Digital transformation in practice, i.e. how to teach elephant to - - PowerPoint PPT Presentation

Miskolc-Lillafüred, Hotel Palota****

24-26 October 2018

Digital transformation in practice, i.e. how to teach elephant to fly?

Keresztesi Kálmán

kalman.keresztesi@controsys.hu

Controsys Irányítástechnikai Kft. PRESENTATION

Miskolc-Lillafüred, Hotel Palota****

24-26 October 2018

Agenda

• Project background
• Current practices
• Digital transformation in automation project collaboration
• Digital transformation in quality management
• Human factors of the transformation process
• Experiences
• Conclusion

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24-26 October 2018

Source: Wikimedia by Srilekha selva Cross-wiki upload from en.wikipedia.org

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The project

• Location: Richter Gedeon Biotechnology Plant, Debrecen
• In operation: 2013-
• System Upgrade for HW and SW components
• Capacity extension - new equipment
• Typical process automation tasks
• HW replacement: Servers (new virtual IT environment)
• HW Extensions: New controllers, servers, client access
• SW upgrade for system components: new control SW version
• Application extension for new equipment introduced for extension
• Application change on some existing equipment

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24-26 October 2018

Project background

• PAS (Process Automation System) + BMS (Building Management System)
• End user: Richter Gedeon Biotechnológiai Üzem
• Automation Department
• Quality Management Department
• System supplier: ABB Mérnöki, Kereskedelmi és Szolgáltató Kft.
• Equipment suppliers
• Subcontractor teams: HW & SW plan, design, configure, test, commission
• All computer based systems must meet compliance requirements stated

in Validation Plan, installation based on GMP & GAMP 5

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GAMP 5 approach: computer systems

• Project & operation phases
• Same workflows to follow

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Practices – prior to project

• End user provides URS and VP approved (signed) documents
• PAS & BMS supplier quotes HW + SW + Services based on end user docs
• Services ca 50% engineering + 50% verification and documentation
• Equipment suppliers and end user provides Functional specifications
• Supplier to provide GAP analisys, then create PVP (Project and Verification

Plan), then HW + SW Design specification and Test protocol documents

• Automation Department & QA approves the specifications and test protocols
• HW to build, HW and system SW to install and test
• SW applications to configure, program and test against approved test

protocols

• Tests: Internal, dry, on site. CT (configuration) and FT (Functional)
• User acceptance tests to prove URS requirements meet

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PROs and CONs of using docs

PROs

• Commonly used tools exist
• (Word, Excel, Access, etc.)
• All teams and participants have

experiences to use the tools

• No new investment for doc SW
• No training costs

CONs

• Slow with high cost human effort to

create, comment and sign docs

• Mix of paper and electronic issues
• Versioning is mostly manual
• Distribution of docs need extra tools
• No snapshot (baseline) capability
• Extra administration & project cost
• Manual traceability - if any
• Cost of create and store paper docs
• Approved paper docs are not

searchable

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24-26 October 2018

• Common in most regulated sites in US and Europe
• Use well known documentation tools (Word, Excel)
• Staff is trained and forced – controlled – to follow the practices
• Effect of inspections: do what you did so far, or do it even better
• 30+ years traditions via continuous improvements an refinements

Existing practice

Source: majapahit.net

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24-26 October 2018

What elephants can do?

Source: Internet

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How to start digital transformation?

Source: Internet

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Introduce digital transformation in automation project collaboration

• Prior the capacity extension Controsys Kft. and ABB Hungary decided

to possibly implement a paperless PAS project

• GAMP5 template was developed in Application LifeCycle Management

SW framework

• GAMP5 template covers 2 main parts of PAS lifecycle
• Project phase
• Operations phase
• Quoted a project including fully electronic

collaboration, document and information management for Richter on a discounted price over traditional paper based documentation

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24-26 October 2018

Duties for ALM based solution provider

• ALM tool is a computer SW – consequently has to be validated before

use in real projects based on GAMP5 rules

• Personalized validation required for every end user
• ABB and Controsys created
• ALM requirement specification
• Functional requirements
• FDA 21 CFR Part 11 based requirements
• Test cases to verify all requirements
• ABB has executed the verifications and created qualification report
• ALM validation design and test cases prepared in ALM SW framework
• ALM core validation reported still on paper based documents!

