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testing and verification, are areas that yet have much to offer to the industry. This paper
emphasizes the importance of a quality process and also discusses about the ways in which it
could be achieved through offline software quality techniques in particular SFMEA Model.
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Computer System Validation (CSV) is the process used to ensure and document that a computerbased system is operating according to predefined requirements. CSV is necessary when replacing paper records, like
Case Report Forms for clinical trials, with an electronic system within the highly regulated data zone that impacts public health and safety. Necessary validation documents are for example the Standard Operating Procedures (SOPs), which outline how the computer system should be used. Here, we describe in detail the System Validation Master Plan, the most important document in Computer System Validation. In contains topics, like: Validation Policy, Definition of Validation, Rules and Regulations in CSV, Legal basis, FDA 21 CFR Part 11, FDA Guidance for industry, ICH Guideline GCP, Annex 11 EU-GMP, Validation Philosophy, Organisation validation document, Audit Reports, Organisation guidelines, Organisation quality management handbook, etc.
The steps of the Validation Life Cycle are: 1. System Specification, 2. System Classification, 3. Validation Planning, 4. Establishing of the validated state, 5. Maintaining the validated state, 6. System Retirement.
In software industry, the concept of quality has become a significant aspect and is
expressed and defined in many different ways. Quality assurance, and in particular software
testing and verification, are areas that yet have much to offer to the industry. This paper
emphasizes the importance of a quality process and also discusses about the ways in which it
could be achieved through offline software quality techniques in particular SFMEA Model.
Software FMEA determines the software failure modes that are likely to cause top
level failure events. Software FMEAs are useful when designing and testing the error
handling part of the software process. It has to be found that there is significant improvement
in quality in terms of reduced RPN values.
Computer System Validation - The Validation Master PlanWolfgang Kuchinke
Computer System Validation (CSV) is the process used to ensure and document that a computerbased system is operating according to predefined requirements. CSV is necessary when replacing paper records, like
Case Report Forms for clinical trials, with an electronic system within the highly regulated data zone that impacts public health and safety. Necessary validation documents are for example the Standard Operating Procedures (SOPs), which outline how the computer system should be used. Here, we describe in detail the System Validation Master Plan, the most important document in Computer System Validation. In contains topics, like: Validation Policy, Definition of Validation, Rules and Regulations in CSV, Legal basis, FDA 21 CFR Part 11, FDA Guidance for industry, ICH Guideline GCP, Annex 11 EU-GMP, Validation Philosophy, Organisation validation document, Audit Reports, Organisation guidelines, Organisation quality management handbook, etc.
The steps of the Validation Life Cycle are: 1. System Specification, 2. System Classification, 3. Validation Planning, 4. Establishing of the validated state, 5. Maintaining the validated state, 6. System Retirement.
Overview on “Computer System Validation” CSVAnil Sharma
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An introduction to Life Sciences Computer System Validation, applicable regulation, SDLC phases, software categorisation, risk/ change/ deviation management, validation deliverable, risk based approach, regulatory inspection, audit findings, causes of compliance failure, key concepts in CSV etc.
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Computerized System Validation Business Intelligence SolutionsDigital-360
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This is the presentation that BMM testlab gave in March 2019 in Stockholm to an audience of gaming operators. It explains the process of having a gaming platform certified by by an accredited laboratory. It also looks at the paragraphs from the new regulations that specify requirements for risk assessment and change management. It also answers some frequently asked questions.
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An introduction to Life Sciences Computer System Validation, applicable regulation, SDLC phases, software categorisation, risk/ change/ deviation management, validation deliverable, risk based approach, regulatory inspection, audit findings, causes of compliance failure, key concepts in CSV etc.
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Executive Summary
Regulated pharmaceutical, biotech and medical device companies are challenged to develop manufacturing capabilities quickly and cost-effectively while at the same time safeguarding product quality and patient safety.
Validation has been an essential part of regulated industries for over 20 years, yet as the field has evolved, little has changed in the business, or manual, approach to validation.
This is the presentation that BMM testlab gave in March 2019 in Stockholm to an audience of gaming operators. It explains the process of having a gaming platform certified by by an accredited laboratory. It also looks at the paragraphs from the new regulations that specify requirements for risk assessment and change management. It also answers some frequently asked questions.
