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

[Stijloor]

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

Damn right!! All this bullsh*t gives our profession a bad name...

Stijloor.

 

[Ramrethan]

This subject just came up tonight at the company I work for. I'd like to hear from others here, because I'm not the most up to date on anything ISO 9001 but....

We were given a short quiz and one of the questions concerned the use of pencil. Tomorrow I'll get the exact wording from the quiz but basically the consultant/instructor took the position that if any record or document is written or filled out in pencil, it would result in a finding/non-conformity. While I agreed that pencil was a poor choice for records, I respectfully disagreed that the use of pencil could result in a finding.

I asked him under what clause of the Standard a finding could be issued. He pointed to 4.2.4 Control of Records. He said records can't be controlled if they're in pencil. I continued to disagree. I said they could be kept [and locked] in a cabinet, an office, a safety deposit box (just kidding) and as long as the record is "legible, readily identifiable, and retrievable", then it can be in pencil, blue ink, black ink, red ink, typed or handwritten.

Again, I don't suggest pencil is preferable or a good idea...but as I understand it, the Standard doesn't proscribe using pencil. I was also clear to point out my understanding was that IF the company established an internal rule that documents must be filled out in ink, or a specific color of ink, then of course a person would be bound by that self-imposed limitation.

Am I wrong? Really, it's been awhile since I've been involved in ISO 9001 auditing and I'm wondering which of us is right. What options do you have when you totally disagree with the auditor's interpretation of a precise clause in the Standards?

I would be inclined to reply that retrievability may be an issue...

 

[Ramrethan]

Usually pencil is not even an option except for sketching and unofficial use...

 

[Wes Bucey]

Damn right!! All this bullsh*t gives our profession a bad name...

Stijloor.

I, for one, do not agree this guy deserves the title "consultant." Some readers might recall my screed (Consulting – Is it in YOUR Career Future?) a while back about consultants where I wrote

Reason for this thread:
Many of my colleagues and associates around the world actually ARE those high paid consultants who deal with the top managers at organizations. When we talk and correspond, one of the main topics that comes up almost every time are the folks who hold themselves out to be “consultants,” but the only thing “consultant” about them is the title they put on a business card. Often we say, “What a shame this guy is so clueless about how to be a REAL consultant.” And then we jump to another topic and mentally dismiss the person from further consideration. On a few occasions, we say, “Wow! That guy is a menace to the profession. He’s so bad, his stink rubs off on the rest of us!” But again, we do nothing, because our “professional ethics” prevent us from bad mouthing a competitor in public, even a stumblebum who gives the word “consultant” a bad taste in anyone’s mouth who crosses his path.

 

[Jim Wynne]

I would be inclined to reply that retrievability may be an issue...

Why might retrievability be an issue?

Usually pencil is not even an option except for sketching and unofficial use...

The fact that pencil is easily erasable is sometimes a feature, not a defect. Not only that, but there are pens with erasable ink.

There is also the persistent myth that records should never be changed, and I think that plays into the no-pencil business. Records that are known to contain potentially significant errors or omissions should be changed.

 

[amanbhai]

Why might retrievability be an issue?

The fact that pencil is easily erasable is sometimes a feature, not a defect. Not only that, but there are pens with erasable ink.

There is also the persistent myth that records should never be changed, and I think that plays into the no-pencil business. Records that are known to contain potentially significant errors or omissions should be changed.

In ISO 9001 may be like this and no one could object but in ISO/ IEC 17025:2005 one can object. The clause of the standard says:

"When mistakes occur in records, each mistake shall be crossed out, not erased, made illegible or deleted, and the correct value entered alongside. All such alterations to records shall be signed or initialled by the person making the correction. In the case of records stored electronically, equivalent measures shall be taken to avoid loss or change of original data."
Ref: Clause 4.13.2.3, ISO/ IEC 17025

 

[Wes Bucey]

Damn right!! All this bullsh*t gives our profession a bad name...

Stijloor.

In ISO 9001 may be like this and no one could object but in ISO/ IEC 17025:2005 one can object. The clause of the standard says:

"When mistakes occur in records, each mistake shall be crossed out, not erased, made illegible or deleted, and the correct value entered alongside. All such alterations to records shall be signed or initialled by the person making the correction. In the case of records stored electronically, equivalent measures shall be taken to avoid loss or change of original data."
Ref: Clause 4.13.2.3, ISO/ IEC 17025

I don't mean this to be offensive, but what you are doing here is directly contrary to the main thrust of many of the arguments - you are engaging in mission creep by imposing strictures from other Standards or regulations than the one(s) in this forum, namely ISO 9000, 9001, 9004, NOT 17025.

 

[Randy]

NASA spent millions developing a pen that would work in space...The Soviet Union gave the Cosmonauts pencils.

Records and everything else can be kept in blood, mud, paint, grease, lemon juice, chicken drippin's or anything else that is decided to be appropriate by the organization unless some requirement or regulation states otherwise...AND AS AN AUDITOR, I COULDN'T CARE LESS

 

[Big Jim]

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.

That's an auditor that should be asked or told not to return. This kind of vindictiveness has no place in any kind of auditing.

 

[Big Jim]

I don't mean this to be offensive, but what you are doing here is directly contrary to the main thrust of many of the arguments - you are engaging in mission creep by imposing strictures from other Standards or regulations than the one(s) in this forum, namely ISO 9000, 9001, 9004, NOT 17025.

Wes,

This is slightly off from your usual style. What's wrong with mentioning that with some standards pencil is specifically prohibited? He didn't claim that makes it right for auditors to try to apply it to improperly. Simply mentioning one of the examples when pencil use is not proper if anything helps to see why some people get it wrong.

Anyway, I'm not offended by his contribution.