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ALM setup & use

• ABB Hungary set up and operates an ALM server
• Multiple ALM projects can be defined on the same server to support

automation projects of ABB Hungary

• ABB Hungary provides licenses to its own staff and to the

subcontractors working on different projects

• GAMP5 related workflows are defined by Controsys and continuously

improved in the ALM framework

• High level, effective collaboration can be achieved with repeatable

standards

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Extend the ALM collaboration

• ABB Hungary plans to extend the methodology to foreign ABB
• perations
• System based templates and unified workflows will be provided to

wider audience & user base

• Company operations can be standardized for project executions
• Online helps and trainings embedded in ALM tool itself can help

penetration

• Possible ways of future ALM framework utilization
• 1. Centrally managed and administered for maintaining global control on
• perations
• 2. Template provided as is and let organizations adapt and customize locally

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Target the end user

• ALM tool is a computer SW – consequently has to be validated before

use in real projects based on GAMP5 rules

• Personalized validation required for every end user
• Contract for project signed – Real difficulties come later
• Organizations are usually not well prepared for electronic ALM
• End users has strong dedication to current practices (paper)
• Existing document store, versioning, but not accessible either for

suppliers or System Integrators

• Even by having ABB QA validation report, new project has been

introduced for the electronic ALM validation at end user

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End user arguments

• SW based ALM expected to be fully specified based on existing

practices

• There are generally differences in workflows for paper based and

electronic ALM

• Default ALM SW solution not necessarily meet end user specific SOPs
• ALM SW has generic, configurable tools to adapt end user requirements
• End user with no experience may result step by step resolution to final

ALM SW

• During the use of ALM SW changes are to be made based on better

understanding of the user SOPs and based on practical experiences

• All above results multi-step iteration to hit the target

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Comparision 1

Paper documents Work items / documents ALM SW Electronic (Word, Excel) docs Creation Independent single work items Manual, as email attachment, (Document repository) Distribution No distrbution needed, web based instant access is available Commenting, replying in documents + redistribute the documents Review Comments, replies, Electronic signature (21 CFR Part 11) Manually sign papers Approval Electronic signature (21 CFR Part 11) Manually maintained in separate document Status Automatically maintained Manual Traceability Automatically available Paper based: n*(print+scan+email) Alternatively Servide Desk / Ticket Change Standard workflow

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Comparision 2

Paper documents Work items / documents ALM SW No Baselining Infinite number of baselines Manually set in documents Versioning Automatically keeps all versions Manual document store and numbering History Automatic, life cycle length Manual on pre-printed test protocol document, printed evidences attached Testing Automatic or manual, evidences electronically attached (JPG, PNG, doc, pdf, etc.) Manual GMP signatures on filled test report Test approval Electronic signature (21 CFR Part 11) Replace paper or fix on paper and GMP sign Record changes No (21 CFR Part 11). Modification

• f content is not possibe, or do by

using „Redefine” in workflow Manually administered Test coverage Automatic dashboard

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Comparision 3

Paper based ALM SW Traditional way (docs + paper) Change any workflow Electronic change, standard like

• ther work items, historized

Electronically scan and store signed documents Backup / restore Schedule automatic backups Immediate restore on new HW N/A Upgrade Generic IT level task after Risk Assessment done Ask QA person, probably full time job Administration Generic IT level job Ask QA person, probably full time job or rarely happens Maintenance Included in Admin job N/A Audit trail Automatic, built in, Login, change + access, etc. Manual Task schedule / release Included, traceable

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• Potential end users have far good IT environment and skills
• QA current practices hardly match available IT capabilities
• Generic fear of inspection and possible consequences, count on

inspectors with traditional experience only

• Attitude to follow existing practices to avoid transitions and possible

difficulties

• Some of the users do not simply believe anything can be done

differently than they do it

• Some of the users do not simply believe this can be done by a SW

based solution

• Generic opinion after an ALM SW demo seen:

Absolutely nice and really looks good, but how could it handle our case?

Experiences

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Meet ALM SW first time

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ALM SW initial acceptance

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• The SW based ALM is functional and active in the Biotech plant in

Debrecen

• Same ALM server is utilized also in other projects of ABB Hungary even

with different application template

• License number is constantly increasing as a result of gained

experience and confidence among users

• No paper based validation document was prepared so far after the

initial ALM validation has been completed!

Achievements

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ALM SW application includes

• Requirements of end user and regulatory requirements (GMP, GAMP)
• Functional and Design specifications for the System HW, SW and for the

application development

• Reviews, approvals of all kinds of work items and configuration items using

electronic signatures based on role based reponsibilities of end user

• FMEA Risk management, risk tasks, Observations and deviations (i.e. bugs),
• Change controls
• Test cases for all levels, test runs, test reporting and test report acceptance
• Tasks and time schedule for the whole project with timekeeping

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24-26 October 2018

Who can use ALM SW GAMP5 template?

• Regulated industries
• Prove compliance
• Use in case of inspection
• All industrial manufacturers and industrial plants using process control &

automation

• Template also can be partially implemented or used
• Ensures proper collaboration and establishes a clear framework for all

automation projects

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24-26 October 2018

Conclusions

• Confirm or deny

?

• Elefant can be definitely

trained to fly!

• Elefants fly differently than we generally think

about flying!

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24-26 October 2018

Questions?

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24-26 October 2018

Thank you for your attention!

www.controsys.hu