Smart Meter
Verification and FDA
21 CFR part 11
Tom O’Banion
Director of Industry Differentiation
Agenda

Review of Terms

Third Party Agency Work
– Overall update
– FDA

AMS Snap-on and ProLink advantages
– AMS Screen shots
Terminology:
Calibration, Validation, and Verification

Definition of terms
– Calibration: Establishing the relationship between flow and signal produced by
sensor.
– Validation: Confirming flow performance by comparing a primary flow standard to
sensor. In F&B, Pharma, and LifeScience, Processes are also often validated
– Verification: Establishing confidence in performance by analysis of secondary
variables associated with flow



Frequently these terms are used interchangeably
Many times calibration or validation is done when only verification is
needed
Micro Motion measures tube stiffness to verify complete performance
Agency
Application
SMV Status
AER (Alberta)
HC fiscal transfer
 Recognized
US EPA
GreenHouse Gas (40 CFR part 98)
 Recognized
US EPA
Acid Rain (40 CFR part 75)
 (EPA will use AGA docs,
FY15)
ISO 9001
Various
 Recognized
IEC (for SIS)
Safety Instrumented Systems
 Recognized via Proof
Test
AGA -11 / API
MPMS Ch 14.9
Natural Gas fiscal transfer
 Recognized
Nmi (NEL and
Pigsar test labs)
Test data used for other Agencies
 Q2 2015
Russia
Various metrology
Est Sep/Oct 2015
NIM (China)
CT, Various JJG1038-2008 rev? Staring April 2014
FDA & TTB
Meter validation
 SMV complies w/ proper
recordkeeping
API 20.2
Allocation / royalty meters
Ballot Feb 2015, est Sep
2015 release
API 5.6
Fiscal Transfer Liquid HC
TBD 2016
NIST
Liquid chemical fiscal transfer
Not yet active
ISO 9001 (Often used in F&B)
7.6 Control of monitoring and measuring equipment
The organization shall determine the monitoring and measurement to be undertaken and the monitoring
and measuring equipment needed to provide evidence of conformity of product to determined
requirements. The organization shall establish processes to ensure that monitoring and measurement
can be carried out and are carried out in a manner that is consistent with the monitoring and
measurement requirements. Where necessary to ensure valid results, measuring equipment shall
a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement
standards traceable to international or national measurement standards; where no such standards exist,
the basis used for calibration or verification shall be recorded (see 4.2.4);
b) be adjusted or re-adjusted as necessary;
c) have identification in order to determine its calibration status;
d) be safeguarded from adjustments that would invalidate the measurement result;
e) be protected from damage and deterioration during handling, maintenance and storage.
In addition, the organization shall assess and record the validity of the previous measuring results when
the equipment is found not to conform to requirements. The organization shall take appropriate action on
the equipment and any product affected.
Records of the results of calibration and verification shall be maintained (see 4.2.4).
FDA
• Official MMI letter stating
SMV is “manufacturer
recommended best
practice”
• Part of Rosemount
Hygienic initiative
• FAQ developed
FDA FAQ for Sales
FAQ for FDA 21 CFR part 11
Recognition of Smart Meter Verification
Aug 2015
Tom O’Banion
1. How often do I run SMV?
It is suggested that SMV be run once per quarter during normal operation. After a new
meter is installed, it’s often useful to run SMV several times to get a good set of initial data.
2. How do I record keep?
The customer should create a Work Practice (SOP = Standard Operating Procedure) that
specifies the steps to run SMV, and generate a report (electronic, paper, or both) that can
be methodically filed by that meter’s tag number.
3. What are the steps to execute?
The specific steps to execute FDA-compliant SMV vary somewhat depending on whether
the user chooses to run the test via faceplate, handheld communicator, ProLink or an AMS
snap-on. Please see the appropriate transmitter manual, such as the 2700 shown below
http://www2.emersonprocess.com/site
admincenter/PM%20Micro%20Motion%
20Documents/2700-Analog-ConfigMMI-20019043.pdf
4. What does the FDA require?
21 CFR part 11 generically describes following “best practice” when it comes to calibration
or verifying the accuracy of the meter. Based on that, we’ve prepared a definitive set of
guidelines which follow the EPA GHG work done a few years ago. We’ve had very good
customer feedback and confirmation that as long as MMI has “irrefutable, engineering /
test based proof” that SMV assures meter accuracy, it is FDA-compliant. FDA as such does
not offer “approvals” but publishes guidelines and requirements which customers and
vendors are expected to follow. Here is MMI’s letter. You may find this as document #GI
002000 Rev A:
Document # GI
002000 Rev A
FAQ Excerpts

Add SMV to SOP

Run SMV once per
quarter and file report

Share in conjunction
with SMV and Zero
Verification Tool
videos

Ask probing questions
about current work
practices, cost of
calibration, etc.

Meters with 800 ECP
can be easily
upgraded to SMV in
the field

When quoting a
project, use the entire
portfolio based on a)
hygienic approvals, b)
need for hygienic
flanges, and c) SMV
availability (e.g. Tseries is not yet SMV
enabled)
Remember, Only Micro Motion Offers a True Verification
Method for Coriolis: Easy, Fast, While the meter continues
to operate





Full flow meter check: tests sensor components, tube stiffness, electronics, and
wiring
– Compares performance and repeatability to the day meter was calibrated
– Loop-back checks of electronics and signal processing to ensure total
system is functioning correctly
Immediate results: no need to trend and interpret results
Convenient: Test can be done with several interfaces and can be scheduled
Safe and Easy: Does not take meter out of the line or stop the process
Fast: Test only take 90 seconds
Internal/External
Requirements
• SMV provides traceable reporting
Difficult Processes
• SMV tracks meter changes to gain confidence
in Flow Calibration Factor
Installation Effects
• Coriolis meters do not require flow
conditioning
Meter Degradation
• Coriolis has no moving parts
SMV YouTube video
Smart Meter Verification video:
https://www.youtube.com/watch?v=Kmp7eZaF3KM
Zero Verification video:
https://www.youtube.com/watch?v=dY_ENuE1H1k
SMV & AMS
Additional Benefits w/ AMS & Prolink

Enables complete test traceability
– Captures meter identification, configuration,
and fingerprint
– Test conditions recorded for user, date, time
and process conditions

Scheduling
– Test automatically runs on user defined
interval
– Print or Save a Report of Results
SMV Test via Prolink
SMV Report
Meter Verification
SNAP-ON
Launch Meter Verification From Device
Menu
Reading Sensor Information
Enter Test Information
Start Meter Verification Test
Alternate
Older transmitters
may have limited
options for Output
Behavior
Running Test Progress
Saving Meter Verification Data
Test Results are Displayed
Click Next for Detailed Results
Display or Print Full Report
Results Documented in Audit Trail
Meter Verification
Scheduler
Launch Scheduler From Tools Menu
Enter Optional Information
Report Settings
Tester Information
Email Settings
Add Task
Set Task Properties and Frequency
Task Is Now Scheduled
Example AMS.OPCServer Data
What To Look For

enable_meter_verification
– Provides the current meter verification test state
– 0 = idle, disabled, abort
– 1 = normal verification (seen when hold last
measurement or fault is selected)
– 6 = background meter verification (seen when
continue measurement is selected)

device_specific_status_4
– Provides meter verification test status
– 0 = None, pass
– 1 = A032, meter verification in progress, output fixed
Committed to
solving your
toughest
challenges