QAL3 methods for different measurement principles from

the point of view of AMS manufacturers, test houses and

plant operators

Mr. Guido Baum

TÜV Rheinland Energie und Umwelt GmbH
Am Grauen Stein, 51105 Cologne
Germany
Phone: +49 221 806 2592
[email protected]
www.qal1.de

1 TÜV Rheinland Energie und Umwelt GmbH

Legislative context

Standard EN 14181 states the requirement of using suitability-tested AMS for

monitoring official limit values

The following Quality Assurance Levels are listed in Standard EN 14181:

- QAL1 (Performance test)

- QAL2 (Installation, calibration)
- QAL3 (Ongoing device check during operation)
- AST (Functional test)

First Europe-wide certification procedure for automated

measuring systems through implementation of QAL1 according to
EN 14181 (prior legislation comprised only directives at national
levels in some European countries)

2 03/04/2013 Presentation TÜV Rheinland

EN 14181 – QA Levels for Monitoring

Set - up
Suitability of QA during
Calibration
AMS Operation
Validation

QAL 3

QAL 1 QAL 2
Annual
Surveillance
Test

3 03/04/2013 Presentation TÜV Rheinland

EN 14181 – Context with other Standards

EN 14181
QA AMS

QAL 1 QAL 2 QAL 3 AST

ISO Type SRM Records / SRM

14956 Approval and Charts
Certification EN xyz EN xyz
EN 15267
Strategy Strategy
EN 15259 EN 15259
EN 15267

4 4
03/04/2013 Presentation TÜVTÜV Rheinland Energie und Umwelt GmbH
Rheinland
EN 14181 – Quality Assurance Level 1 - QAL1

QAL1 = Performance test (Type approval procedure + Audit of manufacturer‘s

QM system)

Concerned are:

The instrument manufacturer and the test house for the actual performance of
type approval procedures, as well as

Plant operators, due to their obligation to employ suitability-tested AMS for
monitoring limit values.

Performance criteria for testing emission measuring system are specified in

the EN 15267 directive series.

In Germany, a notification in the Federal Gazette is required.

A passed performance test according to EN 15267 is prerequisite for the
implementation of automated measuring systems.

5 03/04/2013 Presentation TÜV Rheinland

EN 14181 – Quality Assurance Level 2 - QAL2

QAL2 = Calibration of automated measuring systems

Concerned are: Plant operators and test houses accredited according to § 26
of the Federal Immission Control Act (BImSchG)

The implementation of QAL2 procedures ensures that AMS in operation at

plants provide measurement data of sufficient quality.

 QAL2 procedures comprise:

- Installation of AMS
- Functional test within the scope of QAL2
- Calibration of the AMS by means of paired measurements with a standard
reference method (SRM)
- Determination of the validity range of the calibration curve
- Determination of the variability of the AMS and verification of compliance
with the specified uncertainty
- Report.

6 03/04/2013 Presentation TÜV Rheinland

EN 14181 QAL2 – Frequency of performance

QAL2 shall be A calibration is also

performed: necessary, if:

 At least every 5 years  The values measured are

 At shorter intervals, if frequently outside the range of
stipulated by other legal validity of the calibration curve
requirements  The operating conditions of the
 At shorter intervals, if indicated plant undergo significant changes
in the notification of approval  Any changes or repairs which will
affect the results obtained are
made to the AMS or any of its parts
 The AMS did not pass the AST

A period of max. 6 months is specified for the execution and

implementation of QAL2 (Process concluded by report of competent
authorities).

7 03/04/2013 Presentation TÜV Rheinland

EN 14181 – Quality Assurance Level 3 – QAL3

QAL3 = ongoing quality assurance during operation

Concerned are: Plant operators or contractors commissioned to perform
maintenance works

QAL3 is a procedure designed for maintaining and demonstrating the

quality of the AMS results during ongoing operation.

The requirements for execution of QAL3 tasks are specified in the performance
test report:
• Frequency of performance of QAL3 is defined by maintenance interval
• Technical specifications for QAL3 implementation methodology are stated
in both performance test report and manual
• The necessary equipment for execution of QAL3 (e.g. reference and
auxiliary materials) is described in the performance test report. Device-
specific test materials are part of the suitability-tested AMS.
8 03/04/2013 Presentation TÜV Rheinland
EN 14181 QAL3 – Role of plant owners

 Frequent drift checks at zero and span point

 Interval is based on the maintenance interval determined during the suitability
test procedure (QAL1)
 Suitable test equipment necessary
 service can delegated e.g. to field service of analyser manufacturers
(responsible is the plant owner)
 Plant staff needs to be trained
 Responsibility needs to be defined in the quality management system of the
plant operator
 Necessary actions in case of significant drift effects needs to be defined:
- Analyser adjustment
- Analyser repair

9 03/04/2013 Presentation TÜV Rheinland

EN 14181 QAL3 – Documentation at site

Control charts

Follow- up sheet

Responsibility / Qualification staff

Process instruction for calibration and check

Reports on checks, calibration and interventions

Compliance with valid calibration range

Ongoing Driftcheck (≥ during maintenance interval)

10 03/04/2013 Presentation TÜV Rheinland

EN 14181 QAL3 – Aims and methods

The EN 14181 QAL3 procedure serves the purpose of ensuring and

demonstrating the quality of the AMS through regular drift and precision
checks.

