Fundamentals of Calibration

Course Content:

• Introduction & Course Objectives
• 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?
• Legislative Requirements
  •  ISO 9000 requirements
  •  ISO 13485:2012 requirements
  •  FDA requirements
• Calibration Management
  •  Calibration records
  •  Primary documents: calibration policy procedure, calibration schedule, calibration procedure for each equipment
  •  Product impact evaluation form
• Calibration terminology
  •  Accuracy
  •  Precision
  •  Traceability chain
  •  Out of tolerance (OOT) condition
  •  Optimisation
  •  As found data
  •  As left data
  •  TUR – Test Uncertainty Ratio
  •  Limited Calibration
  •  Uncertainty (measurement & device)
• When to calibrate?
• Calibration Requirements
  •  Precision
  •  Repeatability
  •  Bias
  •  The mean value
  •  Accuracy
  •  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
• Q&A
• Conclude & Follow Up Process

Classroom based, instructor lead, practical hands on course.

Product Description

Awarding Body: Optima Training & Consulting Ltd

National Framework of Qualifications Level: N/a

Certification: Optima Training & Consulting Ltd Certificate of Completion

Renewal: N/a

Entry Requirements:
Minimum age- 18 years old

Minimum English requirements: Leaners must be able to understand and convey the concepts contained in the programme content.

Assessment Details: Class Interaction

Cost Per Person:
The fee is inclusive of all training courseware materials, certificate of completion and 3 months after training support.

Progression Opportunities: Please see related courses

Protection for Enrolled Students: N/A

Should a course not proceed, any payment received will be refunded within 48 hours