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7.1.5.2 Measurement Traceability

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Evan Balcaen, Nov 25, 2015.

  1. Evan Balcaen

    Evan Balcaen New Member

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    Hi Everyone,
    Sorry in advance for the long post!

    I have recently been tasked with learning ISO, becoming our new Quality Manager and preparing us for the new 9001:2015 standard.

    One question I have is regarding 7.1.5.2 Measurement Traceability.

    Our organization (17 Branches across Canada) uses tape measures every day to measure and make cuts on conveyor belts. The standard width tolerances are as follows; Length tolerances are much greater.

    Industry Standard HD Conveyor Belt Width Tolerances:
    up to 24" wide = 1/4"
    24-36" wide = 3/8"
    36 and greater = +/- 1%.

    This is our current tape measure calibration/maintenance procedure:

    Tape Measures (2 years calibration)

    The Master tape must be a Lufkin or Stanley brand, 25/26” (calibrated from manufacturer)
    All working tapes must be verified against a calibrated Master before labeling and released for use.
    Each tape will be marked or tagged with the “use by” date (in service date + 2 years).
    Keep Master tape receipt as proof of calibration.

    Because the standard tolerances of 99% of tapes are less than our standard tolerances for the product we are cutting, the entire tape measure maintenance procedure is not adding any value, and we are needlessly throwing away tapes that are not used often.

    Here are my proposals with evidence from the standard:

    1. If it’s possible can I exempt tapes from 7.1.5.2 in section 4.3?
    2. If we can’t, then does my procedure below meets requirements?
    3. If my procedure still does not meet the requirements then we will have to continue with the way we are doing it now. Is there a better way?


    Sample Tape Measure Maintenance Procedure:

    Technician will check tape measures before use. They will check the tape for the following;
    · Metal tab is present
    · Printed measurements are legible
    · Tape is not kinked or bent.
    If tape does not meet the above requirements, it will be destroyed or marked as N/C and cannot be used.
    Technician will record results on QF 25 (Checkboxes provided with Y/N to the criteria above)

    Note: The play in Metal tab is not a required to be checked for accuracy because the potential movement between the metal end is less than industry standard tolerances. (As per the National NIBA/DIN/ARMP industry standards.)


    Evidence for exempting tapes:

    Annex A: A.5 Applicability

    This International Standard does not refer to “exclusions” in relation to the applicability of its
    requirements to the organization’s quality management system. However, an organization can review
    the applicability of requirements due to the size or complexity of the organization, the management
    model it adopts, the range of the organization’s activities and the nature of the risks and opportunities
    it encounters.
    The requirements for applicability are addressed in 4.3, which defines conditions under which an
    organization can decide that a requirement cannot be applied to any of the processes within the scope
    of its quality management system. The organization can only decide that a requirement is not applicable if its decision will not result in failure to achieve conformity of products and services.


    4.3 Determining the scope of the quality management system
    The organization shall determine the boundaries and applicability of the quality management system
    to establish its scope.
    When determining this scope, the organization shall consider:
    a) the external and internal issues referred to in 4.1;
    b) the requirements of relevant interested parties referred to in 4.2;
    c) the products and services of the organization.
    The organization shall apply all the requirements of this International Standard if they are applicable
    within the determined scope of its quality management system.
    The scope of the organization’s quality management system shall be available and be maintained as
    documented information. The scope shall state the types of products and services covered, and provide
    justification for any requirement of this International Standard that the organization determines is not
    applicable to the scope of its quality management system.
    Conformity to this International Standard may only be claimed if the requirements determined as not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.

    My Notes:
    Could I list tape measures as an exclusion to 7.1.5.2 in 4.3?


    Evidence for my process if we cannot exempt tapes:

    7.1.5.2 Measurement traceability

    When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be:

    My Notes: Measurement traceability is not a requirement for our business, so we are exempt from that, however I do not think we are exempt from providing confidence in the validly of measurement results. I.E. if we say a belt is 36 (+/-)1/4” wide, how can we confidently prove that? So I think if we are going to provide confidence to our customers that we are sending the correct product, then we must include tapes in the program.

    a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information;

    My Notes: For tape measures we can verify them prior to each use, but if they have to conform to international or national standards, chances are they will require measurement of the tip movement/ length verification. As far as I can tell, the use of the word “standards” does not mean industry standards. It means calibration standards that do not take into account the tolerances of the product. Can I get around this by using our own standard. It looks like a grey area.

    b) identified in order to determine their status;

    My Notes: Can I generalize here. I.E. all tapes (identification) in service are fit for use unless a technician deems them unfit before use as per verification guidelines. (Status)

    c) safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results. The organization shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary.

    My Notes: Throw out the tape or mark as N/C if found to be damaged.


    Let me know your thoughts. Thanks!
     
    Atul Khandekar likes this.
  2. Ganesh Sundaresan

    Ganesh Sundaresan Active Member

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    Let us for a moment forget about "Exclusions". You are carrying out a Measurement activity to ensure that the delivered product meets Drawing Specification or Customer requirements. The bottom line is, do you require this measurement to yield valid, reliable and factual result? Guess your answer would be undoubtedly yes. In which case there is no question of Exclusion.

    As for Standards, I think ISO requires to stick with National or International Standards for Calibration methodology. The acceptance of the measuring tool based on the Calibration result can still be at the discretion of the Organization provided it is consistent with the actual application and the ability to meet measurement requirements.
     
