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Using Radios to relay QC messages

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by gcttutor, Apr 19, 2017.

  1. gcttutor

    gcttutor Member

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    Hello,

    I work in a quality lab and our plant is seeking to be ISO certified i.e. going "pharma". My question is, how common is it for ISO certified plants to use radios to relay qc messages?

    For instance, if a sample is tested and passes all specification, would you be able to tell the plant operator that it was good over radio or would the message to the operator have to be documented e.g. email or chat system?
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    It's common - whether they're certified or not. Some plants couldn't operate without such communication methods.
     
  3. gcttutor

    gcttutor Member

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    Do you happen to know whether it's approved by ISO? I would think not, since messages on the radio aren't documented i.e. data integrity issues.
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I'm not quite sure what you mean by "approved by ISO". "ISO" doesn't approve anything. If you mean would a Registrar auditor accept it - as far as I know it's never been a problem since the use of radios isn't likely to be seen as a case of process control (unless your assigned auditor is a whacko, in which case, show them the door).

    Now, practically, if you find that supervision is constantly telling people what to do, over these radios, you may wish to do a root-cause analysis on why. In my experience, if you have developed effective process controls, including instructions, capable processes, maintained equipment, information and so on, why are people being told what to do all the time?
     
  5. MCW8888

    MCW8888 Well-Known Member

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    We use radios too for the same reason. However, the receiver echo the message and we also enter the results in our LIMS system.
     
  6. gcttutor

    gcttutor Member

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    I work in quality control at a chemical manufacturing plant, sometimes there are several steps in the approval process. Product (chemical) needs approval after one addition then needs approval on the next (in order to ensure that the chemical reaction is complete). Essentially, the operator cannot move onto the next step unless he gets the approval from quality control that the reaction has been completed. Hence I had assumed it to be relevant to the process control, whether the approval came from the radio versus a documented source, since the approval controls whether the operator moves onto the next step.
     
  7. gcttutor

    gcttutor Member

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    Okay, thanks for that answer.
     
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Why have you chosen to do this?
     
  9. gcttutor

    gcttutor Member

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    Appears that we're not in the same industry.
     
  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    How would you tell? I've been in quite a few, over the years...
     
  11. tony s

    tony s Well-Known Member

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    This is a good example for satisfying the requirements of clause 8.5.1c, which requires:
    "The organization shall implement production and service provision under controlled conditions. Controlled conditions shall include, as applicable: c) the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met."
    IMHO, after telling the operator of the result of the test, the result should be retained as a documented information. Hence, MCW8888 retain such into their LIMS system. I'm saying this since most CB auditors expect evidences of verification against product/service requirements. Auditors will usually raise the issue against clause 8.6, which requires:
    "The organization shall implement planned arrangements, at appropriate stages, to verify that the product and service requirements have been met. The release of products and services to the customer shall not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer.
    The organization shall retain documented information on the release of products and services. The documented information shall include:
    a) evidence of conformity with the acceptance criteria;
    b) traceability to the person(s) authorizing the release".
     
  12. gcttutor

    gcttutor Member

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    Exactly the type of response that I was looking for. Thank you.
     
    tony s likes this.

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