Calibration Laboratory Audit Preparation Webinar


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Calibration Laboratory Audit Preparation Webinar presented on December 10, 2013 by Keith Bennett, Transcat's Directory of Metrology and Quality Systems

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Calibration Laboratory Audit Preparation Webinar

  1. 1. Calibration Laboratory Audit  Preparation December 10, 2013
  2. 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. 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 is calibrated 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. 4. Audit Preparation • ISO/IEC 17025 General 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. 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. 6. Quality System • Which Elements are 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. 7. Technical Requirements The overall goal is to insure that calibrations  The overall goal is to insure that calibrations performed are correct and reliable. 
  8. 8. Technical Requirements • Primary Elements to 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. 9. Technical Requirements  • Primary Elements to 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. 10. Technical Requirements • Human Factors/Personnel Human Factors/Personnel – Competent • Job Descriptions Job Descriptions • Training – – – – Formal OJT Objective Evidence Qualification Matrix Qualification Matrix
  11. 11. Technical Requirements • Human Factors/Personnel Human Factors/Personnel – Competent • Proficiency Tests y – External – ISO 17043:2010 » National Association for Proficiency  Testing fi i » AB  Developed » National Measurement Institutes (NIST) – Internal » Correlation studies
  12. 12. Technical Requirements • Human Factors/Personnel Human Factors/Personnel – Undue External Pressures • Conflicts of Interests Conflicts of Interests  – Undue Internal Pressures
  13. 13. Technical Requirements • Accommodation and Environmental Controls Accommodation and Environmental Controls  (Adequate to the level of claimed uncertainties) – – – – Temperature/RH p Lighting Vibration Segregation • Incompatible activities
  14. 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. 15. Technical Requirements • Equipment – – – – – – Adequate for use Verified upon receipt Only operated by qualified personnel Adequate instructions for use Adequate instructions for 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. 16. Technical Requirements • Measurement Traceability Measurement Traceability • Metrological Traceability is the property of a  measurement result whereby it can be related to stated  measurement result 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. 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.
  18. 18. Technical Requirements Measurement Traceability easu e e t aceab ty
  19. 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
  20. 20. Technical Requirements Sampling  Sampling Not discussed in this presentation N t di d i thi t ti
  21. 21. Technical Requirements • Handling of M&TE Handling of M&TE – – – – Shipping Receiving R i i Storage Safeguards against damage 
  22. 22. Technical Requirements • Assuring the quality 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. 23. Technical Requirements • Reporting the results 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. 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 di t 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. 25. Scope of Capabilities • Developing your scope 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”
  26. 26. Scope of Capabilities
  27. 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
  28. 28. Uncertainty Analysis
  29. 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. 30. External Audits • Customer • Accreditation  • Industry Specific d S ifi
  31. 31. External Audits Regardless of what body is performing the audit,  Regardless of what body is performing the audit there is a common goal.
  32. 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. 33. Do’s during an Audit • • • • Give the auditor your undivided attention Give the auditor your undivided attention Give the auditor mutual respect Acceptance of findings f fi di Presenting a challenge to a finding
  34. 34. Do’s during an Audit • Give the auditor your undivided attention Give the auditor your undivided attention – Facilities –E i Equipment t – Personnel
  35. 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 Fi di Types Addressing Using to your advantage Using to your advantage
  36. 36. Calibration Laboratory Audit  y Preparation Webinar Questions? Contact us at: 800.828.1470