3 Features of a CMS Identifies instruments that can be calibrated Determines calibration requirements for instrumentsEstablishes calibration proceduresDevelops corrective action proceduresDocuments calibration results and activitiesSupports 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 identificationA recorded history and current calibration statusUse appropriate for the function of the instrumentCalibration procedures requireApproved procedures for calibrationSchedule for calibrationProcess range limitsCalibration standards and test equipmentMust be more accurate than the required accuracy of the instrument (typically 4 times more accurate)Traceable back to national or international standardsPersonnelProof of appropriate trainingPerform within an established change management process
7 Establishing a Calibration Management System Criticality assessmentLife cycle phasesProjectPre-OperationalOperationalTrainingChange controlDocumentationElectronic RecordsAuditing
8 Criticality assessment Process owners, Engineering, and Quality Assurance establish for all instruments involved with the process and their respective criticalityIdentification, range, accuracy, history, capabilitiesCriticality and calibration rationaleCategorization (product critical, process critical, safety critical, non critical)Schedule for calibration service
9 Life cycle phasesProject: 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 TrainingEnsure that all personnel involved with calibration are properly trainedTraining records must be maintainedPersonnel and identification recordsFuture training needsQualification recordsExperience recordsCompetence recordsCourses and presentationscertificates
11 Change ControlUser requests changeEngineering defines detailQA approves changeChange maker documents changeProcess Owner/Engineering/QA signs-off change & document archivedUpdates and refinements of the calibration system must be done in a methodical and documented mannerThe 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 fileApproval proceduresChange proceduresVersion controlDistribution controlAssure only current documents are deployed
13 Electronic RecordsManagement of electronic records for “paperless” calibration operationsFDA 21 CFR Part 11 standard for electronic records, electronic signatures, and time stampsKey concepts: validation, audit trail, copies of records, record retention
14 AuditingPeriodic audits assure that the calibration plan is being followedProvides an opportunity to implement corrective actionFormal audit report documents audit process
15 Calibration Management Software Commercial software packages are available to:Automate calibration management tasksAssure compliance with standards organizationsComply with FDA 21 CFR Part 11 electronic signaturesMaintain documentation and instrument recordsTrace standards used in calibrationTrack changes with audit trailSupport “paperless” calibration managementGenerate reports
24 Standards Organizations ISO - International Origination for StandardizationANSI - American National Standards InstituteNIST - National Institute for Standards and TechnologyASTM - American Society for Testing and MaterialsCLSI (formerly NCCLS) - Clinical and Laboratory Standards InstituteUS EPA – US Environmental Protection AgencyAOAC - Association of Analytical CommunitiesUPC - United States Pharmacopeia
25 ISOISO 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 ANSIANSI 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 NISTNIST 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 ASTMASTM, 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.