is reflecting also the ineffective review process of the lab records / documentations
5- ISO 17025 requirements maybe more tight , it’s the lab. competency ; specially in accreditation & assessment audits ; the Lab is under the assessment acc. ISO IEC 17025 & under the relevant issues of accreditation regulations also--- anyhow the judgment could be defer from one assessor to another one ; the assessor could raise many findings during the assessment but the lead assessor in the final meeting can judge ; he can delete many of them also.
ISO 9001 in section 7.5.3.1 requires that documented information "is available and suitable for use...", so if there is a problem with being able to read your records an auditor could site your records as not being "suitable for use".
ISO 17025 is more direct. In Control of Records, section 8.4.1, it says "The laboratory shall establish and retain legible records to demonstrate fulfilment of the requirements in this document. "
In my mind, I divide this general topic of legibility into different strata:
Signatures: My preference is that the every signature is identified somewhere in the record itself who it belongs to, using a typed/printed name. This could be satisfied with an approval page, or at the first instance of a signature, or via a signature log internal to the document. There is, to my thinking, a spectrum of possibilities. I am NOT a fan of separate signature logs. I know some companies keep these (some even implement them with sincerity!) but they are highly impractical to maintain or reference. I've never witnessed one of these used successfully to identify a truly inscrutable signature.
Data Entry: The best approach IMO is to construct forms such that:
When I have reviewed documents and been unable to tell what is written (sometimes they are sloppy, sometimes they write characters indistinguishable from each other... think "T" and "J" / "0" and "O" in serial numbers, I've reached out to the author to verify and I have made a note of what the "word" actually says.
No law degree here, but the old red-faced test is usually suitable enough to tell if something is legible. Even for people who can read their own sloppy handwriting, when asked to read something back more often than not they volunteer "yeah, that is hard to make out."
Signatures: My preference is that the every signature is identified somewhere in the record itself who it belongs to, using a typed/printed name. This could be satisfied with an approval page, or at the first instance of a signature, or via a signature log internal to the document. There is, to my thinking, a spectrum of possibilities. I am NOT a fan of separate signature logs. I know some companies keep these (some even implement them with sincerity!) but they are highly impractical to maintain or reference. I've never witnessed one of these used successfully to identify a truly inscrutable signature.
Data Entry: The best approach IMO is to construct forms such that:
- folks completing the form only have to record the minimal amount of necessary information
- folks completing the form have more than enough space to write the necessary information
- the form is constructed so that 'at-a-glance' it is obvious what information goes where
When I have reviewed documents and been unable to tell what is written (sometimes they are sloppy, sometimes they write characters indistinguishable from each other... think "T" and "J" / "0" and "O" in serial numbers, I've reached out to the author to verify and I have made a note of what the "word" actually says.
No law degree here, but the old red-faced test is usually suitable enough to tell if something is legible. Even for people who can read their own sloppy handwriting, when asked to read something back more often than not they volunteer "yeah, that is hard to make out."
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