DEBUNKING THE TWO GREAT MYTHS ABOUT CALIBRATION: TRACEABILITY TO NIST IF YOU CANNOT ADJUST, YOU CANNOT CALIBRATE! Bucherview Metrology Services

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Valentine Ramsey
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1 DEBUNKING THE TWO GREAT MYTHS ABOUT CALIBRATION: TRACEABILITY TO NIST IF YOU CANNOT ADJUST, YOU CANNOT CALIBRATE!

2 BY DEFINITION First, let s get everyone on the same page with the definitions of two critical terms used within a quality calibration program...

3 BY DEFINITION Traceability is the property of the result of a measurement or the value of a standard whereby it can be related to stated references, usually national or international standards (SI), through an unbroken chain of calibrations (the paper trail) all having stated uncertainties.

4 BY DEFINITION Calibration is a comparison of two measurement devices or systems, one of known uncertainty (your standard) and one of unknown uncertainty (your test equipment).

5 DID YOU KNOW? The FDA regulates ~ 25% of the U. S. Gross Domestic Product (GDP) As of April 28th, 2011, the US GDP was $15,006,400,000, ($ T) The FDA regulated ~ $3.75 Trillion

6 DID YOU KNOW? And none of this could happen without the use of calibrated test equipment!

7 TRACEABILITY PYRAMID BIPM NMIs Reference standards Working calibration labs General purpose calibration departments (inside a company) User s test equipment

8 TRACEABILITY W/ METROLOGY DEPT. SI Primary standards Secondary standards Reference standards Working standards User s test equipment

9 THE PAPER TRAIL So how does traceability and the paper trail really work? Here s an example of traceability back to the SI when calibrating a common waterbath used by any biotech, pharmaceutical or medical device company...

11 EXAMPLE OF TRACEABILITY NIST Standard Ω (ohm) BIPM Derived Unit of the International System (SI) Hart Scientific Std. SPRT & Black Stack (Ref Std) 4600 (Working Std) Waterbaths

12 WHAT THE FDA SAYS... Several references that you might be interested in: 21 CFR... Part 58 (Good Laboratory Practice [GLP] for Nonclinical Laboratory Studies) Part 110 (cgmp in Manufacturing, packing, or holding human food equipment and utensil maintenance) Part 211 (cgmp for Finished Pharmaceuticals) Part 606 (cgmp for Blood and Blood Components) Part 820 (cgmp for Medical Devices)

13 PART Why discuss the requirements of 21 CFR Part ? Because, of all the stated calibration requirements in 21 CFR Part XXX, Part is the most specific and detailed. The bottom line is this, when it comes to a quality calibration program, it doesn t cost any more to go first-class (to exceed the standard), than it does to ride in coach (just meeting the standard).

14 WHAT THE FDA SAYS... Title 21--Food and Drugs PART 820--QUALITY SYSTEM REGULATION (QSR) (cgmp for Medical Devices)

15 WHAT THE FDA SAYS... The QSR Scope Definitions Quality system Management responsibility Quality audit Personnel Design controls Document controls Purchasing controls Identification Traceability Production and process controls Inspection, measuring, and test equipment Process validation Receiving, in-process, and finished device acceptance Acceptance status Nonconforming product Corrective and preventive action Device labeling Device packaging Handling Storage Distribution Installation General requirements Device master record Device history record Quality system record Complaint files Servicing Statistical techniques.

16 A BASIC QCP Say what you do Written procedures Do what you say Follow procedures Record what you did Keep records Check the results Did it pass or fail Act on the difference Procedures for OOT conditions

17 WHAT THE FDA SAYS... Sec Inspection, measuring, and test equipment. (a) Control of inspection, measuring, and test equipment. Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results. Each manufacturer shall establish and maintain procedures (Administrative SOPs and scheduling protocols software) to ensure that equipment is routinely calibrated, inspected, checked, and maintained. The procedures shall include provisions for handling, preservation, and storage of equipment, so that its accuracy and fitness for use are maintained. These activities shall be documented.