A risk assessment and management process that is focused on loss of containment of pressurized equipment in processing facilities due to material deterioration. These risks are managed primarily through equipment inspection.
CARACTERISTICAS DEL PROCESO DE MODERNIZACION EN VENEZUELA (SIGLO XX).
CARACTERISTICAS DEL MODERNISMO COMO ESTILO DE ARQUITECTURA EN VENEZUELA. 1ERA ETAPA. NEOCOLONIAL VENEZOLANO-ART DECO-ECLECTICISMO. CARLOS RAUL VILLANUEVA (1EROS TIEMPOS DE SU PRODUCCION ARQUITECTONICA. OBRAS. IMAGENES). (ARTICULO DE ANA ELISA FATO OSORIO TITULADO: "ARQ. EN VZLA A MEDIADOS DEL SIGLO XX: LA BUSQUEDA DE IDENTIDAD ENTRE EL NEO-COLONIAL Y EL ART-DECO IDENTIFICADO EN EL MATERIAL DE CONSULTA COMO NEO-COLONIAL EN VZLA.)
ARQUITECTURA ANTILLANA OTRA VARIANTE DEL MOVIMIENTO MODERNO EN LATINOAMERICA.
EL PROCESO DE MIGRACION RURAL A LAS CIUDADES EN VENEZUELA. EXPLOSION DEMOGRAFICA VENEZUELA AGRARIA A PRE-INDUSTRIAL. EL IMPACTO URBANO EN LAS CIUDADES.
LOS ESTUDIOS DE URBANISMO EN LATINOAMERICA Y VENEZUELA. EL CAMBIO DE ENFOQUE DEL BEAUX-ARTS (TRADICION FRANCESA) AL PLANNING TOWN (NORTEAMERICA). URBANISMO VERSUS PLANIFICACION. EL PLAN ROTIVAL PARA CARACAS (ARTICULO DE ARTURO ALMANDOZ TITULADO: "MODERNIZACION URBANISTICA EN AMERICA LATINA. LUMINARIAS EXTRANJERAS Y CAMBIOS DISCIPLINARIOS 1900-1960. IDENTIFICADO EN EL MATERIAL DE CONSULTA COMO URBANISMO EN AMERICA LATINA EN PDF)
EL PAPEL DEL ESTADO COMO MODERNIZADOR DEL PAIS. LA DICTADURA Y PEREZ JIMENEZ.
CARACTERISTICAS DEL MODERNISMO COMO ESTILO DE ARQUITECTURA EN VENEZUELA. 2DA ETAPA. ARQUITECTOS MAS REPRESENTATIVOS:VILLANUEVA-SANABRIA-GALIA-VIVAS (CATALOGO DE IMAGENES CON 2 DE SUS OBRAS MAS REPRESENTATIVAS).
DOCOMOMO EN EL MUNDO. DOCOMOMO EN VENEZUELA.
LA CRISIS DEL OBJETO MODERNO. (ARTICULO DE RAMON Y RODRIGO GUTIERREZ, TITULADO: "UNA MIRADA CRITICA A LA ARQ. LATINOAMERICANA DEL SIGLO XX. DE LAS REALIDADES A LOS DESAFIOS. IDENTIFICADO EN EL MATERIAL DE CONSULTA COMO: "ARQ. LATINOAMERICANA 1930-50).
CONCLUSIONES
Designing management of change procedure to act as barriers to major offshore...Jon Skogdalen
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1. Give an understanding of the elements included in the title; Designing management of change
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2. Shortly describe experiences from major accidents
3. Give an understanding of the different steps in designing a management of change (MOC)
procedure
A change management process is a formal set of procedures and steps that are set in place to manage all changes, updates, or modifications to hardware and software (systems) across an organization. Typically, the change management process should be formalized through a management-approved policy. From an internal aud it perspective the policy should cover
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It is very important for a project to implement a robust project change request process to help manage succesful delivery.
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Ideal for a PMO or project team looking to implement their own change control process.
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Technology Controls in Business - End User Computingguestc1bca2
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The use of spreadsheets in financial reporting and operational processes, is a key tool for some corporations, and is an integral part of the information and decision-making framework.
Everything You Need to Know About Testing Banking Domain Applications.pdfflufftailshop
In the banking industry, consumers increasingly demand digital tools to execute transactions and access services that banks and other financial institutions offer. Ease of use, convenience, personalization, and 24*7 services are among the significant factors driving this consumer demand. In line with this surging demand, organizations compete to deliver the best mobile banking applications and websites that facilitate everything from checking account balances and transferring money to availing loans and trading stocks.
