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Thread: Post your variance, produce report, and show report questions here

  1. #1
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    Default Post your variance, produce report, and show report questions here

    I'll start. I've spent enough time researching and working on this that I can probably answer some questions. Nothing in this thread should be taken as legal advice obviously.

    I'm trying to get my head around what the intention of 1040.10(f)(iii) is getting at. Specifically the underlined portion.

    Code:
     
    (iii) Either multiple safety interlocks or a means to preclude removal or 
    displacement of the interlocked portion of the protective housing shall be 
    provided, if failure of a single interlock would allow;
    I only have one interlock on my case's maintenance panel. Could a "means to preclude removal of the interlocked portion of the protective housing" just be "hex head screws"?

    See also
    http://www.accessdata.fda.gov/script...cfm?FR=1040.10


    Mike

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    I'm no expert but, yes. Having hex head screws or some other form of security screw is perfectly fine. You may also want to slap on a sticker along the lines of "Do not open. No user serviceable parts inside".

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    I have also read recently that, if the projector is built for your own use and not being rented or sold, that interlocks are unnecessary because essentially you'd be protecting yourself from yourself which doesn't make any sense. If you've built it, then you should be aware if the inherent risks of opening the case and performing any maintenance.

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    Quote Originally Posted by 300EVIL View Post
    I'm no expert but, yes. Having hex head screws or some other form of security screw is perfectly fine. You may also want to slap on a sticker along the lines of "Do not open. No user serviceable parts inside".
    That's exactly what I was hoping to hear Adam. It makes sense to me, just wanted a second opinion. Good idea with the sticker.

    Brad, I remember hearing something about that interlocks being unnecessary if the projector was for personal use. It seems like a bit of a stretch and I've never see any mention of this in an official document from the CDHR. I suppose you could write N/A for section 7 and explain the situation in an attachment and see if it works.

    Mike

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    Don't box yourself into a corner, if you variance it so you are the only show-op, then you are going to need to be there to run it, period.

    Steve

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    Presumably a physical lock i.e. a cabinet lock with a key or anti tamper case fixings would also cover this?
    http://img62.imageshack.us/img62/3985/laser.gif

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    Quote Originally Posted by Doc View Post
    Presumably a physical lock i.e. a cabinet lock with a key or anti tamper case fixings would also cover this?
    Doc, this would make sense to me since it limits access.

    Mike

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    Default Product report parts 8 & 9

    Parts 8 & 9 have to do with quality control procedures and testing. I'm not really sure how to answer these questions. For folks that have been through this before, if you need to write up manufacturing test procedures, how extensive do they need to be? Are there any samples floating around so I could get an idea of what is required?

    Code:
    8.1 Attach, and identify as attachments to Part 8, samples
    of documents that describe, specify, or relate to procedures or tests used to
    ensure compliance of your reported product with the standard, including
    compliance with all performance, labeling, and informational requirements.
    These may include: 
    ( ) specification controls for critical components,
    ( ) manufacturing and assembly control procedures,
    ( ) inspection and test control procedures, 
    ( ) assembly and test traveler forms,
    ( ) inspection and test reports and checklists, and/or 
    ( ) other(s) (specify):
     
    8.2 If formal quality control and testing procedures have not been implemented or are not sufficient to assure that your product(s) will comply with the standard, explain how you assure that your products comply and submit supporting documentation. 
     
    NOTE: Section 1010.2(c) REQUIRES THAT CERTIFICATION BE BASED
    ON A TEST, IN ACCORDANCE WITH THE STANDARD, OF EACH UNIT OR ON A PROGRAM 
    IN ACCORDANCE WITH GOOD MANUFACTURING PRACTICES. Failure to maintain an 
    adequate testing program may result in disapproval of the program by CDRH.
    Thanks,
    Mike

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    I think these questions are more aimed at manufacturers who are going to be making more than one. The CDRH wants to know how the manufacturer has designed their sourcing, manufacturing, testing, QC and change control processes so that every unit produced is compliant. You'll be making your case as to why these regulations do not apply to your projector in your product variance (which you can submit at the same time as your product report).

    Also, the FDA has a program for electronic submission of your product report and variance, your laser show report and variance AND your show reports:

    http://www.fda.gov/downloads/ForIndu.../UCM162419.pdf

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    Thanks Robyn yeah I've heard that if you aren't selling projectors but just building for your own use then you can make a case that some of the rules do not apply. When I started this hobby I thought I might end up making projectors to sell. Seriously doubt that will be the case now that I know how much work it is and how much it costs. I was just going over all expenditures last year for the projector...

    Mike

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