Professional Documents
Culture Documents
Division Winter2013
In this Issue
1 Directors Message
2 Networking at ISA
2 Anti-Patterns
3 Alarm management technical report published
3 Alarm Management for Food / Pharmaceutical
Processes
7 Division Meeting at FLM Director
3 ISA Automation Week 2012 Alex Habib, PE
8 Models and Support for Alarm Operation;
Batch vs. Continuous
14 2012 Conference Survey Editor
15 New Members
Andre Michel, PE
16 Division Officers
A message from our Division
Process Analytical Technology (PAT)
Virtualization
Director Alarm Management
Batch Process Controls
Dear members of the Food and Pharmaceutical Industry
Cyber Security
Division (FPID);
Lot Tracking
On behalf of the Food & Pharmaceutical Division, I am Food and Pharma Safety & Security
pleased to confirm that our FPID division board decided to Bio-Pharmaceutical Automation & Process
hold a Food & Pharma symposium in the spring of 2014 at Controls
ISAs Head Quarter at RTP. Control System Validation
Food & Pharma Instrumentation Systems
The decision was based on the following main reasons: (hardware & Software)
1- North Carolina is one of the main centers for the
manufacturing and research facilities of food,
pharma and bio-tech industries in the USA Sincerely
2- ISAs Head quarter provides an excellent meeting Alex Habib, PE
facilities and good support by our staff. FPID Division Director
3- Several ISA divisions had excellent participation 732-679-1887
by operating companies and vendors for example: Alex-habib@msn.com
the Analytical Division, Power Industry and
Water/Waste Treatment, etc.
4- ISA has excellent choices of hotels in the RTP area
at reasonable cost.
5- Our Tar Heel section has a good relationship with
other pharmaceutical societies such as ISPE.
In order to make this Symposium a success; we need your
help to find qualified speakers and potential sponsors.
Following the recommended guidance in this technical In order to know when a process deviation occurs,
report will not necessarily ensure that alarm management scientists developing a product using a particular
problems will be avoided. But it will help to identify and manufacturing process must determine the Proven
address alarm specification, design, implementation, and Acceptable Range (PAR) of each CPP. This is usually
management opportunities that are important to batch determined by running pilot plant experiments during
and discrete processes. It can also help minimize the product/process development. The philosophy is that
generation of nuisance alarms that could complicate and operating a plant such that all CPPs are maintained within
frustrate an operators awareness, understanding, and their PARs maximizes the probability that acceptable
response to abnormal situations. quality product will be produced.
ISA18 has five other working groups producing technical Regarding process alarms, there is a natural tendency for
reports to augment ANSI/ISA-18.2-2009, Management of automation engineers to set CPP alarm limits (i.e., alarm
Alarm Systems for the Process Industries, commonly setpoints) at the PAR values. The problem with this is that
referred to as ISA-18.2. These reports will add rationale, the components involved in making process
usage guidelines, and examples in different areas of alarm measurements (sensors, transducers, etc.) contribute to
management. The other five reports are: some finite uncertainty around the measurement. E.g.,
some flow measurements have a vendor stated
WG1 Alarm Philosophy uncertainty of 1 % of span. A consequence of this is that a
WG2 Alarm Identification and Rationalization measured value that equals a PAR value may or may not
WG3 Basic Alarm Design represent an actual deviation, depending on the
WG4 Enhanced and Advanced Alarm Methods measurement uncertainty involved (MU). Therefore, an
WG5 Alarm Monitoring, Assessment, and Audit important consideration for automation engineers is to
consider MU in setting alarm setpoints- as sometimes the
The committee hopes to follow this technical report soon result will be to set alarm setpoints inside the PAR values.
with those from WG4 and WG5. For more information on These concepts are illustrated in Figure 1.
this and other ISA18 technical reports, visit
identical (variability is usually significant for
bioprocesses), acceptable values for cell mass at a
particular point in time fall in a specified range rather than
being one precise value.
