1. 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.

Documented information of fitness in 7.1.5.1

Discussion in 'IATF 16949:2016 - Automotive Quality Systems' started by judegu, Oct 8, 2018.

  1. judegu

    judegu Active Member

    Joined:
    Jul 11, 2018
    Messages:
    88
    Likes Received:
    10
    Trophy Points:
    7
    Location:
    China
    Hi, guys. Today when reading the standard, one question came to me.

    In Sub cl. 7.1.5.1, the standard says that
    "The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources."

    And here is the question. Which kind of documented information can be regarded as evidence of fitness for purpose?

    Since 7.1.5.1 is part of ISO 9001, so I turned to TS 9002 for the answer.

    In TS 9002, the relevent content is as bellow:
    "Documented information should be available to demonstrate the fitness of purpose of the monitoring and measuring resources selected. This can include schedules outlining how often checks are needed to ensure valid results, or information demonstrating traceability to national standards or any alternative basis used."

    To be honest, it is not the answer I was expecting. In my opinion, the documented information demostrating the fitness, at least, should include the calibaration/verification records (i.e. sub cl. 7.1.5.2.1). And the frequency and traceability, 9002 mentioned, could be part of the documented information but they alone are not be sufficient for IATF 16949.

    When it comes to choose the suitable(or fit) gages, "1/10" principle should be used, at least, it is what I have been told. Thus maybe the documented information should at least include the evidence of the satisfaction regarding this "1/10" principle.

    Moreover, I also did the reality check. I didn`t find anything constructive in my company.

    So here I am. Looking forwards to your opinions.;)
     
  2. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

    Joined:
    Jul 31, 2015
    Messages:
    669
    Likes Received:
    486
    Trophy Points:
    62
    Location:
    USA
    There are now so many ways to show calibration and verification, it seems an obscure-sounding blanket statement helps. The term to keep in mind here is "appropriate."

    I have participated in many discussions regarding terminology (calibration versus verification) and the 1/10 principle, which I have heard so many times through the years that I talked about it as a "rule of 10 to 1" until an associate invited me to tell him where I got this rule. I researched exhaustively and found no mention of it. Since then, someone told me they though it came from an old British standard. I have seen 4-to-1 used too, but 10-to-1 is simpler and, in my view more risk averse.

    Certificates almost never include mention of this detail. Certificates for scales do often refer to NIST Handbook 44, but seldom to Section 6 Table 6 (watch out, Handbook 44 has been revised) where tolerance is established based on criticality. It would be good to determine the Class if you are working with scales calibration, and ask your service provider to indicate pass/fail based on that acceptable error. If providers only give numbers but no Pass/Fail, it could well mean they have never been informed of the Class or required tolerance. This is where fitness for purpose comes in, also in listing the instrument's (any instrument, not just a scale) physical condition at time of calibration/verification.

    So ideally, whatever form of documentation you retain, I would hope to see at least:
    • Identification of the instrument
    • Date of calibration/verification check
    • Pass/Fail determination of accuracy
    • Intervals of the check
    • Amount of error in numerical terms for each interval
    • Physical condition at time of check
    • Test method or procedure used
    • The traceable standard(s) used to do the calibration/verification. If no traceable standards are available, list what was used.
    • Name of the technician performing the check
    • Next due date
    I think that's it.

    I usually see a schedule of some kind, listing what is coming due when. My clients usually understand that frequency of the calibration depends on the instrument's sensitivity, the tolerances, the instrument's storage, typical use and handling, and the cost of getting it wrong. Very often there will be 2 sets of gage blocks. One is used daily and gets checked annually, while the other is kept put away for use within the lab and when the shop set is out for check. Because of its usage, it gets a 3-year frequency.

    Sometimes my clients will adjust their schedule based on the tool's performance. Being able to demonstrate that (could be charts or notes) is excellent to support the fitness for use principle.

    I hope this helps!
     
    judegu likes this.
  3. judegu

    judegu Active Member

    Joined:
    Jul 11, 2018
    Messages:
    88
    Likes Received:
    10
    Trophy Points:
    7
    Location:
    China
    @Jeniffer Kirley

    Quite a helpful answer, Thanks.:)
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    2,137
    Likes Received:
    1,100
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    I'm struggling to understand this statement, and reconciling it with time-based calibrations, like once a year or every three years. Help!
     
  5. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

    Joined:
    Jul 31, 2015
    Messages:
    669
    Likes Received:
    486
    Trophy Points:
    62
    Location:
    USA
    The time is set based on factors that may add risk of the instrument's not performing reliably.
     

Share This Page