technical description - krohne

CALSYS® / AMADAS

TECHNICAL DESCRIPTION

CALSYS / AMADAS – r1509 Technical Description of 29

1 INTRODUCTION ................................................................................................................................................... 3

1.1 ACRONYMS AND DEFINITIONS .................................................................................................................................... 4

2 TECHNICAL SPECIFICATION ................................................................................................................................. 5

2.1 INTRODUCTION ........................................................................................................................................................ 5 2.2 SYSTEM ARCHITECTURE AND DESIGN CONSIDERATIONS .................................................................................................... 5

2.2.1 Architecture ................................................................................................................................................ 5 2.2.2 Integration with DCS ................................................................................................................................... 6 2.2.3 Network printers ......................................................................................................................................... 6 2.2.4 Validation Procedures ................................................................................................................................. 6 2.2.5 Statistical tests ............................................................................................................................................ 6 2.2.6 Training & guidance .................................................................................................................................... 7

2.3 BACK GROUNDS ON CALSYS® & ANALYZER MANAGEMENT .............................................................................................. 8

2.3.1 History ......................................................................................................................................................... 8 2.3.2 Automatic versus manual validation .......................................................................................................... 9 2.3.3 Automatic recording ................................................................................................................................... 9 2.3.4 Statistics and reports .................................................................................................................................. 9 2.3.5 Validation principles ................................................................................................................................. 10 2.3.6 Lab Data .................................................................................................................................................... 11 2.3.7 Design AMADAS: The software ................................................................................................................. 11 2.3.8 What is the purpose of CALSYS

®? .............................................................................................................. 11

2.3.9 Some history on CALSYS® .......................................................................................................................... 12

2.3.10 What templates are available? ................................................................................................................. 12 2.3.11 Various ways CALSYS

® may be operated ................................................................................................... 14

2.3.12 Security in CALSYS® ................................................................................................................................... 14

2.3.13 Instrument Data Sheets ............................................................................................................................ 15 2.3.14 Instrument Validation ............................................................................................................................... 15 2.3.15 Example procedures for CALSYS

® for Quality Control ............................................................................... 16

2.3.16 Example procedures for CALSYS® for Metering: ....................................................................................... 17

2.3.17 Test Equipment ......................................................................................................................................... 18 2.3.18 Witnesses .................................................................................................................................................. 18 2.3.19 Statistical Process Control ......................................................................................................................... 18 2.3.20 Significance Testing ................................................................................................................................... 21 2.3.21 Time-related Performance Indicators ....................................................................................................... 22 2.3.22 Dashboard ................................................................................................................................................. 24 2.3.23 Reporting Facilities .................................................................................................................................... 25 2.3.24 Instrument Maintenance .......................................................................................................................... 26 2.3.25 Scheduling Facility ..................................................................................................................................... 26 2.3.26 Configuration Process ............................................................................................................................... 27


1 INTRODUCTION

Based on the knowledge and expertise gained over the last 15 years our Analyzer Management and Data Acquisition System (CALSYS

® / AMADAS)

has evolved to a stable and mature performance monitoring, management and maintenance suite offering benefits in the field of

Analytical Performance

Analyzer Availability

Analyzer Maintainability

Predictive Maintenance

The AMADAS package is designed to be an open system based on Template/Binding technology in order to allow for easy implementation and flexible project expansion.

As designer and manufacturer of the AMADAS package we can offer extensive customization of the system to meet special and specific requirements. We are independent from any brand of analyzer which allows us to incorporate a variety of critical on-line analyzers and process instrumentation without restriction and to interface with other plant-wide systems in a flexible and robust way.

The AMADAS package, based on our CALSYS® quality management suite, is using the latest state-of–the-art

technology with web-enabling and virtualization technologies for transparency on key performance indicators like analytical performance, availability and maintainability in compliance with the ASTM D 3764 and ASTM D 6299 international standards and reports. Future requirements for additional data management and extended information exchange can be easily implemented.

We believe that the offered technology and project approach will give you a system of the highest quality level with easy implementation at site. We would like to highlight the importance of KROHNE Oil & Gas being a partner with a professional service organization with local and regional support that guarantees the required services throughout the entire product and project lifecycle.


1.1 ACRONYMS AND DEFINITIONS

ALDT Administrative and Logistics Down Time

AMADAS Analyser Management and Data Acquisition System

ASTM American Society for Testing and Materials

DCOM Distributed Component Object Model

DCS Distributed Control Systems

ERP Enterprise Resource Planning

GC Gas Chromatograph

HMI Human Machine Interface

ISO International Organization for Standardization

KOG KROHNE Oil & Gas B.V

LCL Lower Control Limit

LIMS Laboratory Information Management System

LWL Lower Warning Limit

MDT Mean Down Time

MTBM Mean Time Between Maintenance

MTBR Mean Time Between Failure

MTTF Mean Time To Failure

MTTR Mean Time To Repair

ODBC Open Database Connectivity

OIML International Organization of Legal Metrology

OLE Object Linking and Embedding

OPC OLE for Process Control

QMI Quality Measurement Instrument

RTU Remote Terminal Unit

SPC Statistical Process Control

SQL Structured Query Language

TCP Transmission Control Protocol

UCL Upper Control Limit

UWL Upper Warning Limit


2 TECHNICAL SPECIFICATIONS

2.1 INTRODUCTION

The AMADAS system is based on the KROHNE Oil & Gas CALSYS

® software suite and will run

on an AMADAS server with connection to any number of workstations. Communication with DCS and/or other systems is preferably by OPC, Modbus/TCP or Modbus/RTU.

CALSYS® is a full-distributed Analyzer

Management and Data Acquisition System, developed by KOG to optimize plant operation and determine uncertainty for traceable systems such as ISO 9000 and OIML. It has the possibilities to be connected to other (remote) systems using open communication links such as TCP/IP, SQL and OPC.

