Control Engineering’s Process Control Newsletter for December 2001

By Dave Harrold June 4, 2002

In this issue:

  • FDA 21CFR Part 11 awareness survey
  • 21CFR Part 11-aware packaging system
  • Process control strategy training
  • Safety system information
  • Process safety management measurement system
  • New release of data analysis and graphing software
  • Online engineering exercises
  • Conferences, seminars, exhibitions, webcasts
  • December in Control Engineering
  • SCLE presentations archived for viewing

FDA 21CFR Part 11 awareness survey

A number of Control Engineering subscribers work for or provide products and services to industries covered by U.S. FDA (Food and Drug Administration) regulations. One of those regulations, 21CFR Part 11 ‘Electronic Records and Signatures,’ has been getting a fair amount of press during the past 12 to 18 months.

21CFR Part 11 became a regulation in 1997, but the FDA didn’t start applying compliance pressure until about mid-2000. More recently the FDA has began issuing warning letters that if ignored can lead to fines and/or production shutdowns.

Basically, 21CFR Part 11 says, if the production records of FDA regulated products (i.e., pharmaceutical, food, beverage, cosmetic, etc.) are produced electronically, the production records must be securely archived (electronically signed and made tamper-proof) in their original electronic format. In the event of a company’s product incident or recall, the electronic records must be retrievable. That means 21CFR Part 11 touches hard on automation, control, and laboratory systems; and hardcopy (paper) production records no longer comply with FDA regulations for products produced using electronic automation, control, and laboratory systems.

Control Engineering has scheduled an article about electronic records and signatures for April 2002. To help prepare the article, we want to understand awareness of FDA regulation 21CFR Part 11.

If your company is directly or indirectly effected by FDA regulations, please click on the following link to complete a 25-question 21CFR Part 11 awareness survey: .

If you can’t wait till April to learn about 21CFR Part 11, there is a very good white paper available from Intellution (Foxborough, Mass.) at , and/or you can visit .

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21CFR Part 11-aware packaging system

Rockwell Automation (Milwaukee, Wis.) recently introduced their Fill Finish Optimization (FFO) solution, a combination of tools and services designed to reduce pharmaceutical product quarantine time and associated paperwork, improve recipe management, and improve automated and manual procedure sequencing.

In an FFO solution, Rockwell Automation’s pharmaceutical specialists provide manufacturers with consulting and integration support and engineered software solutions. FFO is said to transform thousands of paper-based manual instruction sheets into electronically managed documents designed to help users reach defined quality parameters. If/when those quality parameters aren’t met, the FFO software can require single or dual electronic signatures before saving production data.

For more information, visit .

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Process control strategy training

Regular readers of this e-newsletter know I periodically receive inquiries asking to explain PID (proportional, integral, derivative) control, recommend tuning parameters for a particular application, and/or recommend a control strategy. My reply is always about the same, visit / and read the many articles we have published, buy books from sources such as and , and attend training courses.

I recently heeded my own advice and spent a day attending a process-control strategy course conducted by ControlSoft (Cleveland, O.). I’m generally cautious of these sorts of course offerings, because too often they turn out to be a thinly veiled sales pitch.

The ControlSoft course included a touch of ‘sales’ self-promotion, but for the most part provided attendees practical information about applying PID and multi-variable control strategies. Among the application and control strategy topics discussed were deadtime, gain scheduling, cascade loops, feedforward, interacting loops, and trim control.

Attendees receive what I consider a useful take away: a copy of the ControlSoft software and simulated examples used during the course. The simulated examples provide a good refresher, and the software permits developing and trying various control strategies in a ‘safe’ (offline) environment.

To learn when ControlSoft will be bringing its Process Control Strategy training course to a city near you, visit or call (216) 397-3900.

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Safety system information

Another topic I’m receiving more and more e-mail about is Safety Instrumented Systems (SIS) and its associated Safety Integrity Levels (SIL). Again, I refer inquiries to Control Engineering’s web site and suggest they take a peek at the Safety sub-channel behind the Process Control and Advanced Process Control tab on the home page.

Two sources Control Engineering uses to ensure safety system information accuracy is (Sellersville, Pa.) and SIS-Tech (Houston, Tex.). Both companies focus on helping clients properly design, install, operate, maintain, and decommission SISs.

In addition to consulting services, and SIS-Tech offer training courses and materials.

If you’ve found yourself, or heard others in your company, asking, ‘What is all this safety system talk about? What are safety instrumented systems?’ then you should take a look at and SIS-Tech’s safety system training courses.

SIS-Tech conducts instructor-based courses at its office or on your site. offers self-paced training packages. Both companies have designed training to help attendees understand the vocabulary and issues involved in safety instrumented systems.

Once you’ve completed ‘basic’ training, you will likely find yourself asking questions like, ‘Are there less-complicated and faster ways to verify if my safety instrumented functions meet their SIL targets?’

