Steven Severt
Starting to get Involved
At the end of section 7.1.5.2 Measurement traceability in ISO 9001:2015 there is a note that states:
"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."
This obviously makes plenty of sense, but I'm looking at this from a practical level. I've been working in manufacturing for over fifteen years, and I'm not sure that I've ever really seen this handled in a truly satisfactory manner. With calibration frequencies so infrequent and production volumes and product mixes generally so high in mass production facilities, how do you actually quarantine suspect product if a measuring device is found to be out of calibration during regularly scheduled calibrations? Say that you have your gauges calibrated every six months, do you typically use that as your last known good point in time and thus consider everything manufactured after that date and checked with the out of calibration equipment to be suspect? In my current situation this would not only be an impractical prospect, but it would be impossible to actually quarantine product from that time period and verify dimensions.
I suppose that regular verifications in between calibration times with standards or known values can help to reduce the risk of something like this happening, but with the amount of gauges being used in many facilities, it's still pretty reasonable to think that something will be found during scheduled calibration times that would warrant 'action as necessary' as mentioned in the note.
I'm just curious on peoples' thoughts on this and how a lot of you are meeting the requirements of the note in the standard.
"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."
This obviously makes plenty of sense, but I'm looking at this from a practical level. I've been working in manufacturing for over fifteen years, and I'm not sure that I've ever really seen this handled in a truly satisfactory manner. With calibration frequencies so infrequent and production volumes and product mixes generally so high in mass production facilities, how do you actually quarantine suspect product if a measuring device is found to be out of calibration during regularly scheduled calibrations? Say that you have your gauges calibrated every six months, do you typically use that as your last known good point in time and thus consider everything manufactured after that date and checked with the out of calibration equipment to be suspect? In my current situation this would not only be an impractical prospect, but it would be impossible to actually quarantine product from that time period and verify dimensions.
I suppose that regular verifications in between calibration times with standards or known values can help to reduce the risk of something like this happening, but with the amount of gauges being used in many facilities, it's still pretty reasonable to think that something will be found during scheduled calibration times that would warrant 'action as necessary' as mentioned in the note.
I'm just curious on peoples' thoughts on this and how a lot of you are meeting the requirements of the note in the standard.