CALSYS® is able to validate a wide variety of analyzers and instruments. Once an analyzer or instrument is

validated CALSYS® will evaluate and register the results using statistical and/or client-preferred rules as per

ASTM D 3764 and ASTM D 6299 international standards.

CALSYS® offers the possibility to perform fully automatic, semi-automatic and manual or a combination of

automatic, semi- and manual validation sequences.

The AMADAS package is designed to be an open system based on Template/Binding technology in order to allow for easy implementation and flexible project expansion.

We can ensure you that our proposal complies with related project specifications and our solution will deliver a reliable and field proven solution with the best performance for the applicable Analyzer Maintenance and Data Acquisition System to allow for smooth implementation.

As designer and manufacturer of the AMADAS package we can offer extensive customization of the system to meet special and specific requirements. We are independent from any brand of analyzer which allows us to incorporate a variety of critical on-line analyzers and process instrumentation without restriction and to interface with other plant-wide systems in a flexible and robust way.

2.2 SYSTEM ARCHITECTURE AND DESIGN CONSIDERATIONS

2.2.1 Architecture

The system is easy to operate and very open to interface with other systems. We have virtually interfaced with any make of DCS system available on the market today and established the highest possible degree of integration with these systems.

Our system philosophy has been to use a modular, scalable and configurable design featuring standard building/function blocks and object oriented software modules.

As designer and manufacturer of the package we can offer extensive customization of the package to meet special and specific requirements. We are independent of any brand of analyzer and this allows us to

Analyzer Management System


incorporate all types of analyzer assets and detectors without restriction and to connect to other systems (LIMS, PI, DCS, ERP etc.) in a flexible and robust way.

The CALSYS® system is based on the Microsoft Windows Server operating system. A fast-integrated SQL server

allows quick access to any information in the relational database.

The proposed system can easily interface and communicate with other systems. All main open system standards such as SQL, ODBC, TCP/IP, Active-X, DCOM, MODBUS, OPC etc. are supported.

2.2.2 Integration with DCS

In order to communicate with the DCS, CALSYS® will provide a gateway to DCS. Validation data essential for the

CALSYS® system will be made available by DCS via the OPC link or via the analyzer network. During the design

phase exact data required will be defined. Validation will be possible after the DCS sends a permissive signal. Validation is also possible from DCS.

2.2.3 Network printers

The CALSYS® server will use one (1) network laser printer for reporting tasks and optionally one (1) matrix

printer for alarm and events.

Additionally, a CALSYS® workstation can be equipped with a laser printer per workstation for reporting tasks.

2.2.4 Validation Procedures

Validation starts by sending a permissive signal to the DCS, when an acknowledgement is received by the CALSYS

® server the validation sequence can be activated.

The regular internationally specified (ASTM D3764) validation procedures are supported. During the general design phase we will assess the detailed requirements on validation procedures and evaluation methods. This will be based on our standard templates where we can tune on customer requirements.

2.2.5 Statistical tests

Within CALSYS® there are several statistical tests implemented we also support the ASTM-D3764 for reference

sample method evaluation. This method is implemented with a deviation from the original; this deviation is related to what is adapted to be common practice with petro-chemical industries. The deviation is based on


the fact that reference sample now a days is bought from third parties and it is not produced on the plant itself. The total procedure how to produce the reference sample is not implemented within CALSYS

®.

All available tests are stated within our background information.

2.2.6 Training & guidance

When supplying a CALSYS® system we deem necessary to be closely involved in commissioning, start-up as well as

training of your engineers. After or during implementation of the system KOG proposes to train the engineers who will use the system. This training will guarantee smooth, easy introduction and optimal use of the CALSYS

®

system. Training is therefore included in the proposal. The training will be based on our standard training program but is tailored to the actual system.


2.3 BACK GROUNDS ON CALSYS® & ANALYZER MANAGEMENT

2.3.1 History

Traditionally, calibration of analyzers and instruments used to be regarded of little importance. After installation of an analyzer/instrument it was assumed that the analyzer/instrument was and stayed good and readings of an instrument were actually regarded as true values, even if the equipment has not been validated for a length of time.

Based on data and overviews that are generated by CALSYS® this situation has rapidly changed. CALSYS

®

enhances audibility & traceability, brings process optimization and cost saving.

Beside this and due to the influence of government and/or management, improved quality assurance and increased competition, the need for validation is increasingly understood.

Validation procedures can be manual and then results are written down on forms, archived in a folder for later reference. Not only this is labor intensive but the variation and errors due to human intervention learned that this method had a limited or even poor repeatability and audibility.

Therefore the logical next step was evidently to store data automatically into a computer as this is much more efficient and reduces the human errors. Once the data is collected in a central database it can easily be processed to generate reports and overview and graphs using statistical rules such as:

Failure analysis: by correlating previous and current calibration results, it can be deduced when the equipment has gone out of tolerance.

Reliability: measurements may prove that certain analyzers or type of analyzers have to be readjusted over and over again

Calibration periods: From historical measurements it may appear that calibrations & validations have to be performed less or more often.

Trend analysis: With this it may be checked whether an analyzer suffers from drift.

The main purposes of an Analyzer Management System are the following:

Collection of validation results

Automatic, semi-automatic manual recording

Statistical evaluation and reporting

Maintaining historical data (e.g. for maintenance)

Interfacing with other open systems such as LIMS, DCS etc.

Fault and bad actor finding

Uncertainty and traceability (ISO9000) evaluation

Quality release and blending applications


Although automatic or semi-automatic validation is not always possible, as stated above one of the problems that occur in manual validation is the introduction of human errors. Two typical errors are:

Deviation in the procedures; manual versus automatic validation

Error in manual calculations and entry/storing of data; automatic recording

2.3.2 Automatic versus manual validation

Although operators and instrumentation & maintenance engineers are trained to deal with validation procedures in an identical the actual execution will differ from person to person. Further as time passes by mistakes or habits might creep in, specifically with deviations of the routine business.

