debunking the two great myths a c - ncsl … · bucherview metrology services debunking the two...

Bucherview Metrology Services

DEBUNKING THE TWO GREATMYTHS ABOUT CALIBRATION:

TRACEABILITY TO NISTIF YOU CANNOT ADJUST, YOU CANNOT CALIBRATE!


BY DEFINITION …

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


BY DEFINITION …

Traceability is the property of the resultof a measurement or the value of astandard whereby it can be related tostated references, usually national orinternational standards (SI), through anunbroken chain of calibrations (the papertrail) all having stated uncertainties.


BY DEFINITION …

Calibration is a comparison of twomeasurement devices or systems, one ofknown uncertainty (your standard) andone of unknown uncertainty (your testequipment).


DID YOU KNOW?

The FDA regulates ~ 25% of theU. S. Gross Domestic Product (GDP)

As of April 28th, 2011,the US GDP was

$15,006,400,000,000.00 ($15.006 T)

The FDA regulated~ $3.75 Trillion


DID YOU KNOW?

And none of this couldhappen without the use of calibrated test equipment!


TRACEABILITY PYRAMID

BIPM

NMIs

Reference standards

Working calibration labs

General purpose calibration departments(inside a company)

User’s test equipment


SI

Primary standards

Secondary standards

Reference standards

Working standards

User’s test equipment

TRACEABILITY W/ METROLOGY DEPT.


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 . . .


EXAMPLE OF TRACEABILITY

NIST Standard

Hart Scientific Std.

SPRT & Black Stack (Ref Std)

4600 (Working Std)

Waterbaths

Ω (ohm) BIPMDerived Unit of the International System (SI)


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)


PART 820.72Why discuss the requirements of 21 CFR Part 820.72? Because, of all the stated calibration requirements in 21 CFR Part XXX, Part 820.72 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).


WHAT THE FDA SAYS . . .

Title 21--Food and Drugs

PART 820--QUALITY SYSTEM REGULATION (QSR)(cGMP for Medical Devices)


WHAT THE FDA SAYS . . .The QSR

820.1 Scope.820.3 Definitions.820.5 Quality system.820.20 Management responsibility. 820.22 Quality audit.820.25 Personnel.820.30 Design controls.820.40 Document controls.820.50 Purchasing controls.820.60 Identification.820.65 Traceability.820.70 Production and process controls.

820.75 Process validation.820.80 Receiving, in-process, and finished device acceptance.

820.86 Acceptance status.820.90 Nonconforming product.820.100 Corrective and preventive action.820.120 Device labeling.820.130 Device packaging.820.140 Handling.820.150 Storage.820.160 Distribution.820.170 Installation.820.180 General requirements.820.181 Device master record.820.184 Device history record.820.186 Quality system record.820.198 Complaint files.820.200 Servicing.820.250 Statistical techniques.

820.72 Inspection, measuring, and test equipment.


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


WHAT THE FDA SAYS . . .Sec. 820.72 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.


WHAT THE FDA SAYS . . .Sec. 820.72 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’).



(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 9001-2008 and ISO 13485:2003 require traceability to international or national standards.



(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.


All test equipment that makes a quantitative

measurement requires periodic calibration!

THE BOTTOM LINE IS THIS . . .


• 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.

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.

CALIBRATION MYTHS …


THE 4:1 RULE

To show your uncertainty, withoutperforming calculations, you mustensure your standards are at least fourtimes (4:1) more accurate than the testequipment being calibrated.


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 NationalStandard for Calibration –

(ANSI/NCSL Z540.3-2006)


A BASIC QCP“Say what you do”

Written procedures

“Do what you say”Follow procedures


“Check the results”Did ‘it’ pass or fail

“Act on the difference”Procedures for OOT conditions



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.


16913 50

Ambient +5 °C ~ 70 ± 1 °C

5-25-2010 5-20-2011 5-20-2012

SM-13 1369

30.01 30.037.03 37.042.02 42.070.01 70.0

N/A N/A N/A N/AN/A N/AN/A N/AN/A N/AN/A N/A

N/A N/A N/A N/AN/A N/A N/A N/AN/A N/A N/A N/A

1-16-2011N/A

RECORD WHAT YOU DID

TraceabilityStatement


5-20-2011 Ayumi Jane Deaux5-20-2011 Jay L. Bucher

03

Joe Bagadonuts / Noxious Gas Area / x1369

N/A or a detail description of all events as they happened, and the actions taken.

RECORD WHAT YOU DID

UncertaintyBudget


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


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

LEARNING OBJECTIVES


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