Controlled documents vs. Hardcopy documents printed "For Reference Only"

M

mike5_5

#11
So, based upon the collective guru-like opinions of the Cove, may I conclude that in the eyes fo ISO 9001:2000 (and appropriate Registrar), the following would be an acceptable process.

1) State in the doc control procedure that
" Engineering shall maintain an electronic directory of all valid drawings available for production, including at least the date last revised, and revision number. All non-electronic forms of engineering design documents are considered uncontrolled and can be considered for reference only. If an engineer, designer or drafter has a printed copy of such a document it is their responsibility to verify the current revision level when the document is used to make design decisions. These documents may or may not be stamped 'uncontrolled' or 'for reference only' "

2) Adequacy and effectiveness of this system will be determined if/when this system proves to be a root cause of a problem.

To be honest, I am feeling a little uneasy (or conservative). The safest process is to control the paper copies but I understand the cost vs. benefit concept. Should the paper copies be at least stamped to identify there (uncontrolled) status?

Perhaps I need a leap of faith. This was a finding by our corp QA internal audit and they believe (strongly) that if the paper copies are deemed necessary to the performance of work, than they should be controlled. I am looking for sound reasons either to:

A) Convince Eng. to control them, or

B) Convince Corp. that, although their opinions are welcome, there is no justifcation (by the ISO standard, or previous problems) that require change to the system beyond that of describing the system in the doc. control procedure (text above).

Any further thoughts on this are welcome!
 
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RoxaneB

Super Moderator
Super Moderator
#12
mike5_5 said:
So, based upon the collective guru-like opinions of the Cove, may I conclude that in the eyes fo ISO 9001:2000 (and appropriate Registrar), the following would be an acceptable process.
"guru" makes me sound old. I'm not old. And the heating pad I use after shoveling is in no way indicative of my age!

mike5_5 said:
1) State in the doc control procedure that
" Engineering shall maintain an electronic directory of all valid drawings available for production, including at least the date last revised, and revision number. All non-electronic forms of engineering design documents are considered uncontrolled and can be considered for reference only. If an engineer, designer or drafter has a printed copy of such a document it is their responsibility to verify the current revision level when the document is used to make design decisions. These documents may or may not be stamped 'uncontrolled' or 'for reference only' "
I will admit to not liking the last sentence. "may or may not" In the words of Yoda, "Do or do not...there is no try." In other words, stamp or don't stamp...but a clear decision should be made and consistency verified.

mike5_5 said:
2) Adequacy and effectiveness of this system will be determined if/when this system proves to be a root cause of a problem.
Will the adequacy/effectivness be determined or assessed? Semantics, perhaps. The adequacy/effectivess of the system will be assessed annually (by the sounds of it) via audits. Or, hey, maybe the Top Enginerd could do his/her own self-evaluation of the state of drawing control...taking the initiative. :cool:

mike5_5 said:
To be honest, I am feeling a little uneasy (or conservative). The safest process is to control the paper copies but I understand the cost vs. benefit concept. Should the paper copies be at least stamped to identify there (uncontrolled) status?
Mike...some of us have said to stamp, some of us have said to not stamp, some of us have said to have a watermark embedded in the drawing that will appear when printing. But I think we're all in agreement that you or whomever is responsible for this process and/or finding needs to meet with the Engineering Department to determine, develop and implement a suitable and effective system.

We don't work with you. We don't work with your Engineering Department. You folks are the experts. We have provided solutions that have worked for us in our various experiences, but "one size does not fit all" in Management Systems. :)

mike5_5 said:
Perhaps I need a leap of faith. This was a finding by our corp QA internal audit and they believe (strongly) that if the paper copies are deemed necessary to the performance of work, than they should be controlled. I am looking for sound reasons either to:

A) Convince Eng. to control them, or

B) Convince Corp. that, although their opinions are welcome, there is no justifcation (by the ISO standard, or previous problems) that require change to the system beyond that of describing the system in the doc. control procedure (text above).
Your sound reasons and leap of faith will come when you meet with the Engineering Department. Heck, maybe they'll whole-heartedly agree to control paper copies...a gaggle of Engineers never ceases to amaze me. :rolleyes: But they may also be able to provide with the logic behind their reasons to not control paper copies. :yes: Consider the Engineering Department to be your Customer....keep 'em happy. Talk with them.