Conclusion
This article touches on a few aspects of alarm management
of special interest to practitioners in the regulated food
and pharmaceutical industries, dominated by batch
processes. It is hoped that these aspects of alarm
Figure 5: Distribution of plant automation systems involved with management convinces readers of the need to think
alarm management through needed alarm functionality, as well as to how
alarm records will be utilized, near the beginning of an
The first challenge recognizes that personnel in modern automation project. In so doing, adequate time can be
plants are working to integrate enterprise and process available to consider 3rd party products or any needed
control computer systems, supported in part by the ISA 95 customization of the alarm system. Users should NOT
standard which defines 5 different levels of automation. assume that off-the-shelf commercial systems will
As computer experts are aware, it can be difficult to provide all the alarm functionality they may need in their
communicate and share data and information between plant.
systems, as such information often exists in different time
frames, formats, and contexts in the different systems.
Referring to Figure 5, some alarm information may exist at
Level 3 in what is known as the MOM environment
(Manufacturing Operations Management) which in turn
consists of Manufacturing Execution Systems, Laboratory
Information Management Systems, Maintenance Records,
FPID at Automation Week 2012
As usual, most divisions have held a division meeting
during automation week. FPID was no exception. Led by
our Director, Alex Habib, several of our division officers
reviewed last year performance and planned for the year
to come.
The Mask/Filter is displayed as a row or column of buttons A One Word Summary is the name of that other Category
with their associated Categorization buttons. It allows whose computed intersection with the group indicator
controlled alarm display with selection of any Category in Category contains the fewest listed alarms while
any Categorization. The alarms displayed in the current containing all of the active alarm conditions of the original
(list, graphic, log, or trend) display are those which occur Category. It is thus a computed, most-descriptive summary
in at least one of the selected/highlighted Categories of of the Alarm State of the original Category. Where there is
each Categorization. Thus the selected alarms occur within only one alarmed variable with active Alarm State in the
the intersection of the different Categorization selections, Category the name of that variable with its state becomes
suppressing all others. the One Word Summary. In this case, a low level alarm
condition can, when nothing else is happening, percolate
The selection process is designed to make Category up to any higher level display. As more activity takes place,
selection or deselection easy, whether carried out the level of abstraction provided by the One Word
incrementally or from scratch. The Selected/DeSelected Summary goes up, providing the operator with a constant
button allows all Categories to be selected or deselected, information rate but the best possible description at that
defining the Selection/DeSelection starting point. Similarly level.
the Categorization buttons allow the Categorization
Categories to be all selected or deselected. Collectively the One awkward tendency in alarm processing is to configure
group and individual buttons simplify the Mask/Filter alarm priorities in neutral categories (e.g. categories 1
selection. through 5). This has the side effect of causing most alarms
to be assigned the highest category. A better strategy is to
So far the discussion has addressed Category Selection and define meaningful, user named Categories of grouped
DeSelection. The Category selection process can be alarms, as described above, and then prioritize the
extended in three more ways: Categories. The Priority Summary is the name of that
highest priority Category still containing any of the alarms
Full Selection. This allows the alarms of a selected of the original (e.g. Furnace) Category.
Category to be fully displayed, without regard to other
selections.
The One Word Summary Category will always fall in a of the Metric, are displayed with asterisk. In this form, the
single Categorization. A more powerful use of the display permits operator diagnosis and action on some
underlying concept would make use of intersections prescribed recovery procedure.
between Categories in each Categorization, to further
group and localize the alarms of the overall indicator The Pattern can be used for event prediction as well. In
Category. This is not practical in the above displays. this case the Metric is computed, based only on Cause
However, a special alarm display is provided to allow this events. When the number of such Causes exceeds a
form of analysis. specified threshold, the remaining Main and Secondary
Effect Alarms may then be predicted. The figure below
The figure shows three main display elements: shows the default listed display for the earlier Fire Hazard
(as with any other Category). In this case all occurring
An alphabetical listing of all alarm variables with their alarms are displayed with their alarm state. In addition,
states, similar to that shown later in the default displays. the remaining alarms are indicated as predicted by the
deeper shading. (The right-hand side checkbox display is
A Categorization grouped Category list (similar to the designed to show the complete Alarm State of any selected
Mask/Filter) that allows the Category membership display alarm variable, with other related information.)
of selected alarms.
