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Calibration Laboratory Audit Preparation Webinar
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- 2. Audit Preparation • Calibration laboratories are subject to many types of j y yp audits such as ISO 17025 accreditation, Z540.X, Nuclear 10 CFR 21, FDA, FCC, and many others •Many calibration laboratories provide services to lb l b d multiple industries that are regulated by many of these regulatory bodies these regulatory bodies • Agenda – Common factors relating to calibration labs that will keep this in perspective and manageable – Some basic concepts of preparing for an audit – Do’s and Do Not’s during the process of being audited Do s and Do Not s during the process of being audited
- 3. What are you being audited to? Calibration of Measurement and Test Equipment (M&TE) is a function required by most industries throughout the world. f db d h h h ld Many of these industries have specific requirements for the calibration of their respective M&TE and the processes by which the M&TE is calibrated. the M&TE iscalibrated Although many industries have some unique requirements most requirements are generic. req irements are generic The International Standards Organization (ISO) developed ISO/IEC 17025 ‐ General Requirements for the Competence of ISO/IEC 17025 G lR i f h C f Testing and Calibration Laboratories.
- 4. Audit Preparation • ISO/IEC 17025General Requirements for the ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories – Management Requirements (Section 4) • Contains all elements of ISO 9001 • 25 Elements – Technical Requirements (Section 5) • 28 Elements
- 5. Quality System • Quality Manual Quality Manual –Standard Operating Procedures (SOP’s) – Must Adequately Address all Elements of 17025 Must Adequately Address all Elements of 17025 – Must Adequately Address Other Critical Elements
- 6. Quality System • Which Elementsare important? Which Elements are important? – All need to be addressed – Management Requirements Management Requirements • Most customer audits will focus on these – Industry Specific y p – Technical Requirements • Metrologist
- 7. Technical Requirements The overall goal is to insure that calibrations The overall goalis to insure that calibrations performed are correct and reliable.
- 8. Technical Requirements • Primary Elementsto Produce a Quality Primary Elements to Produce a Quality Calibration – Human Factors Human Factors – Accommodation and Environmental Conditions – Methods Methods – Equipment – Measurement Traceability Measurement Traceability – Sampling – Handling of M&TE Handling of M&TE
- 9. Technical Requirements • Primary Elementsto Produce a Quality Primary Elements to Produce a Quality Calibration (con’t) – Assuring the quality of test and calibration results Assuring the quality of test and calibration results – Reporting the results
- 10. Technical Requirements • Human Factors/Personnel Human Factors/Personnel –Competent • Job Descriptions Job Descriptions • Training – – – – Formal OJT Objective Evidence Qualification Matrix Qualification Matrix
- 11. Technical Requirements • Human Factors/Personnel Human Factors/Personnel –Competent • Proficiency Tests y – External – ISO 17043:2010 » National Association for Proficiency Testing www.proficiency.org fi i » AB Developed » National Measurement Institutes (NIST) – Internal » Correlation studies
- 12. Technical Requirements • Human Factors/Personnel Human Factors/Personnel –Undue External Pressures • Conflicts of Interests Conflicts of Interests – Undue Internal Pressures
- 13. Technical Requirements • Accommodation andEnvironmental Controls Accommodation and Environmental Controls (Adequate to the level of claimed uncertainties) – – – – Temperature/RH p Lighting Vibration Segregation • Incompatible activities
- 14. Technical Requirements • Methods – Need to meet the requirements of the customer and must be adequate for the calibrations performed –Standard Methods – L b Laboratory Developed Methods D l dM h d • Must be Validated – Non‐standard Methods Non‐standard Methods • Must be validated • Generally to meet specific customer requirements
- 15. Technical Requirements • Equipment – – – – – – Adequate for use Verified upon receipt Only operated by qualified personnel Adequate instructions for use Adequate instructionsfor use Must remain in control of lab Identify long term stability (Calibration interval) – – – • Labeled to identify calibration status y • Interim checks Unique identification Segregated and identified when out of control Performance verified before the unit leaves and after unit is received back f f b f h l f b k into the lab Documentation is essential –
- 16. Technical Requirements • Measurement Traceability Measurement Traceability • Metrological Traceability is the property of a measurement result whereby it can be related to stated measurementresult whereby it can be related to stated references, usually national or international standards, through an unbroken chain of comparisons, each step in the chain having stated uncertainties. The purpose of th h i h i t t d t i ti Th f requiring traceability is to ensure that measurements are accurate representations of the specific quantity subject to measurement, within the uncertainty of the measurement. Traceability is characterized by six essential elements. essential elements.
