1. This site uses cookies. By continuing to use this site, you are agreeing to our use of cookies. Learn More.
  2. Hello and Welcome to The Quality Forum Online...Continuing in the spirit of People Helping People !
    Dismiss Notice
Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

Are Capability Studies a regulatory requirement ?

Discussion in 'Medical Devices (21 CFR Part 820)' started by MKenn, Mar 3, 2017.

  1. MKenn

    MKenn Member

    Joined:
    Mar 3, 2017
    Messages:
    5
    Likes Received:
    0
    Trophy Points:
    1
    Location:
    UK
    HI Guys,

    Are Capability Studies a regulatory requirement ?
    I am referring to the Medical Device Industry

    Appreciate some advice and guidance
    thank You
     
  2. Atul Khandekar

    Atul Khandekar Administrator Staff Member

    Joined:
    Jul 24, 2015
    Messages:
    211
    Likes Received:
    142
    Trophy Points:
    42
    Location:
    Pune, India
    What are the two poll options '5' and '6'? Do you mean 'Yes' & 'No' ?
     
  3. yodon

    yodon Member

    Joined:
    Aug 3, 2015
    Messages:
    32
    Likes Received:
    16
    Trophy Points:
    7
    Probably need a little more background. For devices, you have to establish efficacy (it does what you claim it does). This is often through a comparison to a predicate device and established through validation testing or clinical trials. Might you be referring to usability? That's certainly getting more focus in both US and EU. IEC 62366 is the consensus standard for that. If you put a device through the latest release of IEC 60601 testing, then they require evidence of compliance to this standard.
     
  4. MKenn

    MKenn Member

    Joined:
    Mar 3, 2017
    Messages:
    5
    Likes Received:
    0
    Trophy Points:
    1
    Location:
    UK
    Hi Yodon , thanks for reply
    Capability Studies , i mean eg; Process Performance asessment as part of validation periodic review.
    medical devices eg stents etc
     
  5. MKenn

    MKenn Member

    Joined:
    Mar 3, 2017
    Messages:
    5
    Likes Received:
    0
    Trophy Points:
    1
    Location:
    UK
    Hiya Atul,
    Havent a clue what the poll options Prompt was supposed to be for
    I just couldn't submit the post , without entering something for it.
     
    Last edited by a moderator: Mar 4, 2017
  6. Vintage Goose

    Vintage Goose Active Member

    Joined:
    Oct 6, 2015
    Messages:
    63
    Likes Received:
    32
    Trophy Points:
    17
    Going back to the original question, there are no regulations that require a capability study be performed. This is one of many methods that can be used depending on the work being performed. I believe the only regulatory requirment is that valid statistical techniques be used and sampling plans based on a valid statistical rationale (21CFR820.250 or ISO13485:2016 7.3.6).
     
    Atul Khandekar likes this.
  7. Bev D

    Bev D Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    307
    Likes Received:
    315
    Trophy Points:
    62
    Location:
    Maine
    Well then a Cpk/Ppk study would be ruled out since this type of "capability study" is NOT statistically valid and the sample sizes are typically also not determined by statistically valid means...;)
     
  8. MKenn

    MKenn Member

    Joined:
    Mar 3, 2017
    Messages:
    5
    Likes Received:
    0
    Trophy Points:
    1
    Location:
    UK
    thanks for reply
    Sorry Bev D, I don't understand what you mean ?
     
  9. Bev D

    Bev D Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    307
    Likes Received:
    315
    Trophy Points:
    62
    Location:
    Maine
    I was being a bit sarcastic...
    What part would you like clarification on?
     
  10. MKenn

    MKenn Member

    Joined:
    Mar 3, 2017
    Messages:
    5
    Likes Received:
    0
    Trophy Points:
    1
    Location:
    UK
    Hi Vintage Goose -thank you for your reply

    Just querying - Is ISO13485:2016 7.3.6 not more applicalbe to Statistical Methods for Determining Sample Size to complete the initial validation of a process.
    IE : Deciding which statistical techniques to use is dependent on the type of data for which validation is required & deciding on which type of data: variable and attribute.
    I'm querying the process control and performance assessment aspect and how to complete review and assessment to provide evidence of validated state being maintained. and in that context, the use of capability studies for this purpose of maintaining a validated state ???
     
  11. Vintage Goose

    Vintage Goose Active Member

    Joined:
    Oct 6, 2015
    Messages:
    63
    Likes Received:
    32
    Trophy Points:
    17
    Hi, you may be correct, when I see the phrase Capability Study I think of initial validation, whereas for ongoing process control, I think of Process Capaibility. The reality being they are largely the same thing!

    To show that the process is maintaining the validated state, I would start with a SPC Control chart to show that the process is in control, then use capability to show how controlled you are.
     

Share This Page