The same shaded prediction is applied to any display
The Mask/Filter. including the predicted alarms. The Pattern analysis
provides a much simpler substitute for Expert System
Using the Mask/Filter and Set Buttons, any arrangement of application. But it can also be interfaced with an external
the alarm variables and states can be selected (then Expert System, through APIs, to integrate their analyses
highlighted in darker shading). In particular the alarms in consistently into the Pattern display. This supports the
any Category can be selected. The Categorization/Category best of both worlds.
list then indicates (by different shadings), which other
Categories (in every Categorization) include all of the
selected alarms, and which include only some of them. In ADAPTIVE ALARMING
this way, the display expands the One Word Summary as
an intersection of Categorizations. The display can also be Simpler that normal control configuration, these Patterns
used for a number of other What If explorations. and Categories can still become too complex for
convenient user configuration. There is a need for
automatic recognition of usable Alarm situations,
PATTERNS Categories, and Patterns. Moreover, the alarm limits
themselves can call for situation dependence, making the
A number of papers, over the years, have proposed process of setting limits still more complex than it already
showing alarms in terms of recognized sequences of alarm is. The Alarm Tools include a number of mechanisms for
events reflecting causality between the different simplifying all of this:
events.[4,5] Recognition of such a sequence can be used
for diagnosis or prediction. The simplest way is to store Those basic alarms, which do not have inherent limits (as
the sequence and have the system record occurrences of in category 1, above), will be supported by an adapting
events, which follow that order. The earlier reference system, which keeps track of worst case excursions. The
recognized that the actual occurring alarms might never engineer can use these to support semi-automatic setting
follow the sequence directly; moreover there might be of the limits.
several sequences occurring concurrently. Accordingly, a
Metric was computed which identified the longest, Categories and Patterns can be supplied with their own
properly ordered, subsequence occurring within a defined set of alarm limits so that whenever the Category or
time window. The most likely sequences could then be Pattern is selected, the special limits replace the standard
provided to the operator for his more detailed selection ones. In the case of Patterns, the replacement would occur
and analysis. in a timed and sequenced order natural to the Pattern. This
allows the Alarm Tools to support situation dependent
The left-hand figure above shows the resulting ordering alarm limits. The Categories and Patterns used this way
with the displayed Pattern Name buttons, number of would be supported by historical records, which allowed
alarms in the best match sequence, and the normalized the after-the-fact engineer supported adaptation of these
(against the total number of Pattern alarms) Metric. The limits as above.
buttons permit selecting a display for a particular Pattern
(the right-hand figure), with sequence ordered Alarm On recognition of a problematic situation the operator
variables divided into Cause, and Main (important) and could call for a special historian recording action that
Secondary Effect Alarm variables. Each variable is would record potential Pattern events for later
displayed with its current alarm state. Those alarms, which configuration as a Pattern.
occurred in the sequence order, as part of the computation
We have defined a special event based auto-correlation can build standard practices, similar to those developing in
strategy, which allowed an engineer to process months of the continuous control world.
data looking for correlated events constituting potential
Patterns. CONCLUSIONS
Alarms are the main connection between the operator and
POLICIES the automation when addressing operation of the process
outside of the normal support of the automation. Such
Currently many vendors support the configuration of operation, beyond traditional engineered automation,
alarm characteristics on a variable by variable basis. This requires tools that allow the operator to effectively call on
is particularly cumbersome for annunciation, his working experience. The paper first presents a set of
acknowledgment, and similar issues, which depend on tools, based on the simple configuration of multiple
grouped action for effectiveness. A much better strategy intersecting hierarchies of Categories. These tools allow
would be to configure such issues for different Categories, the operator to control his displays by display selection
as grouped Policies, in the same way that priorities are and information masking. The One-Word Summaries
defined above for the same Categories. The earlier Priority provide summary capability. This permits low level
discussion already gives an example of Policy information to percolate up through higher level displays
configuration discipline. in a controlled level of abstraction with high detail when
little is happening and abstraction when more is going on.