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Software testing is required to secure financial applications by implementing functional testing, security testing as well as automation testing because in this domain money is circulating by different payment methods.
Sheet1Cost Summary RubricTopicMaxYour
PointsCommentsPMP Cost Management PlanPMP Cost Management PlanIntroduction/ Purpose10Purpose10Estimate Cost 10Performance Measures (Earned value, accuracy levels, variances thresholds, standards of measurement, etc.)20Contingency Reserve 10Reporting Protocols20Budget 10Cost Change Control Process 20 Performance Monitoring10 Project Reports 10MS Project FilesMS Project Cost report (PDF)20MS Project Deliverables WBS with resource, material and costs (MPP) 10Project Cost -WBS with resource loaded 20100`Cost ReportsMininum of two cost reports (overview, overruns, EVM, Resources costs20`Total 100
Chapter 4 – Section 3 of PMP Template Plan
3. Change Management (Chapter 4)
3.1 Change Management Process
Change management entails thoughtful planning and sensitive implementation, and above all, consultation with, and involvement of, the people affected by the changes. Changes made to the project at any timeline are raised using a request for change is requested before change is initiated and the change request is handled by the implementation team to determine if the change impacts the project risking the timeline, resource, structure or any kind of impact. Any change requires a Quality Assurance decision to approve the change or reject. If the change request is denied the change request is rejected.
3.2 Change Control Process Flowchart
3.3 Change Request Form
Change Request Form
Change Request Number
01
Initiator
Bosch
Brief Description of Request
Editing Workflow configuration change
Submission Request Date
02/04/2017
Request Approve Date
02/05/2017
Reason for Change
The document check-out option is not open and as per the initial configuration request the feature is added for employee using a document at remote locations or exporting to other electronic document managmenet system
Approval Signature
Signed
Date Signed
02/05/2017
Change Request Form
Change Request Number
02
Initiator
Stephen
Brief Description of Request
Security Access change
Submission Request Date
02/04/2017
Request Approve Date
02/05/2017
Reason for Change
System access for Business administrator is requested for creating users in the system and remove access for system owner
Approval Signature
Signed
Date Signed
02/05/2017
3.4 Change Log
Change No.
Type
Description
Initiator
Submission Request Date
Status
Submission Approved Date
Comments
01
Configuration
Editing Workflow configuration change
Bosch
02/04/2017
Approved
02/05/2017
None
02
Configuration
Security Access change
Stephen
02/04/2017
Approved
02/05/2017
None
References:
http://www.businessballs.com/changemanagement.htm
<Implementation of Veeva QMS at Ironwood Pharmaceuticals>
<PMGT 699 – Applied Project Management>
Prepared By
<Srinivasa Shiva Theja Yadlapalli>
<07/27/2019>
1. Executive Summary
1.1 ..Introduction………………………………………………………………………
1.2 .. Purpose………………………………………………………………………….
.
1. Management of Change
for Process Safety
Aication
OPERATIONS
MANAGEMENT
ASSET
MANAGEMENT
HEALTH & SAFETY
MANAGEMENT
A SOLUTION FOR
http://www.focul.net/moc
2. MOC 2016 V2 2
1. The MOC Application
The FoCul Management of Change for Process
Safety ( MOC ) application is a modern
browser based stage gate process that
supports the risk assessment processes
associated with change on process plants.
The application has been developed from best
practices in the process and utility sectors and
incorporates the recommendations made in
“Guidelines for the Management of Change
for Process Safety” published by the Center
for Chemical Process Safety of the AIChE.
The application improves control, efficiency
and auditability while also making the
Management of Change process more
inclusive.
2. The Business Challenge
The principles of managing change for process
safety through a stage gate risk assessment
process are well understood and in many
cases are well implemented.
The challenge to the business lies not in the
technical aspects of the process but in the
efficiency, control and consistency of the
process.
A basic management of change process will
have stage gates relating to concept approval,
risk assessment, construction, commissioning
and records update. In a very simple example
these 5 stage gates will require a total of at
1
COMAH – Control of Major Accident Hazards
least 10 approval steps and will involve
multiple people.
