Survey - Physical traceability of electronic repair parts

G

Graeme

#1
Dear Cove members,

I want to obtain some data and opinions from this most highly regarded gathering related to a recent audit "observation". Although all are welcome to respond, I am most interested in information from those of you who calibrate electronic test and measuring equipment, and equipment manufacturers who calibrate equipment for their customers. Comments from auditors and assessors are also always welcome. Although this directly concerns an ISO 9001 audit, I am posting it in the 17025 area because it involves calibration and a lab that aspires to 17025 accreditation one day.

BACKGROUND:
I am working with an in-house electronic calibration lab in the US commercial aviation industry. The lab is registered to ISO 9001:2000 and is starting work on preparing for laboratory accreditation. We were recently audited by another group in the company - the people who do outside supplier audits. They asked questions about an area that is not part of ISO 9001 but is part of the US Federal Aviation Regulations controlling repair work on aircraft. (FAR Part 145) (Historically the calibration lab has never been required to comply with Part 145 requirements because we do not work on aircraft or any of their component parts.) They wanted to know how we maintain physical traceability of parts purchased for repair (outside our ISO 9001 scope!) back to the original manufacturer. Our answer was that we maintain traceability "to the extent required" which is to verify that the part ordered is correct; the part received is the part that was ordered; and that the part functions when used in the repair. The QUALITY gateway is that the instrument then passes a full calibration before release.

As part of gathering data to respond to this observation, I would like to find out what the range of current practice is among other electronic calibration labs. Unfortunately this does not fit the format of the polls I have seen in The Cove, since about half the questions will need more than a binary choice to answer. I will be stripping out all identifying information before use, and I can publish the compiled results here for those who are interested. (As for the auditors asking questions outside the scope of the ISO 9001 audit, I already have a good idea how to approach that.) In advance, thank you to all.

Instantaneous responses from all active forum members is, of course, a non-achievable goal and would overwhelm my psyche anyway. However, in my wilder dreams I would like to have a statistically valid sample by about May 27, if possible.

SURVEY:
Please feel free to add relevant comments to any questions. If you would like to cut-and-paste, you are welcome to send the completed survey to me at [email protected] or by using the E-Mail button below.

  1. If a unit under calibration requires repair, do you repair it in your facility? (Yes/No)

    If you answered Yes, please continue. Otherwise, please skip to question 7.

    (For the remaining questions, these references may be useful: ISO/IEC 17025:1999 clause 4.6, "Purchasing supplies and services" and ISO 9001:2000 clause 7.4, "Purchasing".)

  2. When you purchase parts to be used in repair, do you have any requirement to maintain physical traceability of each part you use back to the original vendor? (Yes/No)
  3. If you have such a requirement, is it based on the ISO standard or some other government rule or company policy? Please explain.
  4. If you purchase more than the exact number of parts required (for example, because of minimum quantity impositions by the vendor), do you have any requirement to maintain physical traceability of each excess part back to the original vendor? (Yes/No)
  5. If you have such a requirement, is it based on the ISO standard or some other government rule or company policy? Please explain.
  6. Assume that an item that needs repair must always then be calibrated before it is released, and that the result of the calibration (pass/fail) is the only determining quality factor. In that case, would you consider that parts used to repair the instrument "affect the quality of the ... calibrations"? (the process, not the results.) (Yes/No)
  7. Do you have any other comments relevant to this survey?

    The following questions are for classification and comparison purposes only. All identifying information will be removed when I compile the results. Approximate figures are OK; for example, rounded to the nearest 10, 100 or 1000 according to the order of magnitude.
  8. About how many calibrations are done per year?
  9. About how many repairs are done per year?
  10. About how many calibration technicians do you have?
    [/list=1]

    Thank you very much for your time. If you would like to cut-and-paste, you are welcome to send the completed survey to me at [email protected] or by using the E-Mail button below.
 
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