The Pattern concept supports causal modeling for
BATCH CONTROL ALARMING vs. prediction and diagnosis. Logging and trending access time
data. This support exists on top of more organized alarms.
CONTINUOUS CONTROL ALARMING Batch control particularly lends itself to these more
organized alarms, especially ones indicating exceptional
The above Tools address alarms in general terms, as events naturally related to particular phases of the
related to individual process variables, thorough the sequencing.
simple mechanisms provided by the Categories. They
particularly support continuous processes, or the
continuous support facilities in Batch processes, by
allowing the diagnosis between the many different
production activities and failure causality sequences
potentially coexisting in time. In the Batch process, each
unit or train is naturally operating in a more restricted
focus, perhaps in a single phase.
Even in the multi-train facility, the alarms of each train
correlate with the particular phases running in the train.
a) Supply Chain Cost Reduction / Performance 9) If you do not value continuous education, what is your
Enhancement main reason?
b) Line / Process Automation techniques and strategies a) My company is going to tough time and do not have
c) Product safety / product counterfeit prevention & any budget.
detection b) My company hired me because I have all the
d) Process Analytical Technology (PAT) education I need for my position.
e) Manufacturing IT, MES and Virtualization c) I am not a member of a professional organization that
f) Batch Control Standard ISA-88 requires it.
g) Manufacturing Operations Management (ISA-95) d) None of the above
h) Product Tracing & Tracking (Serialization)
i) Project Management 10) What is the method you preferred for continuous
j) Validation education?
k) Plant tour a) Webinar (go to question 11)
l) Food Safety b) Local Seminar / Conference (go to question 12)
m) System and ERP integration c) Focused short course
2) What must a seminar / workshop deliver for you to 11) I prefer Webinars because.
consider it successful? a) This is convenient to be able to do it from my desk, a
conference room and/or from home.
a) Technical Content, b) We have limited (or no) travel budgets for continuous
b) Networking Opportunity, education.
c) Business Acumen/Strategy, c) I have a busy schedule and can only do continuous
d) Other, please specify. education when nothing else is urgent. A recorded
webinar is the perfect tool.
3) How far are you willing to travel? d) Other, please specify.
a) Overnight drivable (100 miles)
b) Plane trip - travel capped at $1000. 12) I prefer local seminar and/or conference because.
c) Plane trip travel capped at $3000. a) If I stay at the office, I get interrupted all the time.
d) Other, please specify. b) I have difficulty to concentrate if I am on-site and
have other things on my mind.
4) If you get the information, you needed what would be a c) We have a limited budget for continuous education
reasonable fee for the conference? but if the course does not involve any major cost such
a) $50 to $100 as air travel or hotel, it is usually approved.
b) $100 to $300 d) We have a no travel policy at the site.
c) $300 to $500 e) Other, please specify.
d) $500 to $1000
13) Would you prefer to participate in a multi-week Lunch
5) If you get the information and attend one or more training & Learn Seminar series instead of going to an offsite
seminars, would be a reasonable fee for the conference? seminar?
a) $50 to $100 a) Yes
b) $100 to $300 b) No
c) $300 to $500 c) Dont know
d) $500 to $1000
14) How long should each session be?
6) Does your company encourage continuing education? a) Less than 1 hour
a) Yes b) Less than 2 hours
b) No c) Less than day
c) Sometimes d) Not important
Yvonne Duckworth CRB Consulting Engineers
15) How many weeks should the program consist of?
