Referenced Documents vs. Uncontrolled Documents - Differences?

A

andygr

#11
Re: Difference between Referenced and Uncontrolled documents?

An additional example of a document of external origin beyond manuals is tecnical data sheets your material properties may have been based on.
A clear cut example is when you referance in a test procedure that you will be forrm salt spray testtin in accordance with ASTM B117.
This document would be referanced as a document of external origin as it is not in your control.
:2cents:
 
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C

CliffK

#12
Re: Difference between Referenced and Uncontrolled documents?

It is a great resource to be able to read all of your postings and I thank each of you for allowing all of us to "listen in". This may or may not be off the subject, at least slightly, but how does the defined "referenced" or "reference" document relate to "documents of external origin"?
As and example, we maintain operation and/or repair manuals for equipment, and in this case let's use a gear reducer manual produced by the manufacturer of the gear reducer. We are told that this is a "document of external origin" and that we must periodically contact the manufacturer to be sure we have the most current document. This discussion makes me question if it would be better considered a "reference document".
Who is telling you that you need to contact the manufacturer periodically? I hope it's not your registrar.

Ask them to show you the words in the standard that require it. ISO 9001 has no such requirement, nor does ISO/TS 16949. ISO 17025 is an exception; it does require you to keep certain documents up to date.

As a practical matter, in the case cited by Andygr, it is a good idea to keep up with changes to the third-party standard, but it's not absolutely necessary. You can elect to use a certain edition of a standard and stay on it (except for ISO 17025). For example, I worked with a client that insisted on using a back level of the IPC standards for printed circuit boards. I was never able to get a clear answer as to why they did this, but it was allowable under ISO 9001.
 

Helmut Jilling

Auditor / Consultant
#13
Re: Difference between Referenced and Uncontrolled documents?

Who is telling you that you need to contact the manufacturer periodically? I hope it's not your registrar.

Ask them to show you the words in the standard that require it. ISO 9001 has no such requirement, nor does ISO/TS 16949. ISO 17025 is an exception; it does require you to keep certain documents up to date.

You ask good questions, but we want to be careful not to overthink this topic. Doc control often consumes far too many resources and time than it has to. The items you mention are related somewhat, but not completely.

Internal or external documents merely refers to whether you authored the document internally or someone external did. If external, it does not matter who it was (customer, supplier, whoever). It merely indicates it originated externally, and you probably don't have revision authority over it.

Controlled vs Uncontrolled documents (including Reference) are defined as described earlier in this post (refer to my post #4 for more). If the accuracy and currency of the documents are important, they should be controlled. But, how you control them is up to you and your procedure. They don't have to all have the full treatment of sign-offs, etc. Unfortunately, procedures often are written to require that.

Uncontrolled, means we are not formally monitoring them to ensure they stay current and accurate.

Owners manuals typically aren't classed as controlled because they don't typically change. Or, some companies merely control them via the revision date.
 
M

METerry

#14
Re: Difference between Referenced and Uncontrolled documents?

It's not our registrar. It's one of our "interpretations" of the standard.
 
A

AndrewQMS

#15
Re: Difference between Referenced and Uncontrolled documents?

I have another question along the same lines.

Lets say that in one of my processes that I mention that employees will fill out a work report. I just want keep an eye that they are indeed filling out a work report but now that I've mentioned it there do I need to control the work reports and identify it in the record matrix as well? I have about 10 simmalar situations like this. :mg:

:thanx:

Andy
 

SteelMaiden

Super Moderator
Super Moderator
#16
Re: Difference between Referenced and Uncontrolled documents?

if you are requiring that it is filled out, and referring to it in the QMS, yes, you need to establish a retention/storage plan. I have a couple, that we say 1 day minimum and discard. They are critical forms to be used further down the process for data entry, so they must be filled out, but once the info is used/entered into the computer program the form is not worth anything.
 
P

Penny Treadwell

#17
Re: Difference between Referenced and Uncontrolled documents?

Faith,
This is the method we have used in our business for sometime with regards to "reference documents", we only use the word Reference document when we are referring to something that is not controlled and truly does not effect product quality. In other words a reference document here is a telephone book or a hand written list of peer phone numbers or a periodic table of elements hanging in a chemical lab (the table may change, but its been a while). All documents that we use to support the QMS are controlled. I have pasted an excerpt below from my document control procedure, hope it helps.

Document owners responsibilities
Approval - Prior to issuing, documents must be approved and verified for completeness and adequacy. Approver(s) are identified in the document. Exception process: Emergency approvals can be made in certain situations, i.e., document servers are down and normal processing is unavailable, Approvers are unavailable for several days. Approvals made be obtained hardcopy and electronic approvals done as soon as possible.

Review and updates - As appropriate and necessary. This should be defined in the documents, or controlled by the document repository.

Changes and revision status - Controlled documents must contain information which identifies the current revision status and changes of the document.

Availability - Controlled Documents must be distributed or made available to all who need to have the latest / correct version of the document to do their job.
Legibility and Identification - Controlled documents must remain legible and be readily identifiable at points of use.

External documents - Controlled documents of external origin must be identified and their distribution controlled. It is the organizations responsibility to ensure the correct version required by the organization is available and meets the relevant criteria of this Document Control Procedure.

Obsolete documents - Controlled documents that are obsolete must be remove from use, and if retained for historical purposes must be appropriately identified to prevent unintended use.

Users responsibilities
Document user responsibilities include:

Alteration or duplication - The user is not permitted to make unauthorized alterations to the document.

Corrections - Contact document author or owner to revise document

Version - Verify version prior to use.

Completeness - Verify completeness of the document prior to use

Deviations - Request deviations from the owner of the document

Document users are responsible to ensure they are using the correct/latest version of a document if the document is removed from its controlled environment.

Obsolete documents - Destroy or return obsolete documents to the owner. If a user is responsibility to store back level documents they are to be kept in a manner that prevents unintentional use. Such documents are to be clearly marked "historical" , "archived" or similar wording.
 
P

potdar

#18
Re: Difference between Referenced and Uncontrolled documents?

if you are requiring that it is filled out, and referring to it in the QMS, yes, you need to establish a retention/storage plan. I have a couple, that we say 1 day minimum and discard. They are critical forms to be used further down the process for data entry, so they must be filled out, but once the info is used/entered into the computer program the form is not worth anything.
Further, not all such (or even regular) reports need have defined and controlled formats. A format can be simply defined as 'plain paper' unless specifically required.
 

SteelMaiden

Super Moderator
Super Moderator
#19
Re: Difference between Referenced and Uncontrolled documents?

ok, now we bring in yet another kind of document. I don't control reports at all. to be a report, the data has to be available, and as such, a report is capable of being generated as often as one wishes. The data doesn't change (unless a correction was made and then the report would call that out). I think that we are probably not making the situation any clearer by introducing another set of semantics that may not be universally defined.:2cents:
 
P

potdar

#20
Re: Difference between Referenced and Uncontrolled documents?

ok, now we bring in yet another kind of document. I don't control reports at all. to be a report, the data has to be available, and as such, a report is capable of being generated as often as one wishes. The data doesn't change (unless a correction was made and then the report would call that out). I think that we are probably not making the situation any clearer by introducing another set of semantics that may not be universally defined.:2cents:
I stand corrected. I was talking about formats for writing reports. They are documents. Reports are records.

But then, now the records are defined as 'a special type of document'. And both documents as well as reports need to be controlled anyway.
 
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