1. This site uses cookies. By continuing to use this site, you are agreeing to our use of cookies. Learn More.
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.

Search Results

Search Again
  1. Evers
    Post

    Is a video "documented information"?

    Hi, A video format can absolutely be used. ISO 9001 (7.5.3) Only requires you to be in control of the documented information, you are free to...
    Post by: Evers, Jun 23, 2021 in forum: ISO 9001:2015 - Quality Management Systems
  2. Evers
    Post

    Good Process Validation book to recommend

    Hi, One that has been in my bookcase for a couple of years is: The process of validation. It's a little bit outdated now (2005), but still...
    Post by: Evers, Apr 13, 2021 in forum: Qualification & Validation (Also 21 CFR Part 11)
  3. Evers
    Post

    Go/No-Go Gauge?

    I think the answer to your question is to take a risk based approach: How critical are the tolerances and what is the deviation when using the...
    Post by: Evers, Apr 13, 2021 in forum: Sampling, Standards and Inspection
  4. Evers
    Post

    How to handle the case that the recommended action cannot be determined??

    If there really is no way to improve the RPN without major changes to the current setup (As Low As Reasonably Possible) or without blowing up...
    Post by: Evers, Jan 29, 2021 in forum: FMEA - Failure Modes and Effects Analysis
  5. Evers
    Post

    How to handle the case that the recommended action cannot be determined??

    If I understand correctly, you have identified a risk with a risk score / risk priority number that is too high to be accepted and needs a control...
    Post by: Evers, Jan 29, 2021 in forum: FMEA - Failure Modes and Effects Analysis
  6. Evers
    Post

    Corrective Action Completion dates

    The way I approached this is by having multiple dates as well as CAPA status: Closed: Yes, No, Pending (waiting for review results). [IMG]
    Post by: Evers, Oct 15, 2020 in forum: ISO 9001:2015 - Quality Management Systems
Showing results 1 to 6 of 6
Search Again