- 17. Technical Requirements • Measurement Traceability – An unbroken chain of comparison: Traceability begins with an unbroken chain of comparisons originating at national, international or intrinsic standards of measurement and ending with the working reference standards of a given metrology laboratory; –Measurement uncertainty: The measurement uncertainty for each step in the traceability chain must be calculated according to defined methods and must be stated bili h i b l l d di d fi d h d d b d at each step of the chain so that an overall uncertainty for the whole chain can be calculated; – Documentation: Each step in the chain must be performed according to documented and generally acknowledged procedures and the results must be documented, i.e., in a and generally acknowledged procedures and the results must be documented i e in a calibration or test report; – Competence: The laboratories or bodies performing one or more steps in the chain must supply evidence of technical competence, e.g., by demonstrating that they are accredited by a recognized accreditation body; accredited by a recognized accreditation body; – Reference to SI units: Where possible, the primary national, international or intrinsic standards must be primary standards for realization of the SI units; – Recalibrations: Calibrations must be repeated at appropriate intervals in such a manner that traceability of the standard is preserved. that traceability of the standard is preserved.
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- 19. Technical Requirements • Methods – Need to meet the requirements of the customer and must be adequate for the calibrations performed –Standard Methods – L b Laboratory Developed Methods D l dM h d • Must be Validated – Non‐standard Methods Non‐standard Methods • Must be validated • Generally to meet specific customer requirements
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- 21. Technical Requirements • Handling ofM&TE Handling of M&TE – – – – Shipping Receiving R i i Storage Safeguards against damage
- 22. Technical Requirements • Assuring thequality of test and calibration results Assuring the quality of test and calibration results – Quality review of completed product • Logging the results to catch trends ogging the results to catch trends
- 23. Technical Requirements • Reporting theresults Reporting the results – There are multiple elements/requirements for what needs to be presented on certificates and data sets of needs to be presented on certificates and data sets of the calibrated M&TE. ISO 17025 is a good standard to develop this.
- 24. Scope of Capabilities • Also know as the Scope of Accreditation identifies your p y capabilities by discipline and sub‐discipline and how capable you are (Uncertainties) in these each respective quantity • Th The scope is used internally as a snapshot of what your i dit ll h t f h t capabilities are and is a useful marketing document so customers know what your capabilities • The quantities and associated uncertainties are also called Calibration and Measurement Capabilities (CMC’s) • Th These are generally considered your Best Measurement ll id d B M Capabilities
- 25. Scope of Capabilities • Developing yourscope will take practice Some Developing your scope will take practice. Some things to consider are: – What is my target What is my target – What are the capabilities of my standards – Where do my capabilities need to be Where do my capabilities need to be – Are my capabilities in line with others – Good source documents to develop scopes are Good source documents to develop scopes are ILAC P14 and the “Guide to the Expression of Uncertainty of Measurement Uncertainty of Measurement”
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- 27. Uncertainty Analysis • Guidance Document Guidance Document –“Guide to the Expression of Uncertainty of Measurement (GUM) Measurement” (GUM) • Recommend training by a respected body or person • This will take a lot of practice
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- 29. Internal Audits • After initial development of Quality System p Q y y •On a recurring basis – Generally on an annual schedule • Performed by a designated quality representative – Impartial – Sh ld h Should have reporting structure independent from i i d d f Operations • Internal audits should be the most stringent of all g external audits • Should audit all elements of the Quality System
- 30. External Audits • Customer • Accreditation •Industry Specific d S ifi
- 31. External Audits Regardless of what body is performing the audit, Regardless of whatbody is performing the audit there is a common goal.
- 32. Do’s during an Audit • Appearance –Initial Tour of the Lab Appearance Initial Tour of the Lab – Facilities –E i Equipment t – Personnel • Identify Common Areas
- 33. Do’s during an Audit • • • • Give the auditor your undivided attention Give the auditoryour undivided attention Give the auditor mutual respect Acceptance of findings f fi di Presenting a challenge to a finding
- 34. Do’s during an Audit • Give theauditor your undivided attention Give the auditor your undivided attention – Facilities –E i Equipment t – Personnel
- 35. Audit Preparation Scope of Capabilities • • • • • • • • • • • • • Internal Audits External Audits Do’s and Do Not’s Initial walk through l lk h h Etiquette Personnel appearance Mutual respect M l Acceptance of findings Challenges (Professional) Findings Fidi Types Addressing Using to your advantage Using to your advantage
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