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7.1.5.2 Measurement Traceability - record keeping

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Bigtallanddopey, Jul 17, 2020.

  1. Bigtallanddopey

    Bigtallanddopey New Member

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    Hi everyone, first time on these forums and hoping you can help me out and clarify something.

    I come from a 16949 background where things can be a little tougher and more is required, especially on the calibration side. However much is the same, in my opinion.

    Myself, the quality manager and rest of the team are trying to bring our QMS into the 21st century and actually have things computerized. At the moment calibration is very labour intensive with lots of recording by hand and records are kept on paper in a cupboard. We all want this to go digital and hopefully make things easier.

    My manager has created an online sharepoint calibration form, it contains the gauge number, type, sizes, location on the shop floor and its calibration status. So far not too bad. However my problem is there is no record of the actual calibration process, there will be no results for example of calibrating a Vernier every 10mm and recording the result. It will just say in calibration or not in calibration.

    I have read 9001 7.1.5.2 over a few times and maybe my manager is right, there is nothing to say we must keep these records. However it doesn't quite sit right with me, its too easy and maybe an auditor will also say this. Will an auditor come along and say you cannot just say is it calibrated yes/no, you need proof? Is there anything that can back my position up and say it needs to be more comprehensive?

    He is also wanting to push all calibrations out to 5/10 years, I don't necessarily agree with this either but again you can decide your own calibration schedule if it is appropriate. Is there anything an auditor will do against this as well?

    TLDR: Can we have a calibration system that does not record any evidence of calibration, no measurements or anything?

    Thanks for any help

    BT&D
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    As you know, the act of calibration determines the device's deviation from a nominal value (the measurand). If you don't record this, you cannot be effective in making decisions about things such as how many uses it can be put to before being worn out of needing recalibration etc. Frankly, whomever thinks that not recorded in the "as found" and "as calibrated" conditions doesn't understand the science - regardless of what ISO 9001:2015 states.

    The standard isn't prescriptive as we know, however, it does state that the equipment is a) suitable and b) is maintained to ensure continuing fitness for their purpose and retain documented information as evidence. Not much clearer instruction to keep records than that. Without the calibration data, it's just an opinion.

    If you're also thinking about traceability, and the impact on calibration & records, the idea behind establishing traceability (the unbroken chain of comparisons) is to avoid an argument with a customer, supplier or regulatory body over a measurement result. If that's not important, then traceability isn't likely necessary.
     
    Last edited: Jul 17, 2020
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  3. Rustle

    Rustle Member

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    Digital plan for keeping track of what needs calibrated and when makes sense, will make things much easier to manage. Would suggest keeping the paper records of calibration though, most auditors will expect to see some type of records for calibration.
    Calibration frequency really depends on what you are doing and tolerances, I have clients who make big metal stuff who calibrate their steel rules every 10 years and other clients who are calibrating daily, & the auditor can challenge this if your own procedure or some other applicable standard stipulates the frequency
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Why? If it's in a spreadsheet (Excel for example) in Sharepoint, why make a paper record?
    Auditors can expect all day long. That's NOT their job and organizations shouldn't be creating management systems activities based on individuals' expectations.

    Why?

    They have equipment which is not robust?

    Why would they do that? Once again, organizations implementing Quality Management Systems shouldn't be trying to predict what some individual auditor might ask about.

    It doesn't say a frequency in any standard I'm aware of. If an organization writes a frequency into their procedure, they are opening up themselves to running a costly, or ineffective calibration system.
     
  5. Rustle

    Rustle Member

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    because it is easier - if the calibration is being logged on paper, adding it into a spreadsheet is extra work. Just file the paper record.

    I try to help my clients avoid issues with auditors, think the original poster is also wanting to avoid grief.

    There are lots of standards in the UK, mainly EN standards for CE marking where there are stipulations about such things and the auditor is usually from a notified body who can effectively shut down the company if they fail the audit (it is often a legal requirement to CE mark construction products in the EU) so you do want to avoid issues with the auditor.

    Andy I'm trying to give sensible practical advice based on implementing management systems and passing audits in the real world.
     
  6. tony s

    tony s Well-Known Member

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    By following the logic, maintenance records of production equipment don't need to be retained. Just have a spreadsheet indicating whether each equipment have been maintained or not. Just indicating whether a measuring equipment is "in calibration" won't be enough to satisfy the requirement for retaining "appropriate documented information as evidence of fitness for purpose".
     
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  7. Bigtallanddopey

    Bigtallanddopey New Member

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    That does apply to us as well, we have many CE marked products. We have the same Auditor for 9001 as we do for many of the CE products which makes things easier, however as many of you will know, the auditor can change one year and the new one will pick up different things.

    That is my thinking also, now to see if I can convince my manager he is wrong. Should be fun.
     
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    While it is true that auditors have varying approaches, I'd counsel that if you have a system which a) works because you get good results and b) complies with the requirements, then anything the auditor makes an issue is simply their opinion and should be referred back to the CB/NB.
     
  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    If the auditor knows what they are doing, yes.

    It's the records which demonstrate the equipment is fit for purpose - before and after calibration.

    Without records, how can anyone justify any calibration frequency. It's common to use time based calibration - which isn't actually effective - but, again, absent of any data, an auditor who knows the science will write a finding.

    That's not an effective system.

    Maybe some equipment doesn't actually need full blown calibration - is there equipment which simply needs a comparison - verification, instead?
     

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