W
Weyli
Difficulties Complying to 4.11
Hi,
We have just gone through our 1st ISO9002 surveillance audit. During which the auditor found out that we are still not fully comply with 4.11.
NCs and observations given are that we have not done the below:-
1. Calibration Report does not contain before and after calibration data.
Q: What if during the initial performance test, result shows it is within spec., therefore no adjustment is made, therefore no after calibration data is indicated in the report. Is this acceptable?
(Note: all our calibration vendors are G25 certified)
2. Calibration Report does not contain Tracebility info to National or International standards. The cal report states only the national / international agency that the calibration standard is traceable to, but the auditor was looking for the actual standard (ie, info including the serial number etc) that is used by the international agency to calibrate the calibration standard used by my calibration vendor.
Q Does the calibration report needs to be this detail?
3. Q:How to determine the calibration frequency of IMTE? The auditor told me that through time, from the differences between the before and after calibration data collected, I can determine the calibration frequency for the IMTE. How do I go about doing that? Is there any standard formula that I can use?
4. We did not specify the environmental conditions to calibrate our IMTE in.
Q Do I need to give instructions to the external calibration vendor to calibrate the IMTE in the environment conditions exactly the same as the environment we use the IMTE in? Let say the multimeter is used in between 40degC 80% to -10degC 40%, does the multimeter needs to be calibrated in these conditions? Our practice is only calibrate the IMTE at room temperature because this is the most frequent condition the IMTE is used in.
5. We should separate the IMTE master list 'Calibration Required' category into 'Calibration Required' and 'Verification Needed'. Reason given is take a Block Gage for example, when I send out for calibration it is actually sent out for 'verification'. Q:Is this separate tracking list a common practice?
6. Q:For 4.11.2(f), how to determine how much data I need to refer back if a certain IMTE is out of cal?
What exactly do I need to do to fully comply with this item?
Thank you for taking time to read this long posting. Any suggestions will be appreciated.
Weyli
Hi,
We have just gone through our 1st ISO9002 surveillance audit. During which the auditor found out that we are still not fully comply with 4.11.
NCs and observations given are that we have not done the below:-
1. Calibration Report does not contain before and after calibration data.
Q: What if during the initial performance test, result shows it is within spec., therefore no adjustment is made, therefore no after calibration data is indicated in the report. Is this acceptable?
(Note: all our calibration vendors are G25 certified)
2. Calibration Report does not contain Tracebility info to National or International standards. The cal report states only the national / international agency that the calibration standard is traceable to, but the auditor was looking for the actual standard (ie, info including the serial number etc) that is used by the international agency to calibrate the calibration standard used by my calibration vendor.
Q Does the calibration report needs to be this detail?
3. Q:How to determine the calibration frequency of IMTE? The auditor told me that through time, from the differences between the before and after calibration data collected, I can determine the calibration frequency for the IMTE. How do I go about doing that? Is there any standard formula that I can use?
4. We did not specify the environmental conditions to calibrate our IMTE in.
Q Do I need to give instructions to the external calibration vendor to calibrate the IMTE in the environment conditions exactly the same as the environment we use the IMTE in? Let say the multimeter is used in between 40degC 80% to -10degC 40%, does the multimeter needs to be calibrated in these conditions? Our practice is only calibrate the IMTE at room temperature because this is the most frequent condition the IMTE is used in.
5. We should separate the IMTE master list 'Calibration Required' category into 'Calibration Required' and 'Verification Needed'. Reason given is take a Block Gage for example, when I send out for calibration it is actually sent out for 'verification'. Q:Is this separate tracking list a common practice?
6. Q:For 4.11.2(f), how to determine how much data I need to refer back if a certain IMTE is out of cal?
What exactly do I need to do to fully comply with this item?
Thank you for taking time to read this long posting. Any suggestions will be appreciated.
Weyli