quality management program chemical on-line analyser ...€¦ · quality management program 101...

Quality Management Program 101 Implementation For

Chemical On-line Analyser Instrumentation: Decoding

ISO/IEC 17025

Presenter: Keikantse M. Pule (Mr)

NLA Conference

Date: 08-10 October 2018

Food for thought

FLIXBOROUGH, UK - June 1, 1974

• Cyclohexane vapor leak as a result of ruptured pipework

• This resulted in an explosion that killed 28 people and injured 36

• Offsite, 53 injuries were reported and the surrounding properties in the area were severely damaged

SEVESO, ITALY - July 10, 1976

• Milan, a reactor at the ICMESA chemical plant overheated

• Resulted in an highest explosion known, the first exposure, to dioxins in a residential area

• A toxic cloud used to make pesticides antiseptics that contains 2,4,5-Trichlorophenol. There was a possibility the toxin could spread to the densely

populated city of Seveso (AND IT DID).2

Food for thought

SCHWEIZERHALLE, SWITZERLAND - November 1, 1986

• Major fire at the Sandoz chemical factory in 1986

• Water used to used to wash chemicals into the river (Rhine, one of Europe's busiest waterways)

• Spillage caused severe pollution, which took years to eradicate, and killed an estimated 500,000 fish.

3

Food for thought

TEXAS CITY, TEXAS, US - March 23, 2005

• BP's Texas (refinery Texas) US, was considered the nation's worst industrial disaster

• Hydrocarbon isomerization unit was restarted and a distillation tower flooded with hydrocarbons resulted in series of explosions.

• A total of 15 people were killed and another 180 were injured……..

"for failing to have adequate written procedures for maintaining the ongoing mechanical integrity of process equipment at the Texas City refinery”…….

4

Food for thought

5

Food for thought

Eish maar, I am thinking Industry 4.0 aka ITO!

Anyway,

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TABLE OF CONTENTS

• 1. Introduction

• 2. Resource requirements

• Facilities and environmental conditions

• Equipment access and availability

• 3. Conclusion

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1. Introduction

• Undetected changes in a chemistry process plant can results in the following:

• Product loss due to deviation from specifications

• Financial losses

• Regulatory infringements

• Job losses

• Therefore real-time monitoring is essential

• This can be achieved by employing on-line analysis

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1. Introduction …..cont

• Undisputed benefits of on-line analysis are:

➢ • Real time monitoring of chemistry parameters

➢ • Collection of a representative sample.

➢ • Adequate sample conditioning.

➢ • Timeous maintenance of the monitoring equipment.

➢ • Capture of the analytical data in systems that allow data manipulation and interpretation

• It is therefore important to understand how the system have to be developed, how they will function, how they will be maintained and how the information they provide is processed and applied.

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2. Resource requirements

• Personnel

• Facilities

• Equipment

• Systems and

• Support services

• This is necessary to manage and perform chemical laboratory activities

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Facilities and environmental conditions

• Environmental conditions should be suitable for carrying out the analysis without compromising the quality of results

• If the analyzers are in remote areas, alternatives should be considered

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• Measures to control on-line analysers facilities

• Measures to control facilities shall be implemented, monitored and periodically reviewed and shall include, but not be limited to:

➢ Access to and use of areas affecting process chemistry activities;

➢ Prevention of contamination, interference or adverse influences on measurement activities

➢ Also includes,

- temperature,

- humidity,

- sufficient lighting and cleanliness in the facilities (shelters/cabins) housing the on-line analysers/equipment

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• The following requirements are also key for the on-line analyser rooms

➢ Adequate drainage provided for the analysers and grab samples

➢ Suitably ventilated and generally a stable temperature environment

➢ Spacious and provide a pleasant working environment for the Chemistry and iinstrumentation personnel designated to operate and maintain the analysers

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• Sample requirements and conditioning

• The sample conditioning system function is to reduce temperature and pressure and to provide flow rate regulation

• In-line sample filtration may also be incorporated to suit the requirements of selected analysers.

• Personnel safety should be considered and all the associated risks identified.

• Seasonal variation of the environmental conditions should be considered.

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• Equipment access and availability

• ‘The laboratory shall have access to equipment (including, but not limited to, measuring instruments, software, measurement standards, reference materials, reference data, reagents, consumables or auxiliary apparatus) that is required for the correct performance of laboratory activities and that can influence the results.’

• All the on-line analysers shall have a maintenance file which will have records of the following

• List of spares available, service records by the supplier

• Breakdowns experienced, nature of problem experienced and troubleshooting steps undertaken

• Calibration records and Instrument availability records.

• 16


• Equipment capability

• The following should be considered when purchasing an on-line analyzer:

• Cost of analyser and operational costs

• Reagent consumption

• Stability

• Long and short term drift

• Accuracy and Reproducibility

• Response to temperature changes, Chemical interferences and sensitivity

• Ease of operation and frequency of operator intervention

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• Maintenance, verification and calibration of equipment

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• Recorded quality control charts

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• Yearly maintenance plans

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3. Conclusions

• It is viable to meet and identify, define and implement the requirements of ISO 17025:2017 as defined by subsections (6.3 and 6.4) of element 6

• It should however be noted that the method validation was not touched upon as it requires analysis of certified reference material (CRM) that are sometimes not possible to analyse with on-line analysis

• The difficulty is mainly due to introduction of the standard by use of external pumps, and sometimes that can introduce the risk of disturbing a chemical process during production.

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Thank You

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