    Jennifer Kirley and Evan Balcaen like this.
  3. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I agree with Ganesh. I feel we should, while on one hand not forget the good management practices asked for in the 2008 version (traceability to NIST or its equivalent), we should be willing to accept reasonable alternatives when practical. For many of us with sensitive equipment like CMM and other electronic measurement tools this means having the OEM service the equipment, to include calibration. The 2015 version just goes a step farther to legitimate such a practice.

    Tape measures and other hand-held equipment could continue to get scheduled for appropriate verification of accuracy, only now explicitly recognized as such based on the feature and sensitivity of the requirement. The concept has always been with us, only as "good practices" referred to in the 2008 requirement for traceability, but that has left a good deal of room for confusion about what was required. Now the requirement is explicitly about the customer and your business needs, and less about a "shall" in the standard.
     
    Last edited: Nov 27, 2015
    Ganesh Sundaresan likes this.
  4. BradM

    BradM Moderator Staff Member

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    Hello Evan! Welcome to the forum!

    First, don't ever feel you have to apologize for given adequate (and yes, detailed) information. It makes it so much easier giving assistance when you have all the information.

    Note...
    Most of the regular members here know one of the most contentious and hotly debated subjects are whether tape measures/rulers need to be calibrated. :)
    Saying that, there are very legitimate differences of opinion on this subject.

    So, if you don't mind, I'd like to see if I can drill down a bit on some of the information that you provided.

    Ok, so the above tolerances for width are listed in inches. Correct? You are stating that is what the tape measures need to obtain. How do you know the tape measure you purchase are more accurate that this?

    I realize you state length tolerances are much greater. Are they documented, and are you sure the tape measures you purchase are more accurate than that tolerance?

    Why two years? Why not five or ten years?

    What is a master tape receipt? Is it a certificate of calibration? Does it provide an untraceable chain to a national standard? Say you purchased tape #1, with a serial number of #1. Does the master tape receipt show that tape #1 was verified?

    I ask all that to make sure that the document you are relying on is sufficient. To me, how robust the initial calibration process (and documentation is), gives a lot more credence to what you can do after the initial purchase.

    Some thoughts....
    In my 20+year of toying around in calibration, I have yet to ever find a ruler/ tape measure that was off!! However, one cannot "assume". So having a decent calibration record on file for a particular instruments shows that it was indeed verified and was acceptable.

    I wouldn't throw anything away. There are quality/ procurement/purchasing costs associated with purchasing the new tools and disposing of the old. Having the device verified by a competent vendor isn't as costly as it may seem.

    If you have some data and justification, you could extend that calibration interval to 5 years (or more).

    Or, like you suggested, perform an initial calibration, and then perform the routine inspections like you listed (do document the inspection was made).

    Or, have two tape measures calibrated (offset their due dates); purchase good ones with good accuracy/resolution. Have them calibrated every two years or so. Assign ID numbers to all your tape measures. Verify your "shop" tape measures against the "standard" tape measures every two years (do also document this inspection).


    I'm sure there are a number of approaches. Just make sure your traceability documents are good, and you have an effective program that assures the tape measures comply with your procedure and no rogue tape measures end up in your processes.
     
    Atul Khandekar and Andy Nichols like this.
  5. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    As always, we start by defining our instrument needs and calibration frequency based on needs and other factors.

    - Sensitive measurement ability or durability?
    - Work environment, storage arrangements
    - "Wear and tear" expected in normal use
    - Cost of instruments, cost of getting it wrong

    I have purchased, then thrown away a tape measure with lines that did not measure accurately. This is on top of the little end piece wearing and adding a fraction of an inch in length, or getting stuck and then measuring short. For this reason I agree with finding a reliable brand and sticking to it.

    Checking against a steel rule which has itself been verified is a good practice too, as is keeping that steel rule safe from damage so it can be judged reliable for a long time.
     
  6. hogheavenfarm

    hogheavenfarm Well-Known Member

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    I worked in a modular factory as QM where this was a big deal. What I did was simple. We set up a set of concrete nails in the floor and used a surveyors steel tape to set them exactly 25 ft apart. Then we put a nail at 12ft and 6ft as well. This steel tape was calibrated to NIST standard. Tape measures were periodically checked against these embedded nails. Any that did not meet all 4 measurement requirements were destroyed. This allowed use of any brand as long as it met the requirements. Any damaged tapes were destroyed. "Good" tapes got a green dot sticker whenever tested. Any tapes found with no sticker were tested immediately. Some variation of this should be sufficient for you.
     
    Andy Nichols likes this.
  7. bozaktwo1

    bozaktwo1 New Member

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    Two years seems like a long period between validations. In my opinion, the measuring instrument needs to be controlled to a degree consummate with the needs of the measuring activity. Frequency of usage, conditions of usage, required accuracy (read: estimate of uncertainty) and historical data (SPC of some sort) can be used to determine an appropriate validation cycle, predict replacement timelines and therefore predict the cost. If the risk is low, I suggest using a low-cost, simple check procedure that can be performed by the operators as they work. If you have never had any rejections, there's probably no good reason to run an expensive, detailed calibration program for your tape measures, unless the customer requires it.

    Another suggestion is to use "GO-NO GO" standards for your measurements instead of tape measures for your most commonly produced belts. To measure a single linear dimension, you can have a piece of aluminum sheet or tube cut with marks on it. Just an idea.
     
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    That's along the lines of what I was thinking...
     
  9. Evan Balcaen

    Evan Balcaen New Member

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    Thanks everyone for your detailed responses. It has really helped me gain insight into this issue. I have put this issue on hold temporarily as we have some larger issues to deal with. Once I update the procedure, I will share it with everyone here.
     
    Atul Khandekar likes this.

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