Drift and precision controls shall be achieved by the use of control charts:

Shewart control charts or CUSUM control charts, manual evaluation is

permitted in exceptional cases

11 03/04/2013 Presentation TÜV Rheinland

EN 14181 QAL3 – Role of analyser manufacturers

 Manufacturer needs to deliver suitable analysers for the measuring task

 Test equipment for QAL3 tests (zero and span check) and for functional test
(AST) needs to be available for a QAL1 tested analyser

AST: zero standard and in minimum 3 to 4 over the range evenly spread
reference materials necessary
 For some analysers device-specific test equipment is required (e.g. for
particulate matter analysers)

Analyser manufacturer has to provide suitable test devices
 Test equipment has to be tested and qualified during the type approval
procedure (QAL1)

Development of test equipment is an important step in the development
of the analyser

Test equipment needs to be available at the beginning of the QAL1
certification process
12 03/04/2013 Presentation TÜV Rheinland
Test materials for performing QAL3

The manufacturer is obliged to carry out regular zero and span point checks as
part of QAL3 testing.
Critical components for QAL3:
Gaseous components:
When testing components H2O, HCl, HF, NH3 and Hg, the production of test
gas through evaporation of appropriate test solutions is necessary for some
AMS.
• Plant operators often have no test gas generator and commission the
manufacturers to perform the checks as part of maintenance works
• The application of wet test gases is performed with the same method used
for dry test gases, i.e. feeding the gases over the entire sampling system.
• Condensations of test gas behind the evaporator must be avoided in any
case. If necessary, the gas supply line to the sampling probe shall be
heated.

13 03/04/2013 Presentation TÜV Rheinland

Test materials for performing QAL3

Different AMS require device-specific test materials.

Dust measuring systems:
• Reference materials for zero and span point checks, e.g. grey glass filters,
grid filters or scattered light bodies for optical measurement methods, test
standards for simulation of the span point in triboelectric measuring
devices.
• Auxiliary materials for zero and span point checks, e.g. mounting racks
and zero tubes
In-situ measuring systems:
• External measuring cells are requisite for testing gas analysers. If
necessary, these shall be heated

The test materials used for QAL3 must undergo testing as part of the
performance test of the AMS followed by a notification of their
suitability.
14 03/04/2013 Presentation TÜV Rheinland
EN 14181 QAL3 – Role of test institutes

At the customer site:

 Check the necessary documentation during the annual functional test (AST)

Documentation of drift checks, „History of AMS“, Training…
 Test institutes need suitable test equipment to perform AST

During the type approval:

 Qualification of device-specific test equipment during the type approval
procedure

Suitability during the laboratory and field test

Stability during the field test

Comparison with other standards

Description of the procedure for conducting functional tests in
QAL1 report

List of the necessary test and auxiliary materials

15 03/04/2013 Presentation TÜV Rheinland

Terminology: Complete measuring system

The terminology of Directive EN 15267 states that only a complete

measuring system and not just the analyser can apply for certification. A
complete measuring system consists of:

Analyser unit (may be integrated in the measurement cabinet)

Sample gas processing equipment comprising sampling probe, solid filtering
device, sampling line, gas conditioning device / gas drying device

Measurement data processing and output unit

Suitability-tested software version

Technical documentation, manual

If required, test materials for performing AST and QAL3 according to EN
14181

Performance test report / Certificate

“History of the AMS” after installation: maintenance log, QAL3 records

16 03/04/2013 Presentation TÜV Rheinland

List of suitability tested analysers:

• The German approach:

EN 15267 certificate issued by TÜV and the UBA. In order to be EN 15267
compliant, the “German” certificate is issued by both UBA (representing LAI
as relevant body) and TÜV. Certificates are published on www.qal1.de
 Status: Implemented

• The MCERTS approach:

UKAS accredited certificate issued by a “certification body” (Sira) and
accepted by the Environment Agency. Certificates are published on
www.siraenvironmental.com or
www.mcerts.net  Status: Implemented

17 03/04/2013 Presentation TÜV Rheinland

Summary

• Production and distribution of measuring systems in

technical conformity with the type approved version
Instrument (hardware / software).
manufacturer: • Development of suitable (device-specific) test equipment
for QAL3 and AST

• Performance, evaluation and documentation of QAL3

tests
Plant operator: • Qualification of the operator staff by training
• Fix responsibilities and implement necessary actions for
QAL3 procedure

• Check of the QAL3 documentation and “analyser history”

of the plant owner during the annual AST
• Use of suitable, device specific reference materials and
Test institute: test procedures
• Qualification of QAL3 procedures and materials during
the type approval

18 03/04/2013 Presentation TÜV Rheinland

 Thank you for your
kind

attention

19 TÜV Rheinland Energie und Umwelt GmbH