To prevent deviations, CALSYS® helps assists an engineer during a validation by guiding him through predefined

procedure step by step and by performing calculations (and conversions) as well as data collection automatically. This is called semi-automatic. With CALSYS

® it is also possible to perform a calibration fully

automatic, e.g. independent form human intervention. The system allows to directly controlling the calibration process (e.g. Valves etc. in sample conditioning system etc.) and reading the analyzer data. A calibration can then be performed periodically or can be started by an operator, for instance from a DCS system. Especially within new build plants or total revamps this method is most preferred.

2.3.3 Automatic recording

An Analyzer Management System as CALSYS® is as good as the data it records. With a system where all data or

collected manually and then typed in a computer, many possible error sources exist, such as mistakes during writing, reading or typing.

More importantly however people who do not have a direct advantage in doing so must enter data. In such cases it is quite common that this will be done less accurate to not at all whilst there are indeed more pressing things to be done!

Automatic data collection is therefore paramount to manual input of data; it will reduce the fast majority of common known errors to naught.

2.3.4 Statistics and reports

An important aspect of CALSYS® is the generation statistics overviews and reports.

Statistics are used to determine and predict the performance of an analyzer. With the use of the CALSYS®

statistical data one is able to conclude/predict:

how good is this analyzer,

direct or scheduled maintenance required

was the analyzer in specs during a certain period or not,

time related statistics such as the availability, the MTBF, MTTR etc,

analyzer uncertainty within set limits,

total system uncertainty within set limit

Besides fixed statistical reports, often a specific evaluation will be needed during the search for errors.


Clearly an analyzer or instrument must be adjusted when a validation result is out of its control limits. There are however also criteria, such as laid down in the ASTM D 3764, which determine when a validation must be regarded as unreliable, or not, on grounds of statistical data. For instance adjustments should be made when validation results show a trend in going into alarm limits soon. Also adjustments should be made if all validation results lay consistently on one side of the norm. In order to do so, historical data are needed.

CALSYS® takes these criteria into consideration, such that after a validation correct advice can be given. A

Statistical Control Chart can be requested/configured to get a good insight of the history of an analyzer.

2.3.5 Validation principles

CALSYS

® predominant starts where a lot of validations and calibrations & validations needed to be done, and/or

traceability is required, and or extended uncertainty evaluation is required (as in custody transfer). Some examples are given:

a) Semi-automatic

Automating the data collection, is semi-automatic, will not only result in cost saving but will also reduce the number of errors as stated earlier.

Depending on the metering system configuration the results of this can be a drastic gain in time.

This can be in the order of a factor five times with respect to manual validation. Automatic collected results will be stored in the CALSYS

® database immediately and can be presented in control charts in a simple manner.

Problems in instruments, that otherwise could not have been found easily, are detected immediately.

b) Manual

Sometimes it is not possible or may not be cost effective to install a semi- or automatic validation system. In these cases a manual validation system will have to be applied. A manual validation system comprises mobile calibration equipment and/or optional workstation computers. The system runs on a laptop PC with which a service engineer travels to different measurement stations. The system is completely manual and assists the user by predefined procedures. These procedures will guide the user step by step through the validation.

After the data has been entered into the system the necessary calculations are performed and the next step is presented. At the end of the validation of all instruments and/or analyzers a total systems calculation and evaluation is performed and presented to the user. The readings and evaluation data are stored on a hard disk and can be copied to a central database for further evaluation.

c) Automatic

In an automatic validation the reference media or signal is fed to the analyzer/instrument by controlling the sample valves and/or reference source automatically. This is mostly done through DCS. The validation procedures are all embedded in CALSYS

® where they can be maintained in a simple manner.


2.3.6 Lab Data

Via a CALSYS® lab workstation lab results can be entered and stored in the CALSYS

® relational database.

2.3.7 Design AMADAS: The software

The hart of the CALSYS® systems the server computer through which validations is automatically. Per type of

analyzer a Script exists which describes and performs the validation. A script is written in a specially designed language, a very complete Basic with special statements, for analyzer’s management. Scripts can run at the same time, allowing validations to run in parallel.

CALSYS® is fully distributed and software modules may run on different computers that are connected to the

network. CALSYS® is modular and offer seamless integration for future workstation, such as a laboratory and

maintenance shop workstation.

CALSYS® has standard reports for statistics and availability and offers the user the capability to create his own

reports. Such as:

Periodic status report

Periodic performance reports

Analyzer logs

Outstanding validation reports

Alarm summary report

2.3.8 What is the purpose of CALSYS®?

CALSYS® is a software-based Analyzer Management System, which is designed to monitor, check and trend all

kinds of measuring equipment. Such equipment ranges from a simple transmitter up to a complex analyzer system, that is capable of measuring multiple streams and has one or more sample conditioning and recovery systems.

CALSYS® is a general-purpose product, which can be used to manage any kind of measurement equipment and

serves a wide variety of applications, such as processing, metering and blending applications.

The software is flexible, powerful and fully user-configurable and is scaleable by its modular nature.

Core functions of CALSYS® are:

Validating analyzers and instruments , manual, semi-automatic and fully automatic

Statistical Evaluation of validation results

Monitoring the operational state of the equipment

Performing time-rated statistics (availability, failure rates, etc.)

CALSYS® will bring you the following benefits:

Tool to draw the attention to the excellent and bad performers

Automate routine work, such as processing validation results and time-related performance indicators

Tool to optimize your analyzers and therefore your production process

Start small, and grow as you like, to a fully automated analyzer management system


2.3.9 Some history on CALSYS®

Over the years KOG has been involved in several studies dealing with analyzer management for refineries and chemical plants as well as remote, unmanned, gas and oil metering systems.