While this process can be managed robustly
as a paper system it is time consuming for key
personnel and requires administrative
support. A paper based process of this nature
is also difficult to audit as the MOC forms are
often physically out with individuals.
The management of record updates relating
to changes is also time consuming and can
delay the progress of changes while the status
of these records is determined.
The paper based system also makes it harder
to quickly identify the history and status of
other live or historical changes which may
impact on the current change.
3. The Solution
FoCul with its unique mix of experienced
Engineers and IT developers has developed a
very effective Management of Change
application. The application allows
Engineering and Operations teams to focus on
the technical aspects of changes rather than
needing to spend time on administration and
chasing physical forms.
This application has been developed over a
number of years based on feedback from
customers (some on Top Tier COMAH1
sites)
and guidance issued by the IChemE, the AICHe
and the HSE2
.
A separate case study of an implementation
at the CHP plant at Sellafield, Cumbria is
available at http://www.focul.net/moc
Users can see the status of every modification
and have a personalised dashboard which
2
Health & Safety Executive – UK regulatory body
3. MOC 2016 V2 3
shows the actions and approvals that are
awaiting their attention.
The stage gate processes are configurable
with options to apply different workflow
configurations to high, medium and low risk
changes. There are also configurable options
to manage emergency changes.
Individually trackable actions can be raised
and interlocked to the stage gate process
meaning that a stage cannot be closed until
the relevant actions have been completed.
Actions are also automatically raised to track
each required document update ( P&IDs etc. )
that was identified during the risk assessment.
Users receive daily notifications of new
actions and a weekly report of all their
outstanding actions.
Very little administrative support is required.
4. The Process
The Management of Change for Process
Safety process uses the following stage gates:
Concept Approval
Risk Classification
Risk Assessment
Specification Review
Construction
Commissioning
Records Review
MOC Review
Each part of this stage gate process is
described in more detail below.
4.1. Concept Approval
The purpose of the concept approval stage is
to make sure that the relevant stakeholders
have been able to add their thoughts at an
early stage and that there is an understanding
of the likely cost and benefits of the change.
The process is configurable but typically this
stage would be reviewed by the Asset /
Maintenance Manager, Operations Manager,
a Production Technician and the budget
holder.
4.2. Risk Classification
The Risk Classification stage of the change is
one of the most important parts of the
process. There is clear evidence from industry
that requiring the same level of control for all
changes causes MOC systems to be bypassed
for simpler changes.
The Risk Classification stage determines if the
risk is High, Medium or Low risk depending on
a series of customer specific criteria. This
classification then determines who should be
involved in the remaining stage gate
processes e.g. high risk modifications may be
configured to require an input from the Safety
Manager.
The Risk Classification can be carried out
before or after the Risk Assessment is
prepared.
4. MOC 2016 V2 4
4.3. Risk Assessment Preparation and
Approval
The Risk assessment stage gate contains a
number of sub processes.
The first sub process is the preparation of a
detailed risk review where the change owner
is able to select topics that need to be
considered further. Having selected the topics
from the configurable checklist the change
owner (or any other authorised person) adds
text describing the issues to be considered
and what mitigations are required.
Above: configurable risk assessment prompts
Trackable actions can be created at any point
and can be interlocked to prevent a particular
stage gate from being completed.
The last part of the risk assessment
preparation is to identify which documents
will need to be reviewed. The application is
designed such that records must be positively
deselected.
Above: configurable prompts for required records
update
Once the risk assessment stage gate has been
prepared the change owner sends it for
review. The list of reviewers is determined by
the risk rating. Each reviewer receives an
email with a link which opens the MOC form.
Once the review process has started the
approvers cannot change the prepared risk
review but they are able to add comments
and interlocked actions detailing any changes
that they require. They also have the option
to disagree with the assessment and request
that it be re-worked and re-submitted for
review.
When the last reviewer gives their approval
the Risk Assessment stage gate is closed,
individual actions are created for each record
that must be updated ( SOPs, P&IDs etc. ) and
the Execution stage gates is started.
4.4. Specification Review
In some cases there can be a delay between
signing off the Risk Assessment and receiving
the design for construction. In that time the
design intent or the existing plant
circumstances may have changed. The
Specification Review stage gate is used to
check these potential issues.
4.5. Construction
The application will support an unlimited
number of construction phases within a
change. This feature is typically used to
separate out the control of tie-ins or civil
works.