Again, SIS-tech and offer assistance: SIS-Tech with instructor-based courses and with an SIL verification package that includes tools to evaluate SIL options.

For more information, visit and/or .

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Process safety management measurement system

OSHA’s (Occupational Health and Safety Administration) 29 CFR 1910.129 ‘Process Safety Management (PSM)’ regulation has touched a great many chemical plants since it became the law in the early ’90s.

Initially many companies created PSM compliance teams that spent countless hours developing procedures, updating documentation, arranging for training, assisting with inspections, and numerous other PSM-related activities.

Because of continuing management pressures on PSM resources, PSM teams struggle to justify their existence with quantified data.

If your company is considering reducing PSM team membership, wondering ‘how close to the edge’ your plant is to having a major accident, or where the weak link is in your PSM program, you should take a look at ProSmart. ProSmart is a software tool developed by the CCPS (Center for Chemical Process Safety) division of AiChE (American Institute of Chemical Engineers, New York, N.Y.) specifically to develop quantitative measures of a company’s or plant’s PSM program.

For more information, visit .

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New release of data analysis and graphing software

OriginLab (Northampton, Mass.) recently released Origin 7.0, a Microsoft Windows-based scientific data analysis and graphing software application.

Origin 7.0 new features include graphing wizard, template library, non-linear data-fitting wizard, Origin C language with code builder, and elements of the Numerical Algorithms Group (NAG) numerical and statistical library.

NAG has a longstanding worldwide reputation for the excellence of its numerical and statistical libraries. Industry, universities and research institutes rely upon the accuracy, reliability, and robustness of these libraries to solve complex problems, in areas such as research, engineering, life and earth sciences, financial analysis. and data mining.

For more information, visit and/or .

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Online engineering exercises

Recently I learned John Hopkins University (Baltimore, Md.) Professor Wilson Rugh has been using the Internet as a teaching aid for several years. When I say teaching aid, I don’t mean posting class notes and assignments, I mean posting interactive multimedia exercises and quizzes to help students, and others, learn complex concepts.

‘Signals, Systems, and Control’ is a free-access site currently offering 19 online learning modules. The site recently received the ‘2001 Premier Award for Excellence in Engineering Education Courseware,’ sponsored by John Wiley & Sons (New York, N.Y.), AutoDesk (San Rafael, Calif.), MathWorks (Natick, Mass.), and Microsoft Research (Redmond, Wa.) Judging was supervised by the National Engineering Education Delivery System (NEEDS, Berkeley, Calif.).

A few of the modules on the ‘Signals, Systems, and Controls’ site are:

  • Listen to Fourier series: Sound is used to introduce basic notions of Fourier series, including harmonic content and filtering. (Prepared by Kevin Rosenbaum, fall 1995);

  • Bode Servo Analysis: A Java applet for control systems. Drag open-loop corner frequencies with the mouse to improve tracking performance and reject sensor noise in a unity-feedback system. (Prepared by Steven Crutchfield, summer 1997); and

  • Sense and Sensitivities: A Java applet that illustrates the utility of the sensitivity and complementary sensitivity functions for linear control-system design. Sketch a reference input and disturbance input with the mouse, and select a sensor noise level. Then drag open-loop system poles and zeros with the mouse to track the reference while rejecting the disturbance and noise. Includes an audio introduction with suggested exercises. (Prepared by Seth Kahn, winter 1999.)

To learn more, visit and/or .

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Conferences, seminars, and exhibitions

Visit / for the latest in upcoming conferences, seminars, and exhibitions, including technology webcasts, at /webcast .

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December in Control Engineering

Closed-loop motor and controller units Integrated servo packages (and some step-motor based systems) are expanding the sophistication of motors and controllers as a combined product. These integrated motor/drive packages offer a complete motion system solution for some distributed applications. Where and how users can benefit from this technology will be explored, along with applicable products.

Open system integration application
This article will explain how RasGas completed an information-integrated LNG and offshore facility using the methods, architectures, techniques, and applications similar to those explained in Control Engineering throughout 2001.

Intelligent connected I/O
I/O devices continue to improve with technology providers offering networking choices, intelligent modules in small packages, and embedded control. This article will show trends and future impact and benefits for a distributed I/O architecture and implications for machine design.

Product Focus: Operator interface terminals
Original Control Engineering/Cahners Research examines trends and user issues with operator-interface terminals. Recent product descriptions from leading suppliers will be included, along with research results.

Back to Basics: RFID (Radio frequency identification)
Radio frequency identification, or RFID, helps track where products, parts, or machinery are located. Find out what’s inside this technology.

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SCLE presentations archived for viewing

Don’t miss the SupplyChainLinkExpo web presentations available for viewing until mid-January. Four Control Engineering technology webcasts are included. Access the information, originally presented during October’s SupplyChainLinkExpo, through Control Engineering Online’s webcast page or at .

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