Howdy everyone. Does anyone know if it is possible to have an uncontrolled appendix as part of a controlled procedure?
The situation I ran into is with test procedures. Our test procedures are controlled documents and someone wants to add a section to them for taking notes during the test. The notes would be kept with the procedure to be used as a reference and history, but will obviously be constantly changing. Can we add the notes at the end of the procedure as an appendix and have a statement that says the notes are uncontrolled and are for reference only? Would it just be better to not have the notes as part of the procedure and just have them attached as a seperate uncontrolled document? Or would attaching them to a controlled procedure create problems?
Incredibly confusing, at first, Richard. But don't fret. Thinking I understand your dilemma, I would do this. Slap a control number on a form titled “Testing Notes”, jot down and file the notes accordingly. Reference the form in the procedure and go on about your day. It’s that simple sir ! Have a good day.
If these notes are important to the understanding of the procedure I would include them into the body of the procedure itself. If they are trivial notes then I would keep them away from the procedure and keep them, perhaps, on the back of a cigarette packet.
Just another idea...How about keeping the notes away from the procedure itself (to avoid any potential "violations" or confusion) and keep a log book for that particulat test where test results, notes, etc. exist. I'm thinking of a spiral notebook labeled "TEST ABC - REF Procedure # Q-123, Testing Notes etc. -- Start Jan 16 2002, End May 4, 2002".
My understanding is that, and please correct me if I'm wrong, you are issueing testers with a copy of the test procedure each time they do a test. They now want an area on the procedure to write notes about a particular test.
OK, my thoughts are now that these notes, that you say will be used for reference and history, are actually records, and that the procedure is really a form with detailed instructions on it. you would then need to control these before notes are added as an internally generated controlled document (because it has procedural instructions on it) and after notes are added as a record.
On writing this I thought another interpretation is that the testers are wanting to write notes about the procedural aspects of the testing, in which case I would look at it from a procedural change point of view, and if really pedantic as part of design procedure (as in they are providing input into the design of a new procedure).
I suggested the idea of making the notes a seperate form, but they want them to be included with the procedure because it's "easier" and now they want to add a section in the procedure to list who is qualified to perform the test (which is another section that will be constantly changing).
I guess it will resort to me pulling out the standard and beating them over the head with it.
Sounds like you have your hands full. I don't have a clear picture of what your procedures look like, etc. but based on the foggy picture I have maybe I'd try this: For each "test", create a "package" -- maybe a 3-ring notebook package for a hardcopy version or a folder in Windows for an electronic version . In it put the procedure -- just the procedure itself in controlled copy format with no notes, etc. Also make a separate section in the "package" where training records are kept for that test showing who can do it and who cannot. Finally, add a section where they can put their notes, comments, etc. instead of putting them on the procedure itself. Just a thought...
I like the idea of the "package". I have done this same sort of thing for some new forms that "we" ( really, I ) developed and sent out to offshore crews to use. I made Excel workbooks, with one page being the form, one page being a guidance note on how to use the form, one page being a control log. And then zipped it into a file along with a procedure ( a Word document). It made things nice and neat.
That is actually one thing I was thinking of. The training list is just to make it easier for someone to check who's qualified (even though we have training matrixes posted in each area ). The notes are basically just for troubleshooting and won't be kept as records.
I tried telling them to just put a pad of sticky notes at the test station for taking notes, but they didn't like that idea.
What kind of problems would be created if the list and notes were attached (stapled) to the procedure, but were still seperate forms and not part of the procedure. I need to figure out something before I'm accused of not being a team player.