CALIBRATION
To establish methods of using, calibrating and maintaining, monitoring and measuring equipment and or resources, as well as associated recordkeeping
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QP 4.2
1) RESPONSIBILITY:
Quality Control Lead:
Allen Quintanilla (PSP East)
Open (PSP West)
Responsibilities:
Maintain the Master Calibration Log
Ensure that all Assets are within their calibration date
2) RELATED REQUIREMENTS:
ISO 13485
7.6 Control of Monitoring and Measuring Equipment
AS9100
7.1.5.1 Monitoring and Measuring Resources
7.1.5.2 Measurement Traceability
3) QUALITY PROCESS OBJECTIVE:
OBJECTIVE:
Ensure that the monitoring and measuring equipment is calibrated per regulatory requirements
Ensure that the temperature is controlled in required environments like the QC room
4) EFFECTIVENESS MEASURE:
Measurable quality objectives are established within the monthly quality meeting report, section quality objectives.
Quality objectives are verified for effectiveness on a monthly basis.
If the quality objectives are not met, management will assign activities to ensure that the quality process will perform within set guidelines.
Sustainability: ≤ 90%
5) ACTIVITIES AND EXPECTATIONS:
ACTIVITIES:
EXPECTATIONS:
6) PROCESS INPUTS:
Source of Input:
Calibration intervals
7) PROCESS OUTPUTS:
Source of Output:
Calibrated equipment
8) RELATED DOCUMENTS:
Policies:
Procedures:
Documents:
Work Instructions:
Guides/References:
9) TRAINING REQUIREMENTS:
Mandatory training (to be completed within the first 30 days of assignment)
QC Lead
10) INTERNAL AUDIT- VALIDATION AND VERIFICATION:
Internal audit performed on: _______
Auditor: _________
Findings: _______
The following elements will be validated and/or verified as part of the scheduled internal auditing process.
Validation:
Quality system validated as part of the internal audit
Verification:
Compliance with all applicable requirements
Corrective actions against this process have been closed and are effective
Training Effectiveness
Status of documented information (have there been any changes or new documents issued and if documents have been changed or added have all applicable employees trained)
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