6 replies to this topic

[JFerrone]

We have a lot of physical documents at our manufacturing site, for a variety of reasons.  A mandate from our new management is that all physical documents on the floor must be controlled.  Which is generally fine, but we have a few areas where things get a bit fuzzy. 

 

The big question currently surrounds forms.  Ordinarily, all of our controlled documents are stamped "Controlled Copy" at the bottom, but not our forms.  We are trying to find the best solution...our electronic documentation system is painfully slow, particularly on the production floor, so printing out copies at the time they are needed would be very time consuming.  Our Quality Manager wants us to post a single controlled copy on the floor, and make copies of that as needed...but is a photocopy of a controlled copy still considered controlled?  

 

Our previous process has been for the leads/supervisors to print a small batch of forms when the slot for them was emptied.  But we also have a rule in place that any document that is printed must be destroyed within 24 hours, to prevent old revisions from circulating.

 

What do other sites do?  We are in the midst of revising our Document System procedure now, any guidance would be appreciated.

[Tony-C]

Hi JFerrone

 

I usually have a register and master copy folder of records for each department. These are used for photocopying and are not marked as controlled.

 

When a record is updated, the register is updated with the new revision, the record master copy is replaced and the old copy filed in an archives obsolete record folder. All photocopies of the obsolete record are removed and destroyed.

 

You record control procedure needs to document this process and the system needs to be regularly audited to ensure the system is working.

 

Kind regards,

 

Tony

 

[Scampi]

I have a binder by the production printer. I replace forms when they are updated with the new copy

I write "copy" on the master with highlighter (it doesn't photocopy) that stays in the binder

 

My program reflects this process, thereby they are still controlled

 

All forms must have a version number and/or a revision date to be considered controlled and the change log to support the changes

 

You can also use sharepoint or drop box whereby you can issue permissions so that only QC/QA are able to modify and everyone else can view/print

[jfrey123]

Short answer: photocopy of a controlled form is still acceptable.  There's no effective difference between printing out the form from the official computer file vs making a photocopy of the document, either way you've got a piece of paper with the proper control numbers and dates that captures the required information.

 

As far as distribution of forms, I ran into similar issues with document control in my first QA role.  We ended up with a file cabinet in an employee accessible area, all production forms were preprinted/copied and kept in sorted file hangers so employees could grab the forms they needed (production logs, sanitation records, etc).  There was a master binder kept in the office with the clean, official version of each record that employees could access to make photocopies to refill the cabinet as needed.  We, of course, ended up with copies of copies being used and replaced in the cabinet, but so long as they were copies of the correctly dated and version numbered record, they were acceptable (as long as they were legible).  When a revision to a form occurred, it was easy enough to publish the new approved form, print off a bunch for the employees, and collect/destroy the old copies with master form removed from the binder and archived.

 

I added inspection of the file cabinet for proper version numbers to a monthly audit, and document control program prohibited employees from taking extra copies out to their work areas (covered under the GMP audits as well).  Couple of auditors tried to catch us on compliance with this system, checking my document revision dates and then asking for batch records from the following day, and we never got caught with an old version being used.

[JFerrone]

Thanks all for your input!  We had an internal audit from QA at headquarters, which does not run a production floor, and they panicked and over-corrected on the control document issue (at least, I feel they did).  They removed everything that wasn't stamped Controlled Copy, which caused arguments with production supervisors, we're trying to come up with something that won't create too much extra work for production, but is still compliant.  With lots of new faces, it's a difficult balance.  But I feel more comfortable with controlled photocopies after reading these, thank you!

[Charles.C]

There are a zillion possibilities on the interpretation/usage of "Controlled". All IMEX have some practical disadvantages. eg -

(1) Some Companies use the Ultimate responsibility avoidance on all documents - Uncontrolled when Printed.

(2) Others go to the opposite, equally simple, extreme, all documents/copies must be Controlled and are footer-printed accordingly.

And various in-between.

 

It is unclear to me as to the specific interpretation of "Controlled"  being used in this Situation.

"Simple" photocopying/distributed Master binders  are recipes for disaster IMEX unless internal controls are impeccable.

 

Maybe easier to simply ask yourself, do the documents/document distribution in use validatably conform to the basic/Standard's documentation requirements, eg are up-to-date, authorised.?

 

If No, then the presence/trust in the word "Controlled" is clearly meaningless.

 

IMEX, direct supply of such documents on the Production floor is best avoided altogether unless access to a master Shared drive is possible.

 

Use of coloured/customised paper from a controlled source is one option for "controlled" documents but this can be insufficiently convenient for some Companies.

[Charles.C]

We have a lot of physical documents at our manufacturing site, for a variety of reasons.  A mandate from our new management is that all physical documents on the floor must be controlled.  Which is generally fine, but we have a few areas where things get a bit fuzzy. 

 

The big question currently surrounds forms.  Ordinarily, all of our controlled documents are stamped "Controlled Copy" at the bottom, but not our forms.  We are trying to find the best solution...our electronic documentation system is painfully slow, particularly on the production floor, so printing out copies at the time they are needed would be very time consuming.  Our Quality Manager wants us to post a single controlled copy on the floor, and make copies of that as needed...but is a photocopy of a controlled copy still considered controlled?  

 

Our previous process has been for the leads/supervisors to print a small batch of forms when the slot for them was emptied.  But we also have a rule in place that any document that is printed must be destroyed within 24 hours, to prevent old revisions from circulating.

 

What do other sites do?  We are in the midst of revising our Document System procedure now, any guidance would be appreciated.

 

Hi JFerrone,

 

There are a zillion possibilities on the interpretation/implementation of "Controlled". All IMEX are likely to have some practical disadvantages. eg -

(1) Some Companies use the Ultimate responsibility avoidance on all documents, eg an explicit "Uncontrolled when Printed."  Usually implies direct PC access.

(2) Others go to the opposite, equally simple, extreme, all documents/copies must be Controlled and are footer-printed accordingly.

And various in-between, eg "controlled documents include the text "Valid on the day of printing" which assists method mentioned in OP but obviously demands automation/Validation/bravery. 

 

It is unclear to me as to the specific interpretation of "Controlled"  being used in this Situation.

"Simple" photocopying/distributed Master binders  are recipes for disaster IMEX unless internal controls are impeccable.

 

Maybe easier to simply ask yourself, do the documents/document distribution in use validatably conform to the basic/Standard's documentation requirements, eg are up-to-date, authorised.?

 

If No, then the presence/trust in the word "Controlled" is clearly meaningless.

 

IMEX, direct supply of such documents on the Production floor is best avoided altogether unless access to a master Shared drive is possible.

 

Use of coloured/customised paper from a controlled source is one option for "controlled" documents but this can be insufficiently convenient for some Companies.