CALSYS® was first developed for manual validations of instruments and analyzers on natural gas metering

systems. This system provides guided assistance, manual data entry and automated reporting facilities covering a complete metering site. All data was stored in a local (portable) database and facilities were there to transfer data to a central database, covering the data of many metering systems throughout the country.

CALSYS® was further developed to handle the validation and performance monitoring of critical analyzers in a

refinery. The system provides facilities for fully automated validations for various types of analyzers. Validations are performed upon commands given via a DCS and analyzers are controlled via a data highway. The system is in continuous contact with the analyzers via both the data highway and the DCS allowing automated data gathering and continuous monitoring.

2.3.10 What templates are available?

Below is a list of all templates available in the demonstration, one table for application area CALSYS® for Quality

Control and one table for CALSYS® for Metering:

Type Template Description

Data Sheet Analyzer Data Sheet Instrument Data Sheet for single measurement analyzers

GC Data Sheet Instrument Data Sheet for analyzers measuring various properties, such as gas chromatographs

Validation Automatic Validation Automatic Validation of non-smart analyzers

GC Automatic Validation Automatic Validation of gas chromatographs

Semi-Automatic Validation Semi-Automatic Validation of non-smart analyzers

GC Semi-Automatic Validation Semi-Automatic Validation of gas chromatographs

Manual Validation Manual Validation of non-smart analyzers

Line Sample Validation Line Sample Validation, manual entry

Reference Measurement Validation Comparing the on-line analyzer with a certified analyzer

Gas Detector Validation Gas Detector Validation, based upon Timed Response

SPC Single Unit Control Chart Control Chart for 'one-reading' validations

Control Chart for Mean Control Chart for 'multi-reading' validations

Control Chart for the Standard Deviation Control Chart for checking instrument variance

Control Chart for the Range Control Chart for checking instrument variance

Historical Chart Long term overview of the analyzer

Significance Non-randomness Test Checks whether data set is randomly distributed

Testing Normal Distribution Test Normal Distribution Test , based upon Shapiro-Wilk

Test on Reproducibility Rate Checks whether WL does not significantly deviate from 95%

One sample t-test Test on systematic errors

One sample F-test Comparison of actual data set against historical deviation

ASTM-E178 Test on Outliers Test on outliers, based upon 'Studentized extreme deviate' test

Dixon's Test on Outliers Check on outliers for extreme values

Availability Operational State Table Viewing and automatic storage of instrument state changes

Reporting Single Validation Report Results from a single validation

Control Chart Report Report with Control Charts and their decision rules

Availability Report Report with Time-related Performance Indicators

Analyzer based Schedule Report View all schedules of a particular analyzer

User based Schedule Report View all validation schedules per user, per time window

Significance Test Report Report with benchmarking results

Historical Overview Report Report with Historical Chart and Maintenance information

Table 1: Templates available for CALSYS® for Quality Control


Type Template Description

Data Sheet Instrument Data Sheet Instrument Data Sheet for metering instrumentation

Orifice Instrument Data Sheet for orifice plate

Reference Bottle Instrument Data Sheet for reference bottles

Test Equipment Instrument Data Sheet for test equipment used for validating the metering instrumentation

Validation Density Validation Semi-automatic validation of density transducers

dP Transmitter Validation Semi-automatic validation of dP transmitters

Pressure Transmitter Validation Semi-automatic validation of pressure transmitters

Temperature Element Validation Semi-automatic validation of temperature elements

Gas Chromatograph Validation Semi-automatic validation of gas chromatographs

Orifice Inspection Manual inspection of orifice plate

ISO 5167 Check ISO-5167 calculation check of flow computer

Integration Check Flow computer integration check of mass totalizer

Error Evaluation Overall metering error evaluation

Calibration P-DP calibration Calibration procedure for Pressure and dP transmitters

Temperature Element Calibration Calibration procedure for Temperature elements

Session GC Session Session definition for gas chromatograph (common header)

Run Session Session definition for meter run

Reporting Density Validation Report Report of validation results per density transducer

DP Validation Report Report of validation results per dP cell

Pressure Validation Report Report of validation results per pressure transmitter

Temperature Validation Report Report of validation results per temperature element

GC Validation Report Report of validation results for gas chromatograph

Field Inspection Report Field Inspection Report for visual inspection

Orifice Inspection Report Report of validation results for orifice inspection

ISO 5167 Calculation ISO 5167 Calculation check report

Integration Check Report Report containing results of integration check

Error Evaluation Overall meter run error evaluation

Table 2: Templates available for CALSYS® for Metering


2.3.11 Various ways CALSYS® may be operated

The CALSYS® software may be operated in various ways, depending on the needs:

1. Using the CALSYS® Task Manager

This is the default interface for operating the CALSYS® product. It has the same look-and-feel as the

Windows Explorer. The Task Manager can be used by all different types of users for all kind of operations such as executing validations, printing reports, changing parameters, etc.

2. Using the Session Manager The Session Manager is used to group instrumentation. In fiscal metering systems, sets of instruments can be grouped and form a so-called fiscal point. In order to determine whether a fiscal point is performing within agreed limits, all the individual analyzers and instruments that are part of the fiscal point must be validated in a pre-defined order and within a limited period of time.

3. Using a dedicated third-party HMI application A dedicated third Human Machine Interface (HMI) application may be used in case of a fully automated and integrated CALSYS

® system, to view instrument live data, to show analyzer status information, to make

use of sophisticated HMI trending and alarming features. It offers very easy access to most CALSYS®

functions. HMI applications are usually tailor-made to customer needs. CALSYS

® uses the OPC Data Access standard for real-time data exchange. OPC stands OLE for Process

Control and is one of the first world-wide accepted standards for real-time data exchange. The CALSYS®

OPC servers support both version 1.0 and version 2.0. The OPC clients support version 2.0

2.3.12 Security in CALSYS®

Access to the CALSYS® software depends on the User groups that a user belongs to. For example, in the project

the following user groups have been defined:

1. QMI Maintenance Users that belong to this user group can perform daily activities like executing validations, reporting, validation scheduling, enter maintenance activities, etc.

