The Use of Pencils and Ink Erasers in Records

T

t.PoN

Is it prohibited to use pencils and ink erasers according to ISO 9001? if yes, then what is the clause.

My interpretation is the protection of record control is:
- Protection from unauthorized access
- Protection from lost
- Protection from unauthorized change.

another reference is tractability of records, but its not always necessary to trace changes, does it

but the use of pencil or ink eraser doesn't mean the record is subject to unauthorized change, does it?

I am asking this because we are here having a debate on this subject. In our company it is prohibited to even buy an ink eraser but that's because we have labs and we are accredited to ISO 17025 which prohibit the use of ink eraser.

I want to hear a third opinion in this subject, so please advise us
 

Jim Wynne

Leader
Admin
Sometimes records are found to contain errors and those errors should be corrected. Complete erasure might not be the best way, though. You should have a defined process for correcting records that includes specific authorities and methods. You don't want to make it appear that records have been retroactively falsified.
 

Marc

Fully vaccinated are you?
Leader
Yup - And a lot of places erasures of pencil or ink are not allowed at all. Strike through minimum. The more "important" the record, the more stringent the requirements.

However, ISO 9001 doesn't specifically address whether a company allows pencils and/or erasures that I am aware of.
 
P

PaulJSmith

ISO 9001 only states that "Records shall remain legible." There is no prohibition on any type of writing device. Yes, you must control them as well, which is were your issue with unauthorized change comes into play. Your procedure should specify what is allowed and what is not with regard to changing any documents or records.
 

John Broomfield

Leader
Super Moderator
Strikethrough so original record can be read but the correct value is clear to users of the record.

Erasers should not be used to keep legible the contemporaneous record.

Records with hidden changes to not deliver confidence.

But often this is ignored, especially with electronic records unless the software keeps an archive of changes, who made them and when they were made.

QA = delivering confidence that requirements will be fulfilled.
 
M

maaquilino

Our document control process states that for hard-copy documents only blue or black ink may be used; that any cross-outs/revisions of verbiage that does not critically impact content be done with one line (strikeout) through the part to be changed, and it's initialed and dated by the person making the change. Anything in the QMS done electronically must be done on a validated system and an audit trail must be used to capture any changes made, when they were made, and who made them. While this is in a regulated environment, imo it's also simple good business practice for non-regulated environments.
 
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