1. PRINCIPLES OF A CALIBRATION MANAGEMENT SYSTEM

2. Calibration Management System (CMS)
Essential elements:
Trained personnel
Instrumentation assessment
Management
Documentation
Corrective action procedures

3. Features of a CMS Identifies instruments that can be calibrated
Determines calibration requirements for instruments
Establishes calibration procedures
Develops corrective action procedures
Documents calibration results and activities
Supports audit trails for calibration system

4. Purpose of a CMS Defines: What is required? Who is responsible?
When does it need to be done?
Why does it need to be done?
How it is accomplished?

5. Important Definitions
Calibration: The operations which assure that an instrument readings are accurate referenced to established standards.
Validation: Proving that a system (equipment, procedure, process, material) will yield expected results.
Qualification: Assuring that equipment can produce expected results.
Instrument: A device which measures a parameter.
Test Equipment: Devices used during the calibration of instruments. These devices must be traceable to known standards.

6. Requirements for a CMS Each instrument requires:
Unique identification
A recorded history and current calibration status
Use appropriate for the function of the instrument
Calibration procedures require
Approved procedures for calibration
Schedule for calibration
Process range limits
Calibration standards and test equipment
Must be more accurate than the required accuracy of the instrument (typically 4 times more accurate)
Traceable back to national or international standards
Personnel
Proof of appropriate training
Perform within an established change management process

7. Establishing a Calibration Management System
Criticality assessment
Life cycle phases
Project
Pre-Operational
Operational
Training
Change control
Documentation
Electronic Records
Auditing

8. Criticality assessment
Process owners, Engineering, and Quality Assurance establish for all instruments involved with the process and their respective criticality
Identification, range, accuracy, history, capabilities
Criticality and calibration rationale
Categorization (product critical, process critical, safety critical, non critical)
Schedule for calibration service

9. Life cycle phases
Project: definines instruments to measure process variables. Ensure proper selection of instrumentation and procedures.
Pre-Operational: ensures transfer of calibration data and historical information to the operational phase. SOPs established.
Operational: calibration, cleaning, decontamination, and documentation of the process instrumentation.

10. Training
Ensure that all personnel involved with calibration are properly trained
Training records must be maintained
Personnel and identification records
Future training needs
Qualification records
Experience records
Competence records
Courses and presentations
certificates

11. Change Control
User requests change
Engineering defines detail
QA approves change
Change maker documents change
Process Owner/Engineering/QA signs-off change & document archived
Updates and refinements of the calibration system must be done in a methodical and documented manner
The changes must be evaluated and approved by all stakeholders including users, Engineering, Quality Assurance, and Process Owner.

12. Documentation Documentation standards must be followed:
Master document file
Approval procedures
Change procedures
Version control
Distribution control
Assure only current documents are deployed

13. Electronic Records
Management of electronic records for “paperless” calibration operations
FDA 21 CFR Part 11 standard for electronic records, electronic signatures, and time stamps
Key concepts: validation, audit trail, copies of records, record retention

14. Auditing
Periodic audits assure that the calibration plan is being followed
Provides an opportunity to implement corrective action
Formal audit report documents audit process

15. Calibration Management Software
Commercial software packages are available to:
Automate calibration management tasks
Assure compliance with standards organizations
Comply with FDA 21 CFR Part 11 electronic signatures
Maintain documentation and instrument records
Trace standards used in calibration
Track changes with audit trail
Support “paperless” calibration management
Generate reports

16. EXAMPLE CALIBRATION MANAGEMENT SYSTEM

17. Calibration Management Technician
Responsible for responding to calibration needs
Perform calibration procedures
Document calibration operations
Handle out-of-calibration conditions
Perform TQM tasks

18. Example of a Traceability Certification

19. Example Calibration Work Form

20. Equipment Log Book

21. Example Calibration SOP

22. Example Calibration Label

23. STANDARDS ORGANIZATIONS

24. Standards Organizations
ISO - International Origination for Standardization
ANSI - American National Standards Institute
NIST - National Institute for Standards and Technology
ASTM - American Society for Testing and Materials
CLSI (formerly NCCLS) - Clinical and Laboratory Standards Institute
US EPA – US Environmental Protection Agency
AOAC - Association of Analytical Communities
UPC - United States Pharmacopeia

25. ISO
ISO International Origination for Standardization: worldwide federation of national standards bodies from 156 different countries that promotes the development of standards and related activities in the world with a view to facilitating the international exchange of goods and services.
Developing by consensus international standards including the ISO 9000 quality series Publishing and updating the SI metric systems of units.
ISO 9000 has become an international reference for quality requirements in business to business dealings, and ISO looks set to achieve at least as much, if not more, in helping organizations to meet their environmental challenges.

26. ANSI
ANSI the American National Standards Institute : administrator and coordinator of the united States private sector voluntary standardization system. ANSI does not itself develop American National Standards : rather it facilities their development by establishing consensus among qualified groups . ANSI is the sole U.S representatives to ISO.
Promoting the use of U.S. standards internationally.
Playing an active role in the governance of ISO.
Promoting the use of standards , including ISO9000, in the U.S.

27. NIST
NIST the National Institute for Standards and Technology : A U.S. federal agency that works with industry and government to advance measurement science and development standards. Examples of measurement –related services provided by NIST.
Providing calibration services and primary standards for mass, temperature, humidity, fluid flow , and other physical properties.
Providing more than 1300 standard references materials to be used in biological, chemical and physical assays.
Performing research an development of new standards , including standards for biotechnology .
NIST’s weights and measures services, a job assigned to the federal government in the Constitution, provide the basis for the fairness and efficiency of sales totaling more than $5 trillion—roughly half of the U.S. economy?
Between 3 percent and 6 percent of the U.S. gross domestic product (GDP) is attributed to measurements and measurement-related operations that rely on NIST for accuracy, reliability, and international recognition?
Eighty percent of global merchandise trade is influenced by testing and other measurement-related requirements of regulations and standards—and that U.S. companies increasingly depend on NIST to help ensure access to global markets that create new business and jobs?
Without NIST, U.S. manufacturers of such products as glucose and cholesterol test kits—in vitro diagnostic (IVD) devices—wouldn’t be able to meet requirements of new European Union regulations and would have been shut out of the $7 billion European market where they now have more than 60 percent of the business?

28. ASTM
ASTM, the American Society for Testing and Materials : coordinates efforts by manufacturers , consumers , and representatives of government and academia to develop by consensus standards of materials , products, systems, and services. Examples of measurement –related services provided by ASTM are:
Developing and publishing technical standards (eg., those covering the requirements for volume –measuring glassware). More than 100,000 ASTM standards are used worldwide.
Providing technical publications and training courses.