2. Laboratory The laboratory personnel use the system to enter lab analyses performed on line samples, or reference samples when the ASTM-D3764 standard is in place.

3. Plant Management Plant Management access the system for overall plant or unit based reporting

4. System Engineering Users of this group may perform maintenance to the CALSYS

® system, like changing report templates

or adding new analyzers. Should not be used for daily operation

Note that the groups above are examples; additional user groups may be defined when required.


2.3.13 Instrument Data Sheets

An instrument data sheet contains the specifications of a particular device. It defines general information (such as the brand and model, the serial number and the tag number) and, in case of an analyzer, information about the analyzer stream and components. By means of data sheets you can archive all your analyzer and equipment data. Datasheet information can be printed out as such or can be used in reports, e.g. validation or availability reports. Parameter values part of a datasheet can be used for calculations or for another purpose.

2.3.14 Instrument Validation

A validation procedure is a sequence of activities to validate the performance of a particular instrument, such as an analyzer or a transmitter. A procedure consists of a number of steps, which are executed one after the other.

Several validation methods can be applied, such as the reference sample, the reference measurement and the line sample method. In general the analyzer reading is compared to a set of reference values. By means of a particular evaluation method it is decided whether or not the analyzer is still performing within specifications or not. If the analyzer performs incorrectly, then it requires calibration (adjustment).

CALSYS® allows all kinds of procedures. Depending on the level of automation one can distinguish manual,

semi-automatic and automatic procedures.

CALSYS® allows you to define procedures for the following validation methods:

1. Reference sample method A predefined reference sample is supplied to the analyzer and one or more readings are taken and compared with the reference value(s).

2. Line sample method A sample is taken from the process (very near to the analyzer) and at the same time the analyzer reading is recorded. The line sample is analyzed in the lab and afterwards compared with the measured value.

3. Reference measurement method A portable analyzer is temporarily lined up in series with the on-line analyzer, and the reading of the on-line analyzer is compared with the reading of the portable analyzer.

4. Response time method This validation method is used when response time is more important than accuracy (e.g. for gas detectors). A certain reference medium is applied and the time to reach a certain response is measured and checked against the maximum allowed time.

5. Timed response method Basically similar to the Response time method, except the response after a predefined amount of time is measured and compared against the minimum response value.

6. Any other type … Any other validation method can be defined. A new procedure may be defined from scratch or may be based on one of the standard or user-defined templates. You can add new methods to the list of standard methods.


2.3.15 Example procedures for CALSYS® for Quality Control

Below a short description of the validation procedures that are available in the CALSYS® for the application area

for Quality Control:

Automatic Validation of non-smart analyzers Non-smart analyzers usually have a 4-20 mA output to retrieve the QMI reading, and in some cases a common alarm signal for analyzer fault indication. Automatic validation may be performed using a reference valve present in the sample conditioning system. CALSYS

® switches this valve to the

reference when a validation is performed, and retrieves a number of readings, taking into account the analyzer lag time. It is possible to include flow alarm and valve indication signals in the validation procedure.

Semi-Automatic Validation of non-smart analyzers In case a fully automatic validation is not possible, e.g. when the reference is not lined-up continuously or some kind of manual interaction is required at the analyzer, the semi-automatic validation may be used. The validation procedure is presented in a number of validation steps, which guides the QMI engineer through the validation. QMI readings are retrieved automatically from the analyzer upon acceptance from the QMI engineer.

Manual Validation of non-smart analyzers When there is no direct link or indirect link (e.g. via DCS), or semi-automatic validation is not practical, manual validation may be used. Manual validations may be executed after the 'real' validation has taken place, and may be combined with other manual validations that have been performed during the day.

Automatic validation of chromatographs Smart analyzers, such as gas and liquid chromatographs, control the validations themselves. CALSYS

®

will request the analyzer to switch to validation mode, retrieves a number of readings, and requests the chromatograph to switch back to the process stream. Automatic validations are available for different makes of chromatographs, including different applications such as chromatographs measuring water in the product.

Semi-Automatic Validation of chromatographs In case a fully automatic validation is not possible, e.g. when the reference is not lined-up continuously or some kind of manual interaction is required at the analyzer, the semi-automatic validation may be used. Dependent of the application, different instructions are shown to guide the QMI engineer through the validation. QMI readings are retrieved automatically from the analyzer upon acceptance from the QMI engineer

Line Sample Validation The Line Sample validation is commonly used to do spot checks on analyzers. The validation procedure is split up in two parts. The first part allows the QMI engineer to enter the value(s) from the analyzer that was retrieved at the moment the line sample was taken. After the samples have been analyzed in the lab, the lab results can be entered in the second part of the validation. The second part will also take care of the evaluation of the line samples.

Reference Measurement Validation In some cases where the reference sample method cannot be used (e.g. it is not possible to make a proper reference or the reference degrades too fast), the Reference Measurement Validation may be used. It is a automatic or manual validation procedure in which the analyzer QMI reading is compared with a reference analyzer that has been lined up in series with the on-line analyzer. QMI readings for the two analyzers may be retrieved automatically or have to be keyed in manually.

Gas Detector Validation This procedure is based upon the timed response method, in which the gas detector reading is compared with a reference value.


2.3.16 Example procedures for CALSYS® for Metering:

Below a short description of the validation procedures that are present in CALSYS® for the application area for

Metering Instrument Validation:

Density Transducer Validation In order to validate the densitometer, a vacuum pump is used. When the vacuum pump is started and near vacuum condition (approximately 30 Pascal) is reached, the corresponding frequency signal is compared with the value in the certificate and the validation of the densitometer is carried out.

