1. Ajit Basrur

    Medical Device News Medical Device Enforcement and Quality Report

    Good read: https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/UCM626352.pdf 1. The FDA has increased its oversight through additional device inspections 2. The FDA has taken a targeted, risk-based enforcement approach to address specific...
  2. J

    Implementation of Total Quality Management/Starting a Quality Department

    The task of creating a quality department from the ground up (or Top Down right? lol) is a little intimidating. I have looked online and found some information but any suggestions on how and where to start would be great. I work for a business which specializes in injection molding (electrical...
  3. Y

    What are your Quality Moments?

    Please can you share me the Quality Moments, need to discuss during quality meet.
  4. E

    QUALITY 4.0 - Somebody here could explain the meaning of Quality 4.0?

    I went this mornig to a seminary organzed by my association for quality. One relation was on "Quality 4.0" but really I haven't understood this new terminology. Somebody here could explain the meaning of Quality 4.0?
  5. PaulJSmith

    Using Bugzilla as a Quality Reporting Tool

    I'd like to benefit once again from the vast experience of this group. Quick background: I work for a very small (less than 25 people) family-owned company that designs and builds our own products (precision time systems). When I started here about 4 years ago, there was a primitive system in...
  6. J

    Internal PPM's in a medium sized metal stamping plant

    I have a question regarding Internal PPM's. I have search the forum and could not believe that there were few post's on this. Our internal PPM average for the 2016 year is 1273. I have been told this is too high. We are a medium sized metal stamping plant & we run around 500 part numbers and I...
  7. N

    Explanation - Quality means doing it right when no one is looking

    First off apologies if this isn't the right forum category for a more general query like this, I just wasn't sure where else to put it. The quote I've outlined below, which comes from Henry Ford (apparently anyways). "Quality means doing it right when no one is looking" Was this...
  8. J

    MDIC (Medical Device Innovation Consortium) and the "Case for Quality"?

    Anyone here know anything about the Medical Device Innovation Consortium (MDIC)? Anyone here know anything about their "Case for Quality" project? Anyone here listen in on their recent webex?
  9. M

    Use of Excel and VBA (visual basic for applications) in quality systems

    Hello all, I'm currently an intern at a Tier 1 Automotive supplier and a lot of my work involves excel spreadsheets of anything from measurement data to finance records. I have taken it upon myself to learn the inner workings of excel to make my job easier. I've successfully created programs...
  10. M

    Is it acceptable to audit to the Nuclear Principles?

    Hello everyone, I'm part of an auditing division at a naval shipyard. Quality is roughly split into nuclear efforts and nonnuclear efforts (I'm in the nonnuc arena). I'm trying to improve quality for the whole shipyard, ~12,000 people. At a high level, the nonnucs are doing adequately with...
  11. S

    Is it a Finding if all Internal Auditors are from the Quality Department?

    In my organization, we have a list of Internal Auditors and all are from different roles in the Quality Department. I feel this is not good. Is this acceptable and would it be a finding in the ISO Certification audit ?
  12. L

    How to Introduce the Quality Function to the production floor in a bad environment

    100 $ Question, for which I need the light of my fellow quality practitioners! Question is: How to introduce the Quality Function on the production floor? Background: The plant is unionized and has 40 years of history behind it. Quality has always been ensured by the production function. We are...
  13. J

    How to measure process quality? Is DPPM the correct metric?

    Hello all, I've been challenged by my boss to review if what we are doing to measure our process in correct. Currently we are using DPPM. The problem I have with the way we do it right now is that we calculate DPPM = total number of defects / total number of produced units * 1 000 000. This...
  14. Wes Bucey

    Planning ahead for 2015

    October 27-29, 2015 Donald E. Stephens Convention Center The Quality Show in Rosemont, Illinois (across from O'Hare Field) is usually a great show to visit and see AND TOUCH old and new gadgets to make a quality professional's life easier. If you are planning to attend, perhaps a bunch of us...
  15. S

    Help a damsel in distress with Quality Jokes

    Hi folks, I am a trainer, and I have do a training on ISO 9001, and I want to salt & pepper the training with jokes and cartoons. Does anyone have any jokes or cartoons about "Quality" to share? Or jokes about how people hate change? Thanks very much for any help. SF Girl
  16. T

    Re-Energizing a Culture of Quality

    Hello, I am looking for ways to re-enegize, re-introduce the meaning of what quality means to our manufacturing staff and supervisors. We are trending poorly with far too many non-conformances and customer credits for the last 18-20 months. I would like to start with the supervisors -...
  17. Marc

    Polish Language Quality and Standards Forum

    Polish Language Quality and Standards Forum http://qfighters.pl
  18. S

    What Would You Train People to Believe?

    If had the freedom and resources to train everyone on SOMETHING quality related, what would you do? Would you teach a tool, an approach, or a philosophy? Would you teach people about "closing the loop," or 5S or PDCA? What fundamental quality skills, attitudes or approaches would you want for...
  19. Miner

    Intro to Measurement System Analysis (MSA) of Continuous Data – Part 1: What and Why?

    This is the first in a series of articles about MSA. The intent is to share a career’s worth of experience with measurement systems and their application in inspection, process control and continual improvement. Calibration, measurement uncertainty and attribute MSA are outside of the scope of...
  20. K

    Providing Confidence that Quality Requirements will be Fulfilled

    I'm trying to get the definition of 'quality assurance' definitively defined :) (sorted) in my head. ISO 9001 2006 Quality Management Fundamentals and Vocabulary at 3.2.11 defines quality assurance as “Quality assurance - part of quality management focused on providing confidence that...
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