Kleber Falcao
a) 2 weeks or less
b) Not more than 2 to 3 weeks Elias Ferreira
c) Not important Forest Gardner
Lethicia Goncalves
16) What time of day / night (Eastern Time)?
a) In the morning Richard
b) At lunch (12:00) Hargenrader
c) In the afternoon Richard Harris
d) At night (after 5:00 PM, I understand this would Nagaraj Hegde
limit participating from Europe )
Chris Heng Cargill Inc
17) Would you pay a minimal fee for such a webinar series? Diane Heurtin HIPP Engineering and
a) Yes Consulting Inc
b) No Hugh Jenkins
c) Maybe, depend on the content. Victor Osvaldo Jesus
A separate invitation with a website link will be sent to you S. Kester
in the next couple of weeks. If you have any comments or Jeffery Kibalo
suggestions on the survey contact Alex-habib@msn.com Robert Koneck
Thomas Kosse Vipa USA
Welcome New Members of ISAs Robert Lesutis
Food & Pharmaceutical Division Lucas Lima
Scott Little Tropicana Products Inc
Name Company Luiz Augusto Longaray
Andrew Almendares Sycal Engineering Inc James Lustig
Loic Alpha Arkadiusz Maciak Wyeth Ayerst Pharmaceuticals
Boyko Baharov Signum Soft Na Elkin Manrique
James Baillargeon Medimmune Lee McDaniel
Michael Baldauff Fujifilm Diosynth Biotechnology Thomas McDonnell
Timothy Barz S. Mecum
Carlos Bedia Keld Moeller
Richard Bellelis JP O Riordan
Pat Boner Randy Oakley
Diego Caceres Eoin O'Brien Tandem Project Management
Richard Carpenter Dermot O'Callaghan Enterprise System Partners
Limited
Yamei Chen Eli Lilly and Co
Danilo Oliveira
Donald Cherry The RMH Group Inc
Jean O'Reilly Roche Molecular Systems
Xavier Climent
Lida Paz
Didier Collas Invensys
Wendell Pearson
Henry Collins
Alessandro Pestana
Chris Cook
Jaideep Raje
Gabriel Coutinho
Joseph Rakos
Brinton Crawford
Donald Richmond
Colm Cronin Leo Pharma
Paul Roberge RTI Products
Phillip Custer Instrument Technologies
Pedro Henrique Rodrigues
Jospeh DeBitetto Fougera Pharmaceuticals Inc
Bryan Rose
Adam Dittbenner Interstates Instrumentation
Ralph Russotto Corrosion Fluid Products Corp
Alexandre Djordjevic
Giovanny Sabogal
Atila Santos
David Adler
Richard Sara Special Assignment
Timothy Shannon davidadler@comcast.net
John Campbell
Katia Silva Petrobras Industry & Science Department VP
Jensy Solano Correa campbjr@msn.com
Renan Souza
Mike Nager
Bruce Summerfield Sales & Marketing Chairman
Luis Fernando Susin PUC PR Phoenix Contact Inc
(717) 944-1300
Zaida Tiruganya
Ingrid Valasco Torres Dennis Brandl
Special Assignment
Brian Vincent Genzyme BR&L Consulting
Michael Walsh Eli Lilly and Company (919) 852-5322
DnBrandl@BRLConsulting.com
Corey Williams Pharmaceutical Calibrations
and Instrumentation Llc Amit Desai
Daniel Xavier Education Chairman
Bayer HealthCare LLC
Carlos Garcia
(510) 705-7309
Christopher Hogan Parsons amit.desai.b@bayer.com
Peter Steimel Total Instrumentation &
Sunil Mehta
Programming Services Inc
Special Assignment
Zubin Varghese Ingersoll Rand PCS Engineering
Mack Hu Dalian Huaqi Electronics Tech (919) 359-4990
Co Ltd Sunil.Mehta@talecris.com
Ken Jones
Kevin Dignam
Wayne Lee Genentech Special Assignment
Michael McInroe Rockwell Automation DPS Engineering & Construction Ltd
353- 21 7305000
Michael Waker kevin.dignam@dpseng.com
Bob Hubby
Facilitator
(508) 349-1050
2012 Division Officers bob.hubby@verison.net
Alex Habib, PE
Division Director James Bouchard
Industry & Science Department VP-Elect Historian
alex-habib@msn.com jamesb@aei.ca
Gary Campbell
Webmaster
gcampbellisa@cox.net
Randy Dwiggins, PE
Standards & Practices
(908) 704-9041
rdwg@nnepharmaplan.com
Bill Dugery
Section-Division Liaison
dugaryw@ace-net.com