Differential Pressure Transmitter Validation In order to validate the differential pressure transmitter, a dead weight tester is used. The dead weight tester will apply a pressure on the membrane of the transmitter. Putting different weights on the tester will result in predefined different pressure variations being applied to the membrane. All differential pressure transmitters are validated under line pressure conditions. During a validation, the values given by the transmitter (observed reading) are read through the flow computer and this is compared with the reference ‘weight value’ (reference reading). The test points will cover the following ranges of the differential pressure transmitter: 0%, 25%, 50%, 75% and 100% up validation, 110% overshoot, 100%, 75%, 50%, 25% and 0% down validation.

Pressure Transmitter Validation For the pressure transmitter also a dead weight tester is used. The dead weight tester will apply a pressure on the membrane of the transmitter. Putting different weights on the tester will result in predefined different pressure variations being applied to the membrane. The weights are certified and represent a certain pressure. During a validation, the values given by the transmitter (observed reading) are read through the flow computer and compared with the reference ‘weight value’ (reference reading). The test points will cover the following ranges of the Pressure transmitter: 0%, 25%, 50%, 75% and 100% up validation, 110% overshoot, 100%, 75%, 50%, 25% and 0% down validation

Temperature Element Validation A certified digital temperature probe is used for the validation of the temperature element. The temperature element that needs to be calibrated is taken out of the thermo-well and placed in a temperature controlled metal block. The certified temperature probe is also placed in the same metal block. During the validation, the values read by the transmitter are routed via the flow computer and are compared with the manually entered value indicated by the precision probe.

Gas Chromatograph Validation A bottle of calibration gas is required for the validation / calibration of the Gas Chromatograph. Up to 4 cycles are retrieved from the gc, and the averages are compared with the reference values. Also the repeatability of the readings is checked and verified against a limit.

Orifice Inspection The step-wise instruction report for carrying out the orifice plate inspection can be printed on request. The person who conducts the inspection follows these instructions and signs them off in the presence of a witness. The inspection is a manual activity where in the orifice plate is removed from the meter run and examined for any physical deformity. A log of date and time is written to the database to indicate when the inspection was carried out.

ISO 5167 calculation check Based on the inputs fed in, the flow computer will calculate the constant output flow based on the ISO 5167 calculation. This result will then be printed as a report along with the used inputs and parameters. The same ISO 5167 calculation is done in Supervisory computer off-line and included along with the same report generated.

Integration Check The totalizer integration is also carried out from the Supervisory computer. The start and end point for this validation is selected from the Supervisory computer. The totalizer integration period can be selected based on the cycle time of the flow computer. A snapshot of the flow computer totalizer data is logged twice, at the start and at the end of an interval. The total flow within the specified time


period is calculated. A validation script executed at the supervisory computer uses the logged data for exactly the same time period.

Error Evaluation The uncertainty of the flow rate measurement is calculated as per the ISO 5168 formula. The uncertainty factor represents the possible variations that are encountered in different instruments for the last validations. The total uncertainty factor combines all these variations. The overall meter run evaluation will be dependent on the combined uncertainty factor.

2.3.17 Test Equipment

Test equipment is equipment that is used to validate analyzers, such as a dead-weight tester, a temperature calibrator and a multi meter. In CALSYS

® you can define such equipment for any validation (and calibration)

procedure that uses a dialog to interact with the operator (i.e. a manual and a semi-automatic procedure).

Test equipment may have a related instrument datasheet, which contains the specifications of the equipment. If the test equipment has to be re-certified after a particular period, then the date at which the next re-certification has to be done might also be entered in the same datasheet.

A validation procedure may check for this date for all of the test equipment and decide to abort when one or more instruments are beyond their next re-certification date.

You can define test equipment in the application directory. Once test equipment is defined it can be selected for each new validation. This information is stored in the historical database and can be printed on the validation report.

2.3.18 Witnesses

Witnesses are persons who are present during the execution of a validation or calibration procedure. Usually one or more persons witness a validation session of a so-called fiscal point. Witnesses can be defined for manual and semi-automatic validation (and calibration) procedures.

2.3.19 Statistical Process Control

Why Statistical Process Control?

Evaluating the performance of your analyzer contributes to the control and improvement of the quality of your process.

"Quality control may generally be defined as a system that is used to maintain a desired level of quality in a product or service" [Mitra, 1993].

Statistical Process Control (SPC) plays an important role in this matter. SPC involves the comparison of the output of a process with a reference standard. In case the discrepancy between the output and the standard exceeds a specific limit, corrective actions are taken.

CALSYS® provides Control Charts and Historical Charts to evaluate the performance of an analyzer, or (to be

more precise) of any instrument, which previously has been validated.


Some background info on SPC

A Control Chart is a graphical SPC-method in which the outcome of an ongoing process is monitored. In combination with a number of Decision Rules, a Control Chart indicates whether an analyzer is performing in or out of specification.

The Variable to be checked by the Control Chart is free defined. It can e.g. be the validation mean and the validation standard deviation. The variable may be expressed relative to the reference value and relative to the span value. The Center line represents the reference value for the variable to be plotted.

A Control Chart checks a particular analyzer measurement against warning and control limits to evaluate the performance of the analyzer. A Control Chart by itself does not lead to a conclusion about the performance of an analyzer. For this purpose Decision Rules are used. A Decision Rule is an expression, which uses the Warning and/or Control Limits to obtain an evaluation result. One or more Decision Rules may be assigned to a Control Chart.

When the variable gets outside one of the two control limits (Upper Control Limit, UCL, and Lower Control Limit, LCL), the analyzer is performing out of specification.

The warning limits (Upper Warning Limit, UWL and Lower Warning Limit, LWL) are used to check whether the analyzer threatens to start performing out of specification before this will actually happen.

