Can you use pencil to sign documents, fill out forms, etc?

[Jason PCSwitches]

It doesn't matter. If they are legible, identifiable & retrievable you can record data with finger-paint if you want as long as your procedures, customers or regulatory/statutory requirements don't state otherwise.

Smart....no, but there is "technically" no violation. Though I would ?? the organization that used finger-paint as a recording media....unless it was preschool.

 

[somashekar]

If you create and keep your records in the safety deposit box, they're good.

What happens, though, when you actually have some work to do, so one of those records has to circulate from a workstation through a couple of persons' hands before it goes into the safety deposit box?

In other words, how do you implement a practical system that doesn't circulate documents to locations where, in theory, they could be changed?

We had this situation and it was pencil that was working for us well. The reason was different. When pens were used, all sort of pens were with the various persons who had to handle and manage the lot traveller records and the ink of the pens were getting on to fingers and then on to the product (medical device cable products) and this was unacceptable. Pencils were the choice and worked well for us and we had to argue with auditors over this. No finding was given, however we were suggested to explore use of some better methods.
We have now overcome this with use of good quality pens and issued by the company and prevented people from using their own any make pens.
But with FDA inspection use of pencil for quality records is a sure NO NO NO.

 

[Bev D]

One reason pencil use is 'frowned upon' is that the notation can be easily erased. but that would occur because of 'ill-intent' or a simple mistake the signer tried to correct (with good intent). We can't completely prevent ill-intent.

Using the logic that is often used against pencils we would also have to guard against computer records since even with the best of 'controls' an electronic record can be altered with almost NO visible signs. Of course this is why many organizations have resisted computer records.

The key here for me is not whether or not the pencil mark can be properly controlled - it's why we have the obsession of permanent un-redactable signatures and data recording is thought to be value add at all? (keeping in mind that this is ISO-9000, not specialized industries/record types that logically must have this kind of control for legal accountability/punishment)

 

[Jim Wynne]

The key here for me is not whether or not the pencil mark can be properly controlled - it's why we have the obsession of permanent un-redactable signatures and data recording is thought to be value add at all?

The answer to that question is simple: we've always done it that way.

 

[dswit]

This is a question that I think everyone in a Quality position has struggled with since the beginning of time. The Regs are extremely vague about requirements, however, if you search for Good Documentation Practices, all say to NEVER use pencil and to use only blue or black indelible ink. The obvious reason that has already been posted several times is the potential for alteration. There are as many arguments for as against, but from personal experience, when retaining records for many years, pencil does degrade over time through handling of the document itself, and/or movement of adjacent files which can cause enough friction to degrade the information.

I've been through many FDA and ISO audits and in one instance the auditor found pencil on one document which caused him to expand his audit to 100% of all documents and records. This alone should be enough of a deterrent.

 

[Wes Bucey]

FWIW:
This consultant cited by OP is simply guilty of "Mission Creep" by substituting his own interpretation (more onerous than most) for the loosey goosey one accepted in most venues.

Obviously, there are some strictures which "might" be imposed on records by

1. government statute (FDA for example)
2. customers (you still have a choice whether to alter YOUR system or to simply reject such customer)
3. normal prudence (are you dealing with situations where documents are handled frequently and graphite from pencil might rub off where ink soaks into the fibers of the paper and has more permanence?)
4. fear (will some saboteur or other malcontent alter documents for nefarious purposes?)

The reality is that ANY document, regardless of materials used in the original, can probably be forged or altered in some way to make detection between genuine and bogus impossible except by extreme forensic measures. The question then becomes whether the document merits extreme protective measures to make it economically unfeasible for "baddies" to attempt alteration or forgery.

There was an article in our local news (Chicago area) this week about the rash of excellent forgeries of state-issued IDs. My understanding is these are available for around $100.00 (USD)

Apart from teenagers seeking IDs to drink alcohol, how about terrorists flying on planes with phony ID? How about identity theft of the schmuck who gives up his personal data to get an ID to match his other documents? How about drunk drivers with suspended licenses who get new licenses to flash if stopped by a cop?

With all the things facing individuals and organizations today, minor issues (especially such a picayune item as pencil versus ink) probably shouldn't be in the curriculum of even an average consultant without making it clear that good judgment and common sense should prevail and that an organization which adopts security measures intended for super sensitive documents (patents, contracts, top secret plans, etc.) for EVERY document, no matter how trivial, is setting itself up for a big cost drain with no resultant value derived.

In my thinking, even an OFI by an auditor would be overkill without clear indications that alteration or loss of legibility would be more than extremely remote possibilities and rarely can folks cite a situation where such alteration or loss of legibility would be a probability without the organization also adopting other security measures (lock and key?) for sensitive documents.

 

[Groo3]

Of course, when taking some exams you MUST bring your # 2 pencil to fill out the exam form. Other state and federal forms must be filled out with a pen. At our site, either may be used to fill out a form, but only a pen should be used when authorizing (signing) a document manually.

In my opinion, the answer can be yes or no, depending on the circumstances / requirements.

 

[Stijloor]

Friends,

Pencil?

Pen?

Aren't there bigger fish to fry?? :mg:

Stijloor.

 

[Jason PCSwitches]

Friends,

Pencil?

Pen?

Don't we have anything else to worry about??? :mg:

Stijloor.

Apparently not.....very few posts today

 

[Jim Wynne]

Friends,

Pencil?

Pen?

Aren't there bigger fish to fry?? :mg:

Stijloor.

I can think of a big one to fry--the consultant who claimed that documents with pencil entries can't be controlled.