Calibration traceability to product

baxterjl · May 17, 2024

Hello all! Newbie here to this forum. I have read everything I can find related to the question I attempting to answer but have not found any specific language, perhaps I have read so much that I am now second guessing common sense in this matter.
AS9100 7.1.5.2 has traceability requirements from the calibrated equipment to the calibration sources/ certificates. My question: Is there a requirement within clause 7.5 or elsewhere that would require documented traceability for calibrated equipment used to certify product back to the individual products they were used on?
Seems like a no brainer since this type of traceability would be needed to accurately process any OOT conditions and or product recalls, just struggling with the specific language within the standard that makes this a requirement.

Thanks in advance!

Tagin · May 17, 2024

In 9001 there is no such requirement; not sure about AS9100. It would be potentially useful to record which specific equipment was used for a specific batch, or even a specific serial number product, produced. Some manufacturing software can record this information for each job.

The closest thing to such a requirement, I think, in 9001 is 8.1e.2:
The organization shall...implement the actions determined in Clause 6, by...determining, maintaining and retaining documented information to the extent necessary...to demonstrate the conformity of products and services to their requirements.

mohan1saish · Saturday at 4:50 AM

As per AS9100:2016 Clause 7.1.5.2 states "The organization shall establish, implement, and maintain a process for the recall of monitoring and measuring equipment requiring calibration or verification."

Requirements:

Traceability: Gauges should be linked to their calibration certificates, including details like gauge code, equipment number, instrument number, etc.
Recall: Recall instruments from line before calibration expires. so only when have traceability you recall from respective departments

if you have 10 vernier caliper, you must have 10 unique identification so that you recall your instruments.

I hope I have answered your question.

Sidney Vianna · Saturday at 7:55 AM

baxterjl said:
My question: Is there a requirement within clause 7.5 or elsewhere that would require documented traceability for calibrated equipment used to certify product back to the individual products they were used on?

No, there isn’t. Remember that in the early stages of the product realization process, many components might not even be serialized. At best, a batch or lot number.

The lack of such traceability between a piece of hardware and an inspection, measuring or testing device will also impact the events when such devices might be found OOT during calibration, which might trigger a recall of a large number of products. That’s the reason many organizations establish the connection between product id and the devises used to establish conformity.

dwperron · Monday at 8:57 AM

baxterjl said:
Hello all! Newbie here to this forum. I have read everything I can find related to the question I attempting to answer but have not found any specific language, perhaps I have read so much that I am now second guessing common sense in this matter.
AS9100 7.1.5.2 has traceability requirements from the calibrated equipment to the calibration sources/ certificates. My question: Is there a requirement within clause 7.5 or elsewhere that would require documented traceability for calibrated equipment used to certify product back to the individual products they were used on?
Seems like a no brainer since this type of traceability would be needed to accurately process any OOT conditions and or product recalls, just struggling with the specific language within the standard that makes this a requirement.

Thanks in advance!

Go all the way to the end of 7.1.5.2:
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.

In order to "take appropriate action" when a piece of equipment has been found to be OOT (unfit for its intended purpose) you need to know what it was used on.

Sidney Vianna · Monday at 9:18 AM

dwperron said:
In order to "take appropriate action" when a piece of equipment has been found to be OOT (unfit for its intended purpose) you need to know what it was used on.

I alluded to this on my previous post. You can take appropriate action in a variety of ways. For example, you COULD recall (in an extreme case) products released from the date when the device was last known to be in tolerance. There is no requirement in the standard that mandates this 1:1 traceability between product and IM&T equipment, but an organization might establish internally to do so to mitigate risks, like in the case of a need for recall.

Calibration traceability to product

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