Typical Decision Rules

The following control charts are available in the CALSYS®:

Single Unit Control Chart Control Chart to be used when only one reading is taken during a validation.

o Control Chart for the Mean When more than one reading is taken during a single validation, the Control Chart for the Mean may be used. This control chart displays the average of the readings within one validation as a single point on the control chart

o Control Chart for the Standard Deviation To be used in combination with the Control Chart for the Mean, in case 6 or more readings are taken within a single validation. This control chart is used to check the variation of the readings within one validation.

o Control Chart for the Range To be used in combination with the Control Chart for the Mean, in case less than 6 readings


are taken within a single validation. This control chart is used to check the variation of the readings within one validation.

Historical Chart Actually the historical chart is not a control chart but a graphical representation of all the maintenance actions that has been carried out for the selected analyzer, including reference changes, calibrations and control limit changes. This chart is usually presented in combination with the maintenance log.


2.3.20 Significance Testing

Why Significance Testing?

Significance Testing can help you to determine the validity of the validation results, check analyzer performance and advise whether or not the limits are set correctly.

Some background information on Significance Testing

CALSYS® provides a number of functions to test the statistical significance of validation results. These functions

are called statistical tests in literature ([Sachs, 1984]). A statistical test is a procedure that decides whether or not a particular hypothesis can statistically be rejected with a particular confidence level. The most commonly used hypothesis is the null hypothesis that states that two sets of data agree with regard to some parameter, e.g. are of the same population (i.e. have the same mean). On the contrary, the alternative hypothesis states that two data sets do not belong to the same population.

A statistical test that only tests the null hypotheses (and not the alternative hypothesis) is called a significance test. Most of the tests provided by CALSYS

® are significance tests.

A statistical test is held against a particular significance level. The most frequently used is the 5% level. Other more strict levels are the 1% and 0.1% levels.

The classical statistical procedures (such as control charts) assume a normal distribution of the validation results. In practice, however, pure normal distribution does not occur. In order to ensure that the outcome of statistical procedures lead to reliable conclusions, a number of tests can be performed to check that the validation results approximate the normal distribution within specific limits.

Furthermore outlier tests are available to test a data set on readings that were taken under abnormal conditions.

Note: Statistical tests are also referred to as 'long-term performance evaluation', 'significance testing' and 'bench-marking'.

The following statistical tests are available in the CALSYS®:

Test on outliers

Two outlier tests are provided, the Dixon's test on outliers and the ASTM-E178 test on outliers. The Dixon's test on outliers is a simple test to determine whether the two extremes (i.e. the maximum and the minimum) of a set of data points can be considered as outliers. The recommended approach within the [ASTM-E178] standard to check for the presence of outliers is the "studentized extreme deviate" test. The ASTM-E178 test is more sensitive to detecting outliers than the Dixon's test

Shapiro-Wilk test on normality

Many statistical techniques are based on the assumption of normal distribution. For most cases this is valid, but there are many cases in the (petro-)chemical industry where data does not show a normal distribution. The Shapiro-Wilk procedure can be used to test a data set for normality

Test on non-randomness

The test on non-randomness checks whether a number of consecutive data points are randomly distributed. The test is able to detect a drift (trend) and an oscillation. A drift or step change in results


indicates loss of control, e.g. currently set warning limits are too loose. Erratic, oscillating results may indicate over control, e.g. currently set warning limits too narrow

Test on systematic errors

The "One sample t test on difference in means", also known as 'Student-t test' or 'Test on systematic errors', checks if the average difference between the instrument output and the related reference , that shows a normal distribution, does not significantly differ from zero

Test on variance

The actual variance of a data set is tested against the historic variance with the F-test, also called the Chi-square test. Significant deviation between the actual and the historic variance indicates that the analyzer is either performing better than or below expectation

Test on reproducibility rate

The number of scores within a particular limit (usually the Warning limit) is expected not to deviate significantly from 95%. The test checks if the number of samples that lie within the limit value relative to the total number of samples does not deviate significantly from 95%. (or more accurately 95.45%: the percentage that lies within the μ +- 2σ range).

CALSYS® advises new Warning and Control limits. For example, when the test on reproducibility rate indicates

that the in-use limits have been set too narrow, CALSYS® can advise new limits, after which the user can

activate these new limits.

2.3.21 Time-related Performance Indicators

CALSYS® provides sophisticated functions to track the availability and other key time-rated figures of the

equipment.

Examples of such figures are:

Availability rate the percentage of time an analyzer (or any piece of equipment) was available for process measuring

Number of failures the number of times a piece of equipment was in failure

Failure rate the percentage of time that an analyzer is in fault condition

Maintenance rate the percentage of time that an analyzer was unavailable due to routine or non-routine maintenance

MTBF Mean Time Between Failures

MTTF Mean Time To Failure

MTBM Mean Time Between Maintenance


MTTR Mean Time To Repair

ALDT Administrative and Logistics Down Time

MDT Mean Down Time

Functionality is provided to define various time-rated figures based on operational state transitions. It is possible to define operational states for analyzers or for any other equipment. An operational state is as it says: it indicates the actual state (status) of a piece of equipment in operation e.g. is the instrument running normally or has it come to a stop because of a major fault. Has the instrument been put in maintenance mode or is it currently being validated. You can keep track of the operational state of any equipment you want. An

operational state not only enables for on-line monitoring of your equipment, but also generates historical data, which can later be used for time-rated statistics.

The following logic tables and calculations are available in the CALSYS®:

Operational State logic table. This logic table is always active and monitors the equipment continuously. Every state change is stored in the database for reporting purposes. The following operational states are used in the demonstration: Required : Equipment is required for process measurement Routine Maintenance : Equipment is in Maintenance for scheduled maintenance Non Routine Maintenance : Equipment is in Maintenance because of break down Fault : Equipment is in Fault because of an active alarm Utilized : Equipment is running normally, no alarms active

Report with Availability calculations The example report is a report showing the commonly used availability calculations. It is possible to define additional availability calculations on the report.


