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Hi Everyone,
Thanks in advance for any response.
Here's the scenario: We have a temperature controller on an extruder system that is calibrated at its typical operating temperature, 100 degrees below and 100 degrees above. The controller's maximum temperature input is several hundred degrees above our highest point and several hundred below the lowest. The controller is not marked for limited calibration.
An ISO auditor objects to this situation. The audtor maintains that any instrument not calibrated to its full range and capabilities must be marked limited calibration. If it wasn't me who had to fix this, I may not object to such an obervation. However, could someone get me out of this?
Of the 5,000 pieces of equipment we manage, more than half are calibrated more with respect to their role in the process than to the mfr's full range. Some special made fixtures are calibrated according to the wishes of the Mfg Engineer who built it.
The auditors are using Clause 7.6 section c. as their basis. Has anyone dealt with this before? How did it go?
Thanks
Gary
Excerpt from BS EN ISO 13485:2003, Sec. 7.6
7.6 Control of monitoring and measuring devices
The organization shall determine the monitoring and measurement to be
undertaken and the monitoring and measuring devices needed to provide
evidence of conformity of product to determined requirements (see
7.2.1).
The organization shall establish documented procedures to ensure that
monitoring and measurement can be carried out and are camed out in a
manner that is consistent with the monitoring and measurement
requirements.
Where necessary to ensure valid results. measuring equipment shall
a) be calibrated or verified at specified intervals. or prior to use,
against measurement standards traceable to international or national
measurement standards; where no such standards exist, the basis used for
calibration or verification shall be recorded;
b) be adjusted or re-adjusted as necessary;
c) be identified to enable the calibration status to be determined;
d) be safeguarded from adjustments that would invalidate the measurement
result;
e) be protected from damage and deterioration during handling,
maintenance and storage.
In addition, the organization shall assess and record the validity of
the previous measuring results when the equipment is found not to
conform to requirements. The organization shall take appropriate action
on the equipment and any product affected. Records of the results of
calibration and verification shall be maintained (see 4.2.4).
Thanks in advance for any response.
Here's the scenario: We have a temperature controller on an extruder system that is calibrated at its typical operating temperature, 100 degrees below and 100 degrees above. The controller's maximum temperature input is several hundred degrees above our highest point and several hundred below the lowest. The controller is not marked for limited calibration.
An ISO auditor objects to this situation. The audtor maintains that any instrument not calibrated to its full range and capabilities must be marked limited calibration. If it wasn't me who had to fix this, I may not object to such an obervation. However, could someone get me out of this?
Of the 5,000 pieces of equipment we manage, more than half are calibrated more with respect to their role in the process than to the mfr's full range. Some special made fixtures are calibrated according to the wishes of the Mfg Engineer who built it.
The auditors are using Clause 7.6 section c. as their basis. Has anyone dealt with this before? How did it go?
Thanks
Gary
Excerpt from BS EN ISO 13485:2003, Sec. 7.6
7.6 Control of monitoring and measuring devices
The organization shall determine the monitoring and measurement to be
undertaken and the monitoring and measuring devices needed to provide
evidence of conformity of product to determined requirements (see
7.2.1).
The organization shall establish documented procedures to ensure that
monitoring and measurement can be carried out and are camed out in a
manner that is consistent with the monitoring and measurement
requirements.
Where necessary to ensure valid results. measuring equipment shall
a) be calibrated or verified at specified intervals. or prior to use,
against measurement standards traceable to international or national
measurement standards; where no such standards exist, the basis used for
calibration or verification shall be recorded;
b) be adjusted or re-adjusted as necessary;
c) be identified to enable the calibration status to be determined;
d) be safeguarded from adjustments that would invalidate the measurement
result;
e) be protected from damage and deterioration during handling,
maintenance and storage.
In addition, the organization shall assess and record the validity of
the previous measuring results when the equipment is found not to
conform to requirements. The organization shall take appropriate action
on the equipment and any product affected. Records of the results of
calibration and verification shall be maintained (see 4.2.4).
