Fundamentals of Calibration
This Fundamentals of Calibration training course is a 1 Day public programme, designed for personnel who are responsible for calibration activities and who need to understand the importance of calibration in quality and / or environmental management systems. All employees need to be aware of the stringent calibration requirements of International standards, such as ISO 9001, and regulatory bodies such as FDA.
Types of Calibration
• Calibration – comparing a measuring instrument with measurement standard to establish the relationship between the values indicated by the instrument and those of the standard.
• Why is calibration necessary?
• ISO 9000 requirements
• ISO 13485:2012 requirements
• FDA requirements
• Calibration records
• Primary documents: calibration policy procedure, calibration schedule, calibration procedure for each equipment
• Product impact evaluation form
• Traceability chain
• Out of tolerance (OOT) condition
• As found data
• As left data
• TUR – Test Uncertainty Ratio
• Limited Calibration
• Uncertainty (measurement & device)
When to calibrate?
• The mean value
• GMP Calibration Requirement (documentation of the calibration of each piece of equipment requiring calibration, specification of accuracy and precision limits, training of calibration personnel)
• Equipment selection
• Calibration intervals
• Management of metrology
• Calibration schedule
• Calibration standards
• Calibration environment
• Audit of calibration systems
• How to implement or improve a calibration programme
Alignment of Operation, Validation and Calibration parameters (temperature, speed, pressure, flow rate, time)
• Operational range & tolerance
• Minimum validation limit & challenge testing
• Recommended Best Practice
• Systems Controls (URS / FDS)
Calibration Quality Systems
• ISO / IEC 17025:2005 (Management Requirement, Technical Requirement)
• ISO 9000
“Swiss Cheese” Model of Calibration
This Fundamentals of Calibration training programme may be of interest to General Engineering, Quality and Manufacturing employees, who perform calibration, are responsible for the maintenance of in-house calibration systems and who are responsible for auditing calibration systems.
Classroom based, instructor lead, practical hands on course.