The change owner completes the required
information in the draft stage gate document
and then presses a button to initiate the
process whereby the required people agree
that construction can start. The particular
roles involved in this approval are
configurable within the application.
When the construction is finished this stage
gate is closed and a Commission stage gate is
made available.
5. MOC 2016 V2 5
4.6. Commissioning
The system will support multiple
commissioning phases. The change owner
completes the required information in the
draft stage gate document and then presses a
button to initiate the process whereby the
required people agree that commissioning can
start. The particular roles involved in this
approval are configurable within the system.
The change owner (or another authorised
person) must complete the pre-
commissioning checklist before they can
confirm that the commissioning stage gate
has been completed.
Above: pre-commissioning check list
4.7. Records Update Completion
Any records requiring review identified during
the Risk Assessment will have had fully
trackable and interlocked actions
automatically created. Those that were
deemed HSE critical will have been
interlocked to prevent commissioning from
being signed off. When the last action is
completed the records review stage gate will
be closed automatically.
Above: dashboard showing outstanding actions
4.8. MOC Review
There is an optional MOC review stage where
the change can be reviewed to determine if
the cost / benefit estimates were met and to
identify if any new learning.
5. Temporary Modifications
Temporary changes have historically caused a
disproportionate number of process safety
issues.
This MOC process identifies temporary
changes and then requires that these are re-
assessed on a periodic basis, typically every 3
months.
6. Out of Hours Emergency
Changes
The application supports out of hours
emergency changes in 3 ways. These settings
are configurable.
Individuals can “sign on behalf” of
others but in so doing they are
required to add additional text
explaining why they are doing so. This
is typically used to record a telephone
conversation with an off-shift
approver.
The application can be accessed
remotely on any web connected
device subject to any IT security
constraints in place.
The application will support a
truncated MOC process. The
truncated MOC form can then be
converted to a fully assessed form at
a later date.
7. Additional Benefits
In addition to being more efficient and
improving control the MOC application also
allows a much wider pool of people to be
included in the MOC processes.
6. MOC 2016 V2 6
Any authorised person can see the latest
status of a change and can add comments if
authorised to do so.
A practical example of this is the way in which
Permit Issuers can check the status of
modifications during the permit issue process.
8. Implementation
FoCul is different from other IT providers in
that our team includes experienced Engineers
who will work with you to develop the best
MOC methodology to suit your business.
Deployment of the web based version of the
application is very straight forward and can be
completed in a matter of hours but it is
important that the application is configured to
meet your specific needs.
We do this using the following approach:
8.1. Needs Analysis
We will work with you to determine how the
application should be configured to work with
your MOC processes.
8.2. Deployment and testing
We will deploy the configured application and
test it with you to ensure that the
configuration meets your needs. We will also
work with you or your IT team to ensure that
they are happy with our systems and
approach.
8.3. Training
We will typically provide training materials
and train key users who will then go on to
train others.
8.4. Support
The support from FoCul includes ongoing pro-
active support and regular upgrades of the
application with new functionality. We will
provide support for the application for as long
as you need us to.
9. Technical Requirements
The application is available as a cloud based
service, a hosted application or as an intranet
application. The servers are located in a
secure data centre and all connections to the
application are encrypted and the application
is backed up daily.
User registration is controlled by the
customers and there are secure automated
password reset processes.
Users require a modern browser such as
Chrome or Internet Explorer 10 and higher.
The application supports XML feeds for
reporting and integration with other systems.
10.About FoCul
FoCul was established in 2000 by an
experienced Manufacturing Engineer with a
passion for finding better ways to manage
processes and knowledge so that teams could
be more effective.
FoCul never left their engineering and
manufacturing base and established a
reputation for providing both highly
configurable products and bespoke IT
solutions for manufacturing teams. We have
completed over 500 applications the great
majority of which are still in regular use today.
Our combination of technical expertise and
real life industrial experience brings value to
our clients. Our collaborative approach allows
us to provide the best solutions and often
leads to partnerships with our clients that
extend over many years.
For more information please contact Sean Cull
Web : http://www.focul.net/moc
Telephone : UK +44 (0)161 660 8226 Option 3
or USA +1 (0)281 404 1507 Option 3
Email : sean.cull@focul.net
LinkedIn :
https://www.linkedin.com/company/focul-ltd