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
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?
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.
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
Establishing a Calibration Management System Criticality assessment Life cycle phases –Project –Pre-Operational –Operational Training Change control Documentation Electronic Records Auditing
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
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.
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
Change Control 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. User requests change Engineering defines detail QA approves change Change maker documents change Process Owner/Engineering/QA signs-off change & document archived
Documentation Documentation standards must be followed: –Master document file –Approval procedures –Change procedures –Version control –Distribution control –Assure only current documents are deployed
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
Auditing Periodic audits assure that the calibration plan is being followed Provides an opportunity to implement corrective action Formal audit report documents audit process
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
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
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.
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.
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.
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: