1. J

    Supplier controls for consumer-grade off-the-shelf products

    Hello - I'm currently working on supplier evaluation and qualification for a medical device software company. All supplied products are off-the-shelf and/or available to the general public, such as cloud and web services, PC hardware, etc. Am I required to monitor such suppliers (e.g. Dell...
  2. E

    High level structure - Planning and operation control

    Please, help me year ago I have worked like quality controller and for every control I wrote down in Xpn or XP chart the result of the technical features of the products controlled. Now I'm working in safety department and my boss ask me to control in every plant of ours steel factory if the...
  3. M

    Controls to ensure that Quality Plans are accurate

    Hi Everybody, Please can anyone help with examples of Controls that can be implemented to ensure that Quality Plans are accurate prior to use. Many thanks in advance for your help.
  4. S

    Complying with IATF 16949 Cl. - Type and extent of control

    How are you addressing the clause (Type and extent of control)? specifically the documented process? Is a simple statement saying that we do incoming inspection and then issue a SCAR if anything is nonconforming sufficient?
  5. R

    Closing out an API/ISO QMS Audit Nonconformance - Magnetic Particle Examination

    Hey guys, it's been a while since I've last posted here and hope you all are keeping well fellow professionals in quality. I am currently closing out findings from my last API/ISO QMS audit and I am having problems coming up with a solution to as follows: The QC inspector performing...
  6. S

    Controls for Investigational Medical Device (a challenging question..)

    Hi everyone, I am trying to understand how much flexibility we have in terms of design or manufacturing controls when going for external validation, especially when it involves a low risk device that does requires IDE application. When I look at CFR 812.1, I see that high risk devices are...
  7. J

    Power switch requirement and on/off touch panel marking

    Hello, We're developing a medical device (safety class I) which is connected to mains and which includes a LCD display with touch panel. The previous generations of this device had a mains switch for controlling power to the device and an on/off push button for starting the machine (from a...
  8. D

    Controls Required for Off-site Work - AS9100B Clause e) e) says "process shall provide for ... the controls required for off-site work... I'm struggling to think of any controls I would impose in addition to the ones I impose for on-site work. They have to use controlled repair schemes, proper ESD handling, calibrated equipment, etc...
  9. T

    Inspection Method and Control Method for Visual Inspection?

    I'm working on a manual fabrication process control plan, thank you all for the suggestions and help cove friends provided. The new obstacle I met is how to define the "specification", "inspection method" and "control method" for a visual inspection station's process character? We named...
  10. S

    Controlled Document Definition - What constitutes a controlled document?

    Hi, I am new to the forum but have read through some very helpful threads. Right now, I am trying to come up with a good document control process and would like to know the following: 1. How do I determine what documents need controlling? My company has the following types: a) Process...
  11. A

    Control of Soldering Irons and Soldering Stations

    Hello everybody, At external audit for ISO9001, we happened to meet an auditor who is a soldering process specialist - he stated the nonformance that we have no control system for soldering irons and/or stations. Can anybody please help me and redirect to any document that suggest WHAT...
  12. selena15

    Difference between control & audit - Cleaning manufacturing equipment

    hi cove i'm quiet :o to put this topic here but it is okay to share even the worst things with others in order to avoid it to them! isn't it! i got an argue with one colleague here, he sent me one procedure concerning how to clean up a manufacturing equipment: machine and between a records...
  13. I

    Control of a Harness Board - Our auditor wants the engineer to Control

    My company manufactures cable harnesses. Our auditor wants the engineer to control a harness board. Any suggestions or ideas on how that could/should be done? Thanks!
  14. L

    Control of Production Equipment, Tools and NC Programs:

    Hello folks, Ok, production equipment and tools are being validated, it's evident through my observations. Nonetheless, it's not being documented and there is no "documented procedure" as required per the standard (AS9100 I've been asked to help production create a procedure, however...
  15. V

    Templates (Forms) requiring Control - Document Control

    Hello, I had an audit that the auditor as told me that all the forms used by the organization should be controled as being part of the QMS. Our understanding is that the templates to control are those that the organization established to be part of the QMS and can't be controlled in the...
  16. intrestedparty

    How make the objective evidence for the control of Foreign object damage?

    Dear Friends How make the objective evidence for the control of Foreign object damage? as per AS 9100 Rev B. Regards Karthi.T
  17. J

    What is the difference between a controlled document and an uncontrolled document?

    can anyone make clear in my mind what is the difference between a controlled document and an uncontrolled document. when does a controlled document become uncontrolled?
  18. S

    Examples of Visual Controls for the Production Floor

    hi all we have launched 5s in our company. I am looking for examples of visual controls for the production floor. Many thanks in advance for the help.
  19. A

    The meaning of "Evaluation/Measurement Technique" & "Control Method" in Control Plan

    What are the differences between "evaluation/measurement technique"and "control method" in a control plan? Can somebody provide me with examples of the two items? thank you
  20. H

    Difference between Controlled & Uncontrolled Documents

    Hey Everyone :tg: Can someone explain the difference between a Controlled and Uncontrolled documents? How do you know what should be watermarked as Controlled or Uncontrolled. This is easily explained I'm sure but I am as green as Georgia pine. :thanx:
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