2.3.22 Dashboard

The embedded data visualization features of CALSYS® can be used to monitor the health of analyzers and to

improve process control through instant response to abnormal behaviour. Plant wide views together with detailed dashboards, SPC control charts, real-time/historical trending, reference cylinder management is the ultimate tool to track trends and to identify bad actors, ensuring optimal analyzer performance.


2.3.23 Reporting Facilities

CALSYS® provides a sophisticated reporting facility that enables us to generate reports easily. Although we

already have an extensive library of report templates, it is easy to add your own reports.

Some background information on reports in CALSYS®

Reports are defined according to the concept of templates and bindings. A report template defines the layout of the report. The report binding defines the variable data. So to print a report one report template and one report binding are required.

A report template (the layout) consists of a header, footer and a body. In the header and footer general information such as text can be placed.

The body is composed of report of objects and sections. A section is a logical part of a report and contains data that is retrieved from the historical database or which is real-time. A section can also contain data that is calculated upon report creation. Besides from sections a report template can contain static objects such as lines and text. Furthermore it is possible to link external objects such as a SPC graph into a report template.

Several standard fields are available such as print date/time, page number, etc. Standard fields can be used anywhere on the report, i.e. in the header and footer and also in the body.

Detail sections can be used for repeating a set of data, for example if you want to print availability figures from different analyzers on a single report. You define the figures once in a detail section, and link the detail section to a data set that defines the instruments for which the detail section has to be repeated.

The following reports are available in the CALSYS®:

Single Validation Report Shows all readings that have been taken during a single validation. Includes information about the reference that has been used for validating the instrument. For metering instrumentation, dedicated reports are available per instrument type.

Control Chart Report Report with the control charts used for evaluating the validation data. Per control chart the set of decision rules is presented, including the result per rule

Availability Report Displays all time-related performance indicators over the specified period. The user may choose pre-defined time periods when activating the report

Analyzer based Schedule Report Shows all the schedules that have been defined for the selected analyzer over the specified time period

User based Schedule Report Shows all the schedules that have been assigned to the selected CALSYS

® user over the specified time

period

Significance Test Report Report with the result of all significance test described in the section Significance Testing, including test specific details


Historical Overview Report Historical Overview of the selected analyzer in graphical and textual format over the specified period, including validation & calibration info, reference changes, limit changes and excluded validations.

2.3.24 Instrument Maintenance

Besides performing validation procedures, and performing statistical calculations, CALSYS® also provide

facilities to incorporate maintenance procedures in the configuration.

Nowadays the equipment manufacturer, in commonly excepted formats, such as the PDF-format, supplies maintenance procedures electronically. By linking the maintenance procedures to the analyzers, the QMI engineer can easily access the procedures that are relevant for the analyzer.

The facility of linking procedures to analyzers does not restrict to the format mentioned above:

Basically all files or documents may be linked as long as the operating system knows how to handle it (you may compare this with double-clicking on file within the Windows Explorer; if Windows knows the type of file, it automatically launches the program needed to view the document)

Besides maintenance procedures any other type of document may be linked, like equipment spare lists, etc.

2.3.25 Scheduling Facility

Scheduling is the process of automatically starting certain activities at regular intervals or at specific times. You can invoke any script, program or document at any time or any interval, every day to once a year.

The Scheduler can perform following items automatically:

Start an external program

Start a validation procedure

Generate a report

Set the value of a real-time tag

Activate an archive object (for automatic backup of configuration or historical data)

The Scheduler provides facilities to trigger events automatically. Events are triggered at a particular date and time. A once triggered event may be repeated at a particular interval time period (i.e. a recurring event).

A schedule contains the information, which is needed to trigger one object. Each schedule leads to a number of triggers, not only because of the fact that a schedule might be recurring, but also because a schedule can be updated. For instance a non-recurring schedule leads to a single trigger, after the schedule has been executed the schedule can be updated and again a trigger will be given.

It is possible to create multiple schedules for a single object. For instance when a specific report needs to be printed every day (daily report) and when the same report is used to print a weekly report, two schedules need to be created for this report, a daily schedule and a weekly schedule.


2.3.26 Configuration Process

The configurator is used to set-up an application and, as such, serves as the central location from where all modules and options are accessible. It is used when a new application is developed, a new instrument is added to an existing application, a change has to be made to an existing validation procedure, etc.

The configurator window shows the application directory in its left pane and has a working area in its right pane, where several windows may reside. Each edit window applies to one object of the application directory.

The application directory resembles very much the folder structure in Windows. The structure of the application directory is up to the requirements of the client, e.g. some customer might want to order all instrumentation according to their psychical location, like per analyzer house, while another customer might want to order their instrumentation unit-based.

Most functional objects that are part of an application use the concept of templates and bindings:

Template : General definition of a procedure, a report, logic, a set of calculations, etc.

Binding: An instance of a template used for a particular analyzer or any other entity.

A template can be compared with a Microsoft Word template. When a new document is created based upon such a template, the new document, called the binding, inherits the layout and styles of the template and data can be entered in an automated way. Templates are used to enhance application building and to improve maintainability of existing applications. A template is defined once and can be used several times within the


application, e.g. a template defining a validation procedure, may be used for a number of analyzers. Using templates enhances the simplicity and maintainability, because the definition is stored in one central location.

So a binding contains the actual definitions applicable for a specific analyzer (or for another entity). As many bindings as required may be defined for a template. Since the actual functionality resides in the template file and not in the binding, functional changes can be implemented very easily. You simply change the template file and all the bindings referring to this template will use the new functionality.

technical description - krohne

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