$4\mathrm{.}2$ Audit situation two:

You are auditing the process for the control of monitoring and measuring resources in a component manufacturer. You see a box containing parts accompanied by the relevant production paperwork. You examine the paperwork, which appears to be complete and accurate.

This shows a repeat order. You see a comment: "Customer supplied gauge number $A123$ to be used to verify that the components meet the requirements given in drawings XB $113$ revision $2."$ The gauge is numbered A$123$ and appears to be in good condition although well used. You ask the Production Operator about the calibration status of the gauge. The operator responds: "I do not hold such details with me$.$ I was given the gauge together with a copy of the customer's order and their drawings. I use it in accordance with the customer's instructions and the components are all acceptable according to the gauge."

Solution $-$ no nonconformity

$\backslash$table$[[$Audit investigation:$],[$There is insufficient evidence to determine conformity or nonconformity because$],[$we do not yet know what the gauge is$,$ whether it is calibrated, what it is being$],[$used for and whether it needs to be calibrated.$],[$Points of investigation and evidence sought:$],[-$ Did the organisation determine the risks that needed to be addressed to$],[$prevent$,$ or reduce, undesired effects? $[6\mathrm{.}1\mathrm{.}1].],[-$ Did the organisation plan to keep documented information $($records$)$ to the$],[$extent necessary to demonstrate product conformity to requirements $[8\mathrm{.}1].],[-$ Determine what the gauge is and how it is used $[7\mathrm{.}1\mathrm{.}5].],[-$ If calibration of the gauge is "a requirement, or is considered by the$],[$organisation to be an essential part of providing confidence in the validity of$],[$measurement results", what documented information $($records$)$ are$],[$available to indicate that is has been appropriately calibrated? $[7\mathrm{.}1\mathrm{.}5].],[-$ Compare any documented information $($records$)$ with the customer's$],[$instructions and requirements on the drawings $[8\mathrm{.}2\mathrm{.}1].],[-$ Does it need to be calibrated $-$ is it fit for purpose? $[7\mathrm{.}1\mathrm{.}5$ and $8\mathrm{.}6.],[-$ What competence is needed to use the device? How was it determined?$],[.],[-$ Review the customer's order. What do their instructions say about the use$],[$of the gauge? Look for evidence that these have been followed $[8\mathrm{.}2\mathrm{.}3\mathrm{.}1$ and$],[8\mathrm{.}2\mathrm{.}1.],[$Did the organisation enquire about use and calibration of this device? $[8\mathrm{.}2\mathrm{.}2],[$and $8\mathrm{.}2\mathrm{.}1.],[$Have there been any problems with the use of the gauge? $[8\mathrm{.}5\mathrm{.}1].]]$

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