6. ?

7. Training removes doubt, instills confidence, and lays the foundation for everyone’s skill and experience level

8. 21CFR Part 820.25 Personnel ANSI/ISO/IEC 17025:2005(E), paragraph 5.2.

9. Sec. 820.25 Personnel. (a)General. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed. (b) Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented. (1) As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs. (2) Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.

10. ISO 10012:2003(E) ANSI/NCSL Z540.3-2006

11. “Say what you do” “Do what you say” “Record what you did” “Check the results” “Act on the difference”

12. You need to establish a QCP to ensure that all operations throughout the metrology department occur in a stable manner. The effective operation of such a system will result in stable processes and, therefore, in a consistent output from those processes. Once stability and consistency are achieved, it is possible to initiate process improvements.

13. Quality manual Quality procedures (administrative – general) Calibration records Calibration procedures (work instructions – specific)

14. Administrative procedures for: Control and use of SOPs, computer software, reference & working standards, labels, training, calibration records, and out-of-tolerance procedures Calibration procedures: Recommend using generic SOPs written for each type of test instrument, then broken down into specific manufacturers, or for special applications or usage Calibration record forms: As with calibration procedures, recommend using generic forms as a template for your records; also use pre-filled templates to save time and transcription errors

15. Quality documents & procedures Equipment OOT policy and procedures Customer service, comments and suggestion program A quality calibration training program Easy access to all quality documents that impact the staff’s ability to do their job

16. Continuity/Training Manuals: Available for all personnel Updated as needed; reviewed annually for accuracy and relevance Everyone must document their training – both reading and hands-on training

17. Community College courses PMEL technicians Attend specialized classes Provide on-the-job-training NCSLI can provide assistance

18. “Train” your customers... Newcomer Orientation Program Explain the benefits of using calibrated test equipment vs uncalibrate equipment Advantages to the customer: a QCP will increase productivity and help make them more successful Lab Liaison Program

19. Miscellaneous Information: TUR: ≥ 4:1 Short cycling protocols Calibration interval analysis Smoothing ‘peaks & valleys’ in your forecasted workload Traceability and the paper-trail Full scale vs. % of reading accuracies The LSD (least significant digit) and how it can affect your readings

20. To maintain traceability, you must ensure your standards are at least four times (4:1) more accurate than the test equipment being calibrated.

21. “Where calibrations provide for verification that measurement quantities are within specified tolerances…Where it is not practical to estimate this probability, the TUR shall be equal to or greater than 4:1.” American National Standard for Calibration – (ANSI/NCSL Z540.3-2006)

22. Smoothing the peaks and valleys… Use yearly forecast from CAMS Smooth the long term items Anticipate holidays, down time, and production schedules Don’t change calibration labels, but document what you’re doing and why

23. Smoothing the peaks and valleys…

24. Use ‘short cycling’ when large groups of items are calibrated over a few days To preclude all those items from coming due all at once, short cycle a portion If they have a 12 month interval, short cycle ¼ @ 3 months, 6 month & 9 months Change their DDC in CAMS to match when you have short cycled each item

25. Use a certified laboratory (ISO 17025) Request ‘As Found’ and ‘As Left’ readings Review the calibration certificate Give your standard an operational check before & after to ensure there is no shipping damage to your equipment; document it! Standards

26. Title Name & address of the calibration laboratory Unique ID of the certificate Name & address of the client Identification of the method used Description and condition of the item calibrated The date(s) of calibration Calibration results and units of measurement Name, function, and signature of authorizing person Environmental conditions during calibration Uncertainty of measurement Evidence that the measurements are traceable *IAW ISO 17025 Calibration certificates*

27. NCSLIwww.ncsli.org/ASQ/MQDwww.asq.org/measure/FDA www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=200821MSCwww.msc-conf.com/msc/ Resources and web links

28. NISTwww.nist.gov/PMELwww.pmel.org/ Work Place Training www.wptraining.com/ Uncertainty calculator www.callabmag.com/freeware.html Resources and web links

29. WWW.B UCHERVIEW -M ETROLOGY. COM