18 WHAT THE FDA SAYS... Sec Inspection, measuring, and test equipment (b) Calibration. Calibration procedures ( say what you do, do what you say ) shall include specific directions and limits for accuracy and precision. When accuracy and precision limits are not met, there shall be provisions for remedial action ( check the results and act on the difference ) to reestablish the limits and to evaluate whether there was any adverse effect on the device's quality. These activities shall be documented (calibration records record what you did ).

19 WHAT THE FDA SAYS... Sec Inspection, measuring, and test equipment. (1) Calibration standards. Calibration standards used for inspection, measuring, and test equipment shall be traceable to national or international standards (the SI). If national or international standards are not practical or available, the manufacturer shall use an independent reproducible standard. If no applicable standard exists, the manufacturer shall establish and maintain an in-house standard. Note: Nothing here refers to traceability to N.I.S.T. in the USA, or to ISO standards in Europe. Also, both ISO and ISO 13485:2003 require traceability to international or national standards.

20 WHAT THE FDA SAYS... Sec Inspection, measuring, and test equipment. (2) Calibration records. The equipment identification, calibration dates, the individual performing each calibration, and the next calibration date shall be documented. These records shall be displayed on or near each piece of equipment or shall be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment. Note: this paragraph is referring to calibration labels that should be attached to each piece of test equipment that has been calibrated.

21 THE BOTTOM LINE IS THIS... All test equipment that makes a quantitative measurement requires periodic calibration!

22 CALIBRATION MYTHS If test equipment As Found was within tolerance then calibration is not required. WRONG! Every time a calibration is performed, the UUT s As Found readings, and the readings of your Standard must be recorded. If test equipment cannot be adjusted or aligned, it cannot be calibrated (e.g. a glass thermometer). WRONG! Calibration is a comparison only - A complete calibration is performed irrelevant of the ability to adjust the test instrument.

23 CALIBRATION MYTHS A calibration laboratory, with a controlled environment is required for traceable calibrations. WRONG! Calibration occurs whenever a standard with know uncertainty is compared to a UUT with unknown uncertainty. Traceability in the USA must be to NIST. WRONG! Traceability is to a national or international standard (the SI), not to an organization or NMI. NIST might maintain a standard/artifact to which your calibrations are traceable, but it s not traceable to NIST.

24 THE 4:1 RULE To show your uncertainty, without performing calculations, you must ensure your standards are at least four times (4:1) more accurate than the test equipment being calibrated.

25 TEST UNCERTAINTY RATIO 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 Z )

26 A BASIC QCP Say what you do Written procedures Do what you say Follow procedures Record what you did Keep records Check the results Did it pass or fail Act on the difference Procedures for OOT conditions

27 RECORD WHAT YOU DID This means recording the results of your measurements, as you found them, and what they were if you had to adjust them, and keeping those records in a secure location.

28 RECORD WHAT YOU DID Ambient +5 C ~ 70 ± 1 C SM N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A Traceability N/A N/A N/A Statement N/A

29 RECORD WHAT YOU DID 03 Uncertainty Budget Joe Bagadonuts / Noxious Gas Area / x1369 N/A or a detail description of all events as they happened, and the actions taken Ayumi Jane Deaux Jay L. Bucher

30 BEST PRACTICES/LESSONS LEARNED Calibration certificates* 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/IEC 17025

31 LEARNING OBJECTIVES In order to maintain traceability, you must be able to show the paper trail from your UUT all the way back to the SI, with appropriate uncertainty budgets during each calibration Calibration is simply a comparison of two measurement devices or systems, one of known uncertainty, and one of unknown uncertainty; adjustment, alignment, and/or repair of the UUT is irrelevant to the calibration process

Comparison between FDA QSR and ISO 13485

Comparison between FDA QSR and ISO 13485 Most countries in the world including the Europe, for the conformity assessment of medical devices to be used by their countrymen, assess not only whether the product