Any further thoughts on this are welcome![/QUOTE]
 
#13
Convincing isn't a good place to start.........

It seems to me that the corporate auditor found some 'low hanging fruit' (why do they always cite document control? It's nothing that gets managements' attention:rolleyes: ). The bigger issue seems to be that no-one can decide what effect all these documents are having on the operation of the Engineering function. My advice would be to get the Engineering management & staff involved and look at the (potential) risks of such practices as binders of old documents.:read:

Do some brain storming, get the engineers involved, find out what the real problem is with the situation - are they needing an 'archive' for the 'obsolete' engineering documents, to refer to when doing design? A lot to take on, but this is more than a simple response to an audit finding. Engineering lives and breathes documents and they should be under an effective system of controls:yes:

Andy
 

Jim Wynne

Staff member
Admin
#14
mike5_5 said:
1) State in the doc control procedure that
" Engineering shall maintain an electronic directory of all valid drawings available for production, including at least the date last revised, and revision number. All non-electronic forms of engineering design documents are considered uncontrolled and can be considered for reference only. If an engineer, designer or drafter has a printed copy of such a document it is their responsibility to verify the current revision level when the document is used to make design decisions. These documents may or may not be stamped 'uncontrolled' or 'for reference only' "
Good, except I think the last sentence is unnecessary, or that you should stamp everything or not stamp everything. The coexistence of stamped and unstamped paper copies could create confusion.


mike5_5 said:
2) Adequacy and effectiveness of this system will be determined if/when this system proves to be a root cause of a problem.
I'm not sure that the "don't holler 'til you're hurt" school of thought fits in with the idea of prevention that should be the general rule. It should be a matter of audit.

mike5_5 said:
To be honest, I am feeling a little uneasy (or conservative). The safest process is to control the paper copies but I understand the cost vs. benefit concept. Should the paper copies be at least stamped to identify there (uncontrolled) status?
You're proposing a requirement for people to take responsibility for the currency of documents that they use, which is the way to go, imo. If you document the fact that only the electronic copies are controlled, and train everyone on what that means and what their responsibilities are, then any problems you have from that point on are not document control issues.

mike5_5 said:
Perhaps I need a leap of faith. This was a finding by our corp QA internal audit and they believe (strongly) that if the paper copies are deemed necessary to the performance of work, than they should be controlled.
Perhaps you need to identify the circumstances under which paper copies are actually necessary, and control them to that extent. (i.e., identify them as controlled and make them subject to recall in the event of changes). I can envision circumstances where it's probably not reasonable to have anything other than a full-size drawing. Trying to decipher a drawing that was formatted for "E"-size paper on a computer screen is a PITA.
 
S

Subie Girl

#15
Work Instruction or Reference Only?

Should the questions below be work instructions or can they be reference only? I'm leaning towards work instruction but wanted your opinions.

The human resource department has created a list of questions to be used by supervisors when they are evaluating a new employee at 30-60-90 days. The questions are geared towards the different work areas but they are only used to help the supervisor remember to ask about these items and any other questions they think of that's not on the list for the trainee to answer. Examples:

HR Review
Can you show me how to view your paycheck stub on-line?
Can you show me how to request vacation on-line?

Quality Review
Do you understand lot code identification?
Do you know what to do with RCR'd product?

Safety Review
Where do you go in the event of a tornado or fire?
Can you operate a tow motor without a license?
 
J

JoShmo

#16
Re: Work Instruction or Reference Only?

Should the questions below be work instructions or can they be reference only? I'm leaning towards work instruction but wanted your opinions.
Not sure what you're asking. "For reference only" is the (bogus) status of a document (hopefully, "controlled"). A work instruction is a category of QMS document from the (bogus) document pyramid, which are required to be controlled. What are you trying to accomplish here? Catgorizing a HR document or understanding if it needs to be controlled?
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#17
Re: Work Instruction or Reference Only?

I would make employee evaluation questions controlled documents, and I would not call them "work instructions", but that is just my opinion. There are a lot of nuances as to the industry and product as well.

I assume these are questions for employees working on the floor and you are using On The Job Training (OJT). Is that correct?

Who is doing the evaluation - HR or the employee's supervisor?
 
S

Subie Girl

#18
Re: Work Instruction or Reference Only?

I've decided to call these documents work instructions, instead of a "Reference Only" document. Better safe than sorry with TS auditors!
 
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